FrancophonIA/ELRC3.0 huggingface dataset:
English: After this initial loading dose, the daily dose (according to indication) should be based on the following table:
Danish: Efter den initiale støddosis bør daglig dosis (under hensyntagen til indikation) baseres på følgende tabel:
English: Diflucan may affect your liver.
Danish: Diflucan kan påvirke Deres lever.
English: Diflucan is administered as a single daily dose.
Danish: Diflucan gives som én enkelt daglig dosis.
English: Your condition should start to clear up within a few days but it may take up to a week.
Danish: Deres svampeinfektion bør aftage i løbet af et par dage, men det kan tage op til én uge.
English: Plasma concentrations are proportional to dose.
Danish: Plasmakoncentrationen er proportional med dosis.
English: No studies have been performed on the effects of Diflucan on the ability to drive or use machines.
Danish: Der er ikke foretaget studier over Diflucans virkning på evnen til at føre motorkøretøj eller betjene maskiner.
English: After successful treatment of long-term chronic infections, nails occasionally remain disfigured.
Danish: Efter en succesfuld behandling af langvarige kroniske infektioner kan neglen af og til forblive beskadiget.
English: There is a risk of developing carbamazepine toxicity.
Danish: Der er risiko for udvikling af carbamazepin-toksicitet.
English: The disturbances in parturition were reflected by a slight increase in the number of still-born pups and decrease of neonatal survival at these dose levels.
Danish: Fødselsforstyrrelserne reflekteredes i en let stigning i antallet af dødfødte unger og nedsat neonatal overlevelse ved disse dosisniveauer.
English: 1 bottle - 150 ml
Danish: 1 flaske - 150 ml
English: C. glabrata shows a wide range of susceptibility while C. krusei is resistant to fluconazole.
Danish: C. glabrata viser et bred følsomhedsspektrum, hvorimod C. krusei er resistent over for fluconazol.
English: The dose will be based on the child's weight in kilograms.
Danish: Dosis er baseret på barnets vægt i kg.
English: - May be harmful to teeth if used for periods of longer than 2 weeks.
Danish: - Det kan være skadeligt for Deres tænder, hvis De bruger produktet i mere end 2 uger.
English: Consequently, reduction of the dose is needed.
Danish: Som konsekvens heraf er dosisreduktion nødvendig.
English: Children to 11 years old
Danish: Børn op til 11 år
English: There is also a direct though imperfect relationship between the AUC or dose and a successful clinical response of oral candidosis and to a lesser extent candidaemia to treatment.
Danish: Der er også en direkte, men ufuldkommen sammenhæng mellem AUC eller dosis og en positiv klinisk respons for behandling af oral candidiasis og i mindre grad candidæmi.
English: There have been reports of overdose with Diflucan and hallucination and paranoid behaviour have been concomitantly reported.
Danish: Der har været rapporter om overdosering med Diflucan, og hallucinationer og paranoid opførsel er samtidig blevet rapporteret.
English: Do not take a double dose to make up for a forgotten dose.
Danish: Tag aldrig dobbeltdosis som erstatning for den glemte dosis.
English: Consideration should be given to official guidance on the appropriate use of antifungals.
Danish: Officielle retningslinjer vedrørende korrekt brug af antimykotika bør følges.
English: In general, the recommended duration of therapy for candidemia is for 2 weeks after first negative blood culture result and resolution of signs and symptoms attributable to candidemia.
Danish: I almindelighed er den anbefalede behandlingsvarighed for candidæmi 2 uger efter første negative bloddyrkning og manglende tegn og symptomer på candidæmi.
English: ≤50 (no dialysis) Regular dialysis
Danish:  50 (ingen dialyse) Regelmæssig dialyse
English: Clinical data indicate that children have a higher fluconazole clearance than observed for adults.
Danish: Kliniske data tyder på, at børn har en højere fluconazol-clearance end den, der ses hos voksne.
English: There is no evidence of circulating metabolites.
Danish: Der er ikke påvist cirkulerende metabolitter.
