FrancophonIA/ELRC3.0 huggingface dataset:
English: In the 22 patients less than 2 years old who received voriconazole in a compassionate use programme, the following adverse reactions (for which a relationship to voriconazole could not be excluded) were reported: photosensitivity reaction (1), arrhythmia (1), pancreatitis (1), blood bilirubin increased (1), hepatic enzymes increased (1), rash (1) and papilloedema (1).
Danish: Hos de 22 patienter under 2 år, som blev behandlet med voriconazol i et compassionate use-program, er følgende bivirkninger (for hvilke en sammenhæng med voriconazol ikke kan udelukkes) rapporteret: Lysoverfølsomhedsreaktioner (1), arytmi (1), pancreatitis (1), forhøjet serum-bilirubin (1), forhøjet antal leverenzymer (1), udslæt (1) og papilødem (1).
English: VFEND oral suspension contains sucrose and should not be given to patients with rare hereditary problems of fructose intolerance, sucrase-isomaltase deficiency or glucose-galactose malabsorption.
Danish: VFEND oral suspension indeholder saccharose og bør ikke gives til patienter med sjældne arvelige problemer med fructoseintolerans, sucrase-isomaltasemangel eller glucose-galactosemalabsorption.
English: Red, scaly patches or ring-shaped skin lesions that may be a symptom of an autoimmune disease called cutaneous lupus erythematosus
Danish: • Røde, skællede pletter eller ringformede hudlæsioner, der kan være symptomer på den autoimmune sygdom som kaldes kutan lupus erythematosus.
English: Your pharmacist should advise you how to measure the medicine using the multi-dosing oral syringe provided in the pack.
Danish: Apoteket kan vise Dem, hvordan De afmåler medicinen ved at bruge doseringssprøjten til flere doser, som findes i pakningen.
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: 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: Therefore, from a microbiological point of view, the reconstituted solution must be used immediately.
Danish: Ud fra et mikrobiologisk synspunkt skal præparatet derfor bruges med det samme efter rekonstituering.
English: Frequent monitoring for adverse reactions and toxicity related to methadone, including QTc prolongation, is recommended when coadministered 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 methadonniveauer stiger efter samtidig administration af voriconazol.
English: Do not take VFEND: If you are allergic to voriconazole or any of the other ingredients of this medicine (listed in section 6).
Danish: Hvis De er allergisk over for voriconazol eller et af de øvrige indholdsstoffer (angivet i punkt 6).
English: Marketing Authorisation Holder Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium.
Danish: Indehaver af markedsføringstilladelsen Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgien.
English: Each tablet contains either 50 mg voriconazole (for VFEND 50 mg film-coated tablets) or 200 mg voriconazole (for VFEND 200 mg film-coated tablets).
Danish: Hver tablet indeholder enten 50 mg voriconazol (VFEND 50 mg filmovertrukne tabletter) eller 200 mg voriconazol (VFEND 200 mg filmovertrukne tabletter).
English: Powder for solution for infusion and powder for oral suspension: Fareva Amboise
Danish: Pulver til infusionsvæske, opløsning og pulver til oral suspension Fareva Amboise
English: Point the tip of the oral syringe towards the inside of the cheek.
Danish: Før spidsen af doseringssprøjten mod indersiden af kinden.
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 tacrolimuskoncentrationerne monitoreres nøje.
English: Dose reduction of NSAIDs may be needed.
Danish: Dosis-reduktion af NSAID kan blive nødvendig.
English: Frequent monitoring for opiateassociated adverse reactions may be necessary (see section 4.5).
Danish: Hyppig monitorering for opiatrelaterede bivirkninger kan være nødvendig (se pkt.
English: Mycophenolic acid Cmax ↔ Mycophenolic acid AUCt ↔
Danish: Mycophenolsyre Cmax ↔ Mycophenolsyre AUCt ↔
English: Allergic reaction or exaggerated immune response
Danish: • Overfølsomhedsreaktion eller overdreven immunreaktion.
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: 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 blev undersøgt på QTc-intervallet.
English: For administration, the twist-off port at the bottom of the infusion bag should be opened and the infusion line connected and primed.
Danish: Ved indgivelse vrides forseglingen af porten i bunden af infusionsposen, og infusionsslangen forbindes og klargøres.
