FrancophonIA/ELRC3.0 huggingface dataset:
English: Co-administration of ketoconazole and other medicinal products known to have potentially hepatotoxic effect (eg paracetamol) is not recommended since the combination may lead to increased risk of liver damage.
Danish: Ketoconazol bør ikke administreres sammen med andre lægemidler, der vides at have en potentielt hepatotoksisk virkning (f.eks. paracetamol), eftersom denne kombination kan medføre en øget risiko for leverskade.
English: Other dihydropyridines Verapamil
Danish: Andre dihydropyridiner Verapamil
English: Patients should be advised against alcohol consumption while on treatment (see section 4.5).
Danish: Patienter skal informeres om, at de ikke bør indtage alkohol, mens de er i behandling (se pkt.
English: Each tablet contains 200 milligram ketoconazole - The other ingredients are maize starch, lactose monohydrate (see section 2), povidone,
Danish: En tablet indeholder 200 mg ketoconazol - Øvrige indholdsstoffer: majsstivelse, lactosemonohydrat (se pkt.
English: Ketoconazole is mainly metabolised through CYP3A4.
Danish: Ketoconazol metaboliseres hovedsageligt via CYP3A4.
English: Acid-neutralising medicines (e.g. aluminium hydroxide) should not be administered for at least 2 hours after the intake of ketoconazole.
Danish: Syreneutraliserende lægemidler (f.eks. aluminiumhydroxid) må ikke administreres før tidligst 2 timer efter indtagelse af ketoconazol.
English: Adrenal insufficiency is common and can be a serious side effect.
Danish: Binyrebarkinsufficiens (nedsat funktion af binyrebarken) er almindelig og kan være en alvorlig bivirkning.
English: AUC: ↓0.28-fold
Danish: AUC: ↓ 0,28 gange
English: Contraindicated due to an alteration of the metabolism of this medicinal product (see section 4.3).
Danish: Kontraindiceret pga. en ændring af dette lægemiddels metabolisme (se pkt.
English: In addition, they should receive an emergency card and be equipped with an emergency glucocorticoid set.
Danish: De skal desuden have udleveret et patientkort og et nødglukokortikoidsæt.
English: In patients with achlorhydria, such as certain AIDS patients and patients on acid secretion suppressors (e.g. H2-antagonists, proton pump inhibitors), it is advised to administer ketoconazole with an acidic beverage e.g. cola beverage, orange juice.
Danish: Hos patienter med aklorhydri, som f.eks. visse aids-patienter og patienter, som får syresekretionshæmmere (f.eks. H2antagonister, protonpumpehæmmere), tilrådes det at administrere ketoconazol sammen med syreholdige drikkevarer, f.eks. cola, appelsinjuice.
English: Enzyme-inducing medicinal products such as rifampicin, rifabutin, carbamazepine, isoniazid, nevirapine, mitotane and phenytoin may significantly reduce the bioavailability of ketoconazole.
Danish: Enzyminducerende lægemidler, som f.eks. rifampicin, rifabutin, carbamazepin, isoniazid, nevirapin, mitotan og phenytoin, kan reducere ketoconazols biotilgænglighed i væsentlig grad. Ketoconazol bør ikke anvendes sammen med potente enzyminduktorer.
English: A review of concomitant medicinal products should be conducted when initiating ketoconazole treatment since ketoconazole is a known strong CYP3A4 inhibitor.
Danish: Samtidige lægemidler skal gennemgås, når ketoconazolbehandling initieres, eftersom ketoconazol er en potent CYP3A4 hæmmer.
English: Studies in animals have shown effects on male and female reproductive parameters (see section 5.3).
Danish: Dyrestudier har påvist virkninger på reproduktionsparametre hos hanner og hunner (se pkt.
English: - A maintenance dose from 400 mg/day to a maximal dose of 1,200 mg/day taken orally in 2 to 3 divided doses may be required to restore normal cortisol levels.
Danish: - En vedligeholdelsesdosis fra 400 mg/dag til maksimalt 1.200 mg/dag oralt fordelt på 2-3 doser kan være nødvendig for at genoprette normale kortisolniveauer.
English: The most serious adverse reaction is hepatotoxicity, primarily as acute hepatocellular toxicity, but may also result in cholestatic injury or a mixed pattern of toxicity.
