FrancophonIA/ELRC3.0 huggingface dataset:
English: CYP3A4-metabolised and/or P-gp substrates known to prolong the QT interval may be contraindicated or not recommended depending on the observed or expected effect with ketoconazole (i.e. resulting in augmentation of the plasma concentration, AUC, Cmax of the drugs) and the known therapeutic margins of the drugs.
Danish: CYP3A4-metaboliserede og/eller P-gp-substrater, der vides at forlænge QT-intervallet, kan være kontraindicerede eller ikke anbefalede afhængigt af den observerede eller forventede virkning med ketoconazol (resulterer i forøgelse af plasmakoncentrationen, AUC, Cmax for lægemidlerne) og lægemidlernes kendte terapeutiske margin.
English: Patients with congenital lactase deficiency, galactosaemia or glucose-galactose intolerance must not be given this medicine unless strictly necessary.
Danish: Patienter med medfødt lactasemangel, galactosæmi eller glucose-galactose-intolerans må kun få dette lægemiddel på tvingende indikation..
English: * Rosuvastatin is not a CYP 3A4 substrate.
Danish: * Rosuvastatin er ikke et CYP3A4-substrat.
English: The overall pharmacological activity of cilostazol increases 35% when coadministered with ketoconazole.
Danish: Cilostazols samlede farmakologiske aktivitet øges med 35 %, når det administreres sammen med ketoconazol.
English: Therefore, do not stop taking Ketoconazole HRA unless your doctor tells you.
Danish: Derfor må du ikke holde op med at tage Ketoconazole HRA, medmindre lægen siger det.
English: Elevated liver enzymes and histological changes in the liver consisting in dose-related lipofuscin accumulation in hepatocytes were reported in rats and dogs after repeated administration of ketoconazole.
Danish: Forhøjede leverenzymer og histologiske ændringer i leveren bestående af dosisrelateret lipofuscinakkumulering i hepatocytter blev rapporteret hos rotter og hunde efter gentagen administration af ketoconazol.
English: Liver enzyme levels returned to normal within 2-12 weeks after a dose decrease or withdrawal of ketoconazole.
Danish: Leverenzymværdierne blev normaliseret inden for 2-12 uger efter dosisreduktion eller seponering af ketoconazol.
English: Cushing's syndrome is caused by overproduction of a hormone called cortisol which is produced by the adrenal glands.
Danish: Cushings syndrom skyldes overproduktion af et hormon, der hedder kortisol og produceres i binyrerne.
English: Liver enzymes should be monitored in all patients receiving ketoconazole.
Danish: Leverenzymer skal monitoreres hos alle patienter, som får ketoconazol.
English: The toxicological profile of ketoconazole has been established from long term studies in rats and dogs.
Danish: Ketoconazols toksikologiske profil er fastlagt på grundlag af langvarige studier med rotter og hunde.
English: Serum or plasma and/or salivary cortisol and/or urinary free cortisol levels should be monitored, within one week following ketoconazole initiation as a minimum, and then periodically thereafter.
Danish: Kortisol i serum eller plasma og/eller spyt og frit kortisol i urinen skal monitoreres som minimum inden for én uge efter initiering af ketoconazol og derefter med jævne mellemrum.
English: Preclinical data show that ketoconazole crosses the placenta and is teratogenic.
Danish: Prækliniske data viser, at ketoconazol passerer placenta og er teratogent.
English: Gastrointestinal Drugs Aprepitant
Danish: Gastrointestinale lægemidler Aprepitant
English: At clinically relevant concentrations inhibition of CYP2B6, 2C9/C8, 2C19 and 2D6 by ketoconazole cannot be excluded.
Danish: Det kan ikke udelukkes, at ketoconazol hæmmer CYP2B6, 2C9/C8, 2C19 og 2D6 ved klinisk relevante koncentrationer.
English: The half-life of ketoconazole increases with dose and duration of treatment.
Danish: Ketoconazols halveringstid øges i takt med dosis og behandlingsvarighed.
English: Block and replace regimen
Danish: Blokerings- og substitutionsregime
English: Patients treated with a block-and-replace regimen should be taught to adjust their glucocorticoid replacement therapy dose under conditions of stress (see section 4.2).
