FrancophonIA/ELRC3.0 huggingface dataset:
English: Renal toxicity (nephrosis in the distal nephron) occurred in repeat oral dose studies in mice at systemic exposure equivalent to 0.3 times the steady state AUC in patients administered Translarna at respective morning, midday, and evening doses of 10-, 10-, 20-mg/kg and higher.
Danish: Nyretoksicitet (nefrose i det distale nefron) forekom i forsøg med gentagne orale doser hos mus ved systemisk eksponering svarende til 0,3 gange steady state AUC hos patienter, som fik Translarna ved morgen-, middags- og aftendoser på hhv. 10, 10, 20 mg/kg og højere.
English: If there is a delay of more than 3 hours after the morning or midday doses or more than 6 hours after the evening dose, the dose should not be taken, and patients should resume their usual dosing schedule.
Danish: Hvis den forsinkes med mere end 3 timer efter morgen- eller middagsdoserne eller med mere end 6 timer efter aftendosis, skal dosis ikke tages, og patienter skal genoptage deres sædvanlige doseringsplan.
English: Ataluren is metabolized by conjugation via uridine diphosphate glucuronosyltransferase (UGT) enzymes, predominantly UGT1A9 in liver, intestine and kidney.
Danish: Ataluren metaboliseres ved konjugation i lever, tarm og nyre via uridin diphosphat glucuronosyltransferase (UGT) -enzymer, hovedsagligt UGT1A9.
English: In Study 1, a post hoc analysis of the primary endpoint showed that from baseline to Week 48, patients receiving ataluren 40 mg/kg/day had a 12.9 meters mean decline in 6MWD, and patients receiving placebo had a 44.1-meter mean decline in 6MWD (Figure 1).
Danish: I studie 1 viste en post-hoc analyse af det primære effektmål, at fra baseline til uge 48 udviste patienter, som fik ataluren 40 mg/kg/dag, en gennemsnitlig nedgang i 6MWD på 12,9 meter, og patienter, som fik placebo, udviste en gennemsnitlig nedgang i 6MWD på 44,1 meter (figur 1).
English: Similarly, ataluren is not expected in vivo to be an inducer of cytochrome P450 isoenzymes.
Danish: Ataluren forventes heller ikke at inducere CYP-isoenzymer in vivo.
English: Serum lipids
Danish: Serumlipider
English: If there is a delay in the administration of ataluren of less than 3 hours after the morning or midday doses or less than 6 hours after the evening dose, the dose should be taken with no changes to the subsequent dose schedules.
Danish: Hvis administrationen af ataluren forsinkes med mindre end 3 timer efter morgen- eller middagsdosis eller med mindre end 6 timer efter aftendosis, skal dosis tages uden ændringer i den efterfølgende doseringsplan.
English: Patients must have a nonsense mutation in the dystrophin gene as part of their underlying disease state, as determined by genetic testing.
Danish: Patienter skal have bekræftet en nonsense-mutation i dystrofin-genet som del af deres grundsygdom ved genetisk test.
English: Non-clinical data revealed no hazard for humans based on a standard male and female fertility study in rats (see section 5.3).
Danish: Prækliniske data afslørede ingen risiko for mennesker baseret på en standard fertilitetsundersøgelse hos han- og hunrotter (se pkt.
English: Each sachet contains 1000 mg of ataluren
Danish: Hvert brev indeholder 1.000 mg ataluren
English: In patients with a baseline 6MWD <350 meters, the mean change in observed 6MWD from baseline to Week 48 was 68 meters better in the ataluren 40 mg/kg/day arm than in the placebo arm (p=0.0053).
Danish: Hos patienter med en baseline 6MWD < 350 meter, blev middelændringen, der blev observeret 6MWD fra baseline til uge 48, 68 meter bedre i ataluren 40 mg/kg/dag armen end i placebo-armen (p=0,0053).
English: In the ITT population, the difference between the ataluren and placebo arms in mean change in observed 6MWD from baseline to Week 48 was 15.4 meters better in the ataluren 40 mg/kg/day arm than in the placebo arm.
Danish: I ITT-populationen var forskellen mellem ataluren og placebo-armene i den gennemsnitlige ændring i observeret 6MWD fra baseline til uge 48 15,4 meter bedre i ataluren 40 mg/kg/dag armen end i placeboarmen.
