Xalkori

Country: European Union

Language: Croatian

Source: EMA (European Medicines Agency)

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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:

Antineoplastična sredstva

Therapeutic area:

Karcinom, ne-malih stanica pluća

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:

odobren

Authorization date:

2012-10-23

Patient Information leaflet

                                56
B. UPUTA O LIJEKU
57
UPUTA O LIJEKU: INFORMACIJE ZA KORISNIKA
XALKORI 200 MG TVRDE KAPSULE
XALKORI 250 MG TVRDE KAPSULE
krizotinib
RIJEČI „VI“ I „VAŠ“ ODNOSE SE I NA ODRASLOG BOLESNIKA I
NJEGOVATELJA PEDIJATRIJSKOG BOLESNIKA.
PAŽLJIVO PROČITAJTE CIJELU UPUTU PRIJE NEGO POČNETE UZIMATI OVAJ
LIJEK JER SADRŽI VAMA VAŽNE
PODATKE.
-
Sačuvajte ovu uputu. Možda ćete je trebati ponovno pročitati.
-
Ako imate dodatnih pitanja, obratite se liječniku, ljekarniku ili
medicinskoj sestri.
-
Ovaj je lijek propisan samo Vama. Nemojte ga davati drugima. Može im
naškoditi, čak i ako su
njihovi znakovi bolesti jednaki Vašima.
-
Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti
liječnika, ljekarnika ili medicinsku
sestru. To uključuje i svaku moguću nuspojavu koja nije navedena u
ovoj uputi. Pogledajte
dio 4.
ŠTO SE NALAZI U OVOJ UPUTI
1.
Što je XALKORI i za što se koristi
2.
Što morate znati prije nego počnete uzimati XALKORI
3.
Kako uzimati XALKORI
4.
Moguće nuspojave
5.
Kako čuvati XALKORI
6.
Sadržaj pakiranja i druge informacije
1.
ŠTO JE XALKORI I ZA ŠTO SE KORISTI
XALKORI je lijek protiv raka koji sadrži djelatnu tvar krizotinib.
Koristi se za liječenje odraslih osoba
s jednom vrstom raka pluća, koji se naziva rak pluća nemalih
stanica, u kojemu je prisutno specifično
razmještanje ili oštećenje gena koji se zove kinaza anaplastičnog
limfoma (engl. _anaplastic lymphoma _
_kinase_, ALK) ili gena zvanog ROS1.
Liječnik Vam može propisati XALKORI kao početno liječenje ako je
Vaša bolest uznapredovali rak
pluća.
Liječnik Vam može propisati XALKORI ako je Vaša bolest
uznapredovala, a prethodno liječenje je
nije moglo zaustaviti.
XALKORI može usporiti ili zaustaviti rast raka pluća te može
pomoći da se tumor smanji.
XALKORI se koristi za liječenje djece i adolescenata (u dobi od ≥ 6
do < 18 godina) s vrstom tumora
koji se naziva anaplastični limfom velikih stanica (engl._ anaplastic
large cell lymphoma_, ALCL) ili
vrstom tumora koji se naziva upalni miofibr
                                
                                Read the complete document

Summary of Product characteristics

                                1
PRILOG I.
SAŽETAK OPISA SVOJSTAVA LIJEKA
2
1.
NAZIV LIJEKA
XALKORI 200 mg tvrde kapsule
XALKORI 250 mg tvrde kapsule
2.
KVALITATIVNI I KVANTITATIVNI SASTAV
XALKORI 200 mg tvrde kapsule
Jedna tvrda kapsula sadrži 200 mg krizotiniba.
XALKORI 250 mg tvrde kapsule
Jedna tvrda kapsula sadrži 250 mg krizotiniba.
Za cjeloviti popis pomoćnih tvari vidjeti dio 6.1.
3.
FARMACEUTSKI OBLIK
Tvrda kapsula.
XALKORI 200 mg tvrde kapsule
Bijele neprozirne i ružičaste neprozirne tvrde kapsule, s otisnutom
oznakom "Pfizer" na kapici i
"CRZ 200" na tijelu.
XALKORI 250 mg tvrde kapsule
Ružičaste neprozirne tvrde kapsule, s otisnutom oznakom “Pfizer”
na kapici i “CRZ 250” na tijelu.
4.
KLINIČKI PODACI
4.1
TERAPIJSKE INDIKACIJE
XALKORI je kao monoterapija indiciran za:

prvu liniju liječenja odraslih bolesnika s uznapredovalim rakom
pluća nemalih stanica (engl.
_non-small cell lung cancer_, NSCLC), pozitivnim na kinazu
anaplastičnog limfoma (engl.
_anaplastic lymphoma kinase,_ ALK)

liječenje odraslih bolesnika s prethodno liječenim ALK-pozitivnim
uznapredovalim rakom
pluća nemalih stanica (engl. _non-small cell lung cancer_, NSCLC)

liječenje odraslih s ROS1-pozitivnim uznapredovalim rakom pluća
nemalih stanica
(NSCLC)

liječenje pedijatrijskih bolesnika (u dobi od ≥ 6 do < 18 godina)
sa sistemskim
ALK-pozitivnim anaplastičnim limfomom velikih stanica (engl.
_anaplastic large cell _
_lymphoma_, ALCL) koji je refraktoran ili u relapsu

liječenje pedijatrijskih bolesnika (u dobi od ≥ 6 do < 18 godina) s
rekurentnim ili
refraktornim ALK-pozitivnim neoperabilnim inflamatornim
miofibroblastičnim tumorom
(IMT).
4.2
DOZIRANJE I NAČIN PRIMJENE
Liječenje lijekom XALKORI mora započeti i nadzirati liječnik s
iskustvom u primjeni lijekova za
liječenje raka.
3
Testiranje na ALK i ROS1
Pri odabiru bolesnika za liječenje lijekom XALKORI neophodno je
provesti testiranje za ALK ili
ROS1 pomoću preciznog i validiranog testa (vidjeti dio 5.1 za podatke
o testovima koji su korišteni u
kliničkim i
                                
                                Read the complete document

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Active ingredient crizotinib

crizotinib

ATC code L01ED01

L01ED01

Marketed by Pfizer Europe MA EEIG

Pfizer Europe MA EEIG

INN (International Name) crizotinib

crizotinib

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