Introduction

Company name: Boehringer Ingelheim Limited

Address: Ellesfield Avenue

Bracknell

Berkshire RG12 8YS

Telephone: Sales & Marketing Enquiries 01344 746959

Telephone: Technical Enquiries 01344 746957

Fax: 01344 741349

Presentation

Each ml of the solution for injection contains 5 mg meloxicam as active ingredient and 150 mg anhydrous ethanol as preservative.

Uses

Metacam is a non-steroidal anti-inflammatory drug (NSAID) for use in dogs and cats.

Dogs:

Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders. Reduction of post-operative pain and inflammation following orthopaedic and soft tissue surgery.

Cats:

Reduction of post-operative pain after ovariohysterectomy and minor soft tissue surgery.

Dosage and administration

Dogs

Musculo-skeletal disorders

Single subcutaneous injection at a dosage of 0.2 mg meloxicam/kg body weight (i.e. 0.4 ml/10 kg body weight).

Metacam 1.5 mg/ml Oral Suspension for Dogs or Metacam 1.0 mg and 2.5 mg Chewable Tablets for Dogs may be used for continuation of treatment at a dosage of 0.1 mg meloxicam/kg body weight, 24 hours after administration of the injection.

Reduction of post-operative pain

(over a period of 24 hours):

Single intravenous or subcutaneous injection at a dosage of 0.2 mg meloxicam/kg body weight (i.e. 0.4  ml/10 kg body weight) before surgery, for example at the time of induction of anaesthesia.

Cats

Reduction of post-operative pain

Single subcutaneous injection at a dosage of 0.3 mg meloxicam/kg body weight (i.e. 0.06 ml/kg body weight) before surgery, for example at the time of induction of anaesthesia.

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 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 animals less than 6 weeks of age nor in cats of less than 2 kg.

Do not use an oral follow-up therapy using meloxicam or other NSAIDs in cats, as no safe dosage for repeated oral administration has been established.

Typical adverse drug reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood, apathy and renal failure have occasionally been reported. In dogs, 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. In very rare cases anaphylactoid reactions may occur and should be treated symptomatically.

If adverse reactions occur, treatment should be discontinued.

Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of renal toxicity. Any oral follow-up therapy using meloxicam or other NSAIDs should not be administered in cats, as appropriate dosage regimens have not been established.

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 drugs 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.

In the case of overdosage symptomatic treatment should be initiated.

For post-operative pain relief in cats, safety has only been documented after thiopental/halothane anaesthesia.

Operator warnings

Accidental self-injection may give rise to pain. People with known hypersensitivity to 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 label to the physician.

Disposal Advice

Any unused product or waste materials derived from the product should be disposed of in accordance with local requirements.

For animal treatment only.

Keep out of reach of children.

Pharmaceutical precautions

Shelf life of broached vial: 28 days

Do not use after the expiry date stated on the carton and on the bottle.

Do not store above 25°C.

Legal category

POM-V

Packaging Quantities

Colourless glass injection vials of 10ml or 20ml sealed with a rubber stopper and aluminium cap.

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 0.73 μg/ml in dogs and 1.1 μg/ml in cats were reached approximately 2.5 hours and 1.5 hours post administration, respectively.

Distribution

There is a linear relationship between the dose administered and plasma concentration observed in the therapeutic dose range in dogs. More than 97 % of meloxicam is bound to plasma proteins. The volume of distribution is 0.3 l/kg in dogs and 0.09 l/kg in cats.

Metabolism

In dogs, 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 in dogs and 15 hours in cats. Approximately 75 % of the administered dose is eliminated via faeces and the remainder via urine.

Marketing authorisation number

EU/2/97/004/006 : 10 ml.

EU/2/97/004/011 : 20 ml.

Marketing authorisation holder

Boehringer Ingelheim Vetmedica GmbH

55216 Ingelheim am Rhein

Germany