Boehringer Ingelheim
Metacam 15 mg/ml oral suspension for pigs 100 ml

For use in non-infectious locomotor disorders to reduce the symptoms of lameness and inflammation and for adjunctive therapy in the treatment of puerperal septicaemia and toxaemia in pigs

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

Metacam 15 mg/ml oral suspension for pigs

2. QUALITATIVE AND QUANTITATIVE COMPOSITION OF Metacam 15 mg/ml

One ml contains:

Active substance(s):
Meloxicam 15 mg

Excipient(s):
Sodium benzoate 1.5 mg

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM OF Metacam 15 mg/ml

Oral suspension
Yellowish viscous oral suspension with a green tinge.

4. CLINICAL PARTICULARS OF Metacam 15 mg/ml

4.1. Target species

Pigs

4.2. Indications for use, specifying the target species

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-MetritisAgalactia syndrome MMA) with appropriate antibiotic therapy.

4.3. Contraindications

Do not use in pigs suffering from impaired hepatic, cardiac or renal function and haemorrhagic disorders, or where there is evidence of ulcerogenic gastrointestinal lesions.
Do not use in case of hypersensitivity to the active substance or to any of the excipients.

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 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.

4.6 Adverse reactions (frequency and seriousness)

None.

4.7 Use during pregnancy, lactation or lay

Can be used during pregnancy and lactation.

4.8 Interaction with other medicinal products and other forms of interaction

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

4.9 Amounts to be administered and administration route

Oral suspension 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.

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.

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

In case of overdose symptomatic treatment should be initiated.

4.11 Withdrawal period

Meat and offal: 5 days.

5. PHARMACOLOGICAL PROPERTIES OF Metacam 15 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. 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.

5.2. Pharmacokinetic particulars

Absorption
After a single oral dose of 0.4 mg meloxicam/kg a Cmax value of 0.81 µg/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.

6. PHARMACEUTICAL PARTICULARS OF Metacam 15 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 years.
Shelf-life after first opening of the immediate packaging: 6 months.

6.4 Special precautions for storage

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

103.00
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on Monday 27 November
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