FrancophonIA/ELRC3.0 huggingface dataset:
English: Escape phenomenon
Danish: Undvigelsesfænomen
English: Increases in liver enzymes (≤ 5N and > 5N) were observed in ~13.5 % and ~2.5% of patients respectively occurring mostly within the first 6 months of treatment.
Danish: Forhøjede leverenzymværdier (≤ 5N og > 5N) blev observeret hos henholdsvis ~13,5 % og ~2,5 % af patienterne og forekom hovedsageligt inden for de første 6 behandlingsmåneder.
English: Your doctor will test your blood before you start the treatment and regularly during the treatment to detect any possible abnormalities and also to measure the levels of cortisol.
Danish: Lægen tester dit blod, før du starter på behandlingen og med jævne mellemrum under behandlingen for at opdage eventuelle unormale forhold samt måle kortisolniveauet.
English: Use in ectopic Adrenocorticotropic Hormone (ACTH) syndrome
Danish: Anvendelse til ektopisk adrenokortikotropt hormon (ACTH)-syndrom
English: Vardenafil is contraindicated in men older than 75 years old (see section
Danish: Vardenafil er kontraindiceret hos mænd over 75 år (se pkt.
English: However, the genotoxic potential was not properly determined for the proposed dosing regimen in the treatment of endogenous Cushing's syndrome.
Danish: Det genotoksiske potentiale blev dog ikke fastlagt på behørig vis for det foreslåede dosisregime til behandling af endogent Cushings syndrom.
English: Careful monitoring of digoxin levels is recommended.
Danish: Digoxinniveauet bør monitoreres omhyggeligt.
English: The dose will be adapted to your condition with the aim to restore normal cortisol levels.
Danish: Dosis vil blive tilpasset din tilstand for at genoprette et normalt kortisolniveau.
English: Respiratory Drugs Salmeterol
Danish: Respiratoriske lægemidler Salmeterol
English: Inhibition of these different transporters at clinically relevant concentrations of ketoconazole cannot be excluded.
Danish: Hæmning af disse forskellige transportører ved klinisk relevante koncentrationer af ketoconazol kan ikke udelukkes.
English: Data of inhibition indicate that risk of interaction with BCRP substrates cannot be excluded at the systemic level with very high doses of ketoconazole.
Danish: Data vedrørende hæmning tyder på, at risiko for interaktion med BCRP-substrater ikke kan udelukkes på systemisk niveau med meget høje doser ketoconazol.
English: Not recommended as it may increase ibrutinib-related toxicity.
Danish: Anbefales ikke, da det kan øge ibrutinib-relateret toksicitet.
English: If you think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Danish: Hvis du har mistanke om, at du er gravid, eller hvis du har planer om at blive gravid, skal du spørge din læge til råds, før du tager dette lægemiddel.
English: Warfarin and other coumarin-like drugs
Danish: Warfarin og andre coumarinlignende lægemidler
English: However in patients with adrenal cortical carcinoma, improvement of hypercortisolism on ketoconazole was limited in some cases.
Danish: Hos patienter med adrenokortikalt karcinom var forbedringen af hyperkortisolisme på ketoconazol dog begrænset i nogle tilfælde.
English: At the last follow-up, clinical signs were improved in 74/134 patients (55.2%), hypertension in 36/90 patients (40), hypokalaemia in 10/26 patients (38.4%), and diabetes mellitus in 23/39 patients (59%).
Danish: Ved den sidste opfølgning var de kliniske tegn forbedret hos 74/134 patienter (55,2 %), hypertension hos 36/90 patienter (40 %), hypokaliæmi hos 10/26 patienter (38,4 %) og diabetes mellitus hos 23/39 patienter (59 %).
English: Józefów 9, 99-300 Kutno Poland
Danish: Józefów 9, 99-300 Kutno Polen
English: Heart disease Ketoconazole HRA can change how your heart beats - this can be serious.
Danish: Hjertesygdom Ketoconazole HRA kan ændre den måde, dit hjerte arbejder på - dette kan være alvorligt.