English: For patients with IA the overall rates of global response at 6 weeks were 64.3% (9/14), the global response rate was 40% (2/5) for patients 2 to <12 years and 77.8% (7/9) for patients 12 to <18 years of age.
Danish: For patienter med IA var de samlede procentsatser for global respons efter 6 uger 64,3 % (9/14), procentsatsen for det globale respons var 40 % (2/5) for patienter på 2 til <12 år og 77,8 % (7/9) for patienter på 12 til <18 år.
English: 2b Push the syringe plunger down fully.
Danish: 2b Tryk stemplet på sprøjten helt i bund.
English: VFEND tablets contain lactose and should not be given to patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
Danish: VFEND tabletter indeholder lactose, og bør ikke gives til patienter med sjældne arvelige problemer med galactoseintolerans, Lapp lactasemangel eller glucose-galactosemalabsorption.
English: The instructions should be followed for reconstitution, dilution and administration of each kit.
Danish: Vejledningen for rekonstitution, fortynding og administration skal følges for hvert enkelt infusionssæt.
English: Rifabutin Cmax  195% Rifabutin AUC  331% Compared to voriconazole 200 mg BID,
Danish: Rifabutin Cmax  195% Rifabutin AUC  331% Sammenlignet med voriconazol 200 mg BID,
English: Voriconazole Cmax and AUC ↔
Danish: Voriconazol Cmax and AUC ↔
English: Frequent monitoring for adverse reactions and toxicity related to NSAIDs is recommended.
Danish: Hyppig monitorering for NSAID-relaterede bivirkninger og toksicitet anbefales.
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before taking VFEND if:
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før De tager VFEND, hvis
English: If a patient develops a rash they should be monitored closely and VFEND discontinued if lesions progress.
Danish: Hvis en patient udvikler udslæt, bør de monitoreres nøje, og VFEND afbrydes, hvis læsionen progredierer.
English: After an oral single-dose (200 mg), AUC was 233% higher in subjects with mild to moderate hepatic cirrhosis (Child-Pugh A and B) compared with subjects with normal hepatic function.
Danish: Efter en oral enkeltdosis (200 mg) var AUC 233% højere hos personer med mild til moderat levercirrose (Child-Pugh klasse A og B) sammenlignet med personer med normal leverfunktion.
English: Astemizole, cisapride, pimozide, quinidine and terfenadine [CYP3A4 substrates]
Danish: Astemizol, cisaprid, pimozid, quinidin and terfenadin [CYP3A4-substrater]
English: There have been reports of skin cancer in patients treated with VFEND for long periods of time.
Danish: Der er set tilfælde af hudkræft hos patienter, der blev behandlet med VFEND i gennem længere tid.
English: Bioequivalence was established between the 200 mg tablet and the 40 mg/ml oral suspension when administered as a 200 mg dose.
Danish: Der er påvist bioækvivalens mellem 200 mg tabletter og 40 mg/ml oral suspension ved administration af en 200 mg dosis.
English: The safety of voriconazole was also investigated in 158 additional paediatric patients aged 2 to <12 years in compassionate use programs.
Danish: Sikkerheden af voriconazol er undersøgt hos yderligere 158 pædiatriske patienter i alderen 2 til <12 år i compassionate use-programmer.
English: The findings of the effect of efavirenz on voriconazole suggest that the metabolism of voriconazole may be induced by an NNRTI.
Danish: Resultaterne fra efavirenz' virkning på voriconazol tyder på at metaboliseringen af voriconazol kan blive induceret af NNRTI.
English: Ibuprofen (400 mg single dose)
Danish: Ibuprofen (400 mg enkeltdosis)
English: Elderly No dose adjustment is necessary for elderly patients (see section 5.2).
Danish: Ældre Dosisjustering er ikke nødvendig hos ældre patienter (se pkt.
English: For prophylaxis use, dose adjustments are not recommended in the case of lack of efficacy or treatmentrelated adverse events.
Danish: Dosisjustering anbefales ikke ved profylaktisk brug i tilfælde af manglende virkning eller behandlingsrelaterede bivirkninger.
English: Cimetidine (400 mg BID) [non-specific CYP450 inhibitor and increases gastric pH]
Danish: Cimetidin (400 mg BID) [non-specifik CYP-hæmmer og øger gastrisk pH]
English: 2a Snap open Blue port. Bend the outer tube by 90° each way to ensure it is fully broken.
