FrancophonIA/ELRC3.0 huggingface dataset:
English: The applicant's argument that traditional manufacturing methods as well as excipients widely used in tablet formulations would not cause potential lower or higher exposure to furosemide when Furosemide Vitabalans is used (compared to the exposure obtained following administration of other furosemide 40 mg tablets) cannot be considered as sufficient evidence to bridge the applied product and other furosemide described in the literature.
Danish: Ansøgerens argumentation om, at traditionelle fremstillingsmetoder og sædvanligt anvendte tablethjælpestoffer udelukker muligheden for lavere eller højere eksponering for furosemid ved anvendelse af Furosemide Vitabalans (end eksponeringen fra andre tabletter indeholdende 40 mg furosemid), anses ikke for tilstrækkelig evidens til at bygge bro mellem det ansøgte produkt og de i litteraturen beskrevne andre furosemidprodukter.
English: Based only on published literature data, it is not possible to conclude that the pharmacokinetic parameters of Furosemide Vitabalans would be within the same range than other furosemide 40 mg tablets referred to.
Danish: Litteraturdata alene giver ikke grundlag for at konkludere, at de farmakokinetiske parametre af Furosemide Vitabalans vil ligge inden for samme område som de andre tabletter indeholdende furosemid, 40 mg, som der henvises til.
English: The CHMP is of the opinion that the applicant has not adequately demonstrated that the submitted published literature on furosemide was directly applicable to Furosemide Vitabalans.
Danish: Det er Udvalget for Humanmedicinske Lægemidlers opfattelse, at indehaveren af markedsføringstilladelsen ikke tilfredsstillende har godtgjort, at den publicerede litteratur om furosemid kunne anvendes direkte på Furosemide Vitabalans .
English: A referral was thus triggered at the CMD(h) and the applicant was asked to justify that the literature provided in support of this application was applicable to the product applied for and to demonstrate that the potentially lower or higher exposure to furosemide, when Furosemide Vitabalans is used compared to the exposure obtained following administration of the product used in the pivotal clinical studies described in the submitted literature, would not influence efficacy or safety.
Danish: Ansøgeren blev herunder anmodet om at begrunde, at den litteratur, der var forelagt til støtte for ansøgningen, kunne anvendes på det ansøgte produkt, og godtgøre, at virkningen og sikkerheden ikke ville berøres af en potentielt lavere eller højere eksponering for furosemid ved anvendelse af Furosemide Vitabalans end ved anvendelse af det produkt, der er anvendt i de kliniske hovedundersøgelser, som beskrives i den forelagte litteratur.
English: The results of this study showing that Furosemide Vitabalans had a similar dissolution profile as the other furosemide presented were not considered sufficient by the CHMP to demonstrate efficacy and safety of the product applied for.
Danish: Det fremgår heraf, at Furosemide Vitabalans havde samme opløselighedsprofil som de andre omhandlede furosemidprodukter, men Udvalget for Humanmedicinske Lægemidler fandt ikke dette tilstrækkeligt som dokumentation af virkningen og sikkerheden af det ansøgte produkt.
English: As discussed previously, in vitro data demonstrating similarity of dissolution profiles between Furosemide Vitabalans and other products containing furosemide do not prove that the bioavailability of these products would be similar, in particular, with a BCS class IV drug substance (low solubility, low permeability).
Danish: Ansøgeren hævdede desuden, at opløselighedsegenskaberne sammen med åbenbar farmaceutisk ækvivalens danner bro mellem Furosemide Vitabalans og andre godkendte produkter indeholdende furosemid, 40 mg. Som tidligere omtalt udgør in vitro-data, der påviser lighed mellem opløselighedsprofilen af Furosemide Vitabalans og af andre furosemidprodukter, ikke et bevis for, at produkterne har samme biotilgængelighed, navnlig for et lægemiddelstof tilhørende BCS klasse IV (lav opløselighed, lav permeabilitet).
English: On the basis of the bibliographic data submitted, taken together with additional pharmaceutical documentation, the applicant failed to establish the relevance of these data to demonstrate the safety and efficacy of Furosemide Vitabalans and associated names.
Danish: Ansøgeren har ikke godtgjort, at den forelagte bibliografiske oversigt kombineret med de supplerende farmaceutiske data er relevante for påvisning af sikkerheden og virkningen af Furosemide Vitabalans og relaterede navne.
English: The CHMP has recommended the refusal of the granting of the marketing authorisation for Furosemide Vitabalans and associated names (see Annex I).
