Boehringer Ingelheim
Metacam 0.5 mg/ml oral suspension for cats 3 ml

Alleviation of inflammation and pain in chronic musculo-skeletal disorders and reduction of post-operative pain and inflammation in cats / Meloxicam

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

Metacam 0.5 mg/ml oral suspension for cats

2. QUALITATIVE AND QUANTITATIVE COMPOSITION OF Metacam 0.5 mg/ml

One ml contains:

Active substance:
Meloxicam 0.5 mg (equivalent to 0.017 mg per drop)

Excipient:
Sodium benzoate 1.5 mg (equivalent to 0.05 mg per drop)

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM OF Metacam 0.5 mg/ml

Oral suspension.
Yellowish viscous oral suspension with a green tinge.

4. CLINICAL PARTICULARS OF Metacam 0.5 mg/ml

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.
Alleviation of pain and inflammation in acute and chronic musculo-skeletal disorders in cats.

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.

4.4 Special warnings

None.

4.5. Special precautions for use

Special precautions for use in animals
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of renal toxicity.
Post-operative pain and inflammation following surgical procedures:
In case additional pain relief is required, multimodal pain therapy should be considered.

Chronic musculoskeletal disorders:
Response to long-term therapy should be monitored at regular intervals by a veterinary surgeon.

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.

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 side effects are in most cases transient and disappear following termination of the treatment but in very rare cases may be serious or fatal.

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 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, anticoagulant, 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 drugs should be avoided.

Pre-treatment with anti-inflammatory substances other than Metacam 2 mg/ml solution for injection for cats at a single dose of 0.2 mg/kg 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

Dosage
Post-operative pain and inflammation following surgical procedures:
After initial treatment with Metacam 2 mg/ml solution for injection for cats, continue treatment 24 hours later with 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 once daily (at 24-hour intervals) for up to four days.

Acute musculo-skeletal disorders:
Initial treatment is a single oral 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 dose of 0.05 mg meloxicam/kg body weight for as long as acute pain and inflammation persist.

Chronic musculo-skeletal disorders:
Initial treatment is a single oral dose of 0.1 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 0.05 mg meloxicam/kg body weight. A clinical response is normally seen within 7 days. Treatment should be discontinued after 14 days at the latest if no clinical improvement is apparent.

Route and method of administration
Dosing procedure using the drop dispenser of the bottle:
Dose of 0.2 mg meloxicam/kg body weight: 12 drops /kg body weight Dose of 0.1 mg meloxicam/kg body weight: 6 drops /kg body weight Dose of 0.05 mg meloxicam/kg body weight: 3 drops /kg body weight.

Dosing procedure using the measuring syringe:
The syringe fits onto the drop dispenser of the bottle and has a kg-body weight scale which corresponds to dose of 0.05 mg meloxicam/kg body weight. Thus for initiation of the treatment of chronic musculoskeletal disorders on the first day, twice the maintenance volume will be required. For initiation of the treatment of acute musculo-skeletal disorders on the first day, 4 times the maintenance volume will be required.

Shake well before use. To be administered orally either mixed with food or directly into the mouth. The suspension can be given using the drop dispenser of the bottle for cats of any body weight. Alternatively and for cats with a body weight of at least 2 kg, the measuring syringe provided in the package can be used.
Particular care should be taken with regard to the accuracy of dosing. The recommended dose should not be exceeded.
Avoid introduction of contamination during use.

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

Meloxicam has a narrow therapeutic safety margin in cats and clinical signs of overdose may be seen at relatively small overdose levels.
In case of overdose, adverse reactions, as listed in section 4.6, are expected to be more severe and more frequent. In case of overdose symptomatic treatment should be initiated.

4.11 Withdrawal period(s)

Not applicable.

5. PHARMACOLOGICAL PROPERTIES OF Metacam 0.5 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
If the animal is fasted when dosed, the maximal plasma concentrations are obtained after approximately 3 hours. If the animal is fed at the time of dosing, the absorption may be slightly delayed.

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.

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 0.5 mg/ml

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 Incompatibilities

None known.

6.3 Shelf life

Shelf-life of the veterinary medicinal product as packaged for sale:
3 ml bottle: 2 years
10 ml, 15 ml and 30 ml bottle: 3 years.

Shelf-life after first opening the immediate packaging:
3 ml bottle: 14 days
10 ml, 15 ml and 30 ml bottle: 6 months.

6.4 Special precautions for storage

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

12.30
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on Tuesday 28 November
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