Lenalidomide Krka d.d.

Land: Den Europæiske Union

Sprog: engelsk

Kilde: EMA (European Medicines Agency)

Aktiv bestanddel:

lenalidomide hydrochloride hydrate

Tilgængelig fra:

Krka, d.d., Novo mesto 

ATC-kode:

L04AX04

INN (International Name):

lenalidomide

Terapeutisk gruppe:

Immunosuppressants

Terapeutisk område:

Multiple Myeloma; Lymphoma, Follicular; Myelodysplastic Syndromes

Terapeutiske indikationer:

Multiple myelomaLenalidomide Krka d.d. as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation.Lenalidomide Krka d.d. 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 Krka d.d. in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy.Myelodysplastic syndromesLenalidomide Krka d.d. 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.Follicular lymphomaLenalidomide Krka d.d. in combination with rituximab (anti-CD20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (Grade 1 – 3a).

Produkt oversigt:

Revision: 2

Autorisation status:

Withdrawn

Autorisation dato:

2021-02-11

Indlægsseddel

84
B. PACKAGE LEAFLET
Medicinal product no longer authorised
85
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LENALIDOMIDE KRKA D.D. 2.5 MG HARD CAPSULES
LENALIDOMIDE KRKA D.D. 5 MG HARD CAPSULES
LENALIDOMIDE KRKA D.D. 7.5 MG HARD CAPSULES
LENALIDOMIDE KRKA D.D. 10 MG HARD CAPSULES
LENALIDOMIDE KRKA D.D. 15 MG HARD CAPSULES
LENALIDOMIDE KRKA D.D. 20 MG HARD CAPSULES
LENALIDOMIDE KRKA D.D. 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 Krka d.d. is and what it is used for
2.
What you need to know before you take Lenalidomide Krka d.d.
3.
How to take Lenalidomide Krka d.d.
4.
Possible side effects
5.
How to store Lenalidomide Krka d.d.
6.
Contents of the pack and other information
1.
WHAT LENALIDOMIDE KRKA D.D. IS AND WHAT IT IS USED FOR
WHAT LENALIDOMIDE KRKA D.D. IS
Lenalidomide Krka d.d. contains the active substance
‘lenalidomide’. This medicine belongs to a
group of medicines which affect how your immune system works.
WHAT LENALIDOMIDE KRKA D.D. IS USED FOR
Lenalidomide Krka d.d. is used in adults for:
-
Multiple myeloma
-
Myelodysplastic syndromes
-
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. Thi

Produktets egenskaber

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Lenalidomide Krka d.d. 2.5 mg hard capsules
Lenalidomide Krka d.d. 5 mg hard capsules
Lenalidomide Krka d.d. 7.5 mg hard capsules
Lenalidomide Krka d.d. 10 mg hard capsules
Lenalidomide Krka d.d. 15 mg hard capsules
Lenalidomide Krka d.d. 20 mg hard capsules
Lenalidomide Krka d.d. 25 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains lenalidomide hydrochloride monohydrate
equivalent to 2.5 mg, 5 mg,
7.5 mg, 10 mg, 15 mg, 20 mg or 25 mg lenalidomide.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule (capsule)
Lenalidomide Krka d.d. 2.5 mg hard capsules
Capsule cap is green, capsule body is green with imprinted black mark
2.5. Capsule content is white to
yellow white or to brown white powder. Hard capsule size: 4, length 14
± 1 mm.
Lenalidomide Krka d.d. 5 mg hard capsules
Capsule cap is blue, capsule body is blue with imprinted black mark 5.
Capsule content is white to
yellow white or to brown white powder. Hard capsule size: 2, length 18
± 1 mm.
Lenalidomide Krka d.d. 7.5 mg hard capsules
Capsule cap is brown, capsule body is brown with imprinted white mark
7.5. Capsule content is white
to yellow white or to brown white powder. Hard capsule size: 1, length
19 ± 1 mm.
Lenalidomide Krka d.d. 10 mg hard capsules
Capsule cap is green, capsule body is brown with imprinted white mark
10. Capsule content is white to
yellow white or to brown white powder. Hard capsule size: 0, length 21
± 1 mm.
Lenalidomide Krka d.d. 15 mg hard capsules
Capsule cap is brown, capsule body is blue with imprinted black mark
15. Capsule content is white to
yellow white or to brown white powder. Hard capsule size: 2, length 18
± 1 mm.
Lenalidomide Krka d.d. 20 mg hard capsules
Capsule cap is green, capsule body is blue with imprinted black mark
20. Capsule content is white to
yellow white or to brown white powder. Hard capsule size: 1, length 19
±