FrancophonIA/ELRC3.0 huggingface dataset:
English: Weight Range (kg)
Danish: Vægtklasse (kg)
English: Your doctor will monitor your blood pressure every 6 months, if you are taking a corticosteroid medicine.
Danish: Din læge vil tage dit blodtryk hver 6. måned, hvis du tager et kortikosteroid-lægemiddel.
English: The onset of reduction in relative bioavailability is estimated to occur approximately 60 hours after the first dose.
Danish: Reduktion i relativ biotilgængelighed skønnes at forekomme cirka 60 timer efter den første dosis.
English: The majority of patients in all treatment groups were Caucasian (90%).
Danish: Størstedelen af patienter i alle behandlingsgrupper var kaukasiske (90 %).
English: General characteristics of ataluren after administration
Danish: Generelle karakteristika af ataluren efter administration
English: Characteristic in specific groups of subjects or patients
Danish: Karakteristika hos en specifik gruppe forsøgspersoner eller patienter
English: Kaplan-Meier Curve of Time to Persistent 10% 6MWD Worsening (Study 1)
Danish: Kaplan-Meier kurve af tid til 10 % vedvarende forværring i 6MWD (Studie 1)
English: The toxicity of the metabolite is unknown.
Danish: Toksiciteten af metabolitten er ukendt.
English: Percent Not 10% Worsened
Danish: Procentdel af ikke 10 % forværret
English: The majority of patients in both treatment groups were Caucasian (76%).
Danish: Størstedelen af patienterne i begge behandlingsgrupper var kaukasere (76 %).
English: 26% worsening
Danish: 26 %Forværring
English: Females were not studied in nmDMD clinical trials.
Danish: Kvinder var ikke inkluderet i nmDMD kliniske forsøg.
English: 44% worsening
Danish: 44 %Forværring
English: It is important to take the correct dose.
Danish: Det er vigtigt at tage den korrekte dosis.
English: Hypertension with use of concomitant systemic corticosteroids
Danish: Hypertension ved samtidig brug af systemiske kortikosteroider
English: In vitro, ataluren is 99.6% bound to human plasma proteins and the binding is independent of plasma concentration.
Danish: In vitro er ataluren 99,6 % bundet til humant plasmaprotein, og bindingen er uafhængig af plasmakoncentration.
English: Contact your doctor if you take more than the recommended dose of Translarna.
Danish: Kontakt lægen, hvis du tager mere end den anbefalede dosis Translarna.
English: Time to 10% worsening in 6MWD was defined as the last time that 6MWD was not 10% worse than baseline.
Danish: Tid til forværring på 10 % i 6MWD blev defineret som sidste gang, 6MWD ikke var 10 % dårligere end ved baseline.
English: The pharmacokinetics of ataluren has been evaluated in study PTC124-GD-030 over a duration of 4 weeks.
Danish: Farmakokinetikken af ataluren er blevet evalueret i studie PTC124-GD-030 over en periode på 4 uger.
English: Your doctor must have done a blood test to confirm that your disease is suitable for treatment with Translarna.
Danish: Din læge skal have foretaget en blodprøve for at bekræfte, at din sygdom er egnet til behandling med Translarna.
English: Drink water or other liquids regularly to avoid dehydration while taking Translarna.
Danish: Drik vand eller andre væsker regelmæssigt for at undgå væsketab, mens du tager Translarna.
English: It is important to administer the correct dose.
Danish: Det er vigtigt at administrere den korrekte dosis.
English: It is unknown whether ataluren/metabolites are excreted in human milk.
Danish: Det er ukendt, om ataluren/metabolitter udskilles i human mælk.
English: Take Translarna by mouth 3 times per day; in the morning, midday and evening.
Danish: Tag Translarna gennem munden 3 gange dagligt; morgen, middag og aften.
English: Changes in lipid profile
Danish: Ændringer i lipidprofil
English: You or your child will have been tested by your doctor before starting treatment with Translarna, in order to confirm that your disease is suitable for treatment with this medicine.
