国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
Piperacillin; Tazobactam
Aurobindo Pharma (Malta) Limited
J01CR; J01CR05
Piperacillin; Tazobactam
2 g/0.25 gram(s)
Powder for solution for infusion
Product subject to prescription which may not be renewed (A)
Combinations of penicillins, incl. beta-lactamase inhibitors; piperacillin and enzyme inhibitor
Not marketed
2010-02-26
PACKAGE LEAFLET: INFORMATION FOR THE USER PIPERACILLIN/TAZOBACTAM AUROBINDO 2 G / 0.25 G POWDER FOR SOLUTION FOR INFUSION PIPERACILLIN/TAZOBACTAM AUROBINDO 4 G / 0.5 G POWDER FOR SOLUTION FOR INFUSION piperacillin/tazobactam READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU . _-_ _ _ Keep this leaflet. You may need to read it again. _-_ _ _ If you have any further questions, ask your doctor, pharmacist or nurse. _-_ _ _ This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. _-_ _ _ If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Piperacillin/Tazobactam Aurobindo is and what it is used for 2. What you need to know before you take Piperacillin/Tazobactam Aurobindo 3. How to take Piperacillin/Tazobactam Aurobindo 4. Possible side effects 5. How to store Piperacillin/Tazobactam Aurobindo 6. Contents of the pack and other information 1. WHAT PIPERACILLIN/TAZOBACTAM AUROBINDO IS AND WHAT IT IS USED FOR Piperacillin belongs to the group of medicines known as “broad spectrum penicillin antibiotics”, it can kill many kinds of bacteria. Tazobactam can prevent some resistant bacteria from surviving the effects of piperacillin. This means that when piperacillin and tazobactam are given together, more types of bacteria are killed. Piperacillin/Tazobactam Aurobindo is used in adults and adolescents to treat bacterial infections, such as those affecting the lower respiratory tract (lungs), urinary tract (kidneys and bladder), abdomen, skin or blood. Piperacillin/Tazobactam Aurobindo may be used to treat bacterial infections in patients with low white blood cell counts (reduced resistance to infections). Piperacillin/Tazobactam Aurobindo is used in children aged 2-12 years to treat infections of the abdomen such as appendici 阅读完整的文件
Health Products Regulatory Authority 03 February 2022 CRN00CQMX Page 1 of 13 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Piperacillin/Tazobactam Aurobindo 2 g/0.25 g powder for solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains piperacillin (as sodium salt) equivalent to 2g piperacillin and tazobactam (as sodium salt) equivalent to 0.25g tazobactam. One vial of powder for solution for infusion contains 4.7 mmol (108mg) of sodium. 3 PHARMACEUTICAL FORM Powder for solution for infusion. White to off-white powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Piperacillin/Tazobactam Aurobindo is indicated for the treatment of the following infections in adults and children over 2 years of age (see sections 4.2 and 5.1): ADULTS AND ADOLESCENTS Severe pneumonia including hospital-acquired and ventilator-associated pneumonia Complicated urinary tract infections (including pyelonephritis) Complicated intra-abdominal infections Complicated skin and soft tissue infections (including diabetic foot infections) Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above. Piperacillin/Tazobactam Aurobindo may be used in the management of neutropenic patients with fever suspected to be due to a bacterial infection. Note: Use for bacteraemia due to extended-beta-lactamase (ESBL) producing _E. coli_ and _K.pneumoniae_ (ceftriaxone non-susceptible), is not recommended in adult patients, see section 5.1. CHILDREN 2 TO 12 YEARS OF AGE Complicated intra-abdominal infections Piperacillin/Tazobactam Aurobindo may be used in the management of neutropenic children with fever suspected to be due to a bacterial infection Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The dose and frequency of Piperacillin/Tazobactam Aurobindo depends on the severity and localisation of the 阅读完整的文件