natgillin/translations-raw huggingface dataset:
I et distributionsstudie med rotter blev der observeret en høj koncentration af ataluren i binyren.
In a rat distribution study a high adrenal concentration of ataluren was observed.
Tilstedeværelse af en nonsense-mutation i dystrofin-genet skal bestemmes ved genetisk test (se pkt.
The presence of a nonsense mutation in the dystrophin gene should be determined by genetic testing (see section 4.4).
Disse fund antyder, at samtidig indgivelse af Translarna og intravenøse aminoglykosider kan potensere den nefrotoksiske effekt af aminoglykosiderne.
These findings suggested that co-administration of Translarna and intravenous aminoglycosides may potentiate the nephrotoxic effect of the aminoglycosides.
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).
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).
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.
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.
Kunstig vanilje aroma: Maltodextrin, kunstige smagsstoffer og propylenglycol.
Artificial vanilla flavour: maltodextrin, artificial flavours and propylene glycol.
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.
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.
Fortæl det altid til lægen, hvis du tager anden medicin eller har gjort det for nylig.
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Samtidig administration af ataluren og mycophenolatmofetil til raske forsøgspersoner påvirkede ikke eksponeringen for den aktive metabolit mycophenolsyre (substrat for UGT1A9).
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).
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.
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).
Reduceret appetit, hypertriglyceridæmi
Decreased appetite, hypertriglyceridaemia
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.
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).
Varmeforseglet aluminiumlamineret foliebrev: polyethylenterephtalat (børnesikring), polyethylen (farve og polyester/folie-binding), aluminiumfolie (fugtspærre), klæbestof (polyurethan-klasse), copolymer af ethylen og methacrylsyre (forseglingsresin til pakningsintegritet).
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).
Opbevaringsforhold efter tilberedning af lægemidlet, se pkt.
For storage conditions after dilution of the medicinal product, see section 6.3.
Der skal udvises forsigtighed, når ataluren administreres samtidig med lægemidler, der inducerer UGT1A9 eller er substrater for OAT1 eller OAT3 (se pkt.
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).
Der blev påvist overførsel af radioaktivt mærket ataluren gennem placenta hos rotter.
Placental transfer was shown of radiolabelled ataluren in rats.
Det er ikke nødvendigt at justere dosis for patienter, som ikke længere er ambulante.
No dosing adjustment is needed for patients who are becoming nonambulatory.
Samtidig brug af intravenøse aminoglykosider (se pkt.
Concomitant use of intravenous aminoglycosides (see sections 4.4 and 4.5).
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.
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).
Der skal udvises forsigtighed, når ataluren administreres sammen med lægemidler, der inducerer UGT1A9 (f.eks. rifampicin).
Caution should be exercised when ataluren is co-administered with medicinal products that are inducers of UGT1A9 (eg rifampicin).
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.
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.
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.
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).
Dosisjustering er ikke nødvendig for patienter med let, moderat eller svært nedsat leverfunktion (se pkt.
No dosage adjustment is required for patients with mild, moderate or severe hepatic impairment (see section 5.2).
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.
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.
(NOEL) for neonatal toksicitet var cirka 3 gange den humane eksponering.
The maternal systemic exposure at the no observed effect level (NOEL) for neonatal toxicity was about 3 times human exposure.
Translarna fås i breve med 125 mg, 250 mg eller 1.000 mg.
Translarna is available in sachets of 125 mg, 250 mg or 1000 mg.
Dosisjustering er ikke nødvendig ved samtidig administration af ataluren og lægemidler, der er substrater for UGT1A9.
No dose adjustment is required when ataluren is co-administered with medicinal products that are substrates of UGT1A9.
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.
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).
Overvågning af nyrefunktion
Renal function monitoring
Translarna fås i 3 styrker, som hver indeholder hhv. 125 mg, 250 mg og 1.000 mg af det aktive stof, der kaldes ataluren.
Translarna is available in 3 strengths, each containing 125 mg, 250 mg and 1000 mg of the active substance, called ataluren.
Middelændring i tidssatte funktionstests (Studie 1)
Mean Change in Timed Function Tests (Study 1)
Der blev ikke observeret nogen umiddelbar forskel i den samlede eksponering for ataluren i kontrolgruppen og grupperne med let og svært nedsat leverfunktion.
No apparent differences of the total ataluren exposure in the control, mild, and severe hepatic impairment groups were observed.
Derudover er det fundet, at ataluren potenserede den nefrotoksiske effekt af intravenøse aminoglykosider.
In addition, ataluren was found to increase nephrotoxicity of intravenous aminoglycosides.
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.
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.
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.
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.
Ataluren metaboliseres ved konjugation i lever, tarm og nyre via uridin diphosphat glucuronosyltransferase (UGT) -enzymer, hovedsagligt UGT1A9.
Ataluren is metabolized by conjugation via uridine diphosphate glucuronosyltransferase (UGT) enzymes, predominantly UGT1A9 in liver, intestine and kidney.
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).
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).
Ataluren forventes heller ikke at inducere CYP-isoenzymer in vivo.
Similarly, ataluren is not expected in vivo to be an inducer of cytochrome P450 isoenzymes.
Serumlipider
Serum lipids
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.
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.
Patienter skal have bekræftet en nonsense-mutation i dystrofin-genet som del af deres grundsygdom ved genetisk test.
Patients must have a nonsense mutation in the dystrophin gene as part of their underlying disease state, as determined by genetic testing.
