FrancophonIA/ELRC3.0 huggingface dataset:
English: Why has Equilis Te been approved?
Danish: Hvorfor blev Equilis Te godkendt?
English: Equilis Te is a vaccine for use in horses.
Danish: Equilis Te er en vaccine til heste.
English: Equilis Te is a vaccine containing purified tetanus toxoid.
Danish: Equilis Te er en vaccine indeholdende oprenset tetanustoksoid.
English: The main measure of effectiveness was the production of protective levels of antibodies against tetanus toxoid after vaccination.
Danish: Det primære effektmål var mængden af beskyttende antistoffer over for tetanustoksin efter vaccinationen.
English: This helps to protect against tetanus.
Danish: Dette er med til at beskytte mod stivkrampe.
English: Most of the studies were performed with Equilis Prequenza Te, a vaccine that protects against equine influenza as well as against tetanus.
Danish: De fleste undersøgelser blev foretaget med Equilis Prequenza Te, en vaccine, der beskytter mod hesteinfluenza og mod stivkrampe.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Equilis Te exceeded the risks for the immunisation of horses from six months of age against tetanus to prevent mortality.
Danish: Udvalget for Veterinærlægemidler (CVMP) konkluderede, at fordelene ved Equilis Te er større end risiciene til immunisering af heste, der er seks måneder gamle eller derover, mod stivkrampe for at forebygge dødelighed.
English: It was concluded that the product is well tolerated by horses of different age.
Danish: Det blev konkluderet, at produktet tåles godt af heste med forskellig alder. Der blev også foretaget undersøgelser med drægtige hopper.
English: The studies showed that Equilis Te is an effective vaccine against tetanus to prevent mortality in horses from 6 months of age.
Danish: Undersøgelserne viste, at Equilis Te er en effektiv vaccine mod stivkrampe for at forebygge dødelighed hos heste fra seks måneder og opefter.
English: How has Equilis Te been studied?
Danish: Hvordan blev Equilis Te undersøgt?
English: Equilis Te is used to vaccinate horses from six months of age against tetanus to prevent mortality.
Danish: Equilis Te anvendes til vaccination af heste, fra de er seks måneder, mod tetanus (stivkrampe) for at forebygge dødelighed.
English: Horses belong to the most susceptible species to tetanus.
Danish: Heste er blandt de mest modtagelige arter over for stivkrampe.
English: What benefit has Equilis Te shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Equilis Te?
English: What is Equilis Te used for?
Danish: Hvad anvendes Equilis Te til?
English: What is Equilis Te?
Danish: Hvad er Equilis Te?
English: How does Equilis Te work?
Danish: Hvordan virker Equilis Te?
English: 09 December 2015 EMA/680058/2015
Danish: Den 9. december 2015 EMA/680058/2015
English: Fresh bilberry fruit medicines should only be used in adults and should not be taken for longer than 4 weeks.
Danish: Lægemidler med friske blåbær bør kun anvendes til voksne og bør ikke tages længere end 4 uger.
English: In its assessment, the HMPC also considered clinical studies on disorders of the circulatory system which were performed 30 - 40 years ago.
Danish: HMPC har desuden vurderet kliniske undersøgelser af kredsløbsforstyrrelser, som er udført for 30-40 år siden.
English: If the symptoms persist for more than 2 weeks, a doctor or a qualified health care practitioner should be consulted.
Danish: Hvis symptomerne vedvarer længere end 2 uger, bør der søges lægehjælp.
English: Fresh bilberry fruit EMA/680058/2015
Danish: Friske blåbær EMA/680058/2015
English: Fresh bilberry fruit is the common name for the fresh fruit of the plant Vaccinium myrtillus L. Fresh bilberry fruit preparations are obtained using a technique to extract compounds from fresh plant material by dissolving them in a solvent (such as methanol), which is then evaporated to obtain a dry extract.
Danish: Friske blåbær er det almindelige navn for den friske frugt af planten Vaccinium myrtillus L. Tilberedninger af friske blåbær fås ved hjælp af en teknik til udtrækning af stoffer fra det friske plantemateriale ved opløsning i et opløsningsmiddel (såsom methanol), der derefter inddampes til en tør ekstrakt.
English: The anthocyanins are also thought to repair tiny blood vessels after damage to the local circulation.