Danish: Patienter, som behandles med et blokerings- og substitutionsregime, skal undervises i at justere dosis i deres substitutionsbehandling med glukokortikoid under stressforhold (se pkt.
English: Although data are limited, the pharmacokinetics of ketoconazole are not significantly different in patients with renal failure compared to healthy subjects, and no specific dose adjustment is recommended in this population.
Danish: Selvom data er begrænsede, er ketoconazols farmakokinetik ikke væsentligt forskellig hos patienter med nyresvigt i forhold til raske forsøgspersoner, og der anbefales ingen særlig dosisjustering for denne population.
English: Not recommended due to a potential increase in colchicine-related toxicity.
Danish: Bør ikke anvendes pga. potentielt øget colchicin-relateret toksicitet.
English: - Ketoconazole inhibits BCRP (Breast Cancer Resistance Protein) in in vitro studies.
Danish: - Ketoconazol hæmmer BCRP (brystcancer-resistensprotein) i in vitro-studier.
English: Monitoring for an effect on the QTc interval is advisable.
Danish: Det tilrådes at monitorere for en eventuel virkning på QTc-intervallet.
English: Exacerbation or development of inflammatory/autoimmune disorders has been described after Cushing's syndrome remission, including after treatment with ketoconazole.
Danish: Eksacerbation eller udvikling af inflammatoriske/autoimmune sygdomme er beskrevet efter remission af Cushings syndrom, også efter behandling med ketoconazol.
English: • Sensation of tingling or pricking
Danish: • Snurrende eller prikkende fornemmelse
English: At steady state, mean peak concentrations of 1.7µg/mL to 15.6µg/mL were reported for total daily doses of 200 mg to 1,200 mg.
Danish: Ved steady state blev der rapporteret gennemsnitlige maksimale koncentrationer på 1,7-15,6 µg/ml ved totale daglige doser på 200-1.200 mg.
English: Ketoconazole should not be administered when liver enzymes are greater than 2 times the upper limit of normal or in association with other hepatotoxic medicinal products.
Danish: Ketoconazol bør ikke anvendes, når leverenzymer er højere end 2 gange den øvre normalgrænse eller i kombination med andre hepatotoksiske lægemidler.
English: Use with hepatotoxic medicinal products
Danish: Anvendelse med hepatotoksiske lægemidler
English: Use with pasireotide
Danish: Anvendelse med pasireotid
English: Concomitant therapy with medicinal products that are contraindicated during treatment with ketoconazole and resulting in potentially life-threatening adverse reactions :
Danish: Samtidig behandling med lægemidler, som er kontraindiceret under behandling med ketoconazol og medfører potentielt livstruende bivirkninger:
English: Adrenal insufficiency may be detected by periodic clinical assessment and monitoring of plasma/serum or salivary cortisol levels.
Danish: Binyrebarkinsufficiens kan påvises ved periodisk klinisk vurdering og monitorering af kortisolniveauet i plasma/serum eller spyt.
English: Ketoconazole has not been demonstrated to induce its own metabolism.
Danish: Det er ikke vist, at ketoconazol inducerer sin egen metabolisme.
English: Date of first authorisation: 19 November 2014 Date of latest renewal: <DD month YYYY>
Danish: Dato for seneste fornyelse: <DD måned ÅÅÅÅ>
English: Serious hepatotoxicity, including jaundice, hepatitis, hepatic necrosis, hepatic cirrhosis, hepatic failure including cases necessitating transplantation or resulting in death.
Danish: Alvorlig hepatotoksicitet herunder gulsot, hepatitis, hepatisk nekrose, hepatisk cirrose Leversvigt, herunder tilfælde, der kræver transplantation eller er dødelige
English: Data from 91 patients with the ectopic ACTH syndrome treated with ketoconazole were reviewed, along with 18 individual case reports.
Danish: Data fra 91 patienter med ektopisk ACTH-syndrom, som blev behandlet med ketoconazol, blev gennemgået sammen med 18 individuelle journaler.
