FrancophonIA/ELRC3.0 huggingface dataset:
English: Canine parainfluenza virus (live attenuated) and canine leptospirosis (inactivated) vaccine
Danish: Vaccine mod hundeparainfluenzavirus (levende, svækkede) og hundeleptospirose (inaktiveret)
English: Other information about Versican Plus Pi/L4:
Danish: Andre oplysninger om Versican Plus Pi/L4:
English: Why has Versican Plus Pi/L4 been approved?
Danish: Hvorfor blev Versican Plus Pi/L4 godkendt?
English: What is the risk associated with Versican Plus Pi/L4?
Danish: Hvilken risiko er der forbundet med Versican Plus Pi/L4?
English: What is Versican Plus Pi/L4?
Danish: Hvad er Versican Plus Pi/L4?
English: How has Versican Plus Pi/L4 been studied?
Danish: Hvordan blev Versican Plus Pi/L4 undersøgt?
English: How does Versican Plus Pi/L4 work?
Danish: Hvordan virker Versican Plus Pi/L4?
English: What is Versican Plus Pi/L4 used for?
Danish: Hvad anvendes Versican Plus Pi/L4 til?
English: What benefit has Versican Plus Pi/L4 shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Versican Plus Pi/L4?
English: European Commission granted a marketing authorisation valid throughout the European Union for Onbrez Breezhaler on 30 November 2009.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Onbrez Breezhaler den 30. november 2009.
English: The full EPAR for Onbrez Breezhaler can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Onbrez Breezhaler findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The medicine contains the active substance indacaterol.
Danish: Lægemidlet indeholder det aktive stof indacaterol.
English: It works by attaching to beta-2 receptors that are found in the muscle cells of many organs and that cause the muscles to relax.
Danish: Den virker ved at binde sig til beta 2-receptorer, som findes i muskelcellerne i mange organer, og som får musklerne til at slappe af.
English: To receive a dose, the patient places a capsule into the inhaler and breathes the powder in through the mouth.
Danish: For at tage en dosis anbringer patienten en kapsel i inhalatoren og indånder pulveret gennem munden.
English: The recommended dose is one 150 microgram capsule, once a day at the same time each day.
Danish: Den anbefalede dosis er en kapsel på 150 mikrogram én gang dagligt på samme tidspunkt hver dag.
English: The main measure of effectiveness was based on changes in the patients' forced expiratory volumes (FEV1, the maximum volume of air a person can breathe out in one second) after 12 weeks.
Danish: Det primære mål for virkning var ændringer i patienternes forcerede ekspirationsvolumen (FEV1, den maksimale luftmængde, som en person kan udånde på et sekund) efter 12 uger.
English: The increase in FEV1 was 130 ml with tiotropium, and 80 ml with formoterol.
Danish: Stigningen i FEV1 var 130 ml med tiotropium og 80 ml med formoterol.
English: The doctor may increase the dose to one 300 microgram capsule once a day in cases of severe COPD.
Danish: Lægen kan øge dosen til én 300 mikrogram-kapsel én gang dagligt i tilfælde af svær KOL.
English: Other common side effects include chest pain, cough and muscle cramps.
Danish: Andre almindelige bivirkninger omfatter brystsmerter, hoste og muskelkramper.
English: This is a summary of the European public assessment report (EPAR) for Onbrez Breezhaler.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Onbrez Breezhaler.
English: This causes the muscles of the airways to relax, helping to keep the airways open and allowing the patient to breathe more easily.
Danish: Dette får muskulaturen i luftvejene til at slappe af, så luftvejene bedre holdes åbne og patienten får lettere ved at trække vejret.
English: Onbrez Breezhaler is used for maintenance (regular) treatment.
Danish: Onbrez Breezhaler anvendes til (regelmæssig) vedligeholdelsesbehandling.
English: Overall, the effects of the 150 and 300 microgram doses of Onbrez Breezhaler were similar, but the results showed that the 300 microgram dose may provide better relief in patients with more severe disease.
Danish: Som helhed var virkningerne af 150- og 300-mikrogramsdoserne af Onbrez Breezhaler ens, men resultaterne viste, at 300-mikrogramsdosen kan give en bedre lindring hos patienter med en svær grad af sygdommen.
