Inflacam 5 mg/ml Solution for Injection for Cattle and Pigs

Composition

Each ml contains:

Active substance:

Meloxicam 5 mg

Excipients:

A clear, yellow solution.

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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, anti-exudative, analgesic and antipyretic effects. 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 and pigs.

4.3 Pharmacokinetics

Absorption

After a single subcutaneous dose of 0.5 mg meloxicam/kg, Cmax values of 2.1 mcg/ml were reached after 7.7 hours in young cattle.

Following single intramuscular doses of 0.4 mg meloxicam/kg, a Cmax value of 1.1 to 1.5 mcg/ml was reached within 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 predominantly found in plasma. In cattle, meloxicam is also a major excretion product in milk and bile whereas 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.

Elimination

Meloxicam is eliminated with a half-life of 26 hours after subcutaneous injection in young cattle.

In pigs, after intramuscular administration the mean plasma elimination half-life is approximately 2.5 hours.

Approximately 50 % of the administered dose is eliminated via urine and the remainder via faeces.

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Target species

Cattle (calves and young cattle) and pigs.

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Indications

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 re-hydration therapy to reduce clinical signs in calves of over one week of age and young, non-lactating cattle.

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 the relief of post-operative pain associated with minor soft tissue such as castration.

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Dosage

Cattle

Single subcutaneous or intravenous injection at a dosage of 0.5 mg meloxicam/kg body weight (i.e. 10 ml/100 kg body weight) in combination with antibiotic therapy or with oral re-hydration therapy, as appropriate.

Pigs

Locomotor disorders:

Single intramuscular injection at a dosage of 0.4 mg meloxicam/kg body weight (i.e. 2 ml/25 kg body weight). If required, a second administration of meloxicam can be given after 24 hours.

Reduction of post-operative pain

Single intramuscular injection at a dosage of 0.4 mg meloxicam/kg body weight (i.e. 0.4 ml/5 kg body weight) before surgery.

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

The use of suitably calibrated measuring equipment is recommended.

Avoid introduction of contamination during use.

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Contraindications

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 case of hypersensitivity to the active substance or to any of the excipients.

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

Do not use in pigs less than 2 days old.

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Adverse reactions

Cattle:

Common (more than 1 but less than 10 animals in 100 animals treated): Injection site swelling¹

Very rare (<1 animal / 10,000 animals treated, including isolated reports): Anaphylactoid reaction².

¹ Slight and transient following subcutaneous administration

² May be serious (including fatal). If such reaction occurs, it should be treated symptomatically.

Pigs:

Very rare (<1 animal / 10,000 animals treated, including isolated reports): Anaphylactoid reaction¹.

¹ May be serious (including fatal). If such reaction occurs, it should be treated symptomatically.

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 also the package leaflet for respective contact details.

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Warnings

Special precautions for safe use in the target species:

Treatment of calves with the veterinary medicinal product 20 minutes before dehorning reduces post-operative pain. The veterinary medicinal product 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.

Treatment of piglets with the veterinary medicinal product before castration reduces post-operative pain. To obtain pain relief during surgery co-medication with an appropriate anaesthetic/sedative is needed.

To obtain the best possible pain relieving post-surgery the veterinary medicinal product should be administered 30 minutes before surgical intervention.

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.

Special precautions to be taken by the person administering the veterinary medicinal product to animals:

Accidental self-injection may give rise to pain.

People with known hypersensitivity to non-steroidal anti-inflammatory drugs (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 the label to the physician.

Special precautions for the protection of the environment:

Not applicable.

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Use during pregnancy, lactation or lay

Pregnancy and lactation:

Cattle: Can be used during pregnancy.

Pigs: 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 anti-coagulant 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

Cattle

Meat and offal: 15 days.

Pigs

Meat and offal: 5 days.

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Incompatibilities

None known.

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Immediate packaging

Cardboard box containing one 20 ml, 50 ml or 100 ml clear type I glass injection vial. Each vial is closed with a type I bromobutyl rubber stopper and sealed with an aluminium cap.

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: 5 years. Shelf life after first opening the immediate packaging: 28 days.

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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 08749/5014

8 DATE OF FIRST AUTHORISATION

08 November 2012

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

September 2025

10 CLASSIFICATION OF VETERINARY MEDICINAL PRODUCTS

Veterinary medicinal product subject to prescription.

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

Approved: 11 December 2025

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Registration holder

Chanelle Pharmaceuticals Manufacturing Ltd

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