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Date: Sunday, April 28, 2024 6:02

Release 5.186
Metacam 2 mg/ml solution for injection for cats
 
Species: Cats
Therapeutic indication: Pharmaceuticals: Neurological preparations: Analgesics, Pharmaceuticals: Anti-inflammatory preparations: Injections: NSAIDs, Pharmaceuticals: Locomotor (including navicular and osteoarthritis)
Active ingredient: Meloxicam
Product:Metacam® 2 mg/ml solution for injection for cats
Product index: Metacam 2 mg/ml solution for injection for cats
Incorporating:
Presentation
Clear yellow solution for injection. One ml contains 2 mg meloxicam as active substance and 150 mg ethanol as excipient.
Uses
Alleviation of mild to moderate post-operative pain and inflammation following surgical procedures in cats, e.g. orthopaedic and soft tissue surgery.
Dosage and administration
Single subcutaneous injection at a dosage of 0.2 mg meloxicam/kg body weight (i.e. 0.1 ml/kg body weight) before surgery, for example at the time of induction of anaesthesia.
To continue treatment for up to five days, this initial dose may be followed 24 hours later by administration of Metacam 0.5 mg/ml oral suspension for cats at a dosage of 0.05 mg meloxicam/kg body weight. The oral follow-up dose may be administered for up to a total of four doses at 24 hour intervals.
Single subcutaneous injection of 0.3 mg meloxicam/kg body weight (i.e. 0.15 ml/kg body weight) has also been shown to be safe and efficacious for the reduction of post-operative pain and inflammation.This treatment can be considered in cats undergoing surgery where no oral follow-up treatment is possible e.g. feral cats. In this case do not use oral follow up treatment. 
Particular care should be taken with regard to the accuracy of dosing. Avoid introduction of contamination during use.
Contra-indications, warnings, etc
Do not use in pregnant or lactating animals.
Do not use in cats 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 cats less than 6 weeks of age nor in cats of less than 2 kg.
Special 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 cat, as there is a potential risk of renal toxicity.
During anaesthesia, monitoring and fluid therapy should be considered as standard practice. In case additional pain relief is required, multimodal pain therapy should be considered.
Typical adverse reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood, lethargy and renal failure have very rarely been reported from post-marketing safety experience.
Gastrointestinal ulceration and elevated liver enzymes were reported in very rare cases from post-marketing safety experience.These adverse reactions are in most cases transient and disappear following termination of the treatment but in very rare cases may be serious or fatal. Anaphylactoid reactions have been observed very rarely from post-marketing safety experience and should be treated symptomatically.
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).
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. Metacam must not be administered in conjunction with other NSAIDs or glucocorticosteroids. Concurrent administration of potential nephrotoxic veterinary medicinal products should be avoided. In animals at anaesthetic risk (e.g. aged animals) intravenous or subcutaneous fluid therapy during anaesthesia should be taken into consideration. When anaesthesia and NSAID are concomitantly administered, a risk for renal function cannot be excluded.
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 pharmacological properties of the products used previously.
In the case of overdose symptomatic treatment should be initiated.
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
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.
This product can cause eye irritation. In case of contact with the eyes, immediately rinse thoroughly with water.
Pharmaceutical precautions
Shelf-life of the veterinary medicinal product as packaged for sale: 2 years.
Shelf-life after first opening the immediate packaging: 28 days.
Keep out of the sight and reach of children. For animal treatment only.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Legal category
Legal category: POM-V
Packaging quantities
Cardboard box containing one colourless glass injection vial of 10 ml or 20 ml, closed with a rubber stopper and sealed with an aluminium cap. Not all pack sizes may be marketed.
Further information
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).
Pharmacokinetic properties
Absorption
Following subcutaneous administration, meloxicam is completely bioavailable and maximal mean plasma concentrations of 1.1 µg/ml were reached approximately 1.5 hours post administration.
Distribution
There is a linear relationship between the dose administered and plasma concentration observed in the therapeutic dose range. More than 97 % of meloxicam is bound to plasma proteins. The volume of distribution is 0.09 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. Five major metabolites were detected all having been shown to be pharmacologically inactive. Meloxicam is metabolised to an alcohol, an acid derivative and to several polar metabolites. As for other species investigated, the main pathway of meloxicam biotransformation in cats is oxidation.
Elimination
Meloxicam is eliminated with a half-life of 24 hours. The detection of metabolites from the parent compound in urine and faeces, but not in plasma is indicative for their rapid excretion. 21% of the recovered dose is eliminated in urine (2% as unchanged meloxicam, 19% as metabolites) and 79% in the faeces (49% as unchanged meloxicam, 30% as metabolites).
Marketing Authorisation Number
UK(GB): Vm 04491/5022
UK(NI): EU/2/97/004/039 : 10 ml
UK(NI): EU/2/97/004/040 : 20 ml
Significant changes
GTIN
GTIN description:Metacam 2 mg/ml Solution for Injection for Cats - 10ml
GTIN:5012917010299
Marketing Authorisation Holder (if different from distributor)
Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim am Rhein
Germany