Country: Ingilterra
Lingwa: Ingliż
Sors: VMD (Veterinary Medicines Directorate)
Marbofloxacin
Ceva Animal Health Ltd
QJ01MA93
Marbofloxacin
Solution for injection
POM-V - Prescription Only Medicine – Veterinarian
Cattle
Antimicrobial
Expired
2010-02-10
Revised: February 2012 AN: 01636/2011 Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Marbokem 100 mg/ml solution for injection [AT, BE, BG, CY, CZ, DK, EE, EL, ES, FR, HU, IE, IT, LT, LU, LV, NL, PL, PT, RO, SK, UK] MARBOKEM 100 mg/ml solution for injection for cattle [DE] 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Marbofloxacin ..........................................100.0 mg For a 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. 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 use in animals with known hypersensitivity to fluoroquinolones. Do not use in cases where the pathogen involved is resistant to other fluoroquinolones (cross resistance). 4.4 SPECIAL WARNINGS None. 4.5 SPECIAL PRECAUTIONS FOR USE i. 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. Revised: February 2012 AN: 01636/2011 Page 2 of 4 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 treatment with other quinolones due to the potential for cross resistance. ii. Special precautions to be taken by the person administering the veterinary medicinal product to animals People with known hypersensitivity to quinolones should avoid any contact with the product. If the product comes into contact with the skin Aqra d-dokument sħiħ