DBL VINORELBINE 10mg/1mL (as tartrate) concentrated injection vial

Country: Australia

Bahasa: Inggeris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

vinorelbine tartrate

Boleh didapati daripada:

Hospira Australia Pty Ltd

Status kebenaran:

Registered

Risalah maklumat

DBL
™
Vinorelbine Injection Concentrate
Page 1
DBL
™
VINORELBINE INJECTION
CONCENTRATE
Vinorelbine _(vi-NOR-el-been)_
CONSUMER MEDICINE INFORMATION_ _
_Date of dispensing _
_Consumer name _
_pharmacy name _
_Consumer address _
_pharmacy address_
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about DBL
™
Vinorelbine Injection Concentrate
(vinorelbine). 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 vinorelbine 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
™
VINORELBINE INJECTION
CONCENTRATE IS USED
FOR
This medicine is used to treat:
•
advanced breast cancer
•
non-small cell lung cancer.
This medicine belongs to a group
of medicines called antineoplastic
or cytotoxic medicines. You may
also hear of these being called
chemotherapy medicines.
_ _
It works by stopping cancer cells
from growing and multiplying. It
may be used alone or in
combination with other medicines
to treat cancer.
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.
_ _
It is available only with a doctor’s
prescription.
There is not enough information
to recommend the use of this
medicine for children.
BEFORE YOU ARE GIVEN
DBL
™ VINORELBINE
INJECTION CONCENTRATE
_WHEN YOU MUST NOT BE _
_GIVEN IT _
YOU MUST NOT BE GIVEN DBL
™
VINORELBINE INJECTION
CONCENTRATE IF YOU HAVE AN
ALLERGY TO:
•
any medicine containing
vinorelbine
•
any other similar medicines,
such as vinblastine,
vincristine or vindesine.
Some of the symptoms of an
allergic reaction may include
shortness of breath, wheezing or
difficulty breathing; swelling of the
face, lips, tongue or other parts o

Ciri produk

Product Information - Australia
Version 4.0
Page 1
DBL™ VINORELBINE INJ ECTION CONCENTRATE
NAME OF THE MEDICINE
Vinorelbine Tartrate
CAS No: 125317-39-7
The chemical structure of vinorelbine tartrate is shown below:
DESCRIPTION
Vinorelbine tartrate is a semi-synthetic vinca alkaloid with
antitumour activity. The chemical name
is 3',4'-didehydro-4'-deoxy-C'-norvincaleukoblastine [R-(
_R_
*,
_R_
*)-2,3 dihydroxybutanedioate
(1:2)(salt)].
Vinorelbine tartrate is a white to yellow or light brown amorphous
powder with the molecular
formula C
45
H
54
N
4
O
8
.2C
4
H
6
O
6
and molecular weight of 1079.12. The aqueous solubility is > 1000
mg/mL in distilled water. DBL™ Vinorelbine Injection Concentrate is
a clear colourless to pale
yellow solution containing 10 mg vinorelbine per mL (present as 13.85
mg of vinorelbine tartrate), in
water for injections. The pH of DBL™ Vinorelbine Injection
Concentrate is approximately 3.0 to
4.0.
PHARMACOLOGY
Vinorelbine is a cytostatic antineoplastic drug. It is a
semi-synthetic member of the vinca alkaloid
family that interferes with microtubule assembly. The vinca alkaloids
are structurally similar
compounds comprised of two multiringed units, vindoline and
catharanthine. Unlike other vinca
alkaloids, the catharanthine unit is the site of structural
modification for vinorelbine. The antitumour
activity of vinorelbine is thought to be due primarily to inhibition
of mitosis at metaphase through its
interaction with tubulin. In intact tectal plates from mouse embryos,
vinorelbine, vincristine, and
vinblastine inhibited mitotic microtubule formation at the same
concentration (2 micromolar),
including a blockade of cells at metaphase. Vincristine produced
depolymerisation of axonal tubules
at 5 micromolar, but vinblastine and vinorelbine did not have this
effect until concentrations of 30
micromolar and 40 micromolar respectively. These data suggest relative
selectivity of vinorelbine
for mitotic microtubules.
Vinorelbine has an active metabolite, 17 deacetylvinorelbine, low
levels o