FrancophonIA/ELRC3.0 huggingface dataset:
English: Mogamulizumab should not be administered subcutaneously or intramuscularly, by rapid intravenous administration, or as an intravenous bolus.
Danish: Mogamulizumab bør ikke administreres subkutant eller intramuskulært, ved hurtig intravenøs administration eller som en intravenøs bolus.
English: As a precautionary measure, it is preferable to avoid the use of mogamulizumab during pregnancy.
Danish: For en sikkerheds skyld bør mogamulizumab undgås under graviditet.
English: A small percentage of patients receiving POTELIGEO tested positive for treatment emergent (treatment induced or treatment boosted) anti mogamulizumab antibodies.
Danish: En lille procentdel af patienter, der fik POTELIGEO, blev testet positive for anti-mogamulizumab-antistoffer, opstået efter behandlingsstart (inducerede eller forstærkede af behandling).
English: - skin pain, itching, skin blisters, skin rash or sore mouth, which are possible signs that you may be developing a severe skin reaction, such as Stevens-Johnson syndrome or toxic epidermal necrolysis.
Danish: - hudsmerter, kløe, hudblærer, hududslæt eller ømhed i munden, som kan være tegn på, at du er ved at udvikle en alvorlig hudreaktion, for eksempel Stevens-Johnsons syndrom eller toksisk epidermal nekrolyse.
English: If you can get pregnant, you will need to use effective contraception during and for at least six months after receiving this treatment.
Danish: Hvis du kan blive gravid, skal du bruge sikker prævention under behandlingen og i mindst 6 måneder efter behandlingen.
English: No mogamulizumab-related toxic effects in the male and female reproductive organs were observed in repeat-dose toxicology studies in sexually mature monkeys up to 26 weeks.
Danish: Der blev ikke observeret nogen toksiske mogamulizumab-relaterede virkninger på hanners og hunners forplantningsorganer i studier af toksiciteten efter gentagne doser på kønsmodne aber på op til 26 uger.
English: Elderly No dose adjustment is required in elderly patients (see section 5.2).
Danish: Ældre Der er ikke behov for justering af dosis til ældre patienter (se pkt.
English: Pharmacological activity of mogamulizumab was noted in foetuses as was evident from a decrease in CCR4 expressing lymphocytes.
Danish: Mogamulizumabs farmakologiske aktivitet blev observeret i fostre som et fald i lymfocytter, der udtrykker CCR4.
English: One case of acute myocardial infarction has been observed in a clinical trial patient with MF / SS receiving mogamulizumab.
Danish: Der er observeret et tilfælde af akut myokardieinfarkt i et klinisk studie hos en patient med MF/SS, der fik mogamulizumab.
English: Tell your doctor or nurse or get medical help immediately if you have any of the following symptoms after starting POTELIGEO:
Danish: Fortæl det til din læge eller sundhedspersonalet eller søg straks læge, hvis du får et eller flere af følgende symptomer, efter du er startet i behandling med POTELIGEO:
English: Store it in the original carton in order to protect from light Reconstituted/diluted solution: Use immediately or store in a refrigerator (2ºC - 8ºC) and use within 4 hours.
Danish: Rekonstitueret/fortyndet opløsning: Bruges straks eller opbevares i køleskab (2 ºC - 8 ºC) og anvendes inden for 4 timer.
English: The infusion may be restarted at a slower rate after symptom resolution.
Danish: Infusionen kan genoptages med en langsommere hastighed, hvis symptomerne forsvinder.
English: Mogamulizumab infusion was administered at a dose of 1 mg/kg once weekly for the first 28-day cycle (on Days 1, 8, 15 and 22), and on days 1 and 15 of subsequent 28-day cycles.
Danish: Infusion af mogamulizumab blev foretaget i en dosis på 1 mg/kg én gang om ugen i den første 28-dages cyklus (på dag 1, 8, 15 og 22) og på dag 1 og 15 i de efterfølgende 28-dages cyklusser.
English: Acute infusion-related reactions (IRRs) have been observed in patients treated with mogamulizumab.
Danish: Der er observeret akutte infusionsrelaterede reaktioner (IRR'er) hos patienter, behandlet med mogamulizumab.
