Quốc gia: Ai-len
Ngôn ngữ: Tiếng Anh
Nguồn: HPRA (Health Products Regulatory Authority)
MARBOFLOXACIN
Krka, d.d., Novo mesto
QJ01MA93
MARBOFLOXACIN
100 Mg/Ml
Solution for Injection
POM
Bovine, Porcine
Marbofloxacin
Antibacterial
Authorised
2012-08-17
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Ubiflox 100 mg/ml solution for injection for cattle and pigs (sows) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of solution for injection contains: ACTIVE SUBSTANCE: Marbofloxacin 100 mg EXCIPIENTS: Disodium edetate 0.10 mg Monothioglycerol 1 mg Metacresol 2 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. Clear, greenish yellow to brownish yellow solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle and pigs (sows). 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES CATTLE Treatment of respiratory infections caused by sensitive strains of _Pasteurella multocida_, _Mannheimia haemolytica,_ _Mycoplasma bovis _and _Histophilus somni_. Treatment of acute mastitis caused by _Escherichia coli _strains sensitive to marbofloxacin during the lactation period. SOWS Treatment of Metritis Mastitis Agalactia Syndrome (postpartum dysgalactiae syndrome, PDS) caused by bacterial strains sensitive to marbofloxacin. 4.3 CONTRAINDICATIONS Do not use in animals with known hypersensitivity to the active substance 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. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 15/07/2016_ _CRN 7022059_ _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. Fluoroquinolones should be reserved for the treatment of clinical conditions which have responded poorly, or are expected to respond po Đọc toàn bộ tài liệu