FrancophonIA/ELRC3.0 huggingface dataset:
English: If you feel dizzy during treatment then do not drive or use machines until you feel better.
Danish: Hvis du føler dig svimmel under behandlingen, skal du ikke føre motorkøretøj eller betjene maskiner, før du får det bedre.
English: Keep the bottle tightly closed in order to protect from moisture.
Danish: Hold flasken tæt lukket for at beskytte mod fugt.
English: Inform your doctor of any change in the medicines you are taking.
Danish: Fortæl lægen om enhver ændring i de lægemidler, du tager.
English: It is important to avoid dehydration by drinking enough fluids (see section 4).
Danish: Det er vigtigt at undgå dehydrering ved at drikke tilstrækkeligt med væske (se afsnit 4).
English: Women who become pregnant should be counselled and referred to an expert in teratology;
Danish: Kvinder, som bliver gravide, bør rådgives og henvises til en ekspert i teratologi
English: • At least one marker from each of the following categories:
Danish: • Mindst én markør i hver af følgende kategorier:
English: Statins occasionally cause myopathy.
Danish: Statiner forårsager undertiden myopati.
English: SPECIAL STORAGE CONDITIONS Store below 30°C.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevares ved temperaturer under 30 °C.
English: • when to increase or decrease your dose.
Danish: • hvornår din dosis skal sættes op eller ned
English: • Advice to patients about the risk of concomitant alcohol intake;
Danish: • Anvisning til patienterne om risikoen ved samtidig alkoholindtagelse
English: Age and gender
Danish: Alder og køn
English: Grapefruit juice
Danish: Grapefrugtjuice
English: It is typically passed down by both father and mother, who also have high cholesterol passed down from their parents.
Danish: Den arves typisk fra både faderen og moderen, som ligeledes har arvet et højt kolesterolindhold fra deres forældre.
English: The objectives of the study are:
Danish: Undersøgelsens formål er:
English: • tiredness, lack of energy or general weakness
Danish: • træthed, manglende energi eller almen svaghed
English: Do not change the dose yourself.
Danish: Du skal ikke på egen hånd ændre din dosis.
English: This being an approval under exceptional circumstances and pursuant to Article 14(8) of Regulation (EC) No 726/2004, the MAH shall conduct, within the stated timeframe, the following measure:
Danish: Dette er en godkendelse under særlige omstændigheder, og i henhold til artikel 14, stk. 8, i forordning (EF) nr. 726/2004 skal indehaveren af markedsføringstilladelsen inden for den fastsatte tidsramme gennemføre følgende foranstaltninger/tiltag:
English: Daily Amount Vitamin E
Danish: Daglig dosis Vitamin E
English: It should be taken on an empty stomach, at least 2 hours after the evening meal because the fat content of a recent meal may adversely impact gastrointestinal tolerability.
Danish: Det bør tages på tom mave mindst 2 timer efter aftensmåltidet, da fedtindholdet i et nyligt måltid kan have negativ indvirkning på den gastrointestinale tolerabilitet.
English: • Symptoms of liver disease for which the patient should consult a doctor;
Danish: • Symptomer på leversygdom, som patienten bør søge læge for
English: This medicine has been authorised under ‘exceptional circumstances'.
Danish: Dette lægemiddel er godkendt under ”særlige vilkår”.
English: • Compliance with the supplementation regimen should be verified at regular scheduled appointments and the importance emphasised.
Danish: • Overholdelsen af tilskudsregimet bør verificeres ved regelmæssige planlagte besøg, og vigtigheden heraf bør understreges.
English: Do not take this medicine if you are pregnant, trying to get pregnant, or think you may be pregnant, as there is a possibility that it could harm an unborn baby.
Danish: Tag ikke dette lægemiddel, hvis du er gravid, planlægger at blive gravid eller har mistanke om, at du er gravid, da der er risiko for, at det kan skade det ufødte barn.
English: Reintroduction of treatment may be considered if the benefits are considered to outweigh the risks associated with potential liver disease.
