ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Rheumocam 1.5 mg/ml oral suspension for dogs
Each ml of Rheumocam 1.5 mg/ml oral suspension contains:
Active substance:
Meloxicam 1.5 mg
Excipient:
Sodium benzoate 5 mg
For a full list of excipients, see section 6.1
Dogs
Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders.
Do not use in pregnant or lactating animals.
Do not use in animals suffering from gastrointestinal disorders such as irritation and haemorrhage,
impaired hepatic, cardiac or renal function and haemorrhagic disorders.
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Do not use in dogs less than 6 weeks of age.
None.
Special precautions to be taken by the person administering the veterinary medicinal product to
animals
People with known hypersensitivity to NSAIDs should avoid contact with the veterinary medicinal
product.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the
label to the physician.
Typical adverse reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood
and apathy have occasionally been reported. These side effects occur generally within the first
treatment week and are in most cases transient and disappear following termination of the treatment
but in very rare cases may be serious or fatal.
The safety of the veterinary medicinal product has not been established during pregnancy and lactation
(see section 4.3).
Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein
binding may compete for binding and thus lead to toxic effects. Rheumocam must not be administered
in conjunction with other NSAIDs or glucocorticosteroids.
Pre-treatment with anti-inflammatory substances may result in additional or increased adverse effects
and accordingly a treatment-free period with such veterinary medicinal products should be observed
for at least 24 hours before commencement of treatment. The treatment-free period, however, should
take into account the pharmacokinetic properties of the veterinary products used previously.
Shake well before use.
To be administered mixed with food.
Initial treatment is a single dose of 0.2 mg meloxicam/kg body weight on the first day. Treatment is to
be continued once daily by oral administration (at 24-hour intervals) at a maintenance dose of 0.1 mg
meloxicam/kg body weight.
Particular care should be taken with regard to the accuracy of dosing.
The suspension can be given using the Rheumocam measuring syringe provided in the package. The
syringe fits onto the bottle and has a kg-body weight scale which corresponds to the maintenance dose
(i.e. 0.1 mg meloxicam/kg body weight). Thus for the first day, twice the maintenance volume will be
required.
A clinical response is normally seen within 3 - 4 days. Treatment should be discontinued after 10 days
at the latest if no clinical improvement is apparent.
In the case of overdosage symptomatic treatment should be initiated.
4.11 Withdrawalperiod
Not applicable.
5.
Pharmacotherapeutic group: Anti-inflammatory and Anti-rheumatic products, Non-steroids
ATC vet code: QM01AC06
5.1 Pharmacodynamic properties
Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by
inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative
and antipyretic effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it
also inhibits collagen-induced thrombocyte aggregation.
In vitro
and
in vivo
studies demonstrated that
meloxicam inhibits cyclooxygenase-2 (COX-2) to a greater extent than cyclooxygenase-1 (COX-1).
5.2 Pharmacokinetic particulars
Absorption
Meloxicam is completely absorbed following oral administration and maximal plasma concentrations
are obtained after approximately 7.5 hours. When the product is used according to the recommended
dosage regime, steady state concentrations of meloxicam in plasma are reached on the second day of
treatment.
Distribution
There is a linear relationship between the dose administered and plasma concentration observed in the
therapeutic dose range. Approximately 97% of meloxicam is bound to plasma proteins. The volume of
distribution is 0.3 l/kg.
Metabolism
Meloxicam is predominantly found in plasma and is also a major biliary excretion product whereas
urine contains only traces of the parent compound. Meloxicam is metabolised to an alcohol, an acid
derivative and to several polar metabolites. All major metabolites have been shown to be
pharmacologically inactive.
Elimination
Meloxicam is eliminated with a half-life of 24 hours. Approximately 75% of the administered dose is
eliminated via faeces and the remainder via urine.
6.1 List of excipients
Saccharin Sodium
Sodium Carboxyl Methyl Cellulose
Colloidal Silicon Dioxide
Citric Acid Monohydrate
Sorbitol Solution
Disodium Hydrogen-Phosphate Dodecahydrate
Sodium Benzoate
Honey Flavour.
6.2 Incompatibilities
None known.
6.3 Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 2 years
Shelf life after first opening the immediate packaging: 6 months
6.4 Special precautions for storage
This veterinary medicinal product does not require any special storage conditions.
6.5 Nature and composition of immediate packaging
42, 100 or 200 ml polyethylene terephthalate (PET) bottle with a tamper resistant child proof closure,
and a 15 ml HDPE bottle with a tamper resistant child proof closure, and a polypropylene measuring
syringe.
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.
Chanelle Pharmaceuticals Manufacturing Ltd.,
Loughrea, Co. Galway, Ireland.
Tel: + 353 91 841788
Fax: + 353 91 842937
e-mail:
sales@chanellegroup.ie
8.
MARKETING AUTHORISATION NUMBERS
42 ml: EU/2/07/078/001
100 ml: EU/2/07/078/002
200 ml: EU/2/07/078/003
15 ml: EU/2/07/078/004
PROHIBITION OF SALE, SUPPLY AND/OR USE
Not applicable.
Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency (EMA)
http://www.ema.europa.eu
Rheumocam 1 mg chewable tablets for dogs
Rheumocam 2.5 mg chewable tablets for dogs
Each chewable tablet contains:
Active substance:
Meloxicam
1 mg
Meloxicam
2.5 mg
For a full list of excipients, see section 6.1.
Chewable tablets
Pale-yellow, single-scored, chewable tablets.
Dogs
Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders.
Do not use in pregnant or lactating animals.
Do not use in animals suffering from gastrointestinal disorders such as irritation and haemorrhage,
impaired hepatic, cardiac or renal function and haemorrhagic disorders.
Do not use in dogs less than 6 weeks of age or less than 4 kg body weight.
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
None.
If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be
sought.
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of
increased renal toxicity.
Special precautions to be taken by the person administering the veterinary medicinal product to
animals
People with known hypersensitivity to Non-steroidal anti-inflammatory drugs (NSAIDS) should avoid
contact with the veterinary medicinal product.
In the case of accidental ingestion, seek medical advice immediately and show the package leaflet or
the label to the physician.
Typical adverse reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood,
apathy and renal failure have occasionally been reported. These side effects occur generally within the
first treatment week and are in most cases transient and disappear following termination of the
treatment but in very rare cases may be serious or fatal.
The safety of the veterinary medicinal product has not been established during pregnancy and
lactation.
Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein
binding may compete for binding and thus lead to toxic effects. Rheumocam must not be administered
in conjunction with other NSAIDs or glucocorticosteroids.
Pre-treatment with anti-inflammatory substances may result in additional or increased adverse effects
and accordingly a treatment-free period with such medicines should be observed for at least 24 hours
before commencement of treatment. The treatment-free period, however, should take into account the
pharmacokinetic properties of the products used previously.
Initial treatment is a single dose of 0.2 mg meloxicam/kg body weight on the first day.
Treatment is to be continued once daily by oral administration (at 24-hour intervals) at a maintenance
dose of 0.1 mg meloxicam/kg body weight.
Each chewable tablet contains either 1 mg or 2.5 mg meloxicam, which corresponds to the daily
maintenance dose for a 10 kg body weight dog, or a 25 kg body weight dog respectively. Each
chewable tablet can be halved for accurate dosing according to the individual body weight of the
animal. Rheumocam chewable tablets can be administered with or without food, are flavoured and are
taken by most dogs voluntarily.