English: Transient decrease of testosterone concentrations
Danish: Forbigående fald i testosteronkoncentrationen
English: At doses > 400 mg/day, half-lives of 3 to 10 hours have been reported.
Danish: Ved doser på >400 mg/dag er der rapporteret halveringstider på 3-10 timer.
English: The doses used in adolescents above 12 years old were similar to the doses used in adults' patients with endogenous Cushing's syndrome.
Danish: De doser, der blev anvendt til unge over 12 år, var de samme som de doser, der blev anvendt til voksne patienter med endogent Cushings syndrom.
English: At treatment initiation, 24-hour urinary free cortisol should be controlled every few days/weeks.
Danish: Ved behandlingens start skal 24-timers frit kortisol i urinen kontrolleres med få dages/ugers mellemrum.
English: If you have taken more than the prescribed dose of Ketoconazole HRA, you must contact your doctor immediately.
Danish: Hvis du har taget mere end den foreskrevne dosis Ketoconazole HRA, skal du straks kontakte lægen.
English: Ketoconazole is extensively metabolised to a large number of inactive metabolites.
Danish: Ketoconazol metaboliseres i stor udstrækning til et stort antal inaktive metabolitter.
English: Interactions between ketoconazole and other medicinal products are listed in the table below (increase is indicated as “↑”, decrease as “↓”, an no change as “↔”).
Danish: Interaktioner mellem ketoconazol og andre lægemidler er anført i tabellen herunder (øgning er angivet som ”↑”, fald som ”↓” og ingen ændring som ”↔”).
English: Treatment should be initiated and supervised by physicians experienced in endocrinology or internal medicine and having the appropriate facilities for monitoring of biochemical responses since the dose must be adjusted to meet the patient's therapeutic need, based on the normalisation of cortisol levels.
Danish: Behandling skal initieres og superviseres af læger med erfaring i endokrinologi eller intern medicin og med passende faciliteter til monitorering af biokemiske responser, da dosis skal justeres i forhold til patientens terapeutiske behov, baseret på normalisering af kortisolniveauet.
English: Alcohol intolerance, anorexia, increased appetite
Danish: Alkoholintolerans, appetitløshed, øget appetit
English: Ketoconazole has been used both as sole medical therapy and in combination with other medicinal products, mainly with metyrapone, in patients with more severe disease or in those not completely responding to a single active substance or in those requiring a dose reduction of at least one of the medicinal products to improve tolerance.
Danish: Ketoconazol er blevet anvendt både som eneste medicinske behandling og i kombination med andre lægemidler, fortrinsvis med metyrapon, til patienter med mere alvorlig sygdom, til patienter, som ikke responderede fuldstændigt på et enkelt aktivstof, og til patienter, hvor dosisreduktion af mindst et af lægemidlerne var nødvendig for at forbedre toleransen.
English: Clinical improvement in hypokalaemia, metabolic alkalosis, diabetes mellitus, and hypertension occurred even in the absence of complete hormonal response.
Danish: Klinisk forbedring af hypokaliæmi, metabolisk alkalose, diabetes mellitus og hypertension forekom også, selvom der ikke var fuldstændig hormonel respons.
English: In a Canadian study, of the 12 assessable patients (out of 15), 10 showed a reduction in urinary free cortisol levels, but only five had complete resolution on ketoconazole doses 400 to 1200 mg/day.
Danish: I et canadisk studie havde 10 af de 12 vurderbare patienter (ud af 15) reduceret niveau af frit kortisol i urinen, men kun 5 opnåede fuldstændig resolution på ketoconazoldoser på 400-1.200 mg/dag.
English: Insomnia, nervousness
Danish: Søvnløshed, nervøsitet
English: Healthcare professionals are asked to report any suspected adverse reactions.
Danish: Sundhedspersoner anmodes om at indberette alle mistænkte bivirkninger.
English: If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.
