Piperacillin Tazobactam 2 g/0.25 g powder for solution for infusion

Riik: Iirimaa

keel: inglise

Allikas: HPRA (Health Products Regulatory Authority)

Toimeaine:

PIPERACILLIN SODIUM; Tazobactam (as sodium salt)

Saadav alates:

Generics (UK) Limited

ATC kood:

J01CR; J01CR05

INN (Rahvusvaheline Nimetus):

PIPERACILLIN SODIUM; Tazobactam (as sodium salt)

Annus:

2/0.25 gram(s)

Ravimvorm:

Powder for solution for infusion

Retsepti tüüp:

Product subject to prescription which may not be renewed (A)

Terapeutiline ala:

Combinations of penicillins, incl. beta-lactamase inhibitors; piperacillin and enzyme inhibitor

Volitamisolek:

Marketed

Loa andmise kuupäev:

2010-02-26

Infovoldik

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TrackWise PR No.
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v3/July 2017
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1/2
1
Times New Roman
9.5 pt
9.5 pt
420 x 360mm
Piperacillin Sodium 2000 mg / 250 mg 10
Leaflet
1258562
1089154
1258562
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(Brescia - IT)
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02 Nov 2017
20:39
PACKAGE LEAFLET: INFORMATION FOR THE USER
PIPERACILLIN TAZOBACTAM 2 G/0.25 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 Piperacillin Tazobactam is and what it is used for
2. What you need to know before you are given
Piperacillin Tazobactam
3. How Piperacillin Tazobactam is given
4. Possible side effects
5. How to store Piperacillin Tazobactam
6. Contents of the pack and other information
1.
WHAT PIPERACILLIN TAZOBACTAM IS AND WHAT IT IS USED FOR
Piperacillin Tazobactam contains piperacillin and tazobactam, which
belong to the group of medicines known as penicillins, including
beta-lactamase inhibitors. 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 ef

Toote omadused

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Piperacillin Tazobactam 2 g/0.25 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 of Piperacillin Tazobactam 2 g/0.25 g contains 4.7 mmol (108
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 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.
Piperacillin / tazobactam 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
Piperacillin / tazobactam 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 ADMINISTRATION
POSOLOGY
The dose and frequency of piperacillin / tazobactam depends on the
severity and localisation of the infection and
expected pathogens.
_Adult and adolescent patients_
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