Axumin

Country: European Union

Language: Slovenian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
19-12-2022
Summary of Product characteristics Summary of Product characteristics (SPC)
19-12-2022
Public Assessment Report Public Assessment Report (PAR)
06-07-2017

Active ingredient:

Fluciclovine (18F)

Available from:

Blue Earth Diagnostics Ireland Ltd

ATC code:

V09IX12

INN (International Name):

fluciclovine (18F)

Therapeutic group:

Diagnostični radiofarmacevtiki

Therapeutic area:

Prostatic Neoplasms; Radionuclide Imaging

Therapeutic indications:

To zdravilo je samo za diagnostično uporabo. Axumin je označen za Positron Emission Tomografija (PET) slikanje za odkrivanje ponovitve raka na prostati pri moških odraslih z suma ponovitve, ki temelji na zvišan krvni prostato specifični antigen (PSA) ravni po primarni kurativnega zdravljenja.

Product summary:

Revision: 16

Authorization status:

Pooblaščeni

Authorization date:

2017-05-21

Patient Information leaflet

                                20
9.
POSEBNA NAVODILA ZA SHRANJEVANJE
10.
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEUPORABLJENIH
ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI
Neuporabljen material je treba odstraniti skladno z lokalnimi
predpisi.
11.
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
Blue Earth Diagnostics Ireland Ltd, 6th Floor, 2 Grand Canal Square,
Dublin 2, Irska
12.
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET
EU/1/17/1186/001
EU/1/17/1186/003
13.
ŠTEVILKA SERIJE
_ _
Lot
14.
NAČIN IZDAJANJA ZDRAVILA
_ _
Predpisovanje in izdaja zdravila je le na recept.
_ _
15.
NAVODILA ZA UPORABO
16.
PODATKI V BRAILLOVI PISAVI
Sprejeta je utemeljitev, da Braillova pisava ni potrebna.
17.
EDINSTVENA OZNAKA – DVODIMENZIONALNA ČRTNA KODA_ _
Navedba smiselno ni potrebna.
18.
EDINSTVENA OZNAKA – V BERLJIVI OBLIKI_ _
Navedba smiselno ni potrebna.
21
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
OVOJNINAH
NALEPKA NA VIALI
1.
IME ZDRAVILA IN POT(I) UPORABE
Axumin 1.600 MBq/ml raztopina za injiciranje
[
18
F]fluciklovin
intravenska uporaba
2.
POSTOPEK UPORABE
3.
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
EXP: ToC + 8 h
4.
ŠTEVILKA SERIJE
Lot
5.
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT
Aktivnost: {YYYY} MBq
Volumen: {xx,x] mL
6.
DRUGI PODATKI
Seibersdorf Labor GmbH, 2444 Seibersdorf, Avstrija
Norsk medisinsk syklotronsenter AS, 0372 Oslo, Norveška
Advanced Accelerator Applications Molecular Imaging France S.A.S.,
13005 Marseille, Francija
Nucleis SA, 4000 Liège, Belgija
Advanced Accelerator Applications Molecular Imaging Italy S.r.l.,
47014, Meldola (FC), Italija
Advanced Accelerator Applications Molecular Imaging France S.A.S.,
92210 Saint-Cloud, Francija
Synektik Pharma Sp. z o.o., 96-320 Mszczonów, Poljska
Advanced Accelerator Applications Molecular Imaging Ibérica, S.L.U.
08950, Esplugues de
Llobregat, Španija
22
PODATKI NA ZUNANJI OVOJNINI
NALEPKA NA ŠČITNIKU
1.
IME ZDRAVILA
Axumin 3.200 MBq/ml raztopina za injiciranje
[
18
F]fluciklovin
2.
NAVEDBA ENE ALI VEČ UČINKOVIN
Ob
                                
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Summary of Product characteristics

                                1
PRILOGA I
POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
2
1.
IME ZDRAVILA
Axumin 1.600 MBq/ml raztopina za injiciranje
Axumin 3.200 MBq/ml raztopina za injiciranje
2.
KAKOVOSTNA IN KOLIČINSKA SESTAVA
Axumin 1.600 MBq/ml raztopina za injiciranje
Ob datumu in uri umerjanja (ToC-time of calibration) en ml raztopine
vsebuje 1.600 MBq
[
18
F]fluciklovina.
Ob datumu in ToC se aktivnost na vialo giblje med 1.600 in 16.000 MBq.
Axumin 3.200 MBq/ml raztopina za injiciranje
Ob datumu in ToC en ml raztopine vsebuje 3.200 MBq [
18
F]fluciklovina.
Ob datumu in ToC se aktivnost na vialo giblje med 3.200 in 32.000 MBq.
Fluor (
18
F) z oddajanjem pozitronskega sevanja z največjo energijo 634 keV,
čemur sledi fotonsko
anihilacijsko sevanje s 511 keV, razpade na stabilni kisik (
18
O) z razpolovnim časom 110 minut.
Pomožne snovi z znanim učinkom
En ml raztopine vsebuje 7,7 mg natrija.
Za celoten seznam pomožnih snovi glejte poglavje 6.1.
3.
FARMACEVTSKA OBLIKA
raztopina za injiciranje
Bistra in brezbarvna raztopina.
4.
KLINIČNI PODATKI
4.1
TERAPEVTSKE INDIKACIJE
Zdravilo je samo za diagnostične namene.
Zdravilo Axumin je indicirano za slikanje s pozitronsko emisijsko
tomografijo (PET) za odkrivanje
ponovnega pojava raka prostate pri odraslih moških, pri katerih
sumimo na ponovitev na podlagi
zvišane krvne ravni prostatičnega specifičnega antigena (PSA) po
primarnem kurativnem zdravljenju.
Za omejitve pri razlaganju pozitivnega rezultata slikanja glejte
poglavji 4.4 in 5.1.
4.2
ODMERJANJE IN NAČIN UPORABE
Slikanje s pozitronsko emisijsko tomografijo (PET) z [
18
F]fluciklovinom morajo opraviti ustrezno
usposobljeni zdravstveni delavci.
Slike sme razlagati samo osebje, usposobljeno za razlago slik PET z [
18
F]fluciklovinom.
3
Odmerjanje
Priporočena aktivnost za odrasle je 370 MBq [
18
F]fluciklovina.
_Posebne populacije _
_ _
_Starejši bolniki _
Prilagajanje odmerkov ni potrebno.
_ _
_Okvara ledvic in jeter _
Zdravila Axumin niso preučevali pri bolnikih z okvaro ledvic ali
jeter.
Odmerjeno aktivnost je treba skrbno izbr
                                
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Similar products

Active ingredient Fluciclovine (18F)

Fluciclovine (18F)

ATC code V09IX12

V09IX12

Marketed by Blue Earth Diagnostics Ireland Ltd

Blue Earth Diagnostics Ireland Ltd

INN (International Name) fluciclovine (18F)

fluciclovine (18F)

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Patient Information leaflet Patient Information leaflet Bulgarian 19-12-2022
Summary of Product characteristics Summary of Product characteristics Bulgarian 19-12-2022
Public Assessment Report Public Assessment Report Bulgarian 06-07-2017
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Summary of Product characteristics Summary of Product characteristics Spanish 19-12-2022
Public Assessment Report Public Assessment Report Spanish 06-07-2017
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Public Assessment Report Public Assessment Report Czech 06-07-2017
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Public Assessment Report Public Assessment Report German 06-07-2017
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Public Assessment Report Public Assessment Report Estonian 06-07-2017
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