Maa: Irlanti
Kieli: englanti
Lähde: HPRA (Health Products Regulatory Authority)
PIPERACILLIN SODIUM TAZOBACTAM SODIUM
Pfizer Healthcare Ireland
PIPERACILLIN SODIUM TAZOBACTAM SODIUM
4/0.5 Grams
Pdr for Soln for Infusion
Product subject to prescription which may not be renewed (A)
Authorised
0000-00-00
8930066 RD PhC 48 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. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 1. What TAZOCIN is and what it is used for 2. Before you use TAZOCIN 3. How to use TAZOCIN 4. Possible side effects 5. How to store TAZOCIN 6. Further information 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). The following information is intended for medical or healthcare professionals only: ✪ INSTRUCTIONS FOR USE TAZOCIN will be given by intravenous infusion (a drip for 30 minutes). ✪ INTRAVENOUS USE Reconstitute each vial with the volume of solvent shown in the table below, using one of the compatible solvents for reconstitution. Swirl until dissolved. When swirled con- stantly, reconstitution generally occurs within 5 to 10 minutes (for Lue koko asiakirja
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT 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 4 g and tazobactam (as sodium salt) equivalent to 0.5 g. Each vial of Tazocin 4 g / 0.5 g contains 11.16 mmol (256 mg) of sodium. Excipients: For a 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. 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. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 04/02/2014_ _CRN 2139390_ _page number: 1_ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY The dose and frequency of Tazocin depends on Lue koko asiakirja