Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
FLORFENICOL
Krka, d.d., Novo mesto
QJ01BA90
FLORFENICOL
300 Mg/Ml
Solution for Injection
POM
Porcine
Florfenicol
Antibacterial
Authorised
2010-06-04
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Fenflor 300 mg/ml solution for injection for pigs. 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. 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. Do not use in the cases of known resistance to the active substance. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 15/03/2013_ _CRN 7013785_ _page number: 1_ 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 of less than 2 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. In the case of self-injection, seek medical advice and show the label to the doctor. Do not use Read the complete document