Danish: Anthocyaniner menes desuden at reparere ganske små blodkar efter skader på det lokale kredsløb.
English: Any applications for the licensing of medicines containing fresh bilberry fruit have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Danish: Ansøgninger om godkendelse af lægemidler, der indeholder friske blåbær, skal indsendes til de nationale lægemiddelmyndigheder, som vurderer ansøgningen om plantelægemidlet og tager hensyn til HMPC's videnskabelige konklusioner.
English: Information on the use and licensing of fresh bilberry fruit medicines in EU Member States should be obtained from the relevant national authorities.
Danish: Oplysninger om europæisk anvendelse og godkendelse af lægemidler, der indeholder friske blåbær, skal indhentes fra de relevante nationale myndigheder i EU's medlemsstater.
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing fresh bilberry fruit.
Danish: EU's medlemsstater tager hensyn til HMPC's konklusioner, når de vurderer ansøgninger om godkendelse af plantelægemidler, der indeholder friske blåbær.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of fresh bilberry fruit.
Danish: Dette dokument er et sammendrag af Udvalget for Plantelægemidlers (HMPC) videnskabelige konklusioner angående den medicinske anvendelse af friske blåbær.
English: Detailed instructions on how to take fresh bilberry fruit medicines and who can use them can be found in the package leaflet that comes with the medicine.
Danish: Detaljerede anvisninger på, hvordan lægemidler med friske blåbær skal anvendes, og hvem der kan bruge dem, findes i indlægssedlen i lægemiddelpakningen.
English: Fresh bilberry fruit
Danish: Friske blåbær
English: This summary is not intended to provide practical advice on how to use medicines containing fresh bilberry fruit.
Danish: Dette sammendrag er ikke en praktisk vejledning i, hvordan plantelægemidler, der indeholder friske blåbær, skal anvendes.
English: What is fresh bilberry fruit?
Danish: Hvad er friske blåbær?
English: Herbal medicines containing fresh bilberry fruit preparations are usually available in solid forms to be taken by mouth.
Danish: Plantelægemidler med tilberedninger af friske blåbær fås normalt i fast form til anvendelse gennem munden.
English: Other information about fresh bilberry fruit medicines
Danish: Andre oplysninger om lægemidler, der indeholder friske blåbær
English: How are fresh bilberry fruit medicines approved in the EU?
Danish: Hvordan godkendes lægemidler, der indeholder friske blåbær, i EU?
English: Results from laboratory studies indicate that bilberries are rich in anthocyanins, which are thought to improve blood circulation by relaxing and dilating (widening) blood vessels and protecting blood vessels from damage.
Danish: Laboratorieundersøgelser viser, at blåbær er rige på anthocyaniner, som menes at forbedre kredsløbet ved at afslappe og udvide blodkarrene og beskytte dem mod skade.
English: The HMPC conclusions on the use of fresh bilberry fruit medicines for relief of discomfort and heaviness of legs related to minor blood circulatory problems and for relief of symptoms of bleeding into the skin from tiny blood vessels are based on their ‘traditional use'.
Danish: HMPC's konklusioner vedrørende anvendelsen af lægemidler med friske blåbær til lindring af ubehag og tyngdefornemmelse i benene forbundet med mindre kredsløbsproblemer og til lindring af symptomer på blødning i huden fra små blodkar er baseret på lægemidlernes "traditionelle anvendelse".
English: What are the risks associated with fresh bilberry fruit medicines?
Danish: Hvilke risici er der forbundet med lægemidler, der indeholder friske blåbær?
English: What evidence supports the use of fresh bilberry fruit medicines?
Danish: Hvilken dokumentation underbygger den medicinske anvendelse af friske blåbær?
English: The HMPC concluded that, on the basis of its long-standing use, fresh bilberry fruit medicines can be used to relieve discomfort and heaviness of legs related to minor blood circulatory problems and to relieve symptoms of bleeding into the skin from tiny blood vessels.
Danish: På baggrund af den mangeårige anvendelse har HMPC konkluderet, at lægemidler med friske blåbær kan anvendes til at lindre ubehag og tyngdefornemmelse i benene forbundet med mindre kredsløbsforstyrrelser og til at lindre symptomer på blødning i huden fra små blodkar.
