TAZOCIN EF 4g/500mg powder for injection vial

Maa: Australia

Kieli: englanti

Lähde: Department of Health (Therapeutic Goods Administration)

Aktiivinen ainesosa:

tazobactam sodium, Quantity: 540 mg (Equivalent: tazobactam, Qty 500 mg); piperacillin sodium, Quantity: 4.17 g (Equivalent: piperacillin, Qty 4 g)

Saatavilla:

Pfizer Australia Pty Ltd

INN (Kansainvälinen yleisnimi):

piperacillin sodium,tazobactam sodium

Lääkemuoto:

Injection, powder for

Koostumus:

Excipient Ingredients: disodium edetate; citric acid monohydrate

Antoreitti:

Intravenous

Kpl paketissa:

1 vial

Prescription tyyppi:

(S4) Prescription Only Medicine

Käyttöaiheet:

Tazocin EF is indicated in the treatment of serious bacterial infections caused by susceptible strains of Beta-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. 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 Beta-lactamase producing piperacillin-resistant organisms. Appropriate culture and susceptibility tests should be performed before treatment in order to identify organisms causing infection to determine their susceptibilities to Tazocin EF. Therapy with Tazocin EF however, may be initiated before results of such tests are known when there is a reason to believe the infection may involve any of the Beta-lactamase producing organisms listed above, however, once these results become available, appropriate therapy should be continued. In serious infections, presumptive therapy with Tazocin EFmay be initiated before susceptibility test results are available. Combination therapy with Tazocin EF and aminoglycosides may be used in the treatment of serious infections caused by Pseudomonas aeruginosa. Both drugs should be used in full therapeutic doses. As soon as results of culture and susceptibility tests become available, antimicrobial therapy should be adjusted.

Tuoteyhteenveto:

Visual Identification: TAZOCIN EF is a white to off white powder packaged in glass vials.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius

Valtuutuksen tilan:

Registered

Valtuutus päivämäärä:

2007-04-11

Pakkausseloste

TAZOCIN EF
®
_Piperacillin sodium/tazobactam sodium for Injection_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about TAZOCIN EF. It
does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking TAZOCIN EF
against the benefits this medicine is
expected to have for you.
IF YOU HAVE ANY QUESTIONS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT TAZOCIN EF IS
USED FOR
The name of your medicine is
TAZOCIN EF. It contains the active
ingredients piperacillin sodium and
tazobactam sodium. They belong to a
group of antibiotics called penicillins
that work by killing bacteria.
Piperacillin is an antibiotic that kills
many types of bacteria. Tazobactam
belongs in the penicillin group but
does not have activity against
bacteria. It helps piperacillin to
overcome bacteria which have
become resistant to piperacillin.
TAZOCIN EF is active against
bacteria which cause serious
infections such as: -
•
Chest infections
•
Urine infections
•
Stomach infections
•
Skin infections
•
Gynaecological infections
•
Septicaemia (blood poisoning).
It is also used to treat many other
infections.
In hospitalised children aged 2 to 12
years, TAZOCIN EF is used to treat
serious infections in the abdomen.
TAZOCIN EF is not recommended
to treat abdominal infections in
children under 2 years.
TAZOCIN EF will not work against
infections caused by viruses such as
colds or flu.
This medicine is available only with
a doctor's prescription.
TAZOCIN EF is not addictive.
BEFORE YOU ARE GIVEN
TAZOCIN EF
_WHEN YOU MUST NOT RECEIVE_
_TAZOCIN EF_
DO NOT HAVE TAZOCIN EF IF:
1.
YOU HAVE EVER HAD AN ALLERGIC
REACTION TO:
•
piperacillin, tazobactam, or any
other penicillin antibiotics
•
any antibiotic in the
cephalosporin group
•
medicines called beta-lactamase
inhibitors.
Some of the symptom

Valmisteyhteenveto

Version: pfptazev10122
Supersedes: pfptazev10821
Page 1 of 25
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: pfptazev10122
Supersedes: pfptazev10821
Page 2 of 25
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
determi