Šalis: Rumunija
kalba: anglų
Šaltinis: HMA (Heads of Medicines Agencies)
marbofloxacin 10 g/ml
Vetoquinol
QJ01MA93
solution for injection or infusion
marbofloxacin
Cattle
2011-10-27
Forcyl SPC – D210 – July 2012 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS _ _ 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Forcyl 160 mg/ml solution for injection for cattle 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: Active substance: Marboflo xacin ............................................... 160 mg Excipients: Benzyl alcohol (E 1519)………………... 15 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Clear yellow greenish to yellow brownish solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES In cattle: - Therapeutic treatment of respiratory infections caused by sensitive strains of _Pasteurella multocida_ and _Mannheimia haemolytica_. In lactating cows: - Treatment of acute mastitis caused by_ _sensitive strains of _Escherichia coli._ 4.3 CONTRAINDICATIONS Do not use in animals with known hypersensitivity to fluoroquinolones 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 The efficacy of the product has not been tested on mastitis caused by Gram positive bacteria . 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Official and local antimicrobial policies should be taken into account when this 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 class of a Perskaitykite visą dokumentą