Revlimid

País: Unió Europea

Idioma: anglès

Font: EMA (European Medicines Agency)

ingredients actius:

lenalidomide

Disponible des:

Bristol-Myers Squibb Pharma EEIG

Codi ATC:

L04AX04

Designació comuna internacional (DCI):

lenalidomide

Grupo terapéutico:

Immunosuppressants

Área terapéutica:

Multiple Myeloma; Lymphoma, Mantle-Cell; Myelodysplastic Syndromes

indicaciones terapéuticas:

Multiple myelomaRevlimid as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation.Revlimid 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.Revlimid in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy.Myelodysplastic syndromesRevlimid as monotherapy is indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate.Mantle cell lymphomaRevlimid as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma.Follicular lymphomaRevlimid in combination with rituximab (anti-CD20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (Grade 1 – 3a).

Resumen del producto:

Revision: 51

Estat d'Autorització:

Authorised

Data d'autorització:

2007-06-14

Informació per a l'usuari

88
B. PACKAGE LEAFLET
89
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
REVLIMID 2.5 MG HARD CAPSULES
REVLIMID 5 MG HARD CAPSULES
REVLIMID 7.5 MG HARD CAPSULES
REVLIMID 10 MG HARD CAPSULES
REVLIMID 15 MG HARD CAPSULES
REVLIMID 20 MG HARD CAPSULES
REVLIMID 25 MG HARD CAPSULES
lenalidomide
This medicine is subject to additional monitoring. This will allow
quick identification of new safety
information. You can help by reporting any side effects you may get.
See the end of section 4 for how to
report side effects.
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 Revlimid is and what it is used for
2.
What you need to know before you take Revlimid
3.
How to take Revlimid
4.
Possible side effects
5.
How to store Revlimid
6.
Contents of the pack and other information
1.
WHAT REVLIMID IS AND WHAT IT IS USED FOR
WHAT REVLIMID IS
Revlimid contains the active substance ‘lenalidomide’. This
medicine belongs to a group of medicines which
affect how your immune system works.
WHAT REVLIMID IS USED FOR
Revlimid 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

Fitxa tècnica

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of new
safety information. Healthcare professionals are asked to report any
suspected adverse reactions. See section
4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Revlimid 2.5 mg hard capsules
Revlimid 5 mg hard capsules
Revlimid 7.5 mg hard capsules
Revlimid 10 mg hard capsules
Revlimid 15 mg hard capsules
Revlimid 20 mg hard capsules
Revlimid 25 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
U
Revlimid 2.5 mg hard capsules
Each capsule contains 2.5 mg of lenalidomide.
U
Excipient(s) with known effect
Each capsule contains 73.5 mg of lactose (as anhydrous lactose).
U
Revlimid 5 mg hard capsules
Each capsule contains 5 mg of lenalidomide.
U
Excipient(s) with known effect
Each capsule contains 147 mg of lactose (as anhydrous lactose).
U
Revlimid 7.5 mg hard capsules
Each capsule contains 7.5 mg of lenalidomide.
U
Excipient(s) with known effect
Each capsule contains 144.5 mg of lactose (as anhydrous lactose).
U
Revlimid 10 mg hard capsules
Each capsule contains 10 mg of lenalidomide.
U
Excipient(s) with known effect
Each capsule contains 294 mg of lactose (as anhydrous lactose).
U
Revlimid 15 mg hard capsules
Each capsule contains 15 mg of lenalidomide.
U
Excipient(s) with known effect
Each capsule contains 289 mg of lactose (as anhydrous lactose).
U
Revlimid 20 mg hard capsules
Each capsule contains 20 mg of lenalidomide.
U
Excipient(s) with known effect
Each capsule contains 244.5 mg of lactose (as anhydrous lactose).
U
Revlimid 25 mg hard capsules
Each capsule contains 25 mg of lenalidomide.
U
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
3.
PHARMACEUTICAL FORM
Hard capsule.
U
Revlimid 2.5 mg hard capsules
Blue-green/white capsules, size 4, 14.3 mm, marked “REV 2.5 mg”.
U
Revlimid 5 mg hard capsules
White capsules, size 2,