Држава: Малезија
Језик: Енглески
Извор: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
AMOXICILLIN TRIHYDRATE
Borneosew Medical Trading (M) Sdn Bhd
AMOXICILLIN TRIHYDRATE
500.00 mcg/mL; 100.00 mcg/mL
Norbrook Laboratories Limited
PACKAGE INSERT 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Betamox 40mg Palatable Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains : ACTIVE SUBSTANCE: Amoxicillin 40 mg (as Amoxicillin Trihydrate) 45.92 mg EXCIPIENTS: For a full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Tablet Off-white circular tablets scored on one face 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs Cats 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For use in the treatment of bacterial infections of the alimentary, respiratory and urogenital tracts and in the eye, ear, skin and wound infections caused by susceptible organisms. _In vitro_, amoxicillin is effective against a range of Gram-positive and Gram- negative bacteria, including: _Bacillus cereus _ _ _ _Bordetella bronchiseptica _ _ _ _Corynebacterium_ spp_ _ _ _ _Chromobacter_ spp _ _ _Citrobacter freundii _ _ _ _Escherichia coli _ _ _ _Flavobacter_ spp_ _ _ _ _Proteus mirabilis _ _ _ _Pasteurella _spp_ including Pasteurella multocida _ _ _ _Salmonella_ spp _ _ _Staphylococci _(penicillin sensitive strains) _ _ _Streptococci _ 4.3 CONTRAINDICATIONS Do not use in known cases of hypersensitivity to amoxicillin. Not for administration to rabbits, guinea pigs, hamsters or gerbils. Caution is advised when used in other small herbivores. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES No special warnings. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS None 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 or skin contact. Hypersensitivity to penicillins may lead to cross- reactions to cephalosporins and vice versa. Allergic reactions to these substances may occasionally be serious. 1. Do not handle this product if you know you are sensitised, or if you have been advised not to work with such preparations. 2. Handle this product with great care to avoid exposure Прочитајте комплетан документ