FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP considered that the cardiovascular risk in patients taking Protelos/Osseor can be managed by restricting its use to patients with no history of heart and circulatory problems and limiting its use to those who cannot take other medicines approved for the treatment of osteoporosis.
Danish: CHMP fandt, at hjerte-kar-risikoen hos patienter i behandling med Protelos/Osseor kan imødegås ved at begrænse anvendelsen til patienter, der er uden tidligere hjerte-karproblemer og ikke kan få andre godkendte lægemidler til behandling af knogleskørhed.
English: As recommended in a previous review, patients who have a history of certain heart or circulatory problems, such as stroke and heart attack, must not use the medicine.
Danish: Som anbefalet i en tidligere gennemgang må lægemidlet ikke anvendes, hvis der er visse hjerte-karproblemer i sygdomshistorien såsom slagtilfælde og hjerteanfald.
English: • Protelos/Osseor must not be used in patients with established, current or past history of ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease, or those with uncontrolled hypertension;
Danish: • Protelos/Osseor må ikke anvendes til patienter med manifest nuværende eller tidligere iskæmisk hjertesygdom, perifer arteriel sygdom og/eller cerebrovaskulær sygdom eller ukontrolleret hypertension.
English: The Committee concluded that given the benefits seen in preventing fractures in patients at high risk, Protelos/Osseor
Danish: På baggrund af de iagttagne fordele ved forebyggelse af knogleskørhed hos patienter med høj risiko konkluderede udvalget, at Protelos/Osseor fortsat bør være
English: • Protelos/Osseor should be stopped if the patient develops ischaemic heart disease, peripheral arterial disease or cerebrovascular disease, or if hypertension is uncontrolled;
Danish: • Protelos/Osseor bør seponeres ved opståen af iskæmisk hjertesygdom, perifer arteriel sygdom eller cerebrovaskulær sygdom og ved ukontrolleret hypertension.
English: Protelos/Osseor (strontium ranelate) is authorised in the EU to treat severe osteoporosis (a disease that makes bones fragile) in women who have been through the menopause and who are at high risk of fracture (broken bones) to reduce the risk of fractures of the spine and the hip.
Danish: Protelos/Osseor (strontiumranelat) er godkendt i EU til behandling af svær knogleskørhed hos kvinder efter overgangsalderen med høj risiko for knoglebrud med henblik på at forebygge brud på rygsøjlen og hofterne.
English: In addition, available data do not show evidence of an increased cardiovascular risk with Protelos/Osseor in patients who did not have a history of heart or circulatory problems.
Danish: Desuden viser de foreliggende data, at Protelos/Osseor ikke øger hjerte-kar-risikoen hos patienter uden tidligere hjertekarproblemer.
English: In arriving at its conclusions, the CHMP noted that study data showed a beneficial effect in preventing fractures, including in patients at high risk of fracture.
Danish: CHMP nåede frem til sine konklusioner efter at have bemærket, at Protelos/Osseor udviste forebyggende virkning, også hos patienter med høj risiko for knoglebrud.
English: • Protelos/Osseor will only be prescribed for preventing fractures in post-menopausal women and men with severe osteoporosis who have a high risk of fracture and cannot be treated with other medicines approved for osteoporosis.
Danish: • Protelos/Osseor vil kun blive udskrevet til forebyggelse af knoglebrud hos kvinder efter overgangsalderen og mænd med svær knogleskørhed og høj risiko for knoglebrud, når det ikke er muligt at anvende andre godkendte lægemidler mod knogleskørhed.
English: • Your treatment with Protelos/Osseor will be stopped if you develop heart or circulatory problems during treatment.
Danish: • Hvis du får hjerte- eller kredsløbsproblemer, vil du blive taget ud af behandlingen med Protelos/Osseor.
English: There was also an unvaccinated control group.
Danish: Desuden var der en uvaccineret kontrolgruppe.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Eryseng Parvo on 8 July 2014.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Eryseng Parvo den 8. juli 2014.
English: For swine erysipelas two laboratory studies were conducted.
Danish: For svinerosen blev der udført to laboratorieundersøgelser.
English: The most common side effect (seen in more than 1 in 10 pigs) with Eryseng Parvo is mild to moderate inflammation at the injection site which typically resolves within four days but in some cases may persist for up to 12 days post-vaccination.
