Nazione: Irlanda
Lingua: inglese
Fonte: HPRA (Health Products Regulatory Authority)
Marbofloxacin
Emdoka
QJ01MA93
Marbofloxacin
20 milligram(s)/millilitre
Solution for injection
POM: Prescription Only Medicine as defined in relevant national legislation
marbofloxacin
Authorised
2013-01-11
Health Products Regulatory Authority 14 September 2020 CRN009V48 Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Marbodug 20 mg/ml solution for injection for cattle and pigs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION EACH ML CONTAINS: ACTIVE SUBSTANCE: Marbofloxacin 20.0 mg EXCIPIENTS Metacresol 2.0 mg Monothioglycerol 0.5 mg Disodiumedetate 0.1 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. Clear yellowish solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES - Cattle: pre-ruminants up to 100 kg b.w. - Pigs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Pre-ruminant calves: Treatment of respiratory infections caused by sensitive strains of _Pasteurella multocida, Mannheimia haemolytica _and _Mycoplasma bovis_. Pigs: Treatment of respiratory infections caused by sensitive strains of _Actinobacillus pleuropneumoniae_, _Mycoplasma _ _hyopneumoniae _and _Pasteurella multocida._ 4.3 CONTRAINDICATIONS Do not use in animals with known hypersensitivity to marbofloxacin or to 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). Do not use in case of disturbance in growth of cartilage and/or during injury of the locomotion system particularly on functionally loaded joints. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. Health Products Regulatory Authority 14 September 2020 CRN009V48 Page 2 of 4 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. Whenever possible, fluoroquinolones should only be used based on susceptibility testing. Use of the product deviating from the in Leggi il documento completo