FrancophonIA/ELRC3.0 huggingface dataset:
English: The relationship between fluconazole use and these events is unclear.
Danish: Det er ikke afklaret, om der er en sammenhæng mellem fluconazol og disse hændelser.
English: After three hours of haemodialysis session, around 50% of fluconazole is eliminated from blood.
Danish: Efter 3 timers hæmodialysebehandling er ca. 50% af fluconazol elimineret fra blodet.
English: Similarly cure is less likely for infections caused by strains with a higher fluconazole MIC.
Danish: Ligeledes kureres i mindre grad infektioner forårsaget af stammer med en højere fluconazol-MIC.
English: 3 mg per kg of body weight (6 mg per kg of body weight might be given on the first day)
Danish: 3 mg/kg legemsvægt (6 mg/kg legemsvægt kan ordineres den første dag)
English: Add water up to the level marked on the bottle (this corresponds to adding 24 ml of water)
Danish: Tilsæt vand op til markeringen på flasken (dette svarer til at tilsætning af 24 ml vand).
English: - Doses of 10 ml contain 5.6 g or more of sugar.
Danish: Doser på 10 ml indeholder 5,6 g sukker eller mere.
English: Coadministation of diuretics did not significantly alter AUC or Cmax.
Danish: Samtidig administration af diuretika ændrede ikke AUC eller Cmax signifikant.
English: A measuring cup is provided with the 175 ml bottle.
Danish: Der leveres en måleske sammen med 175 ml flasken.
English: • To reduce the incidence of recurrent vaginal candidiasis (4 or more episodes a year).
Danish: • For at reducere incidensen af tilbagefald af vaginal candidiasis (4 eller flere episoder om året).
English: For storage conditions of the reconstituted medicinal product, see section 6.3.
Danish: Opbevaringsbetingelser for det rekonstituerede lægemiddel, se pkt.
English: This medicinal product contains 0.154 mmol sodium per ml.
Danish: Dette lægemiddel indeholder 0,154 mmol natrium pr. ml.
English: Fluconazole accumulates in the stratum corneum.
Danish: Fluconazol akkumuleres i stratum corneum.
English: - The other ingredients are:
Danish: • Øvrige indholdsstoffer er:
English: Experience with fluconazole in neonates is limited to pharmacokinetic studies in premature newborns.
Danish: Erfaringerne med fluconazol hos nyfødte er begrænset til farmakokinetiske forsøg med præmature nyfødte.
English: Patients receiving this combination should be monitored for the development of zidovudine-related adverse reactions.
Danish: Patienter, der bliver behandlet med denne kombination, bør monitoreres for udvikling af zidovudinrelaterede bivirkninger.
English: Although not specifically studied, fluconazole has the potential to increase the systemic exposure of other NSAIDs that are metabolized by CYP2C9 (e.g. naproxen, lornoxicam, meloxicam, diclofenac).
Danish: Skønt det ikke specifikt er undersøgt, kan fluconazol muligvis øge den systemiske eksponering af andre NSAID, som metaboliseres af CYP2C9 (f.eks. naproxen, lornoxicam, meloxicam, diclofenac).
English: Diflucan has been associated with rare cases of serious hepatic toxicity including fatalities, primarily in patients with serious underlying medical conditions.
Danish: Diflucan er i sjældne tilfælde blevet forbundet med hepatotoksicitet, herunder letale tilfælde, primært hos patienter med alvorlige tilgrundliggende sygdomme.
English: The symptoms of a possible overdose may include hearing, seeing, feeling and thinking things that are not real (hallucination and paranoid behaviour).
Danish: Symptomer på overdosering kan omfatte at høre, se, og føle ting, der ikke er der, og tænke unormale tanker (hallucinationer og paranoid opførsel).
English: This combination may be used by reducing the dose of ciclosporin depending on ciclosporin concentration.
Danish: Kombinationen kan anvendes med dosisnedsættelse af ciclosporin afhængigt af ciclosporin-koncentrationen.
English: - Diflucan comes in a blister pack containing one capsule.
Danish: Diflucan findes i blisterpakninger med 1 kapsel.
