FrancophonIA/ELRC3.0 huggingface dataset:
English: In vitro activity against clinical isolates has been observed for Acremonium spp., Alternaria spp., Bipolaris spp., Cladophialophora spp., Histoplasma capsulatum, with most strains being inhibited by concentrations of voriconazole in the range 0.05 to 2 μg/ml.
Danish: In vitro-aktivitet over for kliniske isolater er set over for Acremonium spp., Alternaria spp., Bipolaris spp., Cladophialophora spp., Histoplasma capsulatum, hvor de fleste stammer bliver hæmmet af voriconazol-koncentrationer i området fra 0,05 til 2 μg/ml.
English: During oral administration of 200 mg or 300 mg twice daily for 14 days in patients at risk of aspergillosis (mainly patients with malignant neoplasms of lymphatic or haematopoietic tissue), the observed pharmacokinetic characteristics of rapid and consistent absorption, accumulation and non-linear pharmacokinetics were in agreement with those observed in healthy subjects.
Danish: Ved oral administration af 200 mg eller 300 mg 2 gange dagligt i 14 dage hos patienter med risiko for aspergillose (hovedsageligt patienter med ondartede svulster i det lymfatiske eller hæmatopoetiske væv) svarede de observerede farmakokinetiske karakteristika af hurtig og ensartet absorption, akkumulering og ikke-lineær farmakokinetik til, hvad man har observeret hos raske forsøgspersoner.
English: • Tell your doctor immediately if you develop o sunburn o severe skin rash or blisters o bone pain.
Danish: • Fortæl straks Deres læge, hvis De får o solskoldning o alvorligt hududslæt eller blærer o knoglesmerter
English: • Oxycodone and other long acting opiates such as hydrocodone (used for moderate to severe pain)
Danish: • Oxycodon og andre langtidsvirkende opiater, såsom hydrocodon (bruges mod moderate og stærke smerter)
English: The recommended doses in children and adolescent patients are based on a population pharmacokinetic analysis of data obtained from 112 immunocompromised paediatric patients aged 2 to <12 years and 26 immunocompromised adolescent patients aged 12 to <17 years.
Danish: De anbefalede doser for børn og unge er baseret på en farmakokinetisk populationsanalyse af data indsamlet fra 112 immunkompromitterede pædiatriske patienter i alderen 2 til <12 år og 26 immunkompromitterede unge i alderen 12 til <17 år.
English: The pharmacokinetics of voriconazole have been characterised in healthy subjects, special populations and patients.
Danish: Voriconazols farmakokinetik er beskrevet hos raske forsøgspersoner, specielle populationer og patienter.
English: Safety and effectiveness in paediatric subjects below the age of two years has not been established (see sections 4.8 and 5.1).
Danish: Sikkerheden og effekten hos børn under 2 år er ikke undersøgt (se pkt.4.8 og 5.1).
English: Inhibitors or inducers of these isoenzymes may increase or decrease voriconazole plasma concentrations, respectively, and there is potential for voriconazole to increase the plasma concentrations of substances metabolised by these CYP450 isoenzymes.
Danish: Hæmmere eller induktorer af disse isoenzymer kan give henholdsvis en stigning eller et fald i voriconazol-plasmakoncentrationerne, og der er potentiale for, at voriconazol øger plasmaniveauerne for stoffer, der metaboliseres af disse CYP450-isoenzymer.
English: An impurity, present in SBECD, has been shown to be an alkylating mutagenic agent with evidence for carcinogenicity in rodents.
Danish: En urenhed i SBECD har vist sig at være et alkylerende mutagent stof med tegn på karcinogenicitet hos gnavere.
English: Dose reduction of NSAIDs may be needed.
Danish: Dosisreduktion af NSAID kan blive nødvendig.
English: Studies conducted in Caucasian and Japanese healthy subjects have shown that poor metabolisers have, on average, 4-fold higher voriconazole exposure (AUCτ) than their homozygous extensive metaboliser counterparts.
