Lenalidomide Krka (previously Lenalidomide Krka d.d. Novo mesto)
Country: European Union
Language: Maltese
Source: EMA (European Medicines Agency)
Patient Information leaflet
(PIL)
26-07-2023
Summary of Product characteristics
(SPC)
26-07-2023
Public Assessment Report
(PAR)
01-09-2021
Active ingredient:
lenalidomide hydrochloride monohydrate
Available from:
Krka, d.d., Novo mesto
ATC code:
L04AX04
INN (International Name):
lenalidomide
Therapeutic group:
Immunosoppressanti
Therapeutic area:
Multiple Myeloma; Myelodysplastic Syndromes; Lymphoma, Follicular; Lymphoma, Mantle-Cell
Therapeutic indications:
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) huwa indikat għall-kura ta ' pazjenti adulti li ma kienux ikkurati qabel mjeloma multipla li mhumiex eliġibbli għal trapjant tal -. 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 u 5. 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) huwa indikat għall-kura ta ' pazjenti adulti li ma kienux ikkurati qabel mjeloma multipla li mhumiex eliġibbli għal trapjant tal -. 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 u 5. 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).
Product summary:
Revision: 4
Authorization status:
Awtorizzat
Authorization date:
2021-02-11
Patient Information leaflet
92
B. FULJETT TA’ TAGĦRIF
93
FULJETT TA’ TAGĦRIF: INFORMAZZJONI GĦALL-PAZJENT
LENALIDOMIDE KRKA 2.5 MG KAPSULI IBSIN
LENALIDOMIDE KRKA 5 MG KAPSULI IBSIN
LENALIDOMIDE KRKA 7.5 MG KAPSULI IBSIN
LENALIDOMIDE KRKA 10 MG KAPSULI IBSIN
LENALIDOMIDE KRKA 15 MG KAPSULI IBSIN
LENALIDOMIDE KRKA 20 MG KAPSULI IBSIN
LENALIDOMIDE KRKA 25 MG KAPSULI IBSIN
lenalidomide
AQRA SEW DAN IL-FULJETT KOLLU QABEL TIBDA TIEĦU DIN IL-MEDIĊINA
PERESS LI FIH INFORMAZZJONI
IMPORTANTI GĦALIK.
-
Żomm dan il-fuljett. Jista’ jkollok bżonn terġa’ taqrah.
-
Jekk ikollok aktar mistoqsijiet, staqsi lit-tabib jew lill-ispiżjar
tiegħek.
-
Din il-mediċina ġiet mogħtija lilek biss. M’għandekx tgħaddiha
lil persuni oħra. Tista’
tagħmlilhom il-ħsara, anke jekk għandhom l-istess sinjali ta’
mard bħal tiegħek.
-
Jekk ikollok xi effett sekondarju kellem lit-tabib jew lill-ispiżjar
tiegħek. Dan jinkludi xi effett
sekondarju possibbli li mhuwiex elenkat f’dan il-fuljett. Ara
sezzjoni 4.
F’DAN IL-FULJETT
1.
X’inhu Lenalidomide Krka u għalxiex jintuża
2.
X’għandek tkun taf qabel ma tieħu Lenalidomide Krka
3.
Kif għandek tieħu Lenalidomide Krka
4.
Effetti sekondarji possibbli
5.
Kif taħżen Lenalidomide Krka
6.
Kontenut tal-pakkett u informazzjoni oħra
1.
X’INHU LENALIDOMIDE KRKA U GЋALXIEX JINTUŻA
X’INHU LENALIDOMIDE KRKA
Lenalidomide Krka fih is-sustanza attiva ‘lenalidomide’. Din
il-mediċina tappartjeni għal grupp ta’
mediċini li jaffettwaw kif is-sistema immuni tiegħek taħdem.
