PIPERTAZ SANDOZ 4g/0.5g piperacillin (as sodium) 4g and tazobactam (as sodium) 0.5 g powder for injection bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

piperacillin sodium, Quantity: 4.253 g; tazobactam sodium, Quantity: 0.547 g (Equivalent: tazobactam, Qty 0.5 g)

Available from:

Sandoz Pty Ltd

INN (International Name):

piperacillin sodium,tazobactam sodium

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients:

Administration route:

Intravenous

Units in package:

1 bottle, 10 bottles

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

PiperTaz Sandoz is used to treat 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, PiperTaz Sandoz is indicated for the treatment of serious intra-abdominal infections. It has not been evaluated in children below the age of 2 years. While PiperTaz Sandoz (piperacillin/tazobactam) 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 susceptibility to PiperTaz Sandoz (piperacillin/tazobactam). Therapy with PiperTaz Sandoz (piperacillin/tazobactam), however, may be initiated before results of each test are known when there is reason to believe the infection may involve any of the Beta-lactamase producing organisms listed above, however, once these results are available, appropriate therapy should be continued. In serious infections, presumptive therapy with PiperTaz Sandoz (piperacillin/tazobactam) may be initiated before susceptibility test results are available. Combination therapy with PiperTaz Sandoz (piperacillin/tazobactam) and aminoglycosides may be used int he treatment of serious infections caused by Pseudomonas aeruginosa. Both drugs shold be used in full therapeutic doses. As soon as results of culture and susceptibility tests become available, antimicrobial therapy should be adjusted.

Product summary:

Visual Identification: white to off-white sterile, cryodessicated powder; Container Type: Bottle; Container Material: Glass Type II Clear; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2008-12-10

Patient Information leaflet

PIPERTAZ SANDOZ
1
PIPERTAZ SANDOZ
_piperacillin sodium/tazobactam sodium powder for injection _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about PiperTaz Sandoz.
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 having this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
HAVING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT PIPERTAZ SANDOZ
IS USED FOR
This medicine is used to treat serious
bacterial 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, PiperTaz Sandoz is used to
treat serious infections in the
abdomen. It is not recommended to
treat abdominal infections in children
under 2 years.
It contains the active ingredients
piperacillin and tazobactam.
Piperacillin and tazobactam belong to
a group of medicines called
penicillins.
Piperacillin works by killing many
types of bacteria. Tazobactam does
not have activity against bacteria, but
helps piperacillin to overcome
bacteria which have become resistant
to piperacillin.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is not addictive.
BEFORE YOU ARE GIVEN
PIPERTAZ SANDOZ
_WHEN YOU MUST NOT RECEIVE _
_IT _
DO NOT HAVE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
piperacillin , tazobactam, or any
other penicillin antibiotics
•
any antibiotics in the
cephalosporin group
•
medicines called beta-lactamase
inhibitors.
Some of the symptoms of an allergic
reaction may include rash, itching or
hives on the skin, swelling of the
face, lips, ton

Summary of Product characteristics

220429-PiperTaz Sandoz-pi
Page 1 of 20
AUSTRALIAN PRODUCT INFORMATION
PIPERTAZ SANDOZ
® (PIPERACILLIN/TAZOBACTAM) 4 G/ 0.5 G POWDER
FOR INJECTION
1
NAME OF THE MEDICINE
Piperacillin sodium/tazobactam sodium
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
PiperTaz Sandoz contains piperacillin (as the sodium salt) 4 g and
tazobactam (as the sodium
salt) 500 mg.
PiperTaz Sandoz 4 g/0.5 g powder for injection is white to off white,
sterile lyophilised powder,
4.5 g (equivalent to piperacillin 4 g, tazobactam 500 mg).
The product contains no excipients or preservatives.
3
PHARMACEUTICAL FORM
PiperTaz Sandoz is available as a white to off-white sterile,
cryodesiccated powder of
piperacillin and tazobactam as the sodium salts packaged in glass
bottles. Each bottle of
PiperTaz Sandoz contains a total of 2.35 mEq (54 mg) of Na
+
per gram of piperacillin.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
PiperTaz Sandoz (piperacillin/tazobactam) is indicated in the
treatment of serious bacterial
infections caused by susceptible strains of
β
-lactamase producing organisms in the conditions
listed below:
•
lower respiratory tract infections
•
urinary tract infections (complicated and uncomplicated)
•
intra-abdominal infections
•
skin and skin structure infections
•
bacterial septicaemia
•
gynaecological infections.
_Children under the age of 12 years _
In hospitalised children aged 2 to 12 years, PiperTaz Sandoz
(piperacillin/tazobactam) 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 PiperTaz Sandoz (piperacillin/tazobactam) 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
β
-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
susce