FrancophonIA/ELRC3.0 huggingface dataset:
English: Revolade 75 mg film-coated tablets Tablet core
Danish: Revolade 75 mg filmovertrukne tabletter Tabletkerne
English: CARTON OF 75 mg - 14, 28, 84 (3 PACKS of 28) TABLETS
Danish: ÆSKE MED 75 mg - 14, 28, 84 (3 PAKNINGER MED 28) TABLETTER
English: Common Vertigo
Danish: Almindelig Svimmelhed (vertigo)
English: EU/1/10/612/006 84 film-coated tablets (3 packs of 28)
Danish: EU/1/10/612/006 84 filmovertrukne tabletter (3 pakninger med 28)
English: EU/1/10/612/002 (28 film-coated tablets)
Danish: EU/1/10/612/002 (28 filmovertrukne tabletter)
English: Revolade 50 mg film-coated tablets Tablet core
Danish: Revolade 50 mg filmovertrukne tabletter Tabletkerne
English: EU/1/10/612/005 (28 film-coated tablets)
Danish: EU/1/10/612/005 (28 filmovertrukne tabletter)
English: Multipacks of 84 (3 packs of 28 film-coated tablets) - without blue box - 25 mg film-coated tablets
Danish: Multipakning med 84 (3 pakninger med 28 filmovertrukne tabletter) - uden blue box - 25 mg filmovertrukne tabletter
English: Multipacks of 84 (3 packs of 28 film-coated tablets) - without blue box - 50 mg film-coated tablets
Danish: Multipakning med 84 (3 pakninger med 28 filmovertrukne tabletter) - uden blue box - 50 mg filmovertrukne tabletter
English: Revolade 25 mg film-coated tablets Tablet core
Danish: Revolade 25 mg filmovertrukne tabletter Tabletkerne
English: EU/1/10/612/003 84 film-coated tablets (3 packs of 28)
Danish: EU/1/10/612/003 84 filmovertrukne tabletter (3 pakninger med 28)
English: Cytochrome P450 substrates
Danish: CYP-substrater
English: Transaminases increased
Danish: Forhøjet knoglemarvsretikulin
English: CARTON OF 50 mg - 14, 28, 84 (3 PACKS of 28) TABLETS
Danish: ÆSKE MED 50 mg - 14, 28, 84 (3 PAKNINGER MED 28) TABLETTER
English: • high temperature
Danish: • meget kraftig træthedsfølelse
English: CARTON OF 25 mg - 14, 28, 84 (3 PACKS of 28) TABLETS
Danish: ÆSKE MED 25 mg - 14, 28, 84 (3 PAKNINGER MED 28) TABLETTER
English: • common cold
Danish: • almindelig forkølelse
English: • decreased vision
Danish: • nedsat syn
English: • flu-like illness
Danish: • influenzalignende symptomer
English: revolade 25 mg sachets
Danish: revolade 25 mg breve
English: • inflammation of the gum tissue
Danish: • blødende tandkød
English: Wait 2 weeks to assess the effects of this and any subsequent dose adjustments.
Danish: Nedsæt den daglige dosis med 50 mg. Afvent 2 uger for at vurdere virkningen af dette og evt. efterfølgende dosisjusteringer.
English: ≥50,000/µl to ≤100,000/µl
Danish:  50.000 pr. µl til  100.000 pr. µl
English: • toothache
Danish: Trombocyttal
English: • weight loss
Danish: Nedsat leverfunktion
English: Wait 2 weeks to assess the effects of this and any subsequent dose adjustments
Danish: Nedsæt den daglige dosis med 25 mg. Vent derefter 2 uger for at vurdere virkningen af dette og evt. efterfølgende dosisjusteringer
English: • painful urination
Danish: • smerte ved vandladning
English: bronchitis, nasopharyngitis, influenza, oral herpes Uncommon Gastroenteritis, pharyngitis
Danish: infektion i de øvre luftveje, bronkitis, nasopharyngitis, influenza, herpes labialis
English: At poorly tolerated doses in rats and dogs (>10 or 7 times the human clinical exposure in adult or paediatric ITP patients at 75 mg/day and>4 times the human clinical exposure in HCV patients at 100 mg/day, based on AUC), decreased reticulocyte counts and regenerative bone marrow erythroid hyperplasia (rats only) were observed in short-term studies.
Danish: I korttidsstudier sås et fald i retikulocyttal og regenerativ hyperplasi af de røde blodlegemer (kun hos rotter) ved doser, der blev dårligt tålt af rotter og hunde (> 10 eller 7 gange den humane kliniske eksponering hos voksne eller pædriatriske ITP-patienter ved doser på 75 mg/dag og > 4 gange den humane kliniske eksponering hos HCV-patienter ved doser på 100 mg/dag, baseret på AUC).
