FrancophonIA/ELRC3.0 huggingface dataset:
English: atorvastatin lipid-lowering benzylpenicillin severe infections bumetanide treatment or prevention of congestive heart failure captopril treatment or prevention of congestive heart failure ciprofloxacin treatment of infections famotidine treatment of active duodenal ulcer, gastroesophageal reflux disease furosemide treatment or prevention of congestive heart failure methotrexate rheumatoid arthritis, psoriasis olmesartan essential hypertension in adults oseltamivir prevention of influenza phenobarbital sleep-inducing, prevention of seizures pitavastatin lipid-lowering pravastatin lipid-lowering rifampicin treatment for tuberculosis rosuvastatin lipid-lowering sitagliptin type 2 diabetes valsartan treatment or prevention of congestive heart failure Some of these medicines were not tested together with Translarna and your doctor may decide to monitor you closely.
Danish: adefovir behandling af kronisk hepatitis B og/eller hiv atorvastatin lipidsænkning benzylpenicillin alvorlige infektioner bumetanid behandling eller forebyggelse af hjertesvigt captopril behandling eller forebyggelse af hjertesvigt ciprofloxacin behandling af infektioner famotidin behandling af aktivt sår på tolvfingertarmen, gastroøsofageal refluxsygdom furosemid behandling eller forebyggelse af hjertesvigt methotrexat rheumatoid arthrit, psoriasis olmesartan essentiel hypertension hos voksne oseltamivir forebyggelse af influenza phenobarbital indsovningsmiddel, forebyggelse af krampeanfald pitavastatin lipidsænkning pravastatin lipidsænkning rifampicin behandling af tuberkulose rosuvastatin lipidsænkning sitagliptin type 2 diabetes valsartan behandling eller forebyggelse af hjertesvigt
English: A 1-year study in 10-12 weeks old dogs demonstrated findings in the adrenal gland (focal inflammation and degeneration in the glucocorticoid-producing regions of the cortex) and a mild compromise of cortisol production after exogenous stimulation with adrenocorticotropic hormone.
Danish: Et 1-årigt forsøg hos hunde på 10-12 uger viste fund i binyren (fokal inflammation og degeneration i de områder af hjernebarken, der producerer glukokortikoider) og let kompromitteret kortisolproduktion efter eksogen stimulering med binyrestimulerende hormon.
English: Non-ambulatory
Danish: Ikke-ambulante patienter
English: In a separate clinical study, the extent of exposure for adefovir was 60% higher in the presence of ataluren.
Danish: I et separat klinisk studie var eksponeringen for adefovir 60 % højere ved tilstedeværelse af ataluren.
English: Steady-state plasma concentrations are dose-proportional for ataluren doses between 10 and 50 mg/kg, and no accumulation is observed after repeated dosing.
Danish: Plasmakoncentrationer ved steady state er proportionelle med dosis for ataluren-doser mellem 10 og 50 mg/kg, og der observeres ingen akkumulering efter gentagen dosering.
English: The amount of the liquid or semi-solid food can be increased based on your preference.
Danish: Mængden af væske eller halvflydende mad kan øges efter eget ønske.
English: At a single tested, relatively low, maternal dose of 30 mg/kg, the concentration of foetal radioactivity was ≤ 27% of the maternal concentration.
Danish: Ved en enkelt testet, relativt lav, maternel dosis på 30 mg/kg, var koncentrationen af radioaktivitet hos fostre ≤ 27% af den maternelle koncentration.
English: Presence of radioactivity in pup plasma confirmed absorption from the milk by the pups.
Danish: Tilstedeværelsen af radioaktivitet i rotteungernes plasma bekræftede ungernes absorption fra mælken.
English: Breast-feeding should be discontinued during treatment with ataluren.
Danish: Amning skal ophøre under behandling med ataluren.
English: In a 48-week open-label extension study in patients with nmDMD patients who were ambulant or nonambulant demonstrated a similar safety profile.
Danish: I et åbent forlængelsesstudie på 48 uger hos patienter med nmDMD var sikkerhedsprofilen den samme hos ambulante og ikke-ambulante patienter.