Danish: Hvis lægen har fortalt dig, at du ikke tåler visse sukkerarter, skal du kontakte din læge, før du tager dette lægemiddel.
English: In vitro data indicate that ketoconazole is a potent inhibitor of OATP1B1, OATP1B3, OAT3, OCT1 and OCT2 and to a lesser extent of OAT1 and BSEP.
Danish: In vitro-data tyder på, at ketoconazol er en kraftig hæmmer af OATP1B1, OATP1B3, OAT3, OCT1 og OCT2 og i mindre grad af OAT1 og BSEP.
English: Jozefow 9 99-300 Kutno Poland
Danish: Jozefow 9 99-300 Kutno Polen
English: Use in ACTH-independent Cushing's syndrome
Danish: Anvendelse til ACTH-uafhængigt Cushings syndrom
English: They will be checked again after that in case your doctor increases your daily ketoconazole dose.
Danish: Derefter vil din leverfunktion blive kontrolleret igen, hvis din læge øger din daglige dosis ketoconazol.
English: If you interrupt your treatment with Ketoconazole HRA your cortisol level may increase again and your symptoms may come back.
Danish: Hvis du afbryder din behandling med Ketoconazole HRA, kan dit kortisolniveau stige igen og dine symptomer vende tilbage.
English: Indinavir (600mg TID): AUC= 0.8-fold
Danish: Indinavir (600 mg 3 gange dagligt): AUC= 0,8 gange
English: Antidiabetics Repaglinide
Danish: Antidiabetika Repaglinid
English: Considering the rapid absorption of ketoconazole, intake of BCRP substrates should be postponed for 2 hours after ketoconazole intake.
Danish: Under hensyntagen til den hurtige absorption af ketoconazol bør indtagelse af BCRP-substrater udsættes til 2 timer efter indtagelse af ketoconazol.
English: The major identified metabolic pathways are oxidation and degradation of the imidazole and piperazine rings, oxidative O-dealkylation and aromatic hydroxylation.
Danish: De vigtigste påviste metaboliseringsveje er oxidation og nedbrydning af imidazol- og piperazinringene, oxidativ O-dealkylering og aromatisk hydroxylering.
English: There is no evidence to suggest that there is an interaction between ketoconazole and other steroidogenesis inhibitors (i.e. metyrapone).
Danish: Der er ingen evidens for, at der skulle være nogen interaktion mellem ketoconazol og andre steroidgenesehæmmere (dvs. metyrapon).
English: • Transient decrease of testosterone, a male hormone (androgen) made by the body,
Danish: • Forbigående fald i testosteron, et mandligt kønshormon (androgen), der produceres af kroppen, primært i testiklerne.
English: Table 2: Incidence of adverse reactions and marked laboratory abnormalities reported in the literature in adults and adolescents patients
Danish: Tabel 2: Forekomsten af bivirkninger og markante unormale laboratorieværdier, der er rapporteret i litteraturen, hos voksne og unge patienter.
English: No formal evaluation of the effect of age on the pharmacokinetics of ketoconazole has been performed.
Danish: Der er ikke udført nogen formel vurdering af alders virkning på ketoconazols farmakokinetik.
English: The requirements for submission of PSURsfor this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort påDet Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Control of cortisol levels, either in serum/plasma or urine, was used to assess the efficacy of the treatment, along with the evaluation of clinical symptoms of Cushing's syndrome.
Danish: Kontrol af kortisolniveau, enten i serum/plasma eller urin, blev anvendt til at vurdere behandlingens effekt samt til at vurdere de kliniske symptomer på Cushings syndrom.
English: Absorption Ketoconazole is a weak dibasic active substance and thus requires acidity for dissolution and absorption.
Danish: Absorption Ketoconazol er en svag dibasisk aktiv substans og kræver aciditet for at blive opløst og absorberet.
English: Pharmacotherapeutic group: Antimycotics for systemic use, imidazole derivatives, ATC code: J02AB02
Danish: Farmakoterapeutisk klassifikation: antimykotika til systemisk brug, imidazol-derivater. ATC-kode: J02AB02.
