FrancophonIA/ELRC3.0 huggingface dataset:
English: In the FLORENCE study febuxostat demonstrated a superior control of serum uric acid level compared to allopurinol in patients scheduled to receive the latter drug.
Danish: I FLORENCE-studiet viste febuxostat en superior kontrol af serumurinsyreniveauet sammenlignet med allopurinol hos patienter, som var planlagt til at skulle have sidstnævnte lægemiddel.
English: See the package leaflet for further information.
Danish: Se indlægssedlen for yderligere oplysninger.
English: Rosiglitazone/CYP2C8 substrates
Danish: Rosiglitazon/CYP2C8-substrater
English: Prevention and treatment of high uric acid levels in patients undergoing cancer chemotherapy Febuxostat Mylan is available as a 120 mg tablet.
Danish: Forebyggelse og behandling af høje urinsyreniveauer hos patienter i kemoterapi mod kræft Febuxostat Mylan fås som en 120 mg tablet.
English: Tumour Lysis Syndrome: in the pivotal Phase III trial (FLORENCE) only subjects with severe hepatic insufficiency were excluded from trial participation.
Danish: Tumorlyse-syndrom: I det pivotale fase 3-studie (FLORENCE) blev kun patienter med alvorligt leversvigt ekskluderet fra deltagelse i forsøget.
English: No studies have been conducted in patients with severe hepatic impairment (Child-Pugh Class C).
Danish: Der er ikke udført studier hos patienter med svært nedsat leverfunktion (Child-Pugh klasse C).
English: Febuxostat is extensively metabolized by conjugation via uridine diphosphate glucuronosyltransferase (UDPGT) enzyme system and oxidation via the cytochrome P450 (CYP) system.
Danish: Febuxostat metaboliseres i stort omfang ved konjugering via uridindiphosphat-glukuronosyltransferase (UDPGT)-enzymsystemet og oxidation via cytokrom P450 (CYP) -systemet.
English: These tophi may cause joint and bone damage.
Danish: Disse tofi kan beskadige led og knogler.
English: INR and Factor VII activity were also not affected by the co- administration of febuxostat.
Danish: INR og faktor VII-aktivitet blev heller ikke påvirket ved samtidig administration af febuxostat.
English: 42 film-coated tablets
Danish: 42 filmovertrukne tabletter
English: Thirst
Danish: Tørst
English: It may also include ulcers in the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes).
Danish: Syndromet kan også omfatte sår i mund, hals eller næse eller på kønsorganerne samt røde og hævede øjne (konjunktivitis).
English: Population pharmacokinetic/pharmacodynamic analyses were conducted in 211 patients with hyperuricaemia and gout, treated with febuxostat 40-240 mg QD.
Danish: Der blev gennemført populationsfarmakokinetiske/-farmakodynamiske analyser hos 211 patienter med hyperurikæmi og arthritis urica, som blev behandlet med febuxostat 40-240 mg en gang dagligt.
English: Between 46% and 55% of subjects received treatment for gout flares from Week 8 and Week 28.
Danish: Mellem 46% og 55% af deltagerne blev behandlet for udbrud af arthritis urica mellem uge 8 og uge 28.
English: • diarrhoea
Danish: • diarre
English: Liver function test is recommended prior to the initiation of therapy with febuxostat and periodically thereafter based on clinical judgment (see section 5.1).
Danish: Det anbefales at foretage leverfunktionsundersøgelser, inden behandlingen med febuxostat påbegyndes, og derefter med regelmæssige intervaller baseret på klinisk vurdering (se pkt.
English: Febuxostat Mylan tablets contain lactose.
Danish: Febuxostat Mylan tabletter indeholder lactose.
English: No patients with organ transplant have been included in these studies (see section 4.2).
Danish: Der blev ikke rekrutteret organtransplanterede patienter til disse studier (se pkt.
English: Pharmacotherapeutic group: Antigout preparation, preparations inhibiting uric acid production, ATC code: M04AA03
Danish: Farmakoterapeutisk klassifikation: Midler mod arthritis urica, midler der hæmmer urinsyreproduktionen, ATC-kode: M04AA03
English: In each phase 3 pivotal study, febuxostat demonstrated superior ability to lower and maintain serum uric acid levels compared to allopurinol.
