GIOTRIF 20 MG

Negara: Israel

Bahasa: Inggris

Sumber: Ministry of Health

Bahan aktif:

AFATINIB AS DIMALEATE

Tersedia dari:

BOEHRINGER INGELHEIM ISRAEL LTD.

Kode ATC:

L01XE13

Bentuk farmasi:

FILM COATED TABLETS

Komposisi:

AFATINIB AS DIMALEATE 20 MG

Rute administrasi :

PER OS

Jenis Resep:

Required

Diproduksi oleh:

BOEHRINGER INGELHEIM PHARMA GMBH & CO.KG, GERMANY

Area terapi:

AFATINIB

Indikasi Terapi:

GIOTRIF as monotherapy is indicated for the treatment of: • 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.

Tanggal Otorisasi:

2019-02-28

Selebaran informasi

Giotrif
Proposed Patient Information
Film coated tablets 20mg, 30mg, 40mg, 50mg
December 2019
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
The dispensing of this medicine requires a physician’s prescription
GIOTRIF
® 20 MG
GIOTRIF
® 30 MG
GIOTRIF
® 40 MG
GIOTRIF
® 50 MG
FILM-COATED TABLES
Each film-coated
tablet of Giotrif 20 mg contains 20 mg afatinib (as dimaleate).
Each film-coated
tablet of Giotrif 30 mg contains 30 mg afatinib (as dimaleate).
Each film-coated
tablet of Giotrif 40 mg contains 40 mg afatinib (as dimaleate).
Each film-coated tablet of Giotrif 50 mg contains 50 mg afatinib (as
dimaleate).
Inactive ingredients and allergens in this medicine: See in Section 2
'Important information about
some of the ingredients in this medicine' and Section 6 ‘Additional
Information’.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet contains
concise information about this medicine. If you have any further
questions, refer to your physician
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 THIS MEDICINE INTENDED FOR?
This medicine is used as a monotherapy to treat:
•
Adult patients who have non-small cell lung cancer (NSCLC), identified
by a mutation in the
EGFR (Epidermal Growth Factor Receptor) gene,
whose illness is in an advanced localized
or metastatic stage and who have not yet been treated with tyrosine
kinase inhibitors for EGF
receptor.
•
Adult patients who have the squamous type of non-small cell lung
cancer (NSCLC), whose
illness in an advanced localized or metastatic stage and had
progressed during or after
chemotherapy.
THERAPEUTIC GROUP: Antineoplastic, tyrosine kinase inhibitors.
2.
BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
•
You are sensitive (allergic) to the active ingredient afatinib, or to
any of the other
ingredients that this medicine contains (see Se

Karakteristik produk

Giotrif
Updated Prescribing Information
Film coated tablets 20mg, 30mg, 40mg, 50mg
December 2019
1
THE CONTENT OF THIS LEAFLET IS APPROVED BY THE MINISTRY OF HEALTH IN
DECEMBER 2016 AND
UPDATED ACCORDING TO MOH GUIDELINES IN DECEMBER 2019
GIOTRIF
AFATINIB
Film coated tablets
PRESCRIBING INFORMATION
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
Active ingredient:
Giotrif 20 mg: One film-coated tablet contains 20 mg afatinib (as
dimaleate).
Giotrif 30 mg: One film-coated tablet contains 30 mg afatinib (as
dimaleate).
Giotrif 40 mg: One film-coated tablet contains 40 mg afatinib (as
dimaleate).
Giotrif 50 mg: One film-coated tablet contains 50 mg afatinib (as
dimaleate).
Excipient with known effect
Giotrif 20 mg: One film-coated tablet contains 124 mg lactose (as
monohydrate).
Giotrif 30 mg: One film-coated tablet contains 186 mg lactose (as
monohydrate).
Giotrif 40 mg: One film-coated tablet contains 248 mg lactose (as
monohydrate).
Giotrif 50 mg: One film-coated tablet contains 310 mg lactose (as
monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
GIOTRIF 20 mg: 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: 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: 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: Dark blue, oval, biconvex film-coated tablet debossed
with the code “T50” on one side and
the Boehringer Ingelheim company logo on the other.
Giotrif
Updated Prescribing Information
Film coat