FrancophonIA/ELRC3.0 huggingface dataset:
English: How has the medicine been studied?
Danish: Hvordan blev lægemidlet undersøgt?
English: Efavirenz/Emtricitabine/Tenofovir disoproxil Krka is an antiviral medicine used to treat adults infected with human immunodeficiency virus-1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Danish: Efavirenz/Emtricitabine/Tenofovir disoproxil Krka er et antiviralt lægemiddel til behandling af voksne, som er smittet med humant immundefektvirus type 1 (hiv-1), et virus, som forårsager erhvervet immundefektsyndrom (aids).
English: This medicine contains three active substances: efavirenz, which is a non-nucleoside reverse transcriptase inhibitor (NNRTI); emtricitabine, which is a nucleoside reverse transcriptase inhibitor; and tenofovir disoproxil, which is a ‘prodrug' of tenofovir, meaning that it is converted into the active substance tenofovir in the body.
Danish: Lægemidlet indeholder tre aktive stoffer: efavirenz, som er en såkaldt non-nukleosid revers transkriptasehæmmer (NNRTI), emtricitabin, som er en nukleosid revers transkriptasehæmmer, og tenofovirdisoproxil, som er et "prodrug" (forstadium) til tenofovir, dvs. det omdannes til det aktive stof tenofovir i kroppen.
English: Because Efavirenz/Emtricitabine/Tenofovir disoproxil Krka 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 Efavirenz/Emtricitabine/Tenofovir disoproxil Krka er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: What is Efavirenz/Emtricitabine/Tenofovir disoproxil Krka and what is it used for?
Danish: Hvad er Efavirenz/Emtricitabine/Tenofovir disoproxil Krka, og hvad anvendes det til?
English: This is a summary of the European public assessment report (EPAR) for Efavirenz/Emtricitabine/Tenofovir disoproxil Krka.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Efavirenz/Emtricitabine/Tenofovir disoproxil Krka.
English: The medicine contains the active substances efavirenz, emtricitabine and tenofovir disoproxil and is a ‘generic medicine'.
Danish: Lægemidlet indeholder de aktive stoffer efavirenz, emtricitabin og tenofovirdisoproxil og er et "generisk lægemiddel".
English: Efavirenz/Emtricitabine/Tenofovir disoproxil Krka efavirenz / emtricitabine / tenofovir disoproxil
Danish: Efavirenz/Emtricitabine/Tenofovir disoproxil Krka efavirenz/emtricitabin/tenofovirdisoproxil
English: For more information about treatment with Efavirenz/Emtricitabine/Tenofovir disoproxil Krka, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Efavirenz/Emtricitabine/Tenofovir disoproxil Krka, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Other information about Efavirenz/Emtricitabine/Tenofovir disoproxil Krka
Danish: Andre oplysninger om Efavirenz/Emtricitabine/Tenofovir disoproxil Krka
English: Recommendations and precautions to be followed by healthcare professionals and patients for its safe and effective use have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af lægemidlet.
English: For practical information about using Efavirenz/Emtricitabine/Tenofovir disoproxil Krka, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Efavirenz/Emtricitabine/Tenofovir disoproxil Krka, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: For more information, see the package leaflet.
Danish: Du kan finde flere oplysninger i indlægssedlen.
English: It can be used in the following ways:
Danish: Det kan anvendes på følgende måder:
English: This summary was last updated in 11-2012.
Danish: Dette sammendrag blev sidst ajourført i 11-2012.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Xiliarx on 19 November 2008.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Xiliarx den 19. november 2008.
English: Some of the patients were also taking metformin.
Danish: Visse af patienterne tog også metformin.
English: The full EPAR for Xiliarx can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Xiliarx findes på agenturets websted under Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This is a summary of the European public assessment report (EPAR) for Xiliarx.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Xiliarx.
English: The daily dose should not exceed two tablets (100 mg).
Danish: Dagsdosis må ikke være over to tabletter (100 mg).
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 Xiliarx.
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 anvendelsesbetingelserne for Xiliarx.
English: It is available as tablets (50 mg).
Danish: Det fås som tabletter (50 mg).
English: For more information about treatment with Xiliarx, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Xiliarx, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Xiliarx is a medicine that contains the active substance vildagliptin.
Danish: Xiliarx er et lægemiddel, der indeholder det aktive stof vildagliptin.
