Lenalidomide Anabiosis 10 mg harde capsules

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

LENALIDOMIDEHYDROCHLORIDE 1-WATER 12,1 mg/stuk SAMENSTELLING overeenkomend met ; LENALIDOMIDE 10 mg/stuk

Beschikbaar vanaf:

Anabiosis PC Side Road Kimis Avenue 3-7 14122 IRAKLIO ATTIKA (GRIEKENLAND)

ATC-code:

L04AX04

INN (Algemene Internationale Benaming):

LENALIDOMIDEHYDROCHLORIDE 1-WATER 12,1 mg/stuk SAMENSTELLING overeenkomend met ; LENALIDOMIDE 10 mg/stuk

farmaceutische vorm:

Capsule, hard

Samenstelling:

AMMONIA (E 527) ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; 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, 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:

2019-11-20

Bijsluiter

2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LENALIDOMIDE ANABIOSIS 5 MG HARD CAPSULES
LENALIDOMIDE ANABIOSIS 10 MG HARD CAPSULES
LENALIDOMIDE ANABIOSIS 15 MG HARD CAPSULES
LENALIDOMIDE ANABIOSIS 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 Anabiosis is and what it is used for
2.
What you need to know before you take Lenalidomide Anabiosis
3.
How to take Lenalidomide Anabiosis
4.
Possible side effects
5.
How to store Lenalidomide Anabiosis
6.
Contents of the pack and other information
1.
WHAT LENALIDOMIDE ANABIOSIS IS AND WHAT IT IS USED FOR
WHAT LENALIDOMIDE ANABIOSIS IS
Lenalidomide Anabiosis contains the active substance
‘lenalidomide’. This medicine belongs to a group
of medicines which affect how your immune system works.
WHAT LENALIDOMIDE ANABIOSIS IS USED FOR
Lenalidomide Anabiosis is used in adults for:
•
Multiple myeloma
•
Myelodysplastic syndromes
•
Mantle cell lymphoma
•
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 Anabiosis is used on its own as m

Productkenmerken

1.
NAME OF THE MEDICINAL PRODUCT
Lenalidomide Anabiosis 5 mg harde capsules
Lenalidomide Anabiosis 10 mg harde capsules
Lenalidomide Anabiosis 15 mg harde capsules
Lenalidomide Anabiosis 25 mg harde capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
[Product name] 5 mg hard capsules
Each capsule contains lenalidomide hydrochloride hydrate corresponding
to 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] 25 mg hard capsules
Each capsule contains lenalidomide hydrochloride hydrate corresponding
to 25 mg of lenalidomide.
Excipients with known effect:
[Product name] 5 mg hard capsules:
Each capsule contains 0.5 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] 25 mg hard capsules:
Each capsule contains 2.25 mg of sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule.
[Product name] 5 mg hard capsules
Hard, non-transparent capsules, size “4” (approximately 14.3 mm in
length), imprinted in black with ‘5’ on white
body and with white cap, containing off-white to pale yellow or beige
powder or compressed powder.
[Product name] 10 mg hard capsules
Hard, non-transparent capsules, size “2” (approximately 18 mm in
length), imprinted in black with ‘10’ on ivory
body and with green cap, containing off-white to pale yellow or beige
powder or compressed powder.
[Product name] 15 mg hard capsules
Hard, non-transparent capsules, size “1” (approximately 19.4 mm in
length), imprinted in black with ‘15’ on white
body and with blue cap, containing off-white to pale yellow or beige
powder or compressed powder.
[Product name] 25 mg hard capsules
Hard, non-transparent capsules, size “0” (appr