Quốc gia: Ai-len
Ngôn ngữ: Tiếng Anh
Nguồn: HPRA (Health Products Regulatory Authority)
marbofloxacin
Krka, d.d., Novo mesto
QJ01MA93
20 Mg/Ml
Solution for Injection
Bovine Porcine
Antibacterial
Authorised
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Ubiflox 20 mg/ml solution for injection for cattle and pigs. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Solution for injection. Clear, greenish yellow to brownish yellow solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle (pre-ruminant calves up to 100 kg b.w.). Pigs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES CATTLE (PRE-RUMINANT CALVES UP TO 100 KG B.W.) Treatment of respiratory infections caused by sensitive strains of _Pasteurella multocida, Mannheimia haemolytica _and _Mycoplasma bovis._ FATTENING PIGS Treatment of respiratory infections caused by sensitive strains of _Actinobacillus pleuropneumoniae, Mycoplasma_ _hyopneumoniae, Pasteurella multocida._ 4.3 CONTRAINDICATIONS Do not administer in animals with known hypersensitivity to marbofloxacin or any other quinolone or to any of the excipients. Do not use in cases where the pathogen involved is resistant to other fluoroquinolones (cross resistance). 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 1 ml of solution for injection contains: ACTIVE SUBSTANCE: Marbofloxacin 20 mg EXCIPIENTS: Metacresol 2 mg Disodium edetate 0.10 mg Monothioglycerol 0.50 mg For a full list of excipients, see section 6.1. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 05/04/2013_ _CRN 7014304_ _page number: 1_ 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Official and local antimicrobial policies should be taken into account when the product is used. Fluoroquinoles should be reserved for the treatment of clinical conditions which have responded poorly, or are expected to respond poorly, to other classes of antimicrobials. Whenever possible, Đọc toàn bộ tài liệu