FrancophonIA/ELRC3.0 huggingface dataset:
English: Voriconazole Accord film-coated tablets are to be taken at least one hour before, or one hour following, a meal.
Danish: Administration Voriconazole Accord filmovertrukne tabletter skal tages mindst 1 time før eller 1 time efter et måltid.
English: You should avoid any sunlight and sun exposure while being treated.
Danish: De bør helt undgå sollys og ophold i solen under behandlingen.
English: Dosage adjustments in case of co-administration
Danish: Dosisjusteringer i tilfælde af samtidig administration
English: 1 Strains with MIC values above the Susceptible (S) breakpoint are rare, or not yet reported.
Danish: Utilstrækkeligevidens 1 Stammer med MIC-værdier højere end følsomheds-grænseværdien er sjældne eller endnu ikke rapporteret.
English: Provides HCPs with the current recommendations to monitor and manage these risks.
Danish: - Give aktuelle anbefalinger til læger og sundhedspersonale om overvågning og håndtering af disse risici.
English: Contact your doctor immediately if you become pregnant while taking Voriconazole Accord.
Danish: Kontakt straks Deres læge, hvis De bliver gravid, mens De tager Voriconazole Accord.
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 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: A satisfactory global response (complete or partial resolution of all attributable symptoms, signs, radiographic/bronchoscopic abnormalities present at baseline) was seen in 53% of voriconazoletreated patients compared to 31% of patients treated with comparator.
Danish: Der sås tilfredstillende globalt respons (fuldstændig 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 radiolabeled metabolites in plasma.
Danish: Hovedmetabolitten af voriconazol er N-oxid, der står for 72% af de cirkulerende radioaktivt mærkede metabolitter i plasma.
English: Maximum increase in prothrombin time was approximately 2-fold
Danish: Protrombintid blev maksimalt øget ca. 2 gange
English: Voriconazole was shown to be effective against the following rare fungal pathogens:
Danish: Voriconazol har vist sig effektivt over for følgende sjældne patogene svampe:
English: beigelii infections.
Danish: herunder T. beigelii infektioner.
English: Pharmacotherapeutic group: Antimycotics for systemic use, triazole derivatives, ATC code: J02A C03 Mode of action
Danish: Farmakoterapeutisk klassifikation: Antimykotika til systemisk anvendelse - triazolderivater, ATC-kode: J02A C03.
English: Women of child-bearing potential must always use effective contraception during treatment.
Danish: Kvinder i den fertile alder Kvinder i den fertile alder bør altid anvende effektiv antikonceptionsmetode under behandlingen.
English: Ritonavir (protease inhibitor)
Danish: Ritonavir (proteasehæmmer)
English: Voriconazole Accord may cause blurring of vision or uncomfortable sensitivity to light.
Danish: Voriconazole Accord kan forårsage sløring af synet eller ubehagelig lysfølsomhed.
English: If you have liver disease, your doctor may prescribe a lower dose of Voriconazole Accord.
Danish: Hvis De har en leversygdom, kan Deres læge ordinere en lavere dosis af Voriconazole Accord.
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 voriconazolbehandling blev set hos 16 (6 med fuldstændigt, 10 med delvist respons) ud af 28 patienter med S. apiospermum og hos 2 (begge med delvist respons) ud af 7 patienter med S. prolificans infektion.
English: Fifty-three paediatric patients aged 2 to <18 years were treated with voriconazole in two prospective, open-label, 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: Extended and frequent monitoring for respiratory depression and other opiate associated adverse reactions is recommended.
Danish: Udvidet og hyppig monitorering for vejrtrækningsdepression og andre opioid-relaterede bivirkninger anbefales.
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 (inter-quartile range 2027 to 6302 ng/ml), respectively.
Danish: I 10 kliniske studier var medianen for gennemsnitlige og maksimale plasmakoncentrationer hos individuelleforsøgspersoner personer 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: 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 kliniske studier) og yderligere 270 voksne i profylaksestudier).
English: Macrolide antibiotics Erythromycin (1 g BID)
Danish: Macrolidantibiotika Erythromycin (1 g BID)
English: Elevated liver enzymes were also observed more frequently in children.
Danish: Forhøjede leverenzymer er også set oftere hos børn.
English: Considering the assumed limited gastro-enteric transit time in paediatric patients, the absorption of tablets may be different in paediatric compared to adult patients.
