Šalis: Airija
kalba: anglų
Šaltinis: HPRA (Health Products Regulatory Authority)
MARBOFLOXACIN
CP-Pharma Handelsgesellschaft mbH
QJ01MA93
MARBOFLOXACIN
20 Mg/Ml
Solution for Injection
POM
Bovine, Porcine
Marbofloxacin
Antibacterial
Authorised
2013-01-11
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Marbosol 20 mg/ml solution for injection for calves and piglets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml solution for injection contains: Active substance: Marbofloxacin 20 mg Excipients: Metacresol 2 mg Monothioglycerol 0.50 mg For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. Clear, yellow solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle (pre-ruminating calves), piglets. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Pre-ruminating calves: For treatment and prevention of respiratory infections caused by marbofloxacin susceptible _Mannheimia haemolytica_ and _Pasteurella multocida _strains, where the presence of the disease has been established in the group. Piglets: For the treatment of respiratory infections caused by marbofloxacin susceptible _Actinobacillus pleuropneumoniae,_ _Mycoplasma hyopneumoniae _and _Pasteurella multocida _strains. 4.3 CONTRAINDICATIONS Do not use in case of bacterial infections with resistance to other (fluoro)quinolones (cross resistance). Do not use in case of hypersensitivity to the active substance or to any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 01/06/2016_ _CRN 7021352_ _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 poorly, to other classes of antimicrobials. Whenever possible, fluoroqu Perskaitykite visą dokumentą