FrancophonIA/ELRC3.0 huggingface dataset:
English: • Information that Lojuxta may cause liver problems;
Danish: • Information om, at Lojuxta kan forårsage leverproblemer
English: The patient brochure shall include the following key elements:
Danish: Patientbrochuren skal indeholde følgende hovedelementer:
English: Store below 30°C.
Danish: Opbevares ved temperaturer under 30 ºC.
English: • To evaluate the long-term effectiveness of lomitapide in maintaining control of serum lipid levels in clinical practice.
Danish: • At vurdere lomitapids langsigtede virkning til opretholdelse af kontrollen med serumlipidniveauet i klinisk praksis
English: • hair loss (alopecia)
Danish: • hårtab (alopeci).
English: • To evaluate whether prescribers of lomitapide are following the screening and monitoring recommendations as specified in the product information and the educational materials.
Danish: • At vurdere, om de læger, der ordinerer lomitapid, følger anbefalingerne for screening og overvågning i produktinformationen og uddannelsesmaterialet
English: CARTON AND BOTTLE (5 mg, 10 mg, 20 mg, 30 mg, 40 mg and 60 mg)
Danish: KARTON OG FLASKE (5 mg, 10 mg, 20 mg, 30 mg, 40 mg og 60 mg)
English: In the Phase 3 study, 3 of 4 patients with ALT elevations >5x ULN reported alcohol consumption beyond the limits recommended in the protocol.
Danish: I fase 3-studiet opgav 3 ud af 4 patienter med ALAT > 5 x ULN at have et alkoholforbrug, der oversteg de anbefalede grænser i protokollen.
English: • tetracycline antibiotics to treat infections such as urinary tract infections
Danish: • tetracyklin-antibiotika til behandling af infektioner såsom urinvejsinfektion
English: Warnings and precautions Talk to your doctor or pharmacist before taking Lojuxta if you:
Danish: Advarsler og forsigtighedsregler Kontakt lægen eller apotekspersonalet, før du tager Lojuxta:
English: Lomitapide does not inhibit breast cancer resistance protein (BCRP).
Danish: Lomitapid hæmmer ikke brystkræftresistensproteinet (BCRP).
English: Regular screening for steatohepatitis/fibrosis should be performed at baseline and on an annual basis using the following imaging and biomarker evaluations:
Danish: Der bør regelmæssigt screenes for steatohepatitis/fibrose ved baseline og en gang om året under anvendelse af følgende scanninger og vurderinger af biomarkører:
English: • enlarged, damaged or fatty liver
Danish: • forstørret, beskadiget lever eller fedtlever
English: Dry skin Hyperhidrosis
Danish: Tør hud Hyperhidrose
English: p-value is based on the mean percent change b p-value on the mean percent change from baseline based on paired t-test
Danish: p-værdi baseret på gennemsnitlig procentuel ændring b p-værdi beregnet for den gennemsnitlige procentuelle ændring fra baseline og baseret på parret t-test
English: Work with a dietitian to learn what you can eat while taking Lojuxta.
Danish: Få råd fra en diætist om, hvad du kan spise, mens du tager Lojuxta.
English: • All capsules have edible black ink for printing.
Danish: • Alle kapsler er mærket med spiselig sort trykfarve.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 31 July 2013
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF MARKEDSFØRINGSTILLADELSEN Dato for første markedsføringstilladelse: 31. juli 2013 Dato for seneste fornyelse: 23. april 2018
English: • Your dose of Lojuxta may need to be adjusted if you consume peppermint oil or Seville oranges.
Danish: • Det kan være nødvendigt at tilpasse din dosis af Lojuxta, hvis du indtager pebermynteolie eller bitre appelsiner (pomerans).
English: Lojuxta can lower blood levels of:
Danish: Lojuxta kan nedsætte blodets indhold af:
English: The recommended starting dose is 5 mg once daily.
Danish: Den anbefalede startdosis er 5 mg én gang dagligt.
English: The European Medicines Agency will review any new information on this medicine every year and this leaflet will be updated as necessary.
Danish: Det Europæiske Lægemiddelagentur vil hvert år vurdere nye oplysninger om lægemidlet, og denne indlægsseddel vil om nødvendigt blive ajourført.
