Piperin 4 g/0.5 g Powder for Solution for Infusion

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

Piperacillin; Tazobactam

제공처:

Rowex Ltd

ATC 코드:

J01CR; J01CR05

INN (국제 이름):

Piperacillin; Tazobactam

복용량:

4 g/ 0.5 gram(s)

약제 형태:

Powder for solution for infusion

처방전 유형:

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

치료 영역:

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

승인 상태:

Marketed

승인 날짜:

2008-10-10

환자 정보 전단

PACKAGE LEAFLET: INFORMATION FOR THE USER
PIPERIN 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 Piperin is and what it is used for
2.
What you need to know before you use Piperin
3.
How to use Piperin
4.
Possible side effects
5.
How to store Piperin
6.
Contents of the pack and other information
1.
WHAT PIPERIN 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.
Piperin 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. Piperin may be
used to treat bacterial infections in patients with low white blood
cell counts (reduced resistance to
infections).
Piperin 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. Piperin may be used to treat bacterial infections in
patients with low white blood cell
counts (reduced resistance to infections).
In certain serious infections, your doctor may consider using Piperin
in combination

제품 특성 요약

Health Products Regulatory Authority
27 July 2023
CRN00DQXN
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Piperin 4 g/0.5 g Powder for Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial or bottle contains 4 g piperacillin (as piperacillin sodium)
and 0.5 g tazobactam (as tazobactam sodium).
Excipients with known effect:
Each vial or bottle contains 9.44 mmol (217 mg) sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for solution for infusion.
A white to off-white powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Piperin 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.
Piperin 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
Piperin 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 Piperin depends on the severity and
localisation of the infection and expected pathogens.
Health Products Regulatory Authority
27 July 2023
CRN00DQXN
Page 2 of 15
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