Danish: I alle pivotale fase 3-studier påviste febuxostat superior evne til at sænke og vedligeholde serumurinsyreniveauer sammenlignet med allopurinol.
English: Post Marketing long term studies
Danish: Længerevarende studier efter markedsføringen
English: 46% and 38%, of patients on final stable treatment of febuxostat 80 or 120 mg QD, respectively, had complete resolution of the primary palpable tophus from baseline to the Final Visit.
Danish: Hos 46% og 38% af patienterne i endelig stabil behandling med henholdsvis febuxostat 80 og 120 mg en gang dagligt, forsvandt den primære palpable tophus fuldstændigt fra baseline og til det sidste besøg.
English: [For calendar blisters only]: MON
Danish: [Kun kalenderblisterpakninger]:
English: Manufacturer Mylan Hungary Kft Mylan utca 1
Danish: Fremstiller Mylan Hungary Kft Mylan utca 1
English: If serum uric acid is > 6 mg/dL (357 µmol/L) after 2-4 weeks, Febuxostat Mylan 120 mg once daily may be considered.
Danish: Hvis serumurinsyre er > 357 µmol/l (6 mg/dl) efter 2-4 uger, bør det overvejes at give Febuxostat Mylan 120 mg én gang dagligt.
English: Talk to your doctor before taking Febuxostat Mylan:
Danish: Kontakt lægen, før De tager Febuxostat Mylan:
English: Left untreated, larger deposits called tophi may form in and around joints.
Danish: Hvis det ikke behandles, kan der dannes større aflejringer, kaldet tofi, i og omkring ledene.
English: Table 1: Adverse reactions in combined phase 3, long-term extension studies and postmarketing experience Blood and lymphatic system disorders
Danish: Tabel 1: Bivirkninger i kombinerede langvarige fase 3- forlængelsesstudier og efter markedsføringen Blod og lymfesystem
English: Libido decreased, insomnia Rare
Danish: Ikke almindelige Nedsat libido, insomni Sjældne
English: • muscle and/or joint stiffness
Danish: • stive muskler og/eller led
English: • blurred vision, change in vision
Danish: • uskarpt syn, synsforandringer
English: • rash (including various types of rash, please see below under “uncommon” and “rare”
Danish: • udslæt (herunder forskellige typer udslæt - se nedenfor under 'ikke almindelige bivirkninger' og
English: No dose adjustment was required for enrolled patients on the basis of hepatic function.
Danish: Det var ikke nødvendigt at justere dosis for de deltagende patienter ud fra deres leverfunktion.
English: The ability of febuxostat to lower serum uric acid levels was prompt and persistent.
Danish: Febuxostats evne til at sænke serumurinsyreniveauerne var hurtig og vedvarende.
English: The efficacy and safety have not been fully evaluated in patients with severe renal impairment (creatinine clearance <30 mL/min, see section 5.2).
Danish: Sikkerhed og virkning er ikke fuldstændig klarlagt hos patienter med svært nedsat nyrefunktion (kreatininclearance <30 ml/min, se pkt.
English: An interaction study in healthy subjects has been performed with febuxostat to evaluate whether the inhibition of XO may cause an increase in the theophylline circulating levels as reported with other XO inhibitors.
Danish: Der er udført et interaktionsstudie med febuxostat hos raske forsøgsdeltagere for at vurdere, hvorvidt hæmning af XO kan medføre en stigning i niveauet af cirkulerende theophyllin, som det er rapporteret for andre XO-hæmmere.
English: It is especially important to tell your doctor or pharmacist if you are taking medicines containing any of the following substances as they may interact with Febuxostat Mylan and your doctor may wish to consider necessary measures:
Danish: Det er særlig vigtigt, at De fortæller det til Deres læge, hvis De tager lægemidler, der indeholder et eller flere af følgende stoffer, da sådanne lægemidler og Febuxostat Mylan kan påvirke hinanden.
English: Figure 1 Mean Serum Uric Acid Levels in Combined Pivotal Phase 3 Studies
Danish: Figur 1 Gennemsnitlige niveauer for serumurinsyre fra de kombinerede pivotale fase 3-studier
English: Drug interaction studies of febuxostat with drugs (except theophylline) that are metabolized by XO have not been performed in humans.
Danish: Der er ikke udført interaktionstudier mellem febuxostat og lægemidler (undtagen theophyllin), der metaboliseres af XO hos mennesker.
