Krajina: Izrael
Jazyk: angličtina
Zdroj: Ministry of Health
PIPERACILLIN AS SODIUM SALT; TAZOBACTAM AS SODIUM SALT
NEOPHARM (ISRAEL) 1996 LTD
J01CG02
POWDER FOR SOLUTION FOR INFUSION
PIPERACILLIN AS SODIUM SALT 2.0 G/VIAL; TAZOBACTAM AS SODIUM SALT 0.25 G/VIAL
I.V
Required
LABESFAL - LABORATORIOS ALMIRO S.A, FRESENIUS KABI GROUP, PORTUGAL
TAZOBACTAM
- Treatment of systemic and/or local infections caused by susceptible organisms.- Piperacillin/tazobactam in combination with an aminoglycoside is indicated for the treatment of suspected bacterial infections in neutropenic adults and children above 2 years. - Appendicitis complicated by rupture with peritonitis and/or abscess formation in children aged 2-12 years.
2018-12-31
העדוה העדוה לע לע הרמחה הרמחה ( ( עדימ עדימ ןולעב )תוחיטב ןולעב )תוחיטב ל ל אפור אפור ןכדועמ( ןכדועמ( 05.2013 05.2013 ) ) ________________________:ךיראת PIPERACILLIN / TAZOBACTAM - FRESENIUS 2 G/0.25 G REG. NO. 151.27.33273.00 PIPERACILLIN / TAZOBACTAM - FRESENIUS 4 G/0.5 G REG. NO. 151.28.33274.00 םש לעב םש :םושירה לעב םושירה : MEDIC-TRIM HEALTHCARE LTD תורמחהה תושקובמה קרפ ןולעב טסקט יחכונ טסקט שדח ADVERSE EVENTS _Skin and subcutaneous tissue disorders_ : DRESS: drug reaction with eosinophilia and systemic symptoms (adverse event identified post- marketing) ב"צמ ובש ,ןולעה תונמוסמ תורמחהה תושקובמה לע עקר בוהצ . םייוניש םניאש רדגב תורמחה ונמוס עבצב )ןולעב( שי.הנוש ןמסל קר ןכות יתוהמ אלו םייוניש םוקימב טסקטה . רבעוה ראודב ינורטקלא ...................ךיראתב ............................................................ ....................... Prečítajte si celý dokument
_ _ SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Piperacillin/Tazobactam - Fresenius 2 g/0.25 g. Piperacillin/Tazobactam - Fresenius 4 g/0.5 g. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Piperacillin/Tazobactam - Fresenius 2 g/0.25 g: Each vial contains 2 g of piperacillin (as sodium salt) and 0.25 g of tazobactam (as sodium salt). One vial of powder for solution for infusion contains 4.9 mmol (112 mg) of sodium. Piperacillin/Tazobactam - Fresenius 4 g/0.5 g: Each vial contains 4 g of piperacillin (as sodium salt) and 0.5 g of tazobactam (as sodium salt). One vial of powder for solution for infusion contains 9.7 mmol (224 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 Piperacillin/Tazobactam is indicated for the treatment of systemic and/or local infections caused by susceptible organisms. Piperacillin/Tazobactam in combination with an aminoglycoside is indicated for the treatment of suspected bacterial infections in neutropenic adults and children above 2 years. Appendicitis complicated by rupture with peritonitis and/or abscess formation in children aged 2-12 years. Piperacillin/Tazobactam is indicated for the treatment of the following infections in 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) Piperacillin/Tazobactam may be used in the management of neutropenic patients with fever suspected to be due to a bacterial infection. Appropriate culture and susceptibility tests should be performed before treatment in order to identify organisms causing infections and to determine their susceptibilities to Piperacillin/Tazobactam. Because of its broad spectrum of activity against Gram-positive and Gra Prečítajte si celý dokument