FrancophonIA/ELRC3.0 huggingface dataset:
English: Lactose monohydrate Pregelatinized starch Croscarmellose sodium Povidone
Danish: Tabletkerne Lactosemonohydrat Pregelatineret stivelse Croscarmellosenatrium Povidon
English: Coadministration of voriconazole and low dose ritonavir (100 mg BID) should be avoided, unless an assessment of the benefit/risk to the patient justifies the use of voriconazole.
Danish: Samtidig administration af voriconazol og lav-dosis ritonavir (100 mg BID) bør undgås, medmindre en evaluering af fordele og ulemper for patienten vil retfærdiggøre anvendelse af voriconazol.
English: Rifabutin (Potent CYP450 inducer)
Danish: Rifabutin (CYP450-induktor)
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: Completed at least 100 days of study drug prophylaxis Survived to day 180
Danish: Succes efter 180 dage* Succes efter 100 dage Afsluttet mindst 100 dage profylakse med studielægemiddel Overlevet til dag 180
English: EU/1/13/835/001 2 film-coated tablets EU/1/13/835/002 10 film-coated tablets EU/1/13/835/003 14 film-coated tablets EU/1/13/835/004 20 film-coated tablets EU/1/13/835/005 28 film-coated tablets EU/1/13/835/006 30 film-coated tablets EU/1/13/835/007 50 film-coated tablets EU/1/13/835/008 56 film-coated tablets EU/1/13/835/009 100 film-coated tablets EU/1/13/835/019 10x1 film-coated tablets EU/1/13/835/020 14x1 film-coated tablets EU/1/13/835/021 28x1 film-coated tablets EU/1/13/835/022 30x1 film-coated tablets EU/1/13/835/023 56x1 film-coated tablets EU/1/13/835/024 100x1 film-coated tablets
Danish: EU/1/13/835/001 2 filmovertrukne tabletter EU/1/13/835/002 10 filmovertrukne tabletter EU/1/13/835/003 14 filmovertrukne tabletter EU/1/13/835/004 20 filmovertrukne tabletter EU/1/13/835/005 28 filmovertrukne tabletter EU/1/13/835/006 30 filmovertrukne tabletter EU/1/13/835/007 50 filmovertrukne tabletter EU/1/13/835/008 56 filmovertrukne tabletter EU/1/13/835/009 100 filmovertrukne tabletter EU/1/13/835/019 10 x 1 filmovertrukne tabletter EU/1/13/835/020 14 x 1 filmovertrukne tabletter EU/1/13/835/021 28 x 1 filmovertrukne tabletter EU/1/13/835/022 30 x 1 filmovertrukne tabletter EU/1/13/835/023 56 x 1 filmovertrukne tabletter EU/1/13/835/024 100 x 1 filmovertrukne tabletter
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 patienterne ikke kan tåle behandling med disse højere doser, 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: Anticoagulants Warfarin (30 mg single dose, co- administered with 300 mg BID voriconazole)
Danish: Antikoagulantia Warfarin (30 mg enkelt-dosis, administeret sammen med 300 mg BID voriconazol)
English: Ergot alkaloids (e.g., ergotamine and dihydroergotamine)
Danish: Sekalealkaloider (f.eks. ergotamin og dihydroergotamin)
English: In vitro studies showed that voriconazole is metabolised by, the hepatic cytochrome P450 isoenzymes CYP2C19, CYP2C9 and CYP3A4.
Danish: In vitro forsøg har vist, at voriconazol metaboliseres via leverens cytokrom P450-isoenzymer CYP2C19, CYP2C9 og CYP3A4.
English: Voriconazole Accord 50 mg film-coated tablets and 200mg film-coated tablets are available as packs of 2, 10, 14, 20, 28, 30, 50, 56 and 100 or unit dose blister packs (PVC / Aluminium) containing 10x1, 14x1, 28x1, 30x1, 56x1 or 100x1 film-coated tablets.
Danish: Voriconazole Accord 50 mg filmovertrukne tabletter og Voriconazole Accord 200 mg filmovertrukne tabletter fås i pakninger med 2, 10, 14, 20, 28, 30, 50, 56 og 100 stk. eller i enhedsdosisblisterpakninger (PVC/aluminium) indeholdende 10 x 1, 14 x 1, 28 x 1, 30 x 1, 56 x 1 eller 100 x 1 filmovertrukne tabletter.