Danish: Bøj den ydre slange rundt 90° hver vej for at sikre, at den kan fjernes.
English: Also contains sucrose.
Danish: Indeholder saccharose.
English: Remove the oral syringe from the bottle.
Danish: Fjern doseringssprøjten fra flasken.
English: In an independent published study, Voriconazole AUC0-  59%
Danish: I et uafhængigt publiceret studie, Voriconazol AUC   59%
English: All other adolescents (12 to 14 years and ≥50 kg; 15 to 17 years regardless of body weight) Voriconazole should be dosed as adults.
Danish: Øvrige unge (12-14 år og ≥ 50 kg; 15-17 år uanset legemsvægt) Voriconazol doseres som til voksne.
English: The intravenous vehicle, SBECD, is haemodialysed with a clearance of 55 ml/min.
Danish: Hjælpestoffet SBECD i intravenøst VFEND hæmodialyseres med en clearance på 55 ml/min.
English: Fentanyl (5 g/kg single dose)
Danish: Fentanyl (5 g/kg enkeltdosis)
English: For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis De ønsker yderligere oplysninger om VFEND, skal De henvende Dem til den lokale repræsentant for indehaveren af markedsføringstilladelsen.
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 VFEND (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 VFEND (se pkt.
English: VFEND 200 mg film-coated tablets Each tablet contains 253.675 mg lactose monohydrate.
Danish: VFEND 200 mg filmovertrukne tabletter Hver tablet indeholder 253,675 mg lactosemonohydrat.
English: MIC breakpoint (mg/L) ≤S (Susceptible) >R (Resistant)
Danish: MIC grænseværdi (mg/l) ≤ S (følsom)
English: Note: Based on a population pharmacokinetic analysis in 112 immunocompromised paediatric patients 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: These oral dose recommendations for children are based on studies in which voriconazole was administered as the powder for oral suspension.
Danish: De anbefalede orale børnedoseringer er baseret på studier, hvor Voriconazol blev givet som pulver til oral suspension.
English: Dose reduction of methadone may be needed (see section
Danish: Dosisreduktion af methadon kan være nødvendig (se pkt.
English: As VFEND has been known to affect the liver and the kidney, your doctor should monitor the function of your liver and kidney by doing blood tests.
Danish: Da VFEND påvirker lever og nyrer, vil Deres læge tage blodprøver for at kontrollere lever- og nyrefunktionen.
English: Set the infusion rate accurately.
Danish: Infusionshastigheden skal indstilles præcist.
English: Take your suspension at least one hour before, or two hours after a meal.
Danish: De skal tage suspensionen mindst én time før eller 2 timer efter et måltid
English: Each vial contains 200 mg voriconazole, equivalent to a 10 mg/ml solution when reconstituted as directed by your hospital pharmacist or nurse (see the information at the end of this leaflet).
Danish: Hvert hætteglas indeholder 200 mg voriconazol svarende til 10 mg/ml opløsning efter rekonstituering, som foreskrevet af sygehusapoteket eller sygeplejersken (se bagest i indlægssedlen for yderligere oplysninger).
English: Oral Suspension Patients 40 kg and above*
Danish: Oral suspension Patienter 40 kg og derover*
English: Powder and solvent for solution for infusion Each pack contains:
Danish: Pulver og solvens til infusionsvæske, opløsning Hver pakning indeholder:
English: If the required volume of VFEND concentrate as described in the table below requires the use of multiple vials in order to provide the appropriate dose for a given body weight, then multiple infusion kits should be used.
Danish: Hvis det er nødvendigt at anvende flere hætteglas for at få det fornødne volumen VFEND koncentrat til den aktuelle legemsvægt ud fra nedenstående skema, skal der anvendes flere infusionssæt.
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: In an independent published study, Oxycodone Cmax  1.7-fold Oxycodone AUC0-  3.6-fold
Danish: I et uafhængigt publiceret studie, Oxycodon Cmax  1,7 gange Oxycodon AUC   3,6 gange
English: The primary mode of action of voriconazole is the inhibition of fungal cytochrome P450-mediated 14 alpha-lanosterol demethylation, an essential step in fungal ergosterol biosynthesis.
