FrancophonIA/ELRC3.0 huggingface dataset:
English: In an open-label Phase 3 study, 18 of 23 patients with HoFH developed hepatic steatosis (hepatic fat >5.56%) as measured by nuclear magnetic resonance spectroscopy (MRS) (see section 5.1).
Danish: I en åben fase 3-undersøgelse udviklede 18 af 23 patienter med HoFH leversteatose (leverens fedtindhold > 5,56 %), målt ved kernemagnetisk resonansspektroskopi (MRS) (se pkt.
English: • Information on undesirable effects, including diarrhoea, nausea, flatulence, abdominal pain or discomfort, abdominal distension, vomiting, dyspepsia, eructation and decreased appetite;
Danish: • Information om uønskede effekter, herunder diarré, kvalme, flatulens, abdominalsmerter eller abdominalt ubehag, abdominal distension, opkastning, dyspepsi, eruktation og nedsat appetit.
English: • joint pain or swelling, pain in hands or feet
Danish: • smertefulde eller hævede led, smerter i hænder eller fødder
English: The physician educational pack should contain:
Danish: Uddannelsesmateriale til lægerne skal indeholde:
English: Lojuxta with food, drink and alcohol
Danish: Brug af Lojuxta sammen med mad, drikke og alkohol
English: If you take more Lojuxta than you should Contact your doctor or pharmacist immediately.
Danish: Hvis du har taget for meget Lojuxta Kontakt straks lægen eller apoteket.
English: • have had liver problems, including liver problems whilst taking other medicines.
Danish: • hvis du har leverproblemer, herunder leverproblemer, når du får andre lægemidler.
English: − The need to follow a low-fat diet (i.e. patients should follow a diet supplying less than 20% of energy from fat);
Danish: − Nødvendigheden af fedtfattig diæt (dvs. patienterne skal følge en diæt med mindre end 20 % af kalorieindholdet fra fedtstof).
English: • oral contraceptives (see section 2 under ‘Pregnancy and breast-feeding')
Danish: • orale svangerskabsforebyggende midler (se afsnit 2 under ”Graviditet og amning”)
English: Apheresis was discontinued in 3 out of 13 patients who were on it at Week 26, and frequency was reduced in 3 patients while maintaining low LDL-C levels through Week 78.
Danish: Aferese blev seponeret hos 3 ud af 13 patienter, som fik denne behandling i uge 26, og hyppigheden blev reduceret hos 3 patienter, som bibeholdt lave værdier af LDL-C frem til uge 78.
English: At Week 26, the mean percent change in LDL-C from baseline of LDL-C was -40% (p<0.001) in the Intent to Treat (ITT) population.
Danish: I uge 26 var den gennemsnitlige ændring i LDL-C fra baseline -40 % (p<0,001) i ”intent to treat”-populationen.
English: • Advice to exercise caution if Lojuxta is used with other hepatotoxic medicinal products and to consider more frequent monitoring of liver-related tests;
Danish: • Anvisning om forsigtighed ved anvendelse af Lojuxta sammen med andre hepatotoksiske lægemidler og om at overveje hyppigere overvågning af leverrelaterede prøver
English: • Warning about possible loss of effectiveness of oral contraceptives due to diarrhoea or vomiting and need for additional contraception until 7 days after resolution of symptoms;
Danish: • Advarsel om muligheden for nedsat virkning af orale antikonceptionsmidler som følge af diarré eller opkastning og nødvendigheden af supplerende antikonception indtil 7 dage efter at symptomerne er svundet.
English: The maximum dose administered to human subjects in clinical studies was 200 mg as a single dose; there were no adverse reactions.
Danish: Den maksimale dosis, der blev administreret til mennesker i de kliniske undersøgelser, var en enkeltdosis på 200 mg, som var uden bivirkninger.
English: A single-dose, open-label study was conducted to evaluate the pharmacokinetics of 60 mg lomitapide in healthy volunteers with normal hepatic function compared with patients with mild (Child-Pugh A) and moderate (Child-Pugh B) hepatic impairment.
Danish: Der udførtes en åben enkeltdosisundersøgelse til vurdering af farmakokinetikken af 60 mg lomitapid hos raske frivillige med normal leverfunktion, sammenlignet med patienter med let (Child-Pugh A) og moderat (Child-Pugh B) nedsat leverfunktion.
