GIOTRIF FILM-COATED TABLETS 50MG

Krajina: Singapur

Jazyk: angličtina

Zdroj: HSA (Health Sciences Authority)

Aktívna zložka:

Afatinib dimaleate 73.9000mg eqv Afatinib

Dostupné z:

BOEHRINGER INGELHEIM SINGAPORE PTE. LTD.

ATC kód:

L01XE13

Dávkovanie:

50.0000mg

Forma lieku:

TABLET, FILM COATED

Zloženie:

Afatinib dimaleate 73.9000mg eqv Afatinib 50.0000mg

Spôsob podávania:

ORAL

Typ predpisu:

Prescription Only

Výrobca:

Boehringer Ingelheim Pharma GmbH & Co. KG

Stav Autorizácia:

ACTIVE

Dátum Autorizácia:

2013-12-17

Príbalový leták

1 
0281-01 (SG)                                

                                 20140828 
Giotrif®

Abcd 

COMPOSITION 
1 film-coated tablet contains                     
                50 mg, 40 mg, 30 mg, or 20 mg of
afatinib (=free base) 

corresponding to                               

          73.9 mg, 59.12 mg, 44.34 mg, or 29.56 mg 
2-butenamide,  _N_-[4-[3(-chloro-4-fluorophenyl)amino]-7-[[(_3S_)-tetrahydro-3-furanyl]oxy]-6-quinazolinyl]-
4-(dimethylamino)-,(_2E_)-, (_2Z_)-2-butenedioate (1:2) (= _AFATINIB DIMALEATE_)  

Excipients:   
_Tablet Core:_    lactose monohydrate, microcrystalline cellulose (E460), colloidal anhydrous silica
(E551), 

crospovidone, magnesium stearate (E470b) 
_Film coating_:   hypromellose  2910 (E464), macrogol 400, titanium dioxide (E171), talc (E553b), 
polysorbate 80 (E433), Colourant containing indigo carmine (E132) aluminium hydroxide 
(only used for 50 mg, 40 mg and 30 mg tablets) 

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. 

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. 

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. 

50mg: dark blue,�

Súhrn charakteristických

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