English: For practical information about using fresh bilberry fruit medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktiske oplysninger om anvendelsen af lægemidler med friske blåbær, kan du læse indlægssedlen, der ligger i lægemiddelpakningen, eller kontakte din læge eller dit apotek.
English: Further information on the risks associated with fresh bilberry fruit medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Danish: Yderligere oplysninger om risici forbundet med lægemidler, der indeholder friske blåbær, herunder passende forholdsregler, som skal følges med henblik på sikker anvendelse, findes i monografien under fanebladet "All documents" på Det Europæiske Lægemiddelagenturs websted:
English: Although possible beneficial effects were observed, there were limitations in the way the studies were conducted and, therefore, the HMPC conclusions on the use of fresh bilberry fruit medicines are based on their long-standing use.
Danish: Selvom mulige gavnlige virkninger blev observeret, var der mangler i den måde, studierne blev udført på.
English: Further information on the HMPC assessment of fresh bilberry fruit medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Danish: Yderligere oplysninger om HMPC's vurdering af lægemidler, der indeholder friske blåbær, herunder detaljerede oplysninger om udvalgets konklusioner, findes under "All documents" på det europæiske lægemiddelagenturs websted: Hvis du ønsker yderligere oplysninger om behandling med lægemidler, der indeholder friske blåbær, kan du læse indlægssedlen, der ligger i lægemiddelpakningen, eller kontakte din læge eller dit apotek.
English: This summary was last updated in 05-2016
Danish: Dette sammendrag blev sidst ajourført i 05-2016.
English: It is used in addition to diet and exercise in the following ways:
Danish: Det anvendes i forbindelse med diæt og motion på følgende måder:
English: The European Commission granted a marketing authorisation valid throughout the European Union for Jentadueto on 20 July 2012.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Jentadueto den 20. juli 2012.
English: Jentadueto must not be used in patients with:
Danish: Jentadueto må ikke anvendes til patienter med:
English: Jentadueto is taken twice a day.
Danish: Jentadueto tages to gange dagligt.
English: The full EPAR for Jentadueto can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Jentadueto findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Jentadueto
Danish: Andre oplysninger om Jentadueto
English: This is a summary of the European public assessment report (EPAR) for Jentadueto.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Jentadueto.
English: The CHMP noted that fixed dose combinations may increase the likelihood of patients taking their medicine correctly.
Danish: CHMP bemærkede, at faste kombinationsprodukter kan øge sandsynligheden for, at patienterne tager deres medicin korrekt.
English: A risk management plan has been developed to ensure that Jentadueto is used as safely and effectively as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Jentadueto anvendes så sikkert som muligt.
English: For more information about treatment with Jentadueto, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Jentadueto, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Linagliptin has been authorised in the European Union (EU) as Trajenta since 2011.
Danish: Linagliptin har været godkendt i EU under navnet Trajenta siden 2011.
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 Jentadueto.
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 Jentadueto skal anvendes.
English: The strength of tablet to use depends on the dose of the other diabetes medicines that the patient was taking before.
Danish: Den tabletstyrke, der skal bruges, afhænger af den dosis af andre lægemidler mod sukkersyge, patienten tidligere har fået.
English: • diabetic ketoacidosis or diabetic pre-coma (dangerous complications of diabetes);
Danish: • diabetisk ketoacidose eller diabetisk prækoma (farlige komplikationer til sukkersyge)
English: With regard to side effects, the Committee considered that in general the risks seen were only slightly greater than those seen with placebo.
Danish: Hvad angår bivirkningerne, fandt udvalget, at risiciene sædvanligvis kun var lidt større end risiciene i forbindelse med placebo.
English: Linagliptin is a dipeptidyl-peptidase-4 (DPP 4) inhibitor.
Danish: Linagliptin er en hæmmer af dipeptidyl-peptidase-4 (DPP 4).
English: • in patients who are already taking a combination of linagliptin and metformin as separate tablets;
Danish: • - hos patienter, der i forvejen får en kombination af linagliptin og metformin som separate tabletter
English: • liver impairment, or problems with alcoholism or alcohol intoxication.
Danish: • nedsat leverfunktion eller problemer med alkoholisme eller beruselse med alkohol.
