Pipercin 4 g/0.5 g powder for solution for infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Piperacillin; Tazobactam

Available from:

Clonmel Healthcare Ltd

ATC code:

J01CR; J01CR05

INN (International Name):

Piperacillin; Tazobactam

Dosage:

4 g/0.5 gram(s)

Pharmaceutical form:

Powder for solution for infusion

Prescription type:

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

Therapeutic area:

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

Authorization status:

Marketed

Authorization date:

2009-02-13

Patient Information leaflet

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Page 1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE USER
PIPERCIN 4G/0.5G 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.
-
If you get any side effects talk to your doctor or nurse. This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Pipercin is and what it is used for
2.
What you need to know before you are given Pipercin
3.
How Pipercin is given
4.
Possible side effects
5.
How to store Pipercin
6.
Contents of the pack and other information
1.
WHAT PIPERCIN 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.
Pipercin 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. Pipercin may be used
to treat bacterial infections in patients with low white blood cell
counts (reduced resistance to infections).
Pipercin 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.
Pipercin may be used to treat bacterial infections in patients with
low white cell counts (reduced resistance
to infections).
In certain serious infections, your doctor may consider using Pipercin
in combination with other antibiotics.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN PIPERCIN
DO NOT USE PIPERCIN
-
if you are allergic to piperacillin or tazobactam.
-
if you are all

Summary of Product characteristics

Health Products Regulatory Authority
28 February 2024
CRN00CYN5
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pipercin 4 g/0.5 g powder for solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 4 g piperacillin (as sodium salt) and 0.5 g
tazobactam (as sodium salt).
Excipient with known effect
4 g/0.5 g: 216 mg (9.4 mmol) 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
section 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 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.
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, the recommended dose is 4 g piperacillin / 0.5 g
tazob