FrancophonIA/ELRC3.0 huggingface dataset:
English: ácido Valpróico Generis Valproic Acid 145mg Tablet, Sodium
Danish: ácido Valpróico Generis Valproinsyre 145mg Tablet, Natriumvalproat 333mg Tablet
English: Epilim Chronosphere Valproic Acid 145.14mg Sachet, Sodium
Danish: Epilim Chronosphere Valproinsyre 145.14mg Brev, Natriumvalproat
English: Natriumvalproaat Teva Valproic Acid 145mg G, Sodium Valproate
Danish: Natriumvalproaat Teva Valproinsyre 145mg G, Natriumvalproat 333mg
English: Valproat Neuraxpharm Sodium Valproate 500mg Units
Danish: Valproat Neuraxpharm Natriumvalproat 500mg Enhed
English: Sanofi-Aventis Sro
Danish: Den Tjekkiske republic Sanofi-Aventis Sro
English: Sodium Valproate 500mg Container
Danish: Natriumvalproat 500mg Enterotablet
English: Valproate Semisodium 250mg Tablet
Danish: Seminatriumvalporat 250mg Tablet
English: Other information about Ucedane
Danish: Andre oplysninger om Ucedane
English: The initial daily dose of Ucedane should be 100 mg per kilogram body weight, but up to 250 mg/kg can be used if necessary.
Danish: Den indledende daglige dosis af Ucedane er 100 mg pr. kg legemsvægt, om nødvendigt op til 250 mg/kg.
English: This is a summary of the European public assessment report (EPAR) for Ucedane.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Ucedane.
English: The full EPAR for Ucedane can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Ucedane findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The Committee recommended that Ucedane be approved for use in the EU.
Danish: Udvalget anbefalede, at Ucedane godkendes til anvendelse i EU.
English: Treatment may be started as early as the first day of life and the medicine is used for the patient's whole life.
Danish: Behandlingen kan begynde så tidligt som på den første levedag, og lægemidlet anvendes hele livet.
English: What is Ucedane and what is it used for?
Danish: Hvad er Ucedane, og hvad anvendes det til?
English: Ucedane carglumic acid
Danish: Ucedane cargluminsyre
English: As for every medicine, the company provided studies on the quality of Ucedane.
Danish: Som for ethvert andet lægemiddel har virksomheden fremlagt undersøgelser af kvaliteten af Ucedane.
English: It is not intended to provide practical advice on how to use Ucedane.
Danish: Det er ikke en praktisk vejledning i, hvordan Ucedane bør anvendes.
English: What measures are being taken to ensure the safe and effective use of Ucedane?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Ucedane?
English: Ucedane is available as dispersible tablets (200 mg) that are to be dispersed (mixed) in a small amount of water.
Danish: Ucedane fås som dispergible tabletter (200 mg), der skal blandes (dispergeres) med en lille smule vand.
English: When ammonia builds up in the blood, it is toxic to the body, especially the brain.
Danish: Når ammoniak ophobes i blodet, er det giftigt for kroppen, især hjernen.
English: What are the benefits and risks of Ucedane?
Danish: Hvilke fordele og risici er der forbundet med Ucedane?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Ucedane has been shown to have comparable quality and to be bioequivalent to Carbaglu.
Danish: Udvalget for Lægemidler til Mennesker (CHMP) konkluderede, at Ucedane i overensstemmelse med EU's krav er påvist at være af sammenlignelig kvalitet og er bioækvivalent med Carbaglu.
English: If the enzyme is not present, ammonia cannot be broken down and it builds up in the blood.
Danish: Hvis enzymet ikke er til stede, kan ammoniak ikke nedbrydes, men ophobes i blodet.
English: The medicine can only be obtained with a prescription and treatment should be started by a doctor who has experience in treating patients with metabolic diseases such as NAGS deficiency.
Danish: Lægemidlet udleveres kun mod recept, og behandlingen skal påbegyndes af en læge med erfaring i behandling af patienter med stofskiftesygdomme såsom NAGS-mangel.
English: Studies on the benefits and risks of the active substance in the approved use have already been carried out with the reference medicine, Carbaglu, and do not need to be repeated for Ucedane.
Danish: Fordelene og risiciene ved det aktive stof til den godkendte anvendelse er i forvejen undersøgt med referencelægemidlet Carbaglu og behøver ikke gentages for Ucedane.
English: The dose should then be adjusted to maintain normal blood ammonia levels.