Danish: På baggrund af disse manglende beviser fandt udvalget det beret tiget, at medlemsstaterne har rejst betænkelighed ved den potentielle alvorlige risiko for den of fentlige sundhed, anbefalede Udvalget for Humanmedicinske Lægemidler afslag på ansøgningen om udstedelse af markedsføringstilladelse for Furosemide Vitabalans og relaterede navne (se bilag I).
English: On the basis of the bibliographic data submitted, taken together with the pharmaceutical data, the applicant failed to establish the relevance of these data to demonstrate safety and efficacy of Furosemide Vitabalans.
Danish: Ansøgeren har ikke godtgjort, at den forelagte bibliografiske oversigt kombineret med de farmaceutiske data er relevante for påvisning af sikkerheden og virkningen af Furosemide Vitabalans .
English: 360 ELISA Units
Danish: 360 ELISA enheder
English: 1 dose (0.5 ml): Hepatitis A virus (inactivated)1,2
Danish: 1 dosis (0,5 ml): Hepatitis A-virus (inaktiveret)
English: Hepatitis B surface antigen3,4
Danish: Hepatitis B-overfladeantigen
English: 3Produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology 4Adsorbed on aluminium phosphate
Danish: 0,025 milligram Al produceret i gærceller (Saccharomyces cerevisiae) ved rekombinant DNA-teknologi adsorberet på aluminiumphosphat
English: 1Produced on human diploid (MRC-5) cells 2Adsorbed on aluminium hydroxide, hydrated
Danish: 10 mikrogram produceret i human diploid (MRC-5)-celler adsorberet på aluminiumphosphathydrat
English: 1 pre-filled syringe without needle
Danish: 1 fyldt injektionssprøjte uden kanyle
English: 1 pre-filled syringe + 1 needle
Danish: 1 fyldt injektionssprøjte + 1 kanyle
English: 1 pre-filled syringe + 2 needles
Danish: 1 fyldt injektionssprøjte + 2 kanyler
English: 10 micrograms
Danish: 0,2 milligram Al
English: EMA procedure number
Danish: MT (EU) nummer (Særnavn) Navn
English: The European Commission granted a marketing authorisation valid throughout the European Union for Ryzodeg on 21 January 2013.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Ryzodeg den 21. januar 2013.
English: The study in children lasted 16 weeks.
Danish: Undersøgelsen hos børn varede 16 uger.
English: All the studies in adults lasted six months, but one was extended to one year.
Danish: Alle undersøgelserne hos voksne varede seks måneder, men en af dem blev forlænget til et år.
English: Other information about Ryzodeg
Danish: Andre oplysninger om Ryzodeg
English: The full EPAR for Ryzodeg can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Ryzodeg findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Ryzodeg.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Ryzodeg.
English: This means it has a long duration of action.
Danish: Derfor holder dets virkning sig længere.
English: The dose of Ryzodeg is determined individually for each patient.
Danish: Ryzodeg-dosen fastlægges for hver enkelt patient.
English: What measures are being taken to ensure the safe and effective use of Ryzodeg?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Ryzodeg?
English: Because the dose requirements in young children may not be stable and because they cannot express symptoms of hypoglycaemia, Ryzodeg is not suitable for children aged under 2 years.
Danish: Fordi dosiskravene hos små børn ikke nødvendigvis er stabile, og fordi de ikke kan vise symptomer på hypoglykæmi, er Ryzodeg ikke egnet til børn på under to år.
English: For more information about treatment with Ryzodeg, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Ryzodeg, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Ryzodeg.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan Ryzodeg skal anvendes.
English: The Committee concluded that Ryzodeg is generally safe and its side effects are comparable to those of other insulin analogues.
Danish: Udvalget konkluderede, at Ryzodeg generelt er sikkert, og at dets bivirkninger er sammenlignelige med bivirkningerne af andre insulinanaloger.
English: Ryzodeg is injected once or twice a day, at mealtimes.
Danish: Ryzodeg injiceres en eller to gange dagligt i forbindelse med måltider.
English: The differences mean that insulin degludec is absorbed more slowly by the body.
Danish: Forskellene betyder, at insulin degludec optages langsommere i kroppen.
English: The place for injection should be altered with each injection to reduce the risk of developing fatty lumps under the skin that can affect the amount of Ryzodeg absorbed into the blood.
Danish: Der skal vælges et nyt injektionssted, hver gang der injiceres, med henblik på at sænke risikoen for dannelse af fedtknuder under huden, som kan påvirke mængden af Ryzodeg, der optages i blodet.