English: Hepatic fat was prospectively measured using MRS in all eligible patients during the clinical study (Table 7).
Danish: Leverens fedtindhold blev målt prospektivt ved MRS hos alle egnede patienter under det kliniske studie (Tabel 7).
English: If aminotransferase levels do not fall below 3x ULN within approximately 4 weeks refer the patient to a hepatologist for further investigation.
Danish: Hvis aminotransferaserne ikke kommer under 3 x ULN inden for ca. 4 uger, henvises patienten til nærmere undersøgelse ved hepatolog.
English: Of the 23 patients who completed through Week 26, 19 (83%) had LDL-C reductions ≥25% with 8 (35%) having LDL-C <100 mg/dL and 1 having LDL-C <70 mg/dL at that time point.
Danish: Af de 23 patienter, der gennemførte undersøgelsen til og med uge 26, fik de 19 (83 %) reduceret LDL-C med ≥ 25 %, hvoraf 8 (35 %) fik LDL-C < 100 mg/dl og 1 fik LDL-C < 70 mg/dl på dette tidspunkt.
English: The recommended starting dose is a 5 mg capsule each day.
Danish: Den anbefalede startdosis er en 5 mg kapsel dagligt.
English: If your tests show some liver problems, your doctor may decide to reduce your dose or stop the treatment.
Danish: Hvis blodprøverne viser, at der er leverproblemer, vil lægen muligvis sætte din dosis ned eller stoppe behandlingen.
English: Following administration of a radiolabeled oral solution dose to healthy subjects, 93% of the administered dose was recovered in urine and faeces.
Danish: Efter administration af en radioaktivt mærket oral opløsning til raske forsøgspersoner blev 93 % af den administrerede dosis genfundet i urinen og fæces.
English: At baseline, 93% were on a statin, 76% were on ezetimibe, 10% on niacin, 3% on a bile acid sequestrant and 62% were receiving apheresis.
Danish: Ved baseline var 93 % på statin, 76 % var på ezetimib, 10 % på niacin, 3 % på en galdesyresekvestrant, og 62 % fik aferese.
English: In a 1 year repeat-dose study in dogs there were no microscopic changes in the liver although serum AST was minimally increased in females.
Danish: I en etårs undersøgelse med gentagen dosering hos hunde var der ingen mikroskopiske ændringer i leveren, skønt der var minimalt forhøjet serum-ASAT hos hundyrene.
English: • Repeat tests weekly and withhold dosing if there are signs of abnormal liver function (increase in bilirubin or INR), if aminotransferase levels rise above 5x ULN, or if aminotransferase levels do not fall below 3x ULN within approximately 4 weeks.
Danish: • Prøverne gentages hver uge, og doseringen indstilles, hvis der er tegn på abnorm leverfunktion (stigning i bilirubin eller INR), hvis aminotransferase kommer over 5 x ULN, eller hvis aminotransferase ikke kommer under 3 x ULN i løbet af ca. 4 uger.
English: Do not use this medicine after the expiry date which is stated on the label or carton after “EXP”.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på etiketten eller kartonen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: In this study, 10 patients experienced elevations in AST and/or ALT >3 x ULN (see Table 6).
Danish: I denne undersøgelse fik 10 patienter forhøjede værdier af ASAT og/eller ALAT til > 3 x ULN (se Tabel 6).
English: It is not known whether lomitapide is excreted into human milk.
Danish: Det er ukendt, om lomitapid udskilles i human mælk.
English: P-gp substrates: Lomitapide inhibits P-gp in vitro, and may increase the absorption of P-gp substrates.
Danish: P-gp-substrater: Lomitapid hæmmer P-gp in vitro og kan øge absorptionen af P-gp-substrater.
English: At steady state the accumulation of lomitapide was 2.7 at 25 mg and 3.9 at 50 mg.
Danish: I steady state var akkumuleringen af lomitapid 2,7 ved 25 mg og 3,9 ved 50 mg.