English: • bleeding of the gums
Danish: • blødning på nethinden
English: †, hyperbilirubinaemia,
Danish: Almindelig Hyperbilirubinæmi, gulsot
English: Uncommon side effects that may show up in laboratory tests:
Danish: Ikke almindelige bivirkninger, som kan ses i blodprøver:
English: Key primary endpoints
Danish: De væsentligste primære endepunkter Egnet til effektanalyse, n
English: The European Commission granted a marketing authorisation valid throughout the European Union for Eklira Genuair on 20 July 2012.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Eklira Genuair den 20. juli 2012.
English: The full EPAR for Eklira Genuair can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Eklira Genuair 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 Eklira Genuair.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Eklira Genuair.
English: As antimuscarinic bronchodilator medicines may have an effect on the heart and blood vessels, the company will closely monitor the medicine's cardiovascular effects and will carry out a further study in patients to identify any potential risks.
Danish: Da antimuskarine bronkodilatorer kan påvirke hjerte og blodkar, vil virksomheden nøje overvåge lægemidlets kardiovaskulære virkninger og gennemføre endnu en patientundersøgelse med henblik på at identificere eventuelle risici.
English: This helps to keep the airways open and allows the patient to breathe more easily.
Danish: Dette hjælper med at holde luftvejene åbne og gør det lettere for patienterne at trække vejret.
English: This means that it widens the airways by blocking muscarinic receptors.
Danish: Det betyder, at det udvider luftvejene ved at blokere muskarine receptorer.
English: The main measure of effectiveness was how Eklira Genuair improved patients' forced expiratory volumes (FEV1, the maximum volume of air a person can breathe out in one second).
Danish: Det vigtigste mål for virkningen var, hvordan Eklira Genuair forbedrede patienternes forcerede ekspirationsvolumen (FEV1, den maksimale luftmængde, en person kan udånde på et sekund).
English: Eklira Genuair is used for maintenance (regular) treatment.
Danish: Eklira Genuair anvendes til (regelmæssig) vedligeholdelsesbehandling.
English: What is Eklira Genuair and what is it used for?
Danish: Hvad er Eklira Genuair, og hvad anvendes det til?
English: Other information about Eklira Genuair
Danish: Andre oplysninger om Eklira Genuair
English: Therefore, the CHMP decided that Eklira Genuair's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede derfor, at fordelene ved Eklira Genuair opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: COPD is a long-term disease in which the airways and air sacs inside the lungs become damaged or blocked, leading to difficulty breathing.
Danish: KOL er en langvarig sygdom, hvor luftveje og lungeblæresække bliver beskadiget eller blokeret, så vejrtrækningen vanskeliggøres.
English: A main study involving 828 patients with COPD found that Eklira Genuair was more effective than placebo (a dummy treatment) at improving how well the lungs work.
Danish: En hovedundersøgelse med 828 patienter med KOL viste, at Eklira Genuair var mere effektivt end placebo (virkningsløs behandling) til at forbedre lungefunktionen.
English: On average, after six months of treatment, the FEV1 in patients who used 200 and 400 micrograms Eklira Genuair increased compared with placebo by 99 ml and 128 ml respectively.
Danish: Efter seks måneders behandling var FEV1 hos de patienter, der fik 200 og 400 mikrogram Eklira Genuair, i gennemsnit steget i forhold til placebo med henholdsvis 99 ml og 128 ml.
English: The recommended dose of Eklira Genuair is one inhalation twice a day.
Danish: Den anbefalede dosis Eklira Genuair er en inhalation to gange dagligt.
English: The CHMP also noted that there were no major safety concerns with Eklira Genuair, with side effects being reversible and similar to other antimuscarinic bronchodilator medicines.
Danish: CHMP konkluderede ligeledes, at der ikke var væsentlige sikkerhedsproblemer forbundet med Eklira Genuair, hvis bivirkninger er reversible og svarer til bivirkningerne ved andre antimuskarine bronkodilatorer.
English: For more information about treatment with Eklira Genuair, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Eklira Genuair, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The study compared two doses of Eklira Genuair (200 and 400 micrograms) inhaled twice a day with placebo.
Danish: Undersøgelsen sammenlignede to doser af Eklira Genuair (200 og 400 mikrogram inhaleret to gange dagligt) med placebo.
English: Eklira Genuair is a medicine that is used to relieve the symptoms of chronic obstructive pulmonary disease (COPD) in adults.
