Xalkori

Country: European Union

Language: Icelandic

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

Active ingredient:

crizotinib

Available from:

Pfizer Europe MA EEIG

ATC code:

L01ED01

INN (International Name):

crizotinib

Therapeutic group:

Æxlishemjandi lyf

Therapeutic area:

Krabbamein, lungnakrabbamein

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:

Leyfilegt

Authorization date:

2012-10-23

Patient Information leaflet

                                55
B. FYLGISEÐILL
56
FYLGISEÐILL: UPPLÝSINGAR FYRIR NOTANDA LYFSINS
XALKORI 200 MG HÖRÐ HYLKI
XALKORI 250 MG HÖRÐ HYLKI
crizotinib
ORÐIN „ÞÚ“, „ÞIG“, „ÞÉR“ OG „ÞÍN“ ERU NOTUÐ
FYRIR BÆÐI FULLORÐINN SJÚKLING OG FYRIR
UMÖNNUNARAÐILA BARNA.
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 hjúkrunarfræðingsins
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 XALKORI og við hverju það er notað
2.
Áður en byrjað er að nota XALKORI
3.
Hvernig nota á XALKORI
4.
Hugsanlegar aukaverkanir
5.
Hvernig geyma á XALKORI
6.
Pakkningar og aðrar upplýsingar
1.
UPPLÝSINGAR UM XALKORI OG VIÐ HVERJU ÞAÐ ER NOTAÐ
XALKORI er krabbameinslyf sem inniheldur virka efnið crizotinib sem
er notað hjá fullorðnum
sjúklingum til meðferðar á tegund lungnakrabbameins sem nefnist
lungnakrabbamein sem ekki er af
smáfrumugerð (NSCLC) og hefur tiltekna endurröðun eða galla í
annaðhvort geni fyrir prótein sem
nefnist villivaxtar eitilæxlis kínasi (anaplastic lymphoma kinase,
ALK) eða geni sem nefnist ROS1.
Þú gætir fengið ávísað XALKORI sem upphafsmeðferð ef
sjúkdómur þinn er langt gengið
lungnakrabbamein.
Þú gætir fengið ávísað XALKORI ef sjúkdómur þinn er langt
genginn og fyrri meðferð hefur ekki
dugað til að stöðva hann.
XALKORI getur hægt á vexti lungnakrabbameinsins eða stöðvað
hann. Það getur stuðlað að minnkun
æxla.
XALKORI er notað til meðferðar hjá bö
                                
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Summary of Product characteristics

                                1
VIÐAUKI I
SAMANTEKT Á EIGINLEIKUM LYFS
2
1.
HEITI LYFS
XALKORI 200 mg hörð hylki
XALKORI 250 mg hörð hylki
2.
INNIHALDSLÝSING
XALKORI 200 mg hörð hylki
Hvert hart hylki inniheldur 200 mg af crizotinibi.
XALKORI 250 mg hörð hylki
Hvert hart hylki inniheldur 250 mg af crizotinibi.
Sjá lista yfir öll hjálparefni í kafla 6.1.
3.
LYFJAFORM
Hörð hylki.
XALKORI 200 mg hörð hylki
Hvít ógegnsæ og bleik ógegnsæ hörð hylki, með áletruðu
„Pfizer“ á lokinu og „CRZ 200“ á hylkinu.
XALKORI 250 mg hörð hylki
Bleik ógegnsæ hörð hylki, með áletruðu „Pfizer“ á lokinu
og „CRZ 250“ á hylkinu.
4.
KLÍNÍSKAR UPPLÝSINGAR
4.1
ÁBENDINGAR
XALKORI einlyfjameðferð er ætluð til:

Upphafsmeðferðar (first-line) hjá fullorðnum við langt gengnu
lungnakrabbameini sem ekki
er af smáfrumugerð (non-small cell lung cancer, NSCLC) og tjáir
ensímið villivaxtar
eitilæxlis kínasa (anaplastic lymphoma kinase, ALK) (ALK-jákvætt)

Meðferðar hjá fullorðnum við áður meðhöndluðu, langt gengnu
lungnakrabbameini sem ekki
er af smáfrumugerð (non-small cell lung cancer, NSCLC) og tjáir
ensímið villivaxtar
eitilæxlis kínasa (anaplastic lymphoma kinase, ALK) (ALK-jákvætt)

Meðferðar hjá fullorðnum við ROS1-jákvæðu langt gengnu
lungnakrabbameini sem ekki er af
smáfrumugerð (non-small cell lung cancer, NSCLC)

Meðferðar hjá börnum (≥ 6 til < 18 ára) við altæku
ALK-jákvæðu, villivaxtar
stórfrumueitilæxli (ALK-positive anaplastic large cell lymphoma,
ALCL) sem hefur tekið sig
upp á ný eða svarar ekki meðferð

Meðferðar hjá börnum (≥ 6 til < 18 ára) við óskurðtæku
ALK-jákvæðu
vöðvabandvefsfrumuæxli með bólgufrumuíferð (ALK-positive
inflammatory myofibroblastic
tumour, IMT), sem er endurtekið eða svarar ekki meðferð
4.2
SKAMMTAR OG LYFJAGJÖF
Meðferð með XALKORI skal hefja af og vera undir umsjón læknis
með reynslu í lyfjameðferð gegn
krabbameini.
3
ALK og ROS1 prófun
Nákvæmt og gildað próf f
                                
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Active ingredient crizotinib

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ATC code L01ED01

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