Piperacillin Tazobactam Pdr for Soln for Infusion 4g/0.5g

দেশ: মাল্টা

ভাষা: ইংরেজি

সূত্র: Malta Medicines Authority

সক্রিয় উপাদান:

PIPERACILLIN, TAZOBACTAM

থেকে পাওয়া:

Mylan S.A.S. 117 Allee des Parcs, 69800 Saint Priest, France

এটিসি কোড:

J01CR05

INN (আন্তর্জাতিক নাম):

PIPERACILLIN, TAZOBACTAM

ফার্মাসিউটিকাল ফর্ম:

POWDER FOR SOLUTION FOR INFUSION

রচনা:

PIPERACILLIN 4 gram(s) ; TAZOBACTAM 0.5 gram(s)

প্রেসক্রিপশন টাইপ:

POM

থেরাপিউটিক এলাকা:

ANTIBACTERIALS FOR SYSTEMIC USE

অনুমোদন অবস্থা:

Authorised

অনুমোদন তারিখ:

2009-08-25

তথ্য লিফলেট

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_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
PIPERACILLIN/TAZOBACTAM MYLAN 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 is 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
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 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,
per

পণ্য বৈশিষ্ট্য

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SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAME OF THE MEDICINAL PRODUCT
Piperacillin/Tazobactam Mylan 4 g/0.5 g, 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 4 g/0.5 g contains 9.4 mmol (216
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.
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.
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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 expected pathogens.
_ _
_Adult and adolescent patients _
_ _
_Infections _
The usual dose is 4 g piperacillin/0.5 g tazobactam given every 8
hours.
For nosocomial pneumonia and bacterial infections in neutropenic
patients, t