Akeega

Country: European Union

Language: Croatian

Source: EMA (European Medicines Agency)

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Download Patient Information leaflet (PIL)
01-01-1970
Download Summary of Product characteristics (SPC)
01-01-1970
Download Public Assessment Report (PAR)
01-01-1970

Active ingredient:

abiraterone acetate, Niraparib tosilate monohydrate

Available from:

Janssen-Cilag International N.V.

ATC code:

L01

INN (International Name):

niraparib, abiraterone acetate

Therapeutic group:

Antineoplastična sredstva

Therapeutic area:

Tumori Prostate, Кастраци-Uporan

Therapeutic indications:

Treatment of adult patients with prostate cancer.

Authorization status:

odobren

Authorization date:

2023-04-19

Patient Information leaflet

                                41
B. UPUTA O LIJEKU
42
UPUTA O LIJEKU: INFORMACIJE ZA KORISNIKA
AKEEGA 50 MG/500 MG FILMOM OBLOŽENE TABLETE
niraparib/abirateronacetat
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 ili ljekarniku.

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 ili ljekarnika. To
uključuje i svaku moguću nuspojavu koja nije navedena u ovoj uputi
(pogledajte dio 4).
ŠTO SE NALAZI U OVOJ UPUTI
1.
Što je Akeega i za što se koristi
2.
Što morate znati prije nego počnete uzimati lijek Akeega
3.
Kako uzimati lijek Akeega
4.
Moguće nuspojave
5.
Kako čuvati lijek Akeega
6.
Sadržaj pakiranja i druge informacije
1.
ŠTO JE AKEEGA I ZA ŠTO SE KORISTI
Akeega je lijek koji sadrži dvije djelatne tvari – niraparib i
abirateronacetat – i djeluje na dva različita
načina.
Akeega se koristi za liječenje odraslih muškaraca s rakom prostate
koji imaju promjene u određenim
genima i kojima se rak prostate proširio u druge dijelove tijela te
više ne odgovara na lijekove ili
kirurško liječenje kojima se snizuju razine testosterona (takav se
rak naziva i metastatskim rakom
prostate rezistentnim na kastraciju).
Niraparib je vrsta lijeka za liječenje raka koji se zove PARP
inhibitor. PARP inhibitori blokiraju enzim
koji se zove poli [adenozin difosfat-riboza] polimeraza (PARP). PARP
pomaže stanicama popraviti
oštećenu DNA. Kad se njegovo djelovanje blokira, stanice raka ne
mogu popraviti svoju DNA, što
dovodi do smrti tumorske stanice i pomaže kontrolirati rak.
Abirateron zaustavlja stvaranje testosterona u organizmu, što može
usporiti rast raka prostate.
Uz ovaj će Vam lijek liječnik propisati još jedan, koji se zove
prednizon ili prednizolon. To je zato da
se smanji vj
                                
                                Read the complete document

Summary of Product characteristics

                                1
PRILOG I.
SAŽETAK OPISA SVOJSTAVA LIJEKA
2
1.
NAZIV LIJEKA
Akeega 50 mg/500 mg filmom obložene tablete
Akeega 100 mg/500 mg filmom obložene tablete
2.
KVALITATIVNI I KVANTITATIVNI SASTAV
Akeega 50 mg/500 mg filmom obložene tablete
Jedna filmom obložena tableta sadrži 50 mg nirapariba u obliku
niraparibtosilat hidrata i 500 mg
abirateronacetata, što je ekvivalentno 446 mg abiraterona.
Akeega 100 mg/500 mg filmom obložene tablete
Jedna filmom obložena tableta sadrži 100 mg nirapariba u obliku
niraparibtosilat hidrata i 500 mg
abirateronacetata, što je ekvivalentno 446 mg abiraterona.
Pomoćne tvari s poznatim učinkom
Jedna filmom obložena tableta sadrži 241 mg laktoze (vidjeti dio
4.4).
Za cjeloviti popis pomoćnih tvari vidjeti dio 6.1.
3.
FARMACEUTSKI OBLIK
Filmom obložena tableta (tableta).
Akeega 50 mg/500 mg filmom obložene tablete
Žućkastonarančaste do žućkastosmeđe ovalne filmom obložene
tablete (22 mm x 11 mm) s utisnutom
oznakom „N 50 A“ na jednoj strani i bez oznake na drugoj strani.
Akeega 100 mg/500 mg filmom obložene tablete
Narančaste ovalne filmom obložene tablete (22 mm x 11 mm) s
utisnutom oznakom „N 100 A“ na
jednoj strani i bez oznake na drugoj strani.
4.
KLINIČKI PODACI
4.1
TERAPIJSKE INDIKACIJE
Akeega je u kombinaciji s prednizonom ili prednizolonom indicirana za
liječenje odraslih bolesnika s
metastatskim rakom prostate rezistentnim na kastraciju (engl.
_metastatic castration-resistant prostate _
_cancer_, mCRPC) i mutacijama gena _BRCA 1/2_ (germinativnim i/ili
somatskim) u kojih kemoterapija
nije klinički indicirana.
4.2
DOZIRANJE I NAČIN PRIMJENE
Liječenje niraparibom i abirateronacetatom plus prednizonom ili
prednizolonom trebaju započeti i
nadzirati liječnici specijalisti s iskustvom u liječenju raka
prostate.
Prije početka liječenja lijekom Akeega mora se utvrditi pozitivan
status mutacije gena _BRCA_
korištenjem validirane metode testiranja (vidjeti dio 5.1).
Doziranje
Preporučena početna doza lijeka Akeega je 200 mg/1000 mg (dvije
tablet
                                