English: - certain medicines for lowering blood cholesterol: simvastatin, atorvastatin, lovastatin
Danish: - visse lægemidler til sænkning af blodets kolesterol: simvastatin, atorvastatin, lovastatin
English: There are no or limited amount of data from the use of Ketoconazole HRA in pregnant women.
Danish: Der er ingen eller utilstrækkelige data fra anvendelse af ketoconazol til gravide kvinder.
English: Ketoconazole was not genotoxic in vitro and in vivo.
Danish: Ketoconazol var ikke genotoksisk in vitro og in vivo.
English: Ketoconazole is not carcinogenic.
Danish: Ketoconazol er ikke karcinogent.
English: Immunosuppressants Everolimus Sirolimus (rapamycin)
Danish: Immunsuppressiva Everolimus Sirolimus (rapamycin)
English: Anti-infectives Rifabutin Rifampicin Isoniazid
Danish: Antiinfektiva Rifabutin Rifampin Isoniazid
English: More than 800 patients have been treated with ketoconazole with variable treatment duration and modalities.
Danish: Over 800 patienter har fået ketoconazol med forskellige behandlingsvarigheder og behandlingsmetoder.
English: At the last visit, 78 patients (49.3%) were controlled, 37 patients (23.4%) had partial control with at least 50% decrease of UFC (without normalisation), and 43 patients (27.2%) had unchanged UFC levels.
Danish: Ved det sidste besøg blev 78 patienter (49,3 %) kontrolleret, 37 patienter (23,4 %) havde delvis kontrol med mindst 50 % fald i frit kortisol i urinen (uden normalisering), og 43 patienter (27,2 %) havde uændret niveau af frit kortisol i urinen.
English: Package leaflet: Information for the patient Ketoconazole HRA 200 mg tablets ketoconazole This medicine is subject to additional monitoring.
Danish: Indlægsseddel: Information til patienten Ketoconazole HRA 200 mg tabletter ketoconazol Dette lægemiddel er underlagt supplerende overvågning.
English: Antipsychotics, Anxiolytics and Hypnotics Triazolam Alprazolam Midazolam oral
Danish: Antipsykotika, anxiolytika og hypnotika Triazolam Alprazolam Midazolam oral
English: Some combinations may lead to an increased risk of ventricular tachyarrhythmias, including occurrences of torsade de pointes, a potentially fatal arrhythmia (see Table 1 Interactions and recommendations for co-administration, section 4.5).
Danish: Nogle kombinationer kan føre til forhøjet risiko for ventrikulære takyarytmier, herunder torsade de pointes, en potentielt dødelig arytmi (se tabel 1 Interaktioner og anbefalinger vedrørende samtidig administration, pkt.
English: Based on limited data, pharmacokinetics parameters (AUC, Cmax and half-life) of ketoconazole for doses of 5 to 10 mg/kg/days, corresponding approximately to daily doses of 200-800 mg, are similar in paediatric and adult population.
Danish: Ud fra begrænsede data er ketoconazols farmakokinetiske parametre (AUC, Cmax og halveringstid) ved doser på 5-10 mg/kg/dag, omtrent svarende til daglige doser på 200-800 mg, de samme i den pædiatriske og voksne population.
English: Hepatotoxicity does not appear to be dose dependent.
Danish: Hepatotoksicitet synes ikke at være dosisafhængig.
English: Tacrolimus Ciclosporine Budesonide Ciclesonide
Danish: Tacrolimus Ciclosporin Budesonid Ciclesonid
English: Ketoconazole dose should be adjusted accordingly.
Danish: Ketoconazol-dosis skal justeres i overensstemmelse dermed.
English: If these occur, treatment should be stopped immediately and liver function tests should be performed.
Danish: Hvis disse symptomer forekommer, skal behandlingen straks seponeres, og der skal tages leverfunktionsprøver.
English: Nevirapine: plasma levels: ↑1.15-1.28fold compared to historical controls
Danish: plasmaniveau: ↑ 1,15-1,28 gange sammenlignet med historiske kontroller.
