FrancophonIA/ELRC3.0 huggingface dataset:
English: Amphotericin B: Concurrent administration of fluconazole and amphotericin B in infected normal and immunosuppressed mice showed the following results: a small additive antifungal effect in systemic infection with C. albicans, no interaction in intracranial infection with Cryptococcus neoformans, and antagonism of the two medicinal products in systemic infection with A. fumigatus.
Danish: Amphotericin B: Samtidig administration af fluconazol og amphotericin B hos inficerede normale og immunsupprimerede mus viste følgende resultater: en lille additiv antimykotisk effekt ved systemisk infektion med C. albicans, ingen interaktion ved intrakraniel infektion med Cryptococcus neoformans, og antagonisme mellem de to lægemidler ved systemisk infektion med A. fumigatus.
English: Children and adolescents (0 to 17 years old)
Danish: Børn og unge (fra 0-17 år)
English: After oral administration fluconazole is well absorbed, and plasma levels (and systemic bioavailability) are over 90% of the levels achieved after intravenous administration.
Danish: Plasmakoncentrationen (og den systemiske biotilgængelighed) er over 90% af de niveauer, som nås efter intravenøs indgift.
English: The mean age at first dose was 24 hours (range 9-36 hours) and mean birth weight was 0.9 kg (range 0.75-1.10 kg) for 12 pre-term neonates of average gestation around 28 weeks.
Danish: Den gennemsnitlige alder ved den første dosis var 24 timer (9-36 timer), og den gennemsnitlige fødselsvægt var 0,9 kg (0,75-1,1 kg) for 12 for tidligt fødte med en gennemsnitlig gestationsalder på ca. 28 uger.
English: Clear Type I glass infusion vial sealed closed with rubber stoppers and aluminium caps.
Danish: Klar type I-infusionshætteglas forseglet med gummiprop og aluminiumshætte.
English: 1 bottle - 35 ml suspension after reconstitution 1 bottle - 100 ml suspension after reconstitution
Danish: 1 flaske - 35 ml suspension efter rekonstitution 1 flaske - 100 ml suspension efter rekonstitution
English: Celecoxib: During concomitant treatment with fluconazole (200 mg daily) and celecoxib (200 mg) the celecoxib Cmax and AUC increased by 68% and 134%, respectively.
Danish: Celecoxib: Under samtidig behandling med fluconazol (200 mg dagligt) og celecoxib (200 mg) steg Cmax og AUC for celecoxib med henholdsvis 68% og 134%.
English: Pharmacokinetics in children
Danish: Farmakokinetik hos børn
English: - Treatment and prophylaxis of recurrent vaginal candidiasis (4 or more episodes a year)
Danish: - Behandling af og profylaktisk mod tilbagevendende vaginal candidiasis (4 eller flere episoder pr. år)
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTERS (capsules)
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS BLISTER (kapsler)
English: Terfenadine: Because of the occurrence of serious cardiac dysrhythmias secondary to prolongation of the QTc interval in patients receiving azole antifungals in conjunction with terfenadine, interaction studies have been performed.
Danish: Terfenadin: Eftersom der er set alvorlige hjertearytmier sekundært til forlænget QTc-interval hos patienter i behandling med antimykotiske azoler og terfenadin, er der udført interaktionsforsøg.
English: Single dose
Danish: Enkeltdosis
English: The pharmacokinetic properties of fluconazole are similar following administration by the intravenous or oral route.
Danish: Fluconazols farmakokinetiske egenskaber er ens efter intravenøs og oral indgift.
English: Safety and efficacy for genital candidiasis indication in paediatric population has not been established.
Danish: Sikkerhed og virkning ved indikationen genital candidiasis hos børn er ikke klarlagt.
English: A 60 ml or a 175 ml high density polyethylene (HDPE) bottle with either a plastic child-resistant closure or continuous thread aluminum closure containing a white to off-white powder for oral suspension providing a white to off-white orange-flavoured suspension after reconstitution.
Danish: En 60 ml eller en 175 ml højdensitetspolyethylen (HDPE) flaske med enten børnesikret plastiklåg eller et aluminiumskruelåg, der indeholder et hvidt til off-white pulver til oral suspension, der efter rekonstitution giver en hvid til off-white suspension med appelsinsmag.