Danish: Eklira Genuair er et lægemiddel, der anvendes til at lindre symptomerne på kronisk obstruktiv lungesygdom (KOL) hos voksne.
English: For detailed information on using the inhaler correctly, see the instructions in the package leaflet.
Danish: Nærmere oplysninger om korrekt brug af inhalatoren fremgår af anvisningerne i indlægssedlen.
English: Each inhalation provides 375 micrograms of aclidinium bromide equivalent to 322 micrograms of aclidinium.
Danish: Hver inhalation indeholder 375 mikrogram aclidiniumbromid svarende til 322 mikrogram aclidinium.
English: Why is Eklira Genuair approved?
Danish: Hvorfor blev Eklira Genuair godkendt?
English: Other common side effects (which may affect more than 1 patient in 100) are sinusitis (inflammation of the sinuses), cough, nausea (feeling sick) and diarrhoea.
Danish: Andre hyppige bivirkninger (som kan forekomme hos flere end 1 ud af 100 patienter) er bihulebetændelse (sinusitis), hoste, kvalme og diarré.
English: The most common side effects with Eklira Genuair (which may affect more than 5 patients in 100) are headache and nasopharyngitis (inflammation of the nose and throat).
Danish: De hyppigste bivirkninger ved Eklira Genuair (som kan forekomme hos flere end 5 ud af 100 patienter) er hovedpine og betændelse i næse og svælg (nasofaryngitis).
English: Muscarinic receptors control the contraction of muscles and when aclidinium bromide is inhaled, it relaxes the muscles of the airways.
Danish: De muskarine receptorer styrer muskelsammentrækningen, og når aclidiniumbromid inhaleres, afslappes musklerne i luftvejene.
English: Eklira Genuair aclidinium bromide
Danish: Eklira Genuair aclidiniumbromid
English: The CHMP noted that Eklira Genuair was shown to be effective at improving the symptoms of COPD, and its beneficial effects are maintained for up to a year.
Danish: Udvalget for Lægemidler til Mennesker (CHMP) konkluderede, at Eklira Genuair viste sig at være effektivt til at lindre symptomerne ved KOL, og lægemidlets gavnlige virkning blev fastholdt i op til et år.
English: It is not intended to provide practical advice on how to use Eklira Genuair.
Danish: Det er ikke en praktisk vejledning i, hvordan Eklira Genuair bør anvendes.
English: For the full list of all side effects and restrictions with Eklira Genuair, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Eklira Genuair fremgår af indlægssedlen.
English: What are the risks associated with Eklira Genuair?
Danish: Hvilke risici er der forbundet med Eklira Genuair?
English: What measures are being taken to ensure the safe use of Eklira Genuair?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri anvendelse af Eklira Genuair?
English: The active substance in Eklira Genuair, aclidinium bromide, is an antimuscarinic bronchodilator.
Danish: Det aktive stof i Eklira Genuair, aclidiniumbromid, er en antimuskarin bronkodilator.
English: The dose of 400 micrograms Eklira Genuair corresponds to an inhalation providing 322 micrograms of aclidinium.
Danish: Dosen på 400 mikrogram Eklira Genuair svarer til en inhalation med 322 mikrogram aclidinium.
English: Eklira Genuair contains the active substance aclidinium bromide.
Danish: Eklira Genuair indeholder det aktive stof aclidiniumbromid.
English: Eklira Genuair is available as an inhalation powder in a portable inhaler device.
Danish: Eklira Genuair leveres som et inhalationspulver i en bærbar inhalator.
English: Eklira Genuair can only be obtained with a prescription.
Danish: Eklira Genuair udleveres kun efter recept.
English: For practical information about using Eklira Genuair, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Eklira Genuair, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Eklira Genuair 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 Eklira Genuair.
English: How is Eklira Genuair used?
Danish: Hvordan anvendes Eklira Genuair?
English: What benefits of Eklira Genuair have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Eklira Genuair?
English: How does Eklira Genuair work?
Danish: Hvordan virker Eklira Genuair?
English: This summary was last updated in January 2009.
Danish: Dette sammendrag blev sidst ajourført i januar 2009.
English: The withdrawal period is zero days.
Danish: Tilbageholdelsestiden er nul dage.
English: These reactions resolve spontaneously over a period of approximately 14-21 days without any major consequence on the general health status of the animals.
Danish: Disse reaktioner aftager spontant over en periode på ca. 14-21 dage uden væsentlige konsekvenser for dyrenes almene helbredstilstand.
English: What is the time allowed before the animal can be slaughtered and the meat used for human consumption (withdrawal period)?
