FrancophonIA/ELRC3.0 huggingface dataset:
English: Because of non-linear pharmacokinetics, the terminal half-life is not useful in the prediction of the accumulation or elimination of voriconazole.
Danish: Grundet ikke-lineær farmakokinetik er halveringstiden ikke anvendelig i forudsigelsen af akkumuleringen eller udskillelsen af voriconazol.
English: Your doctor may stop the infusion if this occurs.
Danish: Lægen vil muligvis afbryde behandlingen, hvis disse opstår.
English: A 4 hour haemodialysis session does not remove a sufficient amount of voriconazole to warrant dose adjustment.
Danish: En hæmodialysesession på 4 timer fjerner ikke en tilstrækkelig mængde voriconazol til at berettige en dosisjustering.
English: In clinical trials, 705 patients received voriconazole therapy for greater than 12 weeks, with 164 patients receiving voriconazole for over 6 months.
Danish: I kliniske studier fik 705 patienter voriconazolbehandling i mere end 12 uger, heraf fik 164 patienter voriconazol i over 6 måneder.
English: Nine subjects in the voriconazole group and five in the amphotericin B followed by fluconazole group also had mycologically proven infection in deep tissue.
Danish: 9 forsøgspersoner i voriconazolgruppen og 5 forsøgspersoner i amphotericin B efterfulgt af fluconazolgruppen havde også mykologisk påvist infektion i dybtliggende væv.
English: Larger inter-subject variability was observed in paediatric patients compared to adults.
Danish: Der blev set større inter-individuel variation mellem de pædiatriske patienter sammenlignet med voksne.
English: - Reminds patients to take steps to minimize the risk of skin reactions and skin SCC (by avoiding exposure to direct sunlight, use of a sunscreen and protective clothing) and inform HCPs if they experience relevant skin abnormalities.
Danish: - Påminde patienter om, at de skal tage skridt til at minimere risikoen for hudreaktioner og planocellulært hudkarcinom (ved at undgå udsættelse for direkte sollys og ved at bruge solcreme og tage beskyttende tøj på) og underrette læger og sundhedspersonale, hvis de oplever relevante hudabnormiteter.
English: Patients, especially children, with risk factors for acute pancreatitis (e.g., recent chemotherapy, haematopoietic stem cell transplantation (HSCT)), should be monitored closely during voriconazole treatment.
Danish: Patienter, især børn med risikofaktorer for akut pancreatitis (f.eks. nylig kemoterapi, hæmatopoietisk stamcelletransplantation [HSCT]) bør monitoreres tæt under voriconazol-behandling.
English: In that case, intravenous voriconazole administration is recommended.
Danish: I dette tilfælde anbefales intravenøs administration af voriconazol.
English: Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly.
Danish: Behandling kan startes, før resultaterne af kulturbestemmelsen og andre laboratorieundersøgelser foreligger; imidlertid skal den antiinfektive behandling justeres i overensstemmelse med disse resultater, når de foreligger.
English: If infused through a multiple-lumen catheter, TPN needs to be administered using a different port from the one used for Voriconazole Hikma.
Danish: Hvis det infunderes gennem et multi-lumenkateter, skal TPN administreres i en anden port end den, der benyttes til Voriconazole Hikma.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C (in a refrigerator), unless reconstitution has taken place in controlled and validated aseptic conditions.
Danish: Anvendelse af andre opbevaringstider og -betingelser er på brugerens eget ansvar og må ikke overstige 24 timer ved 2°C-8°C (køleskab), medmindre rekonstituering er foretaget under kontrollerede og validerede aseptiske forhold.
English: Ciclosporin (in stable renal transplant recipients receiving chronic ciclosporin therapy)
Danish: Ciclosporin (hos stabile nyretransplanterede patienter, der er i kronisk behandling med ciclosporin)
English: Sunburn or severe skin reaction following exposure to light or sun was experienced more frequently in children.
Danish: Solskoldning eller kraftig hudreaktion pga. lys eller solens stråler sås hyppigere hos børn.
English: No subject experienced an interval exceeding the potentially clinically relevant threshold of 500 msec.
Danish: Ingen forsøgspersoner oplevede et interval, der oversteg den potentielle kliniske relevante grænse på 500 msek.
English: Monitoring of serum amylase or lipase may be considered in this clinical situation.
Danish: Kontrol af serumamylase eller -lipase bør overvejes under disse forhold.