Danish: Du eller dit barn er blevet testet af din læge før påbegyndelse af behandlingen med Translarna for at bekræfte, at din sygdom er egnet til behandling med dette lægemiddel.
English: Remember to take the next dose on time.
Danish: Husk at tage den næste dosis til tiden.
English: Magnesium stearate
Danish: Magnesium stearat
English: If you have any kidney problem, your doctor should check your kidney function regularly.
Danish: Hvis du har nyreproblemer, skal din læge regelmæssigt kontrollere din nyrefunktion.
English: Delayed or missed dose
Danish: Forsinket eller oversprunget dosis
English: It is hypothetised that the in vivo dose response relationship may also be bell-shaped, but in vivo data were too limited to confirm this hypothesis in a mouse model for nmDMD and in humans.
Danish: Det antages, at in vivo dosis-respons-forholdet ligeledes kan være klokkeformet, men in vivo data var for begrænsede til at bekræfte denne antagelse i en musemodel for nmDMD og hos mennesker.
English: Efficacy has not been demonstrated in non-ambulatory patients.
Danish: Effekt er ikke blevet påvist hos ikke-ambulante patienter.
English: Your doctor will test the levels of lipids (fats such as cholesterol and triglycerides) in your blood and your kidney function every 6 to 12 months.
Danish: Din læge vil teste niveauerne af lipider (fedtstoffer som f.eks. kolesterol og triglycerider) i dit blod samt din nyrefunktion hver 6. til 12. måned.
English: 6MWD Results in Patients with a Baseline 6MWD < 350 meters.
Danish: 6MWD resultater hos patienter med en baseline 6MWD < 350 meter.
English: The prepared dose should be mixed well before administration.
Danish: Den tilberedte dosis skal blandes godt inden administration.
English: Increasing the dose above the recommended dose may be associated with reduced effectiveness.
Danish: Øgning af dosis over den anbefalede dosis kan resultere i reduceret effekt.
English: Patients who do not have a nonsense mutation
Danish: Patienter, der ikke har en nonsense-mutation
English: Haematuria, enuresis
Danish: Hæmaturi, enuresis
English: Frequency not known (frequency cannot be estimated from the available data): - Increases in blood lipids - Increases in test for kidney function
Danish: Hyppighed ikke kendt (frekvensen kan ikke estimeres ud fra forhåndenværende data): - Stigninger i fedtstoffer i blodet - Stigninger i nyrefunktionstest
English: Patients should not take a double or extra dose if a dose is missed.
Danish: Patienter må ikke tage en dobbelt eller ekstra dosis, hvis en dosis springes over.
English: Based on data in healthy volunteers, the relative bioavailability of ataluren is approximately 40% lower at steady-state than after the initial dose.
Danish: Baseret på data fra raske frivillige, er den relative biotilgængelighed af ataluren cirka 40 % lavere ved steady state end efter den initiale dosis.
English: The safety and efficacy of Translarna in children <12kg and aged 6 months to 2 years have not yet been established.
Danish: Sikkerheden og virkning af Translarna hos børn <12 kg og i alderen 6 måneder til 2 år er endnu ikke klarlagt.
English: In the event of a suspected overdose, supportive medical care should be provided including consulting with a healthcare professional and close observation of the clinical status of the patient.
Danish: Hvis der er mistanke om overdosering, skal der gives understøttende medicinsk behandling herunder konsultation med en læge og nøje observation af patientens kliniske status.
English: Co. Armagh BT63 5UA
Danish: Co. Armagh BT63 5UA Storbritannien
English: However there were no apparent effects of gender on ataluren plasma exposure in other populations.
Danish: Der var imidlertid ingen tilsyneladende effekt af køn på eksponering for ataluren i plasma hos andre populationer.
English: Hydroxyethyl cellulose
Danish: Hydroxyethylcellulose
English: Higher ataluren exposure was associated with potential decrease in efficacy.
Danish: Højere atalureneksponering var forbundet med potentielt nedsat virkning.
English: In addition, at exposure much higher than in patients an increase of (rare) urinary bladder tumours was found.
