FrancophonIA/ELRC3.0 huggingface dataset:
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.
English: In case of treatment-related adverse events (hepatotoxicity, severe skin reactions including phototoxicity and SCC, severe or prolonged visual disorders and periostitis), discontinuation of voriconazole and use of alternative antifungal agents must be considered.
Danish: I tilfælde af behandlingsrelaterede bivirkninger (hepatotoksicitet, alvorlige hudreaktioner, herunder fototoksicitet og planocellulært karcinom, alvorlige eller langvarige synsforstyrrelser og periostitis) skal seponering af voriconazol og anvendelse af alternative antimykotika overvejes.
English: • Phenytoin (used to treat epilepsy).
Danish: • Phenytoin (medicin mod epilepsi).
English: The breakthrough IFI rate to Day 180 and the primary endpoint of the study, which is Success at Day 180, for patients with AML and myeloablative conditioning regimens respectively, is presented in the table below:
Danish: Tabellen nedenfor viser gennembrudsraten for invasiv svampeinfektion til dag 180 og studiets primære effektmål, som er succes efter 180 dage, hos patienter med henholdsvis AML og myeloablative konditioneringsregimer:
English: Total parenteral nutrition (TPN) need not be discontinued when prescribed with Voriconazole Hikma, but does need to be infused through a separate line.
Danish: Total parenteral ernæring (TPN) behøver ikke at blive afbrudt, når der udskrives Voriconazole Hikma, men de skal infunderes i hver sin dropslange.
English: 9 mg/kg twice daily (a maximum dose of 350 mg twice daily)
Danish: 9 mg/kg 2 gange dagligt (maksimalt 350 mg 2 gange dagligt)
English: 6 See “Visual impairments” paragraph in section 4.8.
Danish: 6 Se afsnittet ”Synsnedsættelse” i pkt.
English: This includes cases of jaundice, hepatitis and hepatic failure leading to death (see section 4.4).
Danish: Dette omfatter tilfælde af icterus, hepatitis og leversvigt, der førte til dødsfald (se pkt.
English: When the recommended intravenous or oral loading dose regimens are administered, plasma concentrations close to steady state are achieved within the first 24 hours of dosing.
Danish: Når den anbefalede intravenøse eller orale initialdosis gives, opnås plasmakoncentrationer tæt på steady state inden for de første 24 timer.
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 reproduction studies, voriconazole was shown to be teratogenic in rats and embryotoxic in rabbits at systemic exposures equal to those obtained in humans with therapeutic doses.
Danish: I reproduktionsstudier har voriconazol vist sig at være teratogent hos rotter og embryotoksisk hos kaniner ved systemisk optagelse svarende til den, der ses ved terapeutiske doser hos mennesker.
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 på 4 mg/kg, 6 mg/kg og 200 mg 2 gange dagligt blev evalueret i 3 pædiatriske farmakokinetik-studier.
English: Depending on your response to treatment, your doctor may decrease the dose to 3 mg/kg twice daily.
Danish: Afhængigt af hvordan behandlingen virker, vil lægen måske nedsætte dosis til 3 mg/kg 2 gange dagligt.
English: Ear and labyrinth disorders hypoacusis, vertigo, tinnitus
Danish: Øre og labyrint hypakusi, vertigo, tinnitus
English: Cimetidine (400 mg BID) [non-specific CYP450 inhibitor and increases gastric pH]
Danish: Cimetidin (400 mg BID) [non-specifik CYP450-hæmmer og øger gastrisk pH]
English: Overall, the safety profile of voriconazole in paediatric population was similar to that in adults.
Danish: Generelt er bivirkningsprofilen for voriconazol den samme hos den pædiatriske population som hos voksne.
English: It is recommended that voriconazole is administered at a maximum rate of 3 mg/kg per hour over 1 to 3 hours.
Danish: Det anbefales, at voriconazol indgives over 1-3 timer med en maksimal hastighed på 3 mg/kg/time.
English: Subjects who are heterozygous extensive metabolisers have on average 2-fold higher voriconazole exposure than their homozygous extensive metaboliser counterparts.
