Country: United Kingdom
Language: English
Source: VMD (Veterinary Medicines Directorate)
Florfenicol
Eurovet Animal Health BV
QJ01BA90
Florfenicol
Expired
Issued 02/03/2010 – AN 01311/2009 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Fenflor 300 mg/ml solution for injection for pigs Florfenicol 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Florfenicol…………300 mg EXCIPIENTS: For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection A light yellow to yellow, clear, viscous liquid. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs, weighing more than 25 kg 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES 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 intended for breeding. Do not use in case of hypersensitivity to the active substance or to any of the excipients. 4.4 SPECIAL WARNINGS None 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Wipe the stopper before removing each dose. Use a dry, sterile syringe and needle. Do not use in piglets less than 25 kg. The product should be used in conjunction with susceptibility testing and take into account official and local antimicrobial policies. Use a suitable draw-off needle or automatic dosing syringe to avoid excessive puncturing of the closure. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS Care should be taken to avoid accidental self-injection. 1/4 Issued 02/03/2010 – AN 01311/2009 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) Commonly observed adverse effects are transient diarrhoea and/or peri-anal and rectal erythema/ oedema which may affect 50% of the animals. These effects can be observed for one week. Transient swelling lasting up to 5 days may be observed at Read the complete document