FluCore

Primær information

  • Handelsnavn:
  • FluCore injektionsvæske, opløsning
  • Lægemiddelform:
  • injektionsvæske, opløsning
  • Brugt til:
  • Mennesker
  • Medicin typen:
  • Allopatiske stof

Dokumenter

  • for sundhedspersonale:
  • Oplysningerne indlægssedlen for dette produkt er i øjeblikket ikke tilgængelig, kan du sende en anmodning til vores kundeservice, og vi vil give dig besked, så snart vi er i stand til at opnå det.


    Anmode informationsbrochure for sundhedspersonale.

Lokation

  • Fås i:
  • FluCore injektionsvæske, opløsning
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisation status:
  • Markedsført
  • Autorisationsnummer:
  • 49384
  • Sidste ændring:
  • 02-02-2018

Indlægsseddel

Indlægsseddel: Information til brugeren

FluCore 400 MBq – 180 GBq/30 ml, injektionsvæske, opløsning

Fludeoxyglucose (

18

F)

Læs denne indlægsseddel grundigt, inden du bliver behandlet med dette lægemiddel, da den

indeholder vigtige oplysninger.

Gem indlægssedlen. Du kan få brug for at læse den igen.

Spørg speciallægen i nuklearmedicin, som skal overvåge behandlingen hvis der er mere, du vil vide.

Tal med speciallægen i nuklearmedicin, hvis en bivirkning bliver værre, eller hvis du får bivirkninger,

som ikke er nævnt her.

Oversigt over indlægssedlen

Virkning og anvendelse

Det skal du vide før du bliver undersøgt med FluCore

Sådan bliver du undersøgt med FluCore

Bivirkninger

Opbevaring

Pakningsstørrelser og yderligere oplysninger

Den nyeste indlægsseddel kan findes på www.indlaegsseddel.dk

1.

Virkning og anvendelse

Dette lægemiddel er et radiofarmaceutisk produkt, som kun er til diagnostisk brug.

Den aktive substans i FluCore er fludeoxyglucose (

F) og det bruges til i forbindelse med diagnostiske

undersøgelser. Ved undersøgelserne fås et billede af cellernes stofskifte i hele eller dele af din krop.

Efter indsprøjtning af en lille mængde FluCore bliver der optaget billeder med et særligt kamera (PET

skanner), som gør det muligt for lægen at se, hvor din sygdom er eller hvordan den forløber.

2.

Det skal du vide før du bliver undersøgt med FluCore

Du må ikke få FluCore

Hvis du er overfølsom (allergisk) over for fludeoxyglucose (

F) eller et af de øvrige indholdsstoffer i

FluCore (angivet i punkt 6).

Advarsler og forsigtighedsregler

Tal med speciallægen i nuklearmedicin før du bliver behandlet med FluCore

hvis du har sukkersyge og hvis din sukkersyge ikke er velkontrolleret

hvis du har en infektion eller en anden betændelsessygdom

hvis du har en nyresygdom

Fortæl det til speciallægen i nuklearmedicin inden du får FluCore:

hvis du er gravid eller tror du er gravid

hvis du ammer

Før FluCore indsprøjtningen skal du:

Undgå al krævende fysisk aktivitet

Drikke rigeligt med vand de sidste 4 timer op til indsprøjtningen for at du kan tisse så tit som muligt i de

første timer efter undersøgelsen

Faste i mindst 4 timer

Børn og teenagere

Tal med din speciallæge i nuklearmedicin hvis du er under 18 år.

Brug af anden medicin sammen med FluCore

Fortæl det altid til speciallægen i nuklearmedicin eller sundhedspersonalet, hvis du bruger anden medicin

eller har brugt det for nylig. Dette gælder også medicin, som ikke er købt på recept, f.eks. naturlægemidler,

vitaminer og mineraler. Dette skyldes at nogle lægemidler kan påvirke lægens tolkning af billederne:

medicin der kan påvirke reguleringen af dit blodsukker (glykæmi), f.eks. medicin mod betændelse

(kortikosteroider), medicin mod krampeanfald (valproat, carbamazepin, phenytoin eller phenobarbital)

eller medicin, der virker på nervesystemet (adrenalin, noradrenalin eller dopamin)

glucose (= druesukker)

insulin

medicin, der øger dannelsen af blodceller

Brug af FluCore sammen med mad og drikke

Du må ikke spise i en periode på mindst 4 timer før du får indsprøjtningen. Du skal drikke rigeligt med vand

og undgå at drikke sukkerholdige væsker.