English: Fluconazole passes into breast milk to reach concentrations lower than those in plasma.
Danish: Fluconazol går over i modermælk og opnår en koncentration, der er lavere end i plasma.
English: Prophylaxis of candidal infections in patients with prolonged neutropenia
Danish: Profylakse ved candidainfektioner hos patienter med langvarig neutropeni
English: The usual doses of this medicine for different infections are below.
Danish: Den sædvanlige dosis for de forskellige typer infektion ses herunder.
English: Cyclophosphamide: Combination therapy with cyclophosphamide and fluconazole results in an increase in serum bilirubin and serum creatinine.
Danish: Cyclophosphamid: Kombinationsbehandling med cyclophosphamid og fluconazol fører til stigning i serum-bilirubin og serum-kreatinin.
English: 6.6 Special precautions for disposal and other handling Do not use the medicinal product if you notice signs of deterioration such as unusual odour, product discoloration, visible particles or crystallization.
Danish: 6.6 Regler for destruktion og anden håndtering Anvend ikke lægemidlet, hvis der er tegn på nedbrydning som unormal lugt, misfarvning, synlige partikler eller udkrystallisering.
English: This is comparable with the fluconazole plasma elimination half-life after a single administration of 3 mg/kg i.v.
Danish: Denne er sammenlignelig med plasma halveringstiden for fluconazol efter en enkelt indgift af 3 mg/kg i.v.
English: You might be given this medicine by your doctor to treat genital thrush, infection of the vagina or penis.
Danish: De kan have fået denne medicin af lægen til at behandle svampeinfektioner i skeden eller penis.
English: SPECIAL STORAGE CONDITIONS (Glass vials) Do not freeze.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Hætteglas: Må ikke nedfryses.
English: There is more information for healthcare professionals in a section at the end of the leaflet
Danish: Der er yderligere oplysninger til lægen eller sundhedspersonalet i sidste afsnit af indlægssedlen.
English: Agranulocytosis, leukopenia, thrombocytopenia, neutropenia
Danish: Agranulocytose, leukopeni, trombocytopeni, neutropeni
English: Coadministration of terfenadine is contraindicated in patients receiving Diflucan at multiple doses of 400 mg per day or higher based upon results of a multiple dose interaction study.
Danish: Samtidig behandling med terfenadin er kontraindiceret hos patienter, der får Diflucan 400 mg dagligt eller højere i flergangsdosering, baseret på resultaterne i et interaktionsforsøg med flerdosisbehandling.
English: Elderly The usual adult dose should be given unless you have kidney problems.
Danish: De skal have den sædvanlige voksendosis, medmindre De har nedsat nyrefunktion.
English: At doses ranging from 80 mg/kg to 320 mg/kg embryolethality in rats was increased and foetal abnormalities included wavy ribs, cleft palate, and abnormal cranio-facial ossification.
Danish: Ved doser mellem 80 og 320 mg/kg steg embryoletaliteten hos rotter; de føtale misdannelser inkluderede bølgeformede ribben, ganespalte og abnorm kranio-facial ossifikation.
English: Cardiovascular system
Danish: Kardiovaskulær system
English: Rifampicin: Concomitant administration of fluconazole and rifampicin resulted in a 25% decrease in the AUC and a 20% shorter half-life of fluconazole.
Danish: Rifampicin: Samtidig behandling med fluconazol og rifampicin resulterer i et 25% fald i AUC og en 20% kortere halveringstid for fluconazol.
English: There are some medicines that may interact with Diflucan.
Danish: Anden medicin kan påvirke virkningen af Diflucan.
English: 50 mg hard capsules: gelatin, titanium dioxide (E171) and patent blue V (E131) 100 mg hard capsules: gelatin, titanium dioxide (E171), erythrosin (E127) and patent blue V (E131) 150 mg hard capsules: gelatin, titanium dioxide (E171) and patent blue V (E131) 200 mg hard capsules: gelatin, titanium dioxide (E171), erythrosine (E127) and indigo carmine (E
Danish: 50 mg hårde kapsler: gelatine; titandioxid (E171); patent blue V (E131) 100 mg hårde kapsler: gelatine; titandioxid (E171); erythrosin (E127); patent blue V (E131) 150 mg hårde kapsler: gelatine; titandioxid (E171); patent blue V (E131) 200 mg hårde kapsler: gelatine; titandioxid (E171); erythrosin (E127); indigotin I (E132)
English: This combination should be avoided (see section 4.4).