English: On average, the increase in FEV1 in patients who received Onbrez Breezhaler was between 150 to 190 ml, while for patients who received placebo the change in FEV1 ranged from a decrease of 10 ml to an increase of 20 ml.
Danish: Gennemsnitligt var forbedringen i FEV1 hos patienter, som fik Onbrez Breezhaler, mellem 150 og 190 ml, mens ændringen i FEV1 hos patienter, som fik placebo, varierede fra et fald på 10 ml til en forøgelse på 20 ml.
English: Therefore, the Agency decided that Onbrez Breezhaler's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede derfor, at fordelene ved Onbrez Breezhaler opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: The most common side effects with Onbrez Breezhaler (which may affect more than 1 in 10 people) are nasopharyngitis (inflammation of the nose and throat) and upper respiratory tract infection (infection of the nose and throat).
Danish: De hyppigste bivirkninger ved Onbrez Breezhaler (som optræder hos mere end 1 ud af 10 patienter) er nasopharyngitis (betændelse i næse og svælg) og infektion i de øvre luftveje (infektion i næse og svælg).
English: The active substance in Onbrez Breezhaler, indacaterol, is a beta-2 adrenergic receptor agonist.
Danish: Det aktive stof i Onbrez Breezhaler, indacaterol, er en beta 2-adrenerg receptoragonist.
English: In three main studies involving over 4,000 patients with COPD, Onbrez Breezhaler was compared with placebo (a dummy treatment), tiotropium or formoterol (other inhaled medicines used to treat COPD).
Danish: I tre hovedundersøgelser, som omfattede over 4 000 patienter med KOL, blev Onbrez Breezhaler sammenlignet med placebo (uvirksomt stof), tiotropium eller formoterol (andre inhalerede lægemidler, som anvendes til behandling af KOL).
English: When Onbrez Breezhaler is inhaled, indacaterol reaches the receptors in the airways and activates them.
Danish: Når Onbrez Breezhaler inhaleres, når indacaterol frem til receptorerne i luftvejene og aktiverer dem.
English: What measures are being taken to ensure the safe and effective use of Onbrez Breezhaler?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Onbrez Breezhaler?
English: The Agency also noted that there were no major safety concerns with Onbrez Breezhaler, with side effects being manageable and similar to other beta-2 adrenergic receptor agonist medicines.
Danish: CHMP bemærkede desuden, at der ikke var større sikkerhedsmæssige problemer med Onbrez Breezhaler, idet bivirkningerne kan behandles og svarer til bivirkningerne af andre lægemidler med beta 2-adrenerge receptoragonister.
English: For more information about treatment with Onbrez Breezhaler, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Onbrez Breezhaler, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Onbrez Breezhaler was more effective than placebo at improving how well the lungs work in patients with COPD.
Danish: Onbrez Breezhaler var mere effektivt end placebo til at forbedre lungefunktionen hos patienter med KOL.
English: For the full list of all side effects and restrictions with Onbrez Breezhaler, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Onbrez Breezhaler fremgår af indlægssedlen.
English: Other information about Onbrez Breezhaler
Danish: Andre oplysninger om Onbrez Breezhaler
English: Onbrez Breezhaler capsules, which contain a power for inhalation, are only used with a Onbrez Breezhaler inhaler and must not be swallowed.
Danish: Onbrez Breezhaler-kapsler indeholder et pulver, der skal inhaleres, og må kun anvendes med en Onbrez Breezhaler-inhalator.
English: Onbrez Breezhaler is a medicine that is used to keep the airways open in adults with chronic obstructive pulmonary disease (COPD).
Danish: Onbrez Breezhaler anvendes til at holde luftvejene fri hos voksne med kronisk obstruktiv lungesygdom (KOL).
English: It is not intended to provide practical advice on how to use Onbrez Breezhaler.
Danish: Det er ikke en praktisk vejledning i, hvordan Onbrez Breezhaler bør anvendes.
English: For practical information about using Onbrez Breezhaler, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Onbrez Breezhaler, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: What is Onbrez Breezhaler and what is it used for?
Danish: Hvad er Onbrez Breezhaler, og hvad anvendes det til?