Danish: Personer, som er heterozygotisk kraftigt metaboliserende, har gennemsnitligt fordoblet voriconazol eksponering i forhold til deres homozygotisk kraftigt metaboliserende modparter.
English: • Everolimus (used for treating advanced kidney cancer and in transplant patients)
Danish: • Everolimus (bruges til behandling af fremskreden nyrekræft og hos patienter, der er blevet transplanteret).
English: A study has been conducted in healthy volunteers which examined the effect on QTc interval of single doses of voriconazole up to 4 times the usual daily dose.
Danish: Der er udført et klinisk studie hos raske frivillige forsøgspersoner, hvor effekten af voriconazolbehandling med enkeltdoser op til 4 gange den sædvanlige daglige dosis på QTcintervallet blev undersøgt.
English: - If you get any side effects, talk to your doctor,pharmacist or nurse.
Danish: - Hvis De oplever bivirkninger, bør De tale med Deres læge, apotekspersonalet eller sundhedspersonalet.
English: The predicted total exposure in children following an oral maintenance dose of 9 mg/kg (maximum of 350 mg) twice daily was comparable to that in adults following 200 mg oral twice daily.
Danish: Den forventede totale eksponering hos børn efter oral vedligeholdelsesbehandling på 9 mg/kg (maksimalt 350 mg) 2 gange dagligt var sammenlignelig med den for voksne efter oral behandling med 200 mg 2 gange dagligt.
English: In the same study, no significant differences in Cmax and AUCτ were observed between healthy elderly males and healthy elderly females (≥ 65 years).
Danish: I samme studie blev der ikke observeret signifikante ændringer i Cmax og AUCτ mellem raske, ældre mænd og raske, ældre, kvinder (≥ 65 år).
English: Repeated-dose toxicity studies with voriconazole indicated the liver to be the target organ.
Danish: Studier vedrørende toksicitet efter gentagne doser voriconazol tyder på, at leveren er målorganet.
English: - Reminds HCPs to discuss with the patient/care giver the risks of phototoxicity/skin SCC and hepatotoxicity, what to look for, how and when to seek immediate attention.
Danish: - Påminde læger og sundhedspersonale om, at de skal drøfte risici for fototoksicitet/planocellulært hudkarcinom og levertoksicitet med patienter/omsorgspersoner, hvad de skal holde øje med, samt hvordan og hvornår de skal søge øjeblikkelig lægehjælp.
English: The primary mode of action of voriconazole is the inhibition of fungal cytochrome P-450-mediated 14 alpha-lanosterol demethylation, an essential step in fungal ergosterol biosynthesis.
Danish: Voriconazols primære virkningsmåde er hæmning af fungal CYP450-medieret 14-α-lanosteroldemethylering, der er et vigtigt trin i biosyntesen af fungal ergosterol.
English: The compatibility of Voriconazole Hikma with diluents other than listed above (or listed below under ‘Incompatibilities') is unknown.
Danish: Voriconazole Hikmas forligelighed med andre fortyndingsmidler end dem, der er nævnt ovenfor (eller under punktet ‘Uforligeligheder'), er ikke kendt.
English: If patient is unable to tolerate intravenous treatment at 4 mg/kg twice daily, reduce the dose to 3 mg/kg twice daily.
Danish: Hvis patienten ikke kan tåle intravenøs behandling med 4 mg/kg 2 gange dagligt, reduceres dosis til 3 mg/kg 2 gange dagligt.
English: Phenytoin (CYP2C9 substrate and potent CYP450 inducer) Careful monitoring of phenytoin levels is recommended when phenytoin is co-administered with voriconazole.
Danish: Phenytoin (CYP2C9-substrat og potent CYP450-induktor) Omhyggelig monitorering af phenytoinniveauer anbefales ved samtidig administratin af voriconazol.
English: Carbamazepine and long-acting barbiturates (e.g., phenobarbital, mephobarbital) [potent CYP450 inducers]
Danish: Carbamazepin og langtidsvirkende benzodiazepiner (f.eks. phenobarbital, mephobarbital) [potente CYP450-induktorer]
English: Breakthrough IFI - Day 180 1 (1.0%)
Danish: Gennembrud invasiv svampeinfektion - dag 180 1 (1,0%)
English: Based on the population pharmacokinetic analysis, 12- to 14year-old adolescents weighing less than 50 kg should receive children's doses (see section 4.2).
