FrancophonIA/ELRC3.0 huggingface dataset:
English: In most of the publications the maintenance dose varied between 600 mg/day and 800 mg/day; - When the effective dose of ketoconazole is established, monitoring of urinary free cortisol and/or plasma cortisol levels may be performed every 3 to 6 months (see section 4.4); - In the case of adrenal insufficiency and depending on the severity of the event, the dose of ketoconazole should be decreased by at least 200 mg/day or the treatment should be temporarily discontinued and/or a corticosteroid therapy should be added until the resolution of the event.
Danish: - I tilfælde af binyrebarkinsufficiens og afhængigt af sværhedsgraden skal man enten nedsætte ketoconazol-dosis med mindst 200 mg/dag, midlertidigt seponere behandlingen og/eller tilføje et kortikosteroid, indtil tilstanden er ophørt.
English: ↑in plasma concentrations of ebastine have been observed
Danish: ↑ i plasmakoncentrationen af ebastin er observeret.
English: Dose adjustment of aprepitant may be required
Danish: Justering af aprepitantdosis kan være nødvendig.
English: AUC: ↑ 10-fold Cmax: ↑ 4-fold
Danish: AUC: ↑ 10 gange Cmax: ↑ 4 gange
English: AUC: ↑ 15.3-fold Cmax: ↑ 4.1-fold
Danish: AUC: ↑ 15,3 gange Cmax: ↑ 4,1 gange
English: Decreased gastric acidity
Danish: Nedsat ventrikelaciditet
English: AUC: ↑ 15-fold Cmax: ↑ 1.4-fold
Danish: AUC: ↑ 15 gange Cmax: ↑ 1,4 gange
English: AUC: ↑2.2-fold Cmax: ↑1.7-fold
Danish: AUC: ↑2,2 gange Cmax: ↑1,7 gange
English: In case of co-administration of an medicinal product known to increase QTc interval (see section 4.5), ECG monitoring is recommended.
Danish: EKG-monitorering tilrådes, når der samtidig gives et lægemiddel, der er kendt for at forlænge QTcintervallet (se pkt.
English: AUC: ↑ 1.4-fold
Danish: AUC: ↑ 1,4 gange
English: How to take Ketoconazole HRA
Danish: Sådan skal du tage Ketoconazole HRA
English: AUC: ↑ 2.5-fold Cmax: ↑ 1.6-fold
Danish: AUC: ↑ 2,5 gange Cmax: ↑ 1,6 gange
English: Liver function tests abnormal
Danish: Abnorme leverfunktionsprøver
English: AUC: ↑ 1.7-fold Cmax: ↑ 1.3-fold
Danish: AUC: ↑ 1,7 gange Cmax: ↑ 1,3 gange
English: Cmax: ↑1.5-fold
Danish: Cmax: ↑ 1,5 gange
English: Cmax: ↑ 2-fold
Danish: Cmax: ↑ 1,1 gang
English: Data on 24 paediatric patients with endogenous Cushing's syndrome treated with ketoconazole are available in the literature, among which 16 were aged over 12 years old and 8 were aged less than 12 years old.
Danish: Data fra 24 pædiatriske patienter med endogent Cushings syndrom, som blev behandlet med ketoconazol, er tilgængelige i litteraturen.
English: AUC: ↑ 1.4-fold Cmax: ↑ 1.3-fold
Danish: AUC: ↑ 1,4 gange Cmax: ↑ 1,3 gange
English: Potential ↑in plasma concentrations of vinca alkaloids.
Danish: Potentiel ↑ i plasmakoncentrationen af vinkaalkaloid.
English: AUC: ↑ 1.6-fold Cmax: ↑ 1.4-fold
Danish: AUC: ↑ 1,6 gange Cmax: ↑ 1,4 gange
English: Dexamethasone, fluticasone, methylprednisolone
Danish: Dexamethason Fluticason Methylprednisolon
English: AUC: ↑ 1.5-fold Cmax: ↑1.7-fold
Danish: AUC: ↑ 1,5 gange Cmax: ↑ 1,7 gange
English: Exceptional cases of a disulfiram-like reaction have been reported when ketoconazole was co-administered with alcohol, characterised by flushing, rash, peripheral oedema, nausea and headache, have been reported.
Danish: Der er rapporteret om enkeltstående tilfælde af en disulfiram-lignende reaktion, når ketoconazol blev administreret sammen med alkohol.
