FrancophonIA/ELRC3.0 huggingface dataset:
English: Doses higher than 60 mg suggest a trend toward nonlinearity and are not recommended.
Danish: Ved doser over 60 mg er der tendens til ulinearitet, og sådanne doser frarådes.
English: The dose of warfarin should be adjusted as clinically indicated.
Danish: Warfarindosis bør justeres efter det kliniske behov.
English: • other medicines used to lower cholesterol such as:
Danish: • andre kolesterolsænkende lægemidler såsom:
English: Very common (may affect more than 1 in 10 people):
Danish: Meget almindelig (forekommer hos mere end 1 ud af 10 behandlede):
English: • low red blood cell count (anaemia)
Danish: • for lavt antal røde blodlegemer (anæmi)
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Danish: Hvis lægen har fortalt dig, at du ikke tåler visse sukkerarter, skal du kontakte lægen, før du tager Lojuxta.
English: • loss of fluid that may cause headache, dry mouth, dizziness, tiredness or unconsciousness
Danish: • væsketab, der kan forårsage hovedpine, mundtørhed, svimmelhed, træthed eller bevidstløshed
English: During the first year, measure liver-related tests (ALT and AST, at a minimum) prior to each increase in dose or monthly, whichever occurs first.
Danish: I det første år bør der tages leverrelaterede prøver (som minimum ALAT og ASAT) før hver dosisforhøjelse, dog mindst én gang om måneden.
English: • Pregnancy (see section 4.6).
Danish: • Graviditet (se pkt.
English: Decrease the dose of Lojuxta if elevations of aminotransferase are observed and discontinue treatment for persistent or clinically significant elevations (see Table 1 for specific recommendations).
Danish: Ved forhøjet aminotransferase bør dosis af Lojuxta nedsættes, og ved persisterende eller klinisk betydningsfulde forhøjelser bør Lojuxta seponeres (se Tabel 1 for konkrete anbefalinger).
English: • Patient Brochures
Danish: • Patientbrochurer
English: • some medicines for bacterial, fungal or HIV infection (see section 2 under ‘Do not take Lojuxta')
Danish: • visse lægemidler mod infektioner med bakterier, svampe eller hiv (se afsnit 2 under ”Tag ikke Lojuxta”)
English: Bile acid sequestrants Lomitapide has not been tested for interaction with bile acid sequestrants (resins such as colesevelam and cholestyramine).
Danish: Lomitapid er ikke undersøgt for interaktion med galdesyresekvestranter (resiner såsom colesevelam og colestyramin).
English: • The need to inform their doctor if they have had any liver problems in the past;
Danish: • Nødvendigheden af at oplyse lægen om eventuelle tidligere leverproblemer
English: • burning or prickling of the skin
Danish: • brændende eller stikkende fornemmelse fra huden
English: Focal hepatic fibrosis was observed in males and females and hepatic cystic degeneration was observed in males only.
Danish: Der iagttoges fokal hepatisk fibrose hos hannerne og hunnerne og hepatisk cystisk degeneration udelukkende hos hannerne.
English: • dizziness, headache, migraine
Danish: • svimmelhed, hovedpine, migræne
English: The extent to which lomitapide-associated hepatic steatosis promotes the elevations in aminotransferase is unknown.
Danish: Det vides ikke, i hvilket omfang lomitapid-associeret leversteatose bidrager til forhøjelsen af aminotransferase-værdierne.
English: Patients should be advised to immediately contact their physician and stop taking Lojuxta if they become pregnant (see section 4.6).
Danish: Patienterne skal instrueres om, at de i tilfælde af graviditet straks skal kontakte lægen og holde op med at tage Lojuxta (se pkt.