English: In clinical trials, visual impairments (including blurred vision, photophobia, chloropsia, chromatopsia, colour blindness, cyanopsia, eye disorder, halo vision, night blindness, oscillopsia, photopsia, scintillating scotoma, visual acuity reduced, visual brightness, visual field defect, vitreous floaters, and xanthopsia) with voriconazole were very common.
Danish: I kliniske forsøg med voriconazol er nedsat syn (herunder sløret syn, fotofobi, kloropsi, kromatopsi, farveblindhed, cyanopsi, øjensygdom, aura, natteblindhed, oscillopsi, fotopsi, scintillerende scotom, nedsat synsskarphed, synsklarhed, synsfeltdefekt, øjenflydere og xanthopsi) meget almindeligt.
English: General disorders and administratio n site conditions pyrexia chest pain, face oedema11, asthenia, chills infusion site reaction, influenza like illness
Danish: Almene symptomer og reaktioner på administrationsstedet pyreksi brystsmerter, ansigtsødem11, asteni, kulderystelser reaktioner på infusionsstedet, influenzalignende sygdom
English: Each tablet contains 251 mg lactose (as monohydrate).
Danish: Hjælpestof, som behandleren skal være opmærksom på Hver tablet indeholder 251 mg lactose (som monohydrat).
English: Sirolimus Cmax  6.6-fold Sirolimus AUC0-∞ 11-fold
Danish: Cmax ↑ 6,6 gange Sirolimus AUC0-∞ ↑ 11 gange
English: • Ritonavir (used for treating HIV) in doses of 100 mg twice daily
Danish: • Ritonavir (medicin mod hiv) i doser på 100 mg 2 gange dagligt
English: Coadministration of voriconazole and low dose ritonavir (100 mg twice daily) should be avoided unless an assessment of the benefit/risk to the patient justifies the use of voriconazole (see sections 4.3 and 4.5).
Danish: Samtidig administration af voriconazol og lavdosis ritonavir (100 mg 2 gange dagligt) bør undgås, medmindre en vurdering af benefit/risk forholdet for patienten retfærdiggør brugen af voriconazol (se pkt.
English: In an oral multiple-dose study, AUCτ was similar in subjects with moderate hepatic cirrhosis (ChildPugh B) given a maintenance dose of 100 mg twice daily and subjects with normal hepatic function given 200 mg twice daily.
Danish: I et oralt flerdosisstudie var AUCτ ens for personer med moderat levercirrose (Child-Pugh klasse B), der fik en vedligeholdelsesdosis på 100 mg 2 gange dagligt, og personer med normal leverfunktion,
English: If you forget to take Voriconazole Accord
Danish: Hvis De har glemt at tage Voriconazole Accord
English: Rare: may affect up to 1 in 1000 people
Danish: Sjældne: Kan forekomme hos op til 1 ud af 1.000 patienter
English: 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: og Histoplasma capsulatum, hvor de fleste stammer bliver hæmmet af voriconazolkoncentrationer i området fra 0,05 til 2 g/ml.
English: Voriconazo le (N=125)
Danish: Voriconazol (n=125)
English: • Health Care Professional (HCP) Checklist for Phototoxicity, SCC and Hepatic toxicity: Reminds HCPs of the risks of phototoxicity, skin SCC and hepatotoxicity reported with voriconazole use.
Danish: • Tjekliste til læger og sundhedspersonale om fototoksicitet, planocellulært karcinom og hepatisk toksicitet: - Påminde læger og sundhedspersonale om de risici for fototoksicitet, planocellulært hudkarcinom og levertoksicitet, der rapporteres i forbindelse med anvendelse af voriconazol.
English: The frequency of phototoxicity reactions is higher in the paediatric population.
Danish: Alvorlige dermatologiske bivirkninger (herunder CSS) Hyppigheden af fototoksiske reaktioner er højere hos den pædiatriske population.
