ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
Aivlosin 42.5 mg/g premix for medicated feeding stuff for pigs
2.
Active substance:
tylvalosin
42.5 mg/g
(as tylvalosin tartrate)
For a full list of excipients see section 6.1.
3.
Premix for medicated feeding stuff.
A beige granular powder.
4.
Pigs
Treatment and prevention of swine enzootic pneumonia caused by susceptible strains of
Mycoplasma
hyopneumoniae
in pigs. At the recommended dose, lung lesions and weight loss
are reduced but infection with
Mycoplasma hyopneumoniae
is not eliminated.
Treatment of porcine proliferative enteropathy (ileitis) caused by
Lawsonia intracellularis
in
herds where there is a diagnosis based on clinical history, post-mortem findings and clinical
pathology results.
Treatment of clinical outbreaks of swine dysentery, caused by
Brachyspira hyodysenteriae
in
herds where the disease has been diagnosed and prevention of further clinical cases.
None.
Acute cases and severely diseased pigs with reduced food or water intake should be treated with a
suitable injectable product.
Generally, strains of
B. hyodysenteriae
have higher MIC values in cases of resistance against other
macrolides, such as tylosin. The clinical relevance of this reduced susceptibility is not fully explored.
Cross-resistance between tylvalosin and other macrolides cannot be excluded.
2
It is sound clinical practice to base treatment on susceptibility testing of the bacteria isolated from the
animal. If this is not possible, therapy should be based on local (regional, farm level) epidemiological
information about susceptibility of target bacteria.
Use of the product deviating from the instructions in the SPC may increase the risk of development
and selection of resistant bacteria and decrease the effectiveness of treatment with other macrolides
due to the potential for cross-resistance.
Special precautions to be taken by the person administering the veterinary medicinal product to
animals
Because Aivlosin has been shown to cause hypersensitivity reactions in laboratory animals, people
with known hypersensitivity to tylvalosin tartrate should avoid any contact with the product.
When mixing the veterinary medicinal product and handling the medicated feed, direct contact with
eyes, skin and mucous membranes should be avoided. Personal protective equipment should be worn
when mixing the veterinary medicinal product or handling the medicated feed: overalls, impervious
gloves and either a disposable half-mask respirator conforming to European Standard EN 149 or a
non-disposable respirator conforming to European Standard EN 140, with a filter to European
Standard EN 143. Wash contaminated skin.
In case of accidental ingestion seek medical advice immediately and show the label to the physician.
None known.
The safety of Aivlosin during pregnancy and lactation has not been established in pigs. Use only in
accordance with risk/benefit assessment by the responsible veterinarian.
Studies in laboratory animals have not produced any evidence of teratogenicity. Maternal toxicity in
rodents has been observed at doses of 400 mg tylvalosin per kg bodyweight and above. In mice, a
slight reduction in the foetal bodyweight was seen at doses causing maternal toxicity.
None known.
In-feed use.
For incorporation into dry feed only.
For treatment and prevention of Swine Enzootic Pneumonia
The dosage is 2.125 mg tylvalosin per kg bodyweight per day in-feed for 7 consecutive days.
Secondary infection by organisms such as
Pasteurella multocida
and
Actinobacillus
pleuropneumoniae
may complicate enzootic pneumonia and require specific medication.
For treatment of Porcine Proliferative Enteropathy (ileitis)
The dosage is 4.25 mg tylvalosin per kg bodyweight per day in-feed for 10 consecutive days.
3
For treatment and prevention of Swine Dysentery
The dosage is 4.25 mg tylvalosin per kg bodyweight per day in-feed for 10 consecutive days.
Indication
Dose of active
ingredient
Duration of
treatment
In feed inclusion
rate
Treatment and prevention of
swine enzootic pneumonia
2.125 mg/kg
bodyweight/day
7 days
1 kg/tonne*
Treatment of PPE (ileitis)
4.25 mg/kg
bodyweight/day
10 days
2 kg/tonne*
Treatment and prevention of
swine dysentery
4.25 mg/kg
bodyweight/day
10 days
2 kg/tonne*
*
Important
: these inclusion rates assume a pig eats equivalent of 5 % bodyweight per day.
In older pigs, or in pigs with reduced appetite, or on restricted feed intake, inclusion levels may need
to be increased to achieve target dosage. Where feed intake is reduced, use the following formula:
Kg Premix/tonne feed =
Dose rate (mg/kg bodyweight) x bodyweight (kg)
Daily feed intake (kg) x Premix strength (mg/g)
As an adjunct to medication, good management and hygiene practices should be introduced in order to
reduce the risk of infection and to control the build up of resistance.
A horizontal ribbon mixer should be used to incorporate the product into the feeding stuff. It is
recommended that Aivlosin is first mixed into 10 kg of the feeding stuff, followed by the rest of the
feeding stuff and mixed well. Medicated feed may then be pelleted. Pelleting conditions involve a
single pre-conditioning step with steam for 5 minutes and pelleting at not more than 70 C under
normal conditions.
No signs of intolerance have been observed in growing pigs at up to 10 times the recommended
dosage.
Meat and offal: 2 days.
5.
Pharmacotherapeutic group: Macrolide antibiotic, ATCvet code: QJ01FA92.
5.1 Pharmacodynamic properties
Tylvalosin tartrate is a macrolide antibiotic that has antibacterial activity against Gram-positive, some
Gram-negative organisms and mycoplasma. It acts by inhibiting protein synthesis in the bacteria cell.
Macrolide antibiotics are the metabolites or semi-synthetic derivatives of metabolites of soil organisms
obtained by fermentation. They have different sized lactone rings and due to the dimethylamino group,
are basic. Tylvalosin has a sixteen membered ring.
Macrolides interfere with protein synthesis by reversibly binding to the 50S ribosome subunit. They
bind to the donor site and prevent the translocation necessary for keeping the peptide chain growing.
Their effect is essentially confined to rapidly dividing organisms. Macrolides are generally considered
bacteriostatic and mycoplasmastatic.
4
It is considered that there are multiple mechanisms responsible for resistance development to
macrolide compounds: namely alteration of the ribosomal target site, utilisation of active efflux
mechanism and production of inactivating enzymes.
Resistance to tylvalosin
by
Mycoplasma hyopneumoniae
and
Lawsonia intracellularis
has not been
reported or found in the field to date. No breakpoint for
Brachyspira hyodysenteriae
has been
established.
Generally strains of
B. hyodysenteriae
have higher MIC values in cases of resistance against other
macrolides, such as tylosin. The clinical relevance of this reduced susceptibility is not fully explored.
Cross-resistance between tylvalosin and other macrolide antibiotics cannot be excluded.
5.2 Pharmacokinetic particulars
Tylvalosin tartrate is rapidly absorbed after oral administration of Aivlosin.
After administration of the recommended dose lung concentrations of 0.060–0.066 µg/ml were found
at 2 and 12 hours post-treatment. The parent compound is widely distributed in the tissues with the
highest concentrations found in the lungs, bile, intestinal mucosa, spleen, kidney and liver.
There is evidence that the concentration of macrolides is higher at the site of infection than in plasma,
in particular in neutrophils, alveolar macrophages and alveolar epithelial cells.
In vitro
metabolism studies have confirmed that the parent compound is rapidly metabolised to 3-O-
acetyltylosin. In a trial with
14
C Aivlosin administered at 2.125 mg/kg to pigs for 7 days over 70 % of
the dose was excreted in the faeces, with urinary excretion accounting for 3 to 4 % of the dose.
6.
6.1
List of excipients
Magnesium trisilicate (sepiolite)
(declared on labelling as carrier)
Wheat feed flour
(declared on labelling as carrier)
Hydroxypropyl cellulose
Non-fat soyabean powder
6.2 Incompatibilities
None known.
6.3 Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 3 years.
Shelf-life after incorporation into feed: 1 month in meal or pellets.
6.4 Special precautions for storage
Store below 30 °C.
Keep the container tightly closed.
Store in the original container.
6.5
Nature and composition of immediate packaging
One aluminium foil/polyester laminated bag containing 5 or 20 kg.
5
Not all pack sizes may be marketed.
6.6
Special precautions for the disposal of unused veterinary medicinal product or waste
materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.
7.
ECO Animal Health Limited
78 Coombe Road
New Malden
Surrey
KT3 4QS
United Kingdom
8.
EU/2/04/044/001 – 20 kg
EU/2/04/044/002 – 5 kg
9.
9 September 2004
07.03.2011
Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency
http://www.ema.europa.eu
.
PROHIBITION OF SALE, SUPPLY AND/OR USE
Consideration should be given to official guidance on the incorporation of medicated premixes in final
feed.
6
1.
Aivlosin 8.5 mg/g premix for medicated feeding stuff for pigs
2.
Active substance:
tylvalosin
8.5 mg/g
(as tylvalosin tartrate)
For a full list of excipients see section 6.1.
3.
Premix for medicated feeding stuff.
A light yellow or light brown-yellow powder.
4.
Pigs
Treatment and prevention of swine enzootic pneumonia caused by susceptible strains of
Mycoplasma
hyopneumoniae
in pigs. At the recommended dose, lung lesions and weight loss
are reduced but infection with
Mycoplasma hyopneumoniae
is not eliminated.
Treatment of porcine proliferative enteropathy (ileitis) caused by
Lawsonia intracellularis
in
herds where there is a diagnosis based on clinical history, post-mortem findings and clinical
pathology results.
Treatment of clinical outbreaks of swine dysentery, caused by
Brachyspira hyodysenteriae
in
herds where the disease has been diagnosed and prevention of further clinical cases.
None.
Acute cases and severely diseased pigs with reduced food or water intake should be treated with a
suitable injectable product.
Generally, strains of
B. hyodysenteriae
have higher MIC values in cases of resistance against other
macrolides, such as tylosin. The clinical relevance of this reduced susceptibility is not fully explored.
Cross-resistance between tylvalosin and other macrolides cannot be excluded.
It is sound clinical practice to base treatment on susceptibility testing of the bacteria isolated from the
animal. If this is not possible, therapy should be based on local (regional, farm level) epidemiological
information about susceptibility of target bacteria.
7
Use of the product deviating from the instructions in the SPC may increase the risk of development
and selection of resistant bacteria and decrease the effectiveness of treatment with other macrolides
due to the potential for cross-resistance.
Special precautions to be taken by the person administering the veterinary medicinal product to
animals
Because Aivlosin has been shown to cause hypersensitivity reactions in laboratory animals, people
with known hypersensitivity to tylvalosin tartrate should avoid any contact with the product.
When mixing the veterinary medicinal product and handling the medicated feed, direct contact with
eyes, skin and mucous membranes should be avoided. Personal protective equipment should be worn
when mixing the veterinary medicinal product or handling the medicated feed: overalls, impervious
gloves and either a disposable half-mask respirator conforming to European Standard EN 149 or a
non-disposable respirator conforming to European Standard EN 140, with a filter to European
Standard EN 143. Wash contaminated skin.
In case of accidental ingestion seek medical advice immediately and show the label to the physician.
None known.
The safety of Aivlosin during pregnancy and lactation has not been established in pigs. Use only in
accordance with risk/benefit assessment by the responsible veterinarian.
Studies in laboratory animals have not produced any evidence of teratogenicity. Maternal toxicity in
rodents has been observed at doses of 400 mg tylvalosin per kg bodyweight and above. In mice, a
slight reduction in the foetal bodyweight was seen at doses causing maternal toxicity.
None known.
In-feed use.
For incorporation into dry feed only.
For treatment and prevention of Swine Enzootic Pneumonia
The dosage is 2.125 mg tylvalosin per kg bodyweight per day in-feed for 7 consecutive days.
Secondary infection by organisms such as
Pasteurella multocida
and
Actinobacillus
pleuropneumoniae
may complicate enzootic pneumonia and require specific medication.
For treatment of Porcine Proliferative Enteropathy (ileitis)
The dosage is 4.25 mg tylvalosin per kg bodyweight per day in-feed for 10 consecutive days.
For treatment and prevention of Swine Dysentery
The dosage is 4.25 mg tylvalosin per kg bodyweight per day in-feed for 10 consecutive days.
8
Indication
Dose of active
ingredient
Duration of
treatment
In feed
inclusion rate
Treatment and prevention of
swine enzootic pneumonia
2.125 mg/kg
bodyweight/day
7 days
5 kg/tonne*
Treatment of PPE (ileitis)
4.25 mg/kg
bodyweight/day
10 days
10 kg/tonne*
Treatment and prevention of
swine dysentery
4.25 mg/kg
bodyweight/day
10 days
10 kg/tonne*
*
Important
: these inclusion rates assume a pig eats equivalent of 5 % bodyweight per day.
In older pigs, or in pigs with reduced appetite, or on restricted feed intake, inclusion levels may need
to be increased to achieve target dosage. Where feed intake is reduced, use the following formula:
Kg Premix/tonne feed =
Dose rate (mg/kg bodyweight) x bodyweight (kg)
Daily feed intake (kg) x Premix strength (mg/g)
As an adjunct to medication, good management and hygiene practices should be introduced in order to
reduce the risk of infection and to control the build up of resistance.
A horizontal ribbon mixer should be used to incorporate the product into the feeding stuff. It is
recommended that Aivlosin is first mixed into 10 kg of the feeding stuff, followed by the rest of the
feeding stuff and mixed well. Medicated feed may then be pelleted. Pelleting conditions involve a
single pre-conditioning step with steam for 5 minutes and pelleting at not more than 70 C under
normal conditions.
No signs of intolerance have been observed in growing pigs at up to 10 times the recommended
dosage.
Meat and offal: 2 days.
5.
Pharmacotherapeutic group: Macrolide antibiotic, ATCvet code: QJ01FA92.
5.1 Pharmacodynamic properties
Tylvalosin tartrate is a macrolide antibiotic that has antibacterial activity against Gram-positive, some
Gram-negative organisms and mycoplasma. It acts by inhibiting protein synthesis in the bacteria cell.
Macrolide antibiotics are the metabolites or semi-synthetic derivatives of metabolites of soil organisms
obtained by fermentation. They have different sized lactone rings and due to the dimethylamino group,
are basic. Tylvalosin has a sixteen membered ring.
Macrolides interfere with protein synthesis by reversibly binding to the 50S ribosome subunit. They
bind to the donor site and prevent the translocation necessary for keeping the peptide chain growing.
Their effect is essentially confined to rapidly dividing organisms. Macrolides are generally considered
bacteriostatic and mycoplasmastatic.
It is considered that there are multiple mechanisms responsible for resistance development to
macrolide compounds: namely alteration of the ribosomal target site, utilisation of active efflux
mechanism and production of inactivating enzymes.
9
Resistance to tylvalosin
by
Mycoplasma hyopneumoniae
and
Lawsonia intracellularis
has not been
reported or found in the field to date. No breakpoint for
Brachyspira hyodysenteriae
has been
established.
