Piperacillin/Tazobactam 4g/0.5g powder for solution for infusion

Land: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Piperacillin; Tazobactam

Fáanlegur frá:

Noridem Enterprises Limited

ATC númer:

J01CR; J01CR05

INN (Alþjóðlegt nafn):

Piperacillin; Tazobactam

Skammtar:

4 g / 0.5 gram(s)

Lyfjaform:

Powder for solution for infusion

Gerð lyfseðils:

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

Lækningarsvæði:

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

Leyfisstaða:

Not marketed

Leyfisdagur:

2011-11-18

Upplýsingar fylgiseðill

PACKAGE LEAFLET: INFORMATION FOR THE USER
PIPERACILLIN/TAZOBACTAM 2G/0.25G POWDER FOR SOLUTION FOR INFUSION
PIPERACILLIN/TAZOBACTAM 4G/0.5G 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.
THE NAME OF YOUR MEDICINE IS ONE OF THE FOLLOWING:
-
Piperacillin/Tazobactam 2g/0.25g Powder for solution for infusion
-
Piperacillin/Tazobactam 4g/0.5g Powder for solution for infusion
_In the rest of this leaflet your medicine is called
Piperacillin/Tazobactam. _
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 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 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 may be used to treat bacterial
infections in patients with low white
blood cell counts (reduced

Vara einkenni

Health Products Regulatory Authority
11 March 2022
CRN00CSZZ
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Piperacillin/Tazobactam 4g/0.5g powder for solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 30mL vial contains 4.17g of piperacillin sodium, equivalent to 4g
of piperacillin and 0.536g tazobactam sodium equivalent
to 0.5g of tazobactam.
Excipient with known effect
Sodium content: 9.4mmol (216.2mg) of sodium/vial of Powder for
solution for infusion.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for solution for infusion.
White to light yellow crystalline 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
Health Products Regulatory Authority
11 March 2022
CRN00CSZZ
Page 2 of 14
The dose and frequency of Piperacillin/Tazobactam depends on the
severity and localisation of the infection and
expected pathogens.
_Adult and adolescent patients _