FrancophonIA/ELRC3.0 huggingface dataset:
English: Upon multiple dosing Cmax and AUC increased in approximate proportion to lomitapide dose.
Danish: Gentagen dosering af lomitapid medførte stigning i Cmax og AUC, der stort set var dosisproportionel.
English: • medicines to treat cancer (e.g. bicalutamide, lapatinib, methotrexate, nilotinib, pazopanib, tamoxifen) or nausea/vomiting with cancer treatment (e.g. fosaprepitant)
Danish: • lægemidler til behandling af kræft (f.eks. bicalutamid, lapatinib, methotrexat, nilotinib, pazopanib, tamoxifen) eller kvalmestillende midler ved kræftbehandling (f.eks. fosaprepitant)
English: Diarrhoea Nausea Flatulence
Danish: Meget almindelig Diarré Kvalme
English: Alanine aminotransferase increased Aspartate aminotransferase increased Hepatic enzyme increased Liver function test abnormal Neutrophil count decreased White blood cell count decreased
Danish: Alaninaminotransferase forhøjet Aspartataminotransferase forhøjet Leverenzymer forhøjet Leverfunktionsprøve unormal Neutrofiltal nedsat Leukocyttal nedsat
English: • medicines to regulate heart rhythm (e.g. digoxin)
Danish: • lægemidler til regulering af hjerterytmen (f.eks. digoxin)
English: Inducers of CYP3A4 Medicines that induce CYP3A4 would be expected to increase the rate and extent of metabolism of lomitapide.
Danish: CYP3A4-induktorer Lægemidler, der inducerer CYP3A4, må forventes at øge hastigheden og omfanget af metaboliseringen af lomitapid.
English: Patient Alert card
Danish: Patientadvarselskort
English: When co-administering CYP3A4 inducers (i.e. aminoglutethimide, nafcillin, non-nucleoside reverse transcriptase inhibitors, phenobarbital, rifampicin, carbamazepine, pioglitazone, glucocorticoids, modafinil and phenytoin) with Lojuxta, the possibility of a drug-drug interaction affecting efficacy should be considered.
Danish: Ved koadministration af CYP3A4-induktorer (dvs. aminoglutethimid, nafcillin, non-nukleoside revers transkriptasehæmmere, phenobarbital, rifampicin, carbamazepin, pioglitazon, glukokortikoider, modafinil og phenytoin) med Lojuxta bør muligheden for lægemiddelinteraktioner med indvirkning på virkningen tages i betragtning.
English: • stomach pain, discomfort or stomach bloating
Danish: • mavesmerter, maveubehag eller oppustet mave
English: LOWER registry - long term prospective observational study to systematically collect information on the safety and effectiveness outcomes of patients treated with lomitapide.
Danish: LOWER-register - langsigtet prospektiv observationsundersøgelse til systematisk indsamling af oplysninger om sikkerhed og effekt hos patienter, der behandles med lomitapid.
English: o St. John's Wort (for depression)
Danish: o Perikum (mod depression)
English: • medicines to treat diabetes (e.g. saxagliptin, sitagliptin)
Danish: • lægemidler til behandling af sukkersyge (f.eks. saxagliptin, sitagliptin)
English: Weight decreased
Danish: Nedsat leverfunktion
English: Inhibitors of CYP3A4 When lomitapide 60 mg was co-administered with ketoconazole 200 mg twice daily, a strong inhibitor of
Danish: CYP3A4-hæmmere Når lomitapid 60 mg blev givet sammen med ketoconazol
English: Liver function test abnormal Prothrombin time prolonged Transaminases increased Vitamin E decreased Vitamin K decreased
Danish: Internationalt normaliseret ratio unormal Leverfunktionsprøve unormal Forlænget protrombintid Transaminaser forhøjet Vitamin E nedsat
English: • if you take any of these medicines that affect the way lomitapide is broken down in the body: o itraconazole, ketoconazole, fluconazole, voriconazole, posaconazole (for fungal infections) ; o telithromycin, clarithromycin, erythromycin (for bacterial infections) o indinavir, nelfinavir, saquinavir (for HIV infection) ; o diltiazem, verapamil (for high blood pressure, or angina), and dronedarone (to regulate heart rhythm).