Prækliniske data afslørede ingen risiko for mennesker baseret på en standard fertilitetsundersøgelse hos han- og hunrotter (se pkt.
Non-clinical data revealed no hazard for humans based on a standard male and female fertility study in rats (see section 5.3).
Hvert brev indeholder 1.000 mg ataluren
Each sachet contains 1000 mg of ataluren
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).
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).
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.
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.
Behandling af patienter med svært nedsat nyrefunktion (eGFR < 30 ml/min) nyresygdom i slutstadiet anbefales ikke (se pkt.
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).
Ældre Sikkerheden og effekten af ataluren hos patienter på 65 år og derover er endnu ikke klarlagt.
The safety and efficacy of ataluren in patients aged 65 and older have not yet been established (see section 5.2).
Hvert brev indeholder 250 mg ataluren
Each sachet contains 250 mg of ataluren
Hvert brev indeholder 125 mg ataluren
Each sachet contains 125 mg of ataluren
Gennemsnitlig ændring i tidssatte funktionstest (Studie 2)
Mean Change in Timed Function Tests (Study 2)
Translarna 125 mg granulat til oral suspension Translarna 250 mg granulat til oral suspension Translarna 1.000 mg granulat til oral suspension
Translarna 125 mg granules for oral suspension Translarna 250 mg granules for oral suspension Translarna 1000 mg granules for oral suspension
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.
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.
Translarna 1.000 mg granulat til oral suspension EU/1/13/902/003
Translarna 1000 mg granules for oral suspension EU/1/13/902/003
Translarna fås i breve med følgende styrker: 125 mg, 250 mg and 1.000 mg ataluren pr. brev.
Translarna is available in the following sachet strengths: 125 mg, 250 mg and 1000 mg of ataluren per sachet.
Sådan skal du tage Translarna
How to take Translarna
Translarna 1.000 mg granulat til oral suspension Hvert brev indeholder 1.000 mg ataluren.
Translarna 1000 mg granules for oral suspension Each sachet contains 1000 mg ataluren.
Translarna 125 mg granulat til oral suspension EU/1/13/902/001
Translarna 125 mg granules for oral suspension EU/1/13/902/001
Translarna 250 mg granulat til oral suspension Hvert brev indeholder 250 mg ataluren.
Translarna 250 mg granules for oral suspension Each sachet contains 250 mg ataluren.
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.
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.
6MWD fra baseline til uge 48) ikke nåede statistisk signifikans (p≤0,05), bør alle andre p-værdier betragtes som nominelle.
As the primary endpoint (change in 6MWD from baseline to Week 48) did not reach statistical significance (p≤0.05),
Translarna 250 mg granulat til oral suspension EU/1/13/902/002
Translarna 250 mg granules for oral suspension EU/1/13/902/002
Translarna 125 mg granulat til oral suspension Hvert brev indeholder 125 mg ataluren.
Translarna 125 mg granules for oral suspension Each sachet contains 125 mg ataluren.
Irland MARKEDSFØRINGSTILLADELSESNUMRE
MARKETING AUTHORISATION NUMBERS
Translarna 1.000 mg granulat til oral suspension ataluren
Translarna 1000 mg granules for oral suspension ataluren
Spørg lægen, hvis der er noget, du er i tvivl om.
Check with them if you are not sure.
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).
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).
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).
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).
Aften mg breve mg breve mg breve mg breve mg breve mg breve mg breve mg breve mg breve
Evening mg sachets mg sachets mg sachets
Gennemsnitlig ændring i 6-minutters gangtest (Studie 1)
Mean Change in 6-Minute Walk Distance (Study 1)
Erytematøst udslæt
Hepatic impairment
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).
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).
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
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.
In vivo var den eneste metabolit, som blev fundet i plasma efter peroral administration af radioaktivt mærket ataluren, ataluren-O-1β-acyl glucuronid.
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.
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.
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.
Hele brevets indhold skal blandes med mindst 30 ml væske (vand, mælk, frugtjuice), eller 3 spiseskefulde halvflydende mad (yoghurt eller æblemos).
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).
Hele brevets indhold skal blandes med mindst 30 ml væske (vand, mælk, frugtjuice) eller 3 spiseskefulde halvflydende mad (yoghurt eller æblemos).
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).
Du må ikke køre bil, cykle eller betjene maskiner, hvis du føler dig svimmel.
If you feel dizzy, do not drive, cycle or use machines.
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).
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).
Translarna 125 mg granulat til oral suspension ataluren
Translarna 125 mg granules for oral suspension ataluren
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.
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.
Translarna 250 mg granulat til oral suspension ataluren
Translarna 250 mg granules for oral suspension ataluren
Gennemsnitlig ændring i seks minutters gangtest (Studie 2)
Mean Change in 6-Minute Walk Distance (Study 2)
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).
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).
Antal breve
Posology
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.
During the randomised, placebo-controlled studies, small increases in mean serum creatinine, BUN, and cystatin C were observed.
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.
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.
Feber, vægttab
Cough, epistaxis
Udseende og pakningsstørrelser
What Translarna looks like and contents of the pack
Doseringstabel
Breastfeeding
Hvis du har taget for meget Translarna
If you take more Translarna than you should
Nedsat nyrefunktion
Renal function tests
Sammendrag af bivirkninger i tabelform
Tabulated list of adverse reactions
Administration
United Kingdom