English: If you take concomitant glucocorticoid replacement therapy with your Ketoconazole HRA treatment, your doctor should inform you how to adapt your glucocorticoid replacement therapy dose if you are under stress or have surgery or an infection.
Danish: Hvis du tager glukokortikoid som substitutionsbehandling sammen med Ketoconazole HRA, vil din læge fortælle dig, hvordan du tilpasser din glukokortikoid-dosis, hvis du er under stress, skal opereres eller får en infektion.
English: Ketoconazole has also been used with other therapies including surgery and pituitary radiation.
Danish: Ketoconazol er også blevet anvendt sammen med andre behandlinger, herunder operation og strålebehandling af hypofysen.
English: In vitro studies have shown that CYP3A4 is the major enzyme involved in the metabolism of ketoconazole.
Danish: In vitro-studier har vist, at CYP3A4 er det vigtigste enzym i ketoconazols metabolisme.
English: Data from 535 patients with Cushing's disease treated with ketoconazole, along with 13 individual case reports are available in the literature.
Danish: Data fra 535 patienter med Cushings sygdom, som blev behandlet med ketoconazol, samt 13 individuelle journaler er tilgængelige i litteraturen.
English: Doses of 80 and 160 mg/kg inhibited ovulation in immature rats.
Danish: Doser på 80 og 160 mg/kg hæmmede ægløsningen hos ikke færdigudviklede rotter.
English: Antiarrhythmics Disopyramide Quinidine
Danish: Antiarytmika Disopyramid Quinidin
English: Overall, ketoconazole was shown to be an effective medicinal product for normalising cortisol levels in all causes of Cushing's syndrome and, if tolerated, ketoconazole treatment can be maintained for a long period.
Danish: Generelt er ketoconazol vist at være et effektivt lægemiddel til normalisering af kortisolniveauet i forbindelse med Cushings syndrom uanset årsag, og hvis behandling med ketoconazol tåles, kan den opretholdes i en langvarig periode.
English: Repeated doses of 200 mg ketoconazole daily resulted in a 17-fold increase in dronedarone exposure
Danish: Gentagne doser af 200 mg ketoconazol dagligt medførte en stigning med faktor 17 i eksponeringen for dronedaron.
English: Specific dosing regimen
Danish: Særligt dosisregime
English: Intracranial pressure increased (papilloedema, fontanelle bulging), paraesthesia
Danish: Øget intrakranielt tryk (papilødem, udbulende fontanelle), paræstesi
English: About 75% of patients achieved a decrease of more than 50% of UFC levels on ketoconazole, compared to pre-treatment levels
Danish: Cirka 75 % af patienterne opnåede et fald på mere end 50 % i niveauet af frit kortisol i urinen, når de blev behandlet med ketoconazol, sammenlignet med niveauet før behandling.
English: Liver enzyme monitoring should be performed once weekly during the first month of treatment and then monthly for 6 months.
Danish: Leverenzymer bør monitoreres én gang ugentligt i den første behandlingsmåned og derefter hver måned i 6 måneder.
English: All potential associated factors of hepatotoxicity, and abnormal liver enzyme levels detected before ketoconazole initiation, should be taken into account before considering ketoconazole treatment.
Danish: Der skal tages højde for alle potentielle faktorer associeret med hepatotoksicitet og for unormale leverenzymværdier, der opdages før initiering af ketoconazol, før ketoconazol-behandling overvejes.
English: Due to the known hepatotoxicity of ketoconazole, the treatment must not be initiated in patients with liver enzymes levels above 2 times the upper limit of normal (see section 4.3).
Danish: På grund af ketoconazols kendte hepatotoksicitet må behandlingen ikke initieres hos patienter med leverenzymniveauer på over 2 gange den øvre normalgrænse (se pkt.
English: Ketoconazole HRA is indicated for the treatment of endogenous Cushing's syndrome in adults and adolescents above the age of 12 years.
Danish: Ketoconazole HRA er indiceret til behandling af endogent Cushings syndrom hos voksne og unge over 12 år.
