Pyrocam 15 mg/ml Oral Suspension for Pigs

Composition

One ml contains:

Active substance:

Meloxicam 15 mg

Excipients:

Methyl parahydroxybenzoate (E218) 1.8 mg

Propyl parahydroxybenzoate 0.2 mg

For a full list of excipients, see section 6.1.

6.1 List of excipients

Vanillin

Microcrystalline cellulose

Carmellose sodium

Citric acid

Sodium hydroxide

Polysorbate 80

Water, purified

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Pharmaceutical form

Oral suspension.

Pale yellow suspension.

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Pharmacological properties

Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids (oxicams).

ATC Vet Code: QM01AC06.

5.1 Pharmacodynamic properties

Meloxicam is an enolcarboxamide 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

After oral administration of the veterinary medicinal product at the dose of 0.4 mg meloxicam/kg body weight in pigs, meloxicam was well absorbed with a mean systemic bioavailability of 92%. Plasma concentrations reached a peak (mean Cmax of 0.8 µg/ml) after 2.25 hours on average.

From data obtained after IV injection it is known that meloxicam is distributed in the body with a low volume of distribution (0.37 L/kg on average), not exceeding the body fluids volume and a high binding rate (98%) to circulating plasma proteins. After oral administration of the veterinary medicinal product, the highest meloxicam concentrations are found in liver and kidney. Comparatively low concentrations are detectable in skeletal muscle. 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 mean plasma elimination half-life is approximately 3.25 hours.

5.3 Environmental properties

Not applicable.

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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.

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 the veterinary medicinal product can be given after 24 hours. In cases of MMA with severely disturbed general demeanour (e.g. anorexia) the use of an injectable meloxicam product approved for the treatment of MMA is recommended.

The veterinary medicinal product is intended for individual treatment only. To be administered preferably mixed with a small quantity of feed. Alternatively to be given prior to feeding, directly into the mouth.

Shake well for at least 1 minute before use.

The suspension should be measured using the syringe provided in the package. The syringe fits onto the bottle and the withdrawal of the dose should be performed on inverted bottle. The syringe has a body weight scale (in kg).

After administration of the veterinary medicinal product, 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 and 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 known.

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 use in animals

If adverse events 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

This veterinary medicinal product may cause hypersensitivity (allergic reactions).

People with known hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs) or parabens should avoid contact with the veterinary medicinal product.

This veterinary medicinal product can cause eye irritation. Personal protective equipment consisting of eye protection should be worn when handling the veterinary medicinal product. In case of contact with the eyes, immediately rinse thoroughly with water.

Avoid oral exposure, including hand-to-mouth contact. Wash hands after use. Do not eat, drink or smoke while handling the veterinary medicinal product.

In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.

Meloxicam may have adverse effects on pregnancy and/or embryofoetal development. Avoid dermal exposure including hand-to-mouth contact. Pregnant women or women attempting to conceive should wear impermeable gloves when administering the veterinary medicinal product.

Special precautions for the protection of the environment

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

The administration of the veterinary medicinal product to pigs at 5-fold overdosing of the recommended dose of 0.4 mg/kg b.w./day given for a duration longer than the recommended duration of treatment (6 days instead of 2 days at maximum) did not induce any toxicological or pathological changes.

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

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

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Immediate packaging

Cardboard box with white, non-transparent round high density polyethylene (HDPE) bottle closed with a two-part tamper evident closure for child resistant packaging consisting of an outer white cap made of polypropylene, an internal natural colour screw closure made of HDPE and a mounted natural colour plug made of low density polyethylene, and with a plastic measuring syringe composed of a transparent body and a white plunger and with a measuring scale ranging from 20 kg to 300 kg, graduated at 20 kg intervals.

Pack sizes:

Bottle with 125 ml oral suspension.

Bottle with 250 ml oral suspension.

Bottle with 1000 ml oral suspension.

Not all pack sizes may be marketed.

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Storage

Do not freeze.

Protect from frost.

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Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 2 years. Shelf life after first opening the immediate packaging: 1 month.

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Disposal of unused product

Medicines should not be disposed of via wastewater.

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

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Additional information

Vm 30282/5002

9 DATE OF FIRST AUTHORISATION

02 January 2024

10 DATE OF REVISION OF THE TEXT

January 2024

PROHIBITION OF SALE, SUPPLY AND/OR USE

11 CLASSIFICATION OF VETERINARY MEDICINAL PRODUCTS

Veterinary medicinal product subject to prescription.

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Registration holder

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerpen

Belgium

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