English: Blood bilirubin increased Gamma-glutamyltransferase increased Neutrophil percentage increased Protein urine
Danish: Blodbilirubin forhøjet Gammaglutamyltransferase forhøjet Neutrofilprocent forhøjet Proteinuri
English: Alopecia
Danish: Alopeci
English: EU/1/13/851/001 - Lojuxta 5 mg hard capsules EU/1/13/851/002 - Lojuxta 10 mg hard capsules EU/1/13/851/003 - Lojuxta 20 mg hard capsules EU/1/13/851/004 - Lojuxta 30 mg hard capsules EU/1/13/851/005 - Lojuxta 40 mg hard capsules EU/1/13/851/006 - Lojuxta 60 mg hard capsules
Danish: EU/1/13/851/001 - Lojuxta, kapsler, hårde, 5 mg EU/1/13/851/002 - Lojuxta, kapsler, hårde, 10 mg EU/1/13/851/003 - Lojuxta, kapsler, hårde, 20 mg EU/1/13/851/004 - Lojuxta, kapsler, hårde, 30 mg EU/1/13/851/005 - Lojuxta, kapsler, hårde, 40 mg EU/1/13/851/006 - Lojuxta, kapsler, hårde, 60 mg
English: • flu or cold, fever, inflammation of your sinuses, cough
Danish: • influenza eller forkølelse, feber, bihulebetændelse, hoste
English: Cmax for R(+)-warfarin and S(-)-warfarin increased 14% and
Danish: Cmax af R(+)-warfarin og S(-)-warfarin øgedes med henholdsvis 14 % og 15 %.
English: Pregelatinised starch (maize) Sodium starch glycolate (Type A) Microcrystalline cellulose Lactose monohydrate Silica, colloidal anhydrous Magnesium stearate
Danish: Stivelse, pregelatineret (majs) Natriumstivelsesglycolat (type A) Mikrokrystallinsk cellulose Lactosemonohydrat Silica, kolloid vandfri Magnesiumstearat
English: HMG-CoA Reductase Inhibitors (“Statins”): Lomitapide increases plasma concentrations of statins.
Danish: HMG-CoA-reduktasehæmmere (statiner): Lomitapid øger plasmakoncentrationen af statiner.
English: Changes in lipids and lipoproteins through Week 26 and Week 78 of lomitapide treatment are presented in Table 5.
Danish: I Tabel 5 er angivet ændringerne i lipider og lipoproteiner til og med uge 26 og uge 78 af lomitapidbehandlingen.
English: − Appropriate advice on effective methods of contraception should be provided, and effective contraception initiated;
Danish: − Fyldestgørende rådgivning om effektiv antikonceptionsmetode skal gives, og effektiv antikonception tages i brug
English: • The use of alcohol during Lojuxta treatment is not recommended.
Danish: • Alkoholindtagelse under behandling med Lojuxta frarådes.
English: In repeat-dose oral toxicology studies in rodents and dogs, the principal drug-related findings were lipid accumulation in the small intestine and/or liver associated with decreases in serum cholesterol and/or triglyceride levels.
Danish: I orale toksikologiske undersøgelser med gentagen dosering hos gnavere og hunde var det vigtigste lægemiddelrelaterede fund lipidakkumulering i tyndtarmen og/eller leveren forbundet med fald i serumkolesterol og/eller -triglycerider.
English: Lomitapide is not expected to directly influence the efficacy of oestrogen based oral contraceptives; however diarrhoea and/or vomiting may reduce hormone absorption.
Danish: Lomitapid forventes ikke direkte at påvirke virkningen af østrogenbaserede orale antikonceptionsmidler, men hormonabsorptionen kan nedsættes ved diarré og/eller opkastning.
English: • some medicines for high blood pressure, angina or to regulate heart rhythm (see section 2 under ‘Do not take Lojuxta')
Danish: • visse lægemidler mod højt blodtryk eller angina eller til regulering af hjerterytmen (se afsnit 2 under ”Tag ikke Lojuxta”)
English: • That Lojuxta was teratogenic in non-clinical studies and that women of child-bearing potential must be non-pregnant and using effective contraception prior to initiating treatment.
Danish: • Angivelse af, at Lojuxta var teratogent i ikke-kliniske undersøgelser, og at kvinder i den fødedygtige alder ikke må være gravide og skal anvende effektiv antikonception, før behandlingen initieres.
English: If the baseline liver-related tests are abnormal, consider initiating the medicinal product after appropriate investigation by a hepatologist and the baseline abnormalities are explained or resolved.
Danish: Ved unormale leverrelaterede prøver ved baseline kan det overvejes at indlede behandling med Lojuxta, når patienten er blevet tilstrækkeligt undersøgt af en hepatolog, og abnormiteterne ved baseline er blevet udredt eller normaliseret.
English: No dose adjustments are required when co-administered with Lojuxta.
Danish: Der er ikke behov for dosisjustering ved koadministration med Lojuxta.
