FrancophonIA/ELRC3.0 huggingface dataset:
English: After intravenous administration, eliglustat total body clearance was 86 L/h.
Danish: Efter intravenøs administration var eliglustats totale kropsclearance 86 l/time.
English: Lower doses of medicinal products that are CYP2D6 substrates may be required.
Danish: Der kan være behov for lavere doser af lægemidler, der er CYP2D6-substrater.
English: No dosing recommendation for URMs can be given.
Danish: Der kan ikke gives nogen dosisanbefaling for URM'er.
English: Avoid consumption of grapefruit or grapefruit juice since it may increase the level of Cerdelga in your blood.
Danish: Undgå indtagelse af grapefrugt eller grapefrugtjuice, da det kan øge indholdet af Cerdelga i blodet.
English: Cerdelga showed sustained improvements in organ volume and haematological parameters over the 8 year treatment period (see Table 3).
Danish: Cerdelga udviste vedvarende forbedringer i organvolumen og hæmatologiske parametre over den 8-årige behandlingsperiode (se tabel 3).
English: Please speak to your doctor regarding these medicines before you start taking Cerdelga.
Danish: Tal med din læge om disse lægemidler, før du begynder at tage Cerdelga.
English: After oral administration, the majority of the administered dose is excreted in urine (41.8%) and faeces (51.4%), mainly as metabolites.
Danish: Efter peroral administration udskilles størstedelen af den administrerede dosis i urinen (41,8 %) og fæces (51,4 %), hovedsagelig som metabolitter.
English: • The active substance is eliglustat (as tartrate).
Danish: • Aktivt stof: eliglustat (som tartrat).
English: Eliglustat was not mutagenic in a standard battery of genotoxicity tests and did not show any carcinogenic potential in standard lifetime bioassays in mice and rats.
Danish: Eliglustat var ikke mutagen i en standard række genotoksicitetstest og udviste ikke noget karcinogent potentiale ved standard levetids-bioassay hos mus og rotter.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Danish: Hvis du har fået at vide af lægen, at du ikke tåler visse sukkerarter, skal du kontakte lægen, før du tager dette lægemiddel.
English: At the time of the highest plasma concentration (59-fold higher than normal therapeutic conditions), the subject experienced dizziness marked by disequilibrium, hypotension, bradycardia, nausea, and vomiting.
Danish: På tidspunktet for den højeste plasmakoncentration (59 gange højere end normale terapeutiske forhold) oplevede forsøgspersonen svimmelhed præget af uligevægt, hypotension, bradykardi, kvalme og opkastning.
English: A lactation study in the rat showed that 0.23% of labelled dose was transferred to pups during 24 hours post-dose, indicating milk excretion of eliglustat and/or its related materials.
Danish: Et studie af diegivende rotter viste, at 0,23 % af den på etiketten anførte dosis blev overført til unger i løbet af 24 timer efter doseringen, hvilket indikerer udskillelse af eliglustat og/eller dens relaterede materialer i mælken.
English: Sixteen patients had an efficacy endpoint assessment at year 8.
Danish: Seksten patienter fik en vurdering af effektendepunkt ved år 8.
English: Breast-feeding is not recommended during treatment with this medicine.
Danish: Det frarådes at amme under behandlingen med dette lægemiddel.
English: Cerdelga has no or negligible influence on the ability to drive and use machines.
Danish: Cerdelga påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: In addition, patient's hepatic or renal status may have an impact on the metabolism of eliglustat.
Danish: Derudover kan patientens lever- eller nyre status have en indvirkning på metabolismen af eliglustat.
English: Tabulated list of adverse reactions Adverse reactions are ranked by system organ class and frequency ([very common (≥1/10); common
Danish: Bivirkninger er klassificeret efter systemorganklasse og hyppighed ([meget almindelig (≥1/10);
English: • atomoxetine - used to treat attention deficit hyperactivity disorder (ADHD) • pravastatin - used to lower cholesterol and prevent heart disease
Danish: • atomoxetin - bruges til at behandle attention deficit hyperactivity disorder (ADHD) • pravastatin - bruges til at sænke kolesteroltallet og forebygge hjertesygdom
English: o Do not consume grapefruit products.
