País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
Flunixin meglumine
Norbrook Laboratories (Ireland) Limited
QM01AG90
Flunixin meglumine
50 milligram(s)/millilitre
Solution for injection
POM: Prescription Only Medicine as defined in relevant national legislation
flunixin
Authorised
1997-04-23
1 NAME OF THE VETERINARY MEDICINAL PRODUCT Flunixin Injection, 50mg/ml Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Flunixin (as flunixin meglumine) 50 mg EXCIPIENTS: QUALITATIVE COMPOSITION OF EXCIPIENTS AND OTHER CONSTITUENTS QUANTITATIVE COMPOSITION IF THAT INFORMATION IS ESSENTIAL FOR PROPER ADMINISTRATION OF THE VETERINARY MEDICINAL PRODUCT Phenol 5.0 mg Sodium Formaldehyde Sulphoxylate Dihydrate 2.5 mg Disodium Edetate Sodium Hydroxide Propylene Glycol Hydrochloric Acid Water for Injections A clear colourless solution for injection. 3 CLINICAL INFORMATION 3.1 TARGET SPECIES Cattle, horses and pigs. 3.2 INDICATIONS FOR USE FOR EACH TARGET SPECIES The veterinary medicinal product is indicated for use in cattle and horses in the alleviation of inflammation and pain. In the horse, the veterinary medicinal product is indicated for the alleviation of inflammatory signs associated with musculo-skeletal disorders and for the alleviation of visceral pain associated with colic. In cattle, the veterinary medicinal product is indicated for the control of acute inflammation associated with respiratory disease. The veterinary medicinal product has also been shown to have some benefit in the treatment of acute pulmonary emphysema (fog fever) and as adjunctive therapy in the treatment of acute mastitis. In pigs, the veterinary medicinal product is indicated as an adjunctive therapy in the treatment of swine respiratory diseases. 3.3 CONTRAINDICATIONS Do not exceed the recommended dose or duration of treatment. Do not administer to pregnant mares. 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. 3.4 SPECIAL WARNINGS The cause of the underlying inflammatory condition or colic should be determined and treated with appropriate concomitant therapy. 3.5 SPECIAL PRECAUTIONS FOR USE Spe Llegiu el document complet