English: Because vildagliptin has been associated with liver problems, patients should have tests to check their liver function before treatment with Xiliarx and at regular intervals during treatment.
Danish: Da vildagliptin er blevet sat i forbindelse med leverproblemer, skal patienterne undersøges for at kontrollere deres leverfunktion inden behandlingen med Xiliarx og med regelmæssige mellemrum under behandlingen.
English: Xiliarx is used to treat type 2 diabetes mellitus.
Danish: Xiliarx anvendes til behandling af type 2 diabetes mellitus.
English: • one tablet in the morning (50 mg per day) when taken with a sulphonylurea.
Danish: • en tablet om morgenen (50 mg pr. dag), når det tages sammen med et sulfonylurinstof.
English: The most common side effect with Xiliarx (seen in between 1 and 10 patients in 100) is dizziness.
Danish: Den hyppigste bivirkning ved Xiliarx (som ses hos mellem 1 og 10 patienter ud af 100) er svimmelhed.
English: Together, these processes reduce blood glucose levels and help to control type 2 diabetes.
Danish: Sammenlagt sænker disse processer blodsukkeret og er derved med til at kontrollere type 2-diabetes.
English: Vildagliptin does not work when the blood glucose is low.
Danish: Vildagliptin virker ikke, når blodsukkeret er lavt.
English: Xiliarx should therefore be used only in patients for whom metformin is inappropriate either because of side effects occurring with metformin or because they have a condition that makes metformin unsuitable for them.
Danish: Xiliarx skal derfor kun anvendes hos patienter, hos hvem metformin er uhensigtsmæssigt enten på grund af de bivirkninger, der indtræffer, eller fordi de har en tilstand, som gør, at metformin ikke er hensigtsmæssigt for dem.
English: Other information about Xiliarx
Danish: Andre oplysninger om Xiliarx
English: The active substance in Xiliarx, vildagliptin, is a dipeptidyl peptidase 4 (DPP-4) inhibitor.
Danish: Det aktive stof i Xiliarx, vildagliptin, er en dipeptidylpeptidase-IV (DPP-IV)-hæmmer.
English: A lower dose of the sulphonylurea may also be considered to reduce the risk of hypoglycaemia (low blood glucose levels).
Danish: En lavere dosis sulfonylurinstof bør også overvejes for at mindske risikoen for hypoglykæmi (lave blodsukkerniveauer).
English: The CHMP also considered the use of Xiliarx on its own and concluded that it was effective in reducing blood glucose but less so than metformin.
Danish: CHMP analyserede også anvendelsen af Xiliarx alene og konkluderede, at det var effektivt til at reducere blodsukkeret, dog i mindre grad end metformin.
English: Xiliarx must not be used in people who are hypersensitive (allergic) to vildagliptin or any of the other ingredients.
Danish: Xiliarx bør ikke anvendes hos patienter, der er overfølsomme (allergiske) over for vildagliptin eller andre af indholdsstofferne.
English: In adults, the recommended dose of Xiliarx is:
Danish: Den anbefalede dosis af Xiliarx til voksne er:
English: The CHMP noted that Xiliarx was effective as an add-on to metformin, a thiazolidinedione, or a sulphonylurea (dual therapy), a sulphonylurea and metformin (triple therapy) or insulin with or without metformin, and concluded that the benefits of the add-on treatment outweigh the risks.
Danish: CHMP bemærkede, at Xiliarx var effektivt som tillægsbehandling til metformin, thiazolidinedion eller et sulfonylurinstof (dobbelt behandling), til et sulfonylurinstof og metformin (tredobbelt behandling) eller til insulin med eller uden metformin, og konkluderede, at fordelene ved tillægsbehandlingen opvejer risiciene.
English: Xiliarx has been studied in eleven main studies involving a total of over 5,000 patients with type 2 diabetes and insufficient control of blood glucose levels.
Danish: Xiliarx blev anvendt i elleve hovedundersøgelser, der tilsammen omfattede over 5 000 patienter med type 2-sukkersyge, hvis blodsukker ikke var tilfredsstillende reguleret.
English: Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose (sugar) in the blood or when the body is unable to use insulin effectively.
Danish: Ved type 2-sukkersyge producerer bugspytkirtlen enten ikke nok insulin til at regulere glukosen (sukkeret) i blodet, eller også er kroppen ikke i stand til at udnytte insulinet effektivt.
