Država: Velika Britanija
Jezik: angleščina
Source: VMD (Veterinary Medicines Directorate)
Florfenicol
Ceva Animal Health Ltd
QJ01BA90
Florfenicol
Solution for injection
POM-V - Prescription Only Medicine – Veterinarian
Cattle, Pigs
Antimicrobial
Authorized
2009-08-25
Revised: September 2022 AN: 01506/2022 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 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 the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Colourless to yellow clear solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle and pigs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES CATTLE: Treatment of respiratory tract infections due to _Mannheimia haemolytica_, _Pasteurella _ _multocida _and_ Histophilus somni _susceptible to florfenicol. 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 administer in cases of hypersensitivity to the active ingredient or any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. Revised: September 2022 AN: 01506/2022 Page 2 of 6 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 moderate depression or moderate dyspnoea a week or more after administration of the second dose. Use of product should be based on susceptibility testing of the bacteria isolated from the animal. If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria. Official national and regional antimicrobial policies should be taken into account when the product is used. Use of the product deviating from the instructions given in the SPC may Preberite celoten dokument