Land: Spanien
Språk: engelska
Källa: HMA (Heads of Medicines Agencies)
florfenicol 300 mg/ml
Emdoka bvba
QJ01BA90
Suspension for injection
florfenicol
Cattle Food, Pigs
2010-03-23
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 _ _ SUMMARY OF PRODUCT CHARACTERISTICS: _ _ 1. NAME OF THE VETERINARY MEDICINAL PRODUCT: Florgane 300 mg/ml Suspension for Injection for Cattle and Pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION: Each ml contains: ACTIVE SUBSTANCE Florfenicol 300 mg EXCIPIENTS n-Butanol 10 mg Potassium metabisulphite (E 224) 0.2 mg For a full list of excipients see section 6.1 3. PHARMACEUTICAL FORM: Suspension for injection. White to yellowish-white suspension. 4. CLINICAL PARTICULARS: 4.1. TARGET SPECIES: Cattle, pigs. 4.2. INDICATIONS FOR USE: _ _ CATTLE: Preventive and therapeutic treatment of respiratory tract infections in cattle caused by florfenicol susceptible _Mannheimia haemolytica,_ _Pasteurella multocida_ and _Histophilus _ _somni_. The presence of the disease in the herd should be established before treatment. _ _ PIGS: Treatment of acute outbreaks of respiratory disease caused by strains of _Actinobacillus _ _pleuropneumoniae _and_ Pasteurella multocida_ susceptible to florfenicol. _ _ 4.3. CONTRA-INDICATIONS: Do not use in adult bulls and boars intended for breeding purposes. Do not use in animals in case of hypersensitivity to florfenicol or to any of the excipients. See section 4.11. 4.4. SPECIAL WARNINGS FOR EACH TARGET SPECIES: None. _ _ 4.5. SPECIAL PRECAUTIONS FOR USE: _I) SPECIAL PRECAUTIONS FOR USE IN ANIMALS: _ Do not use in piglets of less than 2 kg. Use of the product should be based on susceptibili Läs hela dokumentet