ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Econor 50% premix for medicated feed for pigs
Econor 10% premix for medicated feed for pigs
Econor 1% premix for medicated feed for pigs
Econor 0.5% premix for medicated feed for pigs
Econor contains valnemulin in the form of valnemulin hydrochloride.
Econor 50% Econor 10% Econor 1%
Econor 0.5%
Active substance
Valnemulin
hydrochloride
532.5 mg/g
106.5 mg/g
10.65 mg/g
5.325 mg/g
equivalent
to
500 mg/g
100 mg/g
10 mg/g
5 mg/g
valnemulin base
For a full list of excipients, see section 6.1.
Premix for medicated feedingstuff
Pigs
4.2 Indications for use
Econor 10% and 50%:
The treatment and prevention of swine dysentery.
The treatment of clinical signs of porcine proliferative enteropathy (ileitis).
The prevention of clinical signs of porcine colonic spirochaetosis (colitis) when the disease has been
diagnosed in the herd.
Treatment and prevention of swine enzootic pneumonia. At the recommended dosage of 10 - 12 mg/kg
bodyweight lung lesions and weight loss are reduced, but infection with
Mycoplasma hyopneumoniae
is not eliminated.
Econor 0.5% and 1%:
For the treatment and prevention of swine dysentery.
The treatment of clinical signs of porcine proliferative enteropathy (ileitis).
The prevention of clinical signs of porcine colonic spirochaetosis (colitis) when the disease has been
diagnosed in the herd.
Do not administer the product to pigs receiving ionophores.
2
None.
4.5 Special precaution(s) for use
Adverse drug reactions have occurred following the use of Econor. Their occurrence appears to be
mainly associated with breed mixes that include Danish and/or Swedish Landrace. Extreme care
should therefore be taken in the use of Econor in pigs of the Danish and Swedish Landrace breeds, and
their crossbreeds thereof, especially in younger pigs.
Special precautions to be taken by the person administering the veterinary medicinal product to
animals
When mixing the product and handling the final feed containing the product, direct contact with the
skin and mucous membranes should be avoided. In case of accidental ingestion, seek medical advice
immediately and show the product label. People with known hypersensitivity to valnemulin should
administer the product with caution.
Adverse drug reactions following the use of Econor are mainly associated with breeds and cross
breeds of Danish and/or Swedish Landrace.
Most common adverse reactions observed in these pigs are pyrexia, anorexia and in severe cases
ataxia and recumbency. On affected farms, one third of the pigs treated were affected, with a mortality
of 1%. A percentage of such pigs may also suffer oedema or erythema (posterior in distribution), and
palpebral oedema. In controlled trials in susceptible animals mortality was less than 1%.
In the case of an adverse reaction, immediate withdrawal of medication is recommended. Severely
affected pigs should be removed to clean dry pens and given appropriate treatment, including
treatment for concurrent disease.
Valnemulin is well-accepted in feed, but administered at concentrations above 200 mg valnemulin / kg
feed may result in transient reduction in food consumption associated with unpalatability during the
first few days of feeding.
4.7 Use during pregnancy and lactation
Whilst studies in rats and mice have not produced any evidence of teratogenic effect, the safety in
pregnant and lactating sows has not been established.
Valnemulin has been shown to interact with ionophores such as monensin, salinomycin and narasin
and may result in signs indistinguishable from an ionophore toxicosis. Animals should not receive
products containing monensin, salinomycin or narasin, during or at least 5 days before or after
treatment with valnemulin. Severe growth depression, ataxia, paralysis or death may result.
In feed use.
The uptake of medicated feed depends on the clinical condition of the animal. In order to obtain the
correct dosage the concentration of Econor has to be adjusted. Inclusion levels may also need to be
increased in older pigs or pigs on restricted feed to achieve target dosage.
3
Indication Dosage
(active
substance)
Application period of
medicated feed as the
sole daily ration
Application in feed
Treatment of
Incorporation of 75 mg active substance
per kg feed with:
Swine
Dysentery
3-4 mg/kg
bodyweight/day
Minimum of 7 days and
up to 4 weeks or until
signs of disease disappear
Econor 50% - 150 mg / kg feed
Econor 10% - 750 mg / kg feed
Econor 1% - 7.5 g / kg feed
Econor 0.5% - 15 g / kg feed
This dose level is effective in the treatment of clinical disease, but higher dosages or longer duration of
treatment may be necessary for complete elimination of infection. It is important to institute
medication as early as possible in an outbreak of swine dysentery. If there is no response to treatment
within 5 days, the diagnosis should be re-established.
Indication Dosage
(active
substance)
Application period of
medicated feed as the
sole daily ration
Application in feed
Treatment of
Incorporation of 75 mg active substance
per kg feed with:
3-4 mg/kg
bodyweight/day
2 weeks or until signs of
disease disappear
Clinical signs
of Porcine
Proliferative
Enteropathy
(ileitis)
Econor 50% - 150 mg / kg feed
Econor 10% - 750 mg / kg feed
Econor 1% - 7.5 g / kg feed
Econor 0.5% - 15 g / kg feed
This dose level is effective under normal situation in the treatment of clinical signs of disease, but
higher dosages or longer duration of treatment may be necessary for complete elimination of infection.
It is important to institute medication as early as possible in an outbreak of porcine proliferative
enteropathy. If there is no response to treatment within 5 days, the diagnosis should be re-established.
For severely affected animals which fail to respond to treatment within 3-5 days, parenteral treatment
should be considered.
Indication Dosage (active
substance)
Application period of
medicated feed as the
sole daily ration
Application in feed
Prevention of
minimum of 7 days and
up to 4 weeks
Incorporation of 25 mg active substance
per kg feed with:
Swine
Dysentery
1.0 – 1.5 mg/kg
bodyweight/day
Econor 50% - 50 mg / kg feed
Econor 10% - 250 mg / kg feed
Econor 1% - 2.5 g / kg feed
Econor 0.5% - 5 g / kg feed
4 weeks
Clinical signs
of Porcine
Colonic
Spirochaetosis
(colitis)
Long term preventative use of valnemulin should be avoided by improving management practice and
thorough cleansing and disinfection. Consideration should be given to the eradication of infection
from the farm.
4
Indication Dosage (active
substance)
Application period of
medicated feed as the
sole daily ration
Application in feed
Treatment
and
Prevention of
Incorporation of 200 mg active
substance per kg feed with :
10 – 12 mg/kg
bodyweight/day
Up to 3 weeks
Econor 50% - 400 mg/kg feed
Econor 10% - 2 g/kg feed
Swine
Enzootic
Pneumonia
Secondary infection by organisms such as
Pasteurella multocida
and
Actinobacillus
pleuropneumoniae
may complicate enzootic pneumonia and require specific medication.
Mixing Instructions:
The product has been shown to be stable to the pelleting process at temperatures of 75
o
C. Aggressive
pelleting conditions such as temperatures in excess of 80
o
C, and the use of abrasive substances for pre-
mixture should be avoided.
Econor 50%
mg Econor 50% premix/kg feed = Dosage required (mg/kg) x 2 x bodyweight (kg)/Daily feed intake
(kg).
To achieve good mixture and homogeneity of incorporation, the use of pre-mixture is required. The
required quantity of product is thoroughly mixed with a feed ingredient of similar physical nature (e.g.
wheat middlings) in the proportion: 1 part Econor 50% premix to 20 parts feed ingredient.
Econor 10%
mg Econor 10% premix/kg feed = Dosage required (mg/kg) x 10 x bodyweight (kg)/Daily feed intake
(kg).
To achieve good mixture and homogeneity of incorporation, the use of a pre-mixture is recommended.
The required quantity of product is thoroughly mixed with a feed ingredient of similar physical nature
(e.g. wheat middlings) in the proportion: 1 part Econor 10% premix to 10 parts feed ingredient.
Econor 1%
mg Econor 1% premix/kg feed = Dosage required (mg/kg) x 100 x bodyweight (kg)/Daily feed intake
(kg).
To achieve good mixture and homogeneity of incorporation, especially when product is incorporated
at a rate less than 5 kg/tonne feed, the use of a pre-mixture is recommended. The required quantity of
product is thoroughly mixed with a feed ingredient of similar physical nature (e.g. wheat middlings) in
the proportion: 1 part Econor 1% premix to 10 parts feed ingredient.
Econor 0.5%
mg Econor 0.5% premix/kg feed = Dosage required (mg/kg) x 200 x bodyweight (kg)/Daily feed
intake (kg).
4.10 Overdose
Toxic signs have not been seen in pigs given 5 times the recommended dose.
4.11 Withdrawal period
1 day
5
Pharmacotherapeutic group: Antibacterial for systemic use
ATCvet code: QJ01XQ02
5.1 Pharmacodynamic properties:
Valnemulin is an antibiotic belonging to the pleuromutilin group, which acts by the inhibition of the
initiation of protein synthesis at the level of the bacterial ribosome.
Valnemulin has activity against a range of bacteria including those responsible for enteric and
respiratory disease in pigs.
Valnemulin shows high activity against
Mycoplasma spp.
and spirochaetes such as
Brachyspira
hyodysenteriae and Brachyspira pilosicoli.
Species
MIC (Range) (
g/ml) MIC
50
(
g/ml) MIC
90
(
g/ml)
Mycoplasma hyopneumoniae
Brachyspira hyodysenteriae
Brachyspira pilosicoli
Lawsonia intracellularis
0.0009 – 0.125
0.025 – 4.0
0.0156 – 2.0
< 2.0 is the
concentration likely to
cause significant
inhibition of
intracellular growth
0.0025
0.2
0.0156
0.01
1.0
0.5
Valnemulin has little activity against
Enterobacteriaceae
, such as
Salmonella spp.
and
Escherichia
coli
.