Danish: • hvis du får nogen af følgende lægemidler, som påvirker nedbrydningen af lomitapid i kroppen: o itraconazol, ketoconazol, fluconazol, voriconazol, posaconazol (mod svampeinfektioner) o telithromycin, clarithromycin, erythromycin (mod bakterieinfektioner) o indinavir, nelfinavir, saquinavir (mod hiv-infektion) o diltiazem, verapamil (mod højt blodtryk eller angina) og dronedaron (til regulering af hjerterytmen)
English: • medicines to treat diabetes (e.g. pioglitazone, linagliptin)
Danish: • lægemidler til behandling af sukkersyge (f.eks. pioglitazon, linagliptin)
English: Your treatment may affect your ability to drive or use machines.
Danish: Lojuxta kan påvirke evnen til at føre motorkøretøj og betjene maskiner.
English: Table 7:
Danish: Tabel 7:
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Danish: Lægemidlet må kun udleveres efter ordination udstedt af en begrænset lægegruppe (se bilag I: Produktresumé, pkt.
English: • coumarin anticoagulants for thinning the blood ( e.g. warfarin)
Danish: • kumarin-antikoagulantia (blodfortyndende lægemidler, f.eks. warfarin)
English: • medicines to treat low levels of sodium in the blood (e.g. tolvaptan)
Danish: • lægemidler til behandling af lavt natriumindhold i blodet (f.eks. tolvaptan)
English: Concomitant use of moderate or strong CYP3A4 inhibitors with Lojuxta is contraindicated (see section 4.3).
Danish: Moderate eller stærke CYP3A4-hæmmere er kontraindiceret sammen med Lojuxta (se pkt.
English: Use in women of child-bearing potential
Danish: Anvendelse hos fødedygtige kvinder
English: • medicines to treat and prevent blood clots (e.g. dabigatran etexilate)
Danish: • lægemidler til behandling og forebyggelse af blodpropper (f.eks. dabigatranetexilat)
English: • ulcer or sore spot in the throat
Danish: • sår eller ømt punkt i halsen
English: High-density lipoprotein cholesterol (HDL-C) (mg/dL)
Danish: High-density lipoprotein kolesterol (HDL-C) (mg/dl)
English: CYP3A4, lomitapide AUC increased approximately 27-fold and Cmax increased approximately 15-fold.
Danish: 200 mg to gange dagligt (en potent CYP3A4-hæmmer), blev AUC af lomitapid forøget med ca. en faktor 27, og Cmax blev forøget med ca. en faktor 15.
English: When lomitapide 20 mg was co-administered simultaneously with atorvastatin, a weak CYP3A4 inhibitor, lomitapide AUC and Cmax increased approximately 2-fold.
Danish: Anbefaling for koadministration med Lojuxta administreret samtidig med atorvastatin, en svag CYP3A4hæmmer, steg AUC og Cmax af lomitapid til cirka det dobbelte.
English: No adverse effects on the testes were observed in a 1-year study in dogs at 64 times the human exposure at 60 mg.
Danish: I en seks måneders undersøgelse hos hunde iagttoges testikulær toksicitet ved en eksponering, der var 205 gange højere end den humane eksponering (AUC) ved 60 mg. Der blev ikke iagttaget negativ indvirkning på testes i en 1-års undersøgelse hos hunde ved en eksponering, der var 64 gange højere end den humane eksponering ved 60 mg.
English: • medicines to reduce the activity of the immune system (e.g. ciclosporin, tacrolimus)
Danish: • immunundertrykkende lægemidler (f.eks. ciclosporin, tacrolimus)
English: Lomitapide is contraindicated in patients with moderate or severe hepatic impairment including patients with unexplained persistent abnormal liver function tests (see sections 4.3 and 5.2).
Danish: Lomitapid er kontraindiceret ved moderat eller svært nedsat leverfunktion, herunder ved prøver, der viser persisterende abnorm leverfunktion af ukendt årsag (se pkt.
English: Because of the potential for adverse effects based on findings in animal studies with lomitapide (see section 5.3), a decision should be made whether to discontinue breast-feeding or discontinue the medicinal product, taking into account the importance of the medicinal product to the mother.
Danish: 5.3) skal det besluttes, om amning skal ophøre eller behandling med lægemidlet seponeres, idet der tages højde for lægemidlets betydning for moderen.
