País: Irlanda
Idioma: inglés
Fuente: HPRA (Health Products Regulatory Authority)
AMOXICILLIN (EQUIVALENT TO AMOXICILLIN TRIHYDRATE PH. EUR.)
Industrial Veterinaria, S.A.
QJ01CA04
AMOXICILLIN (EQUIVALENT TO AMOXICILLIN TRIHYDRATE PH. EUR.)
500 mg/g
Powder for use in drinking water
POM
Fowl - Chicken, Fowl - Duck, Fowl - Turkey, Porcine
Amoxicillin
Antibacterial
Authorised
2015-10-16
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Rhemox 500 mg/g powder for use in drinking water for pigs, chicken broilers, duck broilers and turkeys for meat production 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each gram contains: ACTIVE SUBSTANCE Amoxicillin trihydrate 500 mg (Equivalent to 435.6 mg Amoxicillin) EXCIPIENTS For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Powder for use in drinking water. Fine and homogeneous white or slightly creamy powder. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs Chicken (broiler), duck (duck broiler) and turkey (turkey for meat production). 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Pigs: Treatment of infections caused by strains of_ Streptococcus suis_ sensitive to amoxicillin_._ Chicken broilers, duck broilers and turkeys for meat production: Treatment of pasteurellosis and colibacillosis caused by strains of_ Pasteurella_ spp. and_ Escherichia coli_ sensitive to amoxicillin. 4.3 CONTRAINDICATIONS Do not use in case of hypersensitivity to penicillins, to other beta-lactams or to the excipient. Do not use orally in rabbits, guinea pigs, hamsters or other small herbivores, given that amoxicillin, as for all aminopenicillins, has deleterious effects on caecal bacteria. Do not use in horse given that amoxicillin, as all aminopenicillins, has an important effect on caecal bacterial. Do not use orally in animals with functional rumen. Do not use in animals with renal disease, including anuria and oliguria. 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 ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ __ Leer el documento completo