English: MIC breakpoint (mg/L)
Danish: MIC-grænseværdi (mg/l)
English: Specimens for fungal culture and other relevant laboratory studies (serology, histopathology) should be obtained prior to therapy to isolate and identify causative organisms.
Danish: Artsbestemmelse af svampekultur og andre relevante laboratorieundersøgelser (serologi, histopatologi) bør foretages før behandling for at isolere og identificere de sygdomsfremkaldende mikroorganismer.
English: Clinical management should include laboratory evaluation of hepatic function (specifically AST and ALT) at the initiation of treatment with voriconazole and at least weekly for the first month of treatment.
Danish: Den kliniske overvågning bør omfatte laboratorievurdering af leverfunktionen (specifikt ASAT og ALAT) ved initiering af voriconazol-behandling og mindst én gang om ugen i den første behandlingsmåned.
English: The terminal half-life of voriconazole depends on dose and is approximately 6 hours at 200 mg (orally).
Danish: Voriconazols terminale halveringstid afhænger af dosis og er ca. 6 timer ved 200 mg (oralt).
English: 9 Includes dyspnoea and dyspnoea exertional.
Danish: 9 Inkluderer dyspnø og belastningsdyspnø.
English: Dose reduction of benzodiazepines should be considered.
Danish: Dosisreduktion af benzodiazepiner bør overvejes.
English: Voriconazole Cmax and AUCτ ↔ The effect of voriconazole on either erythromycin or azithromycin is unknown.
Danish: Voriconazol Cmax og AUCτ ↔ Voriconazols virkning på både erythromycin og azithromycin er ukendt.
English: The primary endpoint was the rate of occurrence of proven and probable IFI during the first year after HSCT.
Danish: Det primære effektmål var forekomsten af påvist og sandsynlig invasiv svampeinfektion i det første år efter HSCT.
English: Frequent monitoring for opiate-associated adverse reactions may be necessary.
Danish: Hyppig monitorering for opioid-relaterede bivirkninger kan være nødvendig.
English: • Concomitant medicinal product that is known to prolong QTc interval.
Danish: • Samtidig administration af medicin, der er kendt for at forlænge QTc-intervallet.
English: The effects on parturition are probably mediated by species-specific mechanisms, involving reduction of oestradiol levels, and are consistent with those observed with other azole antifungal agents.
Danish: Effekten på fødslen er sandsynligvis medieret af artsspecifikke mekanismer, der omfatter fald i østradiolniveuaer, og er konsistent med, det der er observeret ved andre azol-antimykotika.
English: Post-marketing data suggest there might be a higher occurrence of skin reactions (especially erythema) in the paediatric population compared to adults.
Danish: Data efter markedføring tyder på, at der kan være en højere forekomst af hudreaktioner (især erytem) hos børn end hos voksne.
English: Voriconazole has been associated with elevations in liver function tests and clinical signs of liver damage, such as jaundice, and must only be used in patients with severe hepatic impairment if the benefit outweighs the potential risk.
Danish: Voriconazol har været forbundet med forhøjede levertal og kliniske tegn på leverskade, såsom gulsot, og må kun anvendes til patienter med svær leverinsufficiens, hvis fordelen opvejer den potentielle risiko.
English: • Oral contraceptives (if you take Voriconazole Hikma whilst using oral contraceptives, you may get side effects such as nausea and menstrual disorders)
Danish: • Oral svangerskabsforebyggende medicin (hvis De tager Voriconazole Hikma sammen med oral svangerskabsforebyggende medicin, kan De få bivirkninger, såsom kvalme og menstruationsforstyrrelser)
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: 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: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1004/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/15/1004/001
English: The higher intravenous maintenance dose in paediatric patients relative to adults reflects the higher elimination capacity in paediatric patients due to a greater liver mass to body mass ratio.
Danish: Den højere intravenøse vedligeholdelsesdosis hos pædiatriske patienter sammenlignet med voksne skyldes højere eliminationskapacitet hos pædiatriske patienter pga. større levermasse i forhold til legemsvægt.
English: Voriconazole has been associated with QTc interval prolongation.
Danish: Voriconazol har været forbundet med forlængelse af QTc-intervallet.
English: As an evolution towards SCC has been reported, stringent measures for the photoprotection are warranted in this population of patients.
Danish: Da der er rapporteret en udvikling i retning af planocellulært karcinom, kan strenge beskyttelsesforanstaltninger mod lys være påkrævet for denne patientpopulation.
