Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
Marbofloxacin
FATRO S.p.A.
QJ01MA93
Marbofloxacin
40 milligram(s)/millilitre
Solution for injection
POM: Prescription Only Medicine as defined in relevant national legislation
Pigs
marbofloxacin
Antibacterial
Authorised
2015-07-24
Health Products Regulatory Authority 18 April 2019 CRN008MX9 Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT MASTERFLOX 40 mg/ml solution for injection for pigs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains: ACTIVE SUBSTANCE: Marbofloxacin 40 mg EXCIPIENTS: Disodium edetate 0.1 mg For a full list of the excipients, see section 6.1 3 PHARMACEUTICAL FORM Solution for injection. Clear yellow solution, with no visible particles. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs (pigs for fattening). 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Treatment of respiratory infections caused by strains of _Actinobacillus pleuropneumoniae, Pasteurella multocida, Mycoplasma _ _hyopneumoniae _susceptible to marbofloxacin_._ 4.3 CONTRAINDICATIONS Do not use in cases where the pathogen involved is resistant to marbofloxacin and other (fluoro)quinolones (cross-resistance). Do not use in cases of hypersensivity to the active substance, to any other quinolone or to any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR USE This product does not contain an antimicrobial preservative. 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 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. Health Products Regulatory Authority 18 April 2019 CRN008MX9 Page 2 of 4 Special precautions to be taken by the person administering the veterinary medicinal product to animals (Fluoro)quinolones may ca Soma hati kamili