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Metacam Solution for Injection

  • 2mg/ml for Cats » 10ml Bottle £13.39
  • 20mg/ml Cattle/Pig/Horse » 50ml Bottle £40.46
  • 20mg/ml Cattle/Pig/Horse » 100ml Bottle £77.29

Selection of 3 products from

£13.39 to £77.29

Description

For cats, a 2mg/ml solution is available to give by injection. For Cattle, Pigs and Horses the 20mg/ml solution is used; for cats the 2mg/ml solution is used.

Metacam 20 mg/ml Solution for Injection for Cattle, Pigs and Horses

Presentation

One ml of the solution for injection contains 20 mg meloxicam and 150 mg ethanol (as preservative).

Uses

Metacam 20 mg/ml solution is a non-steroidal anti-inflammatory drug (NSAID) for use in cattle, pigs and horses.

Cattle

For use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs in cattle.

For use in diarrhoea, in combination with oral rehydration therapy, to reduce clinical signs in calves of over one week of age and young non-lactating cattle.

For adjunctive therapy in the treatment of acute mastitis, in combination with antibiotic therapy.

For the relief of post-operative pain following dehorning in calves.

Pigs

For use in non-infectious locomotor disorders to reduce the symptoms of lameness and inflammation.

For adjunctive therapy in the treatment of puerperal septicaemia and toxaemia (mastitis-metritis-agalactia syndrome) with appropriate antibiotic therapy.

Horses

For use in the alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal disorders.

For the relief of pain associated with equine colic

Dosage and administration

Cattle: Single subcutaneous or intravenous injection at a dose rate of 0.5 mg meloxicam/kg bodyweight (i.e. 2.5 ml/100 kg bodyweight) in combination with antibiotic therapy or with oral rehydration therapy as appropriate.

Pigs: Single intramuscular injection at a dosage of 0.4 mg meloxicam/kg bodyweight (i.e. 2.0ml/100kg bodyweight) in combination with antibiotic therapy, as appropriate. If required, a second administration of meloxicam can be given after 24 hours.

Horses: Single intravenous injection at a dosage of 0.6 mg meloxicam/kg bodyweight (i.e. 3.0ml/100kg bodyweight). Metacam 15mg/ml oral suspension may be used for the continuation of treatment at a dosage of 0.6 mg meloxicam/kg bodyweight, 24 hours after administration of the injection.

Contra-indications, warnings, etc

Do not use in horses less than 6 weeks of age.

Do not use in animals suffering from impaired hepatic, cardiac or renal function and haemorrhagic disorders, or where there is evidence of ulcerogenic gastrointestinal lesions.

Do not use in pregnant or lactating mares.

Not authorised to use in horses producing milk for human consumption.

Do not use in case of hypersensitivity to the active substance or to any of the excipients.

For the treatment of diarrhoea, do not use in animals less than one week of age.

Treatment of calves with Metacam 20 minutes before dehorning reduces post-operative pain. Metacam alone will not provide adequate pain relief during the dehorning procedure. To obtain adequate pain relief during surgery co-medication with an appropriate analgesic is needed.

If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.

Avoid use in very severely dehydrated, hypovolaemic or hypotensive animals which require parenteral rehydration, as there may be a potential risk of renal toxicity.

In case of inadequate relief of pain when used in the treatment of equine colic, careful re-evaluation of the diagnosis should be made as this could indicate the need for surgical intervention.

In cattle and pigs, subcutaneous, intramuscular as well as intravenous administration is well tolerated; only a slight transient swelling at the injection site following subcutaneous administration was observed in less than 10 % of the cattle treated in clinical studies.

In horses, a transient swelling at the injection site can occur but resolves without intervention.

In very rare cases anaphylactoid reactions, which may be serious (including fatal), may occur and should be treated symptomatically.

Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs or with anti-coagulant agents.

In case of overdose, symptomatic treatment should be initiated.

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 insert or label to the physician.

Disposal Advice

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

For animal treatment only.