Danish: Den hyppigste bivirkning (der ses hos mere end 1 ud af 10 svin) ved Eryseng Parvo er let til moderat inflammation på injektionsstedet, som typisk svinder i løbet af fire dage, men i visse tilfælde kan vare i op til 12 dage efter vaccinationen.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Eryseng Parvo exceed the risks for the approved indication and recommended that Eryseng Parvo be given a marketing authorisation.
Danish: Udvalget for Veterinærlægemidler (CVMP) konkluderede, at fordelene ved Eryseng Parvo overstiger risiciene til den godkendte anvendelse, og anbefalede udstedelse af en markedsføringstilladelse for Eryseng Parvo.
English: Pigs were challenged with parvovirus at day 40 of pregnancy and then euthanized (humanely killed) at day 90 of pregnancy.
Danish: Svinene blev udsat for parvovirus på dag 40 i drægtighedsperioden og derefter aflivet humant (eutaniseret) på dag 90 i drægtighedsperioden.
English: The parvovirus study showed that Eryseng Parvo protected 100% of the foetuses whilst 89% of foetuses were mummified in the control group.
Danish: Parvovirusundersøgelsen viste, at Eryseng Parvo beskyttede 100 % af fostrene, mens 89 % af fostrene i kontrolgruppen var mumificerede.
English: The second laboratory study involved 15 gilts which were vaccinated according to the basic vaccination schedule with a booster dose six months later.
Danish: Den anden laboratorieundersøgelse omfattede 15 gylte, der blev vaccineret efter standardvaccinationsplanen med en forstærkningsdosis seks måneder senere.
English: Other information about Eryseng Parvo:
Danish: Andre oplysninger om Eryseng Parvo:
English: The first study involved 40 pigs; 30 pigs were vaccinated with two doses, separated by three weeks, while a control group of 10 pigs received placebo (dummy treatment).
Danish: Den første undersøgelse omfattede 40 svin, hvor 30 svin blev vaccineret med to doser med tre ugers mellemrum, mens en kontrolgruppe på 10 svin fik virkningsløs behandling (placebo).
English: Eryseng Parvo is a vaccine.
Danish: Eryseng Parvo er en vaccine.
English: In the future, if the animals are exposed to porcine parvovirus and Erysipelothrix rhusiopathiae bacteria, the immune system will be able to respond more quickly.
Danish: Hvis dyret efterfølgende udsættes for disse svineparvovirus og Erysipelothrix rhusiopathiae-bakterier, vil immunsystemet reagere hurtigere.
English: For porcine parvovirus a laboratory study was conducted involving three groups of 11 gilts (female pigs that have not yet had piglets) vaccinated with different concentrations of porcine parvovirus.
Danish: For svineparvovirus blev der udført en laboratorieundersøgelse med tre grupper på hver 11 gylte (ungsøer, der endnu ikke har fået grise), som blev vaccineret med forskellige koncentrationer af svineparvovirus.
English: The withdrawal period for Eryseng Parvo is zero days.
Danish: Tilbageholdelsestiden for Eryseng Parvo er 0 døgn.
English: When Eryseng Parvo is given to pigs the animals' immune system recognises the virus and bacteria as ‘foreign' and makes antibodies against them.
Danish: Når Eryseng Parvo gives til svin, registrerer dyrenes immunsystem de pågældende virus og bakterier som “fremmede” og reagerer ved at danne antistoffer mod dem.
English: Pigs were vaccinated with two doses at an interval of three weeks, with the second dose given three to four weeks before mating.
Danish: Svinene blev vaccineret med to doser med tre ugers mellemrum, så de fik den anden dosis 3-4 uger før bedækning.
English: The measure of effectiveness was the percentage of vaccinated pigs free from specific (diamond shaped) skin lesions at the challenge site.
Danish: Virkningen blev vurderet efter den procentdel af vaccinerede svin, der var fri for specielle (diamantformede) forandringer af det udsatte område af huden.
English: Swine erysipelas is a bacterial disease of pigs characterised by sudden death, fever associated with diamond skin lesions, arthritis and by abortion in pregnant sows.
Danish: Svinerosen er en bakteriesygdom, der er kendetegnet af pludselig død, feber forbundet med diamantformede hudforandringer, ledbetændelse og abort hos drægtige søer.
English: Eryseng Parvo is a veterinary vaccine that contains inactivated (killed) porcine parvovirus and Erysipelothrix rhusiopathiae bacteria.
Danish: Eryseng Parvo er en veterinær vaccine, der indeholder dræbte (inaktiverede) svineparvovirus og Erysipelothrix rhusiopathiae-bakterier.
