natgillin/translations-raw huggingface dataset:
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 Accord (se pkt.
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 Accord (see sections 4.2 and 5.1).
Der er efter markedsføringen rapporteret om langvarige synsrelaterede bivirkninger (se pkt.
There have been post-marketing reports of prolonged visual adverse events (see section 4.4).
Når Deres læge stopper Voriconazole Accord-behandlingen, bør De ikke kunne mærke det.
When Voriconazole Accord treatment is stopped by your doctor you should not experience any effects.
• Planocellulært karcinom i huden (SCC)
• Squamous cell carcinoma of the skin (SCC)
Afhængigt af hvordan behandlingen virker, vil lægen måske øge dosis.
Depending on your response to treatment, your doctor may increase or decrease the daily dose.
Sulfonylurinstof (f.eks. tolbutamid, glipizid, glyburid)
Sulfonylureas (e.g., tolbutamide, glipizide, glyburide)
Meget almindelige: Kan forekomme hos flere end 1 ud af 10 patienter
Very common: may affect more than 1 in 10 people
Dosisreduktion af sulfonylurinstof bør overvejes.
Dose reduction of sulfonylureas should be considered
2 filmovertrukne tabletter 10 filmovertrukne tabletter 14 filmovertrukne tabletter 20 filmovertrukne tabletter 28 filmovertrukne tabletter 30 filmovertrukne tabletter 50 filmovertrukne tabletter 56 filmovertrukne tabletter 100 filmovertrukne tabletter 10 x 1 filmovertrukne tabletter 14 x 1 filmovertrukne tabletter 28 x 1 filmovertrukne tabletter 30 x 1 filmovertrukne tabletter 56 x 1 filmovertrukne tabletter 100 x 1 filmovertrukne tabletter
2 film-coated tablets 10 film-coated tablets 14 film-coated tablets 20 film-coated tablets 28 film-coated tablets 30 film-coated tablets 50 film-coated tablets 56 film-coated tablets 100 film-coated tablets 10x1 film-coated tablets 14x1 film-coated tablets 28x1 film-coated tablets 30x1 film-coated tablets 56x1 film-coated tablets 100x1 film-coated tablets
In vitro aktivitet over for kliniske isolater er set over for Acremonium spp., Alternaria spp., Bipolaris spp., Cladophialophora spp.
In vitro activity against clinical isolates has been observed for Acremonium spp., Alternaria spp.,
Når voriconazol-behandling startes hos patienter, der allerede får ciclosporin anbefales det, at ciclosporin-dosis halveres og ciclosporin-koncentrationerne monitoreres nøje.
When initiating voriconazole in patients already on ciclosporin it is recommended that the ciclosporin dose be halved and ciclosporin level carefully monitored.
Interaktion Geometrisk gennemsnitlig ændring (%)
Interaction Geometric mean changes
[CYP450 induktor; P-gp induktor]
[CYP450 inducer; P-gp inducer]
PVC/aluminiumblister i kartoner med 2, 10, 14, 20, 28, 30, 50, 56 eller 100 filmovertrukne tabletter eller enhedsdosis-PVC/aluminiumblister i pakningsstørrelser med 10 x 1, 14 x 1, 28 x 1, 30 x 1, 56 x 1 eller 100 x 1 filmovertrukne tabletter.
PVC / Aluminium blister in cartons of 2, 10, 14, 20, 28, 30, 50, 56 or 100 film-coated tablets or unit dose PVC / Aluminium blister in pack sizes of 10x1, 14x1, 28x1, 30x1, 56x1 or 100x1 film-coated tablets.
Brug af standarddoser af voriconazol med efavirenz-doser på 400 mg QD eller derover er kontraindiceret (se pkt.
Use of standard doses of voriconazole with efavirenz doses of 400 mg QD or higher is contraindicated (see section 4.3).