Danish: Endvidere blev der ved eksponering, som var meget højere end hos patienter, fundet en stigning af (sjældne) tumorer i urinblæren.
English: Therefore, if treatment with intravenous aminoglycosides is necessary the treatment with Translarna should be stopped and can be resumed 2 days after administration of the aminoglycoside has ended.
Danish: Hvis behandling med intravenøse aminoglykosider er nødvendig, skal behandlingen med Translarna derfor afbrydes, og kan genoptages 2 dage efter, at administration af aminoglykosidet er afsluttet.
English: No effects on male and female fertility were observed, but effects of early juvenile treatment on fertility during adulthood were not investigated.
Danish: Der blev ikke observeret nogen effekt på fertiliteten hos mænd og kvinder, men effekten på fertilitet ved tidlig juvenil behandling ikke undersøgt.
English: Based on data from subjects ranging in age from 2 years to 57 years, there is no apparent effect of age on ataluren plasma exposure.
Danish: Baseret på data fra forsøgspersoner i alderen fra 2 år til 57 år, er der ikke nogen tilsyneladende effekt af alder på eksponering for ataluren i plasma.
English: Due to the low number of other races included in the clinical studies, no conclusions can be drawn on the effect of UGT1A9 in other ethnic groups.
Danish: Givet det lille antal af andre racer inkluderet i de kliniske studier, kan der ikke drages konklusioner om effekten af UGT1A9 hos andre etniske grupper.
English: If you have severe kidney problems (eGFR <30 ml/min) or if you are receiving dialisys because your kidneys do not work (end-stage renal disease) your doctor will established if treatment with Translarna is suitable for you.
Danish: Hvis du har svære nyreproblemer (eGDR < 30 ml/min), eller hvis du får dialyse, fordi dine nyrer ikke fungerer (nyresygdom i slutstadiet), vil din læge fastlægge, om behandling med Translarna er egnet til dig.
English: - If you are allergic to ataluren or any of the other ingredients of this medicine (listed in section 6).
Danish: - Hvis du er allergisk over for ataluren eller et af de øvrige indholdsstoffer i lægemidlet (angivet i pkt.
English: The efficacy of Translarna in children aged 2 - 5 years has been established on extrapolation from patients aged >5years.
Danish: Effekten af Translarna hos børn i alderen 2-5 år er blevet etableret ved ekstrapolering fra patienter > 5 år.
English: Ataluren plasma concentrations at steady state increase proportionally with increasing dose.
Danish: Plasmakoncentrationer af ataluren ved steady state stiger proportionelt med stigende dosis.
English: Patients who experience dizziness should use caution when driving, cycling or using machines.
Danish: Patienter, som oplever svimmelhed, skal udvise forsigtighed, når de fører motorkøretøj, cykler eller betjener maskiner.
English: Although ataluren is practically insoluble in water, ataluren is readily absorbed after oral administration as a suspension.
Danish: Selvom ataluren stort set er uopløselig i vand, absorberes ataluren let efter peroral administration som en suspension.
English: In a 26-week transgenic mouse model for carcinogenicity, no evidence of carcinogenicity was found.
Danish: I en 26-ugers transgen musemodel for karcinogenicitet, blev der ikke fundet tegn på karcinogenicitet.
English: Almac Pharma Services (Ireland) Limited Finnabair Industrial Estate Dundalk, Co. Louth, A91 P9KD Ireland
Danish: Almac Pharma Services (Ireland) Limited Finnabair Industrial Estate Dundalk, Co. Louth, A91 P9KD Irland
English: Take each prepared dose immediately after preparation.
Danish: Tag hver tilberedt dosis umiddelbart efter tilberedning.
English: The first dose should be taken in the morning, the second at midday, and the third in the evening.
Danish: Den første dosis skal tages om morgenen, den anden midt på dagen og den tredje om aftenen.
English: In addition, one case of malignant hibernoma was found at the highest dose in a 2-year rat carcinogenicity study.
Danish: Endvidere blev ét tilfælde af malignt hibernoma fundet ved den højeste dosis i et 2-årigt karcinogenicitetsstudie hos rotter.