English: [CYP3A4 substrates, inhibitors or CYP450 inducers]
Danish: [CYP3A4 substrater, hæmmere eller CYP450 induktorer]
English: Nervous system disorders headache convulsion, syncope, tremor, hypertonia3, paraesthesia, somnolence, dizziness brain oedema, encephalopathy4, extrapyramidal disorder5, neuropathy peripheral, ataxia, hypoaesthesia, dysgeusia hepatic encephalopathy , Guillain-Barre syndrome, nystagmus
Danish: Nervesystemet hovedpine kramper, synkope, tremor, hypertoni3, paræstesi, søvnighed, svimmelhed hjerneødem, encefalopati4, ekstrapyramidal lidelse5, perifer neuropati, ataksi, hypæstesi, dysgeusi hepatisk encefalopati, Guillain-Barrés syndrom, nystagmus
English: Dosage adjustment (Children [2 to <12 years] and young adolescents with low body weight [12 to 14 years and <50 kg])
Danish: Dosisjustering (børn (2- <12 år) og unge med lav legemsvægt (12-14 år og <50 kg))
English: If phototoxic reactions occur multidisciplinary advice should be sought, Voriconazole Accord 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: Each tablet contains 63 mg lactose (as monohydrate).
Danish: Hjælpestof, som behandleren skal være opmærksom på Hver tablet indeholder 63 mg lactose (som monohydrat).
English: Clinical efficacy defined as partial or complete response, has been demonstrated for Aspergillus spp.
Danish: Klinisk virkning (defineret som delvist eller fuldstændigt respons, se neden for under Klinisk erfaring)
English: Monitoring for voriconazole-associated adverse reactions is recommended if voriconazole is used sequentially after fluconazole (see section 4.5).
Danish: Monitorering for voriconazol-relaterede bivirkninger anbefales, hvis voriconazol anvendes sekventielt efter fluconazol (se pkt.
English: Voriconazole Accord contains the active substance voriconazole.
Danish: Voriconazole Accord indeholder: - Aktivt stof: voriconazol.
English: Children (2 to <12 years) and young adolescents with low body weight (12 to 14 years and <50 kg)
Danish: Børn (2 til <12 år) og unge med lav legemsvægt (12-14 år <50 kg)
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Voriconazole Accord 50 mg film-coated tablets Each tablet contains 50 mg voriconazole.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Voriconazole Accord 50 mg filmovertrukne tabletter Hver tablet indeholder 50 mg voriconazol.
English: Each tablet contains either 50 mg voriconazole (for Voriconazole Accord 50 mg film-coated tablets) or 200 mg voriconazole (for VoriconazoleAccord 200 mg film-coated tablets).
Danish: Hver tablet indeholder enten 50 mg voriconazol (Voriconazole Accord 50 mg filmovertrukne tabletter) eller 200 mg voriconazol (Voriconazole Accord 200 mg filmovertrukne tabletter).
English: • Ciclosporin (used in transplant patients)
Danish: • Ciclosporin (anvendes hos transplanterede patienter)
English: Voriconazole Accord contains lactose
Danish: Voriconazole Accord indeholder lactose
English: Itraconazo le (N=109)
Danish: Itraconazol (n=109)
English: There have been reports of skin cancer in patients treated with Voriconazole Accord for long periods of time.
Danish: Der er set tilfælde af hudkræft hos patienter, der blev behandlet med Voriconazole Accord i gennem længere tid.
English: In an animal study, no impairment of fertility was demonstrated in male and female rats (see section 5.3).
Danish: Fertilitet Dyrestudier viste ikke nedsat fertilitet hos han- og hunrotter (se pkt.
English: [potent CYP450 inducers]
Danish: [potente CYP450 induktorer]
English: 200 mg every 12 hours for the first 24 hours
Danish: 200 mg hver 12. time i de første 24 timer
English: What you need to know before you take Voriconazole Accord
Danish: Det skal De vide, før De begynder at tage Voriconazole Accord
English: Ritonavir Cmax and AUCτ ↔ Voriconazole Cmax  66% Voriconazole AUCτ  82%
Danish: Ritonavir Cmax og AUCτ ↔ Voriconazol Cmax ↓ 66% Voriconazol AUCτ ↓ 82%
English: Efavirenz Cmax  38% Efavirenz AUCτ  44% Voriconazole Cmax  61% Voriconazole AUCτ  77%
Danish: Efavirenz Cmax ↑ 38% Efavirenz AUCτ ↑ 44% Voriconazol Cmax ↓ 61% Voriconazol AUCτ ↓ 77%
English: Ethinylestradiol Cmax  36% Ethinylestradiol AUCτ  61% Norethisterone Cmax  15% Norethisterone AUCτ  53% Voriconazole Cmax  14%
Danish: Ethinylestradiol Cmax ↑ 36% Ethinylestradiol AUCτ ↑ 61% Norethisteron Cmax ↑ 15% Norethisteron AUCτ ↑ 53% Voriconazol Cmax ↑ 14% Voriconazol AUCτ ↑ 46%
English: Fluconazole (200 mg QD)
Danish: Fluconazol (200 mg QD)
English: Dose reduction in oxycodone and other long-acting opiates metabolized by CYP3A4 (e.g., hydrocodone) should be considered.
