Lenalidomide Alkaloid-INT 10 mg, harde capsules

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

LENALIDOMIDE 10 mg/stuk

Beschikbaar vanaf:

Alkaloid - INT d.o.o. Slandrova ulica 4 1231 LJUBLJANA-CRNUCE (SLOVENIË)

ATC-code:

L04AX04

INN (Algemene Internationale Benaming):

LENALIDOMIDE 10 mg/stuk

farmaceutische vorm:

Capsule, hard

Samenstelling:

AMMONIA (E 527) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; GELATINE (E 441) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ZWART (E 172) ; INDIGOKARMIJN (E 132) ; KALIUMHYDROXIDE (E 525) ; LACTOSE 0-WATER ; MAGNESIUMSTEARAAT (E 470b) ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK (E 904) ; TITAANDIOXIDE (E 171) ; ZWARTE INKT

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Lenalidomide

Autorisatie datum:

2019-07-15

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LENALIDOMIDE ALKALOID-INT 5 MG, HARDE CAPSULES
LENALIDOMIDE ALKALOID-INT 10 MG HARD CAPSULES
LENALIDOMIDE ALKALOID-INT 15 MG HARD CAPSULES
LENALIDOMIDE ALKALOID-INT 25 MG HARD CAPSULES
lenalidomide
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 Lenalidomide Alkaloid-INT
is and what it is used for
2.
What you need to know before you take Lenalidomide Alkaloid-INT
3.
How to take Lenalidomide Alkaloid-INT
4.
Possible side effects
5.
How to Lenalidomide Alkaloid-INT
6.
Contents of the pack and other information
1
WHAT LENALIDOMIDE ALKALOID-INT IS AND WHAT IT IS USED FOR
Lenalidomide Alkaloid-INT
contains the active substance ‘lenalidomide’. This medicine
belongs to a group of
medicines which affect how your immune system works.
Lenalidomide Alkaloid-INT
is used in adults for
•
Multiple Myeloma
•
Follicular lymphoma
MULTIPLE MYELOMA
Multiple myeloma is a type of cancer which affects a certain kind of
white blood cell, called the plasma cell.
These cells collect in the bone marrow and divide, becoming out of
control. This can damage the bones and
kidneys.
Multiple myeloma generally cannot be cured. However, the signs and
symptoms can be greatly reduced or
disappear for a period of time. This is called a ‘response’.
Newly diagnosed multiple myeloma - in patients who have had a bone
marrow transplant
Lenalidomide Alkaloid-INT
is used on its own as a maintenance therapy after patients have
recovered enough
following a bone marrow transplant.
Newly

Productkenmerken

1.
NAME OF THE MEDICINAL PRODUCT
Lenalidomide Alkaloid-INT 5 mg, harde capsules
Lenalidomide Alkaloid-INT 10 mg, harde capsules
Lenalidomide Alkaloid-INT 15 mg, harde capsules
Lenalidomide Alkaloid-INT 25 mg, harde capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 5 mg of lenalidomide.
Each capsule contains 10 mg of lenalidomide.
Each capsule contains 15 mg of lenalidomide.
Each capsule contains 25 mg of lenalidomide.
Excipient(s) with known effect:
Each capsule contains 66.4 mg of lactose.
Each capsule contains 132.9 mg of lactose.
Each capsule contains 199.3 mg of lactose.
Each capsule contains 332.2 mg of lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule.
Opaque white body and opaque white cap, with a length of approximately
18.0 mm, marked “L9NL” and “5”.
Opaque yellow body and opaque green to light green cap, with a length
of approximately 21.7 mm, marked
“L9NL” and “10”.
Opaque white body and opaque blue to light blue cap, with a length of
approximately 21.7 mm, marked “L9NL”
and “15”.
Opaque white body and opaque white cap, with a length of approximately
21.7 mm, marked “L9NL” and “25”.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Multiple myeloma
Lenalidomide Alkaloid-INT as monotherapy is indicated for the
maintenance treatment of adult patients with
newly diagnosed multiple myeloma who have undergone autologous stem
cell transplantation.
Lenalidomide Alkaloid-INT as combination therapy with dexamethasone,
or bortezomib and dexamethasone, or
melphalan and prednisone (see section 4.2) is indicated for the
treatment of adult patients with previously
untreated multiple myeloma who are not eligible for transplant.
Lenalidomide Alkaloid-INT in combination with dexamethasone is
indicated for the treatment of multiple
myeloma in adult patients who have received at least one prior
therapy.
Follicular lymphoma
Lenalidomide Alkaloid-INT in combination with rituximab (anti-CD20
antibody) is indicated for the