Generally strains of
B. hyodysenteriae
have higher MIC values in cases of resistance against other
macrolides, such as tylosin. The clinical relevance of this reduced susceptibility is not fully explored.
Cross-resistance between tylvalosin and other macrolide antibiotics cannot be excluded.
5.2 Pharmacokinetic particulars
Tylvalosin tartrate is rapidly absorbed after oral administration of Aivlosin.
After administration of the recommended dose lung concentrations of 0.060–0.066 µg/ml were found
at 2 and 12 hours post-treatment. The parent compound is widely distributed in the tissues with the
highest concentrations found in the lungs, bile, intestinal mucosa, spleen, kidney and liver.
There is evidence that the concentration of macrolides is higher at the site of infection than in plasma,
in particular in neutrophils, alveolar macrophages and alveolar epithelial cells.
In vitro
metabolism studies have confirmed that the parent compound is rapidly metabolised to 3-O-
acetyltylosin. In a trial with
14
C Aivlosin administered at 2.125 mg/kg to pigs for 7 days over 70 % of
the dose was excreted in the faeces, with urinary excretion accounting for 3 to 4 % of the dose.
6.
6.1
List of excipients
Magnesium trisilicate (sepiolite)
(declared on labelling as carrier)
Wheat feed flour
(declared on labelling as carrier)
Hydroxypropyl cellulose
Non-fat soyabean powder
Paraffin light liquid
6.2 Incompatibilities
None known.
6.3 Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 3 years.
Shelf-life after incorporation into feed: 2 months in meal, 2 weeks in pellets.
6.4 Special precautions for storage
Do not store above 25 °C.
Keep the container tightly closed.
Store in the original container.
6.5
Nature and composition of immediate packaging
One polyethylene lined paper bag containing 5 or 20 kg.
Not all pack sizes may be marketed.
10
6.6
Special precautions for the disposal of unused veterinary medicinal product or waste
materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.
7.
ECO Animal Health Limited
78 Coombe Road
New Malden
Surrey
KT3 4QS
United Kingdom
8.
EU/2/04/044/003 – 20 kg
EU/2/04/044/004 – 5 kg
9.
9 September 2004
07.03.2011
Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency
http://www.ema.europa.eu
.
PROHIBITION OF SALE, SUPPLY AND/OR USE
Consideration should be given to official guidance on the incorporation of medicated premixes in final
feed.
11
1.
Aivlosin 8.5 mg/g oral powder for pigs
2.
Active substance:
tylvalosin
8.5 mg/g
(as tylvalosin tartrate)
For a full list of excipients see section 6.1.
3.
Oral powder.
A light yellow or light brown-yellow powder.
4.
Pigs
Treatment and prevention of swine enzootic pneumonia caused by susceptible strains of
Mycoplasma
hyopneumoniae
in pigs. At the recommended dose, lung lesions and weight loss
are reduced but infection with
Mycoplasma hyopneumoniae
is not eliminated.
Treatment of porcine proliferative enteropathy caused by
Lawsonia intracellularis
in herds
where there is a diagnosis based on clinical history, post-mortem findings and clinical
pathology results.
Treatment of clinical outbreaks of swine dysentery, caused by
Brachyspira hyodysenteriae
in
herds where the disease has been diagnosed and prevention of further clinical cases.
None.
Acute cases and severely diseased pigs with reduced food and water intake should be treated with a
suitable injectable product.
Generally, strains of
B. hyodysenteriae
have higher MIC values in cases of resistance against other
macrolides such as tylosin. The clinical relevance of this reduced susceptibility is not fully explored.
Cross-resistance between tylvalosin and other macrolides cannot be excluded.
It is sound clinical practice to base treatment on susceptibility testing of the bacteria isolated from the
animal. If this is not possible, therapy should be based on local (regional, farm level) epidemiological
information about susceptibility of target bacteria.
12
Use of the product deviating from the instructions in the SPC may increase the risk of development
and selection of resistant bacteria and decrease the effectiveness of treatment with other macrolides
due to the potential for cross-resistance.
Special precautions to be taken by the person administering the medicinal product to the
animals
Because Aivlosin has been shown to cause hypersensitivity reactions in laboratory animals, people
with known hypersensitivity to tylvalosin tartrate should avoid any contact with the product.
When adding the veterinary medicinal product to the individual feed ration and when handling this
medicated feed, direct contact with eyes, skin and mucous membranes should be avoided. Personal
protective equipment should be worn when handling the veterinary medicinal product or the feed with
product added: overalls, impervious gloves and either a disposable half-mask respirator conforming to
European Standard EN 149 or a non-disposable respirator conforming to European Standard EN 140,
with a filter to European Standard EN 143. Wash contaminated skin.
In case of accidental ingestion seek medical advice immediately and show the label to the physician.
4.6 Adverse Reactions (frequency and seriousness)
None known.
The safety of Aivlosin during pregnancy and lactation has not been established in pigs. Use only in
accordance with risk/benefit assessment by the responsible veterinarian.
Studies in laboratory animals have not produced any evidence of teratogenicity. Maternal toxicity in
rodents has been observed at doses of 400 mg tylvalosin per kg bodyweight and above. In mice, a
slight reduction in the foetal bodyweight was seen at doses causing maternal toxicity.
None known.
For use in individual pigs on farms where only a small number of pigs are to receive the medicine.
Larger groups should be treated with medicated feeding stuff containing the premix.
For treatment and prevention of Enzootic Pneumonia
The dosage is 2.125 mg tylvalosin per kg bodyweight per day for 7 consecutive days.
Secondary infection by organisms such as
Pasteurella multocida
and
Actinobacillus
pleuropneumoniae
may complicate enzootic pneumonia and require specific medication.
For treatment of Porcine Proliferative Enteropathy (ileitis)
The dosage is 4.25 mg tylvalosin per kg bodyweight per day for 10 consecutive days.
For treatment and prevention of Swine Dysentery
The dosage is 4.25 mg tylvalosin per kg bodyweight per day for 10 consecutive days.
This is achieved by thoroughly mixing Aivlosin 8.5 mg/g oral powder into the daily ration for each
individual pig. Scoops of 3 sizes are provided for measuring the correct amount of Aivlosin 8.5 mg/g
oral powder for mixing with the daily ration, according to the schedule below. The feed containing the
oral powder should be provided as the sole ration for the periods recommended above.
13
The pig to be treated should be weighed and the amount of feed that the pig is likely to consume
should be estimated, based on a daily feed intake equivalent to 5 % of bodyweight. Consideration must
be given to pigs whose daily feed intake is reduced or restricted. The correct quantity of Aivlosin
8.5 mg/g oral powder should be added to the estimated quantity of daily ration for each pig, in a
bucket or similar receptacle, and thoroughly mixed.
The product should only be added to dry non-pelleted feed.
Swine Enzootic Pneumonia
2.125 mg/kg bodyweight
PPE (ileitis) & Swine Dysentery
4.25 mg/kg bodyweight
Bodyweight
range (kg)
Scoop
size
Number of
scoops
Bodyweight
range (kg)
Scoop
size
Number of
scoops
6.5–12
5 ml
1
6.5–12
10 ml
1
13–24
10 ml
2
13–24
10 ml
1
25–48
10 ml
4
25–48
10 ml
2
49–72
10 ml
6
49–72
10 ml
3
73–96
10 ml
8
73–96
10 ml
4
97–120
10 ml
5
97–115
25 ml
4
121–144
10 ml
6
116–145
25 ml
5
145–168
10 ml
7
146–175
25 ml
6
169–192
10 ml
8
176–200
25 ml
7
NB: A level scoop of the product
should be measured
NB: A level scoop of the product
should be measured
As an adjunct to medication, good management and hygiene practices should be introduced in order to
reduce the risk of infection and to control the potential build up of resistance.
No signs of intolerance have been observed in growing pigs at up to 10 times the recommended
dosage.
Meat and offal: 2 days.
5.
Pharmacotherapeutic group: Macrolide antibiotic, ATCvet code: QJ01FA92.
5.1 Pharmacodynamic properties
Tylvalosin tartrate is a macrolide antibiotic that has antibacterial activity against Gram-positive, some
Gram-negative organisms and mycoplasma. It acts by inhibiting protein synthesis in the bacteria cell.
Macrolide antibiotics are the metabolites or semi-synthetic derivatives of metabolites of soil organisms
obtained by fermentation. They have different sized lactone rings and due to the dimethylamino group,
are basic. Tylvalosin has a sixteen membered ring.
Macrolides interfere with protein synthesis by reversibly binding to the 50S ribosome subunit. They
bind to the donor site and prevent the translocation necessary for keeping the peptide chain growing.
Their effect is essentially confined to rapidly dividing organisms. Macrolides are generally considered
bacteriostatic and mycoplasmastatic.
14
It is considered that there are multiple mechanisms responsible for resistance development to
macrolide compounds: namely alteration of the ribosomal target site, utilisation of active efflux
mechanism and production of inactivating enzymes.
Resistance to tylvalosin
by
Mycoplasma hyopneumoniae
and
Lawsonia intracellularis
has not been
reported or found in the field to date. No breakpoint for
Brachyspira hyodysenteriae
has been
established. Generally, strains of
B. hyodysenteriae
have higher MIC values in cases of resistance
against other macrolides, such as tylosin. The clinical relevance of this reduced susceptibility is not
fully explored.
Cross-resistance between tylvalosin and other macrolide antibiotics cannot be excluded.
5.2 Pharmacokinetic particulars
Tylvalosin tartrate is rapidly absorbed after oral administration of Aivlosin.
After administration of the recommended dose lung concentrations of 0.060–0.066 µg/ml were found
at 2 and 12 hours post-treatment. The parent compound is widely distributed in the tissues with the
highest concentrations found in the lungs, bile, intestinal mucosa, spleen, kidney and liver.
There is evidence that the concentration of macrolides is higher at the site of infection than in plasma,
in particular in neutrophils, alveolar macrophages and alveolar epithelial cells.
In vitro
metabolism studies have confirmed that the parent compound is rapidly metabolised to 3-O-
acetyltylosin. In a trial with
14
C Aivlosin administered at 2.125 mg/kg to pigs for 7 days over 70 % of
the dose was excreted in the faeces, with urinary excretion accounting for 3 to 4 % of the dose.
6.
6.1
List of excipients
Magnesium trisilicate (sepiolite)
Wheat feed flour
Hydroxypropyl cellulose
Non-fat soyabean powder
Paraffin light liquid
6.2 Incompatibilities
None known.
6.3 Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 3 years.
Feed to which the oral powder has been added should be replaced if not consumed within 24 hours.
6.4 Special precautions for storage
Do not store above 25 °C.
Keep the container tightly closed.
Store in the original container.
6.5
Nature and composition of immediate packaging
One polyethylene lined paper bag containing 1 or 3 kg. Scoops of 5 ml, 10 ml and 25 ml are attached.
15
6.6
Special precautions for the disposal of unused veterinary medicinal product or waste
materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.
7.
ECO Animal Health Limited
78 Coombe Road
New Malden
Surrey
KT3 4QS
United Kingdom
8.
EU/2/04/044/005 – 1 kg
EU/2/04/044/006 – 3 kg
9.
9 September 2004
07.03.2011
Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency
http://www.ema.europa.eu
.
PROHIBITION OF SALE, SUPPLY AND/OR USE
Not applicable.
16
1.
Aivlosin 625 mg/g granules for use in drinking water for chickens
2.
Active substance:
tylvalosin (as tylvalosin tartrate) 625 mg/g
For a full list of excipients, see section 6.1.
3.
Granules for use in drinking water.
White granules.
4.
Chickens
Treatment and prevention of respiratory disease associated with
Mycoplasma gallisepticum
in
chickens.
As an aid in the prevention strategy to reduce the clinical signs and mortality from respiratory disease
in flocks, where infection
in ovum
with
Mycoplasma gallisepticum
is likely because the disease is
known to exist in the parent generation. The prevention strategy should include efforts to eliminate the
infection from the parent generation.
None.
None.
Good management and hygiene practices should be introduced to reduce the risk of re-infection.
It is sound clinical practice to base treatment on susceptibility testing of the bacteria isolated from the
animal. If this is not possible, therapy should be based on local (regional, farm level) epidemiological
information about susceptibility of target bacteria.
Use of the product deviating from the instructions in the SPC may increase the risk of development
and selection of resistant bacteria and decrease the effectiveness of treatment with other macrolides
due to the potential for cross-resistance.
17
Special precautions to be taken by the person administering the veterinary medicinal product to
animals
Tylvalosin has been shown to cause hypersensitivity reactions in laboratory animals; therefore, people
with known hypersensitivity to tylvalosin tartrate should avoid contact with the veterinary medicinal
product.
When mixing the veterinary medicinal product and handling the medicated water, direct contact, with
eyes, skin and mucous membranes should be avoided. Personal protective equipment consisting of
impervious gloves and a half-mask respirator conforming to European Standard EN 149 or a non-
disposable respirator conforming to European Standard EN 140, with a filter conforming to European
Standard EN 143 should be worn when mixing the veterinary medicinal product. Wash contaminated
skin.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the
label to the physician.
None known.
The safety of the veterinary medicinal product has not been established during lay.
None known.
For use in drinking water.
For treatment of respiratory disease associated with
Mycoplasma gallisepticum:
The dosage is 25 mg tylvalosin per kg bodyweight per day in drinking water for 3 consecutive days.
When used as an aid in the prevention strategy
(where infection
in ovum
with
Mycoplasma
gallisepticum
is likely):
The dosage is 25 mg tylvalosin per kg bodyweight per day in drinking water for 3 consecutive days at
1 day old. This is followed by a second treatment with 25 mg tylvalosin per kg bodyweight per day in
drinking water for 3 consecutive days at the period of risk, i.e. at times of management stress such as
administration of vaccines (typically when birds are 2–3 weeks old).
Determine the combined bodyweight (in kg) of all the chickens to be treated. Select the correct
number of sachets according to the amount of product required.
One sachet of 40 g is sufficient to treat a total of 1,000 kg of chickens (e.g. 20,000 birds with an
average bodyweight of 50 g).
One sachet of 400 g is sufficient to treat a total of 10,000 kg of chickens (e.g. 20,000 birds with an
average bodyweight of 500 g).
In order to achieve a correct dose, the preparation of a concentrated (stock) solution might be required
(e.g. to treat a total of 500 kg total bird weight, only 50 % of the prepared stock solution prepared from
the 40 g sachet should be used).
18
The product should be added to a volume of water that the chickens will consume in one day. No other
source of drinking water should be available during the medication period.
Mixing instructions:
The product may be mixed directly into the drinking water system or first mixed as a stock solution
into a smaller amount of water, which is then added into the drinking water system.
When mixing the product directly into the drinking water system, the contents of the sachet should be
sprinkled onto the surface of the water and mixed thoroughly until a clear solution is produced
(usually within 3 minutes).