                                Read the complete document

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Active ingredient abiraterone acetate, Niraparib tosilate monohydrate

abiraterone acetate, Niraparib tosilate monohydrate

ATC code L01

L01

Marketed by Janssen-Cilag International N.V.

Janssen-Cilag International N.V.

INN (International Name) niraparib, abiraterone acetate

niraparib, abiraterone acetate

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Patient Information leaflet Patient Information leaflet Bulgarian 01-01-1970
Summary of Product characteristics Summary of Product characteristics Bulgarian 01-01-1970
Public Assessment Report Public Assessment Report Bulgarian 01-01-1970
Patient Information leaflet Patient Information leaflet Spanish 01-01-1970
Summary of Product characteristics Summary of Product characteristics Spanish 01-01-1970
Public Assessment Report Public Assessment Report Spanish 01-01-1970
Patient Information leaflet Patient Information leaflet Czech 01-01-1970
Summary of Product characteristics Summary of Product characteristics Czech 01-01-1970
Public Assessment Report Public Assessment Report Czech 01-01-1970
Patient Information leaflet Patient Information leaflet Danish 01-01-1970
Summary of Product characteristics Summary of Product characteristics Danish 01-01-1970
Public Assessment Report Public Assessment Report Danish 01-01-1970
Patient Information leaflet Patient Information leaflet German 01-01-1970
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Public Assessment Report Public Assessment Report German 01-01-1970
Patient Information leaflet Patient Information leaflet Estonian 01-01-1970
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Public Assessment Report Public Assessment Report Estonian 01-01-1970
Patient Information leaflet Patient Information leaflet Greek 01-01-1970
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Public Assessment Report Public Assessment Report Greek 01-01-1970
Patient Information leaflet Patient Information leaflet English 01-01-1970
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Public Assessment Report Public Assessment Report English 01-01-1970
Patient Information leaflet Patient Information leaflet French 01-01-1970
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Public Assessment Report Public Assessment Report French 01-01-1970
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Public Assessment Report Public Assessment Report Hungarian 01-01-1970
Patient Information leaflet Patient Information leaflet Maltese 01-01-1970
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Patient Information leaflet Patient Information leaflet Dutch 01-01-1970
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Patient Information leaflet Patient Information leaflet Polish 01-01-1970
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Summary of Product characteristics Summary of Product characteristics Romanian 01-01-1970
Public Assessment Report Public Assessment Report Romanian 01-01-1970
Patient Information leaflet Patient Information leaflet Slovak 01-01-1970
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Public Assessment Report Public Assessment Report Slovak 01-01-1970
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Public Assessment Report Public Assessment Report Slovenian 01-01-1970
Patient Information leaflet Patient Information leaflet Finnish 01-01-1970
Summary of Product characteristics Summary of Product characteristics Finnish 01-01-1970
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Public Assessment Report Public Assessment Report Swedish 01-01-1970
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Summary of Product characteristics Summary of Product characteristics Norwegian 01-01-1970
Patient Information leaflet Patient Information leaflet Icelandic 01-01-1970
Summary of Product characteristics Summary of Product characteristics Icelandic 01-01-1970

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