English: For the full list of all side effects reported with Xiliarx, see the package leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Xiliarx fremgår af indlægssedlen.
English: • one tablet in the morning and another in the evening (100 mg per day), when used alone, with metformin, with a thiazolidinedione, with metformin plus a sulphonylurea, or with insulin (with or without metformin);
Danish: • en tablet om morgenen og en tablet om aftenen(100 mg pr. dag), når det tages alene, sammen med metformin, et thiazolidindion, metformin og et sulfonylurinstof eller insulin (med eller uden metformin),
English: Four studies compared the effects of Xiliarx, taken at doses of 50 or 100 mg a day for 24 weeks, with those of placebo, when used as an add-on to existing treatment with metformin (544 patients), pioglitazone (a thiazolidinedione, 463 patients), glimepiride (a sulphonylurea, 515 patients) or insulin (296 patients).
Danish: I fire undersøgelser blev virkningen af Xiliarx, 50 eller 100 mg dagligt i 24 uger, sammenlignet med placebo som tillægsbehandling til enten metformin (544 patienter), thiazolidindionet pioglitazon (463 patienter), sulfonylurinstoffet glimepirid (515 patienter) eller insulin (296 patienter).
English: Vildagliptin also reduces the amount of glucose made by the liver, by increasing insulin levels and decreasing the levels of the hormone glucagon.
Danish: Vildagliptin nedsætter desuden leverens sukkerproduktion ved at øge insulinindholdet og sænke indholdet af hormonet glukagon.
English: Patients taking Galvus in addition to insulin, with or without metformin, had a reduction in HbA1c levels of 0.77 percentage points, compared with 0.05 percentage points in patients taking placebo in addition to insulin.
Danish: Patienter, der tog Galvus i tillæg til insulin, med eller uden metformin, oplevede et fald i HbA1c-niveauerne på 0,77 procent sammenlignet med 0,05 procent hos patienter, der tog placebo i tillæg til insulin.
English: What is the risk associated with Xiliarx?
Danish: Hvilken risiko er der forbundet med Xiliarx?
English: In combination with glimepiride, both 50 mg and 100 mg daily doses caused a reduction of around 0.6 percentage points.
Danish: I kombination med glimepirid gav både 50 mg og 100 mg dagligt en reduktion på ca. 0,6 procent.
English: • together with metformin, a thiazolidinedione or a sulphonylurea (dual therapy) when the patient's diabetes is insufficiently controlled by this other medicine taken alone, but it is only used in combination with a sulphonylurea in patients who cannot take metformin;
Danish: • sammen med metformin, et thiazolidindion eller et sulfonylurinstof (som dobbelt behandling), når patientens sukkersyge ikke kan kontrolleres tilfredsstillende med denne anden medicin alene, men det anvendes kun i kombination med et sulfonylurinstof til patienter, som ikke kan tage metformin,
English: When used as an add-on to existing treatment for type 2 diabetes, Xiliarx was more effective than placebo in reducing HbA1c levels.
Danish: Som tillægsbehandling til anden medicin til behandling af type 2-sukkersyge var Xiliarx bedre end placebo til at sænke indholdet af HbA1c.
English: A further study compared Galvus with placebo as an add-on treatment in 318 patients who were already taking metformin and glimepiride.
Danish: Der blev også udført en yderligere undersøgelse, hvori Galvus blev sammenlignet med placebo som tillægsbehandling hos 318 patienter, som allerede tog metformin og glimepirid.
English: Why has Xiliarx been approved?
Danish: Hvorfor blev Xiliarx godkendt?
English: A further study compared Galvus with placebo as an add-on treatment in 449 patients who were already taking a stable dose of long-acting insulin.
Danish: Desuden blev Galvus i en undersøgelse sammenlignet med placebo som tillægsbehandling hos 449 patienter, som allerede tog en fast dosis længerevirkende.
English: In all studies, the main measure of effectiveness was the change in blood levels of a substance called glycosylated haemoglobin (HbA1c), which gives an indication of how well blood glucose is controlled.
Danish: I alle undersøgelserne blev medicinens virkning hovedsagelig bedømt ved at måle blodets indhold af et stof, der kaldes glykosyleret hæmoglobin (HbA1c).
