Visipaque GE Healthcare
Innledning |
Bruksområder |
Forsiktighetsregler |
Bruksmåte |
Bivirkninger |
Oppbevaring |
Ytterligere informasjon |
Informasjon til pasienter |
Helsepersonell
Les nøye gjennom dette pakningsvedlegget før du begynner å bruke legemidlet. Det inneholder informasjon som er viktig for deg.
- Ta vare på dette pakningsvedlegget. Du kan få behov for å lese det igjen.
- Hvis du har ytterligere spørsmål, kontakt lege eller apotek.
- Kontakt lege eller apotek dersom noen av bivirkningene blir plagsomme eller du merker bivirkninger som ikke er nevnt i dette pakningsvedlegget.
I dette pakningsvedlegget finner du informasjon om:
- Hva Visipaque er og hva det brukes mot
- Hva du må vite før du bruker Visipaque
- Hvordan du bruker Visipaque
- Mulige bivirkninger
- Hvordan du oppbevarer Visipaque
- Ytterligere informasjon
1. Hva Visipaque er og hva det brukes mot
Legemidlet er kun til bruk ved diagnostiske formål.
Visipaque er et ikke-ionisk røntgenkontrastmiddel som brukes for å gi bedre diagnostisk informasjon.
Visipaque brukes ved røntgenundersøkelse av: blod- eller lymfekar i hjerte, hjernen, bukhulen, bukveggen og underlivet, pulsårer, vener, urinveiene, ryggmargen, livmoren, egglederne, ventrikkel og tarm.
2. Hva du må vite før du bruker Visipaque
Bruk ikke Visipaque
- Hvis du er allergisk (overfølsom) overfor jodiksanol eller et av de andre innholdsstoffene i Visipaque.
- Hvis du har forhøyet produksjon av hormon i skjoldbruskkjertelen
Advarsler og forsiktighetsreglerVis forsiktighet ved bruk av Visipaque
- Hvis du har allergi, astma eller tidligere reaksjon på joderte kontrastmidler
- Hvis du har alvorlig hjertesykdom og høyt blodtrykk i lungepulsåren (pulmonal hypertensjon)
- Hvis du har akutt sykdomstilstand i hjernen, svulster eller epilepsi
- Hvis du har nedsatt leverfunksjon, nyrefunksjon og sukkersyke
- Hvis du har forekomst av unormale proteiner i blodet, såkalt paraproteinemi (myelomatose og Waldenstrøms makroglobulinemi), en høy produksjon av visse proteiner
- Hvis du har myasthenia gravis (en tilstand som medfører alvorlig muskelsvekkelse)
- Hvis du har feokromocytom (konstant eller anfall av høyt blodtrykk på grunn av en sjelden svulst i binyremargen)
- Hvis du har homocysteinuri (en tilstand med økt utskillelse av aminosyren cystein i urinen)
- Hvis du har hypertyreose (høyt stoffskifte)
- Hvis du har struma (forstørret skjoldbruskkjertel)
I sjeldne tilfeller kan overfølsomhetsreaksjoner (utslett og andre mulige allergiske reaksjoner) forekomme.
Du kan oppleve en kortvarig forstyrrelse i hjernen kalt encefalopati under eller rett i etterkant av kontrastmiddelundersøkelsen. Si ifra til legen med en gang dersom du merker noen tegn til denne tilstanden som er beskrevet i avsnitt 4.
Forstyrrelser i skjoldbruskkjertelfunksjonen kan observeres hos både barn og voksne etter injeksjon med Visipaque. Barn kan også bli eksponert via mor under graviditeten. Det kan være nødvendig at legen din tester skjoldbruskkjertelfunksjonen før og/eller etter injeksjon med Visipaque.
Bruk av andre legemidler sammen med Visipaque
Rådfør deg med lege eller apotek dersom du bruker eller nylig har brukt andre legemidler, dette gjelder også reseptfrie legemidler.
Informer legen
- Hvis du behandles for diabetes med metformin
- Hvis du tar legemidler for å hemme immunsystemet, f.eks. i forbindelse med transplantasjoner (interleukin-2)
- Hvis du tar legemidler for høyt blodtrykk eller uregelmessig hjerterytme (såkalte beta blokkere)
Andre legemidler kan også påvirke effekten av Visipaque, og Visipaque kan påvirke effekten av andre legemidler eller resultater av laboratorieundersøkelser. Dette har som regel ingen konsekvenser for deg. Rådfør deg med legen dersom du ønsker mer informasjon.