Danish: Kombinationen bør undgås (se pkt.
English: Voriconazole: (CYP2C9 and CYP3A4 inhibitor): Coadministration of oral voriconazole (400 mg Q12h for 1 day, then 200 mg Q12h for 2.5 days) and oral fluconazole (400 mg on day 1, then 200 mg Q24h for 4 days) to 8 healthy male subjects resulted in an increase in Cmax and AUCτ of voriconazole by an average of 57% (90% CI: 20%, 107%) and 79% (90% CI: 40%, 128%), respectively.
Danish: Voriconazol (CYP2C9- og CYP3A4-hæmmer): Samtidig administration af oral voriconazol (400 mg/12 timer i 1 dag, derefter 200 mg/12 timer i 2,5 dage) og oral fluconazol (400 mg på dag 1, derefter 200 mg/24 timer i 4 dage) hos 8 raske mandlige forsøgspersoner resulterede i en stigning i Cmax og AUCτ for voriconazol med gennemsnitligt 57% (90% CI: 20%, 107%) henholdsvis 79% (90% CI: 40%, 128%).
English: Ciclosporin: Fluconazole significantly increases the concentration and AUC of ciclosporin.
Danish: Ciclosporin: Fluconazol øger koncentrationen og AUC af ciclosporin signifikant.
English: • Prophylaxis of candidal infections in patients with prolonged neutropenia (such as patients with haematological malignancies receiving chemotherapy or patients receiving Hematopoietic Stem Cell Transplantation (see section 5.1)).
Danish: • Mod candida-infektioner hos patienter med forlænget neutropni (f.eks. patienter med hæmatologiske maligniteter, der får kemoterapi, eller patienter der har fået hæmatopoietisk stamcelletransplantation (se pkt.5.1)).
English: Similarly, the Cmax and AUC of the pharmacologically active isomer [S-(+)-ibuprofen] was increased by 15% and 82%, respectively, when fluconazole was coadministered with racemic ibuprofen (400 mg) compared to administration of racemic ibuprofen alone.
Danish: Tilsvarende blev Cmax og AUC for den farmakologisk aktive isomer [S-(+)ibuprofen] øget med henholdsvis 15% og 82%, når fluconazol blev administreret samtidig med racemisk ibuprofen (400 mg) sammenlignet med administration af racemisk ibuprofen alene.
English: Fluconazole in high dose and/or in prolonged regimens should not be used during pregnancy except for potentially life-threatening infections.
Danish: Fluconazol bør kun anvendes i høje doser og/eller i længerevarende behandling til gravide med potentielt livstruende infektioner.
English: If your condition does not clear up within a few days you should go back to your doctor.
Danish: Hvis Deres svampeinfektion ikke aftager i løbet af et par dage, skal De kontakte lægen igen.
English: A three-hour haemodialysis session decreases plasma levels by approximately 50%.
Danish: 3-timers hæmodialyse nedsætter plasmakoncentrationen med ca. 50%.
English: - The active substance is fluconazole.
Danish: Det aktive stof er fluconazol.
English: Adolescents (from 12 to 17 years old):
Danish: Unge (mellem 12-17 år):
English: Excipients: each hard capsule also contains 149.12 mg lactose monohydrate.
Danish: Hjælpestoffer: Hver hård kapsel indeholder også 149,12 mg lactosemonohydrat.
English: Elderly Dosage should be adjusted based on the renal function (see “Renal Impairment”).
Danish: Ældre Dosis bør justeres i henhold til nyrefunktionen (se ”Nedsat nyrefunktion”).
English: Patients on regular dialysis should receive 100% of the recommended dose after each dialysis; on nondialysis days, patients should receive a reduced dose according to their creatinine clearance.
