DBL GEMCITABINE FOR INJECTION gemcitabine (as hydrochloride) 2 g powder for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

gemcitabine hydrochloride

Available from:

Pfizer Australia Pty Ltd

INN (International Name):

Gemcitabine hydrochloride

Authorization status:

Registered

Patient Information leaflet

DBL
™
GEMCITABINE FOR INJECTION
Gemcitabine Hydrochloride (_jem-sie-ta-been) _
CONSUMER MEDICINE INFORMATION_ _
_Date of Dispensing _
_Consumer Name _
_Pharmacist Name _
_Consumer Address _
_Pharmacist Address _
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about DBL
™
Gemcitabine for 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 DBL
™
Gemcitabine for
Injection against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK
YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT DBL
™
GEMCITABINE FOR
INJECTION IS USED FOR
This medicine is used to treat the
following types of cancer:
•
lung cancer
•
pancreatic cancer
•
bladder cancer
•
breast cancer
•
ovarian cancer.
This medicine belongs to a group
of medicines called antineoplastic
or cytotoxic medicines. You may
also hear of these being called
chemotherapy medicines.
This medicine works by killing
cancer cells and stopping cancer
cells from growing and
multiplying.
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.
DBL
™
Gemcitabine for Injection
may be used alone or in
combination with other medicines
to treat cancer.
This medicine is not addictive.
This medicine is available only
with a doctor’s prescription.
BEFORE YOU ARE GIVEN
DBL
™ GEMCITABINE FOR
INJECTION
_WHEN YOU MUST NOT BE _
_GIVEN IT _
YOU MUST NOT BE GIVEN DBL
™
GEMCITABINE FOR INJECTION IF YOU
HAVE AN ALLERGY TO:
•
any medicine containing
gemcitabine hydrochloride
•
any of the ingredients listed at
the end of this leaflet
•
if the packaging is torn or
shows sign of tampering.
Some of the symptoms of an
allergic reaction may include
shortness of breath, wheezing or
difficulty breathing; swelling of

Summary of Product characteristics

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Supersedes: Version 4
Page 1 of 20
AUSTRALIAN
PRODUCT
INFORMATION
–
DBL
TM
GEMCITABINE
FOR
INJECTION
(GEMCITABINE HYDROCHLORIDE) POWDER
FOR INJECTION
1.
NAME OF THE MEDICINE
Gemcitabine hydrochloride
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
200 mg/ vial in single packs
1 g/ vial in single packs
2 g/ vial in single packs
For the full list of excipients, see
SECTION 6.1 LIST OF EXCIPIENTS
.
3.
PHARMACEUTICAL FORM
DBL™ Gemcitabine for Injection is a white to off-white lyophilized
powder in a clear glass
vial.
DBL
TM
Gemcitabine
for
Injection
is
a
white
to
off-white
lyophilised
powder
to
be
reconstituted for intravenous use.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
DBL
TM
Gemcitabine Injection is indicated:
•
for treatment of patients with locally advanced or metastatic
non-small cell lung
cancer.
•
for treatment of patients with locally advanced or metastatic
adenocarcinoma of the
pancreas.
•
for treatment of patients with Fluorouracil refractory pancreatic
cancer.
•
alone or in combination with cisplatin, is indicated for treatment of
patients with
bladder cancer.
•
in combination with paclitaxel, for the treatment of patients with
unresectable, locally
recurrent
or
metastatic
breast
cancer
who
have
relapsed
following
adjuvant/neoadjuvant chemotherapy. Prior chemotherapy should have
included an
anthracycline unless clinically contraindicated.
•
in combination with carboplatin, for the treatment of patients with
recurrent epithelial
ovarian carcinoma, who have relapsed > 6 months following
platinum-based therapy.
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Supersedes: Version 4
Page 2 of 20
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSAGE
NON-SMALL CELL LUNG CANCER:
_Single-agent use (Adults) _
The optimum dose schedule for gemcitabine has not been determined. The
recommended
dose of gemcitabine is 1,000 mg/m
2
, given by 30 minute intravenous infusion. This should be
repeated once weekly for three weeks, followed by a one week rest
period. This four week
cycle is then repeated. Dosage re