FrancophonIA/ELRC3.0 huggingface dataset:
English: If antifungal susceptibility testing is available, the MIC results may be interpreted using breakpoint criteria established by European Committee on Antimicrobial Susceptibility Testing (EUCAST).
Danish: Hvis resistensbestemmelse af svampe er muligt, kan MIC-værdierne tolkes ved at anvende de grænseværdikriterier, der er fastlagt af European Committee on Antimicrobial Susceptibility Testing (EUCAST).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton 1 (or 5) vials including blue box
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Udvendig karton til 1 (eller 5) hætteglas med blue box
English: Not for administration as a bolus injection.
Danish: Ikke til administration som bolusinjektion.
English: Therefore, no dosage adjustment based on gender is necessary.
Danish: Derfor er det ikke nødvendigt med dosisjustering på baggrund af køn.
English: • Treatment of fluconazole-resistant serious invasive Candida infections (including C. krusei).
Danish: • Behandling af fluconazol-resistente alvorlige invasive Candida-infektioner (herunder C. krusei).
English: The inter-individual variability of voriconazole pharmacokinetics is high.
Danish: Den inter-individuelle variabilitet af voriconazols farmakokinetik er høj.
English: A single adverse reaction of photophobia of 10 minutes duration was reported.
Danish: En enkelt bivirkning af fotofobi, der varede 10 minutter, blev rapporteret.
English: In the primary analysis, successful response as assessed by a Data Review Committee (DRC) blinded to study medicinal product was defined as resolution/improvement in all clinical signs and symptoms of infection with eradication of Candida from blood and infected deep tissue sites at 12 weeks after the end of therapy (EOT).
Danish: I den primære analyse var succesfuld respons ifølge en ”Data Review Committee” (DRC), der var blindet over for studiemedicinen, defineret som resolution/forbedring i alle kliniske tegn og symptomer på infektion med eradikation af Candida fra blodet og infektion i dybtliggende vævssteder 12 uger efter endt behandling (EOT).
English: One study enrolled 31 patients with possible, proven or probable invasive aspergillosis (IA), of whom 14 patients had proven or probable IA and were included in the MITT efficacy analyses.
Danish: Det ene studie omfattede 31 patienter med mulig, påvist eller sandsynlig invasiv aspergillose (IA), hvoraf 14 patienter havde påvist eller sandsynlig IA og blev inkluderet i MITT-effektanalyserne.
English: 5 Includes akathisia and parkinsonism.
Danish: 5 Inkluderer akatisi og parkinsonisme.
English: • serious fungal infections caused by Scedosporium sp. or Fusarium sp. (two different species of fungi).
Danish: • alvorlige svampeinfektioner, der skyldes Scedosporium sp. eller Fusarium sp. (to forskellige svampearter).
English: Low dose (100 mg BID)*
Danish: Lav-dosis (100 mg BID)*
English: Pregnancy There are no adequate data on the use of voriconazole in pregnant women available.
Danish: Graviditet Der foreligger ikke tilstrækkelig data fra anvendelse af voriconazol til gravide kvinder.
English: The recommended dosing regimen for prophylaxis is the same as for treatment in the respective age groups.
Danish: Den anbefalede dosering til profylakse er den samme som til behandling i de respektive aldersgrupper.
English: Non-infectious periostitis with elevated fluoride and alkaline phosphatase levels has been reported in transplant patients.
Danish: Non-infektiøs periostitis med forhøjede fluorid- og alkalisk fosfataseniveauer er set hos transplanterede patienter.
English: AUCτ, AUCt and AUC0-∞ represent area under the curve over a dosing interval, from time zero to the time with detectable measurement and from time zero to infinity, respectively.
Danish: AUCτ, AUCt og AUC0-∞ repræsenterer area under the curve inden for et doseringsinterval fra henholdsvis tiden 0 til tidspunktet for en påviselig måling og fra tiden 0 til uendelighed.
English: • Abnormal electrocardiogram (ECG)
Danish: • Unormalt elektrokardiogram (EKG)
English: Prophylaxis with study drug was started immediately after HSCT: 224 received voriconazole and 241 received itraconazole.
