Lenalidomide Krka d.d. Novo mesto (previously Lenalidomide Krka)
Country: European Union
Language: English
Source: EMA (European Medicines Agency)
Patient Information leaflet
(PIL)
17-12-2021
Summary of Product characteristics
(SPC)
17-12-2021
Public Assessment Report
(PAR)
31-08-2021
Active ingredient:
lenalidomide hydrochloride monohydrate
Available from:
Krka, d.d., Novo mesto
ATC code:
L04AX04
INN (International Name):
lenalidomide
Therapeutic group:
Immunosuppressants
Therapeutic area:
Multiple Myeloma; Lymphoma, Follicular
Therapeutic indications:
Multiple myelomaLenalidomide krka d.d. Novo mesto 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. Novo mesto 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. Novo mesto 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 krka d.d. Novo mesto in combination with rituximab (anti-CD20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (Grade 1 – 3a).Multiple myelomaLenalidomide krka d.d. Novo mesto 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. Novo mesto 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. Novo mesto 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 krka d.d. Novo mesto in combination with rituximab (anti-CD20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (Grade 1 – 3a).
Product summary:
Revision: 3
Authorization status:
Authorised
Authorization date:
2021-02-11
Patient Information leaflet
79
B. PACKAGE LEAFLET
80
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LENALIDOMIDE KRKA D.D. NOVO MESTO 2.5 MG HARD CAPSULES
LENALIDOMIDE KRKA D.D. NOVO MESTO 5 MG HARD CAPSULES
LENALIDOMIDE KRKA D.D. NOVO MESTO 7.5 MG HARD CAPSULES
LENALIDOMIDE KRKA D.D. NOVO MESTO 10 MG HARD CAPSULES
LENALIDOMIDE KRKA D.D. NOVO MESTO 15 MG HARD CAPSULES
LENALIDOMIDE KRKA D.D. NOVO MESTO 20 MG HARD CAPSULES
LENALIDOMIDE KRKA D.D. NOVO MESTO 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. Novo mesto is and what it is used for
2.
What you need to know before you take Lenalidomide Krka d.d. Novo
mesto
3.
How to take Lenalidomide Krka d.d. Novo mesto
4.
Possible side effects
5.
How to store Lenalidomide Krka d.d. Novo mesto
6.
Contents of the pack and other information
1.
WHAT LENALIDOMIDE KRKA D.D. NOVO MESTO IS AND WHAT IT IS USED FOR
WHAT LENALIDOMIDE KRKA D.D. NOVO MESTO IS
Lenalidomide Krka d.d. Novo mesto 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. NOVO MESTO IS USED FOR
Lenalidomide Krka d.d. Novo mesto is used in adults for:
-
Multiple myeloma
-
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 c
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Summary of Product characteristics
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Lenalidomide Krka d.d. Novo mesto 2.5 mg hard capsules
Lenalidomide Krka d.d. Novo mesto 5 mg hard capsules
Lenalidomide Krka d.d. Novo mesto 7.5 mg hard capsules
Lenalidomide Krka d.d. Novo mesto 10 mg hard capsules
Lenalidomide Krka d.d. Novo mesto 15 mg hard capsules
Lenalidomide Krka d.d. Novo mesto 20 mg hard capsules
Lenalidomide Krka d.d. Novo mesto 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. Novo mesto 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. Novo mesto 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. Novo mesto 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. Novo mesto 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. Novo mesto 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. Novo mesto 20 mg hard capsules
Capsule cap is green, capsule body is blue with imprinted black mark
20
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