Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Marbofloxacin
Vetoquinol Ireland Limited
QJ01MA93
Marbofloxacin
100 milligram(s)/millilitre
Solution for injection
POM: Prescription Only Medicine as defined in relevant national legislation
Cattle, Pigs
marbofloxacin
Antibacterial
Authorised
1997-10-31
Health Products Regulatory Authority 28 August 2019 CRN00987J Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Marbocyl 10 % Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active Substance: Marbofloxacin 100 mg Excipients: m-Cresol 2.0 mg Monothioglycerol 1.0 mg Disodium Edetate 0.1 mg Excipient Q.S. 1 ml For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Solution for injection. Clear, yellow to green/brown solution 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle and pigs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES In Cattle Marbofloxacin 10% injection is indicated in the treatment of respiratory infections caused by susceptible strains of organisms. It is also indicated in the treatment of acute _E.coli_ mastitis. In Pigs Marbofloxacin 10% injection is indicated in the treatment of Metritis Mastitis Agalactia syndrome caused by susceptible strains of organisms 4.3 CONTRAINDICATIONS None known 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None known Health Products Regulatory Authority 28 August 2019 CRN00987J Page 2 of 4 4.5 SPECIAL PRECAUTIONS FOR USE 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 fluoroquinolones and may decrease the effectiveness of treatment with other quinolones due to the potential for cross resistance. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS None 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) No severe side-effects to be expected at doses up to 3 to 5 times the recomme Read the complete document