English: It is available as tablets (2.5 mg/850 mg and 2.5 mg/1,000 mg).
Danish: Det leveres som tabletter (2,5 mg/850 mg og 2,5 mg/1 000 mg).
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Jentadueto, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Jentadueto, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: Jentadueto linagliptin / metformin hydrochloride
Danish: Jentadueto linagliptin/metforminhydrochlorid
English: • a condition that could lead to reduced supply of oxygen to body tissues (such as in patients who are being treated for worsening heart failure, have recently had a heart attack, have difficulty breathing or a steep fall in blood pressure);
Danish: • en tilstand med nedsat ilttilførsel til kroppens væv (f.eks. patienter, der er i behandling for forværret hjerteinsufficiens, der for nylig har haft et hjerteanfald, der har åndedrætsbesvær, eller som oplever et brat fald i blodtrykket
English: What extra measures are being taken to ensure the safe and effective use of Jentadueto?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Jentadueto?
English: Jentadueto should be taken with food to reduce stomach problems caused by metformin.
Danish: Jentadueto bør tages med et måltid for at undgå maveproblemer forårsaget af metformin.
English: • in combination with a sulphonylurea or insulin (other types of diabetes medicines) in patients who are not satisfactorily controlled on this medicine and metformin.
Danish: • - kombineret med et sulfonylurinstof eller insulin (andre typer lægemidler mod sukkersyge) hos patienter, der ikke kan reguleres tilfredsstillende med dette lægemiddel og metformin.
English: • moderately to severely reduced kidney function or with acute (sudden) conditions which can affect kidney function such as dehydration, severe infection or shock;
Danish: • moderat eller svært nedsat nyrefunktion eller hurtig udvikling af tilstande, der kan påvirke nyrefunktionen, såsom dehydrering, svær infektion eller chok
English: If Jentadueto is taken with a sulphonylurea or insulin, the dose of these medicines may need to be lowered, to avoid hypoglycaemia (low blood sugar levels).
Danish: Hvis Jentadueto tages med et sulfonylurinstof eller insulin, skal dosis af disse lægemidler muligvis nedsættes for at undgå hypoglykæmi (lavt blodsukker).
English: In all studies, the main measure of effectiveness was the change in blood levels of a substance called glycosylated haemoglobin (HbA1c) after 24 weeks of treatment.
Danish: I alle undersøgelserne blev virkningen hovedsagelig bedømt på blodets indhold af glykosyleret hæmoglobin (HbA1c) efter 24 ugers behandling.
English: Therefore the CHMP decided that Jentadueto's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede derfor, at fordelene ved Jentadueto opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Jentadueto.
English: The study compared the effects of adding linagliptin to metformin in these ways, since metformin needs to be taken at least twice per day.
Danish: I undersøgelsen blev virkningerne af at supplere metformin med linagliptin sammenlignet på denne måde, da metformin skal tages mindst to gange dagligt.
English: What is the risk associated with Jentadueto?
Danish: Hvilken risiko er der forbundet med Jentadueto?
English: • in patients who are not satisfactorily controlled on metformin (a diabetes medicine) used on its own;
Danish: • - hos patienter, der ikke kan reguleres tilfredsstillende med metformin (et lægemiddel mod sukkersyge) alene
English: The combination gave a reduction of 1.22 points when metformin was given at 500 mg and a reduction of 1.59 points when metformin was given at 1,000 mg.
Danish: Kombinationen gav en reduktion på 1,22 point, når metformin blev givet i en dosis på 500 mg, og en reduktion på 1,59 point, når metformin blev givet i en dosis på 1 000 mg.
English: Jentadueto is a medicine that contains the active substances linagliptin and metformin hydrochloride.
Danish: Jentadueto er et lægemiddel, der indeholder de to aktive stoffer linagliptin og metforminhydrochlorid.
English: The maximum dose is 5 mg of linagliptin and 2,000 mg of metformin per day.
Danish: Den maksimale dosis er 5 mg linagliptin og 2 000 mg metformin dagligt.
English: This compared with a reduction of 0.45 with linagliptin alone, 0.64 with 500 mg metformin alone, 1.07 with 1,000 mg metformin alone, and 0.13 with placebo.
