Tazocin 4g/0.5g powder for solution for infusion

Šalis: Malta

kalba: anglų

Šaltinis: Medicines Authority

Veiklioji medžiaga:

PIPERACILLIN, TAZOBACTAM, SODIUM

Prieinama:

Pfizer Hellas S.A. 243 Messoghion Ave., Neo Psychiko 15451, Athens, Greece

ATC kodas:

J01CR05

INN (Tarptautinis Pavadinimas):

PIPERACILLIN 4 g TAZOBACTAM 0.5 g SODIUM 261 mg

Vaisto forma:

POWDER FOR SOLUTION FOR INFUSION

Sudėtis:

PIPERACILLIN 4 g TAZOBACTAM 0.5 g SODIUM 261 mg

Recepto tipas:

POM

Gydymo sritis:

ANTIBACTERIALS FOR SYSTEMIC USE

Autorizacija statusas:

Authorised

Leidimo data:

2006-11-08

Pakuotės lapelis

Page 1 of 10
PACKAGE LEAFLET
Page 2 of 10
PACKAGE LEAFLET: INFORMATION FOR THE USER
TAZOCIN 2 G / 0.25 G POWDER FOR SOLUTION FOR INFUSION
TAZOCIN 4 G / 0.5 G POWDER FOR SOLUTION FOR INFUSION
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 Tazocin is and what it is used for
2.
What you need to know before you use Tazocin
3.
How to use Tazocin
4.
Possible side effects
5.
How to store Tazocin
6.
Contents of the pack and other information
1.
WHAT TAZOCIN 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.
Tazocin 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. Tazocin may be used
to treat bacterial infections in patients with low white blood cell
counts (reduced resistance to infections).
Tazocin 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.
Tazocin may be used to treat bacterial infections in patients with low
white blood cell counts (reduced
resistance to infections

Prekės savybės

Page 1 of 18
SUMMARY OF PRODUCT CHARACTERISTICS
Page 2 of 18
1.
NAME OF THE MEDICINAL PRODUCT
Tazocin 2 g / 0.25 g powder for solution for infusion
Tazocin) 4 g / 0.5 g powder for solution for infusion
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.
Each vial contains piperacillin (as sodium salt) equivalent to 4 g and
tazobactam (as sodium salt)
equivalent to 0.5 g.
EXCIPIENT WITH KNOWN EFFECT
Each vial of Tazocin 2 g / 0.25 g contains 130 mg of sodium.
Each vial of Tazocin 4 g / 0.5 g contains 261 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
Tazocin 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.
Tazocin 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.
Page 3 of 18
CHILDREN 2 TO 12 YEARS OF AGE
-
Complicated intra-abdominal infections
Tazocin 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 ADMINIS