Danish: Profylakse med studielægemidlet blev påbegyndt umiddelbart efter HSCT: 224 fik voriconazol, og 241 fik itraconazol.
English: • Allergic reaction or exaggerated immune response
Danish: • Overfølsomhedsreaktion eller overdreven immunreaktion
English: • Low numbers of some types, including severe, of red (sometimes immune-related) and/or white blood cells (sometimes with fever), low numbers of cells called platelets that help blood to clot
Danish: • Lavt antal, herunder alvorligt af visse typer røde (sommetider immunrelateret) og/eller hvide blodlegemer (sommetider med feber), lavt antal celler, som kaldes blodplader (trombocytter), der hjælper blodet med at størkne
English: It is important to cover sun exposed areas of skin and use sunscreen with high sun protection factor (SPF), as an increased sensitivity of skin to the sun's UV rays can occur.
Danish: Det er vigtigt at tildække huden og bruge solcreme med høj solbeskyttelsesfaktor (SPF), da De kan være særlig følsom for solens UVstråler.
English: Duration of treatment The duration of treatment with the intravenous formulation should be no longer than 6 months (see section
Danish: Varighed af behandlingen Behandling med den intravenøse formulering bør ikke vare længere end 6 måneder (se pkt.
English: : Seven (3 complete, 4 partial responses) of 17 patients were successfully treated with voriconazole.
Danish: : 7 (3 med fuldstændigt, 4 med delvist respons) ud af 17 patienter blev succesrigt behandlet med voriconazol.
English: The direction of the arrow for each pharmacokinetic parameter is based on the 90% confidence interval of the geometric mean ratio being within (↔), below (↓) or above (↑) the 80-125% range.
Danish: Pilens retning for hver farmakokinetisk parameter er baseret på 90 % konfidensinterval af det geometriske gennemsnitlige ratio, indenfor (↔), under (↓) eller over (↑) grænserne 80-125 %.
English: Standard genotoxicity and reproduction studies with the excipient SBECD reveal no special hazard for humans.
Danish: Standardgenotoksicitet og reproduktionsstudier med hjælpestoffet SBECD tyder ikke på speciel risiko for mennesker.
English: Amphotericin B → fluconazole (N=122)
Danish: Amphotericin B → fluconazol (N=122)
English: >R (Resistant)
Danish: ≥ R (resistent)
English: Depending on the severity of symptoms, consideration should be given to stopping treatment (see section 4.8).
Danish: Afhængigt af sværhedsgraden af symptomerne bør det overvejes at standse behandlingen (se pkt.
English: For patients with ICC the global response rate at EOT was 85.7% (6/7) and for patients with EC the global response rate at EOT was 70% (7/10).
Danish: For patienter med ICC var procentsatsen for det globale respons ved EOT 85,7 % (6/7), og for patienter med EC var procentsatsen for det globale respons ved EOT 70 % (7/10).
English: Careful monitoring for any occurrence of drug toxicity and/or lack of efficacy, and dose adjustment may be needed.
Danish: Omhyggelig monitorering for tilfælde af toksicitet og/eller mangel på effekt og dosisjustering kan blive nødvendig.
English: • Deterioration of brain function that is a serious complication of liver disease
Danish: • Nedsat hjernefunktion, der er en alvorlig komplikation i forbindelse med leversygdom
English: The reduced dose and/or frequency of voriconazole and fluconazole that would eliminate this effect have not been established.
Danish: Hvilken dosisreduktion og/eller ændring i doseringsfrekvens af voriconazol og fluconazol, der vil eliminere denne virkning, er ikke fastlagt.
English: You should avoid any sunlight and sun exposure while being treated.
Danish: De skal helt undgå sollys og ophold i solen under behandlingen.
English: Please advise your doctor if you have any stomach pains or if your stools have a different consistency.
Danish: De skal kontakte lægen, hvis De får mavesmerter, eller hvis Deres afføring får en anden konsistens.
English: Extended and frequent monitoring for respiratory depression and other opiateassociated adverse reactions is recommended.
Danish: Udvidet og hyppig monitorering for vejrtrækningsdepression og andre opioidrelaterede bivirkninger anbefales.
