国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
Marbofloxacin
Ceva Santé Animale
QJ01MA93
Marbofloxacin
10 mg/tablet
Chewable tablet
POM: Prescription Only Medicine as defined in relevant national legislation
Cats, Dogs
marbofloxacin
Antibacterial
Authorised
2016-04-22
Health Products Regulatory Authority 17 May 2018 CRN000W0N Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Efex 10 mg chewable tablets for cats and dogs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains: ACTIVE SUBSTANCE: Marbofloxacin........................................................... 10.0 mg EXCIPIENT(S): For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Chewable tablet Oblong scored beige tablet. The tablet can be divided in two equal parts. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cats and Dogs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES In cats Marbofloxacin is indicated in the treatment of: o skin and soft tissue infections (wounds, abscesses, phlegmons) caused bysusceptible strains of organisms. upper respiratory tract infections caused susceptible strains of organisms. In dogs Marbofloxacin is indicated in the treatment of: - skin and soft tissue infections (skinfold pyoderma, impetigo, folliculitis, furunculosis, cellulitis) caused by susceptible strains oforganisms. - urinary tract infections (UTI) caused by susceptible strains of organisms associated Health Products Regulatory Authority 17 May 2018 CRN000W0N Page 2 of 7 or not with prostatitis or epididymitis. - respiratory tract infections caused by susceptible strains of organisms. 4.3 CONTRAINDICATIONS Do not use in dogs aged less than 12 months, or less than 18 months for giant breeds of dogs with a longer growth period. Do not use in cats aged less than 16 weeks. Do not use in cases of hypersensitivity to the active substance, other (fluoro)quinolones or any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES A low urinary pH could have an inhibitory effect on the activity of marbofloxacin. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS The chewable tablets are flavoured. In order to avoid any accidental ingestion, store tablets out of reach of the animals. The fluoroquinolones have been shown to induce erosi 阅读完整的文件