When preparing a stock solution the maximum concentration should be 40 g per 1,500 ml or 400 g of
product per 15 litres and it is necessary to mix the solution for 10 minutes. After this time, any
remaining cloudiness will not affect efficacy of the product.
No signs of intolerance have been observed in chickens at up to 150 mg tylvalosin per kg bodyweight
per day for 5 days.
Meat and offal: 2 days.
Not authorised for use in laying birds producing eggs for human consumption. Do not use within
14 days of onset of the laying.
5.
Pharmacotherapeutic group: Macrolide antibiotic, ATCvet code: QJ01FA92.
5.1 Pharmacodynamic properties
Tylvalosin is a macrolide antibiotic. Macrolides are metabolites or derivatives of metabolites of soil
organisms obtained by fermentation. They interfere with protein synthesis by reversibly binding to the
50S ribosome subunit. They are generally considered bacteriostatic.
Tylvalosin has activity against pathogenic organisms isolated from a range of animal species-mainly
Gram-positive organisms and mycoplasma but also some Gram-negative organisms. Tylvalosin has
activity against the following mycoplasma species found in chickens:
Mycoplasma gallisepticum
.
The Minimum Inhibitory Concentration (MIC) of tylvalosin for
M. gallisepticum
ranges from 0.007 to
0.25 µg/ml. Macrolides (including tylvalosin) have been shown to have effects on the innate immune
system, which may augment the direct effects of the antibiotic on the pathogen and aid the clinical
situation.
Bacteria can develop resistance to antimicrobial substances. There are multiple mechanisms
responsible for resistance development to macrolide compounds.
Cross-resistance within the macrolide group of antibiotics cannot be excluded. Reduced susceptibility
for tylvalosin was generally noted in tylosin resistant strains.
19
5.2 Pharmacokinetic particulars
Tylvalosin tartrate is rapidly absorbed after oral administration of the product. Tylvalosin is widely
distributed in tissues with the highest concentrations found in the respiratory tissues, bile, intestinal
mucosa, spleen, kidney and liver.
Tylvalosin has been shown to concentrate in phagocytic cells and gut epithelial cells. Concentrations
(up to 12x) were achieved in the cells (intracellular), compared to the extracellular concentration.
In
vivo
studies have shown tylvalosin to be present in higher concentrations in the mucous lining of the
respiratory and gut tissues compared to the plasma.
The major metabolite of tylvalosin is 3-acetyltylosin (3-AT), which is also microbiologically active.
The terminal half-lifes for the elimination of tylvalosin and its active metabolite 3-AT range from 1 to
1.45 hours. Six hours after treatment, the concentration of tylvalosin in the gastrointestinal tract
mucosa has a mean concentration of 133 ng/g and in the gastrointestinal contents of 1,040 ng/g. The
active metabolite 3-AT has a mean concentration of 57.9 ng/g and 441 ng/g, respectively.
6.
6.1 List of excipients
Lactose monohydrate
6.2 Incompatibilities
None known.
6.3 Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 3 years.
Shelf-life of the medicated drinking water: 24 hours.
Only a sufficient amount of medicated drinking water should be prepared to cover the daily requirements.
Medicated drinking water should be replaced every 24 hours.
6.4. Special precautions for storage
Do not store above 30 C.
Opened sachets should not be stored.
6.5 Nature and composition of immediate packaging
Aluminium foil laminated sachet containing 40 g or 400 g.
Not all pack sizes may be marketed.
6.6
Special precautions for the disposal of unused veterinary medicinal product or waste
materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
product should be disposed of in accordance with local requirements.
20
7.
ECO Animal Health Limited
78 Coombe Road
New Malden
Surrey
KT3 4QS
United Kingdom
8.
EU/2/04/044/007 – 40 g
EU/2/04/044/008 – 400 g
9.
9 September 2004
07.03.2011
Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency
http://www.ema.europa.eu
.
PROHIBITION OF SALE, SUPPLY AND/OR USE
Not applicable.
21
1.
Aivlosin 625 mg/g granules for use in drinking water for pigs
2.
Active substance:
Tylvalosin (as tylvalosin tartrate) 625 mg/g
For a full list of excipients, see section 6.1.
3.
Granules for use in drinking water.
White granules.
4.
Pigs
Treatment and prevention of porcine proliferative enteropathy (ileitis) caused by
Lawsonia
intracellularis
.
The presence of the disease in the herd should be established before preventive treatment.
None.
In severely diseased pigs, if water intake is reduced, pigs should be treated with a suitable injectable
veterinary medicinal product.
Good management and hygiene practices should be followed to reduce the risk of re-infection.
It is sound clinical practice to base treatment on susceptibility testing of the bacteria isolated from the
animal. If this is not possible, therapy should be based on local (regional, farm level) epidemiological
information about susceptibility of target bacteria.
Use of the product deviating from the instructions in the SPC may increase the risk of development
and selection of resistant bacteria and decrease the effectiveness of treatment with other macrolides
due to the potential for cross-resistance.
22
Special precautions to be taken by the person administering the veterinary medicinal product to
animals
Tylvalosin has been shown to cause hypersensitivity reactions in laboratory animals; therefore, people
with known hypersensitivity to tylvalosin tartrate should avoid contact with the veterinary medicinal
product.
When mixing the veterinary medicinal product and handling the medicated water, direct contact with
eyes, skin and mucous membranes should be avoided. Personal protective equipment should be worn
when mixing the veterinary medicinal product: overalls, impervious gloves and either a half-mask
respirator conforming to European Standard EN 149 or a non-disposable respirator conforming to
European Standard EN 140, with a filter to European Standard EN 143. Wash contaminated skin.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the
label to the physician.
None known.
The safety of the veterinary medicinal product has not been established during pregnancy and lactation
in pigs. Use only in accordance with risk/benefit assessment by the responsible veterinarian.
Studies in laboratory animals have not produced any evidence of teratogenicity. Maternal toxicity in
rodents has been observed at doses of 400 mg tylvalosin per kg bodyweight and above. In mice, a
slight reduction in the foetal bodyweight was seen at doses causing maternal toxicity.
None known.
For use in drinking water.
The dose is 5 mg tylvalosin per kg bodyweight per day in drinking water for 5 consecutive days.
Calculate the total amount of product required with the following formula:
Total weight of product in grams = total bodyweight of pigs to be treated in kg x 5 / 625.
Select the correct number of sachets according to the amount of product required.
The 40 g sachet is sufficient to treat a total of 5,000 kg of pigs (e.g. 250 pigs with an average
bodyweight of 20 kg).
The 160 g sachet is sufficient to treat a total of 20,000 kg of pigs (e.g. 400 pigs with an average
bodyweight of 50 kg).
In order to achieve a correct dose, the preparation of a concentrated (stock) solution might be required
(e.g. to treat a total of 2,500 kg total pig weight, only 50 % of the prepared stock solution prepared
from the 40 g sachet should be used).
23
The product should be added to a volume of water that the pigs will consume in one day. No other
source of drinking water should be available during treatment.
Mixing instructions:
The product may be mixed directly into the drinking water system or first mixed as a stock solution
into a smaller amount of water, which is then added into the drinking water system.
When mixing the product directly into the drinking water system, the contents of the sachet should be
sprinkled onto the surface of the water and mixed thoroughly until a clear solution is produced
(usually within 3 minutes).
When preparing a stock solution the maximum concentration should be 40 g of product per 1,500 ml
or 160 g of product per 6,000 ml and it is necessary to mix the solution for 10 minutes. After this time,
any remaining cloudiness will not affect the efficacy of the veterinary medicinal product.
No signs of intolerance have been observed in pigs at up to 100 mg tylvalosin per kg bodyweight per
day for 5 days.
Meat and offal: 1 day.
5.
Pharmacotherapeutic group: Macrolide antibiotic, ATCvet code: QJ01FA92.
5.1 Pharmacodynamic properties
Tylvalosin is a macrolide antibiotic. Macrolides are metabolites or derivatives of metabolites of soil
organisms obtained by fermentation. They interfere with protein synthesis by reversibly binding to the
50S ribosome subunit. They are generally considered bacteriostatic.
Tylvalosin has activity against pathogenic organisms isolated from a range of animal species-mainly
Gram-positive organisms and mycoplasma but also some Gram-negative organisms, including
Lawsonia intracellularis
.
Bacteria can develop resistance to antimicrobial substances. There are multiple mechanisms
responsible for resistance development to macrolide compounds.
Cross-resistance within the macrolide group of antibiotics cannot be excluded.
5.2 Pharmacokinetic particulars
Tylvalosin tartrate is rapidly absorbed after oral administration of the product. Tylvalosin is widely
distributed in tissues with the highest concentrations found in the respiratory tissues, bile, intestinal
mucosa, spleen, kidney and liver. The t
max
for tylvalosin is about 2.2 hours; the terminal half-life for
the elimination is approximately 2.2 hours.
Tylvalosin has been shown to concentrate in phagocytic cells and gut epithelial cells. Concentrations
(up to 12x) were achieved in the cells (intracellular), compared to the extracellular concentration.
In
vivo
studies have shown tylvalosin to be present in higher concentrations in the mucous lining of the
respiratory and gut tissues compared to the plasma.
24
The major metabolite of tylvalosin is 3-acetyltylosin (3-AT), which is also microbiologically active.
6.
6.1 List of excipients
Lactose monohydrate
6.2 Incompatibilities
None known.
6.3 Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Shelf life of the medicated drinking water: 24 hours.
Only a sufficient amount of medicated drinking water should be prepared to cover the daily requirements.
Medicated drinking water should be replaced every 24 hours.
6.4. Special precautions for storage
Do not store above 30 C.
Opened sachets should not be stored.
6.5 Nature and composition of immediate packaging
Aluminium foil laminated sachet containing 40 g or 160 g of granules.
6.6
Special precautions for the disposal of unused veterinary medicinal product or waste
materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
product should be disposed of in accordance with local requirements.
7.
ECO Animal Health Limited
78 Coombe Road
New Malden
Surrey
KT3 4QS
United Kingdom
8.
EU/2/04/044/009 – 40g
EU/2/04/044/010 – 160g
9.
9 September 2004
25
07.03.2011
Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency
http://www.ema.europa.eu
.
PROHIBITION OF SALE, SUPPLY AND/OR USE
Not applicable.
26
1.
Aivlosin 625 mg/g granules for use in drinking water for pheasants
2.
Active substance:
tylvalosin (as tylvalosin tartrate) 625 mg/g
For a full list of excipients, see section 6.1.
3.
Granules for use in drinking water.
White granules.
4.
Pheasants
Treatment of respiratory disease associated with
Mycoplasma gallisepticum
in pheasants.
None.
Treat as soon as possible after clinical signs suggestive of mycoplasmosis are observed.
Treat all the birds in the affected flock.
Good management and hygiene practices should be introduced to reduce the risk of re-infection.
Use of the product should be based on susceptibility testing of the bacteria isolated from the animal. If
this is not possible, therapy should be based on local (regional, farm level) epidemiological
information about susceptibility of the target bacteria.
Use of the product deviating from the instructions may increase the risk of development and selection
of resistant bacteria and decrease the effectiveness of treatment with other macrolides due to the
potential for cross-resistance.
Special precautions to be taken by the person administering the veterinary medicinal product to
animals
Tylvalosin has been shown to cause hypersensitivity reactions in laboratory animals; therefore, people
with known hypersensitivity to tylvalosin tartrate should avoid contact with the veterinary medicinal
product.
27
When mixing the veterinary medicinal product and handling the medicated water, direct contact, with
eyes, skin and mucous membranes should be avoided. Personal protective equipment consisting of
impervious gloves and a half-mask respirator conforming to European Standard EN 149 or a non-
disposable respirator conforming to European Standard EN 140, with a filter conforming to European
Standard EN 143 should be worn when mixing the veterinary medicinal product. Wash contaminated
skin.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the
label to the physician.
None known.
The safety of the veterinary medicinal product has not been established during lay.
None known.
For use in drinking water.
The dosage is 25 mg tylvalosin per kg bodyweight per day in drinking water for 3 consecutive days.
Determine the combined bodyweight (in kg) of all the birds to be treated. Select the correct pack size
and number of sachets according to the amount of product required. For example, one sachet of 40 g is
sufficient to treat a total of 1,000 birds with an average bodyweight of 1 kg, and one sachet of 16 g is
sufficient to treat 1,000 birds with an average bodyweight of 400 g.
In order to achieve a correct dose, the preparation of a concentrated (stock) solution might be required
(e.g. to treat a total of 500 kg total bird weight, only 50 % of the prepared stock solution prepared from
the 40 g sachet should be used).
The veterinary medicinal product should be added to a volume of water that the birds will consume in
one day. The intake of medicated water depends on the clinical condition of the animals. In order to
obtain the correct dosage the concentration of Aivlosin has to be adjusted accordingly.
No other source of drinking water should be available during the medication period.
Mixing instructions:
The veterinary medicinal product may be mixed directly into the drinking water system or first mixed
as a stock solution into a smaller amount of water, which is then added into the drinking water system.
When mixing the veterinary medicinal product directly into the drinking water system, the contents of
the sachet should be sprinkled onto the surface of the water and mixed thoroughly until a clear
solution is produced (usually within 3 minutes).
When preparing a stock solution, the maximum concentration should be 16 g of product per 600 ml or
40 g of product per 1,500 ml and it is necessary to mix the solution for 10 minutes. After this time, any
remaining cloudiness will not affect efficacy of the product.
28
No signs of intolerance have been observed in poultry species at up to 150 mg tylvalosin per kg
bodyweight per day for 5 days.
Meat and offal: 2 days.
Do not release pheasants for at least two days after the end of medication.
Not authorised for use in laying birds producing eggs for human consumption.
5.
Pharmacotherapeutic group: Macrolide antibiotic, ATCvet code: QJ01FA92.
5.1 Pharmacodynamic properties
Tylvalosin is a macrolide antibiotic. Macrolides are metabolites or derivatives of metabolites of soil
organisms obtained by fermentation. They interfere with protein synthesis by reversibly binding to the
50S ribosome subunit. They are generally considered bacteriostatic.
Tylvalosin has activity against pathogenic organisms isolated from a range of animal species-mainly
Gram-positive organisms and mycoplasma but also some Gram-negative organisms. Tylvalosin has
activity against the following mycoplasma species found in poultry:
Mycoplasma gallisepticum
.
The Minimum Inhibitory Concentration of tylvalosin for
M. gallisepticum
ranges from 0.007 to
0.25 µg/ml. Macrolides (including tylvalosin) have been shown to have effects on the innate immune
system, which may augment the direct effects of the antibiotic on the pathogen and aid the clinical
situation.
Bacteria can develop resistance to antimicrobial substances. There are multiple mechanisms
responsible for resistance development to macrolide compounds.
Cross-resistance within the macrolide group of antibiotics cannot be excluded. Reduced susceptibility
for tylvalosin was generally noted in tylosin resistant strains.
