TAZO-PIP AVENIR 4.5 G

מדינה: ישראל

שפה: אנגלית

מקור: Ministry of Health

קנה את זה

עלון מידע עלון מידע (PIL)
17-08-2016
מאפייני מוצר מאפייני מוצר (SPC)
17-08-2016

מרכיב פעיל:

PIPERACILLIN AS SODIUM SALT; TAZOBACTAM AS SODIUM SALT

זמין מ:

BIOAVENIR LTD, ISRAEL

קוד ATC:

J01CG02

טופס פרצבטיות:

POWDER FOR SOLUTION FOR INJECTION

הרכב:

TAZOBACTAM AS SODIUM SALT 500 MG; PIPERACILLIN AS SODIUM SALT 4000 MG

מסלול נתינה (של תרופות):

I.V

סוג מרשם:

Required

תוצרת:

LABORATORY REIG JOFRE S.A., SPAIN

קבוצה תרפויטית:

TAZOBACTAM

איזור תרפויטי:

TAZOBACTAM

סממני תרפויטית:

Antibiotic for the treatment of systemic and/or local bacterial infections caused by susceptible organisms.Tazo-Pip Avenir in combination with an aminoglycoside, is indicated for the treatment of suspected bacterial infections in neutropenic adults and children. Appendicitis complicated by rupture with peritonitis and/or abscess formation in children aged 2-12 years.

תאריך אישור:

2016-09-30

עלון מידע

                                _אפורל ןולעב )תוחיטב עדימ ( הרמחה לע
העדוה_
_ ןכדועמ(_
_05.2013_
_)_
__________ ךיראת
22.7.14
םושירה רפסמו תילגנאב רישכת םש
TAZO-PIP AVENIR 4.5G 146-80-33342-00
__
_____________ םושירה לעב םש
BIOAVENIR
LTD
.
_______________________
! דבלב תורמחהה טורפל דעוימ הז ספוט
תושקובמה תורמחהה
ןולעב קרפ
יחכונ טסקט
שדח טסקט
POSOLOGY
,
DOSAGE
&
ADMINISTER
ATION
Tazo-Pip Avenir 4.5g may be given by slow intravenous
injection (over at least three to five minutes) or by slow
intravenous infusion (over 20-30 minutes).
For reconstitution instructions, see section 6.6.
The treatment of mixed infections caused by piperacillin
susceptible organisms and beta-lactamase producing organisms
susceptible to piperacillin/tazobactam generally do not require
the addition of another antibiotic.
In patients with nosocomial pneumonia and infections in
neutropenic patients Tazo-Pip Avenir can be used with an
aminoglycoside.
If the use of an aminoglycoside is needed with
piperacillin/tazobactam,
both Tazo-Pip Avenir 4.5g and the aminoglycoside must be used in
completely therapeutic doses.
Neutropenic patients with signs of infection (e.g. fever) should
receive immediate empirical antibiotic therapy before laboratory
results are available.
_ADULTS AND CHILDREN OVER 12 YEARS, EACH WITH NORMAL _
_RENAL FUNCTION _
The usual dosage for adults and children over 12 years is Tazo-Pip
Avenir 4.5 g given every eight hours.
POSOLOGY
The dose and frequency of Tazo-Pip Avenir 4.5g
depends
on the severity and localisation of the infection and
expected pathogens.
_Adult and adolescent patients_
_Infections_
The usual dose is 4 g piperacillin / 0.5 g tazobactam given
every 8 hours.
For nosocomial pneumonia and bacterial infections in neutropenic
patients, the recommended dose is 4 g piperacillin / 0.5 g
tazobactam administered every 6 hours. This regimen may also be
applicable to treat patients with other indicated infec
                                
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מאפייני מוצר

                                1. NAME OF THE MEDICINAL PRODUCT
Tazo-Pip Avenir 4.5 g
Powder for Solution for Injection or Infusion.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 4 g piperacillin (as sodium salt) and 0.5 g
tazobactam (as sodium salt).
One vial of powder for solution for injection or infusion contains
9.44 mmol (217 mg) of
sodium.
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3. PHARMACEUTICAL FORM
Powder for solution for injection or infusion.
White to off white powder.
Tazo-Pip Avenir 4.5g (Piperacillin/Tazobactam for Injection) is an
injectable antibacterial
combination product consisting of the semisynthetic antibiotic
piperacillin sodium and the beta-
lactamase inhibitor tazobactam sodium for intravenous administration.
Piperacillin sodium is derived from D( - )-α-aminobenzyl-penicillin.
The chemical name of
piperacillin sodium is sodium
(_2_S,_5_R,_6_R)-6-[(R)-2-(4-ethyl-2,3-dioxo-1-
piperazinecarboxamido)-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-
azabicyclo[3.2.0]heptane-2-carboxylate. The chemical formula is C
23
H
26
N
5
Na0
7
S and the
molecular weight is 539.5. The chemical structure of piperacillin
sodium is:
Tazobactam sodium, a derivative of the penicillin nucleus, is a
penicillanic acid sulfone. Its
chemical name is sodium
(2_S_,3_S_,5_R_)-3-methyl-7-oxo-3-(1H-1,2,3-triazol-1-methyl)-4-thia-1-
azabicyclo[3.2.0]heptane-2-
carboxylic acid 4,4-dioxide. The chemical formula is C
10
H
11
N
4
Na0
5
S and the molecular weight
is 322.3.
The chemical structure of tazobactam sodium is:
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4. CLINICAL PARTICULARS
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4.1 Therapeutic indications
Antibiotic for the treatment of moderate to severe systemic and/or
local bacterial
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.
Appendicitis complicated by rupture with peritonitis and/or abscess
formation in children
aged 2-12 years.
This indication of the medicine has not been evaluate
                                
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