FrancophonIA/ELRC3.0 huggingface dataset:
English: Extavia was more effective than placebo in reducing the number of annual relapses: patients receiving the medicine had on average 0.84 relapses a year, when patients on placebo had 1.27 relapses.
Danish: Extavia var mere effektivt end placebo til at reducere antallet af tilbagefald pr. år: Patienter, der fik lægemidlet, havde i gennemsnit 0,84 tilbagefald pr. år, mens patienter på placebo havde 1,27.
English: The most frequent side effects with Extavia are flu-like symptoms (including fever, chills, joint pain, malaise [feeling unwell], sweating, headache and muscle pain) and reactions at the site of injection.
Danish: De hyppigste bivirkninger ved Extavia er influenzalignende symptomer (herunder feber, kulderystelser, ledsmerter, utilpashed, svedtendens, hovedpine og muskelsmerter) og reaktioner på injektionsstedet.
English: In both studies, Extavia showed a reduction in the number (30%) of clinical relapses.
Danish: I begge studier medførte Extavia en reduktion på 30 % i antallet af kliniske tilbagefald.
English: • who have secondary progressive MS (the type of MS that comes after relapsing-remitting MS), when their disease is active.
Danish: • der har sekundær progressiv multipel sklerose (den type multipel sklerose, der kommer efter recidiverende-remitterende multipel sklerose), når deres sygdom er aktiv.
English: MS is a disease in which inflammation damages the protective insulation around nerves (demyelination) as well as the nerves themselves.
Danish: Multipel sklerose er en sygdom, hvor en betændelsesreaktion skader den beskyttende isolering omkring nerverne (demyelinisering) samt nerverne selv.
English: Extavia is a medicine used to treat adults who have multiple sclerosis (MS).
Danish: Extavia er et lægemiddel til behandling af voksne, der har multipel sklerose.
English: Extavia has also been studied in 1,657 patients in two studies involving secondary progressive MS patients who were able to walk, where it was compared with placebo.
Danish: Extavia er også blevet undersøgt hos 1.657 patienter i to studier af sekundær progressiv multipel sklerose, som var i stand til at gå, hvor det blev sammenlignet med placebo.
English: Extavia can only be obtained with a prescription and treatment should be started by a doctor who has experience in the treatment of MS.
Danish: Extavia fås kun på recept, og behandlingen bør iværksættes af en læge med erfaring i behandling af multipel sklerose.
English: For the full list of side effects and restrictions with Extavia, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Extavia fremgår af indlægssedlen.
English: The active substance in Extavia is the protein interferon beta-1b, one of a group of interferons that can be naturally produced by the body to help it fight against viruses and other attacks.
Danish: Det aktive stof i Extavia er proteinet interferon beta-1b, der tilhører en gruppe interferoner, som dannes naturligt i kroppen for at hjælpe den med at bekæmpe bl.a. virusser.
English: The exact way that Extavia works in MS is not yet known but the active substance, interferon beta-1b, seems to calm down the immune system, and prevents relapses of MS.
Danish: Det vides endnu ikke præcist, hvordan Extavia virker ved multipel sklerose, men det aktive stof, interferon beta-1b, synes at berolige immunsystemet og forebygger tilbagefald af multipel sklerose.
English: Extavia was studied over a two-year period in 338 patients with relapsing remitting MS who were able to walk unaided, where its effectiveness was compared with placebo (a dummy treatment).
Danish: Extavia blev undersøgt over en to-årig periode hos 338 patienter med recidiverende-remitterende multipel sklerose, der var i stand til at gå uden hjælp, og dets virkning blev sammenlignet med placebo (ikke-aktivt stof).
English: What benefits of Extavia have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Extavia?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Extavia 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 Extavia.
English: It is used when the patient is considered to be at high risk of developing MS. Before using Extavia, doctors need to exclude other causes for the symptoms;
Danish: Før anvendelse af Extavia skal lægen udelukke andre årsager til symptomerne
English: How is Extavia used?
Danish: Hvordan anvendes Extavia?
English: How does Extavia work?