Danish: • Indtag ikke grapefrugt-produkter.
English: Cerdelga contains lactose
Danish: Cerdelga indeholder laktose
English: At 2 and 24 hours post-dose, 0.034 % and 0.013 % of labelled dose was detected in foetal tissue, respectively.
Danish: To og 24 timer efter doseringen påvistes henholdvis 0,034 % og 0,013 % af den på etiketten anførte dosis i føtalt væv.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER / WALLET
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP BLISTER/KORT
English: o Patients should be informed that consumption of grapefruit or its juice should be avoided.
Danish: • Patienterne bør oplyses om, at indtagelse af grapefrugt eller saft derfra bør undgås.
English: 14 hard capsules 56 hard capsules 196 hard capsules
Danish: 14 hårde kapsler 56 hårde kapsler 196 hårde kapsler
English: MN = Multiples of Normal, CI = confidence interval * Excludes patients with a total splenectomy.
Danish: MN = Multipla af Normal, CI = konfidensinterval * Patienter med en total splenektomi er ekskluderet.
English: • are an end stage renal disease (ESRD) patient.
Danish: • er en patient med nyresygdom i slutstadiet (ESRD).
English: Based on the aggregate data from all doses tested in this study, Cerdelga met the criteria set in this study to be declared non-inferior to Cerezyme (imiglucerase) in maintaining patient stability.
Danish: På baggrund af de samlede data fra alle doser, der blev testet i dette studie, var Cerdelga non-inferior i forhold til Cerezyme (imiglucerase) med hensyn til at opretholde patienterne stabile.
English: Grapefruit products contain one or more components that inhibit CYP3A and can increase plasma concentrations of eliglustat.
Danish: Grapefrugtprodukter indeholder en eller flere komponenter, der hæmmer CYP3A og kan øge plasmakoncentrationer af eliglustat.
English: • cinacalcet - calcimimetic (used in some dialysis patients and specific cancers)
Danish: • cinacalcet - calcimimetikum (bruges hos nogle dialysepatienter og til bestemte kræftformer)
English: o Using eliglustat together with such products or in patients with hepatic or renal impairment may either make eliglustat less effective, or it may increase the eliglustat levels in the patient's blood.
Danish: • Brug af eliglustat sammen med sådanne produkter eller hos patienter med nedsat lever- eller nyrefunktion kan enten gøre eliglustat mindre effektiv, eller det kan øge eliglustat-niveauerne i patientens blod.
English: Some treatment-naïve patients showed less than 20% spleen volume reduction (sub-optimal results) after 9 months of treatment (see section 5.1).
Danish: Behandlingsnaive patienter udviste en reduktion i miltvolumen på mindre end 20 % (sub-optimale resultater) efter 9 måneders behandling (se pkt.
English: Median time to reach maximum plasma concentrations occurs between 1.5 to 6 hours after dosing, with low oral bioavailability (<5%) due to significant first-pass metabolism.
Danish: Absorption Mediantiden til at nå maksimale plasmakoncentrationer forekommer mellem 1,5 og 6 timer efter doseringen, idet lav peroral biotilgængelighed (< 5 %) skyldes signifikant first-pass-metabolisme.
English: - If you are allergic to eliglustat or any of the other ingredients of this medicine (listed in section 6).
Danish: - hvis du er allergisk over for eliglustat eller et af de øvrige indholdsstoffer i Cerdelga (angivet i punkt 6).
English: Capsule contents Microcrystalline cellulose Lactose monohydrate Hypromellose Glycerol dibehenate
Danish: Kapselindhold Mikrokrystallinsk cellulose Laktosemonohydrat Hypromellose Glycerol dibehenat
English: You may experience dizziness marked by loss of balance, slow heart rate, nausea, vomiting and lightheadedness.
Danish: Du kan opleve svimmelhed med tab af balance, langsom puls, kvalme, opkastning og uklarhed.
English: Study 304 was a single-arm, open-label, multicenter study of Cerdelga in 26 patients.
