Land: Verenigd Koninkrijk
Taal: Engels
Bron: VMD (Veterinary Medicines Directorate)
Marbofloxacin
Ceva Animal Health Ltd
QJ01MA93
Marbofloxacin
Solution for injection
POM-V - Prescription Only Medicine – Veterinarian
Cattle, Pigs
Antimicrobial
Authorized
2010-11-10
Revised: October 2022 AN: 01669/2022 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Marbox 100 mg/ml solution for injection for cattle and pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Marbofloxacin .....................................................100.0 mg For the 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 and pigs (sows). 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES CATTLE: Therapeutic treatment of respiratory infections caused by sensitive strains of _Pasteurella multocida_, _Mannheimia haemolytica_ and _Histophilus somni_. Therapeutic treatment of acute mastitis caused by _E. coli_ strains sensitive to marbofloxacin during the lactation period. SOWS: Treatment of Metritis Mastitis Agalactia Syndrome caused by bacterial strains sensitive to marbofloxacin. 4.3 CONTRAINDICATIONS Do not use in case of known hypersensitivity to the active substance or other (fluoro)quinolones or to any of the excipients. Do not use in case of confirmed or suspected resistance to fluoroquinolones (cross resistance). 4.4 SPECIAL WARNINGS None. Revised: October 2022 AN: 01669/2022 Page 2 of 6 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Use of the product should be based on susceptibility testing and has to take into account official and local antimicrobial policies. It is prudent to reserve the fluoroquinolones for the treatment of clinical conditions that have responded poorly, or are expected to respond poorly, to other classes of antibiotics. 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. As the vial cannot be broached more than 45 times, the user should choose the most appropriate vial si Lees het volledige document