Country: Unjoni Ewropea
Lingwa: Malti
Sors: EMA (European Medicines Agency)
lenalidomide hydrochloride monohydrate
Krka, d.d., Novo mesto
L04AX04
lenalidomide
Immunosoppressanti
Multiple Myeloma; Myelodysplastic Syndromes; Lymphoma, Follicular; Lymphoma, Mantle-Cell
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).
Revision: 4
Awtorizzat
2021-02-11
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 Aqra d-dokument sħiħ
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 Aqra d-dokument sħiħ