Danish: Den alvorligste bivirkning er hepatotoksicitet, primært som akut hepatocellulær toksicitet, men kolestatisk skade eller et blandet toksicitetsmønster er også set.
English: ASAT, ALAT, gammaGT, bilirubin and alkaline phosphatase should be monitored at frequent intervals during treatment (see sections 4.2 and 4.4).
Danish: ASAT, ALAT, gamma-GT, bilirubin og alkalisk fosfatase skal monitoreres med hyppige intervaller under behandlingen (se pkt.
English: Liver problems can rarely happen (may affect up to 1 in 1,000 people).
Danish: Der kan i sjældne tilfælde opstå leverproblemer (kan forekomme hos op til 1 ud af 1.000 personer).
English: The SmPC for concomitantly used products must be consulted for the recommendations regarding coadministration with strong CYP3A4 inhibitors.
Danish: Produktresuméerne for samtidigt anvendte lægemidler skal gennemgås for anbefalinger, for så vidt angår administration sammen med potente CYP3A4-hæmmere.
English: Nausea, abdominal pain, vomiting, diarrhoea
Danish: Kvalme, abdominalsmerter, opkastning, diarré
English: In reproduction studies, ketoconazole impaired fertility in males and females.
Danish: I reproduktionsstudier forringede ketoconazol fertiliteten hos hanner og hunner.
English: Dose adjustment of dihydropyridines and verapamil may be required.
Danish: Dosisjustering af dihydropyridiner og verapamil kan være nødvendig.
English: Tell your doctor or phamacist if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl det altid til lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: You should not take antacids (eg aluminium hydroxide) or other medicines for acid indigestion for at least 2 hours after the intake of Ketoconazole HRA (see section Warning and Precautions).
Danish: Du må ikke tage syreneutraliserende lægemidler (f.eks. aluminiumhydroxid) eller andre lægemidler mod for meget mavesyre før tidligst 2 timer efter, du har taget Ketoconazole HRA (se punktet Advarsler og forsigtighedsregler).
English: If acid secretion suppressors are added to or removed from the concomitant medicinal products then ketoconazole dose should be adjusted according to cortisol levels.
Danish: Hvis syresekretionshæmmere tilføjes eller fjernes fra det samtidige lægemiddel, skal ketoconazoldosis justeres i forhold til kortisolniveauerne.
English: Fesoterodine and solifenacin are contraindicated in patients with renal impairment (see section 4.3).
Danish: Fesoterodin og solifenacin er kontraindicerede hos patienter med nedsat nyrefunktion (se pkt.
English: Ketoconazole should be discontinued without any delay if clinical symptoms of hepatitis develop.
Danish: Ketoconazol skal seponeres straks, hvis der opstår kliniske symptomer på hepatitis.
English: - The active substance is ketoconazole.
Danish: - Aktivt stof: ketoconazol.
English: The oxycodone dose may be adjusted.
Danish: Oxycodondosis kan eventuelt justeres.
English: A daily dose from 400 mg per day (2 tablets) to 1,200 mg per day (6 tablets) taken orally in 2 to 3 divided doses may be required to restore your normal cortisol levels.
Danish: En daglig dosis fra 400 mg dagligt (2 tabletter) til 1.200 mg dagligt (6 tabletter) taget gennem munden fordelt på 2-3 doser kan være nødvendig for at genoprette et normal kortisolniveau.
English: Studies in animal have shown reproductive toxicity (see section 5.3).
Danish: Dyreforsøg har påvist reproduktionstoksicitet (se pkt.
English: Recommendation for coadministration
Danish: Anbefaling ved samtidig administration
English: As a minimum requirement, women of childbearing potential must use an effective method of contraception (see section 4.6).
Danish: Kvinder i den fertile alder skal som minimum anvende sikker kontraception (se pkt.
English: Each tablet contains 200 mg ketoconazole.
Danish: Hver tablet indeholder 200 mg ketoconazol.
English: - In vitro data indicate that ketoconazole is an inhibitor of CYP1A2 and does not significantly inhibit CYP 2A6 and 2E1.
