FrancophonIA/ELRC3.0 huggingface dataset:
English: In type 1 diabetes, the dosage varies between 0.5 and 1.0 IU/kg (0.7 and 1.0 IU/kg in children before puberty), in type 2 diabetes the dosage is 0.3 to 0.6 IU/kg.
Danish: Ved type 1diabetes varierer dosis mellem 0,5 og 1,0 IE/kg (0,7 og 1,0 IE/kg hos børn inden puberteten), ved type 2-diabetes er dosis 0,3 til 0,6 IE/kg.
English: Ultratard is used in patients with diabetes mellitus.
Danish: Ultratard anvendes til patienter med diabetes mellitus.
English: Ultratard doses might also need to be adjusted when given with a number of other medicines which may have an effect on blood sugar (the full list is available in the Package Leaflet).
Danish: Det kan også være nødvendigt at justere doseringen af Ultratard, når det gives sammen med en række andre lægemidler, der kan indvirke på blodsukkeret (den fuldstændige liste fremgår af indlægssedlen).
English: By controlling the blood sugar, the symptoms and complications of diabetes are reduced.
Danish: Ved at holde blodsukkeret under kontrol mindskes sukkersygesymptomerne og -komplikationerne.
English: Diabetes is a disease in which the body does not produce enough insulin to control the blood sugar.
Danish: Diabetes er en sygdom, hvor kroppen ikke producerer tilstrækkeligt insulin til at kontrollere blodsukkeret.
English: They recommended that Ultratard be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Ultratard.
English: Ultratard may cause hypoglycaemia (low blood sugar).
Danish: Ultratard kan forårsage hypoglykæmi (lavt blodsukker).
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) ULTRATARD EPAR summary for the public
Danish: EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) ULTRATARD EPAR - sammendrag for offentligheden
English: Ultratard is given subcutaneously (under the skin) by injection, usually in the thigh.
Danish: Ultratard gives subkutant (under huden) gennem injektion, sædvanligvis i låret.
English: Ultratard is supplied as 40 or 100 IU strengths in vials.
Danish: Ultratard leveres i styrkerne 40 eller 100 IE i hætteglas.
English: What is the risk associated with Ultratard?
Danish: Hvilke risici er der forbundet med Ultratard?
English: Ultratard contains insulin mixed with another substance, zinc, in particles from which the insulin is absorbed much more slowly during the day; and this gives Ultratard a longer duration of action.
Danish: Ultratard indeholder insulin blandet med et andet stof, zink, i partikler, hvorfra insulinen absorberes meget langsommere i løbet af dagen, og dette giver Ultratard en længere virkning.
English: Why has Ultratard been approved?
Danish: Hvorfor er Ultratard blevet godkendt?
English: If convenient it may also be given in the abdominal wall (tummy), the buttocks or the deltoid region (shoulder).
Danish: Hvis det passer bedre, kan det også gives i bugvæggen (maven), i ballerne eller i deltamuskelregionen (skulderen).
English: Ultratard can be used in type 1 diabetes, when the pancreas cannot produce insulin, and in type 2 diabetes, when the body is not able to use insulin effectively.
Danish: Ultratard kan anvendes til type 1-diabetes, når bugspytkirtlen ikke kan producere insulin, og til type 2-diabetes, når kroppen ikke er i stand til at udnytte insulin effektivt.
English: Ultratard should not be used in people who may be hypersensitive (allergic) to insulin human (rDNA) or to any of the other ingredients.
Danish: Ultratard bør ikke anvendes hos personer, som kan være overfølsomme (allergiske) over for insulin human (rDNA) eller et af de øvrige stoffer.
English: The insulin is made by a yeast that has received a gene (DNA), which makes it able to produce insulin.
Danish: Insulinen er fremstillet af gær, der har modtaget et gen (DNA), som sætter den i stand til at producere insulinen.
