Boehringer Ingelheim
Metacam 2 mg/ml solution for injection for cats 10 ml

Alleviation of mild to moderate post-operative pain and inflammation following surgical procedures in cats / Meloxicam

Some countries require a prescription to be issued for the sale of this drug.

Metacam 2 mg/ml solution for injection for cats

2. QUALITATIVE AND QUANTITATIVE COMPOSITION OF Metacam 2 mg/ml

One ml contains:

Active substance:
Meloxicam 2 mg

Excipients:
Ethanol 150 mg

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM OF Metacam 2 mg/ml

Solution for injection.
Clear yellow solution.

4. CLINICAL PARTICULARS OF Metacam 2 mg/ml

4.1. Target species

Cats

4.2. Indications for use, specifying the target species

Alleviation of mild to moderate post-operative pain and inflammation following surgical procedures in cats, e.g. orthopaedic and soft tissue surgery.

4.3. Contraindications

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 case 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.

4.4. Special warnings

None.

4.5. Special precautions for use

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.

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.

4.6 Adverse reactions (frequency and seriousness)

Typical adverse reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood, lethargy and renal failure have occasionally been reported. In very rare cases elevated liver enzymes have been reported.

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.

In very rare cases anaphylactoid reactions may occur and should be treated symptomatically.

The frequency of adverse reactions is defined using the following convention:
very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment)
common (more than 1 but less than 10 animals in 100 animals)
uncommon (more than 1 but less than 10 animals in 1,000 animals)
rare (more than 1 but less than 10 animals in 10,000 animals)
very rare (less than 1 animal in 10,000 animals, including isolated reports).

4.7. Use during pregnancy, lactation or lay

The safety of the veterinary medicinal product has not been established during pregnancy and lactation (see section 4.3).

4.8. Interaction with other medicinal products and other forms of interaction

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.

4.9. Amounts to be administered and administration route

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.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

In the case of overdose symptomatic treatment should be initiated.

4.11 Withdrawal period(s)

Not applicable.

5. PHARMACOLOGICAL PROPERTIES OF Metacam 2 mg/ml

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, 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
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 cat 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).

6. PHARMACEUTICAL PARTICULARS OF Metacam 2 mg/ml

6.1. List of excipients

Ethanol
Poloxamer 188
Macrogol 300
Glycine
Disodium edetate
Sodium hydroxide (for pH adjustment)
Hydrochloric acid (for pH adjustment)
Meglumine
Water for injections

6.2. Incompatibilities

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

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: 28 days.

6.4. Special precautions for storage

This veterinary medicinal product does not require any special storage conditions.

29.80
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