FrancophonIA/ELRC3.0 huggingface dataset:
English: • If resuming Lojuxta after aminotransferase levels resolve to <3x ULN, reduce the dose and monitor liver-related tests more frequently.
Danish: • Hvis behandlingen med Lojuxta genoptages efter at aminotransferaserne er faldet til < 3 x ULN, reduceres dosis og leverrelaterede prøver overvåges hyppigere.
English: Conversely, on discontinuation, CYP3A4 induction may take at least 2 weeks to decline.
Danish: Efter seponering af CYP3A4-induktorer kan CYP3A4-induktionen omvendt være mindst 2 uger om at aftage.
English: Grapefruit juice must be omitted from the diet while patients are treated with Lojuxta.
Danish: Grapefrugtjuice skal undgås af patienter i behandling med Lojuxta.
English: Capsule shell:
Danish: Kapselskal:
English: Entire trial weeks 0-78 N (%)
Danish: Hele undersøgelsen uge 0-78
English: No adverse effects on fertility were observed in male and female rats administered lomitapide at systemic exposures (AUC) estimated to be 4 to 5 times higher than in humans at the maximum recommended human dose (see section 5.3).
Danish: Der blev ikke iagttaget negativ virkning på fertiliteten hos han- eller hunrotter ved indgift af lomitapid ved en systemisk eksponering (AUC), der vurderedes at være 4-5 gange højere end den, der opnås ved brug af den anbefalede maksimale dosis til mennesker (se pkt.
English: • medicines to treat cancer (e.g. everolimus, imatinib, lapatinib, nilotinib, topotecan)
Danish: • lægemidler til behandling af kræft (f.eks. everolimus, imatinib, lapatinib, nilotinib og topotecan)
English: For patients on a stable maintenance dose of Lojuxta who receive any other weak CYP3A4 inhibitor, separate the dose of the medicinal products (Lojuxta and the weak CYP3A4 inhibitor) by 12 hours.
Danish: Til patienter, der får en stabil vedligeholdelsesdosis af Lojuxta, og som er i behandling med en hvilken som helst anden svag CYP3A4-hæmmer, bør lægemidlerne (Lojuxta og den svage CYP3A4-hæmmer) administreres med 12 timers mellemrum.
English: Patients with rare hereditary problems of galactose intolerance, total-lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Danish: Det bør ikke anvendes til patienter med hereditær galactoseintolerans, total lactasemangel eller glucose/galactosemalabsorption.
English: In an oral carcinogenicity study in rats, lomitapide was administered up to 99 weeks at doses up to 7.5 mg/kg/day in males and 2.0 mg/kg/day in females.
Danish: I en oral karcinogenicitetsundersøgelse hos rotter blev lomitapid indgivet i op til 99 uger i doser op til 7,5 mg/kg/dag til hanner og 2,0 mg/kg/dag til hunner.
English: • if you have liver problems or unexplained abnormal liver tests.
Danish: • hvis du har leverproblemer eller af ukendt årsag har unormale leverprøver
English: Dizziness Headache Migraine
Danish: Svimmelhed Hovedpine Migræne
English: Before initiating treatment in women of child-bearing potential, the absence of pregnancy should be confirmed, appropriate advice on effective methods of contraception provided, and effective contraception initiated.
Danish: Før initiering af behandling af kvinder i den fertile alder bør graviditet udelukkes, der bør gives fyldestgørende rådgivning om effektive antikonceptionsmetoder, og effektiv antikonception bør tages i anvendelse.
English: Co-administration of a CYP3A4 inducer is expected to reduce the effect of lomitapide.
Danish: Koadministration af en CYP3A4-induktor forventes at mindske virkningen af lomitapid.
English: Abdominal distension Constipation
Danish: Abdominal distension Konstipation
English: Abdominal pain lower Frequent bowel movements
Danish: Smerter i nedre abdomen Hyppig afføring
English: • dehydration, dry mouth
Danish: • dehydrering, mundtørhed
English: • medicines to treat severe acne (e.g. isotretinoin)
Danish: • lægemidler til behandling af svær acne (f.eks. isotretinoin)
English: Mean percent changes from baseline in LDL-C in the major effectiveness study UP1002/AEGR-733-005 through Week 26 (the Primary Endpoint) using LOCF to each assessment (N=29)
Danish: Gennemsnitlig procentuel ændring fra udgangsværdien af LDL-C i hovedundersøgelsen af virkning UP1002/AEGR-733-005 til og med uge 26 (det primære endepunkt) med LOCF for hver parameter (N=29)
English: Patient brochure
Danish: Patientbrochure
English: In patients with mild hepatic impairment, lomitapide AUC and Cmax were 47% and 4% higher, respectively, compared with healthy volunteers.