English: AUC: ↑ 2.7-fold Cmax:↑ 1.5-fold
Danish: AUC: ↑ 2,7 gange Cmax: ↑ 1,5 gange
English: • Skin redness, drying, itching
Danish: • Rødme, udtørring, kløe i huden
English: • Malaise
Danish: • Træthed
English: AUC: ↑ 2-fold Cmax: ↑1.6-fold
Danish: AUC: ↑ 2 gange Cmax: ↑ 1,6 gange
English: AUC: ↑3.4-fold Cmax: ↑1.6-fold
Danish: AUC: ↑ 3,4 gange Cmax: ↑ 1,6 gange
English: AUC: ↑ 2.1-fold
Danish: AUC: ↑ 2,1 gange
English: AUC: ↑ 5-fold Cmax: ↑ 3.4-fold
Danish: AUC: ↑ 5 gange Cmax: ↑ 3,4 gange
English: In the case of an increase in liver enzymes equal to or greater than 3 times the upper limit of normal, ketoconazole should be stopped immediately and should not be reintroduced due to the risk of serious hepatic toxicity.
Danish: Hvis der påvises forhøjede leverenzymer, der er mindre end 3 gange den øvre normalgrænse, bør leverfunktionen monitoreres tættere, og den daglige dosis bør nedsættes med mindst 200 mg. Ved stigning i leverenzymer til mere end 3 gange den øvre normalgrænse, skal ketoconazol straks seponeres, og behandling må ikke genoptages på grund af risiko for svær hepatotoksicitet.
English: AUC: ↑ 3.6-fold
Danish: AUC: ↑ 3,6 gange
English: Very common side effects (may affect more than 1 in 10 people): • An elevated levels of liver enzymes in your blood
Danish: Meget sjældne bivirkninger (kan forekomme hos op til 1 ud af 10.000 personer): • Feber
English: Ebastine
Danish: Ebastin
English: AUC: ↑ 1.2-fold Cmax: ↑ 1.2-fold
Danish: AUC: ↑ 1,2 gange Cmax: ↑ 1,2 gange
English: AUC: ↑ 1.5-fold Cmax: ↑ 1.5-fold
Danish: AUC: ↑ 1,5 gange Cmax: ↑ 1,5 gange
English: Anticoagulants and antiplatelet drugs Dabigatran
Danish: Antikoagulantia og trombocytfunktionshæmmere
English: • Insomnia
Danish: • Søvnløshed
English: AUC: ↑ 3.0-fold
Danish: AUC: ↑ 3,0 gange
English: AUC: ↑ 4-fold Cmax: ↑ 1.2-fold
Danish: AUC: ↑ 4 gange Cmax: ↑ 1,2 gange
English: isavuconazole - certain antidiabetics: repaglinide, saxagliptin, tolbutamide - certain medicines used for mental disorders: buspirone, aripipazole, haloperidol, reboxetine, risperidone - certain heart medicines - verapamil, digoxin, nadolol, aliskiren - certain anticonvulsivants: carbamazepine, phenitoin - certain glucocorticoids - such as budesonide, fluticasone, dexamethasone, methylprednisolone, ciclesonide - certain stong painkillers (narcotics) - such as alfentanyl, fentanyl, buprenorphine (injection and sublingual),
Danish: clarithromycin, isavuconazol - visse antidiabetika (midler mod sukkersyge): repaglinid, saxagliptin, tolbutamid - visse lægemidler, der anvendes til psykiske lidelser: buspiron, aripiprazol, haloperidol, reboxetin,
English: If you take more Ketoconazole HRA than you should
Danish: Hvis du har taget for meget Ketoconazole HRA
English: • Hot flush
Danish: • Ledsmerter
English: Potential ↑in plasma concentrations of ergot alkaloids
Danish: Potentiel ↑ i plasmakoncentrationen af sekalealkaloider.
English: Cmax: ↑ 6 fold
Danish: AUC: ↑ 9 gange Cmax: ↑ 6 gange
English: • Distortion of the sense of taste
Danish: • Smagsforstyrrelser
English: • Fatigue
Danish: • Mavesmerter
English: Dronedarone
Danish: Dabigatran
English: AUC: ↑ 1.8-fold Cmax: ↑ 1.8-fold
Danish: Cmax: ↑ 1,8 gange
English: Press down at 1 and at the same time pull at 2.
