PipTaz-AFT 4 g/0.5 g piperacillin (as sodium) 4 g and tazobactam (as sodium) 0.5 g powder for injection vial

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Ingredientes ativos:

piperacillin sodium, Quantity: 4170 mg (Equivalent: piperacillin, Qty 4000 mg); tazobactam sodium, Quantity: 540 mg (Equivalent: tazobactam, Qty 500 mg)

Disponível em:

AFT Pharmaceuticals Pty Ltd

DCI (Denominação Comum Internacional):

piperacillin sodium,tazobactam sodium

Forma farmacêutica:

Injection, powder for

Composição:

Excipient Ingredients: nitrogen

Via de administração:

Intravenous

Unidades em pacote:

10 vials, 1 vial

Tipo de prescrição:

(S4) Prescription Only Medicine

Indicações terapêuticas:

PipTaz-AFT 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, PipTaz-AFT 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 PipTaz-AFT 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 PipTaz-AFT. Therapy with PipTaz-AFT, 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 these results become available, appropriate therapy should be continued. In serious infections, presumptive therapy with PipTaz-AFT may be initiated before susceptibility test results are available. Combination therapy with PipTaz-AFT 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.

Resumo do produto:

Visual Identification: White to off-white cake or powder; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Status de autorização:

Licence status A

Data de autorização:

2017-09-21

Folheto informativo - Bula

1
PIPTAZ-AFT 4 G/0.5 G
_Piperacillin (as sodium) 4 g and tazobactam (as sodium) 500 mg powder
for injection _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about PipTaz-AFT 4 g/0.5 g.
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-AFT 4 g/0.5 g 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-AFT 4 G/0.5 G IS USED FOR
The name of your medicine is PipTaz-AFT 4 g/0.5 g. 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-AFT 4 g/0.5 g 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-AFT 4 g/0.5 g is
used to treat serious
infections in the abdomen. PipTaz-AFT 4 g/0.5 g is not recommended to
treat abdominal
infections in children under 2 years.
PipTaz-AFT 4 g/0.5 g will not work against infections caused by
viruses such as colds or flu.
2
This medicine is available only with a doctor's prescription.
PipTaz-AFT 4 g/0.5 g is not addictive.
BEFORE YOU ARE GIVEN PIPTAZ-AFT 4 G/0.5 G
_WHEN YOU MUST NOT BE GIVEN PIPTAZ-AFT 4 G/0.5 G _
YOU SHOULD NOT BE GIVEN PIPTAZ-AFT 4 G/0.5 G IF:
1. YOU HAVE EVER HAD AN ALLERGIC REACTION TO:

piperacillin,

Características técnicas

Page 1 of 20
AUSTRALIAN PRODUCT INFORMATION
PIPTAZ-AFT (PIPERACILLIN SODIUM AND TAZOBACTAM
SODIUM) POWDER FOR INJECTION
1.
NAME OF THE MEDICINE
Piperacillin sodium
Tazobactam sodium
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
PipTaz-AFT 4 g/0.5 g is an injectable antibacterial combination,
consisting of the semisynthetic
antibiotic piperacillin sodium and the β-lactamase inhibitor
tazobactam sodium, for intravenous
administration.
Each vial of PipTaz-AFT 4 g/0.5 g contains approximately 54 mg of
sodium per gram of piperacillin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Piperacillin (as the sodium salt) 4 g and Tazobactam (as the sodium
salt) 500 mg powder for injection.
PipTaz-AFT 4 g/0.5 g is available as a white to off-white sterile,
lyophilized powder of piperacillin and
tazobactam as the sodium salts packaged in glass vials.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
PipTaz-AFT 4 g/0.5 g is indicated in the treatment of serious
bacterial infections caused by susceptible
strains of β-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
Page 2 of 20
_CHILDREN UNDER THE AGE OF 12 YEARS _
In hospitalised children aged 2 to 12 years, PipTaz-AFT 4 g/0.5 g 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 PipTaz-AFT 4 g/0.5 g 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
susceptibilities to PipTaz-AFT 4 g/0.5 g. The