English: Ultratard was effective for both Type 1 and Type 2 diabetes.
Danish: Ultratard var effektivt til behandling af såvel type 1- som type 2-diabetes.
English: Ultratard is a long-acting insulin, it can be given as a once daily or twice daily injection, with or without a fast-acting insulin (at meal times), according to the doctor's recommendation.
Danish: Ultratard er en langtidsvirkende insulin, som kan gives en eller to gange dagligt som injektion med eller uden en hurtigt virkende insulin (til måltider), alt efter hvad lægen anbefaler.
English: The studies measured the level of fasting blood sugar or a substance (glycosylated haemoglobin, HbA1c), which gives an indication of how well the blood sugar is controlled.
Danish: I undersøgelserne målte man blodsukkeret i fastende tilstand eller mængden af et stof (glykosyleret hæmoglobin, HbA1c), der viser, hvor godt blodsukkeret reguleres.
English: Ultratard led to a decrease in the level of HbA1c, indicating that blood sugar levels had been controlled to a similar level to that seen with other human insulin.
Danish: Ultratard medførte et fald i HbA1c-niveauet, hvilket tyder på, at blodsukkeret var blevet holdt under kontrol på et niveau, der svarede til det, der var observeret for anden human insulin.
English: Ultratard contains the active ingredient insulin human (rDNA).
Danish: Ultratard indeholder det aktive stof insulin human (rDNA).
English: Ultratard has been studied in both type 1 and type 2 diabetes, and it has been compared to other types of insulin (porcine, human).
Danish: Ultratard er blevet undersøgt ved både type 1- og type 2-diabetes, og det er blevet sammenlignet med andre former for insulin (insulin fra svin, human insulin).
English: Ultratard is an insulin suspension for injection.
Danish: Ultratard er insulin i form af en injektionsvæske, suspension.
English: What is Ultratard?
Danish: Hvad er Ultratard?
English: For the full description of the side effects reported with Ultratard, please see the Package Leaflet.
Danish: Den fuldstændige beskrivelse af de indberettede bivirkninger ved Ultratard fremgår af indlægssedlen.
English: What benefit has Ultratard shown during the studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Ultratard?
English: The full EPAR for Ultratard is available here.
Danish: Den europæiske offentlige vurderingsrapport (EPAR) for Ultratard kan ses i sin helhed her.
English: What is Ultratard used for?
Danish: Hvad anvendes Ultratard til?
English: Ultratard is a replacement insulin which identical to the insulin made by the pancreas .The active ingredient of Ultratard, insulin human (rDNA), is produced by a method known as ‘recombinant technology'.
Danish: Det aktive stof i Ultratard, insulin human (rDNA), produceres via en metode, der er kendt som ‘rekombinant teknologi'.
English: How is Ultratard used?
Danish: Hvordan anvendes Ultratard?
English: How does Ultratard work?
Danish: Hvordan virker Ultratard?
English: The European Commission issued a Decision on 22 September 2011.
Danish: Europa-Kommissionen traf en afgørelse den 22. september 2011.
English: What is Canazole?
Danish: Hvad er Canazol?
English: The marketing authorisation in Ireland should also be suspended.
Danish: Desuden bør markedsføringstilladelsen i Irland suspenderes.
English: Why was Canazole reviewed?
Danish: Hvorfor blev Canazol vurderet igen?
English: The company which recently marketed this product wanted the authorisation to be recognised in the United Kingdom (the ‘concerned Member State').
Danish: Virksomheden, som for nylig har markedsført dette lægemiddel, ønskede, at markedsføringstilladelsen skulle anerkendes i Det Forenede Kongerige ("den berørte medlemsstat").
English: Without ergosterol, the fungus is killed or prevented from spreading.
Danish: Uden ergosterol dør svampen, eller den forhindres i at sprede sig.
English: However, the Member States were not able to reach an agreement and the Irish medicines regulatory agency referred the matter to the CHMP for arbitration on 25 November 2010.
