Land: Irland
Sprache: Englisch
Quelle: HPRA (Health Products Regulatory Authority)
Amoxicillin
Norbrook Laboratories Limited
QJ01CA04
Amoxicillin
150 milligram(s)/millilitre
Suspension for injection
POM: Prescription Only Medicine as defined in relevant national legislation
amoxicillin
Authorised
1987-10-01
Health Products Regulatory Authority 05 December 2018 CRN008S4D Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Betamox 150 mg/ml Suspension for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: 150 mg amoxicillin (as Amoxicillin Trihydrate), and 0.08 mg butylated hydroxytoluene (E321) and 0.08 mg butylated hydroxyanisole (E320) as antioxidants. For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Suspension for injection. An off-white suspension. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle, Sheep, Pigs, Dogs, Cats. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment of infections caused by a wide range of Gram-positive and Gram-negative pathogenic bacteria including: _Bacillus anthracis _ _Bacillus cereus _ _Bordetella bronchiseptica _ _Clostridium _spp. _Corynebacterium _spp_._ _Erysipelothrix rhusiopathiae_ _Escherichia coli_ _Fusiformis_ spp. _Haemophilus_ spp. _Pasteurella_ spp. _Proteus mirabilis_ _Salmonella_ spp_._ non-penicillinase producing Staphylococci non-penicillinase producing Streptococci Health Products Regulatory Authority 05 December 2018 CRN008S4D Page 2 of 5 4.3 CONTRAINDICATIONS Not for intravenous or intrathecal use Do not use in rabbits, hamsters, gerbils and guinea pigs Do not use in sheep producing milk for human consumption. Do not use in known cases of hypersensitivity to amoxicillin/penicillin. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS None. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE MEDICINAL PRODUCT TO ANIMALS Penicillin and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillin may lead to cross sensitivity to cephalosporins and vice versa. Allergic reaction to these substances can occasionally be serious. 1. Do not handle this product if you know you are sensitised or if you have been advised Lesen Sie das vollständige Dokument