Danish: Det kan overvejes at genoptage behandlingen, hvis fordelene anses for at overstige risiciene ved potentiel leversygdom.
English: The absolute oral bioavailability of lomitapide is 7%.
Danish: Den absolutte orale biotilgængelighed af lomitapid er 7 %.
English: Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden du begynder at bruge dette lægemiddel, da den indeholder vigtige oplysninger.
English: No studies have been conducted in children and adolescents under the age of 18.
Danish: Der er ikke udført undersøgelser hos børn og unge under 18 år.
English: Efficacy phase weeks 0-26
Danish: Virkningsfase uge 0-26
English: There was no clinically relevant effect of age (18-64 years) or gender on the pharmacokinetics of lomitapide.
Danish: Der var ingen klinisk relevant effekt af alder (18-64 år) eller køn på farmakokinetikken af lomitapid.
English: These capsules may cause side effects which can also be symptoms of liver problems.
Danish: Disse kapsler kan medføre bivirkninger, som også kan være tegn på leverproblemer.
English: Patients on 5 mg should remain on 5 mg.
Danish: Patienter på 5 mg skal fastholdes på 5 mg.
English: Frequency of the adverse reactions is defined as: very common (1/10), common (1/100 to <1/10), uncommon (1/1,000 to <1/100), rare (1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Danish: Hyppigheden af bivirkninger er defineret som: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Fifteen of 23 (65%) patients had their lipid-lowering treatment reduced by Week 78, including planned and unplanned reductions/interruptions.
Danish: 15 ud af 23 (65 %) patienter fik deres lipidsænkende behandling sat ned inden uge 78, inklusive planlagte og ikke-planlagte reduktioner eller afbrydelser.
English: Lojuxta is contraindicated during pregnancy.
Danish: Lojuxta er kontraindiceret under graviditeten.
English: After the first year, do these tests at least every 3 months and before any increase in dose.
Danish: Efter det første år skal disse prøver tages mindst hver tredje måned og før enhver dosisforhøjelse.
English: The MAH must agree the content and format of the educational materials together with a communication plan with the national competent authority in each Member State prior to distribution in their territory.
Danish: Indehaveren af markedsføringstilladelsen skal aftale indhold og format af uddannelsesmaterialet samt en kommunikationsplan med de nationale kompetente myndigheder i hver medlemsstat før distribution på dennes område.
English: This should include at least one marker in each of the following categories:
Danish: Denne skal omfatte mindst én markør i hver af følgende kategorier:
English: If you get pregnant while taking this medicine, call your doctor immediately and stop taking the capsules.
Danish: Hvis du bliver gravid, mens du tager dette lægemiddel, skal du straks kontakte lægen og holde op med at tage kapslerne.
English: • To lower the chance of stomach problems, you must stay on a low-fat diet whilst taking this medicine.
Danish: • For at mindske risikoen for problemer med maven skal du holde en fedtfattig diæt, mens du tager dette lægemiddel.
English: • If, after you have started treatment with Lojuxta, you decide that you would like to become pregnant, please inform your doctor, as your treatment will need to be changed.
Danish: • Hvis du efter at have påbegyndt behandling med Lojuxta beslutter, at du gerne vil være gravid, skal du sige det til lægen, da din behandling skal ændres.
English: These side-effects are listed in section 4 and you must tell your doctor immediately if you have any of these signs and symptoms, as they may be caused by liver damage.
Danish: Sådanne bivirkninger er anført i afsnit 4, og du skal straks sige det til lægen, hvis du får nogen af disse tegn og symptomer, da de kan skyldes leverskade.
English: • An explanation of the types of tests required (imaging and blood) to check liver function and the importance of them being performed regularly;
Danish: • En forklaring af de typer prøver, der er nødvendige (skanning og blodprøver) til kontrol af leverfunktionen, og vigtigheden af, at de udføres regelmæssigt
English: These changes are secondary to the mechanism of action of lomitapide.
Danish: Disse ændringer er sekundære til lomitapids virkningsmekanisme.
