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

Country: European Union

Language: Slovak

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
17-12-2021
Summary of Product characteristics Summary of Product characteristics (SPC)
17-12-2021
Public Assessment Report 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:

imunosupresíva

Therapeutic area:

Multiple Myeloma; Lymphoma, Follicular

Therapeutic indications:

Multiple myelomaLenalidomide krka 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. Novo mesto as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4. 2) je indikovaný na liečbu dospelých predtým neliečených pacientov s myelómom je mladších, ktorí nie sú spôsobilí na transplantáciu. Lenalidomide krka 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. 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. 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. Novo mesto as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4. 2) je indikovaný na liečbu dospelých predtým neliečených pacientov s myelómom je mladších, ktorí nie sú spôsobilí na transplantáciu. Lenalidomide krka 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. 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:

oprávnený

Authorization date:

2021-02-11

Patient Information leaflet

                                87
B. PÍSOMNÁ INFORMÁCIA PRE POUŽÍVATEĽA
88
PÍSOMNÁ INFORMÁCIA PRE POUŽÍVATEĽA
LENALIDOMID KRKA D.D. NOVO MESTO 2,5 MG TVRDÉ KAPSULY
LENALIDOMID KRKA D.D. NOVO MESTO 5 MG TVRDÉ KAPSULY
LENALIDOMID KRKA D.D. NOVO MESTO 7,5 MG TVRDÉ KAPSULY
LENALIDOMID KRKA D.D. NOVO MESTO 10 MG TVRDÉ KAPSULY
LENALIDOMID KRKA D.D. NOVO MESTO 15 MG TVRDÉ KAPSULY
LENALIDOMID KRKA D.D. NOVO MESTO 20 MG TVRDÉ KAPSULY
LENALIDOMID KRKA D.D. NOVO MESTO 25 MG TVRDÉ KAPSULY
lenalidomid
POZORNE SI PREČÍTAJTE CELÚ PÍSOMNÚ INFORMÁCIU PREDTÝM, AKO
ZAČNETE UŽÍVAŤ TENTO LIEK, PRETOŽE
OBSAHUJE PRE VÁS DÔLEŽITÉ INFORMÁCIE.
-
Túto písomnú informáciu si uschovajte. Možno bude potrebné, aby
ste si ju znovu prečítali.
-
Ak máte akékoľvek ďalšie otázky, obráťte sa na svojho lekára
alebo lekárnika.
-
Tento liek bol predpísaný iba vám. Nedávajte ho nikomu inému.
Môže mu uškodiť, dokonca aj
vtedy, ak má rovnaké prejavy ochorenia ako vy.
-
Ak sa u vás vyskytne akýkoľvek vedľajší účinok, obráťte sa
na svojho lekára alebo lekárnika.
To sa týka aj akýchkoľvek vedľajších účinkov, ktoré nie sú
uvedené v tejto písomnej informácii.
Pozri časť 4.
V TEJTO PÍSOMNEJ INFORMÁCII SA DOZVIETE:
1.
Čo je Lenalidomid Krka d.d. Novo mesto a na čo sa používa
2.
Čo potrebujete vedieť predtým, ako užijete Lenalidomid Krka d.d.
Novo mesto
3.
Ako užívať Lenalidomid Krka d.d. Novo mesto
4.
Možné vedľajšie účinky
5.
Ako uchovávať Lenalidomid Krka d.d. Novo mesto
6.
Obsah balenia a ďalšie informácie
1.
ČO JE LENALIDOMID KRKA D.D. NOVO MESTO A NA ČO SA POUŽÍVA
ČO JE LENALIDOMID KRKA D.D. NOVO MESTO
Lenalidomid Krka d.d. Novo mesto obsahuje liečivo „lenalidomid“.
Tento liek patrí do skupiny
liekov, ktoré ovplyvňujú činnosť vášho imunitného systému.
NA ČO SA POUŽÍVA LENALIDOMID KRKA D.D. NOVO MESTO
Lenalidomid Krka d.d. Novo mesto sa používa u dospelých na:
-
Mnohopočetný myelóm
-
Folikulárny lymfóm
MNOHOPOČETNÝ MYELÓM
Mnohopočetný myel
                                