Danish: Patienter i regelmæssig dialyse bør få 100% af den anbefalde dosis efter hver dialyse, og på ikkedialyse-dage bør patienten doseres i henhold til kreatininclearance.
English: PHARMACEUTICAL FORM AND CONTENTS 1 hard capsule.
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) 1 hård kapsel.
English: In addition, creatinine clearance (74 ml/min), the percent of medicinal product recovered unchanged in urine (0-24 h, 22%) and the fluconazole renal clearance estimates (0.124 ml/min/kg) for the elderly were generally lower than those of younger volunteers.
Danish: Kreatininclearance (74 ml/min), den procentdel af lægemidlet, der blev genfundet uomdannet i urinen (0-24 time, 22%), og estimater for fluconazols renale clearance (0,124 ml/min/kg) hos ældre var desuden generelt lavere end værdierne hos yngre, frivillige forsøgspersoner.
English: In patients with fungal meningitis, fluconazole levels in the CSF are approximately 80% the corresponding plasma levels.
Danish: Hos patienter med svampemeningit er koncentrationen af fluconazol i cerebrospinalvæsken ca. 80% af den tilsvarende plasmakoncentration.
English: Dermatomycosis
Danish: Dermatomykoser
English: Concomitant use of the following other medicinal products is contraindicated:
Danish: Samtidig anvendelse af følgende lægemidler er kontraindiceret:
English: Calcium channel blockers: Certain calcium channel antagonists (nifedipine, isradipine, amlodipine, verapamil and felodipine) are metabolized by CYP3A4.
Danish: Calciumantagonister: Visse calciumantagonister (nifedipin, isradipin, amlodipin, verapamil og felodipin) metaboliseres via CYP3A4.
English: An indefinite period for patients with chronic immune suppression
Danish: Ubegrænset periode hos patienter med kronisk immunsuppression
English: Excipient: each ml also contains 9 mg sodium chloride (equivalent to 0.154 mmol sodium).
Danish: Hjælpestoffer: Hver ml indeholder også 9 mg natriumchlorid (svarende til 0,154 mmol natrium).
English: Tell your doctor immediately if you are taking astemizole, terfenadine (an antihistamine for treating allergies) or cisapride (used for stomach upsets) or pimozide (used for treating mental illness) or quinidine (used for treating heart arrhythmia) or erythromycin (an antibiotic for treating infections) as these should not be taken with Diflucan (see section: “Do not take Diflucan if you”).
Danish: Fortæl det straks til lægen, hvis De tager astemizol eller terfenadin (antihistaminer til behandling af allergi), cisaprid (anvendes til maveproblemer), pimozid (mod psykiske sygdomme), quinidin (til behandling af uregelmæssig hjerterytme) eller erythromycin (antibiotikum til behandling af infektioner), da De ikke må tage disse lægemidler sammen med Diflucan (se afsnittet: ”Tag ikke Diflucan hvis De”).
English: For the 60 ml bottle:
Danish: For 60 ml flasken:
English: Methadone: Fluconazole may enhance the serum concentration of methadone.
Danish: Methadon: Fluconazol kan øge methadons serumkoncentration.
English: Check with your doctor or nurse if you are not sure why you are being given Diflucan.
Danish: Spørg lægen eller sundhedspersonalet, hvis De er i tvivl om, hvorfor De har fået Diflucan.
English: A 20 ml measuring cup is also provided.
Danish: Et 20 ml målebæger findes også i pakningen.
English: Fluconazole has the potential to increase the systemic exposure of the calcium channel antagonists.
Danish: Fluconazol kan muligvis øge den systemiske eksponering af calciumantagonister.
English: Fluconazole also exhibits activity in vitro against Cryptococcus neoformans and Cryptococcus gattii as well as the endemic moulds Blastomyces dermatiditis, Coccidioides immitis, Histoplasma capsulatum and Paracoccidioides brasiliensis.
Danish: Fluconazol viser også aktivitet mod Cryptococcus neoformans og Cryptococcus gatti samt de endemiske skimmelsvampe Blastomyces dermatitides, Coccidioides immitis, Histoplama capsulatum og Paracoccidioides brasiliensis.
