FrancophonIA/ELRC3.0 huggingface dataset:
English: (the ‘concerned Member States', in this instance Denmark, Finland, France, Ireland, the Netherlands, Poland, Portugal, Spain, Sweden and the United Kingdom).
Danish: andre medlemsstater (de "berørte medlemsstater", her Danmark, Finland, Frankrig, Irland, Holland, Polen, Portugal, Spanien, Sverige og Det Forenede Kongerige).
English: This is a procedure where one Member State (the ‘reference Member State', in this instance Austria) assesses a medicine with a view to granting a marketing authorisation that will be valid nationally as well as in other Member States
Danish: Ved denne procedure vurderer én medlemsstat ("referencemedlemsstaten", her Østrig) et lægemiddel med henblik på udstedelse af en markedsføringstilladelse, der er gyldig i det pågældende land foruden i
English: The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States on 18/12/2017.
Danish: CHMP's udtalelse blev fremsendt til Europa-Kommissionen, som vedtog en endelig juridisk bindende beslutning med gyldighed i alle EU-medlemsstater den 18.12.2017.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Alcover granules did not outweigh their risks, and the marketing authorisation could not be granted in Austria or in the following Member States of the EU: Denmark, Finland, France, Ireland, the Netherlands, Poland, Portugal, Spain, Sweden and the United Kingdom.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Alcover-granulat ikke opvejer risiciene, og at der ikke kan udstedes markedsføringstilladelse i Østrig eller i følgende EU-medlemsstater: Danmark, Finland, Frankrig, Irland, Nederlandene, Polen, Portugal, Spanien, Sverige og Det Forenede Kongerige.
English: On 22 June 2017, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of Alcover granules.
Danish: Den 22. juni 2017 gennemførte Det Europæiske Lægemiddelagentur (EMA) en voldgiftsprocedure efter en uoverensstemmelse blandt medlemsstaterne i Den Europæiske Union (EU) vedrørende godkendelsen af lægemidlet Alcover-granulat.
English: Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the data submitted in support of the marketing authorisation application for Alcover granules were insufficient and of inadequate quality to demonstrate that the medicine would be effective in the proposed uses.
Danish: På grundlag af de aktuelt tilgængelige data og den videnskabelige drøftelse i udvalget konkluderede CHMP, at de indsendte data til støtte for markedsføringstilladelsen for Alcover-granulat var utilstrækkelige og af utilstrækkelig kvalitet til at påvise, at lægemidlet ville være effektivt i de ansøgte indikationer.
English: Debrégeas & Associés Pharma submitted a marketing authorisation application for Alcover granules to the Austrian medicines regulatory agency for a decentralised procedure.
Danish: Debrégeas & Associés Pharma indsendte en ansøgning om markedsføringstilladelse for Alcovergranulat til den østrigske lægemiddelstyrelse med henblik på en decentral procedure.
English: The grounds for the referral were concerns raised by several Member States that the benefits of Alcover granules were not clearly demonstrated and there were various risks including the risk of dependence, misuse and side effects.
Danish: Begrundelsen for indbringelsen var adskillige medlemsstaters betænkeligheder ved, at fordelene ved Alcover-granulat ikke var tydeligt påvist, og at der var forskellige risici, bl.a. risiko for afhængighed, misbrug og bivirkninger.
English: After reviewing the grounds for this request, the CHMP re-examined the opinion and confirmed on 12 October 2017 that the marketing authorisation could not be granted.
Danish: Efter at have gennemgået begrundelsen for anmodningen foretog CHMP en revurdering af udtalelsen og bekræftede den 12. oktober 2017, at der ikke kunne udstedes en markedsføringstilladelse.
English: However, the Member States were not able to reach an agreement and the Austrian medicines regulatory agency referred the matter to the CHMP for arbitration on 22 December 2016.
Danish: Medlemsstaterne var imidlertid ikke i stand til at nå til enighed, og den østrigske lægemiddelstyrelse indbragte den 22. december 2016 sagen for CHMP med henblik på voldgift.
English: After re-examination, the CHMP confirmed its initial opinion that the marketing authorisation could not be granted.
Danish: Efter revurderingen bekræftede CHMP sin oprindelige udtalelse om, at der ikke kunne udstedes markedsføringstilladelse.
English: This decision only concerns the marketing authorisation application for Alcover granules and does not affect Alcover syrup.