English: The European Medicines Agency concluded that Onbrez Breezhaler was shown to be effective at improving the lung function in COPD.
Danish: CHMP konkluderede, at Onbrez Breezhaler var påvist at være effektivt til at bedre lungefunktionen ved KOL.
English: What are the risks associated with Onbrez Breezhaler?
Danish: Hvilke risici er der forbundet med Onbrez Breezhaler?
English: Why is Onbrez Breezhaler approved?
Danish: Hvorfor blev Onbrez Breezhaler godkendt?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Onbrez Breezhaler have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Onbrez Breezhaler.
English: How is Onbrez Breezhaler used?
Danish: Hvordan anvendes Onbrez Breezhaler?
English: What benefits of Onbrez Breezhaler have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Onbrez Breezhaler?
English: How does Onbrez Breezhaler work?
Danish: Hvordan virker Onbrez Breezhaler?
English: 20 October 2015 EMA/481797/2015
Danish: Den 20. oktober 2015 EMA/481797/2015
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom persist for more than one week.
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: The expressed juice may then be dried.
Danish: Den pressede saft kan derefter tørres.
English: This means that there are bibliographic data providing scientific evidence of their effectiveness and safety when used in this way, covering a period of at least 10 years in the EU.
Danish: Det betyder, at der findes litteraturoplysninger,der danner videnskabelig dokumentation for virkning og sikkerhed ved denne anvendelse i en periode på mindst 10 år i EU.
English: For further information on the studies assessed by the HMPC, see the HMPC assessment report.
Danish: Nærmere oplysninger om de undersøgelser, der indgår i HMPC's vurdering, findes i HMPC's vurderingsrapport.
English: However, these data were insufficient to be used as evidence of effectiveness and the HMPC conclusions for this indication are based on the medicines' long-standing use.
Danish: Disse data var ikkestrækkelige som dokumentation for virkningen, hvorfor HMPC's konklusioner vedrørende denne indikation er baseret på lægemidlernes mangeårige anvendelse.
English: When used for prevention and treatment of common cold, cases of serious allergic reactions (such as Stevens-Johnson syndrome, asthma and anaphylactic shock) have been reported, especially in patients who are atopic (have a predisposition to allergic reactions).
Danish: Ved anvendelse til forebyggelse og behandling af forkølelse er der beskrevet tilfælde af alvorlige allergiske reaktioner (såsom Stevens-Johnsons syndrom, astma og anafylaktisk chok), navnlig hos patienter, der er disponeret for allergiske reaktioner (atopiske patienter).
English: Purple coneflower herb medicines should only be used in adults and adolescents above the age of 12 years.
Danish: Lægemidler med purpursolhat, frisk urt, bør kun anvendes hos voksne og børn over 12 år.
English: Purple coneflower herb is the common name for the flowering aerial parts of the plant Echinacea purpurea (L.) Moench.
Danish: Purpursolhat, frisk urt, er fællesnavnet for de friske, blomstrende overjordiske dele af planten Echinacea purpurea (L.) Moench.
English: The HMPC noted possible beneficial effects on wound healing in animal studies.
Danish: HMPC i sin vurdering taget hensyn til den mulige gavnlige virkning på sårheling, der er set i dyrestudier.
English: Any applications for the licensing of medicines containing purple coneflower herb 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 purpursolhat, frisk urt, skal indsendes til de nationale lægemiddelmyndigheder, som vurderer ansøgningen om plantelægemidlet og tager hensyn til HMPC's videnskabelige konklusioner.
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing purple coneflower herb.
Danish: EU's medlemsstater tager hensyn til HMPC's konklusioner, når de vurderer ansøgninger om godkendelse af plantelægemidler, der indeholder purpursolhat, frisk urt.
English: Information on the use and licensing of purple coneflower leaf medicines in EU Member States should be obtained from the relevant national authorities.
Danish: Oplysninger om europæisk anvendelse og godkendelse af lægemidler, der indeholder purpursolhat, frisk urt, skal indhentes fra de relevante nationale myndigheder i EU's medlemsstater.
