Piperacillin/Tazobactam Viatris 2g/0.25g, powder for solution for infusion

Land: Malta

Språk: engelsk

Kilde: Medicines Authority

Tilgjengelig fra:

Viatris Limited Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland

ATC-kode:

J01CR05

INN (International Name):

PIPERACILLIN 2 g TAZOBACTAM 0.25 g

Legemiddelform:

POWDER FOR SOLUTION FOR INFUSION

Sammensetning:

PIPERACILLIN 2 g TAZOBACTAM 0.25 g

Resept typen:

POM

Terapeutisk område:

ANTIBACTERIALS FOR SYSTEMIC USE

Autorisasjon status:

Authorised

Autorisasjon dato:

2009-08-25

Informasjon til brukeren

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PACKAGE LEAFLET
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PACKAGE LEAFLET: INFORMATION FOR THE USER
PIPERACILLIN/TAZOBACTAM
VIATRIS 2 G/0.25 G, POWDER FOR SOLUTION FOR INFUSION
PIPERACILLIN/TAZOBACTAM
VIATRIS 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 Viatris is and what it is used for
2.
What you need to know before you are given Piperacillin/Tazobactam
Viatris
3.
How Piperacillin/Tazobactam Viatris is given
4.
Possible side effects
5.
How to store Piperacillin/Tazobactam Viatris
6.
Contents of the pack and other information
1.
WHAT PIPERACILLIN/TAZOBACTAM VIATRIS IS AND WHAT IT IS USED FOR
Piperacillin/Tazobactam Viatris contains piperacillin and tazobactam,
which belong to the group of
medicines known as penicillins, including beta-lactamase inhibitors.
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 Viatris 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 Viatris may be used to treat
bacterial infections in patients with low
white

Preparatomtale

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SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAME OF THE MEDICINAL PRODUCT
Piperacillin/Tazobactam Viatris 2 g/0.25 g, powder for solution for
infusion
Piperacillin/Tazobactam Viatris 4 g/0.5 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 contains piperacillin (as sodium salt) equivalent to 4 g and
tazobactam (as sodium salt)
equivalent to 0.5 g.
Excipient(s) with known effect
Each vial of Piperacillin/Tazobactam Viatris 2 g/0.25 g contains 103.3
mg of sodium.
Each vial of Piperacillin/Tazobactam Viatris 4 g/0.5 g contains 206.6
mg of sodium.
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.
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 bact