English: Although no specific incompatibilities have been noted, mixing with any other medicinal products prior to infusion is not recommended.
Danish: Selvom der ikke er set specifikke uforligeligheder, anbefales det ikke at blande det med andre lægemidler inden infusion.
English: There was no significant pharmacokinetic interaction between fluconazole and azithromycin.
Danish: Der var ingen signifikant farmakokinetisk interaktion mellem fluconazol og azithromycin.
English: Additional data were available from a compassionate use study.
Danish: Yderligere data var tilgængelige fra et specielt klinisk program (”compassionate use”).
English: ANNEX III SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
Danish: BILAG III PRODUKTRESUMÉ, ETIKETTERING OG INDLÆSSEDDEL
English: In clinical studies, there is an almost 1:1 linear relationship between the AUC and the dose of fluconazole.
Danish: I kliniske forsøg er der en næsten 1:1 lineær sammenhæng mellem AUC og fluconazol-dosis.
English: Pharmacokinetic data were assessed for 113 paediatric patients from 5 studies; 2 single-dose studies, 2 multiple-dose studies, and a study in premature neonates.
Danish: Farmakokinetiske data blev vurderet hos 113 pædiatriske patienter i 5 forsøg; 2 enkeltdosisforsøg, 2 flerdosisforsøg samt 1 forsøg med præmature nyfødte.
English: Ask your doctor or pharmacist for advice before taking any medicines.
Danish: Spørg Deres læge eller apoteket til råds, før De tager nogen form for medicin.
English: Use in children less than 2 weeks old:
Danish: Børn under 2 uger:
English: Taking too many capsules at once may make you unwell.
Danish: Hvis De tager for mange kapsler på en gang, kan De blive utilpas.
English: 5-nortriptyline and/or S-amitriptyline may be measured at initiation of the combination therapy and after one week.
Danish: 5-nortriptylin og/eller S-amitriptylin kan evt. måles ved start af kombinationsbehandling og efter en uge.
English: Oral use after reconstitution.
Danish: Oral anvendelse efter rekonstitution.
English: Distribution The apparent volume of distribution approximates to total body water.
Danish: Distribution Det tilsyneladende fordelingsvolumen svarer til legemets totale vandfase.
English: Fluconazole clearance is proportional to creatinine clearance.
Danish: Fluconazolclearance er proportional med kreatinin-clearance.
English: Therapy should be modified if signs of toxicity develop.
Danish: Behandlingen bør justeres, hvis der udvikles tegn på toksicitet.
English: 800 mg daily may be considered for some infections and especially for meningeal disease.
Danish: 800 mg dagligt kan overvejes til nogle infektioner og især ved meningeale sygdomme.
English: However tell your doctor or pharmacist if you think that a dose has been forgotten.
Danish: Fortæl lægen eller sundhedspersonalet, hvis De tror, at en dosis er blevet glemt.
English: The usual adult dose should be given.
Danish: De skal have den sædvanlige voksendosis.
English: The solution is to be inspected visually for particulate matter and discoloration prior to administration.
Danish: Opløsningen skal inspiceres visuelt for partikler og misfarvning før administration.
English: Depending on the weight and pubertal development, the prescriber would need to assess which posology (adults or children) is the most appropriate.
Danish: Afhængigt af vægt og udvikling vil lægen vurdere, hvilken dosering (voksne eller børn) der er den mest hensigtsmæssige.
English: are taking erythromycin (an antibiotic for treating infections)
Danish: • tager erythromycin (antibiotikum til behandling af infektioner)
English: Current available safety data for other paediatric indications are described in section 4.8.
Danish: De tilgængelige sikkerhedsdata for andre pædiatriske indikationer er beskrevet i afsnit 4.8.
English: No significant pharmacokinetic changes have been observed when tacrolimus is given intravenously.
Danish: Der ses ingen signifikante farmakokinetiske ændringer, hvis tacrolimus gives intravenøst.
English: Plasticised PVC bags: 18 months.