Danish: Tryk ned ved 1 samtidig med at du trækker ved 2.
English: MN = Multiples of Normal
Danish: MN = Multipler af normal
English: Take the next capsule at the usual time.
Danish: Tag den næste kapsel på det sædvanlige tidspunkt.
English: Date of first authorisation: 19 January 2015 Date of latest renewal:
Danish: Dato for første markedsføringstilladelse: 19. januar 2015 Dato for seneste fornyelse:
English: Take one capsule in the morning and one capsule at night.
Danish: Tag en kapsel om morgenen og en kapsel om aftenen.
English: Characteristics in specific groups
Danish: Karakteristika i specifikke grupper
English: The build-up prevents these organs from working properly.
Danish: Denne ophobning forhindrer disse organer i at fungere korrekt.
English: In turn this helps your affected organs to work better.
Danish: Som følge her af hjælper det dine berørte organer med at fungere bedre.
English: All patient number (N)= Per Protocol Population
Danish: Alle patienter (N) = Per Protokol Population
English: amiodarone or sotalol.
Danish: amiodaron eller sotalol.
English: Information for the patient:
Danish: Information til patienten:
English: Reports from the subregistry are to be submitted with each PSUR.
Danish: Rapporter fra underregistret skal fremlægges med hver (PSUR).
English: It may be taken with or without food.
Danish: Den kan tages med eller uden et måltid.
English: Take one capsule at the same time every day.
Danish: Tag en kapsel på samme tid hver dag.
English: Taking Cerdelga with food and drink
Danish: Brug af Cerdelga sammen med mad og drikke
English: Information for healthcare professionals:
Danish: Oplysninger til sundhedsprofessionelle:
English: No significant differences were found in the efficacy and safety profiles of elderly patients and younger patients.
Danish: Der blev ikke fundet signifikante forskelle i lægmidlets virkning og sikkerhed hos ældre patienter og yngre patienter.
English: • Pain in arms, legs or back
Danish: • Smerter i arme, ben eller ryg
English: Your doctor will determine which medicines you can use based on how fast your body breaks down eliglustat.
Danish: Din læge vil afgøre, hvilken medicin du kan bruge, baseret på hvor hurtigt din krop nedbryder eliglustat.
English: Monitoring of clinical response
Danish: Monitorering af klinisk respons
English: In the event of acute overdose, the patient should be carefully observed and given symptomatic treatment and supportive care.
Danish: I tilfælde af akut overdosering skal patienten overvåges nøje og gives symptomatisk behandling og understøttende pleje.
English: • have any other heart problems.
Danish: • har andre hjerteproblemer.
English: For these patients, monitoring for further improvement or an alternative treatment modality should be considered.
Danish: For disse patienter bør man overveje monitorering for yderligere forbedring eller en alternativ behandlingsmodalitet.
English: The majority of extension phase discontinuations were due to transition to commercial product from year 3 onwards.
Danish: Størstedelen af seponeringerne i forlængelsesfasen skyldtes overgangen til kommercielt præparat fra år 3 og fremefter.
English: As a result the amount of this medicine in the blood can differ between patients which could affect how a patient would respond.
Danish: Mængden af medicin i blodet kan derfor variere patienterne imellem, hvilket kan påvirke, hvordan en patient vil reagere.
English: No data are available.
Danish: Der foreligger der ingen data.
English: The capsules should be swallowed whole, preferably with water, and should not be crushed, dissolved, or opened.
Danish: Kapslerne skal sluges hele, helst med vand, og må ikke knuses, opløses eller åbnes.
English: Do not stop taking Cerdelga without talking to your doctor.
Danish: Hold ikke op med at tage Cerdelga uden at tale med din læge.
English: A limited number of patients aged 65 years (n=10) and over were enrolled in clinical trials.
Danish: Et begrænset antal patienter på 65 år (n = 10) og over var inkluderet i kliniske forsøg.
English: Patients who are URMs may not achieve adequate concentrations to achieve a therapeutic effect.
Danish: Patienter, som er URM'er, vil muligvis ikke opnå tilstrækkelige koncentrationer til at opnå en terapeutisk virkning.
English: Not all packs may be marketed in your country.
Danish: Det er ikke sikkert, at alle pakninger markedsføres i dit land.
English: Continue taking Cerdelga every day for as long as your doctor tells you.