5.2 Pharmacokinetic particulars:
In pigs, after a single oral dose of radiolabelled material >90% absorption was demonstrated.
Maximum plasma concentrations (C
max
) of radio-labelled or ‘cold’ material were obtained 1-4 hours
after dosing (T
max
) with a plasma half-life (t½), estimated from non-radioactive data, between 1 and
4½ hours. A linear relationship between concentration and dose administered was established.
After repeat dosing, slight accumulation occurred, but a steady state was achieved within 5 days.
Because of a marked ‘first pass’ effect, plasma concentrations are affected by the method of
administration, but valnemulin is highly concentrated in tissues, particularly the lungs and liver,
relative to plasma. Five days after the last of 15 doses of radiolabelled valnemulin administered to
pigs, the concentration in liver was >6 times that in plasma. Two hours after withdrawal of Premix
given in feed twice daily for 4 weeks at a dose of 15 mg/kg bodyweight/day, liver concentration was
1.58 g/g and lung concentration 0.23 g/g whereas concentrations in plasma were below the limit of
detection.
In pigs valnemulin is extensively metabolised and excretion of parent molecule and metabolites occurs
mainly via bile. 73% - 95% of the daily dose of total radioactivity was recovered from the faeces. The
plasma half-life was 1.3 – 2.7 hours, and the majority of the total radio-activity administered was
excreted within 3 days of the last administration.
6
6.1 List of excipients
Econor 0.5%, Econor 1%, Econor 10%
Hypromellose
Talc
Colloidal anhydrosus silicum
Isopropyl myristate
Lactose
Econor 50%
Hypromellose
Talc
6.2 Incompatibilities
None known
6.3 Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale:
Econor 0.5%: 3 years
Econor 50%, Econor 10%, Econor 1%: 5 years
Shelf-life when incorporated into meal feed and protected from light and moisture: 3 months
Shelf-life when incorporated into pelleted feed and protected from light and moisture: 3 weeks
6.4 Special precautions for storage
Store below 25°C.
Store product in the original container.
Part-used containers should be tightly closed following dispensing.
6.5 Nature and composition of immediate packaging
Econor 10%, Econor 50%:
1 x 1 kg and 1 x 25 kg aluminium-lined plastic bags.
Econor 1%:
1 x 1 kg, 1 x 2.5 kg and 1 x 25 kg aluminium-lined plastic bags.
Econor 0.5%:
1 x 5 kg and 1 x 25 kg aluminium-lined plastic bags.
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
Novartis Animal Health Austria GmbH
Biochemiestrasse 10
A-6250 Kundl
Austria
+ 43 (0)5338 2000
EU/2/98/010/004-006 (Econor 1%)
EU/2/98/010/017-018 (Econor 10%)
EU/2/98/010/021-022 (Econor 50%)
EU/2/98/010/023-024 (Econor 0.5%)
9. DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION
12/03/1999 - 06/03/2009
06/01/2011
PROHIBITION OF SALE, SUPPLY AND/OR USE
Consideration should be given to official guidance on the incorporation of medicated premixes in final
feeds.
Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency (EMA)
http://www.ema.europa.eu
/
.
8
Econor 10% oral powder for pigs
Active substance:
Valnemulin 100 mg/g
(equivalent to valnemulin hydrochloride 106.5 mg/g)
For a full list of excipients, see section 6.1.
Oral powder
White to pale yellow powder
Pigs.
Treatment of Swine Dysentery caused by
Brachyspira hyodysenteriae
.
Treatment of clinical signs of Porcine Proliferative Enteropathy (ileitis) caused by
Lawsonia
intracellularis.
Treatment of swine Enzootic Pneumonia caused by
Mycoplasma hyopneumoniae.
Do not administer the veterinary medicinal product to pigs receiving the ionophores monensin,
salinomycin or narasin.
As an adjunct to treatment, 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.
Especially in the case of swine dysentery, a targeted early eradication programme of the disease
should be considered.
Adverse reactions have occurred following the use of Econor. Their occurrence appears to be mainly
associated with breed mixes that include Danish and/or Swedish Landrace. Extreme care should
therefore be taken in the use of Econor in pigs of the Danish and Swedish Landrace breeds, and their
crossbreeds thereof, especially in younger pigs. When treating infections caused by
Brachyspira spp
.,
therapy should be based on local (regional, farm level) epidemiological information about
susceptibility of the target bacteria.
9
Special precautions to be taken by the person administering the veterinary medicinal product to
animals
Gloves should be worn when handling the veterinary medicinal product. When mixing the veterinary
medicinal product and handling the final feed containing the veterinary medicinal product, direct
contact with the skin and mucous membranes should be avoided. In case of accidental ingestion, seek
medical advice immediately and show the package leaflet or the label to the physician.
People with known hypersensitivity to valnemulin should administer the veterinary medicinal product
with caution.
Adverse reactions following the use of Econor are mainly associated with breeds and cross- breeds of
Danish and/or Swedish Landrace.
Most common adverse reactions observed in these pigs are pyrexia, anorexia and in severe cases
ataxia and recumbency. On affected farms, one third of the pigs treated were affected, with a mortality
of 1%. A percentage of such pigs may also suffer oedema or erythema (posterior in distribution), and
palpebral oedema. In controlled trials in susceptible animals, mortality was less than 1%.
In case of an adverse reaction, immediate withdrawal of medication is recommended. Severely
affected pigs should be removed to clean dry pens and given appropriate treatment, including
treatment for concurrent disease.
Valnemulin is well-accepted in feed, but administration at concentrations above 200 mg valnemulin /
kg feed may result in transient reduction in food consumption, associated with un-palatability during
the first days of feeding.
Laboratory studies in rats and mice have not produced any evidence of teratogenic effect, however, the
safety of the veterinary medicinal product in pregnant and lactating sows has not been established.
Valnemulin has been shown to interact with ionophores such as monensin, salinomycin and narasin
and may result in signs indistinguishable from an ionophore toxicosis. Animals should not receive
veterinary medicinal products containing monensin, salinomycin or narasin, during or at least 5 days
before or after treatment with valnemulin. Severe growth depression, ataxia, paralysis or death may
result.
For use in individual pigs on farms where only a small number of pigs are to receive the veterinary
medicinal product. Larger groups should be treated with medicated feeding stuff containing the
premix.
For severely affected animals, which fail to respond to treatment within 3-5 days, parenteral treatment
should be considered.
10
Treatment of Swine Dysentery
The recommended dose of valnemulin is 3-4 mg/kg bodyweight/day for a minimum of 7 days and up
to 4 weeks, or until signs of disease disappear.
This dose level is effective in the treatment of clinical disease, but higher doses or longer duration of
treatment may be necessary for complete elimination of infection. It is important to institute treatment
as early as possible in an outbreak of swine dysentery. If there is no response to treatment within 5
days, the diagnosis should be re-established.
Treatment of clinical signs of Porcine Proliferative Enteropathy (ileitis).
The recommended dose of valnemulin is 3-4 mg/kg bodyweight/day for 2 weeks or until signs of
disease disappear.
This dose level is effective under normal situations in the treatment of clinical signs of disease, but
higher doses or longer duration of treatment may be necessary for complete elimination of infection. It
is important to institute treatment as early as possible in an outbreak of porcine proliferative
enteropathy. If there is no response to treatment within 5 days, the diagnosis should be re-established.
Treatment of swine Enzootic Pneumonia.
The recommended dose of valnemulin is 10-12 mg/kg bodyweight/day for up to 3 weeks.
At the recommended dose of 10 - 12 mg/kg bodyweight lung lesions and weight loss are reduced, but
infection with
Mycoplasma hyopneumoniae
is not eliminated. Secondary infection by organisms such
as
Pasteurella multocida
and
Actinobacillus pleuropneumoniae
may complicate enzootic pneumonia
and require specific treatment.
Dosing Instructions:
The amount of feed mixed with Econor 10 % oral powder which is necessary for treatment should be
freshly prepared daily.
Daily dose calculation:
Amount Econor 10% oral powder (mg) required = Dose required (mg/kg) x pig bodyweight (kg) x 10 /
daily feed intake (kg).
This is achieved by thoroughly mixing the required amount of Econor oral powder into the daily ration
for each individual pig. The veterinary medicinal product can be used in dry or liquid feeds, where
water or milk co-products have been added. Scoops of 2 sizes are provided for measuring the correct
amount of the veterinary medicinal product for mixing with the daily ration, according to the dosage
guidance table below. The feed containing the oral powder should be provided as the sole ration for
the treatment periods recommended above. The veterinary medicinal product may be mixed in liquid
feeds containing water, or milk-based co-products only.
The pig to be treated should be weighed to calculate the correct dose of the veterinary medicinal
product to be given 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 for growing pigs.
Feed consumption may be reduced in clinically sick animals and also in older pigs therefore feed
intake may need to be adjusted to achieve target dosage intake.
The correct quantity of Econor oral powder should be added to the estimated quantity of the daily
ration for each pig, in a bucket or suitable receptacle and thoroughly mixed.
11
Dosage guidance table
Pig Type
Bodyweight (kg) Dose rate
(mg/kg
bodyweight)
Econor 10% oral
powder (g)
Weaner 25 4 1.0
12 3.0
Grower 50 4 2.0
12 6.0
Finisher 100 4 4.0
12 12
Sow 200 4 8.0
12 24
Scoops – two scoops measuring 1 g and 3 g of Econor 10% oral powder are supplied.