Oxycodon Cmax ↑ 1,7 gange Oxycodon AUC0-∞ ↑ 3,6 gange
Oxycodone Cmax  1.7-fold Oxycodone AUC0-∞  3.6-fold
Planocellulært karcinom i huden (SCC) er blevet rapporeret i forbindelse med langtidbehandling med Voriconazole Accord.
Squamous cell carcinoma of the skin (SCC) has been reported in relation with long-term Voriconazole Accord treatment.
Hvis leverfunktionsværdierne forhøjes mærkbart, bør voriconazol seponeres, medmindre fortsat anvendelse kan forsvares på grundlag af en medicinsk vurdering af risk-benefit-forholdet for patienten.
If the liver function tests become markedly elevated, Voriconazole Accord should be discontinued, unless the medical judgment of the risk-benefit of the treatment for the patient justifies continued use.
Voriconazol er et antimykotika af triazolgruppen.
Voriconazole is a triazole antifungal agent.
Statiner (f.eks. lovastatin)
Statins (e.g., lovastatin)
EU/1/13/835/010 2 filmovertrukne tabletter EU/1/13/835/011 10 filmovertrukne tabletter EU/1/13/835/012 14 filmovertrukne tabletter EU/1/13/835/013 20 filmovertrukne tabletter EU/1/13/835/014 28 filmovertrukne tabletter EU/1/13/835/015 30 filmovertrukne tabletter EU/1/13/835/016 50 filmovertrukne tabletter EU/1/13/835/017 56 filmovertrukne tabletter EU/1/13/835/018 100 filmovertrukne tabletter EU/1/13/835/025 10 x 1 filmovertrukne tabletter EU/1/13/835/026 14 x 1 filmovertrukne tabletter EU/1/13/835/027 28 x 1 filmovertrukne tabletter EU/1/13/835/028 30 x 1 filmovertrukne tabletter EU/1/13/835/029 56 x 1 filmovertrukne tabletter EU/1/13/835/030 100 x 1 filmovertrukne tabletter
EU/1/13/835/010 2 film-coated tablets EU/1/13/835/011 10 film-coated tablets EU/1/13/835/012 14 film-coated tablets EU/1/13/835/013 20 film-coated tablets EU/1/13/835/014 28 film-coated tablets EU/1/13/835/015 30 film-coated tablets EU/1/13/835/016 50 film-coated tablets EU/1/13/835/017 56 film-coated tablets EU/1/13/835/018 100 film-coated tablets EU/1/13/835/025 10x1 film-coated tablets EU/1/13/835/026 14x1 film-coated tablets EU/1/13/835/027 28x1 film-coated tablets EU/1/13/835/028 30x1 film-coated tablets EU/1/13/835/029 56x1 film-coated tablets EU/1/13/835/030 100x1 film-coated tablets
Patienterne har udviklet svære kutane bivirkninger (SCAR), herunder Stevens-Johnsons syndrom (SJS) (ikke almindelig), toksisk epidermal nekrolyse (TEN) (sjælden) og erythema multiforme (sjælden) under behandling med voriconazol (se pkt.
Patients have developed severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS) (uncommon), toxic epidermal necrolysis (TEN) (rare), drug reaction with eosinophilia and systemic symptoms (DRESS) (rare) and erythema multiforme (rare) during treatment with voriconazole (see section 4.4).
Prednisolon (60 mg enkeltdosis)
Prednisolone (60 mg single dose)
3 I kliniske forsøg svarede responset på voriconazol hos patienter med infektion med C. krusei til responset ved C. albicans, C. parapsilosis og C. tropicalis.
3 In clinical studies, response to voriconazole in C. krusei infections was similar to C. albicans, C. parapsilosis and C. tropicalis.
justeres.
includingT.
Hvis De er overfølsom (allergisk) over for voriconazol eller et af de øvrige indholdsstoffer (angivet i punkt 6).
Do not take Voriconazole Accord If you are allergic to voriconazole or any of the other ingredients of this medicine (listed in section 6).
Forsigtighed tilrådes, når Voriconazole Accord gives til patienter, der er overfølsomme over for andre azoler (se også pkt.