Danish: Fortsæt med at tage Cerdelga hver dag, så længe lægen beder dig om det.
English: Gaucher disease type 1 is a lifelong condition and you must continue to take this medicine as prescribed by your doctor to gain the maximum benefit from your medicine.
Danish: Gauchers sygdom type 1 er en livslang sygdom, og du skal fortsætte med at tage dette lægemiddel som ordineret af din læge for at få det maksimale udbytte af din medicin.
English: Eliglustat is moderately bound to human plasma proteins (76 to 83%) and is mainly distributed in plasma.
Danish: Eliglustat er moderat bundet til humane plasmaproteiner (76 til 83 %) og fordeles hovedsageligt i plasma.
English: Gender, body weight, age, and race
Danish: Køn, kropsvægt, alder og race
English: Cerdelga has not been tested in children and adolescents under 18 years of age.
Danish: Cerdelga er ikke blevet testet hos børn og unge under 18 år.
English: Cerdelga must not be used with certain type of medicines.
Danish: Cerdelga må ikke tages sammen med visse typer medicin.
English: Medicines that must not be taken in combination with each other and Cerdelga
Danish: Lægemidler, der ikke må tages i kombination med hinanden og Cerdelga
English: Five Cerdelga-treated patients (26%) achieved a reduction of at least 2 points in the BMB score.
Danish: Fem Cerdelgabehandlede patienter (26%) opnåede en reduktion på mindst 2 point i BMB-scoren.
English: • have had a heart attack or heart failure.
Danish: • har haft et hjerteanfald eller hjertesvigt.
English: The size of the capsule is ‘size 2' (dimensions 18.0 x 6.4 mm).
Danish: Kapslens størrelse er ”størrelse 2” (dimensioner 18,0 x 6,4 mm).
English: Prior to launch of Cerdelga in each Member State the Marketing Authorisation Holder (MAH) must agree the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Danish: Før start af Cerdelga i hver medlemsstat skal indehaveren af markedsføringstilladelsen (MAH) aftale indholdet af og formatet for uddannelsesprogrammet, herunder kommunikationsmedier, distributionsmetoder og andre aspekter ved programmet med den nationale kompetente myndighed.
English: This may cause mild increases in the PR, QRS, and QTc intervals.
Danish: Dette kan forårsage mindre stigninger i PR, QRS- og QTc-intervallerne.
English: While pressing your thumb and finger together at one end of the sleeve (1) gently pull the blister/wallet out to open the sleeve (2).
Danish: Mens du trykker tommelfingeren og en finger sammen i den ene ende af hylsteret (1), trækker du forsigtigt blisterpakken/kortet ud for at åbne hylsteret (2).
English: * The incidence of the adverse reaction was the same or higher with placebo than with Cerdelga in the placebo-controlled pivotal study.
Danish: * Forekomsten af bivirkningen var den samme eller højere med placebo end med Cerdelga i det placebokontrollerede nøglestudie.
English: b Estimates and p-values are based on an ANCOVA model * All patients transitioned to Cerdelga treatment after Month 9.
Danish: b Estimater og p-værdier er baseret på en ANCOVA-model * Alle patienter overgik til Cerdelga-behandling efter måned 9.
English: Eliglustat did not have effects on CNS or respiratory functions.
Danish: Eliglustat havde ingen indvirkning på CNS eller åndedrætsfunktioner.
English: EU/1/14/974/001 56 capsules EU/1/14/974/002 196 capsules EU/1/14/974/003 14 capsules
Danish: EU/1/14/974/001 56 kapsler EU/1/14/974/002 196 kapsler EU/1/14/974/003 14 kapsler
English: There were no clinically meaningful differences between groups for any of the four individual disease parameters (see Table 4).
Danish: Der var ingen klinisk relevante forskelle mellem grupper for nogen af de fire individuelle sygdomsparametre (se tabel 4).
English: o Always consult the doctor who prescribed eliglustat before you start using other medicines.
Danish: • Tal altid med den læge, der ordinerede eliglustat, før du starter med andre lægemidler.
English: Reinstitution of enzyme replacement therapy or an alternative treatment modality should be considered in individual patients who have a sub-optimal response.
Danish: Genindførsel af enzymsubstitutionsterapi eller en alternativ behandlingsmodalitet bør overvejes hos individuelle patienter, som har et sub-optimal respons.
English: There are no or limited amount of data from the use of eliglustat in pregnant women.