English: What is the risk associated with Ryzodeg?
Danish: Hvilken risiko er der forbundet med Ryzodeg?
English: The reduction in HbA1c levels (in percentage points) was 0.7 in patients with type 1 diabetes and between 1 and 1.7 across the trials in patients with type 2 diabetes.
Danish: Mindskelsen af indholdet af HbA1c (i procentpoint) var 0,7 hos patienter med type 1-sukkersyge og mellem 1 og 1,7 i alle undersøgelserne hos patienter med type 2-sukkersyge.
English: Meanwhile, insulin aspart is absorbed faster by the body than human insulin, and therefore it starts to work as soon as it is injected and has a short duration of action.
Danish: Insulin aspart optages imidlertid hurtigere i kroppen end humant insulin og begynder derfor at virke, så snart det injiceres, og virker kun i kort tid.
English: The active substances in Ryzodeg, insulin degludec and insulin aspart, are produced by a method known as ‘recombinant DNA technology': they are made by a yeast that has received a gene (DNA), which makes the yeast able to produce them.
Danish: De aktive stoffer i Ryzodeg, insulin degludec og insulin aspart, fremstilles ved hjælp af en metode, der kaldes "rekombinant DNA-teknologi", dvs. det fremstilles af en gær, som har modtaget et gen (DNA), der sætter gæren i stand til at danne stofferne.
English: The CHMP decided that Ryzodeg's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Ryzodeg opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Ryzodeg.
English: The most frequently reported side effect during treatment with Ryzodeg is hypoglycaemia (low blood glucose levels).
Danish: Den hyppigst indberettede bivirkning under behandling med Ryzodeg er hypoglykæmi (for lavt blodsukker).
English: It is given as an injection under the skin in the abdominal wall (at the front of the waist), upper arm or thigh.
Danish: Det gives som en injektion under huden i bugvæggen (maveskindet), overarmen eller låret.
English: Ryzodeg is a replacement insulin for the insulin normally made by the body.
Danish: Ryzodeg er en erstatningsinsulin for den insulin, der normalt dannes i kroppen.
English: Why has Ryzodeg been approved?
Danish: Hvorfor blev Ryzodeg godkendt?
English: In the study in children, the combined used of Ryzodeg and insulin aspart was at least as effective as insulin detemir and insulin aspart, with average HbA1c reductions of 0.27 and 0.23 percentage points respectively.
Danish: I undersøgelsen hos børn var Ryzodeg i kombination med insulin aspart mindst lige så effektivt som insulin detemir og insulin aspart med en gennemsnitlig mindskelse af HbA1c på henholdsvis 0,27 and 0,23 procentpoint.
English: In the studies in type 2 diabetes, Ryzodeg was either given alone or in combination with other antidiabetes medicines.
Danish: I undersøgelserne af type 2-sukkersyge blev Ryzodeg enten givet alene eller i kombination med anden sukkersygemedicin.
English: What is Ryzodeg?
Danish: Hvad er Ryzodeg?
English: It is available as a solution for injection in a cartridge (100 units/ml) and in a pre-filled pen (100 units/ml).
Danish: Det er en injektionsvæske, opløsning, der leveres i en cylinderampul (100 enheder/ml) og i en fyldt pen (100 enheder/ml).
English: Insulin degludec and insulin aspart are slightly different from human insulin.
Danish: Insulin degludec og insulin aspart er en smule forskellige fra humant insulin.
English: All of the studies measured the level of glycosylated haemoglobin (HbA1c), which is the percentage of haemoglobin in the blood attached to glucose.
Danish: I alle undersøgelserne måltes blodets indhold af glykosyleret hæmoglobin (HbA1c), dvs. den procentdel af blodets hæmoglobin, der er bundet til glukose (sukker).
English: Ryzodeg is a medicine that contains the active substances insulin degludec and insulin aspart.
Danish: Ryzodeg er et lægemiddel, der indeholder de to aktive stoffer insulin degludec og insulin aspart.
English: Ryzodeg was given once a day at mealtime with insulin aspart given at other mealtimes and this treatment was compared with treatment comprising insulin detemir given once or twice a day with insulin aspart given at all mealtimes.
Danish: Ryzodeg blev givet én gang dagligt i forbindelse med et måltid, og insulin aspart blev givet i forbindelse med andre måltider, og denne behandling blev sammenlignet med en behandling, som bestod af insulin detemir givet en eller to gange dagligt samt insulin aspart givet i forbindelse med alle måltider.
English: Ryzodeg is used to treat diabetes in adults, adolescents and children from 2 years of age.
