DBL CISPLATIN 50mg/50mL Injection

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

cisplatin, Quantity: 1 mg/mL

Available from:

Pfizer Australia Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: sodium chloride; mannitol; water for injections

Administration route:

Intravenous

Units in package:

1x50mg/50mL(E), 1x50mg/50mL

Prescription type:

Not scheduled. Not considered by committee, (S4) Prescription Only Medicine

Therapeutic indications:

Cisplatin Injection is indicated for the palliative treatment of metastatic non-seminomatous germ cell carcinoma, advanced-stage refractory ovarian carcinoma, advanced-stage refractory bladder carcinoma and refractory squamous cell carcinoma of the head and neck. It may be used as a single agent or in combination with other chemotherapeutic agents. It may be employed, in appropriate circumstances, in addition to other modalities, eg radiotherapy or surgery.

Product summary:

Visual Identification: Clear, colourless to pale yellow solution, free from visible particulates; Container Type: Vial; Container Material: Glass Type I Coloured; Container Life Time: 2 Years; Container Temperature: Store between 15-25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

1994-01-31

Patient Information leaflet

DBL™ CISPLATIN
INJECTION
_cisplatin_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about DBL Cisplatin
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 being given cisplatin
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT DBL CISPLATIN
INJECTION IS USED FOR
DBL Cisplatin Injection belongs to a
group of medicines known as
antineoplastic or cytotoxic agents.
You may also hear it referred to as a
chemotherapy medicine.
This medicine is used to treat:
•
testicular cancer
•
ovarian cancer
•
bladder cancer
•
cancer of the head and neck
DBL Cisplatin Injection is a
platinum-containing medicine and is
used as an anticancer drug to
interfere with the growth of cancer
cells and eventually destroy them.
Cancer cells are like normal cells
which have changed so that they
grow out of control in the body.
Since the growth of normal body
cells may also be affected by
cisplatin, other effects may also
occur (see Side Effects).
DBL Cisplatin Injection may be used
alone or with other anticancer
therapies.
DBL Cisplatin Injection has been
chosen as your therapy, as the
benefits of treatment are expected to
be greater than the unwanted or side
effects.
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 available only with
a doctor’s prescription.
BEFORE YOU ARE GIVEN
DBL CISPLATIN
INJECTION
_WHEN YOU MUST NOT BE GIVEN_
_IT_
DO NOT USE DBL CISPLATIN INJECTION
IF YOU HAVE AN ALLERGY TO:
•
any medicine containing cisplatin
•
any other platinum-containing
compounds
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an alle

Summary of Product characteristics

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AUSTRALIAN
PRODUCT
INFORMATION
–
DBL
™ CISPLATIN INJECTION (CISPLATIN)
1.
NAME OF THE MEDICINE
Cisplatin
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of DBL Cisplatin Injection contains 1 mg cisplatin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
DBL Cisplatin Injection is a clear, colourless to pale yellow sterile
solution of cisplatin
1 mg/mL, mannitol 1 mg/mL and sodium chloride 9 mg/mL in water for
injections. The
solution does not contain any preservative.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
DBL
Cisplatin
Injection
is
indicated
for
the
palliative
treatment
of
metastatic
non-seminomatous
germ
cell
carcinoma,
advanced-stage
refractory
ovarian
carcinoma,
advanced-stage refractory bladder carcinoma and refractory squamous
cell carcinoma of the
head and neck. It may be used as a single agent or in combination with
other chemotherapeutic
agents. It may be employed, in appropriate circumstances, in addition
to other modalities, e.g.,
radiotherapy or surgery.
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSAGE
The usual dose in adults and children when used as single agent
therapy is 50-100 mg/m
2
as a
single IV infusion every 3-4 weeks, or 15-20 mg/m
2
as a daily IV infusion for 5 days every 3-4
weeks.
DOSAGE ADJUSTMENT
_HEPATIC IMPAIRMENT_
_ _
Human studies show a high uptake of cisplatin in the liver. An
elevated serum glutamic
oxaloacetic transaminase (SGOT) has been reported in some cases and
the adult dosage should
be used with caution.
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_RENAL IMPAIRMENT _
Cisplatin displays high tissue uptake in the kidneys, exhibits dose
related and cumulative
nephrotoxicity, and is excreted mainly in the urine. In addition, the
plasma elimination half-life
of cisplatin is prolonged in renal failure.
Caution should be exercised in patients with pre-existing renal
dysfunction. Cisplatin is
contraindicated in patients with serum creatin