FrancophonIA/ELRC3.0 huggingface dataset:
English: The effect of co-administration of ataluren with other nephrotoxic medicinal products is unknown.
Danish: Effekten af administration af ataluren sammen med andre nefrotoksiske lægemidler kendes ikke.
English: Study 1 evaluated 174 male patients, ages 5 to 20 years.
Danish: I Studie 1 vurderedes 174 mandlige patienter i alderen 5 til 20 år.
English: The most common adverse reactions in the 2 placebo-controlled studies were vomiting, diarrhoea, nausea, headache, upper abdominal pain, and flatulence, all occurring in ≥5% of all ataluren-treated patients.
Danish: De mest almindelige bivirkninger i de 2 placebokontrollerede studier var opkastning, diarré, kvalme, hovedpine, mavesmerter i den øvre del af abdomen samt flatulens, som alle forekom i ≥5 % af alle ataluren-behandlede patienter.
English: Almac Pharma Services 22 Seagoe Industrial Estate Craigavon BT63 5QD United Kingdom
Danish: Almac Pharma Services 22 Seagoe Industrial Estate Craigavon BT63 5QD Storbritannien
English: In the urine, unchanged ataluren and the acyl glucuronide metabolite account for <1% and 49%, respectively, of the administered dose.
Danish: I urinen udgjorde uændret ataluren og acyl glucuronid metabolitten hhv. < 1 % og 49 % af den administrerede dosis.
English: Therefore, caution should be exercised when ataluren is co-administered with medicinal products that are substrates of OAT1 or OATP1B3 because of the risk of increased concentration of these medicinal products (eg oseltamivir, aciclovir, captopril, furosemide, bumetanide, valsartan, pravastatin, rosuvastatin, atorvastatin, pitavastatin).
Danish: Der skal derfor udvises forsigtighed, når ataluren administreres samtidig med lægemidler, der er substrater for OAT1 eller OATP1B3, pga. risikoen for en øget koncentration af disse lægemidler (f.eks. oseltamivir, aciclovir, captopril, furosemid, bumetanid, valsartan, pravastatin, rosuvastatin, atorvastatin, pitavastatin).
English: These results indicate that fewer patients receiving ataluren 40 mg/kg/day worsened in 6MWD over 48 weeks.
Danish: Disse resultater indikerer, at færre patienter, der fik 40 mg/kg/dag ataluren, fik det værre i 6MWD i løbet af 48 uger.
English: In rats and rabbits embryo-foetal toxicity (e.g. increased early resorptions, postimplantation loss, decreased viable foetuses) and signs of delayed development (increased skeletal variations) were found in the presence of maternal toxicity.
Danish: Hos rotter og kaniner blev der fundet embryo-føtal toksicitet (f.eks. øget tidlig resorption, tab efter implantation, færre levedygtige fostre) og tegn på forsinket udvikling (øgede skeletale variationer) ved tilstedeværelse af maternel toksicitet.
English: The primary efficacy endpoint in both trials was change in 6 Minute Walk Distance (6MWD) at Week 48.
Danish: Det primære effektmål i begge forsøg var en ændring i seks minutters gangtest (6 Minute Walk Distance, 6MWD) i uge 48.
English: Nausea, upper abdominal pain, flatulence, abdominal discomfort, constipation
Danish: Kvalme, mavesmerter i den øvre del af abdomen, flatulens, abdominalt ubehag, obstipation
English: Ataluren plasma concentrations in patients from 2 to less than 5 years old were consistent with those seen in patients above the age of 5 years receiving the 10/10/20 mg/kg dose regimen.
Danish: Plasmakoncentrationer af ataluren hos patienter fra 2 til under 5 år svarede til dem, som blev set hos patienter over 5 år, som fik doseringsregimenet 10/10/20 mg/kg.