Danish: Tages den formodede, begrænsede gastroentestinale transittid hos pædiatriske patienter i betragtning, kan tablettens absorption være forskellig hos børn sammenlignet med voksne.
English: However, some may be serious and need medical attention.
Danish: Dog kan der forekomme alvorligere bivirkninger, hvor lægehjælp er påkrævet.
English: • tell your doctor immediately if you develop o sunburn o severe skin rash or blisters.
Danish: • Fortæl straks Deres læge, hvis De får o solskoldning o alvorligt hududslæt eller blærer o knoglesmerter.
English: Continue taking Voriconazole Accord until your doctor tells you to stop.
Danish: Fortsæt med at tage Voriconazole Accord indtil Deres læge siger, De skal stoppe.
English: Voriconazole Accord tablets contain lactose and should not be given to patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
Danish: Voriconazole Accord-tabletter indeholder lactose, og bør ikke gives til patienter med sjældne arvelige problemer med galactoseintolerans, Lapp lactasemangel eller glucose-galactosemalabsorption.
English: Reminds patients to take steps to minimize the risk of skin reactions and skin SCC (by avoiding exposure to direct sunlight, use of a sunscreen and protective clothing) and inform HCPs if they experience relevant skin abnormalities.
Danish: - Påminde patienter om, at de skal tage skridt til at minimere risikoen for hudreaktioner og planocellulært hudkarcinom (ved at undgå udsættelse for direkte sollys og ved at bruge solcreme og tage beskyttende tøj på) og underrette læger og sundhedspersonale, hvis de oplever relevante hudabnormiteter.
English: • Oral contraceptives (if you take Voriconazole Accord whilst using oral contraceptives, you may get side effects such as nausea and menstrual disorders)
Danish: • Oral svangerskabsforebyggende medicin (hvis De tager Voriconazole Accord sammen med oral svangerskabsforebyggende medicin, kan De få bivirkninger, såsom kvalme og menstruationsforstyrrelser)
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: In the 22 patients less than 2 years old who received voriconazole in a compassionate use programme, the following adverse reactions (for which a relationship to voriconazole could not be excluded) were reported: photosensitivity reaction (1), arrhythmia (1), pancreatitis(1), blood bilirubin increased (1), hepatic enzymes increased (1), rash (1) and papilloedema (1).
Danish: Hos de 22 patienter under 2 år, som blev behandlet med voriconazol i et compassionate use program, er følgende bivirkninger (for hvilke en sammenhæng med voriconazol ikke kan udelukkes) rapporteret: Lysoverfølsomheds reaktioner (1), arytmi (1), pancreatitis (1), forhøjet serum-bilirubin (1), forhøjet antal leverenzymer (1), udslæt (1) og papilødem (1).
English: There are no adequate data on the use of voriconazole in pregnant women available.
Danish: Graviditet Der foreligger ikke tilstrækkelig tilgængelig data om brugen af voriconazol hos gravide kvinder.
English: • Exfoliative cutaneous reactions
Danish: • Eksfoliative kutanreaktioner
English: In fluconazole-resistant non albicans species, a successful outcome was seen in3/3 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 C. krusei (fuldstændigt respons) og 6/8 C. glabrata (5 med fuldstændigt, 1 med delvist respons) infektioner.
English: including A. flavus, A. fumigatus, A. terreus, A. niger, A. nidulans, Candida spp., including C. albicans, C. glabrata, C. krusei, C. parapsilosis and C. tropicalis and limited numbers of C. dubliniensis, C. inconspicua, and C. guilliermondii, Scedosporium spp., including S. apiospermum, S. prolificans and Fusarium spp.
Danish: herunder A. flavus, A. fumigatus, A. terreus, A. niger, A. nidulans, Candida spp., herunder C. albicans, C. glabrata, C. krusei, C. parapsilosis, C. tropicalis samt et begrænset antal af C. dubliniensis, C. inconspicua og C. guilliermondii, Scedosporium spp., herunder S. apiospermum, S. prolificans og Fusarium spp.
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
English: In vivo studies indicated that CYP2C19 is significantly involved in the metabolism of voriconazole.
Danish: In vivo forsøg antyder, at CYP2C19 er signifikant involveret i voriconazols metabolisme.
