DaTSCAN

Country: European Union

Language: Croatian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
10-02-2022
Summary of Product characteristics Summary of Product characteristics (SPC)
10-02-2022

Active ingredient:

ioflupan (123)

Available from:

GE Healthcare B.V.

ATC code:

V09AB03

INN (International Name):

ioflupane (123l)

Therapeutic group:

Dijagnostički radiofarmaceutici

Therapeutic area:

Tomography, Emission-Computed, Single-Photon; Lewy Body Disease; Parkinson Disease; Alzheimer Disease

Therapeutic indications:

Ovaj je lijek samo za dijagnostičku uporabu. Kasnije je dizajniran za otkrivanje gubitka funkcionalnih дофаминергических neurona u стриатуме terminali:kod odraslih pacijenata sa klinički nesigurni Паркинсонического sindromi, na primjer, s početkom simptomima, kako bi se razlikovati эссенциальный tremor od Parkinsonove bolesti sindromi povezani s idiopatske Parkinsonove bolesti, прогрессирующем надъядерном paralize i multiple sistemske атрофией. Kasnije ne može razlikovati između Parkinsonove bolesti, множественную sistem gubljenje i прогрессирующем надъядерном paralize. Kod odraslih pacijenata, kako bi razlikovati vjerojatno demencije s тельцами Levy od Alzheimerove bolesti . Kasnije nije u stanju razlikovati demencije s тельцами Levi i Parkinsonove bolesti s demencijom.

Product summary:

Revision: 23

Authorization status:

odobren

Authorization date:

2000-07-27

Patient Information leaflet

                                21
B. UPUTA O LIJEKU
22
UPUTA O LIJEKU: INFORMACIJE ZA KORISNIKA
DATSCAN 74 MBQ/ML OTOPINA ZA INJEKCIJU
ioflupan (
123
I)
_ _
PAŽLJIVO PROČITAJTE CIJELU UPUTU PRIJE NEGO POČNETE PRIMJENJIVATI
OVAJ LIJEK, JER SADRŽI VAMA
VAŽNE PODATKE.
−
Sačuvajte ovu uputu. Možda ćete je trebati ponovno pročitati.
−
Ako imate dodatnih pitanja, obratite se svom liječniku specijalistu
nuklearne medicine koji će
nadgledati Vaš postupak.
−
Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti
liječnika specijalista nuklearne
medicine. To uključuje i svaku moguću nuspojavu koja nije navedena u
ovoj uputi. Pogledajte
dio 4.
ŠTO SE NALAZI U OVOJ UPUTI:
1.
Što je DaTSCAN i za što se koristi
2.
Što morate znati prije nego primite DaTSCAN
3.
Kako se primjenjuje DaTSCAN
4.
Moguće nuspojave
5.
Kako se čuva DaTSCAN
6.
Sadržaj pakiranja i druge informacije
1.
ŠTO JE DATSCAN I ZA ŠTO SE KORISTI
DaTSCAN sadrži djelatnu tvar ioflupan (
123
I) koja se koristi kako bi pomogla identificirati
(dijagnosticirati) stanja u mozgu. Pripada skupini lijekova zvanih
"radiofarmaceutici", koji sadrže malu
količinu radioaktivnosti.
•
Kad se radiofarmaceutik ubrizga, na kratko vrijeme se skuplja u
određenom organu ili području
tijela.
•
Zbog toga što sadrži malu količinu radioaktivnosti može se
detektirati izvan tijela, uporabom
posebnih kamera.
•
Može se snimiti slika, takozvani sken. Taj sken će prikazati gdje se
točno nalazi radioaktivnost
unutar organa i tijela. To liječniku može dati vrijednu informaciju
o funkciji određenog organa.
Kad se DaTSCAN ubrizga odrasloj osobi, po tijelu se raznosi putem
krvi. Zatim se nakuplja u malom
području Vašeg mozga. Promjene u tom području mozga događaju se
kod:
•
Parkinsonizma (uključujući Parkinsonovu bolest) i
•
demencije s Lewyjevim tjelešcima.
Slika (sken) će liječniku dati informacije o svim promjenama u tom
dijelu Vašeg mozga. Sken može
pomoći Vašem liječniku kako bi saznao više o Vašem stanju i
pomoći mu u odluci o mogućem liječenju.

                                
                                Read the complete document

Summary of Product characteristics

                                1
PRILOG I.
SAŽETAK OPISA SVOJSTAVA LIJEKA
_ _
2
1.
NAZIV LIJEKA
DaTSCAN 74 MBq/ml otopina za injekciju
2.
KVALITATIVNI I KVANTITATIVNI SASTAV
Jedan ml otopine sadrži 74 MBq ioflupana (
123
I) u referentnom vremenu (0,07 do 0,13 μg/ml ioflupana).
Jedna jednodozna bočica s 2,5
ml otopine sadrži 185 MBq ioflupana (
123
I) (specifični raspon aktivnosti
2,5 do 4,5 x 10
14
Bq/mmola) u referentnom vremenu.
Jedna jednodozna bočica s 5 ml otopine sadrži 370 MBq ioflupana (
123
I) (specifični raspon aktivnosti
2,5 do 4,5 x 10
14
Bq/mmola) u referentnom vremenu.
_ _
Pomoćne tvari s poznatim učinkom
Ovaj lijek sadrži 39,5 g/l etanola.
Za cjeloviti popis pomoćnih tvari vidjeti dio 6.1.
3.
FARMACEUTSKI OBLIK
Otopina za injekciju.
Prozirna bezbojna otopina.
4.
KLINIČKI PODACI
4.1
TERAPIJSKE INDIKACIJE
Ovaj lijek koristi se samo u dijagnostičke svrhe.
DaTSCAN je indiciran za detekciju gubitka funkcije završetaka
dopaminergičnih neurona u striatumu:
•
U odraslih bolesnika s klinički nesigurnim Parkinsonovim sindromima,
na primjer kod onih s
ranim simptomima, kao pomoć u razlikovanju esencijalnog tremora od
Parkinsonovih sindroma
povezanih s idiopatskom Parkinsonovom bolešću, multiplom sistemskom
atrofijom i
progresivnom supranuklearnom paralizom. DaTSCAN-om nije moguće
razlikovati Parkinsonovu
bolest od multiple sistemske atrofije i progresivne supranuklearne
paralize.
•
U odraslih bolesnika, kao pomoć u razlikovanju vjerojatne demencije s
Lewyjevim tjelešcima od
Alzheimerove bolesti. DaTSCAN-om nije moguće razlikovati demenciju s
Lewyjevim tjelešcima
od demencije u Parkinsonovoj bolesti.
4.2
DOZIRANJE I NAČIN PRIMJENE
Prije primjene, mora biti dostupna odgovarajuća oprema za
oživljavanje.
DaTSCAN se smije koristiti samo u odraslih bolesnika prema preporuci
liječnika s iskustvom u
liječenju poremećaja pokreta i/ili demencije. DaTSCAN smije
koristiti isključivo kvalificirano
medicinsko osoblje s odgovarajućom službenom dozvolom za primjenu i
rukovanje radionuklidima
unutar posebno opremljeni
                                
                                Read the complete document

Similar products

Active ingredient ioflupan (123)

ioflupan (123)

ATC code V09AB03

V09AB03

Marketed by GE Healthcare B.V.

GE Healthcare B.V.

INN (International Name) ioflupane (123l)

ioflupane (123l)

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