Danish: Baseret på den farmakokinetiske populationsanalyse skal 12-14 årige unge, der vejer <50 kg have børnedosis (se pkt.
English: Patients with severe hepatic impairment must be carefully monitored for drug toxicity (see section 4.8).
Danish: Patienter med svær leverinsufficiens skal monitoreres omhyggeligt for lægemiddeltoksicitet (se pkt.
English: • Indinavir and other HIV protease inhibitors (used for treating HIV)
Danish: • Indinavir og andre hiv-proteasehæmmere (medicin mod hiv)
English: No significant differences in Cmax and AUCτ were observed between healthy elderly females (≥ 65 years) and healthy young females (18-45 years).
Danish: Der blev ikke observeret nogen signifikante forskelle i Cmax og AUCτ mellem raske, ældre kvinder (≥65 år) og raske, unge kvinder (18-45 år).
English: Frequent monitoring for adverse reactions and toxicity related to methadone, including QTc prolongation, is recommended when co-administered with voriconazole since methadone levels increased following coadministration of voriconazole.
Danish: Hyppig monitorering af bivirkninger og toksicitet i forbindelse med methadon, herunder QTcforlængelse, anbefales ved samtidig administration af voriconazol, da methadonniveauerne stiger efter samtidig administration af voriconazol.
English: In the pre and postnatal development study in rats at exposures lower than those obtained in humans with therapeutic doses, voriconazole prolonged the duration of gestation and labour and produced dystocia with consequent maternal mortality and reduced perinatal survival of pups.
Danish: I undersøgelser af den præ- og postnatale udvikling hos rotter, forlængede voriconazol, ved en mindre optagelse end den der ses ved terapeutiske doser hos mennesker, gestations- og fødselsvarigheden, medførte dystoci med heraf følgende maternal mortalitet og reducerede den perinatale overlevelse af afkommet.
English: • Enlarged lymph glands (sometimes painful), , failure of blood marrow, (increased eosinophil)
Danish: • Forstørrede lymfekirtler (undertiden smertefuldt), knoglemarvssvigt, øget antal eosinofiler
English: Dose reduction of methadone may be needed (see section 4.5).
Danish: Dosisreduktion af methadon kan være nødvendig (se pkt.
English: and Sporothrix spp.
Danish: og Sporothrix spp.
English: When initiating voriconazole in patients already on tacrolimus, it is recommended that the tacrolimus dose be reduced to a third of the original dose and tacrolimus level carefully monitored.
Danish: Når voriconazol-behandling startes hos patienter, der allerede får tacrolimus, anbefales det, at tacrolimus-dosis reduceres til en tredjedel af det oprindelige, og at tacrolimus-koncentrationerne monitoreres nøje.
English: • Disorder of blood clotting system
Danish: • Sygdom i blodets størkningssystem
English: Fentanyl (5 μg/kg single dose)
Danish: Fentanyl (5 μg/kg enkeltdosis)
English: Protein binding of voriconazole was not affected by impaired hepatic function.
Danish: Proteinbindingen af voriconazol var ikke påvirket af nedsat leverfunktion.
English: • Alfentanil and fentanyl and other short acting opiates such as sufentanil (painkillers used for surgical procedures)
Danish: • Alfentanil og fentanyl samt andre korttidsvirkende opiater, såsom sufentanil (smertestillende medicin, der bruges ved operationer)
English: Patients receiving voriconazole must be carefully monitored for hepatic toxicity.
Danish: Patienter, der behandles med voriconazol, skal monitoreres nøje for levertoksicitet.
English: Success rates and other secondary endpoints are presented in the table below:
Danish: Tabellen nedenfor viser succesrater og andre sekundære effektmål:
English: In an oral multiple dose study, Cmax and AUCτ for healthy young females were 83 % and 113 % higher, respectively, than in healthy young males (18-45 years).