Danish: Hos patienter med let nedsat leverfunktion var AUC og Cmax af lomitapid henholdsvis 47 % og 4 % højere end hos raske forsøgspersoner.
English: What you need to know before you take Lojuxta
Danish: Det skal du vide, før du begynder at tage Lojuxta
English: − The need to take daily dietary supplements (i.e. 400 IU vitamin E, approximately 200 mg linoleic acid, 110 mg eicosapentaenoic acid (EPA), 210 mg alpha linolenic acid (ALA) and 80 mg docosahexaenoic acid (DHA) per day).
Danish: − Nødvendigheden af at tage kosttilskud (dvs. 400 IE vitamin E, cirka 200 mg linolsyre, 110 mg eicosapentaensyre (EPA), 210 mg alfalinolensyre (ALA) og 80 mg docosahexaensyre (DHA) dagligt).
English: Gastrooeosophageal reflux disease Abdominal tenderness Epigastric discomfort Gastric dilatation
Danish: Gastroøsofageal reflukssygdom Abdominal ømhed Epigastrisk ubehag Gastrisk dilatation Hæmatemese
English: • changes to blood clotting tests
Danish: • ændrede blodkoagulationsprøver
English: This means that due to the rarity of the disease it has not been possible to obtain complete information on this medicinal product.
Danish: Det betyder, at det af videnskabelige årsager ikke har været muligt at opnå fuldstændig dokumentation for lægemidlet, fordi det anvendes til en sjælden sygdom.
English: Coadministration of Lojuxta with P gp substrates (such as aliskiren, ambrisentan, colchicine, dabigatran etexilate, digoxin, everolimus, fexofenadine, imatinib, lapatinib, maraviroc, nilotinib, posaconazole, ranolazine, saxagliptin, sirolimus, sitagliptin, talinolol, tolvaptan, topotecan) may increase the absorption of P gp substrates.
Danish: Koadministration af Lojuxta og P-gp-substrater (såsom aliskiren, ambrisentan, colchicin, dabigatran etexilat, digoxin, everolimus, fexofenadin, imatinib, lapatinib, maraviroc, nilotinib, posaconazol, ranolazin, saxagliptin, sirolimus, sitagliptin, talinolol, tolvaptan og topotecan) kan øge absorptionen af P-gp-substrater.
English: • medicines to treat tuberculosis (e.g. isoniazid, rifampicin)
Danish: • lægemidler til behandling af tuberkulose (f.eks. isoniazid, rifampicin)
English: A pharmacokinetic study in patients with ESRD undergoing hemodialysis demonstrated a 36% increase in mean lomitapide plasma concentration compared to matched healthy controls.
Danish: En farmakokinetisk undersøgelse viste 36 % procent højere gennemsnitlig plasmakoncentration af lomitapid hos patienter med ESRD i hæmodialyse end hos matchede raske kontrolpersoner.
English: Week 14
Danish: Uge 14
English: • medicines to treat epilepsy (e.g. phenobarbital, carbamazepine, phenytoin)
Danish: • lægemidler til behandling af epilepsi (f.eks. phenobarbital, carbamazepin, fenytoin)
English: • combined oral contraceptives (e.g. ethinylestradiol, norgestimate)
Danish: • kombinerede orale svangerskabsforebyggende midler (f.eks. ethinylestradiol, norgestimat)
English: High density polyethylene (HDPE) bottle fitted with a polyester/aluminium foil/cardboard induction seal and polypropylene screw cap.
Danish: 6.5 Emballagetype og pakningsstørrelser Flaske af HD-polyethylen (HDPE) med forsegling af polyester/alufolie/karton og polypropylen-skruelåg.
English: The clinical benefit of reductions in background lipid-lowering therapy, including apheresis, is not certain.
Danish: Der er ikke sikker klinisk fordel af at reducere den lipidsænkende baggrundsbehandling, herunder aferese.
English: Consider limiting the maximum dose of Lojuxta according to desired LDL-C response.
Danish: Det bør overvejes at begrænse den maksimale dosis af Lojuxta i henhold til den tilsigtede LDL-Crespons.