English: While affected, do not drive or operate any tools or machines.
Danish: Hvis dette sker, bør De ikke køre bil eller betjene maskiner.
English: This includes any possible side effects not listed in this leaflet (see section 4).
Danish: Dette gælder også mulige bivirkninger, som ikke er medtaget i denne indlægsseddel (se afsnit 4).
English: Candida Species
Danish: Candida-arter
English: The safety and efficacy of voriconazole use for longer than 180 days has not been adequately studied in clinical trials.
Danish: Voriconazols sikkerhed ved anvendelse i mere end 180 dage er ikke undersøgt tilstrækkeligt i kliniske forsøg.
English: A satisfactory global response (complete or partial resolution of all attributable symptoms signs, radiographic/bronchoscopic abnormalities present at baseline) was seen in 53 % of voriconazole-treated patients compared to 31 % of patients treated with comparator.
Danish: Der sås tilfredstillende globalt respons (fuldstændigt eller delvis resolution af alle tilhørende symptomer, radiografiske/bronkoskopiske abnormaliteter ved baseline) hos 53 % af de voriconazolbehandlede patienter sammenlignet med 31 % af patienterne behandlet med komparatoren.
English: The major metabolite of voriconazole is the N-oxide, which accounts for 72 % of the circulating radiolabelled metabolites in plasma.
Danish: Hovedmetabolitten af voriconazol er N-oxid, der står for 72 % af de cirkulerende radioaktivt mærkede metabolitter i plasma.
English: The doctor may decide to decrease the dose if you have mild to moderate cirrhosis.
Danish: Lægen kan beslutte, at dosis skal nedsættes, hvis De har mild til moderat skrumpelever.
English: A positive association between mean, maximum or minimum plasma voriconazole concentration and efficacy in therapeutic studies was not found and this relationship has not been explored in prophylaxis studies.
Danish: En positiv sammenhæng mellem middel, maksimum og minimum plasmavoriconazolkoncentration og effekt i kliniske studier blev ikke fundet, og dette forhold er ikke undersøgt i profylaksestudier.
English: Success at day 180*
Danish: Succes efter 180 dage*
English: The interactions in the table are presented in the following order: contraindications, those requiring dose adjustment and careful clinical and/or biological monitoring, and finally those that have no significant pharmacokinetic interaction but may be of clinical interest in this therapeutic field.
Danish: Interaktionerne i skemaet vises i følgende rækkefølge: kontraindikationer, interaktioner, der kræver justering af dosis og omhyggelig klinisk og/eller biologisk monitorering, og sluttelig interaktioner, der ikke har farmakologisk relevans, men kan være af klinisk interesse.
English: However, a trend towards a higher frequency of liver enzyme elevations, reported as adverse events in clinical trials was observed in paediatric patients as compared to adults (14.2% transaminases increased in paediatrics compared to 5.3% in adults).
Danish: Der er dog observeret en tendens til en højere frekvens af leverenzymstigninger, der blev rapporteret som bivirkninger i kliniske studier hos pædiatriske patienter, sammenlignet med voksne (14,2 % forhøjet transaminase hos pædiatriske patienter sammenlignet med 5,3 % hos voksne.).
English: However, the in vitro activity of voriconazole against Candida species is not uniform.
Danish: In vitro aktiviteten af voriconazol in vitro over for Candida-arter er dog ikke ensartet.
English: This metabolite has minimal antifungal activity and does not contribute to the overall efficacy of voriconazole.
Danish: Denne metabolit har minimal antimykotisk effekt, og den bidrager ikke til voriconazols samlede effekt.
English: In a secondary analysis, which utilised DRC assessments at the latest evaluable time point (EOT, or 2, 6, or 12 weeks after EOT) voriconazole and the regimen of amphotericin B followed by fluconazole had successful response rates of 65 % and 71 %, respectively.
Danish: I en anden analyse, hvor DRC's vurderinger blev anvendt ved det seneste evaluerbare tidspunkt (EOT eller 2, 6 eller 12 uger efter EOT), havde voriconazol og amphotericin B efterfulgt af fluconazol en succesfuld responsrate på henholdsvis 65 % og 71 %.