English: In the randomized, double-blind, Phase 3 pivotal FLORENCE (FLO-01) study comparing febuxostat with allopurinol (346 patients undergoing chemotherapy for haematologic malignancies and at intermediate-to-high risk of TLS), only 22 (6.4%) patients overall experienced adverse reactions, namely 11 (6.4%) patients in each treatment group.
Danish: I det randomiserede, dobbeltblindede, pivotale fase 3-studie FLORENCE (FLO-01), der sammenlignede febuxostat med allopurinol (346 patienter i kemoterapi for hæmatologiske maligniteter og en middel til høj risiko for tumorlyse-syndrom), fik kun 22 (6,4%) patienter bivirkninger, nemlig 11 (6,4%) patienter i hver behandlingsgruppe.
English: The patients should be closely monitored and the dose of mercaptopurine/azathioprine should be subsequently adjusted based on the evaluation of the therapeutic response and the onset of eventual toxic effects.
Danish: Patienterne bør monitoreres nøje, og dosen af mercaptopurin/azathioprin bør efterfølgende reguleres ud fra en vurdering af den terapeutiske effekt og indtrædelse af eventuelle toksiske virkninger.
English: Caution is required when febuxostat is used in patients with alteration of thyroid function (see section 5.1).
Danish: Der skal udvises forsigtighed, når febuxostat anvendes hos patienter med ændring i thyroideafunktionen (se pkt.
English: Uric acid is the end product of purine metabolism in humans and is generated in the cascade of hypoxanthine → xanthine → uric acid.
Danish: Urinsyre er slutproduktet af purinmetabolismen hos mennesker, og den genereres i følgende trin: hypoxanthin → xanthin → urinsyre.
English: Febuxostat is a 2-arylthiazole derivative that achieves its therapeutic effect of decreasing serum uric acid by selectively inhibiting XO. Febuxostat is a potent, nonpurine selective inhibitor of XO (NP-SIXO) with an in vitro inhibition Ki value less than one nanomolar.
Danish: Febuxostat er et 2-arylthiazolderivat, der opnår terapeutiske effekt i form af nedsættelse af serumurinsyren ved selektivt at hæmme XO. Febuxostat er en potent, ikke-purin selektiv XO-hæmmer (non-purine selective inhibitor of XO (NP-SIXO)) med en Ki-værdi for in vitroinhibering, der er mindre end én nanomolær.
English: Overall, 346 patients with haematological malignancies undergoing chemotherapy and at intermediate/high risk of Tumor Lysis Syndrome were included.
Danish: I alt deltog 346 patienter, der var i kemoterapi for hæmatologiske maligniteter og havde en middel/høj risiko for tumorlyse-syndrom.
English: Hypertension, flushing, hot flush, haemorrhage (see section Tumor Lysis Syndrome)
Danish: Hypertension, flushing, hedeture, hæmoragi (se afsnittet Tumorlyse-syndrom)
English: Febuxostat should not be used during pregnancy.
Danish: Febuxostat bør ikke anvendes under graviditet.
English: Febuxostat Mylan 120 mg tablets are also used to treat and prevent high blood levels of uric acid that may occur when you start to receive chemotherapy for blood cancers.
Danish: Febuxostat Mylan 120 mg tabletter anvendes også til at behandle og forebygge forhøjet indhold af urinsyre i blodet, som kan forekomme, når De begynder at få kemoterapi mod blodkræft.
English: The recommended dose in patients with mild hepatic impairment is 80 mg. Limited information is available in patients with moderate hepatic impairment.
Danish: Den anbefalede dosis til patienter med let nedsat leverfunktion er 80 mg. Der er kun begrænset information tilgængelig vedrørende patienter med moderat nedsat leverfunktion.
English: Uncommon Erectile dysfunction
Danish: Ikke almindelige Erektil dysfunktion
English: In the long-term extension studies the incidences of investigator-reported APTC events were 1.2 and 0.6 events per 100 PYs for febuxostat and allopurinol, respectively.
Danish: I de langvarige forlængelsesstudier var forekomsten af investigator-indberettede APTChændelser 1,2 og 0,6 hændelser pr. 100 patientår for henholdsvis febuxostat og allopurinol.
English: Organ transplant recipients
Danish: Organtransplanterede patienter
English: No data is available for febuxostat 120 mg.