English: No dose adjustment is required for Caucasian or Latino patients.
Danish: Der kræves ingen dosisjustering for patienter af kaukasisk eller latinamerikansk race.
English: The following other side effects have also occurred:
Danish: Følgende bivirkninger er også forekommet:
English: • Lojuxta is only indicated for use in adult patients with HoFH;
Danish: • Lojuxta er kun indiceret til anvendelse hos voksne patienter med HoFH
English: Absorption is not limited by penetration of the active substance across the intestinal barrier but is predominantly influenced by an extensive first pass effect.
Danish: Absorptionen begrænses ikke af det aktive stofs passage af tarmbarrieren, men er primært bestemt af en omfattende first pass-effekt.
English: The performance of these tests and their interpretation should involve collaboration between the treating physician and the hepatologist.
Danish: Udførelsen af disse prøver og deres fortolkning bør ske i samarbejde mellem den behandlende læge og hepatolog.
English: These blood tests help your doctor adjust your dose.
Danish: Disse blodprøver skal gøre det muligt for lægen at tilpasse din dosis.
English: Twenty-nine patients were enrolled, of whom 23 completed through Week 78.
Danish: Der blev indrulleret 29 patienter, hvoraf 23 fuldførte til og med uge 78.
English: >5% to ≤10% >10% to ≤15% >15% to ≤20% >20% to ≤25%
Danish: > 5 % til ≤ 10 % > 10 % til ≤ 15 % > 15 % til ≤ 20 % > 20 % til ≤ 25 %
English: Interactions between Lojuxta and other medicinal products and other forms of interaction
Danish: Interaktioner mellem Lojuxta og andre lægemidler samt andre former for interaktion
English: Serious side effects:
Danish: Alvorlige bivirkninger:
English: The effect of Lojuxta on cardiovascular morbidity and mortality has not been determined.
Danish: Virkningen af Lojuxta på kardiovaskulær morbiditet og mortalitet er ikke blevet fastlagt.
English: You also need to take daily vitamin E and essential fatty acid (omega-3 and omega-6) supplements while taking this medicine.
Danish: Du skal også dagligt have tilskud af vitamin E og essentielle fedtsyrer (omega-3 og omega-6), mens du tager dette lægemiddel.
English: Careful titration may then be considered according to LDL-C response and safety/tolerability.
Danish: Derefter kan forsigtig titrering overvejes, afhængigt af LDL-C-respons og sikkerhed/tolerabilitet.
English: • To evaluate the occurrence of the following in patients treated with lomitapide:
Danish: • At evaluere forekomsten af følgende hos patienter, der behandles med lomitapid:
English: Consequently, this would reduce the effect of lomitapide.
Danish: Dette vil i så fald nedsætte virkningen af lomitapid.
English: Alcohol may increase levels of hepatic fat and induce or exacerbate liver injury.
Danish: Alkohol kan øge mængden af hepatisk fedt og fremkalde eller forværre leverskade.
English: Lancaster Way, Wingates Industrial Estate, Westhoughton, Bolton, Lancashire, BL5 3XX United Kingdom
Danish: Lancaster Way, Wingates Industrial Estate, Westhoughton, Bolton, Lancashire, BL5 3XX Storbritannien
English: Effects of lomitapide on other medicinal products
Danish: Lomitapids virkning på andre lægemidler
English: * IU - international units, mg - milligrams
Danish: * IE - internationale enheder, mg - milligram
English: • The need to inform their doctor of all other medicines they are taking as special care should be taken if other medicines which can cause liver problems are taken at the same time;
Danish: • Nødvendigheden af at oplyse deres læge om al anden medicin, de tager, da der kræves særlig forsigtighed ved samtidig brug af andre lægemidler, der kan medføre leverproblemer
English: o Goldenseal (for inflammation and infection)
Danish: o Guldsegl (mod inflammation og infektion)
English: Peak plasma concentrations of lomitapide were reached 4-8 hours following oral dosing.