English: Lomitapide is a selective inhibitor of microsomal transfer protein (MTP), an intracellular lipid-transfer protein that is found in the lumen of the endoplasmic reticulum and is responsible for binding and shuttling individual lipid molecules between membranes.
Danish: Lomitapid er en selektiv hæmmer af mikrosomalt transferprotein (MTP), et intracellulært lipidtransportprotein, der findes i lumen af det endoplasmatiske reticulum, og som er ansvarligt for binding og overførsel af individuelle lipidmolekyler mellem membraner.
English: Patients treated with lomitapide should be advised of the potential risk of dehydration in relation to gastrointestinal adverse reactions and take precautions to avoid fluid depletion.
Danish: Patienter i behandling med lomitapid bør orienteres om den potentielle risiko for dehydrering i forbindelse med gastrointestinale bivirkninger og tage forholdsregler for at undgå væskemangel.
English: LDL-C, direct (mg/dL)
Danish: LDL-C, direkte (mg/dl)
English: • That Lomitapide was teratogenic in non-clinical studies and is contraindicated in women who are or may become pregnant.
Danish: • Lomitapid viste sig at være teratogent i ikke-kliniske undersøgelser og er kontraindiceret hos kvinder, som er eller kan blive gravide.
English: After 2 weeks the dose may be increased, based on acceptable safety and tolerability, to 10 mg and then, at a minimum of 4-week intervals, to 20 mg, 40 mg, and to the maximum recommended dose of 60 mg (see section 4.8).
Danish: Under forudsætning af acceptabel sikkerhed og tolerabilitet kan dosis efter 2 uger sættes op til 10 mg og efter et interval på mindst fire uger til 20 mg, 40 mg og den anbefalede maksimale dosis på 60 mg (se pkt.
English: • increased appetite
Danish: • øget appetit
English: Parameter/Abnormality
Danish: Parameter/unormal værdi
English: Upon discontinuation of atorvastatin the dose of Lojuxta should be up-titrated according to LDL-C response and safety/tolerability.
Danish: Ved seponering af atorvastatin bør dosis af Lojuxta optitreres i henhold til LDL-C-respons og sikkerhed/tolerabilitet.
English: • If you take another medicine that lowers cholesterol by binding bile acids, such as colesevelam or cholestyramine, take the medicine that binds bile acids at least 4 hours before or 4 hours after you take Lojuxta.
Danish: • Hvis du tager anden medicin, der sænker kolesterol ved at binde galdesyrerne, såsom colesevelam eller colestyramin, skal du tage den medicin, der binder galdesyrerne, mindst 4 timer før eller 4 timer efter at du tager Lojuxta.
English: • Lojuxta may cause diarrhoea and vomiting and if it does, patients using oral contraception should use additional contraceptive methods for 7 days after symptoms have resolved;
Danish: • Lojuxta kan forårsage diarré og opkastning, og i så fald skal patienter, der får orale antikonceptionsmidler, anvende supplerende antikonception i syv dage efter at symptomerne er svundet
English: Hepatomegaly
Danish: Hepatomegali
English: - This medicine has been prescribed for you only.
Danish: Lægen har ordineret dette lægemiddel til dig personligt.
English: In rodents, single oral doses of lomitapide ≥600 times higher than the maximum recommended human dose (1 mg/kg) were well tolerated.
Danish: Hos gnavere var en enkelt oral dosis af lomitapid ≥600 gange højere end den anbefalede maksimale dosis til mennesker (1 mg/kg) veltolereret.
English: − The timing of medicine intake (Lojuxta should be taken on an empty stomach, at least 2 hours after the evening meal);
Danish: − Tidspunktet for indtagelsen af lægemidlet (Lojuxta skal tages på tom mave mindst to timer efter aftensmåltidet).
English: Gastrointestinal adverse reactions of severe intensity were reported by 6 (21%) of 29 patients in the Phase 3 clinical study, with the most common being diarrhoea (4 patients, 14%); vomiting (3 patients, 10%); and abdominal pain, distension, and/or discomfort (2 patients, 7%).