Danish: Der foreligger ingen data for febuxostat 120 mg.
English: As there has been no experience with febuxostat, its use in patients with Lesch-Nyhan Syndrome is not recommended.
Danish: Da der ikke er erfaring med febuxostat, frarådes brug af febuxostat til patienter med Lesch-Nyhans syndrom.
English: Two hundred and forty mg febuxostat (2 times the recommended highest dose) was used as a safety evaluation dose.
Danish: Der blev anvendt en dosis på 240 mg febuxostat (to gange den højst anbefalede dosis) til evaluering af sikkerheden.
English: CONFIRMS Study: The CONFIRMS study was a Phase 3, randomized, controlled, 26-week study to evaluate the safety and efficacy of febuxostat 40 mg and 80 mg, in comparison with allopurinol 300 mg or 200 mg, in patients with gout and hyperuricaemia.
Danish: CONFIRMS-studiet: CONFIRMS-studiet var et randomiseret, kontrolleret 26-ugers fase 3-studie til evaluering af sikkerhed og virkning af febuxostat 40 mg og 80 mg ved sammenligning med allopurinol 300 mg eller 200 mg hos patienter med arthritis urica og hyperurikæmi.
English: Rhabdomyolysis*, joint stiffness, musculoskeletal stiffness
Danish: Rabdomyolyse*, stive led, muskuloskeletal stivhed
English: The efficacy and safety of febuxostat has not been studied in patients with severe hepatic impairment (Child Pugh Class C).
Danish: Febuxostats sikkerhed og virkning er ikke undersøgt hos patienter med svært nedsat leverfunktion (Child-Pugh klasse C).
English: • hot flushes or flushing (e.g. redness of the face or neck), increased blood pressure, bleeding (haemorrhage, seen only in patients taking chemotherapy for blood disorders)
Danish: • hedeture eller flushing (rødme i ansigt eller på hals), forhøjet blodtryk, blødning (kun hos patienter, der er i kemoterapi mod blodsygdomme)
English: Weight decrease, increase appetite, anorexia
Danish: Vægttab, øget appetit, anoreksi
English: Prevention and treatment of hyperuricaemia in patients at risk of TLS
Danish: Forebyggelse og behandling af hyperurikæmi hos patienter med risiko for tumorlyse-syndrom
English: When chemotherapy is given, cancer cells are destroyed, and uric acid levels increase in the blood accordingly, unless the formation of uric acid is prevented.
Danish: Kemoterapi dræber kræftcellerne, hvorved indholdet af urinsyre i blodet stiger, medmindre det forebygges, at der dannes urinsyre.
English: Multipack: 84 (2 packs of 42) film-coated tablets
Danish: Multipakning: 84 filmovertrukne tabletter (2 pakker med 42)
English: Nervousness
Danish: Nervøsitet
English: • abnormal liver test results
Danish: • unormale resultater af leverfunktionsundersøgelser
English: The gout flare should be managed concurrently as appropriate for the individual patient.
Danish: Udbruddet bør behandles sideløbende tilpasset den enkelte patient.
English: However, weight-corrected Cmax and AUC were similar between the genders.
Danish: Dog var Cmax og AUC det samme for begge køn, når der blev korrigeret for vægt.
English: The therapeutic target is to decrease and maintain serum uric acid below 6 mg/dL (357 μmol/L).
Danish: Det terapeutiske mål er at nedsætte og fastholde serumurinsyre på under 6 mg/dl (357 μmol/l).
English: FOCUS Study (TMX-01-005) was a 5 years Phase 2, open-label, multicenter, safety extension study for patients who had completed the febuxostat 4 weeks of double blind dosing in study TMX-00-004.
Danish: Studie TMX-01-005 (FOCUS) var et femårigt åbent, forlænget fase 2-multicenterstudie til evaluering af sikkerheden hos patienter, som havde gennemført studie TMX-00-004 med 4 ugers febuxostatbehandling i et dobbeltblindt design.
