PipTaz Sandoz

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Piperacillin monohydrate 4.198 g equivalent to Piperacillin sodium 4.2531g and 4.0g piperacillin;  ;  ; Tazobactam 0.5 g equivalent to Tazobactam sodium 0.54733 g

Available from:

Sandoz New Zealand Limited

INN (International Name):

Piperacillin monohydrate 4.198 g (equivalent to Piperacillin sodium 4.2531 g and 4.0 g piperacillin)

Dosage:

4 g/0.5 g

Pharmaceutical form:

Powder for injection

Composition:

Active: Piperacillin monohydrate 4.198 g equivalent to Piperacillin sodium 4.2531g and 4.0g piperacillin     Tazobactam 0.5 g equivalent to Tazobactam sodium 0.54733 g

Prescription type:

Prescription

Manufactured by:

Sandoz Industrial Products SA

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 PipTaz Sandoz plus an aminoglycoside should be used. 8. Bone and joint infections 9. Polymicrobic infections: PipTaz Sandoz 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, PipTaz Sandoz 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.

Product summary:

Package - Contents - Shelf Life: Bottle, glass, 50 mL Type II with PP rubber stopper and Al cap - 1 dose units - 2 years from date of manufacture stored at or below 25°C - Bottle, glass, 100 mL Type II with PP rubber stopper and Al cap - 1 dose units - 2 years from date of manufacture stored at or below 25°C - Bottle, glass, 50 mL Type II with PP rubber stopper and Al cap - 10 dose units - 2 years from date of manufacture stored at or below 25°C - Bottle, glass, 100 mL Type II with PP rubber stopper and Al cap - 10 dose units - 2 years from date of manufacture stored at or below 25°C

Authorization date:

2015-12-08

Patient Information leaflet

PIPTAZ SANDOZ
®
1
PIPTAZ SANDOZ
®
_piperacillin/tazobactam powder for injection _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about PipTaz Sandoz.
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 having this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
HAVING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT PIPTAZ SANDOZ
IS USED FOR
This medicine is used to treat serious
bacterial 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 Sandoz is used to treat
serious infections in the abdomen. It
is not recommended to treat
abdominal infections in children
under 2 years.
It contains the active ingredients
piperacillin and tazobactam.
Piperacillin and tazobactam belong to
a group of medicines called
penicillins.
Piperacillin works by killing many
types of bacteria. Tazobactam does
not have activity against bacteria, but
helps piperacillin to overcome
bacteria which have become resistant
to piperacillin.
PipTaz Sandoz will not work against
infections caused by viruses such as
colds 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 not addictive.
BEFORE YOU ARE GIVEN
PIPTAZ SANDOZ
_WHEN YOU MUST NOT RECEIVE _
_IT _
DO NOT HAVE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
piperacillin or tazobactam the
active ingredients
•
any other similar medicines such
as antibiotics in the penicillin,
cephalosporin or beta-lactamase
inhibitor groups.
Some of the symptoms of an allergic
reaction

Summary of Product characteristics

211124-piptaz sandoz-ds
Page 1 of 22
NEW ZEALAND DATA SHEET
PIPTAZ SANDOZ (PIPERACILLIN/TAZOBACTAM)
1.
PRODUCT NAME
PIPTAZ SANDOZ; 4 g/0.5 g; injection, powder
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
PIPTAZ SANDOZ contains piperacillin (as sodium salt) 4 g and
tazobactam (as sodium salt)
0.5 g.
One bottle of powder for solution for infusion contains 9.44 mmol (217
mg) of sodium.
_Excipient(s) with known effect:_
Not applicable
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Powder for injection.
White to off-white sterile, cryodesiccated powder in glass bottles.
4.
CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC INDICATIONS
PIPTAZ SANDOZ (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
PIPTAZ
SANDOZ (piperacillin/tazobactam) plus an aminoglycoside should be
used.
8.
Bone and joint infections
9.
Polymicrobic infections: PIPTAZ SANDOZ (piperacillin/tazobactam) 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 PIPTAZ SANDOZ (piperacillin/tazobactam) is indicated only for
the conditions listed
above, infections caused by piperacillin susceptible organisms are
also amenable to PIPTAZ
SANDOZ (piperacillin/tazobactam) treatment due to its piperacillin
content. Therefore, the
treatment of mixed infections caused by piperacillin susceptible
organisms and β-lactamase
211124-piptaz sandoz-ds
Page 2 of 22
producing organisms susceptible to PIPTAZ SANDOZ
(piperacillin/tazobactam) should not
require the addi