English: Post Authorisation safety study (PASS): Multi-country, observational registry to collect clinical information on patients with Cushing Syndrome patients exposed with Ketoconazole (preferably using the existing European Registry on Cushing's syndrome (ERCUSYN) registry where feasible ), to assess drug utilization patterns and to document the safety (eg hepatotoxicity, QT prolongation) and effectiveness of ketoconazole
Danish: Sikkerhedsundersøgelse efter tilladelse til markedsføring (PASS): Observationsregister í flere lande til indsamling af kliniske oplysninger om patienter med Cushings syndrom, som var eksponeret for ketoconazol (fortrinsvis via det eksisterende europæiske register for Cushings syndrom (ERCUSYN), hvor det er muligt) for at vurdere mønstre for anvendelse af lægemidlet og dokumentere ketoconazols sikkerhed (f.eks. hepatotoksicitet, QT-forlængelse) og effekt
English: Urinary free cortisol (UFC) levels were normalised in about 50% of patients on ketoconazole.
Danish: Niveauet af frit kortisol i urinen blev normaliseret hos ca. 50 % af de patienter, som fik ketoconazol.
English: Ketoconazole is widely distributed into tissues; however, only a negligible proportion of ketoconazole reaches the cerebral-spinal fluid.
Danish: Ketoconazol fordeles i de fleste væv, men kun en ubetydelig del af ketoconazol når cerebrospinalvæsken.
English: Photosensitivity, erythema multiforme, dermatitis, erythema, , xeroderma
Danish: Fotosensibilitet, erythema multiforme, dermatit, erytem, xeroderma
English: Not recommended due to an increased bleeding risk.
Danish: Anbefales ikke pga. øget risiko for blødning.
English: Oxycodone
Danish: Oxycodon
English: There is no known antidote to ketoconazole.
Danish: Der er ingen kendt antidot mod ketoconazol.
English: Ketoconazole inhibits primarily the activity of 17α-hydroxylase, but it also inhibits 11-hydroxylation steps, and at higher doses the cholesterol side-chain cleavage enzyme.
Danish: Ketoconazol hæmmer primært 17α-hydroxylases aktivitet, men hæmmer også 11-hydroxyleringstrinene og ved højere doser kolesterol-sidekædens spaltningsenzym.
English: It may be necessary to reduce haloperidol dosage.
Danish: Det kan være nødvendigt at reducere haloperidol-dosis.
English: Patients with Cushing's syndrome and coexisting inflammatory/autoimmune disorders should be supervised after normalisation of cortisol levels on ketoconazole.
Danish: Patienter med Cushings syndrom og samtidige inflammatoriske/autoimmune sygdomme skal monitoreres efter normalisering af kortisolniveauet med ketoconazol.
English: Speak with your doctor if you have a history of liver disease.
Danish: Tal med din læge, hvis du har eller har haft en leversygdom.
English: Allergic conditions including anaphylactic shock, anaphylactoid reaction and anaphylactic reaction and angioedema
Danish: Allergiske tilstande, herunder anafylaktisk shock, anafylaktoid reaktion, anafylaktisk reaktion og angioødem
English: Ketoconazole at doses up to 40 mg/kg had no effects on female fertility in the rat, whilst doses of 75 mg/kg and higher decreased the pregnancy rate and the number of implantation sites.
Danish: Ved doser på op til 40 mg/kg påvirkede ketoconazol ikke fertiliteten hos hunrotter, mens doser på 75 mg/kg og højere reducerede drægtighedsraten og antallet af implantationssteder.
English: Doses of 25 mg/kg and higher in male rats and dogs produced sperm abnormalities and decreased fertility in rats.
Danish: Doser på 25 mg/kg og højere hos hanrotter og -hunde gav sædabnormiteter og nedsatte fertiliteten hos rotter.
English: Ketoconazole HRA may temporarily lower the amount of hormones produced by your adrenal gland (cortisol) to below the normal range, but your doctor will correct this using appropriate hormone medicines or by adjusting the dose of Ketoconazole HRA.
Danish: Ketoconazole HRA kan midlertidig sænke mængden af kortisol, der produceres i binyrerne, til under det normale niveau, men lægen vil korrigere dette med passende hormonmedicin eller ved at justere dosis af Ketoconazole HRA.
