PIPERACILLIN/TAZOBACTAM 4/0.5 Grams Pdr for Soln for Infusion

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

PIPERACILLIN SODIUM STERILE, TAZOBACTAM SODIUM STERILE

Dostępny od:

Fresenius Kabi Limited

Kod ATC:

J01CR05

INN (International Nazwa):

PIPERACILLIN SODIUM STERILE, TAZOBACTAM SODIUM STERILE

Dawkowanie:

4/0.5 Grams

Forma farmaceutyczna:

Pdr for Soln for Infusion

Typ recepty:

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

Dziedzina terapeutyczna:

Combinations of penicillins, incl. beta-lactamase inhibitors

Status autoryzacji:

Authorised

Data autoryzacji:

2008-11-28

Charakterystyka produktu

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.
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.
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