Lenalidomide Accord

Kraj: Unia Europejska

Język: angielski

Źródło: EMA (European Medicines Agency)

Składnik aktywny:

lenalidomide

Dostępny od:

Accord Healthcare S.L.U.

Kod ATC:

L04AX04

INN (International Nazwa):

lenalidomide

Grupa terapeutyczna:

Immunosuppressants

Dziedzina terapeutyczna:

Multiple Myeloma

Wskazania:

Multiple myelomaLenalidomide Accord as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation.Lenalidomide Accord 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.Lenalidomide Accord 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 Accord in combination with rituximab (anti-CD20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (Grade 1 – 3a).

Podsumowanie produktu:

Revision: 11

Status autoryzacji:

Authorised

Data autoryzacji:

2018-09-20

Ulotka dla pacjenta

92
B. PACKAGE LEAFLET
93
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LENALIDOMIDE ACCORD 2.5 MG HARD CAPSULES
LENALIDOMIDE ACCORD 5 MG HARD CAPSULES
LENALIDOMIDE ACCORD 7.5 MG HARD CAPSULES
LENALIDOMIDE ACCORD 10 MG HARD CAPSULES
LENALIDOMIDE ACCORD 15 MG HARD CAPSULES
LENALIDOMIDE ACCORD 20 MG HARD CAPSULES
LENALIDOMIDE ACCORD 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 Accord is and what it is used for
2.
What you need to know before you take Lenalidomide Accord
3.
How to take Lenalidomide Accord
4.
Possible side effects
5.
How to store Lenalidomide Accord
6.
Contents of the pack and other information
1.
WHAT LENALIDOMIDE ACCORD IS AND WHAT IT IS USED FOR
WHAT LENALIDOMIDE ACCORD IS
Lenalidomide Accord contains the active substance ‘lenalidomide’.
This medicine belongs to a group
of medicines which affect how your immune system works.
WHAT LENALIDOMIDE ACCORD IS USED FOR
Lenalidomide Accord 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 m

Charakterystyka produktu

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Lenalidomide Accord 2.5 mg hard capsules
Lenalidomide Accord 5 mg hard capsules
Lenalidomide Accord 7.5 mg hard capsules
Lenalidomide Accord 10 mg hard capsules
Lenalidomide Accord 15 mg hard capsules
Lenalidomide Accord 20 mg hard capsules
Lenalidomide Accord 25 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
Lenalidomide Accord
2.5 mg hard capsules
Each hard capsule contains 2.5 mg of lenalidomide.
_Excipient with known effect _
Each hard capsule contains 36 mg of lactose.
Lenalidomide Accord
5 mg hard capsules
Each hard capsule contains 5 mg of lenalidomide.
_Excipient with known effect_
Each hard capsule contains 33 mg of lactose.
Lenalidomide Accord
7.5 mg hard capsules
Each hard capsule contains 7.5 mg of lenalidomide.
_Excipient with known effect _
Each hard capsule contains 50 mg of lactose.
Lenalidomide Accord
10 mg hard capsules
Each hard capsule contains 10 mg of lenalidomide.
_Excipient with known effect _
Each hard capsule contains 67 mg of lactose.
Lenalidomide Accord 15 mg hard capsules
Each hard capsule contains 15 mg of lenalidomide.
_Excipient with known effect _
Each hard capsule contains 100 mg of lactose.
Lenalidomide Accord 20 mg hard capsules
Each hard capsule contains 20 mg of lenalidomide.
_Excipient with known effect _
Each hard capsule contains 134 mg of lactose.
3
Lenalidomide Accord 25 mg hard capsules
Each hard capsule contains 25 mg of lenalidomide.
_Excipient with known effect _
Each hard capsule contains 167 mg of lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule (capsule)
Lenalidomide Accord 2.5 mg hard capsules
Gelatin hard capsules size “5” approximately 11.0 mm to 11.8 mm in
length, grey cap and opaque
white body with “LENALIDOMIDE” printed on cap in black and “2.5
mg” printed on body in green,
containing white to off white coloured powder.
Lenalidomide Accord 5 mg hard capsules
Gelatin hard capsules size “5” approximatel