English: If you or your child are taking Voriconazole Accord for prevention of fungal infections, your doctor may stop giving Voriconazole Accord if you or your child develop treatment related side effects.
Danish: Hvis De eller Deres barn tager Voriconazole Accord til forebyggelse af svampeinfektioner, kan lægen stoppe behandlingen med Voriconazole Accord, hvis De eller Deres barn får behandlingsrelaterede bivirkninger.
English: The excretion of voriconazole into breast milk has not been investigated.
Danish: Udskillelsen af voriconazol i modermælk er ikke undersøgt.
English: R-methadone (active) Cmax  R-methadone (active) AUCτ  S-methadone Cmax  65% S-methadone AUCτ  103%
Danish: R-methadon (aktiv) Cmax ↑ R-methadon (aktiv) AUCτ ↑ S-methadon Cmax ↑ 65% S-methadon AUCτ ↑ 103%
English: • Non-nucleoside reverse transcriptase inhibitors (e.g., efavirenz, delavirdine, nevirapine) (used for treating HIV) (some doses of efavirenz can NOT be taken at the same time as Voriconazole
Danish: • Non-nucleosid reverse transcriptase-hæmmere (f.eks. efavirenz, delavirdin, nevirapin) (medicin mod hiv) (nogle doser af efavirenc kan IKKE tages på samme tid som Voriconazole Accord)
English: In addition Voriconazole Accord has been associated with phototoxicity including reactions such as ephelides, lentigo, actinic keratosis and pseudoporphyria.
Danish: Derudover har Voriconazole Accord været forbundet med fototoksicitet, herunder reaktioner som efelider, lentigo, aktinisk keratose og pseudoporfyri.
English: including P. marneffei, Phialophora richardsiae, Scopulariopsis brevicaulis and
Danish: herunder P. marneffei, Phialophora richardsiae, Scopulariopsis brevicaulis og Trichosporon spp.
English: Clinical management should include laboratory evaluation of hepatic function (specifically AST and ALT) at the initiation of treatment with Voriconazole Accord and at least weekly for the first month of treatment.
Danish: Den kliniske overvågning bør omfatte laboratorievurdering af leverfunktionen (specifikt ASAT og ALAT) ved initiering af voriconazol -behandling og mindst én gang om ugen i den første behandlingsmåned.
English: • serious fungal infections caused by Scedosporium sp.or Fusarium sp. (two different species of fungi).
Danish: • alvorlige svampeinfektioner forårsaget af Scedosporium- eller Fusarium-arter (to andre typer svamp).
English: • Congenital or acquired QTc -prolongation.
Danish: • Kongenital eller erhvervet QT-forlængelse.
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Voriconazole Accord if:
Danish: Advarsler og forsigtighedsregler Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før De tager Voriconazole Accord, hvis
English: Voriconazole Accord, is a broad spectrum, triazole antifungal agent and is indicated in adults and children aged 2 years and above as follows:
Danish: Voriconazole Accord er et bredspektret triazol-antimykotikum, som er indiceret til følgende hos voksne samt børn over 2 år:
English: Sunburn or severe skin reaction following exposure to light or sun was experienced more frequently in children.
Danish: Solskoldning eller kraftig hudreaktion pga. lys eller solens stråler ses hyppigere hos børn.
English: • Concomitant medicinal product that is known to prolong QTc interval.
Danish: • Samtidig administration af medicin, der er kendt for at forlænge QT-intervallet.
English: The safety of voriconazole was investigated in 288 paediatric patients aged 2 to <12 years (169) and 12 to<18 years (119) who received voriconazole for prophylaxis (183) and therapeutic use (105) in clinical trials.
Danish: Sikkerheden af voriconazol er undersøgt hos 288 pædiatriske patienter i alderen 2 til < 12 år (169) og 12 til < 18 år (119), som fik voriconazol-profylakse (183) og til terapeutisk brug (105) i kliniske studier.
English: Children and adolescents Voriconazole Accord should not be given to children younger than 2 years of age.
Danish: Børn og unge Voriconazole Accord må ikke anvendes til børn under 2 år.
English: Patients, especially children, with risk factors for acute pancreatitis (e.g., recent chemotherapy, haematopoietic stem cell transplantation [HSCT]), should be monitored closely during Voriconazole Accord treatment.