English: There is no information on overdose with mogamulizumab.
Danish: Der er ingen oplysninger om overdosering af mogamulizumab.
English: When the symptoms go away, POTELIGEO can normally continue to be given, but more slowly.
Danish: POTELIGEO kan normalt gives igen, når symptomerne forsvinder, men blot i et langsommere tempo.
English: There are no clinical data available on the effect of mogamulizumab on human fertility.
Danish: Der foreligger ingen kliniske data vedrørende mogamulizumabs virkning på human fertilitet.
English: Fatigue may occur following administration of mogamulizumab (see section 4.8).
Danish: Der kan opstå træthed efter administration af mogamulizumab (se pkt.
English: POTELIGEO has not been studied in patients with severe hepatic impairment (see section 5.2).
Danish: POTELIGEO er ikke blevet undersøgt hos patienter med alvorligt nedsat leverfunktion (se pkt.
English: Based on a population PK analysis, the geometric mean (% coefficient of variation [CV%]) clearance (CL) is 12.0 mL/h (83.7%) and geometric mean elimination half-life (t1/2) is 17 days (65.5%).
Danish: Baseret på en farmakokinetisk populationsanalyse er den geometriske, gennemsnitlige (% variationskoefficient [CV%]) clearance (CL) 12,0 ml/t (83,7%), og den geometriske, gennemsnitlige halveringstid (t1/2) er 17 dage (65,5%).
English: Very common Drug eruption (including skin rash) a Folliculitis, Cellulitis, Candidiasis, Pneumonia, Sepsis, Skin infection, Otitis externa, Herpes zoster, Staphylococcal skin infection, Urinary tract infection, Herpes simplex and cytomegalovirus
Danish: Meget almindelig Lægemiddelinduceret udslæt a Folliculitis, cellulitis, candidiasis, pneumoni, sepsis, hudinfektion, otitis externa, herpes zoster, stafylokokinfektion i huden, urinvejsinfektion, herpes simplex og cytomegalovirus
English: Subjects with MF or SS treated with mogamulizumab are at increased risk of serious infection and/or viral reactivation.
Danish: Patienter med MF eller SS, der behandles med mogamulizumab, har forhøjet risiko for alvorlige infektioner og/eller reaktivering af virus.
English: POTELIGEO contains sodium
Danish: POTELIGEO indeholder natrium
English: The infusion rate should be reduced by at least 50% when re-starting the infusion after symptoms resolve.
Danish: Efter symptomerne er forsvundet, bør infusionshastigheden reduceres med mindst 50%, når infusionen genstartes.
English: Crossover patients received up to 46 months of mogamulizumab therapy, as of December 2016 data cut.
Danish: Patienter, der skiftede præparat, fik op til 46 måneders behandling med mogamulizumab ved dataafskæringspunktet december 2016.
English: The effects of various covariates on the PK s of mogamulizumab were assessed in population PK analyses.
Danish: Forskellige kovariaters virkninger på mogamulizumabs farmakokinetik blev undersøgt i farmakokinetiske populationsanalyser.
English: P value
Danish: P-værdia
English: The following factors had no clinically important effect on the CL of mogamulizumab: age (range: 22 to 101 years), sex, ethnicity (other than Japanese, limited data are available in other ethnic populations), renal impairment, mild or moderate hepatic impairment, disease subtype (mycosis fungoides (MF) or Sézary Syndrome (SS)), degree of CCR4 expression or ECOG status, although it should be noted that patients with ECOG PS ≥2 were excluded from the clinical trials.
Danish: Følgende faktorer havde ingen klinisk væsentlig virkning på mogamulizumabs CL: alder (inden for intervallet 22 til 101 år), køn, etnicitet (bortset fra japansk findes der kun begrænsede data om andre etniciteter), nyresvækkelse, let eller moderat leversvækkelse, sygdommens undertype (mycosis fungoides [MF] eller Sézarys syndrom [SS]), grad af CCR4-ekspression eller ECOG-status.
English: The pack contains a glass vial containing 5 mL concentrate for solution for infusion.
Danish: Pakningen indeholder et hætteglas med 5 ml koncentrat til infusionsvæske, opløsning.