Caution should be used in prescribing Voriconazole Accord to patients with hypersensitivity to other azoles (see also section 4.8).
Andre non-nucleosid reverse transcriptase-hæmmer (NNRTI) (f.eks. delavirdin, nevirapin)*
Transcriptase Inhibitors (NNRTIs) (e.g., delavirdine, nevirapine)*
Ved utilstrækkeligt behandlingsrespons kan dosis øges i trin på 1 mg/kg (eller 50 mg/trin, hvis den maksimale orale dosis på 350 mg blev anvendt initialt).
If patient response to treatment is inadequate, the dose may be increased by 1 mg/kg steps (or by 50 mg steps if the maximum oral dose of 350 mg was used initially).
Tabletkerne Lactosemonohydrat Pregelatineret stivelse Croscarmellosenatrium Povidon
Lactose monohydrate Pregelatinized starch Croscarmellose sodium Povidone
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.
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.
Rifabutin (CYP450-induktor)
Rifabutin (Potent CYP450 inducer)
Voriconazol Cmax ↑ 57% Voriconazol AUCτ ↑ 79% Fluconazol Cmax ND Fluconazol AUCτ ND
Voriconazole Cmax  57% Voriconazole AUCτ  79% Fluconazole Cmax ND Fluconazole AUCτ ND
Succes efter 180 dage* Succes efter 100 dage Afsluttet mindst 100 dage profylakse med studielægemiddel Overlevet til dag 180
Completed at least 100 days of study drug prophylaxis Survived to day 180
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
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
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).
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.
Antikoagulantia Warfarin (30 mg enkelt-dosis, administeret sammen med 300 mg BID voriconazol)
Anticoagulants Warfarin (30 mg single dose, co- administered with 300 mg BID voriconazole)
Sekalealkaloider (f.eks. ergotamin og dihydroergotamin)
Ergot alkaloids (e.g., ergotamine and dihydroergotamine)
In vitro forsøg har vist, at voriconazol metaboliseres via leverens cytokrom P450-isoenzymer CYP2C19, CYP2C9 og CYP3A4.
In vitro studies showed that voriconazole is metabolised by, the hepatic cytochrome P450 isoenzymes CYP2C19, CYP2C9 and CYP3A4.
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.
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.
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.
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.
Almene symptomer og reaktioner på administrationsstedet pyreksi brystsmerter, ansigtsødem11, asteni, kulderystelser reaktioner på infusionsstedet, influenzalignende sygdom
General disorders and administratio n site conditions pyrexia chest pain, face oedema11, asthenia, chills infusion site reaction, influenza like illness
Hjælpestof, som behandleren skal være opmærksom på Hver tablet indeholder 251 mg lactose (som monohydrat).
Each tablet contains 251 mg lactose (as monohydrate).
Cmax ↑ 6,6 gange Sirolimus AUC0-∞ ↑ 11 gange
Sirolimus Cmax  6.6-fold Sirolimus AUC0-∞ 11-fold
• Ritonavir (medicin mod hiv) i doser på 100 mg 2 gange dagligt
• Ritonavir (used for treating HIV) in doses of 100 mg twice daily
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.
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).
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,
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.
Hvis De har glemt at tage Voriconazole Accord
If you forget to take Voriconazole Accord
Sjældne: Kan forekomme hos op til 1 ud af 1.000 patienter
Rare: may affect up to 1 in 1000 people
og Histoplasma capsulatum, hvor de fleste stammer bliver hæmmet af voriconazolkoncentrationer i området fra 0,05 til 2 g/ml.
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.
Voriconazol (n=125)
Voriconazo le (N=125)
• 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.
• 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.
Alvorlige dermatologiske bivirkninger (herunder CSS) Hyppigheden af fototoksiske reaktioner er højere hos den pædiatriske population.
The frequency of phototoxicity reactions is higher in the paediatric population.
