Erlotinib Orion 25 mg Filmdragerad tablett

Šalis: Švedija

kalba: švedų

Šaltinis: Läkemedelsverket (Medical Products Agency)

Veiklioji medžiaga:

erlotinibhydroklorid

Prieinama:

Orion Corporation

ATC kodas:

L01EB02

INN (Tarptautinis Pavadinimas):

erlotinib hydrochloride

Dozė:

25 mg

Vaisto forma:

Filmdragerad tablett

Sudėtis:

erlotinibhydroklorid 27,3 mg Aktiv substans; laktos (vattenfri) Hjälpämne

Recepto tipas:

Receptbelagt

Produkto santrauka:

Förpacknings: Blister, 30 tabletter

Autorizacija statusas:

Avregistrerad

Leidimo data:

2019-01-15

Pakuotės lapelis

PACKAGE LEAFLET: INFORMATION FOR THE USER
ERLOTINIB ORION 25 MG FILM-COATED TABLETS
ERLOTINIB ORION 100 MG FILM-COATED TABLETS
ERLOTINIB ORION 150 MG FILM-COATED TABLETS
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 Erlotinib Orion is and what it is used for
2.
What you need to know before you take Erlotinib Orion
3.
How to take Erlotinib Orion
4.
Possible side effects
5.
How to store Erlotinib Orion
6.
Contents of the pack and other information
1.
WHAT ERLOTINIB ORION IS AND WHAT IT IS USED FOR
Erlotinib Orion contains the active substance erlotinib. Erlotinib
Orion 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 Orion 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
ERLOTINIB ORION
Do not take Erlotinib Orion:
-
if you are allergic to erlotinib or any of the ingredients of this
medicine

Prekės savybės

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Erlotinib Orion 25 mg film-coated tablets
Erlotinib Orion 100 mg film-coated tablets
Erlotinib Orion 150 mg film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Erlotinib Orion 25 mg film-coated tablets
Each tablet contains erlotinib hydrochloride equivalent to 25 mg of
erlotinib.
Erlotinib Orion 100 mg film-coated tablets
Each tablet contains erlotinib hydrochloride equivalent to 100 mg of
erlotinib.
Erlotinib Orion 150 mg film-coated tablets
Each tablet contains erlotinib hydrochloride equivalent to 150 mg of
erlotinib.
Excipient(s) with known effect:
Each 25 mg film-coated tablet contains 29 mg lactose and 0.34 mg
sodium.
Each 100 mg film-coated tablet contains 115 mg lactose and 1.4 mg
sodium.
Each 150 mg film-coated tablet contains 173 mg lactose and 2.1 mg
sodium.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet.
25 mg: White to off-white, round, biconvex coated tablet, diameter 5.6
mm. Engraved “ER” over “25” on
one side, “APO” on the other side.
100 mg: White to off-white, round, biconvex coated tablet, diameter
8.7 mm. Engraved “ER” over “100”
on one side, “APO” on the other side.
150 mg: White to off-white, round, biconvex coated tablet, diameter
10.3 mm. Engraved “ER” over
“150” on one side, “APO” on the other side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_Non-Small Cell Lung Cancer (NSCLC):_
Erlotinib Orion is indicated for the first-line treatment of patients
with locally advanced or metastatic non-
small cell lung cancer (NSCLC) with EGFR activating mutations.
Erlotinib Orion 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.
Erlotinib Orion 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
w