Danish: Dosisreduktion af oxycodon og andre langtidsvirkende opioider, der metaboliseres af CYP3A4 (f.eks. hydrocodon) bør overvejes.
English: (a maximum dose of 350 mg twice daily) Note: Based on a population pharmacokinetic analysis in 112 immunocompromised paediatricpatients aged 2 to <12 years and 26 immunocompromised adolescents aged 12 to <17 years.
Danish: NB: Baseret på en farmakokinetisk populationsanalyse hos 112 immunkompromitterede pædiatriske patienter i alderen 2 til <12 år og 26 immunkompromitterede patienter i aldersgruppen 2 til <17 år.
English: The placebo- adjusted mean maximum increases in QTc from baseline after 800, 1200 and 1600 mg of voriconazole were 5.1, 4.8, and 8.2 msec, respectively and 7.0 msec for ketoconazole 800 mg. No subject in any group had an increase in QTc of ≥60 msec from baseline.
Danish: De placebo-justerede gennemsnitlige maksimale stigninger i QTc i forhold til baseline efter 800 mg, 1200 mg og 1600 mg voriconazol var henholdsvis 5,1 msek., 4,8 msek.
English: achieves a voriconazole exposure similar to 3 mg/kg IV. A 300 mg (or 150 mg for patients less than 40 kg) oral maintenance dose achieves an exposure similar to 4 mg/kg IV.
Danish: En oral vedligeholdelsesdosis på 300 mg (eller 150 mg for patienter <40 kg) resulterer i eksponering svarende til 4 mg/kg i.v.
English: - Visual impairment (change in vision including blurred vision, visual color alterations, abnormal intolerance to visual perception of light, colour blindness, eye disorder, halo vision, night blindness, swinging vision, seeing sparks, visual aura, visual acuity reduced, visual brightness,
Danish: • Nedsat syn (ændring i synet såsom sløret syn, ændringer i farvesyn, unormal manglende tolerance ved synsopfattelse af lys, farveblindhed, øjensygdom, lyscirkler, natteblindhed,
English: If you take more Voriconazole Accord than you should If you take more tablets than prescribed (or if someone else takes your tablets) you must seek medical advice or go to the nearest hospital casualty department immediately.
Danish: Hvis De har taget for mange Voriconazole Accord-tabletter Kontakt lægen eller skadestuen, hvis De har taget flere tabletter, end De har fået foreskrevet (eller hvis andre tager Deres tabletter).
English: Itraconazo le (N=143)
Danish: Itraconazol (n=143)
English: CARTON (Blister pack for 50 mg film-coated tablets - Pack of 2, 10, 14, 20, 28, 30, 50, 56, 100)
Danish: KARTON (blisterpakning for 50 mg filmovertrukne tabletter - pakning med 2, 10, 14, 20, 28, 30, 50, 56,100 stk.)
English: It is recommended that all patients, including children, avoid exposure to direct sunlight during Voriconazole Accord treatment and use measures such as protective clothing and sunscreen with high sun protection factor (SPF).
Danish: Det anbefales, at alle patienter, herunder også børn, undgår udsættelse for sollys under Voriconazole Accord -behandling.
English: CARTON (Blister pack for 200 mg film-coated tablets - Pack of 2, 10, 14, 20, 28, 30, 50, 56, 100)
Danish: KARTON (blisterpakning for 200 mg filmovertrukne tabletter - pakning med 2, 10, 14, 20, 28, 30, 50, 56,100 stk.)
English: If a patient develops skeletal pain and radiologic findings compatible with periostitis Voriconazole Accord discontinuation should be considered after multidisciplinary advice.
Danish: Hvis en patient oplever knoglesmerter, og radiologiske undersøgelser peger på periostitis, bør der søges multidisciplinær rådgivning og seponering af Voriconazole Accord bør overvejes.