Danish: - In vitro-data viser, at ketoconazol hæmmer CYP1A2 og ikke hæmmer CYP 2A6 og 2E1 i signifikant grad.
English: Each tablet contains 19 mg of lactose (as monohydrate).
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver tablet indeholder 19 mg lactose (som monohydrat).
English: Ketoconazole is also a potent inhibitor of P-gp: inhibition of P-gp by ketoconazole can increase patients' exposure to medicinal products which are P-gp substrates (see section 4.5).
Danish: Ketoconazol er også en potent hæmmer af P-glykoprotein (P-gp): Ketoconazols hæmning af P-gp kan øge patienternes eksponering for lægemidler, der er P-gp-substrater (se pkt.
English: Ketoconazole HRA 200 mg tablets
Danish: Ketoconazole HRA 200 mg tabletter
English: Lurasidone:
Danish: Lurasidon:
English: The major route of excretion is through the bile into the intestinal tract.
Danish: Den vigtigste udskillelsesvej er via galden til tarmkanalen.
English: Off-white to light cream, round, 10 mm diameter, biconvex.
Danish: Råhvid til lys flødefarvet rund, bikonveks tablet med en diameter på 10 mm.
English: Ketoconazole is a potent inhibitor of CYP3A4 and P-gp.
Danish: Ketoconazol er en potent hæmmer af CYP3A4 og P-gp.
English: sunitinib, lapatinib, nilotinib, bortezomib, paclitaxel, vincristine, vinblastine, cabozantinib, dabrafenib,
Danish: imatinib, dasatinib, sunitinib, lapatinib, nilotinib, bortezomib, paclitaxel, cabozantinib, dabrafenib,
English: Absorption is impaired when gastric acidity is decreased.
Danish: Absorptionen forringes, når surhedsgraden i ventriklen er nedsat.
English: if you get palpitations or an irregular heartbeat during treatment.
Danish: Kontakt straks lægen, hvis du får hjertebanken eller uregelmæssig hjerterytme (puls) under behandlingen.
English: - certain heart medicines: epleronone, dronedarone, disopyramide, felodipine, nisoldipine,
Danish: - visse typer hjertemedicin: epleronon, dronedaron, disopyramid, felodipin, nisoldipin, ranolazin
English: Contraindicated as it may increase quetiapine-related toxicity (see section 4.3).
Danish: Kontraindiceret, da quetiapinrelateret toksicitet kan øges (se pkt.
English: Ketoconazole at doses of 40 mg/kg/day and higher produces evidence of embryotoxicity and teratogenicity in rats and rabbits.
Danish: Ved doser på 40 mg/kg/dag og derover giver ketoconazol evidens for embryotoksicitet og teratogenicitet hos rotter og kaniner.
English: Initiation and follow up of the treatment must be supervised by specialists in endocrinology.
Danish: Start og opfølgning af behandling skal overvåges af en speciallæge i endokrinologi (hormon- og kirtelsygdomme).
English: Acute hepatocellular injury has been primarily observed as has cholestatic injury or a mixed pattern of toxicity.
Danish: Der er primært observeret akut hepatocellulær skade, kolestatisk skade eller et blandet toksicitetsmønster.
English: Contraindicated due to the increased risk of ergotism and other serious vasospastic adverse reactions (see section 4.3).
Danish: Kontraindiceret på grund af en øget risiko for ergotisme og andre alvorlige vasospastiske bivirkninger (se pkt.
English: In the case of an increase in liver enzymes of less than 3 times the upper limit of normal, more frequent monitoring of liver function tests should be performed and the daily dose should be decreased by at least 200 mg.
Danish: Ved stigning i leverenzymer på mindre end 3 gange den øvre normalgrænse skal leverfunktionen monitoreres hyppigere, og den daglige dosis skal nedsættes med mindst 200 mg.
English: Ketoconazole can be resumed thereafter at a lower dose (see section 4.2).
Danish: Derefter kan ketoconazol genoptages ved en lavere dosis (se pkt.
English: • Menstrual disorders
Danish: • Menstruationsforstyrrelser
English: Effects of other medicinal products on the metabolism of ketoconazole
Danish: Virkninger af andre lægemidler på ketoconazols metabolisme
English: Not recommended due to the risk of increased exposure to these medicinal products and QT prolongation.
