Nazione: Spagna
Lingua: inglese
Fonte: HMA (Heads of Medicines Agencies)
amoxicillin 400 mg, clavulanic acid 100 mg
V.M.D.
QJ01CR02
Tablet
amoxicillin and enzyme inhibitor
Dogs
2011-09-20
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Amoxiclav-VMD 500 mg (BE, NL) Clavucill 400 mg/100 mg (DE, DK, ES, FR, PL, PT, RO, SE) Tablets for dogs. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet (1800 mg) contains: - Active substances: Amoxicillin (as amoxicillin trihydrate) 400 mg/tablet Clavulanic acid (as potassium clavulanate) 100 mg/tablet - Excipients: Erythrosine (E127) 0.5 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. Pale pink, rounded, one side scored, uncoated tablet with a diameter of 18.3 mm. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Dogs Treatment of infections caused by micro-organisms sensitive for the combination amoxicillin/clavulanic acid, especially: - dermatitis (superficial and deep pyodermatitis) caused by _Staphylococcus intermedius_. - urinary tract infections caused by _E. coli_. - respiratory tract infections caused by _Streptococcus_ spp. - enteritis caused by _E. coli_. 4.3 CONTRAINDICATIONS - Do not use in animals with known hypersensitivity to penicillin or other substances of the beta-lactam group. - Do not use in case of serious dysfunction of the kidneys accompanied by anuria and oliguria. - Do not use in rabbits, guinea pigs, hamsters, chinchillas or gerbils. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None known. 4.5 SPECIAL PRECAUTIONS FOR USE _i) Special precautions for use in animals _ - Do not use in case of known resistance to the combination. - Official, national and regional Leggi il documento completo
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Amoxiclav-VMD 500 mg (BE, NL) Clavucill 400 mg/100 mg (DE, DK, ES, FR, PL, PT, RO, SE) Tablets for dogs. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet (1800 mg) contains: - Active substances: Amoxicillin (as amoxicillin trihydrate) 400 mg/tablet Clavulanic acid (as potassium clavulanate) 100 mg/tablet - Excipients: Erythrosine (E127) 0.5 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. Pale pink, rounded, one side scored, uncoated tablet with a diameter of 18.3 mm. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Dogs Treatment of infections caused by micro-organisms sensitive for the combination amoxicillin/clavulanic acid, especially: - dermatitis (superficial and deep pyodermatitis) caused by _Staphylococcus intermedius_. - urinary tract infections caused by _E. coli_. - respiratory tract infections caused by _Streptococcus_ spp. - enteritis caused by _E. coli_. 4.3 CONTRAINDICATIONS - Do not use in animals with known hypersensitivity to penicillin or other substances of the beta-lactam group. - Do not use in case of serious dysfunction of the kidneys accompanied by anuria and oliguria. - Do not use in rabbits, guinea pigs, hamsters, chinchillas or gerbils. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None known. 4.5 SPECIAL PRECAUTIONS FOR USE _i) Special precautions for use in animals _ - Do not use in case of known resistance to the combination. - Official, national and regional Leggi il documento completo