English: Liver enzyme abnormalities and liver monitoring
Danish: Unormale leverenzymværdier og overvågning af leveren
English: Maximum categorical changes in % hepatic fat (major effectiveness study UP1002/AEGR-733-005) Maximum absolute increase in % hepatic fat
Danish: Maksimale kategoriske ændringer i hepatisk fedtprocent (hovedundersøgelse af virkning UP1002/AEGR-733-005)
English: The dose of lomitapide was escalated from 5 mg to an individually determined maximum tolerated dose up to 60 mg. After Week 26, patients remained on lomitapide to determine the effects of longer-term treatment and were allowed to change background lipid-lowering therapies.
Danish: Efter uge 26 forblev patienterne på lomitapid for at bestemme effekterne af længerevarende behandling, og de fik mulighed for at ændre deres lipidsænkende baggrundsbehandling.
English: Defaecation urgency Eructation
Danish: Defækationstrang Eruktation
English: There was no evidence of embryofoetal toxicity in rabbits at 3 times the maximum recommended human dose (MRHD) of 60 mg based on body surface area.
Danish: Lomitapid var teratogent hos rotter uden maternel toksicitet ved en beregnet eksponering (AUC) på to gange den humane eksponering ved 60 mg. Der var ingen tegn på embryoføtal toksicitet hos kaniner ved tre gange den anbefalede maksimale humane dosis (MRHD) på 60 mg, baseret på legemsoverfladeareal.
English: Because of the possibility of interactions with other medicines, your doctor may change the time of day you take your medicines.
Danish: Da Lojuxta kan påvirke virkningen af andre lægemidler og andre lægemidler kan påvirke Lojuxta, vil lægen eventuelt ændre tidspunktet for indtagelse af din medicin.
English: • medicines to regulate heart rhythm (e.g. amiodarone)
Danish: • lægemidler til regulering af hjerterytmen (f.eks. amiodaron)
English: How to take Lojuxta
Danish: Sådan skal du tage Lojuxta
English: Contraception measures in women of child-bearing potential
Danish: Antikonception hos fertile kvinder
English: • Women of childbearing potential should have adequate birth control and should tell their doctors immediately if they suspect they may be pregnant;
Danish: • Kvinder i den fødedygtige alder skal bruge tilstrækkelig antikonception og straks informere lægen,
English: Since the recommended dose regimen involves starting at the low end of the dosing range and escalating cautiously according to individual patient tolerability, no adjustment to the dosing regimen is recommended for the elderly.
Danish: I det anbefalede dosisregime begyndes med en dosis i den nedre del af dosisområdet, efterfulgt af en gradvis forsigtig optrapning, afhængigt af tolerabiliteten hos den enkelte patient.
English: • The capsule shell for the 20 mg capsule contains gelatin and titanium dioxide (E171).
Danish: • Kapselskallen til 20 mg kapsler indeholder gelatine og, titandioxid (E171).
English: Pharmacotherapeutic group: Lipid modifying agents, other lipid modifying agents, ATC code: C10AX12
Danish: Farmakoterapeutisk klassifikation: Lipid-modificerende midler, andre lipid-modificerende midler.
English: • Patients with moderate or severe hepatic impairment and those with unexplained persistent abnormal liver function tests (see section 4.2).
Danish: • Moderat eller svært nedsat leverfunktion, herunder prøver, der viser persisterende abnorm leverfunktion af ukendt årsag (se pkt.
English: Blood alkaline phosphatase increased Blood potassium decreased Carotene decreased International normalised ratio abnormal
Danish: Internationalt normaliseret ratio forhøjet Alkalisk fosfatase i blodet forhøjet Kalium i blodet nedsat Caroten nedsat
English: • indigestion
Danish: • fordøjelsesbesvær
English: International normalised ratio increased
Danish: Maksimal absolut stigning i hepatisk fedtprocent
English: • vomiting blood
Danish: • blodigt opkast
English: • antacids (e.g. ranitidine, cimetidine)
Danish: • lægemidler mod for megen mavesyre (f.eks. ranitidin, cimetidin)
English: • feeling of incomplete defaecation (bowel movement), urgent need to defaecate
Danish: • følelse af ikke at være kommet af med afføringen, tvingende afføringstrang
English: Enhanced Liver Fibrosis (ELF) panel, Fibrometer, AST/ALT ratio, Fib-4 score, Fibrotest (liver fibrosis).
Danish: (ESR), CK-18 Fragment, NashTest (leverinflammation) Udvidet leverfibrosepanel (ELF), Fibrometer, ASAT/ALAT-forhold, Fib-4-score, Fibrotest (leverfibrose)
English: The occurrence and severity of gastrointestinal adverse reactions associated with the use of Lojuxta decreases in the presence of a low fat diet.
