País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
MARBOFLOXACIN
Norbrook Laboratories Limited
QJ01MA93
MARBOFLOXACIN
5 mg/tablet
Tablets
POM
Canine, Feline
Marbofloxacin
Antibacterial
Authorised
2013-03-22
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Softiflox 5 mg flavoured chewable tablets for cats and dogs. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Chewable Tablet contains: Active Substance: Marbofloxacin 5.0 mg Excipients : For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Chewable Tablet. Light brown round convex tablet with breakline. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cats and dogs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES In dogs: Indicated for the treatment of skin and soft tissue infections (skinfold pyoderma, impetigo, folliculitis, furunculosis, cellulitis) caused by susceptible strains of organisms, urinary tract infections associated or not with prostatitis caused by susceptible strains of organisms and respiratory infections, caused by susceptible strains of organisms. In cats: Indicated for the treatment of skin and soft tissue infections (wounds, abscesses phlegmons) and upper respiratory tract infections caused by susceptible strains of organisms. 4.3 CONTRAINDICATIONS Do not use in animals with known hypersensitivity to marbofloxacin or other (fluoro)quinolones or to any of the excipients. Do not use in dogs and cats with central nervous system (CNS) disorders, such as epilepsy, as fluoroquinolones could potentially cause seizures in predisposed animals Do not use in dogs aged less than 12 months or less than 18 months for exceptionally large breeds of dogs, such as Great Danes, Briard, Bernese, Bouvier and Mastiffs, with a longer growth period as the fluoroquinolones have been shown to induce erosion of the articular cartilage in juvenile dogs. Not recommended for use in cats aged less than 16 weeks. IRISH MEDICINES BOARD ____________________________________________________________________________ Llegiu el document complet