FrancophonIA/ELRC3.0 huggingface dataset:
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: 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: Acute renal failure has been observed in severely ill patients undergoing treatment with VFEND.
Danish: Der er observeret akut nyresvigt hos svært syge patienter i behandling med VFEND.
English: A comparison of the paediatric and adult population pharmacokinetic data indicated that the predicted total exposure (AUC) in children following administration of a 9 mg/kg IV loading dose was comparable to that in adults following a 6 mg/kg IV loading dose.
Danish: En sammenligning af de farmakokinetiske populationsdata fra børn og voksne indikerer, at den forventede totale eksponering (AUCτ) hos børn efter administration af intravenøs mætningsdosis på 9 mg/kg var sammenlignelig med den for voksne efter en intravenøs mætningsdosis på 6 mg/kg.
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: Once constituted, VFEND oral suspension should only be administered using the oral syringe supplied with each pack.
Danish: Efter færdigblanding bør VFEND oral suspension kun anvendes ved at bruge doseringssprøjten, der findes i hver pakning.
English: EXP Shelf life after reconstitution: 24 hours when stored at 2°C - 8°C.
Danish: Exp Holdbarhed efter rekonstituering: 24 timer ved 2C-8C.
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 S. apiospermum og hos 2 (begge med delvist respons) ud af 7 patienter med S. prolificans infektion.
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: Nausea, vomiting, diarrhoea
Danish: • Kvalme, opkastning, diarré
English: In vitro data showed a slight increase of resistance of C. glabrata to voriconazole.
Danish: In vitro data viste let øget resistens af C. glabrata over for voriconazol.
English: The bag should be carefully inspected to ensure that there are no particulates.
Danish: Infusionsposen skal nøje inspiceres for at sikre, at den ikke indeholder partikler.
English: • This will provide an extractable volume of 20 ml of clear concentrate containing 10 mg/ml of voriconazole.
Danish: • Der fremkommer hermed en ekstraherbar mængde på 20 ml klart koncentrat indeholdende 10 mg voriconazol/ml.
English: AUC, 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: AUC, AUCt og AUC0- angiver de respektive arealer under plasmakoncentrationstidskurven inden for et dosisinterval, til den sidst kvantificerbare måling samt fra tiden 0 til uendelig.
English: While the bottle is upright, on a flat surface, insert the tip of the oral syringe into the adaptor.
Danish: Når flasken står lodret på en flad overflade, sættes spidsen af doseringssprøjten ned i adaptoren.
English: Therapy must be initiated with the specified loading dose regimen of either intravenous or oral VFEND to achieve plasma concentrations on Day 1 that are close to steady state.
Danish: Behandling skal initieres med den specifikke startdosis enten som intravenøs eller oral VFEND for at opnå plasmakoncentrationer tæt på steady state på Dag 1.
English: Inhibitors or inducers of these isoenzymes may increase or decrease voriconazole plasma concentrations, respectively, and there is potential for voriconazole to increase the plasma concentrations of substances metabolised by these CYP450 isoenzymes.
Danish: Hæmmere eller induktorer af disse isoenzymer kan give henholdsvis en stigning eller et fald i voriconazol-plasmakoncentrationerne og der er potentiale for, at voriconazol øger plasmaniveauerne for stoffer, der metaboliseres af disse CYP450-isoenzymer.
English: • Remove the bag of VFEND solvent for solution for infusion from the foil overwrap (do not use scissors or any other sharp tool).
Danish: • Tag posen med VFEND solvens til infusionsvæske, opløsning, ud af folieomslaget (brug ikke saks eller en anden skarp genstand).
English: Voriconazole has not been studied in patients with severe chronic hepatic cirrhosis (Child-Pugh C).
Danish: Voriconazol er ikke undersøgt hos patienter med svær kronisk levercirrose (Child-Pugh klasse C).
English: Includes drug-induced liver injury, hepatitis toxic, hepatocellular injury and hepatotoxicity.
Danish: Inkluderer medicinudløst leverskade, toksisk hepatitis, hepatocellulær skade og hepatotoksicitet.
English: Median duration of IV voriconazole therapy was 10 days (range 2-85 days).
Danish: Den mediane varighed af i.v.voriconazolbehandling var 10 dage (interval 2-85 dage).
English: When VFEND treatment is stopped by your doctor you should not experience any effects.
Danish: Når Deres læge stopper VFEND-behandlingen, bør De ikke kunne mærke det.
English: Always take this medicine exactly as your doctor has told you.
Danish: Tag altid VFEND nøjagtigt efter lægens anvisning.
English: Includes hypoxic-ischaemic encephalopathy and metabolic encephalopathy.