Dose scheme for the maintenance dose:
Body weight
(kg)
Number of chewable tablets
mg/kg
1 mg 2.5mg
4.0 – 7.0
½
0.13 – 0.1
7.1 – 10.0
1
0.14 – 0.1
10.1 – 15.0
1 ½
0.15 – 0.1
15.1 – 20.0
2
0.13 – 0.1
20.1 – 25.0
1
0.12 – 0.1
25.1 – 35.0
1 ½
0.15 – 0.1
35.1 – 50.0
2
0.14 – 0.1
The use of Rheumocam oral suspension for dogs may be considered for an even more precise dosing.
For dogs weighing less than 4 kg the use of Rheumocam oral suspension for dogs is recommended.
A clinical response is normally seen within 3 – 4 days. Treatment should be discontinued after 10 days
if no clinical improvement is apparent.
In case of overdosage symptomatic treatment should be initiated.
Not applicable.
5.
Pharmacotherapeutic group: Antiinflammatory and antirheumatic products, non-steroids (oxicams),
ATC vet code: QMO1AC06
5.1
Pharmacodynamic properties
Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by
inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative
and antipyretic effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it
also inhibits collagen-induced thrombocyte aggregation. In vitro and in vivo studies demonstrated that
meloxicam inhibits cyclooxygenase-2 (COX-2) to a greater extent than cyclooxygenase-l (COX-I).
5.2
Pharmacokinetic particulars
Absorption
Meloxicam is completely absorbed following oral administration and maximal plasma concentrations
are obtained after approximately 4.5 hours. When the product is used according to the recommended
dosage regime, steady state concentrations of meloxicam in plasma are reached on the second day of
treatment.
Distribution
There is a linear relationship between the dose administered and plasma concentration observed in the
therapeutic dose range. Approximately 97 % of meloxicam is bound to plasma proteins. The volume
of distribution is 0.3 l/kg.
Metabolism
Meloxicam is predominantly found in plasma and is also a major biliary excretion product whereas
urine contains only traces of the parent compound. Meloxicam is metabolised to an alcohol, an acid
derivative and to several polar metabolites. All major metabolites have been shown to be
pharmacologically inactive.
Elimination
Meloxicam is eliminated with a half-life of 24 hours. Approximately 75 % of the administered dose is
eliminated via faeces and the remainder via urine.
6.
6.1
List of excipients
Lactose Monohydrate
Silicified microcrystalline cellulose
Sodium acid citrate
Crospovidone
Talc
Pork Flavour
Magnesium Stearate
6.2
Incompatibilities
Not applicable.
6.3
Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 3 years
6.4
Special precautions for storage
This veterinary medicinal product does not require any special storage conditions.
6.5
Nature and composition of immediate packaging
Rheumocam chewable tablets are supplied in:
PVC/PVDC (250. 60) blister packs with a 20 micron Foil.
Pack sizes: 20 and 100 tablets
Not all pack sizes may be marketed.
6.6
Special precautions for the disposal of unused veterinary medicinal products 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.
Chanelle Pharmaceuticals Manufacturing Ltd.,
Loughrea,
Co. Galway,
Ireland
8.
EU/2/07/078/005
EU/2/07/078/006
EU/2/07/078/007
EU/2/07/078/008
9.
10.01.2008
Detailed information on this product is available on the website of the European Medicines Agency
(EMA)
http://www.ema.europa.eu
PROHIBITION OF SALE, SUPPLY AND/OR USE
Not applicable.
Rheumocam 15 mg/ml oral suspension for horses
Each ml of Rheumocam 15 mg/ml oral suspension contains:
Active substance:
Meloxicam 15 mg
Excipient:
Sodium benzoate 5 mg
For a full list of excipients, see section 6.1
Oral suspension.
Honey flavoured, white to off-white viscous oral suspension.
Horses
Alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal disorders in
horses.
Do not use in pregnant or lactating mares.
Do not use in horses suffering from gastrointestinal disorders such as irritation and haemorrhage,
impaired hepatic, cardiac or renal function and haemorrhagic disorders.
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Do not use in horses less than 6 weeks of age.
None.
If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be
sought.
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of renal
toxicity.
Special precautions to be taken by the person administering the veterinary medicinal product to
animals
People with known hypersensitivity to Non Steroidal Anti-inflammatory Drugs (NSAIDs) should
avoid contact with the veterinary medicinal product.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the
label to the physician.
Isolated cases of adverse reactions typically associated with NSAIDs were observed in clinical trials
(slight urticaria, diarrhoea). Symptoms were reversible.
Laboratory studies in cattle have not provided any evidence for teratogenic, foetotoxic, or
maternotoxic effects. However, no data have been generated in horses. Therefore the use in this
species is not recommended during pregnancy and lactation.
Do not administer concurrently with glucocorticoids, other non-steroidal anti-inflammatory drugs or
with anti-coagulant agents.
To be administered either mixed with food or directly into the mouth at a dosage of 0.6 mg/kg body
weight, once daily, up to 14 days. In case the product is mixed with food, it should be added to a
small quantity of food, prior to feeding.
The suspension should be given using the Rheumocam measuring syringe provided in the package.
The syringe fits onto the bottle and has a 2 ml scale.
Shake well before use.
Avoid introduction of contamination during use.
In the case of overdose symptomatic treatment should be initiated.
4.11 Withdrawal period
Meat and offal: 3 days.
Not authorised for use in lactating animals producing milk for human consumption.
5.
Pharmacotherapeutic group: Anti-inflammatory and Anti-rheumatic products, non-steroids (oxicams)
ATC vet code: QM01AC06
5.1 Pharmacodynamic properties
Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by
inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative
and antipyretic effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it
also inhibits collagen-induced thrombocyte aggregation. Meloxicam also has anti-endotoxic
properties because it has been shown to inhibit production of thromboxane B
2
induced by intravenous
E. coli endotoxin administration in calves and pigs.
5.2 Pharmacokinetic particulars
Absorption
When the product is used according to the recommended dosage regime, the oral bioavailability is
approximately 98%. Maximal plasma concentrations are obtained after approximately 2 – 3 hours.
The accumulation factor of 1.08 suggests that meloxicam does not accumulate when administered
daily.
Distribution
Approximately 98% of meloxicam is bound to plasma proteins. The volume of distribution is 0.12
l/kg.
Metabolism
The metabolism is qualitatively similar in rats, mini-pigs, humans, cattle and pigs, although
quantitatively there are differences. The major metabolites found in all species were the 5-hydroxy-
and 5-carboxy- metabolites and the oxalyl- metabolite. The metabolism in horses was not
investigated. All major metabolites have been shown to be pharmacologically inactive.
Elimination
Meloxicam is eliminated with a terminal half-life of 7.7 hours.
6.
6.1 List of excipients
Saccharin sodium
Carmellose sodium
Silica, colloidal anhydrous
Citric acid monohydrate
Sorbitol, liquid (non-crystallising)
Disodium phosphate dodecahydrate
Sodium benzoate
Honey aroma
Purified water
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 first opening of the immediate packaging: 3 months
6.4 Special precautions for storage
This veterinary medicinal product does not require any special storage conditions.
After administration of the veterinary medicinal product, close the bottle by replacing the cap, wash
the measuring syringe with warm water and let it dry.