English: In combination with metformin and glimepiride, 50 mg Galvus taken twice a day reduced HbA1c levels by 1 percentage point, compared with a reduction of 0.3 percentage points in patients taking placebo.
Danish: I en kombination med metformin og glimepirid reducerede 50 mg Galvus to gange dagligt HbA1cniveauet med 1 procent sammenlignet med en reduktion på 0,3 procent hos patienter, der tog placebo.
English: What is Xiliarx?
Danish: Hvad er Xiliarx?
English: With metformin and with pioglitazone, the 100 mg daily dose was more effective than the 50 mg daily dose, with a reduction in HbA1c levels of between 0.8 and 1.0 percentage points.
Danish: Sammen med metformin og pioglitazon virkede en dosis på 100 mg dagligt bedre end 50 mg dagligt og gav en reduktion i indholdet af HbA1c på mellem 0,8 og 1,0 procent.
English: • together with insulin (with or without metformin) in patients whose diabetes is not sufficiently controlled by diet and exercise plus a stable dose of insulin.
Danish: • sammen med insulin (med eller uden metformin) til patienter, når patienternes sukkersyge ikke kan kontrolleres tilfredsstillende med diæt, motion og en fast dosis insulin.
English: In contrast, patients adding placebo to their existing treatment showed smaller changes in HbA1c levels, ranging from a fall of 0.3 to a rise of 0.2 percentage points.
Danish: Hos de patienter, der i stedet fik placebo som tillægsbehandling til den medicin, de fik i forvejen, var ændringen i HbA1c-niveauet derimod mindre (mellem et fald på 0,3 procent og en stigning på 0,2 procent).
English: • on its own (monotherapy) in patients whose diabetes is not sufficiently controlled by diet and exercise and who cannot take metformin;
Danish: • alene (monoterapi) til patienter, hvis sukkersyge ikke kan kontrolleres tilstrækkeligt med diæt og motion, og for hvem behandling med metformin ikke anses for egnet.
English: • together with a sulphonylurea and metformin (triple therapy) in patients whose diabetes is not sufficiently controlled by these medicines plus diet and exercise;
Danish: • sammen med et sulfonylurinstof og metformin (som tredobbelt behandling), når patienternes sukkersyge ikke kan kontrolleres tilfredsstillende med disse lægemidler samt diæt og motion,
English: How has Xiliarx been studied?
Danish: Hvordan blev Xiliarx undersøgt?
English: What benefit has Xiliarx shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Xiliarx?
English: By increasing levels of incretin hormones in the blood, vildagliptin stimulates the pancreas to produce more insulin when blood glucose levels are high.
Danish: Det får bugspytkirtlen til at producere mere insulin, når blodsukkeret er højt.
English: What is Xiliarx used for?
Danish: Hvad anvendes Xiliarx til?
English: How is Xiliarx used?
Danish: Hvordan anvendes Xiliarx?
English: In the study involving 296 patients taking insulin, adding Galvus caused a greater reduction in HbA1c levels than adding placebo, but the size of this effect was small possibly due to the fact that the study included long-term patients who were less likely to show improvement..
Danish: I undersøgelsen af 296 patienter, der tog insulin, gav Galvus som tillægsbehandling et større fald i HbA1c-niveauet end placebo.
English: Five of these studies looked at the effects of Xiliarx taken alone in a total of 3,644 patients, comparing it with placebo (a dummy treatment), metformin, rosiglitazone (a thiazolidinedione) or gliclazide (a sulphonylurea).
Danish: Det blev her sammenlignet med placebo (en virkningsløs behandling), med metformin, rosiglitazon (et thiazolidindion) eller gliclazid (et sulfonylurinstof).
English: This medicine is the same as Galvus, which is already authorised in the European Union (EU).
Danish: Markedsføringstilladelsen var baseret på den tilladelse, som blev udstedt for Galvus i 2007 ('informeret samtykke')
English: However, in another study involving 449 patients taking insulin, the size of this effect was significant.
Danish: Virkningen var imidlertid lille, hvilket sikkert skyldes, at undersøgelsen omfattede patienter, der havde været i behandling i lang tid, og at det derfor var mindre sandsynligt, at der kunne observeres forbedringer hos dem. I en anden undersøgelse af 449 patienter, der tog insulin, var størrelsen af virkningen signifikant.
English: How does Xiliarx work?