Danish: Bør ikke anvendes pga. risikoen for øget eksponering for disse lægemidler samt QT-forlængelse.
English: Coadministration of potent enzyme inducers of CYP3A4 may decrease the bioavailibity of ketoconazole.
Danish: Samtidig administration af potente CYP3A4induktorer kan nedsætte ketoconazols biotilgængelighed.
English: Since ketoconazole is excreted in the milk, mothers who are under treatment must not breast-feed whilst being treated with Ketoconazole HRA (see section 4.3).
Danish: Eftersom ketoconazol udskilles i mælk, må mødre, som er i behandling Ketoconazole HRA, ikke amme (se pkt.
English: Reboxetine: AUC: ↑ 1.5-fold of both enantiomers
Danish: AUC: ↑ 1,5 gange af begge enantiomerer
English: In addition, you should receive an emergency card and should be equipped with an emergency glucocorticoid set.
Danish: Derudover skal du have udleveret et patientkort og et nødglukokortikoidsæt.
English: When urinary free/serum/ plasma cortisol levels are normalised or close to target and the effective dose of ketoconazole is established, monitoring can be undertaken every 3 to 6 months (see section 4.2 for dose adjustment in case of adrenal insufficiency).
Danish: Når frit kortisol i urinen/kortisol i serum/plasma er normaliseret eller tæt på målværdierne, og den effektive dosis ketoconazol er fastlagt, kan monitorering udføres hver 3. til 6. måned (se pkt.
English: Ketoconazole is a steroidogenesis inhibitor.
Danish: Ketoconazol er en steroidgenese-hæmmer.
English: cabazitaxel, crizotinib, ibrutinib - certain medicines used to treat infections: rifabutin, telithromycin, rifampicin, isoniazide, clarithromycin,
Danish: cabazitaxel, crizotinib, ibrutinib - andre lægemidler til behandling af infektioner: rifabutin, telithromycin, rifampicin, isoniazid,
English: Dose of edoxaban needs to be reduced when used concomitantly, please consult edoxaban SmPC.
Danish: Dosis af edoxaban skal reduceres, når det anvendes samtidigt (se produktresuméet til edoxaban).
English: The following list is not an inclusive list of interactions between ketoconazole and other medicinal products
Danish: Listen herunder med interaktioner mellem ketoconazol og andre lægemidler er ikke udtømmende.
English: Dyspepsia, flatulence, tongue discoloration, dry mouth, dysgeusia
Danish: Dyspepsi, flatulens, misfarvning af tungen, mundtørhed, dysgeusi
English: Ketoconazole is a potent inhibitor of CYP3A4: inhibition of CYP3A4 by ketoconazole can increase patients' exposure to a number of medicinal products which are metabolised through this enzymatic system (see section
Danish: Ketoconazol er en potent hæmmer af CYP3A4: Ketoconazols hæmning af CYP3A4 kan øge patienternes eksponering for en række lægemidler, der metaboliseres via dette enzymsystem (se pkt.
English: Not recommended due to the increased risk of QT prolongation and extrapyramidal symptoms.
Danish: Bør ikke anvendes pga. øget risiko for QT-forlængelse og ekstrapyramidale symptomer.
English: Talk to your doctor or pharmacist before taking Ketoconazole HRA.
Danish: Kontakt lægen eller apotekspersonalet, før du tager Ketoconazole HRA.
English: The most frequent adverse reactions are adrenal insufficiency, nausea, vomiting, abdominal pain, diarrhoea, pruritus, rash and the hepatic enzymes increased.
Danish: De hyppigste bivirkninger er binyrebarkinsufficiens, kvalme, opkastning, abdominalsmerter, diarré, pruritus, udslæt og forhøjede leverenzymer.
English: Anticonvulsants Carbamazepine Phenytoin
Danish: Antiepileptika Carbamazepin Phenytoin
English: Careful monitoring A cilostazol dose of 50 mg twice daily is recommended in combination with ketoconazole.
Danish: En cilostazol-dosis på 50 mg 2 gange dagligt bør anvendes ved kombination med Ketoconazole HRA.
English: Beta Blockers Nadolol
Danish: Betablokkere Nadolol
English: You should contact your doctor immediately if you have symptoms such as weakness, fatigue, lack of appetite, nausea, vomiting or low blood pressure.