English: Adverse reactions reported in >1 ataluren-treated patients with nmDMD at a frequency greater than placebo in the 2 placebo-controlled studies (pooled analysis)
Danish: Bivirkninger rapporteret hos >1 ataluren-behandlede patienter med nmDMD ved en forekomst, som var hyppigere end placebo i de 2 placebokontrollerede studier (sammenlagt analyse)
English: Based on the in vitro studies, ataluren is not expected to be an inhibitor of neither p-gp mediated transport nor of cytochrome P450 mediated metabolism.
Danish: Baseret på in vitro studier forventes ataluren ikke at hæmme hverken P-gp medieret transport eller CYP-medieret metabolisme.
English: Treatment should not be initiated in previously untreated patients with eGFR <30 ml/min (see sections 4.2 and 5.2).
Danish: Behandling bør ikke påbegyndes hos tidligere ubehandlede patienter med eGFR < 30 ml/min (se pkt.
English: Open the sachet only at the time you are taking the medicine and use the entire amount from the sachet.
Danish: Åbn først brevet, når du skal tage lægemidlet, og brug hele brevets indhold.
English: Translarna should be administered orally after mixing it to a suspension in liquid or in semi-solid food.
Danish: Translarna skal indgives peroralt efter opblanding til en suspension i væske eller halvflydende mad.
English: Nonclinical in vitro experiments in nonsense mutation cellular assays and fish larvae cultured in an ataluren solution have shown that ataluren enabled ribosomal readthroughwith a bell-shaped (inverted-U shaped) concentration-response relationship.
Danish: Ikke-kliniske in vitro studier af nonsense-mutation med cellulære analyser og fiskelarver dyrket i en ataluren-opløsning har vist at ataluren muliggør ribosomal aflæsning med et klokkeformet (omvendt U-form) koncentrations-respons-forhold.
English: ≥75 meters without the need for assistive devices during a screening 6-Minute Walk Test (6MWT).
Danish: Alle patienter skulle være i stand til at gå ≥75 meter uden hjælpemidler under en seks minutters gangtest (6MWT) ved screening.
English: There should be 6 hours between morning and midday doses, 6 hours between midday and evening doses, and 12 hours between the evening dose and the first dose on the next day.
Danish: Der bør være 6 timer mellem morgen- og middagsdoserne, 6 timer mellem middags- og aftendoserne, og 12 timer mellem aftendosen og den første dosis den næste dag.
English: Since the mechanism by which ataluren increases nephrotoxicity of intravenous aminoglycosides is not known, concomitant use of other nephrotoxic medicinal products with ataluren is not recommended.
Danish: Da den mekanisme, hvormed ataluren potenserer den nefrotoksiske effekt af intravenøse aminoglykosider, ikke er kendt, frarådes samtidig brug af andre nefrotoksiske lægemidler og ataluren.
English: In particular do not take Translarna with the antibiotics gentamicin, tobramycin, or streptomycin given by injection.
Danish: I særdeleshed må du ikke tage Translarna sammen med antibiotika, der indeholder gentamicin-, tobramycin- eller streptomycin, der indgives som injektioner.
English: No dosage adjustment is required for patients with mild or moderate renal impairment.
Danish: Dosisjustering er ikke nødvendig for patienter med let eller moderat nedsat nyrefunktion.
English: In addition, a 3 to 8 fold increase in ataluren metabolite has been reported in patients with severe renal impairment (eGFR <30 ml/min).
Danish: Endvidere er der rapporteret en 3 til 8 gange stigning i ataluren-metabolit hos patienter med svært nedsat nyrefunktion (eGFR < 30 ml/min).
English: Paediatric patients with body weight ≥12 kg are treated as per the dosing recommendations by body weight range (see above dosing table).
Danish: Pædiatriske patienter med en legemsvægt ≥ 12 kg behandles ifølge doseringsanbefalingerne efter legemsvægtklasse (se ovenstående doseringstabel).
English: If you become pregnant while taking Translarna, consult your doctor immediately as it is recommended not to take Translarna while you are pregnant or breast-feeding.
