Pitaz 2 g/0,25 g poeder voor oplossing voor infusie

Country: Netherlands

Language: Dutch

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

Active ingredient:

PIPERACILLINE NATRIUM 0-WATER 2,085 g/g SAMENSTELLING overeenkomend met ; PIPERACILLINE 0-WATER 2 g/g ; TAZOBACTAM NATRIUM 0,2683 g/g SAMENSTELLING overeenkomend met ; TAZOBACTAM 0,25 g/g

INN (International Name):

PIPERACILLINE NATRIUM 0-WATER 2,085 g/g SAMENSTELLING overeenkomend met ; PIPERACILLINE 0-WATER 2 g/g ; TAZOBACTAM NATRIUM 0,2683 g/g SAMENSTELLING overeenkomend met ; TAZOBACTAM 0,25 g/g

Pharmaceutical form:

Poeder voor oplossing voor infusie

Composition:

GEEN HULPSTOFFEN

Administration route:

Intraveneus gebruik

Authorization date:

2024-04-03

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
PITAZ 2 G/0,25 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 Pitaz is and what it is used for
2.
What you need to know before you use Pitaz
3.
How to use Pitaz
4.
Possible side effects
5.
How to store Pitaz
6.
Contents of the pack and other information
1.
WHAT PITAZ 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.
Pitaz 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. Pitaz may be
used to treat bacterial infections in patients with low white blood
cell counts (reduced resistance to
infections).
Pitaz 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. Pitaz 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 Pitaz in
combination with other
antibiotics.
2.
WHA

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Pitaz 2 g/0,25 g poeder voor oplossing voor infusie
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains piperacillin (as sodium salt) equivalent to 2 g and
tazobactam (as sodium salt)
equivalent to 0.25 g.
Excipient with known effect
Each vial of Pitaz 2 g/0.25 g contains 108 mg of sodium.
3.
PHARMACEUTICAL FORM
Powder for solution for infusion
White or almost white loose lump or powder
The solution for infusion has:
•
pH 5.0-7.0
•
osmolality: 600-700 mOsm/kg (when reconstituted with 10mL WFI)
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Pitaz 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.
Pitaz 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
Pitaz 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
2
Posology
The dose and frequency of Pitaz depends on the severity and
localisation of the infection and expected
pathogens.
Adult and adolescent
The usual dose is 4 g piperacillin/0.5 g tazoba