Danish: Voriconazols primære virkningsmåde er hæmning af fungal CYP-medieret 14-α-lanosteroldemethylering, der er et vigtigt trin i biosyntesen af fungal ergosterol.
English: • Fluconazole (used for fungal infections)
Danish: • Fluconazol (bruges mod svampeinfektioner)
English: A placebo-controlled, randomized, single-dose, crossover study to evaluate the effect on the QTc interval of healthy volunteers was conducted with three oral doses of voriconazole and ketoconazole.
Danish: Et placebokontrolleret, randomiseret, enkeltdosis, crossover studie, der undersøgte effekten på QTcintervallet hos raske frivillige forsøgspersoner, blev udført med 3 orale doser af voriconazol og ketoconazol.
English: • The active substance is voriconazole.
Danish: • Aktivt stof: voriconazol.
English: In vitro, voriconazole displays broad-spectrum antifungal activity with antifungal potency against Candida species (including fluconazole -resistant C. krusei and resistant strains of C. glabrata and C. albicans) and fungicidal activity against all Aspergillus species tested.
Danish: Voriconazol udviser bredspektret antimykotisk aktivitet in vitro med antimykotisk styrke over for Candida arter (herunder fluconazol resistente C. krusei og resistente stammer af C. glabrata og C. albicans) og fungicid aktivitet over for alle undersøgte Aspergillus arter.
English: However tell your doctor or pharmacist if you think that a dose has been forgotten.
Danish: Spørg lægen, hvis De mener, at en dosis er blevet glemt.
English: Oxycodone (10 mg single dose)
Danish: Oxycodon (10 mg enkeltdosis)
English: • Once the syringe is reconnected to the blue port of the infusion bag, the contents are then emptied into the infusion bag from the syringe to provide a final voriconazole solution containing 0.5-5 mg/ml.
Danish: • Når sprøjten igen er påsat den blå port på infusionsposen, tømmes sprøjtens indhold tilbage i infusionsposen, og den endelige voriconazol-infusionsvæske på 0,5-5 mg/ml fremkommer.
English: Patients 40 kg and above*
Danish: Patienter 40 kg og derover*
English: • For dilution, gently invert the vial, vial adapter and syringe assembly and withdraw the required volume of the reconstituted concentrate into the syringe (see table below).
Danish: • Koncentratet fortyndes ved forsigtigt at vende hætteglasset med adapter og sprøjte, og det fornødne volumen koncentrat udtages i sprøjten (se skema nedenfor).
English: Reconstitution and Dilution information
Danish: Information om rekonstituering og fortynding
English: Carbamazepine and long-acting barbiturates (e.g., phenobarbital, mephobarbital) [potent CYP450 inducers]
Danish: Carbamazepin og langtidsvirkende benzodiazepiner (f.eks. phenobarbital, mephobarbital) [potente CYP-induktorer]
English: • The VFEND solvent for solution for infusion is then added to the vial by unscrewing the syringe from the bag, connecting it to the vial adapter and then emptying the contents from the syringe into the vial.
Danish: • VFEND solvens til infusionsvæske, opløsning, tilføres derefter hætteglasset ved at fjerne engangssprøjten fra posen, forbinde den til hætteglasadapteren og derefter tømme indholdet ned i hætteglasset.
English: It is likely that these subjects may metabolize voriconazole more similarly to children than to adults.
Danish: Det er sandsynligt, at disse patienters metabolisering af voriconazol mere ligner børns end voksnes.
English: Instructions for use: Shake the closed bottle of constituted suspension for approximately 10 seconds before each use.
Danish: Brugsanvisning Omryst den lukkede flaske med færdigblandet suspension i ca. 10 sek. før hver brug.
English: Therefore, no adjustment is necessary for oral dosing for patients with mild to severe renal impairment (see section 5.2).
Danish: Derfor er dosisjustering ikke nødvendig for oral dosering hos patienter med mild til svær nedsat nyrefunktion (se pkt.
English: Treatment of invasive aspergillosis.
Danish: Behandling af invasiv aspergillose.
English: Phenytoin Cmax  67% Phenytoin AUC  81% Compared to voriconazole 200 mg BID,
Danish: Phenytoin Cmax  67% Phenytoin AUC  81% Sammenlignet med voriconazol 200 mg BID,
English: Put the tip of the oral syringe into the mouth.