English: Treatment of patients with severe renal impairment (eGFR <30 ml/min) or end-stage renal disease is not recommended (see sections 4.4 and 5.2).
Danish: Behandling af patienter med svært nedsat nyrefunktion (eGFR < 30 ml/min) nyresygdom i slutstadiet anbefales ikke (se pkt.
English: The safety and efficacy of ataluren in patients aged 65 and older have not yet been established (see section 5.2).
Danish: Ældre Sikkerheden og effekten af ataluren hos patienter på 65 år og derover er endnu ikke klarlagt.
English: Each sachet contains 250 mg of ataluren
Danish: Hvert brev indeholder 250 mg ataluren
English: Each sachet contains 125 mg of ataluren
Danish: Hvert brev indeholder 125 mg ataluren
English: Mean Change in Timed Function Tests (Study 2)
Danish: Gennemsnitlig ændring i tidssatte funktionstest (Studie 2)
English: Translarna 125 mg granules for oral suspension Translarna 250 mg granules for oral suspension Translarna 1000 mg granules for oral suspension
Danish: Translarna 125 mg granulat til oral suspension Translarna 250 mg granulat til oral suspension Translarna 1.000 mg granulat til oral suspension
English: The mean change in timed function tests from baseline to Week 48 was better in the ataluren 40 mg/kg/day arm than placebo in observed time to run/walk 10 meters (better by 1.2 seconds, p=0.117), time to climb 4 stairs (better by 1.8 seconds, p=0.058), and time to descend 4 stairs (better by 1.8 seconds, p=0.012), Figure 5.
Danish: Den gennemsnitlige ændring i tidssatte funktionstest fra baseline til uge 48 var bedre i ataluren 40 mg/kg/dag armen end placebo i observeret tid til at løbe/gå 10 meter (1,2 sekunder bedre, p=0,117), tid til at gå op ad 4 trin (1,8 sekunder bedre, p=0,058) og tid til at gå ned ad 4 trin (1,8 sekunder bedre, p=0,012), Figur 5.
English: Translarna 1000 mg granules for oral suspension EU/1/13/902/003
Danish: Translarna 1.000 mg granulat til oral suspension EU/1/13/902/003
English: Translarna is available in the following sachet strengths: 125 mg, 250 mg and 1000 mg of ataluren per sachet.
Danish: Translarna fås i breve med følgende styrker: 125 mg, 250 mg and 1.000 mg ataluren pr. brev.
English: How to take Translarna
Danish: Sådan skal du tage Translarna
English: Translarna 1000 mg granules for oral suspension Each sachet contains 1000 mg ataluren.
Danish: Translarna 1.000 mg granulat til oral suspension Hvert brev indeholder 1.000 mg ataluren.
English: Translarna 125 mg granules for oral suspension EU/1/13/902/001
Danish: Translarna 125 mg granulat til oral suspension EU/1/13/902/001
English: Translarna 250 mg granules for oral suspension Each sachet contains 250 mg ataluren.
Danish: Translarna 250 mg granulat til oral suspension Hvert brev indeholder 250 mg ataluren.
English: In timed function tests (TFTs), tests of time to run/walk 10 meters, time to climb 4 stairs, and time to descend 4 stairs, ataluren-treated patients demonstrated smaller increases in the time it takes to run/walk 10 meters, climb 4 stairs, and descend 4 steps, indicating slowing of nmDMD progression relative to placebo.
Danish: I tidssatte funktionstests (TFT'er), tests af løb/gå-tid for 10 meter, tid til at gå 4 trin op, og tid til at gå ned ad 4 trin, udviste ataluren-behandlede patienter mindre stigninger i den tid, der tager at løbe/gå.
English: As the primary endpoint (change in 6MWD from baseline to Week 48) did not reach statistical significance (p≤0.05),
Danish: 6MWD fra baseline til uge 48) ikke nåede statistisk signifikans (p≤0,05), bør alle andre p-værdier betragtes som nominelle.
English: Translarna 250 mg granules for oral suspension EU/1/13/902/002
Danish: Translarna 250 mg granulat til oral suspension EU/1/13/902/002
English: Translarna 125 mg granules for oral suspension Each sachet contains 125 mg ataluren.
