PIPTAZ 4 g/0.5 g piperacillin (as piperacillin sodium) and tazobactam (as tazobactam sodium) 4 g / 500 mg powder for injection vial

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Ingrédients actifs:

tazobactam sodium, Quantity: 547 mg (Equivalent: tazobactam, Qty 500 mg); piperacillin sodium, Quantity: 4.253 g (Equivalent: piperacillin, Qty 4 g)

Disponible depuis:

Juno Pharmaceuticals Pty Ltd

DCI (Dénomination commune internationale):

piperacillin sodium,tazobactam sodium

forme pharmaceutique:

Injection, powder for

Composition:

Excipient Ingredients:

Mode d'administration:

Intravenous

Unités en paquet:

10 x 50 mL vials

Type d'ordonnance:

(S4) Prescription Only Medicine

indications thérapeutiques:

Piperacillin and tazobactam 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; and Gynaecological infections. Children under the age of 12 years: In hospitalised children aged 2 to 12 years, Piperacillin and 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 two years. While Piperacillin and 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 isolate and identify organisms causing infection and to determine their susceptibility to Piperacillin and tazobactam. Therapy with Piperacillin and tazobactam, however, may be initiated before results of such tests are known when there is reason to believe the infection may involve any of the beta-lactamase producing organisms listed above; however, once results become available, appropriate therapy should be continued. In serious infections, presumptive therapy with Piperacillin and tazobactam may be initiated before susceptibility test results are available. Combination therapy with Piperacillin and tazobactam 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.

Descriptif du produit:

Visual Identification: white or almost white lyophilized powder; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Statut de autorisation:

Registered

Date de l'autorisation:

2009-04-17

Notice patient

1
PIPTAZ
_Piperacillin/tazobactam for Injection_
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about PIPTAZ. 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 PIPTAZ
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 PIPTAZ IS USED
FOR
The name of your medicine is
PIPTAZ. It contains the active
ingredients piperacillin and
tazobactam. 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.
PIPTAZ 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, PIPTAZ is used to treat
serious infections in the abdomen.
PIPTAZ is not recommended to treat
abdominal infections in children
under 2 years.
PIPTAZ
will
not
work
against
infections caused by viruses such as
colds or flu.
This medicine is available only with
a doctor's prescription.
PIPTAZ is not addictive.
BEFORE YOU ARE GIVEN
PIPTAZ
_WHEN YOU MUST NOT RECEIVE _
_PIPTAZ_
DO NOT HAVE PIPTAZ 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 symptoms of an allergic
reaction may include rash, itching or
hives on the skin, sw

Résumé des caractéristiques du produit

Juno Pharmaceuticals Pty Ltd
Australian Product Information
Piptaz PI v1.0
Page | 1
AUSTRALIAN PRODUCT INFORMATION
_PIPTAZ _
_(PIPERACILLIN (AS SODIUM) AND TAZOBACTAM (AS SODIUM)) _
_POWDER FOR INJECTION_
_ _
_ _
1 NAME OF THE MEDICINE
The name of the medicine is piperacillin (as sodium) and tazobactam
(as sodium).
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Piptaz contains 4 g piperacillin sodium and 500 mg tazobactam sodium.
Piptaz is an injectable antibacterial combination, consisting of the
semi-synthetic antibiotic
piperacillin
sodium
and
the
β-lactamase
inhibitor
tazobactam
sodium,
for
intravenous
administration.
Each vial of Piptaz contains a total of 2.35 mEq (54 mg) of Na+ per
gram of piperacillin.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3. PHARMACEUTICAL FORM
Powder for injection.
Piptaz is available as a white to off-white sterile, lyophilised
powder of piperacillin and
tazobactam as the sodium salts packaged in glass vials.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Piptaz is indicated for 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; and
• Gynaecological infections.
_Children under the age of 12 years _
In hospitalized children aged 2-12 years, Piptaz 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 two years.
While Piptaz 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
e006287
Product information - clean
1.3.1.1 Pg. 1
Juno Pharmaceuticals Pty Ltd
Australian Product Information
Piptaz PI v1.0
Page | 2
producing, piperacillin resistant