Danish: Du skal straks kontakte lægen, hvis du får symptomer såsom svaghed, træthed, appetitløshed, kvalme, opkastning eller lavt blodtryk.
English: Not recommended due to increased risk of isavuconazole adverse reactions, please consult isavuconazole SmPC
Danish: Anbefales ikke på grund af forhøjet risiko for bivirkninger med isavuconazol (se produktresuméet til isavuconazol SmPC).
English: Contents of the pack and other information What Ketoconazole HRA contains
Danish: Pakningsstørrelser og yderligere oplysninger Ketoconazole HRA indeholder
English: Midazolam IV
Danish: Midazolam i.v.
English: Buspirone
Danish: Buspiron
English: What you need to know before you take Ketoconazole HRA 3.
Danish: Det skal du vide, før du begynder at tage Ketoconazole HRA 3.
English: All patients should be monitored and informed about the signs and symptoms associated with hypocortisolism (e.g. weakness, fatigue, anorexia, nausea, vomiting, weight-loss, hypotension, hyponatraemia, hyperkalaemia and/or hypoglycaemia).
Danish: Alle patienter skal monitoreres og informeres om de tegn og symptomer, der er associeret med hypokortisolisme (f.eks. svaghed, træthed, anoreksi, kvalme, opkastning, vægttab, hypotension, hyponatriæmi, hyperkaliæmi og/eller hypoglykæmi).
English: Microcrystalline cellulose Silica colloidal Magnesium stearate
Danish: Mikrokrystallinsk cellulose Kolloidt silica Magnesiumstearat
English: Dose adjustment of each medicinal product may be required.
Danish: Dosisjustering af det enkelte lægemiddel kan være nødvendig.
English: Contraindicated due to the risk of potentially prolonged or increased sedation and respiratory depression (see section 4.3).
Danish: Kontraindiceret pga. risiko for potentielt langvarig eller dybere sedation og respirationsdepression (se pkt.
English: As a precautionary measure, in case of a dose increase after the first six months of treatment, monitoring of liver enzymes should be repeated on a weekly basis for one month.
Danish: Hvis dosis øges efter de første 6 måneders behandling, skal monitorering af leverenzymer gentages hver uge i én måned som en sikkerhedsforanstaltning.
English: No alcohol should be consumed during treatment with ketoconazole.
Danish: Du må ikke drikke alkohol, mens du er i behandling med ketoconazol.
English: Potent inhibitors of CYP3A4 (e.g. antivirals such as ritonavir, ritonavir-boosted darunavir and ritonavirboosted fosamprenavir) may increase the bioavailability of ketoconazole, these medicinal products should be used with caution when co-administered with ketoconazole and patients should be monitored closely for signs and symptoms of adrenal insuficiency.
Danish: Potente CYP3A4-hæmmere (f.eks. antivirale lægemidler såsom ritonavir, ritonavir-boostet darunavir og ritonavir-boostet fosamprenavir) kan øge ketoconazols biotilgængelighed, og disse lægemidler skal anvendes med forsigtighed, når de administreres sammen med ketoconazol.
English: Therefore, ketoconazole is an inhibitor of cortisol and aldosterone synthesis.
Danish: Derfor er ketoconazol en kortisol- og aldosteronsyntesehæmmer.
English: Domperidone:
Danish: Domperidon:
English: Cmax ↑ 9.6 fold
Danish: Cmax ↑ 9,6 gange
English: Antimigraine Drugs Ergots alkaloids such as dihydroergotamine, ergometrine (ergonovine), ergotamine, methylergometrine (methylergonovine)
Danish: Midler mod migræne Sekalealkaloider, som f.eks. dihydroergotamin, ergometrin, ergotamin, methylergometrin
English: Domperidone
Danish: Domperidon
English: Coexisting inflammatory/autoimmune disorders Tell your doctor if you suffer from an autoimmune disorder, you will be closely supervised.
Danish: Samtidige betændelses-/autoimmune sygdomme Fortæl det til lægen, hvis du har en autoimmun sygdom.
English: If clinical symptoms are suggestive of adrenal insufficiency, cortisol levels should be measured and ketoconazole should be temporarily discontinued or the dose reduced and if necessary corticosteroid substitution should be initiated.