English: No trend in latency to event onset was identified for drug eruptions and rashes; both early and late-onset events occurred.
Danish: Der blev ikke påvist nogen tendens til forsinkelse før bivirkningens indtræden for så vidt angår lægemiddeludslæt og udslæt; bivirkninger med både tidlig og senere indtræden forekom.
English: The effect of renal impairment on the clearance of mogamulizumab was evaluated by a population PK analysis in patients with mild (creatinine clearance [CrCL] between 60 and 89; n= 157), moderate (CrCL between 59 and 30; n= 80), or severe renal impairment (CrCL less than 30 mL/min; n= 2).
Danish: Virkningen af nyresvækkelse på mogamulizumabs clearance blev undersøgt med en farmakokinetisk populationsanalyse hos patienter med let (kreatininclearance [CrCL] mellem 60 og 89; n= 157), moderat (CrCL mellem 59 og 30; n= 80) eller svær nyresvækkelse (CrCL under 30 ml/min; n= 2).
English: No specific studies in animals have been performed to evaluate the effect of mogamulizumab on fertility.
Danish: Der er ikke udført specifikke dyrestudier til undersøgelse af mogamulizumabs virkning på fertiliteten.
English: The metabolic pathway of mogamulizumab has not been characterised.
Danish: Mogamulizumabs metaboliseringsvej er ikke beskrevet.
English: POTELIGEO is a clear to slightly opalescent, colourless solution.
Danish: POTELIGEO er en klar til let opaliserende farveløs opløsning.
English: Citric acid monohydrate, glycine, polysorbate 80, sodium hydroxide, hydrochloric acid, water for injections.
Danish: Citronsyremonohydrat, glycin, polysorbat 80, natriumhydroxid, saltsyre, vand til injektionsvæsker.
English: The pharmacokinetics (PK) of mogamulizumab was evaluated in adult patients with T-cell leukaemialymphoma (ATL) and CTCL over a dose range of 0.01 to 1 mg/kg administered as multiple doses of mogamulizumab every week or every 2 weeks, and included the recommended 1.0 mg/kg dose and regimen (days 1, 8, 15 and 22 for the first 28-day cycle and on Days 1 and 15 for subsequent 28-day cycles).
Danish: Mogamulizumabs farmakokinetik blev undersøgt på voksne patienter med T-celle-leukæmi-lymfom (ATL) og CTCL i et dosisinterval på 0,01 til 1 mg/kg, der blev administreret som flere doser mogamulizumab hver uge eller hver anden uge og omfattede den anbefalede dosis på 1,0 mg/kg og det anbefalede regime (dag 1, 8, 15 og 22 i den første 28-dages cyklus og dag 1 og 15 i de efterfølgende 28-dages cyklusser).
English: See section 4.2 for dose modification information.
Danish: 4.2 for information om dosisændring.
English: Each mL of concentrate contains 4 mg of mogamulizumab.
Danish: Hver ml koncentrat indeholder 4 mg mogamulizumab.
English: • POTELIGEO should be permanently discontinued for a life-threatening (Grade 4) infusion-related reaction (see section 4.4).
Danish: • POTELIGEO bør seponeres permanent i tilfælde af en livstruende (grad 4) infusionsrelateret reaktion (se pkt.
English: POTELIGEO 4 mg/mL concentrate for solution for infusion mogamulizumab
Danish: POTELIGEO 4 mg/ml koncentrat til infusionsvæske, opløsning mogamulizumab
English: Mogamulizumab has minor influence on the ability to drive and use machines.
Danish: Mogamulizumab påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
English: Overall response rate (confirmed CR + PR, %)
Danish: Overordnet responsrate (bekræftet CR + PR, %)
English: Clear to slightly opalescent, colourless solution.
Danish: Klar til let opaliserende, farveløs opløsning.
English: The safety profile in elderly patients (≥ 65 years) was generally consistent with that of adult patients,
Danish: Sikkerhedsprofilen hos ældre patienter (≥ 65 år) svarede generelt til sikkerhedsprofilen hos voksne patienter, bortset fra dermatologiske reaktioner og infusionsrelaterede reaktioner, der blev observeret oftere hos ældre patienter.