Danish: Patienter, især børn med risikofaktorer for akut pancreatitis (f.eks. nylig kemoterapi, hæmatopoietisk stamcelletransplantation (HSCT)) bør monitoreres tæt under behandling med Voriconazole Accord.
English: After an oral single-dose (200 mg), AUC was 233 % higher in subjects with mild to moderate hepatic cirrhosis (Child-Pugh A and B) compared with subjects with normal hepatic function.
Danish: Efter en oral enkeltdosis (200 mg) var AUC 233% højere hos personer med mild til moderat levercirrose (Child-Pugh klasse A og B) sammenlignet med personer med normal leverfunktion.
English: For prophylaxis use, dose adjustments are not recommended in the case of lack of efficacy or treatment-related adverse events.
Danish: Dosisjustering anbefales ikke ved profylaktisk brug i tilfælde af manglende virkning eller behandlingsrelaterede bivirkninger.
English: If you are already being treated with phenytoin your blood concentration of phenytoin will need to be monitored during your treatment with Voriconazole Accord and your dose may be adjusted.
Danish: Hvis De allerede er i behandling med phenytoin er det nødvendigt at måle mængden af phenytoin i Deres blod under Deres behandling med Voriconazole Accord og det kan være nødvendigt at justere dosis.
English: Your doctor should also monitor your liver function while you are being treated with Voriconazole Accord by doing blood tests.
Danish: Deres læge vil også kontrollere Deres leverfunktion under behandling med Voriconazole Accord ved at tage blodprøver.
English: Voriconazole Accord must not be used during pregnancy unless the benefit to the mother clearly outweighs the potential risk to the foetus.
Danish: Voriconazole Accord må ikke anvendes under graviditet, medmindre den forventede fordel for moderen klart opvejer den potentielle risiko for fostret.
English: Cerebrospinal fluid samples from eight patients in a compassionate programme showed detectable voriconazole concentrations in all patients.
Danish: Prøver af cerebrospinalvæsken fra 8 patienter i et særligt klinisk program (compassionate use) viste målbare voriconazolkoncentrationer hos alle patienter.
English: Voriconazole may also be available as powder for solution for infusion, powder and solvent for solution for infusion and powder for oral suspension, however not under this tradename.
Danish: Voriconazol findes også som pulver til infusionsvæske; opløsning, pulver og solvens til infusionsvæske; opløsning, og som pulver til oral suspension, dog ikke under dette handelsnavn.
English: Omeprazole (40 mg QD)*
Danish: Omeprazol (40 mg QD)*
English: Immunosuppressants
Danish: Immunosupprimerende midler
English: It is therefore recommended to use the oral suspension formulation in children aged
Danish: Derfor anbefales det at bruge den orale suspension til børn i alderen 2 til <12 år.
English: The recommended doses in children and adolescent patients are based on a population pharmacokinetic analysis of data obtained from 112 immunocompromised paediatric patients aged 2 to <12 years and 26 immunocompromised adolescent patients aged 12to <17 years.
Danish: De anbefalede doser til børn og unge er baseret på en farmakokinetisk populationsanalyse af data fra 112 immunkompromitterede pædiatriske patienter i alderen 2 til <12 år og 26 immunkompromitterede unge i alderen 12 til <17 år.
English: The efficacy and survival benefit of voriconazole versus conventional amphotericin B in the primary treatment of acute invasive aspergillosis was demonstrated in an open, randomised, multicentre study in 277immunocompromised patients treated for 12 weeks.
Danish: Effekt og overlevelse ved voriconazol versus en konventionel amphotericin B i primær behandling af akut invasiv aspergillose blev vist i et åbent, randomiseret multicenterstudie med 277 immunkompromitterede patienter behandlet i 12 uger.
English: Reminds HCPs to provide a Patient Alert Card to the patient.
Danish: - Påminde læger og sundhedspersonale om, at de skal udlevere et patientadvarselskort til patienten.
English: Frequent monitoring for opiate associated adverse reactions may be necessary.
Danish: Hyppig monitorering for opioidrelaterede bivirkninger kan være nødvendig.
English: These oral dose recommendations for children are based on studies in which voriconazole was administered as the powder for oral suspension.
Danish: De anbefalede orale børnedoseringer er baseret på studier, hvor voriconazol blev givet som pulver til oral suspension.