Danish: Der er ingen eller utilstrækkelige data fra anvendelse af eliglustat til gravide kvinder.
English: If you cannot swallow the capsule whole, tell your doctor.
Danish: Hvis du ikke kan sluge kapslen hel, skal du fortælle det til din læge.
English: Use of eliglustat in patients with pre-existing cardiac conditions has not been studied during clinical trials.
Danish: Brug af eliglustat hos patienter med eksisterende hjertesygdomme er ikke blevet undersøgt i kliniske studier.
English: There are many medicines in these categories and depending on how your body breaks down Cerdelga the effects may differ from person to person.
Danish: Der er mange slags medicin i disse kategorier, og afhængigt af hvordan din krop nedbryder Cerdelga, kan virkningen være forskellig fra den ene person til den anden.
English: Effects on skeletal pathology
Danish: Virkning på skeletpatologi
English: a Cerezyme/Cerdelga - Originally Randomized to Cerezyme b Cerdelga - Originally Randomized to Cerdelga
Danish: a Cerezyme/Cerdelga - Oprindeligt randomiseret til Cerezyme b Cerdelga - Oprindeligt randomiseret til Cerdelga
English: Electrocardiographic evaluation
Danish: Elektrokardiografisk evaluering
English: Effects of eliglustat in toxicology studies were reversible and exhibited no evidence of delayed or recurring toxicity.
Danish: Virkninger af eliglustat i toksikologiske studier var reversible og udviste ingen tegn på forsinket eller tilbagevendende toksicitet.
English: The patient alert card shall contain the following key elements:
Danish: Patientadvarselskortet skal indeholde følgende hovedelementer:
English: • Obligation to conduct post-authorisation measure
Danish: • Forpligtelse til at udføre foranstaltninger efter godkendelse Beskrivelse
English: Results of study 304 indicate that skeletal improvements are maintained or continue to improve during at least 8 years of treatment with Cerdelga.
Danish: Resultater fra studie 304 indikerer, at skeletforbedringer vedligeholdes eller forbedres fortsat i mindst 8 år efter behandling med Cerdelga.
English: Embryofoetal development in rats and rabbits was not affected up to clinically relevant exposure (based on AUC).
Danish: Fosterudviklingen hos rotter og kaniner blev ikke påvirket op til klinisk relevant eksponering (baseret på AUC).
English: In order to investigate the long-term safety of eliglustat in patients prescribed eliglustat, the MAH is to create a sub-registry to the International Collaborative Gaucher Group (ICGG) Gaucher Registry to collect safety data according to an agreed protocol.
Danish: For at undersøge sikkerheden på langt sigt af eliglustat hos patienter, der er ordineret eliglustat, skal MAH oprette et underregister i International Collaborative Gaucher Group (ICGG) Gaucher-registret for at indsamle sikkerhedsdata i henhold til en aftalt protokol
English: (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare
Danish: almindelig (≥1/100 til <1/10); ikke almindelig (≥1/1.000 til <1/100); sjælden (≥1/10.000 til <1/1.000);
English: During the open-label long term treatment period with Cerdelga (extension phase), all patients with complete data who continued to receive Cerdelga showed further improvements throughout the extension phase.
Danish: I den åbne periode med langtidsbehandling med Cerdelga (forlængelsesfasen) udviste alle patienter med komplette data, som fortsatte med at få Cerdelga, yderligere forbedringer i hele forlængelsesfasen.
English: There are no known effects on fertility at normal doses.
Danish: Der er ingen kendte virkninger på frugtbarhed ved normale doser.
English: If you take more capsules than you were told to, consult your doctor immediately.
Danish: Hvis du tager flere kapsler, end du blev anvist, skal du straks kontakte din læge.
English: The capsules may be taken with or without food.
Danish: Kapslerne kan tages med eller uden et måltid.
English: Long-term clinical outcomes in treatment-naïve GD1 patients - study 304
Danish: Langsigtede kliniske resultater hos behandlingsnaive GD1-patienter - studie 304
English: Table 3: Change from baseline to year 8 in study 304
Danish: Tabel 3: Ændring fra baseline til år 8 i studie 304
English: Based on the population pharmacokinetic analysis, gender, body weight, age, and race had limited or no impact on the pharmacokinetics of eliglustat.
Danish: Baseret på den farmakokinetiske populationsanalyse havde køn, kropsvægt, alder og race kun begrænset eller ingen indvirkning på farmakokinetikken af eliglustat.
