Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Amoxicillin (as trihydrate), Clavulanic acid (as potassium clavulanate, diluted : cellulose, microcrystalline(1:1))
Virbac
QJ01CR02
Amoxicillin (as trihydrate), Clavulanic acid (as potassium clavulanate, diluted : cellulose, microcrystalline(1:1))
*** AWAITING VALUE ***
Tablet
POM: Prescription Only Medicine as defined in relevant national legislation
Dogs
amoxicillin and enzyme inhibitor
Antibacterial
Authorised
2015-07-17
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Twinox 400 mg/100 mg tablets for dogs 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) 0.5 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. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _1_ _9_ _/_ _0_ _8_ _/_ _2_ _0_ _1_ _5_ _C_ _R_ _N_ _ _ _7_ _0_ _2_ _1_ _5_ _0_ _0_ _p_ _a_ _g_ _e_ _ _ _n_ _ Læs hele dokumentet