Danish: Studie 304 var et enkeltgruppe, open-label, multicenterstudie af Cerdelga hos 26 patienter.
English: Eliglustat is a substrate of the efflux transporter P-gp.
Danish: Eliglustat er et substrat af efflukstransporteren P-gp.
English: Talk to your doctor or pharmacist before taking Cerdelga, if you:
Danish: Kontakt lægen eller apotekspersonalet, før du tager Cerdelga, hvis du:
English: Cerdelga may increase the level of the following types of medicines in the blood:
Danish: Cerdelga kan øge mængden af følgende typer medicin i blodet:
English: If you are pregnant, think that you may be pregnant or are planning to have a baby, tell your doctor who will discuss with you whether you can take this medicine during your pregnancy.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid eller planlægger at blive gravid, skal du spørge din læge eller apotekspersonalet til råds, før du tager dette lægemiddel under graviditeten.
English: There is limited experience in the treatment of elderly with eliglustat.
Danish: Der er begrænset erfaringer med brugen af eliglustat i behandling af ældre.
English: Haemoglobin Level (g/dL) 16 11.33 Liver Volume (MN)
Danish: Hæmoglobinniveau (g/dl) 16 11,33 Levervolumen (MN) Trombocyttal (x109/l)
English: • have an irregular, or abnormal heart beat, inluding a heart condition called long QT syndrome.
Danish: • har en uregelmæssig eller unormal hjerterytme, inklusive en hjertesygdom betegnet langt QT
English: Individual disease parameters of spleen volume, liver volume, haemoglobin levels and platelet count remained stable through 4 years (see Table 5).
Danish: Individuelle sygdomsparametre for miltvolumen, levervolumen, hæmoglobinniveau og trombocyttal forblev stabile i 4 år (se tabel 5).
English: Nonclinical studies demonstrated a wide distribution of eliglustat to tissues, including bone marrow.
Danish: Ikke-kliniske studier har vist en udtalt fordeling af eliglustat til vævene, herunder knoglemarven.
English: The safety and efficacy of Cerdelga in children and adolescents under the age of 18 years has not been established.
Danish: Cerdelgas sikkerhed og virkning hos børn og unge under 18 år er endnu ikke klarlagt.
English: Pack sizes of 14 hard capsules in 1 blister wallet, 56 hard capsules in 4 blister wallets of 14 capsules each or 196 hard capsules in 14 blister wallets of 14 capsules each
Danish: Pakningsstørrelser med 14 hårde kapsler i 1 blisterkort, 56 hårde kapsler i 4 blisterkort med 14 kapsler i hver eller 196 hårde kapsler i 14 blisterkort med 14 kapsler i hver.
English: Lower doses of substances which are P-gp substrates (e.g. digoxin, colchicine, dabigatran, phenytoin, pravastatin) may be required.
Danish: Lavere doser af stoffer, der er P-gp-substrater (f.eks. digoxin, colchicin, dabigatran, phenytoin, pravastatin) kan være påkrævet.
English: Table 1: Tabulated list of adverse reactions
Danish: Tabel 1: Tabuleret liste over bivirkninger
English: The highest eliglustat plasma concentration observed to date occurred in a Phase 1 single-dose dose escalation study in healthy subjects, in a subject taking a dose equivalent to approximately 21 times the recommended dose for GD1 patients.
Danish: Den højeste eliglustat-plasmakoncentration, der hidtil er observeret, fandt sted i et enkeltdosis dosisoptrappende fase 1-studie med raske forsøgspersoner hos en forsøgsperson, som tog en dosis svarende til ca. 21 gange den anbefalede dosis for GD1-patienter.
English: In this trial with demonstrated ability to detect small effects, the upper bound of the onesided 95% confidence interval for the largest placebo-adjusted, baseline-corrected QTcF was below 10 msec, the threshold for regulatory concern.
Danish: I dette forsøg med påvist evne til at detektere små virkninger lå den øvre grænse for det ensidige 95 % konfidensinterval for den største placebojusterede, baseline-korrigerede QTcF på under 10 msek, hvilket er den tærskel, som er relevant i regulatorisk sammenhæng.
