FrancophonIA/ELRC3.0 huggingface dataset:
English: This strain has been chosen because it protects birds against the virulent H5N1 field strains (cross-protection), while allowing differentiation of vaccinated from infected birds.
Danish: Den pågældende virusstamme er valgt, fordi den beskytter fuglene mod de sygdomsfremkaldende H5N1-feltstammer (krydsbeskyttelse).
English: This kind of ‘reassortment' between H and N types happens naturally in the wild but in this case has been carried out in the laboratory to produce a virus with these very specific properties.
Danish: I dette tilfælde er den dog udført i laboratoriet for at frembringe en virus med netop disse ganske bestemte egenskaber.
English: Other information about Poulvac FluFend H5N3 RG:
Danish: Andre oplysninger om Poulvac FluFend H5N3 RG:
English: A field trial
Danish: • Hos ænder:
English: What is the risk associated with Poulvac FluFend H5N3 RG?
Danish: Hvilke risici er der forbundet med Poulvac FluFend H5N3 RG?
English: Why has Poulvac FluFend H5N3 RG been approved?
Danish: Hvorfor blev Poulvac FluFend H5N3 RG godkendt?
English: How has Poulvac FluFend H5N3 RG been studied?
Danish: Hvordan blev Poulvac FluFend H5N3 RG undersøgt?
English: How does Poulvac FluFend H5N3 RG work?
Danish: Hvordan virker Poulvac FluFend H5N3 RG?
English: What is Poulvac FluFend H5N3 RG used for?
Danish: Hvad anvendes Poulvac FluFend H5N3 RG til?
English: What benefit has Poulvac FluFend H5N3 RG shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Poulvac FluFend H5N3 RG?
English: EMA/CHMP/906885/2011
Danish: EMA/CHMP/906885/2011 EMEA/H/C/002068
English: The effects of Ioa were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Ioa blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: The full EPAR for Ioa can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Ioa findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Ioa is a contraceptive pill.
Danish: Ioa er en p-pille.
English: Ioa was investigated in two main studies involving a total of 4,433 women aged 18 to 50 years old.
Danish: Ioa blev undersøgt i to hovedundersøgelser, der omfattede i alt 4 433 kvinder i alderen 18 til 50 år.
English: This is a summary of the European public assessment report (EPAR) for Ioa.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Ioa.
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 Ioa.
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 Ioa.
English: No clinical study data on Ioa are available in adolescents under 18 years old.
Danish: Der foreligger ingen data fra kliniske undersøgelser af Ioa hos unge under 18 år.
English: In women aged 18 to 35, the Pearl Index was around 0.4 with Ioa and 0.8 with the comparator medicine in the first study, and around 1.2 with Ioa and 1.9 with the comparator medicine in the
Danish: Hos kvinder i alderen 18 til 35 år var Pearl Index ca. 0,4 med Ioa og 0,8 med sammenligningslægemidlet i den første undersøgelse, og det var ca. 1,2 med Ioa og 1,9 med sammenligningslægemidlet i den anden undersøgelse.
English: For more information about treatment with Ioa, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Ioa, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: What is the risk associated with Ioa?
Danish: Hvilken risiko er der forbundet med Ioa?
English: The Pearl Index is a standard way of measuring the effectiveness of contraceptives, which measures how many unwanted pregnancies occur in 100 women-years (corresponding to 1,300 menstrual cycles).
Danish: Pearl Index er en standardmetode til at måle svangerskabsforebyggende midlers effektivitet, hvor man måler, hvor mange uønskede graviditeter der forekommer i 100 kvindeår (svarende til 1.300 menstruationscyklusser).
English: The most frequent side effects with Ioa (seen in more than 1 user in 10) are acne and changes to menstrual periods (e.g. absence or irregularity).
Danish: De mest almindelige bivirkninger med Ioa (som optræder hos flere end 1 ud af 10 patienter) er acne og ændringer i menstruationsperioderne (f.eks. fravær eller uregelmæssighed).
English: The main measure of effectiveness was the number of women aged 18 to 35 who became pregnant during or shortly after treatment, expressed in terms of a pregnancy rate using the ‘Pearl Index'.
