Giotrif

Država: Evropska unija

Jezik: angleščina

Source: EMA (European Medicines Agency)

Aktivna sestavina:

afatinib

Dostopno od:

Boehringer Ingelheim International GmbH

Koda artikla:

L01XE13

INN (mednarodno ime):

afatinib

Terapevtska skupina:

Antineoplastic agents

Terapevtsko območje:

Carcinoma, Non-Small-Cell Lung

Terapevtske indikacije:

Giotrif as monotherapy is indicated for the treatment ofEpidermal Growth Factor Receptor (EGFR) TKI-naïve adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutation(s);locally advanced or metastatic NSCLC of squamous histology progressing on or after platinum-based chemotherapy.

Povzetek izdelek:

Revision: 15

Status dovoljenje:

Authorised

Datum dovoljenje:

2013-09-25

Navodilo za uporabo

46
B. PACKAGE LEAFLET
47
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
GIOTRIF 20 MG FILM-COATED TABLETS
afatinib
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 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 any of these side effects get serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist. See section 4.
WHAT IS IN THIS LEAFLET
1.
What GIOTRIF is and what it is used for
2.
What you need to know before you take GIOTRIF
3.
How to take GIOTRIF
4.
Possible side effects
5.
How to store GIOTRIF
6.
Contents of the pack and other information
1.
WHAT GIOTRIF IS AND WHAT IT IS USED FOR
GIOTRIF is a medicine which contains the active substance afatinib. It
works by blocking the activity
of a group of proteins called the ErbB family (including EGFR
[epidermal growth factor receptor or
ErbB1], HER2 [ErbB2], ErbB3 and ErbB4). These proteins are involved in
the growth and spread of
cancer cells, and can be affected by changes (mutations) in the genes
that produce them. By blocking
the activity of these proteins this medicine can inhibit growth and
spread of cancer cells.
This medicine is used on its own to treat adult patients with a
specific type of cancer of the lung
(non-small cell lung cancer):

that is identified by a change (mutation) in the gene for EGFR.
GIOTRIF can be prescribed to
you as your first treatment or if prior chemotherapy treatment has
been insufficient.

of squamous type if prior chemotherapy treatment has been
insufficient.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE GIOTRIF
DO NOT TAKE GIOTRIF
-
if you are allergic to afatinib or any of the other ingredients of
this medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or p

Lastnosti izdelka

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
GIOTRIF 20 mg film-coated tablets
GIOTRIF 30 mg film-coated tablets
GIOTRIF 40 mg film-coated tablets
GIOTRIF 50 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
GIOTRIF 20 mg film-coated tablets
One film-coated tablet contains 20 mg afatinib (as dimaleate).
_Excipient with known effect_
One film-coated tablet contains 118 mg lactose (as monohydrate).
GIOTRIF 30 mg film-coated tablets
One film-coated tablet contains 30 mg afatinib (as dimaleate).
_Excipient with known effect_
One film-coated tablet contains 176 mg lactose (as monohydrate).
GIOTRIF 40 mg film-coated tablets
One film-coated tablet contains 40 mg afatinib (as dimaleate).
_Excipient with known effect_
One film-coated tablet contains 235 mg lactose (as monohydrate).
GIOTRIF 50 mg film-coated tablets
One film-coated tablet contains 50 mg afatinib (as dimaleate).
_Excipient with known effect_
One film-coated tablet contains 294 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
GIOTRIF 20 mg film-coated tablets
White to yellowish, round, biconvex and bevel-edged film-coated tablet
debossed with the code “T20”
on one side and the Boehringer Ingelheim company logo on the other.
GIOTRIF 30 mg film-coated tablets
Dark blue, round, biconvex and bevel-edged film-coated tablet debossed
with the code “T30” on one
side and the Boehringer Ingelheim company logo on the other.
GIOTRIF 40 mg film-coated tablets
Light blue, round, biconvex and bevel-edged film-coated tablet
debossed with the code “T40” on one
side and the Boehringer Ingelheim company logo on the other.
GIOTRIF 50 mg film-coated tablets
Dark blue, oval, biconvex film-coated tablet debossed with the code
“T50” on one side and the
Boehringer Ingelheim company logo on the other.
3
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
GIOTRIF as monotherapy is indicated for the treatment of

Epidermal Growth Facto