English: Further information on the HMPC assessment of purple coneflower herb 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 purpursolhat, frisk urt, herunder detaljerede oplysninger om udvalgets konklusioner, findes under "All documents" på Det Europæiske Lægemiddelagenturs websted: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Further information on the risks associated with purple coneflower herb 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 purpursolhat, frisk urt, herunder passende forholdsregler, som skal følges med henblik på sikker anvendelse, findes i monografien under fanebladet "All documents" på Det Europæiske Lægemiddelagenturs websted: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Herbal medicines containing purple coneflower herb preparations are usually available in liquid or solid forms to be taken by mouth and in semi-solid (such as ointments) or liquid forms to be applied to the skin.
Danish: Plantelægemidler med tilberedninger af purpursolhat, frisk urt, fås normalt i flydende eller fast form til indtagelse gennem munden samt i halvfast (såsom salver) eller flydende form til påføring på huden.
English: The most relevant clinical trials performed in adults indicated that purple coneflower herb medicines containing the expressed juice to be taken by mouth can prevent and improve the symptoms of cold more rapidly than placebo when taken early.
Danish: De mest relevante kliniske undersøgelser blev udført på voksne og viste, at lægemidler med presset saft af frisk purpursolhatindtaget gennem munden, kan forebygge og bedre symptomerne på forkølelse hurtigere end placebo, når de indtages tidligt i forløbet.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of purple coneflower herb.
Danish: Dette er et sammendrag af Komiteen for Plantelægemidlers (HMPC) videnskabelige konklusioner angående den medicinske anvendelse af purpursolhat, frisk urt.
English: Detailed instructions on how to take purple coneflower herb medicines and who can use them can be found in the package leaflets that come with the medicines.
Danish: Detaljerede anvisninger for, hvordan lægemidler med purpursolhat, frisk urt, skal anvendes, og hvem der kan bruge dem, findes i indlægssedlen i lægemiddelpakningen.
English: The flowering aerial parts for medicinal uses are obtained from plants that have been cultivated or found in the wild.
Danish: De blomstrende overjordiske dele til medicinsk anvendelse fås enten fra dyrkede eller vildtvoksende planter.
English: This summary is not intended to provide practical advice on how to use medicines containing purple coneflower herb.
Danish: Dette sammendrag er ikke en praktisk vejledning i, hvordan plantelægemidler, der indeholder purpursolhat, frisk urt, anvendes.
English: The HMPC conclusions on the use of purple coneflower herb medicines for superficial wounds are based on their ‘traditional use'.
Danish: HMPC's konklusioner vedrørende anvendelsen af lægemidler med purpursolhat, frisk urt, til overfladiske sår er baseret på lægemidlernes "traditionelle anvendelse".
English: In its assessment, the HMPC considered a number of clinical studies comparing purple coneflower herb medicines with placebo for short-term prevention and treatment of upper airways infections.
Danish: HMPC har i sin vurdering inddraget en række kliniske undersøgelser, hvor kortvarig behandling med lægemidler indeholdende purpursolhat, frisk urt, sammenlignes med placebo ved kortvarig forebyggelse og behandling af øvre luftvejsinfektioner.
English: Purple coneflower herb medicines must not be used in patients who are hypersensitive (allergic) to purple coneflower or other plants of the Asteraceae (Compositae) family.
Danish: Lægemidler med purpursolhat, frisk urt, må ikke anvendes til patienter, der er overfølsomme (allergiske) over for purpursolhat eller andre planter i kurvblomstfamilien.
English: How are purple coneflower herb medicines approved in the EU?
Danish: Hvordan godkendes lægemidler, der indeholder purpursolhat, frisk urt, i EU?
English: The HMPC also concluded that, on the basis of their long-standing use, purple coneflower herb medicines to be applied to the skin can be used to treat small superficial wounds.
Danish: På baggrund af den mangeårige anvendelse har HMPC desuden konkluderet, at lægemidler med purpursolhat, frisk urt, til påføring på huden kan anvendes til behandling af små overfladiske sår.
English: What are the risks associated with purple coneflower herb medicines?
Danish: Hvilke risici er der forbundet med lægemidler, der indeholder purpursolhat, frisk urt?
English: Purple coneflower herb preparations are made by expressing the juice of the fresh herb.
Danish: Purpursolhat, frisk urt, forarbejdes ved at presse saften fra den friske plante.