English: What Febuxostat Mylan is and what it is used for What you need to know before you take Febuxostat Mylan How to take Febuxostat Mylan Possible side effects
Danish: Febuxostat Mylans virkning og anvendelse Det skal De vide, før De begynder at tage Febuxostat Mylan Sådan skal De tage Febuxostat Mylan Bivirkninger
English: • Theophylline (used to treat asthma)
Danish: • Theophyllin (anvendes til behandling af astma)
English: 14 film-coated tablets 28 film-coated tablets 42 film-coated tablets 84 film-coated tablets 28 x 1 film-coated tablets 28 film-coated tablets (calendar) 84 film-coated tablets (calendar)
Danish: 14 filmovertrukne tabletter 28 filmovertrukne tabletter 42 filmovertrukne tabletter 84 filmovertrukne tabletter 28 x 1 filmovertrukne tabletter 28 filmovertrukne tabletter (kalender) 84 filmovertrukne tabletter (kalender)
English: These crystals can cause sudden, severe pain, redness, warmth and swelling in a joint (known as a gout attack).
Danish: Disse krystaller kan medføre pludselig, kraftig smerte, rødme, varme og hævelse i et led (anfald af urinsyregigt).
English: Be aware that you may experience dizziness, sleepiness, blurred vision and numbness or tingling sensation during treatment and should not drive or operate machines if affected.
Danish: Vær opmærksom på, at De kan blive svimmel eller søvnig, få uskarpt syn eller opleve en følelsesløs eller prikkende fornemmelse under behandlingen.
English: In the Tumor Lysis Syndrome pivotal trial febuxostat 120 mg daily was administered to patients undergoing several chemotherapy regimens, including monoclonal antibodies.
Danish: I det pivotale studie af tumorlyse-syndrom blev der administreret 120 mg dagligt til patienter i flere forskellige kemoterapiregimer, herunder monoklonale antistoffer.
English: Iron oxide black (E172)
Danish: Jernoxid, sort (E172)
English: In male rats, a statistically significant increase in urinary bladder tumours (transitional cell papilloma and carcinoma) was found only in association with xanthine calculi in the high dose group, at approximately 11 times human exposure.
Danish: Hos hanrotter blev der kun fundet en statistisk signifikant stigning i urinblæretumorer (transitiocellulært papillom og karcinom) i forbindelse med xanthinsten i højdosisgruppen ved cirka 11 gange den humane eksponering.
English: Xanthine deposition
Danish: Aflejring af xanthin
English: Administration of febuxostat (80 mg or 120 mg once daily) with warfarin had no effect on the pharmacokinetics of warfarin in healthy subjects.
Danish: Administration of febuxostat (80 mg eller 120 mg en gang dagligt) sammen med warfarin påvirkede ikke warfarins farmakokinetik hos raske forsøgspersoner.
English: Rare Anaphylactic reaction*, drug hypersensitivity*
Danish: Sjældne Anafylaktisk reaktion*, lægemiddeloverfølsomhed
English: Diabetes mellitus, hyperlipidemia, decrease appetite, weight increase
Danish: Diabetes mellitus, hyperlipidæmi, nedsat appetit, vægtstigning Sjældne
English: The efficacy and safety of febuxostat has not been established in patients with acute severe TLS, e.g. in patients who failed on other urate lowering therapies.
Danish: Febuxostats virkning og sikkerhed er ikke blevet klarlagt hos patienter med svært akut tumorlysesyndrom, f.eks. hos patienter, hvor andre former for uratsænkende behandling ikke havde nogen virkning.
English: • itching, hives, skin inflammation, skin discoloration, small red or purple spots on the skin, small, flat red spots on the skin, flat, red area on the skin that is covered with small confluent bumps, rash, areas of redness and spots on the skin, other type of skin conditions
Danish: • kløe, nældefeber, betændelse i huden, misfarvning af huden, små røde eller rødviolette pletter på huden, små, flade, røde pletter på huden, fladt, rødt område på huden dækket af små sammenflydende buler, udslæt, områder med pletter og rødme, andre former for hudproblemer
English: Patients should be advised of the signs and symptoms and monitored closely for symptoms of allergic/hypersensitivity reactions (see section 4.8).
Danish: Patienterne bør informeres om symptomerne på allergiske reaktioner og overfølsomhedsreaktioner og monitoreres nøje for disse symptomer (se pkt.
English: Stevens-Johnson Syndrome and Toxic epidermal necrolysis are characterised by progressive skin rashes associated with blisters or mucosal lesions and eye irritation.