English: Omeprazole Cmax 116% Omeprazole AUCτ  280% Voriconazole Cmax 15% Voriconazole AUCτ  41%
Danish: Omeprazol Cmax ↑ 116% Omeprazol AUCτ ↑ 280% Voriconazol Cmax ↑ 15% Voriconazol AUCτ ↑ 41%
English: cutaneous lupus erythemato sus*, ephelides*, lentigo*
Danish: efelider*, lentigo*
English: Some medicines, when taken at the same time as Voriconazole Accord, may affect the way Voriconazole Accord works or Voriconazole Accord may affect the way they work.
Danish: Visse typer medicin kan påvirke virkningen af Voriconazole Accord, eller Voriconazole Accord kan påvirke virkningen af anden medicin, når den tages samtidig med Voriconazole Accord.
English: Candida albicans1
Danish: Candida albicans1 Candida tropicalis1
English: No pharmacokinetic data are available for patients with severe hepatic cirrhosis (Child-Pugh C) (see sections 4.2 and 4.4).
Danish: Der er ingen tilgængelige farmakokinetiske data på patienter med alvorlig levercirrose (Child-Pugh klasse C).
English: Gastrointestin al disorders diarrhoea, vomiting, abdominal pain, nausea cheilitis, dyspepsia, constipation, gingivitis peritonitis, pancreatitis, swollen tongue, duodenitis, gastroenteritis, glossitis
Danish: akut respiratory distress-syndrom, lungeødem mave-tarmkanalen diarré, opkastning, abdominalsmerter, kvalme keilit, dyspepsi, obstipation, gingivitis peritonitis, pankreatitis, hævet tunge, duodenitis, gastroenteritis, glossitis
English: In an oral multiple dose study, Cmax and AUCτ for healthy young females were 83% and 113% higher,
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: Ritonavir (potent CYP450 inducer; CYP3A4 inhibitor and substrate)
Danish: Ritonavir (potent CYP450-induktor; CYP3A4-hæmmer og -substrat)
English: Efavirenz may be coadministered with voriconazole if the maintenance dose of voriconazole is increased to 400 mg every 12 hours and the efavirenz dose is reduced by 50 %, i.e. to 300 mg once daily.
Danish: Efavirenz kan gives sammen med voriconazol, hvis vedligeholdelsesdosis for voriconazol øges til 400 mg hver 12. time, og efavirenz-dosis reduceres med 50%, dvs. til 300 mg 1 gang dagligt.
English: When voriconazole is discontinued, ciclosporin levels must be carefully monitored and the dose
Danish: Når voriconazol seponeres skal ciclosporinkoncentrationerne monitoreres nøje og dosis om nødvendigt
English: 4.7 Effects on ability to drive and use machines Voriconazole Accord has moderate influence on the ability to drive and use machines.
Danish: Voriconazole Accord kan påvirke evnen til at føre motorkøretøj eller betjene maskiner i moderat grad.
English: Metabolism and nutrition disorders oedema peripheral hypoglycaemia, hypokalaemia, hyponatraemia
Danish: Metabolisme og ernæring perifert ødem hypoglykæmi, hypokaliæmi,
English: - Allergic skin reactions (sometimes severe), including rapid swelling (oedema) of the dermis, subcutaneous tissue, mucosa and submucosal tissues, itchy or sore patches of thick, red skin with silvery scales of skin, irritation of the skin and mucous membranes, life-threatening skin condition that causes large portions of the epidermis, the skin's outermost layer, to detach from the layers of skin below - Small dry scaly skin patches, sometimes thick with spikes or ‘horns'
Danish: • Allergiske hudreaktioner (sommetider svære), herunder hurtig hævelse (ødem) i huden, underhuden, slimhinder og vævet under slimhinden, kløende eller ømme pletter af tyk, rød hud med sølvfarvede hudskæl, irritation i hud og slimhinder, livstruende hudtilstand, der får store dele af overhuden, det yderste hudlag, til at løsnes fra hudlagene nedenunder.
English: Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those that are obtained without a prescription.
Danish: Fortæl det altid til lægen eller apoteket, hvis De bruger anden medicin eller har brugt det for nylig.
English: When treatment with voriconazole is stopped, the initial dosage of efavirenz should be restored (see sections 4.4 and 4.5)
Danish: Når behandling med voriconazol stoppes, skal den initiale dosis af efavirenz genoptages (se pkt.