Danish: Virkningen blev hovedsagelig bedømt på, hvor stort et antal kvinder mellem 18 og 50 år, der blev gravide under eller kort tid efter behandlingen, udtrykt i graviditetshyppighed ved hjælp af "Pearl Index".
English: Ioa works by changing the body's hormonal balance to prevent ovulation, by altering the cervical mucus and by thinning the endometrium (the lining of the womb).
Danish: Ioa virker ved at ændre kroppens hormonbalance og forhindre ægløsning ved at ændre den cervikale sekretion og gøre endometrium (livmodervæggen) tyndere.
English: Ioa comes in blisters containing 28 tablets (24 white tablets followed by 4 yellow tablets), which are taken in sequence using stickers to identify the days of the week for each tablet.
Danish: Ioa leveres i blisterpakker med 28 tabletter (24 hvide tabletter efterfulgt af 4 gule tabletter), der tages i rækkefølge, og hvor der anvendes klistermærker til at markere ugedagene for hver tablet.
English: The CHMP decided that the benefits of Ioa are greater than its risks and recommended that it be given
Danish: CHMP besluttede, at fordelene ved Ioa opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: A lower Pearl Index represents a lower
Danish: Et lavere Pearl Index viser en lavere sandsynlighed for at blive gravid.
English: The participants were given either Ioa or another contraceptive pill containing drospirenone and ethinyl estradiol for one year (13 menstrual cycles).
Danish: Deltagerne fik enten Ioa eller en anden p-pille, der indeholder drospirenon og ethinylestradiol, i et år og ethinylestradiol i et år (13 menstruationscyklusser).
English: It should not be used in women who have a disorder affecting blood clotting (such as protein C deficiency), migraine with aura (visual or other symptoms), severe liver problems with the liver still not functioning normally, certain types of cancer, or abnormal bleeding from the genital area whose cause has not been diagnosed.
Danish: Det må ikke anvendes til kvinder, som har en lidelse, der påvirker blodets evne til at størkne (f.eks. protein C-mangel), migræne med aura (synsforstyrrelser eller andre symptomer), svære leverproblemer, hvor leveren stadig ikke fungerer normalt, visse kræfttyper eller unormale blødninger fra skeden, hvis årsag ikke er diagnosticeret.
English: How has Ioa been studied?
Danish: Hvordan blev Ioa undersøgt?
English: It must not be used when a woman has, or has had, venous or arterial thrombosis (blood clots in the veins or arteries) including a stroke or a heart attack or when a woman has some of the risk factors for thrombosis (severe high blood pressure, diabetes with damage to the blood vessels or high cholesterol levels).
Danish: Det må ikke anvendes til kvinder, der har eller har haft venøs eller arteriel trombose (blodpropper i vener eller arterier), herunder slagtilfælde eller hjerteanfald, eller til kvinder, der har nogle af risikofaktorerne for trombose (stærkt forhøjet blodtryk, diabetes med beskadigede blodkar eller højt kolesteroltal).
English: The European Commission granted a marketing authorisation valid throughout the European Union for
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Ioa den 16. november 2011.
English: Ioa is a medicine available as 24 white ‘active' tablets that contain the active substances nomegestrol acetate (2.5 mg) and estradiol (1.5 mg), and four yellow ‘inactive' (placebo) tablets that do not
Danish: Ioa er et lægemiddel, der fås som 24 hvide "aktive" tabletter, der indeholder de aktive stoffer nomegestrolacetat (2,5 mg) og estradiol (1,5 mg), og fire gule "inaktive" tabletter (placebo), som ikke indeholder noget aktivt stof.
English: Ioa is a combined contraceptive pill that contains two active substances, nomegestrol acetate (a progestogen) and estradiol (an oestrogen).
Danish: Ioa er en kombineret p-pille, som indeholder to aktive stoffer, nomegestrolacetat (et progestogen) og estradiol (et østrogen).
English: Ioa should not be used in women who are hypersensitive (allergic) to nomegestrol acetate, estradiol or any of the other ingredients.
Danish: Ioa bør ikke anvendes af kvinder, der kan være overfølsomme (allergiske) over for nomegestrolacetat, estradiol eller andre af indholdsstofferne.
English: For the full list of all side effects reported with Ioa,
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Ioa fremgår af indlægssedlen.
English: For the full list of restrictions, see
Danish: Den fuldstændige liste over begrænsningerne fremgår af indlægssedlen.
