Piperacillin/Tazobactam Kabi

País: Nova Zelândia

Língua: inglês

Origem: Medsafe (Medicines Safety Authority)

Ingredientes ativos:

Piperacillin sodium 2.085 g equivalent to piperacillin 2g; Tazobactam sodium 0.2683 g equivalent to tazobactam 0.25g

Disponível em:

Fresenius Kabi New Zealand Limited

Forma farmacêutica:

Powder for injection

Composição:

Active: Piperacillin sodium 2.085 g equivalent to piperacillin 2g Tazobactam sodium 0.2683 g equivalent to tazobactam 0.25g

Tipo de prescrição:

Prescription

Indicações terapêuticas:

Piperacillin/ Tazobactam is indicated for the treatment of the following systemic and/or local bacterial infections in which susceptible organisms have been detected or are suspected: 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 7. Bacterial infections in neutropenic patients. Full therapeutic doses of Piperacillin/ Tazobactam Kabi plus an aminoglycoside should be used. 8. Bone and joint infections 9. Polymicrobic infections: Piperacillin/Tazobactam Kabi is indicated for polymicrobic infections including those where aerobic and anaerobic organisms are suspected (intra-abdominal, skin and skin structure, upper and lower respiratory tract, gynaecological). Children under the age of 12 years: In hospitalised children aged 2 to 12 years, Piperacillin/ Tazobactam is indicated for the treatment of serious intra-abdominal infections.

Resumo do produto:

Package - Contents - Shelf Life: Vial, glass, single dose, Type II glass vial (50mL) closed with elastomeric stopper and flip off cap - 1 dose units - 24 months from date of manufacture stored at or below 25°C - Vial, glass, single dose, Type II glass vial (50mL) closed with elastomeric stopper and flip off cap - 5 dose units - 24 months from date of manufacture stored at or below 25°C - Vial, glass, single dose, Type II glass vial (50mL) closed with elastomeric stopper and flip off cap - 10 dose units - 24 months from date of manufacture stored at or below 25°C

Data de autorização:

2021-01-12

Folheto informativo - Bula

PIPERACILLIN/ TAZOBACTAM KABI INJECTION
Piperacillin/ Tazobactam Kabi 2g/0.25g & Piperacillin/ Tazobactam Kabi
4g/ 0.5 g
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Piperacillin/
Tazobactam Kabi Injection. 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 Piperacillin/ Tazobactam Kabi
Injection 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 PIPERACILLIN/ TAZOBACTAM
KABI INJECTION IS USED FOR
The name of your medicine is
Piperacillin/ Tazobactam Kabi Injection.
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.
Piperacillin/ Tazobactam Kabi
Injection 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, Piperacillin/ Tazobactam Kabi
Injection is used to treat serious
infections in the abdomen. Piperacillin/
Tazobactam Kabi Injection is not
recommended to treat abdominal
infections in children under 2 years.
Piperacillin/Tazobactam Kabi Injection
will not work against infections caused
by viruses such as colds or flu.
This medicine is available only with a
doctor's prescription.
Piperacillin/ Tazobactam Kabi Injection
is not addictive.
BEFORE YOU ARE GIVEN
PIPER

Características técnicas

1 NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Piperacillin/Tazobactam Kabi 2.0g/0.25g powder for solution for
injection
Piperacillin/Tazobactam Kabi 4.0g/0.5 g powder for solution for
injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2 g/0.25 g single dose vial contains piperacillin sodium (2.09g)
equivalent to 2 grams of
piperacillin and tazobactam sodium (268.3mg) equivalent to 250 mg of
tazobactam.
Each 4 g/0.5 g single dose vial contains piperacillin sodium (4.2g)
equivalent to 4 grams of
piperacillin and tazobactam sodium (536.6mg) equivalent to 500 mg of
tazobactam.
Pharmacotherapeutic group: Antibacterials for systemic use, Combined
of penicillins inc.
beta lacatamase inhibitors ; ATC code : J01C R05.
There are no excipients.
3.
PHARMACEUTICAL FORM
Powder for injection
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Piperacillin/ Tazobactam Kabi is indicated for the treatment of the
following systemic and/or
local bacterial infections in which susceptible organisms have been
detected or are
suspected:
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
7.
Bacterial infections in neutropenic patients. Full therapeutic doses
of Piperacillin/
Tazobactam Kabi plus an aminoglycoside should be used.
8.
Bone and joint infections
9. Polymicrobic infections: Piperacillin/ Tazobactam Kabi is indicated
for polymicrobic
infections including those where aerobic and anaerobic organisms are
suspected (intra-
abdominal, skin and skin structure, upper and lower respiratory tract,
gynaecological).
2
While Piperacillin/ Tazobactam Kabi is indicated only for the
conditions listed above,
infections caused by piperacillin susceptible organisms are also
amenable to Piperacillin/
Tazobactam Kabi treatment due to its piperacillin content. Therefore,
the treatment of
mixed infections caused by piperacillin susceptible organisms and beta
-lactamase
producing o