Graviditet og amming
Rådfør deg med lege eller apotek før du tar noen form for medisin.
Visipaque skal ikke brukes hvis du er gravid med mindre fordelen av undersøkelsen oppveier mulig risiko og anses viktig. Legen din vil vurdere om du bør bruke Visipaque. Det anbefales å overvåke barnets skjoldbruskkjertelfunksjon hvis Visipaque har vært gitt til moren under graviditeten.
Erfaring med joderte kontrastmidler viser at lite substans blir utskilt i morsmelk, og amming kan fortsette som normalt etter en undersøkelse med Visipaque.
Kjøring og bruk av maskiner
Du bør unngå bilkjøring og håndtering av maskiner de nærmeste 24 timer etter bruk av Visipaque, da sene reaksjoner i unntakstilfeller kan forekomme.
3. Hvordan du bruker Visipaque
Visipaque injiseres i en blodåre før og i løpet av røntgenkontrastundersøkelsen ved hjelp av en sprøyte.
Visipaque skal inspiseres før bruk for å se om løsningen inneholder partikler, misfarging og skader av emballasjen. Flaskene er beregnet på kun en pasient og eventuelle rester må kastes. Flasken på 500 ml er beregnet til bruk i multidosepumpe til flere pasienter i løpet av en arbeidsdag. Produktet skal ikke blandes med andre legemidler.
Dosering
Doseringen avhenger av hvilke undersøkelse som skal tas, pasientens tilstand og anvendt teknikk.
Doseringen avhenger av hvilke undersøkelse som skal tas, pasientens tilstand og anvendt teknikk.
Dersom du får for mye av Visipaque
Overdosering er usannsynlig hos pasienter med normal nyrefunksjon. Det finnes ingen motgift mot Visipaque. Behandling av eventuell overdosering skjer på sykehuset. Hos pasienter med forsinket utskillelse på grunn av nyresvikt, og hos pasienter som har fått svært høye doser, kan Visipaque fjernes ved hemodialyse.
4. Mulige bivirkninger
Som alle legemidler kan Visipaque forårsake bivirkninger, men ikke alle får det.
Overfølsomhetsreaksjoner opptrer vanligvis som symptomer fra luftveiene eller huden som f.eks utslett, rødhet, elveblest, kløe, hudreaksjon, hevelse i ansikt og hals, hevelse i svelget, pustebesvær eller vannansamling i lungene.
De kan opptre enten umiddelbart etter injeksjonene eller opptil noen få dager senere.
Nedenfor finner du en liste over mulige bivirkninger i forbindelse med bruk av Visipaque.
Etter injeksjon i blodåre:Mindre vanlige (kan forekomme hos inntil 1 av 100 pasienter)
- overfølsomhet
- hodepine
- rødme
- kvalme, oppkast
- utslett, kløe, urtikaria (elveblest)
- nedsatt nyrefunksjon, inkludert akutt nyresvikt
- toksisk nefropati
- varmefølelse
- brystsmerter
- svimmelhet, sensoriske forstyrrelser (inkludert smaksforstyrrelser, parestesi (endringer i følesansen), luktforstyrrelser)
- uregelmessig hjerterytme, lavt blodtrykk
- hoste, nysing
- feber, smerte, ubehag
- frysninger
- hjerteinfarkt
- rødme
- reaksjoner på injeksjonsstedet
- kuldefølelse
- føle seg opphisset
- engstelse
- slag
- besvimelse
- forbigående skjelving
- overfølsomhet
- forbigående blindhet
- forbigående synshemming (inkludert dobbeltsyn, tåkesyn)
- øyelokkødem
- høyt blodtrykk
- dårlig blodtilstrømning
- vanskeligheter med å puste
- halsirritasjon, helvelse i strupehodet og svelget
- smerte/ubehag i maven
- diaré
- sterk svetting
- kraftløshet (f.eks. sykdomsfølelse, tretthet)
- hevelse i ansiktet, lokale hevelser i hud og slimhinner
- hjertestans
- hjertebank
- ryggsmerter
- muskelkramper
- allergisk reaksjon, allergisk sjokk, inkludert livstruende eller fatale allergiske reaksjoner
- forstyrrelser i skjoldbruskkjertel funksjonen
- forvirringstilstand
- koma
- bevissthetsforstyrrelser
- sjokk
- krampeanfall
- brystsmerter, blodpropp, smerte og hevelse i venene
- problemer med å puste (på grunn av vann i lungene), pustestopp, pustevansker, bronkospasme, tetthet i halsen
- akutt bukspyttkjertelbetennelse, forverring av bukspyttkjertelbetennelse
- leddsmerter
- hevelse og ømhet i spyttkjertlene
- allergiske hudreaksjoner som kan være svært alvorlige f.eks. hudutslett/hudutslett med rødme, blemmer på huden, kløende flekker, legemiddelutslett, allergisk betennelse i huden, hudavskalling
- forbigående forstyrrelse i hjernen (encefalopati), som kan føre til forvirringstilstand, hukommelsestap, hallusinasjoner, synsforstyrrelser, synstap, krampeanfall, koordinasjonsvansker, ensidig bevegelsestap, taleforstyrrelser og bevisshetstap.