English: Treatment with ketoconazole in paediatric patients allowed normalisation of urinary free cortisol levels and clinical improvement, including recovering of growth rate and gonadal function, normalisation of blood pressure, Cushing's syndrome features and weight loss in most of the cases.
Danish: Behandling med ketoconazol til pædiatriske patienter muliggjorde normalisering af niveauet af frit kortisol i urinen og kliniske forbedringer, herunder genvinding af vækstrate og gonadefunktion, normalisering af blodtryk, kendetegn på Cushings syndrom og vægttab i de fleste tilfælde.
English: Antivirals products Saquinavir (saquinavir/ritonavir 1000/100 mg bid)
Danish: Antivirale præparater Saquinavir (saquinavir/ritonavir 1000/100 mg 2 gange dagligt)
English: Medicinal product by therapeutic area
Danish: Lægemiddel efter terapeutisk område
English: Although hepatotoxicity is usually observed at treatment initiation and within the first six months of treatment, monitoring of liver enzymes should be done under medical criteria.
Danish: Selvom hepatotoksicitet normalt observeres i forbindelse med behandlingsstart og inden for de første 6 måneders behandling, skal leverenzymer monitoreres i henhold til kliniske kriterier.
English: - Ketoconazole can inhibit the transport of medicinal products by P-gp, which may result in an increased plasma concentration of these medicinal products.
Danish: - Ketoconazol kan hæmme lægemiddeltransporten via P-gp, hvilket kan medføre en øget plasmakoncentration af disse lægemidler.
English: Mean peak plasma concentrations of approximately 3.5 μg/ml are reached within 1 to 2 hours, following oral administration of a single 200 mg dose taken with a meal.
Danish: Gennemsnitlige maksimale plasmakoncentrationer på ca. 3,5 μg/ml nås i løbet af 1-2 timer efter oral administration af en enkelt 200 mg dosis i forbindelse med et måltid.
English: A 17 years old girl was treated on ketoconazole 1,200 mg/day for an adrenal carcinoma with liver metastasis and had altered liver function tests at 22 days.
Danish: En 17-årig pige blev behandlet med ketoconazol 1.200 mg/dag for et binyrekarcinom med levermetastaser og havde ændrede leverfunktionsprøver efter 22 dage.
English: Ciclesonide active metabolite:
Danish: Ciclesonid-aktiv metabolit:
English: The efficacy and safety of ketoconazole in the treatment of Cushing's syndrome from all causes have been described through several published retrospective studies, chart reviews and case reports.
Danish: Ketoconazols virkning og sikkerhed i behandlingen af Cushings syndrom, uanset årsag, er beskrevet i flere publicerede retrospektive studier, journalgennemgange og journaler.
English: Ketoconazole did not produce any change in rosuvastatin pharmacokinetics, therefore, co-administration of ketoconazole and rosuvastatin is unlikely to increase the risk of toxicity of rosuvastatin.
Danish: ketoconazol gav ingen ændring i rosuvastatins farmakokinetik, og det er derfor usandsynligt, at samtidig administration af ketoconazol og rosuvastatin øger risikoen for rosuvastatin-toksicitet.
English: - Do not use this medicine after the expiry date which is stated on the carton and on the blister after EXP.
Danish: - Brug ikke lægemidlet efter den udløbsdato, der står på karton og blister efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Data on the use of ketoconazole in patients older than 65 years are limited, but there is no evidence to suggest that specific dose adjustment is required in these patients (see section 5.2).
Danish: Der er begrænsede data om brug af ketoconazol til patienter over 65 år, men der er ingen evidens for, at særlig dosisjustering skulle være nødvendig hos disse patienter (se pkt.
English: Fesoterodine active metabolite:
Danish: Fesoterodin-aktiv metabolit:
English: Other statins that are not CYP3A4 substrates (pravastatin and fluvastatin) can be co-administered with ketoconazole.
