Lenalidomide ratiopharm 2,5 mg, harde capsules

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

LENALIDOMIDEHYDROCHLORIDE 1-WATER 3 mg/stuk SAMENSTELLING overeenkomend met ; LENALIDOMIDE 2,5 mg/stuk

Beschikbaar vanaf:

Ratiopharm GmbH Graf-Arco-Strasse 3 89079 ULM (DUITSLAND)

ATC-code:

L04AX04

INN (Algemene Internationale Benaming):

LENALIDOMIDEHYDROCHLORIDE 1-WATER 3 mg/stuk SAMENSTELLING overeenkomend met ; LENALIDOMIDE 2,5 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) ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK (E 904) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; ZWARTE INKT

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Lenalidomide

Autorisatie datum:

2018-11-20

Bijsluiter

Lenalidomide, NL/H/4068/001-007, 08.03.2023
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BIJSLUITER: INFORMATIE VOOR DE GEBRUIKER
LENALIDOMIDE RATIOPHARM 2,5 MG, HARDE CAPSULES
LENALIDOMIDE RATIOPHARM 5 MG, HARDE CAPSULES
LENALIDOMIDE RATIOPHARM 7,5 MG, HARDE CAPSULES
LENALIDOMIDE RATIOPHARM 10 MG, HARDE CAPSULES
LENALIDOMIDE RATIOPHARM 15 MG, HARDE CAPSULES
LENALIDOMIDE RATIOPHARM 20 MG, HARDE CAPSULES
LENALIDOMIDE RATIOPHARM 25 MG, HARDE 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 [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
WHAT [PRODUCT NAME] IS
[Product name] contains the active substance ‘lenalidomide’. This
medicine belongs to a group of
medicines which affect how your immune system works.
WHAT {PRODUCT NAME] IS USED FOR
[Product name] is used in adults for
•
Multiple myeloma
•
Myelodysplastic syndromes
•
Mantle cell lymphoma
•
Follicular lymphoma
MULTIPLE MY
ELOMA
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 fo

Productkenmerken

Lenalidomide, NL/H/4068/001-007, 08.03.2023
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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAAM VAN HET GENEESMIDDEL
Lenalidomide ratiopharm 2,5 mg, harde capsules
Lenalidomide ratiopharm 5 mg, harde capsules
Lenalidomide ratiopharm 7,5 mg, harde capsules
Lenalidomide ratiopharm 10 mg, harde capsules
Lenalidomide ratiopharm 15 mg, harde capsules
Lenalidomide ratiopharm 20 mg, harde capsules
Lenalidomide ratiopharm 25 mg, harde capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
[Product name] 2.5 mg hard capsules
Each capsule contains lenalidomide hydrochloride hydrate corresponding
to 2.5 mg of lenalidomide.
[Product name] 5 mg hard capsules
Each capsule contains lenalidomide hydrochloride hydrate corresponding
to 5 mg of lenalidomide.
[Product name] 7.5 mg hard capsules
Each capsule contains lenalidomide hydrochloride hydrate corresponding
to 7.5 mg of lenalidomide.
[Product name] 10 mg hard capsules
Each capsule contains lenalidomide hydrochloride hydrate corresponding
to 10 mg of lenalidomide.
[Product name] 15 mg hard capsules
Each capsule contains lenalidomide hydrochloride hydrate corresponding
to 15 mg of lenalidomide.
[Product name] 20 mg hard capsules
Each capsule contains lenalidomide hydrochloride hydrate corresponding
to 20 mg of lenalidomide.
[Product name] 25 mg hard capsules
Each capsule contains lenalidomide hydrochloride hydrate corresponding
to 25 mg of lenalidomide.
Excipients with known effect:
[Product name] 2.5 mg hard capsules:
Each capsule contains 0.5 mg of sodium.
[Product name] 5 mg hard capsules:
Each capsule contains 0.5 mg of sodium.
[Product name] 7.5 mg hard capsules:
Each capsule contains 0.67 mg of sodium.
[Product name] 10 mg hard capsules:
Each capsule contains 0.9 mg of sodium.
[Product name] 15 mg hard capsules:
Each capsule contains 1.35 mg of sodium.
[Product name] 20 mg hard capsules:
Each capsule contains 1.80 mg of sodium.
Lenalidomide, NL/H/4068/001-007, 08.03.2023
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