6.5 Nature and composition of immediate packaging
HDPE bottle containing 100 or 250 ml with a tamper proof child resistant closure and a polypropylene
measuring syringe.
Not all pack sizes may be marketed.
6.7
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.
Chanelle Pharmaceuticals Manufacturing Limited
Loughrea,
Co. Galway,
Ireland.
8.
EU/2/07/078/009
100 ml
EU/2/07/078/010
250 ml
9.
10.01.2008
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.
Rheumocam 20 mg/ml solution for injection for cattle, pigs and horses
One ml contains:
Active substance:
Meloxicam
20 mg
Excipient:
Ethanol (96 percent): 159.8 mg
For a full list of excipients, see section 6.1.
Solution for injection,
Clear yellow solution.
Cattle, pigs and horses
Cattle:
For use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs in
cattle.
For use in diarrhoea in combination with oral re-hydration therapy to reduce clinical signs in calves of
over one week of age and young, non-lactating cattle.
For adjunctive therapy in the treatment of acute mastitis, in combination with antibiotic therapy.
Pigs:
For use in non-infectious locomotor disorders to reduce the symptoms of lameness and inflammation.
For adjunctive therapy in the treatment of puerperal septicaemia and toxaemia (mastitis-metritis-
agalactia syndrome) with appropriate antibiotic therapy.
Horses:
For use in the alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal
disorders.
For the relief of pain associated with equine colic.
See also section 4.7.
Do not use in horses less than 6 weeks of age.
Do not use in animals suffering from impaired hepatic, cardiac or renal function and haemorrhagic
disorders, or where there is evidence of ulcerogenic gastrointestinal lesions.
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
For the treatment of diarrhoea in cattle, do not use in animals of less than one week of age.
None.
If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be
sought.
Avoid use in very severely dehydrated, hypovolaemic or hypotensive animals which require parenteral
rehydration, as there may be a potential risk of renal toxicity.
In case of inadequate relief of pain when used in the treatment of equine colic, careful re-evaluation of
the diagnosis should be made as this could indicate the need for surgical intervention.
Special precautions to be taken by the person administering the veterinary medicinal product to
animals
Accidental self-injection may give rise to pain. People with known hypersensitivity to Non-Steroidal
Anti-Inflammatory Drugs (NSAIDs) should avoid contact with the veterinary medicinal product. In
case of accidental self-injection, seek medical advice immediately and show the package leaflet or the
label to the physician.
In cattle and pigs, subcutaneous, intramuscular as well as intravenous administration is well tolerated;
only a slight transient swelling at the injection site following subcutaneous administration was
observed in less than 10 % of the cattle treated in clinical studies.
In horses, a transient swelling at the injection site can occur but resolves without intervention.
In very rare cases anaphylactoid reactions may occur and should be treated symptomatically.
Cattle and pigs:
Can be used during pregnancy and lactation.
Horses:
Do not use in pregnant or lactating mares.
See also section 4.3.
Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs
or with anti-coagulant agents.
Maximum number of piercings is 14 for the 20 ml, 50 ml and 100 ml stoppers and 20 for the 250 ml
stopper.
Cattle:
Single subcutaneous or intravenous injection at a dosage of 0.5 mg meloxicam/kg body weight (i.e.
2.5 ml/100 kg body weight) in combination with antibiotic therapy or with oral re-hydration therapy,
as appropriate.
Pigs:
Single intramuscular injection at a dosage of 0.4 mg meloxicam/kg body weight (i.e. 2.0 ml/100 kg
body weight) in combination with antibiotic therapy, as appropriate. If required, a second
administration of meloxicam can be given after 24 hours.
Horses:
Single intravenous injection at a dosage of 0.6 mg meloxicam/kg body weight (i.e. 3.0 ml/100 kg body
weight).
For use in the alleviation of inflammation and the relief of pain in both acute and chronic musculo –
skeletal disorders, Rheumocam 15 mg/ml oral suspension may be used for continuation of treatment at
a dosage of 0.6 mg meloxicam/kg body weight, 24 hours after administration of the injection.
Avoid introduction of contamination during use.
In the case of overdose, symptomatic treatment should be initiated.
4.11 Withdrawal periods
Cattle:
Meat and offal: 15 days
Milk: 5 days
Pigs:
Meat and offal: 5 days
Horses:
Meat and offal: 5 days.
Not authorised for use in horses producing milk for human consumption
Pharmacotherapeutic group: Antiinflammatory and antirheumatic products, non-steroids (oxicams)
ATCvet code: QM01AC06
5.1 Pharmacodynamic properties
Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by
inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, anti-exudative, analgesic
and antipyretic effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it
also inhibits collagen-induced thrombocyte aggregation. Meloxicam also has anti-endotoxic properties
because it has been shown to inhibit production of thromboxane B2 induced by E. coli endotoxin
administration in calves, lactating cows and pigs.
5.2 Pharmacokinetic particulars
Absorption
After a single subcutaneous dose of 0.5 mg meloxicam/kg, C
max
values of 2.1 μg/ml and 2.7 μg/ml
were reached after 7.7 hours and 4 hours in young cattle and lactating cows, respectively.
After two intramuscular doses of 0.4 mg meloxicam/kg, a C
max
value of 1.9 μg/ml was reached after 1
hour in pigs.
Distribution
More than 98 % of meloxicam is bound to plasma proteins. The highest meloxicam concentrations are
to be found in liver and kidney. Comparatively low concentrations are detectable in skeletal muscle
and fat.
Metabolism
Meloxicam is predominantly found in plasma. In cattle, meloxicam is also a major excretion product
in milk and bile whereas urine contains only traces of the parent compound. In pigs, bile and urine
contain only traces of the parent compound. Meloxicam is metabolised to an alcohol, an acid
derivative and to several polar metabolites. All major metabolites have been shown to be
pharmacologically inactive. The metabolism in horses has not been investigated.
Elimination
Meloxicam is eliminated with a half-life of 26 hours and 17.5 hours after subcutaneous injection in
young cattle and lactating cows, respectively.
In pigs, after intramuscular administration the mean plasma elimination half-life is approximately 2.5
hours.
In horses, after intravenous injection meloxicam is eliminated with a terminal half-life of 8.5 hours.
Approximately 50 % of the administered dose is eliminated via urine and the remainder via faeces.
6.1 List of excipients
-
Ethanol (96%)
-
Poloxamer 188
-
Macrogol 400
-
Glycine
-
Disodium edetate
-
Sodium hydroxide
-
Hydrochloric acid, concentrated
-
Meglumine
-
Water for injections
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 first opening the immediate packaging: 28 days
6.4 Special precautions for storage
This veterinary medicinal product does not require any special storage conditions.
6.5 Nature and composition of immediate packaging
Cardboard box with 1 colourless glass injection vial containing 20 ml, 50 ml, 100 ml or 250 ml. Each
vial is closed with a rubber stopper and sealed with an aluminium cap.
Not all pack sizes may be marketed.
6.6 Special precautions for the disposal of unused veterinary medicinal products 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.
Chanelle Pharmaceuticals Manufacturing Ltd.,
Loughrea,
Co. Galway,
Ireland.
Tel: + 353 91 841788
Fax: + 353 91 842937
8.
EU/0/00/000/000
20 ml
EU/0/00/000/000
50 ml
EU/0/00/000/000
100 ml
EU/0/00/000/000
250 ml
9.