English: There is limited data on the safety of voriconazole in patients with abnormal liver function tests (aspartate transaminase [AST], alanine transaminase [ALT], alkaline phosphatase [ALP], or total bilirubin >5 times the upper limit of normal).
Danish: Der findes begrænsede data om sikkerheden af voriconazol til patienter med unormale leverfunktionsværdier (aspartat-aminotransferase (ASAT), alanin-aminotransferase (ALAT), alkalisk fosfatase (AP) eller total-bilirubin > 5 gange den øvre normalgrænse).
English: Tell your doctor if you are taking any of the following medicines, as a dose adjustment or monitoring may be required to check that the medicines and/ or Voriconazole Accord are still having the desired effect:
Danish: Fortæl det til lægen, hvis De tager følgende medicin, da det kan være nødvendigt at justere dosis og kontrollere, om medicinen og/eller Voriconazole Accord stadig har den ønskede virkning:
English: Studies conducted in Caucasian and Japanese healthy subjects have shown that poor metabolisers have, on average, 4-fold higher voriconazole exposure (AUCτ) than their homozygous extensive metaboliser counterparts.
Danish: Studier hos kaukasiske og japanske raske personer har vist, at personer med dårlig metaboliseringsevne gennemsnitligt har 4 gange højere voriconazol eksponering (AUCτ), end deres homozygotisk kraftigt metaboliserende modparter.
English: 12 weeks after EOT 104 (42%)
Danish: 2 uger efter EOT 125 (50%) 6 uger efter EOT 104 (42%) 12 uger efter EOT 104 (42%)
English: The safety of voriconazole was also investigated in 158 additional paediatric patients aged 2 to <12 years in compassionate use programs.
Danish: Sikkerheden af voriconazol er undersøgt hos yderligere 158 pædiatriske patienter i alderen 2 til < 12 år, i compassionate use-programmer.
English: Other proton pump inhibitors that are CYP2C19 substrates may also be inhibited by voriconazole and may result in increased plasma concentrations of these medicinal products.
Danish: Andre protonpumpehæmmere, som er CYP2C19 substrater kan også blive hæmmet af voriconazol og kan medføre forhøjede plasmakoncentrationer af disse lægemidler.
English: Although not studied, increased plasma concentrations of these medicinal products can lead to QTc prolongation and rare occurrences of torsades de pointes
Danish: Selvom det ikke er undersøgt kan forøgede plasmakoncentrationer af disse lægemidler føre til QTc forlængelse og i sjældne tilfælde torsades de pointes.
English: MIC breakpoint (mg/L)
Danish: MIC grænseværdi (mg/l)
English: Take your box of Voriconazole Accord tablets with you.
Danish: Tag æsken med Voriconazole Accord tabletter med.
English: Dose reduction of methadone may be needed.
Danish: Dosis-reduktion af methadon kan være nødvendig.
English: Voriconazole Accord must not be taken during pregnancy, unless indicated by your doctor.
Danish: De må ikke tage Voriconazole Accord under graviditet, medmindre det er foreskrevet af Deres læge.
English: Voriconazole Accord should be discontinued if premalignant skin lesions or squamous cell carcinoma are identified (see below the section under Long-term treatment).
Danish: Voriconazole Accord bør seponeres, hvis der påvises præmaligne hudlæsioner eller planocellulært karcinom (se afsnittet ”Langtidsbehandling” nedenfor).
English: In vitro, voriconazole displays broad-spectrum antifungal activity with antifungal potency against Candida species (including fluconazole resistant C. krusei and resistant strains of C. glabrata and C. albicans) and fungicidal activity against all Aspergillus species tested.
Danish: Voriconazol udviser bredspektret antimykotisk aktivitet in vitro med antimykotisk styrke over for Candida arter (herunder fluconazol resistente C. krusei og resistente stammer af C. glabrata og C. albicans) og fungicid aktivitet over for alle undersøgte Aspergillus arter.
English: [P-gp substrate]
Danish: [P-gp substrat]
English: Increased ciclosporin levels have been associated with nephrotoxicity.
Danish: Forhøjede ciclosporin-koncentrationer har været forbundet med nefrotoksicitet.
English: Other oral coumarins (e.g., phenprocoumon, acenocoumarol)
Danish: Andre orale coumariner (f.eks. phenprocoumon, acenocoumarol)