5.2 Pharmacokinetic particulars
Tylvalosin tartrate is rapidly absorbed after oral administration of the veterinary medicinal product.
Tylvalosin is widely distributed in tissues with the highest concentrations found in the respiratory
tissues, bile, intestinal mucosa, spleen, kidney and liver.
Tylvalosin has been shown to concentrate in phagocytic cells and gut epithelial cells. Concentrations
(up to 12 times) were achieved in the cells (intracellular), compared to the extracellular concentration.
In vivo
studies have shown tylvalosin to be present in higher concentrations in the mucous lining of
the respiratory and gut tissues compared to the plasma.
The major metabolite of tylvalosin is 3-acetyltylosin (3-AT), which is also microbiologically active.
The terminal half-lifes for the elimination of tylvalosin and its active metabolite 3-AT range from 1 to
1.45 hours. Six hours after treatment, the concentration of tylvalosin in the gastrointestinal tract
mucosa has a mean concentration of 133 ng/g and in the gastrointestinal contents of 1,040 ng/g. The
active metabolite 3-AT has a mean concentration of 57.9 ng/g and 441 ng/g, respectively.
29
6.
6.1 List of excipients
Lactose
6.2 Incompatibilities
None known.
6.3 Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 3 years.
Shelf-life of the medicated drinking water: 24 hours.
Only a sufficient amount of medicated drinking water should be prepared to cover the daily requirements.
Medicated drinking water should be replaced every 24 hours.
6.4. Special precautions for storage
Do not store above 30 C.
Opened sachets should not be stored.
6.5 Nature and composition of immediate packaging
Aluminium foil laminated sachets containing either 16 g or 40 g.
Not all pack sizes may be marketed.
6.6
Special precautions for the disposal of unused veterinary medicinal product or waste
materials derived from the use of such products
Any unused veterinary medicinal products or waste materials derived from such veterinary medicinal
product should be disposed of in accordance with local requirements.
7.
ECO Animal Health Limited
78 Coombe Road
New Malden
Surrey
KT3 4QS
United Kingdom
8.
EU/2/04/044/011 – 16 g
EU/2/04/044/012 – 40 g
9.
9 September 2004
30
07.03.2011
Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency
http://www.ema.europa.eu
.
PROHIBITION OF SALE, SUPPLY AND/OR USE
Not applicable.
31
1.
Aivlosin 42.5 mg/g oral powder for pigs
2.
Active substance:
tylvalosin
42.5 mg/g
(as tylvalosin tartrate)
For a full list of excipients see section 6.1.
3.
Oral powder.
A beige granular powder.
4.
Pigs
Treatment and prevention of swine enzootic pneumonia caused by susceptible strains of
Mycoplasma
hyopneumoniae
in pigs. At the recommended dose, lung lesions and weight loss
are reduced but infection with
Mycoplasma hyopneumoniae
is not eliminated.
Treatment of porcine proliferative enteropathy caused by
Lawsonia intracellularis
in herds
where there is a diagnosis based on clinical history, post-mortem findings and clinical
pathology results.
Treatment of clinical outbreaks of swine dysentery, caused by
Brachyspira hyodysenteriae
in
herds where the disease has been diagnosed and prevention of further clinical cases.
None.
Acute cases and severely diseased pigs with reduced food and water intake should be treated with a
suitable injectable veterinary medicinal product.
Generally, strains of
B. hyodysenteriae
have higher MIC values in cases of resistance against other
macrolides such as tylosin. The clinical relevance of this reduced susceptibility is not fully explored.
Cross-resistance between tylvalosin and other macrolides cannot be excluded.
It is sound clinical practice to base treatment on susceptibility testing.
32
Special precautions to be taken by the person administering the veterinary medicinal product to
animals
Because the veterinary medicinal product has been shown to cause hypersensitivity reactions in
laboratory animals, people with known hypersensitivity to tylvalosin tartrate should avoid any contact
with the veterinary medicinal product.
When adding the veterinary medicinal product to the individual feed ration and when handling this
medicated feed, direct contact with eyes, skin and mucous membranes should be avoided. Personal
protective equipment should be worn when handling the veterinary medicinal product or the feed with
the veterinary medicinal product added: overalls, impervious gloves and either a disposable half-mask
respirator conforming to European Standard EN 149 or a non-disposable respirator conforming to
European Standard EN 140, with a filter to European Standard EN 143. Wash contaminated skin.
In case of accidental ingestion seek medical advice immediately and show the label to the physician.
None known.
The safety of Aivlosin during pregnancy and lactation has not been established in pigs. Use only in
accordance with risk/benefit assessment by the responsible veterinarian.
Studies in laboratory animals have not produced any evidence of teratogenicity. Maternal toxicity in
rodents has been observed at doses of 400 mg tylvalosin per kg bodyweight and above. In mice, a
slight reduction in the foetal bodyweight was seen at doses causing maternal toxicity.
Cross-resistance to other macrolide antibiotics cannot be excluded.
For use in individual pigs on farms where only a small number of pigs are to receive the treatment.
Larger groups should be treated with medicated feeding stuff containing the premix.
For treatment and prevention of Swine Enzootic Pneumonia
The dosage is 2.125 mg tylvalosin per kg bodyweight per day for 7 consecutive days.
Secondary infection by organisms such as
Pasteurella multocida
and
Actinobacillus
pleuropneumoniae
may complicate enzootic pneumonia and require specific medication.
For treatment of Porcine Proliferative Enteropathy (ileitis)
The dosage is 4.25 mg tylvalosin per kg bodyweight per day for 10 consecutive days.
For treatment and prevention of Swine Dysentery
The dosage is 4.25 mg tylvalosin per kg bodyweight per day for 10 consecutive days.
This is achieved by thoroughly mixing Aivlosin into approximately 200–500 g of feed and then
thoroughly mixing this pre-mixture into the remainder of the daily ration.
Scoops of 2 sizes are provided for measuring the correct amount of Aivlosin for mixing with the daily
ration, according to the schedule below. The feed containing the oral powder should be provided as the
sole ration for the periods recommended above.
33
The pig to be treated should be weighed and the amount of feed that the pig is likely to consume
should be estimated, based on a daily feed intake equivalent to 5 % of bodyweight. Consideration must
be given to pigs whose daily feed intake is reduced or restricted. The correct quantity of Aivlosin
should be added to the estimated quantity of daily ration for each pig, in a bucket or similar receptacle,
and thoroughly mixed.
The veterinary medicinal product should only be added to dry non-pelleted feed.
Swine Enzootic Pneumonia
2.125 mg/kg bodyweight
PPE (ileitis) & Swine Dysentery
4.25 mg/kg bodyw
eight
Bodyweight
range (kg)
Scoop
size
Number of
scoops
Bodyweight
range (kg)
Scoop
size
Number of
scoops
7.5–12
1 ml
1
7.5–12
1 ml
2
13–25
1 ml
2
13–19
1 ml
3
26–38
1 ml
3
20–33
5 ml
1
39–67
5 ml
1
34–67
5 ml
2
68–134
5 ml
2
68–100
5 ml
3
135–200
5 ml
3
101–134
5 ml
4
201–268
5 ml
4
135–200
5 ml
6
201–268
5 ml
8
NB: A level scoop of the product should be measured
As an adjunct to medication, good management and hygiene practices should be introduced in order to
reduce the risk of infection and to control the potential build up of resistance.
No signs of intolerance have been observed in growing pigs at up to 10 times the recommended
dosage.
Meat and offal: 2 days.
5.
Pharmacotherapeutic group: Macrolide antibiotic, ATCvet code: QJ01FA92.
5.1 Pharmacodynamic properties
Tylvalosin tartrate is a macrolide antibiotic that has antibacterial activity against Gram-positive, some
Gram-negative organisms and mycoplasma. It acts by inhibiting protein synthesis in the bacteria cell.
Macrolide antibiotics are the metabolites or semi-synthetic derivatives of metabolites of soil organisms
obtained by fermentation. They have different sized lactone rings and due to the dimethylamino group,
are basic. Tylvalosin has a sixteen membered ring.
Macrolides interfere with protein synthesis by reversibly binding to the 50S ribosome subunit. They
bind to the donor site and prevent the translocation necessary for keeping the peptide chain growing.
Their effect is essentially confined to rapidly dividing organisms. Macrolides are generally considered
bacteriostatic and mycoplasmastatic.
34
It is considered that there are multiple mechanisms responsible for resistance development to
macrolide compounds: namely alteration of the ribosomal target site, utilisation of active efflux
mechanism and production of inactivating enzymes.
Resistance to tylvalosin
by
Mycoplasma hyopneumoniae
and
Lawsonia intracellularis
has not been
reported or found in the field to date. No breakpoint for
Brachyspira hyodysenteriae
has been
established. Generally, strains of
B. hyodysenteriae
have higher MIC values in cases of resistance
against other macrolides, such as tylosin. The clinical relevance of this reduced susceptibility is not
fully explored.
Cross-resistance between tylvalosin and other macrolide antibiotics cannot be excluded.
5.2 Pharmacokinetic particulars
Tylvalosin tartrate is rapidly absorbed after oral administration of Aivlosin.
After administration of the recommended dose lung concentrations of 0.060–0.066 µg/ml were found
at 2 and 12 hours post-treatment. The parent compound is widely distributed in the tissues with the
highest concentrations found in the lungs, bile, intestinal mucosa, spleen, kidney and liver.
There is evidence that the concentration of macrolides is higher at the site of infection than in plasma,
in particular in neutrophils, alveolar macrophages and alveolar epithelial cells.
In vitro
metabolism studies have confirmed that the parent compound is rapidly metabolised to 3-O-
acetyltylosin. In a trial with
14
C Aivlosin administered at 2.125 mg/kg to pigs for 7 days over 70 % of
the dose was excreted in the faeces, with urinary excretion accounting for 3 to 4 % of the dose.
6.
6.1
List of excipients
Magnesium trisilicate (sepiolite)
Wheat feed flour
Hydroxypropyl cellulose
Non-fat soyabean powder
6.2 Incompatibilities
None known.
6.3 Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 3 years.
Feed to which the oral powder has been added should be replaced if not consumed within 24 hours.
6.4
Special precautions for storage
Store below 30 °C.
Keep the container tightly closed.
Store in the original container.
6.5
Nature and composition of immediate packaging
One aluminium foil/polyester laminated bag containing 500 g. Scoops of 1 ml and 5 ml are attached.
35
6.6
Special precautions for the disposal of unused veterinary medicinal product or waste
materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.
7.
ECO Animal Health Limited
78 Coombe Road
New Malden
Surrey
KT3 4QS
United Kingdom
8.
EU/2/04/044/013
9.
9 September 2004
07.03.2011
Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency
http://www.ema.europa.eu
.
PROHIBITION OF SALE, SUPPLY AND/OR USE
Not applicable.
36
ANNEX II
A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE
B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
REGARDING SUPPLY OR USE
C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
WITH REGARD TO SAFE AND EFFECTIVE USE
D. STATEMENT OF THE MRLs
37
A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE
Name and address of the manufacturer responsible for batch release
Gallows Green Services Limited
Cod Beck Blenders, Cod Beck Estate
Dalton Lane, Dalton
Thirsk, North Yorkshire
YO7 3HR
United Kingdom
B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
REGARDING SUPPLY OR USE
To be supplied only on veterinary prescription.
OTHER CONDITIONS:
Consideration should be given to official guidance on the incorporation of medicated premixes in final
feed.
C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
WITH REGARD TO SAFE AND EFFECTIVE USE OF THE PRODUCT
Not applicable
D. STATEMENT OF THE MRLs
Tylvalosin is an allowed substance as described in Table 1 of the annex to Commission Regulation
(EU) No 37/2010:
Pharmacologically
active substance
Marker
residue
Animal
species
MRL
Target
tissues
Other
provisions
Therapeutic
classification
Tylvalosin
Sum of
tylvalosin
and 3-O-
acetyltylo
sin
Porcine 50 µg/kg
50 µg/kg
50 µg/kg
50 µg/kg
Muscle
Skin and fat
Liver
Kidney
NO ENTRY
Anti-
infectious
agents /
Antibiotics
Poultry 50 µg/kg
50 µg/kg
Skin and fat
Liver
Not for use
in animals
from which
eggs are
produced for
human
consumption
The excipients listed in section 6.1 of the SPC are either allowed substances for which Table 1 of the
annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are
considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this
product.
38
ANNEX III
LABELLING AND PACKAGE LEAFLET
39
A. LABELLING
40
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
1.
Aivlosin 42.5 mg/g premix for medicated feeding stuff for pigs
Aivlosin 8.5 mg/g premix for medicated feeding stuff for pigs
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Active substance
Tylvalosin
42.5 mg/g
(as tylvalosin tartrate)
8.5 mg/g
Carrier
:
Magnesium trisilicate, wheat feed flour.
3.
Premix for medicated feeding stuff
4.
PACKAGE SIZE
20 kg
5 kg
5.
Pigs
6.
INDICATIONS
Treatment and prevention of swine enzootic pneumonia.
Treatment of porcine proliferative enteropathy (ileitis).
Treatment of clinical outbreaks of swine dysentery in herds where the disease has been
diagnosed, and prevention of further clinical cases.
7.
METHOD AND ROUTE OF ADMINISTRATION
In-feed use. For incorporation into dry feed only.
41
Tylvalosin
Mixing Instructions
A horizontal ribbon mixer should be used to incorporate the product into feeding stuff. It is
recommended that Aivlosin is first mixed with 10 kg of the feeding stuff, followed by the rest of the
feeding stuff and mixed well. Medicated feed may then be pelleted. Pelleting conditions involve a
single pre-conditioning step with steam for 5 minutes and pelleting at not more than 70 C under
normal conditions.
No known incompatibilities.
Read the package leaflet before use.
8.
Withdrawal period:
Meat and offal: 2 days.
9.
SPECIAL WARNINGS, IF NECESSARY
People with known hypersensitivity to tylvalosin tartrate should avoid any contact with the product.
When mixing the veterinary medicinal product and handling the medicated feed, direct contact with
eyes, skin and mucous membranes should be avoided. Personal protective equipment should be worn
when mixing the veterinary medicinal product or handling the medicated feed: overalls, impervious
gloves and either a disposable half-mask respirator conforming to European Standard EN 149 or a
non-disposable respirator conforming to European Standard EN 140, with a filter to European
Standard EN 143. Wash contaminated skin.
In case of accidental ingestion seek medical advice immediately and show the label to the physician.
10. EXPIRY DATE
EXP **/****
11. SPECIAL STORAGE CONDITIONS
Store below 30°C
(Aivlosin 42.5 mg/g)
Do not store above 25°C.
(Aivlosin 8.5 mg/g)
Keep the container tightly closed.
Store in the original container.
Do not use after the expiry date stated on the label.
Shelf life after incorporation into meal or pelleted feed: 1 month.
