TAFINLAR 50 MG

国: イスラエル

言語: 英語

ソース: Ministry of Health

有効成分:

DABRAFENIB AS MESILATE

から入手可能:

NOVARTIS ISRAEL LTD

ATCコード:

L01XE23

医薬品形態:

HARD CAPSULE

構図:

DABRAFENIB AS MESILATE 50 MG

投与経路:

PER OS

処方タイプ:

Required

製:

NOVARTIS PHARMACEUTICAL MANUFACTURING LLC, SLOVENIA

治療領域:

DABRAFENIB

適応症:

Dabrafenib as monotherapy or in combination with trametinib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.Non-small cell lung cancer (NSCLC) :Dabrafenib in combination with trametinib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a BRAF V600 mutation.Adjuvant treatment of melanoma :Dabrafenib in combination with trametinib is indicated for the adjuvant treatment of adult patients with Stage III melanoma with BRAF V600 mutation, following complete resection.BRAF V600E Mutation-Positive Locally Advanced or Metastatic Anaplastic Thyroid CancerTAFINLAR is indicated, in combination with trametinib, for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation and with no satisfactory locoregional treatment optionsBRAF V600E Mutation-Positive Unresectable or Metastatic Solid TumorsTafinlar is indicated, in combination with trametinib, for the treatment of adult and pediatric patients 6 years of age and older with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options. Limitations of Use: Dabrafenib is not indicated for treatment of patients with colorectal cancer because of known intrinsic resistance to BRAF inhibition. Dabrafenib is indicated, in combination with trametinib, for the treatment of pediatric patients 6 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy

承認日:

2019-02-28

情報リーフレット

كدلج يف تاريغت
ريغ عويش( بينيتيمارت ةكراشمب رلانيفت
نولوانتي نيذلا صاخشلأا ىدل ةريطخ
ةيدلج لعف دودر نع غ
ِّ
ل
ُ
ب
:يلي امم
ً
ايأ تظحلا اذإ .)فورعم
تاحرقت .دلجلا رشقت .ةيزكرم تلاصيوح عم
،فده لكش ىلع وأ ةيرئاد ،دلجلا ىلع
رمحلأا نولل ةلئام عقب
∙
نكمي ريطخلا يدلجلا حفطلا اذه نإ
.نينيعلا يفو ةيلسانتلا ءاضعلأا يف
،فنلأا يف ،ةرجنحلا يف ،مفلا يف
.)
Stevens-Johnson syndrome
( ازنإولفنلإاب ةهيبش ضارعأو ةنوخس دعب
رهظي نأ
DRESS-syndrome or drug hypersensitivity
( ةيوافميللا ددغلا مخضتو ةنوخس
،راشتنلإا عساو حفط
∙
.)
syndrome
ً
اروف ةيبط ةدعاسم يقلتل هجوتو ءاودلا
لامعتسإ نع فقوت
فلتخم عون
)100 نيب نم نيلمعتسم 1-10(
رلانيفت نولوانتي نيذلا نيجلاعتملا ىدل
عئاش لكشب روطتي دق
ناطرس نم عون مهيدل روطتي دق نورخآ
صاخشأ ._)_
_cuSCC_
_(_
ةيفشرحلا ايلاخلا ناطرس
ىمسي دلجلا ناطرس نم
اهلاصئتسإ ناكملإابو ةيعضوم هذه دلجلا
تاريغت ىقبت ،ةداع ._)_
_BCC_
_(_
ةيدعاقلا ايلاخلا ناطرس
ىمسي دلجلا
.جاعزإ نود نم رلانيفت ـب جلاعلا ةلصاوم
نكميو ةيحارج ةيلمعب
مارولأا هذه .ةديدج ةينيماتق ماروأ
)امونلايم( روهظ
ً
اضيأ نوظحلاي دق رلانيفت نولوانتي
نيذلا صاخشلأا ضعب
.جاعزإ نود نم رلانيفت ـب جلاعلا ةلصاوم
نكميو ةيحارج ةيلمعب بلغلأا ىلع
اهلاصئتسإ متي ةينيماتقلا
كلوانت ءانثأ رهش لك ةيناث هصحفيس
اهدعبو ،رلانيفت لوانتب

製品の特徴

Page 1 of 47
TAF API NOV23 V6.1
Tafinlar
®
50 mg
Tafinlar
®
75 mg
1.
NAME OF THE MEDICINAL PRODUCT
Tafinlar
®
50 mg
Tafinlar
®
75 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tafinlar 50 mg hard capsules
Each hard capsule contains dabrafenib mesilate equivalent to 50 mg of
dabrafenib.
Tafinlar 75 mg hard capsules
Each hard capsule contains dabrafenib mesilate equivalent to 75 mg of
dabrafenib.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule
Tafinlar 50 mg hard capsules
Opaque dark red capsules, with capsule shell imprinted with ‘GS
TEW’ and ’50 mg’.
Tafinlar 75 mg hard capsules
Opaque dark pink capsules, with capsule shell imprinted with ‘GS
LHF’ and ’75 mg’.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Melanoma
Dabrafenib as monotherapy or in combination with trametinib is
indicated for the treatment of
adult patients with unresectable or metastatic melanoma with a BRAF
V600 mutation (see
sections 4.4 and 5.1).
Adjuvant treatment of melanoma
Dabrafenib in combination with trametinib is indicated for the
adjuvant treatment of adult
patients with Stage III melanoma with a BRAF V600 mutation, following
complete resection.
Non-small cell lung cancer (NSCLC)
Dabrafenib in combination with trametinib is indicated for the
treatment of adult patients with
advanced non-small cell lung cancer with a BRAF V600 mutation.
Anaplastic Thyroid Cancer (ATC
)
Page 2 of 47
TAF API NOV23 V6.1
Dabrafenib is indicated, in combination with trametinib, for the
treatment of patients with
locally advanced or metastatic anaplastic thyroid cancer (ATC) with
BRAF V600E mutation
and with no satisfactory locoregional treatment options
_[see section 4.2]_
.
BRAF V600E Mutation-Positive Unresectable or Metastatic Solid Tumors
Dabrafenib is indicated,
in combination with trametinib, for the treatment of adult and
pediatric patients 6 years of age and older with unresectable or
metastatic solid tumors
with BRAF V600E mutation who have progressed following prior treatment
and have