Страна: Ирландия
Език: английски
Източник: HPRA (Health Products Regulatory Authority)
AMOXICILLIN TRIHYDRATE PH. EUR.
Bela-Pharm GmbH & Co. KG
QJ01CA04
AMOXICILLIN TRIHYDRATE PH. EUR.
1000 mg/g
Powder for use in drinking water
POM
Fowl - Chicken, Fowl - Duck, Fowl - Turkey
Amoxicillin
Antibacterial
Authorised
2016-06-24
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Biocillin 1000 mg/g Powder for use in drinking water for chickens, ducks and turkeys 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1.0 g powder contains: ACTIVE SUBSTANCE: Amoxicillin trihydrate 1000 mg (equivalent to 871 mg Amoxicillin) For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Powder for use in drinking water. White, crystalline powder. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Chickens, ducks, turkeys 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Treatment of infections in chickens, turkeys and ducks caused by bacteria susceptible to amoxicillin. 4.3 CONTRAINDICATIONS Do not treat infections caused by bacteria producing the enzyme beta lactamase. Do not administer to rabbits, hamsters, gerbils, guinea pigs or any other small herbivore. Do not use in animals with known hypersensitivity to penicillins or other ß-lactam antibiotics or to any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 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_ _ _ _0_ _6_ _/_ _0_ _3_ _/_ _2_ _0_ _1_ _7_ _C_ _R_ _N_ _ _ _7_ _0_ _2_ _5_ _8_ _2_ _0_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Official, national and regional antimicrobial policies should be taken into account when the product is used. Use of the product should be based on susceptibility testing of the bacteria isolated from the anim Прочетете целия документ