(Aivlosin 42.5 mg/g)
Shelf life after incorporation into meal 2 months and into pelleted feed: 2 weeks.
(Aivlosin 8.5 mg/g)
42
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
WASTE MATERIALS, IF ANY
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.
13. THE WORDS “FOR ANIMAL TREATMENT ONLY“ AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
For animal treatment only – to be supplied only on veterinary prescription.
Consideration should be given to official guidance on the incorporation of medicated premixes in final
feed.
14. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
Keep out of the reach and sight of children.
ECO Animal Health Limited
78 Coombe Road
New Malden
Surrey
KT3 4QS
United Kingdom
16. MARKETING AUTHORISATION NUMBERS
EU/2/04/044/001
(Aivlosin 42.5 mg/g – 20 kg)
EU/2/04/044/002
(Aivlosin 42.5 mg/g – 5 kg)
EU/2/04/044/004
(Aivlosin 8.5 mg/g – 5 kg)
17. MANUFACTURER’S BATCH NUMBER
Batch No:
43
EU/2/04/044/003
(Aivlosin 8.5 mg/g – 20 kg)
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
1.
Aivlosin 8.5 mg/g oral powder for pigs
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Active substance
Tylvalosin
8.5 mg/g
(as tylvalosin tartrate)
3.
Oral powder.
4.
PACKAGE SIZE
1 kg
3 kg
5.
Pigs
6.
INDICATIONS
Treatment and prevention of swine enzootic pneumonia.
Treatment of porcine proliferative enteropathy (ileitis).
Treatment and prevention of swine dysentery.
7.
METHOD AND ROUTE OF ADMINISTRATION
Oral use.
Read the package leaflet before use.
Only to be added to dry food.
8.
Withdrawal period:
Meat and offal: 2 days.
44
9.
SPECIAL WARNINGS, IF NECESSARY
Direct contact with the eyes, skin and mucous membranes should be avoided and personal protective
equipment should be worn. In case of accidental ingestion seek medical advice immediately and show
label to physician. Read the package leaflet before use.
10. EXPIRY DATE
EXP **/****
11. SPECIAL STORAGE CONDITIONS
Do not store above 25 °C.
Keep the container tightly closed.
Store in the original container.
Do not use after the expiry date stated on the label.
Feed to which the oral powder has been added should be replaced if not consumed within 24 hours.
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
WASTE MATERIALS, IF ANY
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.
13. THE WORDS “FOR ANIMAL TREATMENT ONLY“ AND CONDITIONS OR
RESTRICTIONS REGARDING SALE AND SUPPLY, if applicable
For animal treatment only – to be supplied only on veterinary prescription.
14. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN“
Keep out of the reach and sight of children.
ECO Animal Health Limited
78 Coombe Road
New Malden
Surrey
KT3 4QS
United Kingdom
45
16. MARKETING AUTHORISATION NUMBERS
EU/2/04/044/005 – 1 kg
EU/2/04/044/006 – 3 kg
17. MANUFACTURER’S BATCH NUMBER
Batch No:
46
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Granules for use in drinking water for chickens (40 g sachet)
1.
Aivlosin 625 mg/g granules for use in drinking water for chickens
Tylvalosin (as tylvalosin tartrate)
2.
QUANTITY OF THE ACTIVE SUBSTANCE
Tylvalosin (as tylvalosin tartrate)
625 mg/g
3.
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
40 g
4.
ROUTE OF ADMINISTRATION
In drinking water use
5.
Withdrawal period:
Meat and offal: 2 days.
Not for laying birds.
6.
BATCH NUMBER
Batch {number}
7.
EXPIRY DATE
EXP {month/year}
Medicated drinking water should be replaced every 24 hours.
8.
SPECIAL STORAGE CONDITIONS
Do not store above 30 C.
Opened sachets should not be stored.
9.
THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
For animal treatment only – to be supplied only on veterinary prescription.
47
ECO Animal Health Limited
78 Coombe Road
New Malden
Surrey
KT3 4QS
United Kingdom
11 MARKETING AUTHORISATION NUMBER
EU/2/04/044/007
48
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
Granules for use in drinking water for chickens (400 g sachet)
1.
Aivlosin 625 mg/g granules for use in drinking water for chickens
Tylvalosin (as tylvalosin tartrate)
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Tylvalosin (as tylvalosin tartrate)
625 mg/g
3.
Granules for use in drinking water
4.
PACKAGE SIZE
400 g
5.
Chicken
6.
INDICATIONS
Treatment and prevention of respiratory disease associated with
Mycoplasma gallisepticum
in
chickens.
7.
METHOD AND ROUTE OF ADMINISTRATION
Read the package leaflet before use.
8.
Withdrawal period:
Meat and offal: 2 days.
Not for laying birds.
9.
SPECIAL WARNINGS, IF NECESSARY
Read the package leaflet before use.
49
10. EXPIRY DATE
EXP {month/year}
Medicated drinking water should be replaced every 24 hours.
11. SPECIAL STORAGE CONDITIONS
Do not store above 30 C.
Opened sachets should not be stored.
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
WASTE MATERIALS, IF ANY
Dispose of in accordance with local requirements.
13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
For animal treatment only – to be supplied only on veterinary prescription.
14. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
Keep out of the reach and sight of children.
ECO Animal Health Limited
78 Coombe Road
New Malden
Surrey
KT3 4QS
United Kingdom
16. MARKETING AUTHORISATION NUMBER
EU/2/04/044/008
17. MANUFACTURER’S BATCH NUMBER
Batch {number}
50
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Granules for use in drinking water for pigs – 40 g sachet
1.
Aivlosin 625 mg/g granules for use in drinking water for pigs
Tylvalosin (as tylvalosin tartrate)
2.
QUANTITY OF THE ACTIVE SUBSTANCE
Tylvalosin (as tylvalosin tartrate)
625 mg/g
3.
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
40 g
4.
ROUTE OF ADMINISTRATION
In drinking water use
5.
Withdrawal period:
Meat and offal: 1 day.
6.
BATCH NUMBER
Batch {number}
7.
EXPIRY DATE
EXP {month/year}
Medicated drinking water should be replaced every 24 hours.
8.
SPECIAL STORAGE CONDITIONS
Do not store above 30 C.
Opened sachets should not be stored.
9.
THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
For animal treatment only – to be supplied only on veterinary prescription.
51
ECO Animal Health Limited
78 Coombe Road
New Malden
Surrey
KT3 4QS
United Kingdom
11 MARKETING AUTHORISATION NUMBER
EU/2/04/044/009
52
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
Granules for use in drinking water for pigs – 160 g sachet
1.
Aivlosin 625 mg/g granules for use in drinking water for pigs
Tylvalosin (as tylvalosin tartrate)
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Tylvalosin (as tylvalosin tartrate)
625 mg/g
3.
Granules for use in drinking water.
4.
PACKAGE SIZE
160 g
5.
Pigs
6.
INDICATIONS
Treatment and prevention of porcine proliferative enteropathy (ileitis) caused by
Lawsonia
intracellularis
.
7.
METHOD AND ROUTE OF ADMINISTRATION
Read the package leaflet before use.
8.
Withdrawal period:
Meat and offal: 1 day.
9.
SPECIAL WARNINGS, IF NECESSARY
Read the package leaflet before use.
53
10. EXPIRY DATE
EXP {month/year}
Medicated drinking water should be replaced every 24 hours.
11. SPECIAL STORAGE CONDITIONS
Do not store above 30 C.
Opened sachets should not be stored.
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
WASTE MATERIALS, IF ANY
Dispose of in accordance with local requirements.
13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
For animal treatment only – to be supplied only on veterinary prescription.
14. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
Keep out of the reach and sight of children.
ECO Animal Health Limited
78 Coombe Road
New Malden
Surrey
KT3 4QS
United Kingdom
16. MARKETING AUTHORISATION NUMBER
EU/2/04/044/010
17. MANUFACTURER’S BATCH NUMBER
Batch {number}
54
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
16 g and 40 g Aluminium foil laminated sachet for pheasants
1.
Aivlosin 625 mg/g granules for use in drinking water for pheasants
Tylvalosin (as tylvalosin tartrate)
2.
QUANTITY OF THE ACTIVE SUBSTANCE
Tylvalosin (as tylvalosin tartrate)
625 mg/g
3.
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
16 g
40 g
4.
ROUTE OF ADMINISTRATION
In drinking water use
5.
Withdrawal period:
Meat and offal: 2 days.
Not for laying birds.
6.
BATCH NUMBER
Lot {number}
7.
EXPIRY DATE
EXP {month/year}
Medicated drinking water should be replaced every 24 hours.
8.
SPECIAL STORAGE CONDITIONS
Do not store above 30 C.
Opened sachets should not be stored.
55
9.
THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
For animal treatment only – to be supplied only on veterinary prescription.
ECO Animal Health Limited
78 Coombe Road
New Malden
Surrey
KT3 4QS
United Kingdom
11 MARKETING AUTHORISATION NUMBERS
EU/2/04/044/011 – 16 g
EU/2/04/044/012 – 40 g
56
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
Aluminium foil/polyester laminated bag containing 500 g – oral powder
1.
Aivlosin 42.5 mg/g oral powder for pigs
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
(as tylvalosin tartrate)
42.5 mg/g
3.
Oral powder.
4.
PACKAGE SIZE
500 g
5.
Pigs
6.
INDICATIONS
Treatment and prevention of swine enzootic pneumonia.
Treatment of porcine proliferative enteropathy (ileitis).
Treatment and prevention of swine dysentery.
7.
METHOD AND ROUTE OF ADMINISTRATION
Oral use.
Read the package leaflet before use.
Only to be added to dry food.
8.
Withdrawal period:
Meat and offal: 2 days.
57
Tylvalosin
9.
SPECIAL WARNINGS, IF NECESSARY
Direct contact with the eyes, skin and mucous membranes should be avoided and personal protective
equipment should be worn. In case of accidental ingestion seek medical advice immediately and show
label to physician. Read the package leaflet before use.
10. EXPIRY DATE
EXP {month/year}
11. SPECIAL STORAGE CONDITIONS
Store below 30 °C Keep the container tightly closed.
Store in the original container.
Feed to which the oral powder has been added should be replaced if not consumed within 24 hours.
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
WASTE MATERIALS, IF ANY
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.
13. THE WORDS “FOR ANIMAL TREATMENT ONLY“ AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
For animal treatment only – to be supplied only on veterinary prescription.
14. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN“
Keep out of the reach and sight of children.
ECO Animal Health Limited
78 Coombe Road
New Malden
Surrey
KT3 4QS
United Kingdom
16. MARKETING AUTHORISATION NUMBER
EU/2/04/044/013
58
17. MANUFACTURER’S BATCH NUMBER
Batch No:
59
B. PACKAGE LEAFLET
60
PACKAGE LEAFLET
Aivlosin 42.5 mg/g premix for medicated feeding stuff for pigs
1.
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing Authorisation Holder:
ECO Animal Health Limited
78 Coombe Road
New Malden
Surrey
KT3 4QS
United Kingdom
Manufacturer for the batch release:
Gallows Green Services Limited
Cod Beck Blenders, Cod Beck Mill
Dalton, Thirsk, North Yorkshire
YO7 3HR
United Kingdom
2.
Aivlosin 42.5 mg/g premix for medicated feeding stuff for pigs
3.
STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS
Active substance
tylvalosin
42.5 mg/g
(as tylvalosin tartrate)
Carrier:
Magnesium trisilicate, wheat feed flour.
4.
INDICATIONS
Treatment and prevention of swine enzootic pneumonia caused by susceptible strains of
Mycoplasma hyopneumoniae
. At the recommended dose, lung lesions and weight loss are
reduced but infection with
Mycoplasma hyopneumoniae
is not eliminated.
Treatment of porcine proliferative enteropathy (ileitis) caused by
Lawsonia intracellularis
in
herds where there is a diagnosis based on clinical history, post-mortem findings and clinical
pathology results.
Treatment of clinical outbreaks of swine dysentery in herds, caused by
Brachyspira
hyodysenteriae,
where the disease has been diagnosed, and prevention of further clinical
cases.
5.
None.
61
6.
ADVERSE REACTIONS
None known.
If you notice any serious effects not mentioned in this leaflet, please inform your veterinary surgeon.
7.
Pigs.
8.
DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION
In-feed use.
For incorporation into dry feed only.
For treatment and prevention of Swine Enzootic Pneumonia:
The dosage is 2.125 mg tylvalosin per kg bodyweight per day in-feed for 7 consecutive days.
Secondary infection by organisms such as
Pasteurella multocida
and
Actinobacillus
pleuropneumoniae
may complicate enzootic pneumonia and require specific medication.
For treatment of Porcine Proliferative Enteropathy (ileitis):
The dosage is 4.25 mg tylvalosin per kg bodyweight per day in-feed for 10 consecutive days.
For treatment and prevention of Swine Dysentery:
The dosage is 4.25 mg tylvalosin per kg bodyweight per day in-feed for 10 consecutive days.
Indication
Dose of active
ingredient
Duration of
treatment
In feed inclusion rate
Treatment and prevention of
swine enzootic pneumonia
2.125 mg/kg
bodyweight/day
7 days
1 kg/tonne*
Treatment of PPE (ileitis)
4.25 mg/kg
bodyweight/day
10 days
2 kg/tonne*
Treatment and prevention of
swine dysentery
4.25 mg/kg
bodyweight/day
10 days
2 kg/tonne*
*
Important
: these inclusion rates assume a pig eats equivalent of 5 % bodyweight per day.
In older pigs, or in pigs with reduced appetite, or on restricted feed intake, inclusion levels may need
to be increased to achieve target dosage. Where feed intake is reduced, use the following formula:
Kg Premix/tonne feed =
Dose rate (mg/kg bodyweight) x bodyweight (kg)
Daily feed intake (kg) x Premix strength (mg/g)
Acute cases and severely diseased pigs with reduced food and water intake should be treated with a
suitable injectable product.
In addition to medical treatment, good management and hygiene practices should be established on the
farm in order to reduce the risk of infection and to control the build up of resistance.
The medicated feed should be fed as the sole ration.
9.
ADVICE ON CORRECT ADMINISTRATION
Mixing Instructions
A horizontal ribbon mixer should be used to incorporate the product into feeding stuff. It is
recommended that Aivlosin is first mixed with 10 kg of the feeding stuff, followed by the rest of the
62
feeding stuff and mixed well. Medicated feed may then be pelleted. Pelleting conditions involve a
single pre-conditioning step with steam for 5 minutes and pelleting at not more than 70 C under
normal conditions.
No known incompatibilities.
10. WITHDRAWAL PERIOD
Meat and offal: 2 days.
11. SPECIAL STORAGE PRECAUTIONS
Keep out of the reach and sight of children.
Store below 30 °C.
Keep the container tightly closed.
Store in the original container.
Do not use after the expiry date stated on the label.
Shelf life after incorporation into feed: meal and pellets: 1 month.