Danish: Gastrointestinale bivirkninger af svær intensitet blev beskrevet af 6 (21 %) af 29 patienter i det kliniske fase 3-studie; heraf var de hyppigste diarré (4 patienter, 14 %), opkastning (3 patienter, 10 %) samt abdominalsmerter, abdominal distension og/eller abdominalt ubehag (2 patienter, 7 %).
English: Table 4 lists all adverse reactions for subjects who received lomitapide monotherapy (N=291) treated in Phase 2 studies in subjects with elevated LDL-C (N=462).
Danish: Tabel 4 angiver alle bivirkninger hos personer, der fik monoterapi med lomitapid (N=291) i fase 2undersøgelser hos personer med forhøjet LDL-C (N=462).
English: You should not take more than 40 mg of simvastatin when using Lojuxta (see section 2 under ‘Do not take Lojuxta')
Danish: Du bør ikke tage mere end 40 mg simvastatin, når du bruger Lojuxta (se afsnit 2 under “Tag ikke
English: • It is not known if Lojuxta is passed into breast milk.
Danish: • Det vides ikke, om Lojuxta går over i modermælken.
English: The most commonly reported adverse reactions of severe intensity were diarrhoea (4 subjects, 14%), vomiting (3 patients, 10%), and abdominal distension and ALT increased (2 subjects each, 7%).
Danish: De oftest beskrevne bivirkninger af svær intensitet var diarré (4 patienter, 14 %), opkastning (3 patienter, 10 %) samt abdominal distension og forhøjet ALAT (2 patienter af hver, 7 %).
English: Mean Percent Change from Baseline in LDL-C
Danish: Gennemsnitlig ændring i % af LDL-C fra baseline
English: • Advice on escalating Lojuxta dose gradually to improve tolerability of the medicine;
Danish: • Anvisninger for gradvis dosiseskalering af Lojuxta for at forbedre tolerabiliteten af lægemidlet
English: On withdrawal of a CYP3A4 inducer, the possibility of increased exposure should be considered and a reduction in the dose of Lojuxta may be necessary.
Danish: Ved seponering af en CYP3A4-induktor bør muligheden for øget eksponering tages i betragtning, og dosisreduktion af Lojuxta kan være nødvendig.
English: Gastrointestinal adverse reactions occurred more frequently during the dose escalation phase of the study and decreased once patients established the maximum tolerated dose of lomitapide.
Danish: Gastrointestinale bivirkninger forekom hyppigere i dosiseskaleringsfasen af undersøgelsen og aftog, når patienterne havde nået den maksimale tolererede dosis af lomitapid.
English: Lojuxta may affect the way other medicines work.
Danish: Lojuxta kan påvirke den måde, andre lægemidler virker på.
English: The effect of administration of more than one weak CYP3A4 inhibitor has not been tested, but the effect on the exposure of lomitapide is expected to be greater than for co-administration of the individual inhibitors with lomitapide.
Danish: Effekten af administration af mere end én svag CYP3A4-hæmmer er ikke undersøgt, men virkningen på eksponeringen for lomitapid forventes at være større end med koadministration af de enkelte hæmmere med lomitapid.
English: Dietary counselling should be provided.
Danish: Patienterne bør have rådgivning om diæt.
English: Concomitant use of moderate CYP3A4 inhibitors are expected to increase lomitapide exposure by 4-10 fold based on the results of the study with the strong CYP3A4 inhibitor ketoconazole and on historical data for the model CYP3A4 probe midazolam.
Danish: Samtidig anvendelse af moderate CYP3A4-hæmmere forventes at øge eksponeringen for lomitapid med en faktor 4-10, baseret på resultaterne af undersøgelsen med den potente CYP3A4-hæmmer ketoconazol og historiske data om CYP3A4modelstoffet midazolam.
English: Use of alcohol
Danish: Samtidig alkoholindtagelse
English: Do not take any of the following medicines with Lojuxta:
Danish: Tag ikke nogen af følgende lægemidler, når du får Lojuxta:
English: Coumarin anticoagulants: When lomitapide 60 mg was administered to steady state and 6 days following warfarin 10 mg, INR increased 1.26-fold.
Danish: Kumarin-antikoagulantia: Når lomitapid 60 mg blev administreret til steady state og 6 dage efter warfarin 10 mg, øgedes INR med en faktor 1,26.