Danish: Dosis bør derefter justeres for at opretholde et normalt indhold af ammoniak i blodet.
English: Because Ucedane is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Ucedane er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses dets fordele og risici for at være de samme som for referencelægemidlet.
English: This means that Ucedane contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Carbaglu.
Danish: Det betyder, at Ucedane indeholder samme aktive stof og virker som et "referencelægemiddel", der allerede er godkendt i Den Europæiske Union (EU), og som hedder Carbaglu.
English: Why is Ucedane approved?
Danish: Hvorfor blev Ucedane godkendt?
English: For more information about treatment with Ucedane, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Ucedane, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Ucedane contains the active substance carglumic acid and is a ‘generic medicine'.
Danish: Ucedane indeholder det aktive stof cargluminsyre og er et "generisk lægemiddel".
English: Patients with this lifelong disease lack a liver enzyme called NAGS, which normally helps to break down ammonia.
Danish: Patienter med denne livsvarige sygdom mangler leverenzymet NAGS, der normalt medvirker til at nedbryde ammoniak.
English: Therefore, the CHMP's view was that, as for Carbaglu, the benefit outweighs the identified risk.
Danish: Det var derfor CHMP's opfattelse, at fordelene opvejer de identificerede risici som for Carbaglu.
English: Ucedane is a medicine used for the treatment of hyperammonaemia (high blood levels of ammonia) in patients with N-acetylglutamate synthase (NAGS) deficiency.
Danish: Ucedane er et lægemiddel, der anvendes til behandling af hyperammonæmi (for højt indhold af ammoniak i blodet) hos patienter med mangel på N-acetylglutamatsyntase (NAGS).
English: Ucedane therefore helps break down ammonia, reducing ammonia blood levels and its toxic effects.
Danish: Ucedane medvirker derfor til at nedbryde ammoniak, nedsætte indholdet af ammoniak i blodet og giftvirkningen deraf.
English: The active substance in Ucedane, carglumic acid, is very similar in structure to N-acetylglutamate, which activates an enzyme that breaks down ammonia.
Danish: Det aktive stof i Ucedane, cargluminsyre, har en struktur, der stærkt ligner strukturen af N-acetylglutamat, som aktiverer et enzym, der nedbryder ammoniak.
English: For practical information about using Ucedane, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Ucedane, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: How is Ucedane used?
Danish: Hvordan anvendes Ucedane?
English: How has Ucedane been studied?
Danish: Hvordan blev Ucedane undersøgt?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ucedane have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Ucedane.
English: How does Ucedane work?
Danish: Hvordan virker Ucedane?
English: Date of first authorisation: 09 November 2015
Danish: Dato for første markedsføringstilladelse: 9. november 2015
English: These effects were sustained in longer-term studies.
Danish: Disse virkninger blev opretholdt i længerevarende studier.
English: This may occur regardless of blood sugar level.
Danish: Dette kan forekomme uanset niveauet af blodsukker.
English: Not evaluated for statistical significance as a result of the sequential testing procedure for secondary end points
Danish: Ikke evalueret for statistisk signifikans som følge af den sekventielle testprocedure for sekundære endepunkter
English: The patient may need to take extra insulin and drink water.
Danish: Patienten skal muligvis tage ekstra insulin og drikke vand.
English: This finding was consistent across subgroups.
Danish: Dette fund var konsistent på tværs af undergrupper.
English: Edistride can be taken orally once daily at any time of day with or without food.
Danish: Edistride kan tages oralt én gang dagligt på et hvilket som helst tidspunkt af dagen med eller uden mad.
English: • if you have a liver problem.
Danish: • Hvis du har et leverproblem.
English: Diet and exercise can help your body use its blood sugar better.
Danish: Kost og motion kan hjælpe din krop med at bruge blodsukkeret bedre.
English: • Signs/symptoms of DKA.
Danish: • Tegn/symptomer på DKA.
English: Patients should consider monitoring ketones levels three to four hours after changing pump materials.
Danish: Patienterne bør overveje at monitorere ketonniveauerne tre til fire timer efter skift af pumpematerialer.
English: Ketone levels should be also checked in situations that may predispose to or increase risk of DKA.
Danish: Ketonniveauerne bør også checkes i situationer, der kan prædisponere for eller øge risikoen for DKA.
English: Large to very large
Danish: Stor til meget stor
English: • It should be ensured that ketone levels are normal.
Danish: • Det bør sikres, at ketonniveauerne er normale.