English: Change in renal function tests (increased creatinine, blood urea nitrogen, cystatin C)
Danish: Ændring i nyrefunktionstest (forhøjet kreatinin, blodureanitrogen, cystatin C)
English: Also rat and dog studies showed changes in plasma lipid (cholesterol and triglycerides) suggestive of changes in fat metabolism.
Danish: Desuden viste rotte- og hundestudier ændringer i plasmalipider (kolesterol og triglycerider), som antyder ændringer i fedtstofmetabolismen.
English: Nonclinical in vitro studies suggest that continuous exposure to ataluren may be important for maximizing activity and that effects of the active substance on ribosomal read-through of premature stop codons reverse shortly after withdrawal of ataluren.
Danish: Ikke-kliniske in vitro studier antyder, at kontinuerlig eksponering for ataluren muligvis er vigtig for maksimering af aktivitet, og at det aktive stofs effekt på ribosomal aflæsning af præmaturt stop codon reverseres kort tid efter seponering af ataluren.
English: In the rat pre/postnatal developmental toxicity study, at exposure about 5 times human exposure, significant maternal toxicity as well as effects on offspring body weight and development of ambulatory activity were observed.
Danish: I toksicitetsstudier af præ-/postnatal udvikling hos rotter ved en eksponering på omtrent 5 gange den humane eksponering observeredes signifikant maternel toksicitet såvel som effekt på afkommets kropsvægt og udvikling af ambulant aktivitet.
English: The medicine is taken by mouth mixed in liquid or semi-solid food.
Danish: Lægemidlet tages gennem munden blandet med væske eller halvfast føde.
English: You may experience mild headache, nausea, vomiting or diarrhoea.
Danish: Du kan få let hovedpine, kvalme, opkastning eller diaré.
English: An approximately 40% decrease of mean total ataluren exposure in the moderate hepatic impairment group versus the control group was noted probably due to the small sample size and variability.
Danish: Et fald på cirka 40 % i den gennemsnitlige eksponering for ataluren blev observeret i gruppen med moderat nedsat leverfunktion sammenlignet med kontrolgruppen, hvilket sandsynligvis skyldes den lille prøvestørrelse og variabilitet.
English: Patients were randomised in a 1:1 ratio and received ataluren 40 mg/kg/day (n=115) or placebo (n=115) 3 times per day (morning, midday, and evening).
Danish: Patienterne blev randomiseret i et 1:1 forhold og fik ataluren 40 mg/kg/dag (n=115) eller placebo (n=115) 3 gange om dagen (morgen, middag og aften).
English: In vitro, ataluren is not a substrate for the p-glycoprotein transporter.
Danish: In vitro er ataluren er ikke et substrat for p-glykoproteintransporteren.
English: TRANSLARNA 10 mg/kg, 10 mg/kg, 20 mg/kg (N=57) Placebo (N=57)
Danish: TRANSLARNA 10, 10, 20 mg/kg (N=57) Placebo (N=57)
English: In the clinical program investigating the efficacy and safety of monotherapy ataluren in patients with nonsense mutation cystic fibrosis, no statistically significant effect was observed in the primary and key secondary clinical outcome measures (ppFEV1 and pulmonary exacerbation rate) in adults and children aged 6 years and older.
Danish: I det kliniske program, der undersøgte effekten og sikkerheden af monoterapeutisk ataluren hos patienter med nonsens-mutation cystisk fibrose, blev der ikke observeret nogen statistisk signifikant effekt i de primære og vigtigste sekundære kliniske resultatmål (ppFEV1 og pulmonal eksacerbationsrate) hos voksne og børn i alderen 6 år og derover.
English: Therefore, patients with severe renal impairment or end-stage renal disease should be treated with ataluren only if the anticipated clinical benefit outweighs the potential risk, and should be closely monitored for possible metabolite toxicity and decrease in efficacy.
Danish: Patienter med svært nedsat nyrefunktion eller nyresygdom i slutstadiet bør derfor kun behandles med ataluren, hvis den forventede kliniske gavn opvejer den potentielle risiko, og bør monitoreres nøje for mulig metabolit-toksicitet og nedsat virkning.