Danish: Andre statiner, der ikke er CYP3A4-substrater (pravastatin og fluvastatin), kan administreres sammen med ketoconazol.
English: It is used to treat endogenous Cushing's syndrome (when the body produces an excess of cortisol) in adults and adolescents above the age of 12 years.
Danish: Det anvendes til at behandle endogent Cushings syndrom (når kroppen producerer for meget kortisol) hos voksne og unge over 12 år.
English: Electrophysiological studies have shown that ketoconazole inhibits the rapidly activating component of the cardiac delayed rectifier potassium current, prolongs the action potential duration, and may prolong the QT interval.
Danish: Elektrofysiologiske studier har vist, at ketoconazol hæmmer den hurtigt aktiverende komponent i hjertets forsinkede korrigerende kaliumstrøm, forlænger varigheden af aktionspotentialet og kan forlænge QTintervallet.
English: System organ class
Danish: Organsystemklasse Hyppighed
English: A 14 year-old girl who was treated for Cushing's disease with ketoconazole 200 mg twice daily presented one month later with jaundice, fever anorexia, nausea and vomiting.
Danish: En 14-årig pige, som blev behandlet for Cushings sygdom med ketoconazol 200 mg 2 gange dagligt, kom en måned senere med gulsot, feber, anoreksi, kvalme og opkastning.
English: Careful monitoring and dose adjustment of these medicinal products may be required.
Danish: Omhyggelig monitorering og dosisjustering af disse lægemidler kan være nødvendig.
English: Data from 17 patients with adrenal tumours and from 2 patients with primary nodular adrenocortical hyperplasia (NAH) treated with ketoconazole are available in the literature along with 17 individual case reports of patients with benign or malignant tumours or NAH and 2 paediatric cases of McCune Albright syndrome.
Danish: Data fra 17 patienter med tumorer i binyrerne og fra 2 patienter med primær nodulær adrenokortikal hyperplasi (NAH), som blev behandlet med ketoconazol, er tilgængelige i litteraturen sammen med 17 individuelle journaler fra patienter med benigne eller maligne tumorer eller NAH og 2 pædiatriske tilfælde af McCune Albright-syndrom.
English: Apart from adrenal blocking effect, ketoconazole may also have direct effects on corticotropic tumour cells in patients with Cushing's disease.
Danish: Bortset fra den binyreblokerende virkning kan ketoconazol også direkte påvirke kortikotrope tumorceller hos patienter med Cushings sygdom.
English: After ketoconazole withdrawal, liver enzymes returned to normal levels within 3 weeks (section 5.1).
Danish: Efter seponering af ketoconazol vendte leverenzymerne tilbage til normale niveauer inden for 3 uger (pkt.
English: There are some medicines that must not be taken with Ketoconazole HRA (see section 2).
Danish: Der er nogle lægemidler, som du ikke må tage sammen med Ketoconazole HRA (se punkt 2).
English: Vincristine, vinblastine (vinca alkaloids)
Danish: Vincristin, vinblastin (vinkaalkaloider)
English: The recommended initial dose is usually 600 mg per day taken orally (3 tablets per day in 3 divided times).
Danish: Den anbefalede startdosis er normalt 600 mg dagligt taget gennem munden (3 tabletter om dagen fordelt på 3 tidspunkter).
English: Ketoconazole has a high potential for clinically important medicinal products interactions.
Danish: Ketoconazol har et stort potentiale for klinisk relevante lægemiddelinteraktioner.
English: Coexisting inflammatory/autoimmune disorders
Danish: Samtidige inflammatoriske/autoimmune sygdomme
English: The recommended dose at initiation in adults and adolescents is 400-600 mg/day taken orally in two or three divided doses and this dose can be increased rapidly to 800-1,200 mg/day in two or three divided doses.
Danish: Den anbefalede startdosis til voksne og unge er 400-600 mg/dag oralt fordelt på 2-3 doser, og denne dosis kan hurtigt øges til 800-1.200 mg/dag fordelt på 2-3 doser.