Negara: Irlandia
Bahasa: Inggris
Sumber: HPRA (Health Products Regulatory Authority)
MARBOFLOXACIN
Krka, d.d., Novo mesto
QJ01MA93
MARBOFLOXACIN
100 Mg/Ml
Solution for Injection
POM
Bovine
Marbofloxacin
Antibacterial
Authorised
2012-08-17
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Ubiflox Cattle 100 mg/ml solution for injection for cattle. 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. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Treatment of respiratory infections caused by sensitive strains of _Pasteurella multocida_, _Mannheimia haemolytica _and _Histophilus somni._ 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 100 mg EXCIPIENTS: Disodium edetate 0.10 mg Monothioglycerol 1 mg Metacresol 2 mg For a full list of excipients, see section 6.1. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 13/02/2013_ _CRN 7013946_ _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, fluoroquinolones should only be used based on susceptibility testing. Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to the fluoroquinolones and may decrease the effectiveness of tre Baca dokumen lengkapnya