English: For swine erysipelas, the first laboratory study showed that 90% (27 out of 30) of vaccinated pigs were protected against Erysipelothrix rhusiopathiae serotype 1 remaining free of specific skin lesions whilst 93% (28 out of 30) of vaccinated pigs were protected against Erysipelothrix rhusiopathiae serotype 2 remaining free of specific skin lesions.
Danish: For svinerosen viste den første laboratorieundersøgelse, at 90 % (27 ud af 30) af de vaccinerede svin var beskyttet mod Erysipelothrix rhusiopathiae serotype 1 og forblev fri for specielle hudforandringer, mens 93 % (28 ud af 30) af de vaccinerede svin var beskyttet mod Erysipelothrix rhusiopathiae serotype 2 og forblev fri for specielle hudforandringer.
English: Eryseng Parvo contains an adjuvant (aluminium hydroxide, DEAE-dextran and ginseng) to enhance the immune response.
Danish: Eryseng Parvo indeholder aluminiumhydroxid, DEAE-dextran og ginseng, der virker som adjuvans, dvs. forstærker immunreaktionen.
English: The pigs were challenged a further six months later with injections of the bacteria Erysipelothrix rhusiopathiae serotypes 1 and 2 and the measure of effectiveness was the percentage of pigs protected by vaccination.
Danish: Svinene blev udsat for smitte yderligere seks måneder senere ved indsprøjtning af bakterierne Erysipelothrix rhusiopathiae serotype 1 og 2, og virkningen blev bedømt efter den procentdel af svinene, der blev beskyttet af vaccinationen.
English: Eryseng Parvo is available as a suspension for injection.
Danish: Eryseng Parvo leveres som injektionsvæske, suspension.
English: Porcine parvovirus causes infertility, still births and small litters in sows (female pigs that have had piglets).
Danish: Svineparvovirus medfører ufrugtbarhed, dødfødsler og små kuld hos søer (hungrise, der har fået grise).
English: The second laboratory study showed 93% (14 out of 15) pigs were protected against challenge with Erysipelothrix rhusiopathiae serotypes 1 and 2.
Danish: Den anden laboratorieundersøgelse viste, at 93 % (14 ud af 15) svin var beskyttet mod udsættelse for Erysipelothrix rhusiopathiae serotype 1 og 2.
English: The measure of effectiveness was absence of porcine parvovirus and anti-porcine parvovirus antibodies in the foetuses.
Danish: Virkningen blev bedømt på fravær af svineparvovirus og antistoffer mod svineparvovirus hos fostrene.
English: Porcine parvovirosis and swine erysipelas vaccine (inactivated)
Danish: Svineparvovirose- og svineerysipelasvaccine (inaktiveret)
English: What is the risk associated with Eryseng Parvo?
Danish: Hvilken risiko er der forbundet med Eryseng Parvo?
English: Why has Eryseng Parvo been approved?
Danish: Hvorfor blev Eryseng Parvo godkendt?
English: All pigs were challenged 22 days after the second vaccination dose with injections of the bacteria Erysipelothrix rhusiopathiae serotypes 1 and 2.
Danish: Alle svinene blev 22 dage efter den anden vaccination udsat for bakterierne Erysipelothrix rhusiopathiae serotype 1 og 2 ved indsprøjtning.
English: This will help protect them against porcine parvovirus and swine erysipelas.
Danish: Derved opnås bedre beskyttelse mod svineparvovirus og svinerosen.
English: Eryseng Parvo is used to protect embryonic and foetal (unborn) piglets against porcine parvovirus infection via the placenta.
Danish: Eryseng Parvo anvendes til at beskytte ufødte grise mod at blive smittet med svineparvovirus gennem moderkagen.
English: What is Eryseng Parvo?
Danish: Hvad er Eryseng Parvo?
English: Eryseng Parvo is also used to protect male and female pigs against swine erysipelas caused by Erysipelothrix rhusiopathiae, serotype 1 and serotype 2.
Danish: Eryseng Parvo anvendes desuden til at beskytte han- og hungrise mod svinerosen (erysipelas) forårsaget af Erysipelothrix rhusiopathiae-bakterier af serotype 1 og 2.
English: It contains a strain of porcine parvovirus called NADL-2 and a strain of Erysipelothrix rhusiopathiae called R32E11.
Danish: Svineparvovirus i vaccinen er af stammen NADL-2, og Erysipelothrix rhusiopathiae-bakterierne er af stammen R32E11.