English: You will need to use effective contraception during and for at least six months after receiving this treatment.
Danish: Du skal bruge sikker prævention under behandlingen og i mindst 6 måneder efter behandlingen.
English: Intravenous use after dilution.
Danish: Til intravenøs brug efter fortynding.
English: Discard the vial if cloudiness, discolouration or particulates are observed.
Danish: Kassér hætteglasset, hvis der ses uklarheder, misfarvning eller partikler.
English: - The other excipients are citric acid monohydrate, glycine, polysorbate 80, sodium hydroxide, hydrochloric acid, and water for injections.
Danish: - Øvrige indholdsstoffer: citronsyremonohydrat, glycin, polysorbat 80, natriumhydroxid, saltsyre og vand til injektionsvæsker.
English: No clinically important differences in the clearance of mogamulizumab were found between patients with mild to severe renal impairment and patients with normal renal function.
Danish: Der blev ikke observeret nogen klinisk væsentlige forskelle i mogamulizumabs clearance mellem patienter med let til svær nyresvækkelse og patienter med normal nyrefunktion.
English: Mogamulizumab has not been studied in patients with severe hepatic impairment (TB greater than 3 times ULN and any AST).
Danish: Mogamulizumab er ikke undersøgt hos patienter med svær leversvækkelse (TB højere end 3 gange ULN og en hvilken som helst ASATkoncentration).
English: No clinically important differences in the clearance of mogamulizumab were found between patients with mild to moderate hepatic impairment and patients with normal hepatic function.
Danish: Der blev ikke observeret nogen klinisk væsentlige forskelle i mogamulizumabs clearance mellem patienter med let til moderat leversvækkelse og patienter med normal leverfunktion.
English: Based on a population pharmacokinetic analysis, no dose adjustment is recommended in patients with mild or moderate hepatic impairment.
Danish: På baggrund af en farmakokinetisk populationsanalyse anbefales der ikke justering af dosis til patienter med let til moderat nedsat leverfunktion.
English: Unopened vial: Store in a refrigerator (2ºC - 8ºC).
Danish: Uåbnet hætteglas: Opbevares i køleskab (2 ºC - 8 ºC).
English: • POTELIGEO should be permanently discontinued for a life-threatening (Grade 4) rash (see section 4.4).
Danish: • POTELIGEO bør seponeres permanent i tilfælde af livstruende (grad 4) udslæt (se pkt.
English: Based on a population pharmacokinetic analysis, no dose adjustment is recommended in patients with mild to severe renal impairment (see section 5.2).
Danish: På baggrund af en farmakokinetisk populationsanalyse anbefales der ikke justering af dosis til patienter med let til moderat nedsat nyrefunktion (se pkt.
English: The effect of hepatic impairment on the clearance of mogamulizumab was evaluated by a population PK analysis in patients with mild hepatic impairment (total bilirubin [TB] less than or equal to the upper limit of normal [ULN] and AST greater than ULN or TB less than 1 to 1.5 times ULN and any AST; n= 80) or moderate (TB greater than 1.5 to 3 times ULN and any AST; n=3) hepatic impairment.
Danish: Virkningen af leversvækkelse på mogamulizumabs clearance blev undersøgt med en farmakokinetisk populationsanalyse hos patienter med let leversvækkelse (total bilirubin [TB] mindre end eller lig med den øvre normalgrænse [ULN] og ASAT højere end ULN eller TB mindre end 1-1,5 gange ULN og en hvilken som helst ASAT-koncentration; n= 80) eller moderat leversvækkelse (TB højere end 1,5- 3 gange ULN og en hvilken som helst ASAT-koncentration; n=3).
English: Mogamulizumab exhibits linear PK from the dose in a dose range of 0.01 mg/kg to 1 mg/kg.
Danish: Mogamulizumab udviser en lineær farmakokinetik med dosis i et dosisinterval på 0,01 mg/kg til 1 mg/kg.
English: No adverse effects on male and female reproductive organs were observed in repeat-dose toxicity studies in cynomolgus monkeys (see section 5.3).
Danish: Der blev ikke observeret nogen uønskede virkninger på hanners og hunners reproduktionsorganer i toksicitetsstudier med gentagne doser hos cynomolgusaber (se pkt.
