Tafinlar

מדינה: ניו זילנד

שפה: אנגלית

מקור: Medsafe (Medicines Safety Authority)

מרכיב פעיל:

Dabrafenib mesilate 88.88mg equivalent to dabrafenib 75 mg;  ;  

זמין מ:

Novartis New Zealand Ltd

INN (שם בינלאומי):

Dabrafenib mesilate 88.88 mg (equivalent to dabrafenib 75 mg)

כמות:

75 mg

טופס פרצבטיות:

Capsule

הרכב:

Active: Dabrafenib mesilate 88.88mg equivalent to dabrafenib 75 mg     Excipient: Colloidal silicon dioxide Hypromellose Iron oxide red Magnesium stearate Microcrystalline cellulose Purified water Titanium dioxide

סוג מרשם:

Prescription

תוצרת:

Glaxo Wellcome Manufacturing Pte Ltd

סממני תרפויטית:

TAFINLAR is indicated for the treatment of patients with BRAF V600 mutation positive unresectable Stage III or metastatic (Stage IV) melanoma. Tafinlar in combination with trametinib is indicated for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600 mutation. TAFINLAR in combination with MEKINIST, is indicated for the adjuvant treatment of patients with Stage III melanoma with a BRAF V600 mutation, following complete resection.

leaflet_short:

Package - Contents - Shelf Life: Bottle, plastic, HDPE with child resistant PP closure - 28 capsules - 36 months from date of manufacture stored at or below 30°C - Bottle, plastic, HDPE with child resistant PP closure - 120 capsules - 36 months from date of manufacture stored at or below 30°C

תאריך אישור:

2013-09-24

עלון מידע

TAFINLAR
®
1
TAFINLAR
®
_dabrafenib (as mesilate) capsules _
NZ CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
PLEASE READ THIS LEAFLET CAREFULLY
BEFORE YOU START USING TAFINLAR.
This leaflet answers some common
questions about TAFINLAR.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
final page. More recent information
on the medicine may be available.
YOU SHOULD ENSURE THAT YOU SPEAK
TO YOUR PHARMACIST OR DOCTOR TO
OBTAIN THE MOST UP TO DATE
INFORMATION ON THE MEDICINE.
YOU CAN ALSO DOWNLOAD THE MOST UP
TO DATE LEAFLET FROM
WWW.MEDSAFE.GOVT.NZ.
The updates may contain important
information about the medicine and
its use of which you should be aware.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking TAFINLAR
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT TAFINLAR IS
USED FOR
TAFINLAR capsules contain the
active substance dabrafenib, which
belongs to a group of medicines
called "Selective BRAF-inhibitors".
TAFINLAR can be used by itself or
in combination with another
medicine called MEKINIST.
IF YOU ARE TAKING THESE MEDICINES
TOGETHER, PLEASE READ THE
MEKINIST CONSUMER MEDICINE
INFORMATION AS WELL AS THIS ONE
CAREFULLY.
TAFINLAR is a medicine used to:
•
Treat types of:
−
Skin cancers called melanoma
−
Thyroid cancers called
anaplastic thyroid cancer
(ATC)
−
lung cancers called non-small
cell lung cancer (NSCLC)
that have spread to other parts of
the body.
•
Prevent melanoma from coming
back after the melanoma has been
removed by surgery.
All of these cancers have changes
(mutations) in a gene called "BRAF"
that may have caused the cancer to
develop.
TAFINLAR targets proteins made
from this mutated BRAF gene and
slows down or stops the development
of you

מאפייני מוצר

NEW ZEALAND DATA SHEET
TAFINLAR
 CAPSULES
_Dabrafenib mesilate_
Page 1 of 49
1. PRODUCT NAME
TAFINLAR 50 mg hard capsules
TAFINLAR 75 mg hard capsules
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
TAFINLAR 50 mg capsule
Each hard capsule contains 50mg of dabrafenib (as mesilate).
TAFINLAR 75 mg capsule
Each hard capsule contains 75mg of dabrafenib (as mesilate).
EXCIPIENTS
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Hard capsules.
TAFINLAR 50 mg capsule
Opaque, size 2, hard capsule composed of a dark red body and dark red
cap containing a white
to slightly coloured solid. The capsule shell is imprinted with GS TEW
and 50 mg.
TAFINLAR 75 mg capsule
Opaque, size 1, hard capsule composed of a dark pink body and dark
pink cap containing a
white to slightly coloured solid. The capsule shell is imprinted with
GS LHF and 75 mg.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Unresectable or metastatic melanoma
TAFINLAR as monotherapy is indicated for the treatment of patients
with BRAF V600
mutation positive unresectable Stage III or metastatic (Stage IV)
melanoma.
TAFINLAR in combination with MEKINIST is indicated for the treatment
of patients with
unresectable or metastatic melanoma with a BRAF V600 mutation.
Adjuvant treatment of melanoma
TAFINLAR in combination with MEKINIST, is indicated for the adjuvant
treatment of patients
with Stage III melanoma with a BRAF V600 mutation, following complete
resection.
Anaplastic thyroid cancer (ATC)
TAFINLAR in combination with MEKINIST is indicated for the treatment
of patients with
locally advanced or metastatic anaplastic thyroid cancer (ATC) with a
BRAF V600 mutation.
Non-small cell lung cancer (NSCLC)
TAFINLAR in combination with MEKINIST is indicated for the treatment
of patients with
advanced non-small cell lung cancer (NSCLC) with a BRAF V600 mutation.
NEW ZEALAND DATA SHEET
TAFINLAR
 CAPSULES
_Dabrafenib mesilate_
Page 2 of 49
4.2 DOSE AND METHOD OF ADMINISTRATION
Treatment with TAFINLAR should be initiated by a physician experience