Danish: Medlemsstaterne kunne imidlertid ikke nå til enighed, og den irske lægemiddelkontrolmyndighed indbragte den 25. november 2010 sagen for CHMP med henblik på voldgift.
English: It works by preventing the formation of ergosterol, which is an important part of fungal cell walls.
Danish: Det virker ved at forhindre dannelsen af ergosterol, som er en vigtig del af svampecellevæggen.
English: Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the currently available data were not sufficient to show therapeutic equivalence with the reference medicine and that further data would need to be generated.
Danish: På baggrund af en vurdering af de tilgængelige data og den videnskabelige drøftelse i udvalget konkluderede CHMP, at de data, der foreligger i øjeblikket, ikke er tilstrækkelige til at påvise terapeutisk ækvivalens med referencelægemidlet, og at det er nødvendigt at fremskaffe yderligere data.
English: Pinewood Laboratories Ltd submitted Canazole for mutual recognition on the basis of the initial authorisation granted by Ireland on 8 December 2000.
Danish: Pinewood Laboratories Ltd indsendte en ansøgning om gensidig anerkendelse af Canazol på baggrund af den første markedsføringstilladelse, der blev udstedt af Irland den 8. december 2000.
English: Canazole is a generic medicine based on a ‘reference medicine', Canesten, which is authorised in the United Kingdom.
Danish: Canazol er et generisk lægemiddel, der er baseret på et "referencelægemiddel", Canesten, som er godkendt i Det Forenede Kongerige.
English: The grounds for the referral were that the United Kingdom did not agree that Canazole cream and Canesten cream are similar enough to have therapeutic equivalence.
Danish: Begrundelsen for indbringelsen var, at Det Forenede Kongerige ikke var enigt i, at Canazol creme og Canesten creme ligner hinanden tilstrækkeligt til at have terapeutisk ækvivalens.
English: In addition, the Committee has also recommended that the marketing authorisation for Canazole in Ireland be suspended until further studies are done.
Danish: Endvidere anbefalede udvalget, at markedsføringstilladelsen for Canazol i Irland suspenderes, indtil der er foretaget yderligere undersøgelser.
English: The European Medicines Agency has completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Canazole.
Danish: Det Europæiske Lægemiddelagentur (EMA) har gennemført en voldgiftsprocedure efter en uoverensstemmelse mellem Den Europæiske Unions medlemsstater vedrørende markedsføringstilladelsen for Canazol.
English: It is used to treat skin infections caused by fungi, such as thrush, ringworm or athlete's foot.
Danish: Det anvendes til behandling af hudinfektioner, der er forårsaget af svampe, såsom trøske, ringorm og fodsvamp.
English: Canazole is a cream that contains the active substance clotrimazole (1%).
Danish: Canazol er en creme, der indeholder det aktive stof clotrimazol (1 %).
English: The active substance in Canazole, clotrimazole, is an antifungal medicine that belongs to the group called triazoles.
Danish: Det aktive stof i Canazol, clotrimazol, er et lægemiddel mod svamp, som tilhører den gruppe, der kaldes "triazoler".
English: Questions and answers on Canazole (clotrimazole cream 1%) EMA/837098/2011
Danish: Spørgsmål og svar vedrørende Canazol (clotrimazol creme 1%) EMA/206825/2011
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Canazole do not outweigh its risks, and the marketing authorisation granted in Ireland cannot be recognised in other Member States of the EU.
Danish: EMA's Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Canazol ikke opvejer risiciene, og at den markedsføringstilladelse, der er udstedt i Irland, ikke kan anerkendes i de øvrige EU-medlemsstater.
English: The CHMP therefore concluded that the benefits of Canazole do not outweigh its risks and recommended that the marketing authorisation should not be granted in the concerned Member State.