NB: a level scoop of the veterinary medicinal product should be measured.
To achieve good mixture and homogeneity, the use of a pre-mixture can be used. The required
quantity of Econor is thoroughly mixed with the feed in the proportion: 1 part Econor oral powder to
10 parts feed before the final addition of the remainder of the feed.
Toxic signs have not been seen in pigs given 5 times the recommended dose.
4.11 Withdrawal period
Meat and offal: 1 day
Pharmacotherapeutic group: Antibacterials for systemic use, Pleuromutilins. ATC vet code:
QJ01XQ02
5.1 Pharmacodynamic properties:
Valnemulin is an antibiotic belonging to the pleuromutilin group, which acts by the inhibition of the
initiation of protein synthesis at the level of the bacterial ribosome.
Valnemulin has activity against a range of bacteria including those responsible for enteric and
respiratory disease in pigs.
Valnemulin shows high activity against
Mycoplasma spp.
and spirochaetes such as
Brachyspira
hyodysenteriae and Brachyspira pilosicoli
and
Lawsonia intracellularis.
Species
MIC of wild-type population
(µg/ml)
Brachyspira hyodysenteriae
≤0.125
Brachyspira pilosicoli
≤0.125
Lawsonia intracellularis
≤0.125
Mycoplasma hyopneumoniae
≤0.008
12
Valnemulin has little activity against
Enterobacteriaceae
, such as
Salmonella spp.
and
Escherichia
coli
.
There appears to be no resistance development to valnemulin to date by
M. hyopneumoniae
and
L. intracellularis.
There have been some increases of MICs of valnemulin against
B. hyodysenteriae
and to a lesser
degree
B. pilosicoli,
some of which appear to have developed resistance.
Valnemulin binds to the ribosome and inhibits bacterial protein synthesis. Resistance development
primarily occurs because of changes at the binding site associated with mutations of the ribosomal
DNA genes.
5.2 Pharmacokinetic particulars
In pigs, after a single oral dose of radiolabelled material more than 90% absorption was demonstrated.
Maximum plasma concentrations (C
max
) of radio-labelled or ‘cold’ material were obtained 1-4 hours
after dosing (T
max
) with a plasma half-life (t½), estimated from non-radioactive data, between 1 and
4,5 hours. A linear relationship between concentration and dose administered was established.
After repeat dosing, slight accumulation occurred, but a steady state was achieved within 5 days.
Because of a marked ‘first pass’ effect, plasma concentrations are affected by the method of
administration, but valnemulin is highly concentrated in tissues, particularly the lungs and liver,
relative to plasma. Five days after the last of 15 doses of radiolabelled valnemulin administered to
pigs, the concentration in liver was >6 times that in plasma. Two hours after withdrawal of product
given in feed twice daily for 4 weeks at a dose of 15 mg/kg bodyweight/day, liver concentration was
1.58 g/g and lung concentration 0.23 g/g whereas concentrations in plasma were below the limit of
detection.
At a dose of 3.8 mg/kg administration, the total colon contents concentration was 1.6 µg/g.
In pigs valnemulin is extensively metabolised and excretion of parent molecule and metabolites occurs
mainly via bile. 73% - 95% of the daily dose of total radioactivity was recovered from the faeces. The
plasma half-life was 1.3 – 2.7 hours, and the majority of the total radio-activity administered was
excreted within 3 days of the last administration.
6.1 List of excipients
Hypromellose
Talc
Silica, colloidal anhydrous
Isopropyl myristate
Lactose
6.2 Incompatibilities
None known
6.3 Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 5 years
Once opened use within 6 months.
Feed to which Econor oral powder has been added should be replaced if not consumed within 24
hours.
13
6.4 Special precautions for storage
Store below 25°C.
Store the product in the original container.
Part-used containers should be tightly closed following dispensing.
6.5 Nature and composition of immediate packaging
Aluminium-lined plastic bags of 1 kg.
Plastic scoops: 50% HIPS (High Impact Polystyrene) and 50%GPPS (General Purpose Polystyrene)
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.
Novartis Animal Health Austria GmbH
Biochemiestrasse 10
A-6250 Kundl
Austria
+ 43 (0)5338 2000
EU/2/98/010/025
9. DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION
12/03/1999 - 06/03/2009
06/01/2011
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
14
ANNEX II
A. MANUFACTURING AUTHORISATION HOLDER(S)
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
15
A. MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH
RELEASE
Name and address of the manufacturer(s) responsible for batch release
Novartis Santé Animale S.A.S.
Usine de Huningue
26, rue de la Chapelle
BP 224
68332 Huningue cedex
France
The printed package leaflet of the medicinal product must state the name and address of the
manufacturer responsible for the release of the concerned batch.
B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
REGARDING SUPPLY OR USE
To be supplied only on veterinary prescription.
Consideration should be given to official guidance on the incorporation of medicated premixes in final
feeds.
C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH
REGARD TO THE SAFE AND EFFECTIVE USE OF THE PRODUCT
Not applicable
D. STATEMENT OF THE MRLs
The following constituents of Econor are included in table 1 of the annex to Commission Regulation
(EU) No 37/2010 as follows:
Pharmaco-
logically
active
substance
Marker
residue
Animal
species
MRL
Target
tissues
Other provisions Therapeutic
classification
Valnemulin Porcine 100 µg/kg
500 µg/kg
50 µg/kg
Kidney
Liver
Muscle
NO ENTRY
Anti-infectious
agents
/ Antibiotics
Hypromellose
- covered by
entry for food
additives with
an E number
(E464)
N / A
All food
producing
species
No MRL
required
N / A Only substances
approved as
additives in
foodstuffs for
human
consumption, with
the exception of
preservatives listed
in part C of Annex
III to European
Parliament and
Council Directive
95/2/EC
No entry
1
16
OJ No L 320 of 28.11.98
Pharmaco-
logically
active
substance
Marker
residue
Animal
species
MRL
Target
tissues
Other provisions Therapeutic
classification
Purified talc -
covered by
entry for food
additives with
an E number
(E553b)
N / A
All food
producing
species
No MRL
required
N / A Only substances
approved as
additives in
foodstuffs for
human
consumption, with
the exception of
preservatives listed
in part C of Annex
III to European
Parliament and
Council Directive
95/2/EC
No entry
Silica,
colloidal
anhydrous -
covered by
entry for food
additives with
an E number
(E551)
N / A
All food
producing
species
No MRL
required
N / A Only substances
approved as
additives in
foodstuffs for
human
consumption, with
the exception of
preservatives listed
in part C of Annex
III to European
Parliament and
Council Directive
95/2/EC
No entry
N / A: Not applicable
Lactose and isopropyl myristate (at doses up to 5 mg/kg bw) are considered not within the scope of
Regulation (EC) No. 470/2009.
17
ANNEX III
LABELLING AND PACKAGE LEAFLET
18
A. LABELLING
19
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
Econor 1% premix for medicated feed for pigs
2. STATEMENT OF THE ACTIVE AND OTHER SUBSTANCES
Valnemulin
10 mg/g
Premix for medicated feed
4. PACKAGE SIZE
1 kg
2.5 kg
25 kg
5. TARGET SPECIES
Pigs
6. INDICATION(S)
The treatment and prevention of swine dysentery.
The treatment of clinical signs of porcine proliferative enteropathy (ileitis).
The prevention of clinical signs of porcine colonic spirochaetosis (colitis) when the disease has been
diagnosed in the herd.
7. METHOD AND ROUTE OF ADMINISTRATION
In-feed use
Mixing Instructions:
Read the package leaflet before use
8. WITHDRAWAL PERIOD
Withdrawal period: 1 day
20
9. SPECIAL WARNINGS:
Do not administer the product to pigs receiving ionophores.
Whilst studies in rats and mice have not produced any evidence of teratogenic effect, the safety during
pregnancy and lactation has not been established in pigs.
When mixing the product and handling the final feed containing the product, direct contact with the
skin and mucous membranes should be avoided. In case of accidental ingestion, seek medical advice
immediately and show the product label. People with known hypersensitivity to valnemulin should
administer the product with caution.
Adverse drug reactions have occurred following the use of Econor. Extreme care should therefore be
taken in the use of Econor in pigs of the Danish and Swedish Landrace breeds, and their crossbreeds
thereof, especially in younger pigs.
See package leaflet for further information.
10. EXPIRY DATE
{month/year}
11. SPECIAL STORAGE CONDITIONS
Do not store above 25°C.
Store product in the original container.
Part-used containers should be tightly closed following dispensing.
Shelf life:
Shelf-life when incorporated into meal feed and protected from light and moisture: 3 months.
Shelf-life when incorporated into pelleted feed and protected from light and moisture: 3 weeks
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED VETERINARY
MEDICINAL 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.
13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
For animal treatment only.
Veterinary medicinal product subject to prescription.
Consideration should be given to official guidance on the incorporation of medicated premixes
in final feeds
.
21
14. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
Keep out of the reach and sight of children.
Marketing Authorisation holder:
Novartis Animal Health Austria GmbH
Biochemiestraße 10
A-6250 Kundl
Austria
EU/2/98/010/004 (1 kg)
EU/2/98/010/005 (2.5 kg)
EU/2/98/010/006 (25 kg)
17. MANUFACTURER’S BATCH NUMBER
[leave blank]
22
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
Econor 10% premix for medicated feed for pigs
2. STATEMENT OF THE ACTIVE AND OTHER SUBSTANCES
Valnemulin
100 mg/g
Premix for medicated feed
4. PACKAGE SIZE
1 kg
25 kg
5. TARGET SPECIES
Pigs
6. INDICATION(S)
The treatment and prevention of swine dysentery.
