Xalkori

Country: European Union

Language: Maltese

Source: EMA (European Medicines Agency)

Patient Information leaflet Patient Information leaflet (PIL)
02-12-2022
Summary of Product characteristics Summary of Product characteristics (SPC)
02-12-2022
Public Assessment Report Public Assessment Report (PAR)
02-12-2022

Active ingredient:

crizotinib

Available from:

Pfizer Europe MA EEIG

ATC code:

L01ED01

INN (International Name):

crizotinib

Therapeutic group:

Aġenti antineoplastiċi

Therapeutic area:

Karċinoma, Pulmun Mhux taċ-Ċellula Żgħira

Therapeutic indications:

XALKORI as monotherapy is indicated for:The first‑line treatment of adults with anaplastic lymphoma kinase (ALK)‑positive advanced non‑small cell lung cancer (NSCLC)The treatment of adults with previously treated anaplastic lymphoma kinase (ALK)‑positive advanced non‑small cell lung cancer (NSCLC)The treatment of adults with ROS1‑positive advanced non‑small cell lung cancer (NSCLC)The treatment of paediatric patients (age ≥6 to.

Product summary:

Revision: 33

Authorization status:

Awtorizzat

Authorization date:

2012-10-23

Patient Information leaflet

                                57
B. FULJETT TA’ TAGĦRIF
58
FULJETT TA’ TAGĦRIF: INFORMAZZJONI GĦALL-UTENT
XALKORI 200 MG KAPSULI IEBSIN
XALKORI 250 MG KAPSULI IEBSIN
crizotinib
IL-KLIEM “INT” U “TIEGĦEK” JINTUŻAW BIEX JIRREFERU KEMM
GĦALL-PAZJENT ADULT KIF UKOLL GĦAL MIN
JIEĦU ĦSIEB IL-PAZJENT PEDJATRIKU.
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, lill-ispiżjar, jew
l-infermier 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, lill-ispiżjar jew
l-infermier tiegħek. Dan
jinkludi xi effett sekondarju possibbli li mhuwiex elenkat f’dan
il-fuljett. Ara sezzjoni 4.
F’DAN IL-FULJETT
1.
X’inhu XALKORI u għalxiex jintuża
2.
X’għandek tkun taf qabel ma tieħu XALKORI
3.
Kif għandek tieħu XALKORI
4.
Effetti sekondarji possibbli
5.
Kif taħżen XALKORI
6.
Kontenut tal-pakkett u informazzjoni oħra
1.
X’INHU XALKORI U GĦALXIEX JINTUŻA
XALKORI huwa mediċina għal kontra l-kanċer li fih s-sustanza attiva
crizotinib li tittratta adulti li
għandhom tip ta’ kanċer tal-pulmun li jissejjaħ kanċer
tal-pulmun b’ċelloli mhux żgħar, li jippreżenta
ruħu b’arranġament mill-ġdid jew difett speċifiku jew f’ġene
msejjaħ kinase tal-limfoma anaplastika
(ALK) jew ġene msejjaħ ROS1.
XALKORI jista’ jingħatalek b’riċetta għat-trattament tal-bidu
jekk il-marda tiegħek tkun fi stadju
avvanzat ta’ kanċer tal-pulmun.
XALKORI jista’ jiġi preskritt lilek jekk il-marda tiegħek qegħda
fi stadju avvanzat u t-trattament ta’
qabel ma għenekx twaqqaf il-marda tiegħek.
XALKORI jista’ jittardja jew iwaqqaf it-tkabbir tal-kanċer
tal-pulmun. Jista’ jgħin biex iċekken it-
tumuri.
XALKORI jintuża għat-trattament ta
                                
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Summary of Product characteristics

                                1
ANNESS I
SOMMARJU TAL-KARATTERISTIĊI TAL-PRODOTT
2
1.
ISEM IL-PRODOTT MEDIĊINALI
XALKORI 200 mg kapsuli ibsin
XALKORI 250 mg kapsuli ibsin
2.
GĦAMLA KWALITATTIVA U KWANTITATTIVA
XALKORI 200 mg kapsuli ibsin
Kull kapsula iebsa fiha 200 mg crizotinib.
XALKORI 250 mg kapsuli ibsin
Kull kapsula iebsa fiha 250 mg ta’ crizotinib.
Għal-lista sħiħa ta’ eċċipjenti, ara sezzjoni 6.1.
3.
GĦAMLA FARMAĊEWTIKA
Kapsula iebsa.
XALKORI 200 mg kapsuli ibsin
Kapsula iebsa, bajda opaka u roża opaka, b’“Pfizer” fuq
l-għatu u “CRZ 200” fuq il-biċċa l-oħra.
XALKORI 250 mg kapsuli ibsin
Kapsula iebsa, roża opaka, b’“Pfizer” imnaqqxa fuq il-qoxra u
“CRZ 250” fuq il-biċċa l-oħra.
4.
TAGĦRIF KLINIKU
4.1
INDIKAZZJONIJIET TERAPEWTIĊI
XALKORI bħala monoterapija huwa indikat:

Fl-adulti għat-trattament primarju ta’ kanċer avvanzat
taċ-ċelloli mhux żgħar tal-pulmun
(NSCLC) pożittiv għall-kinase tal-limfoma anaplastika (ALK).

Fl-adulti għat-trattament ta’ kanċer avvanzat taċ-ċelloli mhux
żgħar tal-pulmun (NSCLC)
pożittiv għall-kinase tal-limfoma anaplastika (ALK) li tkun ġiet
ittrattata qabel.

Fl-adulti għat-trattament ta’ kanċer avvanzat taċ-ċelloli mhux
żgħar tal-pulmun (NSCLC)
pożittiv għal ROS1.

Fil-pazjenti pedjatriċi (b’età ta’ ≥ 6 sa < 18-il sena)
għat-trattament ta’ limfoma anaplastika
taċ-ċelloli kbar (ALCL) sistemika pożittiva għall-kinase
tal-limfoma anaplastika (ALK)
rikaduta jew refrattarja.

Fil-pazjenti pedjatriċi (b’età ta’ ≥ 6 sa < 18-il sena)
għat-trattament ta’ tumur mijofibroblastiku
infjammatorju (IMT) li ma jistax jitneħħa, pożittiv għall-kinase
tal-limfoma anaplastika
(ALK) rikorrenti jew refrattarju.
4.2
POŻOLOĠIJA U METODU TA’ KIF GĦANDU JINGĦATA
It-trattament b’XALKORI għandu jinbeda u jiġi sorveljat minn tabib
b’esperjenza fl-użu ta’ prodotti
mediċinali għal kontra l-kanċer.
3
Ittestjar tal-ALK u tal-ROS1
Hemm bżonn ta’ test preċiż u validat jew għall-ALK jew għal
ROS1 
                                
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