English: Granules for oral suspension.
Danish: Granulat til oral suspension.
English: It is unlikely that the pharmacokinetics of ataluren are significantly affected by UGT1A9 polymorphisms in a Caucasian population.
Danish: Det er usandsynligt, at atalurens farmakokinetik påvirkes signifikant af UGT1A9 polymorfisme hos en kaukasisk population.
English: For example, you might take Translarna at 7:00 AM in the morning with breakfast, at 1:00 PM in the afternoon with lunch, and again at around 7:00 PM in the evening with dinner.
Danish: Du kan f.eks. tage Translarna kl. 7:00 om morgenen med morgenmaden, kl. 13:00 midt på dagen med frokosten, og igen kl. 19:00 om aftenen med aftensmaden.
English: These results indicate that ataluren 40 mg/kg/day slows the loss of walking ability in nmDMD patients.
Danish: Disse resultater indikerer, at ataluren 40 mg/kg/dag forsinker tabet af evnen til at gå hos nmDMDpatienter.
English: Background incidence of this tumour type in rats as well as humans is very low and the mechanism causing these tumours in the rat studies (including its relation to ataluren treatment) is unknown.
Danish: Baggrundshyppighed af denne tumortype hos rotter, såvel som hos mennesker, er meget lav, og mekanismen, som forårsagede disse tumorer i rottestudierne (herunder relationen til behandling med ataluren), kendes ikke.
English: Safety data from 28 weeks of therapy showed a similar safety profile of ataluren in patients 2-5 years as compared with patients aged 5 years and older.
Danish: Sikkerhedsdata fra 28-ugers behandling viser en tilsvarende sikkerhedsprofil af ataluren hos patienter i alderen fra 2-5 år sammenlignet med patienter på 5 år eller derover.
English: Adverse reactions were generally mild or moderate in severity, and no treatment-related serious adverse events were reported among ataluren-treated patients in these 2 studies.
Danish: Bivirkningerne var generelt milde eller moderate i sværhedsgrad og der blev ikke rapporteret nogen behandlingsrelaterede alvorlige bivirkninger blandt de ataluren-behandlede patienter i disse 2 studier.
English: Coadministration of corticosteroids (deflazacort, prednisone, or prednisolone) with ataluren did not affect the plasma concentrations of ataluren.
Danish: Samtidig administration af kortikosteroider (deflazacort, prednison, eller prednisolon) og ataluren påvirkede ikke plasmakoncentrationerne af ataluren.
English: A higher frequency of malaise (7.1%), pyrexia (42.9%), ear infection (28.6%), and rash (21.4%) were reported in patients aged 2-5 years compared with patients 5 years of age and older.
Danish: En højere hyppighed af utilpashed (7,1 %), pyreksi (42,9 %), øreinfektion (28,6 %) og udslæt (21,4 %) blev rapporteret hos patienter i alderen fra 2-5 år sammenlignet med patienter på 5 år eller derover.
English: Usually prescribed for acyclovir treatment of chickenpox [varicella]
Danish: Normalt ordineret til aciclovir behandling af skoldkopper [varicella]
English: Treatment with Translarna should only be initiated by specialist physicians with experience in the management of Duchenne/Becker muscular dystrophy.
Danish: Behandling med Translarna bør kun initieres af en speciallæge med erfaring i behandling af Duchenne/Becker muskeldystrofi.
English: Translarna is used to treat patients aged 2 years and older, who are able to walk.
Danish: Translarna anvendes til at behandle patienter på 2 år eller derover, som kan gå.
English: These data indicate no apparent drug-drug interaction between corticosteroids and ataluren, and no dose adjustments are required.
Danish: Disse indikerer ingen tilsyneladende lægemiddelinteraktion mellem kortikosteroider og ataluren, og dosisjustering er ikke påkrævet.
English: The safety, pharmacokinetics and exploratory effectiveness of Translarna were assessed in an openlabel study in children between 2 and 5 years of age with nmDMD.