The treatment of clinical signs of porcine proliferative enteropathy (ileitis).
The prevention of clinical signs of porcine colonic spirochaetosis (colitis) when the disease has been
diagnosed in the herd.
Treatment and prevention of swine enzootic pneumonia. At the recommended dosage of 10 – 12
mg/kg bodyweight, lung lesions and weight loss are reduced, but infection with
Mycoplasma
hyopneumoniae
is not eliminated.
7. METHOD AND ROUTE OF ADMINISTRATION
In-feed use
Mixing Instructions:
Read the package leaflet before use
8. WITHDRAWAL PERIOD
Withdrawal period: 1 day
23
9. SPECIAL WARNING(S):
Do not administer the product to pigs receiving ionophores.
Whilst studies in rats and mice have not produced any evidence of teratogenic effect, the safety during
pregnancy and lactation has not been established in pigs.
When mixing the product and handling the final feed containing the product, direct contact with the
skin and mucous membranes should be avoided. In case of accidental ingestion, seek medical advice
immediately and show the product label. People with known hypersensitivity to valnemulin should
administer the product with caution.
Adverse drug reactions have occurred following the use of Econor. Extreme care should therefore be
taken in the use of Econor in pigs of the Danish and Swedish Landrace breeds, and their crossbreeds
thereof, especially in younger pigs.
See package leaflet for further information.
10. EXPIRY DATE
{month/year}
11. SPECIAL STORAGE CONDITIONS
Do not store above 25°C.
Store product in the original container.
Part-used containers should be tightly closed following dispensing.
Shelf life:
Shelf-life when incorporated into meal feed and protected from light and moisture: 3 months.
Shelf-life when incorporated into pelleted feed and protected from light and moisture: 3 weeks
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED VETERINARY
MEDICINAL 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.
13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
For animal treatment only.
Veterinary medicinal product subject to prescription.
Consideration should be given to official guidance on the incorporation of medicated premixes
in final feeds
.
24
14. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
Keep out of the reach and sight of children.
Marketing Authorisation holder:
Novartis Animal Health Austria GmbH
Biochemiestraße 10
A-6250 Kundl
Austria
EU/2/98/010/017 (1 kg)
EU/2/98/010/018 (25 kg)
17. MANUFACTURER’S BATCH NUMBER
[leave blank]
25
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
Econor 50% premix for medicated feed for pigs
2. STATEMENT OF THE ACTIVE AND OTHER SUBSTANCES
Valnemulin
500 mg/g
Premix for medicated feed
4. PACKAGE SIZE
1 kg
25 kg
5. TARGET SPECIES
Pigs
6. INDICATION(S)
The treatment and prevention of swine dysentery.
The treatment of clinical signs of porcine proliferative enteropathy (ileitis).
The prevention of clinical signs of porcine colonic spirochaetosis (colitis) when the disease has been
diagnosed in the herd.
Treatment and prevention of swine enzootic pneumonia. At the recommended dosage of 10 - 12 mg/kg
bodyweight lung lesions and weight loss are reduced, but infection with
Mycoplasma hyopneumoniae
is not eliminated.
7. METHOD AND ROUTE OF ADMINISTRATION
In-feed use.
Mixing Instructions:
Read the package leaflet before use
8. WITHDRAWAL PERIOD
Withdrawal period: 1 day
26
9. SPECIAL WARNING(S):
Do not administer the product to pigs receiving ionophores.
Whilst studies in rats and mice have not produced any evidence of teratogenic effect, the safety during
pregnancy and lactation has not been established in pigs.
When mixing the product and handling the final feed containing the product, direct contact with the
skin and mucous membranes should be avoided. In case of accidental ingestion, seek medical advice
immediately and show the product label. People with known hypersensitivity to valnemulin should
administer the product with caution.
Adverse drug reactions have occurred following the use of Econor. Extreme care should therefore be
taken in the use of Econor in pigs of the Danish and Swedish Landrace breeds, and their crossbreeds
thereof, especially in younger pigs.
See package leaflet for further information.
10. EXPIRY DATE
{month/year}
11. SPECIAL STORAGE CONDITIONS
Do not store above 25°C.
Store product in the original container.
Part-used containers should be tightly closed following dispensing.
Shelf life:
Shelf-life when incorporated into meal feed and protected from light and moisture: 3 months.
Shelf-life when incorporated into pelleted feed and protected from light and moisture: 3 weeks
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED VETERINARY
MEDICINAL 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.
13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
For animal treatment only.
Veterinary medicinal product subject to prescription.
Consideration should be given to official guidance on the incorporation of medicated premixes
in final feeds.
27
14. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
Keep out of the reach and sight of children.
Marketing Authorisation holder:
Novartis Animal Health Austria GmbH
Biochemiestraße 10
A-6250 Kundl
Austria
EU/2/98/010/021 (1 kg)
EU/2/98/010/022 (25 kg)
17. MANUFACTURER’S BATCH NUMBER
[leave blank]
28
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
Econor 0.5% premix for medicated feed for pigs
2. STATEMENT OF THE ACTIVE AND OTHER SUBSTANCES
Valnemulin
5 mg/g
Premix for medicated feed
4. PACKAGE SIZE
5 kg
25 kg
5. TARGET SPECIES
Pigs
6. INDICATION(S)
For the treatment and prevention of swine dysentery.
The treatment of clinical signs of porcine proliferative enteropathy (ileitis).
The prevention of clinical signs of porcine colonic spirochaetosis (colitis) when the disease has been
diagnosed in the herd.
7. METHOD AND ROUTE OF ADMINISTRATION
In-feed use
Mixing Instructions:
Read the package leaflet before use
8. WITHDRAWAL PERIOD
Withdrawal period: 1 day
29
9. SPECIAL WARNING(S):
Do not administer the product to pigs receiving ionophores.
Whilst studies in rats and mice have not produced any evidence of teratogenic effect, the safety during
pregnancy and lactation has not been established in pigs.
When mixing the product and handling the final feed containing the product, direct contact with the
skin and mucous membranes should be avoided. In case of accidental ingestion, seek medical advice
immediately and show the product label. People with known hypersensitivity to valnemulin should
administer the product with caution.
Adverse drug reactions have occurred following the use of Econor. Extreme care should therefore be
taken in the use of Econor in pigs of the Danish and Swedish Landrace breeds, and their crossbreeds
thereof, especially in younger pigs.
See package leaflet for further information.
10. EXPIRY DATE
{month/year}
11. SPECIAL STORAGE CONDITIONS
Do not store above 25°C.
Store product in the original container.
Part-used containers should be tightly closed following dispensing.
Shelf life:
Shelf-life when incorporated into meal feed and protected from light and moisture: 3 months.
Shelf-life when incorporated into pelleted feed and protected from light and moisture: 3 weeks
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED VETERINARY
MEDICINAL 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.
13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
For animal treatment only.
Veterinary medicinal product subject to prescription.
Consideration should be given to official guidance on the incorporation of medicated premixes
in final feeds.
30
14. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
Keep out of the reach and sight of children.
Marketing Authorisation holder:
Novartis Animal Health Austria GmbH
Biochemiestraße 10
A-6250 Kundl
Austria
EU/2/98/010/023 (5kg)
EU/2/98/010/024 (25 kg)
17. MANUFACTURER’S BATCH NUMBER
[leave blank]
31
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
Econor 10% oral powder for pigs
2. STATEMENT OF THE ACTIVE AND OTHER SUBSTANCES
Valnemulin 100 mg/g
Oral powder
4. PACKAGE SIZE
1 kg
5. TARGET SPECIES
Pigs
6. INDICATION(S)
Treatment of swine dysentery.
Treatment of clinical signs of porcine proliferative enteropathy (ileitis).
Treatment of swine enzootic pneumonia.
7. METHOD AND ROUTE OF ADMINISTRATION
Oral use
Read the package leaflet before use
8. WITHDRAWAL PERIOD
Withdrawal period:
Meat and offal: 1 day
32
9. SPECIAL WARNING(S):
Do not administer the veterinary medicinal product to pigs receiving monensin, salinomycin or
narasin.
As an adjunct to medication, good management and hygiene practices should be introduced in order to
reduce the risk on infection and to control the potential build up of resistance.
When mixing the product and handling the final feed containing the veterinary medicinal product,
direct contact with the skin and mucous membranes should be avoided.
Extreme care should be taken in the use of Econor in pigs of the Danish and Swedish Landrace breeds,
and their crossbreeds thereof, especially in younger pigs.
See package leaflet for further information.
10. EXPIRY DATE
EXP {month/year}
Once opened use within 6 months.
Medicated feed should be replaced, if not consumed within 24 hours.
11. SPECIAL STORAGE CONDITIONS
Store below 25°C.
Store the product in the original container.
Part-used containers should be tightly closed following dispensing.
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED VETERINARY
MEDICINAL 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.
13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
For animal treatment only -
veterinary medicinal product subject to prescription.
14. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
Keep out of the reach and sight of children.
33
Novartis Animal Health Austria GmbH
Biochemiestraße 10
A-6250 Kundl
Austria
EU/2/98/010/025
17. MANUFACTURER’S BATCH NUMBER
Batch {number}
34
B. PACKAGE LEAFLET
35
PACKAGE LEAFLET
Econor 1% premix for medicated feed for pigs
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE IN THE EEA, IF DIFFERENT
Marketing Authorisation holder:
Novartis Animal Health Austria GmbH
Biochemiestraße 10
A-6250 Kundl
Austria
Manufacturer
Novartis Santé Animale S.A.S.
