Nchi: Nyuzilandi
Lugha: Kiingereza
Chanzo: Medsafe (Medicines Safety Authority)
Piperacillin monohydrate 4 g (as piperacillin sodium 4.17g); ; ; Tazobactam 500mg; ; Piperacillin monohydrate 4 g (as piperacillin sodium 4.17g); Tazobactam 500mg (as tazobactam sodium 0.5366 g)
Pfizer New Zealand Limited
Piperacillin monohydrate 4 g (as piperacillin sodium 4.17g)
4g/500mg
Powder for injection
Active: Piperacillin monohydrate 4 g (as piperacillin sodium 4.17g) Tazobactam 500mg Piperacillin monohydrate 4 g (as piperacillin sodium 4.17g) Tazobactam 500mg (as tazobactam sodium 0.5366 g) Excipient: Citric acid monohydrate Disodium edetate dihydrate Sodium bicarbonate
Vial, glass, 4.5g, 1 dose unit
Prescription
Prescription
Qilu Tianhe Pharmaceutical Co Ltd
Indicated for the treatment of the following systemic and/or local bacterial infections in which susceptible organisms have been detected or are suspected: 1. Lower respiratory tract infections 2. Urinary tract infections (complicated and uncomplicated) 3. Intra-abdominal infections 4. Skin and skin structure infections 5. Bacterial septicaemia 6. Gynaecological infections 7. Bacterial infections in neutropenic patients. Full therapeutic doses of TAZOCIN EF plus an aminoglycoside should be used. 8. Bone and joint infections 9. Polymicrobic infections: TAZOCIN EF is indicated for polymicrobic infections including those where aerobic and anaerobic organisms are suspected (intra-abdominal, skin and skin structure, upper and lower respiratory tract, gynaecological). Children under the age of 12 years In hospitalised children aged 2 to 12 years, TAZOCIN EF is indicated for the treatment of serious intra-abdominal infections.
Package - Contents - Shelf Life: Vial, glass, 4.5g - 1 dose units - 36 months from date of manufacture stored below 30°C 48 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) 6 hours reconstituted stored at or below 25°C - Vial, glass, 4.5g - 10 dose units - 36 months from date of manufacture stored below 30°C 48 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) 6 hours reconstituted stored at or below 25°C
1991-03-18
New Zealand Consumer Medicine Information TAZOCIN EF ® 1 TAZOCIN EF ® _Piperacillin sodium/tazobactam sodium powder for Injection _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about TAZOCIN EF. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking TAZOCIN EF against the benefits this medicine is expected to have for you. IF YOU HAVE ANY QUESTIONS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET. You may need to read it again. WHAT TAZOCIN EF IS USED FOR The name of your medicine is TAZOCIN EF. It contains the active ingredients piperacillin sodium and tazobactam sodium. They belong to a group of antibiotics called penicillins that work by killing bacteria. Piperacillin is an antibiotic that kills many types of bacteria. Tazobactam belongs in the penicillin group but does not have activity against bacteria. It helps piperacillin to overcome bacteria which have become resistant to piperacillin. TAZOCIN EF is active against bacteria which cause serious infections such as: - • Chest infections • Urine infections • Stomach infections • Skin infections • Gynaecological infections • Septicaemia (blood poisoning). It is also used to treat many other infections. In hospitalised children aged 2 to 12 years, TAZOCIN EF is used to treat serious infections in the abdomen. TAZOCIN EF is not recommended to treat abdominal infections in children under 2 years. TAZOCIN EF will not work against infections caused by viruses such as colds or flu. Your doctor may have prescribed TAZOCIN EF for another reason. Ask your doctor if you have any questions about why Tazocin EF has been prescribed for you. This medicine is available only with a doctor's prescription. TAZOCIN EF is not addictive. BEFORE YOU ARE GIVEN TAZOCIN EF _WHEN YOU MUST NOT RECEIVE _ _TAZOCIN EF _ DO NOT HAVE TAZOCIN EF IF: 1. Soma hati kamili
Version: pfdtazev11223 Supersedes: pfdtazev10923 Page 1 of 23 NEW ZEALAND DATA SHEET 1. PRODUCT NAME TAZOCIN EF 4.5 g piperacillin/tazobactam 4.0 g/0.5 g powder for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of TAZOCIN EF 4.5 g contains piperacillin sodium 4.170 g equivalent to 4 g piperacillin and tazobactam sodium 0.5366 g equivalent to 500 mg tazobactam. EXCIPIENT(S) WITH KNOWN EFFECT: • Disodium edetate dihydrate (EDTA). The theoretical sodium content of each vial of TAZOCIN EF is 2.84 mEq (65 mg) of sodium per gram of piperacillin which may increase a patient’s overall sodium intake. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for injection TAZOCIN EF is available as a white to off-white sterile, cryodesiccated powder of piperacillin and tazobactam as the sodium salts packaged in glass vials. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS TAZOCIN EF is indicated for the treatment of the following systemic and/or local bacterial infections in which susceptible organisms have been detected or are suspected: 1. Lower respiratory tract infections 2. Urinary tract infections (complicated and uncomplicated) 3. Intra-abdominal infections 4. Skin and skin structure infections 5. Bacterial septicaemia 6. Gynaecological infections 7. Bacterial infections in neutropenic patients. Full therapeutic doses of TAZOCIN EF plus an aminoglycoside should be used. 8. Bone and joint infections Version: pfdtazev11223 Supersedes: pfdtazev10923 Page 2 of 23 9. Polymicrobic infections: TAZOCIN EF is indicated for polymicrobic infections including those where aerobic and anaerobic organisms are suspected (intra-abdominal, skin and skin structure, upper and lower respiratory tract, gynaecological). While TAZOCIN EF is indicated only for the conditions listed above, infections caused by piperacillin susceptible organisms are also amenable to TAZOCIN EF treatment due to its piperacillin content. Therefore, the treatment of mixed infections caused by piperacillin suscep Soma hati kamili