Flunixin Injection

Presentation:
Flunixin Injection is a clear colourless solution for injection containing, per ml:
Flunixin, as Flunixin Meglumine 50 mg
Phenol, as preservative 5 mg
Sodium Formaldehyde Sulphoxylate Dihydrate 2.5 mg

Uses:
Flunixin meglumine is a relatively potent non-narcotic, nonsteroidal analgesic with anti-inflammatory, anti-endotoxic and anti-pyretic properties.

In horses, indicated for the alleviation of inflammation and pain associated with musculo-skeletal disorders and for the alleviation of visceral pain associated with colic, also indicated for the treatment of endotoxaemia or septic shock associated with gastric torsion and for other conditions in which the circulation of the blood to the gastrointestinal tract is compromised.

In cattle, indicated for the control of acute inflammation associated with respiratory disease. It may also be used as adjunctive therapy in the treatment of acute mastitis.

In Pigs, Flunixin Injection is indicated as an adjunctive therapy in the treatment of swine respiratory diseases.

Dosage & Administration:
Flunixin Injection is indicated for intravenous administration to cattle and horses and intramuscular injection to pigs.

Horses: For use in equine colic, the recommended dose rate is 1.1 mg flunixin/kg bodyweight equivalent to 1 ml per 45 kg bodyweight. Treatment may be repeated once or twice if colic recurs.

For use in musculo-skeletal disorders, the recommended dose rate is 1.1 mg flunixin/kg bodyweight equivalent to 1 ml per 45 kg bodyweight, once daily for up to 5 days according to clinical response.

For the treatment of endotoxaemia or septic shock associated with gastric torsion and with other conditions in which the circulation of blood to the gastrointestinal tract is compromised: 0.25 mg/kg (1 ml per 200 kg) every 6-8 hours.

Cattle: The recommended dose rate is 2.2 mg flunixin/kg bodyweight equivalent to 2 ml per 45 kg bodyweight. Repeat as necessary at 24 hour intervals for up to 5 consecutive days.

Pigs: For use in pigs, the recommended dose rate is 2 ml per 45 kg bodyweight (equivalent to 2.2 mg flunixin/kg) once by intramuscular injection, in the neck, in conjunction with appropriate antimicrobial therapy. The injection volume should be limited to a maximum of 5 ml per injection site.

The stopper should not be punctured more than 50 times. A draw off needle should be used to avoid excessive puncturing of the stopper.

Do not exceed the recommended dose or duration of treatment.

An appropriately graduated syringe must be used to allow accurate administration of the required dose volume. This is particularly important when injecting small volumes.

Cattle should be treated with flunixin in conjunction with disease-specific therapy and an improvement in housing conditions.

The use of flunixin in conjunction with disease-specific antibiotic therapy may mask antibiotic resistance of the bacteria, due to alleviation of inflammation symptoms.

Withdrawal Period:
Cattle: Meat: 7 Days
Milk: 36 Hours
Horses: Meat: 7 Days
Pigs: Meat: 22 Days
Do not use in mares producing milk for human consumption.

Contraindictions, Warnings etc:
Do not exceed the recommended dose or the duration of treatment.

Use is contraindicated in animals suffering from cardiac, hepatic or renal disease, where there is the possibility of gastro-intestinal ulceration or bleeding, where there is evidence of a blood dyscrasia or hypersensitivity to the product.

Do not use in dehydrated animals suffering from ileusassociated colic.

The cause of the underlying inflammatory condition or colic should be determined and treated with appropriate concomitant therapy.

Non-steroidal anti-inflammatory drugs are not permitted under the Rules of Racing and under rules covering other competitive events. Horses intended for racing and competition should be prevented from racing or competing when in need of treatment and horses which have been recently treated should be dealt with according to local requirements. Appropriate precautions must be taken to ensure compliance with competition regulations.

Due to the excipient propylene glycol, life-threatening shock reactions may occur in rare cases. The solution for injection should therefore be injected slowly and be of approximate body temperature.

Avoid intra-arterial injection. Use in any animal less than 6 weeks of age or in aged animals may involve additional risk. If such use cannot be avoided animals may require a reduced dosage and careful clinical management.

Do not use in piglets weighing less than 6 kg. Avoid use in any dehydrated, hypovolaemic or hypotensive animal except in the case of endotoxaemia or septic shock. It is preferable that NSAIDs, which inhibit prostaglandin synthesis are not administered to animals undergoing general anaesthesia until fully recovered.

Flunixin meglumine is a non steroidal anti-inflammatory drug (NSAID). Untoward effects include gastrointestinal irritation, ulceration and, in dehydrated or hypovolaemic animals, potential for renal damage.

In pigs, transient irritation may occur at the injection site, this resolves spontaneously within 14 days. Rare cases of anaphylactic reaction have been reported. May be used in pregnant and lactating cattle. Do not administer to pregnant mares.

Do not administer to pregnant sows, gilts at mating and in breeding boars.

Safety studies in pregnant mares or sows have not been conducted. The product should not be used in lactating sows. Monitor drug compatibility closely where adjunctive therapy is required.

Do not administer other non-steroidal anti-inflammatory drugs (NSAIDs) concurrently or within 24 hours of each other. Some NSAIDs may be highly bound to plasma proteins and compete with other highly bound drugs which can lead to toxic effects.

Concurrent administration of potentially nephrotoxic drugs should be avoided.

Overdose studies in the target species have shown the product to be well tolerated. Overdosage is associated with gastrointestinal toxicity.

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

Operator Warnings: Avoid eye contact and direct contact with skin.

In the case of accidental contact with eyes, rinse immediately with plenty of water and seek medical advice.

Avoid accidental self-injection. To avoid possible sensitisation reactions, avoid contact with the skin. Gloves should be worn during application.

The product may cause reactions in sensitive individuals. If you have known hypersensitivity for non-steroidal antiinflammatory products do not handle the product. Reactions may be serious. Wash hands after use.

Pharmaceutical Precautions:
Do not store above 25°C. Keep the vial in the outer carton to protect from light.
Avoid introduction of contamination.
Following withdrawal of the first dose, use the product within 28 days. Discard unused product.
Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation authority.