Quốc gia: Nam Phi
Ngôn ngữ: Tiếng Anh
Nguồn: South African Health Products Regulatory Authority (SAHPRA)
Fresenius Kabi Manufacturing SA (Pty) Ltd
See ingredients
INJECTION
EACH 1 ml AMPOULE CONTAINS PENTAZOCINE 30 mg
Registered
1990-03-03
Page 1 of 20 APPROVED PACKAGE INSERT SCHEDULING STATUS: PROPRIETARY NAME AND DOSAGE FORM: TAZOCIN ® 4 EF Injection COMPOSITION: Piperacillin/Tazobactam is an injectable antibacterial combination consisting of the semi-synthetic antibiotic piperacillin sodium and the beta-lactamase inhibitor tazobactam sodium for intravenous administration. Piperacillin sodium is derived from D(-)- -aminobenzylpenicillin. The chemical name of piperacillin sodium is sodium (2S,5R,6R)-6-[(R)-2-(4-ethyl-2,3-dioxo-l-piperazinecarboxamido)-2-phenylaceta- mido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid. Tazobactam sodium is a derivative of the penicillin nucleus. Chemically, tazobactam is a penicillanic acid sulfone. Its chemical name is sodium (2S-(2 ,3ß,5 )]-3-methyl-7-oxo-3-(1H-1,2,3-triazol-1-methyl)-4-thia- 1-azabicyclo[3.2.0]heptane-2-carboxylic acid 4,4-dioxide. TAZOCIN 4 EF Injection contains piperacillin sodium equivalent to piperacillin 4 g and tazobactam sodium equivalent to tazobactam 500 mg. PHARMACOLOGICAL CLASSIFICATION: A 20.1.1 Broad and Medium Spectrum Antibiotics S4 Page 2 of 20 PHARMACOLOGICAL ACTION: Piperacillin, a broad spectrum, semi-synthetic penicillin active against many Gram-positive and Gram- negative aerobic and anaerobic bacteria, exerts bactericidal activity by inhibition of both septum and cell wall synthesis. Tazobactam, a triazolylmethyl penicillanic acid sulfone, is an inhibitor of many ß- lactamases, including the plasmid and chromosomally mediated enzymes. The presence of tazobactam in the piperacillin/tazobactam formulation enhances and extends the antibiotic spectrum of piperacillin. Microbiology Piperacillin/tazobactam is highly active against piperacillin-sensitive micro-organisms as well as ß- lactamase producing, piperacillin-resistant micro-organisms. Gram-negative bacteria: Most plasmid mediated ß-lactamase producing and non-producing strains of _Escherichia coli, Klebsiella_ spp (including _K. oxytoca, K. pneumoniae_), _Proteus vulgaris, Proteus Đọc toàn bộ tài liệu