Piperacillin/Tazobactam Aurobindo 4 g/0.5 g powder for solution for infusion
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
15-11-2022
Summary of Product characteristics
(SPC)
04-02-2022
Active ingredient:
Piperacillin; Tazobactam
Available from:
Aurobindo Pharma (Malta) Limited
ATC code:
J01CR; J01CR05
INN (International Name):
Piperacillin; Tazobactam
Dosage:
4 g/0.5 gram(s)
Pharmaceutical form:
Powder for solution for infusion
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Combinations of penicillins, incl. beta-lactamase inhibitors; piperacillin and enzyme inhibitor
Authorization status:
Marketed
Authorization date:
2010-02-26
Patient Information leaflet
PACKAGE LEAFLET: INFORMATION FOR THE USER
PIPERACILLIN/TAZOBACTAM AUROBINDO 2 G / 0.25 G POWDER FOR SOLUTION FOR
INFUSION
PIPERACILLIN/TAZOBACTAM AUROBINDO 4 G / 0.5 G POWDER FOR SOLUTION FOR
INFUSION
piperacillin/tazobactam
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 Aurobindo is and what it is used for
2.
What you need to know before you take Piperacillin/Tazobactam
Aurobindo
3.
How to take Piperacillin/Tazobactam Aurobindo
4.
Possible side effects
5.
How to store Piperacillin/Tazobactam Aurobindo
6.
Contents of the pack and other information
1.
WHAT PIPERACILLIN/TAZOBACTAM AUROBINDO IS AND WHAT IT IS USED FOR
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.
Piperacillin/Tazobactam Aurobindo 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. Piperacillin/Tazobactam Aurobindo may be used to treat
bacterial infections in patients
with low white blood cell counts (reduced resistance to infections).
Piperacillin/Tazobactam Aurobindo is used in children aged 2-12 years
to treat infections of the
abdomen such as appendici
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Summary of Product characteristics
Health Products Regulatory Authority
03 February 2022
CRN00CQMX
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Piperacillin/Tazobactam Aurobindo 4 g/0.5 g powder for solution for
infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains piperacillin (as sodium salt) equivalent to 4g
piperacillin and tazobactam (as sodium salt) equivalent to 0.5g
tazobactam.
One vial of powder for solution for infusion contains 9.4 mmol (216mg)
of sodium.
3 PHARMACEUTICAL FORM
Powder for solution for infusion.
White to off-white powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Piperacillin/Tazobactam Aurobindo 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 Aurobindo may be used in the management of
neutropenic patients with fever suspected to be due to
a bacterial infection.
Note: Use for bacteraemia due to extended-beta-lactamase (ESBL)
producing _E. coli_ and _K.pneumoniae_ (ceftriaxone
non-susceptible), is not recommended in adult patients, see section
5.1.
CHILDREN 2 TO 12 YEARS OF AGE
Complicated intra-abdominal infections
Piperacillin/Tazobactam Aurobindo 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 Aurobindo depends on
the severity and localisation of the in
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