English: • Patients with excessive alcohol consumption or who use illicit drugs.
Danish: • Patienter med overdrevent alkoholforbrug eller som bruger narkotika.
English: Do not stop taking Edistride without talking to your doctor first.
Danish: Hold ikke op med at tage Edistride uden først at tale med din læge.
English: The recommended actions are listed in Table 1.
Danish: De anbefalede foranstaltninger er angivet i tabel 1.
English: • Patients with low insulin needs.
Danish: • Patienter med lavt insulinbehov
English: Probable DKA
Danish: Sandsynlig DKA
English: Edistride is used in adult patients (aged 18 years and older).
Danish: Edistride anvendes til voksne patienter (18 år og derover).
English: After administration of a 50 mg [
Danish: Efter indgivelse af en 50 mg [
English: - on its own - if you cannot tolerate metformin.
Danish: - alene, hvis du ikke kan tåle metformin.
English: • For renal function with GFR < 60 mL/min, at least 2 to 4 times per year.
Danish: • Ved nyrefunktion med GFR <60 ml/min, mindst 2 til 4 gange om året.
English: Throughout the study, insulin dose was adjusted as deemed appropriate.
Danish: Gennem hele studiet blev insulindosis justeret som anset for passende.
English: Trace or Small
Danish: Antydning eller lille
English: • If it is 12 hours or more until your next dose, take a dose of Edistride as soon as you remember.
Danish: • Hvis der er 12 timer eller mere til din næste dosis: Tag en dosis Edistride, så snart du kommer i tanke om det.
English: • Do not take a double dose of Edistride to make up for a forgotten dose.
Danish: • Du må ikke tage en dobbeltdosis Edistride som erstatning for den glemte dosis.
English: Alu/Alu blister
Danish: Alu/Alu blisterkort
English: • Edistride is used together with insulin.
Danish: • Edistride anvendes sammen med insulin.
English: If you have type 2 diabetes, it can also help prevent heart disease.
Danish: Hvis du har type 2-diabetes, kan det også hjælpe med at forebygge hjertesygdom.
English: • Insulin therapy should be continuously optimised.
Danish: • Insulinbehandling skal kontinuerligt optimeres
English: • if you have very high levels of sugar in your blood which may make you dehydrated (lose too much body fluid).
Danish: • Hvis du har meget høje niveauer af sukker i blodet, som kan gøre dig dehydreret (få dig til at tabe for meget kropsvæske).
English: Edistride is not recommended for children and adolescents under 18 years of age, because it has not been studied in these patients.
Danish: Børn og teenagere Edistride frarådes til børn og teenagere under 18 år, da det ikke er blevet undersøgt hos disse patienter.
English: • Your doctor may start you on a 5 mg dose if you have a liver problem.
Danish: • Din læge kan starte din behandling med en 5 mg dosis, hvis du har en leversygdom.
English: • Talk with your doctor about the risk of diabetic ketoacidosis before you start to take Edistride.
Danish: • Tal med din læge om risikoen for diabetisk ketoacidose, før du begynder at tage Edistride.
English: • Patients with recent or recurrent history of DKA.
Danish: • Patienter med nylig eller tilbagevendende DKA
English: • Summary of the recommendations for patients, particularly regarding blood ketone measurement and managing sick days.
Danish: • Sammenfatning af anbefalingerne for patienterne, særligt i forbindelse med måling af blodketoner og måling og håndtering af sygedage.
English: • Patients unable or unwilling to monitor ketones.
Danish: • Patienter, som er ude af stand til eller uvillige til at monitorere ketoner.
English: Subjects with mean daily insulin dose reduction of at least 10% (%)
Danish: Forsøgspersoner med gennemsnitlig daglig reduktion af insulindosis på mindst 10 % (%)
English: Frequency categories are defined according to the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), and not known (cannot be estimated from the available data).
Danish: Hyppighedskategorier inddeles efter følgende konvention: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Randomised and treated patients with baseline and at least 1 post-baseline efficacy measurement.
Danish: Randomiserede og behandlede patienter med baseline og mindst 1 post-baseline-effektmåling.
English: It is important to stay on any diet and exercise program recommended by your doctor while taking Edistride.
Danish: Det er vigtigt at forblive på et diæt- og træningsprogram, som lægen anbefaler, mens du tager Edistride.
English: Eighty-one percent (81%) of the subjects had a body mass index (BMI)  27.
Danish: 81 % af forsøgspersonerne havde et body mass index (BMI) på  27.