Usine de Huningue
26, rue de la Chapelle
BP 224
68332 Huningue cedex
France
Econor 1% premix for medicated feed for pigs
Valnemulin hydrochloride
3. STATEMENT OF THE ACTIVE AND OTHER SUBSTANCES
Econor 1% premix contains valnemulin in the form of valnemulin hydrochloride.
Valnemulin hydrochloride
10.65 mg/g
equivalent to valnemulin base
10 mg/g
Other ingredients:
Hypromellose
Talc
Colloidal anhydrous silica
Isopropyl myristate
Lactose
4. INDICATION(S)
The treatment and prevention of swine dysentery.
The treatment of clinical signs of porcine proliferative enteropathy (ileitis).
The prevention of clinical signs of porcine colonic spirochaetosis (colitis) when the disease has been
diagnosed in the herd.
5. CONTRAINDICATIONS
Do not administer the product to pigs receiving ionophores.
36
6. ADVERSE REACTIONS
Adverse drug reactions following the use of Econor are mainly associated with breeds and cross
breeds of Danish and/or Swedish Landrace.
Most common adverse reactions observed in these pigs are pyrexia, anorexia and in severe cases
ataxia and recumbency. On affected farms, one third of the pigs treated were affected, with a mortality
of 1%. A percentage of such pigs may also suffer oedema or erythema (posterior in distribution), and
palpebral oedema. In controlled trials in susceptible animals mortality was less than 1%.
In the case of an adverse reaction, immediate withdrawal of medication is recommended. Severely
affected pigs should be removed to clean dry pens and given appropriate treatment, including
treatment for concurrent disease.
Valnemulin is well-accepted in feed, but administered at concentrations above 200 mg valnemulin / kg
feed may result in transient reduction in food consumption associated with unpalatability during the
first few days of feeding.
If you notice any other side effects, please inform your veterinary surgeon.
7. TARGET SPECIES
Pigs
8. DOSAGE, ROUTE AND METHOD OF ADMINISTRATION
In-feed use
The uptake of medicated feed depends on the clinical condition of the animal. In order to obtain the
correct dosage the concentration of Econor has to be adjusted. Inclusion levels may also need to be
increased in older pigs or pigs on restricted feed to achieve target dosage.
Indication Dosage
(mg active
substance/kg)
Application period of
medicated feed as the sole
daily ration
Application in feed
Treatment of
Incorporation of 75 mg active
substance per kg feed with:
Econor 1% - 7.5 g/kg feed
3-4 mg/kg
bodyweight/day
Minimum of 7 days and up
to 4 weeks or until signs of
disease disappear
Swine
Dysentery
This dose level is effective in the treatment of clinical disease, but higher dosages or longer duration of
treatment may be necessary for complete elimination of infection. It is important to institute
medication as early as possible in an outbreak of swine dysentery. If there is no response to treatment
within 5 days, the diagnosis should be re-established.
Indication
Dosage
(mg active
substance/kg)
Application period of
medicated feed as the
sole daily ration
Application in feed
Treatment of
clinical signs
Incorporation of 75 mg active
substance per kg feed with:
Econor 1% - 7.5 g/kg feed
Porcine
Proliferative
Enteropathy
(ileitis)
3-4 mg/kg
bodyweight/day
2 weeks or until signs of
disease disappear
37
This dose level is effective under normal situation in the treatment of clinical signs of disease, but
higher dosages or longer duration of treatment may be necessary for complete elimination of infection.
It is important to institute medication as early as possible in an outbreak of porcine proliferative
enteropathy. If there is no response to treatment within 5 days, the diagnosis should be re-established.
For severely affected animals which fail to respond to treatment within 3-5 days, parenteral treatment
should be considered.
Indication
Dosage
(mg active
substance/kg)
Application period of
medicated feed as the
sole daily ration
Application in feed
Prevention of
Incorporation of 25 mg active
substance per kg feed with:
Econor 1% - 2.5 g/kg feed
minimum of 7 days and
up to 4 weeks
Swine
Dysentery
1.0 – 1.5 mg/kg
bodyweight/day
4 weeks
Clinical
signs of
Porcine
Colonic
Spirochaetosis
(colitis)
Long term preventative use of valnemulin should be avoided by improving management practice and
thorough cleansing and disinfection. Consideration should be given to the eradication of infection
from the farm.
9. ADVICE ON CORRECT ADMINISTRATION:
Mixing Instructions:
mg Econor 1% premix/kg feed = Dosage required (mg/kg) x 100 x bodyweight (kg)/Daily feed intake
(kg)
The product has been shown to be stable to the pelleting process at temperatures of 75
o
C. Aggressive
pelleting conditions such as temperatures in excess of 80
o
C, and the use of abrasive substances for pre-
mixture should be avoided.
To achieve good mixture and homogeneity of incorporation, especially when product is incorporated
at a rate less then 5 kg/tonne feed, the use of a pre-mixture is recommended. The required quantity of
product is thoroughly mixed with a feed ingredient of similar physical nature (e.g. wheat middlings) in
the proportion: 1 part Econor 1% premix to 10 parts feed ingredient.
Consideration should be given to official guidance on the incorporation of medicated premixes
in final feeds
.
10. WITHDRAWAL PERIOD
1 day
38
11. SPECIAL STORAGE CONDITIONS
Keep out of the reach and sight of children.
Do not store above 25°C.
Store product in the original container.
Part-used containers should be tightly closed following dispensing.
Shelf life:
Shelf-life of the veterinary medicinal product as packaged for sale: 5 years
Shelf-life when incorporated into meal feed and protected from light and moisture: 3 months.
Shelf-life when incorporated into pelleted feed and protected from light and moisture: 3 weeks
12. SPECIAL WARNINGS:
Valnemulin has been shown to interact with ionophores such as monensin, salinomycin and narasin
and may result in signs indistinguishable from an ionophore toxicosis. Animals should not receive
products containing monensin, salinomycin or narasin, during or at least 5 days before or after
treatment with valnemulin. Severe growth depression, ataxia, paralysis or death may result.
Whilst studies in rats and mice have not produced any evidence of teratogenic effect, the safety during
pregnancy and lactation has not been established in pigs.
When mixing the product and handling the final feed containing the product, direct contact with the
skin and mucous membranes should be avoided. In case of accidental ingestion, seek medical advice
immediately and show the product label. People with known hypersensitivity to valnemulin should
administer the product with caution.
Adverse drug reactions have occurred following the use of Econor. Their occurrence appears to be
mainly associated with breed mixes that include Danish and/or Swedish Landrace. Extreme care
should therefore be taken in the use of Econor in pigs of the Danish and Swedish Landrace breeds, and
their crossbreeds thereof, especially in younger pigs.
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
06/01/2011
Detailed information on this product is available on the website of the European Medicines Agency
(EMA)
http://www.ema.europa.eu
/.
15. OTHER INFORMATION
Valnemulin is an antibiotic belonging to the pleuromutilin group, which act by the inhibition of the
initiation of protein synthesis at the level of the bacterial ribosome.
39
PACKAGE LEAFLET
Econor 10% premix for medicated feed for pigs
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE IN THE EEA, IF DIFFERENT
Marketing Authorisation holder:
Novartis Animal Health Austria GmbH
Biochemiestraße 10
A-6250 Kundl
Austria
Manufacturer
Novartis Santé Animale S.A.S.
Usine de Huningue
26, rue de la Chapelle
BP 224
68332 Huningue cedex
France
Econor 10% premix for medicated feed for pigs
Valnemulin hydrochloride
3. STATEMENT OF THE ACTIVE AND OTHER SUBSTANCES
Econor 10% premix contains valnemulin in the form of valnemulin hydrochloride.
Valnemulin hydrochloride
106.5 mg/g
equivalent to valnemulin base
100 mg/g
Other ingredients
Hypromellose
Talc
Colloidal anhydrous silica
Isopropyl myristate
Lactose
4. INDICATION(S)
The treatment and prevention of swine dysentery.
The treatment of clinical signs of porcine proliferative enteropathy (ileitis).
The prevention of clinical signs of porcine colonic spirochaetosis (colitis) when the disease has been
diagnosed in the herd.
Treatment and prevention of swine enzootic pneumonia. At the recommended dosage of 10 – 12
mg/kg bodyweight, lung lesions and weight loss are reduced, but infection with
Mycoplasma
hyopneumoniae
is not eliminated.
40
5. CONTRAINDICATIONS:
Do not administer the product to pigs receiving ionophores.
6. ADVERSE REACTIONS :
Adverse drug reactions following the use of Econor are mainly associated with breeds and cross
breeds of Danish and/or Swedish Landrace.
Most common adverse reactions observed in these pigs are pyrexia, anorexia and in severe cases
ataxia and recumbency. On affected farms, one third of the pigs treated were affected, with a mortality
of 1%. A percentage of such pigs may also suffer oedema or erythema (posterior in distribution), and
palpebral oedema. In controlled trials in susceptible animals mortality was less than 1%.
In the case of an adverse reaction, immediate withdrawal of medication is recommended. Severely
affected pigs should be removed to clean dry pens and given appropriate treatment, including
treatment for concurrent disease.
Valnemulin is well-accepted in feed, but administered at concentrations above 200 mg valnemulin / kg
feed may result in transient reduction in food consumption associated with unpalatability during the
first few days of feeding.
If you notice any other side effects, please inform your veterinary surgeon.
