PIPERACILLIN/TAZOBACTAM TEVA 4g/500 Milligram Pdr for Soln for Infusion
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
31-01-2018
Summary of Product characteristics
(SPC)
31-01-2018
Active ingredient:
PIPERACILLIN SODIUM, TAZOBACTAM (AS SODIUM SALT)
Available from:
Teva Pharma B.V.
ATC code:
J01CR05
INN (International Name):
PIPERACILLIN SODIUM, TAZOBACTAM (AS SODIUM SALT)
Dosage:
4g/500 Milligram
Pharmaceutical form:
Pdr for Soln for Infusion
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Combinations of penicillins, incl. beta-lactamase inhibitors
Authorization status:
Authorised
Authorization date:
2010-09-03
Patient Information leaflet
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
PIPERACILLIN/TAZOBACTAM
TEVA 4 G/500 MG
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.
-
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 Teva is and what it is used for
2. What you need to know before you use Piperacillin/Tazobactam Teva
3. How to use Piperacillin/Tazobactam Teva
4. Possible side effects
5. How to store Piperacillin/Tazobactam Teva
6. Contents of the pack and other information
1. WHAT PIPERACILLIN/TAZOBACTAM TEVA 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 Teva 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 Teva may be used to treat bacterial
infections in patients with low
white blood cell counts (reduced resistance to infections).
Piperacillin/Tazobactam Teva is used in children aged 2-12 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 Teva may be used to
treat bacterial infections in patients
with low white blood cell counts (reduced resistance to infections).
In
certain
serious
infections,
your docto
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Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Piperacillin/Tazobactam Teva 4 g/500 mg Powder for Solution for
Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains piperacillin (as sodium salt) equivalent to 4 g and
tazobactam (as sodium salt) equivalent to 0.5 g.
Each vial of Piperacillin/Tazobactam Teva 4 g/500 mg contains 9.4 mmol
(216 mg) of sodium.
This medicinal product contains no excipients.
3 PHARMACEUTICAL FORM
Powder for solution for infusion.
White or off-white powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Piperacillin/Tazobactam Teva 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 Teva 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 Teva 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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