10.01.2008
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
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
A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE
Name and address of the manufacturer responsible for batch release
Chanelle Pharmaceuticals Manufacturing Ltd.,
Loughrea,
Co. Galway,
Ireland
B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
REGARDING SUPPLY OR USE
To be supplied only on veterinary prescription.
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 active substance in
Rheumocam 15 mg/ml oral suspension for horses is an allowed substance as
described in table 1 of the annex to Commission Regulation (EU) 37/2010:
Pharmacolo-
gically active
substance
Marker
residue
Animal
species
MRL
Target
tissues
Other
provisions
Therapeutic
classification
Meloxicam
Meloxicam
Bovine,
caprine,
porcine,
rabbit,
Equidae
20 μg/kg
65 μg/kg
65 μg/kg
Muscle
Liver
Kidney
NO
ENTRY
Anti-
inflammatory
agents/Nonster
oidal anti-
inflammatory
agents
Bovine,
caprine
15 μg/kg
Milk
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.
A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE
Name and address of the manufacturer responsible for batch release
Chanelle Pharmaceuticals Manufacturing Ltd.,
Loughrea,
Co. Galway,
Ireland
And
Eurovet Animal Health B.V.
Handelsweg 25,
5531 AE Bladel,
The Netherlands
B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
REGARDING SUPPLY OR USE
To be supplied only on veterinary prescription.
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 active substance in
Rheumocam 20 mg/ml solution for injection for cattle, pigs and horses is an
allowed substance as described in table 1 of the annex to Commission Regulation (EU) 37/2010:
Pharmacolo-
gically active
substance
Marker
residue
Animal
species
MRL
Target
tissues
Other
provisions
Therapeutic
classification
Meloxicam
Meloxicam
Bovine,
caprine,
porcine,
rabbit,
Equidae
20 μg/kg
65 μg/kg
65 μg/kg
Muscle
Liver
Kidney
NO
ENTRY
Anti-
inflammatory
agents/Nonster
oidal anti-
inflammatory
agents
Bovine,
caprine
15 μg/kg
Milk
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.
ANNEX III
LABELLING AND PACKAGE LEAFLET
A. LABELLING
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
{Carton for 15 ml, 42 ml, 100 ml or 200 ml bottle}
Rheumocam 1.5 mg/ml oral suspension for dogs
2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Each ml contains: 1.5 mg of meloxicam
5 mg of sodium benzoate
Oral suspension
4. PACKAGE SIZE
15 ml
42 ml
100 ml
200 ml
5. TARGET SPECIES
Dogs.
6.
INDICATION(S)
Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders.
7. METHOD AND ROUTE(S) OF ADMINISTRATION
Shake well before use.
To be administered mixed with food.
Read the package leaflet before use.
8. WITHDRAWAL PERIOD
Not applicable.
9. SPECIAL WARNING(S), IF NECESSARY
Do not use in pregnant or lactating animals.
10. EXPIRY DATE
EXP {month/year}
Once opened use within 6 months.
11. SPECIAL STORAGE CONDITIONS
Not applicable.
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT 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.
Chanelle Pharmaceuticals Manufacturing Ltd.,
Loughrea,
Co. Galway,
Ireland.
EU/2/07/078/004 15 ml
EU/2/07/078/001 42 ml
EU/2/07/078/002 100 ml
EU/2/07/078/003 200 ml
17. MANUFACTURER’S BATCH NUMBER
BN{number}
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
Carton
1.
Rheumocam 1 mg chewable tablets for dogs
Rheumocam 2.5 mg chewable tablets for dogs
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Each chewable tablet contains:
Active substance:
Meloxicam
1 mg
Meloxicam
2.5 mg
3.
Chewable tablet
4.
PACKAGE SIZE
20 tablets
100 tablets
5.
Dogs
6.
Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders.
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
Oral use
Read the package leaflet before use.
8.
Not applicable
9.
SPECIAL WARNING(S), IF NECESSARY
Read the package leaflet before use.
10. EXPIRY DATE
EXP {month/year}
11. SPECIAL STORAGE CONDITIONS
This veterinary medicinal product does not require any special storage conditions.
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
Chanelle Pharmaceuticals Manufacturing Ltd.,
Loughrea,
Co. Galway,
Ireland
EU/2/07/078/005
EU/2/07/078/006
EU/2/07/078/007
EU/2/07/078/008
17. MANUFACTURER’S BATCH NUMBER
BN
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
{Carton for 100 ml or 250 ml bottle}
Rheumocam 15 mg/ml oral suspension for horses
Meloxicam
2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Each ml contains: 15 mg of meloxicam
5 mg of sodium benzoate
Oral suspension
4. PACKAGE SIZE
100 ml
250 ml
5. TARGET SPECIES
Horses.
6.
Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in horses.
7. METHOD AND ROUTE(S) OF ADMINISTRATION
Shake well before use.
To be administered either mixed with a small quantity of food, prior to feeding, or directly into the
mouth.
Read the package leaflet before use.
8. WITHDRAWAL PERIOD
Meat and offal: 3 days.
Not authorised for use in lactating animals producing milk for human consumption.
9. SPECIAL WARNING(S), IF NECESSARY
Do not use in pregnant or lactating mares.
10. EXPIRY DATE
EXP {month/year}
Once opened use within 3 months.
11. SPECIAL STORAGE CONDITIONS
After administration of the veterinary medicinal product, close the bottle by replacing the cap, wash
the measuring syringe with warm water and let it dry.
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT 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.
Chanelle Pharmaceuticals Manufacturing Ltd.,
Loughrea,
Co. Galway,
Ireland.
EU/2/07/078/009
100 ml
EU/2/07/078/010
250 ml
17. MANUFACTURER’S BATCH NUMBER
BN{number}
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
{Carton for 20 ml, 50 ml, 100 ml and 250 ml}
Rheumocam 20 mg/ml solution for injection for cattle, pigs and horses
Meloxicam
2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Meloxicam 20 mg/ml
Ethanol (96 percent) 159.8 mg/ml
Solution for injection
4. PACKAGE SIZE
20 ml,
50 ml,
100 ml,
250 ml
5. TARGET SPECIES
Cattle, pigs and horses
6. INDICATIONS
Cattle:
Acute respiratory infection.
Diarrhoea in calves of over one week of age and young, non-lactating cattle.
Acute mastitis.
Pigs:
Non-infectious locomotor disorders.
Puerperal septicaemia and toxaemia (MMA syndrome) with antibiotic therapy.
Horses:
Acute and chronic musculo-skeletal disorders.
Pain associated with equine colic.
7. METHOD AND ROUTES OF ADMINISTRATION
Cattle:
Single subcutaneous or intravenous injection.
Pigs:
Single intramuscular injection. If required, a second administration can be given after 24 hours.
Horses:
Single intravenous injection.
Read the package leaflet before use.
8. WITHDRAWAL PERIODS
Cattle:
meat and offal: 15 days; milk: 5 days
Pigs:
meat and offal: 5 days
Horses:
meat and offal: 5 days.
Not authorised for use in horses producing milk for human consumption
9. SPECIAL WARNING(S), IF NECESSARY
Read the package leaflet before use.
10. EXPIRYDATE
EXP {month/year}
Shelf life after first opening the immediate packaging: 28 days
Once broached, use by…
11. SPECIAL STORAGE CONDITIONS
This veterinary medicinal product does not require any special storage conditions.
