GIOTRIF FILM-COATED TABLETS 50MG

Riik: Singapur

keel: inglise

Allikas: HSA (Health Sciences Authority)

Toimeaine:

Afatinib dimaleate 73.9000mg eqv Afatinib

Saadav alates:

BOEHRINGER INGELHEIM SINGAPORE PTE. LTD.

ATC kood:

L01XE13

Annus:

50.0000mg

Ravimvorm:

TABLET, FILM COATED

Koostis:

Afatinib dimaleate 73.9000mg eqv Afatinib 50.0000mg

Manustamisviis:

ORAL

Retsepti tüüp:

Prescription Only

Valmistatud:

Boehringer Ingelheim Pharma GmbH & Co. KG

Volitamisolek:

ACTIVE

Loa andmise kuupäev:

2013-12-17

Infovoldik

1
Abcd
PACKAGE LEAFLET: INFORMATION FOR THE USER
GIOTRIF
® 20 MG FILM-COATED TABLETS
GIOTRIF
®
30 MG FILM-COATED TABLETS
GIOTRIF
® 40 MG FILM-COATED TABLETS
Afatinib (as dimaleate)
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 you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. 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
7.
Marketing Authorisation Holder and Manufacturer
8.
Product registration number
9.
Date of revision
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 is prescribed to you
as your first treatment.
•
of squamous type if prior chemotherapy treatment has been
insufficient.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE GIOTRIF
DO NOT TAKE GIOTRIF
2
•
if you are allergic to afatinib or any o

Toote omadused

1
Giotrif®
Abcd
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
One film-coated tablet contains 20 mg, 30 mg, 40 mg or 50 mg afatinib
(as dimaleate).
Excipient with known effect:
GIOTRIF 20 mg: One film-coated tablet contains 118 mg lactose (as
monohydrate).
GIOTRIF 30 mg: One film-coated tablet contains 176 mg lactose (as
monohydrate).
GIOTRIF 40 mg: One film-coated tablet contains 235 mg lactose (as
monohydrate).
GIOTRIF 50 mg: 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.
GIOTRIF 20mg: white to slightly yellowish, round, biconvex,
bevel-edged film-coated tablet debossed with the
code T20 on one side and the Boehringer Ingelheim company symbol on
the other side.
GIOTRIF 30mg: dark blue, round, biconvex, bevel-edged film-coated
tabled debossed with the code T30 on
one side and with the Boehringer Ingelheim company symbol on the other
side.
GIOTRIF 40mg: light blue, round, biconvex, bevel-edged film-coated
tablet debossed with the code T40 on one
side and with the Boehringer Ingelheim company symbol on the other
side.
GIOTRIF 50mg: dark blue, oval, biconvex, film-coated tablet debossed
with the code T50 on one side and with
the Boehringer Ingelheim company symbol on the other side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
•
GIOTRIF is indicated for the first line treatment of patients with
locally advanced or metastatic non-
small cell lung cancer (NSCLC) with Epidermal Growth Factor Receptor
(EGFR) mutation(s).
•
GIOTRIF as monotherapy is indicated for the treatment of locally
advanced or metastatic NSCLC of
squamous histology progressing on or after platinum-based chemotherapy
2
4.2 DOSAGE AND ADMINISTRATION
_ _
The recommended dose of GIOTRIF
is 40 mg orally once daily.
GIOTRIF
should be taken without food. Food should not