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Date: Thursday, April 25, 2024 13:43

Release 2.101
Meflosyl 5% Solution for Injection
 
Species: Horses and other equidae
Therapeutic indication: Pharmaceuticals: Neurological preparations: Analgesics, Pharmaceuticals: Anti-inflammatory preparations: Injections: NSAIDs, Pharmaceuticals: Locomotor (including navicular and osteoarthritis)
Active ingredient: Flunixin Meglumine
Product:Meflosyl® 5% Solution for Injection
Product index: Meflosyl
Withdrawal notes: Not to be used in horses intended for human consumption. Treated horses may never be slaughtered for human consumption. The horse must have been declared as not intended for human consumption under national horse passport legislation.
Incorporating:
Presentation
Meflosyl 5% Solution for Injection is a clear, colourless to faintly yellow 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
Indicated for the alleviation of inflammation and pain associated with musculo-skeletal disorders and for the alleviation of visceral pain associated with colic.
Dosage and administration
For intravenous administration.
For use in musculo-skeletal disorders, the recommended dose 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 if 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.
Contra-indications, warnings, etc
Do not exceed the recommended dose or duration of treatment.
Do not administer to pregnant mares.
Intra-arterial injection should be avoided.
Do not mix Meflosyl 5% Injection with other medicaments prior to administration.
Do not use known cases of hypersensitivity to the active substance or to any of the excipients.
Do not use in animals suffering from cardiac, hepatic or renal disease where there is a possibility of gastro-intestinal ulceration or bleeding
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.
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.
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.
Do not use in pregnant mares. Safety studies in pregnant mare have not been conducted,
Withdrawal period
Not to be used in horses intended for human consumption.
Treated horses may never be slaughtered for human consumption.
The horse must have been declared as not intended for human consumption under national horse passport legislation.
User warnings
Flunixin meglumine is a non-steroidal anti-inflammatory drug (NSAID). The product may cause an allergic reaction in people sensitised to NSAIDs.
People with known hypersensitivity to NSAIDs should avoid contact with the product. Hypersensitivity reactions may be serious.
To avoid possible sensitisation reactions and/or skin irritation, avoid contact with skin. Gloves should be worn during application. Wash hands after use. In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
This product may cause eye irritation. Avoid contact with eyes. In the case of accidental contact with eyes, rinse immediately with plenty of water and seek medical advice.
Pharmaceutical precautions
Following withdrawal of the first dose, use the product within 28 days. Discard unused material.
Do not store above 25°C. Protect from light.
Keep container in outer carton.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
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.
Keep out of the sight and reach of children.
For animal treatment only.
Legal category
Legal category: POM-V
Packaging quantities
50 ml and 100 ml vials. Not all pack sizes may be marketed.
Further information
Overdosage studies in the target species, have shown the product to be well tolerated. Overdosage is associated with gastro-intestinal toxicity.
Marketing Authorisation Number
Vm 42058/4085
Significant changes
GTIN
GTIN description:50 ml:
GTIN:08714015013741
GTIN description:100 ml:
GTIN:08714015013734