Lenalidomide Krka (previously Lenalidomide Krka d.d. Novo mesto)

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

lenalidomide hydrochloride monohydrate

Saatavilla:

Krka, d.d., Novo mesto 

ATC-koodi:

L04AX04

INN (Kansainvälinen yleisnimi):

lenalidomide

Terapeuttinen ryhmä:

Immunosuppressants

Terapeuttinen alue:

Multiple Myeloma; Myelodysplastic Syndromes; Lymphoma, Follicular; Lymphoma, Mantle-Cell

Käyttöaiheet:

Multiple myelomaLenalidomide Krka 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 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 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 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 lymphomaLenalidomide Krka as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (see sections 4.4 and 5.1).Follicular lymphomaLenalidomide Krka 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 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 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 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 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 lymphomaLenalidomide Krka as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (see sections 4.4 and 5.1).Follicular lymphomaLenalidomide Krka in combination with rituximab (anti-CD20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (Grade 1 – 3a).

Tuoteyhteenveto:

Revision: 4

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2021-02-11

Pakkausseloste

90
B. PACKAGE LEAFLET
91
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LENALIDOMIDE KRKA 2.5 MG HARD CAPSULES
LENALIDOMIDE KRKA 5 MG HARD CAPSULES
LENALIDOMIDE KRKA 7.5 MG HARD CAPSULES
LENALIDOMIDE KRKA 10 MG HARD CAPSULES
LENALIDOMIDE KRKA 15 MG HARD CAPSULES
LENALIDOMIDE KRKA 20 MG HARD CAPSULES
LENALIDOMIDE KRKA 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 is and what it is used for
2.
What you need to know before you take Lenalidomide Krka
3.
How to take Lenalidomide Krka
4.
Possible side effects
5.
How to store Lenalidomide Krka
6.
Contents of the pack and other information
1.
WHAT LENALIDOMIDE KRKA IS AND WHAT IT IS USED FOR
WHAT LENALIDOMIDE KRKA IS
Lenalidomide Krka contains the active substance ‘lenalidomide’.
This medicine belongs to a group of
medicines which affect how your immune system works.
WHAT LENALIDOMIDE KRKA IS USED FOR
Lenalidomide Krka 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 bo

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Lenalidomide Krka 2.5 mg hard capsules
Lenalidomide Krka 5 mg hard capsules
Lenalidomide Krka 7.5 mg hard capsules
Lenalidomide Krka 10 mg hard capsules
Lenalidomide Krka 15 mg hard capsules
Lenalidomide Krka 20 mg hard capsules
Lenalidomide Krka 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 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 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 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 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 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 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
± 1 mm.
Lenalidomide Krka 25 mg hard capsules
Capsule cap is brown, capsule body is brown with imprinted w