Danish: Hvordan virker Xiliarx?
English: Xiliarx used on its own was effective at reducing levels of HbA1c, but was less effective than the comparator medicines.
Danish: Xiliarx anvendt alene var effektivt til at reducere indholdet af HbA1c, dog mindre effektivt end de lægemidler, det blev sammenlignet med. I den undersøgelse, der sammelignede Xiliarx med metformin, blev der opnået væsentligt bedre resultater med metformin: et fald i indholdet af HbA1c på
English: In the study comparing Xiliarx with metformin, significantly better results were seen with metformin: a reduction in HbA1c of 1.5 percentage points after 52 weeks compared with a reduction of around 1 percentage point in patients treated with Xiliarx.
Danish: 1,5 procent efter 52 uger sammenlignet med et fald på ca. 1 procent hos patienter behandlet med Xiliarx.
English: The physician information should contain the following key messages:
Danish: Læge informationen skal indeholde følgende nøglebudskaber:
English: • Physician information
Danish: • Læge information
English: • The role and use of patient alert card.
Danish: • Rollen og anvendelsen af patientinformationskortet.
English: The Marketing Authorisation Holder (MAH) shall ensure that, prior to launch, all physicians who are expected to prescribe/use Simponi are provided with a physician information pack containing the following:
Danish: Indehaveren af markedsføringstilladelsen skal inden lancering, sikre at alle læger som forventes at ordinere/anvende Simponi er forsynet med en læge informationspakke indeholdende følgende:
English: • The risk of acute injection-related reactions and delayed serious systemic hypersensitivity reactions, the need for instructing patients on techniques for administration, and guidance for Health Care Professionals on how to report administration errors,
Danish: • Risikoen for akutte injektionsrelaterede reaktioner og forsinkede overfølsomhedsreaktioner, behovet for at instruere patienter i administrationsteknikken og vejledning af sundhedspersonale i hvordan administrationsfejl rapporteres.
English: • The contraindication of Simponi in patients with history of moderate to severe heart failure (NYHA III/IV), and potential risk of congestive heart failure being worsened by Simponi,
Danish: • Kontraindikation af Simponi hos patienter med moderat til svær hjerteinsufficiens (NYHA III/IV) og potential risiko for forværret hjerteinsufficiens med Simponi.
English: • The risk of serious infections, including opportunistic bacterial, viral and fungal infections in patients treated with Simponi,
Danish: • Risikoen for alvorlige infektioner, inklusiv opportunistiske bakterielle, virus- og svampe infektioner hos patienter behandlet med Simponi.
English: • The need to evaluate patients for both active and inactive tuberculosis prior to starting the treatment, including use of appropriate screening tests,
Danish: • Behovet for at vurdere risikoen for både aktiv og inaktiv tuberkulose hos patienter før behandling med Simponi, inklusiv brug af hensigtsmæssige undersøgelsesmetioder.
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
Danish: BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL EN SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: ANNEX CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
Danish: BILAG BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL EN SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: • Patient Alert Card
Danish: • Patientinformationskort
English: The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
Danish: Medlemsstaterne skal sikre at alle krav eller restriktioner nævnt forneden er implementeret med hensyn til sikkerhed og effektiv anvendelse af det medicinske produkt:
English: • The Summary of Product Characteristics
Danish: • Produktresume
English: The MAH should submit appropriate scientific evidence to demonstrate a positive benefit-risk balance of the medicinal product in any indication.
Danish: Indehaveren af markedsføringstilladelsen bør fremlægge relevant videnskabelig evidens, der dokumenterer et positivt benefit/risk-forhold for lægemidlet i en given indikation.
English: For the suspension of medicinal products containing nalidixic acid, flumequine, pipemidic acid and cinoxacin to be lifted, the competent authorities shall ensure that the below conditions have been completed by the marketing authorisation holders
Danish: For at kunne ophæve suspenderingen af lægemidler, der indeholder nalidixinsyre, flumequin, pipemedinsyre og cinoxacin, skal de kompetente myndigheder sikre, at nedenstående betingelser er opfyldt af indehaverne af markedsføringstilladelse
English: Conditions for lifting the suspension of the marketing authorisation(s)
Danish: Betingelser for ophævelse af suspenderingen af markedsføringstilladelserne
English: Member State EU/EEA
Danish: Medlemsland EU/EEA