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), procentsatsten 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: Use in paediatric patients aged 2 to <12 years with hepatic or renal insufficiency has not been studied (see sections 4.8 and 5.2).
Danish: Anvendelse hos pædiatriske patienter i alderen 2 til <12 år med lever- eller nyreinsufficiens er ikke undersøgt (se punkt 4.8 og 5.2).
English: Voriconazole is indicated for paediatric patients aged two years or older.
Danish: Voriconazol er indiceret til pædiatriske patienter på 2 år eller ældre.
English: The visual impairmentswere generally mild, rarely resulted in discontinuation and were not associated with long-term sequelae.
Danish: Synsnedsættelsen er generelt mild, og resulterer sjældent i afbrydelse af behandlingen og har ikke været forbundet med langtidsvirkninger.
English: The species most frequently involved in causing human infections include C. albicans, C. parapsilosis, C. tropicalis, C. glabrata and C. krusei, all of which usually exhibit minimum inhibitory concentration (MICs) of less than 1 mg/L for voriconazole.
Danish: De arter, der oftest forårsager infektioner hos mennesker, omfatter C. albicans, C. parapsilosis, C. tropicalis, C. glabrata og C. krusei, der alle typisk har mindste hæmmende koncentrations (MIC)værdier på mindre end 1 mg/l for voriconazol.
English: In addition VORICONAZOLE HIKMA has been associated with phototoxicity including reactions such as ephelides, lentigo, actinic keratosis and pseudoporphyria.
Danish: Derudover har VORICONAZOLE HIKMA været forbundet med fototoksicitet, herunder reaktioner som efelider, lentigo, aktinisk keratose og pseudoporfyri.
English: The second study enrolled 22 patients with invasive candidiasis including candidaemia (ICC), and esophageal candidiasis (EC) requiring either primary or salvage therapy, of whom 17 were included in the MITT efficacy analyses.
Danish: Det andet studie omfattede 22 patienter med invasiv candidiasis, herunder candidaæmi (ICC) og øsofagal candidiasis (EC), som krævede enten primær eller substituerende behandling, hvoraf 17 blev inkluderet i MITT-effektanalyserne.
English: 10 Includes drug-induced liver injury, hepatitis toxic, hepatocellular injury and hepatotoxicity.
Danish: 10 Inkluderer medicinudløst leverskade, toksisk hepatitis, hepatocellulær skade og hepatotoksicitet.
English: If patient response to treatment is inadequate, the maintenance dose may be increased to 300 mg twice daily for oral administration.
Danish: Hvis patientens respons på behandlingen er utilstrækkeligt, kan vedligeholdelsesdosis øges til 300 mg 2 gange dagligt ved oral administration.
English: Therapy could then be switched to the oral formulation at a dose of 200 mg every 12 hours.
Danish: Behandlingen kunne derefter skiftes til orale doser på 200 mg hver 12. time.
English: In children experiencing photoaging injuries such as lentigines or ephelides, sun avoidance and dermatologic follow-up are recommended even after treatment discontinuation.
Danish: Børn, der oplever fotoældningsskader som lentigines eller efelider, anbefales at undgå solen, ligesom dermatologisk opfølgning anbefales, også efter behandlingen er seponeret.
English: • Treatment of invasive aspergillosis.
Danish: • Behandling af invasiv aspergillose.
English: Uncommon ≥ 1/1,000 to <
Danish: Ikke almindelig ≥ 1/1.000 til
English: Currently available data are described in sections 4.8 and 5.1 but no recommendation on a posology can be made.
Danish: 4.8 og 5.1, men der kan ikke gives doseringsanbefalinger.
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: Alle andre unge (12 til 14 år ≥50 kg; 15 til 17 år uanset legemsvægt) Voriconazol skal doseres som til voksne.
English: • Life threatening allergic reaction
Danish: • Livstruende allergisk reaktion
English: Maximum increase in prothrombin time was approximately 2-fold
Danish: Protrombintid blev maksimalt øget ca. 2 gange.
English: - Reminds HCPs to provide a Patient Alert Card to the patient.
Danish: - Påminde læger og sundhedspersonale om, at de skal udlevere et patientadvarselskort til patienten.
English: Proven or probable IFIs developed in 7.5% (3/40) of patients during the first year after HSCT, including one candidemia, one scedosporiosis (both relapses of prior IFI), and one zygomycosis.
Danish: 7,5% (3/40) af patienterne udviklede påvist eller sandsynlig svampeinfektion i løbet af det første år efter HSCT, herunder 1 candidæmi, 1 scedosporiose (begge remission af forudgående invasiv svampeinfektion) og 1 zygomycose.