Danish: Dette skal sammenholdes med en reduktion på 0,45 med linagliptin alene, 0,64 with 500 mg metformin alene, 1,07 med 1 000 mg metformin alene, og 0,13 med placebo.
English: The studies looked at the effectiveness of linagliptin used on its own (503 patients), in combination with metformin (701 patients), with metformin plus a sulphonylurea (1,058 patients) or with another diabetes medicine pioglitazone (389 patients).
Danish: I undersøgelserne undersøgtes effektiviteten af linagliptin, dels anvendt alene (503 patienter), dels i kombination med metformin (701 patienter), med metformin plus et sulfonylurinstof (1 058 patienter) og med et andet middel mod sukkersyge, pioglitazon (389 patienter).
English: The active substances in Jentadueto, linagliptin and metformin hydrochloride, each working in a different way.
Danish: De aktive stoffer i Jentadueto, linagliptin og metforminhydrochlorid, virker på forskellige måder.
English: For the full list of all side effects reported with Jentadueto, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Jentadueto fremgår af indlægssedlen.
English: Why has Jentadueto been approved?
Danish: Hvorfor blev Jentadueto godkendt?
English: The most frequent side effect with the combination of linagliptin plus metformin was diarrhoea (seen in around 2% of patients, with a similar rate seen in patients taking metformin plus placebo).
Danish: Den hyppigste bivirkning med kombinationen af linagliptin og metformin var diarré (sås hos ca. 2% af patienterne og hos en tilsvarende andel af dem, der fik metformin plus placebo).
English: When linagliptin and metformin were given with a sulphonylurea or insulin, hypoglycaemia was the most frequent side effect (seen in more than 1 patient in 10).
Danish: Når linagliptin og metformin blev givet sammen med et sulfonylurinstof eller insulin, var hypoglykæmi den hyppigste bivirkning (som optrådte hos flere end 1 ud af 10 patienter).
English: Metformin was given at either 500 mg or 1,000 mg twice per day, for both the combination and the single treatment.
Danish: Metformin blev givet i en dosis af enten 500 mg eller 1 000 mg to gange dagligt, både ved kombinationsbehandling og enkeltstofbehandling.
English: The studies with linagliptin showed that it was more effective than placebo at reducing HbA1c levels.
Danish: Undersøgelserne med linagliptin viste, at det er mere effektivt end placebo til at nedsætte mængden af HbA1c.
English: Linagliptin also reduces the amount of glucose made by the liver, by increasing insulin levels and decreasing the levels of the hormone glucagon.
Danish: Linagliptin nedsætter desuden leverens sukkerafgivelse ved at øge insulinindholdet og sænke indholdet af hormonet glukagon.
English: When used on its own, linagliptin gave a reduction of 0.46 points compared with a rise of 0.22 points.
Danish: Når linagliptin blev anvendt alene, gav det en reduktion på 0,46 point, sammenholdt med en stigning på 0,22 point.
English: This gives an indication of how well blood glucose is controlled.
Danish: Mængden af dette stof er et mål for, hvor godt blodsukkeret er reguleret.
English: The study looking at adding linagliptin 2.5 mg twice per day or 5 mg once per day to metformin showed a similar reduction in HbA1c levels compared with placebo (0.74 and 0.80 points more than placebo respectively).
Danish: I den undersøgelse, hvor metformin blive suppleret med linagliptin 2,5 mg to gange dagligt eller 5 mg én gang dagligt, sås en tilsvarende reduktion i mængden af HbA1c i forhold til placebo (hhv. 0,74 og 0,80 point mere end placebo).
English: Linagliptin was given at 2.5 mg twice per day in the combination treatment and at 5 mg once per day in the single treatment.
Danish: Linagliptin blev givet i en dosering af 2,5 mg to gange dagligt i kombinationsbehandlingen og 5 mg én gang dagligt som enkeltstofbehandling.
English: Another study carried out in 1040 patients with type 2 diabetes compared patients taking 5 mg linagliptin and insulin given with metformin, with patients taking placebo given with insulin and metformin.
Danish: I en anden undersøgelse med 1040 patienter med type 2-sukkersyge blev patienter, som blev behandlet med 5 mg linagliptin og insulin givet sammen med metformin, sammenlignet med patienter, der blev behandlet med placebo givet sammen med insulin og metformin.