Danish: Denne beslutning vedrører kun markedsføringstilladelsen for Alcover-granulat og påvirker ikke Alcoversyrup.
English: The active substance in Alcover granules, sodium oxybate, attaches to receptors (targets) on nerve cells of the brain and spinal cord for a substance called gammaaminobutyric acid (GABA), leading to a calming of the activity of these cells.
Danish: Det aktive stof i Alcover-granulat, natriumoxybat, binder til receptorer (mål) på nervecellerne i hjernen og i rygmarven for et stof, der hedder gammaaminobutansyre (GABA), og som reducerer nervecellernes aktivitet.
English: What are Alcover granules?
Danish: Hvad er Alcover-granulat?
English: Alcover granules are a medicine that was expected to be used to treat acute alcohol withdrawal syndrome and to support medium to long-term abstinence in alcohol-dependent adults with a very high level of alcohol consumption.
Danish: Alcover-granulat er et lægemiddel, der forventedes anvendt til at behandle akutte alkoholabstinenser og til at understøtte mellemlang til langvarig afholdenhed hos alkoholafhængige voksne med et meget højt forbrug af alkohol.
English: Since it targets these receptors in the same way as alcohol, Alcover granules were to be used to treat the effects of stopping alcohol use in alcohol-dependent patients, including agitation, tremor (shaking) and problems sleeping, and to support continued abstinence.
Danish: Eftersom lægemidlet er rettet mod disse receptorer på samme måde som alkohol, skulle Alcover-granulatet anvendes til at behandle symptomerne ved at stoppe alkoholforbruget hos alkoholafhængige patienter, herunder uro, rysten og søvnproblemer, og til at understøtte fortsat afholdenhed.
English: Questions and answers on Alcover granules (sodium oxybate 750, 1250 and 1750 mg)
Danish: Spørgsmål og svar om Alcover-granulat (natriumoxybat 750, 1 250 og 1 750 mg)
English: Questions and answers on Alcover granules (sodium oxybate 750, 1250 and 1750 mg) EMA/833763/2017
Danish: Spørgsmål og svar om Alcover-granulat (natriumoxybat 750, 1 250 og 1 750 mg) EMA/816779/2017
English: However, the CHMP concluded that, since the benefits of Alcover granules were not clearly demonstrated, the marketing authorisation could not be granted in the reference and concerned Member States.
Danish: CHMP fandt imidlertid, at der ikke kunne udstedes markedsføringstilladelse i referencemedlemsstaten og de berørte medlemsstater, eftersom fordelene ved Alcover-granulat ikke var tydeligt påvist.
English: The European Commission granted a marketing authorisation valid throughout the EU for Imprida on 17 January 2007.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Imprida den 17. januar 2007.
English: This is a summary of the European public assessment report (EPAR) for Imprida.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Imprida.
English: The full EPAR for Imprida can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Imprida findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Imprida is taken by mouth as one tablet once a day with some water.
Danish: Imprida tages oralt som en tablet en gang dagligt med vand.
English: Other information about Imprida
Danish: Andre oplysninger om Imprida
English: Imprida amlodipine / valsartan
Danish: Imprida amlodipin/valsartan
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 Imprida.
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 Imprida skal anvendes.
English: For more information about treatment with Imprida, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Imprida, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The CHMP decided that Imprida's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Imprida opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Imprida.
English: Both are anti-hypertensive medicines that have been available separately in the European Union (EU) since the mid-1990s.
Danish: Begge er lægemidler mod forhøjet blodtryk, og begge har hver for sig været på markedet i Den Europæiske Union (EU) siden midten af
English: By lowering the blood pressure, the risks associated with by high blood pressure, such as having a stroke, are reduced.
Danish: Ved at nedsætte blodtrykket mindskes de risici, som er forbundet med forhøjet blodtryk, såsom slagtilfælde.
English: What is the risk associated with Imprida?
Danish: Hvilken risiko er der forbundet med Imprida?
English: The most common side effects with Imprida (seen in between 1 and 10 patients in 100) are headache, nasopharyngitis (inflammation of the nose and throat), influenza (flu), hypokalaemia (low blood potassium levels), various types of oedema (swelling), fatigue (tiredness), flushing (reddening), asthenia (weakness) and hot flushes.