Danish: Translarna 125 mg granulat til oral suspension Hvert brev indeholder 125 mg ataluren.
English: MARKETING AUTHORISATION NUMBERS
Danish: Irland MARKEDSFØRINGSTILLADELSESNUMRE
English: Translarna 1000 mg granules for oral suspension ataluren
Danish: Translarna 1.000 mg granulat til oral suspension ataluren
English: Check with them if you are not sure.
Danish: Spørg lægen, hvis der er noget, du er i tvivl om.
English: The recommended dose is the same for all age ranges, i.e. 10 mg/kg body weight in the morning, 10 mg/kg body weight at midday, and 20 mg/kg body weight in the evening (for a total daily dose of 40 mg/kg body weight).
Danish: Den anbefalede dosis er den samme for alle aldersgrupper, dvs. 10 mg/kg legemsvægt om morgenen, 10 mg/kg legemsvægt midt på dagen, og 20 mg/kg legemsvægt om aftenen (for en samlet daglig dosis på 40 mg/kg legemsvægt).
English: In these patients, the mean change in timed function tests from baseline to Week 48 was better in the ataluren 40 mg/kg/day arm than placebo in time to run/walk 10 meters (better by 3.5 seconds), time to climb 4 stairs (better by 6.4 seconds), and time to descend 4 stairs (better by 5.0 seconds).
Danish: Hos disse patienter var middeltiden i tidssatte funktionstests fra baseline til uge 48 bedre i ataluren 40 mg/kg/dag armen end placebo for tid til at løbe/gå 10 meter (3,5 sekunder bedre), tid til at gå op ad 4 trin (6,4 sekunder bedre), og tid til at gå ned ad 4 trin (5,0 sekunder bedre).
English: Evening mg sachets mg sachets mg sachets
Danish: Aften mg breve mg breve mg breve mg breve mg breve mg breve mg breve mg breve mg breve
English: Mean Change in 6-Minute Walk Distance (Study 1)
Danish: Gennemsnitlig ændring i 6-minutters gangtest (Studie 1)
English: Hepatic impairment
Danish: Erytematøst udslæt
English: Thus, the mean change in observed 6MWD from baseline to Week 48 was 31.3 meters better in the ataluren 40 mg/kg/day arm than in the placebo arm (p=0.056).
Danish: Den gennemsnitlige ændring i observeret 6MWD fra baseline til uge 48 var således 31,3 meter bedre hos gruppen, som fik ataluren 40 mg/kg/dag, end hos gruppen, som fik placebo (p=0,056).
English: Package leaflet: Information for the patient Translarna 125 mg granules for oral suspension Translarna 250 mg granules for oral suspension Translarna 1000 mg granules for oral suspension ataluren This medicine is subject to additional monitoring.
Danish: Indlægsseddel: Information til patienten Translarna 125 mg granulat til oral suspension Translarna 250 mg granulat til oral suspension Translarna 1.000 mg granulat til oral suspension ataluren
English: In vivo, the only metabolite detected in plasma after oral administration of radio-labelled ataluren was the ataluren-O-1β-acyl glucuronide; exposure to this metabolite in humans was approximately 8% of the plasma AUC of ataluren.
Danish: In vivo var den eneste metabolit, som blev fundet i plasma efter peroral administration af radioaktivt mærket ataluren, ataluren-O-1β-acyl glucuronid.
English: If you are late by more than 3 hours after the morning or midday doses, or by more than 6 hours after the evening dose, do not take the dose.
Danish: Hvis du er mere end 3 timer for sent på den med morgen- eller middagsdosis, eller mere end 6 timer for sent på den med aftendosis, må du ikke tage dosis.
English: -12.9 m
Danish: -1,2 s
English: The full contents of each sachet should be mixed with at least 30 ml of liquid (water, milk, fruit juice), or 3 tablespoons of semi-solid food (yoghurt or apple sauce).
Danish: Hele brevets indhold skal blandes med mindst 30 ml væske (vand, mælk, frugtjuice), eller 3 spiseskefulde halvflydende mad (yoghurt eller æblemos).
English: The full contents of each sachet should be mixed with at least 30 ml of liquid (water, milk, fruit juice) or 3 tablespoons of semi-solid food (yoghurt or apple sauce).