English: What benefit has Ioa shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Ioa?
English: Ioa
Danish: Hvad er Ioa?
English: MA (EU) number (Invented) name
Danish: MA (EU) nr.
English: This was considered acceptable since Revatio and Viagra have the same qualitative composition and are made in the same way by the same manufacturer.
Danish: Dette blev anset for at være acceptabelt, idet Revatio og Viagra har den samme kvalitative sammensætning og fremstilles på samme måde af den samme producent.
English: The full EPAR for Mysildecard can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Mysildecard 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 Mysildecard.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Mysildecard.
English: In this case Mysildecard was not compared with the reference product Revatio, but with Viagra.
Danish: I dette tilfælde blev Mysildecard ikke sammenlignet med referenceproduktet Revatio, men i stedet med Viagra.
English: This means that Mysildecard is similar to a ‘reference medicine' already authorised in the European Union (EU) called Revatio.
Danish: Det betyder, at Mysildecard er identisk med et "referencelægemiddel", som allerede er godkendt i Den Europæiske Union (EU), og som hedder Revatio.
English: Lower doses of Mysildecard may be needed in patients taking some medicines that affect the way Mysildecard is broken down in the body.
Danish: Der kan være behov for lavere doser af Mysildecard til patienter, som tager lægemidler, der kan påvirke den måde, hvorpå Mysildecard nedbrydes i kroppen.
English: The Committee recommended that Mysildecard be approved for use in the EU.
Danish: Udvalget anbefalede, at Mysildecard godkendes til anvendelse i EU.
English: The active substance in Mysildecard, sildenafil, belongs to a group of medicines called ‘phosphodiesterase-type-5 (PDE5) inhibitors', which means that it blocks the PDE5 enzyme.
Danish: Det aktive stof i Mysildecard, sildenafil, tilhører en gruppe af lægemidler kaldet "phosphodiesterase type-5 (PDE5)-hæmmere", hvilket betyder, at det blokerer PDE5-enzymet.
English: Mysildecard contains the active substance sildenafil.
Danish: Mysildecard indeholder det aktive stof sildenafil.
English: Mysildecard is available as tablets (20 mg).
Danish: Mysildecard fås som tabletter (20 mg).
English: In adults, it is used in patients with class II (slight limitation of physical activity) or class III (marked limitation of physical activity) PAH.
Danish: Hos voksne anvendes lægemidlet til at behandle patienter med klasse II-PAH (lettere begrænsning af fysisk aktivitet) eller klasse III-PAH (markant begrænsning af fysisk aktivitet).
English: Because the effectiveness and safety of sildenafil in PAH is already well established, studies in people have been limited to tests to determine that it is bioequivalent to another authorised sildenafilcontaining tablet.
Danish: Da sildenafils virkning og sikkerhed ved behandling af PAH allerede er veletableret, har patientundersøgelserne været begrænset til at påvise, at lægemidlet er bioækvivalent med en anden godkendt tablet, der indeholder sildenafil.
English: In children aged one to 17, the recommended dose is 20 mg three times a day in those over 20 kg. Higher doses should not be used.
Danish: Hos børn i alderen 1-17 år er den anbefalede dosis 20 mg tre gange dagligt til de, der vejer over 20 kg. Der må ikke anvendes højere doser.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Mysildecard was considered to be comparable to Revatio.
Danish: Udvalget for Lægemidler til Mennesker (CHMP) konkluderede, at det i overensstemmelse med EU's krav er påvist, at Mysildecard er sammenligneligt med Revatio.
English: Other information about Mysildecard
Danish: Andre oplysninger om Mysildecard
English: What are the benefits and risks of Mysildecard?
Danish: Hvilke fordele og risici er der forbundet med Mysildecard?
English: What measures are being taken to ensure the safe and effective use of Mysildecard?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Mysildecard?
English: Mysildecard is a medicine used to treat adults and children from 1 year of age with pulmonary arterial hypertension (PAH, abnormally high blood pressure in the arteries of the lungs).
Danish: Mysildecard anvendes til at behandle voksne og børn fra 1 år og opefter med pulmonal arteriel hypertension (PAH), som er unormalt højt blodtryk i lungearterierne.