English: The elimination of ataluren is likely dependent on hepatic and renal glucuronidation of ataluren followed by renal and hepatic excretion of the resulting glucuronide metabolite.
Danish: Elimination af ataluren afhænger sandsynligvis af glukuronidering af ataluren i leveren og nyrerne efterfulgt af renal og hepatisk udskillelse af den resulterende glukuronidmetabolit.
English: After a single oral dose of radiolabeled ataluren, approximately half of the administered radioactive dose is recovered in the faeces and the remainder was recovered in the urine.
Danish: Efter en enkelt oral dosis af radioaktivt mærket ataluren, genfindes cirka halvdelen af den administrerede radioaktive dosis i fæces og den resterende del i urinen.
English: Common side effects (may affect up to 1 in 10 people): - Decreased appetite - High blood triglyceride levels - Headache - Feeling sick - Weight loss - High blood pressure - Cough - Nosebleed - Constipation - Wind - Stomach discomfort - Stomach pain - Rash - Arm or leg pain - Chest pain - Involuntary urination - Blood in urine - Fever
Danish: Almindelige bivirkninger (kan påvirke op til 1 ud af 10 personer): - Nedsat appetit - Høje blodkoncentrationer af triglycerid - Hovedpine - Sløj - Vægttab - Højt blodtryk - Hoste - Næseblod - Forstoppelse - Luft i maven - Mavegener - Mavesmerter - Udslæt - Smerter i arm eller ben - Brystsmerter - Ufrivillig vandladning - Blod i urinen - Feber
English: Peak plasma levels of ataluren are attained approximately 1.5 hours after dosing in subjects who received medicinal product within 30 minutes of a meal.
Danish: Maksimale plasmaniveauer af ataluren opnås cirka 1,5 timer efter dosering hos forsøgspersoner, som fik lægemidlet inden for 30 minutter efter et måltid.
English: In the ITT population, the hazard ratio for ataluren versus placebo was 0.75 (p=0.160), representing a 25% reduction in the risk of 10% 6MWD worsening.
Danish: I ITT-populationen var risikoforholdet for ataluren versus placebo 0,75 (p=0,160), hvilket repræsenterer en reduktion på 25 % i risikoen for 10 % forværring af 6MWD.
English: Change in lipid profile (increased triglycerides and cholesterol)
Danish: Ændring i lipidprofil (forhøjede triglycerider og kolesterol)
English: Silica, colloidal anhydrous (E551)
Danish: Silica, kolloid vandfri (E551)
English: Available pharmacodynamic/toxicological data in animals have shown excretion of ataluren/metabolites in milk (see section 5.3).
Danish: De tilgængelige farmakodynamiske/toksikologiske data fra dyr viser, at ataluren/metabolitter udskilles i mælk (se pkt.
English: Administration of ataluren on a body weight-adjusted basis (mg/kg) resulted in similar steady-state exposures (AUC) among children and adolescents with nmDMD over a broad range of body weights.
Danish: legemsvægt (mg/kg) resulterede i tilsvarende steady-state eksponeringer (AUC) blandt børn og unge med nmDMD over et bredt interval af legemsvægte.
English: The adverse reactions reported in patients with nmDMD treated with the recommended daily dose of 40 mg/kg/day ataluren in the 2 placebo-controlled studies are presented in Table 1.
Danish: Bivirkningerne, der blev rapporteret hos patienter med nmDMD, som blev behandlet med den anbefalede daglige dosis på 40 mg/kg/dag ataluren i de 2 placebokontrollerede studier, er anført i Tabel 1.
English: Based on a pharmacokinetic assessment conducted in groups with either mild, moderate or severe hepatic impairment versus a control group of healthy subjects, no dose adjustment is required for patients with any degree of hepatic impairment.