English: If treatment with moderate or strong CYP3A4 inhibitors is unavoidable, Lojuxta should be stopped during the course of treatment.
Danish: Hvis behandling med moderate eller stærke CYP3A4-hæmmere ikke kan undgås, må Lojuxta seponeres, så længe denne behandling står på.
English: Examples of weak CYP3A4 inhibitors include: alprazolam, amiodarone, amlodipine, atorvastatin, azithromycin, bicalutamide, cilostazol, cimetidine, ciclosporin, clotrimazole, fluoxetine, fluvoxamine, fosaprepitant, ginkgo, goldenseal, isoniazid, ivacaftor, lacidipine, lapatinib, linagliptin, nilotinib, oestrogen-containing oral contraceptives, pazopanib, peppermint oil, propiverine, ranitidine, ranolazine, roxithromycin, Seville oranges, tacrolimus, ticagrelor and tolvaptan.
Danish: Eksempler på svage CYP3A4hæmmere: alprazolam, amiodaron, amlodipin, atorvastatin, azithromycin, bicalutamid, cilostazol, cimetidin, ciclosporin, clotrimazol, fluoxetin, fluvoxamin, fosaprepitant, ginkgo, guldsegl, isoniazid, ivacaftor, lacidipin, lapatinib, linagliptin, nilotinib, østrogenholdige orale antikonceptionsmidler, pazopanib, pebermynteolie, propiverin, ranitidin, ranolazin, roxithromycin, bitre appelsiner (pomerans), tacrolimus, ticagrelor og
English: o Hepatic events o Gastrointestinal events o Small bowel, hepatic, colorectal and pancreatic tumours o Events associated with coagulopathy o Major Adverse Cardiovascular Events (MACE) events o Death, including cause of death
Danish: o Hepatiske hændelser o Gastrointestinale hændelser o Tyndtarmstumorer, levertumorer, kolorektale tumorer og pankreastumorer o Hændelser forbundet med koagulopati o Alvorlige, uønskede kardiovaskulære hændelser (mace)
English: • medicines to reduce blood pressure (e.g. talinolol, aliskiren, ambrisentan)
Danish: • lægemidler mod forhøjet blodtryk (f.eks. talinolol, aliskiren, ambrisentan)
English: When lomitapide 60 mg was administered to steady state prior to rosuvastatin 20 mg, rosuvastatin Tmax increased from 1 to 4 hours, AUC was increased 32%, and its Cmax was unchanged.
Danish: Når lomitapid 60 mg blev administreret til steady state inden rosuvastatin 20 mg, øgedes Tmax af rosuvastatin fra 1 til 4 timer, AUC øgedes 32 %, mens Cmax var uændret.
English: Uncommon (may affect up to 1 in 100 people):
Danish: Ikke almindelig (forekommer hos op til 1 ud af 100 behandlede):
English: • medicines to treat anxiety disorders and depression (e.g. alprazolam, fluoxetine, fluvoxamine)
Danish: • lægemidler til behandling af angsttilstande og depression (f.eks. alprazolam, fluoxetin,
English: • Patients with a known significant or chronic bowel disease such as inflammatory bowel disease or malabsorption.
Danish: • Kendt betydelig eller kronisk tarmsygdom såsom inflammatorisk tarmsygdom eller malabsorption.
English: Common (may affect up to 1 in 10 people):
Danish: Almindelig (forekommer hos op til 1 ud af 10 behandlede):
English: • At the request of the European Medicines Agency; • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: • på anmodning fra Det Europæiske Lægemiddelagentur • når risikostyringssystemet ændres, særligt som følge af, at der er modtaget nye oplysninger,
English: Total Cholesterol (TC) (mg/dL)
Danish: Totalkolesterol (TC) (mg/dl)
English: • The other ingredients are: pregelatinized starch, sodium starch glycolate (Type A), microcrystalline cellulose, lactose monohydrate, silica colloidal anhydrous and magnesium stearate (for information on lactose monohydrate, see section 2 under ‘Lojuxta contains lactose').
Danish: • Øvrige indholdsstoffer: pregelatineret stivelse, natriumstivelsesglycolat (type A), mikrokrystallinsk cellulose, lactosemonohydrat, kolloid vandfri silica og magnesiumstearat (vedrørende lactosemonohydrat, se afsnit 2 under “Lojuxta indeholder lactose”).
