Lenalidomide Mylan

Country: European Union

Language: Icelandic

Source: EMA (European Medicines Agency)

Patient Information leaflet Patient Information leaflet (PIL)
12-07-2023
Summary of Product characteristics Summary of Product characteristics (SPC)
12-07-2023

Active ingredient:

lenalídómíð

Available from:

Mylan Ireland Limited

ATC code:

L04AX07

INN (International Name):

lenalidomide

Therapeutic group:

Ónæmisbælandi lyf

Therapeutic area:

Mergæxli

Therapeutic indications:

Multiple myelomaLenalidomide Mylan as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. Lenalidomide Mylan as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant. Lenalidomide Mylan 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 Mylan 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: 8

Authorization status:

Leyfilegt

Authorization date:

2020-12-18

Patient Information leaflet

                                93
B. FYLGISEÐILL
94
FYLGISEÐILL: UPPLÝSINGAR FYRIR SJÚKLING
LENALIDOMIDE MYLAN 2,5 MG HÖRÐ HYLKI
LENALIDOMIDE MYLAN 5 MG HÖRÐ HYLKI
LENALIDOMIDE MYLAN 7,5 MG HÖRÐ HYLKI
LENALIDOMIDE MYLAN 10 MG HÖRÐ HYLKI
LENALIDOMIDE MYLAN 15 MG HÖRÐ HYLKI
LENALIDOMIDE MYLAN 20 MG HÖRÐ HYLKI
LENALIDOMIDE MYLAN 25 MG HÖRÐ HYLKI
lenalídómíð
LESIÐ ALLAN FYLGISEÐILINN VANDLEGA ÁÐUR EN BYRJAÐ ER AÐ NOTA
LYFIÐ. Í HONUM ERU MIKILVÆGAR
UPPLÝSINGAR.
-
Geymið fylgiseðilinn. Nauðsynlegt getur verið að lesa hann
síðar.
-
Leitið til læknisins, lyfjafræðings eða hjúkrunarfræðings ef
þörf er á frekari upplýsingum.
-
Þessu lyfi hefur verið ávísað til persónulegra nota. Ekki má
gefa það öðrum. Það getur valdið
þeim skaða, jafnvel þótt um sömu sjúkdómseinkenni sé að
ræða.
-
Látið lækninn eða lyfjafræðing vita um allar aukaverkanir.
Þetta gildir einnig um aukaverkanir
sem ekki er minnst á í þessum fylgiseðli. Sjá kafla 4.
Í FYLGISEÐLINUM ERU EFTIRFARANDI KAFLAR
:
1.
Upplýsingar um Lenalidomide Mylan og við hverju það er notað
2.
Áður en byrjað er að nota Lenalidomide Mylan
3.
Hvernig nota á Lenalidomide Mylan
4.
Hugsanlegar aukaverkanir
5.
Hvernig geyma á Lenalidomide Mylan
6.
Pakkningar og aðrar upplýsingar
1.
UPPLÝSINGAR UM LENALIDOMIDE MYLAN OG VIÐ HVERJU ÞAÐ ER NOTAÐ
Lenalidomide Mylan inniheldur virka efnið „lenalídómíð“.
Lyfið tilheyrir flokki lyfja sem geta haft
áhrif á hvernig ónæmiskerfi líkamans starfar.
Lenalidomide Mylan er notað hjá fullorðnum við:
•
mergæxli
•
heilkenni mergmisþroska
•
klofasmáfrumueitilæxli
•
eitilbúaeitilæxli.
MERGÆXLI
Mergæxli eru tegund krabbameins sem hefur áhrif á ákveðna tegund
hvítra blóðkorna sem nefnast
plasmafrumur. Þessar frumur safnast saman í beinmerg og fjölga sér
stjórnlaust. Slíkt getur skaðað
bein og nýru.
Mergæxli er yfirleitt ekki hægt að lækna. Hins vegar er hægt að
draga verulega úr einkennum og þau
geta horfið í ákveðinn tím
                                
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Summary of Product characteristics

                                1
VIÐAUKI I
SAMANTEKT Á EIGINLEIKUM LYFS
2
1.
HEITI LYFS
Lenalidomide Mylan 2,5 mg hörð hylki
Lenalidomide Mylan 5 mg hörð hylki
Lenalidomide Mylan 7,5 mg hörð hylki
Lenalidomide Mylan 10 mg hörð hylki
Lenalidomide Mylan 15 mg hörð hylki
Lenalidomide Mylan 20 mg hörð hylki
Lenalidomide Mylan 25 mg hörð hylki
2.
INNIHALDSLÝSING
Lenalidomide Mylan 2,5 mg hörð hylki
Hvert hylki inniheldur 2,5 mg af lenalídómíði.
Lenalidomide Mylan 5 mg hörð hylki
Hvert hylki inniheldur 5 mg af lenalídómíði.
Lenalidomide Mylan 7,5 mg hörð hylki
Hvert hylki inniheldur 7,5 mg af lenalídómíði.
Lenalidomide Mylan 10 mg hörð hylki
Hvert hylki inniheldur 10 mg af lenalídómíði.
Lenalidomide Mylan 15 mg hörð hylki
Hvert hylki inniheldur 15 mg af lenalídómíði.
Lenalidomide Mylan 20 mg hörð hylki
Hvert hylki inniheldur 20 mg af lenalídómíði.
Lenalidomide Mylan 25 mg hörð hylki
Hvert hylki inniheldur 25 mg af lenalídómíði.
Sjá lista yfir öll hjálparefni í kafla 6.1.
3.
LYFJAFORM
Hart hylki (hylki).
Lenalidomide Mylan 2,5 mg hörð hylki
Græn og hvít hylki, stærð 4, 14 mm, merkt „MYLAN/LL 2.5“.
Lenalidomide Mylan 5 mg hörð hylki
Hvít hylki, stærð 2, 18 mm, merkt „MYLAN/LL 5“.
Lenalidomide Mylan 7,5 mg hörð hylki
Ljósgrá og hvít hylki, stærð 2, 18 mm, merkt „MYLAN/LL7.5“.
Lenalidomide Mylan 10 mg hörð hylki
Græn og ljósgrá hylki, stærð 0, 22 mm, merkt „MYLAN/LL 10“.
Lenalidomide Mylan 15 mg hörð hylki
Hvít hylki, stærð 0, 22 mm, merkt „MYLAN/LL 15“.
3
Lenalidomide Mylan 20 mg hörð hylki
Græn og hvít hylki, stærð 0, 22 mm, merkt „MYLAN/LL 20“.
Lenalidomide Mylan 25 mg hörð hylki
Hvít hylki, stærð 0, 22 mm, merkt „MYLAN/LL 25“.
4.
KLÍNÍSKAR UPPLÝSINGAR
4.1
ÁBENDINGAR
Mergæxli (multiple myeloma)
Lenalidomide Mylan sem einlyfjameðferð er ætlað til
viðhaldsmeðferðar á fullorðnum sjúklingum
með nýgreint mergæxli sem hafa gengist undir samgena
stofnfrumuígræðslu.
Lenalidomide Mylan sem samsett meðferð 
                                
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Active ingredient lenalídómíð

lenalídómíð

ATC code L04AX07

L04AX07

Marketed by Mylan Ireland Limited

Mylan Ireland Limited

INN (International Name) lenalidomide

lenalidomide

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