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

Valsts: Īrija

Valoda: angļu

Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)

Aktīvā sastāvdaļa:

PIPERACILLIN SODIUM; Tazobactam sodium

Pieejams no:

Stravencon Ltd

ATĶ kods:

J01CR; J01CR05

SNN (starptautisko nepatentēto nosaukumu):

PIPERACILLIN SODIUM; Tazobactam sodium

Deva:

4/0.5 gram(s)

Zāļu forma:

Powder for solution for infusion

Receptes veids:

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

Ārstniecības joma:

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

Autorizācija statuss:

Marketed

Autorizācija datums:

2014-10-17

Lietošanas instrukcija

PACKAGE LEAFLET: INFORMATION FOR THE USER
Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion
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 or
pharmacist.
-
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 or
pharmacist. 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 use Piperacillin/
Tazobactam
3. How to use Piperacillin/Tazobactam
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 resistance to infections).
Piperacillin/Tazobactam is used in children aged 2-12 years
to treat infections of the abdomen such as appendicitis,
peritonitis (infection of the fluid and lining of the abdominal
organs), and gallbladder (biliary) infections. Piperacillin/
Tazobactam may be used to treat bacterial infections in
patients with low white blood cell counts (reduced r

Produkta apraksts

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 vial contains piperacillin sodium equivalent to 4 g piperacillin
and tazobactam sodium equivalent to 0.5 g
tazobactam.
Each vial of Piperacillin/Tazobactam contains 9.4 mmol (216mg) of
sodium.
3 PHARMACEUTICAL FORM
Powder for solution for infusion.
Off-white to white cake or 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 localization of the infection and
expected pathogens.
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