国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
AMOXICILLIN TRIHYDRATE PH. EUR. (EQUIVALENT TO 697 MG AMOXICILLIN)
Krka, d.d., Novo mesto
QJ01CA04
AMOXICILLIN TRIHYDRATE PH. EUR. (EQUIVALENT TO 697 MG AMOXICILLIN)
800 mg/g
Powder for use in drinking water
POM
Fowl - Chicken, Porcine
Amoxicillin
Antibacterial
Authorised
2015-08-21
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Amatib 800 mg/g oral powder for pigs and chickens 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each gram contains: ACTIVE SUBSTANCE: Amoxicillin trihydrate 800 mg (corresponds to 697 mg of amoxicillin). EXCIPIENTS: For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral powder. White to pale yellow powder. Appearance of the product after dilution: Colourless to pale yellowish solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs. Chickens (chicks, broilers, pullets, breeders). 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES PIGS: Treatment of respiratory tract infections, gastro-intestinal tract infections, meningitis, arthritis and secondary infections caused by micro-organisms susceptible to amoxicillin. CHICKENS: Treatment of respiratory tract infections and gastro-intestinal tract infections (other than salmonella infections) caused by micro-organisms susceptible to amoxicillin. 4.3 CONTRAINDICATIONS Do not use in known cases of hypersensitivity to penicillin or other substances of the beta-lactam group. Do not use in animals with serious kidney disease including anuria or oliguria. Do not use in rabbits, guinea pigs, hamsters, gerbils or any other small herbivores. Do not use in ruminants or horses. Do not use in the presence of ß-lactamase-producing bacteria. 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_ _1_ _/_ _2_ _0_ _1_ _7_ _C_ _R_ _N_ _ _ _7_ _0_ 完全なドキュメントを読む