[CYP3A4 substrater, hæmmere eller CYP450 induktorer]
[CYP3A4 substrates, inhibitors or CYP450 inducers]
Nervesystemet hovedpine kramper, synkope, tremor, hypertoni3, paræstesi, søvnighed, svimmelhed hjerneødem, encefalopati4, ekstrapyramidal lidelse5, perifer neuropati, ataksi, hypæstesi, dysgeusi hepatisk encefalopati, Guillain-Barrés syndrom, nystagmus
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
Dosisjustering (børn (2- <12 år) og unge med lav legemsvægt (12-14 år og <50 kg))
Dosage adjustment (Children [2 to <12 years] and young adolescents with low body weight [12 to 14 years and <50 kg])
Hvis der opstår fototoksiske reaktioner, bør der søges multidisciplinær rådgivning, og patienten bør henvises til dermatolog.
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.
Hjælpestof, som behandleren skal være opmærksom på Hver tablet indeholder 63 mg lactose (som monohydrat).
Each tablet contains 63 mg lactose (as monohydrate).
Klinisk virkning (defineret som delvist eller fuldstændigt respons, se neden for under Klinisk erfaring)
Clinical efficacy defined as partial or complete response, has been demonstrated for Aspergillus spp.
Monitorering for voriconazol-relaterede bivirkninger anbefales, hvis voriconazol anvendes sekventielt efter fluconazol (se pkt.
Monitoring for voriconazole-associated adverse reactions is recommended if voriconazole is used sequentially after fluconazole (see section 4.5).
Voriconazole Accord indeholder: - Aktivt stof: voriconazol.
Voriconazole Accord contains the active substance voriconazole.
Børn (2 til <12 år) og unge med lav legemsvægt (12-14 år <50 kg)
Children (2 to <12 years) and young adolescents with low body weight (12 to 14 years and <50 kg)
KVALITATIV OG KVANTITATIV SAMMENSÆTNING Voriconazole Accord 50 mg filmovertrukne tabletter Hver tablet indeholder 50 mg voriconazol.
QUALITATIVE AND QUANTITATIVE COMPOSITION Voriconazole Accord 50 mg film-coated tablets Each tablet contains 50 mg voriconazole.
Hver tablet indeholder enten 50 mg voriconazol (Voriconazole Accord 50 mg filmovertrukne tabletter) eller 200 mg voriconazol (Voriconazole Accord 200 mg filmovertrukne tabletter).
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).
• Ciclosporin (anvendes hos transplanterede patienter)
• Ciclosporin (used in transplant patients)
Voriconazole Accord indeholder lactose
Voriconazole Accord contains lactose
Itraconazol (n=109)
Itraconazo le (N=109)
Der er set tilfælde af hudkræft hos patienter, der blev behandlet med Voriconazole Accord i gennem længere tid.
There have been reports of skin cancer in patients treated with Voriconazole Accord for long periods of time.
Fertilitet Dyrestudier viste ikke nedsat fertilitet hos han- og hunrotter (se pkt.
In an animal study, no impairment of fertility was demonstrated in male and female rats (see section 5.3).
[potente CYP450 induktorer]
[potent CYP450 inducers]
200 mg hver 12. time i de første 24 timer
200 mg every 12 hours for the first 24 hours
Det skal De vide, før De begynder at tage Voriconazole Accord
What you need to know before you take Voriconazole Accord
Ritonavir Cmax og AUCτ ↔ Voriconazol Cmax ↓ 66% Voriconazol AUCτ ↓ 82%
Ritonavir Cmax and AUCτ ↔ Voriconazole Cmax  66% Voriconazole AUCτ  82%
Efavirenz Cmax ↑ 38% Efavirenz AUCτ ↑ 44% Voriconazol Cmax ↓ 61% Voriconazol AUCτ ↓ 77%
Efavirenz Cmax  38% Efavirenz AUCτ  44% Voriconazole Cmax  61% Voriconazole AUCτ  77%
Ethinylestradiol Cmax ↑ 36% Ethinylestradiol AUCτ ↑ 61% Norethisteron Cmax ↑ 15% Norethisteron AUCτ ↑ 53% Voriconazol Cmax ↑ 14% Voriconazol AUCτ ↑ 46%
Ethinylestradiol Cmax  36% Ethinylestradiol AUCτ  61% Norethisterone Cmax  15% Norethisterone AUCτ  53% Voriconazole Cmax  14%
Fluconazol (200 mg QD)
Fluconazole (200 mg QD)
Dosisreduktion af oxycodon og andre langtidsvirkende opioider, der metaboliseres af CYP3A4 (f.eks. hydrocodon) bør overvejes.