GĦALXIEX JINTUŻA LENALIDOMIDE KRKA
Lenalidomide Krka jintuża fl-adulti għal:
-
Majeloma multipla
-
Sindromi majelodisplastiċi
-
Limfoma taċ-ċelluli mantle
-
Limfoma follikulari
MAJELOMA MULTIPLA
Majeloma multipla hi tip ta’ kanċer li jaffettwa ċertu tip ta’
ċellula tad-demm bajda, imsejħa ċ-ċellula
tal-plażma. Dawn iċ-ċelluli jinġabru fil-mudullun u jiddividu, bla
kontroll. Dan jista’ jagħmel ħsara lill-
għadam u lill-kliewi.
Il-majeloma multipla ġeneralment ma tistax tiġi kkurata. Madank
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Summary of Product characteristics
1
ANNESS I
SOMMARJU TAL-KARATTERISTIĊI TAL-PRODOTT
2
1.
ISEM IL-PRODOTT MEDIĊINALI
Lenalidomide Krka 2.5 mg kapsuli ibsin
Lenalidomide Krka 5 mg kapsuli ibsin
Lenalidomide Krka 7.5 mg kapsuli ibsin
Lenalidomide Krka 10 mg kapsuli ibsin
Lenalidomide Krka 15 mg kapsuli ibsin
Lenalidomide Krka 20 mg kapsuli ibsin
Lenalidomide Krka 25 mg kapsuli ibsin
2.
GĦAMLA KWALITATTIVA U KWANTITATTIVA
Kull kapsula iebsa fiha lenalidomide hydrochloride monohydrate
ekwivalenti għal 2.5 mg, 5 mg, 7.5 mg,
10 mg, 15 mg, 20 mg jew 25 mg ta’ lenalidomide.
Għal-lista sħiħa ta’ eċċipjenti, ara sezzjoni 6.1.
3.
GĦAMLA FARMAĊEWTIKA
Kapsula iebsa (kapsula)
Lenalidomide Krka 2.5 mg kapsuli ibsin
L-għatu tal-kapsula huwa aħdar, il-korp tal-kapsula huwa aħdar
b’marka sewda ta’ 2.5 stampata fuqu. Il-
kontenut tal-kapsula huwa trab abjad għal isfar bajdani jew għal
kannella bajdani. Daqs tal-kapsula iebsa: 4,
tul 14 ± 1 mm.
Lenalidomide Krka 5 mg kapsuli ibsin
L-għatu tal-kapsula huwa blu, il-korp tal-kapsula huwa blu b’marka
sewda ta’ 5 stampata fuqu. Il-kontenut
tal-kapsula huwa trab abjad għal isfar bajdani jew għal kannella
bajdani. Daqs tal-kapsula iebsa: 2, tul 18 ± 1
mm.
Lenalidomide Krka 7.5 mg kapsuli ibsin
L-għatu tal-kapsula huwa kannella, il-korp tal-kapsula huwa kannella
b’marka bajda ta’ 7.5 stampata fuqu.
Il-kontenut tal-kapsula huwa trab abjad għal isfar bajdani jew għal
kannella bajdani. Daqs tal-kapsula iebsa:
1, tul 19 ± 1 mm.
Lenalidomide Krka 10 mg kapsuli ibsin
L-għatu tal-kapsula huwa aħdar, il-korp tal-kapsula huwa kannella
b’marka bajda ta’ 10 stampata fuqu.
Il-kontenut tal-kapsula huwa trab abjad għal isfar bajdani jew għal
kannella bajdani. Daqs tal-kapsula iebsa:
0, tul 21 ± 1 mm.
Lenalidomide Krka 15 mg kapsuli ibsin
L-għatu tal-kapsula huwa kannella, il-korp tal-kapsula huwa blu
b’marka sewda ta’ 15 stampata fuqu.
Il-kontenut tal-kapsula huwa trab abjad għal isfar bajdani jew għal
kannella bajdani. Daqs tal-kapsula iebsa:
2, tul 18 ± 1 mm.
Lenalidomide Krka 2
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