Presentation

Meflosyl 5% Solution for Injection is a sterile aqueous solution containing 50 mg flunixin as flunixin meglumine, 5 mg phenol as an antimicrobial preservative, 3.3 mg sodium formaldehyde sulfoxylate dihydrate and 0.1 mg disodium edetate dihydrate as an antioxidant per ml.

Flunixin meglumine is a potent non-steroidal and non-narcotic analgesic agent possessing anti-inflammatory, anti-endotoxic and anti-pyretic properties.

Uses

Horses: Meflosyl 5% Solution for Injection is indicated for the alleviation of inflammation and pain associated with musculo-skeletal disorders. It is also indicated for the alleviation of visceral pain associated with colic.

Cattle: Meflosyl 5% Solution for Injection is indicated for the control of acute inflammation associated with respiratory disease. It has been shown to have some benefit in the treatment of experimental acute bovine pulmonary emphysema (Fog Fever).

Meflosyl 5% Solution for Injection may also be used as an adjunctive therapy in the treatment of acute mastitis.

Dosage and administration

Horses

a) Musculo-skeletal disorders: The recommended dose is 1 ml of Meflosyl 5% Solution for Injection per 45 kg bodyweight (equivalent to 1.1 mg flunixin per kg) once daily by intravenous injection. Treatment should be given for up to 5 days depending on clinical response.

b) Colic: The recommended dose for the alleviation of visceral pain associated with colic is 1 ml of Meflosyl 5% Solution for Injection per 45 kg bodyweight (equivalent to 1.1 mg flunixin per kg), by intravenous injection. Treatment may be repeated on one or two further occasions if signs of colic recur. The cause of colic should be determined and treated with appropriate therapy.

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

Cattle

The recommended dosage is 2 ml Meflosyl 5% Injection per 45 kg bodyweight (equivalent to 2.2 mg flunixin per kg), by intravenous injection, repeated at 24 hour intervals, as required, for up to 5 consecutive days. The cause of the acute inflammatory condition should be determined and treated with appropriate therapy.

Contra-indications, warnings, etc

FOR ANIMAL TREATMENT ONLY

Do not exceed the recommended dose or duration of treatment.

Do not administer to pregnant mares.

Avoid intra-arterial injection.

Do not mix Meflosyl 5% Injection with other medicaments prior to administration.

Do not use in horses showing hypersensitivity to flunixin meglumine.

Monitor drug compatibility closely when concurrent therapy is required.

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.

Avoid use in hypovolaemic animals, except in the case of endotoxaemia or septic shock. It is preferable that NSAID's which inhibit prostaglandin synthesis are not administered to animals undergoing general anaesthesia until fully recovered. Non-steroidal anti-inflammatory drugs are not permitted under the Rules of Racing and under rules governing other competitive events. The Royal College of Veterinary Surgeons has given advice to the veterinary profession regarding the use of anti-inflammatory drugs in competing horses.

It states that "if a veterinarian recommends the discontinuation of any such drug not less than 8 days before racing, he should feel sure that he has catered for all but the most exceptional case!"

Use is contra-indicated in animals suffering from cardiac, hepatic or renal disease where there is a possibility of gastro-intestinal ulceration or bleeding or in cases of known hypersensitivity.

Withdrawal period:

Animals must not be slaughtered for human consumption during treatment. Cattle and horses may be slaughtered for human consumption only after 7 days from the last treatment.

Milk for human consumption must not be taken during treatment. Milk for human consumption may only be taken from cattle after 36 hours from the last treatment.

User warnings:

Avoid eye contact and direct contact with skin. To avoid possible sensitisation reactions, avoid contact with skin. Gloves should be worn during application. Wash hands after use. In case of accidental contact with eyes, rinse immediately with plenty of water and seek medical advice.

The product may cause reactions in sensitive individuals. If you have known hypersensitivity for non-steroidal anti-inflammatory products, do not handle the product. Reactions may be serious. Avoid accidental self-injection.

Pharmaceutical precautions

Following withdrawal of the first dose, use the product within 28 days. Discard unused material.

Keep out of the reach and sight of children.

Do not store above 25°C. Protect from light.

Keep container in outer carton.

When container is broached (opened) for the first time, using the in-use shelf-life which is specified on the package leaflet, the date on which any product remaining in the vial should be discarded should be worked out. This discard date should be written in the space provided.