Dit blodsukkerniveau skal måles inden du får indsprøjtningen, da højt blodsukker (hyperglykæmi) kan

vanskeliggøre lægens vurdering af billederne.

Graviditet og amning

Inden du får indsprøjtningen med FluCore skal du fortælle speciallægen i nuklearmedicin, hvis der er en

chance for , at du måske er gravid, hvis din menstruation er udeblevet eller hvis du ammer.

Hvis du er i tvivl, er det vigtigt, at du fortæller det til speciallægen i nuklearmedicin.

Hvis du er gravid

Lægen vil kun foretage denne undersøgelse under din graviditet, hvis det forventes, at fordelene opvejer

risikoen.

Hvis du ammer

Du skal afbryde amningen i 12 timer efter indsprøjtningen, malke modermælken ud og kassere den.

Genoptagelse af amningen skal være efter aftale med speciallægen i nuklearmedicin, som overvåger

behandlingen.

Hvis du er gravid, ammer, kan være gravid, eller planlægger at blive gravid, tal med speciallægen i

nuklearmedicin, før du får dette lægemiddel.

Trafik- og arbejdssikkerhed

FluCore påvirker ikke arbejdssikkerheden eller evnen til at færdes sikkert i trafikken.

FluCore indeholder natrium og ethanol

FluCore kan indeholde mere end 1 mmol natrium (23 mg). Hvis du er på natrium- eller saltfattig diæt, skal

du tage hensyn hertil.

Denne medicin indeholder en mindre mængde alkohol, mindre end 100 mg pr. dosis.

3.

Sådan bliver du undersøgt med FluCore

Der er strenge regler for anvendelse, håndtering og bortskaffelse af radioaktive lægemidler. FluCore

anvendes kun i specielt kontrollerede områder. Det vil kun blive håndteret og givet af personer, som er

uddannet og kvalificeret til at anvende det sikkert. Disse personer vil tage særlige forholdsregler for sikker

håndtering og undervejs fortælle dig, hvad de gør.

Speciallægen i nuklearmedicin, som skal overvåge behandlingen, vil beslutte hvilken dosis FluCore, der

passer til dig. Det vil være den mindste dosis, der er nødvendig for at opnå den ønskede information.

Den dosis, der normalt anbefales til voksne ligger mellem 100 og 400 MBq (afhængig af patientens

kropsvægt, typen af det kamera, der anvendes og indstilling på kameraet).

Megabecquerel (MBq) er måleenheden for radioaktivitet.

Anvendelse i børn og teenagere

Hvis FluCore skal anvendes til børn og teenagere, bliver den mængde, der skal indsprøjtes, beregnet ud fra

barnets kropsvægt.

Indgivelse af FluCore og behandlingsforløbet

Du skal have FluCore som en indsprøjtning. En læge eller sygeplejerske/bioanalytiker vil give dig

indsprøjtningen. Du vil få indsprøjtet FluCore i en blodåre.

Én indsprøjtning er tilstrækkelig til at udføre den undersøgelse, som lægen har brug for.

Efter indsprøjtningen er du nødt til at ligge helt stille uden at læse eller tale. Du vil blive tilbudt noget at

drikke og du vil blive bedt om at lade vandet umiddelbart efter at undersøgelsen er udført.

Mens billederne bliver taget er du nødt til at

ligge helt stille. Du må ikke bevæge dig eller tale.

Behandlingsvarighed

Lægen vil informere dig om den normale varighed af behandlingen.

Du modtager FluCore som en enkelt indsprøjtning i en blodåre 45-60 minutter inden optagelsen på kameraet

finder sted. Selve optagelsen tager mellem 30 og 60 minutter.

Efter Flucore indsprøjtningen skal du:

Undgå tæt kontakt med små børn og gravide kvinder i de første 12 timer efter indsprøjtningen

Sørge for at tisse hyppigt for at få lægemidlet ud af kroppen

Hvis du har fået for meget FluCore

Du får kun en enkelt indsprøjtning med FluCore, der er nøjagtig kontrolleret af den speciallæge i

nuklearmedicin, som skal overvåge behandlingen. Det er derfor usandsynligt, at du får for meget. Skulle det

alligevel ske, at du får for meget, vil du modtage en passende behandling. Den speciallæge i nuklearmedicin,

som er ansvarlig for behandlingen, vil anbefale at du drikker rigeligt med væske for at få FluCore ud af

kroppen (denne type medicin udskilles nemlig gennem nyrerne, dvs. via urinen).