Danish: Hvor lang tid skal der gå, før dyret kan slagtes, og kødet kan anvendes til konsum (tilbageholdelsestid)?
English: These studies have been performed under laboratory conditions as well as under typical farming conditions representative of different pig production systems.
Danish: Disse undersøgelser blev udført på laboratoriebetingelser samt på typiske landbrugsbetingelser, der er repræsentative for forskellige svineproduktionssystemer.
English: If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR).
Danish: Hvis du ønsker yderligere oplysninger om baggrunden for CVMP's anbefalinger, kan du læse den faglige drøftelse (også en del af denne EPAR).
English: Through this the immune system will be able to react more quickly when it is exposed to the virus.
Danish: Herved vil immunsystemet være i stand til at reagere hurtigere, når det bliver udsat for virusset senere.
English: A transient increase in body temperature, normally not exceeding 1°C, may occur until 2 days after vaccination.
Danish: En forbigående stigning i kropstemperaturen, normalt ikke overstigende 1°C, kan forekomme indtil 2 dage efter vaccinationen.
English: Information on the prescription status of this product may be found on the outer package.
Danish: Oplysninger om udleveringsbestemmelserne for dette produkt findes på den ydre emballage.
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease.
Danish: Vacciner virker ved at "lære" immunsystemet (organismens naturlige forsvar), hvordan det skal forsvare organismen mod sygdommen.
English: The vaccine is given by injection into a muscle in the neck, in the area behind the ear.
Danish: Vaccinen gives ved injektion i en nakkemuskel i området bag øret.
English: This active immune response helps to protect the pig against the disease caused by this virus.
Danish: Denne aktive immunrespons er med til at beskytte svinet mod den sygdom, som dette virus medfører.
English: Onset of protection against PCV2 occurs from as early as two weeks after the injection and lasts for 22 weeks.
Danish: Beskyttelsen mod PCV2 indtræder allerede 2 uger efter injektionen og varer i 22 uger.
English: The immune response to vaccination was monitored by determining antibody titres in the vaccinated animals.
Danish: Immunresponsen på vaccinationen blev undersøgt ved at bestemme antistoftitre i de vaccinerede dyr.
English: When a pig is given the vaccine, the pig's immune system recognises the protein as ‘foreign' and reacts by building up an active immune response.
Danish: Når et svin vaccineres, opfatter svinets immunsystem proteinet som "fremmed" og reagerer ved at opbygge en aktiv immunrespons.
English: It is generally accepted that infection with PCV2 is essential but not sufficient to cause disease.
Danish: Det er den almindelige opfattelse, at infektion med PCV2 er nødvendig for, men ikke tilstrækkelig til, at sygdommen opstår.
English: Occasionally, an increase of rectal temperature up to 2.5 °C lasting less than 24 hours may occur.
Danish: Af og til kan rektaltemperaturen stige med op til 2,5 °C varende mindre end 24 timer.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Porcilis PCV to Intervet International BV on 12/ 01/ 2009.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Porcilis PCV til Intervet International BV den 12. januar 2009.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) PORCILIS PCV EPAR summary for the public
Danish: EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) PORCILIS PCV EPAR - sammendrag for offentligheden
English: Vaccination may result in a transient impairment of growth rate in the immediate period after administration of the vaccine.
Danish: Vaccination kan resultere i forbigående nedsat tilvækst i perioden umiddelbart efter vaccinationen.
English: If you are accidentally injected with this product, seek prompt medical advice even if only a very small amount is injected and take the package leaflet with you.
Danish: Hvis du ved et uheld injiceres med dette produkt, skal du søge omgående lægehjælp, også selvom det kun drejer sig om en meget lille mængde.
English: The vaccine does not contain any live PCV2.
Danish: Vaccinen indeholder ikke noget levende PCV2.
English: Some piglets may be depressed and show a reduced feed intake for up to 5 days.
Danish: Nogle smågrise kan blive nedstemte og få nedsat ædelyst i op til 5 dage.
English: Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendations on the conditions of use.
Danish: Formålet er at forklare, hvordan Udvalget for Veterinærlægemidlers (CVMP) vurdering af den foreliggende dokumentation førte til, at man anbefalede at anvende lægemidlet som beskrevet nedenfor.
English: In pigs transient local reactions at the injection site may occur after vaccination mainly in the form of a hard, warm and sometimes painful swelling (diameter up to 10 cm).
Danish: Hos svin kan der undertiden observeres forbigående lokale reaktioner på injektionsstedet i form af en hård, varm og nogle gange smertefuld hævelse (med en diameter på op til 10 cm).