English: Because Mysildecard is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Mysildecard er et generisk lægemiddel, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: For more information about treatment with Mysildecard, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Mysildecard, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: In adults, Mysildecard is taken at a dose of 20 mg three times a day.
Danish: Hos voksne gives Mysildecard som en 20 mg-dosis tre gange dagligt.
English: It is not intended to provide practical advice on how to use Mysildecard.
Danish: Det er ikke en praktisk vejledning i, hvordan Mysildecard bør anvendes.
English: Mysildecard can only be obtained with a prescription and treatment should be started and monitored by a doctor who has experience in the treatment of PAH.
Danish: Mysildecard udleveres kun efter recept, og behandlingen bør iværksættes og overvåges af en læge med erfaring i at behandle pulmonal arteriel hypertension.
English: What is Mysildecard and what is it used for?
Danish: Hvad er Mysildecard, og hvad anvendes det til?
English: Therefore, the CHMP's view was that as for Revatio the benefit of Mysildecard outweighs the identified risks.
Danish: Det var derfor CHMP's opfattelse, at fordelene ved Mysildecard opvejer de identificerede risici som for Revatio.
English: For practical information about using Mysildecard, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Mysildecard, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Why is Mysildecard approved?
Danish: Hvorfor blev Mysildecard godkendt?
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom dose would be 10 mg three times a day but Mysildecard can only be used when a 20 mg dose is to be given.
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Mysildecard have 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 Mysildecard.
English: How does Mysildecard work?
Danish: Hvordan virker Mysildecard?
English: How has Mysildecard been studied?
Danish: Hvordan blev Mysildecard undersøgt?
English: How is Mysildecard used?
Danish: Hvordan anvendes Mysildecard?
English: Strength Pharmaceutical Form
Danish: Produktnavn Styrke Farmaceutisk form
English: Route of Administration
Danish: Administration Pakning
English: Packaging
Danish: Pakkestørrelse
English: Enbrel can be taken with or without food or drink.
Danish: Enbrel kan anvendes med eller uden mad og drikke.
English: This appearance is normal for Enbrel.
Danish: Dette udseende er normalt for Enbrel.
English: Enbrel should only be used during pregnancy if clearly needed.
Danish: Enbrel bør kun anvendes under graviditet, hvis det er absolut nødvendigt.
English: Hold the pen at a right angle (90º) to the injection site.
Danish: Hold pennen i en ret vinkel (90º) mod injektionsstedet.
English: Do not warm Enbrel in any other way (for example, do not warm it in a microwave or in hot water).
Danish: Enbrel må ikke opvarmes på nogen anden måde (må for eksempel ikke opvarmes i mikrobølgeovn eller i varmt vand).
English: • Instructional materials to share with patients
Danish: • Instruktionsmaterial, som kan uddeles til patienter
English: Date of first authorisation: 03 February 2000 Date of last renewal: 03 February 2010
Danish: Dato for første tilladelse: 03. februar 2000 Dato for sidste fornyelse: 03. februar 2010
English: • The risk of opportunistic infections and tuberculosis (TB)
Danish: • Information om risikoen for opportunistiske infektioner og tuberkulose (TB)
English: Administration of live vaccines to infants for 16 weeks after the mother's last dose of Enbrel is generally not recommended.
Danish: Administration af levende vacciner til spædbørn inden for 16 uger efter moderens sidste Enbrel-dosis anbefales generelt ikke.
English: • Teaching guide to facilitate training of the patients in the safe use of the pre-filled pen
Danish: • Undervisningsguide til at lette træningen af patienterne i sikker brug af den fyldte pen
English: Package Leaflet: Information for the User
Danish: Indlægsseddel: Information til brugeren
English: The difference between Enbrel alone and methotrexate alone was also significant (p<0.05).
Danish: Forskellen mellem Enbrel alene og methotrexat alene var også signifikant (p<0,05).
English: The healthcare professional's educational material should contain the following key elements:
Danish: Sundhedspersonalets uddannelsesmateriale skal indeholde følgende hovedelementer:
English: The package leaflet is updated accordingly.
Danish: Indlægssedlen opdateres tilsvarende.
English: From a microbiological point of view, the reconstituted medicinal product should be used immediately.
Danish: Fra et mikrobiologisk synspunkt bør det rekonstituerede lægemiddel anvendes omgående.