Danish: De hyppigste bivirkninger ved Imprida (som optræder hos mellem 1 og 10 patienter ud af 100) er hovedpine, betændelse i næse og hals (nasopharyngitis), influenza, lavt kaliumindhold i blodet (hypokaliæmi), forskellige former for hævelser (ødemer), træthed, rødmen, kraftesløshed (asteni) og hedeture.
English: The dose of Imprida to be used depends on the doses of amlodipine or valsartan that the patient was taking before.
Danish: Den dosis af Imprida, der skal anvendes, afhænger af, hvilken dosis amlodipin eller valsartan patienten fik tidligere.
English: Imprida must also not be used in combination with aliskiren-containing medicines (also used to treat essential hypertension) in patients with type 2 diabetes or in patients with moderate or severe kidney impairment.
Danish: Imprida må heller ikke anvendes i kombination med lægemidler, der indeholder aliskiren (som også anvendes til behandling af essentiel hypertension), hos patienter med type 2-diabetes eller patienter med moderat eller svær nyresygdom.
English: Imprida must not be used in patients who have severe liver or bile problems, patients with certain heart problems and patients with severe hypotension (low blood pressure).
Danish: Imprida må ikke anvendes til patienter med svær lever- eller galdeblæresygdom, patienter med visse hjerteproblemer eller patienter med svær hypotension (lavt blodtryk).
English: The company also presented evidence that the levels of amlodipine and valsartan in the blood were the same in people taking Imprida and people taking the separate medicines.
Danish: Virksomheden fremlagde desuden dokumentation for, at blodets indhold af amlodipin og valsartan er den samme hos personer, der får Imprida, som hos dem, der får de to lægemidler hver for sig.
English: For the full list of all side effects reported with Imprida, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Imprida fremgår af indlægssedlen.
English: What is Imprida?
Danish: Hvad er Imprida?
English: Why has Imprida been approved?
Danish: Hvorfor blev Imprida godkendt?
English: Imprida must not be used in patients who are hypersensitive (allergic) to amlodipine or other medicines in the ‘dihydropyridine derivatives' class, to valsartan, or to any of the other ingredients.
Danish: Imprida må ikke anvendes til patienter, der er overfølsomme (allergiske) over for amlodipin eller andre lægemidler i gruppen af "dihydropyridinderivater", valsartan eller andre af indholdsstofferne.
English: Imprida is used in patients who have essential hypertension (high blood pressure) that is not adequately controlled on either amlodipine or valsartan taken alone.
Danish: Imprida anvendes til patienter med essentiel hypertension (forhøjet blodtryk), når blodtrykket ikke kan kontrolleres tilstrækkeligt med amlodipin eller valsartan alene.
English: Imprida is a medicine that contains two active substances, amlodipine and valsartan.
Danish: Imprida er et lægemiddel, der indeholder de to aktive stoffer amlodipin og valsartan.
English: Imprida contains two active substances, amlodipine and valsartan.
Danish: Imprida indeholder to aktive stoffer, amlodipin og valsartan.
English: What is Imprida used for?
Danish: Hvad anvendes Imprida til?
English: What benefit has Imprida shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Imprida?
English: How has Imprida been studied?
Danish: Hvordan blev Imprida undersøgt?
English: How is Imprida used?
Danish: Hvordan anvendes Imprida?
English: How does Imprida work?
Danish: Hvordan virker Imprida?
English: 16 January, 2014
Danish: 16. januar 2014
English: • Take your tablet twice daily, once in the morning (breakfast) and once in the evening (dinner).
Danish: • Tag din tablet to gange dagligt, én gang om morgenen (morgenmad) og én gang om aftenen
English: • if you are 75 years old or older, you should not start taking this medicine.
Danish: • hvis du er 75 år eller derover, bør du ikke begynde at tage dette lægemiddel.
English: This is because you may be more prone to some side effects.
Danish: Det skyldes, at du kan være mere tilbøjelig til at få nogle bivirkninger.
English: Race There were no clinically relevant differences in systemic exposures between White, Black or Asian races.
Danish: Race Der var ingen klinisk relevant forskel i systemiske eksponering mellem hvid, sort eller asiatisk race.
English: • Do not use this medicine after the expiry date which is stated on the blister or carton after ‘EXP'.
Danish: • Brug ikke lægemidlet efter den udløbsdato, der står på blisteren eller æsken efter ‘EXP'.