Danish: Stevens-Johnsons syndrom og toksisk epidermal nekrolyse kendetegnes ved progredierende hududslæt forbundet med blærer eller slimhindelæsioner og øjenirritation.
English: PHARMACEUTICAL FORM AND CONTENTS
Danish: LÆGEMIDDELFORM OG INDHOLD
English: • increase in gout symptoms
Danish: • øget forekomst af gigtsymptomer
English: Mylan Denmark ApS Tel: +45 28 11 69 32
Danish: Mylan Denmark ApS Tlf: + 45 28 11 69 32
English: Patients with an overdose should be managed by symptomatic and supportive care.
Danish: I tilfælde af overdosering bør patienten modtage symptomatisk og understøttende behandling.
English: In animals, reproduction studies up to 48 mg/kg/day showed no dose-dependent adverse effects on fertility (see section 5.3).
Danish: I reproduktionsstudier hos dyr med doser på op til 48 mg/kg/dag sås ingen dosisafhængig påvirkning af fertiliteten (se pkt.
English: Inducers of glucuronidation
Danish: Induktorer af glukuronidering
English: These adverse reactions were mostly mild or moderate in severity.
Danish: Disse bivirkninger var for det meste af let til moderat sværhedsgrad.
English: Thus, co-administration of febuxostat with other CYP2D6 substrates is not expected to require any dose adjustment for those compounds.
Danish: Derfor forventes samtidig administration af febuxostat og andre CYP2D6-substrater ikke at kræve dosisjustering af disse stoffer.
English: Somnolence, dizziness, paraesthesia and blurred vision have been reported with the use of febuxostat.
Danish: Der er rapporteret døsighed, svimmelhed, paræstesi og uskarpt syn i forbindelse med anvendelse af febuxostat.
English: 28 film-coated tablets 84 film-coated tablets
Danish: 28 filmovertrukne tabletter 84 filmovertrukne tabletter
English: Tumor Lysis Syndrome
Danish: Tumorlyse-syndrom
English: The recommended oral dose of Febuxostat Mylan is 80 mg once daily without regard to food.
Danish: Den anbefalede orale dosis af Febuxostat Mylan er 80 mg én gang dagligt uden hensyntagen til fødeindtagelse.
English: After single or multiple oral 80 and 120 mg once daily doses, Cmax is approximately 2.8-3.2 µg/mL, and 5.05.3 µg/mL, respectively.
Danish: Efter enkelte eller gentagne orale doser på 80 og 120 mg én gang dagligt er Cmax henholdsvis cirka 2,8-3,2 mikrog/ml og 5,05,3 mikrog/ml.
English: Should you experience allergic reactions to Febuxostat Mylan, stop taking this medicine (see also section 4).
Danish: Hold op med at tage medicinen, hvis De får allergiske reaktioner på Febuxostat Mylan (se også punkt 4).
English: 62% of patients required no dose adjustment to maintain sUA <6 mg/dL and 38% of patients required a dose adjustment to achieve a final stable dose.
Danish: 62% af patienterne behøvede ikke dosisjustering for at opretholde et serumurinsyreniveau < 357 µmol/l (6 mg/dl), mens 38% af patienterne havde behov for dosisjustering for at opnå en endelig stabil dosis.
English: Rates of adjudicated hospitalization for heart failure, hospital admissions for arrhythmias not associated with ischemia, venous thromboembolic events and hospitalization for transient ischemic attacks were comparable for febuxostat and allopurinol.
Danish: Omfanget af bekræftede hospitalsindlæggelser pga. hjertesvigt, indlæggelser pga. arytmi uden sammenhæng med iskæmi, venøse tromboemboliske hændelser samt indlæggelse for transiente iskæmiske attacks var sammenlignelige for febuxostat og allopurinol.
English: Reduction in serum uric acid level to <6.0 mg/dL (357 µmol/L) was noted by the Week 2 visit and was maintained throughout treatment.
Danish: Reduktionen i serumurinsyreniveauerne til <357 µmol/l (6,0 mg/dl) blev observeret ved uge 2-besøget og blev vedligeholdt gennem hele behandlingen.
English: Desipramine/CYP2D6 substrates
Danish: Desipramin/CYP2D6-substrater
English: • increase in blood thyroid stimulating hormone (TSH) level
Danish: • stigning i blodets indhold af det hormon, der stimulerer skjoldbruskkirtlen (TSH)