Danish: Studier hos kaukasiske og japanske raske personer har vist, at personer med dårlig metaboliseringsevne gennemsnitligt har 4 gange højere voriconazol eksponering (AUCτ) end deres homozygotisk kraftigt metaboliserende modparter.
English: Voriconazole Hikma must not be used during pregnancy unless the benefit to the mother clearly outweighs the potential risk to the foetus.
Danish: Voriconazole Hikma må ikke anvendes under graviditet, medmindre den forventede fordel for moderen klart opvejer den potentielle risiko for fostret.
English: The excretion of voriconazole into breast milk has not been investigated.
Danish: Udskillelsen af voriconazol i mælk er ikke undersøgt.
English: The pharmacokinetics of voriconazole are non-linear due to saturation of its metabolism.
Danish: Voriconazols farmakokinetik er ikke-lineær på grund af mætning af dets metabolisme.
English: 6 weeks after EOT
Danish: 6 uger efter EOT
English: Infections and infestations sinusitis pseudomembranous colitis
Danish: Infektioner og parasitære sygdomme sinusitis pseudomembranøs colitis
English: Hikma Farmacêutica (Portugal), S.A. Estrada do Rio da Mó n.º 8, 8A e 8B, Fervença 2705-906 Terrugem SNT Portugal
Danish: Estrada do Rio da Mó n.º 8, 8A e 8B, Fervença 2705-906 Terrugem SNT
English: Voriconazole Hikma may cause blurring of vision or uncomfortable sensitivity to light.
Danish: Voriconazole Hikma kan forårsage sløring af synet eller ubehagelig lysfølsomhed.
English: Other Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) (e.g., delavirdine, nevirapine)*
Danish: Andre non-nukleoside reverse transcriptase-hæmmere (NNRTI'er) (f.eks. delavirdin, nevirapin)*
English: There is limited data on the safety of voriconazole in patients with abnormal liver function tests (aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase (ALP), or total bilirubin >5 times the upper limit of normal).
Danish: Der findes begrænsede data om sikkerheden af voriconazol til patienter med unormale leverfunktionsværdier (aspartataminotransferase [ASAT], alaninaminotransferase [ALAT], alkalisk fosfatase [AP] eller totalbilirubin > 5 gange den øvre normalgrænse).
English: • Kidney failure, blood in the urine, changes in kidney function tests.
Danish: • Nyresvigt, blod i urinen, ændringer i nyrefunktionstests.
English: Preclinical data on the intravenous vehicle, SBECD indicated that the main effects were vacuolation of urinary tract epithelium and activation of macrophages in the liver and lungs in the repeated-dose toxicity studies.
Danish: Prækliniske data vedrørende det intravenøse hjælpestof SBECD tyder på, at de primære virkninger er vakuolisering af urinvejsepithelium og aktivering af makrofager i lever og lunger i toksicitetsstudier efter gentagne doser.
English: Voriconazole Hikma must not be infused into the same line or cannula concomitantly with other drug infusions, including parenteral nutrition (e.g. Aminofusin 10% Plus).
Danish: Vriconazol Hikma må ikke infunderes i samme dropslange eller kanyle samtidig med andre lægemiddelinfusioner, herunder parenteral ernæring (f.eks. Aminofusin 10 % Plus).
English: • Treatment of candidaemia in non-neutropenic patients
Danish: • Behandling af candidæmi hos ikke-neutropene patienter.
English: The absorption of voriconazole is not affected by changes in gastric pH.
Danish: Absorptionen af voriconazol påvirkes ikke af ændringer i mavesyrens pH.
English: In clinical trials, there have been cases of serious hepatic reactions during treatment with voriconazole (including clinical hepatitis, cholestasis and fulminant hepatic failure, including fatalities).
Danish: Der har i kliniske studier været tilfælde af alvorlige hepatiske reaktioner under behandling med voriconazol (herunder klinisk hepatitis, cholestasis og fulminant leversvigt, som førte til dødsfald).