Danish: Plastificerede PVC poser: 18 måneder.
English: An inadequate period of treatment may lead to recurrence of active infection.
Danish: Hvis behandlingen er for kortvarig, kan det medføre recidiv af den aktive infektion.
English: Intravenous infusion should be administrated at a rate not exceeding 10 ml/minute.
Danish: Intravenøs infusion bør administreres med en hastighed, der ikke overskrider 10 ml/min.
English: In patients with severe renal insufficiency, (GFR< 20 ml/min) half life increased from 30 to 98 hours.
Danish: Hos patienter med alvorligt nedsat nyrefunktion, (GFR<20 ml/min) stiger halveringstiden fra 30 til 98 timer.
English: Fluconazole has been studied for treatment of tinea capitis in children.
Danish: Fluconazol er blevet undersøgt til behandling af tinea capitis hos børn.
English: Treatment of infections requiring multiple dosing should be continued until clinical parameters or laboratory tests indicate that active fungal infection has subsided.
Danish: Ved infektioner, der kræver flergangsdosering, skal behandlingen fortsættes, indtil kliniske parametre eller laboratorieprøver viser, at den aktive svampeinfektion er aftaget.
English: Furthermore, it was shown in healthy volunteers that fluconazole delayed the elimination of fentanyl significantly.
Danish: Endvidere er det hos raske forsøgspersoner vist, at fluconazol forsinkede eliminationen af fentanyl signifikant.
English: Hard capsule.
Danish: Hårde kapsler.
English: Based on analyses of pharmacokinetic/pharmacodynamic (PK/PD) data, susceptibility in vitro and clinical response EUCAST-AFST (European Committee on Antimicrobial susceptibility Testing-subcommittee on Antifungal Susceptibility Testing) has determined breakpoints for fluconazole for Candida species (EUCAST Fluconazole rational document (2007)-version 2).
Danish: Baseret på analyser af farmakokinetiske/farmakodynamiske data (PK/PD), følsomheden in vitro og klinsk respons har EUCAST-AFST (European Committee on Antimicrobial Susceptibility Testingsubcommittee on Antifungal Susceptibility Testing) fastlagt breakpoints for fluconazol for Candidaarter (EUCAST fluconazol rational document (2007)-version 2).
English: Fluconazole may be infused through an existing line with one of the above listed fluids.
Danish: Fluconazol kan indgives via et eksisterende drop med en af ovennævnte væsker.
English: Breakpoints (according to EUCAST)
Danish: Grænseværdier (i henhold til EUCAST)
English: The half-life of zidovudine was likewise prolonged by approximately 128% following combination therapy with fluconazole.
Danish: Zidovudins halveringstid blev ligeledes forlænget med ca. 128% ved kombinationsbehandling med fluconazol.
English: In life threatening infections the daily dose can be increased to 800 mg
Danish: Ved livstruende infektioner kan den daglige dosis øges til 800 mg.
English: Data from several hundred pregnant women treated with standard doses (<200 mg/day) of fluconazole, administered as a single or repeated dose in the first trimester, show no undesirable effects in the foetus.
Danish: Data fra adskillige hundrede gravide kvinder i behandling med fluconazol-standarddosis (<200 mg/dag), administreret som enkelt eller gentagen dosis i det første trimester, viste ingen uønskede virkninger på fostret.
English: Dose of amitriptyline/nortriptyline should be adjusted, if necessary.
Danish: Dosis af amitriptylin/nortriptylin bør justeres, hvis nødvendigt.
English: Interaction with saquinavir/ritonavir has not been studied and might be more marked.
Danish: Interaktion med sanquinavir/ritonavir er ikke blevet undersøgt og kan være betydelig.
English: Frequent monitoring of blood glucose and appropriate reduction of sulfonylurea dose is recommended during coadministration.
Danish: Hyppig monitorering af blodglucose og passende dosisreduktion af sulfonylurinstof anbefales ved kombinationsbehandling.
