Metacam 15 mg/ml Oral Suspension for Pigs

Composition

Each ml contains:

Active substance:

Meloxicam: 15 mg

Excipients:

Yellowish viscous oral suspension with a green tinge.

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Pharmacological properties

4.1 ATCvet code:

QM01AC06

4.2 Pharmacodynamics

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. Meloxicam also has anti-endotoxic properties because it has been shown to inhibit production of thromboxane B2 induced by intravenous E. coli endotoxin administration in pigs.

4.3 Pharmacokinetics

Absorption After a single oral dose of 0.4 mg meloxicam/kg a Cmax value of 0.81 mcg/ml was reached after 2 hours.

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 predominantly found in plasma. 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.

Elimination After oral administration the mean plasma elimination half-life is approximately 2.3 hours. Approximately 50 % of the administered dose is eliminated via urine and the remainder via faeces.

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Target species

Pigs

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Indications

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 MMA) with appropriate antibiotic therapy.

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Dosage

Oral use.

To be administered at a dosage of 0.4 mg/kg body weight (i.e. 2.7 ml/100 kg) in combination with antibiotic therapy, as appropriate. If required, a second administration of Meloxicam can be given after 24 hours.

In cases of MMA with severely disturbed general demeanour (e.g. anorexia) the use of Metacam 20 mg/ml solution for injection is recommended.

To be administered preferably mixed with a small quantity of feed. Alternatively to be given prior to feeding, or directly into the mouth.

The suspension should be given using the measuring syringe provided in the package. The syringe fits onto the bottle and has a kg-body weight scale.

To ensure a correct dosage, body weight should be determined as accurately as possible.

Shake well before use.

After administration of the veterinary medicinal product, close the bottle by replacing the cap, wash the measuring syringe with warm water and let it dry.

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Contraindications

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

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

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Adverse reactions

None.

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

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.

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Warnings

Special precautions for safe use in the target species Avoid use in very severely dehydrated, hypovolaemic or hypotensive pigs which require parenteral rehydration, as there may be a potential risk of renal toxicity.

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.

This veterinary medicinal product can cause eye irritation. In case of contact with the eyes, immediately rinse thoroughly with water.

Special precautions for the protection of the environment:

Not applicable.

3.11 Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance

Not applicable.

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Use during pregnancy, lactation or lay

Pregnancy and lactation Can be used during pregnancy and lactation.

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Interactions

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

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Overdose

In case of overdose symptomatic treatment should be initiated.

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Special warnings

None.

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Withdrawal period

Meat and offal: 5 days.

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Incompatibilities

None known.

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Immediate packaging

Cardboard box containing one polyethylene bottle of 100 ml or 250 ml with a polyethylene tip adapter, a tamper-proof child-resistant closure and a measuring syringe. Not all pack sizes may be marketed.

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Storage

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

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Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years. Shelf life after first opening of the immediate packaging: 6 months

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Disposal of unused product

Medicines should not be disposed of via wastewater.

Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.

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Additional information

Vm 61700/5057

8 DATE OF FIRST AUTHORISATION

05 July 2010

9 DATE OF THE LAST REVISION OF THE SUMMARY OF THE PRODUCT CHARACTERISTICS

April 2026

10 CLASSIFICATION OF VETERINARY MEDICINAL PRODUCT

Veterinary medicinal product subject to prescription

Find more product information by searching for the ‘Product Information Database’ on www.gov.uk.

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Registration holder

Boehringer Ingelheim Vetmedica GmbH

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