English: In mature male rats, no effects on sperm parameters were observed at systemically non-toxic doses.
Danish: Hos modne hanrotter blev der ikke observeret nogen indvirkning på sædcelleparametre ved systemiske ikke-toksiske doser.
English: Composite Stability Endpoint Patients who are Stable on Cerdelga (%)
Danish: Sammesatte stabilitetsendepunkt Patienter som er stabile på Cerdelga (%)
English: There is limited experience with Cerdelga treatment of patients who are PMs or URMs.
Danish: Der er begrænset erfaring med behandling med Cerdelga hos patienter, som er PM'er eller URM'er.
English: Do not open, crush, dissolve, or chew the capsule before swallowing it.
Danish: Kapslen må ikke åbnes, knuses, opløses eller tygges, før den sluges.
English: Please tell your doctor or pharmacist if you are using, or have recently used, or might use, any other medicines.
Danish: Fortæl altid lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: The overall adverse reaction profile of Cerdelga is based on 1400 patient-years of treatment exposure and pooled results from the primary analysis periods and extension periods of two pivotal Phase 3 studies (ENGAGE and ENCORE), one 8-year, long term Phase 2 study (Study 304) and one supporting Phase 3b study (EDGE).
Danish: Den samlede bivirkningsprofil for Cerdelga er baseret på 1400 patienter med eksponering af behandling og samlede resultater fra de primære analyseperioder og forlængelsesperioder i to pivotale fase 3 studier (ENGAGE og ENCORE), et 8-årigt, langsigtet fase 2 studie (Studie 304) og et understøttende fase 3b studie (EDGE).
English: • dextromethorphan - cough medicine
Danish: • dextromethorphan - hostemedicin
English: Fourteen (78%) continued on 84 mg Cerdelga twice daily.
Danish: Fjorten (78%) fortsatte med at modtage 84 mg Cerdelga to gange dagligt.
English: Cerdelga contains the active substance eliglustat which decreases the production of glucosylceramide, thereby preventing its buildup.
Danish: Cerdelga indeholder det aktive stof eliglustat der nedsætter produktionen af glucosylceramid, hvilket forhindrer ophobning.
English: Cerdelga is to be taken orally.
Danish: Cerdelga skal tages peroralt.
English: Effect of severe renal impairment was evaluated in a single dose phase 1 study.
Danish: Virkning af alvorlig nedsat nyrefunktion blev evalueret i et enkeltdosis fase 1-studie.
English: In study 02607, lumbar spine and femur BMD T- and Z-scores were maintained within the normal range in patients treated with Cerdelga for up to 4 years.
Danish: I studie 02607 blev lændehvirvelsøjle og lårben BMD-T og Z-scorer vedligeholdt indenfor det normale interval hos patienter i behandling med Cerdelga i op til 4 år.
English: • The other ingredients are: o In the capsule: microcrystalline cellulose, lactose monohydrate (see section 2 under ‘Cerdelga contains lactose'), hypromellose and glycerol dibehenate.
Danish: • Øvrige indholdsstoffer: o I kapslen: mikrokrystallinsk cellulose, laktosemonohydrat (se punkt 2 under ”Cerdelga indeholder laktose”), hypromellose og glyceroldibehenat.
English: • amlopidine, ranolazine - used to treat angina pectoris
Danish: • amlodipin, ranolazin - bruges til at behandle angina pectoris
English: • metoprolol - used to lower blood pressure and/or reduce heart rate
Danish: • metoprolol - bruges til at sænke blodtrykket og/eller mindske hjertefrekvensen
English: If you are an intermediate metaboliser or extensive metaboliser:
Danish: Hvis du er en intermediær metabolisator eller ekstensiv metabolisator:
English: Headache*, dizziness*, dysgeusia
Danish: Hovedpine*, svimmelhed*, dysgeusi
English: As a precautionary measure, it is recommended to avoid the use of Cerdelga during pregnancy.
Danish: For en sikkerheds skyld bør Cerdelga undgås under graviditeten.