English: Norethisterone/ethinylestradiol (1 mg/0.035 mg QD)
Danish: Norethisteron/ethinylestradiol (1 mg/0,035 mg QD)
English: Pharmacotherapeutic group: Antimycotics for systemic use, - triazole derivatives ATC code: J02AC03
Danish: Farmakoterapeutisk klassifikation: Antimykotika til systemisk anvendelse - triazolderivater, ATCkode: J02AC03
English: Monitoring of pancreatic function
Danish: Monitorering af pancreasfunktionen
English: Rare ≥ 1/10,000 to <
Danish: Sjælden ≥ 1/10.000 til
English: Packs of 1 or 5 vials.
Danish: Pakninger med 1 eller 5 hætteglas.
English: All occurred in paediatric patients, who received up to five times the recommended intravenous dose of voriconazole.
Danish: De opstod alle hos pædiatriske patienter, som fik op til 5 gange den anbefalede intravenøse dosis af voriconazol.
English: The Investigator's assessment of successful outcome at each of these time points is shown in the following table.
Danish: Den forsøgsansvarliges vurdering af succesfuld resultat på et hvilket som helst af disse tidspunkter er vist i skemaet nedenfor:
English: Fifty-three paediatric patients aged 2 to <18 years were treated with voriconazole in two prospective, openlabel, non-comparative, multi-center clinical trials.
Danish: 53 pædiatriske patienter i alderen 2 til <18 år blev behandlet med voriconazol i to kliniske prospektive, åbne, ikke-komparative, multicenterstudier.
English: Other Candida spp.4
Danish: Andre Candida spp.4
English: Voriconazole is rapidly and almost completely absorbed following oral administration, with maximum plasma concentrations (Cmax) achieved 1-2 hours after dosing.
Danish: Voriconazol absorberes hurtigt og næsten fuldstændigt efter oral administration med maksimale plasmakoncentrationer (Cmax) 1-2 timer efter dosisindtagelse.
English: In 10 therapeutic studies, the median for the average and maximum plasma concentrations in individual subjects across the studies was 2425 ng/ml (inter-quartile range 1193 to 4380 ng/ml) and 3742 ng/ml (interquartile range 2027 to 6302 ng/ml), respectively.
Danish: I 10 kliniske studier var medianen for gennemsnitlige og maksimale plasmakoncentrationer hos individuelle forsøgspersoner på tværs af studierne henholdsvis 2425 ng/ml (inter-kvartil fra 1193 til 4380 ng/ml) og 3742 ng/ml (inter-kvartil fra 2027 til 6302 ng/ml).
English: Hospira UK Limited Queensway Royal Leamington Spa Warwickshire CV31 3RW UK
Danish: Hospira UK Limited Queensway Royal Leamington Spa Warwickshire CV31 3RW Storbritannien
English: : Successful response to voriconazole therapy was seen in 16 (6 complete, 10 partial responses) of 28 patients with S. apiospermum and in 2 (both partial responses) of 7 patients with S. prolificans infection.
Danish: : Succesrigt respons på voriconazol behandling blev set hos 16 (6 med fuldstændigt, 10 med delvist respons) ud af 28 patienter med infektion med S. apiospermum og hos 2 (begge med delvist respons) ud af 7 patienter med infektion med S. prolificans.
English: Serious side effects - Stop taking Voriconazole Hikma and see a doctor immediately
Danish: Alvorlige bivirkninger - stop med at tage Voriconazole Hikma og søg læge øjeblikkeligt
English: The recommended dosing regimen is as follows:
Danish: Den anbefalede dosering er følgende:
English: The overall rate of response (ICC and EC combined) was 88.9% (8/9) for 2 to <12 years old and 62.5% (5/8) for 12 to <18 years old.
Danish: Den samlede procentsats for respons (ICC sammenlagt med EC) var 88,9 % (8/9) for 2 til <12 år og 62,5 % (5/8) for 12 til <18 år.
English: The safety profile of voriconazole in adults is based on an integrated safety database of more than 2,000 subjects (including 1,603 adult patients in therapeutic trials) and an additional 270 adults in prophylaxis trials).