Spørg speciallægen i nuklearmedicin eller sundhedspersonalet, hvis du er usikker på noget.

4.

Bivirkninger

Dette lægemiddel kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.

Den lille mængde ioniserende stråling, man udsættes for ved indsprøjtning med dette radiofarmaceutiske

lægemiddel giver en meget lille risiko for udvikling af kræft og arvelige anormaliteter.

Din læge har vurderet, at fordelen ved at du får lavet undersøgelsen med FluCore overstiger risikoen ved at

blive udsat for strålingen.

Indberetning af bivirkninger til Sundhedsstyrelsen

Hvis du oplever bivirkninger, bør du tale med din læge, sygeplejerske eller apoteket. Dette gælder også

mulige bivirkninger, som ikke er medtaget i denne indlægsseddel. Du eller dine pårørende kan også

indberette bivirkninger direkte til Sundhedsstyrelsen på www.meldenbivirkning.dk, eller ved at kontakte

Sundhedsstyrelsen via mail, med almindeligt brev eller telefonisk for at rekvirere et indberetningsskema.

Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af

dette lægemiddel.

5.

Opbevaring

Du skal ikke opbevare denne medicin. FluCore opbevares under speciallægens ansvar på et passende sted.

Opbevaring af radiofarmaceutiske lægemidler skal ske i overensstemmelse med nationale lovgivning om

radioaktivt materiale. Denne information er derfor kun henvendt til speciallægen.

Dette lægemiddel vil ikke blive brugt efter udløbsdatoen, som er angivet på etiketten.

6.

Pakningsstørrelser og yderligere oplysninger

FluCore indeholder:

Aktivt stof: Fludeoxyglucose (

1 ml injektionsvæske, opløsning indeholder 13,3 MBq – 6 GBq fludeoxyglucose (

F) på tidspunktet for

kalibrering.

Øvrige indholdsstoffer:

Natriumchlorid

Ethanol

Vand til injektionsvæsker

Udseende og pakningsstørrelser

Udseende

:

Klar, farveløs eller svagt gul opløsning

Pakningsstørrelse: Ét hætteglas á 30 ml

Aktiviteten per hætteglas er mellem 400 MBq – 180 GBq fludeoxyglucose (

F) på tidspunktet for

kalibrering.

Indehaver af markedsføringstilladelsen

Herlev Hospital

Klinisk Fysiologisk afdeling

Herlev Ringvej 75

2730 Herlev

Fremstiller

Herlev Hospital

Klinisk Fysiologisk afdeling

Herlev Ringvej 75

2730 Herlev

Denne indlægsseddel blev sidst revideret januar 2013.

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EU/3/18/2018 (Celgene Europe Limited)

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EU/3/18/2017 (Spedding Research Solutions SAS)

EU/3/18/2017 (Spedding Research Solutions SAS)

EU/3/18/2017 (Active substance: Ambroxol hydrochloride) - Orphan designation - Commission Decision (2018)3384 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/236/17

Europe -DG Health and Food Safety

29-5-2018

EU/3/18/2016 (Abeona Therapeutics Europe SL)

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29-5-2018

EU/3/18/2015 (Baxalta Innovations GmbH)

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Europe -DG Health and Food Safety

21-5-2018

EU/3/07/522 (Best Regulatory Consulting Ltd)

EU/3/07/522 (Best Regulatory Consulting Ltd)

EU/3/07/522 (Active substance: (manganese, dichloro [(4aR, 13aR, 17aR, 21aR)-1, 2, 3, 4, 4a, 5, 6, 12, 13, 13a, 14, 15, 16, 17, 17a, 18, 19, 20, 21, 21a-eicosahydro-11, 7-nitrilo-7H-dibenzo[ b,h] [1,4,7,10] tetraazacycloheptadecine-?N5, ?N13, ?N18, ?N21, ?N22]-)) - Transfer of orphan designation - Commission Decision (2018)3136 of Mon, 21 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/089/07/T/01

Europe -DG Health and Food Safety

18-5-2018

Ovaleap (Teva B.V.)