12. SPECIAL WARNINGS
Because Aivlosin has been shown to cause hypersensitivity reactions in laboratory animals, people
with known hypersensitivity to tylvalosin tartrate should avoid any contact with the product.
When mixing the veterinary medicinal product and handling the medicated feed, direct contact with
eyes, skin and mucous membranes should be avoided. Personal protective equipment should be worn
when mixing the veterinary medicinal product or handling the medicated feed: overalls, impervious
gloves and either a disposable half-mask respirator conforming to European Standard EN 149 or a
non-disposable respirator conforming to European Standard EN 140, with a filter to EN 143. Wash
contaminated skin.
In case of accidental ingestion seek medical advice immediately and show the label to the physician.
The safety of Aivlosin during pregnancy and lactation has not been established in pigs. Use only in
accordance with risk/benefit assessment by the responsible veterinarian. Studies in laboratory animals
have not produced any evidence of teratogenicity. Maternal toxicity in rodents has been observed at
doses of 400 mg tylvalosin per kg bodyweight and above. In mice, a slight reduction in the foetal
bodyweight was seen at doses causing maternal toxicity.
It is sound clinical practice to base treatment on susceptibility testing of the bacteria isolated from the
animal. If this is not possible, therapy should be based on local (regional, farm level) epidemiological
information about susceptibility of target bacteria.
Use of the product deviating from the instructions may increase the risk of development and selection
of resistant bacteria and decrease the effectiveness of treatment with other macrolides due to the
potential for cross-resistance.
Generally, strains of
B. hyodysenteriae
have higher MIC values in cases of resistance against other
macrolides, such as tylosin. The clinical relevance of this reduced susceptibility is not fully explored.
Cross-resistance between tylvalosin and other macrolides cannot be excluded.
63
13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIALS, IF ANY
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.
14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
07.03.2011
Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency
http://www.ema.europa.eu
.
15. OTHER INFORMATION
Not all pack sizes may be marketed. Consideration should be given to official guidance on the
incorporation of medicated premixes in final feed.
For any information about this veterinary medicinal product, please contact the local representative of
the marketing authorisation holder.
België/Belgique/Belgien
Alpharma BVBA Belgium
Garden Square, Laarstraat 16,
B-2610 Antwerp,
BELGIË/BELGIQUE/BELGIEN.
Tel: +32 3 287 38 80
Fax: +32 3 287 38 81
Luxembourg/Luxemburg
ECO Animal Health Ltd.,
The Grange, 100 The High Street,
London, N14 6BN,
Royaume-Uni
Tel: +44 (0) 20 8447 8899
Email:
sales@ecoanimalhealth.com
Република България
ECO Animal Health Ltd.,
The Grange, 100 The High Street,
London, N14 6BN,
Великобритания (Обединеното кралство)
телефон: +44 (0) 20 8447 8899
Email:
sales@ecoanimalhealth.com
Magyarország
Dunavet-B ZRt,
7020 Dunaföldvár, Ady E. u. 5.
MAGYARORSZÁG.
Tel: +36 75 542 940
Email:
dunavet-bp@externet.hu
Česká republika
Cymedica spol. sr.o.,
Pod Nádražím 853, 268 01 Hořovice,
ČESKÁ REPUBLIKA.
Tel: +420 800 137 269
Email:
info@cymedica.cz
Malta
ECO Animal Health Ltd.,
The Grange, 100 The High Street,
London, N14 6BN,
Ir-Renju Unit.
Tel: +44 (0) 20 8447 8899
Email:
sales@ecoanimalhealth.com
Danmark
Scanvet Animal Health A/S
Kongevejen 66
DK-3480 Fredensborg,
Danmark
Tel.: 48 48 43 17
Fax: 48 48 28 24
Email:
info@scanvet.dk
Nederland
Eurovet Animal Health BV
Handelsweg 25
5531 AE Bladel
Nederland
Tel: +31 (0)497-544300
Fax: +31 (0)497-544337
Email:
info@eurovet-ah.com
64
Deutschland
ESTEVE GmbH
Max-Planck-Strasse 11
D-85716 Unterschleissheim, Deutschland
HRB München 99927
Tel: +49-89-31566772
Email:
info-esteve@t-online-de
Norge
ECO Animal Health Ltd.,
The Grange, 100 The High Street,
London, N14 6BN,
Storbritannia
Tel: +44 (0) 20 8447 8899
Email:
sales@ecoanimalhealth.com
Eesti
AS Magnum Veterinaaria
Vae 16, Laagri, Harju mk
Eesti
Tel: +372 6 501 920
Fax: +372 6 501 996
Österreich
ESTEVE GmbH
Max-Planck-Strasse 11
D-85716 Unterschleissheim, Deutschland
HRB München 99927
Tel: +49-89-31566772
Email:
info-esteve@t-online-de
Polska
Calier Polska Sp. z o.o.
Ul. Wyszyńskiego 38
66-400 Gorzów Wlkp
Polska
Tel: +48 95 7214521
fax: +48 95 7214532
E-mail:
calierpolska@calier.com.pl
España
ESTEVE Veterinaria
Laboratorios Dr. Esteve, S.A.
Mare de Deu de Montserrat, 221
08041 Barcelona
España
Tel: +34 93 4466000
Email:
veterinaria@esteve.es
Portugal
ESTEVE veterinaria
Esteve Farma, Lda.
Avenida do Forte n° 3
Edifício Suécia III - Piso 1
2794-044 Carnaxide
Portugal
Tel: +351 214246027
Email:
e.veterinaria@esteve.es
France
Alpharma sarl
Silic 411, 3 Impasse de la Noisette,
91374 Verrières le Buisson Cedex,
France
Tél: +33 1 69 53 40 50
Fax: +33 1 69 53 40 51
România
SC DELOS IMPEX 96 SRL,
81 Horia, Closca si Crisan Street,
Otopeni City,
Ilfov District,
România
Tel: +40 372 714 413
Email:
delosmedica@yahoo.com
Ireland
ECO Animal Health Ltd,
The Grange, 100 The High Street,
London, N14 6BN,
UNITED KINGDOM.
Tel: +44 (0) 20 8447 8899
Email:
sales@ecoanimalhealth.com
Slovenija
ECO Animal Health Ltd,
The Grange, 100 The High Street,
London, N14 6BN,
Velika Britanija.
Tel: +44 (0) 20 8447 8899
Email:
sales@ecoanimalhealth.com
65
Ísland
ECO Animal Health Ltd.,
The Grange, 100 The High Street,
London, N14 6BN,
Bretland
Tel: +44 (0) 20 8447 8899
Email:
sales@ecoanimalhealth.com
Slovenská republika
Cymedica SK spol. s.r.o.,
Družstevná 1415/8, 960 01 Zvolen,
SLOVENSKÁ REPUBLIKA.
Tel: +421(0) 455400040
Email:
cymedica@cymedica.sk
Italia
Alpharma BVBA Belgium
Garden Square, Laarstraat 16,
B-2610 Antwerp,
BELGIO.
Tel: +32 3 287 38 80
Fax: +32 3 287 38 81
Suomi/Finland
ECO Animal Health Ltd.,
The Grange, 100 The High Street,
London, N14 6BN,
Iso-Britannia
Tel: +44 (0) 20 8447 8899
Email:
sales@ecoanimalhealth.com
Κύπρος
Cycon Chemicals Ltd
5, Promitheos, 1065 Nicosia
CYPRUS/ΚΥΠΡΟΣ.
Τηλ: + 357-22818498
Sverige
ECO Animal Health Ltd.,
The Grange, 100 The High Street,
London, N14 6BN,
Storbritannien
Tel: +44 (0) 20 8447 8899
Email:
sales@ecoanimalhealth.com
Latvija
Magnum Veterinārija SIA
Ulbrokas iela 23, Rīga, LV-1021,
Latvija
Tel: +371 671 60091
Fax: +371 671 60095
United Kingdom
ECO Animal Health Ltd.,
The Grange, 100 The High Street,
London, N14 6BN,
United Kingdom
Tel: 020 8447 8899
Email:
sales@ecoanimalhealth.com
Lietuva
UAB „Magnum Veterinarija“
J. Urbšio g. 3, LT-35169, Panevėžys, Lietuva.
Tel.: +370 45 502 730
Fax: +370 45 502 733
66
PACKAGE LEAFLET
Aivlosin 8.5 mg/g premix for medicated feeding stuff for pigs
1.
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing Authorisation Holder:
ECO Animal Health Limited
78 Coombe Road
New Malden
Surrey
KT3 4QS
United Kingdom
Manufacturer for the batch release:
Gallows Green Services Limited
Cod Beck Blenders, Cod Beck Mill
Dalton, Thirsk, North Yorkshire
YO7 3HR
United Kingdom
2.
Aivlosin 8.5 mg/g premix for medicated feeding stuff for pigs
3.
STATEMENT OF ACTIVE SUBSTANCE AND OTHER INGREDIENTS
Active substance
tylvalosin
8.5 mg/g
(as tylvalosin tartrate)
Carrier:
Magnesium trisilicate, wheat feed flour.
4.
INDICATIONS
Treatment and prevention of swine enzootic pneumonia caused by susceptible strains of
Mycoplasma hyopneumoniae
. At the recommended dose, lung lesions and weight loss are
reduced but infection with
Mycoplasma hyopneumoniae
is not eliminated.
Treatment of porcine proliferative enteropathy (ileitis) caused by
Lawsonia intracellularis
in
herds where there is a diagnosis based on clinical history, post-mortem findings and clinical
pathology results.
Treatment of clinical outbreaks of swine dysentery in herds, caused by
Brachyspira
hyodysenteriae,
where the disease has been diagnosed, and prevention of further clinical
cases.
5.
None.
67
6. ADVERSE REACTIONS
None known.
If you notice any serious effects not mentioned in this leaflet, please inform your veterinary surgeon.
7.
Pigs.
8.
DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION
In-feed use.
For incorporation into dry feed only.
For treatment and prevention of Swine Enzootic Pneumonia:
The dosage is 2.125 mg tylvalosin per kg bodyweight per day in-feed for 7 consecutive days.
Secondary infection by organisms such as
Pasteurella multocida
and
Actinobacillus
pleuropneumoniae
may complicate enzootic pneumonia and require specific medication.
For treatment of Porcine Proliferative Enteropathy (ileitis):
The dosage is 4.25 mg tylvalosin per kg bodyweight per day in-feed for 10 consecutive days.
For treatment and prevention of Swine Dysentery:
The dosage is 4.25 mg tylvalosin per kg bodyweight per day in-feed for 10 consecutive days.
Indication
Dose of active
ingredient
Duration of
treatment
In feed inclusion rate
Treatment and prevention of
swine enzootic pneumonia
2.125 mg/kg
bodyweight/day
7 days
5 kg/tonne*
Treatment of PPE (ileitis)
4.25 mg/kg
bodyweight/day
10 days
10 kg/tonne*
Treatment and prevention of
swine dysentery
4.25 mg/kg
bodyweight/day
10 days
10 kg/tonne*
*
Important
: these inclusion rates assume a pig eats equivalent of 5 % bodyweight per day.
In older pigs, or in pigs with reduced appetite, or on restricted feed intake, inclusion levels may need
to be increased to achieve target dosage. Where feed intake is reduced, use the following formula:
Kg Premix/tonne feed =
Dose rate (mg/kg bodyweight) x bodyweight (kg)
Daily feed intake (kg) x Premix strength (mg/g)
Acute cases and severely diseased pigs with reduced food and water intake should be treated with a
suitable injectable product.
In addition to medical treatment, good management and hygiene practices should be established on the
farm in order to reduce the risk of infection and to control the build up of resistance.
The medicated feed should be fed as the sole ration.
68
9.
ADVICE ON CORRECT ADMINISTRATION
Mixing Instructions
A horizontal ribbon mixer should be used to incorporate the product into feeding stuff. It is
recommended that Aivlosin is first mixed with 10 kg of the feeding stuff, followed by the rest of the
feeding stuff and mixed well. Medicated feed may then be pelleted. Pelleting conditions involve a
single pre-conditioning step with steam for 5 minutes and pelleting at not more than 70 C under
normal conditions.
No known incompatibilities.
10. WITHDRAWAL PERIOD
Meat and offal: 2 days.
11. SPECIAL STORAGE PRECAUTIONS
Keep out of the reach and sight of children.
Do not store above 25 °C.
Keep the container tightly closed.
Store in the original container.
Do not use after the expiry date stated on the label.
Shelf life after incorporation into feed:
Meal:
2 months
Pellets:
2 weeks.
12. SPECIAL WARNINGS
Because Aivlosin has been shown to cause hypersensitivity reactions in laboratory animals, people
with known hypersensitivity to tylvalosin tartrate should avoid any contact with the product.
When mixing the veterinary medicinal product and handling the medicated feed, direct contact with
eyes, skin and mucous membranes should be avoided. Personal protective equipment should be worn
when mixing the veterinary medicinal product or handling the medicated feed: overalls, impervious
gloves and either a disposable half-mask respirator conforming to European Standard EN 149 or a
non-disposable respirator conforming to European Standard EN 140, with a filter to EN 143. Wash
contaminated skin.
In case of accidental ingestion seek medical advice immediately and show the label to the physician.
The safety of Aivlosin during pregnancy and lactation has not been established in pigs. Use only in
accordance with risk/benefit assessment by the responsible veterinarian. Studies in laboratory animals
have not produced any evidence of teratogenicity. Maternal toxicity in rodents has been observed at
doses of 400 mg tylvalosin per kg bodyweight and above. In mice, a slight reduction in the foetal
bodyweight was seen at doses causing maternal toxicity.
It is sound clinical practice to base treatment on susceptibility testing of the bacteria isolated from the
animal. If this is not possible, therapy should be based on local (regional, farm level) epidemiological
information about susceptibility of target bacteria.
69
Use of the product deviating from the instructions may increase the risk of development and selection
of resistant bacteria and decrease the effectiveness of treatment with other macrolides due to the
potential for cross-resistance.
Generally, strains of
B. hyodysenteriae
have higher MIC values in cases of resistance against other
macrolides, such as tylosin. The clinical relevance of this reduced susceptibility is not fully explored.
Cross-resistance between tylvalosin and other macrolides cannot be excluded.
13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIALS, IF ANY
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.
14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
07.03.2011
Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency
http://www.ema.europa.eu
.
15. OTHER INFORMATION
Not all pack sizes may be marketed. Consideration should be given to official guidance on the
incorporation of medicated premixes in final feed.
For any information about this veterinary medicinal product, please contact the local representative of
the marketing authorisation holder.
België/Belgique/Belgien
Alpharma BVBA Belgium
Garden Square, Laarstraat 16,
B-2610 Antwerp,
BELGIË/BELGIQUE/BELGIEN.