English: If you suspect you have diabetic ketoacidosis, contact a doctor or the nearest hospital straight away and do not take this medicine.
Danish: Hvis du har mistanke om, at du har diabetisk ketoacidose, skal du straks kontakte en læge eller nærmeste hospital og tag ikke denne medicin.
English: • Signs/symptoms of DKA - if not adequately managed DKA can be severe and fatal.
Danish: • Tegn/symptomer på DKA - hvis DKA ikke behandles korrekt, kan det være alvorligt og letalt.
English: This increase was not accompanied by any increase in the percentage of 24-hour glucose readings < 70 mg/dL.
Danish: Denne stigning blev ikke ledsaget af nogen stigning i procentdelen af 24 timers glukosemålinger <70 mg/dl.
English: It may be more pronounced in patients with very high blood glucose concentrations.
Danish: Det kan være mere udtalt hos patienter med meget høje koncentrationer af glukose i blodet.
English: Do not take Edistride:
Danish: Tag ikke Edistride:
English: • Dapagliflozin is not a substitute for insulin (and does not alter insulin-sensitivity).
Danish: • Dapagliflozin er ikke en erstatning for insulin (og ændrer ikke insulinfølsomheden).
English: Blood Ketone (betahydroxybutyrate)
Danish: Blodketoner (betahydroxybutyrat)
English: Therefore, glucose monitoring must be supplemented by ketone monitoring.
Danish: Derfor skal monitorering af glukose suppleres med monitorering af ketoner.
English: • Guide for Health Care Professionals including a prescriber's checklist
Danish: • Vejledning for sundhedspersonale, herunder en tjekliste til ordination
English: Edistride works by removing excess sugar from your body via your urine.
Danish: Edistride virker ved at fjerne det overskydende sukker fra kroppen via urinen.
English: Improvement in homeostasis model assessment for beta cell function (HOMA beta-cell) has been observed in clinical studies with Edistride.
Danish: Der er blevet observeret forbedring i homeostasemodelvurdering for betacellefunktion (HOMA beta-cell) i kliniske studier med Edistride.
English: • It should be ensured that the patient demonstrates the ability to monitor ketone levels.
Danish: • Det bør sikres, at patienten viser evnen til at overvåge ketonniveauerne.
English: Use of alternative methods to monitor glycaemic control is advised.
Danish: Brug alternative metoder til overvågning af den glykæmiske kontrol anbefales.
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Danish: Patienter med sjældne arvelige problemer med galactoseintolerans, total lactasemangel eller glukose-galactosemalabsorption bør ikke tage dette lægemiddel.
English: Fifty-one percent (51%) of the subjects were men, 84% were White, 8% were Asian, 4% were Black and 4% were of other racial groups.
Danish: 51 % af forsøgspersonerne var mænd, 84 % var hvide, 8 % var asiatiske, 4 % var sorte og 4 % kom fra andre racegrupper.
English: p-values for the secondary endpoints and for single components are nominal.
Danish: p-værdier for det sekundære endepunkt og for enkeltkomponenter er nominelle.
English: The patient alert card should contain the following key elements:
Danish: Patientoplysningskortet skal indeholde følgende hovedelementer:
English: C]-dapagliflozin dose, 96% was recovered, 75% in urine and 21% in faeces.
Danish: C]-dapagliflozindosis blev 96 % genfundet, 75 % i urinen og 21 % i afføringen.
English: Edistride and other diabetes medicines
Danish: Edistride og anden diabetesmedicin
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Danish: Edistride kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: • DKA should be treated as per standard of care.
Danish: • DKA bør behandles ifølge standarden.
English: • if you are on medicines to lower your blood pressure (anti-hypertensives) and have a history of low blood pressure (hypotension).
Danish: • Hvis du tager medicin, der skal sænke dit blodtryk (anti-hypertensiva) og har en sygehistorie med for lavt blodtryk (hypotension).
English: • Your doctor may ask you to take Edistride:
Danish: • Lægen kan bede dig om at tage Edistride:
English: If you are taking Edistride for type 1 diabetes: • The recommended dose is one 5 mg tablet each day.
Danish: Hvis du tager Edistride mod type 1-diabetes: • Den anbefalede dosis er én 5 mg tablet hver dag.
English: Microcrystalline cellulose (E460i) Lactose
Danish: Mikrokrystallinsk cellulose (E460i) Lactose
English: Your doctor may decide to temporarily or permanently stop your treatment with Edistride.
