SUMMARY OF PRODUCT CHARACTERISTICS

Meflosyl 5% Solution for Injection

Active substance:

Flunixin (as flunixine meglumine 83 mg/ml) 50 mg

Excipients:

Phenol 5 mg/ml

Sodium formaldehyde sulfoxylate dihydrate 3.3 mg/ml

Disodium edetate dihydrate 0.1 mg/ml

For a full list of excipients, see section 6.1.

Solution for injection.

A clear, colourless to faintly yellow liquid, visually free from particles.

Horse, cattle.

Horse

Indicated for the alleviation of inflammation and pain associated in musculo-skeletal disorders and for the alleviation of visceral pain associated with colic.

Cattle

Indicated for the control of acute inflammation associated with respiratory disease. The product has also been known to have some benefit in the treatment of experimental acute bovine pulmonary emphysema (Fog Fever). It may also be used as an adjunctive therapy in the treatment of acute mastitis.

Do not exceed the recommended dose or duration of treatment.

Do not administer to pregnant mares.

Do not use in animals showing hypersensitivity to flunixin meglumine.

Do not use in animals suffering from cardiac, hepatic or renal disease, where there is a possibility of gastro-intestinal ulceration or bleeding.

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 less than 8 days before racing, he should feel sure that he has catered for all but the most exceptional case!

Intra-arterial injection should be avoided.

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 NSAIDs which inhibit prostaglandin synthesis are not administered to animals undergoing general anaesthesia until fully recovered.

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.

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

Safe for use in pregnant and lactating cattle. Do not use in pregnant mares. Safety studies in pregnant mares have not been conducted.

Monitoring of drug compatibility is required in case of adjunctive therapy.

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.

Indicated for the intravenous administration to cattle and horses.

Horse

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

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

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/kg (= 1 ml per 200 kg bodyweight) administered every 6-8 hours.

Cattle

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

Overdosage studies in the target species have shown the product to be well tolerated. Flunixin meglumine is a non-steroidal anti-inflammatory drug. Overdosage is associated with gastro-intestinal toxicity.

Horses

During treatment and within 7 days after the last injection, animals should not be slaughtered for human consumption.

Cattle

During treatment and within 7 days after the last injection, animals should not be slaughtered for human consumption.

Milk for human consumption must not be taken during treatment.

Milk from treated cattle may be taken for human consumption, only from 36 hours after the last injection.

Summary presentation of the active ingredient

Flunixin meglumine is a potent, non narcotic, non steroidal analgesic agent with anti-inflammatory, antipyretic and anti-endotoxic activity.

Flunixin meglumine is a potent inhibitor of cyclo-oxygenase and thereby of the endogenous production of prostaglandins.

Flunixin has no influence on natural or per injection administered prostaglandin F₂-alpha.

It has been demonstrated that flunixin has an anti-endotoxin activity, in particular against the effects of endotoxins formed by E Coli.

Absorption/Elimination

Studies in horses have shown that onset of activity occurs within 2 hours (= 15 to 60 minutes) after parenteral administration when used in musculo-skeletal disorders.

Peak response occurs between 12 and 16 hours and the duration of activity is 24-36 hours (30-40 hours).

When used in equine colic, studies have shown alleviation of pain within 15 minutes (intravenous).

The plasma half-life in horse-serum is 1.6 hours following a single dose of 1.1 mg/kg. Measurable amounts are detectable in horse plasma at eight hours post injection.

Flunixin is mainly excreted via the bile. A minor part is eliminated via the urine.

Phenol

Sodium formaldehyde sulfoxylate dihydrate

Disodium Edetate Dihydrate

Propylene Glycol

Diolamine

Hydrochloric Acid

Hydrochloric Acid or Sodium Hydroxide

Water for Injections

Do not mix with other medicaments prior to administration.

Shelf-life of the veterinary medicinal product as packaged for sale: 3 years.

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

Do not store above 25°C.

Protect from light

Following withdrawal of the first dose use the product within 28 days.

Discard unused product.

Colourless type I glass vials of 50 and 100 ml. The vials are closed with rubber stoppers and sealed with aluminium caps.

Not all pack sizes may be marketed.

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

Zoetis UK Limited

5th Floor, 6 St. Andrew Street

London

EC4A 3AE

Vm:42058/4085

Date:27 March 1998

Date:July 2014

01 July 2014