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

Valsts: Īrija

Valoda: angļu

Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)

Aktīvā sastāvdaļa:

Piperacillin; Tazobactam

Pieejams no:

AS Kalceks

ATĶ kods:

J01CR05

SNN (starptautisko nepatentēto nosaukumu):

Piperacillin; Tazobactam

Zāļu forma:

Powder for solution for infusion

Ārstniecības joma:

piperacillin and enzyme inhibitor

Autorizācija statuss:

Marketed

Autorizācija datums:

2023-01-20

Lietošanas instrukcija

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/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 will be 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 the active substances piperacillin
and tazobactam.
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.
This medicine 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.
This medicine may be used to treat bacterial infections in patients
with low white blood cell
counts (reduced resistance to infections).
−
CHILDREN AGED 2 TO 12 YEARS
to treat infections of the abdomen such as appendicitis,
peritonitis (infection of the fluid and lining of the abdominal
o

Produkta apraksts

Health Products Regulatory Authority
20 January 2023
CRN00CMND
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains piperacillin sodium equivalent to 4 g piperacillin
and tazobactam sodium equivalent to 0.5 g tazobactam.
Sodium content per vial: 216 mg of sodium.
3 PHARMACEUTICAL FORM
Powder for solution for infusion (powder 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, adolescents 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.
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 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 suspected
pathogens.
_Adult and adolescent patien