Danish: Inkluderer hypoksisk-iskæmisk encefalopati og metabolisk encefalopati.
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 effektiv.
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 VFEND)
Danish: • Non-nucleosid reverse transcriptase-hæmmere (f.eks. efavirenz, delavirdin, nevirapin) (medicin mod hiv) (nogle doser af efavirenz kan IKKE tages på samme tid som VFEND)
English: Do not administer to the patient as a bolus injection.
Danish: Må ikke gives til patienten som bolusinjektion.
English: Considering the assumed limited gastroenteric 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: 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 (AUC), end deres homozygotisk kraftigt metaboliserende modparter.
English: In a study in healthy volunteers investigating the impact of voriconazole on retinal function, voriconazole caused a decrease in the electroretinogram (ERG) waveform amplitude.
Danish: I et studie med raske frivillige, der undersøgte voriconazols betydning for retinafunktionen, forårsagede voriconazol et fald i elektroretinogrammet (ERG) bølgeformamplituden.
English: Other medicines and VFEND
Danish: Brug af anden medicin sammen med VFEND
English: Preclinical data on the intravenous vehicle SBECD indicated that the main effects were vacuolation of urinary tract epithelium and activation of macrophages in the liver and lungs in the repeated-dose toxicity studies.
Danish: Prækliniske data vedrørende hjælpestoffet SBECD i intravenøst VFEND tyder på at de primære virkninger er vakuolisering af urinvejsepithelium og aktivering af makrofager i lever og lunger i toksicitetsstudier efter gentagne doser.
English: Increased tacrolimus levels have been associated with nephrotoxicity.
Danish: Forhøjede tacrolimuskoncentrationer har været forbundet med nefrotoksicitet.
English: If you are already being treated with rifabutin your blood counts and side effects to rifabutin will need to be monitored.
Danish: Hvis De allerede er i behandling med rifabutin, er det nødvendigt at tage blodprøver samt være opmærksom på bivirkninger forbundet med rifabutin.
English: Photosensitivity reactions such as ephelides, lentigo and actinic keratosis have been reported, especially during long-term therapy (see section 4.4).
Danish: Lysfølsomhedsreaktioner som efelider, lentigo og aktinisk keratose er rapporteret, især under langtidsbehandling (se pkt.
English: In vitro activity against clinical isolates has been observed for Acremonium spp., Alternaria spp., Bipolaris spp., Cladophialophora spp., and Histoplasma capsulatum, with most strains being inhibited by concentrations of voriconazole in the range 0.05 to 2 µg/ml.
Danish: In vitro aktivitet over for kliniske isolater er set over for Acremonium spp., Alternaria spp., Bipolaris spp., Cladophialophora spp., Histoplasma capsulatum, hvor de fleste stammer bliver hæmmet af voriconazolkoncentrationer i området fra 0,05 til 2 g/ml.
English: • serious invasive Candida sp. infections when the fungus is resistant to fluconazole (another antifungal medicine),
Danish: • alvorlige invasive infektioner med Candida-arter, når svampen er resistent over for fluconazol (et andet middel mod svampeinfektion)
English: Disorder of blood clotting system
Danish: • Sygdom i blodets størkningssystem
English: • Non-steroidal anti-inflammatory drugs (e.g., ibuprofen, diclofenac) (used for treating pain and inflammation)
Danish: • Non-steroide anti-inflammatoriske lægemidler (f.eks. ibuprofen og diclofenac) (bruges til behandling af smerter og betændelsestilstande)
English: Without the loading dose, accumulation occurs during twice daily multiple dosing with steady-state plasma voriconazole concentrations being achieved by Day 6 in the majority of subjects.
Danish: Uden initialdosis forekommer akkumulering ved 2 gange dagligt dosering indtil steady state plasma voriconazolkoncentrationer, som hos de fleste forsøgspersoner er opnået på dag 6.
English: Push the plunger back in to the syringe.
Danish: Skub stemplet tilbage i sprøjten.
English: Tell your doctor if you experience this.
Danish: Kontakt Deres læge, hvis De oplever dette
English: If the liver function tests become markedly elevated, VFEND should be discontinued, unless the medical judgment of the risk-benefit of the treatment for the patient justifies continued use.
Danish: Hvis leverfunktionsværdierne forhøjes mærkbart, bør VFEND seponeres, medmindre fortsat anvendelse kan forsvares på grundlag af en medicinsk vurdering af risk-benefit-forholdet for patienten.
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: Use in children and adolescents The recommended dose for children and teenagers is as follows:
Danish: Den anbefalede dosis til børn og teenagere:
English: When there is also a potential for voriconazole to increase the plasma concentrations of substances metabolised by CYP3A4 isoenzymes (certain antihistamines, quinidine, cisapride, pimozide), coadministration is contraindicated (see below and section 4.3).