English: Teenagers aged 12 to 14 years weighing 50 kg or more; and all teenagers older than 14
Danish: Teenagere fra 12 til 14 år, der vejer mere end 50 kg samt alle teenagere over 14 år
English: Children (2 to <12 years) and young adolescents with low body weight (12 to 14 years and <50 kg) Voriconazole should be dosed as children as these young adolescents may metabolize voriconazole more similarly to children than to adults.
Danish: Børn (2 til <12 år) og unge med lav legemsvægt (12-14 år <50 kg) Til unge bør voriconazol doseres som til børn, da disse unge i højere grad metaboliserer voriconazol som børn end som voksne.
English: Voriconazole is eliminated via hepatic metabolism with less than 2 % of the dose excreted unchanged in the urine.
Danish: Voriconazol udskilles ved levermetabolisme, hvor mindre end 2 % af dosis udskilles uforandret i urinen.
English: If you are already being treated with phenytoin, your blood concentration of phenytoin will need to be monitored during your treatment with Voriconazole Hikma and your dose may be adjusted.
Danish: Hvis De allerede er i behandling med phenytoin er det nødvendigt at måle mængden af phenytoin i Deres blod under Deres behandling med Voriconazole Hikma, og det kan være nødvendigt at justere 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: Oral dosage forms of voriconazole are available from other manufacturers.
Danish: Orale doseringsformer af voriconazol fås fra andre producenter.
English: • Heart rhythm problems including very fast heartbeat, very slow heartbeat, fainting
Danish: • Forstyrrelser i hjerterytmen, herunder meget hurtig puls, meget langsom puls, besvimelse
English: Infusion of total parenteral nutrition can occur silmultaneously with Voriconazole Hikma but not in the same line or cannula.
Danish: Infusion med total parenteral ernæring kan ske samtidig med Voriconazole Hikma, men ikke i samme dropslange eller kanyle.
English: When the Voriconazole Hikma infusion is complete, the line may be used for administration of other intravenous products.
Danish: Når infusionen af Voriconazole Hikma er tilendebragt, kan dropslangen anvendes til administration af andre intravenøse produkter.
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: 2 weeks after EOT
Danish: 2 uger efter EOT
English: The MITT group included 40 patients with prior IFI, including 31 with aspergillosis, 5 with candidiasis, and 4 with other IFI.
Danish: MITT-gruppen omfattede 40 patienter med forudgående invasiv svampeinfektion, herunder 31 med aspergillose, 5 med candidiasis og 4 med andre former for invasiv svampeinfektion.
English: Dose adjustments in prophylaxis studies have not been explored.
Danish: Dosisjusteringer er ikke undersøgt i profylaksestudier.
English: Voriconazole Hikma powder for solution for infusion will be reconstituted and diluted to the correct concentration by your hospital pharmacist or nurse.
Danish: Voriconazole Hikma pulver til infusion, opløsning, vil blive rekonstitueret og fortyndet til den korrekte koncentration af sygehusapoteket eller sygeplejersken.
English: Ranitidine (150 mg BID) [increases gastric pH]
Danish: Ranitidin (150 mg BID) [øger gastrisk pH]
English: If you are already being treated with rifabutin, your blood counts and side effects to rifabutin will need to be monitored.
Danish: Hvis De allerede er i behandling med rifabutin, er det nødvendigt at tage blodprøver samt være opmærksom på bivirkninger forbundet med rifabutin.
English: Frequent monitoring for adverse reactions and toxicity related to methadone, including QTc prolongation, is recommended.
Danish: Hyppig monitorering for methadon-relaterede bivirkninger og toksicitet, herunder forlængelse af QTcintervallet, anbefales.
English: Your doctor should also monitor your liver function while you are being treated with Voriconazole Hikma by doing blood tests.
Danish: Deres læge vil også kontrollere Deres leverfunktion under behandling med Voriconazole Hikma ved at tage blodprøver.
English: VORICONAZOLE HIKMA should be discontinued if premalignant skin lesions or squamous cell carcinoma are identified (see below the section under Long-term treatment).