English: Safety phase weeks 26-78 N (%)
Danish: Sikkerhedsfase uge 26-78
English: Recommendation concerning co-administration with Lojuxta
Danish: Anbefaling for koadministration med Lojuxta
English: A single arm, open-label study (UP1002/AEGR-733-005) evaluated the efficacy and safety of lomitapide when co-administered with a low-fat diet and other lipid-lowering therapies in adult patients with HoFH.
Danish: En åben enkeltgruppeundersøgelse (UP1002/AEGR-733-005) vurderede virkningen og sikkerheden i forbindelse med lomitapid givet sammen med fedtfattig diæt og andre lipidsænkende behandlinger til voksne patienter med HoFH.
English: • glucocorticoids (e.g. beclometasone, prednisolone) steroid medicines used to treat inflammation in conditions such as severe asthma, arthritis
Danish: • glukokortikoider (f.eks. beclometason, prednisolon), som er steroide lægemidler, der anvendes til behandling af inflammation ved tilstande såsom svær astma og arthritis
English: Patients taking warfarin should undergo regular monitoring of the INR, especially after any changes in the dose of Lojuxta.
Danish: Ved warfarinbehandling bør INR regelmæssigt overvåges, navnlig efter enhver dosisændring af Lojuxta.
English: Interactions between moderate CYP3A4 inhibitors and lomitapide have not been studied.
Danish: Interaktion mellem moderate CYP3A4-hæmmere og lomitapid er ikke undersøgt.
English: Patients should follow a diet supplying less than 20% of energy from fat prior to initiating treatment, and should continue this diet during treatment.
Danish: Før initiering af behandlingen bør patienterne følge en diæt med et kalorieindhold fra fedtstoffer på mindre end 20 % og fortsætte på denne diæt under behandlingen.
English: Inhibition of MTP reduces lipoprotein secretion and circulating concentrations of lipoprotein-borne lipids including cholesterol and triglycerides.
Danish: Hæmning af MTP nedsætter udskillelsen af lipoproteiner og nedsætter den cirkulerende koncentration af lipoprotein-bårne lipider, herunder kolesterol og triglycerider.
English: Lojuxta contains the active substance called lomitapide.
Danish: Lojuxta indeholder det aktive stof lomitapid.
English: Clinical data suggest that hepatic fat accumulation is reversible after stopping treatment with Lojuxta, but whether histological sequelae remain is unknown, especially after long-term use.
Danish: De kliniske data tyder på, at fedtakkumuleringen i leveren er reversibel efter ophør af behandlingen med Lojuxta, men det vides ikke, om der er histologiske sequelae, navnlig efter langvarig anvendelse.
English: The effect of concomitant administration of lomitapide with other hepatotoxic medicine is unknown.
Danish: Virkningen af anvendelse af lomitapid sammen med andre hepatotoksiske lægemidler kendes ikke.
English: Lojuxta is indicated as an adjunct to a low-fat diet and other lipid-lowering medicinal products with or without low density lipoprotein (LDL) apheresis in adult patients with homozygous familial hypercholesterolaemia (HoFH).
Danish: Lojuxta er indiceret som tillægsbehandling til fedtfattig diæt og andre lipidsænkende lægemidler, med eller uden aferese af lav-densitetslipoprotein (LDL), hos voksne patienter med homozygot familiær hyperkolesterolæmi (HoFH).
English: • Take this medicine once a day at bedtime with a glass of water at least 2 hours after your evening meal (see section 2 under ‘Lojuxta with food, drink and alcohol').
Danish: • Tag Lojuxta ved sengetid med et glas vand mindst 2 timer efter aftensmåltidet (se afsnit 2 under “Brug af Lojuxta sammen med mad, drikke og alkohol”).
English: CYP3A4 inducers exert their effect in a time-dependent manner, and may take at least 2 weeks to reach maximal effect after introduction.
Danish: CYP3A4-induktorer har tidsafhængig virkning og kan være mindst 2 uger om at nå maksimal effekt efter påbegyndelse af behandlingen med dem.
English: Fenofibrate, niacin and ezetimibe: When lomitapide was administered to steady state prior to micronised fenofibrate 145 mg, extended release niacin 1000 mg, or ezetimibe 10 mg, no clinically significant effects on the exposure of any of these medicinal products were observed.