English: Additionally, in a clinical trial in GD1 patients stabilised on enzyme replacement therapy (ERT) (i.e. having already achieved therapeutic goals on ERT prior to initiating Cerdelga treatment), plasma GL-1 levels were normal in most patients and decreased upon Cerdelga treatment.
Danish: Derudover, i et klinisk forsøg med GD1-patienter, der blev stabiliseret på enzymsubstitutionsterapi (ERT) (dvs. som allerede havde opnået terapeutiske mål på ERT forud for påbegyndelse af Cerdelga-behandling), var plasma-GL1-niveauerne normale hos de fleste patienter og faldt efter Cerdelga-behandling.
English: Primary metabolic pathways of eliglustat involve sequential oxidation of the octanoyl moiety followed by oxidation of the 2,3-dihydro-1,4-benzodioxane moiety, or a combination of the two pathways, resulting in multiple oxidative metabolites.
Danish: Primære metaboliske veje for eliglustat involverer sekventiel oxidering af octanoyldelen efterfulgt af oxidering af 2,3-dihydro-1,4-benzodioxan-delen eller en kombination af de to veje, hvilket resulterer i flere oxidative metabolitter.
English: Three (17%) patients continued to receive 42 mg twice daily.
Danish: Tre (17%) patienter fortsatte med at modtage 42 mg to gange dagligt.
English: o This patient is using eliglustat (Cerdelga) for the treatment of Gaucher Disease type 1.
Danish: • Denne patient bruger eliglustat (Cerdelga) til behandling af Gauchers sygdom type 1.
English: Standard Deviation
Danish: Standardafvigelse
English: Reversible inhibition of spermatogenesis was observed in the rat at 10-fold of predicted human exposure based on AUC, a systemically toxic dose.
Danish: Reversibel hæmning af spermatogenesen blev observeret hos rotter ved en 10-dobling af den forudsete humane eksponering baseret på AUC, en systemisk toksisk dosis.
English: The MAH shall ensure that in each Member State where Cerdelga is marketed, all patients who are prescribed Cerdelga are provided with a patient alert card.
Danish: MAH skal sikre, at i alle medlemsstater, hvor Cerdelga markedsføres, forsynes alle patienter, der ordineres Cerdelga, med et patientadvarselskort.
English: o Eliglustat should not be used concomitantly with medicines that may have an impact on liver enzymes that play a role in the metabolism of eliglustat.
Danish: • Eliglustat bør ikke bruges samtidig med lægemidler, der kan have en indvirkning på leverenzymer, der spiller en rolle for metabolismen af eliglustat.
English: The MAH shall ensure that in each Member State where Cerdelga is marketed, all healthcare professionals who are expected to prescribe Cerdelga are provided with a prescriber guide.
Danish: MAH skal sikre, at i alle medlemsstater, hvor Cerdelga markedsføres, forsynes alle sundhedsprofessionelle, der forventes at ordinere Cerdelga, med en ordinationsvejledning.
English: At maternal toxic doses in rats, foetuses showed a higher incidence of dilated cerebral ventricles, abnormal number of ribs or lumbar vertebrae, and many bones showed poor ossification.
Danish: Ved maternelle toksiske doser hos rotter udviste fostre en højere forekomst af dilaterede cerebrale ventrikler, et unormalt antal ribben eller lændehvirvler, og mange knogler udviste dårlig ossifikation.
English: Dry skin, urticaria*
Danish: Tør hud, urticaria*
English: The principal target organs for eliglustat in toxicology studies are the GI tract, lymphoid organs, the liver in rat only and, in the male rat only, the reproductive system.
Danish: De vigtigste målorganer for eliglustat i de toksikologiske studier er mave-tarm-kanalen, lymfoide organer, leveren kun hos rotter, det reproduktive system kun hos hanrotter.
English: In clinical trials in treatment-naïve GD1 patients, plasma GL-1 levels were elevated in the majority of these patients and decreased upon Cerdelga treatment.
Danish: I kliniske forsøg hos behandlingsnaive GD1-patienter var plasma GL-1-niveauer forhøjet hos de fleste af disse patienter og faldt efter Cerdelga-behandling.