Ovaleap (Teva B.V.)

Ovaleap (Active substance: Follitropin alfa) - Centralised - Renewal - Commission Decision (2018)3154 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2608/R/23

Europe -DG Health and Food Safety

18-5-2018

EU/3/14/1328 (Roche Registration GmbH)

EU/3/14/1328 (Roche Registration GmbH)

EU/3/14/1328 (Active substance: 4-{[(2R,3S,4R,5S)-4-(4-chloro-2-fluoro-phenyl)-3-(3-chloro-2-fluoro-phenyl)-4-cyano-5-(2,2-dimethyl-propyl)-pyrrolidine-2-carbonyl]-amino}-3-methoxy-benzoic acid) - Transfer of orphan designation - Commission Decision (2018)3149 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/100/14/T/01

Europe -DG Health and Food Safety

18-5-2018

EU/3/16/1684 (Pharma Gateway AB)

EU/3/16/1684 (Pharma Gateway AB)

EU/3/16/1684 (Active substance: Modified mRNA encoding the UGT1A1 protein) - Transfer of orphan designation - Commission Decision (2018)3132 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/047/16/T/01

Europe -DG Health and Food Safety

18-5-2018

Prasugrel Mylan (Mylan S.A.S.)

Prasugrel Mylan (Mylan S.A.S.)

Prasugrel Mylan (Active substance: prasugrel) - Centralised - Authorisation - Commission Decision (2018)3160 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4644

Europe -DG Health and Food Safety

18-5-2018

Odefsey (Gilead Sciences Ireland UC)

Odefsey (Gilead Sciences Ireland UC)

Odefsey (Active substance: emtricitabine / rilpivirine / tenofovir alafenamide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3152 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4156/T/30

Europe -DG Health and Food Safety

18-5-2018

EU/3/14/1306 (Chiesi Farmaceutici S.p.A.)

EU/3/14/1306 (Chiesi Farmaceutici S.p.A.)

EU/3/14/1306 (Active substance: Cysteamine bitartrate) - Transfer of orphan designation - Commission Decision (2018)3151 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/070/14/T/01

Europe -DG Health and Food Safety

18-5-2018

EU/3/14/1252 (Chiesi Farmaceutici S.p.A.)

EU/3/14/1252 (Chiesi Farmaceutici S.p.A.)

EU/3/14/1252 (Active substance: Cysteamine bitartrate) - Transfer of orphan designation - Commission Decision (2018)3133 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/164/13/T/01

Europe -DG Health and Food Safety

18-5-2018

EU/3/10/778 (Chiesi Farmaceutici S.p.A.)

EU/3/10/778 (Chiesi Farmaceutici S.p.A.)

EU/3/10/778 (Active substance: Cysteamine bitartrate (gastroresistant)) - Transfer of orphan designation - Commission Decision (2018)3137 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/034/10/T/01

Europe -DG Health and Food Safety

18-5-2018

EU/3/14/1383 (IQVIA RDS Ireland Limited)

EU/3/14/1383 (IQVIA RDS Ireland Limited)

EU/3/14/1383 (Active substance: Single-chain urokinase plasminogen activator) - Transfer of orphan designation - Commission Decision (2018)3150 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/125/14/T/01

Europe -DG Health and Food Safety

18-5-2018

EU/3/13/1220 (IQVIA RDS Ireland Limited)

EU/3/13/1220 (IQVIA RDS Ireland Limited)

EU/3/13/1220 (Active substance: Poly[2-[(4-{[1-carboxy-2-(hexadecylcarbamoyl)ethyl]sulfanyl}-2,3-bis({2-[((2S)-2-(2-{[(2R)-2-carbamoyl-(2-{[(2S)-1-ethoxy-3-(3-hydroxy-4oxo-1,4-dihydropyridin-1-yl)-1-oxopropan-2-yl]carbamoyl}ethyl]sulfanyl}-3-{[(2S)-1-ethoxy-3-(3-hydroxy-4-oxo-1,4-dihydropyridin-1-yl)-1-oxopropan-2-yl]carbamoyl}propanamido)-3-(3-hydroxy-4-oxo-1,4-dihydropyridin-1-yl)propanoyl Ethyl ester) )-methoxy]acetyl}oxy)butyl)sulfanyl]-3-(hexadecylcarbamoyl)propanoic acid]-poly(ethylene glycol)-este...