English: [CYP2C9 substrates]
Danish: [CYP2C9 substrater]
English: As the half-life of alfentanil is prolonged in a 4-fold manner when alfentanil is coadministered with voriconazole, and in an independent published study concomitant use of voriconazole with fentanyl resulted in an increase in the mean AUC0-∞ of fentanyl, frequent monitoring for opiate-associated adverse reactions (including a longer respiratory monitoring period) may be necessary.
Danish: Når alfentanil administreres samtidig med voriconazol forlænges alfentanils halveringstid 4 gange, og i et uafhængigt, publiceret studie resulterede samtidig behandling med voriconazol og fentanyl i en forhøjelse af gennemsnitligt AUC 0- for fentanyl.
English: Dose reduction of alfentanil, fentanyl and other short-acting opiates similar in structure to alfentanil and metabolised by CYP3A4 (e.g., sufentanil) should be considered.
Danish: Det bør overvejes, at reducere dosis af alfentanil, fentanyl samt andre korttidsvirkende opioider, hvis struktur ligner alfentanil og metabliseres af CYP3A4 (f.eks. sufentanil).
English: The effect of voriconazole on either erythromycin or azithromycin is unknown
Danish: Voriconazol Cmax og AUCτ ↔ Voriconazol Cmax og AUCτ ↔ Voriconazols virkning på både erythromycin og azithromycin er ukendt.
English: Voriconazo le (N=98)
Danish: Voriconazol (n=98)
English: [CYP3A4 substrate, P-gp substrate]
Danish: [CYP3A4 substrat, P-gp substrat]
English: [CYP2C9 and CYP3A4 substrates]
Danish: [CYP2C9 og CYP3A4 substrater]
English: Alfentanil (20 μg/kg single dose, with concomitant naloxone)
Danish: Alfentanil (20 μg/kg enkeltdosis, samtidig med naloxon) Fentanyl (5 g/kg enkeltdosis)
English: Voriconazole Accord 200 mg film-coated tablets Each tablet contains 200 mg voriconazole.
Danish: Voriconazole Accord 200 mg filmovertrukne tabletter Hver tablet indeholder 200 mg voriconazol.
English: [CYP2C9 substrate]
Danish: [CYP2C9 substrat]
English: The absolute bioavailability of voriconazole after oral administration is estimated to be 96%.When multiple doses of voriconazole are administered with high fat meals, Cmax and AUCτ are reduced by 34 % and 24 %, respectively.
Danish: Hvis flere doser voriconazol indtages sammen med meget fede måltider, vil Cmax og AUCτ blive reduceret med henholdsvis 34% og 24%.
English: How to take Voriconazole Accord Always take this medicine exactly as your doctor has told you.
Danish: Tag altid Voriconazole Accord nøjagtigt efter lægens anvisning.
English: The plasma protein binding of voriconazole was similar in subjects with different degrees of renal impairment.
Danish: Voriconazols plasmaproteinbinding var den samme hos patienter med forskellige grader af nedsat nyrefunktion (se pkt.
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).The oral maintenance dose of 200 mg (or 100 mg for patients less than 40 kg)
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: [CYP3A4 substrate; CYP2C19 inhibitor]
Danish: [CYP3A4 substrat; CYP2C19 hæmmer]
English: There is a small chance that skin cancer could develop with long-term use of Voriconazole Accord.
Danish: Der er en lille risiko for, at langvarig brug af Voriconazole Accord kan forårsage hudkræft.
English: [potent CYP450 inducer]
Danish: [potent CYP450 induktor]
English: [CYP2C9 substrate and potentCYP450 inducer]
Danish: [CYP2C9 substrat og potent CYP450 induktor]
English: Success at Day 180* * Primary endpoint of study ** Using a margin of 5%, non inferiority is demonstrated *** Difference in proportions, 95% CI obtained after adjustment for randomization
Danish: * Studiets primære effektmål ** Der påvises non-inferioritet med en margin på 5% *** Forskel i andele, 95% konfidensinterval efter justering for randomisering
English: Voriconazole Cmax  18% Voriconazole AUCτ  23%
Danish: Voriconazol Cmax ↑ 18% Voriconazol AUCτ ↑ 23%
English: Short-acting Opiates
Danish: Korttidsvirkende opioider
English: Medicinal product
Danish: FARMACEUTISKE OPLYSNINGER