English: • Information on the importance of following a low-fat diet (a diet supplying less than 20% of energy from fat);
Danish: • Information om vigtigheden af at følge en fedtfattig diæt (en diæt med mindre end 20 % af kalorieindholdet fra fedtstof)
English: Other reactions reported by at least 20% of patients include abdominal pain, abdominal discomfort, abdominal distension, constipation, and flatulence.
Danish: Andre reaktioner, der blev beskrevet af mindst 20 % af patienterne, var abdominalsmerter, abdominalt ubehag, abdominal distension, konstipation og flatulens.
English: In the renal impairment population, lomitapide was only studied in patients with end-stage renal disease (ESRD).
Danish: I populationen med nedsat nyrefunktion blevet lomitapid kun undersøgt hos patienter med nyresygdom i terminalstadiet (ESRD).
English: Data in the pivotal clinical study were analysed with respect to the impact of potential covariates on lomitapide exposure.
Danish: Data i det kliniske hovedstudie blev analyseret for indvirkningen af mulige kovariater på eksponeringen for lomitapid.
English: CYP isoforms 2E1, 1A2, 2B6, 2C8, and 2C19 are involved to a lesser extent and isoforms 2D6 and 2C9 are not involved in the metabolism of lomitapide.
Danish: CYP-isoformerne 2E1, 1A2, 2B6, 2C8 og 2C19 er involveret i mindre omfang, og isoformerne 2D6 og 2C9 er ikke involveret i metaboliseringen af lomitapid.
English: In ferrets, lomitapide was both maternally toxic and teratogenic at <1 times the MRHD.
Danish: Hos desmerkatte var lomitapid både maternelt toksisk og teratogent ved < 1 gange MRHD.
English: Administration with food may increase exposure to lomitapide.
Danish: Administration sammen med et måltid kan øge eksponeringen for lomitapid.
English: A copy of the patient brochure and patient alert card shall be provided to all patients at the time Lojuxta treatment is initiated.
Danish: Der skal udleveres en kopi af patientbrochuren og patientadvarselskortet til alle patienter ved initiering af behandlingen med Lojuxta.
English: Liver related tests should be monitored.
Danish: Leverrelaterede test skal monitoreres.
English: Lomitapide was not mutagenic or genotoxic in a battery of in vitro and in vivo studies.
Danish: Lomitapid var ikke mutagent eller genotoksisk i en gruppe af in vitro- og in vivo-undersøgelser.
English: The safety and efficacy of lomitapide in children <18 years have not been established and the use of this medicinal product in children is therefore not recommended.
Danish: Sikkerheden og virkningen af lomitapid hos børn og unge under 18 år er ikke klarlagt, hvorfor det frarådes at anvende dette lægemiddel hos børn.
English: Gastroenteritis Gastrointestinal infection Influenza
Danish: Gastroenteritis Gastrointestinal infektion Influenza
English: Your doctor may advise you to stop taking Lojuxta or to stop breast-feeding.
Danish: Lægen vil muligvis bede dig holde op med at tage Lojuxta eller holde op med at amme.
English: These capsules should be given to you by a doctor experienced in the treatment of lipid disorders who will also monitor you regularly.
Danish: Kapslerne skal ordineres af en læge, som har erfaring med behandling af forstyrrelser i blodlipiderne, og som også skal kontrollere dig regelmæssigt.
English: Median presented for TG and Lp(a).
Danish: Medianværdi angivet for TG og Lp(a).
English: Post-marketing reports of dehydration and hospitalisation in patients treated with lomitapide have been reported.
Danish: Efter markedsføringen er der rapporteret om dehydrering og hospitalsindlæggelse hos patienter i behandling med lomitapid.
English: The liver enzyme changes can occur at any time during therapy, but occur most often during dose escalation.
Danish: Ændringerne i leverenzymer kan forekomme på ethvert tidspunkt under behandlingen, men optræder oftest under dosiseskalering.
English: Patients taking Lojuxta should avoid consumption of grapefruit juice.
Danish: Patienter i behandling med Lojuxta bør undgå indtagelse af grapefrugtjuice.
English: Risk of supratherapeutic or subtherapeutic anticoagulation with coumarin based anticoagulants
Danish: Risiko for superterapeutisk eller subterapeutisk antikoagulation med kumarinbaserede antikoagulantia
English: • if you take more than 40 mg of simvastatin daily (another medicine used to lower cholesterol).