7. TARGET SPECIES
Pigs
8. DOSAGE, ROUTE(S) AND METHOD OF ADMINISTRATION
In-feed use
The uptake of medicated feed depends on the clinical condition of the animal. In order to obtain the
correct dosage the concentration of Econor has to be adjusted. Inclusion levels may also need to be
increased in older pigs or pigs on restricted feed to achieve target dosage.
Indication Dosage
(mg active
substance/kg)
Application period of
medicated feed as the sole
daily ration
Application in feed
Treatment of
Incorporation of 75 mg active
substance per kg feed with:
Econor 10% - 750 mg/kg
feed
3-4 mg/kg
bodyweight/day
Minimum of 7 days and up
to 4 weeks or until signs of
disease disappear
Swine
Dysentery
This dose level is effective in the treatment of clinical disease, but higher dosages or longer duration of
treatment may be necessary for complete elimination of infection. It is important to institute
medication as early as possible in an outbreak of swine dysentery. If there is no response to treatment
within 5 days, the diagnosis should be re-established.
41
Indication
Dosage
(mg active
substance/kg)
Application period of
medicated feed as the
sole daily ration
Application in feed
Treatment of
clinical signs
Incorporation of 75 mg active
substance per kg feed with:
Econor 10% - 750 mg/kg
feed
Porcine
Proliferative
Enteropathy
(ileitis)
3-4 mg/kg
bodyweight/day
2 weeks or until signs of
disease disappear
This dose level is effective under normal situation in the treatment of clinical signs of disease, but
higher dosages or longer duration of treatment may be necessary for complete elimination of infection.
It is important to institute medication as early as possible in an outbreak of porcine proliferative
enteropathy. If there is no response to treatment within 5 days, the diagnosis should be re-established.
For severely affected animals which fail to respond to treatment within 3-5 days, parenteral treatment
should be considered.
Indication
Dosage
(mg active
substance/kg)
Application period of
medicated feed as the
sole daily ration
Application in feed
Prevention of
Incorporation of 25 mg active
substance per kg feed with:
Econor 10% - 250 mg/kg
feed
minimum of 7 days and
up to 4 weeks
Swine
Dysentery
1.0 – 1.5 mg/kg
bodyweight/day
4 weeks
Clinical
signs of
Porcine
Colonic
Spirochaetosis
(colitis)
Long term preventative use of valnemulin should be avoided by improving management practice and
thorough cleansing and disinfection. Consideration should be given to the eradication of infection
from the farm.
Indication Dosage
(mg active
substance/kg)
Application period of
medicated feed as the sole
daily ration
Application in feed
Treatment &
Prevention of
Incorporation of 200 mg active
substance per kg feed with :
Econor 10% - 2 g/kg feed
10 – 12 mg/kg
bodyweight/day
Up to 3 weeks
Swine
Enzootic
Pneumonia
Secondary infection by organisms such as
Pasteurella multocida
and
Actinobacillus
pleuropneumoniae
may complicate enzootic pneumonia and require specific medication.
42
9. ADVICE ON CORRECT ADMINISTRATION:
Mixing Instructions:
mg Econor 10% premix/kg feed = Dosage required (mg/kg) x 10 x bodyweight (kg)/Daily feed intake
(kg)
The product has been shown to be stable to the pelleting process at temperatures of 75
o
C. Aggressive
pelleting conditions such as temperatures in excess of 80
o
C, and the use of abrasive substances for pre-
mixture should be avoided.
To achieve good mixture and homogeneity of incorporation, the use of a pre-mixture is recommended.
The required quantity of product is thoroughly mixed with a feed ingredient of similar physical nature
(e.g. wheat middlings) in the proportion: 1 part Econor 10% premix to 10 parts feed ingredient.
Consideration should be given to official guidance on the incorporation of medicated premixes
in final feeds
.
10. WITHDRAWAL PERIOD
1 day
11. SPECIAL STORAGE CONDITIONS
Keep out of the reach and sight of children.
Do not store above 25°C.
Store product in the original container.
Part-used containers should be tightly closed following dispensing.
Shelf life:
Shelf-life of the veterinary medicinal product as packaged for sale: 5years
Shelf-life when incorporated into meal feed and protected from light and moisture: 3 months.
Shelf-life when incorporated into pelleted feed and protected from light and moisture: 3 weeks
12. SPECIAL WARNING(S):
Valnemulin has been shown to interact with ionophores such as monensin, salinomycin and narasin
and may result in signs indistinguishable from an ionophore toxicosis. Animals should not receive
products containing monensin, salinomycin or narasin, during or at least 5 days before or after
treatment with valnemulin. Severe growth depression, ataxia, paralysis or death may result.
Whilst studies in rats and mice have not produced any evidence of teratogenic effect, the safety during
pregnancy and lactation has not been established in pigs.
When mixing the product and handling the final feed containing the product, direct contact with the
skin and mucous membranes should be avoided. In case of accidental ingestion, seek medical advice
immediately and show the product label. People with known hypersensitivity to valnemulin should
administer the product with caution.
43
Adverse drug reactions have occurred following the use of Econor. Their occurrence appears to be
mainly associated with breed mixes that include Danish and/or Swedish Landrace. Extreme care
should therefore be taken in the use of Econor in pigs of the Danish and Swedish Landrace breeds, and
their crossbreeds thereof, especially in younger pigs.
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
06/01/2011
Detailed information on this product is available on the website of the European Medicines Agency
(EMA)
http://www.ema.europa.eu
/.
15. OTHER INFORMATION
Valnemulin is an antibiotic belonging to the pleuromutilin group, which act by the inhibition of the
initiation of protein synthesis at the level of the bacterial ribosome.
44
PACKAGE LEAFLET
Econor 50% premix for medicated feed for pigs
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE IN THE EEA, IF DIFFERENT
Marketing Authorisation holder:
Novartis Animal Health Austria GmbH
Biochemiestraße 10
A-6250 Kundl
Austria
Manufacturer:
Sandoz GmbH
Schaftenau Plant
A-6336 Langkampfen
Austria
Econor 50% premix for medicated feed for pigs
Valnemulin hydrochloride
3. STATEMENT OF THE ACTIVE AND OTHER SUBSTANCES
Econor 50% premix contains valnemulin in the form of valnemulin hydrochloride.
equivalent to valnemulin base
532.5 mg/g
Other ingredients:
Hypromellose
Talc
4. INDICATION(S)
The treatment and prevention of swine dysentery.
The treatment of clinical signs of porcine proliferative enteropathy (ileitis).
The prevention of clinical signs of porcine colonic spirochaetosis (colitis) when the disease has been
diagnosed in the herd.
Treatment and prevention of swine enzootic pneumonia. At the recommended dosage of 10 - 12 mg/kg
bodyweight lung lesions and weight loss are reduced, but infection with
Mycoplasma hyopneumoniae
is not eliminated.
5. CONTRAINDICATIONS:
Do not administer the product to pigs receiving ionophores.
45
Valnemulin hydrochloride
500 mg/g
6. ADVERSE REACTIONS :
Adverse drug reactions following the use of Econor are mainly associated with breeds and cross
breeds of Danish and/or Swedish Landrace.
Most common adverse reactions observed in these pigs are pyrexia, anorexia and in severe cases
ataxia and recumbency. On affected farms, one third of the pigs treated were affected, with a mortality
of 1%. A percentage of such pigs may also suffer oedema or erythema (posterior in distribution), and
palpebral oedema. In controlled trials in susceptible animals mortality was less than 1%.
In the case of an adverse reaction, immediate withdrawal of medication is recommended. Severely
affected pigs should be removed to clean dry pens and given appropriate treatment, including
treatment for concurrent disease.
Valnemulin is well-accepted in feed, but administered at concentrations above 200 mg valnemulin / kg
feed may result in transient reduction in food consumption associated with unpalatability during the
first few days of feeding.
If you notice any other side effects, please inform your veterinary surgeon.
7. TARGET SPECIES
Pigs
8. DOSAGE, METHOD AND ROUTE(S) OF ADMINISTRATION
In-feed use.
The uptake of medicated feed depends on the clinical condition of the animal. In order to obtain the
correct dosage the concentration of Econor has to be adjusted. Inclusion levels may also need to be
increased in older pigs or pigs on restricted feed to achieve target dosage.
Indication Dosage
(mg active
substance/kg)
Application period of
medicated feed as the sole
daily ration
Application in feed
Treatment of
Incorporation of 75 mg active
substance per kg feed with:
Econor 50% - 150 mg/ kg
feed
Swine
Dysentery
3-4 mg/kg
bodyweight/day
Minimum of 7 days and up
to 4 weeks or until signs of
disease disappear
This dose level is effective in the treatment of clinical disease, but higher dosages or longer duration of
treatment may be necessary for complete elimination of infection. It is important to institute
medication as early as possible in an outbreak of swine dysentery. If there is no response to treatment
within 5 days, the diagnosis should be re-established.
46
Indication
Dosage
(mg active
substance/kg)
Application period of
medicated feed as the
sole daily ration
Application in feed
Treatment of
clinical signs
Incorporation of 75 mg active
substance per kg feed with:
Econor 50% - 150 mg/ kg
feed
Porcine
Proliferative
Enteropathy
(ileitis)
3-4 mg/kg
bodyweight/day
2 weeks or until signs of
disease disappear
This dose level is effective under normal situation in the treatment of clinical signs of disease, but
higher dosages or longer duration of treatment may be necessary for complete elimination of infection.
It is important to institute medication as early as possible in an outbreak of porcine proliferative
enteropathy. If there is no response to treatment within 5 days, the diagnosis should be re-established.
