Lenalidomide Krka d.d.

Country: European Union

Language: Czech

Source: EMA (European Medicines Agency)

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Download Patient Information leaflet (PIL)
10-07-2023
Download Summary of Product characteristics (SPC)
10-07-2023
Download Public Assessment Report (PAR)
10-07-2023

Active ingredient:

lenalidomide hydrochloride hydrate

Available from:

Krka, d.d., Novo mesto 

ATC code:

L04AX04

INN (International Name):

lenalidomide

Therapeutic group:

Imunosupresiva

Therapeutic area:

Multiple Myeloma; Lymphoma, Follicular; Myelodysplastic Syndromes

Therapeutic indications:

Multiple myelomaLenalidomide Krka 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. as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4. 2) je indikován k léčbě dospělých pacientů s dříve neléčeným mnohočetným myelomem, kteří nejsou způsobilí pro transplantaci. Lenalidomide Krka 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. 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. 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: 2

Authorization status:

Staženo

Authorization date:

2021-02-11

Patient Information leaflet

                                81
B. PŘÍBALOVÁ INFORMACE
Přípavek již není registrován
82
PŘÍBALOVÁ INFORMACE: INFORMACE PRO PACIENTA
LENALIDOMID KRKA D.D. 2,5 MG TVRDÉ TOBOLKY
LENALIDOMID KRKA D.D. 5 MG TVRDÉ TOBOLKY
LENALIDOMID KRKA D.D. 7,5 MG TVRDÉ TOBOLKY
LENALIDOMID KRKA D.D. 10 MG TVRDÉ TOBOLKY
LENALIDOMID KRKA D.D. 15 MG TVRDÉ TOBOLKY
LENALIDOMID KRKA D.D. 20 MG TVRDÉ TOBOLKY
LENALIDOMID KRKA D.D. 25 MG TVRDÉ TOBOLKY
lenalidomidum
PŘEČTĚTE SI POZORNĚ TUTO PŘÍBALOVOU INFORMACI DŘÍVE, NEŽ
ZAČNETE TENTO PŘÍPRAVEK UŽÍVAT, PROTOŽE
OBSAHUJE PRO VÁS DŮLEŽITÉ ÚDAJE.
-
Ponechte si příbalovou informaci pro případ, že si ji budete
potřebovat přečíst znovu.
-
Máte-li jakékoli další otázky, zeptejte se svého lékaře nebo
lékárníka.
-
Tento přípravek byl předepsán výhradně Vám. Nedávejte jej
žádné další osobě. Mohl by jí ublížit,
a to i tehdy, má-li stejné známky onemocnění jako Vy.
-
Pokud se u Vás vyskytne kterýkoli z nežádoucích účinků,
sdělte to svému lékaři nebo lékárníkovi.
Stejně postupujte v případě jakýchkoli nežádoucích účinků,
které nejsou uvedeny v této příbalové
informaci. Viz bod 4.
CO NALEZNETE V TÉTO PŘÍBALOVÉ INFORMACI
1.
Co je Lenalidomid Krka d.d. a k čemu se používá
2.
Čemu musíte věnovat pozornost, než začnete Lenalidomid Krka d.d.
užívat
3.
Jak se Lenalidomid Krka d.d. užívá
4.
Možné nežádoucí účinky
5.
Jak Lenalidomid Krka d.d. uchovávat
6.
Obsah balení a další informace
1.
CO JE LENALIDOMID KRKA D.D. A K ČEMU SE POUŽÍVÁ
CO JE LENALIDOMID KRKA D.D.
Lenalidomid Krka d.d. obsahuje léčivou látku „lenalidomid“.
Tento léčivý přípravek patří do skupiny
léků, které ovlivňují činnost imunitního systému
(obranyschopnost).
K ČEMU SE LENALIDOMID KRKA D.D. SE POUŽÍVÁ
Lenalidomid Krka d.d. se používá u dospělých k léčbě:
-
Mnohočetného myelomu
-
Myelodysplastického syndromu
-
Folikulárního lymfomu
MNOHOČETNÝ MYELOM
Mnohočetný myelom je typ zhoubného nádor
                                
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Summary of Product characteristics

                                1
PŘÍLOHA I
SOUHRN ÚDAJŮ O PŘÍPRAVKU
Přípavek již není registrován
2
1.
NÁZEV PŘÍPRAVKU
Lenalidomid Krka d.d. 2,5 mg tvrdé tobolky
Lenalidomid Krka d.d. 5 mg tvrdé tobolky
Lenalidomid Krka d.d. 7,5 mg tvrdé tobolky
Lenalidomid Krka d.d. 10 mg tvrdé tobolky
Lenalidomid Krka d.d. 15 mg tvrdé tobolky
Lenalidomid Krka d.d. 20 mg tvrdé tobolky
Lenalidomid Krka d.d. 25 mg tvrdé tobolky
2.
KVALITATIVNÍ A KVANTITATIVNÍ SLOŽENÍ
Jedna tvrdá tobolka obsahuje lenalidomidi hydrochloridum monohydricum
odpovídající lenalidomidum
2,5 mg; 5 mg; 7,5 mg; 10 mg; 15 mg; 20 mg a 25 mg.
Úplný seznam pomocných látek viz bod 6.1.
3.
LÉKOVÁ FORMA
Tvrdá tobolka (tobolka)
Lenalidomid Krka d.d. 2,5 mg tvrdé tobolky
Víčko tobolky je zelené, tělo tobolky je zelené s vytištěnou
černou značkou 2.5. Obsah tobolky je bílý
až žlutobílý nebo hnědobílý prášek. Velikost tvrdé tobolky:
4, délka 14 ± 1 mm.
Lenalidomid Krka d.d. 5 mg tvrdé tobolky
Víčko tobolky je modré, tělo tobolky je modré s vytištěnou
černou značkou 5. Obsah tobolky je bílý až
žlutobílý nebo hnědobílý prášek. Velikost tvrdé tobolky: 2,
délka 18 ± 1 mm.
Lenalidomid Krka d.d. 7,5 mg tvrdé tobolky
Víčko tobolky je hnědé, tělo tobolky je hnědé s vytištěnou
bílou značkou 7.5. Obsah tobolky je bílý až
žlutobílý nebo hnědobílý prášek. Velikost tvrdé tobolky: 1,
délka 19 ± 1 mm.
Lenalidomid Krka d.d. 10 mg tvrdé tobolky
Víčko tobolky je zelené, tělo tobolky je hnědé s vytištěnou
bílou značkou 10. Obsah tobolky je bílý až
žlutobílý nebo hnědobílý prášek. Velikost tvrdé tobolky: 0,
délka 21 ± 1 mm.
Lenalidomid Krka d.d. 15 mg tvrdé tobolky
Víčko tobolky je hnědé, tělo tobolky je modré s vytištěnou
černou značkou 15. Obsah tobolky je bílý až
žlutobílý nebo hnědobílý prášek. Velikost tvrdé tobolky: 2,
délka 18 ± 1 mm.
Lenalidomid Krka d.d. 20 mg tvrdé tobolky
Víčko tobolky je zelené, tělo tobolky je modré s vytištěnou
černou zna
                                
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Similar products

Active ingredient lenalidomide hydrochloride hydrate

lenalidomide hydrochloride hydrate

ATC code L04AX04

L04AX04

Marketed by Krka, d.d., Novo mesto 

Krka, d.d., Novo mesto 

INN (International Name) lenalidomide

lenalidomide

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