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF USUSED PRODUCTS OR
WASTE MATERIALS, IF ANY
Read the package leaflet before use
13. THE WORDS ‘FOR ANIMAL TREATMENT ONLY’ AND CONDITIONS OF
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.
Chanelle Pharmaceuticals Manufacturing Ltd
Loughrea
Co. Galway
Ireland
EU/0/00/000/000
20 ml
EU/0/00/000/000
50 ml
EU/0/00/000/000
100 ml
EU/0/00/000/000
250 ml
17. MANUFACTURER’S BATCH NUMBER
Lot {number}
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
{Label for 100ml and 200ml bottles}
Rheumocam 1.5 mg/ml oral suspension for dogs
2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Each ml contains: 1.5 mg of meloxicam
5 mg of sodium benzoate
Oral suspension
4. PACKAGE SIZE
100ml
200ml
5. TARGET SPECIES
Dogs.
6. INDICATION(S)
Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders.
7. METHOD AND ROUTE(S) OF ADMINISTRATION
Shake well before use.
Avoid introduction of contamination during use.
To be administered mixed with food.
Read the package leaflet before use.
8. WITHDRAWAL PERIOD
Not applicable.
9. SPECIAL WARNING(S), IF NECESSARY
Do not use in pregnant or lactating animals.
10. EXPIRY DATE
EXP {month/year}
Once opened use within 6 months.
11. SPECIAL STORAGE CONDITIONS
Not applicable.
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT 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.
Chanelle Pharmaceuticals Manufacturing Ltd.,
Loughrea,
Co. Galway,
Ireland.
EU/2/07/078/002 100 ml
EU/2/07/078/003 200 ml
17. MANUFACTURER’S BATCH NUMBER
BN{number}
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
{Label for 15ml and 42 ml bottle}
Rheumocam 1.5 mg/ml oral suspension for dogs
2. QUANTITY OF THE ACTIVE SUBSTANCE(S)
Meloxicam 1.5 mg/ml
3. CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
(15 ml) (42ml)
4. ROUTE(S) OF ADMINISTRATION
Shake well before use.
To be administered mixed with food.
5. WITHDRAWAL PERIOD
Not applicable.
6. BATCH NUMBER
BN {number}
7. EXPIRY DATE
EXP {month/year}
Once opened use within 6 months.
8. THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Blister
1.
Rheumocam 1 mg chewable tablets for dogs
Rheumocam 2.5 mg chewable tablets for dogs
2.
Chanelle Pharmaceuticals Manufacturing Ltd.
3.
EXPIRY DATE
EXP {month/year}
4.
BATCH NUMBER
BN
5.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
{Label for 100ml and 250ml bottles}
Rheumocam 15 mg/ml oral suspension for horses
Meloxicam
2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Each ml contains: 15 mg of meloxicam
5 mg of sodium benzoate
Oral suspension
4. PACKAGE SIZE
100ml
250ml
5. TARGET SPECIES
Horses.
6. INDICATION(S)
Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in horses.
7. METHOD AND ROUTE(S) OF ADMINISTRATION
Shake well before use.
Avoid introduction of contamination during use.
To be administered either mixed with a small quantity of food, prior to feeding, or directly into the
mouth.
Read the package leaflet before use.
8. WITHDRAWAL PERIOD
Meat and offal: 3 days.
Not authorised for use in lactating animals producing milk for human consumption.
9. SPECIAL WARNING(S), IF NECESSARY
Do not use in pregnant or lactating mares.
10. EXPIRY DATE
EXP {month/year}
Once opened use within 3 months.
11. SPECIAL STORAGE CONDITIONS
After administration of the veterinary medicinal product, close the bottle by replacing the cap, wash
the measuring syringe with warm water and let it dry.
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT 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.
Chanelle Pharmaceuticals Manufacturing Ltd.,
Loughrea,
Co. Galway,
Ireland.
EU/2/07/078/009
100 ml
EU/2/07/078/010
250 ml
17. MANUFACTURER’S BATCH NUMBER
BN{number}
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
{Label for 50 ml, 100 ml and 250 ml}
Rheumocam 20 mg/ml solution for injection for cattle, pigs and horses
Meloxicam
2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Meloxicam 20 mg/ml
Ethanol (96 percent) 159.8 mg/ml
Solution for injection
4. PACKAGE SIZE
50 ml,
100 ml,
250 ml
5. TARGET SPECIES
Cattle, pigs and horses
6. INDICATIONS
Read package leaflet before use.
7. METHOD AND ROUTES OF ADMINISTRATION
Cattle:
SC or IV injection.
Pigs:
IM injection.
Horses:
IV injection.
8. WITHDRAWAL PERIODS
Cattle:
meat and offal: 15 days; milk: 5 days
Pigs:
meat and offal: 5 days
Horses:
meat and offal: 5 days.
Not authorised for use in horses producing milk for human consumption
9. SPECIAL WARNING(S), IF NECESSARY
Read the package leaflet before use.
10. EXPIRYDATE
EXP {month/year}
Shelf life after first opening the immediate packaging: 28 days
Once broached, use by…
11. SPECIAL STORAGE CONDITIONS
This veterinary medicinal product does not require any special storage conditions.
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF USUSED PRODUCTS OR
WASTE MATERIALS, IF ANY
Read the package leaflet before use
13. THE WORDS ‘FOR ANIMAL TREATMENT ONLY’ AND CONDITIONS OF
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.
Chanelle Pharmaceuticals Manufacturing Ltd
Loughrea
Co. Galway
Ireland
EU/0/00/000/000
50 ml
EU/0/00/000/000
100 ml
EU/0/00/000/000
250 ml
17. MANUFACTURER’S BATCH NUMBER
Lot {number}
MINIMUM
PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
{Label for 20 ml bottles}
Rheumocam 20 mg/ml Solution for injection for Cattle, Pigs and Horses
Meloxicam
2. QUANTITY OF THE ACTIVE SUBSTANCE
Meloxicam 20 mg/ml
Ethanol (96 percent) 159.8 mg/ml
3. CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
20 ml
4. ROUTES OF ADMINISTRATION
Cattle:
SC or IV injection.
Pigs:
IM injection.
Horses:
IV injection.
5. WITHDRAWAL PERIOD
Cattle:
meat and offal: 15 days; milk: 5 days
Pigs:
meat and offal: 5 days
Horses:
meat and offal: 5 days.
Not authorised for use in horses producing milk for human consumption.
6. BATCH NUMBER
Lot {number}
7. EXPIRY DATE
EXP {month/year}
Shelf life after first opening the immediate packaging: 28 days
Once broached use by …
8. THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
B. PACKAGE LEAFLET
PACKAGE LEAFLET FOR:
Rheumocam 1.5 mg/ml oral suspension for dogs
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Chanelle Pharmaceuticals Manufacturing Ltd.,
Loughrea, Co. Galway, Ireland.
Tel: + 353 91 841788
Fax: + 353 91 842937
e-mail: sales@chanellegroup.ie
Rheumocam 1.5 mg/ml oral suspension for dogs
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each ml contains: 1.5 mg of meloxicam
5 mg of sodium benzoate
Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders.
Do not use in pregnant or lactating animals.
