MEKINIST 0.5 MG

Страна: Израел

Език: английски

Източник: Ministry of Health

Активна съставка:

TRAMETINIB AS DIMETHYL SULFOXIDE

Предлага се от:

NOVARTIS ISRAEL LTD

АТС код:

L01XE25

Лекарствена форма:

FILM COATED TABLETS

Композиция:

TRAMETINIB AS DIMETHYL SULFOXIDE 0.5 MG

Начин на приложение:

PER OS

Вид предписание :

Required

Произведено от:

LEK PHARMACEUTICALS D.D., SLOVENIA

Терапевтична област:

TRAMETINIB

Терапевтични показания:

Trametinib as monotherapy or in combination with dabrafenib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation. Trametinib monotherapy has not demonstrated clinical activity in patients who have progressed on a prior BRAF inhibitor therapy. Non-small cell lung cancer (NSCLC) :Trametinib in combination with dabrafenib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a BRAF V600 mutation.Adjuvant treatment of melanoma :Trametinib in combination with dabrafenib is indicated for the adjuvant treatment of adult patients with Stage III melanoma with a 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 TumorsMekinist is indicated, in combination with dabrafenib, 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: Trametinib is not indicated for treatment of patients with colorectal cancer because of known intrinsic resistance to BRAF inhibitionTrametinib is indicated, in combination with dabrafenib, 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

Дата Оторизация:

2020-10-31

Листовка

MEK APL MAR22 V5
Page 2 of 14
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
The medicine is dispensed with a doctor's prescription only
MEKINIST
® 0.5 MG, FILM-COATED TABLETS
Each film-coated tablet contains trametinib (as dimethyl sulfoxide)
0.5 mg
MEKINIST
®
2 MG, FILM-COATED TABLETS
Each film-coated tablet contains trametinib (as dimethyl sulfoxide) 2
mg
Inactive ingredients and allergens: See section 6 ‘Additional
information’ and section 2 under ‘Important
information about some of this medicine’s ingredients’.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This
leaflet contains concise information
about the medicine. If you have any further questions, refer to your
doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if it
seems to you that their medical condition is similar to yours.
1.
WHAT IS THE MEDICINE INTENDED FOR?
Mekinist is used as monotherapy or in combination with an additional
medicine containing dabrafenib
for the treatment of adults with a type of skin cancer called melanoma
that has spread to other parts of
the body or cannot be removed by surgery.
Mekinist in combination with dabrafenib is also used for the adjuvant
treatment of stage III melanoma in
adults, following complete removal of the lesion by surgery.
Mekinist in combination with dabrafenib is also used for the treatment
of adults with an advanced stage
of lung cancer called non-small cell lung cancer (NSCLC).
Mekinist in combination with dabrafenib is also intended for the
treatment of a type of thyroid cancer called
anaplastic thyroid cancer (ATC) that has a mutation in the BRAF gene
(BRAF V600E mutation), which has
spread to other parts of the body or is in one place and in advanced
state, and after no satisfactory results
have been obtained from local treatment options.
Mekinist in combination with dabrafenib is intended for the treatment
of solid tumours in adults and
children 6 years and older whic

Данни за продукта

Page 1 of 43
MEK API MAR23 V5
MEKINIST® 0.5 MG
MEKINIST® 2 MG
1.
NAME OF THE MEDICINAL PRODUCT
Mekinist® 0.5 mg film-coated tablets
Mekinist® 2 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Mekinist 0.5 mg film-coated tablets
Each film-coated tablet contains trametinib dimethyl sulfoxide
equivalent to 0.5 mg of trametinib.
Mekinist 2 mg film-coated tablets
Each film-coated tablet contains trametinib dimethyl sulfoxide
equivalent to 2 mg of trametinib.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Mekinist 0.5 mg film-coated tablets
Yellow, modified oval, biconvex, film-coated tablets, with ‘GS’
debossed on one face and ‘TFC’ on
the opposing face.
Mekinist 2 mg film-coated tablets
Pink, round, biconvex, film-coated tablets, with ‘GS’ debossed on
one face and ‘HMJ’ on the
opposing face.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Melanoma
Trametinib as monotherapy or in combination with dabrafenib 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). Trametinib monotherapy has not demonstrated clinical activity in
patients who have progressed
on a prior BRAF inhibitor therapy (see section 5.1).
Adjuvant treatment of melanoma
Trametinib in combination with dabrafenib 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)
Trametinib in combination with dabrafenib is indicated for the
treatment of adult patients with
advanced non-small cell lung cancer with a BRAF V600 mutation.
Page 2 of 43
MEK API MAR23 V5
Anaplastic Thyroid Cancer (ATC)
Trametinib is indicated, in combination with dabrafenib, 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-Positi