Erlotinib Teva 25 mg, filmomhulde tabletten

Country: Olanda

Lingwa: Olandiż

Sors: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Ingredjent attiv:

ERLOTINIBHYDROCHLORIDE SAMENSTELLING overeenkomend met ; ERLOTINIB

Disponibbli minn:

Teva Nederland B.V. Swensweg 5 2031 GA HAARLEM

Kodiċi ATC:

L01XE03

INN (Isem Internazzjonali):

ERLOTINIBHYDROCHLORIDE COMPOSITION corresponding to ; ERLOTINIB

Għamla farmaċewtika:

Filmomhulde tablet

Kompożizzjoni:

CELLULOSE, MICROKRISTALLIJN (E 460) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; LACTOSE 1-WATER ; MACROGOL 4000 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT (E 487) ; NATRIUMZETMEELGLYCOLAAT ; PLANTAARDIGE OLIE, GEHYDREERD ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; LACTOSE 1-WATER ; MACROGOL 4000 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT (E 487) ; NATRIUMZETMEELGLYCOLAAT (E468) ; PLANTAARDIGE OLIE, GEHYDREERD ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171),

Rotta amministrattiva:

Oraal gebruik

Żona terapewtika:

Erlotinib

Sommarju tal-prodott:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); LACTOSE 1-WATER; MACROGOL 4000; MAGNESIUMSTEARAAT (E 470b); NATRIUMLAURILSULFAAT (E 487); NATRIUMZETMEELGLYCOLAAT (E468); PLANTAARDIGE OLIE, GEHYDREERD; SILICIUMDIOXIDE (E 551); TITAANDIOXIDE (E 171);

Data ta 'l-awtorizzazzjoni:

2017-04-24

Fuljett ta 'informazzjoni

1
BIJSLUITER: INFORMATIE VOOR DE GEBRUIKER
ERLOTINIB TEVA 25 MG, FILMOMHULDE TABLETTEN
ERLOTINIB TEVA 100 MG, FILMOMHULDE TABLETTEN
ERLOTINIB TEVA 150 MG, FILMOMHULDE TABLETTEN
Erlotinib
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 is and what it is used for
2.
What you need to know before you take
3.
How to take
4.
Possible side effects
5.
How to store
6.
Contents of the pack and other information
1.
WHAT IS AND WHAT IT IS USED FOR
contains the active substance erlotinib.
is a medicine used to treat
cancer by preventing the activity of a protein called epidermal growth
factor receptor (EGFR). This
protein is known to be involved in the growth and spread of cancer
cells.
is indicated for adults. This medicine can be
prescribed to you if you have non-small
cell lung cancer at an advanced stage. It can be prescribed as initial
therapy or as therapy if your
disease remains largely unchanged after initial chemotherapy, provided
your cancer cells have specific
EGFR mutations. It can also be prescribed if previous chemotherapy has
not helped to stop your
disease.
This medicine can also be prescribed to you in combination with
another treatment called gemcitabine
if you have cancer of the pancreas at a metastatic stage.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
DO NOT TAKE :

if you are allergic to erlotinib or any of the other ingredients of
this med

Karatteristiċi tal-prodott

1
1.
NAAM VAN HET GENEESMIDDEL
Erlotinib Teva 25 mg, filmomhulde tabletten
Erlotinib Teva 100 mg, filmomhulde tabletten
Erlotinib Teva 150 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 25 mg erlotinib (as erlotinib
hydrochloride)
One film-coated tablet contains 100 mg erlotinib (as erlotinib
hydrochloride)
One film-coated tablet contains 150 mg erlotinib (as erlotinib
hydrochloride)
Excipients with known effect:
25 mg: Each film-coated tablet contains 27.531 mg lactose monohydrate.
100 mg: Each film-coated tablet contains 110.125 mg lactose
monohydrate.
150 mg: Each film-coated tablet contains 165.188 mg lactose
monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
25 mg: White, round, biconvex tablets, with debossing
25 on one side with
dimensions of about 6.1 x 3.3 mm.
100 mg: White, round, biconvex tablets, with debossing
100 on one side with
dimensions of about 10.1 x 4.1 mm.
150 mg: White, round, biconvex tablets, with debossing
150 on one side with
dimensions of about 11.1 x 5.4 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Non-Small Cell Lung Cancer (NSCLC)
is indicated for the first-line treatment of patients
with locally advanced or metastatic
non-small cell lung cancer (NSCLC) with EGFR activating mutations.
is also indicated for switch maintenance treatment in
patients with locally advanced
or metastatic NSCLC with EGFR activating mutations and stable disease
after first-line chemotherapy.
is also indicated for the treatment of patients with
locally advanced or metastatic
NSCLC after failure of at least one prior chemotherapy regimen. In
patients with tumours without
EGFR activating mutations, erlotinib is indicated when other treatment
options are not considered
suitable.
When prescribing , factors associated with prolonged
survival should be taken into
account. No survival benefit or