Do not use in animals suffering from gastrointestinal disorders such as irritation and haemorrhage,
impaired hepatic, cardiac or renal function and haemorrhagic disorders.
Do not use in case of hypersensitivity.
Do not use in dogs less than 6 weeks of age.
6.
ADVERSE REACTIONS
Typical adverse reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood
and apathy have occasionally been reported. These side effects occur generally within the first
treatment week and are in most cases transient and disappear following termination of the treatment
but in very rare cases may be serious or fatal.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your
veterinary surgeon.
Dogs.
8.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Shake well before use. To be administered mixed with food.
Avoid introduction of contamination during use.
Initial treatment is a single dose of 0.2 mg meloxicam/kg body weight on the first day. Treatment is to
be continued once daily by oral administration (at 24-hour intervals) at a maintenance dose of 0.1 mg
meloxicam/kg body weight.
The suspension can be given using the measuring syringe provided in the package. The syringe has a
scale which corresponds to the volume required.
The following dosing table indicates what volume to administer depending on the weight of the dog:
Bodyweight (kg)
Maintenance Dosage (ml)
7.5
0.5
15
1
22.5
1.5
30
2
37.5
2.5
45
3
52.5
3.5
60
4
For the first day, twice the maintenance dosage will be required.
A clinical response is normally seen within 3 to 4 days. Treatment should be discontinued after 10
days at the latest if no clinical improvement is apparent.
9.
ADVICE ON CORRECT ADMINISTRATION
Particular care should be taken with regard to the accuracy of dosing. Please carefully follow the
instructions of the veterinarian.
Not applicable.
11.
SPECIAL STORAGE PRECAUTIONS
This veterinary medicinal product does not require any special storage conditions.
Keep out of the reach and sight of children.
Do not use after the expiry date (EXP) stated on the carton and the bottle.
12.
SPECIAL WARNING(S)
If side effects occur, treatment should be discontinued and the advice of a veterinarian should be
sought. Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk
of increased renal toxicity.
Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein
binding may compete for binding and thus lead to toxic effects. Rheumocam must not be administered
in conjunction with other NSAIDs or glucocorticosteriods.
Pre-treatment with anti-inflammatory substances may result in additional or increased adverse effects
and accordingly a treatment-free period with such veterinary products should be observed for at least
24 hours before commencement of treatment. The treatment-free period, however, should take into
account the pharmacokinetic properties of the veterinary products used previously.
In the case of overdosage symptomatic treatment should be initiated.
People with known hypersensitivity to NSAIDs should avoid contact with the veterinary medicinal
product.
In case of accidental ingestion, seek medical advice immediately and show this package leaflet or the
label to the physician.
13.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIAL, 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
Detailed information on this product is available on the website of the European Medicines Agency
(EMA)
http://www.ema.europa.eu
15.
OTHER INFORMATION
To be supplied only on veterinary prescription.
15, 42, 100 or 200 ml bottle with a measuring syringe.
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
Eurovet NV
Poorthoevestraat 4
3550 Heusden-Zolder
Belgien
Magyarország
Primavet
H-1142 Budapest
Hungary
Česká republika
Orion OYJ
Zelený pruh 95/97,
140 00, Praha, ČR
Danmark
ScanimalHealth ApS
Klokkestøbervej 2
DK-9490 Pandrup
Denmark
Nederland
Eurovet Animal Health BV
Handelsweg 25
5531 AE Bladel
Nederland
Deutschland
Albrecht GmbH
Hauptstrasse 6-8
88326 Aulendorf
Deutschland
Eesti
Optimer ltd.
Pärnu mnt. 463
10916 Tallinn
Estonia
Österreich
Richter Pharma AG
Feldgasse 19
4600 Wels
Austria
Ελλάδα
PROVET A.E.
Λεωφ. Ποσειδώνος 77
174 55 Άλιμος, Αττική
Polska
Orion Pharma Poland Sp. z o.o.
ul. Grochowska 278, klatka B lok. 31
03-841 Warszawa
Portugal
ESTEVE FARMA, Lda.
Av. do Forte 3
Edifício Suécia II - Piso 4 A
2794-044 CARNAXIDE
Portugal
Ireland
Chanelle Pharmaceuticals Manufacturing Ltd.
Loughrea
Co. Galway
Ireland
Ísland
Icepharma hf,
Lynghálsi 13,
110 Reykjavík
Iceland
Italia
ESTEVE SpA.
Via Ippolito Rosellini, 12 - 1º piano
20124 MILANO (Italia).
Suomi/Finland
Orion Pharma Eläinlääkkeet
PL 425, 20101 Turku
Sverige
Omnidea AB
Kaptensgatan 12
114 57 Stockholm
Sweden
United Kingdom
Chanelle Vet UK Ltd
Freemans House
127 High Street
Hungerford
RG17 0DL
UK
PACKAGE LEAFLET FOR
Rheumocam 1 mg chewable tablets for dogs
Rheumocam 2.5 mg chewable tablets for dogs
1.
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Chanelle Pharmaceuticals Manufacturing Ltd.
Loughrea,
Co. Galway,
Ireland.
2.
Rheumocam 1 mg chewable tablets for dogs
Rheumocam 2.5 mg chewable tablets for dogs
Meloxicam
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each chewable tablet contains:
Active substance:
Meloxicam
1 mg
Meloxicam
2.5 mg
4.
Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders.
5.
Do not use in pregnant or lactating animals.
Do not use in animals suffering from gastrointestinal disorders such as irritation and haemorrhage,
impaired hepatic, cardiac or renal function and haemorrhagic disorders.
Do not use in dogs less than 6 weeks of age or less than 4 kg body weight.
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
6.
Typical adverse drug reactions of non-steroidal anti-inflammatory drugs such as loss of appetite,
vomiting, diarrhoea, faecal occult blood, apathy and renal failure have occasionally been reported.
These side effects occur generally within the first treatment week and are in most cases transient and
disappear following termination of the treatment but in very rare cases may be serious or fatal.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your
veterinary surgeon.
7.
Dogs
8.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Initial treatment is a single dose of 0.2 mg meloxicam/kg body weight on the first day.
Treatment is to be continued once daily by oral administration (at 24-hour intervals) at a maintenance
dose of 0.1 mg meloxicam/kg body weight.
Each chewable tablet contains either 1 mg or 2.5 mg meloxicam, which corresponds to the daily
maintenance dose for a 10 kg body weight dog, or a 25 kg body weight dog respectively. Each
chewable tablet can be halved for accurate dosing according to the individual body weight of the
animal. Rheumocam chewable tablets can be administered with or without food, are flavoured and are
taken by most dogs voluntarily.
Dose scheme for the maintenance dose:
Body weight
(kg)
Number of chewable tablets
mg/kg
1 mg
2.5 mg
4.0 – 7.0
½
0.13 – 0.1
7.1 – 10.0
1
0.14 – 0.1
10.1 – 15.0
1 ½
0.15 – 0.1
15.1 – 20.0
2
0.13 – 0.1
20.1 – 25.0
1
0.12 – 0.1
25.1 – 35.0
1 ½
0.15 – 0.1
35.1 – 50.0
2
0.14 – 0.1
The use of Rheumocam oral suspension for dogs may be considered for an even more precise dosing.
For dogs weighing less than 4 kg the use of Rheumocam oral suspension for dogs is recommended.
A clinical response is normally seen within 3 – 4 days. Treatment should be discontinued after 10 days
if no clinical improvement is apparent.
