Land: Malta
Sprache: Englisch
Quelle: HMA (Heads of Medicines Agencies)
florfenicol 300 mg/ml
CEVA Santé Animale
QJ01BA90
Solution for injection
florfenicol
Cattle, Pigs
2012-02-13
1/5 Dokument1C553-SPC-EndProcedure.doc May 09 SUMMARY OF PRODUCT CHARACTERISTICS (S.P.C.) 1. NAME OF THE VETERINARY MEDICINAL PRODUCT FLORKEM 300 mg/ml solution for injection for cattle and pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE : Florfenicol ........................................................ 300 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Pale yellow to yellow clear solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle and pigs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Diseases caused by florfenicol susceptible bacteria. CATTLE: Treatment of respiratory tract infections due to _Mannheimia haemolytica_, _Pasteurella multocida _and_ _ _Histophilus somni _. PIGS: Treatment of acute outbreaks of swine respiratory disease caused by strains of _Actinobacillus _ _pleuropneumoniae_ and _Pasteurella multocida_ susceptible to florfenicol. 4.3 CONTRAINDICATIONS Do not use in adult bulls or boars intended for breeding purposes. Do not use in cattle producing milk for human consumption. Do not administer in cases of hypersensitivity to the active ingredient or any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 2/5 Dokument1C553-SPC-EndProcedure.doc May 09 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Wipe the stopper before removing each dose. Use a dry, sterile needle and syringe. Do not use in piglets of less than 2 kg. Under field conditions, approximately 30% of treated pigs presented with pyrexia (40°C) associated with either Lesen Sie das vollständige Dokument