Danish: Baseret på en farmakokinetisk vurdering udført for grupper med enten let, moderat eller svært nedsat leverfunktion sammenlignet med en kontrolgruppe af raske deltagere er en dosisjustering ikke nødvendig for patienter med en hvilken som helst grad af nedsat leverfunktion.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton Box
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Æske
English: This means that there is more evidence to come about this medicine.
Danish: Det betyder, at der forventes yderligere dokumentation for lægemidlet.
English: No serious adverse reactions were observed in these subjects.
Danish: Ingen alvorlige bivirkninger blev observeret hos disse forsøgspersoner.
English: Translarna is used to treat Duchenne muscular dystrophy resulting from a specific genetic defect that affects normal muscle function.
Danish: Translarna anvendes til at behandle Duchennes muskeldystrofi, der er forårsaget af en specifik genetisk defekt, der påvirker normal muskelfunktion.
English: The serum creatinine elevations resolved in all cases, with discontinuation of the intravenous aminoglycoside, and either continuation or interruption of Translarna.
Danish: Forhøjelserne i serumkreatinin fortog sig i alle tilfælde efter seponering af intravenøs aminoglykosid, samt ved enten fortsættelse eller afbrydelse af Translarna.
English: - If you are receiving treatment with certain antibiotics, such as gentamicin, tobramycin, or streptomycin by injection into a vein.
Danish: - Hvis du får behandling med visse typer antibiotika såsom gentamicin, tobramycin eller streptomycin ved injektion i en vene.
English: Based on the urinary recovery of radioactivity in a single-dose study of radiolabeled ataluren, the oral bioavailability of ataluren is estimated to be ≥ 55%.
Danish: Baseret på genfindelse af radioaktivitet i urin i et enkelt-dosis forsøg med radioaktivt mærket ataluren skønnes den orale biotilgængelighed af ataluren at være ≥ 55 %.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Aluminium sachet
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER Aluminiumbrev
English: In a clinical study, the extent of exposure for ciprofloxacin was 32% higher in the presence of ataluren.
Danish: I et klinisk studie var eksponeringen for ciprofloxacin 32 % højere ved tilstedeværelse af ataluren.
English: The steady-state is established after approximately two weeks of thrice daily dosing.
Danish: Steady state opnås efter cirka to uger med dosering tre gange dagligt.
English: In order to confirm the efficacy and safety of ataluren in the treatment of ambulant patients with nmDMD aged 5 years or older, the MAH should conduct and submit the results of a multicentre, randomised, double-blind, 18-month, placebocontrolled study, followed by a 18-month open label extension, according to an agreed protocol.
Danish: For at bekræfte effekten og sikkerheden af ataluren til behandling af ambulante patienter med nmDMD på 5 år eller mere, skal indehaveren af markedsføringstilladelsen foretage og indsende resultaterne af et multicenter, randomiseret, dobbeltblindet, placebokontrolleret forsøg på 18 måneder efterfulgt af en open-label forlængelse på 18 måneder ifølge en aftalt protokol.
English: The table below provides information on which sachet strength(s) to use in the preparation of the recommended dose by body weight range.
Danish: Nedenstående tabel giver information om hvilke(n) styrke(r) brev(e), der skal bruges ved tilberedning af den anbefalede dosis iht.
English: Sachets should only be opened at the time of dose preparation.
Danish: Breve bør først åbnes, når dosis skal tilberedes.
English: Weeks
Danish: Uger
English: If you stop taking Translarna
Danish: Hvis du holder op med at tage Translarna
English: Duchenne muscular dystrophy is caused by genetic changes that result in an abnormality in a muscle protein called dystrophin which is needed for muscles to work properly.
Danish: Duchennes muskeldystrofi er forårsaget af genetiske ændringer, der resulterer i en abnormitet i et muskelprotein, er kaldes dystrofin, som er nødvendig for, at musklerne kan fungere korrekt.