Danish: Sikkerheden, farmakokinetikken og den eksplorative effektivitet af Translarna blev vurderet i et åbent studie hos børn i alderen fra 2 til 5 år med nmDMD.
English: Patients who do not have a nonsense mutation should not receive ataluren.
Danish: Patienter, som ikke har en nonsense-mutation, må ikke få ataluren.
English: Ataluren plasma half-life ranges from 2-6 hours and is unaffected either by dose or repeated administration.
Danish: Plasmahalveringstiden af ataluren varierer fra 2-6 timer og påvirkes hverken af dosis eller gentagen administration.
English: A nonsense mutation in DNA results in a premature stop codon within an mRNA.
Danish: En nonsense-mutation i DNA resulterer i et præmaturt stop codon inden for en mRNA.
English: Study 2 evaluated 230 male patients, ages 7 to 14 years.
Danish: I Studie 2 evalueredes 230 mandlige patienter i alderen 7 til 14 år.
English: Caution should be exercised when ataluren is co-administered with adefovir.
Danish: Der skal udvises forsigtighed, når ataluren administreres samtidig med adefovir.
English: In a statistical based model the estimated mean difference was 13.0 meters (p=0.213), Figure 4.
Danish: I en statistisk baseret model var den anslåede gennemsnitlige forskel 13,0 meter (p=0,213), Figur 4.
English: As a precautionary measure, it is recommended to avoid the use of ataluren during pregnancy.
Danish: For en sikkerheds skyld anbefales det at undgå ataluren under graviditet.
English: But, take the next doses on time.
Danish: Men du skal tage den næste dosis til tiden.
English: Pharmacotherapeutic group:Other drugs for disorders of the musculo-skeletal system, ATC code: M09AX03
Danish: Farmakoterapeutisk klassifikation: Andre lægemidler mod sygdomme i bevægeapparatet, ATC-kode: M09AX03
English: This premature stop codon in the mRNA causes disease by terminating translation before a full-length protein is generated.
Danish: Dette præmature stop codon i mRNA forårsager sygdom ved at stoppe translationen, før der genereres et fuldlængdeprotein.
English: Age-adjusted dosing is not required.
Danish: Dosisjustering baseret på alder er ikke nødvendig.
English: There was no difference between ataluren 80 mg/kg/day and placebo.
Danish: Der var ingen forskel på ataluren 80 mg/kg/dag og placebo.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology and genotoxicity.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi og genotoksicitet.
English: Aminoglycosides have been shown to reduce the readthrough activity of ataluren in vitro.
Danish: Det er påvist, at aminoglykosider reducerer atalurens ”readthrough” aktivitet in vitro.
English: If this is unavoidable (e.g. vancomycin to treat MRSA) careful monitoring of renal function is advised (see section 4.5).
Danish: Hvis dette ikke kan undgås (f.eks. vancomycin til behandling af MRSA), tilrådes omhyggelig overvågning af nyrefunktionen (se pkt.
English: Description of selected adverse reactions (laboratory abnormalities)
Danish: Beskrivelse af udvalgte bivirkninger (laboratorieabnormiteter)
English: Pack of 30 sachets.
Danish: Pakning med 30 breve.
English: Patients should maintain adequate hydration while taking ataluren (see section 4.4).
Danish: Patienter skal sørge for tilstrækkelig hydrering, mens de tager ataluren (se pkt.
English: One out of two 26-week rat repeat dose studies, initiated in 4-5 weeks old rats, showed a dose related increase of the incidence of malignant hibernoma, a rare tumour in rats.
Danish: Et af to 26-ugers rotteforsøg med gentagne doser, initieret hos rotter på 4-5 uger, viste en dosisrelateret stigning i forekomsten af malignt hibernoma, en sjælden tumor hos rotter.
English: Pain in extremity, musculoskeletal chest pain
Danish: Smerter i ekstremiteterne, muskoskeletale brystsmerter
English: Translarna enables the production of working dystrophin and helps muscles work properly.
Danish: Translarna muliggør produktionen af virksom dystrofin, og hjælper musklerne til at fungere korrekt.
