Țară: Franța
Limbă: engleză
Sursă: HMA (Heads of Medicines Agencies)
amoxicillin 400 mg, clavulanic acid 100 mg
Dechra Limited
QJ01CR02
Tablet
amoxicillin and enzyme inhibitor
Cats, Dogs
2012-05-01
Revised: March 2011 AN: 01855/2009 Page 1 of 6 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Clavudale 500 mg tablet for dogs (UK, Ireland, France, Austria, Belgium, Czech Republic, Greece, Hungary, Iceland, Luxembourg, Norway, Poland, Portugal, Slovak Republic) Clavudale 400 mg / 100 mg tablet for dogs (Germany, Netherlands, Denmark, Spain, Finland, Sweden) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: ACTIVE SUBSTANCES: Amoxicillin (as amoxicillin trihydrate) 400 mg Clavulanic acid (as potassium clavulanate) 100 mg EXCIPIENTS: Erythrosine (E127) 7.5 mg For a full list of excipients see section 6.1. 3. PHARMACEUTICAL FORM Tablet. Pink oblong scored tablets. The tablet can be divided into equal halves. 4. CLINICAL PARTICULARS _4.1 TARGET SPECIES _ Dogs _4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES _ For the treatment of bacterial infections susceptible to amoxicillin in combination with clavulanic acid where clinical experience and/or sensitivity testing indicates the product as the drug of choice. Uses include: Skin infections (including deep and superficial pyodermas) associated with Staphylococci and Streptococci; Infections of the oral cavity (mucous membrane) associated with Clostridia, Corynebacteria, Staphylococci, Streptococci, _Bacteroides_ spp. and Pasteurellae.; Urinary tract infections associated with Staphylococci, Streptococci, _Escherichia coli _and _Proteus _spp; Respiratory tract infections associated with Staphylococci, Streptococci and Pasteurellae; Gastrointestinal infections associated with _Escherichia coli_ and _Proteus_ spp. Revised: March 2011 AN: 01855/2009 Page 2 of 6 _4.3 CONTRAINDICATIONS _ Do not use in rabbits, guine Citiți documentul complet