PIPERACILLIN/TAZOBACTAM
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
11-04-2018
Summary of Product characteristics
(SPC)
13-04-2018
Active ingredient:
PIPERACILLIN SODIUM ; TAZOBACTAM SODIUM
Available from:
Hospira UK Limited
ATC code:
J01CR05
INN (International Name):
PIPERACILLIN SODIUM ; TAZOBACTAM SODIUM
Dosage:
2000/250 Milligram
Pharmaceutical form:
Pdr for Soln Inj/Inf
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
piperacillin and enzyme inhibitor
Authorization status:
Not marketed
Authorization date:
2008-09-05
Patient Information leaflet
Page 1 of 7 Pfleet: 2016-0021153
PACKAGE LEAFLET: INFORMATION FOR THE USER
PIPERACILLIN/TAZOBACTAM 2 G/0.25 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, 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 2 g/0.25 g powder for solution for
infusion is and what it
is used for
2.
What you need to know before you use Piperacillin/Tazobactam 2 g/0.25
g powder for
solution for infusion.
3.
How to use Piperacillin/Tazobactam 2 g/0.25 g powder for solution for
infusion
4.
Possible side effects
5.
How to store Piperacillin/Tazobactam 2 g/0.25 g powder for solution
for infusion
6.
Contents of the pack and other information
1.WHAT PIPERACILLIN/TAZOBACTAM 2 G/0.25 G POWDER FOR SOLUTION FOR
INFUSION 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 2 g/0.25 g powder for solution for infusion 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
2 g/0.25 g powder for solution for infusion may be used to treat
bacterial infections in patients
with low white blood cell counts (reduced resistance to
Read the complete document
Summary of Product characteristics
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 piperacillin (as sodium salt) equivalent to 2 g and
tazobactam (as sodium salt) equivalent to 0.25 g.
Each vial of Piperacillin/Tazobactam 2 g/0.25 g powder for solution
for infusion contains 4.72 mmol (109 mg) of
sodium.
Excipients:
For the 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 2-12 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.
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