English: Package leaflet: Information for the patient Cerdelga 84 mg hard capsules eliglustat This medicine is subject to additional monitoring.
Danish: Indlægsseddel: Information til patienten Cerdelga 84 mg hårde kapsler eliglustat Dette lægemiddel er underlagt supplerende overvågning.
English: Eighteen patients completed 8 years of treatment.
Danish: Atten patienter fuldførte 8 års behandling.
English: For patients with stable disease who switch from enzyme replacement therapy to eliglustat, monitoring for disease progression (e.g. after 6 months with regular monitoring thereafter) should be performed for all disease domains to evaluate disease stability.
Danish: For patienter, hvis sygdom er stabil, og som skifter fra enzym-substitutionsterapi til eliglustat, skal monitorering for sygdomsprogression (f.eks. efter 6 måneder og med regelmæssig monitorering derefter) udføres for alle sygdommens karakteristika for at evaluere sygdommens stabilitet.
English: In these four studies a total of 393 patients between the ages of 16-75 years received eliglustat for a median duration of 3.5 years (up to 9.3 years).
Danish: I disse fire undersøgelser fik i alt 393 patienter i alderen 16-75 år eliglustat i en medianvarighed på 3,5 år (op til 9,3 år).
English: The prescriber guide shall contain the following key elements:
Danish: Ordinationsvejledningen skal indeholde følgende hovedelementer:
English: No clinically significant QTc prolonging effect of eliglustat was observed for single doses up to 675 mg.
Danish: Der blev ikke observeret nogen klinisk signifikant QTc-forlængende virkning af eliglustat for enkeltdoser på op til 675 mg.
English: Nineteen patients completed 4 years of treatment.
Danish: Nitten patienter fuldførte 4 års behandling.
English: Absolute Change in Haemoglobin Level (g/dL)
Danish: Absolut ændring i hæmoglobinniveau (g/dl)
English: In the primary analysis periods of the three clinical studies, a total of 5 PMs and 5 URMs were treated with Cerdelga.
Danish: I de tre kliniske studiers primære analyseperiode blev i alt 5 PM'er og 5 URM'er behandlet med Cerdelga.
English: Population pharmacokinetic analysis shows that the CYP2D6 predicted phenotype based on genotype is the most important factor affecting pharmacokinetic variability.
Danish: Populationsfarmakokinetisk analyse viser, at den CYP2D6-forventede fænotype baseret på genotype er den vigtigste faktor, der påvirker farmakokinetisk variation.
English: Food does not have a clinically relevant effect on eliglustat pharmacokinetics.
Danish: Fødevarer har ikke nogen klinisk relevant indvirkning på eliglustats farmakokinetik.
English: • have a slow heart rate.
Danish: • har en langsom hjertefrekvens.
English: Do not give this medicine to children or adolescents.
Danish: Dette lægemiddel må ikke gives til børn og unge.
English: It is unknown whether eliglustat or its metabolites are excreted in human milk.
Danish: Det er ukendt, om eliglustat/metabolitter udskilles i human mælk.
English: The active substance in this medicine has been shown to pass in trace amounts into breast milk in animals.
Danish: Det aktive stof i dette lægemiddel er påvist at udskilles i meget små mængder i modermælken hos dyr.
English: Each pack contains 14, 56 or 196 hard capsules.
Danish: Hver pakke indeholder 14, 56 eller 196 hårde kapsler.
English: After intravenous administration, the volume of distribution was 816 L, suggesting wide distribution to tissues in humans.
Danish: Efter intravenøs administration var fordelingsvolumenet 816 liter, hvilket antyder en udtalt fordeling til vævene hos mennesker.
English: The most frequently reported adverse reaction with Cerdelga is dyspepsia, in approximately 6% of the clinical trial patients.
Danish: Den hyppigst rapporterede bivirkning med Cerdelga er dyspepsi, som forekommer hos ca. 6 % af kliniske forsøgspatienter.
English: While there was no apparent effect on heart rate, concentration-related increases were observed for the placebo corrected change from baseline in the PR, QRS, and QTc intervals.
Danish: Omend der ikke var nogen synlig indvirkning på hjertefrekvensen, blev der observeret koncentrationsrelaterede stigninger for den placebo-korrigerede ændring fra baseline i PR, QRS og QTc-intervallerne.