Danish: Fenofibrat, niacin og ezetimib: Når lomitapid blev administreret til steady state inden mikroniseret fenofibrat 145 mg, niacin 1000 mg som depotformulering eller ezetimib 10 mg, iagttoges ingen klinisk betydningsfuld effekt på eksponeringen for nogen af disse lægemidler.
English: Other liver-related changes in repeat-dose toxicity studies in rats and dogs included increased serum aminotransferases, subacute inflammation (rats only), and single-cell necrosis.
Danish: Andre leverrelaterede forandringer i toksicitetsundersøgelserne med gentagen dosering hos rotter og hunde omfattede forhøjede serumaminotransferaser, subakut inflammation (kun rotter) og enkeltcellenekrose.
English: If a patient has biopsy-proven steatohepatitis or fibrosis, the benefit-risk should be reassessed and treatment stopped if necessary.
Danish: Hvis steatohepatitis eller fibrose verificeres ved biopsi, bør benefit/risk-forholdet revurderes og behandlingen om nødvendigt seponeres.
English: Lomitapide increases the plasma concentrations of warfarin.
Danish: Lomitapid øger plasmakoncentrationen af warfarin.
English: Lojuxta has not been investigated in patients aged 65 years or older.
Danish: Lojuxta er ikke undersøgt hos patienter over 65 år.
English: Lojuxta is used to treat adult patients with very high cholesterol because of a condition that runs in their families (homozygous familial hypercholesterolaemia or HoFH).
Danish: Lojuxta anvendes til behandling af voksne patienter med meget højt kolesterol, der skyldes en arvelig sygdom (homozygot familiær hyperkolesterolæmi eller HoFH).
English: Muscle aches and pains (myalgia) or weakness
Danish: Muskelømhed og muskelsmerter (myalgi) eller muskelsvaghed
English: Week 0
Danish: Uge 0
English: Lomitapide increases plasma concentrations of statins.
Danish: Lomitapid øger plasmakoncentrationen af statiner.
English: Lojuxta is used with a low-fat diet and other lipid lowering treatments to decrease your cholesterol levels.
Danish: Lojuxta anvendes sammen med fedtfattig diæt og anden lipidsænkende behandling til at nedsætte kolesterolniveauet.
English: Mean (SD)
Danish: Gennems nit (SD)
English: Lomitapide had no effect on reproductive function in female rats at doses up to 1 mg/kg or in male rats at doses up to 5 mg/kg.
Danish: Lomitapid havde ingen indvirkning på reproduktionsfunktionen hos hunrotter i doser op til 1 mg /kg eller hos hanrotter i doser op til 5 mg/kg.
English: Caution should be exercised when Lojuxta is used with other medicinal products known to have potential for hepatotoxicity, such as isotretinoin, amiodarone, acetaminophen (>4 g/day for ≥3 days/week), methotrexate, tetracyclines, and tamoxifen.
Danish: Forsigtighed bør udvises ved anvendelse af Lojuxta sammen med andre lægemidler med kendt hepatotoksisk potentiale såsom isotretinoin, amiodaron, paracetamol (> 4 g dagligt i ≥ 3 dage om ugen), methotrexat, tetracykliner og tamoxifen.
English: No clinically meaningful elevations in total bilirubin or alkaline phosphatase were observed.
Danish: Der blev ikke iagttaget klinisk betydningsfulde forhøjede værdier af totalbilirubin eller alkalisk fosfatase.
English: • Information that Lojuxta was teratogenic in non-clinical studies and should not be taken during pregnancy or by patients trying to get pregnant;
Danish: • Information om, at Lojuxta var teratogent i de ikke-kliniske undersøgelser og ikke må anvendes under graviditet eller af patienter, der planlægger at blive gravide
English: Oral contraceptives: When lomitapide 50 mg was administered to steady state along with an oestrogen-based oral contraceptive, no clinically meaningful or statistically significant impact on the pharmacokinetics of the components of the oral contraceptive (ethinyl estradiol and 17-deacetyl norgestimate, the metabolite of norgestimate) was observed.