English: Instructions for use: Shake the closed bottle of the reconstituted suspension before each use.
Danish: Brugsanvisning: Ryst den lukkede flaske med den rekonstituerede suspension inden brug.
English: A = Non-species related breakpoints have been determined mainly on the basis of PK/PD data and are independent of MIC distributions of specific species.
Danish: A = Non-species-relaterede breakpoints er blevet fastlagt primært på baggrund af PK/PD-data og er uafhængige af MIC-fordelingen hos specifikke arter.
English: Breast-feeding may be maintained after a single use of a standard dose 200 mg fluconazole or less.
Danish: Amning kan fortsættes efter en enkelt standarddosis på 200 mg fluconazol eller mindre.
English: Indefinitely at a daily dose of 200 mg
Danish: På ubestemt tid med en daglig dosis på 200 mg
English: Diflucan is indicated in term newborn infants, infants, toddlers, children and adolescents aged from 0 to 17 years old:
Danish: Diflucan er indiceret til nyfødte (født til termin), spædbørn, småbørn, børn og unge i alderen 0-17 år:
English: Patients have rarely developed exfoliative cutaneous reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, during treatment with fluconazole.
Danish: Patienter har i sjældne tilfælde udviklet eksfoliative kutane reaktioner, som f.eks. Stevens-Johnsons syndrom og toksisk epidermal nekrolyse under behandling med fluconazol.
English: The mean AUC was 76.4 ± 20.3 µgh/ml, and the mean terminal half-life was 46.2 hours.
Danish: Gennemsnitligt AUC var 76,4 ± 20,3 µg·t/ml, og den gennemsnitlige halveringstid var 46,2 timer.
English: 1 bottle - 35 ml suspension after reconstitution
Danish: 1 flaske - 35 ml suspension efter rekonstitution
English: Follow the dose prescribed by your doctor (either adults or children posology).
Danish: Følg den dosis, som lægen har ordineret (enten voksen- eller børnedosering).
English: In vitro, fluconazole displays antifungal activity against most clinically common Candida species (including C. albicans, C. parapsilosis, C. tropicalis).
Danish: Fluconazol viser in vitro en antimykotisk aktivitet mod de fleste klinisk almindelige Candida-arter (herunder C. albicans, C. parapsilosis, C. tropicalis).
English: Adolescents from 12 to 17 years old
Danish: Unge fra 12-17 år
English: Depending on the extent and duration of the induced neutropenia (see Adults posology)
Danish: Afhængigt af sværhedsgrad og varighed af den inducerede neutropeni (se under dosering til voksne)
English: Cryptococcal meningitis or internal fungal infections caused by Candida
Danish: Kryptokokmeningitis eller indre svampeinfektioner, der skyldes Candida
English: Infants, toddlers and children (from 28 days to 11 years old):
Danish: Spædbørn, småbørn og børn (fra 28 dage til 11 år):
English: Dose of orally administered tacrolimus should be decreased depending on tacrolimus concentration.
Danish: Dosis af oral tacrolimus bør nedsættes afhængigt af tacrolimuskoncentrationen.
English: If patients with invasive/systemic fungal infections develop rashes, they should be monitored closely and fluconazole discontinued if bullous lesions or erythema multiforme develop.
Danish: Hvis patienter med invasive/systemiske svampeinfektioner udvikler udslæt, skal de monitoreres tæt og fluconazol seponeres, hvis der udvikles bulløse læsioner eller erythema multiforme.
English: Excipient: each 1 ml also contains 0.1334 g of sucrose and 0.9635 g of glycerol.
Danish: Hjælpestoffer: 1 ml indeholder også 0,1334 g saccharose og 0,9635 g glycerol.
English: This medicine will be given by your doctor or nurse as a slow injection (infusion) into your vein.
Danish: Det vil normalt være en læge eller sygeplejerske, der giver Dem denne medicin som en indsprøjtning (infusion) i en blodåre.
English: Interaction studies with antipyrine indicate that single or multiple doses of fluconazole 50 mg do not affect its metabolism.