Tel: +32 3 287 38 80
Fax: +32 3 287 38 81
Luxembourg/Luxemburg
ECO Animal Health Ltd.,
The Grange, 100 The High Street,
London, N14 6BN,
Royaume-Uni
Tel: +44 (0) 20 8447 8899
Email:
sales@ecoanimalhealth.com
Република България
ECO Animal Health Ltd.,
The Grange, 100 The High Street,
London, N14 6BN,
Великобритания (Обединеното кралство)
телефон: +44 (0) 20 8447 8899
Email:
sales@ecoanimalhealth.com
Magyarország
Dunavet-B ZRt,
7020 Dunaföldvár, Ady E. u. 5.
MAGYARORSZÁG.
Tel: +36 75 542 940
Email:
dunavet-bp@externet.hu
Česká republika
Cymedica spol. sr.o.,
Pod Nádražím 853, 268 01 Hořovice,
ČESKÁ REPUBLIKA.
Tel: +420 800 137 269
Email:
info@cymedica.cz
Malta
ECO Animal Health Ltd.,
The Grange, 100 The High Street,
London, N14 6BN,
Ir-Renju Unit.
Tel: +44 (0) 20 8447 8899
Email:
sales@ecoanimalhealth.com
70
Danmark
Scanvet Animal Health A/S
Kongevejen 66
DK-3480 Fredensborg,
Danmark
Tel.: 48 48 43 17
Fax: 48 48 28 24
Email:
info@scanvet.dk
Nederland
Eurovet Animal Health BV
Handelsweg 25
5531 AE Bladel
Nederland
Tel: +31 (0)497-544300
Fax: +31 (0)497-544337
Email:
info@eurovet-ah.com
Deutschland
ESTEVE GmbH
Max-Planck-Strasse 11
D-85716 Unterschleissheim, Deutschland
HRB München 99927
Tel: +49-89-31566772
Email:
info-esteve@t-online-de
Norge
ECO Animal Health Ltd.,
The Grange, 100 The High Street,
London, N14 6BN,
Storbritannia
Tel: +44 (0) 20 8447 8899
Email:
sales@ecoanimalhealth.com
Eesti
AS Magnum Veterinaaria
Vae 16, Laagri, Harju mk
Eesti
Tel: +372 6 501 920
Fax: +372 6 501 996
Österreich
ESTEVE GmbH
Max-Planck-Strasse 11
D-85716 Unterschleissheim, Deutschland
HRB München 99927
Tel: +49-89-31566772
Email:
info-esteve@t-online-de
Polska
Calier Polska Sp. z o.o.
Ul. Wyszyńskiego 38
66-400 Gorzów Wlkp
Polska
Tel: +48 95 7214521
fax: +48 95 7214532
E-mail:
calierpolska@calier.com.pl
España
ESTEVE Veterinaria
Laboratorios Dr. Esteve, S.A.
Mare de Deu de Montserrat, 221
08041 Barcelona
España
Tel: +34 93 4466000
Email:
veterinaria@esteve.es
Portugal
ESTEVE veterinaria
Esteve Farma, Lda.
Avenida do Forte n° 3
Edifício Suécia III - Piso 1
2794-044 Carnaxide
Portugal
Tel: +351 214246027
Email:
e.veterinaria@esteve.es
France
Alpharma sarl
Silic 411, 3 Impasse de la Noisette,
91374 Verrières le Buisson Cedex,
France
Tél: +33 1 69 53 40 50
Fax: +33 1 69 53 40 51
România
SC DELOS IMPEX 96 SRL,
81 Horia, Closca si Crisan Street,
Otopeni City,
Ilfov District,
România
Tel: +40 372 714 413
Email:
delosmedica@yahoo.com
71
Ireland
ECO Animal Health Ltd,
The Grange, 100 The High Street,
London, N14 6BN,
UNITED KINGDOM.
Tel: +44 (0) 20 8447 8899
Email:
sales@ecoanimalhealth.com
Slovenija
ECO Animal Health Ltd,
The Grange, 100 The High Street,
London, N14 6BN,
Velika Britanija.
Tel: +44 (0) 20 8447 8899
Email:
sales@ecoanimalhealth.com
Ísland
ECO Animal Health Ltd.,
The Grange, 100 The High Street,
London, N14 6BN,
Bretland
Tel: +44 (0) 20 8447 8899
Email:
sales@ecoanimalhealth.com
Slovenská republika
Cymedica SK spol. s.r.o.,
Družstevná 1415/8, 960 01 Zvolen,
SLOVENSKÁ REPUBLIKA.
Tel: +421(0) 455400040
Email:
cymedica@cymedica.sk
Italia
Alpharma BVBA Belgium
Garden Square, Laarstraat 16,
B-2610 Antwerp,
BELGIO.
Tel: +32 3 287 38 80
Fax: +32 3 287 38 81
Suomi/Finland
ECO Animal Health Ltd.,
The Grange, 100 The High Street,
London, N14 6BN,
Iso-Britannia
Tel: +44 (0) 20 8447 8899
Email:
sales@ecoanimalhealth.com
Κύπρος
Cycon Chemicals Ltd
5, Promitheos, 1065 Nicosia
CYPRUS/ΚΥΠΡΟΣ.
Τηλ: + 357-22818498
Sverige
ECO Animal Health Ltd.,
The Grange, 100 The High Street,
London, N14 6BN,
Storbritannien
Tel: +44 (0) 20 8447 8899
Email:
sales@ecoanimalhealth.com
Latvija
Magnum Veterinārija SIA
Ulbrokas iela 23, Rīga, LV-1021,
Latvija
Tel: +371 671 60091
Fax: +371 671 60095
United Kingdom
ECO Animal Health Ltd.,
The Grange, 100 The High Street,
London, N14 6BN,
United Kingdom
Tel: 020 8447 8899
Email:
sales@ecoanimalhealth.com
Lietuva
UAB „Magnum Veterinarija“
J. Urbšio g. 3, LT-35169, Panevėžys, Lietuva.
Tel.: +370 45 502 730
Fax: +370 45 502 733
72
PACKAGE LEAFLET
Aivlosin 8.5 mg/g oral powder for pigs
1.
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing Authorisation Holder:
ECO Animal Health Limited
78 Coombe Road
New Malden
Surrey
KT3 4QS
United Kingdom
Manufacturer for the batch release:
Gallows Green Services Limited
Cod Beck Blenders, Cod Beck Mill
Dalton, Thirsk, North Yorkshire
YO7 3HR
United Kingdom
2.
Aivlosin 8.5 mg/g oral powder for pigs
3.
STATEMENT OF ACTIVE SUBSTANCE AND OTHER INGREDIENTS
Active substance
tylvalosin
8.5 mg/g
(as tylvalosin tartrate)
4.
INDICATIONS
Treatment and prevention of swine enzootic pneumonia caused by susceptible strains of
Mycoplasma hyopneumoniae
. At the recommended dose, lung lesions and weight loss are
reduced but infection with
Mycoplasma hyopneumoniae
is not eliminated.
Treatment of porcine proliferative enteropathy caused by
Lawsonia intracellularis
.
Treatment of clinical outbreaks of swine dysentery in herds, where the disease has been
diagnosed, and prevention of further clinical cases.
5.
None.
6.
ADVERSE REACTIONS
None known.
If you notice any side effects, please inform your veterinary surgeon.
73
7.
Pigs.
8.
DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION
For oral use.
For use in individual pigs on farms where only a small number of pigs are to receive the medicine.
Larger groups should be treated with medicated feeding stuff containing the premix.
9.
ADVICE ON CORRECT ADMINISTRATION
The oral powder is for use in individual pigs on farms where only a small number of pigs are to
receive the medicine. Larger groups should be treated with medicated feeding stuff containing the
premix.
For treatment and prevention of Swine Enzootic Pneumonia
The dosage is 2.125 mg tylvalosin per kg bodyweight per day in-feed for 7 consecutive days.
Secondary infection by organisms such as
Pasteurella multocida
and
Actinobacillus
pleuropneumoniae
may complicate enzootic pneumonia and require specific medication.
For treatment of Porcine Proliferative Enteropathy (ileitis)
The dosage is 4.25 mg tylvalosin per kg bodyweight per day for 10 consecutive days.
For treatment and prevention of Swine Dysentery
The dosage is 4.25 mg tylvalosin per kg bodyweight per day for 10 consecutive days.
This is achieved by thoroughly mixing Aivlosin 8.5 mg/g oral powder into the daily ration for each
individual pig. Scoops of 3 sizes are provided for measuring the correct amount of Aivlosin 8.5 mg/g
oral powder for mixing with the daily ration, according to the schedule below. The feed containing the
oral powder should be provided as the sole ration for the periods recommended above.
The pig to be treated should be weighed and the amount of feed that the pig is likely to consume
should be estimated, based on a daily feed intake equivalent to 5 % of bodyweight. Consideration must
be given to pigs whose daily feed intake is reduced or restricted. The correct quantity of Aivlosin 8.5
mg/g oral powder should then be added to the estimated quantity of daily ration for each pig, in a
bucket or similar receptacle, and thoroughly mixed.
The product should only be added to dry non-pelleted feed.
Swine Enzootic Pneumonia
2.125 mg/kg bodyweight
PPE (ileitis) & Swine Dysentery
4.25 mg/kg bodyweight
Bodyweight
range (kg)
Scoop
size
Number of
scoops
Bodyweight
range (kg)
Scoop
size
Number of
scoops
6.5–12
5 ml
1
6.5–12
10 ml
1
13–24
10 ml
2
13–24
10 ml
1
25–48
10 ml
4
25–48
10 ml
2
49–72
10 ml
6
49–72
10 ml
3
73–96
10 ml
8
73–96
10 ml
4
97–120
10 ml
5
97–115
25 ml
4
121–144
10 ml
6
116–145
25 ml
5
145–168
10 ml
7
146–175
25 ml
6
74
169–192
10 ml
8
176–200
25 ml
7
NB: A level scoop of the product
should be measured
NB: A level scoop of the product
should be measured
Acute cases and severely diseased pigs with reduced food or water intake should be treated with a
suitable injectable product.
In addition to medical treatment, good management and hygiene practices should be established on the
farm in order to reduce the risk of infection and to control the potential development of resistance.
10. WITHDRAWAL PERIOD
Meat and offal: 2 days.
11. SPECIAL STORAGE PRECAUTIONS
Keep out of the reach and sight of children.
Do not store above 25 °C.
Keep the container tightly closed.
Store in the original container.
Do not use after the expiry date stated on the label.
Feed to which the oral powder has been added should be replaced if not consumed within 24 hours.
12. SPECIAL WARNINGS
Because Aivlosin has been shown to cause hypersensitivity reactions in laboratory animals people
with known hypersensitivity to tylvalosin tartrate should avoid any contact with the product.
When adding the veterinary medicinal product to the individual feed ration and when handling this
feed, direct contact with eyes, skin and mucous membranes should be avoided. Personal protective
equipment should be worn when handling the veterinary medicinal product or the feed with product
added: overalls, impervious gloves and either a disposable half-mask respirator conforming to
European Standard EN 149 or a non-disposable respirator conforming to European Standard EN 140,
with a filter to EN 143. Wash contaminated skin.
In case of accidental ingestion seek medical advice immediately and show the label to the physician.
The safety of Aivlosin during pregnancy and lactation has not been established in pigs. Use only in
accordance with risk/benefit assessment by the responsible veterinarian. Studies in laboratory animals
have not produced any evidence of teratogenicity. Maternal toxicity in rodents has been observed at
doses of 400 mg tylvalosin per kg bodyweight and above. In mice, a slight reduction in the foetal
bodyweight was seen at doses causing maternal toxicity.
It is sound clinical practice to base treatment on susceptibility testing of the bacteria isolated from the
animal. If this is not possible, therapy should be based on local (regional, farm level) epidemiological
information about susceptibility of target bacteria.
Use of the product deviating from the instructions may increase the risk of development and selection
of resistant bacteria and decrease the effectiveness of treatment with other macrolides due to the
potential for cross-resistance.
Cross-resistance to other macrolide antibiotics cannot be excluded.
75
13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIALS, IF ANY
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.
14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
07.03.2011
Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency
http://www.ema.europa.eu
.
15. OTHER INFORMATION
Not all pack sizes may be marketed.
For any information about this veterinary medicinal product, please contact the local representative of
the marketing authorisation holder.
België/Belgique/Belgien
Alpharma BVBA Belgium
Garden Square, Laarstraat 16,
B-2610 Antwerp,
BELGIË/BELGIQUE/BELGIEN.
Tel: +32 3 287 38 80
Fax: +32 3 287 38 81
Luxembourg/Luxemburg
ECO Animal Health Ltd.,
The Grange, 100 The High Street,
London, N14 6BN,
Royaume-Uni
Tel: +44 (0) 20 8447 8899
Email:
sales@ecoanimalhealth.com
Република България
ECO Animal Health Ltd.,
The Grange, 100 The High Street,
London, N14 6BN,
Великобритания (Обединеното кралство)
телефон: +44 (0) 20 8447 8899
Email:
sales@ecoanimalhealth.com
Magyarország
Dunavet-B ZRt,
7020 Dunaföldvár, Ady E. u. 5.
MAGYARORSZÁG.
Tel: +36 75 542 940
Email:
dunavet-bp@externet.hu
Česká republika
Cymedica spol. sr.o.,
Pod Nádražím 853, 268 01 Hořovice,
ČESKÁ REPUBLIKA.
Tel: +420 800 137 269
Email:
info@cymedica.cz
Malta
ECO Animal Health Ltd.,
The Grange, 100 The High Street,
London, N14 6BN,
Ir-Renju Unit.
Tel: +44 (0) 20 8447 8899
Email:
sales@ecoanimalhealth.com
Danmark
Scanvet Animal Health A/S
Kongevejen 66
DK-3480 Fredensborg,
Danmark
Tel.: 48 48 43 17
Fax: 48 48 28 24
Email:
info@scanvet.dk
Nederland
Eurovet Animal Health BV
Handelsweg 25
5531 AE Bladel
Nederland
Tel: +31 (0)497-544300
Fax: +31 (0)497-544337
Email:
info@eurovet-ah.com
76
Deutschland
ESTEVE GmbH
Max-Planck-Strasse 11
D-85716 Unterschleissheim, Deutschland
HRB München 99927
Tel: +49-89-31566772
Email:
info-esteve@t-online-de
Norge
ECO Animal Health Ltd.,
The Grange, 100 The High Street,
London, N14 6BN,
Storbritannia
Tel: +44 (0) 20 8447 8899
Email:
sales@ecoanimalhealth.com
Eesti
AS Magnum Veterinaaria
Vae 16, Laagri, Harju mk
Eesti
Tel: +372 6 501 920
Fax: +372 6 501 996
Österreich
ESTEVE GmbH
Max-Planck-Strasse 11
D-85716 Unterschleissheim, Deutschland
HRB München 99927
Tel: +49-89-31566772
Email:
info-esteve@t-online-de
Polska
Calier Polska Sp. z o.o.