Danish: Anbring spidsen af doseringssprøjten i munden.
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: Indinavir Cmax ↔ Indinavir AUC ↔ Voriconazole Cmax ↔ Voriconazole AUC ↔
Danish: Indinavir Cmax ↔ Indinavir AUC ↔ Voriconazol Cmax ↔ Voriconazol AUC ↔
English: Kidney failure, blood in the urine, changes in kidney function tests
Danish: • Nyresvigt, blod i urinen, ændringer i prøver for nyrefunktionen.
English: Warfarin (30 mg single dose, co- administered with 300 mg BID voriconazole) [CYP2C9 substrate]
Danish: Warfarin (30 mg enkelt-dosis, administeret sammen med 300 mg BID voriconazol) [CYP2C9-substrat]
English: Method of administration VFEND oral suspension is to be taken at least one hour before, or two hours following, a meal.
Danish: Administration VFEND oral suspension skal tages mindst 1 time før eller 2 timer efter et måltid.
English: Coadministration of standard doses of voriconazole with efavirenz doses of 400 mg once daily or higher is contraindicated, because efavirenz significantly decreases plasma voriconazole concentrations in healthy subjects at these doses.
Danish: Administration af standarddoser af voriconazol sammen med efavirenz-doser på 400 mg 1 gang daglig eller derover er kontraindiceret, da efavirenz ved disse doser reducerer plasmakoncentrationen af voriconazol signifikant hos raske forsøgspersoner.
English: Add 2 measuring cups (measure cup included in the carton) of water (total of 46 ml) to the bottle.
Danish: Tilsæt 2 målebægre vand (i alt 46 ml) til flasken.
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 specificeret, er lægemiddelinteraktionsstudierne udført hos raske voksne mandlige forsøgspersoner ved anvendelse af oral voriconazol på 200 mg 2 gange dagligt indtil steady state.
English: Maintenance dose (after first 24 hours)
Danish: Vedligeholdelsesdosis (efter de første 24 timer)
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: Coadministration of voriconazole and sirolimus is contraindicated (see section
Danish: Samtidig administration af voriconazol og sirolimus er kontraindiceret (se pkt.
English: Coadministration with ergot alkaloids (ergotamine, dihydroergotamine), which are CYP3A4 substrates, since increased plasma concentrations of these medicinal products can lead to ergotism (see section 4.5).
Danish: Samtidig administration af sekalealkaloider (ergotamin, dihydroergotamin), som er CYP3A4substrater, da øgede plasmakoncentrationer af disse lægemidler kan medføre ergotisme (se pkt.
English: Other treated fungal infections (often with either partial or complete response) included isolated cases of Alternaria spp., Blastomyces dermatitidis, Blastoschizomyces capitatus, Cladosporium spp., Coccidioides immitis, Conidiobolus coronatus, Cryptococcus neoformans, Exserohilum rostratum, Exophiala spinifera, Fonsecaea pedrosoi, Madurella mycetomatis, Paecilomyces lilacinus, Penicillium spp.
Danish: Andre behandlede svampeinfektioner (ofte med delvist eller fuldstændigt respons) omfatter isolerede tilfælde af Alternaria spp., Blastomyces dermatitidis, Blastoschizomyces capitatus, Cladosporium spp., Coccidioides immitis, Conidiobolus coronatus, Cryptococcus neoformans, Exserholium rostratum, Exophiala spinifera, Fonsecaea pedrosoi, Madurella mycetomatis, Paecilomyces lilacinus, Penicillium spp.
English: The potential to block the venting action exists if large amounts of air or drug are injected when the vial is inverted.
Danish: Der er risiko for, at sprøjten ikke kan ventilere ordentligt, hvis der tilbageføres store mængder luft eller lægemiddel i hætteglasset.
English: • candidaemia (another type of fungal infection due to Candida sp) in non-neutropenic patients (patients without abnormally low white blood cells count),
Danish: • infektion i blodet af Candida-arter (candidæmi) hos patienter, der ikke har et lavt antal hvide blodlegemer
English: VFEND 50 mg film-coated tablets Each tablet contains 63.42 mg lactose monohydrate.
Danish: VFEND 50 mg filmovertrukne tabletter Hver tablet indeholder 63,42 mg lactosemonohydrat.