Danish: Hvis du bliver gravid, mens du tager Translarna, skal du straks tale med lægen, da det anbefales, at du ikke tager Translarna, mens du er gravid eller ammer.
English: Do not use this medicine after the expiry date, which is stated on the carton and sachet after ‘EXP'.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på kartonen og brevet efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: An increase in ataluren exposure and in ataluren metabolite has been reported in patients with severe renal impairment (eGFR <30 ml/min).
Danish: En stigning i ataluren-eksponering og ataluren-metabolit er rapporteret hos patienter med svært nedsat nyrefunktion (eGFR < 30 ml/min).
English: Recommended dosing intervals are 6 hours between morning and midday doses, 6 hours between midday and evening doses, and 12 hours between the evening dose and the first dose on the next day.
Danish: Det anbefalede dosisinterval er 6 timer mellem morgen- og middagsdoserne, 6 timer mellem middags- og aftendoserne og 12 timer mellem aftendosis og den første dosis den næste dag.
English: What you need to know before you take Translarna Do not take Translarna
Danish: Det skal du vide, før du begynder at tage Translarna Tag ikke Translarna:
English: Other medicines and Translarna
Danish: Brug af anden medicin sammen med Translarna
English: At a single, relatively low, maternal dose of 30 mg/kg radiolabelled ataluren, the highest measured concentration of radioactivity in rat milk was 37% of the maternal plasma concentration.
Danish: Ved en enkelt, relativt lav, maternel dosis på 30 mg/kg radioaktivt mærket ataluren var den højeste målte koncentration af radioaktivitet i rottemælk 37 % af den maternelle plasmakoncentration.
English: The prepared dose should be discarded if not consumed within 24 hours of preparation if kept refrigerated (2 - 8 °C), or within 3 hours at room temperature (15 - 30 °C).
Danish: Den tilberedte dosis skal kasseres, hvis den ikke anvendes inden for 24 timer efter tilberedning, hvis den opbevares nedkølet (2 - 8 °C), eller inden for 3 timer ved opbevaring ved stuetemperatur (15 - 30 °C).
English: The safety profile of ataluren is based on pooled data from two randomised, double-blind, 48-week placebo-controlled studies conducted in a total of 232 male patients with Duchenne muscular dystrophy (nmDMD) caused by a nonsense mutation treated at the recommended dose of 40 mg/kg/day (10, 10, 20 mg/kg; n=172) or at a dose of 80 mg/kg/day (20, 20, 40 mg/kg; n=60), as compared to placebo-treated patients (n=172).
Danish: Sikkerhedsprofilen for ataluren er baseret på sammenlagte data fra to randomiserede, dobbeltblindede, 48-ugers placebokontrollerede studier, som blev gennemført med ialt 232 mandlige patienter med Duchennes muskeldystrofi (nmDMD) forårsaget af en nonsense-mutation, som blev behandlet med den anbefalede dosis på 40 mg/kg/dag (10, 10, 20 mg/kg; n=172 eller med en dosis på 80 mg/kg/dag (20, 20, 40 mg/kg; n=60) sammenlignet med placebobehandlede patienter (n=172).
English: These findings were seen in dogs at systemic exposure equivalent to 0.8 times the steady state AUC in patients administered Translarna at respective morning, midday, and evening doses of 40 mg/kg/day and higher.
Danish: Disse fund blev set hos hunde ved systemisk eksponering svarende til 0,8 gange steady state AUC hos patienter, som fik Translarna ved de respektive morgen-, middags-, og aftendoser på 40 mg/kg/dag og højere.
English: Patients were required to have documented confirmation of the presence of a nonsense mutation in the dystrophin gene as determined by gene sequencing.
Danish: Patienter skulle desuden have dokumenteret bekræftelse på tilstedeværelse af en nonsense-mutation i dystrofingenet som påvist ved gen-sekvensering.
English: The pharmacokinetics of ataluren are unlikely to be affected by medicinal products that inhibit the p-glycoprotein transporter.
Danish: Det er ikke sandsynligt, at atalurens farmakokinetik påvirkes af lægemidler, der hæmmer p-glykoproteintransporteren.
