Meflosyl 5%

4.1 Target species Horses. 4.2 Indications for use, specifying the target species For the alleviation of inflammation and pain associated with musculo-skeletal disorders and for the alleviation of visceral pain associated with colic. 4.3 Contraindications Do not exceed the recommended dose or duration of treatment. Do not administer to pregnant mares. Do not use in 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. 4.4 Special warnings for each target species 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. 4.5 Special precautions for use i) Special precautions for use in animals 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. ii) Special precautions to be taken by the person administering the veterinary medicinal product to animals 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. 4.6 Adverse reactions (frequency and seriousness) 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. 4.7 Use during pregnancy, lactation or lay Do not use in pregnant mares. Safety studies in pregnant mares have not been conducted. 4.8 Interaction with other medicinal products and other forms of interaction 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.