English: Natural orange flavour (containing orange oil and maltodextrin)
Danish: Naturlig orangesmag ( indeholder appelsinolie og maltodextrin)
English: The effect of fluconazole on other medicinal products
Danish: Fluconazols virkning på andre lægemidler
English: Measure 66 ml of still water and add the water to the bottle.
Danish: Afmål 66 ml vand og hæld vandet i flasken.
English: However, growth rates may vary widely in individuals, and by age.
Danish: Væksthastigheden har dog betydelig individuel variation og aldersvariation.
English: Sometimes doses are increased up to 800 mg
Danish: I visse tilfælde kan dosis øges til højst 800 mg
English: Fluconazole is metabolised only to a minor extent.
Danish: Fluconazol metaboliseres kun i lille omfang.
English: The enzyme inhibiting effect of fluconazole persists 4-5 days after discontinuation of fluconazole treatment due to the long half-life of fluconazole (see section 4.3).
Danish: Den enzymhæmmende effekt af fluconazol fortsætter i 4-5 dage efter ophør med fluconazolbehandling pga. fluconazols lange halveringstid (se pkt.
English: ATC classification Pharmacotherapeutic group: Antimycotics for systemic use, triazole derivatives, ATC code: J02AC01.
Danish: Farmakoterapeutisk klassifikation: Antimykotika til systemisk brug, triazol-derivater, ATC kode: J 02 AC 01.
English: The solution should only be used if the solution is clear and free from particles.
Danish: Opløsningen må kun anvendes, hvis den er klar og uden partikler.
English: Frequent monitoring for adverse events is recommended.
Danish: Hyppig monitorering for bivirkninger anbefales.
English: Species-related breakpoints (S</R>)
Danish: Antimykotikum Species-relaterede breakpoints (S≤/R>)
English: The effect of other medicinal products on fluconazole
Danish: Andre lægemidlers virkning på fluconazol
English: Any unused suspension should be not be used after this date and should be returned to your pharmacist.
Danish: Efter den noterede udløbsdato må ubrugt suspension ikke anvendes, og skal afleveres til apoteket.
English: IE = There is insufficient evidence that the species in question is a good target for therapy with the medicinal product.
Danish: IE = Der er utilstrækkelig evidens for, at den pågældende art er et godt mål for terapi med lægemidlet.
English: 7 to 21 days (until oropharyngeal candidiasis is in remission).
Danish: 7-21 dage (indtil orofaryngeal candidiasis er i bedring).
English: Administration of a loading dose (on day 1) of twice the usual daily dose enables plasma levels to approximate to 90% steady-state levels by day 2.
Danish: Indgift af støddosis (på dag 1) af dobbelt normal daglig dosis giver plasmakoncentrationer på ca. 90% af steady state på dag 2.
English: 1 to 3 weeks
Danish: 1-3 uger
English: Losartan: Fluconazole inhibits the metabolism of losartan to its active metabolite (E-31 74) which is responsible for most of the angiotensin Il-receptor antagonism which occurs during treatment with losartan.
Danish: Losartan: Fluconazol hæmmer losartans metabolisering til dets aktive metabolit (E-31 74), som er ansvarlig for størstedelen af angiotensin-II-receptor-antagonismen under losartanbehandling.
English: Immunosuppresors (i.e. ciclosporin, everolimus, sirolimus and tacrolimus):
Danish: Immunsuppressiva (f.eks. ciclosporin, everolimus, sirolimus og tacrolimus):
English: Neonates excrete fluconazole slowly.
Danish: Nyfødte udskiller fluconazol langsomt.
English: Instructions to make up the suspension:
Danish: Brugsanvisning til suspensionen:
English: Potentiated and prolonged effects of triazolam have been observed at concomitant treatment with fluconazole.
Danish: Potenseret og forlænget virkning af triazolam er set ved samtidig behandling med fluconazol.
English: A dose of 100, 200 and 400 mg in adults corresponds to a 3, 6 and 12 mg/kg dose in children to obtain a comparable systemic exposure.