Danish: Ryzodeg anvendes til behandling af sukkersyge hos voksne, unge og børn på to år og derover.
English: Ryzodeg has been studied in one main study involving 548 adults with type 1 diabetes and in four main studies involving 1,866 adults with type 2 diabetes.
Danish: Ryzodeg blev undersøgt i én hovedundersøgelse med 548 voksne med type 1-sukkersyge og fire hovedundersøgelser med 1 866 voksne med type 2-sukkersyge.
English: Ryzodeg has also been studied in one main study in 362 children aged between 1 and 17 years with type 1 diabetes.
Danish: Ryzodeg er også blevet undersøgt i en hovedundersøgelse, der omfattede 362 børn i alderen 1-17 år med type 1-sukkersyge.
English: The studies compared Ryzodeg given at mealtimes with insulin glargine or insulin detemir (long-acting insulins), or with biphasic insulin (an insulin formulation consisting of a mixture of intermediate- and rapid-acting insulin).
Danish: I undersøgelserne sammenlignedes Ryzodeg givet i forbindelse med måltider med insulin glargin eller insulin detemir (langtidsvirkende insulin) eller med bifasisk insulin (en blanding af mellemlangtidsvirkende og hurtigvirkende insulin).
English: The replacement insulin acts in the same way as natural insulin, and helps glucose from the blood to enter cells.
Danish: Erstatningsinsulinet virker på samme måde som naturligt insulin og bevirker, at sukkeret fra blodet føres ind i cellerne.
English: Diabetes is a disease in which the body does not produce enough insulin to control the level of blood sugar or when the body is unable to use insulin effectively.
Danish: Ved sukkersyge producerer bugspytkirtlen enten ikke nok insulin til at regulere blodsukkeret, eller også er kroppen ikke i stand til at udnytte insulinet effektivt.
English: Injecting Ryzodeg at a main meal provides long-acting insulin to control blood sugar until the next dose as well as short-acting insulin to help deal with the extra sugar from the meal.
Danish: Når Ryzodeg injiceres i forbindelse med et hovedmåltid, tilføres der langtidsvirkende insulin, som kontrollerer blodsukkeret frem til den næste dosis, samt korttidsvirkende insulin, som medvirker til at håndtere den ekstra sukker fra måltidet.
English: The CHMP concluded that Ryzodeg is effective in controlling blood glucose levels in adults, adolescents and children aged over 2 years with diabetes.
Danish: CHMP konkluderede, at Ryzodeg er effektivt til at regulere blodsukkeret hos voksne, unge og børn på over to år med sukkersyge.
English: It also noted that in the studies with adults Ryzodeg reduces the risk of hypoglycaemia during the night in patients with type 1 and type 2diabetes.
Danish: Udvalget bemærkede desuden, at Ryzodeg i undersøgelserne hos voksne nedsatte risikoen for natlig hypoglykæmi hos patienter med type 1- og type 2-sukkersyge.
English: The studies in adults showed that Ryzodeg was at least as effective as long-acting insulins and biphasic insulin in controlling blood glucose levels in patients with type 1 and type 2 diabetes.
Danish: Undersøgelserne hos voksne viste, at Ryzodeg var mindst ligeså effektivt som langtidsvirkende insulin og bifasisk insulin til at regulere blodsukkeret hos patienter med type 1- og type 2-sukkersyge.
English: In the studies in type 1 diabetes, patients also received injections of rapid acting insulin at other mealtimes.
Danish: I undersøgelserne af type 1-sukkersyge fik patienterne desuden injektioner med hurtigvirkende insulin i forbindelse med andre måltider.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ryzodeg 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 Ryzodeg.
English: In type 1 diabetes, Ryzodeg is used with rapid-acting insulin, which is injected at other mealtimes.
Danish: Ved type 1-sukkersyge anvendes Ryzodeg sammen med hurtigvirkende insulin, som injiceres i forbindelse med andre måltider.
English: How has Ryzodeg been studied?
Danish: Hvordan blev Ryzodeg undersøgt?
English: What benefit has Ryzodeg shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Ryzodeg?
English: By controlling the level of blood glucose, the symptoms and complications of diabetes are reduced.
Danish: Når blodsukkeret reguleres, mindskes sukkersygesymptomerne ogkomplikationerne.
English: What is Ryzodeg used for?
Danish: Hvad anvendes Ryzodeg til?
English: How is Ryzodeg used?
Danish: Hvordan anvendes Ryzodeg?
English: How does Ryzodeg work?
