TAZOPIP 2 g/0.25 g piperacillin (as sodium) 2 g and tazobactam (as sodium) 0.25 g powder for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

piperacillin sodium, Quantity: 2.1 g (Equivalent: piperacillin, Qty 2 g); tazobactam sodium, Quantity: 0.27 g (Equivalent: tazobactam, Qty 0.25 g)

Available from:

Alphapharm Pty Ltd

INN (International Name):

piperacillin sodium,tazobactam sodium

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients:

Administration route:

Intravenous

Units in package:

1 vial

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

TAZOPIP is indicated in the treatment of serious bacterial infections caused by susceptible strains of beta -lactamase producing organisms in the conditions as listed: 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, TAZOPIP 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 TAZOPIP 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 TAZOPIP. Therapy with TAZOPIP 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 TAZOPIP may be initiated before susceptibility test results are available. Combination therapy with TAZOPIP 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.

Product summary:

Visual Identification: White to off white powder; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2009-09-21

Patient Information leaflet

TAZOPIP POWDER
FOR INJECTION
_Piperacillin (as sodium) and Tazobactam (as sodium)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about TAZOPIP.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking TAZOPIP against
the benefits expected for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT TAZOPIP IS USED
FOR
TAZOPIP contains the active
ingredients piperacillin and
tazobactam. This medicine belongs
to a group of medicines called
antibiotics called penicillins. It works
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.
This medicine is active against
bacteria which cause serious
infections such as: -
•
Chest infections
•
Urine infections
•
Stomach infections
•
Skin infections
•
Gynaecological infections
•
Septicaemia (blood poisoning).
TAZOPIP is also used to treat many
other infections.
In hospitalised children aged 2 to 12
years, TAZOPIP is used to treat
serious infections in the abdomen.
TAZOPIP is not recommended to
treat abdominal infections in children
under 2 years.
TAZOPIP will not work against
infections caused by viruses such as
cold or flu.
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 available only with
a doctor's prescription.
This medicine is not addictive.
BEFORE YOU ARE GIVEN
TAZOPIP
_WHEN YOU MUST NOT RECEIVE_
_TAZOPIP_
DO NOT RECEIVE TAZOPIP IF YOU
HAVE AN ALLERGY TO:
•
any medicine containing
piperacillin, tazobactam, or any
other penicillin

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
TAZOPIP
_piperacillin (as sodium) and tazobactam (as sodium) powder for
injection _
1
NAME OF THE MEDICINE
Piperacillin (as sodium) and tazobactam (as sodium)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
TAZOPIP is an injectable antibacterial combination, consisting of the
semisynthetic antibiotic piperacillin
sodium and the beta-lactamase inhibitor tazobactam sodium, for
intravenous administration.
Each vial of TAZOPIP contains piperacillin and tazobactam 2 g/0.25 g
or 4 g/0.5 g (as the sodium salts). The
product contains no excipients or preservatives.
3
PHARMACEUTICAL FORM
Powder for injection.
TAZOPIP 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
TAZOPIP for injection is indicated in the treatment of serious
bacterial infections caused by susceptible strains
of beta-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, TAZOPIP for injection 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 TAZOPIP for injection 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 TAZOPIP.
Therapy with TAZOPIP for injection may be initiated before results of
such tests are known when there is
r