Danish: • hvis du dagligt tager mere end 40 mg simvastatin (et andet kolesterolsænkende lægemiddel)
English: Dose reduction of the P gp substrate should be considered when used concomitantly with Lojuxta.
Danish: Dosisreduktion af det pågældende P-gp-substrat bør overvejes ved samtidig anvendelse af Lojuxta.
English: Monitoring for evidence of progressive liver disease.
Danish: Overvågning for tegn på progressiv leversygdom.
English: Frequency of adverse reactions in elevated LDL-C patients System Organ Class
Danish: Hyppigheden af bivirkninger hos patienter med forhøjet LDL-C Systemorganklasse
English: Consistent with the mechanism of action of lomitapide, most treated patients exhibited increases in hepatic fat content.
Danish: I overensstemmelse med virkningsmekanismen af lomitapid fik størstedelen af de behandlede patienter stigninger i det hepatiske fedtindhold.
English: The dose should be escalated gradually to minimise the incidence and severity of gastrointestinal adverse reactions and aminotransferase elevations.
Danish: Dosis bør øges gradvist for at minimere forekomsten og sværhedsgraden af gastrointestinale bivirkninger og forhøjede aminotransferaseværdier.
English: • The active substance is lomitapide.
Danish: • Aktivt stof: lomitapid.
English: Tell your doctor or pharmacist if you are taking any of the following medicines:
Danish: Sig det til lægen eller på apoteket, hvis du tager nogen af følgende lægemidler:
English: Patients will be instructed to carry this card and show it to all doctors who treat them.
Danish: Patienterne skal have at vide, at de skal have kortet på sig og vise det til alle læger, der behandler dem.
English: The clinical studies supporting the safety and efficacy of lomitapide in HoFH would have been unlikely to detect this adverse outcome given their size and duration.
Danish: De kliniske undersøgelser til støtte for sikkerheden og virkningen af lomitapid ved HoFH kan på grund af deres omfang og varighed ikke forventes at have vist denne bivirkning.
English: Because bile acid sequestrants can interfere with the absorption of oral medicines, bile acid sequestrants should be taken at least 4 hours before or at least 4 hours after Lojuxta.
Danish: Da galdesyresekvestranter kan interferere med absorptionen af orale lægemidler, bør galdesyresekvestranter tages mindst 4 timer før eller mindst 4 timer efter Lojuxta.
English: Ecchymosis Papule
Danish: Ekkymose Papulae
English: Sixteen males (55%) and 13 females (45%) were included with a mean age of 30.7 years, ranging from 18 to 55 years.
Danish: Undersøgelsen omfattede 16 mænd (55 %) og 13 kvinder (45 %) med en gennemsnitsalder på 30,7 år og en variationsbredde på 1855 år.
English: In this study, the median levels of serum vitamin E, ALA, linoleic acid, EPA, DHA, and arachidonic acid decreased from baseline to Week 26 but remained above the lower limit of the reference range.
Danish: I dette studie faldt medianniveauet af serum-vitamin E, ALA, linolsyre, EPA, DHA og arakidonsyre fra udgangsværdien til uge 26, men holdt sig over undergrænsen af referenceområdet.
English: • purple discoloration of the skin, solid bumps on the skin, rash, yellow bumps on the skin
Danish: • lilla misfarvning af huden, massive knopper på huden, udslæt, gule knopper på huden
English: The most common adverse reactions were gastrointestinal effects.
Danish: De hyppigste bivirkninger var gastrointestinale.
English: There have been no concomitant or subsequent clinically meaningful elevations in serum bilirubin, INR, or alkaline phosphatase.
Danish: Der har ikke været nogen samtidige eller efterfølgende klinisk betydningsfulde stigninger i serumbilirubin, INR eller alkalisk fosfatase.
English: Patients with mild hepatic impairment (Child-Pugh A) should not exceed 40 mg daily.
Danish: Ved let nedsat leverfunktion (Child-Pugh A) bør 40 mg dagligt ikke overskrides.
English: Additional contraceptive measures should be used until resolution of symptoms (see section 4.5).
