Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

Piperacillin; Tazobactam

Tilgængelig fra:

Fresenius Kabi Deutschland GmbH

ATC-kode:

J01CR; J01CR05

INN (International Name):

Piperacillin; Tazobactam

Dosering:

4/0.5 gram(s)

Lægemiddelform:

Powder for solution for infusion

Recept type:

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

Terapeutisk område:

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

Autorisation status:

Marketed

Autorisation dato:

2008-11-28

Produktets egenskaber

Health Products Regulatory Authority
26 April 2022
CRN00CQ4T
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 4 g of piperacillin (as sodium salt) and 0.5 g of
tazobactam (as sodium salt).
One vial of powder for solution for infusion contains 9.7 mmol (224
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 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 a