English: Patients were randomised in a 1:1:1 ratio and received ataluren or placebo 3 times per day (morning, midday, and evening), with 57 receiving ataluren 40 mg/kg/day (10, 10, 20 mg/kg), 60 receiving ataluren 80 mg/kg/day (20, 20, 40 mg/kg), and 57 receiving placebo.
Danish: Patienter blev randomiseret i et 1:1:1 forhold, og de fik ataluren eller placebo 3 gange dagligt (morgen, middag og aften), og 57 patienter fik ataluren 40 mg/kg/dag (10, 10, 20 mg/kg), 60 fik ataluren 80 mg/dk/dag (20, 20, 40 mg/kg) og 57 fik placebo.
English: ≥150 meters and less than 80% predicted without the need for assistive devices during a screening
Danish: Alle patienter skulle være i stand til at gå ≥150 meter og mindre end 80 % blev forudsagt ikke at have behov for hjælpemidler under en screening med 6MWT.
English: Discard the prepared dose if not taken within 24 hours of preparation if kept refrigerated (2 - 8 °C), or within 3 hours at room temperature (1530 °C).
Danish: Kasser den tilberedte dosis, hvis den ikke tages inden for 24 timer efter tilberedning, hvis den opbevares nedkølet (2 - 8 °C), eller inden for 3 timer ved stuetemperatur (15 - 30 °C).
English: Evening
Danish: Middag
English: In a rat distribution study a high adrenal concentration of ataluren was observed.
Danish: I et distributionsstudie med rotter blev der observeret en høj koncentration af ataluren i binyren.
English: The presence of a nonsense mutation in the dystrophin gene should be determined by genetic testing (see section 4.4).
Danish: Tilstedeværelse af en nonsense-mutation i dystrofin-genet skal bestemmes ved genetisk test (se pkt.
English: These findings suggested that co-administration of Translarna and intravenous aminoglycosides may potentiate the nephrotoxic effect of the aminoglycosides.
Danish: Disse fund antyder, at samtidig indgivelse af Translarna og intravenøse aminoglykosider kan potensere den nefrotoksiske effekt af aminoglykosiderne.
English: A post-hoc analysis of time to persistent 10% worsening in 6MWD showed that 26% of patients in the ataluren 40 mg/kg/day arm had progressed at Week 48 compared to 44% in the placebo group (p=0.0652) (Figure 2).
Danish: En post-hoc analyse af tid til 10 % vedvarende forværring i 6MWD viste, at 26 % af patienterne i gruppen, som fik 40 mg/kg/dag ataluren, var blevet værre ved uge 48 sammenlignet med 44 % i placebo-gruppen (p=0,0652) (figur 2).
English: Over 48 weeks, ataluren-treated patients showed less decline in muscle function, as evidenced by smaller increases in the time to run/walk 10 meters, climb 4 steps, and descend 4 steps in the atalurentreated group relative to placebo.
Danish: Over 48 uger viste ataluren-behandlede patienter mindre fald i muskelfunktion, hvilket fremgik af mindre stigninger i den tid, det tog at løbe/gå 10 meter, gå op ad 4 trin, og gå ned ad 4 trin i den ataluren-behandlede gruppe i forhold til placebo.
English: Artificial vanilla flavour: maltodextrin, artificial flavours and propylene glycol.
Danish: Kunstig vanilje aroma: Maltodextrin, kunstige smagsstoffer og propylenglycol.
English: Because changes in lipid profile (increased triglycerides and cholesterol) were reported for some patients in clinical trials, it is recommended that total cholesterol, LDL, HDL, and triglycerides be monitored on an annual basis in nonsense mutation Duchenne muscular dystrophy (nmDMD) patients receiving ataluren, or more frequently as needed based on the patient's clinical status.
Danish: Da ændringer i lipidprofil (forhøjede triglycerider og kolesterol) blev rapporteret for visse patienter i kliniske forsøg, anbefales det, at total kolesterol, LDL, HDL og triglycerider overvåges på årlig basis hos patienter med nonsense mutation Duchennes muskeldystrofi (nmDMD), som får ataluren, eller hyppigere efter behov baseret på patientens kliniske status.