Danish: Der bør anvendes supplerende antikonception, indtil symptomerne er forsvundet (se pkt.
English: • if you have bowel problems or cannot absorb food from your bowel.
Danish: • hvis du har tarmproblemer eller ikke kan optage føde fra tarmen
English: If you stop taking this medicine your cholesterol may rise again.
Danish: Hvis du holder op med at tage Lojuxta, kan dit kolesteroltal stige igen.
English: Patients were instructed to maintain a low-fat diet (<20% calories from fat) and their lipid-lowering therapies at study entry, including apheresis if applicable, from 6 weeks prior to baseline through at least Week 26.
Danish: Patienterne fik besked på at holde en fedtfattig diæt (<20 % af kalorieindholdet fra fedt) og fortsætte med deres lipidsænkende behandling ved undersøgelsens begyndelse herunder eventuel aferese, fra uge 6 før baseline og mindst til og med uge 26.
English: • Before starting treatment you should confirm you are not pregnant and are using effective contraception, as advised by your doctor.
Danish: • Før påbegyndelse af behandlingen skal du sikre dig, at du ikke er gravid, og du skal bruge effektiv svangerskabsforebyggelse efter lægens råd.
English: All patients receiving lomitapide in addition to a statin should be advised of the potential increased risk of myopathy and told to report promptly any unexplained muscle pain, tenderness, or weakness.
Danish: Alle patienter, der får lomitapid som tillægsbehandling til et statin, bør informeres om den potentielle øgede risiko for myopati og instrueres i straks at melde uforklarlig muskelsmerte, -ømhed eller -svaghed.
English: Diarrhoea occurred in 79% of patients, nausea in 65%, dyspepsia in 38%, and vomiting in 34%.
Danish: Diarré forekom hos 79 % af patienterne, kvalme hos 65 %, dyspepsi hos 38 % og opkastning hos 34 %.
English: • Information about taking Lojuxta at bedtime with water at least 2 hours after the evening meal and without food;
Danish: • Information om, at Lojuxta skal tages ved sengetid med vand mindst to timer efter aftensmåltidet og uden fødeindtagelse
English: • Periodic safety update reports
Danish: • Periodiske opdaterede sikkerhedsberetninger (PSUR'er)
English: Elevations in ALT and/or AST >5 x ULN were managed with a dose reduction or temporary suspension of lomitapide dosing, and all patients were able to continue with study drug treatment.
Danish: Forhøjelser i ALAT og/eller ASAT til > 5 x ULN blev behandlet med dosisreduktion eller midlertidig seponering af lomitapid, og alle patienter kunne fortsætte med forsøgsmedicinen.
English: Although cases of hepatic dysfunction (elevated aminotransferase with increase in bilirubin or International Normalized Ratio [INR]) or hepatic failure have not been reported, there is concern that lomitapide could induce steatohepatitis, which can progress to cirrhosis over several years.
Danish: Skønt der ikke er beskrevet tilfælde af hepatisk dysfunktion (forhøjede aminotransferaser med stigning i bilirubin eller International Normalized Ratio [INR]) eller leversvigt, er der bekymring for, at lomitapid kan fremkalde steatohepatitis, som efter nogle år kan progrediere til cirrhose.
English: • The safety and effectiveness of Lojuxta in children below the age of 18 have not been established;
Danish: • Lojuxtas sikkerhed og virkning hos børn under 18 år er ikke klarlagt
English: Lojuxta has not been investigated in children less than 18 years of age.
Danish: Lojuxta er ikke undersøgt hos børn under 18 år.
English: Lomitapide is not a P-gp substrate but does inhibit P-gp.
Danish: Lomitapid er ikke et P-gp-substrat, men det hæmmer P-gp.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Lojuxta in one or more subsets of the paediatric population in HoFH (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Lojuxta i en eller flere undergrupper af den pædiatriske population ved HoFH (se pkt.
English: Embryofoetal toxicity was observed in rabbits in the absence of maternal toxicity at ≥6.5 times the MRHD.
Danish: Hos kaniner iagttoges embryoføtal toksicitet i fravær af maternel toksicitet ved ≥ 6,5 gange MRHD.