English: E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES
Danish: E. SÆRLIG FORPLIGTELSE TIL AT AFSLUTTE FORANSTALTNINGER EFTER UDSTEDELSE AF MARKEDSFØRINGSTILLADELSE TIL LÆGEMIDLER GODKENDT UNDER SÆRLIGE OMSTÆNDIGHEDER
English: In high-dose males, an increased incidence of pancreatic acinar cell adenoma was observed at an exposure 6 times that in humans at 60 mg based on AUC.
Danish: I hannerne på høje doser var der øget forekomst af adenom af acinære celler i pancreas ved en eksponering på 6 gange den humane eksponering ved 60 mg baseret på AUC.
English: Marketing Authorisation Holder Amryt Pharmaceuticals DAC 90 Harcourt Street Dublin 2
Danish: Indehaver af markedsføringstilladelsen Amryt Pharmaceuticals DAC 90 Harcourt Street
English: In patients with moderate hepatic impairment, lomitapide AUC and Cmax were 164% and 361% higher, respectively, compared with healthy volunteers.
Danish: Hos patienter med moderat nedsat leverfunktion var AUC og Cmax af lomitapid henholdsvis 164 % og 361 % højere end hos raske forsøgspersoner.
English: If you use contraceptive pills and suffer from an episode of diarrhoea or vomiting that lasts more than 2 days, you must use an alternative method of contraception (e.g. condoms, diaphragm) for 7 days following resolution of symptoms.
Danish: Hvis du bruger p-piller og får en episode med diarré eller opkastning af mere end 2 dages varighed, skal du bruge anden svangerskabsforebyggelse (f.eks. kondomer eller pessar) i 7 dage, efter at symptomerne er svundet.
English: Approximately
Danish: Cirka
English: Decreased red blood cell parameters as well as poikilocytosis and/or anisocytosis were observed in dogs.
Danish: Hos hunde iagttoges nedsatte erytrocytparametre samt poikilocytose og/eller anisocytose.
English: Systemic exposures to lomitapide at these doses were estimated to be 4 times (females) and 5 times (males) higher than the human exposure at 60 mg based on AUC.
Danish: Den systemiske eksponering for lomitapid ved disse doser blev beregnet til at være henholdsvis 4 gange (hunner) og fem gange (hanner) højere end den humane eksponering ved 60 mg, baseret på AUC.
English: Lomitapide is extensively metabolised, predominantly by CYP3A4.
Danish: Lomitapid bliver ekstensivt metaboliseret, hovedsagelig af CYP3A4.
English: If you stop taking Lojuxta
Danish: Hvis du holder op med at tage Lojuxta
English: In a dietary carcinogenicity study in mice, lomitapide was administered up to 104 weeks at doses ranging from 0.3 to 45 mg/kg/day.
Danish: I en karcinogenicitetsundersøgelse hos mus blev lomitapid administreret i foderet i indtil 104 uger i doser fra 0,3-45 mg/kg/dag.
English: In the lomitapide clinical studies, one patient with HoFH developed markedly elevated aminotransferase (ALT 24x ULN, AST 13x ULN) within days of initiating the strong CYP3A4 inhibitor clarithromycin.
Danish: I de kliniske studier med lomitapid fik én patient med HoFH markant forhøjede aminotransferaser (ALAT 24 x ULN, ASAT 13 x ULN) få dage efter at være sat i behandling med clarithromycin, der er en stærk CYP3A4-hæmmer.
English: • Information about clinical findings (i.e., hepatic enzyme increases and steatosis) in subjects treated with Lojuxta during the developmental phase;
Danish: • Information om de kliniske fund i udviklingsfasen (forhøjede leverenzymer og steatose) hos personer, der blev behandlet med Lojuxta
English: Patients treated with Lojuxta should take daily supplements that contain 400 international units vitamin E and approximately 200 mg linoleic acid, 210 mg ALA, 110 mg EPA, and 80 mg DHA.
Danish: Patienter i behandling med Lojuxta bør tage dagligt tilskud af 400 internationale enheder vitamin E og cirka 200 mg linolsyre, 210 mg ALA, 110 mg EPA og 80 mg DHA.
English: • If confirmed, reduce the dose and obtain additional liver-related tests if not already measured (such as alkaline phosphatase, total bilirubin, and INR).
Danish: • Ved bekræftelse reduceres dosis, og der tages supplerende leverrelaterede prøver, hvis dette ikke allerede er sket (såsom alkalisk fosfatase, totalbilirubin og INR).
English: Patients with end-stage renal disease receiving dialysis should not exceed 40 mg daily (see section 5.2).
