País: Nueva Zelanda
Idioma: inglés
Fuente: Medsafe (Medicines Safety Authority)
Piperacillin monohydrate 4.198 g equivalent to Piperacillin sodium 4.2531g and 4.0g piperacillin; ; ; Tazobactam 0.5 g equivalent to Tazobactam sodium 0.54733 g
Sandoz New Zealand Limited
Piperacillin monohydrate 4.198 g (equivalent to Piperacillin sodium 4.2531 g and 4.0 g piperacillin)
4 g/0.5 g
Powder for injection
Active: Piperacillin monohydrate 4.198 g equivalent to Piperacillin sodium 4.2531g and 4.0g piperacillin Tazobactam 0.5 g equivalent to Tazobactam sodium 0.54733 g
Prescription
Sandoz Industrial Products SA
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 PipTaz Sandoz plus an aminoglycoside should be used. 8. Bone and joint infections 9. Polymicrobic infections: PipTaz Sandoz 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, PipTaz Sandoz is indicated for the treatment of serious intra-abdominal infections. It has not been evaluated in this indication for paediatric patients below the age of 2 years.
Package - Contents - Shelf Life: Bottle, glass, 50 mL Type II with PP rubber stopper and Al cap - 1 dose units - 2 years from date of manufacture stored at or below 25°C - Bottle, glass, 100 mL Type II with PP rubber stopper and Al cap - 1 dose units - 2 years from date of manufacture stored at or below 25°C - Bottle, glass, 50 mL Type II with PP rubber stopper and Al cap - 10 dose units - 2 years from date of manufacture stored at or below 25°C - Bottle, glass, 100 mL Type II with PP rubber stopper and Al cap - 10 dose units - 2 years from date of manufacture stored at or below 25°C
2015-12-08
PIPTAZ SANDOZ ® 1 PIPTAZ SANDOZ ® _piperacillin/tazobactam powder for injection _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about PipTaz Sandoz. 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 having this medicine against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT HAVING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET. You may need to read it again. WHAT PIPTAZ SANDOZ IS USED FOR This medicine is used to treat serious bacterial 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, PipTaz Sandoz is used to treat serious infections in the abdomen. It is not recommended to treat abdominal infections in children under 2 years. It contains the active ingredients piperacillin and tazobactam. Piperacillin and tazobactam belong to a group of medicines called penicillins. Piperacillin works by killing many types of bacteria. Tazobactam does not have activity against bacteria, but helps piperacillin to overcome bacteria which have become resistant to piperacillin. PipTaz Sandoz will not work against infections caused by viruses such as colds or flu. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is not addictive. BEFORE YOU ARE GIVEN PIPTAZ SANDOZ _WHEN YOU MUST NOT RECEIVE _ _IT _ DO NOT HAVE THIS MEDICINE IF YOU HAVE AN ALLERGY TO: • piperacillin or tazobactam the active ingredients • any other similar medicines such as antibiotics in the penicillin, cephalosporin or beta-lactamase inhibitor groups. Some of the symptoms of an allergic reaction Leer el documento completo
211124-piptaz sandoz-ds Page 1 of 22 NEW ZEALAND DATA SHEET PIPTAZ SANDOZ (PIPERACILLIN/TAZOBACTAM) 1. PRODUCT NAME PIPTAZ SANDOZ; 4 g/0.5 g; injection, powder 2. QUALITATIVE AND QUANTITATIVE COMPOSITION PIPTAZ SANDOZ contains piperacillin (as sodium salt) 4 g and tazobactam (as sodium salt) 0.5 g. One bottle of powder for solution for infusion contains 9.44 mmol (217 mg) of sodium. _Excipient(s) with known effect:_ Not applicable For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Powder for injection. White to off-white sterile, cryodesiccated powder in glass bottles. 4. CLINICAL PARTICULARS 4.1. T HERAPEUTIC INDICATIONS PIPTAZ SANDOZ (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: 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 PIPTAZ SANDOZ (piperacillin/tazobactam) plus an aminoglycoside should be used. 8. Bone and joint infections 9. Polymicrobic infections: PIPTAZ SANDOZ (piperacillin/tazobactam) 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 PIPTAZ SANDOZ (piperacillin/tazobactam) is indicated only for the conditions listed above, infections caused by piperacillin susceptible organisms are also amenable to PIPTAZ SANDOZ (piperacillin/tazobactam) treatment due to its piperacillin content. Therefore, the treatment of mixed infections caused by piperacillin susceptible organisms and β-lactamase 211124-piptaz sandoz-ds Page 2 of 22 producing organisms susceptible to PIPTAZ SANDOZ (piperacillin/tazobactam) should not require the addi Leer el documento completo