English: The CANVAS and CANVAS-R studies and the CREDENCE and DECLARE Studies are planned to be completed in 2017 and 2020, respectively.
Danish: CANVAS- og CANVAS-R-undersøgelserne samt CREDENCE- og DECLARE-undersøgelserne afsluttes efter planen i henholdsvis 2017 og 2020.
English: After an oral dose, the non-absorbed fraction recovered in faeces was 20-30 %.
Danish: Efter en oral dosis var den ikke-absorberede fraktion, der blev genfundet i fæces, 20-30 %.
English: Subjects with mean daily insulin dose reduction of at least 10 % (%)
Danish: Forsøgspersoner med gennemsnitlig daglig reduktion af insulindosis på mindst 10 % (%)
English: • if you are taking another medicine for diabetes that contains “pioglitazone”, you should not start taking this medicine.
Danish: • hvis du tager et andet lægemiddel mod diabetes, der indeholder pioglitazon, bør du ikke begynde at tage dette lægemiddel.
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), 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 (≥ 1/1000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1000), meget sjælden (< 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: This medicine is used for a type of diabetes called “type 2 diabetes” in adult patients (aged 18 years and older) and usually occurs when you are older.
Danish: Dette lægemiddel anvendes til en type diabetes, der hedder “type 2-diabetes” hos voksne patienter (18 år og derover) som sædvanligvis opstår når du er blevet ældre.
English: The maximum daily dose is 3000 mg metformin and should preferably be divided into 2 - 3 daily doses.
Danish: Den maksimale daglige dosis er 3000 mg metformin og skal helst fordeles på 2-3 daglige doser.
English: Consequently, the EC requested on 6 July 2016 to extend the current procedure to include all of the authorised products of the class of SGLT2 inhibitors.
Danish: Derfor anmodede Europa-Kommissionen den 6. juli 2016 PRAC om at udvide den igangværende procedure til at omfatte alle godkendte lægemidler i klassen af SGLT2
English: If you forget to take Xigduo Do not take a double dose of this medicine to make up for a forgotten dose.
Danish: Hvis du har glemt at tage Xigduo Du må ikke tage en dobbeltdosis af dette lægemiddel som erstatning for den glemte dosis.
English: Dapagliflozin is approximately 91 % protein bound.
Danish: Dapagliflozin er ca. 91 % proteinbundet.
English: • changes in laboratory blood tests (creatinine or urea)
Danish: • ændringer i laboratorieblodprøver (kreatinin eller urea)
English: The patient should be informed and more frequent blood glucose monitoring perfomed, especially at the beginning of treatment with such medicinal products.
Danish: Patienten bør informeres, og der skal foretages hyppigere blodglucosemonitorering, især i begyndelsen af behandlingen med den slags lægemidler.
English: Due to the limited therapeutic experience with dapagliflozin in patients 75 years and older, initiation of therapy in this population is not recommended.
Danish: På grund af den begrænsede terapeutiske erfaring med dapagliflozin til patienter på 75 år og derover, anbefales det ikke at starte behandling i denne population.
English: • This medicine is used if your diabetes cannot be controlled with other medicines used to treat diabetes, along with diet and exercise.
Danish: • Dette lægemiddel anvendes, hvis din diabetes ikke kan kontrolleres med andre lægemidler til behandling af diabetes, sammen med diæt og motion.
English: In feces, approximately 15 % of the dose was excreted as parent drug.
Danish: I afføringen blev ca. 15 % af dosen udskilt som det oprindelige lægemiddel.
English: Dapagliflozin works by removing excess sugar from your body via your urine and lowers the amount of sugar in your blood.
Danish: Dapagliflozin virker ved at fjerne det overskydende sukker fra din krop via urinen og nedsætter mængden af sukker i dit blod.
English: In the clinical program, 34.4 % of subjects had a history of cardiovascular disease (excluding hypertension) at baseline and 67.9 % had hypertension.
Danish: I det kliniske program havde 34,4 % af forsøgspersonerne kardiovaskulær sygdom (eksklusive hypertension) i anamnesen ved baseline, og 67,9 % havde hypertension.
English: The prospective randomised (UKPDS) study has established the long-term benefit of intensive blood glucose control in type 2 diabetes.
Danish: Det prospektive randomiserede studie (UKPDS) har fastslået fordelen på langt sigt ved intensiv blodglucosekontrol ved type 2-diabetes.
