Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
ENROFLOXACIN
Bayer Limited
QJ01MA90
ENROFLOXACIN
100 Mg/Ml
Solution for Injection
POM
Porcine
Enrofloxacin
Antibacterial
Authorised
2011-09-23
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Baytril Max 100 mg/ml solution for injection for pigs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains: ACTIVE SUBSTANCE: Enrofloxacin 100 mg EXCIPIENT(S): n-Butanol 30 mg Benzyl alcohol (E 1519) 20 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Clear, yellow solution for injection. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Pig 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment of bacterial bronchopneumonia caused by enrofloxacin-sensitive _Actinobacillus pleuropneumoniae_, _Pasteurella multocida _and complicated by _Haemophilus parasuis _as secondary pathogen in pigs. 4.3 CONTRAINDICATIONS Do not use in case of hypersensitivity to the active substance or to any of the excipients. Do not use in case of resistance against other fluoroquinolone due to the potential for cross-resistance. Do not use in animals with central nervous system-associated seizure disorders. Do not use in the presence of existing disorders of cartilage development or musculoskeletal damage around functionally significant or weight-bearing joints. Do not use for prophylaxis. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 08/07/2016_ _CRN 7022663_ _page number: 1_ 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Repeated injections should be administered at different sites. Official, national and regional antimicrobial policies should be taken into account when the product is used. Fluoroquinolones should be reserved for the treatment of clinical conditions which have responded poorly, or are expected to respo Lugege kogu dokumenti