Maa: Malesia
Kieli: englanti
Lähde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
AMOXICILLIN TRIHYDRATE
Borneosew Medical Trading (M) Sdn Bhd
AMOXICILLIN TRIHYDRATE
250.00 mcg/mL; 100.00 mcg/mL
Norbrook Laboratories Limited
PACKAGE INSERT 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Betamox 200mg Palatable Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION EACH TABLET CONTAINS: ACTIVE SUBSTANCE: Amoxicillin 200 mg (as Amoxicillin Trihydrate 229.7 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 Betamox 200mg Palatable Tablets should not be given to penicillin sensitive animals. As with other penicillins, amoxicillin should not be used orally or parenterally in rabbits, guinea pigs, hamsters or gerbils. Caution is advised when used in other very small herbivores. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES No special warnings. 4.5 SPECIAL PRECAUTIONS FOR USE i. Special precautions for use in animals No special precautions for use ii. 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 sensitise Lue koko asiakirja