Copiktra

Country: European Union

Language: Croatian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
13-07-2022
Summary of Product characteristics Summary of Product characteristics (SPC)
13-07-2022
Public Assessment Report Public Assessment Report (PAR)
21-09-2023

Active ingredient:

duvelisib

Available from:

Secura Bio Limited

ATC code:

L01EM04

INN (International Name):

duvelisib

Therapeutic group:

Antineoplastična sredstva

Therapeutic area:

Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, Follicular

Therapeutic indications:

Copiktra monotherapy is indicated for the treatment of adult patients with: Relapsed or refractory chronic lymphocytic leukaemia (CLL) after at least two prior therapies.  Follicular lymphoma (FL) that is refractory to at least two prior  systemic therapies.

Product summary:

Revision: 2

Authorization status:

odobren

Authorization date:

2021-05-19

Patient Information leaflet

                                36
B. UPUTA O LIJEKU
37
UPUTA O LIJEKU: INFORMACIJE ZA BOLESNIKA
COPIKTRA 15 MG TVRDE KAPSULE
COPIKTRA 25 MG TVRDE KAPSULE
duvelisib
Ovaj je lijek pod dodatnim praćenjem. Time se omogućuje brzo
otkrivanje novih sigurnosnih
informacija. Prijavom svih sumnji na nuspojavu i Vi možete pomoći.
Za postupak prijavljivanja
nuspojava, pogledajte dio 4.
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.
-
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. To uključuje i svaku
moguću nuspojavu koja nije navedena u ovoj uputi. Pogledajte dio 4.
ŠTO SE NALAZI U OVOJ UPUTI:
1.
Što je Copiktra i za što se koristi
2.
Što morate znati prije nego počnete uzimati lijek Copiktra
3.
Kako uzimati lijek Copiktra
4.
Moguće nuspojave
5.
Kako čuvati lijek Copiktra
6.
Sadržaj pakiranja i druge informacije
1.
ŠTO JE COPIKTRA I ZA ŠTO SE KORISTI
Copiktra je lijek protiv raka koji sadrži djelatnu tvar duvelisib.
Djeluje tako da blokira učinke enzima
potrebnih za rast i preživljenje B-limfocita (vrste bijelih krvnih
stanica). Ti su enzimi pretjerano
aktivni u određenim kanceroznim bijelim krvnim stanicama; njihovim
blokiranjem lijek Copiktra
može ubiti i smanjiti broj kanceroznih B-limfocita.
Copiktra se primjenjuje za liječenje karcinoma B-limfocita koji se
nazivaju
•
kroničnom limfocitnom leukemijom (ili malim limfocitnim limfomom)
•
folikularnom leukemijom.
Kod tih se bolesti B-limfociti prebrzo umnožavaju i predugo žive,
zbog čega postoji previše takvih
stanica u krvi ili limfnim čvorovima. Copiktra se primjenjuje kada su
bolesnicima prethodno dane
barem dvije druge terapije koje nisu djelovale ili više ne djeluju.
2.
ŠTO MORATE ZNATI PRIJE NEGO POČNETE UZIMATI LIJEK COPI
                                
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Summary of Product characteristics

                                1
PRILOG I.
SAŽETAK OPISA SVOJSTAVA LIJEKA
2
Ovaj je lijek pod dodatnim praćenjem. Time se omogućuje brzo
otkrivanje novih sigurnosnih
informacija. Od zdravstvenih radnika se traži da prijave svaku sumnju
na nuspojavu za ovaj lijek. Za
postupak prijavljivanja nuspojava vidjeti dio 4.8.
1.
NAZIV LIJEKA
Copiktra 15 mg tvrde kapsule
Copiktra 25 mg tvrde kapsule
2.
KVALITATIVNI I KVANTITATIVNI SASTAV
Copiktra 15 mg tvrde kapsule
Jedna tvrda kapsula sadrži 15 mg duvelisiba (u obliku hidrata).
Copiktra 25 mg tvrde kapsule
Jedna tvrda kapsula sadrži 25 mg duvelisiba (u obliku hidrata).
Za cjeloviti popis pomoćnih tvari vidjeti dio 6.1.
3.
FARMACEUTSKI OBLIK
Tvrda kapsula
Copiktra 15 mg tvrde kapsule
Neprozirne, ružičaste, tvrde kapsule od želatine, veličine br. 2 s
oznakom „duv 15 mg” otisnutom
crnom tintom. Dimenzije: otprilike 18 mm x 6 mm (duljina i promjer).
Copiktra 25 mg tvrde kapsule
Neprozirne, bijele do gotovo bijele i narančaste, tvrde kapsule od
želatine, veličine br. 2 s oznakom
„duv 25 mg” otisnutom crnom tintom. Dimenzije: otprilike 18 mm x 6
mm (duljina i promjer).
4.
KLINIČKI PODACI
4.1
TERAPIJSKE INDIKACIJE
_ _
Monoterapija lijekom Copiktra indicirana je za liječenje odraslih
bolesnika s:
•
relapsnom ili refraktornom kroničnom limfocitnom leukemijom (CLL)
nakon najmanje dvije
prethodne terapije (vidjeti dijelove 4.4 i 5.1)
•
folikularnim limfomom (FL) koji nije reagirao na najmanje dvije
prethodne sistemske terapije
(vidjeti dijelove 4.4 i 5.1).
4.2
DOZIRANJE I NAČIN PRIMJENE
Liječenje lijekom Copiktra treba voditi liječnik s iskustvom u
primjeni lijekova za liječenje raka.
3
Doziranje
Preporučena doza iznosi 25 mg duvelisiba dvaput dnevno. Ciklus se
sastoji od 28 dana. S liječenjem
treba nastaviti do progresije bolesti ili neprihvatljive toksičnosti.
_Odgođene ili propuštene doze _
Ako propuste dozu za manje od 6 sati, bolesnike je potrebno
savjetovati da propuštenu dozu uzmu
odmah, a sljedeću dozu kako je uobičajeno. Ako je doza propuštena
za više od 6 sati, 
                                