Danish: VORICONAZOLE HIKMA bør seponeres, hvis der påvises præmaligne hudlæsioner eller planocellulært karcinom (se afsnittet ”Langtidsbehandling” nedenfor).
English: Visual impairments may be associated with higher plasma concentrations and/or doses.
Danish: Synsnedsættelse kan være forbundet med højere plasmakoncentrationer og/eller doser.
English: In addition voriconazole shows in vitro fungicidal activity against emerging fungal pathogens, including those such as Scedosporium or Fusarium which have limited susceptibility to existing antifungal agents.
Danish: Derudover viser voriconazol fungicid aktivitet in vitro over for pludseligt opstående patogene svampe, herunder Scedosporium eller Fusarium, som har begrænset følsomhed over for eksisterende svampemidler.
English: Voriconazole has not been studied in patients with severe chronic hepatic cirrhosis (Child-Pugh C).
Danish: Voriconazol er ikke undersøgt hos patienter med svær kronisk levercirrose (Child-Pugh-klasse C).
English: • Nausea, vomiting, diarrhoea
Danish: • Kvalme, opkastning, diarré
English: Contact your doctor immediately if you become pregnant while being treated with Voriconazole Hikma.
Danish: Kontakt straks Deres læge, hvis De bliver gravid, mens De tager Voriconazole Hikma.
English: Increased ciclosporin levels have been associated with nephrotoxicity.
Danish: Forhøjede ciclosporinkoncentrationer har været forbundet med nefrotoksicitet.
English: Volume of Voriconazole Hikma Concentrate (10 mg/ml) required for:
Danish: Nødvendig mængde Voriconazole Hikma-koncentrat (10 mg/ml) til:
English: Tacrolimus (0.1 mg/kg single dose)
Danish: Tacrolimus (0,1 mg/kg enkeltdosis)
English: Tell your doctor if you are taking any of the following medicines, as a dose adjustment or monitoring may be required to check that the medicines and/or Voriconazole Hikma are still having the desired effect:
Danish: Fortæl det til lægen, hvis De tager følgende medicin, da det kan være nødvendigt at justere dosis og kontrollere, om medicinen og/eller Voriconazole Hikma stadig har den ønskede virkning:
English: For administration, the required volume of the reconstituted concentrate is added to a recommended compatible infusion solution (detailed below) to obtain a final voriconazole solution containing 0.5-5 mg/ml.
Danish: Ved administration tilsættes det krævede volumen af det rekonstituerede koncentrat til en anbefalet forligelig infusionsopløsning (detaljer nedenfor) for at opnå en endelig voriconazol-opløsning på 0,5-5 mg/ml.
English: • Infusion site reaction
Danish: • Reaktioner på infusionsstedet
English: There is no known antidote to voriconazole.
Danish: Der er ingen kendt antidot for voriconazol.
English: Although not studied, increased plasma concentrations of these medicinal products can lead to QTc prolongation and rare occurrences of torsades de pointes.
Danish: Selvom det ikke er undersøgt, kan forøgede plasmakoncentrationer af disse lægemidler føre til QTcforlængelse og i sjældne tilfælde torsades de pointes.
English: The intravenous vehicle, SBECD, is haemodialysed with a clearance of 55 ml/min.
Danish: Det intravenøse hjælpestof SBECD hæmodialyseres med en clearance på 55 ml/min.
English: Voriconazole is haemodialysed with a clearance of 121 ml/min.
Danish: Voriconazol hæmodialyseres med en clearance på 121 ml/min.
English: When there is also a potential for voriconazole to increase the plasma concentrations of substances metabolised by CYP3A4 isoenzymes (certain antihistamines, quinidine, cisapride, pimozide), co-administration is contraindicated (see below and section 4.3).
Danish: Hvis der også er en mulighed for, at voriconazol øger plasmaniveauerne af substanser, der metaboliseres af CYP3A4-isoenzymer (visse antihistaminer, quinidin, cisaprid, pimozid), er samtidig administration kontraindiceret (se nedenfor og pkt.
English: • Sinus bradycardia
Danish: • Sinusbradykardi.