Danish: Fedtfattig diæt mindsker hyppigheden og sværhedsgraden af gastrointestinale bivirkninger under anvendelse af Lojuxta.
English: Gastrooesophageal reflux disease Haemorrhoidal haemorrhage Regurgitation
Danish: Hyppig afføring Gastrisk dilatation Gastriske lidelser Gastroøsofageal reflukssygdom Hæmorroidal blødning Regurgitation
English: • constipation
Danish: • forstoppelse
English: • bleeding from your rectum (back passage) or blood in your stool
Danish: • blødning fra endetarmen eller blod i afføringen
English: • Lojuxta 5 mg is an orange cap/orange body hard capsule with “5 mg” printed on the body and “A733“ printed on the cap in black ink.
Danish: • Lojuxta 5 mg har orange overdel og orange underdel, mærket “5 mg” på underdelen og “A733“ på overdelen med sort trykfarve.
English: Hepatobiliary disorders
Danish: Hepatotoksiske midler
English: If treatment with antifungal azoles (e.g., itraconazole, ketoconazole, fluconazole, voriconazole, posaconazole); the antiarrhythmic dronedarone; macrolide antibiotics (e.g., erythromycin, clarithromycin); ketolide antibiotics (e.g., telithromycin); HIV protease inhibitors; the calcium channel blockers diltiazem and verapamil is unavoidable, therapy with Lojuxta should be suspended during the course of treatment (see sections 4.3 and 4.4).
Danish: Ved tvingende behov for behandling med antimykotiske azoler (f.eks. itraconazol, ketoconazol, fluconazol, voriconazol, posaconazol), det antiarytmiske lægemiddel dronedaron, makrolidantibiotika (f.eks. erythromycin, clarithromycin), ketolidantibiotika (f.eks. telithromycin), hiv-proteasehæmmere eller calciumantagonisterne diltiazem og verapamil bør Lojuxta seponeres under denne behandling (se pkt.
English: Drug interactions
Danish: Lægemiddelinteraktioner
English: The signs and symptoms of liver problems include: o nausea (feeling sick) o vomiting (being sick) o stomach pain o muscle aches and pains o fever o skin or whites of your eyes turn yellow o being more tired than usual o feeling like you have the flu
Danish: • der er ofte blevet indberettet om prøver, der viser unormal leverfunktion (forekommer hos op til 1 ud af 10 behandlede) Tegn og symptomer på leverproblemer er følgende: o kvalme o opkastning o mavesmerter o muskelømhed eller -smerter o feber o gulfarvning af huden eller af det hvide i øjnene o unormal træthed o influenzalignende fornemmelse
English: Titanium dioxide (E171) Red iron oxide (E172) Yellow iron oxide (E172)
Danish: Titandioxid (E171) Jernoxid, rød (E172) Jernoxid, gul (E172)
English: Excipient with known effect Each hard capsule contains 194.84 mg of lactose (as monohydrate) (see section 4.4).
Danish: Hjælpestof, som behandleren skal være opmærksom på Hver hård kapsel indeholder 194,84 mg lactose (som monohydrat) (se pkt.
English: Faeces hard
Danish: Hårde fæces
English: Excipient with known effect Each hard capsule contains 259.79 mg of lactose (as monohydrate) (see section 4.4).
Danish: Hjælpestof, som behandleren skal være opmærksom på Hver hård kapsel indeholder 259,79 mg lactose (som monohydrat) (se pkt.
English: Excipient with known effect Each hard capsule contains 389.68 mg of lactose (as monohydrate) (see section 4.4).
Danish: Hjælpestof, som behandleren skal være opmærksom på Hver hård kapsel indeholder 389,68 mg lactose (som monohydrat) (se pkt.
English: What Lojuxta is and what it is used for What you need to know before you take Lojuxta How to take Lojuxta
Danish: Det skal du vide, før du begynder at tage Lojuxta Sådan skal du tage Lojuxta Bivirkninger
English: Weak CYP3A4 inhibitors are expected to increase the exposure of lomitapide when taken simultaneously.
Danish: Samtidig brug af svage CYP3A4-hæmmere forventes at øge eksponeringen for lomitapid.
English: Lojuxta 30 mg hard capsules Lojuxta 40 mg hard capsules Lojuxta 60 mg hard capsules lomitapide
Danish: Lojuxta, kapsler, hårde, 30 mg Lojuxta, kapsler, hårde, 40 mg Lojuxta, kapsler, hårde, 60 mg lomitapid
English: Excipient with known effect Each hard capsule contains 140.23 mg of lactose (as monohydrate) (see section 4.4).