Danish: Doser på 100, 200 og 400 mg til voksne svarer til doser på 3, 6 og 12 mg/kg til børn for opnåelse af samme systemiske eksponering.
English: Male rats treated with 5 and 10 mg/kg/day had an increased incidence of hepatocellular adenomas.
Danish: Hanrotter behandlet med 5 og 10 mg/kg/dag havde en øget hyppighed af hepatocellulære adenomer.
English: - tinea unguium (onychomycosis)
Danish: - tinea unguinium (onykomykose)
English: Monitoring for voriconazole associated adverse events is recommended if voriconazole is used sequentially after fluconazole.
Danish: Monitorering for voriconazol-relaterede bivirkninger anbefales, hvis voriconazol anvendes sekventielt efter fluconazol.
English: If you forget to take Diflucan
Danish: Hvis De har glemt at tage Diflucan
English: Concomitant use of the following other medicinal products cannot be recommended:
Danish: Samtidig anvendelse af følgende lægemidler kan ikke anbefales:
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 to 8 ° C, unless dilution has taken place in controlled and validated aseptic conditions.
Danish: Hvis det ikke anvendes straks, er ansvaret for i-brug-opbevaringstid og opbevaringsbetingelser forud for anvendelse brugerens og bør normalt ikke være længere end 24 timer ved 2-8°C, medmindre rekonstitution/fortynding er foretaget under kontrollerede og validerede aseptiske forhold.
English: There have been reports of superinfection with Candida species other than C. albicans, which are often inherently not susceptible to fluconazole (e.g. Candida krusei).
Danish: Der har været rapporter om tilfælde af superinfektion med andre Candida-arter end C. albicans, som ofte ifølge deres natur ikke er følsomme for fluconazol (f.eks. Candida krusei).
English: Some azoles, including fluconazole, have been associated with prolongation of the QT interval on the electrocardiogram.
Danish: Nogle azoler, herunder fluconazol, er blevet forbundet med forlængelse af QT-intervallet i ekg.
English: In animal studies, there is a correlation between MIC values and efficacy against experimental mycoses due to Candida spp.
Danish: Der er i dyreforsøg set korrelation mellem mindste hæmmende koncentrations(MIC)-værdier og effekt over for eksperimentelle mykoser pga. Candida spp.
English: Fluconazole in standard doses and short-term treatments should not be used in pregnancy unless clearly necessary.
Danish: Fluconazol bør ikke anvendes i standarddoseringer og kortvarig behandling til gravide, medmindre det er absolut nødvendigt.
English: Add a small quantity of still water and shake it vigorously.
Danish: Tilsæt en lille mængde almindeligt vand og ryst flasken kraftigt.
English: - Doses of 10 ml contain 1.3 g of sugar.
Danish: - Doser på 10 ml indeholder 1,3 g sukker.
English: Ninety percent steady state levels are reached by day 4-5 with multiple once daily dosing.
Danish: 90% af steady state-niveauet er nået 4-5 dage efter gentagen daglig éngangsdosering.
English: Breast-feeding is not recommended after repeated use or after high dose fluconazole.
Danish: Amning anbefales ikke efter gentagne doser eller efter høje fluconazoldoser.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Single use only.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Kun til engangsbrug.
English: Important information about some of the ingredients of Diflucan
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i Diflucan
English: Tell your doctor if you are pregnant, trying to become pregnant or breast-feeding.
Danish: Fortæl lægen hvis De er gravid, prøver at blive gravid eller ammer.
English: 14 to 30 days (until oesophageal candidiasis is in remission).
Danish: 14-30 dage (indtil øsofageal candidiasis er i bedring).
English: Plasticised PVC bag.
Danish: Plastificeret PVC pose
English: Benzodiazepines (short acting), i.e. midazolam, triazolam: Following oral administration of midazolam, fluconazole resulted in substantial increases in midazolam concentrations and psychomotor effects.
Danish: Benzodiazepiner (korttidsvirkende), f.eks. midazolam, triazolam: Efter oral administration af midazolam medførte fluconazol en væsentlig stigning i midazolams koncentration og en væsentligt øget psykomotorisk påvirkning.