English: • mirabegron - used to treat overactive bladders
Danish: • mirabegron - bruges til at behandle overaktive blærer
English: Eliglustat is a potent and specific inhibitor of glucosylceramide synthase, and acts as a substrate reduction therapy (SRT) for GD1.
Danish: Eliglustat er en kraftig og specifik hæmmer af glucosylceramidsyntase og virker som substratreduktionsterapi (SRT) for GD1.
English: Spleen Volume (MN)
Danish: Miltvolumen (MN)
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Cerdelga therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Danish: Det skal besluttes, om amning eller behandling med Cerdelga skal ophøre, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: Therapy with Cerdelga should be initiated and supervised by a physician knowledgeable in the management of Gaucher disease.
Danish: Behandling med Cerdelga skal påbegyndes og tilses af en læge, som har kendskab til behandling af Gauchers sygdom.
English: The list of substances in section 4.5 is not an inclusive list and the prescriber is advised to consult the SmPC of all other prescribed medicinal products for potential drug-drug interactions with eliglustat.
Danish: 4.5 er ikke en udførlig liste, og receptudstederen bør kigge i produktresuméet for alle andre ordinerede lægemidler for mulige lægemiddelinteraktioner med eliglustat.
English: These medicines can interfere with your body's ability to break down Cerdelga and this can result in higher levels of Cerdelga in your blood.
Danish: Disse lægemidler kan forstyrre din krops evne til at nedbryde Cerdelga, og dette kan resultere i højere niveauer af Cerdelga i blodet.
English: Tell your doctor if you are breast-feeding.
Danish: Fortæl din læge, hvis du ammer.
English: Cerdelga contains the active substance eliglustat and is used for the long term treatment of adult patients with Gaucher disease type 1.
Danish: Cerdelga indeholder det aktive stof eliglustat og anvendes til langtidsbehandling af voksne patienter med Gauchers sygdom type 1.
English: The one URM who received 84 mg twice daily did not have an adequate response.
Danish: Den ene URM, som fik 84 mg to gange dagligt, havde ikke en tilstrækkelig klinisk respons.
English: If a dose is missed, the prescribed dose should be taken at the next scheduled time; the next dose should not be doubled.
Danish: Hvis en dosis er sprunget over, skal den ordinerede dosis tages på det næste planlagte tidspunkt.
English: Mean haemoglobin levels were 12.8 and 12.1 g/dL, and platelet counts were 78.5 and 75.1 x 109/L, respectively.
Danish: De gennemsnitlige hæmoglobin niveauer var 12,8 and 12,1 g/dl, og trombocytniveauerne var henholdsvis 78,5 og 75,1 x 109/l.
English: Effects on testes and reversible inhibition of spermatogenesis were observed in rats (see section 5.3).
Danish: Effekt på testikler og reversibel hæmning af spermatogenesen blev observeret hos rotter (se pkt.
English: • imatinib - anticancer (used to treat cancer)
Danish: • imatinib - anticancer (bruges til at behandle cancer)
English: Difference (CerdelgaPlacebo) [95% CI]
Danish: Forskel (Cerdelga - placebo) [95 % CI]
English: Consumption of grapefruit or its juice should be avoided.
Danish: Indtagelse af grapefrugt eller grapefrugtjuice skal undgås.
English: Swallow one 84 mg capsule whole once a day with water.
Danish: Slug én 84 mg kapsel hel en gang om dagen med vand.
English: SRT aims to reduce the rate of synthesis of the major substrate glucosylceramide (GL-1) to match its impaired rate of catabolism in patients with GD1, thereby preventing glucosylceramide accumulation and alleviating clinical manifestations.
Danish: SRT har til formål at reducere synteseraten af substratet glucosylceramid (GL-1) for at matche den nedsatte katabolismerate hos patienter med GD1 og derved forhindre akkumulering af glukosylceramid og mindskning af kliniske manifestationer.
English: Effects of mild and moderate hepatic impairment were evaluated in a single dose phase 1 study.
Danish: Virkninger af let og moderat nedsat leverfunktion blev evalueret i et enkeltdosis fase 1-studie.