Danish: Hvis kliniske symptomer tyder på binyrebarkinsufficens, skal kortisolniveauet måles og ketoconazol seponeres midlertidig eller dosis reduceres, og det skal vurderes, om substitutionsbehandling med kortikosteroid skal initieres.
English: Blood and lymphatic system disorders
Danish: Blod og lymfesystem Ikke almindelig
English: Headache, dizziness, somnolence
Danish: Hovedpine, svimmelhed, døsighed
English: Endocrine disorders Common
Danish: Det endokrine system
English: Dose adjustment of saxagliptin may be required.
Danish: Justering af saxagliptindosis kan være nødvendig.
English: Contraindicated due to the increased risk of hyperkalaemia and hypotension (see section 4.3).
Danish: Kontraindiceret på grund af øget risiko for hyperkaliæmi og hypotension (se pkt.
English: • Photosensitivity (increase in the reaction to sunlight: redness, itching rash)
Danish: • Lysfølsomhed (øget reaktion på sollys:
English: In the case of increase of liver enzymes levels above 3 times the upper limit of normal, Ketoconazole should be stopped immediately and should not be reintroduced because of the risk of serious hepatic toxicity.
Danish: Ved stigning i leverenzymer på 3 gange den øvre normalgrænse eller mere skal ketoconazol straks seponeres, og behandling må ikke genoptages på grund af risikoen for alvorlig hepatotoksicitet.
English: It may be necessary to lower the dose of alfentanil and fentanyl.
Danish: Det kan være nødvendigt at reducere altentanil- og fentanyldosis.
English: Cmax: ↑ have been observed
Danish: Cmax: ↑ er observeret.
English: Contraindicated due to the large increase in these medicinal products concentrations (see section 4.3).
Danish: Kontraindiceret pga. stærkt øgede koncentrationer af disse lægemidler (se pkt.
English: Antineoplastics Irinotecan
Danish: Antineoplastiske stoffer Irinotecan
English: Dose adjustment of nadolol may be required.
Danish: Justering af nadololdosis kan være nødvendig.
English: Ketoconazole HRA is able to block the activity of the enzymes responsible for the synthesis of cortisol and consequently is able to decrease the over-production of cortisol by your body and to improve the symptoms of Cushing's syndrome.
Danish: Ketoconazole HRA kan derfor reducere kroppens overproduktion af kortisol og dermed forbedre symptomerne på Cushings syndrom.
English: Contraindicated in patients with renal impairment (see section 4.3).
Danish: Kontraindiceret hos patienter med nedsat nyrefunktion (se pkt.
English: What you need to know before you take Ketoconazole HRA Do not take Ketoconazole HRA
Danish: Det skal du vide, før du begynder at tage Ketoconazole HRA Tag ikke Ketoconazole HRA:
English: Ketoconazole HRA is available in packs containing 60 tablets.
Danish: Ketoconazole HRA fås i pakninger med 60 tabletter.
English: Quetiapine:
Danish: Quetiapin:
English: Not recommended due to the risk of QT interval prolongation and serious hepatic adverse reactions.
Danish: Anbefales ikke på grund af risikoen for forlænget QT-interval og alvorlige leverbivirkninger.
English: AUC: ↑ have been observed
Danish: AUC: ↑ er observeret.
English: Dosing regimens for maintenance therapy Subsequent maintenance therapy can be administered in one of two ways: - Block-only regimen: the maintenance dose of ketoconazole may be continued as described above; - Block-and-replace regimen: the maintenance dose of ketoconazole should be further increased by 200 mg and concomitant corticosteroid replacement therapy should be added (see section 4.4).
Danish: Dosisregimer ved vedligeholdelsesbehandling Efterfølgende vedligeholdelsesbehandling kan administreres på en af to måder: - Kun blokeringsregime: Vedligeholdelsesdosis af ketoconazol kan fortsættes som beskrevet ovenfor.
English: However, ketoconazole may be an inhibitor of BCRP at the intestinal level at clinically relevant concentrations.
Danish: Ketoconazol i klinisk relevante koncentrationer kan dog være en hæmmer af BCRP på tarmniveau.