Danish: Hele brevets indhold skal blandes med mindst 30 ml væske (vand, mælk, frugtjuice) eller 3 spiseskefulde halvflydende mad (yoghurt eller æblemos).
English: If you feel dizzy, do not drive, cycle or use machines.
Danish: Du må ikke køre bil, cykle eller betjene maskiner, hvis du føler dig svimmel.
English: The recommended dose is 10 mg/kg body weight in the morning, 10 mg/kg body weight at midday, and 20 mg/kg body weight in the evening (for a total daily dose of 40 mg/kg body weight).
Danish: Den anbefalede dosis er 10 mg/kg legemsvægt om morgenen, 10 mg/kg legemsvægt midt på dagen, og 20 mg/kg legemsvægt om aftenen (for en daglig dosis på i alt 40 mg/kg legemsvægt).
English: Translarna 125 mg granules for oral suspension ataluren
Danish: Translarna 125 mg granulat til oral suspension ataluren
English: The mean change in timed function tests from baseline to Week 48 was better in the ataluren 40 mg/kg/day arm than placebo in time to run/walk 10 meters (better by 1.5 seconds), time to climb 4 stairs (better by 2.4 seconds), and time to descend 4 stairs (better by 1.6 seconds), Figure 3.
Danish: Middeltiden i tidssatte funktionstests fra baseline til uge 48 var bedre i ataluren 40 mg/kg/dag armen end placebo for tid til at løbe/gå 10 meter (1,5 sekunder bedre), tid til at gå op ad 4 trin (2,4 sekunder bedre), og tid til at gå ned ad 4 trin (1,6 sekunder bedre), figur 3.
English: Translarna 250 mg granules for oral suspension ataluren
Danish: Translarna 250 mg granulat til oral suspension ataluren
English: Mean Change in 6-Minute Walk Distance (Study 2)
Danish: Gennemsnitlig ændring i seks minutters gangtest (Studie 2)
English: The recommended dose is 10 mg/kg body weight in the morning, 10 mg/kg body weight at midday, and 20 mg/kg body weight in the evening (adding up to a total daily dose of 40 mg/kg body weight).
Danish: Den anbefalede dosis er 10 mg/kg kropsvægt om morgenen, 10 mg/kg kropsvægt om middagen, og 20 mg/kg kropsvægt om aftenen (hvilket giver en samlet dosis på 40 mg/kg kropsvægt).
English: Posology
Danish: Antal breve
English: During the randomised, placebo-controlled studies, small increases in mean serum creatinine, BUN, and cystatin C were observed.
Danish: Under de randomiserede, placekontrollerede studier af nmDMD observeredes små stigninger i gennemsnitlig serumkreatinin, BUN og cystatin C. Tendensen var, at disse værdier stabiliseredes tidligt i studiet og ikke steg yderligere ved fortsat behandling.
English: If you are late in taking Translarna by less than 3 hours after the morning or midday doses, or by less than 6 hours after the evening dose, take the dose.
Danish: Tag dosis, hvis du er mindre end 3 timer for sent på den med at tage Translarna efter morgen- eller middagsdosis, eller mindre end 6 timer for sent på den med aftendosis.
English: Cough, epistaxis
Danish: Feber, vægttab
English: What Translarna looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: Breastfeeding
Danish: Doseringstabel
English: If you take more Translarna than you should
Danish: Hvis du har taget for meget Translarna
English: Renal function tests
Danish: Nedsat nyrefunktion
English: Tabulated list of adverse reactions
Danish: Sammendrag af bivirkninger i tabelform
English: United Kingdom
Danish: Administration
English: The slower you press, the easier the injection will feel.
Danish: Jo langsommere du trykker, jo lettere vil det føles at injicere.
English: Always store in the box.
Danish: Opbevar altid i æsken.
English: Do not sell separately.
Danish: Må ikke sælges separat.
English: The two medicinal products should never be mixed.
Danish: De to lægemidler må aldrig blandes.
English: Figure T -------WAIT!
Danish: Figur T -------VENT!
English: Race and ethnicity
Danish: Race og etnicitet
English: Your doctor may need to change your dose of these other medicines to reduce this risk.