9.
ADVICE ON CORRECT ADMINISTRATION
To ensure correct dosage, body weight should be determined as accurately as possible to avoid
underdosing or overdosing.
10. WITHDRAWAL PERIOD
Not applicable
11. SPECIAL STORAGE PRECAUTIONS
Keep out of the reach and sight of children.
This veterinary medicinal product does not require any special storage conditions
12. SPECIAL WARNING(S)
Precautions for use in animals
If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be
sought.
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of renal
toxicity.
Precautions to be taken by the person administering the product.
People with known hypersensitivity to NSAIDs should avoid contact with the veterinary medicinal
product.
In case of accidental ingestion, seek medical advice immediately and show this package leaflet or the
label to the physician.
Use during pregnancy and lactation.
Interactions
Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein
binding may compete for binding and thus lead to toxic effects. Rheumocam must not be administered
in conjunction with other NSAIDs or glucocorticosteroids.
Pre-treatment with anti-inflammatory substances may result in additional or increased adverse effects
and accordingly a treatment-free period with such drugs should be observed for at least 24 hours
before commencement of treatment. The treatment-free period, however, should take into account the
pharmacokinetic properties of the products used previously.
In the case of overdosage symptomatic treatment should be initiated.
13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIAL, 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
Detailed information on this product is available on the website of the European Medicines Agency
(EMA)
http://www.ema.europa.eu
15. OTHER INFORMATION
20 tablets
100 tablets
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
Eurovet NV
Poorthoevestraat 4
3550 Heusden-Zolder
Belgien
Česká republika
Orion OYJ
Zelený pruh 95/97,
140 00, Praha, ČR
Nederland
Eurovet Animal Health BV
Handelsweg 25
5531 AE Bladel
Nederland
Deutschland
Albrecht GmbH
Hauptstrasse 6-8
88326 Aulendorf
Deutschland
Österreich
Richter Pharma AG
Feldgasse 19
4600 Wels
Austria
Ελλάδα
PROVET A.E.
Λεωφ. Ποσειδώνος 77
174 55 Άλιμος, Αττική
Polska
Orion Pharma Poland Sp. z o.o.
ul. Grochowska 278, klatka B lok. 31
03-841 Warszawa
România
Allfeed International
Montera Vet Group of Countries
B-dul Iuliu Maniu nr. 220
Bucureşti, sector 6
Romania
Ireland
Chanelle Pharmaceuticals Manufacturing Ltd.
Loughrea
Co. Galway
Ireland
Slovenija
Distributer
ORION CORPORATION P.O.Box 65
FI-02101, Espoo, Finland
Predstavnik:
IRIS d.o.o.
1000 Ljubljana
Cesta vGorice 8
Slovenská republika
Orion OYJ
Ružová dolina 6,
821 08 Bratislava, SR
Suomi/Finland
Orion Pharma Eläinlääkkeet
Pl 425, 20101 Turku
Sverige
Omnidea AB
Kaptensgatan 12
114 57 Stockholm
Sweden
Latvija
Orion Pharma
Kubiliaus str.6
LT-08234 Vilnius, Lithuania
United Kingdom
Chanelle Vet UK Ltd
Freemans House
127 High Street
Hungerford
RG17 0DL
UK
Lietuva
Orion Pharma
Kubiliaus str.6
LT-08234 Vilnius, Lithuania
PACKAGE LEAFLET FOR:
Rheumocam 15 mg/ml oral suspension for horses
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Chanelle Pharmaceuticals Manufacturing Ltd.,
Loughrea, Co. Galway, Ireland.
Tel: + 353 91 841788
Fax: + 353 91 842937
e-mail: sales@chanellegroup.ie
Rheumocam 15 mg/ml oral suspension for horses
Meloxicam
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each ml contains: 15 mg of meloxicam
5 mg of sodium benzoate
Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in horses.
Do not use in pregnant or lactating mares.
Do not use in horses suffering from gastrointestinal disorders such as irritation and haemorrhage,
impaired hepatic, cardiac or renal function and haemorrhagic disorders.
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Do not use in horses less than 6 weeks of age.
6.
ADVERSE REACTIONS
Isolated cases of adverse reactions typically associated with Non-Steroidal Anti-Inflammatory Drugs
(NSAIDs) were observed in clinical trials (slight urticaria, diarrhoea). Symptoms were reversible.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your
veterinary surgeon.
Horses.
8.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Oral suspension to be administered at a dosage of 0.6 mg/kg body weight, once daily, up to 14 days.
This is equivalent to 1 ml of Rheumocam per 25 kg body weight of horse. For example, a horse
weighing 400 kg will receive 16 ml of Rheumocam, a horse weighing 500 kg will receive 20 ml of
Rheumocam, and a horse weighing 600 kg will receive 24 ml of Rheumocam.
Shake well before use. To be administered either mixed with a small quantity of food, prior to feeding,
or directly into the mouth.
The suspension should be given using the measuring syringe provided in the package. The syringe fits
onto the bottle and has a 2 ml scale.
Avoid introduction of contamination during use.
9.
ADVICE ON CORRECT ADMINISTRATION
None.
Meat and offal: 3 days.
Not authorised for use in lactating animals producing milk for human consumption.
11.
SPECIAL STORAGE PRECAUTIONS
Keep out of the reach and sight of children.
This veterinary medicinal product does not require any special storage conditions.
After administration of the veterinary medicinal product, close the bottle by replacing the cap, wash
the measuring syringe with warm water and let it dry.
Do not use after the expiry date (EXP) stated on the carton and the bottle.
Shelf life after first opening of the container: 3 months.
12.
SPECIAL WARNING(S)
Precautions for use in animals:
If side effects occur, treatment should be discontinued and the advice of a veterinarian should be
sought.
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of
increased renal toxicity.
Precautions to be taken by the person administering the product:
People with known hypersensitivity to NSAIDs should avoid contact with the veterinary medicinal
product.
In case of accidental ingestion, seek medical advice immediately and show this package leaflet or the
label to the physician.
Use during pregnancy and lactation:
Interactions:
Do not administer concurrently with glucocorticoids, other non-steroidal anti-inflammatory drugs or
with anti-coagulant agents.
Overdose:
In the case of overdose symptomatic treatment should be initiated.
13.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIAL, 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
Detailed information on this product is available on the website of the European Medicines Agency
(EMA)
http://www.ema.europa.eu
15.
OTHER INFORMATION
To be supplied only on veterinary prescription.
100 or 250 ml bottle with a measuring syringe.
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
Eurovet NV
Poorthoevestraat 4
3550 Heusden-Zolder
Belgien
Danmark
ScanimalHealth ApS
Klokkestøbervej 2
DK-9490 Pandrup
Danmark
Nederland
Eurovet Animal Health BV
Handelsweg 25
5531 AE Bladel
Nederland
Deutschland
Albrecht GmbH
Hauptstrasse 6-8
88326 Aulendorf
Deutschland
Österreich
Richter Pharma AG
Feldgasse 19
4600 Wels
Austria
Portugal
Prodivet ZN, Nutrição e Comércio de Produtos
Químicos, Farmacêuticos e Cosméticos, S.A.
Av. Infante D. Henrique, nº 333-H, 3º Piso,
Esc.41
1800-282 Lisboa
Portugal
Ireland
Chanelle Pharmaceuticals Manufacturing Ltd.
