Mekinist 2mg tablets

Țară: Regatul Unit

Limbă: engleză

Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredient activ:

Trametinib

Disponibil de la:

Novartis Pharmaceuticals UK Ltd

Codul ATC:

L01XE25

INN (nume internaţional):

Trametinib

Dozare:

2mg

Forma farmaceutică:

Tablet

Calea de administrare:

Oral

Clasă:

No Controlled Drug Status

Tip de prescriptie medicala:

Valid as a prescribable product

Rezumat produs:

BNF: 08010500; GTIN: 5010678913217 5010678913194

Prospect

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MEKINIST
® 0.5 MG FILM-COATED TABLETS
MEKINIST
® 2 MG FILM-COATED TABLETS
trametinib
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, nurse or
pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, nurse or pharmacist.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Mekinist is and what it is used for
2.
What you need to know before you take Mekinist
3.
How to take Mekinist
4.
Possible side effects
5.
How to store Mekinist
6.
Contents of the pack and other information
1.
WHAT MEKINIST IS AND WHAT IT IS USED FOR
Mekinist is a medicine that contains the active substance trametinib.
It is used either on its own or in
combination with another medicine containing dabrafenib to treat 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 to treat a type of lung
cancer called non-small cell lung
cancer (NSCLC).
Both cancers have a particular change (mutation) in a gene called BRAF
at the V600 position. This
mutation in the gene may have caused the cancer to develop. Your
medicine targets proteins made
from this mutated gene and slows down or stops the development of your
cancer.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MEKINIST
Mekinist should only be used to treat melanomas and NSCLC with the
BRAF mutation. Therefore,
before starting tr

Caracteristicilor produsului

OBJECT 1
MEKINIST 2 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 30-Apr-2018 | Novartis
Pharmaceuticals UK Ltd
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions. See
section 4.8 for how to report adverse reactions.
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, approximately
4.8 x 8.9 mm, with “GS” debossed
on one face and “TFC” on the opposing face.
Mekinist 2 mg film-coated tablets
Pink, round, biconvex, film-coated tablets, approximately 7.5 mm, 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).
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.
4.2 Posology and method of administration
Treatment with trametinib should only be initiated and supervised by a
physician experienced in the
administration of anti-cancer medicinal pr