Quốc gia: Ai-len
Ngôn ngữ: Tiếng Anh
Nguồn: HPRA (Health Products Regulatory Authority)
Marbofloxacin
Norbrook Laboratories 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
2013-02-22
Health Products Regulatory Authority 22 November 2017 CRN000VF0 Page 1 of 6 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Marbonor 100 mg/ml Solution for Injection for cattle and pig 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Marbofloxacin 100.0 mg EXCIPIENTS: Monothioglycerol 1.0 mg Metacresol 2.0 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. Clear yellow to amber solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle and Pigs (sows) 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES CATTLE Treatment of respiratory infections caused by susceptible strains of _Pasteurella _ _multocida_, _Mannheimia haemolytica_ and _Mycoplasma bovis_. Treatment of acute mastitis caused by _Escherichia coli _strains susceptible to marbofloxacin during the lactation period. SOWS Treatment of Metritis Mastitis Agalactia Syndrome (postpartum dysgalactia syndrome, PDS) caused by bacterial strains susceptible to marbofloxacin. 4.3 CONTRAINDICATIONS Do not use in cases where the pathogen involved is resistant to other fluoroquinolones (cross resistance). Do not use in cases of hypersensitivity to the active substance or to any of the excipients. Health Products Regulatory Authority 22 November 2017 CRN000VF0 Page 2 of 6 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES The efficacy data showed that the product has insufficient efficacy for the treatment of acute forms of mastitis induced 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 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 upon susceptibility testing. Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria r Đọc toàn bộ tài liệu