Danish: I et oralt flerdosisstudie med raske, unge kvinder var Cmax og AUCτ henholdsvis 83 % og 113 % højere end hos raske, unge mænd (18-45 år).
English: The required volume of the reconstituted concentrate is then added to a recommended compatible infusion solution listed below to obtain a final Voriconazole Hikma solution containing 0.5 to 5 mg/ml of voriconazole.
Danish: Den nødvendige mængde af det rekonstituerede koncentrat tilsættes derefter til en anbefalet, kompatibel infusionsvæske fra nedenstående liste, så der opnås en endelig opløsning med Voriconazole Hikma, der indeholder 0,5 til 5 mg/ml voriconazol.
English: *ADR identified post-marketing
Danish: *Bivirkninger set efter markedsføring
English: Voriconazole should be administered with caution to patients with potentially proarrhythmic conditions, such as
Danish: Voriconazol skal indgives med forsigtighed hos patienter med potentiel proarytmiske tilstande, såsom
English: Please refer to the treatment tables above.
Danish: Se doseringsskemaerne ovenfor.
English: When voriconazole treatment is stopped, the initial dose of efavirenz should be restored (see section 4.2 and 4.4).
Danish: Når voriconazol-behandling standses, bør initialdosis af efavirenz genoptages (se pkt.4.2 og 4.4).
English: If any of these side effects persist or are troublesome, please tell your doctor.
Danish: Hvis bivirkningerne fortsætter eller er generende, skal De kontakte lægen.
English: Long term exposure (treatment or prophylaxis) greater than 180 days (6 months) requires careful assessment of the benefit-risk balance and physicians should therefore consider the need to limit the exposure to VORICONAZOLE HIKMA (see sections 4.2 and 5.1).
Danish: Langtidseksponering (behandling eller profylakse) i mere end 180 dage (6 måneder) kræver nøje vurdering af benefit/risk-forholdet, og lægen bør derfor overveje at begrænse eksponeringen for VORICONAZOLE HIKMA (se pkt.
English: • Warfarin and other anticoagulants (e.g. phenprocoumon, acenocoumarol; used to slow down clotting of the blood)
Danish: • Warfarin og anden blodfortyndende medicin (f.eks. phenprocoumon, acenocoumarol; bruges til at nedsætte blodets evne til at størkne)
English: Voriconazole Cmax and AUCτ ↔
Danish: Voriconazol Cmax og AUCτ ↔
English: • Cisapride (used for stomach problems)
Danish: • Cisaprid (medicin mod maveproblemer)
English: • Patient Alert Card for Phototoxicity and SCC: - Reminds patients of the risk of phototoxicity and skin SCC.
Danish: • Patientadvarselskort om fototoksicitet og planocellulært karcinom: - Påminde patienter om risikoen for fototoksicitet og planocellulært hudkarcinom.
English: Voriconazole Hikma must not be diluted with 4.2% Sodium Bicarbonate Infusion.
Danish: Voriconazole Hikma må ikke fortyndes med 4,2 % natriumcarbonat-infusionsvæske.
English: Efavirenz (a non-nucleoside reverse transcriptase inhibitor) [CYP450 inducer; CYP3A4 inhibitor and substrate] Efavirenz 400 mg QD, coadministered with voriconazole 200 mg BID*
Danish: Efavirenz (en non-nukleosid reverse transcriptase-hæmmer) (CYP450-induktor; CYP3A4hæmmer og -substrat) Efavirenz 400 mg QD administreret sammen med voriconazol 200 mg BID*
English: Astemizole, cisapride, pimozide, quinidine and terfenadine [CYP3A4 substrates]
Danish: Astemizol, cisaprid, pimozid, quinidin og terfenadin [CYP3A4-substrater]
English: Your doctor will determine your dose depending on your weight and the type of infection you have.
Danish: Lægen fastlægger dosis for hver enkelt patient afhængig af vægt og infektionstype.
English: Median duration of IV voriconazole therapy was 10 days (range 2-85 days).
Danish: voriconazolbehandling var 10 dage (interval 2-85 dage).
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 natrium- eller saltfattig diæt.
