Tazocin EF

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Piperacillin monohydrate 2 g (as piperacillin sodium 2.085g);  ;  ; Tazobactam 250mg; Piperacillin monohydrate 2 g (as piperacillin sodium 2.085g); Tazobactam 250mg (as tazobactam sodium 0.2683 g)

Available from:

Pfizer New Zealand Limited

INN (International Name):

Piperacillin monohydrate 2 g (as piperacillin sodium 2.085g)

Dosage:

2g/250mg

Pharmaceutical form:

Powder for injection

Composition:

Active: Piperacillin monohydrate 2 g (as piperacillin sodium 2.085g)     Tazobactam 250mg Piperacillin monohydrate 2 g (as piperacillin sodium 2.085g) Tazobactam 250mg (as tazobactam sodium 0.2683 g) Excipient: Citric acid monohydrate Disodium edetate dihydrate Sodium bicarbonate

Units in package:

Vial, glass, single dose, 1 dose unit

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Qilu Tianhe Pharmaceutical Co Ltd

Therapeutic indications:

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 TAZOCIN EF plus an aminoglycoside should be used. 8. Bone and joint infections 9. Polymicrobic infections: TAZOCIN EF 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, TAZOCIN EF is indicated for the treatment of serious intra-abdominal infections.

Product summary:

Package - Contents - Shelf Life: Vial, glass, 2.25g vials - 10 dose units - 36 months from date of manufacture stored at or below 25°C 48 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) 6 hours reconstituted stored at or below 25°C - Vial, glass, single dose, - 1 dose units - 36 months from date of manufacture stored at or below 25°C 48 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) 6 hours reconstituted stored at or below 25°C

Authorization date:

1991-03-18

Patient Information leaflet

New Zealand Consumer Medicine Information
TAZOCIN EF
®
1
TAZOCIN EF
®
_Piperacillin sodium/tazobactam sodium powder for Injection _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about TAZOCIN EF. 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 TAZOCIN EF
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 TAZOCIN EF IS
USED FOR
The name of your medicine is
TAZOCIN EF. It contains the active
ingredients piperacillin sodium and
tazobactam sodium. 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.
TAZOCIN EF 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, TAZOCIN EF is used to treat
serious infections in the abdomen.
TAZOCIN EF is not recommended
to treat abdominal infections in
children under 2 years.
TAZOCIN EF will not work against
infections caused by viruses such as
colds or flu.
Your doctor may have prescribed
TAZOCIN EF for another reason.
Ask your doctor if you have any
questions about why Tazocin EF has
been prescribed for you.
This medicine is available only with
a doctor's prescription.
TAZOCIN EF is not addictive.
BEFORE YOU ARE GIVEN
TAZOCIN EF
_WHEN YOU MUST NOT RECEIVE _
_TAZOCIN EF _
DO NOT HAVE TAZOCIN EF IF:
1.

Summary of Product characteristics

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NEW ZEALAND DATA SHEET
1. PRODUCT NAME
TAZOCIN EF

4.5 g piperacillin/tazobactam 4.0 g/0.5 g powder for injection
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of TAZOCIN EF 4.5 g contains piperacillin sodium 4.170 g
equivalent to 4 g
piperacillin and tazobactam sodium 0.5366 g equivalent to 500 mg
tazobactam.
EXCIPIENT(S) WITH KNOWN EFFECT:
•
Disodium edetate dihydrate (EDTA).
The theoretical sodium content of each vial of TAZOCIN EF is 2.84 mEq
(65 mg) of sodium
per gram of piperacillin which may increase a patient’s overall
sodium intake.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Powder for injection
TAZOCIN EF 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
TAZOCIN EF 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 TAZOCIN EF plus
an aminoglycoside should be used.
8.
Bone and joint infections
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9.
Polymicrobic infections: TAZOCIN EF 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).
While TAZOCIN EF is indicated only for the conditions listed above,
infections caused by
piperacillin susceptible organisms are also amenable to TAZOCIN EF
treatment due to its
piperacillin content. Therefore, the treatment of mixed infections
caused by piperacillin
suscep