Danish: Plasmaspidskoncentrationerne af lomitapid blev nået 4-8 timer efter oral indtagelse.
English: Omega-6 Linoleic acid
Danish: Omega-6 Linolsyre
English: • total cholesterol
Danish: • totalkolesterol
English: Therefore the use of this medicine in children and adolescents is not recommended.
Danish: Det frarådes derfor at anvende dette lægemiddel til børn og unge.
English: You must also tell your doctor or pharmacist if you are taking any of the following medicines, as they may need to change your dose of Lojuxta:
Danish: Du skal også fortælle det til lægen eller på apoteket, hvis du tager nogen af følgende lægemidler, da det kan være nødvendigt at ændre din dosis af Lojuxta:
English: • triglycerides (fat carried in the blood)
Danish: • triglycerider (fedt, der transporteres i blodet)
English: • some herbal medicines:
Danish: • visse plantelægemidler:
English: 4.5 Interaction with other medicinal products and other forms of interaction Effects of other medicinal products on lomitapide and other forms of interaction Table 2:
Danish: 4.5 Interaktion med andre lægemidler og andre former for interaktion Virkningerne af andre lægemidler på lomitapid og andre former for interaktion Tabel 2:
English: Your doctor will tell you:
Danish: Lægen skal rådgive dig om:
English: Information that the educational materials for patients included in the prescribers pack can be used for patient counselling.
Danish: Oplysning om, at informationsmaterialet til patienterne i de ordinerende lægers informationspakke kan anvendes til patientrådgivning.
English: The remainder was excreted in faeces, primarily as oxidised metabolites.
Danish: Resten blev udskilt i fæces, hovedsagelig som oxiderede metabolitter.
English: • The need to avoid grapefruit juice;
Danish: • Nødvendigheden af at undgå grapefrugtjuice
English: Inter-individual variability in lomitapide AUC was approximately 50%.
Danish: Den interindividuelle variabilitet i AUC af lomitapid var ca. 50 %.
English: The risk of myopathy with simvastatin is dose related.
Danish: Risikoen for myopati med simvastatin er dosisrelateret.
English: Gastrointestinal reactions contributed to the reasons for early discontinuation from the study for 4 (14%) patients.
Danish: Gastrointestinale reaktioner var medvirkende begrundelse for tidlig udtræden af studiet hos 4 (14 %) af patienterne.
English: You should contact your doctor before you stop taking this medicine.
Danish: Kontakt lægen, før du holder op med at bruge dette lægemiddel.
English: Of the parameters examined (race, body mass index (BMI), gender, weight, age), only BMI could be classified as a potential covariate.
Danish: At de undersøgte parametre (race, legemsmasseindeks (BMI), køn, vægt, alder) kunne kun BMI klassificeres som en potentiel kovariat.
English: (dehydration)
Danish: (dehydrering)
English: The purpose of the patient alert card is to inform health care professionals of potential drug-drug interactions before any additional medicinal product is prescribed.
Danish: Formålet med patientadvarselskortet er at informere sundhedspersonale om potentielle lægemiddelinteraktioner, før der ordineres yderligere medicin.
English: Oral use.
Danish: Til oral anvendelse.
English: In animal studies lomitapide was highly concentrated (200-fold) in the liver.
Danish: I dyreforsøg var lomitapid stærkt koncentreret (med en faktor 200) i leveren.
English: Gastrointestinal adverse reactions were reported by 27 (93%) of 29 patients in the Phase 3 clinical study.
Danish: Der blev indberettet gastrointestinale bivirkninger hos 27 (93 %) af 29 patienter i det kliniske fase 3-studie.
English: There is insufficient information to determine if Lojuxta requires dose adjustment in other races.
Danish: Der er ikke tilstrækkelige oplysninger til at fastslå, om Lojuxta kræver dosisjustering hos andre racer.
