Metacam
Active substance
ATC code
Species
Horses
Indications
Alleviation of inflammation and relief of pain in both acute and chronic musculoskeletal disorders in horses.
Dose to be administered and administration route
Oral use.
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 measuring syringe provided in the package. The syringe fits onto the bottle and has a kg-body weight scale.
To ensure a correct dosage, body weight should be determined as accurately as possible.
Shake well before use.
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.
Avoid introduction of contamination during use.
Adverse reactions
Horses:
|
Very rare (<1 animal / 10,000 animals treated, including isolated reports): |
Diarrhoea1, abdominal pain, colitis Appetite loss, lethargy Urticaria, anaphylactoid reaction2 |
1 Reversible
2 May be serious (including fatal) and should be treated symptomatically.
If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Dispensing
POM-V - Prescription Only Medicine – VeterinarianReferences
TRUSTED SOURCE
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Metacam 15 mg/ml oral suspension for horses
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml contains:
Active substance:
Meloxicam 15 mg
Excipient:
Sodium benzoate 1.5 mg
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Oral suspension
Yellowish viscous oral suspension with a green tinge.
4. CLINICAL PARTICULARS
4.1 Target species
Horses
4.2 Indications for use, specifying the target species
Alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal disorders in horses.
4.3 Contraindications
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 cases of hypersensitivity to the active substance or to any of the excipients. Do not use in horses less than 6 weeks of age.
4.4 Special warnings for each target species
None.
4.5 Special precautions for use
Special precautions for use in animals
Avoid use in any dehydrated, hypovolaemic or hypotensive animals 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 nonsteroidal 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.
This product can cause eye irritation. In case of contact with the eyes, immediately rinse thoroughly with water.
4.6 Adverse reactions (frequency and seriousness)
Diarrhoea, typically associated with NSAIDs, was very rarely observed in clinical trials. The clinical sign was reversible.
Loss of appetite, lethargy, abdominal pain, colitis and urticaria have been reported very rarely from post- marketing safety experience.
Anaphylactoid reactions, which may be serious (including fatal), have been observed very rarely from post-marketing safety experience and should be treated symptomatically.
If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reactions)
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
4.7 Use during pregnancy, lactation or lay
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.
4.8 Interaction with other medicinal products and other forms of interaction
Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs or with anticoagulant agents.
4.9 Amounts to be administered and administration route
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 measuring syringe provided in the package. The syringe fits onto the bottle and has a kg-body weight scale.
Shake well before use.
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.
Avoid introduction of contamination during use.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary In case of overdose symptomatic treatment should be initiated.
4.11 Withdrawal period(s) Meat and offal: 3 days.
5. PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: Anti-inflammatory 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, 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 antiendotoxic properties because it has been shown to inhibit production of thromboxane B2 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 oxalylmetabolite. 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. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sodium benzoate Sorbitol, liquid Glycerol Saccharin sodium Xylitol
Sodium dihydrogen phosphate dihydrate Silica, colloidal anhydrous
Hydroxyethylcellulose
Citric acid Honey aroma Water, purified
6.2 Major 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: 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
Cardboard box containing one polyethylene bottle of 100 ml or 250 ml with a polyethylene tip adapter and a tamper-proof child-resistant closure and a 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. MARKETING AUTHORISATION HOLDER
Boehringer Ingelheim
Vetmedica GmbH 55216
Ingelheim/Rhein
GERMANY
8. MARKETING AUTHORISATION NUMBERS
EU/2/97/004/009 100 ml
EU/2/97/004/030 250 ml
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation:07.01.1998
Date of last renewal: 06.12.2007
10. DATE OF REVISION OF THE TEXT
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.
| Art. Nr. | 04491/5018 |
|---|---|
| EAN | 5012917010107 |
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