English: Very common
Danish: Ikke almindelig
English: • paracetamol - to treat pain
Danish: • paracetamol (smertestillende)
English: Week 18
Danish: Uge 18
English: • abnormal lung function test
Danish: • unormal lungefunktionsprøve
English: Patients with results suggesting the presence of steatohepatitis or fibrosis should be considered for liver biopsy.
Danish: Ved mistanke om steatohepatitis eller fibrose bør leverbiopsi overvejes.
English: Moderate CYP3A4 inhibitors are predicted to have a substantial impact on lomitapide's pharmacokinetics.
Danish: Moderate CYP3A4-hæmmere forventes at have betydelig indvirkning på farmakokinetikken af lomitapid.
English: • If resuming Lojuxta after aminotransferase levels resolve to <3x ULN, consider reducing the dose and monitor liver-related tests more frequently.
Danish: • Hvis behandlingen med Lojuxta genoptages, efter at aminotransferaserne er faldet til < 3x ULN, bør det overvejes at nedsætte dosis og øge hyppigheden af overvågningen af leverrelaterede prøver.
English: • Information about the existence and importance of the Lomitapide Observational Worldwide Evaluation Registry aiming to systematically collect information on the safety and effectiveness outcomes of patients treated with lomitapide.
Danish: • Information om eksistensen og vigtigheden af Lomitapide Observational Worldwide Evaluation Registry, der systematisk indsamler oplysninger om sikkerheds- og virkningsmæssige udfald for patienter, der behandles med lomitapid
English: Rash erythematous Xanthoma
Danish: Erytematøst udslæt Xantom
English: Doses of simvastatin >40 mg should not be used with Lojuxta (see section 4.3).
Danish: Der bør ikke anvendes simvastatin i doser >40 mg sammen med Lojuxta (se pkt.
English: Week 26
Danish: Uge 26
English: Week 2
Danish: Uge 2
English: This card will give information about interactions with: o CYP 3A4 inhibitors o CYP 3A4 inducers o coumarin anticoagulants o statins o P-gp substrates o Oestrogen-containing oral contraceptives
Danish: Kortet skal indeholde information om interaktioner med: o CYP 3A4-hæmmere o CYP 3A4-induktorer o kumarin-antikoagulantia o statiner o P-gp-substrater o østrogenholdige orale antikonceptionsmidler
English: Do not take Lojuxta: • if you are allergic to lomitapide or any of the other ingredients of this medicine (listed in section
Danish: • hvis du er allergisk over for lomitapid eller et af de øvrige indholdsstoffer i Lojuxta (angivet i afsnit 6)
English: Patients should avoid consumption of grapefruit juice (see sections 4.4 and 4.5).
Danish: Patienterne bør undgå grapefrugtjuice (se pkt.
English: When lomitapide 60 mg was administered to steady state prior to simvastatin 40 mg, simvastatin acid AUC and Cmax increased 68% and 57%, respectively.
Danish: Når lomitapid 60 mg blev administreret til steady state inden simvastatin 40 mg, øgedes AUC og Cmax af simvastatinsyre med henholdsvis 68 % og 57 %.
English: • Importance of fatty acid and soluble vitamins supplementation;
Danish: • Vigtigheden af tilskud af fedtsyrer og opløselige vitaminer.
English: Highest liver function test results post first dose (major effectiveness study UP1002/AEGR-733-005)
Danish: Højeste resultater af leverfunktionsprøver (hovedundersøgelse af virkning UP1002/AEGR-733-005)
English: Oestrogen-containing oral contraceptives are weak CYP3A4 inhibitors (see section 4.2).
Danish: Østrogenholdige orale antikonceptionsmidler er svage CYP3A4-hæmmere (se pkt.
English: • medicines to reduce blood pressure (e.g. amlodipine, lacidipine)
Danish: • lægemidler mod forhøjet blodtryk (f.eks. amlodipin, lacidipin)
English: Based on observations of decreased essential fatty acid and vitamin E levels in clinical studies, patients should take daily dietary supplements that provide 400 IU vitamin E and approximately 200 mg linoleic acid, 110 mg eicosapentaenoic acid (EPA), 210 mg alpha linolenic acid (ALA) and 80 mg docosahexaenoic acid (DHA) per day, throughout treatment with Lojuxta.
