Piperacilline/Tazobactam 4 g/0,5 g, poeder voor oplossing voor infusie

País: Países Bajos

Idioma: neerlandés

Fuente: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Ingredientes activos:

PIPERACILLINE NATRIUM 0-WATER 4,17 g/flacon SAMENSTELLING overeenkomend met ; PIPERACILLINE 0-WATER 4 g/flacon ; TAZOBACTAM NATRIUM 547,3 mg/flacon SAMENSTELLING overeenkomend met ; TAZOBACTAM 500 mg/flacon

Disponible desde:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

Código ATC:

J01CR05

Designación común internacional (DCI):

PIPERACILLINE NATRIUM 0-WATER 4,17 g/flacon SAMENSTELLING overeenkomend met ; PIPERACILLINE 0-WATER 4 g/flacon ; TAZOBACTAM NATRIUM 547,3 mg/flacon SAMENSTELLING overeenkomend met ; TAZOBACTAM 500 mg/flacon

formulario farmacéutico:

Poeder voor oplossing voor injectie of infusie

Composición:

GEEN HULPSTOFFEN,

Vía de administración:

Intraveneus gebruik

Área terapéutica:

Piperacillin and beta-lactamase inhibitor

Resumen del producto:

Hulpstoffen: GEEN HULPSTOFFEN;

Fecha de autorización:

1900-01-01

Información para el usuario

Sandoz B.V.
Page 1
Piperacilline/Tazobactam 4 g/0,5 g
RVG 34088
V9
1.3.1.3 Bijsluiter
April 2022
BIJSLUITER: INFORMATIE VOOR DE PATIËNT
PIPERACILLINE/TAZOBACTAM 4 G/0,5 G, POEDER VOOR OPLOSSING VOOR INFUSIE
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 [nationally completed name] is and what it is used for
2.
What you need to know before you use [nationally completed name]
3.
How to use [nationally completed name]
4.
Possible side effects
5.
How to store [nationally completed name]
6.
Contents of the pack and other information
1.
WHAT [NATIONALLY COMPLETED NAME] 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.
[nationally completed name] 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. [nationally completed name] may be used to treat bacterial
infections in patients with low
white blood cell counts (reduced resistance to infections).
[nationally completed name] 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 a

Ficha técnica

Sandoz B.V.
Page 1
Piperacilline/Tazobactam 4 g/0,5 g
RVG 34088
1311-V13B
1.3.1.1. Samenvatting van de Productkenmerken
Mei 2023
1.
NAAM VAN HET GENEESMIDDEL
Piperacilline/Tazobactam 4 g/0,5 g, poeder voor oplossing voor infusie
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
[nationally completed name] 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.
[nationally completed name] 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
Sandoz B.V.
Page 2
Piperacilline/Tazobactam 4 g/0,5 g
RVG 34088
1311-V13B
1.3.1.1. Samenvatting van de Productkenmerken
Mei 2023
[nationally completed name] 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 METHO