Страна: ЮАР
Язык: английский
Источник: South African Health Products Regulatory Authority (SAHPRA)
Adcock
ADCO-CEFACLOR BD 187 Granules for Suspension ADCO-CEFACLOR BD FORTE 375 Granules for Suspension SCHEDULING STATUS: S4 PROPRIETARY NAME (and dosage form): ADCO-CEFACLOR BD 187 Granules for Suspension ADCO-CEFACLOR BD FORTE 375 Granules for Suspension COMPOSITION: After mixing, each 5 mL ADCO-CEFACLOR BD 187 suspension contains 187 mg cefaclor . After mixing, each 5 mL ADCO-CEFACLOR BD FORTE 375 suspension contains 375 mg cefaclor. Cefaclor is chemically designated as 3-chloro-7-D-(2-phenylglycinamido)-3-cephem-4-carboxylic acid monohydrate. PHARMACOLOGICAL CLASSIFICATION: A 20.1.1 Broad and Medium Spectrum Antibiotics PHARMACOLOGICAL ACTION: Cefaclor is a semi-synthetic cephalosporin antibiotic with a broad spectrum of bactericidal activity against certain Gram- positive and Gram-negative micro-organisms. Human pharmacology: Cefaclor is absorbed after oral administration whether taken with food or while fasting. Approximately 60% of the agent is excreted unchanged in the urine within 8 hours. Cefaclor is not appreciably metabolised. The presence of food in the gastro-intestinal tract delays absorption and lowers peak serum levels, but does not alter the total amount of cefaclor absorbed. Microbiology: In vitro tests demonstrate that the bactericidal action of the cephalosporins results from inhibition of cell- wall synthesis. Cefaclor is active against the following organisms in vitro: Strains of staphylococci, including coagulase-positive, coagulase-negative and penicillinase-producing strains, are moderately sensitive. Streptococcus pyogenes (group A beta-haemolytic streptococci). Streptococcus pneumoniae. Escherichia coli. Proteus mirabilis. Klebsiella sp. Haemophilus influenzae, including ampicillin-resistant strains. Moraxella (Branhamella) catarrhalis. Note: Cefaclor has no activity against Pseudomonas species, Прочитать полный документ