Danish: CHMP konkluderede således, at fordelene ved Canazol ikke opvejer risiciene, og CHMP anbefalede, at der ikke udstedes markedsføringstilladelse i den berørte medlemsstat.
English: Questions and answers on Canazole (clotrimazole cream
Danish: Spørgsmål og svar vedrørende Canazol (clotrimazol creme 1%)
English: A reduced dose is used in children.
Danish: Der anvendes en mindre dosis til børn.
English: Other information about Wilzin:
Danish: Andre oplysninger om Wilzin:
English: It is available as capsules (blue: 25 mg; orange: 50 mg).
Danish: Det fås som kapsler (blå: 25 mg, orange: 50 mg).
English: The marketing authorisation was renewed on 13 October 2009.
Danish: Tilladelsen blev fornyet den 13. oktober
English: The European Commission granted a marketing authorisation valid throughout the European Union for Wilzin to Orphan Europe SARL on 13 October 2004.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Wilzin til Orphan Europe den 13.oktober 2004.
English: Wilzin should be taken on an empty stomach, at least one hour before or two to three hours after meals.
Danish: Wilzin skal tages på tom mave mindst én time før eller to-tre timer efter et måltid.
English: Wilzin zinc EPAR summary for the public
Danish: Wilzin zink EPAR - sammendrag for offentligheden
English: Delaying the first dose to mid-morning or taking the dose with a small amount of food containing protein, such as meat, may help.
Danish: Det kan hjælpe at vente med den første dosis til midt på formiddagen eller at tage medicinen sammen med en lille smule proteinholdig føde f.eks. kød.
English: The main measure of effectiveness was whether patients had adequate control of copper levels.
Danish: Det primære effektmål var, om patienternes kobberværdier var blevet tilfredsstillende kontrolleret.
English: This protein attaches to copper and prevents it being transferred into the blood.
Danish: Dette protein binder sig til kobber og forhindrer, at det transporteres over i blodet..
English: The maximum dose of Wilzin is 50 mg five times a day.
Danish: Den maksimale dosis af Wilzin er 50 mg fem gange dagligt.
English: Patients who are switching from a ‘chelating agent' (another type of medicine for Wilson's disease) to Wilzin should continue to take the chelating agent for two to three weeks after starting Wilzin, because Wilzin takes some time to start working fully.
Danish: Patienter, som skifter fra et ‘chelaterende middel' (en anden type lægemiddel, der anvendes ved Wilsons sygdom) til Wilzin bør fortsætte med at tage det chelaterende middel i to til tre uger efter at være startet med Wilzin, fordi det tager noget tid, inden Wilzin virker fuldt ud.
English: The usual dose for adults is 50 mg three times a day.
Danish: Den anbefalede dosis til voksne er 50 mg 3 gange dagligt.
English: Gastric irritation is usually worst with the first morning dose and disappears after the first few days of treatment.
Danish: Maveirritationen er sædvanligvis værst med morgendosen og svinder få dage efter påbegyndelse af behandlingen.
English: Wilzin is a medicine that contains the active substance zinc.
Danish: Wilzin er et lægemiddel, der indeholder det aktive stof zink.
English: Because zinc has been used to treat Wilson's disease for many years, the company presented the results of studies from the published literature.
Danish: Da zink har været anvendt til at behandle Wilsons' sygdom i mange år, fremlagde virksomheden resultaterne af undersøgelser fra den offentliggjorte faglitteratur.
English: Wilzin has been shown to be effective in reducing the absorption of copper and reducing the amount of copper in the body.
Danish: Wilzin har vist sig at være effektivt til at nedsætte kobberoptagelsen og mindske kobbermængden i kroppen.
English: It works by stimulating the body to produce a protein called metallothionein in the cells lining the gut.
Danish: Det virker ved at stimulere kroppen til at danne et protein, der kaldes metallothionein, i tarmvæggenes celler.
English: In the main study, 91% of the patients evaluated (91 out of 100) had adequate control of their copper levels within the first year of treatment with Wilzin.
