Nazione: Irlanda
Lingua: inglese
Fonte: HMA (Heads of Medicines Agencies)
amoxicillin 200 mg, clavulanic acid 50 mg
Dechra Limited
QJ01CR02
Tablet
amoxicillin and enzyme inhibitor
Cats, Dogs
2012-05-01
Revised: March 2011 AN: 01854/2009 Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Clavudale 250 mg tablet for dogs (UK, Ireland, France, Austria, Belgium, Czech Republic, Greece, Hungary, Iceland, Luxembourg, Norway, Poland, Portugal, Slovak Republic) Clavudale 200 mg / 50 mg tablet for dogs (Germany, Netherlands, Denmark, Spain, Finland, Sweden) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: ACTIVE SUBSTANCES: Amoxicillin (as amoxicillin trihydrate) 200 mg Clavulanic acid (as potassium clavulanate) 50 mg EXCIPIENTS: Erythrosine (E127) 3.75 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; Revised: March 2011 AN: 01854/2009 Page 2 of 9 Gastrointestinal infections associated with Escherichia coli and Proteus spp. Revised: March 2011 AN: Leggi il documento completo