For severely affected animals which fail to respond to treatment within 3-5 days, parenteral treatment
should be considered.
Indication
Dosage
(mg active
substance/kg)
Application period of
medicated feed as the
sole daily ration
Application in feed
Prevention of
Incorporation of 25 mg active
substance per kg feed with:
Econor 50% - 50 mg/ kg
feed
minimum of 7 days and
up to 4 weeks
Swine
Dysentery
1.0 – 1.5 mg/kg
bodyweight/day
4 weeks
Clinical
signs of
Porcine
Colonic
Spirochaetosis
(colitis)
Long term preventative use of valnemulin should be avoided by improving management practice and
thorough cleansing and disinfection. Consideration should be given to the eradication of infection
from the farm.
Indication Dosage
(mg active
substance/kg)
Application period of
medicated feed as the sole
daily ration
Application in feed
Treatment &
Prevention of
Incorporation of 200 mg active
substance per kg feed with :
Econor 50% - 400 mg/kg
feed
Swine
Enzootic
Pneumonia
10 – 12 mg/kg
bodyweight/day
Up to 3 weeks
Secondary infection by organisms such as
Pasteurella multocida
and
Actinobacillus
pleuropneumoniae
may complicate enzootic pneumonia and require specific medication.
47
9. ADVICE ON CORRECT ADMINISTRATION:
Mixing Instructions:
mg Econor 50% premix/kg feed = Dosage required (mg/kg) x 2 x bodyweight (kg)/Daily feed intake
(kg)
The product has been shown to be stable to the pelleting process at temperatures of 75
o
C. Aggressive
pelleting conditions such as temperatures in excess of 80
o
C, and the use of abrasive substances for pre-
mixture should be avoided.
To achieve good mixture and homogeneity of incorporation, the use of a pre-mixture is required. The
required quantity of product is thoroughly mixed with a feed ingredient of similar physical nature (e.g.
wheat middlings) in the proportion: 1 part Econor 50% premix to 20 parts feed ingredient.
Consideration should be given to official guidance on the incorporation of medicated premixes
in final feeds
.
10. WITHDRAWAL PERIOD
1 day
11. SPECIAL STORAGE CONDITIONS
Keep out of the reach and sight of children.
Do not store above 25°C.
Store product in the original container.
Part-used containers should be tightly closed following dispensing.
Shelf life:
Shelf-life of the veterinary medicinal product as packaged for sale: 5 years
Shelf-life when incorporated into meal feed and protected from light and moisture: 3 months.
Shelf-life when incorporated into pelleted feed and protected from light and moisture: 3 weeks
12. SPECIAL WARNING(S)
Valnemulin has been shown to interact with ionophores such as monensin, salinomycin and narasin
and may result in signs indistinguishable from an ionophore toxicosis. Animals should not receive
products containing monensin, salinomycin or narasin, during or at least 5 days before or after
treatment with valnemulin. Severe growth depression, ataxia, paralysis or death may result.
Whilst studies in rats and mice have not produced any evidence of teratogenic effect, the safety during
pregnancy and lactation has not been established in pigs.
When mixing the product and handling the final feed containing the product, direct contact with the
skin and mucous membranes should be avoided. In case of accidental ingestion, seek medical advice
immediately and show the product label. People with known hypersensitivity to valnemulin should
administer the product with caution.
48
Adverse drug reactions have occurred following the use of Econor. Their occurrence appears to be
mainly associated with breed mixes that include Danish and/or Swedish Landrace. Extreme care
should therefore be taken in the use of Econor in pigs of the Danish and Swedish Landrace breeds, and
their crossbreeds thereof, especially in younger pigs.
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
06/01/2011
Detailed information on this product is available on the website of the European Medicines Agency
(EMA)
http://www.ema.europa.eu/
.
15. OTHER INFORMATION
Valnemulin is an antibiotic belonging to the pleuromutilin group, which acts by the inhibition of the
initiation of protein synthesis at the level of the bacterial ribosome.
49
PACKAGE LEAFLET
Econor 0.5% premix for medicated feed for pigs
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE IN THE EEA, IF DIFFERENT
Marketing Authorisation holder:
Novartis Animal Health Austria GmbH
Biochemiestraße 10
A-6250 Kundl
Austria
Manufacturer:
Novartis Santé Animale S.A.S.
Usine de Huningue
26, rue de la Chapelle
BP 224
68332 Huningue cedex
France
Econor 0.5% premix for medicated feed for pigs
Valnemulin hydrochloride
3. STATEMENT OF THE ACTIVE AND OTHER SUBSTANCES
Econor 0.5% premix contains valnemulin in the form of valnemulin hydrochloride.
Valnemulin hydrochloride
5.325 mg/g
equivalent to valnemulin base
5 mg/g
Other ingredients
Hypromellose
Talc
Colloidal anhydrous silica
Isopropyl myristate
Lactose
4. INDICATION(S)
For the treatment and prevention of swine dysentery.
The treatment of clinical signs of porcine proliferative enteropathy (ileitis).
The prevention of clinical signs of porcine colonic spirochaetosis (colitis) when the disease has been
diagnosed in the herd.
5. CONTRAINDICATIONS:
Do not administer the product to pigs receiving ionophores.
50
6. ADVERSE REACTIONS :
Adverse drug reactions following the use of Econor are mainly associated with breeds and cross
breeds of Danish and/or Swedish Landrace.
Most common adverse reactions observed in these pigs are pyrexia, anorexia and in severe cases
ataxia and recumbency. On affected farms, one third of the pigs treated were affected, with a mortality
of 1%. A percentage of such pigs may also suffer oedema or erythema (posterior in distribution), and
palpebral oedema. In controlled trials in susceptible animals mortality was less than 1%.
In the case of an adverse reaction, immediate withdrawal of medication is recommended. Severely
affected pigs should be removed to clean dry pens and given appropriate treatment, including
treatment for concurrent disease.
Valnemulin is well-accepted in feed, but administered at concentrations above 200 mg valnemulin / kg
feed may result in transient reduction in food consumption associated with unpalatability during the
first few days of feeding.
If you notice any other side effects, please inform your veterinary surgeon.
7. TARGET SPECIES
Pigs
8. DOSAGE, ROUTE(S) AND METHOD OF ADMINISTRATION
In-feed use
The uptake of medicated feed depends on the clinical condition of the animal. In order to obtain the
correct dosage the concentration of Econor has to be adjusted. Inclusion levels may also need to be
increased in older pigs or pigs on restricted feed to achieve target dosage.
Indication Dosage
(mg active
substance/kg)
Application period of
medicated feed as the sole
daily ration
Application in feed
Treatment of
Incorporation of 75 mg active
substance per kg feed with:
Econor 0.5% - 15 g/kg feed
Swine
Dysentery
3-4 mg/kg
bodyweight/day
Minimum of 7 days and up
to 4 weeks or until signs of
disease disappear
This dose level is effective in the treatment of clinical disease, but higher dosages or longer duration of
treatment may be necessary for complete elimination of infection. It is important to institute
medication as early as possible in an outbreak of swine dysentery. If there is no response to treatment
within 5 days, the diagnosis should be re-established.
Indication
Dosage
(mg active
substance/kg)
Application period of
medicated feed as the
sole daily ration
Application in feed
Treatment of
clinical signs
Incorporation of 75 mg active
substance per kg feed with:
Econor 0.5% - 15 g/kg feed
Porcine
Proliferative
Enteropathy
(ileitis)
3-4 mg/kg
bodyweight/day
2 weeks or until signs of
disease disappear
51
This dose level is effective under normal situation in the treatment of clinical signs of disease, but
higher dosages or longer duration of treatment may be necessary for complete elimination of infection.
It is important to institute medication as early as possible in an outbreak of porcine proliferative
enteropathy. If there is no response to treatment within 5 days, the diagnosis should be re-established.
For severely affected animals which fail to respond to treatment within 3-5 days, parenteral treatment
should be considered.
Indication
Dosage
(mg active
substance/kg)
Application period of
medicated feed as the
sole daily ration
Application in feed
Prevention of
Incorporation of 25 mg active
substance per kg feed with:
Econor 0.5% - 5 g/kg feed
Swine
Dysentery
minimum of 7 days and
up to 4 weeks
1.0 – 1.5 mg/kg
bodyweight/day
Clinical
signs of
Porcine
Colonic
Spirochaetosis
(colitis)
4 weeks
Long term preventative use of valnemulin should be avoided by improving management practice and
thorough cleansing and disinfection. Consideration should be given to the eradication of infection
from the farm.
9. ADVICE ON CORRECT ADMINISTRATION:
Mixing Instructions:
mg Econor 0.5% premix/kg feed = Dosage required (mg/kg) x 200 x bodyweight (kg) / Daily feed
intake (kg)
The product has been shown to be stable to the pelleting process at temperatures of 75
o
C. Aggressive
pelleting conditions such as temperatures in excess of 80
o
C, and the use of abrasive substances for pre-
mixture should be avoided.
Consideration should be given to official guidance on the incorporation of medicated premixes
in final feeds
.
10. WITHDRAWAL PERIOD
1 day
11. SPECIAL STORAGE CONDITIONS
Keep out of the reach and sight of children.
Do not store above 25°C.
Store product in the original container.
Part-used containers should be tightly closed following dispensing.
52
Shelf life:
Shelf-life of the veterinary medicinal product as packaged for sale: 3 years
Shelf-life when incorporated into meal feed and protected from light and moisture: 3 months.