English: Immediate systemic hypersensitivitylike reactions may occur after vaccination, resulting in minor neurological symptoms such as tremors and/or excitation, which normally resolve within minutes without requiring treatment.
Danish: Umiddelbart efter vaccinationen kan der opstå en akut overfølsomhedslignende reaktion resulterende i lettere neurologiske symptomer såsom kramper og/eller ekscitation, som normalt aftager efter nogle minutter uden at kræve behandling.
English: PCV2 associated infections may include clinical signs such as weight loss or failure to grow, enlarged lymph nodes, difficulty in breathing, diarrhoea, pale skin and jaundice (yellowing of the skin).
Danish: PCV2-relaterede infektioner kan omfatte kliniske symptomer som vægttab eller manglende vækst, forstørrede lymfeknuder, åndenød, diarré, bleg hud og gulsot (gulfarvning af huden).
English: It contains a protein (antigen) from the porcine circovirus type 2 virus (PCV2).
Danish: Det indeholder et protein (antigen) fra porcint circovirus type 2 virus (PCV2).
English: Porcilis PCV contains small amounts of a protein from PCV2.
Danish: Porcilis PCV indeholder små mængder af et protein fra PCV2.
English: monitored included weight gain, mortality as well as faecal and nasal shedding.
Danish: De undersøgte effektmål omfattede vægtforøgelse, dødelighed samt fækal og nasal udskillelse.
English: Porcilis PCV contains mineral oil.
Danish: Porcilis PCV indeholder mineralolie.
English: Porcilis PCV is a vaccine.
Danish: Porcilis PCV er en vaccine.
English: Porcilis PCV has been studied in pigs in a number of trials.
Danish: Porcilis PCV blev undersøgt hos svin i en række undersøgelser.
English: Other information about Porcilis PCV:
Danish: Andre oplysninger om Porcilis PCV:
English: Porcine circovirus type 2 (PCV2) is known to cause a wide variety of syndromes in pigs, together known as Porcine circovirus type 2-related diseases (PCVD).
Danish: Porcint circovirus type 2 (PCV2) er kendt for at give en lang række syndromer hos svin med fællesbetegnelsen porcint circovirus type 2-relaterede sygdomme (PCVD).
English: This helps to reduce the amount of virus in the animal's blood and lymphoid tissues and to reduce weight loss associated with PCV2 infection occurring during the fattening period.
Danish: Dette er med til at reducere virusmængden i dyrets blod og lymfoide væv, og det er med til at reducere vægttab i forbindelse med en PCV2-infektion, som opstår under opvæksten.
English: The trials showed that vaccination of pigs with Porcilis PCV helps to reduce the amount of virus in the animal's blood and lymphoid tissues and to reduce weight loss associated with PCV2 infection occurring during the fattening period.
Danish: Undersøgelserne viste, at vaccination af svin med Porcilis PCV er med til at reducere virusmængden i dyrets blod og lymfoide væv, og at det er med til at reducere vægttab i forbindelse med en PCV2-infektion, som opstår under opvæksten.
English: Porcilis PCV is a vaccine for use in pigs, which is available as an emulsion for injection.
Danish: Porcilis PCV er en vaccine til svin, der fås som injektionsvæske, emulsion.
English: Porcilis PCV is used to vaccinate pigs from three days of age against PCV2 infection.
Danish: Porcilis PCV anvendes til vaccination af svin mod PCV2-infektion, fra de er tre dage gamle.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Porcilis PCV exceed the risks for the active immunisation of pigs, over the age of three days, against PCV2, and recommended that Porcilis PCV be given a marketing authorisation.
Danish: Udvalget for Veterinærlægemidler (CVMP) konkluderede, at fordelene ved Porcilis PCV er større end risiciene med hensyn til aktiv immunisering af svin, der er over 3 dage gamle, mod PCV2.
English: What is the risk associated with Porcilis PCV?
Danish: Hvilken risiko er der forbundet med Porcilis PCV?
English: Accidental injection/self injection may result in severe pain and swelling, particularly if injected into a joint or finger, and, in rare cases, could result in the loss of the affected finger if prompt medical attention is not given.
Danish: Uforsætlig injektion/selvinjektion kan medføre alvorlige smerter og hævelser, navnlig ved injektion i led eller fingre.
English: Why has Porcilis PCV been approved?
Danish: Hvorfor blev Porcilis PCV godkendt?
English: What is Porcilis PCV?
Danish: Hvad er Porcilis PCV?
English: What is Porcilis PCV used for?
Danish: Hvad anvendes Porcilis PCV til?