Loughrea
Co. Galway
Ireland
Suomi/Finland
Scanvet Animal Health oy
PB 27
FI 13721
Parola
Finland
Sverige
Omnidea AB
Kaptensgatan 12
114 57 Stockholm
Sweden
United Kingdom
Chanelle Vet UK Ltd
Freemans House
127 High Street
Hungerford
RG17 0DL
UK
PACKAGE LEAFLET
Rheumocam 20 mg/ml solution for injection for cattle, pigs and horses
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder
Chanelle Pharmaceuticals Manufacturing Ltd., Loughrea, Co. Galway, Ireland
Manufacturers for the batch release
:
Chanelle Pharmaceuticals Manufacturing Ltd., Loughrea, Co. Galway, Ireland
and
Eurovet Animal Health B.V. Handelsweg 25, 5531 AE Bladel, The Netherlands
Rheumocam 20 mg/ml solution for injection for cattle, pigs and horses
Meloxicam
3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS
One ml contains:
Meloxicam 20 mg
Ethanol (96 percent) 159.8 mg/ml
Clear, yellow solution.
4. INDICATION(S)
Cattle:
For use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs in
cattle.
For use in diarrhoea in combination with oral re-hydration therapy to reduce clinical signs in calves of
over one week of age and young, non-lactating cattle.
For adjunctive therapy in the treatment of acute mastitis, in combination with antibiotic therapy.
Pigs:
For use in non-infectious locomotor disorders to reduce the symptoms of lameness and inflammation.
For adjunctive therapy in the treatment of puerperal septicaemia and toxaemia (mastitis-metritis-
agalactia syndrome) with appropriate antibiotic therapy.
Horses:
For use in the alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal
disorders.
For the relief of pain associated with equine colic.
5. CONTRAINDICATIONS
Do not use in horses less than 6 weeks of age.
Do not use in pregnant or lactating mares.
Do not use in animals suffering from impaired hepatic, cardiac or renal function and haemorrhagic
disorders, or where there is evidence of ulcerogenic gastrointestinal lesions.
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
For the treatment of diarrhoea in cattle, do not use in animals of less than one week of age.
6. ADVERSE REACTIONS
In cattle and pigs, subcutaneous, intramuscular as well as intravenous administration is well tolerated;
only a slight transient swelling at the injection site following subcutaneous administration was
observed in less than 10 % of the cattle treated in clinical studies.
In horses, a transient swelling at the injection site can occur but resolves without intervention.
In very rare cases anaphylactoid reactions may occur and should be treated symptomatically.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your
veterinary surgeon.
7. TARGET SPECIES
Cattle, pigs and horses
8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Cattle:
Single subcutaneous or intravenous injection at a dosage of 0.5 mg meloxicam/kg body weight (i.e.
2.5 ml/100 kg body weight) in combination with antibiotic therapy or with oral re-hydration therapy,
as appropriate.
Pigs:
Single intramuscular injection at a dosage of 0.4 mg meloxicam/kg body weight (i.e. 2.0 ml/100 kg
body weight) in combination with antibiotic therapy, as appropriate. If required, a second
administration of meloxicam can be given after 24 hours.
Horses:
Single intravenous injection at a dosage of 0.6 mg meloxicam/kg body weight (i.e. 3.0 ml/100 kg body
weight).
For use in the alleviation of inflammation and the relief of pain in both acute and chronic
musculoskeletal disorders, Rheumocam 15 mg/ml oral suspension may be used for continuation of
treatment at a dosage of 0.6 mg meloxicam/kg body weight, 24 hours after administration of the
injection.
9. ADVICE ON CORRECT ADMINISTRATION
Avoid introduction of contamination during use.
Maximum number of piercings is 14 for the 20 ml, 50 ml and 100 ml stoppers and 20 for the 250 ml
stopper.
10. WITHDRAWAL PERIODS
Cattle:
meat and offal: 15 days; milk: 5 days
Pigs:
meat and offal: 5 days
Horses:
meat and offal: 5 days
Not authorised for use in horses producing milk for human consumption.
11. SPECIAL STORAGE PRECAUTIONS
Keep out of the reach and sight of children.
This veterinary medicinal product does not require any special storage conditions.
Do not use after the expiry date (EXP) stated on the carton and vial.
Shelf life after first opening the container: 28 days.
12. SPECIAL WARNING(S)
Precautions for use in animals
If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be
sought.
Avoid use in very severely dehydrated, hypovolaemic or hypotensive animals which require parenteral
rehydration, as there may be a potential risk of renal toxicity.
In case of inadequate relief of pain when used in the treatment of equine colic, careful re-evaluation of
the diagnosis should be made as this could indicate the need for surgical intervention.
Precautions to be taken by the person administering the product
Accidental self-injection may give rise to pain. People with known hypersensitivity to Non-Steroidal
Anti-Inflammatory Drugs (NSAIDs) should avoid contact with the veterinary medicinal product.
In case of accidental self-injection, seek medical advice immediately and show this package leaflet or
the label to the physician.
Use during pregnancy and lactation
Cattle and pigs
:
Can be used during pregnancy and lactation.
Interactions
Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs
or with anti-coagulant agents.
In the case of overdose, symptomatic treatment should be initiated.
13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIALS, IF ANY
Waste materials should be disposed of in accordance with local requirements.
14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
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
Cardboard box containing one colourless glass injection vial of 20 ml, 50 ml, 100 ml or 250 ml.
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
Eurovet NV
Poorthoevestraat 4
3550 Heusden-Zolder
Belgien
Česká republika
Orion OYJ
Zelený pruh 95/97,
140 00, Praha, ČR
Danmark
ScanimalHealth ApS
Klokkestøbervej 2
DK-9490 Pandrup
Denmark
Nederland
Eurovet Animal Health BV
Handelsweg 25
5531 AE Bladel
Nederland
Deutschland
Albrecht GmbH
Hauptstrasse 6-8
88326 Aulendorf
Deutschland
Österreich
Richter Pharma AG
Feldgasse 19
4600 Wels
Austria
Polska
Orion Pharma Poland Sp. z o.o.
ul. Grochowska 278, klatka B lok. 31
03-841 Warszawa
România
Distribuit de
ORION CORPORATION P.O.Box 65
FI-02101, Espoo, Finland
Reprezentat:
Vanelli S.R.L.
Sos.Iasi
Tg.Frumos, km. 10, Iasi 707410
Ireland
Chanelle Pharmaceuticals Manufacturing Ltd.
Loughrea
Co. Galway
Ireland
Slovenija
Distributer
ORION CORPORATION P.O.Box 65
FI-02101, Espoo, Finland
Predstavnik:
IRIS d.o.o.
1000 Ljubljana
Cesta vGorice 8
Slovenská republika
Orion OYJ
Ružová dolina 6,
821 08 Bratislava, SR
Sverige
Omnidea AB
Kaptensgatan 12
114 57 Stockholm
Sweden
United Kingdom
Chanelle Vet UK Ltd
Freemans House
127 High Street
Hungerford
RG17 0DL
UK
Source: European Medicines Agency
- Please bookmark this page (add it to your favorites).
- If you wish to link to this page, you can do so by referring to the URL address below this line.
https://theodora.com/drugs/eu/rheumocam_veterinary.html
Copyright © 1995-2021 ITA all rights reserved.