Country: Ireland
Language: English
Source: HMA (Heads of Medicines Agencies)
florfenicol 300 mg
Pfizer Limited
QJ01BA90
Solution for injection
florfenicol
Cattle Food, Pigs Food
2011-06-21
Issued: December 2011 AN: 01064/2010 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Colfen 300 mg/ml Solution for Injection for Cattle and Pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Florfenicol…………300 mg EXCIPIENT(S): For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. A light yellow to yellow, clear, viscous liquid practically free from particles. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle and pigs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Cattle: diseases caused by florfenicol susceptible bacteria. Preventive and therapeutic treatment of respiratory tract infections in cattle due to _Mannheimia haemolytica, Pasteurella multocida _and_ Histophilus somni_. The presence of the disease in the herd should be established before preventive treatment. Pigs: treatment of acute outbreaks of respiratory disease caused by strains of _Actinobacillus pleuropneumoniae _and_ Pasteurella multocida _susceptible to florfenicol. 4.3 CONTRAINDICATIONS Do not administer to boars and adult bulls intended for breeding purposes. Do not use in cases of known hypersensitivity to the active substance or to any of the excipients. Do not use in cases of known resistance to the active substance. Issued: December 2011 AN: 01064/2010 Page 2 of 6 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Swab the stopper before removing each dose. Use a Read the complete document