Dose reduction in oxycodone and other long-acting opiates metabolized by CYP3A4 (e.g., hydrocodone) should be considered.
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.
(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.
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.
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.
En oral vedligeholdelsesdosis på 300 mg (eller 150 mg for patienter <40 kg) resulterer i eksponering svarende til 4 mg/kg i.v.
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.
• Nedsat syn (ændring i synet såsom sløret syn, ændringer i farvesyn, unormal manglende tolerance ved synsopfattelse af lys, farveblindhed, øjensygdom, lyscirkler, natteblindhed,
- 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,
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).
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.
Itraconazol (n=143)
Itraconazo le (N=143)
KARTON (blisterpakning for 50 mg filmovertrukne tabletter - pakning med 2, 10, 14, 20, 28, 30, 50, 56,100 stk.)
CARTON (Blister pack for 50 mg film-coated tablets - Pack of 2, 10, 14, 20, 28, 30, 50, 56, 100)
Det anbefales, at alle patienter, herunder også børn, undgår udsættelse for sollys under Voriconazole Accord -behandling.
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).
KARTON (blisterpakning for 200 mg filmovertrukne tabletter - pakning med 2, 10, 14, 20, 28, 30, 50, 56,100 stk.)
CARTON (Blister pack for 200 mg film-coated tablets - Pack of 2, 10, 14, 20, 28, 30, 50, 56, 100)
Hvis en patient oplever knoglesmerter, og radiologiske undersøgelser peger på periostitis, bør der søges multidisciplinær rådgivning og seponering af Voriconazole Accord bør overvejes.
If a patient develops skeletal pain and radiologic findings compatible with periostitis Voriconazole Accord discontinuation should be considered after multidisciplinary advice.
Omeprazol Cmax ↑ 116% Omeprazol AUCτ ↑ 280% Voriconazol Cmax ↑ 15% Voriconazol AUCτ ↑ 41%
Omeprazole Cmax 116% Omeprazole AUCτ  280% Voriconazole Cmax 15% Voriconazole AUCτ  41%
efelider*, lentigo*
cutaneous lupus erythemato sus*, ephelides*, lentigo*
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.
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.
Candida albicans1 Candida tropicalis1
Candida albicans1
Der er ingen tilgængelige farmakokinetiske data på patienter med alvorlig levercirrose (Child-Pugh klasse C).
No pharmacokinetic data are available for patients with severe hepatic cirrhosis (Child-Pugh C) (see sections 4.2 and 4.4).
akut respiratory distress-syndrom, lungeødem mave-tarmkanalen diarré, opkastning, abdominalsmerter, kvalme keilit, dyspepsi, obstipation, gingivitis peritonitis, pankreatitis, hævet tunge, duodenitis, gastroenteritis, glossitis
Gastrointestin al disorders diarrhoea, vomiting, abdominal pain, nausea cheilitis, dyspepsia, constipation, gingivitis peritonitis, pancreatitis, swollen tongue, duodenitis, gastroenteritis, glossitis
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).
In an oral multiple dose study, Cmax and AUCτ for healthy young females were 83% and 113% higher,
Ritonavir (potent CYP450-induktor; CYP3A4-hæmmer og -substrat)
Ritonavir (potent CYP450 inducer; CYP3A4 inhibitor and substrate)