English: The 84-day survival rate for voriconazole was statistically significantly higher than that for the comparator and a clinically and statistically significant benefit was shown in favour of voriconazole for both time to death and time to discontinuation due to toxicity.
Danish: Overlevelsesraten efter 84 dage var for voriconazol statistisk signifikant højere end for komparatoren, og der sås klinisk og statistisk signifikant fordel ved brug af voriconazol, både med hensyn til tid til død og tid til seponering på grund af toksicitet.
English: Chemical and physical stability of the of the diluted solutions for infusion has been demonstrated for 36 hours at 2°C to 8°C followed by 3 hours at room temperature.
Danish: Den kemiske og fysiske stabilitet af de fortyndede infusionsopløsninger er påvist i 36 timer ved 2°C8°C efterfulgt af 3 timer ved stuetemperatur.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu .
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Voriconazole Hikma if:
Danish: Advarsler og forsigtighedsregler Kontakt lægen, apotekspersonalet eller sundhedspersonalet før De tager Voriconazole Hikma, hvis:
English: If you have liver disease, your doctor may prescribe a lower dose of Voriconazole Hikma.
Danish: Hvis De har en leversygdom, kan Deres læge ordinere en lavere dosis af Voriconazole Hikma.
English: 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: Pharmacokinetic-Pharmacodynamic analyses of clinical trial data identified positive associations between plasma voriconazole concentrations and both liver function test abnormalities and visual disturbances.
Danish: Farmakokinetiske-farmakodynamiske analyser af kliniske data identificerede positiv forbindelse mellem plasma voriconazolkoncentrationer og både abnorme leverfunktionsværdier og synsforstyrrelser.
English: 4 Includes hypoxic-ischaemic encephalopathy and metabolic encephalopathy.
Danish: 4 Inkluderer hypoksisk-iskæmisk encefalopati og metabolisk encefalopati.
English: Serum creatinine levels should be closely monitored in these patients and, if increases occur, consideration should be given to changing to oral voriconazole therapy (see section 5.2).
Danish: Serumkreatininniveauer bør nøje følges hos disse patienter, og såfremt der opstår stigninger, bør det overvejes at skifte til oral behandling med voriconazol (se pkt.
English: Dose reduction of sulfonylureas should be considered.
Danish: Dosisreduktion af sulfonylurinstoffer bør overvejes.
English: Reconstitute and dilute before use - see leaflet.
Danish: ANVENDELSESMÅDE Rekonstitueres og fortyndes før brug - se indlægssedlen.
English: R-methadone (active) Cmax ↑ 31% R-methadone (active) AUCτ ↑ S-methadone Cmax ↑ 65% S-methadone AUCτ ↑ 103%
Danish: R-methadon (aktiv) Cmax ↑ 31 % R-methadon (aktiv) AUCτ ↑ 47 S-methadon Cmax ↑ 65 % S-methadon AUCτ ↑ 103 %
English: 4 EUCAST has not determined non-species related breakpoints for voriconazole.
Danish: 4 EUCAST har ikke defineret ikke-artsrelaterede grænseværdier for voriconazol.
English: If you or your child are taking Voriconazole Hikma for prevention of fungal infections, your doctor may stop giving Voriconazole Hikma if you or your child develop treatment related side effects.
Danish: Hvis De eller Deres barn tager Voriconazol Hikma til forebyggelse af svampeinfektioner, kan lægen ophøre med at give Voriconazol Hikma, hvis De eller Deres barn udvikler behandlingsrelaterede bivirkninger.
English: The severity of the adverse reactions was generally mild to moderate.
Danish: Bivirkningernes sværhedsgrad var generelt mild til moderat.
English: A comparison of the paediatric and adult population pharmacokinetic data indicated that the predicted total exposure (AUCτ) in children following administration of a 9 mg/kg IV loading dose was comparable to that in adults following a 6 mg/kg IV loading dose.
Danish: En sammenligning af de farmakokinetiske populationsdata fra børn og voksne indikerer, at den forventede totale eksponering (AUCτ) hos børn efter administration af intravenøs mætningsdosis på 9 mg/kg var sammenlignelig med den for voksne efter en intravenøs mætningsdosis på 6 mg/kg.
