Piperacillin/Tazobactam 2 g/0.25 g Powder for Solution for Infusion

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

PIPERACILLIN SODIUM; Tazobactam sodium

Beschikbaar vanaf:

Wockhardt UK Limited

ATC-code:

J01CR; J01CR05

INN (Algemene Internationale Benaming):

PIPERACILLIN SODIUM; Tazobactam sodium

Dosering:

2 g/0.25 gram(s)

farmaceutische vorm:

Powder for solution for injection/infusion

Prescription-type:

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

Therapeutisch gebied:

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

Autorisatie-status:

Marketed

Autorisatie datum:

2009-06-19

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
PIPERACILLIN/TAZOBACTAM 2 G/0.25 G POWDER FOR SOLUTION
FOR INFUSION
PIPERACILLIN/TAZOBACTAM 4 G/0.5 G POWDER FOR SOLUTION
FOR INFUSION
PIPERACILLIN (AS SODIUM) WITH TAZOBACTAM (AS SODIUM)
PLEASE 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 is 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.
THE NAME OF YOUR MEDICINE IS PIPERACILLIN/TAZOBACTAM
2 G/0.25 G AND 4 G/0.5 G POWDER FOR SOLUTION FOR INFUSION.
_In the rest of this leaflet Piperacillin/Tazobactam 2 g/0.25 g and _
_4 g/0.5 g Powder for Solution for Infusion is called Piperacillin _
_with Tazobactam._
WHAT IS IN THIS LEAFLET:
1. What Piperacillin with Tazobactam is and what it is used for
2. What you need to know before you are given Piperacillin
with Tazobactam
3. How Piperacillin with Tazobactam is given
4. Possible side effects
5. How to store Piperacillin with Tazobactam
6. Contents of the pack and other information
1. WHAT PIPERACILLIN WITH TAZOBACTAM IS AND WHAT IT IS
USED FOR
Piperacillin belongs to the group of medicines called 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 with Tazobactam 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 with Tazobactam may be
used to treat bac

Productkenmerken

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 2 g piperacillin (as sodium salt) and 0.25 g
tazobactam (as sodium salt).
One vial of powder for solution for injection or infusion contains
4.72 mmol (109 mg) of sodium.
For a 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.
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