Shelf-life when incorporated into pelleted feed and protected from light and moisture: 3 weeks
12. SPECIAL WARNING(S)
Valnemulin has been shown to interact with ionophores such as monensin, salinomycin and narasin
and may result in signs indistinguishable from an ionophore toxicosis. Animals should not receive
products containing monensin, salinomycin or narasin, during or at least 5 days before or after
treatment with valnemulin. Severe growth depression, ataxia, paralysis or death may result.
Whilst studies in rats and mice have not produced any evidence of teratogenic effect, the safety during
pregnancy and lactation has not been established in pigs.
When mixing the product and handling the final feed containing the product, direct contact with the
skin and mucous membranes should be avoided. In case of accidental ingestion, seek medical advice
immediately and show the product label. People with known hypersensitivity to valnemulin should
administer the product with caution.
Adverse drug reactions have occurred following the use of Econor. Their occurrence appears to be
mainly associated with breed mixes that include Danish and/or Swedish Landrace. Extreme care
should therefore be taken in the use of Econor in pigs of the Danish and Swedish Landrace breeds, and
their crossbreeds thereof, especially in younger pigs.
13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED VETERINARY
MEDICINAL 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
06/01/2011
Detailed information on this product is available on the website of the European Medicines Agency
(EMA)
http://www.ema.europa.eu/
.
15. OTHER INFORMATION
Valnemulin is an antibiotic belonging to the pleuromutilin group, which act by the inhibition of the
initiation of protein synthesis at the level of the bacterial ribosome.
53
PACKAGE LEAFLET
Econor 10% oral powder for pigs
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing Authorisation holder:
Novartis Animal Health Austria GmbH
Biochemiestraße 10
A-6250 Kundl
Austria
Manufacturer for the batch release:
Novartis Santé Animale S.A.S.
26, rue de la Chapelle
BP 224
68332 Huningue cedex
France
Econor 10% oral powder for pigs
Valnemulin hydrochloride
3. STATEMENT OF THE ACTIVE AND OTHER SUBSTANCES
Valnemulin hydrochloride
106.5 mg/g
equivalent to valnemulin base
100 mg/g
Other ingredients
Hypromellose
Talc
Silica Colloidal anhydrous
Isopropyl myristate
Lactose
4. INDICATION(S)
The treatment of swine dysentery.
The treatment of clinical signs of porcine proliferative enteropathy (ileitis).
Treatment of swine enzootic pneumonia.
5. CONTRAINDICATIONS:
Do not administer the veterinary medicinal product to pigs receiving the ionophores monensin,
salinomycin or narasin.
54
6. ADVERSE REACTIONS:
Adverse reactions following the use of Econor are mainly associated with breeds and cross breeds of
Danish and/or Swedish Landrace.
Most common adverse reactions observed in these pigs are pyrexia, anorexia and in severe cases
ataxia and recumbency. On affected farms, one third of the pigs treated were affected, with a mortality
of 1%. A percentage of such pigs may also suffer oedema or erythema (posterior in distribution), and
palpebral oedema. In controlled trials in susceptible animals mortality was less than 1%.
In the case of an adverse reaction, immediate withdrawal of medication is recommended. Severely
affected pigs should be removed to clean dry pens and given appropriate treatment, including
treatment for concurrent disease.
Valnemulin is well-accepted in feed, but administered at concentrations above 200 mg valnemulin / kg
feed may result in transient reduction in food consumption associated with unpalatability during the
first few days of feeding.
If you notice any serious side effects or other side effects not mentioned in this leaflet, please inform
your veterinary surgeon.
7. TARGET SPECIES
Pigs
8. DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION
Oral use.
For use in individual pigs on farms where only a small number of pigs are to receive the veterinary
medicinal product. Larger groups should be treated with medicated feeding stuff containing the
premix.
For severely affected animals which fail to respond to treatment within 3-5 days, parenteral treatment
should be considered.
Treatment of Swine Dysentery
The recommended dose of valnemulin is 3-4 mg/kg bodyweight/day for a minimum of 7 days and up
to 4 weeks or until signs of disease disappear.
This dose level is effective in the treatment of clinical disease, but higher doses or longer duration of
treatment may be necessary for complete elimination of infection. It is important to institute treatment
as early as possible in an outbreak of swine dysentery. If there is no response to treatment within 5
days, the diagnosis should be re-established.
Treatment of clinical signs of Porcine Proliferative Enteropathy (ileitis).
The recommended dose of valnemulin is 3-4 mg/kg bodyweight/day for 2 weeks or until signs of
disease disappear.
This dose level is effective under normal situations in the treatment of clinical signs of disease, but
higher doses or longer duration of treatment may be necessary for complete elimination of infection. It
is important to institute treatment as early as possible in an outbreak of porcine proliferative
enteropathy. If there is no response to treatment within 5 days, the diagnosis should be re-established.
55
Treatment of swine Enzootic Pneumonia.
The recommended dose of valnemulin is 10-12 mg/kg bodyweight/day for up to 3 weeks.
At the recommended dose of 10 - 12 mg/kg bodyweight lung lesions and weight loss are reduced, but
infection with
Mycoplasma hyopneumoniae
is not eliminated. Secondary infection by organisms such
as
Pasteurella multocida
and
Actinobacillus pleuropneumoniae
may complicate enzootic pneumonia
and require specific treatment.
9. ADVICE ON CORRECT ADMINISTRATION:
The amount of feed mixed with Econor which is necessary for treatment should be prepared daily.
Daily dose calculation:
Amount Econor (mg) required = Dose required (mg/kg) x pig bodyweight (kg) x 10 / daily feed intake
(in kg).
This is achieved by thoroughly mixing the required amount of Econor oral powder into the daily ration
for each individual pig. The veterinary medicinal product can be used in dry or liquid feeds, where
water, or milk co-products have been added. Scoops of 2 sizes are provided for measuring the correct
amount of the veterinary medicinal product for mixing with the daily ration, according to the dosage
guidance table below. The feed containing the oral powder should be provided as the sole ration for
the treatment periods recommended above. The veterinary medicinal product may be mixed in liquid
feeds containing water, or milk-based co-products only.
The pigs to be treated should be weighed to calculate the correct dose of Econor oral powder to be
given 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 for growing pigs.
Feed consumption may be reduced in clinically sick animals and also in older pigs therefore feed
intake may need to be adjusted to achieve target dosage intake.
The correct quantity of Econor oral powder should be added to the estimated quantity of the daily
ration for each pig, in a bucket or suitable receptacle and thoroughly mixed.
Dosage guidance table
Pig Type
Bodyweight (kg) Dose rate
(mg/kg
bodyweight)
Econor 10% oral
powder (g)
Weaner 25 4 1
12 3
Grower 50 4 2
12 6
Finisher 100 4 4
12 12
Sow 200 4 8
12 24
Scoops – two scoops measuring 1 g and 3 g of Econor 10% oral powder are supplied.
NB: a level scoop of the veterinary medicinal product should be measured.
To achieve good mixture and homogeneity, the use of a pre-mixture can be used. The required
quantity of Econor is thoroughly mixed with the feed in the proportion: 1 part Econor oral powder to
10 parts feed before the final addition of the remainder of the feed.
56
10. WITHDRAWAL PERIOD
1 day
11. SPECIAL STORAGE PRECAUTIONS
Keep out of the reach and sight of children.
Store below 25°C.
Store the product in the original container.
Part-used containers should be tightly closed following dispensing.
Shelf life:
Shelf-life of the veterinary medicinal product as packaged for sale: 5 years.
Once opened use within 6 months.
Feed to which the Econor oral powder has been added should be replaced if not consumed within 24
hours.
Do not use after the expiry dare which is stated on the label after “EXP”.
12. SPECIAL WARNING(S):
Valnemulin has been shown to interact with ionophores such as monensin, salinomycin and narasin,
and may result in signs indistinguishable from an ionophore toxicosis. Animals should not receive
monensin, salinomycin or narasin, during or at least 5 days before or after treatment with valnemulin.
Severe growth depression, ataxia, paralysis or death may result.
As an adjunct to medication, good management and hygiene practices should be introduced in order to
reduce the risk on infection and to control the potential build up of resistance. Especially in the case of
swine dysentery, a targeted early eradication programme of the disease should be considered.
Whilst studies in rats and mice have not produced any evidence of teratogenic effect, the safety during
pregnancy and lactation has not been established in pigs.
Adverse reactions have occurred following the use of Econor. Their occurrence appears to be mainly
associated with breed mixes that include Danish and/or Swedish Landrace. Extreme care should
therefore be taken in the use of Econor in pigs of the Danish and Swedish Landrace breeds, and their
crossbreeds thereof, especially in younger pigs.
Toxic signs have not been seen in pigs given 5 times the recommended dose.
When treating infections caused by
Brachyspira spp
., therapy should be based on local (regional, farm
level) epidemiological information about susceptibility of the target bacteria.
Gloves should be worn when handling the veterinary medicinal product. When mixing the veterinary
medicinal product and handling the final feed containing the product, direct contact with the skin and
mucous membranes should be avoided. In case of accidental ingestion, seek medical advice
immediately and show the package leaflet or label to the physician. People with known
hypersensitivity to valnemulin should administer the veterinary medicinal product with caution.
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.
57
14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
06/01/2011
Detailed information on this product is available on the website of the European Medicines Agency
15. OTHER INFORMATION
Valnemulin is an antibiotic belonging to the pleuromutilin group, which act by the inhibition of the
initiation of protein synthesis at the level of the bacterial ribosome.
58
Source: European Medicines Agency
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