English: The differences favoring ataluren versus placebo in mean changes in timed function tests at Week 48 in the ITT population reached the threshold for a clinically meaningful difference (changes ~1 to 1.5 seconds).
Danish: Forskellene, som favoriserer ataluren versus placebo i de gennemsnitlige ændringer i tidssatte funktionstest i uge 48 i ITT-populationen, nåede tærsklen for en klinisk relevant forskel (ændringer ~1 til 1,5 sekunder).
English: Adverse reactions reported in >1 patient in the 40 mg/kg/day group at a frequency greater than that of the placebo group are presented by MedDRA System Organ Class, Preferred Term, and frequency.
Danish: Bivirkninger rapporteret hos >1 patient i 40 mg/kg/dag-gruppen med en forekomst, der var hyppigere end placebogruppens, er anført efter MedDRA systemorganklasse, foretrukket term og hyppighed.
English: Caution should also be exercised when ataluren is co-administered with OAT3 substrates (eg, ciprofloxacin), especially those OAT3 substrates with a narrow therapeutic window.
Danish: Der bør også udvises forsigtighed, når ataluren administreres samtidig med substrater for OAT3 (f.eks. ciprofloxacin), særligt substrater for OAT3 med et smalt terapeutisk vindue.
English: Studies in animals have shown reproductive toxicity only at doses that resulted in maternal toxicity (see section 5.3).
Danish: Dyrestudier har udelukkende påvist reproduktionstoksicitet ved doser, som medførte maternel toksicitet (se pkt.
English: Elevations of serum creatinine occurred in several nmCF patients treated with ataluren and intravenous aminoglycosides together with other antibiotics for cystic fibrosis exacerbations.
Danish: Forhøjelser i serumkreatinin forekom hos flere patienter med nmCF, der blev behandlet samtidig med ataluren og intravenøse aminoglykosider sammen med andre antibiotika mod forværring af cystisk fibrose.
English: The co-administration of these medicinal products with ataluren should be avoided (see section 4.3).
Danish: Samtidig administration af disse lægemidler og ataluren bør undgås (se pkt.
English: In a clinical study to evaluate the potential for ataluren to inhibit the OATP1B3 transport system using a single-dose of 80 mg telmisartan, an in-vitro selective OATP1B3 substrate, ataluren increased the exposure to telmisartan by 28%.
Danish: I et klinisk studie, som havde til formål at evaluere ataluren som en potentiel hæmmer af OATP1B3 transportsystemet ved brug af en enkelt-dosis på 80 mg telmisartan, et selektivt substrat in vitro, øgede ataluren eksponeringen for telmisartan med 28 %.
English: Other endpoints included in both trials were time to persistent 10% worsening in 6MWD, change in time to run/walk 10 meters at Week 48, change in time to climb 4 stairs at Week 48, and change in time to descend 4 stairs at Week 48.
Danish: Andre effektmål inkluderet i begge forsøg var tid til vedvarende 10 % forværring i 6MWD, ændring i tid til 10 meters løb/gang i uge 48, ændring i tid til at gå op ad fire trin i uge 48 samt ændring i tid til at gå ned ad 4 trin i uge 48.
English: Following multiple dosing, the increase in ataluren and ataluren metabolite is anticipated to be higher in patients with severe renal impairment and end-stage renal disease when compared with patients with normal renal function at steady state.
Danish: Efter flere doseringer forventes stigningen i ataluren og ataluren-metabolit at være højere hos patienter med svært nedsat nyrefunktion og nyresygdom i slutstadiet, sammenlignet med patienter med normal nyrefunktion ved steady state.
English: In a pharmacokinetic study in subjects with varying degrees of renal impairment, following a single dose administration, ataluren plasma exposure changed by -13%, 27%, and 61% for the mild, moderate and severe groups, respectively, and 46% for the end-stage renal disease group compared with the normal renal function group.
