Страна: Австралия
Език: английски
Източник: Department of Health (Therapeutic Goods Administration)
tazobactam sodium, Quantity: 540 mg (Equivalent: tazobactam, Qty 500 mg); piperacillin sodium, Quantity: 4.17 g (Equivalent: piperacillin, Qty 4 g)
Pfizer Australia Pty Ltd
piperacillin sodium,tazobactam sodium
Injection, powder for
Excipient Ingredients: disodium edetate; citric acid monohydrate
Intravenous
1 vial
(S4) Prescription Only Medicine
Tazocin EF is indicated in the treatment of serious bacterial infections caused by susceptible strains of Beta-lactamase producing organisms in the conditions listed below: 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. 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. It has not been evaluated in this indication for paediatric patients below the age of 2 years. While Tazocin EF is indicated only for the conditions listed above, it may be used as a single agent in the treatment of mixed infections caused by piperacillin susceptible and Beta-lactamase producing piperacillin-resistant organisms. Appropriate culture and susceptibility tests should be performed before treatment in order to identify organisms causing infection to determine their susceptibilities to Tazocin EF. Therapy with Tazocin EF however, may be initiated before results of such tests are known when there is a reason to believe the infection may involve any of the Beta-lactamase producing organisms listed above, however, once these results become available, appropriate therapy should be continued. In serious infections, presumptive therapy with Tazocin EFmay be initiated before susceptibility test results are available. Combination therapy with Tazocin EF and aminoglycosides may be used in the treatment of serious infections caused by Pseudomonas aeruginosa. Both drugs should be used in full therapeutic doses. As soon as results of culture and susceptibility tests become available, antimicrobial therapy should be adjusted.
Visual Identification: TAZOCIN EF is a white to off white powder packaged in glass vials.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius
Registered
2007-04-11
TAZOCIN EF ® _Piperacillin sodium/tazobactam sodium 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. 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. YOU HAVE EVER HAD AN ALLERGIC REACTION TO: • piperacillin, tazobactam, or any other penicillin antibiotics • any antibiotic in the cephalosporin group • medicines called beta-lactamase inhibitors. Some of the symptom Прочетете целия документ
Version: pfptazev10122 Supersedes: pfptazev10821 Page 1 of 25 AUSTRALIAN PRODUCT INFORMATION - TAZOCIN EF (PIPERACILLIN/TAZOBACTAM) POWDER FOR INJECTION 1. NAME OF THE MEDICINE Piperacillin sodium/Tazobactam sodium 2. QUALITATIVE AND QUANTITATIVE COMPOSITION TAZOCIN EF is an injectable antibacterial combination, consisting of the semisynthetic antibiotic piperacillin sodium and the -lactamase inhibitor tazobactam sodium, for intravenous administration. Each vial of TAZOCIN EF contains piperacillin/tazobactam injection 2.0 g/0.25 g † . Each vial of TAZOCIN EF contains piperacillin/tazobactam injection 4.0 g/0.5 g. For the full list of excipients, see Section 6.1 - List of excipients. 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 in the treatment of serious bacterial infections caused by susceptible strains of -lactamase producing organisms in the conditions listed below: 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 Version: pfptazev10122 Supersedes: pfptazev10821 Page 2 of 25 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. It has not been evaluated in this indication for paediatric patients below the age of 2 years. While TAZOCIN EF is indicated only for the conditions listed above, it may be used as a single agent in the treatment of mixed infections caused by piperacillin susceptible and - lactamase producing, piperacillin-resistant organisms. Appropriate culture and susceptibility tests should be performed before treatment in order to identify organisms causing infection to determi Прочетете целия документ