Erlotinib Vipharm 100 mg filmomhulde tabletten

Země: Nizozemsko

Jazyk: nizozemština

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

Aktivní složka:

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

Dostupné s:

Vipharm S.A. ul. A. i F. Radziwillow 9 05-850 OZARÓW MAZOWIECKI (POLEN)

ATC kód:

L01XE03

INN (Mezinárodní Name):

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

Léková forma:

Filmomhulde tablet

Složení:

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),

Podání:

Oraal gebruik

Terapeutické oblasti:

Erlotinib

Přehled produktů:

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);

Datum autorizace:

1900-01-01

Informace pro uživatele

Erlotinib Vipharm 25/100/150 mg
(as hydrochloride)
Film-coated tablets
M1.3.1_PIL NL/H/4481/001-003/IB/004 v.nl
Page 1 of 8
1.3.1
Package leaflet - Core
PACKAGE LEAFLET: INFORMATION FOR THE USER
Erlotinib Vipharm 25 mg filmomhulde tabletten
Erlotinib Vipharm 100 mg filmomhulde tabletten
Erlotinib Vipharm 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 [Product name] is and what it is used for
2.
What you need to know before you take [Product name]
3.
How to take [Product name]
4.
Possible side effects
5.
How to store [Product name]
6.
Contents of the pack and other information
1
WHAT [PRODUCT NAME] IS AND WHAT IT IS USED FOR
[Product name] contains the active substance erlotinib. [Product name]
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.
[Product name] 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.
Erl

Charakteristika produktu

Erlotinib Vipharm 25/100/150 mg
(as hydrochloride)
Film-coated tablets
SmPC NL/H/4481/001-003/IB/004 v.nl plus renewal: update sections 9 and
10
Page 1 of 22
1.3.1
Summary of Product Characteristics
1.
NAME OF THE MEDICINAL PRODUCT
Erlotinib Vipharm 25 mg filmomhulde tabletten
Erlotinib Vipharm 100 mg filmomhulde tabletten
Erlotinib Vipharm 150 mg filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
[Product name] 25 mg film-coated tablets: One film-coated tablet
contains 25 mg erlotinib (as erlotinib
hydrochloride).
Excipient(s) with known effect
Each film-coated tablet contains 17.7 mg lactose monohydrate. Each
film-coated tablet contains less than 1 mmol
sodium (23 mg).
[Product name] 100 mg film-coated tablets: One film-coated tablet
contains 100 mg erlotinib (as erlotinib
hydrochloride).
Excipient(s) with known effect
Each film-coated tablet contains 70.7 mg lactose monohydrate. Each
film-coated tablet contains less than 1 mmol
sodium (23 mg).
[Product name] 150 mg film-coated tablets: One film-coated tablet
contains 150 mg erlotinib (as erlotinib
hydrochloride).
Excipient(s) with known effect
Each film-coated tablet contains 106 mg lactose monohydrate. Each
film-coated tablet contains less than 1 mmol
sodium (23 mg).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
[Product name] 25 mg film-coated tablets: White, round, biconvex
tablets with “E9OB” debossed on one side
and “25” on the other, with a diameter of approximately 6 mm.
[
Product name] 100 mg film-coated tablets: 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.
Product name] 150 mg film-coated tablets: White, round, biconvex
tablets with “E9OB” debossed on one side
and “150” on the other, with a diameter of approximately 10.4 mm.
Erlotinib Vipharm 25/100/150 mg
(as hydroch