English: • In the event of a rash (drug related) with severity of Grade 2 or 3 (moderate or severe), treatment with mogamulizumab must be interrupted and the rash should be treated appropriately until rash improves to Grade 1 or less (mild severity), at which time mogamulizumab treatment may be resumed.
Danish: • Behandling med mogamulizumab bør afbrydes i tilfælde af udslæt (lægemiddelrelateret) af sværhedsgrad 2 eller 3 (moderat eller alvorlig) og udslættet behandles, indtil det er forbedret til grad 1 eller derunder (let sværhedsgrad).
English: Carcinogenicity or genotoxicity studies have not been conducted with mogamulizumab.
Danish: Der er ikke udført studier af mogamulizumabs karcinogenicitet eller genotoksicitet.
English: Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.
Danish: Du eller dine pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: On a power model analysis, no deviation from dose proportionality was evident.
Danish: Der var ingen tegn på afvigelse fra dosisproportionaliteten på en styrkemodelanalyse.
English: Patients receiving POTELIGEO have experienced drug rash (drug eruption), some of which were severe and/or serious.
Danish: Patienter, der fik POTELIGEO, har oplevet lægemiddelinduceret udslæt, hvoraf nogle tilfælde var svære og/eller alvorlige.
English: Symptoms may include skin rashes or blistering, nausea or diarrhoea that doesn't go away, stomach pain or vomiting, joint pain or stiffness, dry or irritated eyes or blurred vision, mouth sores, irritation or pain, a cough that does not go away or difficulty breathing, sensitive genitals, jaundice (turning yellow), dark urine, and any swelling.
Danish: Symptomerne kan omfatte hududslæt eller blæredannelse i huden, kvalme eller diarré, der ikke forsvinder, mavesmerter eller opkastning, ledsmerter eller stive led, tørre eller irriterede øjne eller sløret syn, sår, irritation eller smerter i munden, hoste, der ikke forsvinder, eller vejtrækningsbesvær, følsomme kønsorganer, gulsot (gulfarvning af huden), mørkfarvet urin og eventuelt hævelse.
English: Tumour lysis syndrome (TLS) has been observed in patients receiving mogamulizumab.
Danish: Der er observeret tumorlysesyndrom (TLS) hos patienter, som fik mogamulizumab.
English: - fever, chills, nausea, vomiting, confusion, shortness of breath, seizures, irregular heartbeat, dark or cloudy urine, unusual tiredness and/or muscle or joint pain.
Danish: - feber, kulderystelser, kvalme, opkastning, forvirring, stakåndethed, krampeanfald, uregelmæssig hjerterytme, mørkfarvet eller grumset urin, usædvanlig træthed og/eller muskelsmerter eller ledsmerter.
English: Complications of allogeneic hematopoietic stem cell transplantation (HSCT) after mogamulizumab Complications, including severe graft versus host disease (GVHD), have been reported in patients with T-cell lymphomas other than MF or SS who received allogeneic HSCT after mogamulizumab.
Danish: Komplikationer af allogen hæmatopoietisk stamcelletransplantation (HSCT) efter mogamulizumab Hos patienter med andre T-cellelymfomer end MF eller SS, som fik allogen HSCT efter mogamulizumab, er der indberettet komplikationer, herunder svær graft versus host-sygdom (GVDH).
English: PFS, months ITT Population IB/II III/IV ITT=intent to treat Paediatric population The European Medicines Agency has waived the obligation to submit the results of studies with mogamulizumab in all subsets of the paediatric population in cutaneous T-cell lymphoma (CTCL) (MF and SS are subtypes of CTCL).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med mogamulizumab i alle undergrupper af den pædiatriske population med kutant T-cellelymfom (CTCL) (MF og SS er undertyper af CTCL).
English: Each vial of 5 mL contains 20 mg of mogamulizumab.
Danish: Hvert hætteglas på 5 ml indeholder 20 mg mogamulizumab.
English: - Each vial contains 20 mg of mogamulizumab in 5 mL of concentrate, corresponding to 4 mg/mL.
Danish: - Hvert hætteglas indeholder 20 mg mogamulizumab i 5 ml koncentrat svarende til 4 mg/ml.