Danish: I et farmakokinetisk studie med forsøgspersoner med varierende grader af nedsat nyrefunktion ændredes atalurenplasma-eksponering, efter en enkeltdosis-administration, med henholdsvis -13 %, 27 % og 61 % for grupperne med let, moderat og svært nedsat nyrefunktion, og med 46 % for gruppen med nyresygdom i slutstadiet, sammenlignet med gruppen med normal nyrefunktion.
English: Mix the prepared dose well before taking it.
Danish: Bland den tilberedte dosis godt før du tager den.
English: Each prepared dose is best administered immediately after preparation.
Danish: Hver tilberedt dosis administreres fortrinsvis umiddelbart efter tilberedning.
English: Effect of ataluren on pharmacokinetics of other medicinal products Based on in vitro studies, ataluren has the potential to inhibit UGT1A9, organic anion transporter 1 (OAT1), organic anion transporter 3 (OAT3) and organic anion transporting polypeptide 1B3 (OATP1B3).
Danish: Effekten af ataluren på andre lægemidlers farmakokinetik Baseret på in vitro studier er ataluren en potentiel hæmmer af UGT1A9, organisk aniontransporter 1 (OAT1), organisk aniontransporter 3 (OAT3) og organisk aniontransporterende polypeptid 1B3 (OATP1B3).
English: In a statistical based model the estimated mean difference was 31.7 meters (adjusted p=0.0367).
Danish: I en statistisk modelestimering var middeldifferencen 31,7 meter (justeret p=0,0367).
English: In a 2-year rat carcinogenicity study, one case of hibernoma was found.
Danish: I et 2-års karcinogenicitetsstudie med rotter forekom der ét tilfælde af hibernoma.
English: Co-administration of rifampicin, a strong inducer of metabolic enzymes including UGT1A9, decreased ataluren exposure by 29%.
Danish: Samtidig administration af rifampicin, der er en potent induktor af metaboliske enzymer (herunder UGT1A9), reducerede eksponeringen for ataluren med 29 %.
English: Translarna is white to off-white granules for oral suspension in sachets.
Danish: Translarna er hvidt til off-white granulat til oral suspension i breve.
English: Frequency groupings are defined to the following convention: very common (≥ 1/10) and common (≥ 1/100 to < 1/10).
Danish: (≥ 1/10) og almindelig (≥ 1/100 til < 1/10).
English: If you forget to take Translarna
Danish: Hvis du har glemt at tage Translarna
English: No clinically relevant change in the plasma concentrations of corticosteroids was seen with co-administration of ataluren.
Danish: Der sås ingen klinisk relevante ændringer i plasmakoncentrationer af kortikosteroider ved samtidig administration af ataluren.
English: Effect of other medicinal products on ataluren pharmacokinetics Based on in vitro studies, ataluren is a substrate of UGT1A9.
Danish: Effekten af andre lægemidler på atalurens farmakokinetik Baseret på in vitro studier er ataluren substrat for UGT1A9.
English: Medicinal products that affect the p-glycoprotein transporter
Danish: Lægemidler, der påvirker p-glykoproteintransporteren (P-gp)
English: The other ingredients are: polydextrose (E1200), macrogol, poloxamer, mannitol (E421), crospovidone, hydroxyethyl cellulose, artificial vanilla flavour (maltodextrin, artificial flavours and propylene glycol), silica, colloidal anhydrous (E551), magnesium stearate.
Danish: Øvrige indholdsstoffer: polydextrose (E1200), macrogol, poloxamer, mannitol (E421), crospovidon, hydroxyethylcellulose, kunstig vaniljearoma (maltodextrin, kunstige aromastoffer og propylenglycol), kolloid vandfri silica (E551), magnesiumstearat.
English: Contents of the pack and other information What Translarna contains
Danish: Pakningsstørrelser og yderligere oplysninger Translarna indeholder:
English: Granules for oral suspension 30 sachets
Danish: Granulat til oral suspension 30 breve