English: Ketoconazole daily dose should be periodically adjusted on an individual basis with the aim to normalise urinary free cortisol and/or plasma cortisol levels.
Danish: Dosisjustering Den daglige dosis af ketoconazol skal justeres individuelt med jævne mellemrum for at normalisere frit kortisol i urinen og/eller plasma-kortisolniveauet.
English: Careful monitoring of adverse reactions (respiratory depression, sedation) is recommended.
Danish: Bivirkninger (respirationsdepression, sedation) bør monitoreres omhyggeligt.
English: Adrenal insufficiency may occur in patients on ketoconazole without corticosteroid substitution (block-only regimen) or if there is an insufficient glucocorticoid replacement therapy (for the patients treated with a blockand-replace regimen).
Danish: Binyrebarkinsufficiens kan forekomme hos patienter, som får ketoconazol uden kortikosteroidsubstitution (kun blokeringsregime), eller hvis substitutionsbehandlingen med glukokortikoid er utilstrækkelig (hos patienter, som behandles med et blokerings- og substitutionsregime).
English: The safety and efficacy of Ketoconazole HRA in children aged less than 12 years have not been established.
Danish: Ketoconazole HRAs sikkerhed og virkning hos børn under 12 år er ikke klarlagt.
English: Medicinal products affecting the absorption of ketoconazole
Danish: Lægemidler, der påvirker absorptionen af ketoconazol
English: Medicines that can interact with Ketoconazole HRA include: - pasireotide, another drug used to treat a subset of the Cushing's syndrome because it can lead to severe side effects in patients suffering from cardiac disorders - medicines taken by mouth that prevent blood clots from forming: rivaroxaban, apixaban, edoxaban,
Danish: Lægemidler, der kan interagere med Ketoconazole HRA, er bl.a.: - pasireotid, et andet lægemiddel, der anvendes til at behandle en undergruppe af Cushing's syndrom, fordi det kan føre til alvorlige bivirkninger hos patienter, som lider af hjerteproblemer - lægemidler, der tages gennem munden og forhindrer, at der dannes blodpropper: rivaroxaban, apixaban,
English: AUC ↑ 12.9 fold
Danish: AUC ↑ 12,9 gange
English: Dizziness or somnolence have been reported during treatement with Ketoconazole HRA.
Danish: Svimmelhed eller søvnighed er rapporteret under behandling med Ketoconazole HRA.
English: Mizolastine Halofantrine
Danish: Mizolastin Halofantrin
English: - Prior to the start of ketoconazole - Within one week after the beginning of the treatment - As clinically indicated thereafter.
Danish: - Før initiering af ketoconazol - Inden for én uge efter behandlingsstart.
English: Ketoconazole is also a potent inhibitor of androgens synthesis, inhibiting the activity of C17-20 lyase in the adrenals and also in Leydig cells.
Danish: Ketoconazol er også en potent androgensyntesehæmmer, idet det hæmmer aktiviteten af C17-20-lyase i både binyrerne og i Leydigs celler.
English: Ketoconazole is contraindicated during pregnancy and it should not be used in women of childbearing potential not using an effective method of contraception (see section 4.3).
Danish: Ketoconazol er kontraindiceret under graviditet og bør ikke anvendes til kvinder i den fertile alder, som ikke anvender sikker kontraception (se pkt.
English: The buprenorphine dose should be adjusted.
Danish: Buprenorphin-dosis skal justeres.
English: • Azoospermia (no sperm count)
Danish: • Azoospermi (ingen sædceller)
English: The safety of ketoconazole has been evaluated based on published literature and use of ketoconazole as an antifungal treatment.
Danish: Ketoconazols sikkerhed er vurderet ud fra den tilgængelige litteratur og ud fra anvendelse af ketoconazol til behandling af svampeinfektioner.
English: Studies in pregnant rats and in guinea pigs with 3H-ketoconazole indicate that ketoconazole crosses the placenta.
Danish: Studier med drægtige rotter og med marsvin med 3H-ketoconazol viser, at ketoconazol passerer placenta.