English: How has Eryseng Parvo been studied?
Danish: Hvordan blev Eryseng Parvo undersøgt?
English: What is Eryseng Parvo used for?
Danish: Hvad anvendes Eryseng Parvo til?
English: What benefit has Eryseng Parvo shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Eryseng Parvo?
English: How does Eryseng Parvo work?
Danish: Hvordan virker Eryseng Parvo?
English: Velmetia is taken twice a day.
Danish: Velmetia tages to gange dagligt.
English: The European Commission granted a marketing authorisation valid throughout the EU for Velmetia on 16 July 2008.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Velmetia den 16. juli 2008.
English: The full EPAR for Velmetia can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Velmetia findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Velmetia.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Velmetia.
English: Velmetia was more effective than metformin alone.
Danish: Velmetia var mere effektivt end metformin alene.
English: Other information about Velmetia
Danish: Andre oplysninger om Velmetia
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 Velmetia.
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 Velmetia.
English: The company carried out additional studies to show that the active substances in Velmetia are absorbed by the body in the same way as the two medicines given separately.
Danish: Virksomheden gennemførte yderligere undersøgelser for at vise, at det aktive stof i Velmetia optages i kroppen på samme måde som de to lægemidler givet hver for sig.
English: The results of three further studies were used to support the use of Velmetia.
Danish: Der blev fremlagt resultater af tre yderligere undersøgelser til støtte for anvendelsen af Velmetia.
English: The most common side effect with Velmetia (seen in between 1 and 10 patients in 100) is nausea (feeling sick).
Danish: Den hyppigste bivirkning ved Velmetia (som optræder hos mellem 1 og 10 patienter ud af 100) er kvalme.
English: For more information about treatment with Velmetia, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Velmetia, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The company presented the results of three studies of Januvia/Xelevia to support the use of Velmetia in patients who were not satisfactorily controlled on their existing metformin treatment.
Danish: Virksomheden fremlagde resultaterne af tre undersøgelser af Januvia/Xelevia til støtte for brugen af Velmetia til patienter, som ikke kunne kontrolleres tilfredsstillende med den nuværende metforminbehandling.
English: Velmetia sitagliptin / metformin hydrochloride
Danish: Velmetia sitagliptin/metforminhydrochlorid
English: The CHMP decided that Velmetia's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Velmetia opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: Velmetia should be taken with food to avoid any stomach problems caused by metformin.
Danish: Velmetia skal indtages sammen med mad for at undgå maveproblemer forårsaget af metformin.
English: If Velmetia is taken with a sulphonylurea or insulin, the dose of the sulphonylurea or insulin may need to be lowered, to avoid hypoglycaemia (low blood sugar levels).
Danish: Hvis Velmetia tages sammen med et sulfonylurinstof eller insulin, skal dosen af sulfonylurinstof eller insulin muligvis sænkes for at undgå hypoglykæmi (lavt blodsukkerniveau).
English: It must also not be used in patients who consume excessive amounts of alcohol or who are alcoholic, or in women who are breast-feeding.
Danish: Det må heller ikke gives til patienter med overdrevet alkoholforbrug, alkoholikere eller ammende kvinder.
English: In the first of the three further studies, Velmetia was more effective than metformin or sitagliptin alone.
Danish: I den første af tre yderligere undersøgelser var Velmetia mere effektivt end metformin eller sitagliptin alene.
English: Velmetia is a medicine that contains two active substances, sitagliptin and metformin hydrochloride.
Danish: Velmetia er et lægemiddel, der indeholder de to aktive stoffer sitagliptin og metforminhydrochlorid.
English: Velmetia is used in patients with type 2 diabetes to improve the control of blood glucose (sugar) levels.
Danish: Velmetia anvendes til patienter med type 2-diabetes til at forbedre reguleringen af blodglukoseniveauet (blodsukkerniveauet).
English: The active substances in Velmetia, sitagliptin and metformin hydrochloride, each have a different mode of action.
Danish: De aktive stoffer i Velmetia, sitagliptin og metforminhydrochlorid, virker hver især forskelligt.
English: Velmetia must not be used in people who are hypersensitive (allergic) to sitagliptin, metformin or any of the other ingredients.
Danish: Velmetia må ikke anvendes hos patienter, der er overfølsomme (allergiske) over for sitagliptin, metformin eller andre af indholdsstofferne.