English: The findings of the effect of efavirenz on voriconazole suggest that the metabolism of voriconazole may be induced by a NNRTI.
Danish: Resultaterne fra efavirenz' virkning på voriconazol tyder på, at metaboliseringen af voriconazol kan blive induceret af NNRTI.
English: 6 mg/kg every 12 hours 400 mg every 12 hours 200 mg every 12 hours
Danish: 6 mg/kg hver 12. time 400 mg hver 12. time 200 mg hver 12. time
English: This medicinal product is for single use only and any unused solution should be discarded and only clear solutions without particles should be used.
Danish: Dette lægemiddel er kun til engangsbrug, og eventuel ubrugt opløsning skal kasseres.
English: There was evidence of attenuation with repeated doses of voriconazole.
Danish: Der er bevis for, at synsændringerne mindskes ved gentagne doser af voriconazol.
English: • Benzodiazepines (e.g., midazolam, triazolam) (used for severe insomnia and stress)
Danish: • Benzodiazepiner (f.eks. midazolam, triazolam) (medicin mod alvorlig søvnløshed og stress)
English: After IV voriconazole therapy, the median duration of oral voriconazole therapy was 76 days (range 2-232 days).
Danish: voriconazolbehandling var den mediane varighed af oral voriconazolbehandling 76 dage (interval 2-232 dage).
English: Ethinylestradiol Cmax ↑ 36% Ethinylestradiol AUCτ ↑ 61% Norethisterone Cmax ↑ 15% Norethisterone AUCτ ↑ 53% Voriconazole Cmax ↑ 14% Voriconazole AUCτ ↑ 46%
Danish: Ethinylestradiol Cmax ↑ 36 % Ethinylestradiol AUCτ ↑ 61 % Norethisteron Cmax ↑ 15 % Norethisteron AUCτ ↑ 53 % Voriconazol Cmax ↑ 14 % Voriconazol AUCτ ↑ 46 %
English: If VORICONAZOLE HIKMA 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 VORICONAZOLE HIKMA 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: • Anxiety, depression, confusion, agitation, inability to sleep, hallucinations
Danish: • Angst, depression, forvirring, uro, søvnløshed, hallucinationer
English: Adults
Danish: Ældre
English: Primary Prophylaxis of Invasive Fungal Infections - Efficacy in HSCT recipients without prior proven or probable IFI
Danish: Primær profylakse af invasive svampeinfektioner - virkning hos HSC-transplanterede atienter uden forudgående påvist eller sandsynlig invasiv svampeinfektion
English: Fluconazole (CYP2C9, CYP2C19 and CYP3A4 inhibitor) Coadministration of oral voriconazole and oral fluconazole resulted in a significant increase in Cmax and AUCτ of voriconazole in healthy subjects.
Danish: Fluconazol (CYP2C9-, CYP2C19- og CYP3A4-hæmmer) Samtidig administration af oral voriconazol og oral fluconazol hos frivillige, raske forsøgspersoner resulterede i en signifikant stigning i Cmax og AUCτ for voriconazol.
English: Voriconazole Hikma must not be used during pregnancy, unless indicated by your doctor.
Danish: De må ikke tage Voriconazole Hikma under graviditet, medmindre det er foreskrevet af Deres læge.
English: - Reminds HCPs of use of the HCP Checklist and the Patient Alert Card and how to obtain additional copies.
Danish: - Påminde læger og sundhedspersonale om, at de skal benytte tjeklisten til læger og sundhedspersonale og patientadvarselskortet, samt oplyse om hvordan de kan skaffe flere eksemplarer.
English: Voriconazole Hikma is intended for patients with worsening, possibly life-threatening, fungal infections.
Danish: Voriconazole Hikma er beregnet til patienter med forværrede og potentielt livstruende svampeinfektioner.
English: Mycophenolic acid (1 g single dose) [UDP-glucuronyl transferase substrate]
Danish: Mycophenolsyre (1 g enkeltdosis) [UDP-glucuronyltransferasesubstrat]
English: After reconstitution each ml contains 10 mg of voriconazole.
Danish: Efter rekonstituering indeholder 1 ml 10 mg voriconazol.