English: Reduced absorption of fat-soluble vitamins and serum fatty acids
Danish: Nedsat absorption af fedtopløselige vitaminer og fedtsyrer i serum
English: 400 IU*
Danish: 400 IE*
English: Hepatic events related to elevated aminotransferases and progressive liver disease
Danish: Hepatiske hændelser relateret til forhøjede aminotransferaser og progressiv leversygdom
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Danish: Du kan finde yderligere information om dette lægemiddel på Det europæiske Lægemiddelagenturs hjemmeside: http://www.ema.europa.eu.
English: Increases in the dose of Lojuxta may lead to supratherapeutic anticoagulation, and decreases in the dose may lead to subtherapeutic anticoagulation.
Danish: Dosisforøgelse af Lojuxta kan medføre supraterapeutisk antikoagulation, og dosisreduktion kan medføre subterapeutisk antikoagulation.
English: Lojuxta has not been studied in patients with severe hepatic impairment (Child-Pugh score 10-15).
Danish: Lojuxta er ikke undersøgt hos patienter med svært nedsat leverfunktion (Child-Pugh-score 10-15).
English: Table 3 lists all adverse reactions reported across the 35 patients treated in the Phase 2 Study UP1001 and in the Phase 3 Study UP1002/AEGR-733-005 or its extension study AEGR-733-012.
Danish: Tabel 3 angiver alle bivirkninger, der er beskrevet hos de 35 behandlede patienter i fase 2undersøgelsen UP1001 og i fase 3-undersøgelsen UP1002/AEGR-733-005 eller dennes forlængelse AEGR-733-012.
English: AUCs for R(+)-warfarin and S(-)-warfarin increased 25% and 30%, respectively.
Danish: AUC af R(+)-warfarin og S(-)-warfarin øgedes med henholdsvis 25 % og 30 %.
English: Patients shall be informed of the necessity to carry the patient alert card with them and show it to all doctors that treat them.
Danish: Patienterne skal informeres om nødvendigheden af at have patientadvarselskortet på sig og vise det til alle læger, som behandler dem.
English: Haemodialysis is unlikely to be beneficial given that lomitapide is highly protein bound.
Danish: Hæmodialyse hjælper sandsynligvis ikke, da lomitapid i høj grad er proteinbundet.
English: Hard, capsule.
Danish: Kapsler, hårde.
English: The Prescriber Guide shall include the following key elements:
Danish: Ordinationsvejledningen skal indeholde følgende hovedelementer:
English: Please tell your doctor if you are breastfeeding or planning to breast-feed.
Danish: Sig det til lægen, hvis du ammer eller planlægger at amme.
English: Lomitapide does not induce CYPs 1A2, 3A4, or 2B6, and does not inhibit CYPs 1A2, 2B6, 2C9, 2C19, 2D6, or 2E1.
Danish: Lomitapid inducerer ikke CYP1A2, -3A4 eller -2B6 og hæmmer ikke CYP1A2, -2B6, -2C9, -2C19, -2D6 eller -2E1.
English: list is not intended to be comprehensive and prescribers should check the prescribing information of medicinal products to be co-administered with Lojuxta for potential CYP3A4 mediated interactions.
Danish: Denne liste er ikke udtømmende, og den ordinerende læge bør kontrollere produktoplysningerne for lægemidler, der skal koadministreres med Lojuxta, med henblik på potentielle CYP3A4-medierede interaktioner.
English: Animal studies have shown developmental toxicity (teratogenicity, embryotoxicity, see section 5.3).
Danish: Dyreforsøg har påvist udviklingstoksicitet (teratogenicitet, embryotoksicitet, se pkt.
English: However, since the medicinal product is dosed in an escalating fashion according to individual patient safety and tolerability, no adjustment to the dosing regimen is recommended based on race.
Danish: Da Lojuxta doseres ved eskalering i henhold til sikkerheden og tolerabiliteten hos den enkelte patient, anbefales imidlertid ingen justering af dosisregimet baseret på race.
English: Change p-valueb
Danish: ændrin g p-værdib
English: − The absence of pregnancy should be confirmed;
Danish: − Graviditet skal udelukkes