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Documents in other languages

Patient Information leaflet Patient Information leaflet Bulgarian 13-07-2022
Summary of Product characteristics Summary of Product characteristics Bulgarian 13-07-2022
Public Assessment Report Public Assessment Report Bulgarian 21-09-2023
Patient Information leaflet Patient Information leaflet Spanish 13-07-2022
Summary of Product characteristics Summary of Product characteristics Spanish 13-07-2022
Public Assessment Report Public Assessment Report Spanish 21-09-2023
Patient Information leaflet Patient Information leaflet Czech 13-07-2022
Summary of Product characteristics Summary of Product characteristics Czech 13-07-2022
Public Assessment Report Public Assessment Report Czech 21-09-2023
Patient Information leaflet Patient Information leaflet Danish 13-07-2022
Summary of Product characteristics Summary of Product characteristics Danish 13-07-2022
Public Assessment Report Public Assessment Report Danish 21-09-2023
Patient Information leaflet Patient Information leaflet German 13-07-2022
Summary of Product characteristics Summary of Product characteristics German 13-07-2022
Public Assessment Report Public Assessment Report German 21-09-2023
Patient Information leaflet Patient Information leaflet Estonian 13-07-2022
Summary of Product characteristics Summary of Product characteristics Estonian 13-07-2022
Public Assessment Report Public Assessment Report Estonian 21-09-2023
Patient Information leaflet Patient Information leaflet Greek 13-07-2022
Summary of Product characteristics Summary of Product characteristics Greek 13-07-2022
Public Assessment Report Public Assessment Report Greek 21-09-2023
Patient Information leaflet Patient Information leaflet English 13-07-2022
Summary of Product characteristics Summary of Product characteristics English 13-07-2022
Public Assessment Report Public Assessment Report English 21-09-2023
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Summary of Product characteristics Summary of Product characteristics French 13-07-2022
Public Assessment Report Public Assessment Report French 21-09-2023
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Public Assessment Report Public Assessment Report Lithuanian 21-09-2023
Patient Information leaflet Patient Information leaflet Hungarian 13-07-2022
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Public Assessment Report Public Assessment Report Hungarian 21-09-2023
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Patient Information leaflet Patient Information leaflet Polish 13-07-2022
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Public Assessment Report Public Assessment Report Polish 21-09-2023
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Public Assessment Report Public Assessment Report Portuguese 21-09-2023
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Summary of Product characteristics Summary of Product characteristics Romanian 13-07-2022
Public Assessment Report Public Assessment Report Romanian 21-09-2023
Patient Information leaflet Patient Information leaflet Slovak 13-07-2022
Summary of Product characteristics Summary of Product characteristics Slovak 13-07-2022
Public Assessment Report Public Assessment Report Slovak 21-09-2023
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Summary of Product characteristics Summary of Product characteristics Slovenian 13-07-2022
Public Assessment Report Public Assessment Report Slovenian 21-09-2023
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Summary of Product characteristics Summary of Product characteristics Finnish 13-07-2022
Public Assessment Report Public Assessment Report Finnish 21-09-2023
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Summary of Product characteristics Summary of Product characteristics Swedish 13-07-2022
Public Assessment Report Public Assessment Report Swedish 21-09-2023
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Summary of Product characteristics Summary of Product characteristics Norwegian 13-07-2022
Patient Information leaflet Patient Information leaflet Icelandic 13-07-2022
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