English: As Voriconazole Hikma has been known to affect the liver and the kidney, your doctor should monitor the function of your liver and kidneys by doing blood tests.
Danish: Da Voriconazole Hikma påvirker lever og nyrer, vil Deres læge tage blodprøver for at kontrollere lever- og nyrefunktionen.
English: Intravenous use only
Danish: Kun til intravenøs anvendelse.
English: Careful monitoring of full blood counts and adverse reactions to rifabutin (e.g., uveitis) is recommended when rifabutin is co-administered with voriconazole.
Danish: Omhyggelig monitorering af fuldt blodbillede og bivirkninger til rifabutin (f.eks. uveitis) anbefales, når rifabutin administreres samtidigt med voriconazol.
English: Very common: may affect more than 1 in 10 people
Danish: Meget almindelige: Det forekommer hos flere end 1 ud af 10 patienter
English: Prophylaxis of invasive fungal infections in high risk allogeneic hematopoietic stem cell transplant (HSCT) recipients.
Danish: Profylakse mod invasive svampeinfektioner hos højrisikopatienter, der har fået en allogen hæmatopoietisk stamcelletransplantation (HSCT).
English: In an overdose, haemodialysis may assist in the removal of voriconazole and SBECD from the body.
Danish: Ved overdosering kan hæmodialyse muligvis medvirke til af fjerne voriconazol og SBECD fra kroppen.
English: Voriconazole Cmax ↑ 57% Voriconazole AUCτ ↑ 79% Fluconazole Cmax ND Fluconazole AUCτ ND
Danish: Voriconazol Cmax ↑ 57 % Voriconazol AUCτ ↑ 79 % Fluconazol Cmax ND Fluconazol AUCτ ND
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 200 mg of voriconazole.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hvert hætteglas indeholder 200 mg voriconazol.
English: Depending upon your response to treatment, your doctor may increase or decrease the daily dose.
Danish: Afhængigt af hvordan behandlingen virker, vil lægen måske øge dosis.
English: Prednisolone Cmax ↑ 11% Prednisolone AUC0-∞ ↑ 34%
Danish: Prednisolon Cmax ↑ 11 % Prednisolon AUC0-∞ ↑ 34 %
English: If patients are unable to tolerate treatment, reduce the intravenous dose by 1 mg/kg steps.
Danish: Hvis patienten ikke tåler behandlingen, kan intravenøs dosis reduceres i trin på 1 mg/kg.
English: Psychiatric disorders depression, hallucination, anxiety, insomnia, agitation, confusional state
Danish: Psykiske forstyrrelser depression, hallucinationer, angst, søvnløshed, agitation, konfusion
English: However, lower voriconazole exposure was observed in some young adolescents with low body weight compared to adults.
Danish: Sammenlignet med voksne blev der dog set lavere voriconazoleksponering hos nogle unge med lav legemsvægt.
English: Mycophenolic acid Cmax ↔ Mycophenolic acid AUCt ↔
Danish: Mycophenolsyre Cmax ↔ Mycophenolsyre AUCτ ↔
English: If patient is unable to tolerate treatment at a higher dose reduce the oral dose by 50 mg steps to the 200 mg twice daily (or 100 mg twice daily for patients less than 40 kg) maintenance dose.
Danish: Hvis patienten ikke kan tåle behandling med den højere dosis, reduceres den orale dosis med 50 mg ad gangen til en vedligeholdelsesdosis på 200 mg 2 gange dagligt (eller 100 mg 2 gange dagligt hos patienter med en legemsvægt under 40 kg).
English: Unless otherwise specified, drug interaction studies have been performed in healthy adult male subjects using multiple dosing to steady state with oral voriconazole at 200 mg twice daily (BID).
Danish: Medmindre andet er angivet, er lægemiddelinteraktionsstudierne udført hos raske voksne mandlige forsøgspersoner ved anvendelse af oral voriconazol på 200 mg 2 gange dagligt indtil steady state.
English: INFORMATION IN BRAILLE Justification for not including Braille accepted
Danish: INFORMATION I BRAILLE-SKRIFT Fritaget fra krav om brailleskrift.