Danish: Interaktionsforsøg med phenazon tyder på, at enkeltdosis eller gentagne doser af fluconazol 50 mg ikke påvirker dets metabolisering.
English: Azithromycin: An open-label, randomized, three-way crossover study in 18 healthy subjects assessed the effect of a single 1200 mg oral dose of azithromycin on the pharmacokinetics of a single 800 mg oral dose of fluconazole as well as the effects of fluconazole on the pharmacokinetics of azithromycin.
Danish: Azithromycin: I et åbent, randomiseret, trevejs-crossover forsøg med 18 raske forsøgspersoner blev det vurderet, om en enkelt oral dosis på 1.200 mg azithromycin havde effekt på farmakokinetikken af en enkelt oral dosis på 800 mg fluconazol såvel som fluconazols effekt på azithromycins farmakokinetik.
English: After administration of 2-8 mg/kg fluconazole to children between the ages of 9 months to 15 years, an AUC of about 38 µgh/ml was found per 1 mg/kg dose units.
Danish: Efter administration af 2-8 mg/kg fluconazol til børn i alderen 9 måneder til 15 år fandtes en AUC på 38 µg·t/ml pr. 1 mg/kg dosisenhed.
English: After reconstitution, the volume of the suspension is 110 ml, providing a usable volume of 100 ml.
Danish: Efter rekonstitution er volumen af suspensionen 110 ml, der giver en brugbar volumen på 100 ml.
English: During post-marketing surveillance, there have been very rare cases of QT prolongation and torsades de pointes in patients taking Diflucan.
Danish: Efter markedsføring er der set meget sjældne tilfælde af forlængelse af QT-intervallet og torsades de pointes hos patienter i behandling med Diflucan.
English: Like all medicines, Diflucan can cause side effects, although not everybody gets them
Danish: Diflucan kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: The dilution is to be made under aseptic conditions.
Danish: Rekonstitution/fortynding skal laves under aseptiske forhold.
English: Thus, multiple dose use of fluconazole at these doses is unlikely to have an effect on the efficacy of the combined oral contraceptive.
Danish: Det er således næppe sandsynligt, at gentagne doser af fluconazol på dette niveau vil påvirke effekten af et oralt kontraceptivum af kombinationstypen.
English: HMG-CoA reductase inhibitors should be discontinued if a marked increase in creatinine kinase is observed or myopathy/rhabdomyolysis is diagnosed or suspected.
Danish: HMG-CoA-reduktase-hæmmere bør seponeres, hvis der ses markant stigning i kreatinkinase, eller hvis myopati/rabdomyolyse diagnosticeres eller mistænkes.
English: Amitriptyline, nortriptyline: Fluconazole increases the effect of amitriptyline and nortriptyline.
Danish: Amitriptylin, nortriptylin: Fluconazol øger effekten af amitriptylin og nortriptylin.
English: After reconstitution, the volume of the suspension is 40 ml, providing a usable volume of 35 ml.
Danish: Efter rekonstitution er volumen af suspensionen 40 ml, der giver en brugbar volumen på 35 ml.
English: The average fluconazole plasma elimination half-life varied between 15 and 18 hours and the distribution volume was approximately 880 ml/kg after multiple doses.
Danish: Den gennemsnitlige plasma-halveringstid for fluconazol var 1518 timer, og distributionsvolumen var ca. 880 ml/kg efter gentagne doser.
English: Glass vials: 5 years.
Danish: Hætteglas: 5 år.
English: Longer periods depending on both the severity of infection or underlying immune compromisation and infection
Danish: Længere afhængigt af både infektionens sværhedsgrad og underliggende immunsuppression / infektion.
English: A pharmacokinetic study was conducted in 22 subjects, 65 years of age or older receiving a single 50 mg oral dose of fluconazole.
Danish: Et farmakokinetisk forsøg blev foretaget med 22 personer, der var 65 år eller ældre, og som fik en enkelt dosis 50 mg fluconazol.
English: The pharmacokinetics of fluconazole has not been studied in paediatric population with renal insufficiency (for “Term newborn infants” who often exhibit primarily renal immaturity please see below).