Danish: For dialysepatienter i terminalstadiet bør 40 mg dagligt ikke overskrides (se pkt.
English: Concomitant use of HMG-CoA reductase inhibitors (‘statins')
Danish: Samtidig anvendelse af HMG-CoA-reduktasehæmmere (“statiner”)
English: Grapefruit juice is a moderate inhibitor of CYP3A4 and is expected to substantially increase exposure to lomitapide.
Danish: Grapefrugt juice er en moderat hæmmer af CYP3A4 og forventes at øge eksponeringen for lomitapid væsentligt.
English: • High sensitivity C-reactive protein (hs-CRP), erythrocyte sedimentation rate (ESR), CK18 Fragment, NashTest (liver inflammation)
Danish: • Højfølsom bestemmelse af C-reaktivt protein (hs-CRP), sænkningsreaktion (ESR), CK-18 Fragment, NashTest (leverinflammation)
English: • muscle pain (myalgia)
Danish: • muskelsmerter (myalgi)
English: • low density lipoprotein (LDL) cholesterol (“bad” cholesterol)
Danish: • LDL-kolesterol (Low Density Lipoprotein) (”skadeligt” kolesterol)
English: SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES
Danish: SÆRLIG FORPLIGTELSE TIL AT AFSLUTTE FORANSTALTNINGER EFTER UDSTEDELSE AF MARKEDSFØRINGSTILLADELSE TIL LÆGEMIDLER GODKENDT UNDER SÆRLIGE OMSTÆNDIGHEDER
English: Lomitapide appears to be a sensitive substrate for CYP3A4 metabolism.
Danish: Lomitapid synes at være et følsomt substrat for metabolisering ved CYP3A4.
English: In patients taking coumarins (such as warfarin) and Lojuxta concomitantly, INR should be determined before starting Lojuxta and monitored regularly with dosage of coumarins adjusted as clinically indicated (see section 4.4).
Danish: Ved koadministration af kumariner (såsom warfarin) og Lojuxta bør INR bestemmes før initiering af behandlingen med Lojuxta og patienten overvåges regelmæssigt med henblik på tilpasning af dosis af kumarin til det kliniske behov (se pkt.
English: Treatment with Lojuxta should be initiated and monitored by a physician experienced in the treatment of lipid disorders.
Danish: Behandlingen med Lojuxta bør indledes og overvåges af en læge med erfaring i behandling af forstyrrelser i blodlipiderne.
English: It is recommended to increase the frequency of LDL-C assessment during such concomitant use and consider increasing the dose of Lojuxta to ensure maintenance of the desired level of efficacy if the CYP3A4 inducer is intended for chronic use.
Danish: Ved sådan koadministration anbefales det at øge hyppigheden af LDL-C-bestemmelserne og overveje at øge dosis af Lojuxta for at sikre opretholdelse af den ønskede virkning, hvis den pågældende CYP3A4-induktor påtænkes anvendt kronisk.
English: When lomitapide 20 mg was coadministered simultaneously or 12 hours apart with ethinyl estradiol/norgestimate, a weak CYP3A4 inhibitor, no clinically meaningful increase in lomitapide exposure was observed.
Danish: Når lomitapid 20 mg blev administreret samtidig med eller med 12 timers mellemrum fra ethinylestradiol/norgestimat, en svag CYP3A4-hæmmer, blev der ikke set nogen klinisk relevant stigning i eksponeringen for lomitapid.
English: • Treatment with Lojuxta should be initiated and monitored by a physician experienced in the treatment of lipid disorders;
Danish: • Behandlingen med Lojuxta bør indledes og overvåges af en læge med erfaring i behandling af forstyrrelser i blodlipiderne
English: • medicines to treat HIV (e.g. maraviroc)
Danish: • lægemidler til behandling af hiv (f.eks. maraviroc)
English: Concomitant use of CYP3A4 inducers
Danish: Samtidig anvendelse af CYP3A4-induktorer
English: Lomitapide can cause elevations in the liver enzymes alanine aminotransferase [ALT] and aspartate aminotransferase [AST] and hepatic steatosis (see section 5.1).
Danish: Lomitapid kan medføre forhøjede værdier af leverenzymerne alaninaminotransferase [ALAT] og aspartataminotransferase [ASAT] samt leversteatose (se pkt.