Danish: Lægen kan beslutte at stoppe behandlingen med Edistride midlertidigt eller permanent.
English: Before starting treatment, patients should be evaluated with respect to DKA risk.
Danish: Inden start af behandlingen skal patienterne vurderes med henblik på DKA-risiko.
English: Dapagliflozin 10 mg should not be used for treatment of patients with type 1 diabetes.
Danish: Dapagliflozin 10 mg bør ikke anvendes til behandling af patienter med type 1-diabetes.
English: • They work by lowering the amount of sugar (glucose) in your blood.
Danish: • Det virker ved at sænke indholdet af sukker (glukose) i blodet.
English: Diabetic ketoacidosis was reported with common frequency.
Danish: Diabetisk ketoacidose blev rapporteret med hyppigheden almindelig.
English: If you are taking Edistride for type 1 diabetes, it is important that you keep using insulin.
Danish: Hvis du tager Edistride mod type 1-diabetes, er det vigtigt, at du fortsætter med at tage insulin.
English: Insulin injections should be given within 2 hours of an unexplained high blood glucose/ketone value and dapagliflozin treatment should be interrupted.
Danish: Insulininjektionerne skal gives inden for 2 timer efter en uforklarlig høj blodglukose/ketonværdi, og dapagliflozinbehandlingen bør afbrydes.
English: More information is given below under ‘Other medicines and Edistride'.
Danish: Der gives yderligere oplysninger under ”Brug af anden medicin sammen med Edistride”.
English: • Guidance to the physician for assessing whether the patient is prepared and engaged to perform self-ketone testing before and during therapy.
Danish: • Vejledning til lægen til bedømmelse af, om patienten er klar og indstillet på at udføre egentest af ketoner før og under behandlingen.
English: Your doctor may want to lower the dose of these other medicines, to prevent you from getting low blood sugar levels (hypoglycaemia).
Danish: Din læge kan ønske at nedsætte dosen af disse andre lægemidler for at undgå at du får for lavt blodsukker (hypoglykæmi).
English: • It is recommended that patients obtain several baseline ketone levels over one to two weeks prior to initiation of dapagliflozin therapy, and patients should become familiar with how their behaviours and circumstances affect their ketone levels.
Danish: • Det anbefales, at patienterne opnår flere baseline ketonniveauer over en til to uger før påbegyndelse af dapagliflozinbehandling, og patienterne bør blive fortrolige med, hvordan adfærd og omstændigheder påvirker deres ketonniveau.
English: • Patients with increased insulin requirements due to acute medical illness or surgery.
Danish: • Patienter med øget behov for insulin på grund af akut medicinsk sygdom eller kirurgi
English: Superiority of dapagliflozin over placebo was not demonstrated for MACE (p=0.172).
Danish: Overlegenheden af dapagliflozin over placebo blev ikke påvist for MACE (p = 0,172).
English: Inadequate insulin doses (missed insulin dose or insulin pump failure) were the most common precipitating factors.
Danish: Utilstrækkelige insulindoser (glemt insulindosis eller insulinpumpefejl) var de mest almindelige udløsende faktorer.
English: All randomised patients who took at least one dose of double-blind study medication during the short-term double-blind period.
Danish: Alle randomiserede patienter der tog mindst én dosis dobbelt-blindet studiemedicin under den kortvarige dobbelt-blinde periode.
English: Warnings and precautions Contact a doctor or the nearest hospital straight away:
Danish: Advarsler og forsigtighedsregler Du skal straks kontakte læge eller nærmeste hospital:
English: If you take more Edistride tablets than you should, talk to a doctor or go to a hospital immediately.
Danish: Hvis du har taget flere Edistride tabletter, end du skulle, skal du straks tale med lægen eller tage på hospitalet.
English: Supplemental carbohydrate may be required in addition to hydration and additional rapid insulin (see Table 1 in section 4.2).
Danish: Der kan være behov for supplerende kulhydrater ud over hydrering og yderligere hurtigvirkende insulin (se tabel 1 i pkt.
English: Do not drive or use any tools or machines, if you feel dizzy taking Edistride.
Danish: Lad være med at arbejde med værktøj eller maskiner, hvis du bliver svimmel, når du tager Edistride.
English: glimepiride 4 mg/day;
Danish: glimepirid 4 mg/dag;
English: DKA events occurred evenly distributed over the clinical study period.
Danish: DKA-hændelser opstod jævnt fordelt i den kliniske studieperiode.