- hevelser
- hjerte-lunge stans
- forhøyet kreatininnivå i blodet (nedsatt nyrefunksjon)
- nedsatt bevegelighet
- jodforgiftning
Etter injeksjon i ryggmargskanalen:
Mindre vanlige (kan forekomme hos inntil 1 av 100 pasienter)
Mindre vanlige (kan forekomme hos inntil 1 av 100 pasienter)
- hodepine
- oppkast
- overfølsomhet
- svimmelhet
- kvalme
- frysninger
- smerte på injeksjonsstedet
- forbigående forstyrrelse i hjernen (encefalopati), som kan føre til forvirringstilstand, hukommelsestap, hallusinasjoner, synsforstyrrelser, synstap, krampeanfall, koordinasjonsvansker, ensidig bevegelsestap, taleforstyrrelser og bevisshetstap.
- muskelkramper
Etter injeksjon i hulrom (som for eksempel livmor og eggledere):
Svært vanlige (kan forekomme hos flere enn 1 av 10 pasienter)
Etter injeksjon i leddSvært vanlige (kan forekomme hos flere enn 1 av 10 pasienter)
- magesmerte
- blødning fra underlivet
- hodepine, kvalme, feber
- oppkast
- overfølsomhet
- frysninger
- smerte på injeksjonsstedet
Vanlige (kan forekomme hos inntil 1 av 10 pasienter)
Etter undersøkelser av mage-tarmkanalen- smerte på injeksjonsstedet
- overfølsomhet
- frysninger
Vanlige (kan forekomme hos inntil 1 av 10 pasienter)
- diaré, kvalme, magesmerte
- oppkast
- overfølsomhet
- frysninger
Melding av bivirkninger
Kontakt lege, apotek eller sykepleier dersom du opplever bivirkninger, inkludert mulige bivirkninger som ikke er nevnt
i dette pakningsvedlegget. Du kan også melde fra om bivirkninger direkte via meldeskjema som finnes på nettsiden til Statens legemiddelverk:
www.legemiddelverket.no/pasientmelding. Ved å melde fra om bivirkninger
bidrar du med informasjon om sikkerheten ved bruk av dette legemidlet.
5. Hvordan du oppbevarer Visipaque
Oppbevares utilgjengelig for barn.
Bruk ikke Visipaque etter utløpsdatoen som er angitt på etiketten. Utløpsdatoen henviser til den siste dagen i den måneden.
Oppbevares beskyttet mot lys. Skal ikke fryses.
Oppbevares beskyttet mot lys. Skal ikke fryses.
6. Ytterligere informasjon
Sammensetning av Visipaque
- Virkestoffet er jodiksanol.
- Andre innholdsstoffer er små mengder trometamol, natriumkalsiumedetas, kalsiumklorid, natriumklorid, saltsyre (pH justering) og vann til injeksjonsvæske.
Hvordan Visipaque ser ut og innholdet i pakningen![](data:image/jpeg;base64,iVBORw0KGgoAAAANSUhEUgAAAkwAAAHTCAYAAADVvEfIAAAAAXNSR0IArs4c6QAAAARnQU1BAACx
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)
Visipaque injeksjonsvæske er en klar, fargeløs til lys gul løsning.
Innehaver av markedsføringstillatelsen
GE Healthcare AS
Postboks 4220 Nydalen
NO-0401 Oslo
TilvirkerPostboks 4220 Nydalen
NO-0401 Oslo
GE Healthcare AS
Nycoveien 1
NO-0485 Oslo
Nycoveien 1
NO-0485 Oslo
eller
GE Healthcare Ireland Limited
IDA Business Park
Carrigtohill
Co. Cork, Irland
IDA Business Park
Carrigtohill
Co. Cork, Irland
Dette pakningsvedlegget ble sist oppdatert 19.05.2022