English: If you forget to take Lojuxta
Danish: Hvis du har glemt at tage Lojuxta
English: Apolipoprotein B (apo B) (mg/dL)
Danish: Apolipoprotein B (ApoB) (mg/dl)
English: Exercise additional caution if administering more than 1 weak CYP3A4 inhibitor with Lojuxta.
Danish: Ekstra forsigtighed bør udvises ved administration af mere end én svag CYP3A4-hæmmer sammen med Lojuxta.
English: • Imaging for tissue elasticity, e.g. Fibroscan, acoustic radiation force impulse (ARFI), or magnetic resonance (MR) elastography
Danish: • Scanning for vævselasticitet, f.eks. Fibroscan, acoustic radiation force impulse (ARFI) eller magnetisk resonans (MR)-elastografi
English: Refer patients with persistent elevations in aminotransferase >3x ULN to a hepatologist for further investigation.
Danish: Patienter med persisterende forhøjede aminotransferaseværdier > 3x ULN henvises til nærmere undersøgelse ved hepatolog.
English: • Importance of fatty acid and fat soluble vitamin (Vitamin E) supplementation;
Danish: • Vigtigheden af tilskud af fedtsyrer og fedtopløselige vitaminer (vitamin E)
English: Absolute values and percent changes from baseline to Weeks 26 and 78 in lipids and lipoproteins (major effectiveness study UP1002/AEGR-733-005) Parameter (units)
Danish: Absolutte værdier og procentuelle ændringer i lipider og lipoproteiner fra baseline til uge 26 og 78 (hovedundersøgelse af virkning UP1002/AEGR-733-005)
English: Hepatic steatosis and risk of progressive liver disease
Danish: Leversteatose og risiko for progressiv leversygdom
English: Table 1 summarizes recommendations for dose adjustment and monitoring for patients who develop elevated aminotransferase during therapy with Lojuxta.
Danish: Dosisændring baseret på forhøjede hepatiske aminotransferaser Tabel 1 sammenfatter anbefalingerne for dosisjustering og overvågning for patienter, som får forhøjede aminotransferaser under behandlingen med Lojuxta.
English: • medicines to treat angina - chest pain caused by the heart (e.g. ranolazine)
Danish: • lægemidler til behandling af angina (brystsmerter fra hjertet) (f.eks. ranolazin)
English: • Information about contraindication in patients with moderate or severe pre-existing hepatic impairment/disease, including those with unexplained persistent abnormal liver function tests;
Danish: • Information om kontraindikationen hos patienter med præeksisterende moderat eller svær leverfunktionsnedsættelse/leversygdom, herunder ved prøver, der viser persisterende unormal leverfunktion af ukendt årsag
English: The MAH shall provide an educational pack prior to launch targeting all physicians who are expected to prescribe/use lomitapide.
Danish: der er rettet til alle læger, der forventes at ordinere/anvende lomitapid.
English: PHARMACEUTICAL FORM AND CONTENTS 28 hard capsules
Danish: LÆGEMIDDELFORM OG ANTAL (PAKNINGSSTØRRELSE) 28 kapsler, hårde
English: Pack sizes are: 28 capsules
Danish: Pakningsstørrelser: 28 kapsler
English: Paraesthesia Somnolence
Danish: Paræstesi Somnolens
English: • Enhanced Liver Fibrosis (ELF) panel, Fibrometer, AST/ALT ratio, Fib-4 score, Fibrotest (liver fibrosis)
Danish: • Enhanced Liver Fibrosis (ELF)-panel, Fibrometer, ASAT/ALAT-forhold, Fib-4-score, Fibrotest (leverfibrose)
English: There were statistically significant increases in the incidences of liver adenoma and carcinoma at doses ≥1.5 mg/kg/day in males (≥ 2 times the human exposure at 60 mg daily based on AUC) and ≥7.5 mg/kg/day in females (≥ 9 times the human exposure at 60 mg based on AUC).
Danish: Der var statistisk signifikant stigning i forekomsten af leveradenom og leverkarcinom ved doser ≥ 1,5 mg/kg/dag til hanner (≥ 2 gange den humane eksponering ved 60 mg daglig baseret på AUC) og ≥ 7,5 mg/kg/dag til hunner (≥ 9 gange den humane eksponering ved 60 mg baseret på AUC).