Danish: Fluconazols farmakokinetik er ikke blevet undersøgt hos børn med nedsat nyrefunktion (se nedenstående for ”Nyfødte (født til termin)” som ofte udviser primær umoden nyrefunktion).
English: The combination may be used while taking increased consideration to the risk of increased serum bilirubin and serum creatinine.
Danish: Kombinationen kan anvendes med øget opmærksomhed på risikoen for stigning i serum-bilirubin og serum-kreatinin.
English: Torsade de pointes (see section 4.4), QT prolongation (see section 4.4)
Danish: Torsades de pointes (se pkt 4.4), QT-forlængelse (se pkt.4.4)
English: Method of administration The capsules should be swallowed whole and independent of food intake.
Danish: Administrationsmåde Kapslerne skal synkes hele og kan tages uafhængigt af måltider.
English: Peak plasma concentrations in the fasting state occur between 0.5 and 1.5 hours post-dose.
Danish: Den maksimale plasmakoncentration i fastende tilstand nås 0,5-1,5 time efter dosisindtagelse.
English: To be taken into consideration by patients on a controlled sodium diet.
Danish: Der skal tages hensyn hertil hos patienter på diæt med kontrolleret saltindtagelse.
English: Rifabutin: Fluconazole increases serum concentrations of rifabutin, leading to increase in the AUC of rifabutin up to 80%.
Danish: Rifabutin: Fluconazol øger serumkoncentrationen af rifabutin, hvilket fører til en stigning i AUC for rifabutin med op til 80%.
English: Concomitant repeated administration of 200 mg fluconazole and 250 mg phenytoin intravenously, caused an increase of the phenytoin AUC24 by 75% and Cmin by 128%.
Danish: Samtidig gentagen administration af 200 mg fluconazol og 250 mg phenytoin intravenøst forårsagede en stigning i phenytoins AUC24 med 75% og Cmin med 128%.
English: This combination may be used with a dose adjustment of sirolimus depending on the effect/concentration measurements.
Danish: Kombinationen kan anvendes med dosisjustering af sirolimus afhængigt af effekt/koncentrationsmålinger.
English: • Dermatomycosis including tinea pedis, tinea corporis, tinea cruris, tinea versicolor and dermal candida infections when systemic therapy is indicated.
Danish: • Dermatomykoser inklusive tinea pedis, tinea corporis, tinea cruris, tinea versicolor og dermale candida-infektioner, når systemisk behandling er indiceret.
English: In the event of overdose, symptomatic treatment (with supportive measures and gastric lavage if necessary) may be adequate.
Danish: I tilfælde af overdosering er symptomatisk behandling (med understøttende foranstaltninger og om nødvendigt maveskylning) sandsynligvis tilstrækkelig.
English: 50 to 100 mg daily Up to 28 days.
Danish: 50-100 mg dagligt Op til 28 dage.
English: Theophylline: In a placebo controlled interaction study, the administration of fluconazole 200 mg for 14 days resulted in an 18% decrease in the mean plasma clearance rate of theophylline.
Danish: Theophyllin: I et placebokontrolleret interaktionsforsøg resulterede administration af fluconazol 200 mg i 14 dage i et 18% fald i gennemsnitlig plasmaclearance af theophyllin.
English: - Acute vaginal candidiasis - Candidal balanitis
Danish: - Akut vaginal candidiasis - Candidal balanitis
English: Non-steroidal anti-inflammatory drugs: The Cmax and AUC of flurbiprofen was increased by 23% and 81%, respectively, when coadministered with fluconazole compared to administration of flurbiprofen alone.
Danish: Non-steroide antiinflammatoriske lægemidler: Cmax og AUC for flurbiprofen blev øget med henholdsvis 23% og 81% ved kombinationsbehandling med fluconazol sammenlignet med administration af flurbiprofen alene.
English: If concomitant benzodiazepine therapy is necessary in patients being treated with fluconazole, consideration should be given to decreasing the benzodiazepine dose, and the patients should be appropriately monitored.
Danish: Hvis samtidig behandling med benzodiazepin er nødvendig hos patienter i behandling med fluconazol, bør det overvejes at give en mindre benzodiazepindosis, og patienterne bør moniteres i passende grad.