English: The meal resulted in a delay of 1 to 2 hours in the peak concentrations and a decrease in the maximum plasma concentration of 29 % of dapagliflozin and 17 % of metformin.
Danish: Måltidet medførte en forsinkelse på 1 til 2 timer i peakkoncentrationerne og et fald i den maksimale plasmakoncentration på 29 % af dapagliflozin og 17 % af metformin.
English: Possible signs of losing too much fluid from your body are listed at the top of section 4 ‘Possible side effects'.
Danish: Mulige tegn på overdrevent væsketab fra kroppen er anført øverst i punkt 4, "Bivirkninger".
English: When the patient plans to become pregnant, and during pregnancy, it is recommended that diabetes is not treated with this medicinal product, but insulin be used to maintain blood glucose levels as close to normal as possible, to reduce the risk of malformations of the foetus associated with abnormal blood glucose levels.
Danish: Når patienten planlægger at blive gravid og under graviditeten anbefales det, at diabetes ikke behandles med dette lægemiddel, men at insulin anvendes til at opretholde blodglucoseniveauerne så tæt på normal som muligt, for at reducere risikoen for misdannelser af føtus, som er forbundet med abnorme blodglucoseniveauer.
English: Metformin increases the transport capacity of specific types of membrane glucose transporters (GLUT-1 and GLUT-4).
Danish: Metformin forøger transportkapaciteten hos specifikke typer af membranglucosetransportører (GLUT-1 og GLUT-4).
English: • These are medicines taken by mouth for diabetes.
Danish: • Begge stoffer er medicin, der indtages gennem munden mod diabetes.
English: These clinically relevant glycaemic effects were sustained in long-term extensions up to 104 weeks.
Danish: Disse klinisk relevante glykæmiske virkninger blev opretholdt i langtidsstudier i op til 104 uger.
English: Patients should be alerted to the risk of hypoglycaemia when this medicinal product is used in combination with other glucose-lowering medicinal products known to cause hypoglycaemia.
Danish: Patienterne bør advares om risikoen for hypoglykæmi, når dette lægemiddel anvendes i kombination med andre glucosesænkende lægemidler, som er kendt for at forårsage hypoglykæmi.
English: • If renal function falls below GFR < 60 mL/min, treatment should be discontinued.
Danish: • Hvis nyrefunktionen falder til under GFR < 60 ml/min bør behandlingen seponeres.
English: Xigduo should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
Danish: Xigduo bør ikke anvendes til patienter med type 1-diabetes mellitus eller til behandling af diabetisk ketoacidose.
English: A meta-analysis of cardiovascular events in the clinical program was performed.
Danish: Der blev udført en metaanalyse af kardiovaskulære bivirkninger i det kliniske program.
English: Stop taking Xigduo and see a doctor as soon as possible if you notice any of the following serious or potentially serious side effects:
Danish: Stop med at tage Xigduo og opsøg hurtigst muligt en læge, hvis du får nogen af følgende alvorlige eller potentielt alvorlige bivirkninger:
English: • if you have a history of serious heart disease or if you have had a stroke.
Danish: • hvis du har en sygehistorie med alvorlig hjertesygdom, eller hvis du har haft et slagtilfælde.
English: However, dose reduction may be considered in relation to declining renal function.
Danish: Dosisreduktion kan dog overvejes i relation til nedsat nyrefunktion.
English: Gender The mean dapagliflozin AUCss in females was estimated to be about 22 % higher than in males.
Danish: Den gennemsnitlige dapagliflozin AUCss hos kvinder blev vurderet til at være ca. 22 % højere end hos mænd.
English: Use alternative methods to monitor glycaemic control.
Danish: Brug alternative metoder til overvågning af den glykæmiske kontrol.
English: If necessary, the dose of the glucose-lowering medicinal product should be adjusted during therapy with the other medicinal product and on its discontinuation.
Danish: Om nødvendigt skal dosen af det glucosesænkende lægemiddel justeres under behandling med det andet lægemiddel og ved seponering af det.
English: Pharmacotherapeutic group: Drugs used in diabetes, Combinations of oral blood glucose-lowering drugs, ATC code: A10BD15
Danish: Farmakoterapeutisk klassifikation: Lægemidler mod diabetes, kombinationer af orale blodglucosesænkende lægemidler, ATC-kode: A10BD15
English: Results of (LOCF
Danish: Resultater af (LOCF