English: Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Danish: Fortæl det altid til lægen, hvis du tager anden medicin eller har gjort det for nylig.
English: Co-administration of ataluren with mycophenolate mofetil in healthy subjects did not affect the exposure of its active metabolite, mycophenolic acid (a substrate of UGT1A9).
Danish: Samtidig administration af ataluren og mycophenolatmofetil til raske forsøgspersoner påvirkede ikke eksponeringen for den aktive metabolit mycophenolsyre (substrat for UGT1A9).
English: Patients with severe renal impairment (eGFR <30 ml/min) or end-stage renal disease should be treated with ataluren only if the anticipated clinical benefit outweighs the potential risk (see sections 4.2 and 4.4).
Danish: Patienter med svært nedsat nyrefunktion (eGFR < 30 ml/min) eller nyresygdom i slutstadiet bør kun behandles med ataluren, hvis den forventede kliniske gavn opvejer den potentielle risiko (se pkt.
English: Decreased appetite, hypertriglyceridaemia
Danish: Reduceret appetit, hypertriglyceridæmi
English: Translarna is indicated for the treatment of Duchenne muscular dystrophy resulting from a nonsense mutation in the dystrophin gene, in ambulatory patients aged 2 years and older (see section 5.1).
Danish: Translarna er indiceret til behandling af Duchennes muskeldystrofi, der er forårsaget af en nonsensemutation i dystrofin-genet hos ambulante patienter i alderen 2 år og derover (se pkt.
English: Heat-sealed laminated aluminium foil sachet: polyethylene terephthalate (child resistance), polyethylene (coloring and polyester/foil bond), aluminum foil (moisture barrier), adhesive (polyurethane class), copolymer of ethylene and methacrylic acid (sealant resin for packaging integrity).
Danish: Varmeforseglet aluminiumlamineret foliebrev: polyethylenterephtalat (børnesikring), polyethylen (farve og polyester/folie-binding), aluminiumfolie (fugtspærre), klæbestof (polyurethan-klasse), copolymer af ethylen og methacrylsyre (forseglingsresin til pakningsintegritet).
English: For storage conditions after dilution of the medicinal product, see section 6.3.
Danish: Opbevaringsforhold efter tilberedning af lægemidlet, se pkt.
English: Caution should be exercised when ataluren is co-administered with medicinal products that are inducers of UGT1A9, or substrates of OAT1 or OAT3 (see section 4.5).
Danish: Der skal udvises forsigtighed, når ataluren administreres samtidig med lægemidler, der inducerer UGT1A9 eller er substrater for OAT1 eller OAT3 (se pkt.
English: Placental transfer was shown of radiolabelled ataluren in rats.
Danish: Der blev påvist overførsel af radioaktivt mærket ataluren gennem placenta hos rotter.
English: No dosing adjustment is needed for patients who are becoming nonambulatory.
Danish: Det er ikke nødvendigt at justere dosis for patienter, som ikke længere er ambulante.
English: Concomitant use of intravenous aminoglycosides (see sections 4.4 and 4.5).
Danish: Samtidig brug af intravenøse aminoglykosider (se pkt.
English: Ataluren should not be co-administered with intravenous aminoglycosides, based on cases of decreased renal function observed in a clinical trial in patients with nmCF (see section 4.3).
Danish: Ataluren må ikke administreres samtidig med intravenøse aminoglykosider baseret på tilfælde af nedsat nyrefunktion observeret i et klinisk forsøg hos patienter med nmCF (nonsense mutation Cystisk Fibrose) (se pkt.
English: Caution should be exercised when ataluren is co-administered with medicinal products that are inducers of UGT1A9 (eg rifampicin).
Danish: Der skal udvises forsigtighed, når ataluren administreres sammen med lægemidler, der inducerer UGT1A9 (f.eks. rifampicin).