English: Dehydration Increased appetite
Danish: Dehydrering Øget appetit
English: • Before initiating treatment in women of child-bearing potential:
Danish: • Før initiering af behandling af kvinder i den fødedygtige alder:
English: 4.7 Effects on ability to drive and use machines Lojuxta has minor influence on the ability to drive and use machines.
Danish: 4.7 Virkning på evnen til at føre motorkøretøj og betjene maskiner Lojuxta påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
English: Adverse clinical consequences of these reductions were not observed with lomitapide treatment of up to 78 weeks.
Danish: Der blev ikke iagttaget negative kliniske følger af reduktionen i disse værdier ved behandling med lomitapid i op til 78 uger.
English: The elimination half-life of lomitapide was approximately 29 hours.
Danish: Eliminationshalveringstiden af lomitapid var ca. 29 timer.
English: Alternatively, your doctor may decrease your dose of Lojuxta.
Danish: Alternativt kan lægen nedsætte din dosis af Lojuxta.
English: Genetic confirmation of HoFH should be obtained whenever possible.
Danish: Diagnosen HoFH bør om muligt altid verificeres genetisk.
English: The “bad” cholesterol can lead to heart attacks, strokes or other events at an early age.
Danish: Det “skadelige” kolesterol kan i en tidlig alder medføre hjerteanfald, slagtilfælde eller andre hændelser.
English: In the Phase 3 study, patients were provided daily dietary supplements of vitamin E, linoleic acid, ALA, EPA and DHA.
Danish: I fase 3-studiet fik patienterne dagligt tilskud af vitamin E, linolsyre, ALA, EPA og DHA.
English: Ask your doctor, or dietitian how to obtain these supplements.
Danish: Spørg lægen eller diætisten om, hvorfra du kan skaffe disse kosttilskud.
English: Your doctor will give you a blood test to check your liver before you start taking these capsules, if your dose is increased, and regularly during treatment.
Danish: Lægen vil tage en blodprøve til kontrol af leveren, før du begynder at tage kapslerne, hver gang din dosis bliver sat op, samt regelmæssigt under behandlingen.
English: The terminal half-life of lomitapide was not affected.
Danish: Den terminale halveringstid af lomitapid var ikke påvirket.
English: Prescribers are encouraged to enrol all patients treated with Lojuxta into a global registry.
Danish: De ordinerende læger opfordres til at indføre alle patienter, der behandles med Lojuxta, i et globalt register.
English: More frequent monitoring of liver-related tests may be warranted.
Danish: Hyppigere overvågning af leverrelaterede prøver kan være nødvendig.
English: You may in some cases experience loss of fluids/dehydration, e.g. in case of vomiting, nausea and diarrhoea.
Danish: Du kan i nogle tilfælde opleve væsketab/dehydrering, f.eks. i tilfælde af opkastning, kvalme og diarré.
English: Appropriate patient selection
Danish: Korrekt valg af patienter
English: • apolipoprotein-B, a protein that carries “bad cholesterol” in the blood
Danish: • apolipoprotein-B, et protein, der transporterer “skadeligt kolesterol” i blodet
English: There is limited experience with lomitapide in patients aged 65 years or older.
Danish: Der er begrænset erfaring med anvendelse af lomitapid hos patienter over 65 år.
English: Other forms of primary hyperlipoproteinemia and secondary causes of hypercholesterolaemia (e.g., nephrotic syndrome, hypothyroidism) must be excluded.
Danish: Andre former for primær hyperlipoproteinæmi og sekundære årsager til hyperkolesterolæmi (f.eks. nefrotisk syndrom, hypotyroidisme) skal være udelukket.
English: • Women should tell their doctor immediately if they suspect that they might be pregnant.
Danish: • Kvindelige patienter skal straks informere lægen, hvis de har mistanke om at være gravide
English: Following intravenous administration, the volume of distribution of lomitapide was high (mean=1200 litres) despite a high degree (>99.8%) of binding to plasma protein.
Danish: Efter intravenøs administration var fordelingsvolumenet af lomitapid højt (gennemsnit = 1200 l) trods høj plasmaproteinbinding (> 99.8 %).