Danish: Hjælpestof, som behandleren skal være opmærksom på Hver hård kapsel indeholder 140,23 mg lactose (som monohydrat) (se pkt.
English: • medicines to reduce the activity of the immune system (e.g. sirolimus)
Danish: • immunundertrykkende lægemidler (f.eks. sirolimus)
English: Pharyngeal lesion Upper-airway cough syndrome
Danish: Faryngeal læsion Syndrom med hoste fra øvre luftveje
English: • medicines to treat gout (e.g. colchicine)
Danish: • lægemidler til behandling af urinsur gigt (podagra) (f.eks. colchicin)
English: The medicinal product is contraindicated in patients with moderate or severe hepatic impairment and those with unexplained persistent abnormal liver function tests.
Danish: Lojuxta er kontraindiceret ved moderat eller svært nedsat leverfunktion og ved prøver, der viser persisterende abnorm leverfunktion af ukendt årsag.
English: • anti-histamine medicines to treat hayfever (e.g. fexofenadine)
Danish: • antihistaminer, som er lægemidler til behandling af høfeber (f.eks. fexofenadin)
English: Excipient with known effect Each hard capsule contains 70.12 mg of lactose (as monohydrate) (see section 4.4).
Danish: Hjælpestof, som behandleren skal være opmærksom på Hver hård kapsel indeholder 70,12 mg lactose (som monohydrat) (se pkt.
English: For patients on a stable maintenance dose of Lojuxta who receive atorvastatin either: • Separate the dose of the medicinal products by 12 hours
Danish: Til patienter, der får en stabil vedligeholdelsesdosis af Lojuxta, og som er i behandling med atorvastatin, bør:
English: Lojuxta 5 mg, 10 mg hard capsules Gelatin
Danish: Lojuxta, kapsler, hårde, 5 mg, 10 mg
English: Titanium dioxide (E171) Yellow iron oxide (E172)
Danish: Titandioxid (E171) Jernoxid, gul (E172)
English: Lojuxta 5 mg hard capsules Lojuxta 10 mg hard capsules Lojuxta 20 mg hard capsules lomitapide
Danish: Lojuxta, kapsler, hårde, 5 mg Lojuxta, kapsler, hårde, 10 mg Lojuxta, kapsler, hårde, 20 mg lomitapid
English: • Lojuxta 20 mg is a white cap/white body hard capsule with “20 mg” printed on the body and “A733” printed on the cap in black ink.
Danish: • Lojuxta 20 mg har hvid overdel og hvid underdel, mærket “20 mg” på underdelen og “A733“ på overdelen med sort trykfarve.
English: Lojuxta 5 mg: each hard capsule contains lomitapide mesylate equivalent to 5 mg lomitapide.
Danish: Lojuxta 5 mg: Hver hård kapsel indeholder lomitapidmesylat svarende til 5 mg lomitapid.
English: Prothrombin time prolonged Pulmonary function test abnormal White blood cell count increased
Danish: Forlænget protrombintid Lungefunktionsprøve unormal Leukocyttal forhøjet
English: • The capsule shell for the 5 mg and 10 mg capsules contains gelatin, titanium dioxide (E171) and red iron oxide (E172).
Danish: • Kapselskallen til 5 og 10 mg kapsler indeholder gelatine, titandioxid (E171) og jernoxid, rød
English: Lomitapide is a “lipid-modifying agent” which works by blocking the action of “microsomal triglyceride transfer protein.” This protein is located within the liver and the gut cells, where it is involved in assembling fatty substances into larger particles that are then released into the blood stream.
Danish: Dette protein findes i cellerne i leveren og tarmene, hvor det medvirker til at samle fedtstoffer til større partikler, der derefter frigives til blodbanen.
English: Excipient with known effect Each hard capsule contains 129.89 mg of lactose (as monohydrate) (see section 4.4).
Danish: Hjælpestof, som behandleren skal være opmærksom på Hver hård kapsel indeholder 129,89 mg lactose (som monohydrat) (se pkt.
English: Lojuxta 40 mg, 60 mg hard capsules Gelatin
Danish: Lojuxta, kapsler, hårde, 40 mg, 60 mg
English: Contact your doctor immediately if you experience any unexplained muscle aches and pains, tenderness or weakness.