English: • Acute breathing difficulty, chest pain, swelling of the face (mouth, lips and around eyes), fluid accumulation in the lungs
Danish: • Akut vejrtrækningsbesvær, brystsmerter, hævelser i ansigtet (mund, læber og omkring øjnene), ophobning af væske i lungerne
English: Omeprazole Cmax ↑ 116% Omeprazole AUCτ ↑ 280% Voriconazole Cmax ↑ 15% Voriconazole AUCτ ↑ 41% Other proton pump inhibitors that are CYP2C19 substrates may also be inhibited by voriconazole and may result in increased plasma concentrations of these medicinal products.
Danish: Omeprazol Cmax ↑ 116 % Omeprazol AUCτ ↑ 280 % Voriconazol Cmax ↑ 15 % Voriconazol AUCτ ↑ 41 % Andre protonpumpehæmmere, som er CYP2C19-substrater, kan også blive hæmmet af voriconazol og kan medføre forhøjede plasmakoncentrationer af disse lægemidler.
English: The safety of voriconazole was investigated in 288 paediatric patients aged 2 to <12 years (169) and 12 to <18 years (119) who received voriconazole for prophylaxis (183) and therapeutic use (105) in clinical trials.
Danish: Sikkerheden af voriconazol er undersøgt hos 288 pædiatriske patienter i alderen 2 til <12 år (169) og 12 til <18 år (119), som fik voriconazol-profylakse (183) til terapeutisk brug (105) i kliniske studier.
English: The accumulation of 14 alpha-methyl sterols correlates with the subsequent loss of ergosterol in the fungal cell membrane and may be responsible for the antifungal activity of voriconazole.
Danish: Akkumulering af 14-α-methylsteroler er korreleret med det efterfølgende tab af ergosterol i den fungale cellemembran og kan være ansvarlig for den antigungale virkning af voriconazol.
English: • Congenital or acquired QTc-prolongation
Danish: • Kongenit eller erhvervet QTc-forlængelse.
English: In an independent published study, Voriconazole AUC0-∞ ↓ 59%
Danish: I et uafhængigt, publiceret studie Voriconazol AUC0-∞ ↓ 59 %
English: Children aged 2 to less than 12 years and teenagers aged 12 to 14 years weighing less than 50 kg
Danish: Børn fra 2 år til under 12 år samt teenagere fra 12 til 14 år, der vejer mindre end 50 kg
English: The majority of abnormal liver function tests either resolved during treatment without dose adjustment or following dose adjustment, including discontinuation of therapy.
Danish: Størstedelen af abnorme leverfunktionsprøver blev normale igen under behandlingen enten med eller uden dosisjustering, herunder afbrydelse af behandling.
English: Voriconazole is a broad spectrum, triazole antifungal agent and is indicated in adults and children aged 2 years and above as follows:
Danish: Voriconazol er et bredspektret triazol-antimykotikum, som er indiceret til følgende hos voksne samt børn over 2 år:
English: The efficacy and survival benefit of voriconazole versus conventional amphotericin B in the primary treatment of acute invasive aspergillosis was demonstrated in an open, randomised, multicentre study in 277 immunocompromised patients treated for 12 weeks.
Danish: Effekt og overlevelse ved voriconazol versus en konventionel amphotericin B i primær behandling af akut invasiv aspergillose blev vist i et åbent, randomiseret multicenterstudie med 277 immunkompromitterede patienter behandlet i 12 uger.
English: For prophylaxis use, dose adjustments are not recommended in the case of lack of efficacy or treatment related adverse events.
Danish: Dosisjustering anbefales ikke ved profylaktisk brug i tilfælde af manglende virkning eller behandlingsrelaterede bivirkninger.
English: Cerebrospinal fluid samples from eight patients in a compassionate programme showed detectable voriconazole concentrations in all patients.
Danish: Prøver af cerebrospinalvæsken fra 8 patienter i et særligt klinisk program (”compassionate use”) viste målbare voriconazolkoncentrationer hos alle patienter.
English: In vivo studies indicated that CYP2C19 is significantly involved in the metabolism of voriconazole.
Danish: In vivo-studier antyder, at CYP2C19 er signifikant involveret i voriconazols metabolisme.
English: If you develop skin disorders as described above, your doctor may refer you to a dermatologist, who after consultation may decide that it is important for you to be seen on a regular basis.
Danish: Hvis De får skader på huden, som beskrevet ovenfor, vil lægen måske henvise Dem til en hudlæge, som efter en undersøgelse muligvis beslutter, at det er vigtigt, at De går til regelmæssig kontrol.