TAZOCIN EF 2g/250mg powder for injection vial

Country: Аустралија

Језик: Енглески

Извор: Department of Health (Therapeutic Goods Administration)

Активни састојак:

piperacillin sodium,tazobactam sodium

Доступно од:

Pfizer Australia Pty Ltd

INN (Међународно име):

piperacillin sodium,tazobactam sodium

Статус ауторизације:

Registered

Карактеристике производа

Version: pfptazev10919
Supersedes: pfptazev10519
Page 1 of 20
AUSTRALIAN
PRODUCT
INFORMATION
-
TAZOCIN EF
 (PIPERACILLIN/TAZOBACTAM)
POWDER FOR INJECTION
1.
NAME OF THE MEDICINE
Piperacillin sodium/Tazobactam sodium
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
TAZOCIN EF is an injectable antibacterial combination, consisting of
the semisynthetic
antibiotic
piperacillin
sodium
and
the

-lactamase
inhibitor
tazobactam
sodium,
for
intravenous administration.
Each vial of TAZOCIN EF contains piperacillin/tazobactam injection 2.0
g/0.25 g
†
.
Each vial of TAZOCIN EF contains piperacillin/tazobactam injection 4.0
g/0.5 g.
For the full list of excipients, see Section 6.1 - List of excipients.
3.
PHARMACEUTICAL FORM
Powder for injection.
TAZOCIN EF is available as a white to off-white sterile,
cryodesiccated powder of piperacillin
and tazobactam as the sodium salts packaged in glass vials.
_ _
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
TAZOCIN EF is indicated in the treatment of serious bacterial
infections caused by susceptible
strains of

-lactamase producing organisms in the conditions listed below:
1.
Lower respiratory tract infections
2.
Urinary tract infections (complicated and uncomplicated)
3.
Intra-abdominal infections
4.
Skin and skin structure infections
5.
Bacterial septicaemia
6.
Gynaecological infections
Version: pfptazev10919
Supersedes: pfptazev10519
Page 2 of 20
Children under the age of 12 years
In hospitalised children aged 2 to 12 years, TAZOCIN EF is indicated
for the treatment of
serious intra-abdominal infections. It has not been evaluated in this
indication for paediatric
patients below the age of 2 years.
While TAZOCIN EF is indicated only for the conditions listed above, it
may be used as a single
agent in the treatment of mixed infections caused by piperacillin
susceptible and

-lactamase
producing, piperacillin-resistant organisms. Appropriate culture and
susceptibility tests should
be performed before treatment in order to identify organisms causing
infection to determin