Danish: På grundlag af de iagttagne fald i niveauet af essentielle fedtsyrer og vitamin E i de kliniske studier bør patienterne dagligt have kosttilskud af 400 IE vitamin E og cirka 200 mg linolsyre, 110 mg icosapentaensyre, 210 mg alfalinolensyre (ALA) og 80 mg docosahexaensyre (DHA), så længe de er i behandling med Lojuxta.
English: The risk of liver damage is increased when this medicine is used at the same time as statins.
Danish: Risikoen for leverskade er øget, når Lojuxta anvendes sammen med statiner.
English: What Lojuxta contains
Danish: Lojuxta indeholder:
English: The applicant shall set up a long term prospective observational study to systematically collect information on the safety and effectiveness outcomes of patients treated with lomitapide.
Danish: Ansøgerne skal tilrettelægge en langsigtet prospektiv observationsundersøgelse til systematisk indsamling af oplysninger om sikkerheds- og virkningsmæssige udfald hos patienter, der behandles med lomitapid.
English: • changes to blood cell count
Danish: • ændret blodtælling
English: Week 22
Danish: Uge 22
English: Gastrointestinal disorders
Danish: Gastrointestinale effekter
English: Abdominal discomfort Dyspepsia
Danish: Abdominalt ubehag Dyspepsi
English: Pulmonary histiocytosis was observed in rodents.
Danish: Hos gnavere iagttoges pulmonal histiocytose.
English: Alanine aminotransferase increased Aspartate aminotransferase increased Weight decreased
Danish: Meget almindelig Alaninaminotransferase forhøjet Aspartataminotransferase forhøjet Vægttab
English: Other medicines and Lojuxta
Danish: Brug af anden medicin sammen med Lojuxta
English: Use of strong or moderate inhibitors of CYP3A4 is contraindicated with Lojuxta.
Danish: Potente eller moderate CYP3A4-hæmmere er kontraindiceret sammen med Lojuxta.
English: • Not to take Lojuxta if patient has liver problems, or unexplained abnormal liver tests;
Danish: • Indtagelse af Lojuxta skal undgås ved leverproblemer eller unormale leverprøver af ukendt årsag
English: • Do not take this medicine with food, as taking these capsules with food can cause stomach problems.
Danish: • Tag ikke Lojuxta sammen med et måltid, da det kan give maveproblemer.
English: Nasopharyngitis Sinusitis
Danish: Nasofaryngitis Sinuitis
English: Lojuxta contains lactose.
Danish: Lojuxta indeholder lactose.
English: Pain in extremity Joint swelling Muscle twitching
Danish: Smerter i ekstremiteter Hævede led Muskelsitren
English: When administered with atorvastatin, the dose of Lojuxta should either be taken 12 hours apart or be decreased by half (see section 4.2).
Danish: Ved administration sammen med atorvastatin bør lægemidlerne enten gives med 12 timers mellemrum, eller dosis af Lojuxta halveres (se pkt.
English: Very-low-density lipoprotein cholesterol (VLDL-C) (mg/dL)
Danish: Very-low-density lipoprotein kolesterol (VLDL-C) (mg/dl)
English: Week 6
Danish: Uge 6
English: Capsule content:
Danish: Kapselindhold
English: Before initiating treatment in women of child-bearing potential, appropriate advice on effective methods of contraception should be provided, and effective contraception initiated.
Danish: Før initiering af behandling af fertile kvinder bør der gives tilstrækkelig vejledning om effektiv antikonception, og effektiv antikonception bør tages i anvendelse.
English: Patients taking oestrogen-based oral contraceptives should be advised about possible loss of effectiveness due to diarrhoea and/or vomiting (see section 4.5).
Danish: Patienter, der får østrogenbaserede orale antikonceptionsmidler, bør informeres om muligheden for nedsat effektivitet ved diarré og/eller opkastning (se pkt.
English: When lomitapide 60 mg was administered to steady state prior to atorvastatin 20 mg, atorvastatin acid AUC and Cmax increased 52% and 63%, respectively.
Danish: Når lomitapid 60 mg blev administreret til steady state inden atorvastatin 20 mg, øgedes AUC og Cmax af atorvastatinsyre med henholdsvis 52 % og 63 %.
English: • medicines to treat bacterial or fungal infections (e.g. nafcillin, azithromycin, roxithromycin,
Danish: • lægemidler til behandling af bakterie- og svampeinfektioner (f.eks. nafcillin, azithromycin,
English: Patients taking oestrogen-based oral contraceptives should be advised about possible loss of effectiveness due to diarrhoea and/or vomiting.