Danish: Hvis der også er en mulighed for, at voriconazol øger plasmaniveauerne af substanser, der metaboliseres af CYP3A4-isoenzymer (visse antihistaminer, quinidin, cisaprid, pimozid), er samtidig administration kontraindiceret (se neden for og pkt.
English: The effects on parturition are probably mediated by species-specific mechanisms, involving reduction of oestradiol levels, and are consistent with those observed with other azole antifungal agents.
Danish: Effekten på fødslen er sandsynligvis medieret af artsspecifikke mekanismer, der omfatter fald i østradiolniveuaer, og er konsistent med det, der er observeret ved andre azol-antimykotika.
English: VFEND is supplied as a white to off-white powder for oral suspension providing a white to off-white, orange flavoured suspension when constituted with water.
Danish: VFEND er et hvidt til råhvidt pulver til oral suspension, der efter sammenblanding med vand giver en hvid til råhvid suspension med appelsinsmag.
English: Squamous cell carcinoma of the skin (SCC) has been reported in relation with long-term VFEND treatment.
Danish: Planocellulært karcinom i huden (SCC) er blevet rapporeret i forbindelse med langtidbehandling med VFEND.
English: After IV voriconazole therapy, the median duration of oral voriconazole therapy was 76 days (range 2-232 days).
Danish: Efter i.v.-voriconazolbehandling var den mediane varighed af oral voriconazolbehandling 76 dage (interval 2-232 dage).
English: Compared to voriconazole 200 mg BID,
Danish: Sammenlignet med voriconazol 200 mg BID,
English: If phototoxic reactions occur multidisciplinary advice should be sought, VFEND discontinuation and use of alternative antifungal agents should be considered and the patient should be referred to a dermatologist.
Danish: Hvis der opstår fototoksiske reaktioner, bør der søges multidisciplinær rådgivning, og patienten bør henvises til dermatolog.
English: VFEND should be administered primarily to patients with progressive, possibly life-threatening infections.
Danish: VFEND bør fortrinsvis gives til patienter med fremadskridende, muligt livstruende infektioner.
English: In the table below, since the majority of the studies were of an open nature, all causality adverse reactions and their frequency categories in 1,873 adults from pooled therapeutic (1,603) and prophylaxis (270) studies, by system organ class, are listed.
Danish: Da størstedelen af studierne var ublindede, er alle kausale bivirkninger, hvor der er en mulig årsagssammenhæng, og deres hyppighedskategorier hos 1.873 voksne fra sammenlagte terapeutiske studier (1.603) og profylaksestudier (270) anført efter systemorganklasse i skemaet nedenfor.
English: Solvent for solution for infusion: Clear diluent solution.
Danish: Solvens til infusionsvæske, opløsning: klar fortyndingsopløsning.
English: When multiple doses of voriconazole oral suspension are administered with high fat meals, Cmax and AUCτ are reduced by 58% and 37% respectively.
Danish: Hvis flere doser voriconazol oral suspension indtages sammen med meget fede måltider, vil Cmax og AUC blive reduceret med henholdsvis 58% og 37%.
English: Depending on your response to treatment, your doctor may increase or decrease the daily dose.
Danish: Afhængigt af hvordan behandlingen virker, vil lægen måske øge eller nedsætte dosis.
English: When cleared, proceed as directed.
Danish: Når dette er klaret, fortsættes som beskrevet.
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: Dose adjustments in prophylaxis studies have not been explored.
Danish: Dosisjustering er ikke undersøgt i profylaksestudier.
English: Pharmacokinetic/pharmacodynamic Relationship
Danish: Farmakokinetiske-farmakodynamiske relationer
English: The overall incidence of transaminase increases >3 xULN (not necessarily comprising an adverse event) in the voriconazole clinical programme was 18.0% (319/1,768) in adults and 25.8% (73/283) in paediatric subjects who received voriconazole for pooled therapeutic and prophylaxis use.
Danish: I voriconazols kliniske program var den samlede incidens af transferase stigninger >3×ULN (ikke nødvendigvis med bivirkninger) 18,0 % (319/1.768) hos voksne og 25,8 % (73/283) hos pædiatriske forsøgspersoner, der blev behandlet med voriconazol til samlet terapeutisk og profylaktisk brug.
English: This should be taken into consideration if you are on a strictly controlled sodium diet.
Danish: Dette skal De tage hensyn til, hvis De er på natriumeller saltfattig diæt.
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 12 to <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: Wash the oral syringe as instructed below.
Danish: Vask doseringssprøjten som er angivet nedenfor.
English: EUCAST has not determined non-species related breakpoints for voriconazole.
