Vinorelbine Ebewe

Страна: Новая Зеландия

Язык: английский

Источник: Medsafe (Medicines Safety Authority)

Активный ингредиент:

Vinorelbine tartrate 13.85 mg/mL Equivalent to 10 mg/mL of vinorelbine

Доступна с:

Sandoz New Zealand Limited

ИНН (Международная Имя):

Vinorelbine tartrate 13.85 mg/mL (Equivalent to 10 mg/mL of vinorelbine)

дозировка:

10 mg/mL

Фармацевтическая форма:

Concentrate for injection

состав:

Active: Vinorelbine tartrate 13.85 mg/mL Equivalent to 10 mg/mL of vinorelbine Excipient: Water for injection

Штук в упаковке:

Vial, glass, Type I with butyl rubber stop and crimp cap 1 mL, 1 mL

класс:

Prescription

Тип рецепта:

Prescription

Производитель:

Minakem High Potent SA

Терапевтические показания :

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.

Обзор продуктов:

Package - Contents - Shelf Life: Vial, glass, Type I with butyl rubber stop and crimp cap 1 mL - 1 mL - 2 years from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, Type I with butyl rubber stop and crimp cap 5 x 1 mL - 5 mL - 2 years from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, Type I with butyl rubber stop and crimp cap 5 mL - 5 mL - 2 years from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, Type I with butyl rubber stop and crimp cap 5 x 5 mL - 25 mL - 2 years from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)

Дата Авторизация:

2004-07-26

тонкая брошюра

VINORELBINE EBEWE_ _
vinorelbine tartrate 10mg/mL
Concentrated Solution for Injection
CONSUMER MEDICINE INFORMATION
_ _
_ _
_ _
WHAT IS IN THIS LEAFLET
__________
______________________________________________________________________
Vinorelbine Ebewe
Vinorelbine Ebewe _CMI_v2.0_6Apr06.doc
Page 1 of 5
This leaflet answers some
common questions about
Vinorelbine Ebewe.
It does not contain all the
available information.
It does not take the place of
talking to your doctor and
pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you being
given Vinorelbine Ebewe
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 IN A SAFE
PLACE.
You may need to read it again.
WHAT IS VINORELBINE
EBEWE USED FOR
Vinorelbine Ebewe is used to
treat advanced breast cancer
and a type of lung cancer.
Vinorelbine Ebewe belongs to a
group of medicines called
antineoplastic or cytotoxic
medicines. You may also hear
of these being called
chemotherapy medicines.
Vinorelbine Ebewe is thought to
work by stopping cancer cells
from growing and multiplying.
Vinorelbine Ebewe may be used
in combination with other
medicines to treat cancer.
If you have breast cancer, you
have probably taken another
medicine to treat it before.
However, your doctor has now
recommended you should be
given Vinorelbine Ebewe.
YOUR DOCTOR MAY HAVE
PRESCRIBED VINORELBINE EBEWE
FOR ANOTHER REASON. ASK YOUR
DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY
VINORELBINE EBEWE HAS BEEN
PRESCRIBED FOR YOU.
Vinorelbine Ebewe is not
addictive.
This medicine is available only
with a doctor's prescription.
VINORELBINE EBEWE IS NOT
RECOMMENDED FOR USE IN
CHILDREN, AS THERE IS NOT
ENOUGH INFORMATION ON ITS
EFFECTS IN CHILDREN
BEFORE YOU ARE GIVEN
VINORELBINE EBEWE
_When you must not be given _
_it _
DO NOT HAVE VINORELBINE
EBEWE IF YOU HAVE AN ALLERGY
TO VINORELBINE EBEWE OR ANY
OF THE INGREDIENTS LISTED AT THE
END OF THIS LEAFLET. Symptom

Характеристики продукта

 
20130620_Vinorelbine Ebewe_Datasheet_v4.0_clean 

Page 1 of 15 
DATA SHEET 
VINORELBINE EBEWE 
10 MG IN 1 ML AND 50 MG IN 5 ML INJECTION CONCENTRATE 
NAME OF THE MEDICINE 
Vinorelbine  

Chemical name: 3',4'-didehydro-4'- deoxy-C'- norvincaleukoblastine [R-(R*,R*)-2,3 
dihydroxybutanedioate (1:2)(salt)] 
Molecular formula: C
45
H
54
N
4
O
8. 
2C
4
H
6
O
6 
Molecular weight: 1,079.12.  
CAS: 125317-39-7 vinorelbine tartrate, 71486-22-1 vinorelbine 
DESCRIPTION 
_ACTIVE:  _Vinorelbine tartrate (13.85 mg, equivalent to 10 mg
vinorelbine per mL) 
_INACTIVE:  _Water for injection, Nitrogen 
Vinorelbine Ebewe injection
concentrate is a clear colourless to
pale yellow solution. The aqueous 
solubility is > 1,000 mg/mL in distilled water.  The
pH of Vinorelbine Ebewe injection concentrate is 
approximately 3.5. 
PHARMACOLOGY 
Vinorelbine is a cytostatic antineoplastic medicine.  It is a
semisynthetic 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 and 40 micromolar, respectively.  These
data suggest relative selectivity of 
vinorelbine for