Country: Малта
Језик: Енглески
Извор: Medicines Authority
PIPERACILLIN, TAZOBACTAM, SODIUM
Pfizer Hellas S.A. 243 Messoghion Ave., Neo Psychiko 15451, Athens, Greece
J01CR05
PIPERACILLIN 2 g TAZOBACTAM 0.25 g SODIUM 130 mg
POWDER FOR SOLUTION FOR INFUSION
PIPERACILLIN 2 g TAZOBACTAM 0.25 g SODIUM 130 mg
POM
ANTIBACTERIALS FOR SYSTEMIC USE
Authorised
2006-11-08
Page 1 of 10 PACKAGE LEAFLET Page 2 of 10 PACKAGE LEAFLET: INFORMATION FOR THE USER TAZOCIN 2 G / 0.25 G POWDER FOR SOLUTION FOR INFUSION TAZOCIN 4 G / 0.5 G POWDER FOR SOLUTION FOR INFUSION Piperacillin / Tazobactam READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 Tazocin is and what it is used for 2. What you need to know before you use Tazocin 3. How to use Tazocin 4. Possible side effects 5. How to store Tazocin 6. Contents of the pack and other information 1. WHAT TAZOCIN 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. Tazocin 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. Tazocin may be used to treat bacterial infections in patients with low white blood cell counts (reduced resistance to infections). Tazocin is used in children aged 2-12 years to treat infections of the abdomen such as appendicitis, peritonitis (infection of the fluid and lining of the abdominal organs), and gallbladder (biliary) infections. Tazocin may be used to treat bacterial infections in patients with low white blood cell counts (reduced resistance to infections Прочитајте комплетан документ
Page 1 of 18 SUMMARY OF PRODUCT CHARACTERISTICS Page 2 of 18 1. NAME OF THE MEDICINAL PRODUCT Tazocin 2 g / 0.25 g powder for solution for infusion Tazocin) 4 g / 0.5 g powder for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains piperacillin (as sodium salt) equivalent to 2 g and tazobactam (as sodium salt) equivalent to 0.25 g. Each vial contains piperacillin (as sodium salt) equivalent to 4 g and tazobactam (as sodium salt) equivalent to 0.5 g. EXCIPIENT WITH KNOWN EFFECT Each vial of Tazocin 2 g / 0.25 g contains 130 mg of sodium. Each vial of Tazocin 4 g / 0.5 g contains 261 mg of sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for solution for infusion. White to off-white powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Tazocin 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. Tazocin 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. Page 3 of 18 CHILDREN 2 TO 12 YEARS OF AGE - Complicated intra-abdominal infections Tazocin 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 ADMINIS Прочитајте комплетан документ