Држава: Ирска
Језик: Енглески
Извор: HPRA (Health Products Regulatory Authority)
FLORFENICOL
Kela n.v.
QJ01BA90
FLORFENICOL
300 Mg/Ml
Solution for Injection
POM
Bovine, Porcine
Florfenicol
Antibacterial
Authorised
2012-02-24
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT FLORFENIKEL 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. Clear, light yellow to yellow solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle, pigs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Cattle: Treatment of respiratory tract infections due to strains of _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 and boars intended for breeding purposes. Do not use in piglets of less than 2 kg. Do not use in case of hypersensitivity to florfenicol or to any of the excipients. Do not use in case of resistance to the active substance. Do not administer intravenously. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 21/11/2016_ _CRN 7023769_ _page number: 1_ 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals The stopper must be cleaned before removing each dose. Use a dry, sterile syringe and needle. 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 a Прочитајте комплетан документ