Europe -DG Health and Food Safety

18-5-2018

EU/3/16/1745 (Novartis Europharm Limited)

EU/3/16/1745 (Novartis Europharm Limited)

EU/3/16/1745 (Active substance: Autologous T cells transduced with lentiviral vector containing a chimeric antigen receptor directed against CD19) - Transfer of orphan designation - Commission Decision (2018)3146 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/087/16/T/01

Europe -DG Health and Food Safety

18-5-2018

EU/3/14/1266 (Novartis Europharm Limited)

EU/3/14/1266 (Novartis Europharm Limited)

EU/3/14/1266 (Active substance: Autologous T cells transduced with lentiviral vector containing a chimeric antigen receptor directed against CD19) - Transfer of orphan designation - Commission Decision (2018)3145 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/187/13/T/01

Europe -DG Health and Food Safety

18-5-2018

EU/3/14/1298 (Genzyme Europe B.V.)

EU/3/14/1298 (Genzyme Europe B.V.)

EU/3/14/1298 (Active substance: Synthetic double-stranded siRNA oligonucleotide directed against antithrombin mRNA and covalently linked to a ligand containing three N-acetylgalactosamine residues) - Transfer of orphan designation - Commission Decision (2018)3148 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/041/14/T/01

Europe -DG Health and Food Safety

18-5-2018

EU/3/14/1297 (Genzyme Europe B.V.)

EU/3/14/1297 (Genzyme Europe B.V.)

EU/3/14/1297 (Active substance: Synthetic double-stranded siRNA oligonucleotide directed against antithrombin mRNA and covalently linked to a ligand containing three N-acetylgalactosamine residues) - Transfer of orphan designation - Commission Decision (2018)3147 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/039/14/T/01

Europe -DG Health and Food Safety

18-5-2018

EU/3/04/204 (Gilead Sciences Ireland UC)

EU/3/04/204 (Gilead Sciences Ireland UC)

EU/3/04/204 (Active substance: Aztreonam lysinate (inhalation use)) - Transfer of orphan designation - Commission Decision (2018)3131 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMEA/OD/006/04/T/03

Europe -DG Health and Food Safety

18-5-2018

EU/3/17/1936 (Pharma Gateway AB)

EU/3/17/1936 (Pharma Gateway AB)

EU/3/17/1936 (Active substance: 1-[4-bromo-5-[1-ethyl-7-(methylamino)-2-oxo-1,2-dihydro-1,6-naphthyridin-3-yl]-2-fluorophenyl]-3-phenylurea) - Transfer of orphan designation - Commission Decision (2018)3133 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/119/17/T/01

Europe -DG Health and Food Safety

18-5-2018

EU/3/16/1817 (IQVIA RDS Ireland Limited)

EU/3/16/1817 (IQVIA RDS Ireland Limited)

EU/3/16/1817 (Active substance: Human donor haematopoietic stem and progenitor cells that have been treated ex vivo with the protein transduction domain of the HIV-1 transactivation protein fused to MYC transcription factor) - Transfer of orphan designation - Commission Decision (2018)3143 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/191/16/T/01

Europe -DG Health and Food Safety

18-5-2018

EU/3/15/1562 (IQVIA RDS Ireland Limited)

EU/3/15/1562 (IQVIA RDS Ireland Limited)

EU/3/15/1562 (Active substance: A highly purified formulation of Staphylococcus aureus protein A) - Transfer of orphan designation - Commission Decision (2018)3144 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/111/15/T/01

Europe -DG Health and Food Safety

18-5-2018

Giotrif (Boehringer Ingelheim International GmbH)

Giotrif (Boehringer Ingelheim International GmbH)

Giotrif (Active substance: afatinib) - Centralised - Renewal - Commission Decision (2018)3159 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2280/R/26

Europe -DG Health and Food Safety

18-5-2018

Juluca (ViiV Healthcare UK Limited)

Juluca (ViiV Healthcare UK Limited)

Juluca (Active substance: dolutegravir / rilpivirine) - Centralised - Authorisation - Commission Decision (2018)3161 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4427

Europe -DG Health and Food Safety

18-5-2018

Nordimet (Nordic Group B.V.)

Nordimet (Nordic Group B.V.)

Nordimet (Active substance: methotrexate) - PSUSA - Modification - Commission Decision (2018)3155 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/2014/201706

Europe -DG Health and Food Safety