English: The discontinuation of fluconazole presumably caused an enhanced CYP3A4 activity which led to increased metabolism of prednisone.
Danish: Seponeringen af fluconazol forårsagede formentlig en øget CYP3A4-aktivitet, som førte til øget metabolisering af prednison.
English: Write the expiry date of the reconstituted suspension on the bottle label (the shelf life of the reconstituted suspension is 28 days).
Danish: Noter udløbsdatoen for den rekonstituerede suspension på flaskeetiketten (holdbarheden for den rekonstituerede suspension er 28 dage).
English: Fentanyl: One fatal case of fentanyl intoxication due to possible fentanyl fluconazole interaction was reported.
Danish: Fentanyl: Et letalt tilfælde af fentanylforgiftning er blevet rapporteret i forbindelse med en mulig fentanyl-fluconazol-interaktion.
English: The maximum dose for children is 400 mg daily.
Danish: Den højeste dosis til børn er 400 mg dagligt.
English: One 180 ml amber Type III glass bottle with threaded aluminum caps.
Danish: 180 ml brun type III-hætteglas med aluminiumskruelåg.
English: This medicinal product is authorised in the Member States of the EEA under the following names: [See Annex I - To be completed nationally]
Danish: Dette lægemiddel er godkendt i EEAs medlemslande under følgende navne: [Se bilag I - Udfyldes nationalt]
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 fluconazole.
Danish: Akkumulering af 14-alfa-methylsterol korrelerer med det efterfølgende fald i ergosterol-koncentrationen i svampens cellemembran og kan være årsagen til fluconazols antimykotisk effekt.
English: Increased tacrolimus levels have been associated with nephrotoxicity.
Danish: Forhøjet tacrolimus-koncentration er forbundet med nefrotoksicitet.
English: With coadministration, serum phenytoin concentration levels should be monitored in order to avoid phenytoin toxicity.
Danish: Ved kombinationsbehandling anbefales monitorering af serum-phenytoin for at undgå phenytointoksicitet.
English: Diflucan is indicated in adults for the treatment of:
Danish: Diflucan er indiceret til voksne til behandling af:
English: Once opened, Diflucan may be used for a maximum of 30 days.
Danish: Efter åbning kan Diflucan kun anvendes i højst 30 dage.
English: There are few pharmacokinetic data to support this posology in term newborn infants (see section 5.2).
Danish: Der er kun få farmakokinetiske data til at understøtte nedenstående dosering til nyfødte (se pkt.
English: The most common cause of fungal infections is a yeast called Candida.
Danish: Den almindeligste svampeinfektion skyldes en gærsvamp, der hedder Candida.
English: The reduced dose and/or frequency of voriconazole and fluconazole that would eliminate this effect have not been established.
Danish: Hvilken dosisreduktion og/eller ændring i doseringsfrekvens af voriconazol og fluconazol, der vil elimenere denne virkning, er ikke fastlagt.
English: Mechanism(s) of resistance
Danish: Resistensmekanisme(r)
English: The same dose as above but given once every 3 days.
Danish: Dosis er den samme som ovenstående, men skal gives hver 3. dag.
English: The same dose as above but given once every 2 days.
Danish: Dosis er den samme som ovenfor, men skal gives hver 2. dag.
English: Vitamin A: Based on a case-report in one patient receiving combination therapy with all-trans-retinoid acid (an acid form of vitamin A) and fluconazole, CNS related undesirable effects have developed in the form of pseudotumour cerebri, which disappeared after discontinuation of fluconazole treatment.
Danish: Vitamin A: Baseret på en caserapport på en patient, der fik kombinationsbehandling med all-transretinoidsyre (en syreform af vitamin A) og fluconazol, blev der set udvikling af CNS-bivirkninger i form af pseudotumor cerebri, som forsvandt efter seponering af fluconazol.
English: Patients who are receiving high dose theophylline or who are otherwise at increased risk for theophylline toxicity should be observed for signs of theophylline toxicity while receiving fluconazole.
