País: Irlanda
Idioma: inglés
Fuente: HPRA (Health Products Regulatory Authority)
Amoxicillin trihydrate
Bela-Pharm GmbH & Co. KG
QJ01CA04
Amoxicillin trihydrate
1000 milligram(s)/gram
Powder for use in drinking water
POM: Prescription Only Medicine as defined in relevant national legislation
Chickens, Ducks, Turkeys
amoxicillin
Antibacterial
Authorised
2016-06-24
Health Products Regulatory Authority 18 June 2021 CRN009Z5X Page 1 of 4 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 Each g 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 use this product to treat infections caused by bacteria producing the enzyme beta lactamase. Do not use in rabbits, hamsters, gerbils, guinea pigs or any other small herbivore. Do not use in cases of hypersensitivity to amoxicillin trihydrate, penicillins or other ß-lactam antibiotics. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 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 animal. If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria. Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacterial resistance to amoxicillin and may decrease its effectiveness. Health Products Regulatory Authority 18 June 2021 CRN009Z5X Page 2 of 4 Special precautions to be taken by the person administering the veterinary medicinal product to animals Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion and skin contact. Hypersensitivity to penicillin Leer el documento completo