Akeega

Country: European Union

Language: Norwegian

Source: EMA (European Medicines Agency)

Buy It Now

Download Patient Information leaflet (PIL)
01-01-1970
Download Summary of Product characteristics (SPC)
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:

Antineoplastiske midler

Therapeutic area:

Prostatic Neoplasmer, Kastrering-Resistant

Therapeutic indications:

Treatment of adult patients with prostate cancer.

Authorization status:

autorisert

Authorization date:

2023-04-19

Patient Information leaflet

                                41
B. PAKNINGSVEDLEGG
42
PAKNINGSVEDLEGG: INFORMASJON TIL BRUKEREN
AKEEGA 50 MG/500 MG FILMDRASJERTE TABLETTER
niraparib/abirateronacetat
LES NØYE GJENNOM DETTE PAKNINGSVEDLEGGET FØR DU BEGYNNER Å BRUKE
DETTE LEGEMIDLET. DET
INNEHOLDER INFORMASJON SOM ER VIKTIG FOR DEG.

Ta vare på dette pakningsvedlegget. Du kan få behov for å lese det
igjen.

Spør lege eller apotek hvis du har flere spørsmål eller trenger mer
informasjon.

Dette legemidlet er skrevet ut kun til deg. Ikke gi det videre til
andre. Det kan skade dem, selv
om de har symptomer på sykdom som ligner dine.

Kontakt lege eller apotek dersom du opplever bivirkninger, inkludert
mulige bivirkninger som
ikke er nevnt i dette pakningsvedlegget. Se avsnitt 4.
I DETTE PAKNINGSVEDLEGGET FINNER DU INFORMASJON OM:
1.
Hva Akeega er og hva det brukes mot
2.
Hva du må vite før du bruker Akeega
3.
Hvordan du bruker Akeega
4.
Mulige bivirkninger
5.
Hvordan du oppbevarer Akeega
6.
Innholdet i pakningen og ytterligere informasjon
1.
HVA AKEEGA ER OG HVA DET BRUKES MOT
Akeega er et legemiddel som inneholder to virkestoffer: niraparib og
abirateronacetat, som virker på to
forskjellige måter.
Akeega brukes til behandling av voksne menn med prostatakreft som har
forandringer i visse gener,
og hvor prostatakreften har spredt seg til andre deler av kroppen og
ikke lenger responderer på
medisinsk eller kirurgisk behandling som senker testosteronnivået
(også kalt kastrasjonsresistent
prostatakreft).
Niraparib er en type kreftmedisin som kalles PARP-hemmer. PARP-hemmere
blokkerer et enzym kalt
poly[adenosindifosfatribose]-polymerase (PARP). PARP bidrar til
cellenes reparasjon av skadet DNA.
Når PARP blokkeres, kan ikke kreftceller reparere sitt DNA, noe som
forårsaker kreftcelledød og
bidrar til å kontrollere kreften.
Abirateron hindrer at kroppen din lager testosteron, og dette kan
bremse veksten av prostatakreft.
Når du tar dette legemidlet, vil legen også skrive ut et annet
legemiddel som kalles prednison eller
prednisolon. Dette skal reduse
                                
                                Read the complete document

Summary of Product characteristics

                                1
VEDLEGG I
PREPARATOMTALE
2
1.
LEGEMIDLETS NAVN
Akeega 50 mg/500 mg filmdrasjerte tabletter
Akeega 100 mg/500 mg filmdrasjerte tabletter
2.
KVALITATIV OG KVANTITATIV SAMMENSETNING
Akeega 50 mg/500 mg filmdrasjerte tabletter
Hver filmdrasjerte tablett inneholder niraparibtosylatmonohydrat
tilsvarende 50 mg niraparib og
500 mg abirateronacetat tilsvarende 446 mg abirateron.
Akeega 100 mg/500 mg filmdrasjerte tabletter
Hver filmdrasjerte tablett inneholder niraparibtosylatmonohydrat
tilsvarende 100 mg niraparib og
500 mg abirateronacetat tilsvarende 446 mg abirateron.
Hjelpestoff med kjent effekt
Hver filmdrasjerte tablett inneholder 241 mg laktose (se pkt. 4.4).
For fullstendig liste over hjelpestoffer, se pkt. 6.1.
3.
LEGEMIDDELFORM
Tablett, filmdrasjert (tablett).
Akeega 50 mg/500 mg filmdrasjerte tabletter
Guloransje til gulbrune, ovale, filmdrasjerte tabletter (22 mm x 11
mm), preget med "N 50 A" på den
ene siden, og glatte på den andre siden.
Akeega 100 mg/500 mg filmdrasjerte tabletter
Oransje, ovale, filmdrasjerte tabletter (22 mm x 11 mm), preget med "N
100 A" på den ene siden, og
glatte på den andre siden.
4.
KLINISKE OPPLYSNINGER
4.1
INDIKASJON(ER)
Akeega er indisert sammen med prednison eller prednisolon til
behandling av voksne pasienter med
metastaserende, kastrasjonsresistent prostatakreft (mCRPC) og BRCA
1/2-mutasjoner (kimbane
og/eller somatiske), hvor kjemoterapi ikke er klinisk indisert.
4.2
DOSERING OG ADMINISTRASJONSMÅTE
Behandling med niraparib og abirateronacetat pluss prednison eller
prednisolon skal startes og ledes
av en legespesialist med erfaring innen medisinsk behandling av
prostatakreft.
Før oppstart av behandling med Akeega må positiv BRCA-status
fastslås ved bruk av en validert
analysemetode (se pkt. 5.1).
Dosering
Den anbefalte startdosen av Akeega er 200 mg/1 000 mg (to 100 mg
niraparib/500 mg abirateronacetat
tabletter), som én daglig dose til omtrent samme tid hver dag (se
"Administrasjonsmåte" nedenfor).
Tablettene på 50 mg/500 mg er tilgjengelige for dosereduksjon.