Danish: Hvordan virker Ryzodeg?
English: MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration
Danish: MF (EU)-nummer (Særnavn) Navn
English: Dehydration may be a contributing factor in some of these cases.
Danish: Dehydrering kan i visse af disse tilfælde være en bidragende faktor.
English: However, these conditions are reported more frequently in the younger children in general.
Danish: Disse tilstande rapporteres dog generelt mere hos små børn.
English: Date of first authorisation: 31 July 2014 Date of latest renewal: 19 July 2018
Danish: Dato for første markedsføringstilladelse: 31. juli 2014 Dato for seneste fornyelse: 19. juli 2018
English: Frequency not known
Danish: Hyppighed ikke kendt
English: There have been cases reported where this increase to abnormal high values was already observed after 4 weeks.
Danish: Der er blevet rapporteret tilfælde, hvor denne stigning til abnormt høje værdier blev set allerede efter 4 uger.
English: This effect is considered clinically not relevant.
Danish: Denne effekt betragtes ikke som klinisk relevant.
English: A lower ataluren dose should be considered.
Danish: En lavere ataluren-dosis bør overvejes.
English: Do not stop taking Translarna without talking to your doctor.
Danish: Du må ikke holde op med at tage Translarna uden at tale med din læge.
English: Your dose of Translarna depends on your body weight.
Danish: Din Translarna-dosis afhænger af din kropsvægt.
English: Your doctor or pharmacist will tell you the exact number of sachets and what strength to take at each time.
Danish: Din læge eller apotekspersonalet vil fortælle dig det nøjagtige antal breve og hvilken styrke, du skal tage på hvert tidspunkt.
English: You may have one or more of the following side effects after taking Translarna:
Danish: Du kan få en eller flere af de følgende bivirkninger, efter at du har taget Translarna:
English: Do not give this medicine to children under the age of 2 years or weighing less than 12 kg as it has not been tested in this group of patients.
Danish: Giv ikke dette lægemiddel til børn under 2 år, eller som vejer under 12 kg, da det ikke er blevet afprøvet hos denne gruppe patienter.
English: Final study report to be submitted Due date:
Danish: En afsluttende forsøgsrapport skal indsendes Tidsfrist:
English: Long term safety data is not available.
Danish: Langtids-sikkerhedsdata er ikke tilgængelige.
English: A standard package of reproduction toxicity studies was available.
Danish: Der forelå en standardpakke af reproduktionstoksicitetsstudier.
English: A risk to the breastfed new-borns/infants cannot be excluded.
Danish: En risiko for nyfødte/spædbørn kan ikke udelukkes.
English: Patients should take the entire dose.
Danish: Patienter skal tage hele dosis.
English: However, the magnitude of this effect could be larger for the 40 mg dose of telmisartan.
Danish: Størrelsen af effekten kunne dog være større for dosen på 40 mg telmisartan.
English: Ataluren should be administered orally every day in 3 doses.
Danish: Ataluren skal indgives oralt hver dag i 3 doser.
English: Ataluren does not distribute into red blood cells.
Danish: Ataluren distribueres ikke i røde blodlegemer.
English: Potential interactions with other medicinal products
Danish: Potentielle interaktioner med andre lægemidler
English: Tell your doctor if you are taking any of the following medicines:
Danish: Fortæl det til lægen, hvis du tager nogen af følgende lægemidler:
English: Separation between ataluren and placebo was maintained from Week 16 through the end of the study.
Danish: Adskillelse mellem ataluren og placebo blev opretholdt fra uge 16 til og med studiets afslutning.
English: The significance for humans is not known.
Danish: Betydningen for mennesker kendes ikke.
English: Very common side effects (may affect more than 1 in 10 people): - Vomiting
Danish: Meget almindelige bivirkninger (kan påvirke flere end 1 ud af 10 personer): - Opkastning
English: Translarna is a medicine that contains the active substance ataluren.
Danish: Translarna er et lægemiddel, der indeholder det aktive stof ataluren.
English: There are no adequate data from the use of ataluren in pregnant women.
Danish: Der foreligger ikke tilstrækkelige data fra anvendelse af ataluren til gravide kvinder.
English: Translarna may not be as effective in treating your symptoms if you take more than the recommended dose.
Danish: Translarna vil muligvis ikke være lige så effektiv til behandling af dine symptomer, hvis du tager mere end den anbefalede dosis.
English: These may affect your kidney function.
Danish: Det kan påvirke din nyrefunktion.
English: White to off-white granules.
Danish: Hvidt til offwhite granulat.