Danish: Sikkerhedsprofilen for voriconazol hos voksne er baseret på en integreret sikkerhedsdatabase med data fra mere end 2.000 personer (herunder 1.603 voksne patienter i terapeutiske studier og yderligere 270 voksne i profylaksestudier).
English: The majority of patients receiving voriconazole treatment of the above mentioned rare infections were intolerant of, or refractory to, prior antifungal therapy.
Danish: Størstedelen af patienterne, der fik voriconazolbehandling for ovennævnte sjældne infektioner, var intolerante over for eller responderede ikke på tidligere antimykotisk behandling.
English: This should be taken into consideration for patients on a controlled sodium diet.
Danish: Dette skal der tages hensyn til, hvis patienten er på en kontrolleret natriumdiæt.
English: • Heart rhythm or conduction problems that (sometimes life threatening)
Danish: • Problemer med hjerterytmen eller -ledning (sommetider livstruende)
English: The volume of distribution at steady state for voriconazole is estimated to be 4.6 L/kg, suggesting extensive distribution into tissues.
Danish: Steady state fordelingsvolumen af voriconazol er anslået til at være 4,6 l/kg, hvilket indikerer udbredt fordeling ud i vævene.
English: The survival rate at Day 180 was 80.0% (32/40) and at 1 year was 70.0% (28/40).
Danish: Overlevelsesraten var 80,0% (32/40) efter 180 dage og 70,0% (28/40) efter 1 år.
English: Squamous cell carcinoma of the skin has been reported in patients, some of whom have reported prior phototoxic reactions.
Danish: Planocellulært karcinom i huden er rapporteret hos patienter, hvoraf nogle tidligere har rapporteret fototoksiske reaktioner.
English: Compared to efavirenz 600 mg QD,
Danish: Sammenlignet med efavirenz 600 mg QD,
English: • Jaundice; changes in blood tests of liver function
Danish: • Gulsot; ændringer i blodprøver for leverfunktion
English: • You are known to have cardiomyopathy, irregular heart beat, slow heart rate or an abnormality of electrocardiogram (ECG) called ‘long QTc syndrome'.
Danish: • De ved, at De har problemer i hjertemuskulaturen (kardiomyopati), uregelmæssig puls, langsom puls eller et unormalt elektrokardiogram (ekg), et såkaldt ”forlænget QTcsyndrom”.
English: For storage conditions after reconstitution of the medicinal product, see section 6.3.
Danish: Opbevaringsforhold efter rekonstituering af lægemidlet, se pkt.
English: • Red, scaly patches or ring-shaped skin lesions that may be a symptom of an autoimmune disease called cutaneous lupus erythematosus
Danish: • Røde, skællede pletter eller ringformede hudlæsioner, der kan være symptomer på den autoimmune sygdom som kaldes kutan lupus erythematosus.
English: Aspergillus infections - efficacy in aspergillosis patients with poor prognosis Voriconazole has in vitro fungicidal activity against Aspergillus spp.
Danish: Aspergillus-infektioner - effekt hos aspergillose-patienter med dårlig prognose Voriconazol har in vitro fungicid aktivitet over for Aspergillus spp.
English: The study comprised 55 patients with serious refractory systemic Candida infections (including candidaemia, disseminated and other invasive candidiasis) where prior antifungal treatment, particularly with fluconazole, had been ineffective.
Danish: Studiet omfatter 55 patienter med alvorlige refraktære systemiske Candida-infektioner (herunder candidæmi, dissemineret og andre invasive candidiasis), hvor tidligere antimykotisk behandling, især med fluconazol, ikke har været effektivt.
English: • Low blood sugar, low blood potassium, low sodium in the blood
Danish: • Lavt blodsukker, lavt indhold af kalium i blodet, lavt indhold af natrium i blodet
English: The safety and efficacy of voriconazole in children below 2 years has not been established.
Danish: Sikkerhed og effekt af voriconazol til børn under 2 år er ikke fastlagt.
English: The median duration of study drug prophylaxis was 96 days for voriconazole and 68 days for itraconazole in the MITT group.
Danish: Medianvarigheden af profylaksen med studielægemidlet var 96 dage for voriconazol og 68 dage for itraconazol i MITT-gruppen.