English: Each vial contains 217.6 mg of sodium.
Danish: Hvert hætteglas indeholder 217,6 mg natrium.
English: Dose reduction of statins should be considered.
Danish: Det bør overvejes at reducere statin-dosis.
English: Diclofenac (50 mg single dose)
Danish: Diclofenac (50 mg enkeltdosis)
English: • Non-steroidal anti-inflammatory drugs (e.g., ibuprofen, diclofenac) (used for treating pain and inflammation)
Danish: • Non-steroide antiinflammatoriske lægemidler (f.eks. ibuprofen og diclofenac) (bruges til behandling af smerter og betændelsestilstande)
English: 12 weeks after EOT
Danish: 12 uger efter EOT
English: Therapy must be initiated with the specified loading dose regimen of either intravenous or oral voriconazole to achieve plasma concentrations on Day 1 that are close to steady state.
Danish: Behandling skal initieres med den specifikke startdosis enten som intravenøs eller oral voriconazol for at opnå plasmakoncentrationer tæt på steady state på Dag 1.
English: Each vial contains 200 mg voriconazole, equivalent to 10 mg/ml solution when reconstituted as directed by your hospital pharmacist or nurse.
Danish: Hvert hætteglas indeholder 200 mg voriconazol svarende til 10 mg/ml opløsning efter rekonstituering som foreskrevet af sygehusapoteket eller sygeplejersken.
English: Monitoring for adverse reactions related to oral contraceptives, in addition to those for voriconazole, is recommended.
Danish: Monitorering for bivirkninger relateret til oral antikonception udover bivirkninger relateret til voriconazol anbefales.
English: Instances of hepatic reactions were noted to occur primarily in patients with serious underlying medical conditions (predominantly haematological malignancy).
Danish: Hepatiske reaktioner opstod primært hos patienter med andre alvorlige tilgrundliggende sygdomme (først og fremmest malign hæmatologisk sygdom).
English: The studies included cerebral, sinus, pulmonary and disseminated aspergillosis in patients with bone marrow and solid organ transplants, haematological malignancies, cancer and AIDS.
Danish: Disse studier omfatter cerebral, sinusrelateret, pulmonal og dissemineret aspergillose hos knoglemarvs- og organtransplanterede patienter, patienter med maligne hæmatologiske lidelser, cancer og AIDS.
English: For patients less than 40 kg the oral dose may be increased to 150 mg twice daily.
Danish: Hos patienter med en legemsvægt under 40 kg kan den orale dosis øges til 150 mg 2 gange dagligt.
English: • Low blood pressure, inflammation of a vein (which may be associated with the formation of a blood clot)
Danish: • Lavt blodtryk, betændelsestilstand i en vene (som kan forbindes med dannelse af blodpropper)
English: Infusions of blood products must not occur simultaneously with Voriconazole Hikma.
Danish: Infusioner med blodprodukter må ikke indgives samtidigt med Voriconazole Hikma.
English: • Inflammation of the tissue surrounding the bone
Danish: • Betændelse i vævet omkring knoglen
English: Breakthrough IFI - Day 180 2 (1.6%)
Danish: Gennembrud invasiv svampeinfektion - dag 180 2 (1,6%)
English: Increased tacrolimus levels have been associated with nephrotoxicity.
Danish: Forhøjede tacrolimus-koncentrationer har været forbundet med nefrotoksicitet.
English: Voriconazole Hikma must not be infused into the same line or cannula concomitantly with other intravenous products.
Danish: Voriconazole Hikma må ikke infunderes i samme dropslange eller kanyle samtidigt med andre intravenøse produkter.
English: This represents a heterogeneous population, containing patients with haematological malignancy, HIV infected patients with oesophageal candidiasis and refractory fungal infections, non-neutropenic patients with candidaemia or aspergillosis and healthy volunteers.
Danish: Databasen repræsenterer en heterogen population indeholdende patienter med maligne hæmatologiske sygdomme, hiv-inficerede patienter med øsofageal candidiasis og refraktære svampeinfektioner, non-neutropene patienter med candidæmi eller aspergillosis og raske forsøgspersoner.