English: The first included 1,091 patients who were not satisfactorily controlled on diet and exercise alone and compared the effect of Velmetia with that of metformin or sitagliptin alone.
Danish: Den første undersøgelse omfattede 1 091 patienter, som ikke kunne kontrolleres tilstrækkeligt med diæt og motion alene, og sammenlignede virkningen af Velmetia med virkningen af metformin eller sitagliptin alene.
English: What is the risk associated with Velmetia?
Danish: Hvilken risiko er der forbundet med Velmetia?
English: Why has Velmetia been approved?
Danish: Hvorfor er Velmetia blevet godkendt?
English: For the full list of all side effects reported with Velmetia, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Velmetia fremgår af indlægssedlen.
English: What is Velmetia?
Danish: Hvad er Velmetia?
English: How has Velmetia been studied?
Danish: Hvordan er Velmetia blevet undersøgt?
English: What is Velmetia used for?
Danish: Hvad anvendes Velmetia til?
English: What benefit has Velmetia shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Velmetia?
English: How is Velmetia used?
Danish: Hvordan anvendes Velmetia?
English: How does Velmetia work?
Danish: Hvordan virker Velmetia?
English: To get the most benefit from the medicine, it should be used regularly and at the same time every day.
Danish: For at få det største udbytte af lægemidlet skal man bruge den regelmæssigt på samme tidspunkt hver dag.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Avamys to Glaxo Group Ltd on 11 January 2008.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Avamys til GLAXO Group Ltd den 11. januar 2008.
English: This is generally mild or moderate and tends to affect adults who have used Avamys for more than six weeks.
Danish: Den vil generelt være mild eller moderat og har en tendens til at påvirke voksne, der bruger Avamys i mere end seks uger.
English: The lowest effective dose that keeps symptoms controlled should be used.
Danish: Den effektive minimumsdosis, som holder symptomerne under kontrol, skal anvendes.
English: It usually starts to work from eight hours after the first spray, but it may take several days to get the maximum benefit.
Danish: Den begynder normalt at virke otte timer efter første pust, dog kan det vare adskillige dage, før man oplever det fulde udbytte.
English: The Committee recommended that Avamys be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Avamys.
English: Each symptom was measured on a scale from 0 to 3, with a maximum total score of
Danish: Hvert symptom blev målt på en skala fra 0 til 3 med en samlet maksimal score på 12.
English: The effects of Avamys were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Avamys blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: However, it was not possible to determine if Avamys worked in children below the age of six years, because there were too few children below this age included the studies.
Danish: Det var dog ikke muligt at afgøre, om Avamys virkede hos børn under seks år, fordi der deltog for få børn i den aldersgruppe i undersøgelsen.
English: Other information about Avamys:
Danish: Andre oplysninger om Avamys:
English: Similar results were seen in children aged six years and above.
Danish: Lignende resultater blev observeret hos børn fra seks år.
English: It works in a similar way to naturally occurring corticosteroid hormones, reducing the activity of the immune system by attaching to receptors in various types of immune cell.
Danish: Det fungerer på samme måde som naturligt forekommende kortikosteroide hormoner ved at reducere immunsystemets aktivitet, idet det binder til receptorer i forskellige immunceller.
English: This can be reduced to one spray in each nostril once symptoms are controlled.
Danish: Dette kan reduceres til et pust i hvert næsebor, når symptomerne er under kontrol.
English: This leads to a reduction the release of substances that are involved in the inflammation process, such as histamine, reducing the symptoms of allergy.
Danish: Dette medfører en reduktion af frigivelsen af stoffer, der er involveret i betændelsesprocessen, f.eks. histamin, hvilket reducerer de allergiske symptomer.
English: Avamys should only be used for as long as the patient is exposed to the allergen, such as pollen, house dust mites or other animals.
Danish: Avamys må kun bruges så længe, patienten er udsat for allergener såsom pollen, husstøvmider eller andre dyr.
English: The active substance in Avamys, fluticasone furoate, is a corticosteroid.
Danish: Det aktive stof i Avamys, fluticasonfuroat, er et kortikosteroid.
English: Avamys was compared with placebo (a dummy treatment) in six main studies involving almost 2,500 patients.
Danish: Avamys blev sammenlignet med placebo (et virkningsløst præparat) i seks hovedundersøgelser, der omfattede næsten 2500 patienter.
English: The full EPAR for Avamys can be found here.
Danish: Den fuldstændige EPAR om Avamys findes her.