English: Not for bolus injection.
Danish: Ikke til bolusinjektion.
English: P-Value
Danish: p-værdi
English: Indinavir Cmax ↔ Indinavir AUCτ ↔ Voriconazole Cmax ↔ Voriconazole AUCτ ↔
Danish: Indinavir Cmax ↔ Indinavir AUCτ ↔ Voriconazol Cmax ↔ Voriconazol AUCτ ↔
English: Scedosporium and Fusarium infections Voriconazole was shown to be effective against the following rare fungal pathogens:
Danish: Scedosporium- og Fusarium-infektioner Voriconazol har vist sig effektivt over for følgende sjældne patogene svampe:
English: In fluconazole-resistant non albicans species, a successful outcome was seen in 3/3 C. krusei (complete responses) and 6/8 C. glabrata (5 complete, 1 partial response) infections.
Danish: I fluconazol-resistente ikke-albicans arter er et succesfuldt resultat set hos 3/3 infektioner med C. krusei (fuldstændigt respons) og 6/8 med C. glabrata (5 med fuldstændigt, 1 med delvist respons).
English: However, some may be serious and need medical attention.
Danish: Dog kan der forekomme alvorligere bivirkninger, hvor lægehjælp er nødvendig.
English: If you or your child develops skin disorders, your doctor may refer you to a dermatologist, who after consultation may decide that it is important for you or your child to be seen on a regular basis.
Danish: Hvis De eller Deres barn udvikler hudlidelser, kan lægen henvise Dem til en hudspecialist, som efter konsultation kan beslutte, at det er vigtigt, at De eller Deres barn tilses regelmæssigt.
English: Dose reduction of methadone may be needed.
Danish: Dosisreduktion af methadon kan være nødvendig.
English: After administration of a radiolabelled dose of voriconazole, approximately 80 % of the radioactivity is recovered in the urine after multiple intravenous dosing and 83 % in the urine after multiple oral dosing.
Danish: Efter administration af en radioaktivt mærket dosis af voriconazol bliver næsten 80 % af radioaktiviteten genfundet i urinen efter gentagne intravenøse doser, og 83 % i urinen efter gentagne orale doser.
English: Oral*
Danish: Oralt*
English: Children and adolescents Voriconazole Hikma should not be given to children younger than 2 years of age.
Danish: Børn og teenagere Voriconazole Hikma må ikke anvendes til børn under 2 år.
English: Dermatological reactions were very common in patients treated with voriconazole in clinical trials, but these patients had serious underlying diseases and were receiving multiple concomitant medicinal products.
Danish: Dermatologiske reaktioner var meget almindelige hos patienter behandlet med voriconazol i kliniske studier, men disse patienter havde alvorlige tilgrundliggende sygdomme og fik samtidig behandling med anden medicin.
English: 30 ml clear Type I glass vial closed with a chlorobutyl rubber stopper and sealed with an aluminium flip off seal with a red plastic matte top button.
Danish: 30 ml klar type I-hætteglas, der er lukket med chlorobutyl-gummiprop og forseglet med et aluminiumsvippelåg med en rød knap med mat plast i toppen.
English: It is estimated that, on average, increasing the oral dose from 200 mg twice daily to 300 mg twice daily leads to a 2.5-fold increase in exposure (AUCτ).
Danish: Det er skønnet, at en gennemsnitlig stigning i den orale dosis fra 200 mg 2 gange dagligt til 300 mg 2 gange dagligt fører til en 2,5 gange stigning i eksponering (AUCτ).
English: • Very fast heart rate or skipped heartbeats, sometimes with erratic electrical impulses
Danish: • Meget hurtig puls eller uregelmæssig hjerterytme, sommetider med uregelmæssige elektriske impulser
English: Stability after reconstitution:
Danish: Stabilitet efter rekonstituering:
English: As GPMT (guinea pig maximisation test) result was positive, prescribers should be aware of the hypersensitivity potential of the intravenous formulation.
Danish: Da resultaterne af GPMT ("guinea pig maximation test") er positive, bør lægen være opmærksom på de overfølsomhedsfremkaldende egenskaber i den intravenøse lægemiddelform.