Šalis: Airija
kalba: anglų
Šaltinis: HPRA (Health Products Regulatory Authority)
FLORFENICOL
Dopharma Research B.V.
QJ01BA90
FLORFENICOL
300 Mg/Ml
Solution for Injection
POM
Bovine, Porcine
Florfenicol
Antibacterial
Authorised
2014-03-28
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Flordofen 300 mg/ml Solution for injection for cattle and pigs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Solution for injection Clear slightly yellowish solution 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle and pigs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES CATTLE: Prevention and treatment of respiratory tract infections in cattle due to _Mannheimia haemolytica, Pasteurella multocida_ and _Histophilus somni_, susceptible to florfenicol. 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 adult bulls and boars intended for breeding purposes. Do not use in case of hypersensitivity or previous allergic reactions to florfenicol or to any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. Each ml contains ACTIVE SUBSTANCE: Florfenicol 300 mg EXCIPIENTS: For a full list of excipients, see section 6.1 HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 19/07/2016_ _CRN 7022234_ _page number: 1_ 4.5 SPECIAL PRECAUTIONS FOR USE This veterinary medicinal product does not contain an antimicrobial preservative. SPECIAL PRECAUTIONS FOR USE IN ANIMALS Do not administer to piglets of less than 2 kg. 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 t Perskaitykite visą dokumentą