Danish: Lægen vil muligvis ændre din dosis af disse andre lægemidler for at nedsætte risikoen.
English: Can I still use the pen?
Danish: Kan jeg stadig bruge pennen?
English: Your doctor will tell you what to do if you get low blood sugar.
Danish: Lægen vil fortælle dig, hvad du skal gøre, hvis du får lavt blodsukker.
English: Look for Particles
Danish: Se efter partikler
English: “Click”
Danish: “Klik”
English: DO NOT use if the [1] is not showing.
Danish: DU MÅ IKKE bruge pennen, hvis der ikke står [1].
English: This removes the large air bubbles.
Danish: Dette fjerner de store luftbobler.
English: These are removed in step 6.
Danish: Disse fjernes i trin 6.
English: Most of this reduction was observed within the first two weeks of treatment.
Danish: Størstedelen af denne reduktion blev observeret inden for de første 2 behandlingsuger.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21 March 2014
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 21. marts 2014
English: Elderly patients (>65 years)
Danish: Ældre patienter (> 65 år)
English: Results at 104 weeks are presented in Table 3.
Danish: Resultaterne efter 104 uger er vist i tabel 3.
English: Use each pen only once.
Danish: Brug kun hver pen én gang.
English: If you get:
Danish: Hvis du får:
English: P value (noninferiority)
Danish: P-værdi (non-inferioritet)
English: You have Type 2 diabetes either:
Danish: Du har type-2 diabetes enten:
English: In addition some other side effects have been reported (frequency not known, cannot be estimated from the available data):
Danish: Desuden er der rapporteret nogle andre bivirkninger (hyppigheden ikke kendt, kan ikke estimeres ud fra forhåndenværende data):
English: A pen cannot be re-used.
Danish: En pen kan ikke genbruges.
English: (122 mild, 99 moderate, 15 severe)a
Danish: (122 let, 99 moderat, 15 svær)a
English: Count to 5------
Danish: Tæl til 5------
English: Populations not studied
Danish: Populationer, der ikke er undersøgt
English: Small air bubbles are okay and do not need to rise to the top.
Danish: Små luftbobler er i orden og behøver ikke at skulle stige til tops.
English: 4b Check medicine through the viewing window.
Danish: 4b Kontroller medicinen gennem inspektionsvinduet.
English: The duration of studies ranged from 32 weeks to up to 3 years.
Danish: Studierne varede fra 32 uger og op til 3 år.
English: It is important to avoid dehydration by drinking plenty of fluids.
Danish: Det er vigtigt at undgå dehydrering ved at drikke rigeligt med
English: Conditions you need to look out for:
Danish: Forhold du skal være opmærksom på:
English: Pancreatitis can be severe and life-threatening.
Danish: Pancreatitis kan være en alvorlig og livstruende tilstand.
English: Get medical help immediately if you get these symptoms.
Danish: Søg straks læge hvis du får disse symptomer.
English: This effect was not considered clinically relevant.
Danish: Denne effekt blev ikke anset for at være klinisk relevant.
English: Read both sides of this leaflet
Danish: Læs begge sider af denne indlægsseddel
English: Thereafter, patients can resume dosing on their usual day of administration.
Danish: Herefter kan patienterne genoptage doseringen på deres sædvanlige administrationsdag.
English: A small increase in islet cell number was also observed.
Danish: Der blev også observeret en lille stigning i antallet af øceller.
English: 1a Wash your hands (Figure D).
Danish: 1a Vask dine hænder (Figur D).
English: Wash Hands and Check Pen
Danish: Vask hænder og undersøg pennen
English: Eperzan should be administered once a week on the same day each week.
Danish: Eperzan bør administreres én gang om ugen på samme dag hver uge.
English: 5 Times
Danish: 5 gange
English: ATC code: A10BJ04
Danish: ATC-kode: A10BJ04
English: Keep twisting until you see [3] in the window.
Danish: Fortsæt med at dreje til du kan se [3] i vinduet.
English: Solvent: A clear, colourless solution.
Danish: Solvens: En klar, farveløs opløsning.
English: Eperzan is not recommended for children and adolescents.
Danish: Eperzan anbefales ikke til børn og unge.
English: The white injection button will also pop out from the bottom of the pen.