                                Read the complete document

Summary of Product characteristics

                                1
PRÍLOHA I
SÚHRN CHARAKTERISTICKÝCH VLASTNOSTÍ LIEKU
2
1.
NÁZOV LIEKU
Lenalidomid Krka d.d. Novo mesto 2,5 mg tvrdé kapsuly
Lenalidomid Krka d.d. Novo mesto 5 mg tvrdé kapsuly
Lenalidomid Krka d.d. Novo mesto 7,5 mg tvrdé kapsuly
Lenalidomid Krka d.d. Novo mesto 10 mg tvrdé kapsuly
Lenalidomid Krka d.d. Novo mesto 15 mg tvrdé kapsuly
Lenalidomid Krka d.d. Novo mesto 20 mg tvrdé kapsuly
Lenalidomid Krka d.d. Novo mesto 25 mg tvrdé kapsuly
2.
KVALITATÍVNE A KVANTITATÍVNE ZLOŽENIE
Každá tvrdá kapsula obsahuje monohydrát lenalidomídium-chloridu,
čo zodpovedá 2,5 mg, 5 mg,
7,5 mg, 10 mg, 15 mg, 20 mg alebo 25 mg lenalidomidu.
Úplný zoznam pomocných látok, pozri časť 6.1.
3.
LIEKOVÁ FORMA
Tvrdá kapsula (kapsula).
Lenalidomid Krka d.d. Novo mesto 2,5 mg tvrdé kapsuly
Viečko kapsuly je zelené, telo kapsuly je zelené s vytlačenou
čiernou značkou 2.5. Obsah kapsuly je
biely až žltobiely alebo až hnedobiely prášok. Veľkosť tvrdej
kapsuly: 4, dĺžka 14 ± 1 mm.
Lenalidomid Krka d.d. Novo mesto 5 mg tvrdé kapsuly
Viečko kapsuly je modré, telo kapsuly je modré s vytlačenou
čiernou značkou 5. Obsah kapsuly je
biely až žltobiely alebo až hnedobiely prášok. Veľkosť tvrdej
kapsuly: 2, dĺžka 18 ± 1 mm.
Lenalidomid Krka d.d. Novo mesto 7,5 mg tvrdé kapsuly
Viečko kapsuly je hnedé, telo kapsuly je hnedé s vytlačenou bielou
značkou 7.5. Obsah kapsuly je
biely až žltobiely alebo až hnedobiely prášok. Veľkosť tvrdej
kapsuly: 1, dĺžka 19 ± 1 mm.
Lenalidomid Krka d.d. Novo mesto 10 mg tvrdé kapsuly
Viečko kapsuly je zelené, telo kapsuly je hnedé s vytlačenou
bielou značkou 10. Obsah kapsuly je
biely až žltobiely alebo až hnedobiely prášok. Veľkosť tvrdej
kapsuly: 0, dĺžka 21 ± 1 mm.
Lenalidomid Krka d.d. Novo mesto 15 mg tvrdé kapsuly
Viečko kapsuly je hnedé, telo kapsuly je modré s vytlačenou
čiernou značkou 15. Obsah kapsuly je
biely až žltobiely alebo až hnedobiely prášok. Veľkosť tvrdej
kapsuly: 2, dĺžka 18 ± 1 mm.
Lenalidom
                                
                                Read the complete document

Similar products

Active ingredient lenalidomide hydrochloride monohydrate

lenalidomide hydrochloride monohydrate

ATC code L04AX04

L04AX04

Marketed by Krka, d.d., Novo mesto 

Krka, d.d., Novo mesto 

INN (International Name) lenalidomide

lenalidomide

Documents in other languages

Patient Information leaflet Patient Information leaflet Bulgarian 17-12-2021
Summary of Product characteristics Summary of Product characteristics Bulgarian 17-12-2021
Public Assessment Report Public Assessment Report Bulgarian 31-08-2021
Patient Information leaflet Patient Information leaflet Spanish 17-12-2021
Summary of Product characteristics Summary of Product characteristics Spanish 17-12-2021
Public Assessment Report Public Assessment Report Spanish 31-08-2021
Patient Information leaflet Patient Information leaflet Czech 17-12-2021
Summary of Product characteristics Summary of Product characteristics Czech 17-12-2021
Public Assessment Report Public Assessment Report Czech 31-08-2021
Patient Information leaflet Patient Information leaflet Danish 17-12-2021
Summary of Product characteristics Summary of Product characteristics Danish 17-12-2021
Public Assessment Report Public Assessment Report Danish 31-08-2021
Patient Information leaflet Patient Information leaflet German 17-12-2021
Summary of Product characteristics Summary of Product characteristics German 17-12-2021
Public Assessment Report Public Assessment Report German 31-08-2021
Patient Information leaflet Patient Information leaflet Estonian 17-12-2021
Summary of Product characteristics Summary of Product characteristics Estonian 17-12-2021
Public Assessment Report Public Assessment Report Estonian 31-08-2021
Patient Information leaflet Patient Information leaflet Greek 17-12-2021
Summary of Product characteristics Summary of Product characteristics Greek 17-12-2021
Public Assessment Report Public Assessment Report Greek 31-08-2021
Patient Information leaflet Patient Information leaflet English 17-12-2021
Summary of Product characteristics Summary of Product characteristics English 17-12-2021
Public Assessment Report Public Assessment Report English 31-08-2021
Patient Information leaflet Patient Information leaflet French 17-12-2021
Summary of Product characteristics Summary of Product characteristics French 17-12-2021
Public Assessment Report Public Assessment Report French 31-08-2021
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Patient Information leaflet Patient Information leaflet Lithuanian 17-12-2021
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Patient Information leaflet Patient Information leaflet Maltese 17-12-2021
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Patient Information leaflet Patient Information leaflet Polish 17-12-2021
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Patient Information leaflet Patient Information leaflet Romanian 17-12-2021
Summary of Product characteristics Summary of Product characteristics Romanian 17-12-2021
Public Assessment Report Public Assessment Report Romanian 31-08-2021
Patient Information leaflet Patient Information leaflet Slovenian 17-12-2021
Summary of Product characteristics Summary of Product characteristics Slovenian 17-12-2021
Public Assessment Report Public Assessment Report Slovenian 31-08-2021
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Summary of Product characteristics Summary of Product characteristics Finnish 17-12-2021
Public Assessment Report Public Assessment Report Finnish 31-08-2021
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Summary of Product characteristics Summary of Product characteristics Swedish 17-12-2021
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Patient Information leaflet Patient Information leaflet Croatian 17-12-2021
Summary of Product characteristics Summary of Product characteristics Croatian 17-12-2021
Public Assessment Report Public Assessment Report Croatian 31-08-2021

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