Ul. Wyszyńskiego 38
66-400 Gorzów Wlkp
Polska
Tel: +48 95 7214521
fax: +48 95 7214532
E-mail:
calierpolska@calier.com.pl
España
ESTEVE Veterinaria
Laboratorios Dr. Esteve, S.A.
Mare de Deu de Montserrat, 221
08041 Barcelona
España
Tel: +34 93 4466000
Email:
veterinaria@esteve.es
Portugal
ESTEVE veterinaria
Esteve Farma, Lda.
Avenida do Forte n° 3
Edifício Suécia III - Piso 1
2794-044 Carnaxide
Portugal
Tel: +351 214246027
Email:
e.veterinaria@esteve.es
France
Alpharma sarl
Silic 411, 3 Impasse de la Noisette,
91374 Verrières le Buisson Cedex,
France
Tél: +33 1 69 53 40 50
Fax: +33 1 69 53 40 51
România
SC DELOS IMPEX 96 SRL,
81 Horia, Closca si Crisan Street,
Otopeni City,
Ilfov District,
România
Tel: +40 372 714 413
Email:
delosmedica@yahoo.com
Ireland
ECO Animal Health Ltd,
The Grange, 100 The High Street,
London, N14 6BN,
UNITED KINGDOM.
Tel: +44 (0) 20 8447 8899
Email:
sales@ecoanimalhealth.com
Slovenija
ECO Animal Health Ltd,
The Grange, 100 The High Street,
London, N14 6BN,
Velika Britanija.
Tel: +44 (0) 20 8447 8899
Email:
sales@ecoanimalhealth.com
77
Ísland
ECO Animal Health Ltd.,
The Grange, 100 The High Street,
London, N14 6BN,
Bretland
Tel: +44 (0) 20 8447 8899
Email:
sales@ecoanimalhealth.com
Slovenská republika
Cymedica SK spol. s.r.o.,
Družstevná 1415/8, 960 01 Zvolen,
SLOVENSKÁ REPUBLIKA.
Tel: +421(0) 455400040
Email:
cymedica@cymedica.sk
Italia
Alpharma BVBA Belgium
Garden Square, Laarstraat 16,
B-2610 Antwerp,
BELGIO.
Tel: +32 3 287 38 80
Fax: +32 3 287 38 81
Suomi/Finland
ECO Animal Health Ltd.,
The Grange, 100 The High Street,
London, N14 6BN,
Iso-Britannia
Tel: +44 (0) 20 8447 8899
Email:
sales@ecoanimalhealth.com
Κύπρος
Cycon Chemicals Ltd
5, Promitheos, 1065 Nicosia
CYPRUS/ΚΥΠΡΟΣ.
Τηλ: + 357-22818498
Sverige
ECO Animal Health Ltd.,
The Grange, 100 The High Street,
London, N14 6BN,
Storbritannien
Tel: +44 (0) 20 8447 8899
Email:
sales@ecoanimalhealth.com
Latvija
Magnum Veterinārija SIA
Ulbrokas iela 23, Rīga, LV-1021,
Latvija
Tel: +371 671 60091
Fax: +371 671 60095
United Kingdom
ECO Animal Health Ltd.,
The Grange, 100 The High Street,
London, N14 6BN,
United Kingdom
Tel: 020 8447 8899
Email:
sales@ecoanimalhealth.com
Lietuva
UAB „Magnum Veterinarija“
J. Urbšio g. 3, LT-35169, Panevėžys, Lietuva.
Tel.: +370 45 502 730
Fax: +370 45 502 733
78
PACKAGE LEAFLET FOR
Aivlosin 625 mg/g granules for use in drinking water for chickens
(attached as concertina label directly to the immediate package)
1.
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing Authorisation Holder:
ECO Animal Health Limited
78 Coombe Road
New Malden
Surrey
KT3 4QS
United Kingdom
Manufacturer for the batch release
:
Gallows Green Services Limited
Cod Beck Blenders, Cod Beck Estate
Dalton Lane, Dalton
Thirsk, North Yorkshire
YO7 3HR
United Kingdom
2.
Aivlosin 625 mg/g granules for use in drinking water for chickens
Tylvalosin (as tylvalosin tartrate)
3.
STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENT
Active substance:
tylvalosin as tartrate
625 mg/g
White granules.
4.
INDICATIONS
Treatment and prevention of respiratory disease associated with
Mycoplasma gallisepticum
in
chickens.
As an aid in the prevention strategy to reduce the clinical signs and mortality from respiratory disease
in flocks, where infection
in ovum
with
Mycoplasma gallisepticum
is likely because the disease is
known to exist in the parent generation. The prevention strategy should include efforts to eliminate the
infection from the parent generation.
5.
None.
79
6.
None known.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your
veterinary surgeon.
7.
Chickens.
8.
DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION
For use in drinking water.
For treatment of respiratory disease associated with
Mycoplasma gallisepticum:
The dosage is 25 mg tylvalosin per kg bodyweight per day in drinking water for 3 consecutive days.
When used as an aid in the prevention strategy (where infection
in ovum
with
Mycoplasma
gallisepticum
is likely):
The dosage is 25 mg tylvalosin per kg bodyweight per day in drinking water for 3 consecutive days at
1 day old. This is followed by a second treatment with 25 mg tylvalosin per kg bodyweight per day in
drinking water for 3 consecutive days at the period of risk,
i.e. at times of management stress such as
administration of vaccines (typically when birds are 2–3 weeks old).
Determine the combined bodyweight (in kg) of all the chickens to be treated. Select the correct
number of sachets according to the amount of product required.
One sachet of 40 g is sufficient for a total of 1,000 kg of chickens (e.g. 20,000 birds with an average
bodyweight of 50 g). One sachet of 400 g is sufficient to treat a total of 10,000 kg of chickens (e.g.
20,000 birds with an average bodyweight of 500 g).
In order to achieve a correct dose, the preparation of a concentrated (stock) solution might be required
(e.g. to treat a total of 500 kg total bird weight, only 50 % of the prepared stock solution prepared from
the 40 g sachet should be used).
The product should be added to a volume of water that the chickens will consume in one day. No other
source of drinking water should be available during the medication period.
9.
ADVICE ON CORRECT ADMINISTRATION
The product may be mixed directly into the drinking water system or first mixed as a stock solution
into a smaller amount of water, which is then added into the drinking water system.
When mixing the product directly into the drinking water system, the contents of the sachet should be
sprinkled onto the surface of the water and mixed thoroughly until a clear solution is produced
(usually within 3 minutes).
When preparing a stock solution the maximum concentration should be 40 g per 1,500 ml or 400 g of
product per 15 litres and it is necessary to mix the solution for 10 minutes. After this time, any
remaining cloudiness will not affect the efficacy of the veterinary medicinal product.
80
10. WITHDRAWAL PERIOD
Meat and offal: 2 days.
Not authorised for use in laying birds producing eggs for human consumption. Do not use within 14
days of onset of the laying.
11. SPECIAL STORAGE PRECAUTIONS
Keep out of the reach and sight of children.
Do not store above 30 C.
Opened sachets should not be stored.
Do not use after the expiry date, which stated on the label as “EXP”.
Shelf-life of the medicated drinking water: 24 hours.
Only a sufficient amount of medicated drinking water should be prepared to cover the daily requirements.
Medicated drinking water should be replaced every 24 hours.
12. SPECIAL WARNINGS
Good management and hygiene practices should be introduced in order to reduce the risk of re-
infection.
It is sound clinical practice to base treatment on susceptibility testing of the bacteria isolated from the
animal. If this is not possible, therapy should be based on local (regional, farm level) epidemiological
information about susceptibility of target bacteria.
Use of the product deviating from the instructions may increase the risk of development and selection
of resistant bacteria and decrease the effectiveness of treatment with other macrolides due to the
potential for cross-resistance.
Tylvalosin has been shown to cause hypersensitivity reactions in laboratory animals; therefore, people
with known hypersensitivity to tylvalosin tartrate should avoid contact with the veterinary medicinal
product.
When mixing the veterinary medicinal product and handling the medicated water, direct contact, with
eyes, skin and mucous membranes should be avoided. Personal protective equipment should
consisting of impervious gloves and a half-mask respirator conforming to European Standard EN 149
or a non-disposable respirator conforming to European Standard EN 140, with a filter conforming to
European Standard EN 143 be worn when mixing the veterinary medicinal product. Wash
contaminated skin.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the
label to the physician.
13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIALS, IF ANY
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
product should be disposed of in accordance with local requirements.
81
14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
07.03.2011
Detailed information on this product is available on the website of the European Medicines Agency
15. OTHER INFORMATION
Aivlosin 625 mg/g granules for use in drinking water for chickens is available in sachets containing
40 g or 400 g. Not all pack sizes may be marketed.
For any information about this veterinary medicinal product, please contact the local representative of
the marketing authorisation holder.
België/Belgique/Belgien
Alpharma BVBA Belgium
Garden Square, Laarstraat 16,
B-2610 Antwerp,
BELGIË/BELGIQUE/BELGIEN.
Tel: +32 3 287 38 80
Fax: +32 3 287 38 81
Luxembourg/Luxemburg
ECO Animal Health Ltd.,
The Grange, 100 The High Street,
London, N14 6BN,
Royaume-Uni
Tel: +44 (0) 20 8447 8899
Email:
sales@ecoanimalhealth.com
Република България
ECO Animal Health Ltd.,
The Grange, 100 The High Street,
London, N14 6BN,
Великобритания (Обединеното кралство)
телефон: +44 (0) 20 8447 8899
Email:
sales@ecoanimalhealth.com
Magyarország
Dunavet-B ZRt,
7020 Dunaföldvár, Ady E. u. 5.
Magyarország
Tel: +36 75 542 940
Email:
dunavet-bp@externet.hu
Česká republika
ECO Animal Health Ltd.,
The Grange, 100 The High Street,
London, N14 6BN,
Velká Británie
Tel: +44 (0) 20 8447 8899
Email:
sales@ecoanimalhealth.com
Malta
ECO Animal Health Ltd.,
The Grange, 100 The High Street,
London, N14 6BN,
Ir-Renju Unit
Tel: +44 (0) 20 8447 8899
Email:
sales@ecoanimalhealth.com
Danmark
ECO Animal Health Ltd.,
The Grange, 100 The High Street,
London, N14 6BN,
Det Forenede Kongerige
Tel: +44 (0) 20 8447 8899
Email:
sales@ecoanimalhealth.com
Nederland
Eurovet Animal Health BV
Handelsweg 25
5531 AE Bladel
Nederland
Tel: +31 (0)497-544300
Fax: +31 (0)497-544337
E-mail:
info@eurovet-ah.com
82
Deutschland
ESTEVE GmbH
Max-Planck-Strasse 11
D-85716 Unterschleissheim, Deutschland
HRB München 99927
Tel: +49-89-31566772
Norge
ECO Animal Health Ltd.,
The Grange, 100 The High Street,
London, N14 6BN,
Storbritannia
Tel: +44 (0) 20 8447 8899
Email:
sales@ecoanimalhealth.com
Eesti
ECO Animal Health Ltd.,
The Grange, 100 The High Street,
London, N14 6BN,
Ühendkuningriik
Tel: +44 (0) 20 8447 8899
Email:
sales@ecoanimalhealth.com
Österreich
ESTEVE GmbH
Max-Planck-Strasse 11
D-85716 Unterschleissheim, Deutschland
HRB München 99927
Tel: +49-89-31566772
Polska
ECO Animal Health Ltd.,
The Grange, 100 The High Street,
London, N14 6BN,
Wielka Brytania.
Tel: +44 (0) 20 8447 8899
Email:
sales@ecoanimalhealth.com
España
ESTEVE Veterinaria
Laboratorios Dr. Esteve, S.A.
Mare de Deu de Montserrat, 221
08041 Barcelona
España
Tel: +34 93 4466000
Email:
veterinaria@esteve.es
Portugal
ESTEVE veterinaria
Esteve Farma, Lda.
Avenida do Forte n° 3
Edifício Suécia III - Piso 1
2794-044 Carnaxide
Portugal
Tel: +351 214246027
Email:
e.veterinaria@esteve.es
France
Alpharma sarl
Silic 411, 3 Impasse de la Noisette,
91374 Verrières le Buisson Cedex,
France
Tél: +33 1 69 53 40 50
Fax: +33 1 69 53 40 51
România
SC DELOS IMPEX 96 SRL,
81 Horia, Closca si Crisan Street,
Otopeni City,
Ilfov District,
România
Tel: +40 372 714 413
Email:
delosmedica@yahoo.com
Ireland
ECO Animal Health Ltd,
The Grange, 100 The High Street,
London, N14 6BN,
United Kingdom
Tel: +44 (0) 20 8447 8899
Email:
sales@ecoanimalhealth.com
Slovenija
ECO Animal Health Ltd,
The Grange, 100 The High Street,
London, N14 6BN,
Velika Britanija
Tel: +44 (0) 20 8447 8899
Email:
sales@ecoanimalhealth.com
83
Ísland
ECO Animal Health Ltd.,
The Grange, 100 The High Street,
London, N14 6BN,
Bretland
Tel: +44 (0) 20 8447 8899
Email:
sales@ecoanimalhealth.com
Slovenská republika
ECO Animal Health Ltd.,
The Grange, 100 The High Street,
London, N14 6BN,
Velika Britanija
Tel: +44 (0) 20 8447 8899
Email:
sales@ecoanimalhealth.com
Italia
Esteve, S.p,A,
Via Ippolito Rosellini, 12, 1º piano
20124 Milano
Italia
Tel: +39 0269964201
Email:
estevespa@esteve.es
Suomi/Finland
ECO Animal Health Ltd.,
The Grange, 100 The High Street,
London, N14 6BN,
Iso-Britannia
Tel: +44 (0) 20 8447 8899
Email:
sales@ecoanimalhealth.com
Κύπρος
Cycon Chemicals Ltd
5, Promitheos, 1065 Nicosia
Κύπρος
Τηλ: + 357-22818498
Sverige
ECO Animal Health Ltd.,
The Grange, 100 The High Street,
London, N14 6BN,
Storbritannien
Tel: +44 (0) 20 8447 8899
Email:
sales@ecoanimalhealth.com
Latvija
ECO Animal Health Ltd.,
The Grange, 100 The High Street,
London, N14 6BN,
Anglija
Tel: +44 (0) 20 8447 8899
Email:
sales@ecoanimalhealth.com
United Kingdom
ECO Animal Health Ltd.,
The Grange, 100 The High Street,
London, N14 6BN,
United Kingdom
Tel: +44 (0) 20 8447 8899
Email:
sales@ecoanimalhealth.com
Lietuva
ECO Animal Health Ltd.,
The Grange, 100 The High Street,
London, N14 6BN,
Jungtinė Karalystė.
Tel: +44 (0) 20 8447 8899
84
Source: European Medicines Agency
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