English: The long plasma elimination half-life provides the basis for single dose therapy for vaginal candidiasis, once daily and once weekly dosing for other indications.
Danish: Den lange plasmahalveringstid har skabt basis for enkeltdosisbehandling ved vaginal candidiasis og dosering 1 gang dagligt og 1 gang ugentligt ved andre indikationer.
English: -- = Susceptibility testing not recommended as the species is a poor target for therapy with the medicinal product.
Danish: -- = Følsomhedstest anbefales ikke, da arten er et dårligt mål for terapi med lægemidlet.
English: AIDS patients are more prone to the development of severe cutaneous reactions to many medicinal products.
Danish: Aids-patienter er mere tilbøjelige til at udvikle alvorlige hudreaktioner i forbindelse med mange lægemidler.
English: Concomitant use of the following other medicinal products lead to precautions and dose adjustments:
Danish: Samtidig anvendelse af følgende lægemidler medfører forsigtighedsregler og dosisjustering:
English: Thus, the alteration of fluconazole disposition in the elderly appears to be related to reduced renal function characteristics of this group.
Danish: Ændringen i fluconazols fordeling hos ældre synes derfor at være relateret til nedsat nyrefunktion, som er karakteristisk hos denne patientgruppe.
English: The following adverse reactions have been observed and reported during treatment with Diflucan with the following frequencies: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Danish: Følgende bivirkninger er set ved behandling med Diflucan med følgende hyppighed: meget almindelig (≥1/10); almindelig (≥1/100 til < 1/10); ikke almindelig (≥1/1.000 til < 1/100); sjælden ( ≥1/10.000 til < 1/1.000); meget sjælden (≥1/10.000); ukendt hyppighed (kan ikke estimeres ud fra forhåndenværende data).
English: The medicinal product does not require any special storage conditions.
Danish: Dette lægemiddel kræver ingen særlige opbevaringsbetingelser.
English: - A measuring cup is also provided to measure the correct dose .
Danish: Et målebæger findes også i pakningen til afmåling af korrekt dosis.
English: Frequent monitoring for adverse events and toxicity related to NSAIDs is recommended.
Danish: Hyppig monitorering for NSAID-relaterede bivirkninger og toksicitet anbefales.
English: - tinea pedis, - tinea corporis, - tinea cruris, - candida infections
Danish: - tinea pedis - tinea corporis - tinea cruris - candida-infektioner
English: The Cmax was 1.54 µg/ml and occurred at 1.3 hours post-dose.
Danish: Cmax var 1,54 µg/ml og blev nået 1,3 timer efter indtagelse.
English: There have been reports of multiple congenital abnormalities (including brachycephalia, ears dysplasia, giant anterior fontanelle, femoral bowing and radio-humeral synostosis) in infants whose mothers were treated for at least three or more months with high doses (400-800 mg daily) of fluconazole for coccidioidomycosis.
Danish: Der er indberettet multiple, kongenitale anormaliteter (inklusive brakycefali, øredysplasi, stor forreste fontanelle, femoral bøjning og radial-humeral synostose) hos spædbørn, hvis mødre var blevet behandlet i mindst tre eller flere måneder med høje doser fluconazol (400-800 mg dagligt) for kokcidioidomykose.
English: Dose adjustment of carbamazepine may be necessary depending on concentration measurements/effect.
Danish: Dosisjustering af carbamazepin kan blive nødvendig afhængigt af koncentrationsmålinger/effekt.
English: These have been divided into non-species related breakpoints; which have been determined mainly on the basis of PK/PD data and are independent of MIC distributions of specific species, and species related breakpoints for those species most frequently associated with human infection.
Danish: Disse er blevet delt i ikkeartsrelaterede breakpoints, som primært er fastlagt på baggrund af PK/PD-data og er uafhængige af MIC-fordelingen hos specifikke arter, og i arts-relaterede breakpoints for de arter, som hyppigst er forbundet med infektion hos mennesker.