מדינה: אירלנד
שפה: אנגלית
מקור: HPRA (Health Products Regulatory Authority)
MARBOFLOXACIN
Industrial Veterinaria, S.A.
QJ01MA93
MARBOFLOXACIN
100 Mg/Ml
Solution for Injection
POM
Bovine, Porcine
Marbofloxacin
Antibacterial
Authorised
2013-05-17
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Boflox, 100 mg/ml solution for injection for cattle and pigs 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. Yellow greenish to yellow brownish, clear solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle and pigs (sows). 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES In cattle: - treatment of respiratory infections caused by strains of _Histophilus somni_, _Mannheimia haemolytica_, _Mycoplasma_ _bovis, Pasteurella multocida _susceptible to marbofloxacin. - treatment of acute mastitis caused by strains of _Escherichia coli _susceptible to marbofloxacin during the lactation period. In pigs: - treatment of Postpartum Dysgalactia Syndrome –PDS-(Metritis Mastitis Agalactia syndrome), caused by bacterial strains susceptible to marbofloxacin. 4.3 CONTRAINDICATIONS Do not use in cases where the pathogen involved is resistant to other fluoroquinolones (cross resistance). Do not use in animals with known hypersensitivity to the active substance or to any other quinolone or to any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 19/01/2016_ _CRN 7020663_ _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 קרא את המסמך השלם