Danish: Patienter i behandling med høje doser theophyllin, eller som af andre årsager har en øget risiko for theophyllintoksicitet, bør observeres for tegn på theophyllintoksicitet ved samtidig behandling med fluconazol.
English: These reports included seriously ill patients with multiple confounding risk factors, such as structural heart disease, electrolyte abnormalities and concomitant treatment that may have been contributory.
Danish: Disse rapporter omfatter alvorligt syge patienter med flere sammenblandede risikofaktorer, som strukturel hjertesygdom, elektrolytforstyrrelser og samtidig brug af anden medicin.
English: The clinical significance of results obtained in these studies is unknown.
Danish: Det vides ikke, om resultaterne fra disse studier er klinisk signifikante.
English: The capsules should be swallowed whole and independent of food intake.
Danish: Kapslerne skal synkes hele og kan tages uafhængigt af måltider.
English: Important information about some of the ingredients of Diflucan Diflucan contains 0.154 mmol sodium per ml.
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i Diflucan Diflucan indeholder 0,154 mmol natrium pr. ml.
English: Carcinogenesis
Danish: Karcinogenicitet
English: If concomitant therapy is necessary, the patient should be observed for symptoms of myopathy and rhabdomyolysis and creatinine kinase should be monitored.
Danish: Hvis samtidig behandling er nødvendig, skal patienten observeres for symptomer på myopati og rabdomyolyse, og kreatinkinase bør monitoreres.
English: Such a hormone change has not been observed in women treated with fluconazole (see section 5.1).
Danish: Tilsvarende hormonforandringer er ikke set hos kvinder behandlet med fluconazol (se pkt.
English: There were no foetal effects at 5 or 10 mg/kg; increases in foetal anatomical variants (supernumerary ribs, renal pelvis dilation) and delays in ossification were observed at 25 and 50 mg/kg and higher doses.
Danish: Der var ingen føtale virkninger ved 5 eller 10 mg/kg; stigning i føtale anatomiske varianter (overtallige ribben, dilatation af pelvis renalis) og forsinket ossifikation er set ved 25 og 50 mg/kg og højere doser.
English: Plasma elimination half-life for fluconazole is approximately 30 hours.
Danish: Plasmahalveringstiden for fluconazol er ca. 30 timer.
English: Fluconazole is a triazole antifungal agent.
Danish: Fluconazol er et triazol-antimykotikum.
English: In addition to the observed/documented interactions mentioned below, there is a risk of increased plasma concentration of other compounds metabolized by CYP2C9 and CYP3A4 coadministered with fluconazole.
Danish: Ud over de observerede/dokumenterede interaktioner anført nedenfor er der en risiko for øget plasmakoncentration af andre stoffer metaboliseret af CYP2C9 og CYP3A4 ved administration sammen med fluconazol.
English: to children of 11 days-11 months old.
Danish: til børn i alderen 11 dage til 11 måneder.
English: Of a radioactive dose, only 11% is excreted in a changed form in the urine.
Danish: Kun 11% af en radioaktiv dosis udskilles i urinen som metabolitter.
English: 150 mg every third day for a total of 3 doses (day 1, 4, and 7) followed by 150 mg once weekly maintenance dose
Danish: 150 mg hver 3. dag i alt 3 gange (dag 1, 4 og 7) efterfulgt af 150 mg én gang ugentligt som vedligeholdelsesdosis
English: - Do not use the medicine if you notice signs of deterioration such as unusual odour, product discoloration, visible particles or crystallisation.
Danish: De må ikke tage medicinen, hvis der er tegn på forringelse som unormal lugt, misfarvning, synlige partikler eller krystallisering.
English: Oral contraceptives: Two pharmacokinetic studies with a combined oral contraceptive have been performed using multiple doses of fluconazole.
Danish: Orale kontraceptiva: Der er udført 2 farmakokinetiske forsøg med et oral kontraceptivum af kombinationstypen og gentagen dosering med fluconazol.
English: Symptomatic treatment (with supportive measures and gastric lavage if necessary) may be adequate.
Danish: Behandling af symptomerne (med generelle støtteforanstaltninger og om nødvendigt maveskylning) kan være tilstrækkeligt.