VINORELBINE EBEWE 50 mg/5 mL (as tartrate) injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

vinorelbine tartrate, Quantity: 13.85 mg/mL

Available from:

Sandoz Pty Ltd

Pharmaceutical form:

Injection, concentrated

Composition:

Excipient Ingredients: water for injections; nitrogen

Administration route:

Intravenous

Units in package:

1 x 5mL vial

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of advanced breast cancer after failure of standard therapy, as a single agent or in combination; and as first line treatment for advanced non-small cell lung cancer, as a single agent or in combination.

Product summary:

Visual Identification: Clear, colourless to pale yellow solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2006-04-27

Patient Information leaflet

Vinorelbine Ebewe®
1
VINORELBINE EBEWE®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING VINORELBINE EBEWE?
Vinorelbine Ebewe contains the active ingredient vinorelbine tartrate.
Vinorelbine Ebewe is used to treat lung cancer and
advanced breast cancer. For more information, see Section 1. Why am I
using Vinorelbine Ebewe?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE VINORELBINE EBEWE?
Do not use if you have ever had an allergic reaction to vinorelbine or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Vinorelbine Ebewe?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Vinorelbine Ebewe and affect how it
works.
A list of these medicines is in Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW DO I USE VINORELBINE EBEWE?
Vinorelbine Ebewe is given as a slow infusion (drip) into your veins.
Vinorelbine Ebewe must only be given by a doctor or
nurse.
More instructions can be found in Section 4. How do I use Vinorelbine
Ebewe? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING VINORELBINE EBEWE?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Vinorelbine Ebewe.
•
Keep all appointments with your doctor to check on your progress and
monitor side effects.
•
If you become pregnant while taking Vinorelbine Ebewe, tell your
doctor immediately.
THINGS YOU
SHOULD NOT DO
•
You should not breast-feed while you are being treated with
Vinorelbine Ebewe.
•
Do not use if you have or have had an infection or high temperature in
the last 2 weeks.
•
Do not use if you are currently receiving radiation therapy.
•
Do not use if you have recently

Summary of Product characteristics

220209-vinorelbine-ebewe-pi
Page 1 of 19
AUSTRALIAN PRODUCT INFORMATION
VINORELBINE EBEWE
® (VINORELBINE TARTRATE)
1
NAME OF THE MEDICINE
Vinorelbine tartrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 mL of Vinorelbine Ebewe contains 13.85 mg of vinorelbine tartrate
(equivalent to 10 mg
vinorelbine).
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Vinorelbine Ebewe is available as a concentrated injection for
intravenous use.
Vinorelbine Ebewe is a clear, colourless to pale yellow solution in a
clear glass vial.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Vinorelbine Ebewe is indicated for the treatment of advanced breast
cancer after failure of
standard therapy, as a single agent or in combination; and as first
line treatment for advanced
non-small cell lung cancer, as a single agent or in combination.
4.2
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
_ADULTS _
Single agent treatment is usually given at 25 - 30 mg/m
2
weekly.
In combination chemotherapy, the dose may be the same and the
frequency of administration
reduced, i.e. days 1 and 8 or days 1 and 5 every three weeks.
METHOD OF ADMINISTRATION
Vinorelbine Ebewe should be administered either by slow bolus over 6
to 10 minutes after
dilution in 50 mL of a normal saline solution or by a short infusion
over 20 to 30 minutes after
dilution in 125 mL of normal saline solution. Administration should
always be followed by at
least 250 mL normal saline infusion to flush the vein and prevent
phlebitis. Vinorelbine Ebewe
is a moderate vesicant. Insertion of a central venous line may be
necessary (see Section 4.8
Adverse effects (Undesirable effects)).
_CAUTION._
Vinorelbine Ebewe must only be administered intravenously through an
infusion line.
It is extremely important that the intravenous needle or catheter be
properly positioned before
any vinorelbine is injected. Leakage into surrounding tissue during
intravenous administration
of
Vinorelbine
Ebewe
may
cause
considerable
irritation,
local
tissue
necrosis
and/or
t