Danish: Den hvide injektionsknap vil også komme frem i bunden af pennen.
English: Healthcare professionals may utilise the following alternate method of reconstitution that allows for more rapid dissolution.
Danish: Læger og sundhedspersonale kan benytte følgende alternative metode til rekonstitution, der muliggør en hurtigere opløsning.
English: This medicine is injected once a week.
Danish: Dette lægemiddel injiceres én gang om ugen.
English: After that, you can go back to having your injection on the usual day.
Danish: Herefter kan du gå tilbage til at tage din injektion den sædvanlige dag.
English: Generally, injection site reactions were mild in intensity and did not require treatment.
Danish: Generelt var reaktioner på injektionsstedet lette i intensitet og krævede ikke behandling.
English: Never mix insulin and Eperzan together.
Danish: Bland aldrig insulin og Eperzan sammen.
English: It must not be administered intravenously or intramuscularly.
Danish: Det må ikke administreres intravenøst eller intramuskulært.
English: Count to 5
Danish: Tæl til 5
English: It is not known if Eperzan is safe and effective in people under 18 years of age.
Danish: Det vides ikke, om Eperzan er sikkert og virker hos personer under 18 år.
English: If you need to give yourself both at the same time, use two separate injections.
Danish: Hvis du skal give dig selv begge lægemidler på samme tidspunkt, så gør det med to særskilte injektioner.
English: This is because it takes time for Eperzan to clear from your body.
Danish: Det skyldes, at det tager tid, inden Eperzan er ude af kroppen.
English: Store pens and needles in the original carton until use.
Danish: Opbevar penne og nåle i den original karton indtil brug.
English: The pancreas changes were not associated with histomorphologic abnormalities or evidence of increased proliferation.
Danish: Ændringerne i pancreas var ikke forbundet med histomorfologiske abnormiteter eller tegn på øget proliferation.
English: Inspect, and continue to swirl the pen until all the powder is dissolved.
Danish: Inspicer og fortsæt med at rotere pennen, indtil alt pulver er opløst.
English: Push Straight Down
Danish: Tryk lige ned
English: A small amount of foam on top of the solution at the end of the reconstitution is normal.
Danish: En lille smule skum oven på opløsningen er normalt i slutningen af rekonstitutionen.
English: • swelling, sometimes of the face, mouth or throat, causing difficulty in breathing.
Danish: • hævelse, sommetider i ansigtet, munden eller halsen, hvilket giver åndedrætsbesvær.
English: Caution should be exercised in patients receiving medicinal products with a narrow therapeutic index or medicinal products that require careful clinical monitoring.
Danish: Der skal udvises forsigtighed hos patienter, som får lægemidler med et snævert terapeutisk indeks eller lægemidler, der kræver omhyggelig klinisk monitorering.
English: Since the relative stress of lactation energy demands is much lower in humans than mice and humans have large energy reserves, the mortalities observed in lactating mice are considered not relevant to humans.
Danish: Da den relative belastning på grund af energiforbruget ved laktation er langt mindre hos mennesker end hos mus, og mennesker har store energireserver, anses de mortaliteter, der er observeret hos diegivende mus, ikke at være relevante for mennesker.
English: You will mix them together by twisting the pen.
Danish: Du blander dem ved at dreje pennen.
English: Insert, Push Button, & Wait
Danish: Stik ind, tryk på knappen & vent
English: Important warnings
Danish: Vigtige advarsler
English: Japanese patients showed approximately 30 to 40% higher exposures than Caucasians, likely attributable to lower body weight.
Danish: Japanske patienter viste eksponeringer, der var ca. 30-40 % højere end hos kaukasiere, hvilket sandsynligvis skyldes lavere legemsvægt.
English: • If a box of pens will be stored for more than 4 weeks, keep them refrigerated (2°C to 8°C).
Danish: • Hvis en æske med penne skal opbevares længere end 4 uger, skal de opbevares på køl (2 °C to 8 °C).
English: Eperzan should not be used for treatment of diabetic ketoacidosis.
Danish: Eperzan bør ikke anvendes til behandling af diabetisk ketoacidose.
English: This is to make sure the medicine has dissolved.
Danish: Dette er for at være sikker på, at lægemidlet er helt opløst.