Danish: EUCAST har ikke defineret ikke-artsrelaterede grænseværdier for voriconazol.
English: Multiple intravenous doses of 3, 4, 6, 7 and 8 mg/kg twice daily and multiple oral doses (using the powder for oral suspension) of 4 mg/kg, 6 mg/kg, and 200 mg twice daily were evaluated in 3 paediatric pharmacokinetic studies.
Danish: Multiple intravenøse doser på 3, 4, 6, 7 og 8 mg/kg 2 gange dagligt og multiple orale doser (pulver til oral suspension) på 4 mg/kg, 6 mg/kg samt 200 mg 2 gange dagligt, blev evalueret i 3 pædiatriske farmakokinetik-studier.
English: High dose (400 mg BID)
Danish: Høj-dosis (400 mg BID)
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: 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 C. krusei (fuldstændigt respons) og 6/8 C. glabrata (5 med fuldstændigt, 1 med delvist respons) infektioner.
English: VFEND is intended for patients with worsening, possibly life-threatening, fungal infections.
Danish: VFEND er beregnet til patienter med forværrede og potentielt livstruende svampeinfektioner.
English: If VFEND is continued, however, dermatologic evaluation should be performed on a systematic and regular basis, to allow early detection and management of premalignant lesions.
Danish: Hvis behandling med VFEND fortsættes på trods af forekomsten af fototoksicitetsrelaterede læsioner, bør der udføres systematisk og regelmæssig dermatologisk evaluering med henblik på tidlig påvisning og behandling af præmaligne læsioner.
English: If multiple vials are required, each individual vial used must be administered using a separate sterile sodium chloride bag.
Danish: Hvis det er nødvendigt at anvende flere hætteglas, skal disse administreres i hver deres sterile natriumchloridpose.
English: Children and adolescents VFEND should not be given to children younger than 2 years of age.
Danish: VFEND må ikke anvendes til børn under 2 år.
English: Slowly pull back the plunger of the oral syringe to the graduation mark that marks the dose for you.
Danish: Træk stemplet langsomt tilbage i doseringssprøjten, indtil De når den markering, der angiver Deres dosis.
English: Reconstituted VFEND needs to be diluted with a compatible infusion solution first before it is infused.
Danish: Rekonstitueret VFEND skal fortyndes med egnede fortyndingsmidler før infusion.
English: In the clinical programme, no dosage adjustment was made on the basis of gender.
Danish: Der var ingen dosisjusteringer i det kliniske program på grund af køn.
English: If you get any side effects, talk to your doctor or, pharmacist or nurse.
Danish: Hvis De oplever bivirkninger, bør De tale med Deres læge, sygeplejerske eller apoteket.
English: Hold the vial adapter over the vial and press down firmly, until the vial locks into place.
Danish: Hold adapteren over hætteglasset, og pres fast nedad, indtil hætteglasset er låst på plads.
English: This represents a heterogeneous population, containing patients with haematological malignancy, HIV-infected patients with oesophageal candidiasis and refractory fungal infections, non-neutropenic patients with candidaemia or aspergillosis and healthy volunteers.
Danish: Databasen repræsenterer en heterogen population indeholdende patienter med maligne hæmatologiske sygdomme, hiv-inficerede patienter med øsofageal candidiasis og refraktære svampeinfektioner, non-neutropene patienter med candidæmi eller aspergillosis og raske forsøgspersoner.
English: For administration, the required volume of the reconstituted concentrate is added to a recommended compatible infusion solution (detailed in the table below) to obtain a final voriconazole solution containing 0.5-5 mg/ml.
Danish: Ved administration tilsættes det krævede volumen af det rekonstituerede koncentrat til en anbefalet forligelig infusionsopløsning (detaljer i tabellen nedenfor) for at opnå en endelig voriconazol opløsning på 0,5-5 mg/ml.
English: Method of administration VFEND film-coated tablets are to be taken at least one hour before, or one hour following, a meal.
Danish: Administration VFEND filmovertrukne tabletter skal tages mindst 1 time før eller 1 time efter et måltid.
English: The medicines in the following list must not be taken during your VFEND treatment:
Danish: Følgende typer medicin må ikke indtages under behandlingen med VFEND:
English: HDPE tablet containers containing 2, 30 or 100 film-coated tablets.
Danish: HDPE tabletbeholdere med 2, 30 eller 100 filmovertrukne tabletter.
English: When initiating voriconazole in patients already receiving omeprazole doses of 40 mg or above, it is recommended that the omeprazole dose be halved.
Danish: Når voriconazol-behandling startes hos patienter, der allerede får omeprazoldoser på 40 mg eller derover anbefales det, at omeprazol-dosis halveres.