English: Upper respiratory tract infection
Danish: Almindelig Infektion i øvre luftveje
English: In patients with stage IB/II disease, given the limited number of subjects with a response and immaturity of the data, no conclusion on duration of response can be made.
Danish: På grund af det begrænsede antal patienter med respons og dataenes utilstrækkelighed kan der ikke gives nogen konklusion af responsvarigheden hos patienter med sygdom i stadie IB/II.
English: Table 3: Overall and Compartmental Response Rate in Early Disease Stages
Danish: Tabel 3: Responsrate samlet og på områdeniveau i tidlige sygdomsstadier Mogamulizumab Vorinostat
English: • The infusion of POTELIGEO should be temporarily interrupted for mild to severe (Grades 1-3) infusion-related reactions and symptoms treated.
Danish: • I tilfælde af lette til alvorlige (grad 1-3) infusionsrelaterede reaktioner bør infusionen af POTELIGEO afbrydes midlertidigt og symptomerne behandles.
English: The incidence of infusion related reactions was highest after the first infusion (28.8% of subjects),
Danish: Forekomsten af infusionsrelaterede reaktioner var højest efter den første infusion (28,8% af patienterne) og faldt til ≤ 3,8% af patienterne efter to eller flere infusioner.
English: POTELIGEO 4 mg/mL concentrate for solution for infusion.
Danish: POTELIGEO 4 mg/ml koncentrat til infusionsvæske, opløsning.
English: MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Danish: FREMSTILLER AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
English: Each vial contains 20 mg of mogamulizumab in 5 mL, corresponding to 4 mg/mL.
Danish: Hvert hætteglas indeholder 20 mg mogamulizumab i 5 ml svarende til 4 mg/ml.
English: Mix diluted solution by gentle inversion.
Danish: Bland den fortyndede opløsning ved at vende posen forsigtigt om.
English: Pharmacotherapeutic group: Antineoplastic and immunomodulating agents, monoclonal antibodies ATC code: L01XC25
Danish: Farmakoterapeutisk klassifikation: Antineoplastiske og immunmodulerende midler, monoklonale antistoffer
English: - chills, nausea or vomiting, headache, wheezing, itching, flushing, rash, dizziness or feeling faint, difficulty breathing and fever, which may be signs of an infusion reaction.
Danish: - kulderystelser, kvalme eller opkastning, hovedpine, hvæsende vejrtrækning, kløe, rødme, udslæt, svimmelhed eller mathed, vejrtrækningsbesvær og feber, som kan være tegn på en infusionsreaktion.
English: - signs of infection, which may include a fever, sweats or chills, flu-like symptoms, sore throat or difficulty swallowing, cough, shortness of breath, stomach pain, nausea or vomiting, diarrhoea and feeling very unwell.
Danish: - tegn på infektion, som kan være feber, svedtendens eller kulderystelser, influenzalignende symptomer, ondt i halsen eller synkebesvær, hoste, stakåndethed, mavesmerter, kvalme eller opkastning, diarré og svær utilpashed.
English: - chest pain, shortness of breath, fast or slow heartbeat, sweating, dizziness, nausea or vomiting, weakness, feeling faint and feeling unwell.
Danish: - brystsmerter, stakåndethed, hurtig eller langsom hjerterytme, svedtendens, svimmelhed, kvalme eller opkastning, svækkelse, mathed og utilpashed.
English: All remaining SOCs reported SADRs in one patient (0.3%).
Danish: For alle resterende systemorganklasser blev der indberettet SADR'er for én patient
English: The subjects had a medical history including various risk factors.
Danish: Patienterne havde flere risikofaktorer i anamnesen.
English: If reaction recurs, discontinuing the infusion should be considered (see section 4.4).
Danish: Det bør overvejes at seponere infusionen, hvis der igen opstår en reaktion (se pkt.
English: The majority of treatment-related dermatologic reactions were Grade 1 or 2, with Grade ≥3 drug rash occurring in 4.3% of patients.
Danish: eller 2, mens hududslæt grad ≥3 opstod hos 4,3% af patienterne.
English: Hypothyroidism
Danish: Almindelig Hypothyreoidisme