Vinorelbine Te Arai

Ülke: Yeni Zelanda

Dil: İngilizce

Kaynak: Medsafe (Medicines Safety Authority)

Aktif bileşen:

Vinorelbine tartrate 41.55mg equivalent to vinorelbine 30mg;  

Mevcut itibaren:

Te Arai BioFarma Limited

Doz:

30 mg

Farmasötik formu:

Capsule

Kompozisyon:

Active: Vinorelbine tartrate 41.55mg equivalent to vinorelbine 30mg   Excipient: Gelatin Iron oxide red Macrogol 400 Polysorbate 80 Purified water   Sorbitol Titanium dioxide

Reçete türü:

Prescription

Terapötik endikasyonlar:

Vinorelbine is indicated in adults over 18. For the treatment of advanced breast cancer after failure of standard therapy as a single agent or in combination.

Ürün özeti:

Package - Contents - Shelf Life: Blister pack, Al-Al in cardboard carton - 1 capsules - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Blister pack, PVC/PVDC/Aluminium in cardboard carton - 1 capsules - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)

Yetkilendirme tarihi:

2018-06-27

Bilgilendirme broşürü

Consumer Medicine Information
VINORELBINE TE ARAI 20mg soft capsule
VINORELBINE TE ARAI 30mg soft capsule
VINORELBINE TE ARAI 80mg soft capsule Vinorelbine as tartrate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, ask your doctor or your pharmacist.
•
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them,
even if their symptoms are the same as yours.
•
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1.
What Vinorelbine soft capsule is and what it is used for
2.
Before you take Vinorelbine soft capsule
3.
How to take Vinorelbine soft capsule
4.
Possible side effects
5
Storing Vinorelbine soft capsule
6.
Further information
1. What Vinorelbine soft capsule is and what it is used for
Vinorelbine belongs to a family of medicines used to treat cancer
called the vinca-alkaloid family.
Vinorelbine is used to treat:
o Non-small cell lung cancer
o Advanced breast cancer that has not responded to other medicines.
It is NOT recommended for use by children under 18 years old.
2. Before you take Vinorelbine soft capsule
DO NOT TAKE VINORELBINE SOFT CAPSULE
If you are allergic (hypersensitive) to the active ingredient,
vinorelbine, or any of the related family of
cancer drugs called the vinca alkaloids.
•
If you are allergic to any of the other ingredients in Vinorelbine
capsules (refer to section 6 of
this leaflet).
•
If you are pregnant or think that you might be pregnant.
•
If you are breast feeding.
•
If you have a severe liver disease.
•
If you have had an operation on your stomach or small bowel, or if you
have gut disorder which
affects how you absorb food. These may affect how your body absorbs
Vinorelbine.
•
If you have a low white blood cell count (neutrophils, leucocytes) or
a severe infection current
or recent within two weeks.
•
If you re

Ürün özellikleri

NEW ZEALAND DATA SHEET
Vinorelbine Te Arai
New Zealand Data Sheet Vinorelbine Te Arai v 1.0 March 2021
Page 1 of 17
1 PRODUCT NAME
Vinorelbine Te Arai 20 mg soft capsules
Vinorelbine Te Arai 30 mg soft capsules
Vinorelbine Te Arai 80 mg soft capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 20 mg vinorelbine (as tartrate)
Each capsule contains 30 mg vinorelbine (as tartrate)
Each capsule contains 80 mg vinorelbine (as tartrate)
3 PHARMACEUTICAL FORM
Soft capsule.
Vinorelbine 20 mg: An oval-shaped light brown soft capsule, with the
size of 11x7 mm filled with a
transparent, colourless to slightly yellow liquid.
Vinorelbine 30 mg: An oblong-shaped pink soft capsule, with the size
of 18x6 mm filled with a
transparent, colourless to slightly yellow liquid.
Vinorelbine 80 mg: An oblong-shaped pale-yellow soft capsule, with the
size of 21x8 mm filled with a
transparent, colourless to slightly yellow liquid.
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
Vinorelbine is indicated in adults over 18
_Non-small cell lung cancer _
Vinorelbine is indicated for the first line treatment of advanced
non-small cell lung cancer, as a single
agent or in combination.
_Breast cancer _
Vinorelbine is indicated for the treatment of advanced breast cancer
after failure of standard therapy
as a single agent or in combination.
4.2
Dose and method of administration
Vinorelbine must be given strictly by the oral route. They should be
swallowed whole with water and
should not be chewed or sucked. It is recommended that the capsule be
taken with food.
_ADULTS (aged over 18 years) _
_Single agent _
The recommended regimen is:
First three administrations: 60 mg/m
2
, administered once weekly.
Subsequent administrations: Beyond the third administration,
increasing the dose of vinorelbine to 80
mg/m
2
once weekly is recommended, except in those patients for whom the
neutrophil count has
dropped once below 500/mm
3
or more than once between 500 and 1000/mm
3
during the first 3
administrations at 60 mg/m
2
.
NEW ZEALAND