English: Elderly No dose adjustment is necessary for elderly patients (see section 5.2).
Danish: Dosisjustering er ikke nødvendig hos ældre patienter (se pkt.
English: Careful monitoring of phenytoin plasma levels is recommended.
Danish: Det anbefales, at plasmakoncentrationer af phenytoin monitoreres omhyggeligt.
English: In a study in healthy volunteers investigating the impact of voriconazole on retinal function, voriconazole caused a decrease in the electroretinogram (ERG) waveform amplitude.
Danish: I et studie med raske frivillige, der undersøgte voriconazols betydning for retinafunktionen, forårsagede voriconazol et fald i bølgeformamplituden på elektroretinogrammet (ERG).
English: Chemical and physical in-use stability has been demonstrated for 36 hours at 2°C to 8° C for the reconstituted solution.
Danish: Der er vist kemisk og fysisk stabilitet i 36 timer ved 2°C-8°C for den rekonstituerede opløsning.
English: Digoxin (0.25 mg QD) [P-gp substrate]
Danish: Digoxin (0,25 mg QD) [P-gp-substrat]
English: In the table below, since the majority of the studies were of an open nature all causality adverse reactions, and their frequency categories in 1,873 adults from pooled therapeutic (1,603) and prophylaxis (270) studies, by system organ classare listed.
Danish: Da størstedelen af studierne var ublindede, er alle kausale bivirkninger, hvor der er en mulig årsagssammenhæng, og deres hyppighedskategorier hos 1.873 voksne fra sammenlagte terapeutiske studier (1.603) og profylaksestudier (270) anført efter systemorganklasse i skemaet nedenfor.
English: Frequent monitoring for opiateassociated adverse reactions may be necessary (see section 4.5).
Danish: Hyppig monitorering for opiat-relaterede bivirkninger kan være nødvendig (se pkt.
English: Voriconazole should be administered with caution in patients with concomitant medication that is known to prolong QTc interval.
Danish: Voriconazol bør anvendes med forsigtighed hos patienter, der samtidig tager medicin, som er kendt for at forlænge QTc-intervallet.
English: Pharmacokinetic/pharmacodynamic relationship
Danish: Farmakokinetiske-farmakodynamiske relationer
English: Voriconazole Hikma must not be administered simultaneously with any blood product or any short-term infusion of concentrated solutions of electrolytes, even if the two infusions are running in separate lines.
Danish: Voriconazole Hikma må ikke gives samtidigt med andre blodprodukter eller andre korttidsinfusioner af elektrolytter, selv om de to infusioner gives i hver sin dropslange.
English: Without the loading dose, accumulation occurs during twice daily multiple dosing with steady-state plasma voriconazole concentrations being achieved by day 6 in the majority of subjects.
Danish: Uden initialdosis forekommer akkumulering ved 2 gange dagligt dosering indtil steady state plasma voriconazolkoncentrationer, som hos de fleste forsøgspersoner er opnået på dag 6.
English: • Joint inflammation, inflammation of the veins under the skin (which may be associated with the formation of a blood clot)
Danish: • Ledbetændelse, betændelse i årerne under huden (som kan forbindes med dannelse af blodpropper)
English: In the clinical programme, no dosage adjustment was made on the basis of gender.
Danish: Der var ingen kønsbaserede dosisjusteringer i det kliniske program.
English: The overall incidence of transaminase increases >3 xULN (not necessarily comprising an adverse event) in the voriconazole clinical programme was 18.0% (319/1768) in adults and 25.8% (73/283) in paediatric subjects who received voriconazole for pooled therapeutic and prophylaxis use.
Danish: I voriconazols kliniske program var den samlede incidens af transferase stigninger >3×ULN (ikke nødvendigvis med bivirkninger) 18,0 % (319/1.768) hos voksne og 25,8 % (73/283) hos pædiatriske forsøgspersoner, der blev behandlet med voriconazol til samlet terapeutisk og profylaktisk brug.