Danish: Kontakt straks lægen, hvis du får muskelømhed,
English: Lojuxta 20 mg hard capsules
Danish: Lojuxta, kapsler, hårde, 20 mg
English: Accumulation of lomitapide in plasma was consistent with that predicted after a single dose following once daily oral dosing above 25 mg for up to 4 weeks.
Danish: Efter en daglig oral dosis på over 25 mg i indtil fire uger var akkumuleringen af lomitapid i plasma i overensstemmelse med det iagttagne efter en enkelt dosis.
English: Each hard capsule contains lomitapide mesylate equivalent to 20 mg lomitapide.
Danish: Hver hård kapsel indeholder lomitapidmesylat svarende til 20 mg lomitapid.
English: Each hard capsule contains lomitapide mesylate equivalent to 5 mg lomitapide.
Danish: Hver hård kapsel indeholder lomitapidmesylat svarende til 5 mg lomitapid.
English: Recommendation concerning co-administration with Lojuxta no clinically meaningful increase in lomitapide exposure was observed.
Danish: Når lomitapid og atorvastatin blev taget med 12 timers mellemrum, blev der ikke set nogen klinisk relevant stigning i eksponeringen for lomitapid.
English: The dose of Lojuxta should be taken 12 hours apart from any other concomitant weak CYP3A4 inhibitors.
Danish: Lojuxta og enhver anden svag CYP3A4-hæmmer bør tages med 12 timers mellemrum.
English: • Lojuxta 60 mg is a yellow cap/yellow body hard capsule with “60 mg” printed on the body and “A733” printed on the cap in black ink.
Danish: • Lojuxta 60 mg har gul overdel og gul underdel, mærket “60 mg” på underdelen og “A733“ på overdelen med sort trykfarve.
English: Lojuxta 5 mg hard capsules
Danish: Lojuxta, kapsler, hårde, 5 mg
English: • blister
Danish: • blærer
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Danish: BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG ANVENDELSE
English: (E172) and yellow iron oxide (E172).
Danish: og jernoxid, gul (E172).
English: • Lojuxta 30 mg is an orange cap/yellow body hard capsule with “30 mg” printed on the body and “A733” printed on the cap in black ink.
Danish: • Lojuxta 30 mg har orange overdel og gul underdel, mærket “30 mg” på underdelen og “A733“ på overdelen med sort trykfarve.
English: Lojuxta 10 mg: each hard capsule contains lomitapide mesylate equivalent to 10 mg lomitapide.
Danish: Lojuxta 10 mg: Hver hård kapsel indeholder lomitapidmesylat svarende til 10 mg lomitapid.
English: Lojuxta 30 mg: each hard capsule contains lomitapide mesylate equivalent to 30 mg lomitapide.
Danish: Lojuxta 30 mg: Hver hård kapsel indeholder lomitapidmesylat svarende til 30 mg lomitapid.
English: Each hard capsule contains lomitapide mesylate equivalent to 30 mg lomitapide.
Danish: Hver hård kapsel indeholder lomitapidmesylat svarende til 30 mg lomitapid.
English: Lojuxta 20 mg: each hard capsule contains lomitapide mesylate equivalent to 20 mg lomitapide.
Danish: L2ojuxta 20 mg: Hver hård kapsel indeholder lomitapidmesylat svarende til 20 mg lomitapid.
English: Aerophagia
Danish: Kapselskal
English: The MAH shall complete, within the stated timeframe, the below measure: Description
Danish: Indehaveren af markedsføringstilladelsen skal inden for den fastsatte tidsramme gennemføre følgende foranstaltning:
English: • Patient Alert Cards
Danish: • Patientadvarselskort
English: • Lojuxta 10 mg is an orange cap/white body hard capsule with “10 mg” printed on the body and “A733“ printed on the cap in black ink.
Danish: • Lojuxta 10 mg har orange overdel og hvid underdel, mærket “10 mg” på underdelen og “A733“ på overdelen med sort trykfarve.
English: • Lojuxta 40 mg is a yellow cap/white body hard capsule with “40 mg” printed on the body and “A733” printed on the cap in black ink.
Danish: • Lojuxta 40 mg har gul overdel og hvid underdel, mærket “40 mg” på underdelen og “A733“ på overdelen med sort trykfarve.
English: Each hard capsule contains lomitapide mesylate equivalent to 60 mg lomitapide.
Danish: Hver hård kapsel indeholder lomitapidmesylat svarende til 60 mg lomitapid.