Lenalidomide Devatis 15 mg, harde capsules

देश: नीदरलैंड

भाषा: डच

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

सक्रिय संघटक:

LENALIDOMIDE 15 mg/stuk

थमां उपलब्ध:

Devatis GmbH Spitalstrasse 22 795 39 LORRACH (DUITSLAND)

INN (इंटरनेशनल नाम):

LENALIDOMIDE 15 mg/stuk

फार्मास्यूटिकल फॉर्म:

Capsule, hard

रचना:

AMMONIA (E 527) ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; GELATINE (E 441) ; 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, AMMONIA (E 527) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; GELATINE (E 441) ; 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

प्रशासन का मार्ग:

Oraal gebruik

प्राधिकरण की तारीख:

2020-11-02

सूचना पत्रक

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LENALIDOMIDE DEVATIS 2,5 MG, HARDE CAPSULES
LENALIDOMIDE DEVATIS 5 MG, HARDE CAPSULES
LENALIDOMIDE DEVATIS 7,5 MG, HARDE CAPSULES
LENALIDOMIDE DEVATIS 10 MG, HARDE CAPSULES
LENALIDOMIDE DEVATIS 15 MG, HARDE CAPSULES
LENALIDOMIDE DEVATIS 20 MG, HARDE CAPSULES
LENALIDOMIDE DEVATIS 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 {Invented name} is and what it is used for
2.
What you need to know before you take {Invented name}
3.
How to take {Invented name}
4.
Possible side effects
5.
How to store {Invented name}
6.
Contents of the pack and other information
1.
WHAT {INVENTED NAME} IS AND WHAT IT IS USED FOR
WHAT {INVENTED NAME} IS
{Invented name} contains the active substance ‘lenalidomide’. This
medicine belongs to a group of
medicines which affect how your immune system works.
WHAT {INVENTED NAME} IS USED FOR
{Invented name} 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

उत्पाद विशेषताएं

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Lenalidomide Devatis 2,5 mg, harde capsules
Lenalidomide Devatis 5 mg, harde capsules
Lenalidomide Devatis 7,5 mg, harde capsules
Lenalidomide Devatis 10 mg, harde capsules
Lenalidomide Devatis 15 mg, harde capsules
Lenalidomide Devatis 20 mg, harde capsules
Lenalidomide Devatis 25 mg, harde capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
{Invented name} 2.5 mg hard capsules
Each capsule contains 2.5 mg of lenalidomide.
Excipient(s) with known effect
Each capsule contains 20 mg of lactose (as anhydrous lactose).
{Invented name} 5 mg hard capsules
Each capsule contains 5 mg of lenalidomide.
Excipient(s) with known effect
Each capsule contains 40 mg of lactose (as anhydrous lactose).
{Invented name} 7.5 mg hard capsules
Each capsule contains 7.5 mg of lenalidomide.
Excipient(s) with known effect
Each capsule contains 60 mg of lactose (as anhydrous lactose).
{Invented name} 10 mg hard capsules
Each capsule contains 10 mg of lenalidomide.
Excipient(s) with known effect
Each capsule contains 80 mg of lactose (as anhydrous lactose).
{Invented name} 15 mg hard capsules
Each capsule contains 15 mg of lenalidomide.
Excipient(s) with known effect
Each capsule contains 120 mg of lactose (as anhydrous lactose).
{Invented name} 20 mg hard capsules
Each capsule contains 20 mg of lenalidomide.
Excipient(s) with known effect
Each capsule contains 160 mg of lactose (as anhydrous lactose).
{Invented name} 25 mg hard capsules
Each capsule contains 25 mg of lenalidomide.
Excipient(s) with known effect
Each capsule contains 200 mg of lactose (as anhydrous lactose).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
2
Hard capsule
{Invented name} 2.5 mg hard capsules
Size 4 hard gelatin capsules (length: 14.4 mm) with a blue-green cap
and a white body imprinted with
“2.5 mg” with black ink. Capsules are filled with white to
off-white powder.
{Invented name} 5 mg hard capsules
Size 2 hard gelatin capsules (length: 17.8 mm) with a white