Erlotinib Zentiva 100 mg, filmomhulde tabletten

Krajina: Holandsko

Jazyk: holandčina

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

Aktívna zložka:

ERLOTINIBHYDROCHLORIDE 109,3 mg/stuk SAMENSTELLING overeenkomend met ; ERLOTINIB 100 mg/stuk

Dostupné z:

Zentiva k.s. U kabelovny 130 102 37 PRAGUE 10 (TSJECHIË)

ATC kód:

L01XE03

INN (Medzinárodný Name):

ERLOTINIBHYDROCHLORIDE 109,3 mg/stuk SAMENSTELLING overeenkomend met ; ERLOTINIB 100 mg/stuk

Forma lieku:

Filmomhulde tablet

Zloženie:

CALCIUMWATERSTOFFOSFAAT 0-WATER (E 341) ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; HYPROLOSE (E 463) ; HYPROMELLOSE (E 464) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT ; NATRIUMZETMEELGLYCOLAAT ; POLYETHYLEENGLYCOL (E 1521) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171), CALCIUMWATERSTOFFOSFAAT 0-WATER (E 341) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; HYPROLOSE (E 463) ; HYPROMELLOSE (E 464) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT (E 487) ; NATRIUMZETMEELGLYCOLAAT ; POLYETHYLEENGLYCOL (E 1521) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171), CALCIUMWATERSTOFFOSFAAT 0-WATER (E 341) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; HYPROLOSE (E 463) ; HYPROMELLOSE (E 464) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT (E 487) ; NATRIUMZETMEELGLYCOLAAT (E468) ; POLYETHYLEENGLYCOL (E 1521) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171),

Spôsob podávania:

Oraal gebruik

Terapeutické oblasti:

Erlotinib

Prehľad produktov:

Hulpstoffen: CALCIUMWATERSTOFFOSFAAT 0-WATER (E 341); CELLULOSE, MICROKRISTALLIJN (E 460); HYPROLOSE (E 463); HYPROMELLOSE (E 464); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); NATRIUMLAURILSULFAAT (E 487); NATRIUMZETMEELGLYCOLAAT (E468); POLYETHYLEENGLYCOL (E 1521); SILICIUMDIOXIDE (E 551); TITAANDIOXIDE (E 171);

Dátum Autorizácia:

1900-01-01

Príbalový leták

ERLOTINIB HYDROCHLORIDE_25 mg_100 mg_150 mg_film-coated
tablet_NL_en_NL-H-4482-
001-003_ EPAR 05/2023 + DL 10/2023
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ERLOTINIB ZENTIVA 25 MG, FILMOMHULDE TABLETTEN
ERLOTINIB ZENTIVA 100 MG, FILMOMHULDE TABLETTEN
ERLOTINIB ZENTIVA 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 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 Erlotinib Zentiva is and what it is used for
2. What you need to know before you take Erlotinib Zentiva
3. How to take Erlotinib Zentiva
4. Possible side effects
5. How to store Erlotinib Zentiva
6. Contents of the pack and other information
1.
WHAT ERLOTINIB ZENTIVA IS AND WHAT IT IS USED FOR
Erlotinib Zentiva contains the active substance erlotinib. Erlotinib
Zentiva 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.
Erlotinib Zentiva 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

Súhrn charakteristických

ERLOTINIB HYDROCHLORIDE_25 mg_100 mg_150 mg_film-coated
tablet_NL_en_NL-H-4482-
001-003_ EPAR 05/2023 + DL 10/2023
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAAM VAN HET GENEESMIDDEL
Erlotinib Zentiva 25 mg, filmomhulde tabletten
Erlotinib Zentiva 100 mg, filmomhulde tabletten
Erlotinib Zentiva 150 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Erlotinib Zentiva 25 mg, filmomhulde tabletten: Each film-coated
tablet contains 25 mg erlotinib
(as erlotinib hydrochloride).
Excipient with known effect: Each film-coated tablet contains 17.7 mg
lactose monohydrate.
Erlotinib Zentiva 100 mg, filmomhulde tabletten: Each film-coated
tablet contains 100 mg erlotinib
(as erlotinib hydrochloride).
Excipient with known effect: Each film-coated tablet contains 70.7 mg
lactose monohydrate.
Erlotinib Zentiva 150 mg, filmomhulde tabletten: Each film-coated
tablet contains 150 mg erlotinib
(as erlotinib hydrochloride).
Excipient with known effect: Each film-coated tablet contains 106 mg
lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Erlotinib Zentiva 25 mg, filmomhulde tabletten: White, round, biconvex
tablets with “E9OB”
debossed on one side and “25” on the other, with a diameter of
approximately 6 mm.
Erlotinib Zentiva 100 mg, filmomhulde tabletten: White, round,
biconvex tablets with a score line on
both sides, on one side the tablet is debossed with “E9OB” above
the score line and “100” below
the score line, with a diameter of approximately 10 mm. The tablet can
be divided into equal doses.
Erlotinib Zentiva 150 mg, filmomhulde tabletten: White, round,
biconvex tablets with “E9OB”
debossed on one side and “150” on the other, with a diameter of
approximately 10.4 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Non-small cell lung cancer (NSCLC)
Erlotinib Zentiva is indicated for the first-line treatment of
patients with locally advanced or metastatic
non-small cell lung cancer (NSCLC) with EGFR activating mutat