English: • if you are pregnant, trying to get pregnant, or think you may be pregnant (see section 2 under ‘Pregnancy and breast-feeding').
Danish: • hvis du er gravid, planlægger at blive gravid eller har mistanke om, at du er gravid (se afsnit 2 under ”Graviditet og amning”).
English: • Concomitant administration of >40 mg simvastatin (see section 4.5).
Danish: • Samtidig administration af >40 mg simvastatin (se pkt.
English: The median absolute increase in hepatic fat was 6% after both 26 weeks and 78 weeks of treatment, from 1% at baseline, measured by MRS. Hepatic steatosis is a risk factor for progressive liver disease including steatohepatitis and cirrhosis.
Danish: Den mediane absolutte stigning i leverens fedtindhold var 6 % både efter 26 ugers og 78 ugers behandling, fra 1 % ved baseline, målt ved MRS. Leversteatose er en risikofaktor for progressiv leversygdom, herunder steatohepatitis og cirrhose.
English: Tell your doctor immediately if you have any of these symptoms as your doctor may decide to stop the treatment.
Danish: Fortæl det straks til lægen, hvis du får nogen af disse symptomer, da lægen muligvis vil stoppe behandlingen.
English: Your doctor may increase your dose slowly over time, up to a maximum of 60 mg each day.
Danish: Dosen kan af din læge efterhånden langsomt sættes op til højst 60 mg dagligt.
English: At both Week 26 and Week 78, there were significant reductions in LDL-C, TC, apo B, TG, non-HDL-C, VLDL-C and changes in HDL-C trended lower at Week 26 and returned to baseline levels by Week 78.
Danish: Både i uge 26 og uge 78 var der signifikant reduktion i LDL-C, TC, ApoB, TG, non-HDL-C, VLDL-C, og HDL-C udviste faldende tendens i uge 26 og vendte tilbage til baseline inden uge 78.
English: Educational materials for patients
Danish: Oplysningsmateriale til patienter
English: • Gamma-GT and serum albumin to detect possible liver injury
Danish: • Gamma-GT og serumalbumin til påvisning af eventuel leverskade
English: Baseline Week 26/LOCF (N=29)
Danish: Parameter (enheder) Baseline Uge 26/LOCF (N=29)
English: Difficulty controlling INR contributed to early discontinuation from the Phase 3 study for one of five patients taking concomitant warfarin.
Danish: Problemer med regulering af INR bidrog til tidlig udtræden af fase 3-studiet for 1 ud af 5 patienter, der samtidig fik warfarin.
English: Cmax and AUC were increased following either a high-fat meal (77% and 58%, respectively) or low fat meal (70% and 28%, respectively).
Danish: Cmax og AUC blev forøget efter enten et fedtrigt måltid (henholdsvis 77 % og 58 %) eller et fedtfattigt måltid (henholdsvis 70 % and 28 %).
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Danish: Indehaveren af markedsføringstilladelsen skal udføre de påkrævede aktiviteter og foranstaltninger vedrørende lægemiddelovervågning, som er beskrevet i den godkendte RMP, der fremgår af modul 1.8.2 af markedsføringstilladelsen, og enhver efterfølgende godkendt opdatering af RMP.
English: Lomitapide pharmacokinetics is approximately dose-proportional for oral single doses in the therapeutic range.
Danish: Farmakokinetikken af lomitapid er tilnærmelsesvis dosisproportional ved orale enkeltdoser i det terapeutiske område.
English: The mean dose of lomitapide was 45 mg at Week 26 and 40 mg at Week 78.
Danish: Den gennemsnitlige dosis af lomitapid var 45 mg i uge 26 og 40 mg i uge 78.
English: In rare cases, myopathy may take the form of rhabdomyolysis with or without acute renal failure secondary to myoglobinuria, and can lead to fatality.
Danish: I sjældne tilfælde kan myopatien antage form af rhabdomyolyse med eller uden akut nyresvigt sekundært til myoglobinuri og være fatal.