Danish: Perorale antikonceptionsmidler: Ved administration af lomitapid 50 mg til steady state sammen med et østrogenbaseret oralt antikonceptionsmiddel iagttoges ingen klinisk betydningsfuld eller statistisk signifikant virkning på farmakokinetikken af komponenterne af det orale antikonceptionsmiddel (ethinylestradiol og 17-deacetylnorgestimat, metabolitten af norgestimat).
English: Patients receiving Lojuxta as adjunctive therapy to a statin should be monitored for adverse events that are associated with the use of high doses of statins.
Danish: Når Lojuxta anvendes som tillægsbehandling til et statin, bør patienten overvåges for bivirkninger, der er forbundet med brug af høje doser af statiner.
English: • decrease in levels of potassium, carotene, vitamin E, vitamin K in your blood
Danish: • fald i blodets indhold af kalium, caroten, vitamin E og vitamin K
English: Triglycerides (TG) (mg/dL)a
Danish: Triglycerider (TG) (mg/dl)a
English: The most serious adverse reactions during treatment were liver aminotransferase abnormalities (see section 4.4).
Danish: De alvorligste bivirkninger under behandlingen var abnorme leveraminotransferaseværdier (se pkt.
English: Given its mechanism of action in the small intestine, lomitapide may reduce the absorption of fat-soluble nutrients.
Danish: Som følge af sin virkningsmekanisme kan lomitapid nedsætte optagelsen af fedtopløselige næringsstoffer fra tyndtarmen.
English: Name and address of the manufacturers responsible for batch release
Danish: Navn og adresse på de fremstillerne, der er ansvarlige for batchfrigivelse
English: See section 2 under ‘ Lojuxta with food, drink and alcohol'.
Danish: Se afsnit 2 under ”Brug af Lojuxta sammen med mad, drikke og alkohol”.
English: Number of Patients with Assessments >3 to ≤5 x ULN >5 to ≤10 x ULN >10 to ≤20 x ULN >20 x ULN
Danish: Antal patienter vurderet > 3 til ≤ 5 x ULN > 5 til ≤ 10 x ULN > 10 til ≤ 20 x ULN > 20 x ULN
English: Monitoring of liver function tests
Danish: Overvågning af leverfunktionsprøver
English: • inflammation of the stomach and intestine that causes diarrhoea and vomiting
Danish: • inflammation af maven og tarmen med diarré og opkastning
English: PER - Pregnancy exposure registry - 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: PER - graviditetseksponeringsregister - til evaluering af forekomst og udfald af graviditet hos kvinder i den fertile alder, der behandles med lomitapid, og som beslutter at fortsætte graviditeten efter rådgivning fra en teratolog.
English: Medicinal products
Danish: Lægemidler
English: Data from individuals who had repeat measurements after stopping lomitapide show that hepatic fat accumulation is reversible, but whether histological sequelae remain is unknown.
Danish: Data fra patienter, der fik gentaget målingerne efter ophør af behandlingen med lomitapid, viser, at akkumuleringen af hepatisk fedt er reversibel, men det vides ikke, om der er histologiske sequelae.
English: In the event of overdose, the patient should be treated symptomatically and supportive measures instituted as required.
Danish: I tilfælde af overdosering skal patientens symptomer behandles, og der skal iværksættes supplerende behandling efter behov.
English: Hepatic steatosis Hepatotoxicity Hepatomegaly
Danish: Steatosis hepatis Hepatotoksicitet Hepatomegali
English: The long term consequences of hepatic steatosis associated with lomitapide treatment are unknown.
Danish: De langsigtede konsekvenser af leversteatose i forbindelse med behandling med lomitapid er ukendte.
English: • aminoglutethimide - a medicine used to treat Cushing's syndrome
Danish: • aminoglutethimid (lægemiddel til behandling af Cushings syndrom)
English: Other medicines may affect the way Lojuxta works.
Danish: Andre lægemidler kan ændre den måde, som Lojuxta virker på.
English: In cases of protracted or severe diarrhoea and/or vomiting lasting more than 2 days, additional contraceptive measures should be used for 7 days after resolution of symptoms.
Danish: Ved langvarig eller svær diarré og/eller opkastning af mere end 2 dages varighed bør der anvendes supplerende antikonception i 7 dage, efter at symptomerne er svundet.