Land: Maleisië
Taal: Engels
Bron: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
PIPERACILLIN; TAZOBACTAM
PFIZER (MALAYSIA) SDN. BHD.
PIPERACILLIN; TAZOBACTAM
4.5 gm mcg/mL
Wyeth Lederle S.r.l
Pfizer Confidential Pfizer Confidential Page 1 of 17 TAZOCIN EF (Piperacillin sodium/Tazobactam sodium) 1. NAME OF THE MEDICINAL PRODUCT TAZOCIN EF 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains a total of 2.84 mEq (65 mg) of sodium per gram of piperacillin. _4.5 g vial: _ Each single-dose vial contains piperacillin sodium equivalent to 4 g of piperacillin and tazobactam sodium equivalent to 0.5 g of tazobactam. It also contains 1 mg of edetate disodium (dihydrate) (EDTA) per vial. 3. PHARMACEUTICAL FORM Piperacillin/tazobactam powder for solution for injection or infusion is a sterile, off-white to white lyophilized cake or powder, contained in a glass vial. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Piperacillin/tazobactam is indicated for the treatment of the following systemic and/or local bacterial infections in which susceptible organisms have been detected or are suspected. Lower respiratory tract infections; urinary tract infections (complicated and uncomplicated); intra-abdominal infections; skin and skin structure infections; bacterial septicemia. Polymicrobic infections: piperacillin/tazobactam is indicated for polymicrobic infections including those where aerobic and anaerobic organisms are suspected (intra-abdominal, skin and skin structure, lower respiratory tract). Piperacillin/tazobactam, in combination with an aminoglycoside, is indicated for bacterial infections in neutropenic adults or children. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Piperacillin/tazobactam must be given by slow intravenous infusion (e.g. over 20-30 minutes) or slow intravenous injection (over at least 3-5 minutes). DURATION OF THERAPY The duration of therapy should be guided by the severity of the infection and the patient’s clinical and bacteriological progress. DOSAGE Neutropenic patients with signs of infection (e.g. fever) should receive immediate empirical antibiotic therapy before laboratory results are available. Pfizer Confidential Page 2 of 17 _ADULTS AND CHILDREN AGED 12 YEARS AND OLDER: Lees het volledige document