English: Adding solvent e.
Danish: Tilsætning af solvens e.
English: Treatment with Enbrel should continue until remission is achieved, for up to 24 weeks.
Danish: Behandlingen med Enbrel bør fortsættes indtil remission er nået, i op til 24 uger.
English: However, it cannot be excluded that the combination of Enbrel with methotrexate could be associated with an increase in the rate of infections.
Danish: Det kan dog ikke udelukkes, at kombinationen Enbrel og methotrexat kan være forbundet med en stigning i infektionsraten.
English: Enbrel is a medicine that is made from two human proteins.
Danish: Enbrel er et lægemiddel fremstillet af to proteiner, som findes naturligt hos mennesker.
English: Two large clinical trials evaluating the use of Enbrel in the treatment of CHF were terminated early due to lack of efficacy.
Danish: To store kliniske forsøg, der evaluerede brugen af Enbrel i behandlingen af CHF, blev afsluttet før tiden på grund af manglende effektivitet.
English: The recommended injection site is the middle of the front of the thighs.
Danish: Det anbefalede injektionssted er foran midt på lårene.
English: The dosage of Enbrel is based on body weight for paediatric patients.
Danish: Doseringen af Enbrel er baseret på legemsvægt for pædiatriske patienter.
English: Long-term experience with Enbrel was generally comparable to the original 48-week study and did not reveal any new safety findings.
Danish: Erfaringerne fra langtidsstudiet med Enbrel var generelt sammenlignelige med det oprindelige 48-ugers studie og gav ingen nye sikkerhedsresultater.
English: Enbrel treatment may increase mortality in patients with established sepsis.
Danish: Enbrelbehandling kan forøge dødeligheden hos patienter med etableret sepsis.
English: • Vaccinations: If possible, children should be up to date with all vaccinations before using Enbrel.
Danish: • Vaccinationer: Hvis det er muligt, skal børn være ajour med alle vaccinationer, før du får Enbrel.
English: If you have used more Enbrel than you should (either by injecting too much on a single occasion or by using it too frequently), talk to a doctor or pharmacist immediately.
Danish: Hvis du har anvendt mere Enbrel, end du bør (enten ved at injicere for meget en enkelt gang eller ved at anvende det for ofte), bør du straks tale med lægen eller apoteket.
English: It is recommended that paediatric patients, if possible, be brought up to date with all immunisations in agreement with current immunisation guidelines prior to initiating Enbrel therapy (see Vaccinations, above).
Danish: Det anbefales, at pædiatriske patienter om muligt bringes à jour med al immunisering i overensstemmelse med gældende retningslinjer for immunisering, før behandling med Enbrel påbegyndes (se Vaccinationer ovenfor).
English: If you received Enbrel during pregnancy, your baby may have a higher risk of getting an infection.
Danish: Hvis du har taget Enbrel under graviditeten, kan dit spædbarn have en øget risiko for at få en infektion.
English: Enbrel has not been studied in children aged less than 2 years.
Danish: Enbrel er ikke undersøgt hos børn under 2 år.
English: Administration of Enbrel should be discontinued if a patient develops a serious infection.
Danish: Indgivelse af Enbrel skal ophøre, hvis en patient udvikler en alvorlig infektion.
English: No data are available on the secondary transmission of infection by live vaccines in patients receiving Enbrel.
Danish: Der er ingen data til rådighed om sekundær transmission af infektion via levende vacciner hos patienter, som får Enbrel.
English: It is important that you tell the baby's doctors and other healthcare professionals about the use of Enbrel during pregnancy before the baby receives any vaccine (for more information see section 2, “Vaccinations”).
Danish: Det er vigtigt, at du fortæller læger og andre sundhedspersoner, at du har taget Enbrel under graviditeten, inden dit spædbarn vaccineres (for mere information, se afsnit 2 ”Vaccinationer”).
English: Serious infections affect fewer than 1 in 100 patients treated with Enbrel.
Danish: Alvorlige infektioner påvirker færre end 1 ud af 100 patienter, der behandles med Enbrel.
English: Enbrel works by reducing the inflammation associated with certain diseases.
Danish: Enbrel virker ved at reducere inflammationen i forbindelse med visse sygdomme.