Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
AMOXICILLIN (AS TRIHYDRATE), CLAVULANIC ACID (AS POTASSIUM CLAVULANATE, DILUTED : CELLULOSE, MICROCRYSTALLINE(1:1))
Virbac S.A.
QJ01CR02
AMOXICILLIN (AS TRIHYDRATE), CLAVULANIC ACID (AS POTASSIUM CLAVULANATE, DILUTED : CELLULOSE, MICROCRYSTALLINE(1:1))
200/50
Tablets
POM
Canine
Amoxicillin and enzyme inhibitor
Antibacterial
Authorised
2015-07-17
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Twinox 200 mg/50 mg tablets for dogs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: ACTIVE SUBSTANCES Amoxicillin (as amoxicillin trihydrate) 200 mg Clavulanic acid (as potassium clavulanate) 50 mg EXCIPIENT Erythrosine (E127) 0.25 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. Pale pink, rounded, one side scored, uncoated and divisible tablet. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Treatment of infections caused by micro-organisms sensitive to the combination amoxicillin/clavulanic acid, especially: - dermatitis (superficial and deep pyoderma) caused by _Staphylococcus (pseud)intermedius_. - urinary tract infections caused by _E. coli _and _Staphylococcus _spp. - 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 or to any of the excipients. - 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. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 19/08/2015_ _CRN 7021500_ _page number: 1_ 4.5 SPECIAL PRECAUTIONS FOR USE i. Special precautions for use in animals - Do not use in known cases of resistance to the combination. - Official, national and regional antimicrobial policies with respect to the use of broad-spectrum antibiotics should be taken into account. - Do no Lire le document complet