English: Prednisone: There was a case report that a liver-transplanted patient treated with prednisone developed acute adrenal cortex insufficiency when a three month therapy with fluconazole was discontinued.
Danish: Prednison: Der har været en caserapport, hvor en levertransplanteret patient i behandling med prednison udviklede akut binyrebarkinsufficiens, da en tre måneders behandling med fluconazol blev seponeret.
English: Phenytoin: Fluconazole inhibits the hepatic metabolism of phenytoin.
Danish: Phenytoin: Fluconazol hæmmer den hepatiske metabolisering af phenytoin.
English: Everolimus: Although not studied in vivo or in vitro, fluconazole may increase serum concentrations of everolimus through inhibition of CYP3A4.
Danish: Everolimus: Selv om det ikke er undersøgt in vivo og in vitro, kan fluconazol muligvis øge serumkoncentrationen af everolimus via hæmning af CYP3A4.
English: Cisapride: There have been reports of cardiac events including torsades de pointes in patients to whom fluconazole and cisapride were coadministered.
Danish: Cisaprid: Der har været rapporter om hjertetilfælde, herunder torsades de pointes, hos patienter, som fik fluconazol sammen med cisaprid.
English: Take special care with Diflucan
Danish: Vær ekstra forsigtig med at tage Diflucan
English: A clear, colourless to slightly yellow solution with a viscosity greater than water.
Danish: Klar, farveløs til lysegul opløsning med en højere viskositet end vand.
English: Carbamazepine: Fluconazole inhibits the metabolism of carbamazepine and an increase in serum carbamazepine of 30% has been observed.
Danish: Carbamazepin: Fluconazol hæmmer metaboliseringen af carbamazepin, og der er set stigning i serumcarbamazepin på ca. 30%.
English: Diflucan treated patients who are concomitantly treated with medicinal products with a narrow therapeutic window metabolised through CYP2C9, CYP2C19 and CYP3A4, should be monitored (see section 4.5).
Danish: Patienter, der får Diflucan samtidig med lægemidler med et smalt terapeutisk vindue, og som metaboliseres via CYP2C9, CYP2C19 og CYP3A4, skal monitoreres (se pkt.
English: Diflucan also contains glycerol.
Danish: Diflucan indeholder også glycerol.
English: Diflucan should be administered with caution to patients with these potentially proarrhythmic conditions.
Danish: Diflucan bør administreres med forsigtighed til patienter med potentielt proarytmiske tilstande .
English: - In each bottle the mixture of powder and water makes 35 ml of suspension.
Danish: I hver flaske er det totale volumen af vand og pulver 35 ml suspension.
English: Glycerol may cause headache, stomach upset, and diarrhoea.
Danish: Glyercol kan give hovedpine, mavepine og diarré.
English: Fluconazole is removed by haemodialysis and to a lesser extent by peritoneal dialysis.
Danish: Fluconazol fjernes ved hæmodialyse og i mindre grad ved peritonealdialyse.
English: If your condition has not cleared up after one week, you should go back to your doctor.
Danish: Hvis Deres svampeinfektion ikke aftager i løbet af én uge, skal De kontakte lægen igen.
English: A controlled study found that concomitant fluconazole 200 mg once daily and cisapride 20 mg four times a day yielded a significant increase in cisapride plasma levels and prolongation of QTc interval.
Danish: Et kontrolleret forsøg har vist, at fluconazol 200 mg én gang dagligt sammen med cisaprid 20 mg 4 gange dagligt gav en signifikant stigning i plasmakoncentrationen af cisaprid og forlængelse af QTc-intervallet.
English: Important information about some of the ingredients of Diflucan This medicine contains a small amount of lactose (milk sugar).
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i Diflucan Denne medicin indeholder en lille mængde lactose (mælkesukker).
English: There have been reports of uveitis in patients to whom fluconazole and rifabutin were coadministered.
Danish: Der har været rapporter om uveitis hos patienter, som blev behandlet med fluconazol og rifabutin samtidig.
English: The onset of parturition was slightly delayed at 20 mg/kg orally and dystocia and prolongation of parturition were observed in a few dams at 20 mg/kg and 40 mg/kg intravenously.