English: Ataluren enables ribosomal readthrough of mRNA containing such a premature stop codon, resulting in production of a full-length protein.
Danish: Ataluren muliggør ribosomal aflæsning af mRNA, som indeholder et sådant præmaturt stop codon, hvilket resulterer i produktion af et fuldlængdeprotein.
English: Significance of the urinary bladder tumours for humans is considered unlikely.
Danish: At urinblæretumorer skulle være signifikant for mennesker, betragtes som usandsynligt.
English: In addition to the above mentioned effects, several other less adverse effects were found in the repeat dose studies; in particular decreased body weight gain, food intake and increased liver weight without a histological correlate and of unclear clinical significance.
Danish: Foruden de ovenfor nævnte virkninger, blev der set flere andre mindre alvorlige bivirkninger i studierne med gentagen dosering; i særdeleshed reduceret vægtøgning, reduceret fødeindtagelse og øget levervægt uden et histologisk korrelat og af uvis klinisk signifikans.
English: Healthy volunteers receiving a single oral dose of 200 mg/kg of ataluren experienced transient, low-grade symptoms of headache, nausea, vomiting, and diarrhoea.
Danish: Raske frivillige, som fik en enkelt oral dosis på 200 mg/kg ataluren, havde forbigående, milde symptomer i form af hovedpine, kvalme, opkastning og diarré.
English: The efficacy and safety of Translarna were assessed in 2 randomised, double-blind, placebo-controlled, trials in nmDMD.
Danish: Virkningen og sikkerheden af Translarna blev vurderet i 2 randomiserede, dobbeltblindede, placebokontrollerede forsøg om nmDMD.
English: An open-label study was performed including patients aged 2-5 years (n=14) to evaluate the PK and safety of ataluren.
Danish: Et åbent studie blev udført med patienter i alderen fra 2-5 år (n=14) med henblik på at evaluere farmakokinetik [PK] og sikkerhed af ataluren.
English: The effect of ataluren on driving, on cycling, or on using machines has not been tested.
Danish: Virkningen af ataluren på evnen til at føre motorkøretøj, cykle eller betjene maskiner er ikke blevet undersøgt.
English: An increase in serum lipids, i.e. cholesterol and triglycerides, was observed.
Danish: Der blev observeret en stigning i serumlipider, dvs. kolesterol og triglycerider.
English: The amount of the liquid or semi-solid food can be increased based on patient preference.
Danish: Mængden af væske eller halvflydende mad kan øges i henhold til patientens præference.
English: Exposure at the no observed adverse effect level (NOAEL) was similar to (rabbit) or 4 times (rat) the systemic exposure in humans (40 mg/kg/day).
Danish: Eksponering ved niveauet uden observerede negative effekter (NOAEL) svarede til (kanin) eller var 4 gange (rotte) højere end den systemiske eksponering hos mennesker (40 mg/kg/dag).
English: Translarna is available in packs containing 30 sachets.
Danish: Translarna fås i pakninger med 30 breve.
English: In both studies, 1/232 (0.43%) patients treated with ataluren discontinued due to an adverse reaction of constipation and 1/172 (0.58%) placebo patients discontinued treatment due to an adverse reaction of disease progression (loss of ambulation).
Danish: I begge studier afbrød 1/232 (0,43 %) af patienter behandlet med ataluren behandlingen på grund af en bivirkning i form af forstoppelse og 1/172 (0,58 %) af placebopatienter afbrød behandlingen på grund af en bivirkning i form af sygdomsprogression (tab af ambulation).
English: Ataluren-treated patients experienced clinical benefit as measured by numerically favorable differences versus placebo across the primary and secondary efficacy endpoints.
Danish: Ataluren-behandlede patienter oplevede klinisk fordel målt ved numerisk gunstige forskelle versus placebo på tværs af de primære og sekundære effektmål.
English: There were no apparent differences in either steady-state relative bioavailability or apparent clearance due to loss of ambulation.
Danish: Der var ingen åbenlyse forskelle i hverken den relative biotilgængelighed ved steady state eller den tilsyneladende clearance på grund af manglende mobilisering.