Keep out of reach and sight of children.

Withdrawal Period

Cattle:

Meat and offal – 15 days.

Milk – 120 hours.

Pigs:

Meat and offal – 5 days.

Horses:

Meat and offal - 5 days.

Pharmaceutical precautions

Shelf life of broached vial: 28 days

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

Avoid introduction of contamination during use.

Legal category

POM-V

Packaging Quantities

Cardboard box with 1 colourless glass injection vial each containing 50 ml, 100 ml or 250 ml.

Cardboard box with 12 colourless glass injection vials each containing 100 ml.

Cardboard box with 6 colourless glass injection vials each containing 250 ml.

Each vial is closed with a rubber stopper and sealed with an 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, anti-exudative, analgesic and antipyretic properties. Meloxicam also has anti-endotoxic properties because it has been shown to inhibit production of thromboxane B2 induced by E. coli endotoxin administration in calves, lactating cows and pigs.

Pharmacokinetic properties

Absorption

After a single subcutaneous dose of 0.5mg meloxicam/kg, Cmax values of 2.1μg/ml and 2.7μg/ml were reached after 7.7 hours and 4 hours in young cattle and lactating cows, respectively. After two intramuscular doses of 0.4mg meloxicam/kg, a Cmax value of 1.9 μg/ml was reached after 1 hour in pigs.

Distribution

More than 98% of meloxicam is bound to plasma proteins. The highest meloxicam concentrations are to be found in liver and kidney. Comparatively low concentrations are detectable in skeletal muscle and fat.

Metabolism

Meloxicam is predominately found in plasma. In cattle, meloxicam is also a major excretion product in milk and bile where as urine contains only traces of the parent compound. In pigs, bile and urine contain 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. The metabolism in horses has not been investigated.

Elimination

Meloxicam is eliminated with a half life of 26 hours and 17.5 hours after subcutaneous injection in young cattle and lactating cows, respectively. In pigs, after intramuscular injection, the mean plasma elimination half life is approximately 2.5 hours. In horses, after intravenous injection meloxicam is eliminated with a terminal half-life of 8.5 hours. Approximately 50% of the administered dose is eliminated via urine and the remainder via faeces.

Marketing Authorisation Holder (if different from distributor)

Boehringer Ingelheim Vetmedica GmbH

55216 Ingelheim am Rhein

Germany

Marketing authorisation number

EU/2/97/004/007 : 50 ml.

EU/2/97/004/008 : 100 ml.

EU/2/97/004/031 : 250 ml.

EU/2/97/004/015 : 12 x 100 ml.

EU/2/97/004/032 : 6 x 250 ml.

GTIN (Global Trade Item No)

Metacam 20 mg/ml Solution for Injection for Cattle, Pigs and Horses - 50ml

5012917010084

Metacam 20 mg/ml Solution for Injection for Cattle, Pigs and Horses - 100ml

5012917010268

Metacam 20 mg/ml Solution for Injection for Cattle, Pigs and Horses - 100ml x 12

5012917010312

Metacam 20 mg/ml Solution for Injection for Cattle, Pigs and Horses - 250ml

5012917010244

Metacam 20 mg/ml Solution for Injection for Cattle, Pigs and Horses - 250ml x 6

5012917010350

Metacam 2 mg/ml Solution for Injection for Cats

Presentation

One ml of the solution for injection contains 2 mg meloxicam as active ingredient and 150 mg ethanol.

Uses

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

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.

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.

The use of NSAIDs in animals with gastrointestinal disorders (e.g. irritation and haemorrhage), impaired hepatic, cardiac or renal function may involve additional risks. If use cannot be avoided, such patients require careful monitoring.

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.

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.

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 veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

For animal treatment only.

Keep out of reach and sight 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.

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

EU/2/97/004/039 : 10 ml

EU/2/97/004/040 : 20 ml

GTIN (Global Trade Item No)

Metacam 2 mg/ml Solution for Injection for Cats - 10ml

5012917010299

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