Danish: Fødslens indtræden var let forsinket efter 20 mg/kg oralt, og dystoci og forlænget fødsel blev set hos nogle få moderdyr efter 20 og 40 mg/kg intravenøst.
English: The dose should be based on the nature and severity of the fungal infection.
Danish: Dosis afhænger af svampeinfektionens art og sværhedsgrad.
English: Another study at a 400 mg and 800 mg daily dose of fluconazole demonstrated that fluconazole taken in doses of 400 mg per day or greater significantly increases plasma levels of terfenadine when taken concomitantly.
Danish: Et andet forsøg med henholdsvis 400 mg og 800 mg fluconazol én gang dagligt viste, at fluconazol i doser på 400 mg eller mere dagligt øger plasmakoncentrationen af terfenadin signifikant.
English: Sulfonylureas: Fluconazole has been shown to prolong the serum half-life of concomitantly administered oral sulfonylureas (e.g., chlorpropamide, glibenclamide, glipizide, tolbutamide) in healthy volunteers.
Danish: Sulfonylurinstoffer: Fluconazol er vist at forlænge serumhalveringstiden af samtidigt administrerede orale sulfonylurinstoffer (f.eks. chlorpropamid, glibenclamid, glipizid, tolbutamid) hos raske forsøgspersoner.
English: The most frequently (>1/10) reported adverse reactions are headache, abdominal pain, diarrhoea, nausea, vomiting, alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased and rash.
Danish: De hyppigst rapporterede bivirkninger (>1/10) er hovedpine, abdominalsmerter, diarré, kvalme, opkastning, forhøjet alanin-aminotransferase, forhøjet aspartat-aminotransferase, forhøjet alkalisk fosfatase og udslæt
English: If treatment for genital candidiasis is imperative in adolescents (from 12 to 17 years old), the posology should be the same as adults posology.
Danish: Hvis behandling af genitial candidiasis hos unge (fra 12-17 år) er tvingende nødvendig, bør dosis være den samme som til voksne.
English: Fungal strains which have developed one or more of these resistance mechanisms are known to exhibit high minimum inhibitory concentrations (MICs) to fluconazole which impacts adversely efficacy in vivo and clinically.
Danish: Svampearter, som har udviklet en eller flere resistensmekanisme(r), er kendte for at udvise høje mindste hæmmende koncentrationsværdier (MIC) over for fluconazol.
English: - Do not use Diflucan after the expiry date which is stated on the pack after EXP.
Danish: Anvend ikke Diflucan efter den udløbsdato, der står på pakningen.
English: Diflucan is formulated in sodium chloride 9 mg/ml (0.9%) solution for infusion, each 200 mg (100 ml bottle) containing 15 mmol each of Na+ and C1-.
Danish: Diflucan er formuleret i natriumchlorid 9 mg/ml (0,9%) opløsning til infusion, og hver 200 mg (100 ml flaske) indeholder 15 mmol af både Na+ og Cl-.
English: Any remaining suspension should be discarded 28 days after reconstitution.
Danish: Al ikke anvendt suspension skal kasseres 28 dage efter rekonstitution.
English: - Prophylaxis of Candida in immunocompromised patients
Danish: - Profylakse ved Candida hos immunsupprimerede patienter
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 25 ml solution
Danish: INDHOLDSMÆNGDE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 25 ml opløsning
English: - A 5 ml measuring spoon and/or a 5 ml graduated syringe with a press-in bottle adaptor might also be provided to measure the correct dose .
Danish: En 5 ml måleske og/eller en 5 ml doseringssprøjte med en tryk-ind flaskeadaptor findes i nogle pakninger til afmåling af korrekt dosis.
English: Patients who develop abnormal liver function tests during fluconazole therapy must be monitored closely for the development of more serious hepatic injury.
Danish: Patienter, som udvikler unormale leverfunktionsværdier under behandling med fluconazol, skal monitoreres tæt for udvikling af mere alvorlige leverskader.
English: LIST OF EXCIPIENTS Excipients: sodium chloride, water for injections and sodium hydroxide.
Danish: LISTE OVER HJÆLPESTOFFER Hjælpestoffer: natriumchlorid, vand til injektionsvæsker og natriumhydroxid.