English: Phosphodiesterase(PD E5) inhibitors Sildenafil
Danish: Fosfodiesterase-5(PDE-5)-hæmmere Sildenafil
English: Ask your doctor or pharmacist for more information if you are taking Ketoconazole HRA with other medicines.
Danish: Spørg lægen eller apotekspersonalet, hvis der er mere, du vil vide, hvis du tager Ketoconazole HRA sammen med andre lægemidler.
English: Observed teratogenic effects were mainly skeletal anomalies, including cleft palate, brachydactylia, ectrodactylia and syndactylia.
Danish: De observerede teratogene virkninger var fortrinsvis skeletanomalier, herunder ganespalte, brakydaktyli, ektrodaktyli og syndaktyli.
English: The pharmacokinetics of ketoconazole were not significantly different in patients with renal failure compared to healthy subjects.
Danish: Ketoconazols farmakokinetik var ikke væsentligt forskellig hos patienter med nyresvigt i forhold til raske forsøgspersoner.
English: Adrenal function should be monitored at regular intervals since adrenal insuficiency can occur during the treatment under conditions of a relative cortisol deficiency due to an increased glucocorticoid demand (e.g. in case of stress, surgery, or infection); and/or in case of ketoconazole overtreatment (for the patients treated with a block-only regimen); or if there is insufficient glucocorticoid replacement therapy (for the patients treated with a block-and-replace regimen).
Danish: Binyrebarkfunktionen skal monitoreres med regelmæssige mellemrum, eftersom binyrebarkinsufficiens kan forekomme under behandlingen under forhold med en relativ kortisolmangel på grund af et øget glukokortikoidbehov (f.eks. i forbindelse med stress, operation eller infektion) og/eller ved overbehandling med ketoconazol (hos patienter i behandling med kun blokeringsregime), eller hvis substitutionsbehandlingen med glukokortikoid er utilstrækkelig (hos patienter, som behandles med et blokerings- og substitutionsregime).
English: Do not breastfeed your baby if you are taking Ketoconazole HRA.
Danish: Du må ikke amme dit barn, hvis du tager Ketoconazole HRA.
English: The treatment must not be initiated in patients with liver enzymes levels above 2 times the upper limit of normal
Danish: Behandlingen må ikke initieres hos patienter med leverenzymer, som ligger mere end 2 gange over den øvre normalgrænse.
English: Stop taking Ketoconazole HRA and tell your doctor straight away if you experience any of the following: - long-lasting severe headache or blurred vision - severe lack of appetite (anorexia) - weight loss - nausea or vomiting - unusual tiredness or fever - stomach pain - muscle weakness - yellowing of the skin or whites of the eyes - unusually dark urine or pale stools
Danish: Du skal holde op med at tage Ketoconazole HRA og straks kontakte din læge, hvis du oplever en af følgende bivirkninger: - langvarig kraftig hovedpine eller sløret syn - svær appetitløshed (anoreksi) - vægttab - kvalme eller opkastning - usædvanlig træthed eller feber - mavesmerter - muskelsvækkelse - gulfarvning af huden eller det hvide i øjnene - usædvanlig mørk urin eller lys afføring
English: You should know that your liver enzyme tests will be regularly monitored before starting the treatment, once weekly during the first month after Ketoconazole HRA initiation and then monthly for 6 months due to the risk of serious hepatic toxicity.
Danish: Du skal vide, at du regelmæssigt vil få taget prøver for at undersøge din leverfunktion på grund af risiko for svær leverskade: før behandlingen starter; én gang om ugen i den første måned, efter at du er begyndt med Ketoconazole HRA og derefter hver måned i 6 måneder.
English: In the literature, among 24 paediatric patients treated with ketoconazole, two developed severe hepatoxicity.
Danish: I litteraturen udviklede 2 ud af 24 pædiatriske patienter, som blev behandlet med ketoconazol, svær hepatotoksicitet.
English: Ketoconazole HRA is a medicine that contains the active substance ketoconazole.
Danish: Ketoconazole HRA er et lægemiddel, der indeholder det aktive stof ketoconazol.
English: • Intolerance to alcohol
Danish: • Ikke tåle alkohol
English: • Nervousness
Danish: • Nervøsitet