Lenalidomide Mylan

Land: Europese Unie

Taal: Engels

Bron: EMA (European Medicines Agency)

Werkstoffen:

lenalidomide

Beschikbaar vanaf:

Mylan Ireland Limited

ATC-code:

L04AX07

INN (Algemene Internationale Benaming):

lenalidomide

Therapeutische categorie:

Immunosuppressants

Therapeutisch gebied:

Multiple Myeloma

therapeutische indicaties:

Multiple myelomaLenalidomide Mylan as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation.Lenalidomide Mylan as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant.Lenalidomide Mylan in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy.Follicular lymphomaLenalidomide Mylan in combination with rituximab (anti-CD20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (Grade 1-3a).

Product samenvatting:

Revision: 8

Autorisatie-status:

Authorised

Autorisatie datum:

2020-12-18

Bijsluiter

99
B. PACKAGE LEAFLET
100
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LENALIDOMIDE MYLAN 2.5 MG HARD CAPSULES
LENALIDOMIDE MYLAN 5 MG HARD CAPSULES
LENALIDOMIDE MYLAN 7.5 MG HARD CAPSULES
LENALIDOMIDE MYLAN 10 MG HARD CAPSULES
LENALIDOMIDE MYLAN 15 MG HARD CAPSULES
LENALIDOMIDE MYLAN 20 MG HARD CAPSULES
LENALIDOMIDE MYLAN 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, pharmacist or
nurse.
-
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 Mylan is and what it is used for
2.
What you need to know before you take Lenalidomide Mylan
3.
How to take Lenalidomide Mylan
4.
Possible side effects
5.
How to store Lenalidomide Mylan
6.
Contents of the pack and other information
1.
WHAT LENALIDOMIDE MYLAN IS AND WHAT IT IS USED FOR
Lenalidomide Mylan contains the active substance ‘lenalidomide’.
This medicine belongs to a group
of medicines which affect how your immune system works.
Lenalidomide Mylan 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
Lenalidomi

Productkenmerken

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Lenalidomide Mylan 2.5 mg hard capsules
Lenalidomide Mylan 5 mg hard capsules
Lenalidomide Mylan 7.5 mg hard capsules
Lenalidomide Mylan 10 mg hard capsules
Lenalidomide Mylan 15 mg hard capsules
Lenalidomide Mylan 20 mg hard capsules
Lenalidomide Mylan 25 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
Lenalidomide Mylan 2.5 mg hard capsules
Each capsule contains 2.5 mg of lenalidomide.
Lenalidomide Mylan 5 mg hard capsules
Each capsule contains 5 mg of lenalidomide.
Lenalidomide Mylan 7.5 mg hard capsules
Each capsule contains 7.5 mg of lenalidomide.
Lenalidomide Mylan 10 mg hard capsules
Each capsule contains 10 mg of lenalidomide.
Lenalidomide Mylan 15 mg hard capsules
Each capsule contains 15 mg of lenalidomide.
Lenalidomide Mylan 20 mg hard capsules
Each capsule contains 20 mg of lenalidomide.
Lenalidomide Mylan 25 mg hard capsules
Each capsule contains 25 mg of lenalidomide.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule (capsule).
Lenalidomide Mylan 2.5 mg hard capsules
Green and white capsules, size 4, 14 mm, marked “MYLAN /LL 2.5”.
Lenalidomide Mylan 5 mg hard capsules
White capsules, size 2, 18 mm, marked “MYLAN/LL 5”.
Lenalidomide Mylan 7.5 mg hard capsules
Light grey and white capsules, size 2, 18 mm, marked
“MYLAN/LL7.5”.
Lenalidomide Mylan 10 mg hard capsules
Green and light grey capsules, size 0, 22 mm, marked “MYLAN/LL
10”.
Lenalidomide Mylan 15 mg hard capsules
White capsules, size 0, 22 mm, marked “MYLAN/LL15”.
3
Lenalidomide Mylan 20 mg hard capsules
Green and white capsules, size 0, 22 mm, marked “MYLAN/LL 20”.
Lenalidomide Mylan 25 mg hard capsules
White capsules, size 0, 22 mm, marked “MYLAN/LL 25”.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Multiple myeloma
Lenalidomide Mylan as monotherapy is indicated for the maintenance
treatment of adult patients with
newly diagnosed multiple myeloma who have undergone autologous st