Country: Italy
Language: English
Source: HMA (Heads of Medicines Agencies)
flunixin meglumine 50 mg/ml
S.P. Veterinaria S.A
QM01AG90
Solution for injection
flunixin
Cattle Food, Horses Food, Pigs Food
2009-11-25
LABELLING AND PACKAGE LEAFLET A. LABELLING PARTICULARS TO APPEAR ON THE OUTER PACKAGE CARTON 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Fluvex 50 mg/ml solution for injection for cattle, pigs and horses 2. STATEMENT OF ACTIVE AND OTHERS SUBSTANCES Active substance: Flunixin (as flunixin meglumine) 50.0 mg (Equivalent to 82.9 mg de flunixin meglumine) Excipients: Phenol 5 mg Sodium Formaldehyde Sulfoxylate Dihydrate 2.5 mg Other excipients q.s.t. 1 ml 3. PHARMACEUTICAL FORM Solution for injection. 4. PACKAGE SIZE 50 ml. 100 ml. 250 ml. 5. TARGET SPECIES Cattle, horses and pigs. 6. INDICATIONS CATTLE Prescribed for the control of acute inflammation and pyrexia associated to bovine respiratory disease. HORSES Prescribed for alleviation of inflammation and pain associated with acute and chronic musculo-skeletal disorders, and for visceral pain associated to colic. PIGS Recommended as adjuctive therapy in the treatment of metritis-mastitis agalactia syndrome (MMA) in sows. 7. METHOD AND ROUTE OF ADMINISTRATION Read the package leaflet before use. Cattle and horses: intravenous Pigs: intramuscular deep 8. WITHDRAWAL PERIOD Cattle: Meat: 14 days Milk: 2 days Horses: Meat: 28 days Do not use in horses producing milk for human consumption Pigs: Meat: 28 days 9. SPECIAL WARNING Read the package leaflet before use. 10. EXPIRY DATE EXP: month/year Once opened, used by: 28 days. Read the complete document
PART IB 1: SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Fluvex 50 mg/ml solution for injection for cattle, pigs and horses 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of the product contains: Active substance: Flunixin (as flunixin meglumine) 50.0 mg (Equivalent to 82.9 mg de flunixin meglumine) Excipients: Phenol 5 mg Sodium Formaldehyde Sulfoxylate Dihydrate 2.5 mg Other excipients q.s.t. 1 ml 3. PHARMACEUTICAL FORM Solution for injection. Colorless liquid 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle, horses and pigs. 4.2. INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES CATTLE Prescribed for the control of acute inflammation and pyrexia associated to bovine respiratory disease. HORSES Prescribed for alleviation of inflammation and pain associated with acute and chronic musculo-skeletal disorders, and for visceral pain associated to colic. PIGS Recommended as adjuctive therapy in the treatment of metritis-mastitis agalactia syndrome (MMA) in sows. 4.3. CONTRAINDICATIONS Do not use in animals which suffer from hepatic or renal diseases. Do not use in animals which present digestive ulcers or bleeding. Do not use when blood dyscrasia signs are present. Do not use in animals which suffer from hypersensitivity to flunixin meglumine. Do not use in dehydrated or hypovolemic animals or in animals which suffer arterial hypotension. 4.4. SPECIAL WARNINGS FOR EACH TARGET SPECIE The cause of the inflammatory condition or colic must be determined and treated with an appropriate concomitant treatment. Horses intended for racing and competit Read the complete document