Akeega

Country: European Union

Language: Latvian

Source: EMA (European Medicines Agency)

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

Antineoplastiski līdzekļi

Therapeutic area:

Prostatas Audzējiem, Kastrācija-Izturīgs

Therapeutic indications:

Treatment of adult patients with prostate cancer.

Authorization status:

Autorizēts

Authorization date:

2023-04-19

Patient Information leaflet

                                41
B. LIETOŠANAS INSTRUKCIJA
42
LIETOŠANAS INSTRUKCIJA: INFORMĀCIJA LIETOTĀJAM
AKEEGA 50 MG/500 MG APVALKOTĀS TABLETES
_niraparibum/abirateroni acetas_
PIRMS ZĀĻU LIETOŠANAS UZMANĪGI IZLASIET VISU INSTRUKCIJU, JO TĀ
SATUR JUMS SVARĪGU INFORMĀCIJU.

Saglabājiet šo instrukciju! Iespējams, ka vēlāk to vajadzēs
pārlasīt.

Ja Jums rodas jebkādi jautājumi, vaicājiet ārstam vai farmaceitam.

Šīs zāles ir parakstītas tikai Jums. Nedodiet to citiem. Tās var
nodarīt ļaunumu pat tad, ja šiem
cilvēkiem ir līdzīgas slimības pazīmes.

Ja Jums rodas jebkādas blakusparādības, konsultējieties ar ārstu
vai farmaceitu. Tas attiecas arī
uz iespējamām blakusparādībām, kas nav minētas šajā
instrukcijā (skatīt 4. punktu).
ŠAJĀ INSTRUKCIJĀ VARAT UZZINĀT:
1.
Kas ir Akeega un kādam nolūkam to lieto
2.
Kas Jums jāzina pirms Akeega lietošanas
3.
Kā lietot Akeega
4.
Iespējamās blakusparādības
5.
Kā uzglabāt Akeega
6.
Iepakojuma saturs un cita informācija
1.
KAS IR AKEEGA UN KĀDAM NOLŪKAM TO LIETO
Akeega satur divas aktīvās vielas: niraparibu un abiraterona
acetātu, un iedarbojas divos dažādos
veidos.
Akeega lieto, lai ārstētu pieaugušus vīriešus, kuriem ir
prostatas vēzis un izmaiņas noteiktos gēnos un
kuriem prostatas vēzis ir izplatījies uz citām ķermeņa daļām un
vairs nereaģē uz medikamentozu vai
ķirurģisku terapiju, kas pazemina testosterona līmeni (ko sauc arī
par metastātisku, pret kastrāciju
rezistentu prostatas vēzi).
Niraparibs ir pretvēža zāles, ko sauc par PARP inhibitoru. PARP
inhibitori bloķē enzīmu, ko sauc par
poli adenozīna difosfāta ribozes polimerāzi (PARP). PARP palīdz
šūnām atjaunot bojāto DNS. Kad
PARP ir bloķēta, vēža šūnas nespēj atjaunot savu DNS, tādēļ
vēža šūnas iet bojā, un tas palīdz
kontrolēt vēzi.
Abiraterons organismā pārtrauc testosterona sintēzi, tādēļ var
palēnināties prostatas vēža augšana.
Ja lietosiet šīs zāles, ārsts Jums nozīmēs arī citas zāle
                                
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Summary of Product characteristics

                                1
I PIELIKUMS
ZĀĻU APRAKSTS
2
1.
ZĀĻU NOSAUKUMS
Akeega 50 mg/500 mg apvalkotās tabletes
Akeega 100 mg/500 mg apvalkotās tabletes
2.
KVALITATĪVAIS UN KVANTITATĪVAIS SASTĀVS
Akeega 50 mg/500 mg apvalkotās tabletes
Katra apvalkotā tablete satur nirapariba tosilāta monohidrātu, kas
atbilst 50 mg nirapariba
(_niraparibum_), un 500 mg abiraterona acetāta (_abirateroni
acetas_), kas atbilst 446 mg abiraterona.
Akeega 100 mg/500 mg apvalkotās tabletes
Katra apvalkotā tablete satur nirapariba tosilāta monohidrātu, kas
atbilst 100 mg nirapariba
(_niraparibum_), un 500 mg abiraterona acetāta (_abirateroni
acetas_), kas atbilst 446 mg abiraterona.
Palīgvielas ar zināmu iedarbību
Katra apvalkotā tablete satur 214 mg laktozes (skatīt 4.4.
apakšpunktu).
Pilnu palīgvielu sarakstu skatīt 6.1. apakšpunktā.
3.
ZĀĻU FORMA
Apvalkotā tablete (tablete).
Akeega 50 mg/500 mg apvalkotās tabletes
Dzeltenīgi oranžas līdz dzeltenīgi brūnas, ovālas apvalkotas
tabletes (22 mm x 11 mm) ar iespiedumu
“N 50 A” vienā pusē un gludu otru pusi.
Akeega 100 mg/500 mg apvalkotās tabletes
Oranžas, ovālas apvalkotas tabletes (22 mm x 11 mm) ar iespiedumu
“N 100 A” vienā pusē un gludu
otru pusi.
4.
KLĪNISKĀ INFORMĀCIJA
4.1.
TERAPEITISKĀS INDIKĀCIJAS
Akeega kombinācijā ar prednizonu vai prednizolonu ir indicēts
pieaugušu pacientu ārstēšanai, kuriem
ir metastātisks, pret kastrāciju rezistents prostatas vēzis (mCRPC
-_ metastatic castration resistant _
_prostate cancer_) un BRCA 1./2. gēna mutācijas (dzimumšūnu un/vai
somatisko šūnu) un kuriem
ķīmijterapija nav klīniski indicēta.
4.2.
DEVAS UN LIETOŠANAS VEIDS
Ārstēšana ar niraparibu un abiraterona acetātu kopā ar prednizonu
vai prednizolonu jāsāk un jāuzrauga
ārstiem speciālistiem, kuriem ir prostatas vēža medikamentozas
ārstēšanas pieredze.
Pirms Akeega lietošanas uzsākšanas ar validētu testa metodi
jānosaka BRCA statuss (skatīt
5.1. apakšpunktu).
Devas
Akeega ieteicamā sākumdeva ir 200 mg/1000 mg (divas 
                                
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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 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 Norwegian 01-01-1970
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
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

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