English: Incidences of small intestinal carcinoma and/or combined adenoma and carcinoma (rare tumours in mice) were significantly increased at doses ≥15 mg/kg/day in males (≥ 26 times the human exposure at 60 mg based on AUC) and at 15 mg/kg/day in females (22 times the human exposure at 60 mg based on AUC).
Danish: Forekomsten af tyndtarmskarcinom og/eller kombineret -adenom og -karcinom (tumorer, der er sjældne hos mus) var signifikant øget ved doser ≥ 15 mg/kg/dag til hanner (≥ 26 gange den humane eksponering ved 60 mg baseret på AUC) og ved 15 mg/kg/dag til hunner (22 gange den humane eksponering ved 60 mg baseret på AUC).
English: The use of alcohol during lomitapide treatment is not recommended.
Danish: Alkoholindtagelse under behandling med lomitapid frarådes.
English: • Withhold dosing and obtain additional liver-related tests if not already measured (such as alkaline phosphatase, total bilirubin, and INR).
Danish: • Doseringen indstilles, og der tages yderligere leverrelaterede prøver, hvis dette ikke allerede er sket (såsom alkalisk fosfatase, totalbilirubin og INR).
English: • Decrease the dose of Lojuxta by half.
Danish: • Dosis af Lojuxta halveres.
English: • Contraindication for use in patients with a known significant or chronic bowel disease such as inflammatory bowel disease or malabsorption;
Danish: • Kontraindikation for anvendelse hos patienter med kendt betydningsfuld eller kronisk tarmsygdom såsom inflammatorisk tarmsygdom eller malabsorption.
English: • medicines to treat and prevent blood clots (e.g. cilostazol, ticagrelor)
Danish: • lægemidler til behandling og forebyggelse af blodpropper (f.eks. cilostazol, ticagrelor)
English: Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Danish: Fortæl det altid til lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: In vitro assessment of drug interactions: Lomitapide inhibits CYP3A4.
Danish: In vitro-bestemmelse af lægemiddelinteraktioner: Lomitapid hæmmer CYP3A4.
English: MTP plays a key role in the assembly of apo B containing lipoproteins in the liver and intestines.
Danish: MTP spiller en vigtig rolle i opbygningen af ApoB-holdige lipoproteiner i leveren og tarmene.
English: • To evaluate the occurrence and outcomes of pregnancy in females of reproductive potential treated with lomitapide who decide to continue the pregnancy following advice from a teratologist.
Danish: • At vurdere forekomst og udfald af graviditet hos kvinder i den fødedygtige alder, som er behandlet med lomitapid og beslutter at fortsætte graviditeten efter rådgivning fra læge med erfaring i teratologi
English: If aminotransferase elevations are accompanied by clinical symptoms of liver injury (such as nausea, vomiting, abdominal pain, fever, jaundice, lethargy, flu-like symptoms), increases in bilirubin ≥2x ULN, or active liver disease, discontinue treatment with Lojuxta and refer the patient to a hepatologist for further investigation.
Danish: Hvis de forhøjede aminotransferaseværdier er ledsaget af kliniske tegn på leverskade (såsom kvalme, opkastning, abdominalsmerter, feber, gulsot, letargi, influenzalignende symptomer), stigninger i bilirubin ≥ 2 x ULN eller aktiv leversygdom, bør behandlingen med Lojuxta seponeres og patienten henvises til hepatolog til nærmere undersøgelse.
English: Use of Lojuxta is contraindicated in patients treated with high doses of simvastatin (>40 mg) (see sections 4.3 and 4.4).
Danish: Lojuxta er kontraindiceret hos patienter, der får høje doser af simvastatin (>40 mg) (se pkt.
English: Frequency of adverse reactions in HoFH patients System Organ Class
Danish: Hyppighed af bivirkninger hos HoFH-patienter
English: Mean percent change from baseline through Week 26 using last observation carried forward (LOCF) to each assessment is shown in Figure 1.
Danish: Figur 1 angiver den gennemsnitlige procentuelle ændring fra baseline til og med uge 26 med sidste observation fremført (LOCF) for hver parameter.
English: Decreased appetite
Danish: Nedsat appetit
English: Effects on lomitapide levels
Danish: Virkning på lomitapidkoncentration
English: • The Prescriber Guide
Danish: • Ordinationsvejledning
English: By blocking this protein, the medicine decreases the level of fats and cholesterol (lipids) in the blood.
Danish: Lojuxta blokerer dette protein og nedsætter derved indholdet af fedtstoffer og kolesterol (lipider) i blodet.