Danish: Patienter, der får østrogenbaserede orale antikonceptionsmidler, bør informeres om muligheden for nedsat effektivitet ved diarré og/eller opkastning.
English: • Concomitant use of Lojuxta with strong or moderate cytochrome P450 (CYP) 3A4 inhibitors (e.g., antifungal azoles such as itraconazole, fluconazole,ketoconazole, voriconazole, posaconazole; macrolide antibiotics such as erythromycin or clarithromycin; ketolide antibiotics such as telithromycin; HIV protease inhibitors; the calcium channel blockers diltiazem and verapamil, and the anti-arrhythmic dronedarone [see section 4.5]).
Danish: • Brug af Lojuxta sammen med stærke eller moderate hæmmere af cytokrom P450 (CYP) 3A4 (f.eks. antimykotiske azoler såsom itraconazol, fluconazol, ketoconazol, voriconazol, posaconazol, makrolidantibiotika såsom erythromycin eller clarithromycin, ketolidantibiotika såsom telithromycin, hiv-proteasehæmmere, calciumkanalblokkerne diltiazem og verapamil, samt det antiarytmiske middel dronedaron (se pkt.
English: Non high-density lipoprotein cholesterol (Non-HDL-C) (mg/dL)
Danish: Non-high-density lipoprotein kolesterol (Non-HDL-C) (mg/dl)
English: Week 10
Danish: Uge 10
English: Medicinal products that induce CYP3A4 would be expected to increase the rate and extent of metabolism of lomitapide.
Danish: Lægemidler, der inducerer CYP3A4, må forventes at øge hastigheden og omfanget af metaboliseringen af lomitapid.
English: • Information about interactions with CYP3A4 inhibitors and inducers, coumarin anticoagulants, statins, P-gp substrates, oral contraceptives, bile acid sequestrants;
Danish: • Information om interaktioner med CYP3A4-hæmmere og -induktorer, kumarin-antikoagulantia, statiner, P-gp-substrater, orale antikonceptionsmidler og galdesyresekvestranter
English: Abdominal pain upper Abdominal distension Abdominal pain Vomiting
Danish: Abdominalsmerter Øvre abdominalsmerter Flatulens
English: Measure ALT, AST, alkaline phosphatase, total bilirubin, gamma-glutamyl transferase (gamma-GT) and serum albumin before initiation of treatment with Lojuxta.
Danish: Før behandlingen med Lojuxta bør foretages bestemmelse af ALAT, ASAT, alkalisk fosfatase, totalbilirubin, gammaglutamyltransferase (gamma-GT) og serumalbumin.
English: • medicines to treat cystic fybrosis (e.g. ivacaftor)
Danish: • lægemidler til behandling af cystisk fibrose (f.eks. ivacaftor)
English: • medicines which lower cholesterol (e.g. atorvastatin)
Danish: • kolesterolsænkende lægemidler (f.eks. atorvastatin)
English: • medicines to treat excessive daytime sleepiness (e.g. modafinil)
Danish: • lægemidler til behandling af udtalt søvnighed i dagtimerne (f.eks. modafinil)
English: • Advice on monitoring liver function (measuring hepatic enzymes and total bilirubin) before and during treatment with Lojuxta and routine screening to detect presence of steatohepatitis and hepatic fibrosis including specific details of the screening tests at baseline and annually as follows: - Imaging for tissue elasticity, e.g. Fibroscan, acoustic radiation force impulse (ARFI), or magnetic resonance (MR) elastography; - Measurement of biomarkers and/or scoring methods.
Danish: • Anvisning om overvågning af leverfunktionen (bestemmelse af leverenzymer og totalbilirubin) før og efter behandlingen med Lojuxta og rutinemæssig screening for steatohepatitis og hepatisk fibrose, herunder konkrete detaljer om en screeningstest ved baseline og årligt som følger:
English: CAPTURE study - effects of lomitapide on carotid and aortic atherosclerosis in patients treated with lomitapide in usual care.The applicant shall conduct a clinical study with adequate surrogate endpoints on vascular outcomes using imaging techniques to monitor vascular function, disease stabilisation and/or regression.
Danish: Ansøgeren skal gennemføre en klinisk undersøgelse med fyldestgørende surrogatendepunkter for vaskulære udfald ved anvendelse af scanningsteknikker til overvågning af den vaskulære funktion og sygdommens stabilisering og/eller regression.