                                
                                Read the complete document

Similar products

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

Documents in other languages

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
Summary of Product characteristics Summary of Product characteristics German 01-01-1970
Public Assessment Report Public Assessment Report German 01-01-1970
Patient Information leaflet Patient Information leaflet Estonian 01-01-1970
Summary of Product characteristics Summary of Product characteristics Estonian 01-01-1970
Public Assessment Report Public Assessment Report Estonian 01-01-1970
Patient Information leaflet Patient Information leaflet Greek 01-01-1970
Summary of Product characteristics Summary of Product characteristics Greek 01-01-1970
Public Assessment Report Public Assessment Report Greek 01-01-1970
Patient Information leaflet Patient Information leaflet English 01-01-1970
Summary of Product characteristics Summary of Product characteristics English 01-01-1970
Public Assessment Report Public Assessment Report English 01-01-1970
Patient Information leaflet Patient Information leaflet French 01-01-1970
Summary of Product characteristics Summary of Product characteristics French 01-01-1970
Public Assessment Report Public Assessment Report French 01-01-1970
Patient Information leaflet Patient Information leaflet Italian 01-01-1970
Summary of Product characteristics Summary of Product characteristics Italian 01-01-1970
Public Assessment Report Public Assessment Report Italian 01-01-1970
Patient Information leaflet Patient Information leaflet Latvian 01-01-1970
Summary of Product characteristics Summary of Product characteristics Latvian 01-01-1970
Public Assessment Report Public Assessment Report Latvian 01-01-1970
Patient Information leaflet Patient Information leaflet Lithuanian 01-01-1970
Summary of Product characteristics Summary of Product characteristics Lithuanian 01-01-1970
Public Assessment Report Public Assessment Report Lithuanian 01-01-1970
Patient Information leaflet Patient Information leaflet Hungarian 01-01-1970
Summary of Product characteristics Summary of Product characteristics Hungarian 01-01-1970
Public Assessment Report Public Assessment Report Hungarian 01-01-1970
Patient Information leaflet Patient Information leaflet Maltese 01-01-1970
Summary of Product characteristics Summary of Product characteristics Maltese 01-01-1970
Public Assessment Report Public Assessment Report Maltese 01-01-1970
Patient Information leaflet Patient Information leaflet Dutch 01-01-1970
Summary of Product characteristics Summary of Product characteristics Dutch 01-01-1970
Public Assessment Report Public Assessment Report Dutch 01-01-1970
Patient Information leaflet Patient Information leaflet Polish 01-01-1970
Summary of Product characteristics Summary of Product characteristics Polish 01-01-1970
Public Assessment Report Public Assessment Report Polish 01-01-1970
Patient Information leaflet Patient Information leaflet Portuguese 01-01-1970
Summary of Product characteristics Summary of Product characteristics Portuguese 01-01-1970
Public Assessment Report Public Assessment Report Portuguese 01-01-1970
Patient Information leaflet Patient Information leaflet Romanian 01-01-1970
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
Summary of Product characteristics Summary of Product characteristics Slovak 01-01-1970
Public Assessment Report Public Assessment Report Slovak 01-01-1970
Patient Information leaflet Patient Information leaflet Slovenian 01-01-1970
Summary of Product characteristics Summary of Product characteristics Slovenian 01-01-1970
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
Public Assessment Report Public Assessment Report Finnish 01-01-1970
Patient Information leaflet Patient Information leaflet Swedish 01-01-1970
Summary of Product characteristics Summary of Product characteristics Swedish 01-01-1970
Public Assessment Report Public Assessment Report Swedish 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
Patient Information leaflet Patient Information leaflet Croatian 01-01-1970
Summary of Product characteristics Summary of Product characteristics Croatian 01-01-1970
Public Assessment Report Public Assessment Report Croatian 01-01-1970

Search alerts related to this product

Alerts Akeega abiraterone acetate, Niraparib tosilate niraparib,

Akeega abiraterone acetate, Niraparib tosilate niraparib,

View documents history

Documents history Documents history

Akeega