Piperin 2 g/0.25g Powder for Solution for Infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Piperacillin; Tazobactam

Available from:

Rowex Ltd

ATC code:

J01CR; J01CR05

INN (International Name):

Piperacillin; Tazobactam

Dosage:

2g / 0.25 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:

Not marketed

Authorization date:

2008-10-10

Patient Information leaflet

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 with other antibiotics.
2
WHAT YOU NEED TO KNOW BEFORE YOU USE PIPERIN
DO NOT USE PIPERIN
• if you are allergic to piperacillin or tazobactam or any of the
other ingredients of this medicine (listed in section
6).
• if you are allergic to antibiotics known as penicillins,
cephalosporins or other beta-lactamase inhibitors, as you
may be allergic to Piperin.
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before using Piperin
• if you have allergies. If you have several allergies, make sure
you tell your doctor or other healthcare
professional before receiving this product.
• if you are suffering from diarrhoea before, or if you develop
diarrhoea during or after your treatment. In this
case, make sure you tell your doctor or other healthcare professional
immediately. Do not take any medicine for
the diarrhoea without first checking with your doctor.
• if you have low levels of pota

Summary of Product characteristics

Health Products Regulatory Authority
08 July 2021
CRN009ZZ2
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Piperin 2 g/0.25g Powder for Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 2 g piperacillin (as piperacillin sodium) and 0.25
g tazobactam (as tazobactam sodium).
Excipients with known effect
Each vial contains 4.72 mmol (109 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.
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.
_Adult and adolescent patients_
_Infections _
The usual dose is 4 g piperacillin / 0.5 g tazobactam given every 8
hours.
Health Products Regulatory Authority
08 July 2021
CRN009ZZ2
Page 2 of 13
For nosocomial pneumonia and bacterial infections in neutropenic
patients, the recommended dose