Danish: I hovedundersøgelsen fik 91 % af patienterne (91 af 100) begrænset kobberniveauet tilstrækkeligt i løbet af det første års behandling med Wilzin.
English: The Committee recommended that Wilzin be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Wilzin.
English: The full EPAR for Wilzin can be found here.
Danish: Den fuldstændige EPAR for Wilzin findes her.
English: Zinc has been used to treat Wilson's disease since 1958.
Danish: Zink har været anvendt til at behandle Wilsons' sygdom siden 1958.
English: The most common side effects with Wilzin (seen in between 1 and 10 patients in 100) are gastric irritation (irritation of the stomach) and increased blood levels of enzymes (amylase, lipase and alkaline phosphatase).
Danish: De hyppigste bivirkninger ved Wilzin (optræder hos mellem 1 og 10 patienter ud af 100) er maveirritation og forhøjede niveauer af enzymer i blodet (amylase, lipase og alkalisk fosfatase).
English: Wilson's disease is a rare inherited disorder where patients lack an enzyme that is needed to eliminate the copper contained in food from the body.
Danish: Wilsons sygdom er en sjælden, arvelig sygdom, hvor patienten mangler et enzym, der er nødvendigt, for at kroppen kan udskille det kobber, der indtages med føden.
English: Because the number of patients with Wilson's disease is low, the disease is considered ‘rare', and Wilzin was designated an ‘orphan medicine' (a medicine used in rare diseases) on 31 July 2001.
Danish: Da antallet af patienter med Wilsons sygdom er lavt, betragtes sygdommen som sjælden, og Wilzin blev udpeget som lægemiddel til sjældne sygdomme den 31. juli 2001.
English: The main study involved 148 patients who were treated with Wilzin, but did not compare Wilzin with any other treatments.
Danish: I hovedundersøgelsen, som omfattede 148 patienter behandlet med Wilzin, blev Wilzin ikke sammenlignet med andre behandlinger.
English: The Committee for Medicinal products for Human Use (CHMP) noted that Wilson's disease is a fatal disease and the other medicines already being used for the disease can have severe side effects.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) bemærkede, at Wilsons sygdom er dødelig, og at der kan være alvorlige bivirkninger forbundet med de lægemidler, der allerede anvendes.
English: Wilzin should not be used in people who may be hypersensitive (allergic) to zinc or any of the other ingredients.
Danish: Wilzin bør ikke anvendes til patienter, som kan være overfølsomme (allergiske) over for zink eller andre af indholdsstofferne.
English: Wilzin is a long-term treatment.
Danish: Behandlingen med Wilzin er langtidsbehandling.
English: In total, data to support the use of Wilzin came from 255 patients with Wilson's disease.
Danish: De oplysninger, som understøttede anvendelsen af Wilzin, kom fra i alt 255 patienter med Wilsons' sygdom.
English: The active substance in Wilzin is the zinc cation (positively charged zinc), which blocks the absorption of copper from the diet.
Danish: Det aktive stof i Wilzin er zink-kationen (positivt ladet zink), der blokerer for optagelsen af kobber fra føden.
English: What is the risk associated with Wilzin?
Danish: Hvilken risiko er der forbundet med Wilzin?
English: Wilzin treatment should be started by a doctor who has experience in the treatment of Wilson's disease.
Danish: Behandlingen med Wilzin bør igangsættes af en læge med erfaring i behandling af Wilsons sygdom.
English: This results in copper building up in the body, first in the liver, then in other organs such as the eye and the brain.
Danish: Dette medfører, at kobber ophobes i kroppen, først i leveren, derefter i andre organer som f.eks. øjnene og hjernen Dette kan blandt andet medføre leversygdom og skader på nervesystemet.
English: Therefore, the Committee decided that Wilzin's benefits are greater than its risks for the treatment of Wilson's disease.