English: Because small increases in mean serum creatinine, blood urea nitrogen (BUN), and cystatin C were observed in the controlled studies of nmDMD, it is recommended that serum creatinine, BUN, and cystatin C be monitored every 6 to 12 months in nmDMD patients receiving ataluren, or more frequently as needed based on the patient's clinical status.
Danish: Da små stigninger i gennemsnitlig serumkreatinin, blodurinkvælstof (BUN) og cystatin C blev observeret i det kontrollerede studier af nmDMD, anbefales det, at serumkreatinin, BUN og cystatin C overvåges hver 6. til 12. måned hos patienter med nmDMD, der får ataluren, eller hyppigere efter behov baseret på patientens kliniske status.
English: The European Medicines Agency has waived the obligation to submit the results of studies with ataluren in two subsets of the paediatric population from birth to less than 28 days and infants from 28 days to less than 6 months in nmDMD, as per Paediatric Investigation Plan (PIP) decision in the granted indication (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med ataluren vedrørende nmDMD for to undergrupper af den pædiatriske population fra fødslen til højst 28 dage, og spædbørn fra 28 dage til højst 6 måneder, ifølge beslutningen i det Pædiatriske Forsknings- og Udviklingsprogram (PIP) for den godkendte indikation (se pkt.
English: No dosage adjustment is required for patients with mild, moderate or severe hepatic impairment (see section 5.2).
Danish: Dosisjustering er ikke nødvendig for patienter med let, moderat eller svært nedsat leverfunktion (se pkt.
English: Because hypertension with use of concomitant systemic corticosteroids was reported for some patients in clinical trials, it is recommended that resting systolic and diastolic blood pressure be monitored every 6 months in nmDMD patients receiving ataluren concomitantly with corticosteroids, or more frequently as needed based on the patient's clinical status.
Danish: Da der blev rapporteret hypertension ved samtidig brug af systemiske kortikosteroider hos visse patienter i kliniske forsøg, anbefales overvågning af systolisk og diastolisk blodtryk i hvile hver 6. måned hos patienter med nmDMD, der får ataluren samtidig med kortikosteroider, eller hyppigere efter behov baseret på patientens kliniske status.
English: The maternal systemic exposure at the no observed effect level (NOEL) for neonatal toxicity was about 3 times human exposure.
Danish: (NOEL) for neonatal toksicitet var cirka 3 gange den humane eksponering.
English: Translarna is available in sachets of 125 mg, 250 mg or 1000 mg.
Danish: Translarna fås i breve med 125 mg, 250 mg eller 1.000 mg.
English: No dose adjustment is required when ataluren is co-administered with medicinal products that are substrates of UGT1A9.
Danish: Dosisjustering er ikke nødvendig ved samtidig administration af ataluren og lægemidler, der er substrater for UGT1A9.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with ataluren in one subset of the paediatric population aged 6 months to less than 5 years old in nmDMD, as per Paediatric Investigation Plan (PIP) decision in the granted indication (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med ataluren vedrørende nmDMD for en undergruppe af den pædiatriske population i alderen fra 6 måneder til højst 5 år, ifølge beslutningen i det Pædiatriske Forsknings- og Udviklingsprogram (PIP) for den godkendte indikation (se pkt.
English: Renal function monitoring
Danish: Overvågning af nyrefunktion
English: Translarna is available in 3 strengths, each containing 125 mg, 250 mg and 1000 mg of the active substance, called ataluren.
Danish: Translarna fås i 3 styrker, som hver indeholder hhv. 125 mg, 250 mg og 1.000 mg af det aktive stof, der kaldes ataluren.
English: Mean Change in Timed Function Tests (Study 1)
Danish: Middelændring i tidssatte funktionstests (Studie 1)
English: No apparent differences of the total ataluren exposure in the control, mild, and severe hepatic impairment groups were observed.
Danish: Der blev ikke observeret nogen umiddelbar forskel i den samlede eksponering for ataluren i kontrolgruppen og grupperne med let og svært nedsat leverfunktion.
English: In addition, ataluren was found to increase nephrotoxicity of intravenous aminoglycosides.
Danish: Derudover er det fundet, at ataluren potenserede den nefrotoksiske effekt af intravenøse aminoglykosider.