NAVELBINE vinorelbine 10mg/mL (as tartrate) injection vial

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

vinorelbine tartrate, Quantity: 13.85 mg/mL (Equivalent: vinorelbine, Qty 10 mg/mL)

Tilgjengelig fra:

Pierre Fabre Australia Pty Ltd

Legemiddelform:

Injection, concentrated

Sammensetning:

Excipient Ingredients: water for injections

Administreringsrute:

Intravenous

Enheter i pakken:

10 x 1ML, 1 x 1mL

Resept typen:

(S4) Prescription Only Medicine

Indikasjoner:

Navelbine 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. Navelbine is indicated for the treatment, in combination with cisplatin, of patients with completely resected non-small cell lung cancer of stage IB or greater.

Produkt oppsummering:

Visual Identification: A clear, colourless to pale yellow solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Autorisasjon status:

Licence status A

Autorisasjon dato:

1998-02-16

Informasjon til brukeren

NAVELBINE IV
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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 NAVELBINE IV?
Navelbine IV contains the active ingredient vinorelbine tartrate.
Navelbine IV is used to treat lung cancer and advanced breast
cancer. For more information, see Section 1. Why am I using Navelbine
IV?1. Why am I using Navelbine IV? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE NAVELBINE IV?
Do not use if you have ever had an allergic reaction to 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
Navelbine IV? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Navelbine IV 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 NAVELBINE IV?
Navelbine IV is given as a slow infusion (drip) into your veins.
Navelbine IV must only be given by a doctor or nurse.
More instructions can be found in Section 4. How do I use Navelbine
IV? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING NAVELBINE IV?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Navelbine IV.
•
Keep all appointments with your doctor to check on your progress and
monitor side effects.
•
If you become pregnant while taking Navelbine IV, tell your doctor
immediately.
THINGS YOU
SHOULD NOT DO
•
You should not breast-feed while you are being treated with Navelbine
IV.
•
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 had a yellow fever vaccination or plan
to have one.
•
Do not u

Preparatomtale

Version: A05-{210721}
Page 1
Supersedes: A04-080620
AUSTRALIAN PRODUCT INFORMATION – NAVELBINE
® INJECTION
(VINORELBINE TARTRATE) CONCENTRATED INJECTION
1
NAME OF THE MEDICINE
Vinorelbine tartrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 mL contains 10 mg vinorelbine (as tartrate) and each 5 mL
contains 50 mg
vinorelbine (as tartrate).
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Concentrated injection
NAVELBINE Injection is a clear, colourless to pale yellow solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
NAVELBINE 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.
NAVELBINE is indicated for the treatment, in combination with
cisplatin, of patients with
completely resected non-small cell lung cancer of stage IB or greater.
4.2
DOSE AND METHOD OF ADMINISTRATION
ADULTS
_ADVANCED BREAST CANCER AND NON-SMALL CELL LUNG CANCER _
•
Single agent treatment is usually given at 25-30 mg/m
2
weekly intravenously.
•
In combination chemotherapy the dose may be the same and the frequency
of
administration reduced, ie: day 1 and 8 or day 1 and 5 every 3 weeks.
Version: A05-{210721}
Page 2
Supersedes: A04-080620
_RESECTED NON-SMALL CELL LUNG CANCER (STAGE IB OR GREATER) _
In combination with cisplatin for treatment of patients with
completely resected non-small
cell lung cancer (Stage IB or greater), NAVELBINE may be administered
at an initial dose of
25-30 mg/m
2
intravenously at weekly intervals for 16 weeks. The dose of cisplatin
is
100 mg/m
2
administered intravenously over 1 hour, on days 1, 29, 57 and 85.
•
NAVELBINE should be administered either by infusion over 6 to 10
minutes after
dilution in 50 mL of a normal saline solution or by a infusion over 20
to 30 minutes, after
dilution in 125 mL of normal saline solution. Administration should
always be followed
by at