English: For more information about treatment with purple coneflower herb medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med lægemidler, der indeholder purpursolhat, frisk urt, kan du læse indlægssedlen, der ligger i lægemiddelpakningen, eller kontakte din læge eller dit apotek.
English: The HMPC concluded that purple coneflower herb medicines to be taken by mouth can be used short term for the prevention and treatment of common colds.
Danish: HMPC har konkluderet, at lægemidler med purpursolhat, frisk urt, til indtagelse gennem munden kan anvendes kortvarigt til forebyggelse og behandling af forkølelse.
English: Other information about purple coneflower herb medicines
Danish: Andre oplysninger om lægemidler, der indeholder purpursolhat, frisk urt
English: For practical information about using purple coneflower herb 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 purpursolhat, frisk urt, kan du læse indlægssedlen, der ligger i lægemiddelpakningen, eller kontakte din læge eller dit apotek.
English: What evidence supports the use of purple coneflower herb medicines?
Danish: Hvilken dokumentation underbygger den medicinske anvendelse af purpursolhat, frisk urt?
English: What is purple coneflower herb?
Danish: Hvad er purpursolhat, frisk urt?
English: For the treatment of superficial wounds, a doctor or a qualified healthcare practitioner should be consulted if symptoms
Danish: Hvis symptomerne varer længere end en uge ved behandling af overfladiske sår, bør der søges råd hos en læge eller en anden kvalificeret sundhedsmedarbejder.
English: The HMPC conclusions on the short-term use of purple coneflower herb medicines to prevent and treat common cold are based on their ‘well-established use' in this indication.
Danish: HMPC's konklusioner om den kortvarige anvendelse af lægemidler med purpursolhat, frisk urt, til forebyggelse og behandling af forkølelse er baseret på den "almindelig anerkendte anvendelse".
English: A doctor or pharmacist should be consulted if symptoms persist for more than 10 days when using purple coneflower herb medicines for the treatment of common colds.
Danish: Hvis symptomerne varer længere end 10 dage ved anvendelse af purpursolhat, frisk urt, til behandling af forkølelse, bør der søges råd hos en læge eller på apoteket.
English: Allergic reactions such as rash have been reported with the use of purple coneflower herb medicines.
Danish: Ved brug af lægemidler med purpursolhat, frisk urt, er beskrevet allergiske reaktioner såsom udslæt.
English: Convincing data to identify a patient population in which the benefits of buflomedil clearly outweigh its identified risks.
Danish: Overbevisende data, der fastlægger en patientpopulation, hos hvem fordelene ved buflomedil klart overstiger de fundne risici.
English: Annex III Conditions for lifting the suspension
Danish: Bilag III Betingelser for ophævelse af suspenderingen af markedsføringstilladelsen
English: For the suspension to be lifted the Marketing Authorisation Holders would need to provide the National Competent Authorities with the following:
Danish: For at suspenderingen kan ophæves, skal indehaveren af markedsføringstilladelsen fremlægge følgende for de nationale kompetente myndigheder:
English: It is a well-known substance, which has been used to control pain for many years.
Danish: Det er et velkendt stof, der har været brugt i mange år til at kontrollere smerter.
English: There must be a gap of at least four hours between treating each episode of pain.
Danish: Der skal være et tidsrum på mindst fire timer mellem behandling af hver enkelt smerteepisode.
English: The tablets contain 100, 200, 400, 600 or 800 micrograms of fentanyl.
Danish: Tabletterne indeholder 100, 200, 400, 600 eller 800 mikrogram fentanyl.
English: Patients should be closely monitored for these side effects.
Danish: Patienterne bør følges tæt med hensyn til disse bivirkninger.
English: Alternatively, the tablets can be placed under the tongue.
Danish: Alternativt kan tabletten lægges under tungen.
English: The European Commission granted a marketing authorisation valid throughout the EU for Effentora on 4 April 2008.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Effentora den 4. april 2008.
English: This medicine can only be obtained by ‘special' prescription.
Danish: Lægemidlet udleveres kun efter "særlig" recept.
English: Each patient ranked their pain intensity on an 11-point scale.
Danish: Hver patient vurderede sin smerteintensitet på en skala med 11 point.