PIPERACILLIN TAZOBACTAM - FRESENIUS 4 G0.5 G

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

PIPERACILLIN AS SODIUM SALT; TAZOBACTAM AS SODIUM SALT

Available from:

NEOPHARM (ISRAEL) 1996 LTD

ATC code:

J01CG02

Pharmaceutical form:

POWDER FOR SOLUTION FOR INFUSION

Composition:

PIPERACILLIN AS SODIUM SALT 4.0 G/VIAL; TAZOBACTAM AS SODIUM SALT 0.5 G/VIAL

Administration route:

I.V

Prescription type:

Required

Manufactured by:

LABESFAL - LABORATORIOS ALMIRO S.A, FRESENIUS KABI GROUP, PORTUGAL

Therapeutic area:

TAZOBACTAM

Therapeutic indications:

- 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.

Authorization date:

2018-12-31

Patient Information leaflet

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
............................................................
.......................

Summary of Product characteristics

_ _
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