Danish: Udvalget besluttede derfor, at fordelene ved Wilzin opvejer risiciene ved behandling af Wilzins sygdom.
English: What is Wilzin?
Danish: Hvad er Wilzin?
English: Why has Wilzin been approved?
Danish: Hvorfor blev Wilzin godkendt?
English: The summary of opinion of the Committee for Orphan Medicinal Products for Wilzin is available here.
Danish: Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Wilzin findes her.
English: Over time, the amount of copper in the body falls, improving the symptoms of the disease.
Danish: Den mindskede kobbermængde i kroppen resulterer i en bedring i sygdomssymptomerne.
English: For the full list of all side effects reported with Wilzin, see the Package Leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Wilzin fremgår af indlægssedlen.
English: Wilzin is used to treat Wilson's disease.
Danish: Wilzin anvendes til behandling af Wilsons sygdom.
English: What is Wilzin used for?
Danish: Hvad anvendes Wilzin til?
English: The copper is then passed out of the body in the stools.
Danish: Det bundne kobber udskilles derefter med afføringen.
English: How has Wilzin been studied?
Danish: Hvordan blev Wilzin undersøgt?
English: What benefit has Wilzin shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Wilzin?
English: How is Wilzin used?
Danish: Hvordan anvendes Wilzin?
English: For more information, see the Package Leaflet.
Danish: De nærmere oplysninger fremgår af indlægssedlen.
English: How does Wilzin work?
Danish: Hvordan virker Wilzin?
English: ** Based on historical comparison
Danish: ** Baseret på historisk sammenligning.
English: The combination was generally well tolerated.
Danish: Kombinationen var generelt veltolereret.
English: Date of first authorisation: 9 January 2012 Date of latest renewal: 9 September 2016
Danish: Dato for første tilladelse: 9. januar 2012 Dato for seneste fornyelse af tilladelsen: 9. september 2016
English: This combination should be used with caution.
Danish: Denne kombination bør anvendes med forsigtighed.
English: ---, not performed.
Danish: ---, ikke udført.
English: Component of a multipack, can't be sold separately.
Danish: Komponenten i en multipack kan ikke sælges separat.
English: 10000 Zagreb, Croatia
Danish: 10000 Zagreb Kroatien
English: Risk to the infant cannot be excluded.
Danish: En risiko for spædbørn kan ikke udelukkes.
English: Keep the medicine container with you so that you can easily describe what you have taken.
Danish: Behold pakningen, så du nemt kan beskrive, hvad du har taget.
English: This is very important because the amount of virus may start to increase if the medicine is stopped for even a short time.
Danish: Dette er meget vigtigt, da mængden af virus kan begynde at stige, hvis medicineringen standses - selv i kort tid.
English: Tell your doctor immediately if you are pregnant or intend to become pregnant.
Danish: Fortæl det straks til din læge, hvis du er gravid eller har til hensigt at blive gravid.
English: - If any member of your family (parents, grandparents, brothers or sisters) has died suddenly due to a heart problem or was born with heart problems.
Danish: • hvis et familiemedlem (forældre, bedsteforældre, brødre eller søstre) pludseligt er afgået ved døden på grund af et hjerteproblem eller var født med hjerteproblemer.
English: This leaflet was last revised in Other sources of information
Danish: Denne indlægsseddel blev senest revideret Andre informationskilder
English: It is used by adults, adolescents and children 3 years of age and older.
Danish: Det anvendes af voksne, unge og børn, der er over 3 år.
English: Some patients have more serious symptoms that may affect mood or the ability to think clearly.
Danish: Nogle patienter har haft mere alvorlige symptomer, der kan påvirke humøret eller evnen til at tænke klart.
English: Precautions to prevent transmission should be taken in accordance with national guidelines.
Danish: Der bør derfor træffes forholdsregler til at forhindre dette i overensstemmelse med nationale retningslinjer.