Danish: Hvordan virker Extavia?
English: In a study involving 487 patients with a single demyelinating event, treatment with Extavia for two years was shown to reduce the risk of developing clinically defined MS: 28% of the patients who received Extavia developed MS, compared with 45% of those who received placebo.
Danish: I et studie af 487 patienter med et enkelt tilfælde af demyelinisering blev det påvist, at behandling med Extavia i to år reducerede risikoen for udvikling af klinisk definitiv multipel sklerose.
English: Extavia contains the active substance interferon beta-1b.
Danish: Extavia indeholder det aktive stof interferon beta-1b. Lægemidlet er identisk med Betaferon, som allerede er godkendt i EU.
English: As the company had supplied the additional information requested, the ‘exceptional circumstances' ended on 22 March 2017
Danish: Da virksomheden havde fremlagt de ønskede yderligere oplysninger, som man havde anmodet om, blev de "særlige omstændigheder" ophævet 22. marts 2017.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Ilaris on 23 October 2009.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Ilaris den 23. oktober 2009.
English: Ilaris was originally authorised under ‘exceptional circumstances', because, for scientific reasons, limited information was available at the time of approval.
Danish: Ilaris blev oprindelig godkendt under "særlige omstændigheder", da der af videnskabelige årsager kun forelå begrænsede oplysninger på godkendelsestidspunktet.
English: The full EPAR for Ilaris can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Ilaris findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The proportion of patients with no relapse was lower (around 57%) for children aged 2 to 4 years.
Danish: Andelen af patienter uden tilbagefald var lavere (ca. 57 %) hos børn i alderen 2-4 år.
English: This is a summary of the European public assessment report (EPAR) for Ilaris.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Ilaris.
English: − familial mediterranean fever (FMF);
Danish: − familiær middelhavsfeber (FMF)
English: Other information about Ilaris
Danish: Andre oplysninger om Ilaris
English: Ilaris must not be used in patients with active or severe infection.
Danish: Ilaris må ikke anvendes til patienter, som har en aktiv eller svær infektion.
English: Some infections were unusual or opportunistic infections due to reduced white blood cell levels.
Danish: Der blev også konstateret visse usædvanlige eller opportunistiske infektioner som følge af et reduceret antal hvide blodlegemer.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits seen with Ilaris outweigh its risks and recommended that it be authorised in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Ilaris opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: The main risk with this medicine is infection, mostly affecting the nose and throat.
Danish: Den væsentligste risiko forbundet med dette lægemiddel er infektion, hovedsageligt i næsen og halsen.
English: The most common infections were of the nose and throat.
Danish: De hyppigste infektioner optrådte i næsen og halsen.
English: By attaching to interleukin-1 beta, canakinumab blocks its activity, helping to reduce inflammation thereby relieving the symptoms of the diseases.
Danish: Ved at binde sig til interleukin-1 beta blokerer canakinumab dets aktivitet og bidrager derved til at lindre sygdommenes symptomer.
English: What measures are being taken to ensure the safe and effective use of Ilaris?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Ilaris?
English: Ilaris is a medicine for treating the following inflammatory conditions:
Danish: Ilaris er et lægemiddel til behandling for de følgende betændelsestilstande:
English: The response rates with Ilaris and placebo were 46% and 8%, respectively in patients with TRAPS, 35% and 6% in patients with HIDS/MKD, and 61% and 6% in patients with FMF.
Danish: Responsraten med Ilaris og placebo var henholdsvis 46 % og 8 % hos patienter med TRAPS, henholdsvis 35 % og 6 % hos patienter med HIDS/MKD og henholdsvis 61 % og 6 % hos patienter med FMF.
English: The active substance in Ilaris, canakinumab, is a monoclonal antibody, a type of protein that has been designed to recognise and attach to a messenger molecule or ‘cytokine' in the body called interleukin-1 beta.
Danish: Det aktive stof i Ilaris, canakinumab, er et monoklonalt antistof, en type protein, der er opbygget, så det genkender og binder sig til et signalmolekyle, eller "cytokin", i kroppen kaldet interleukin-1 beta.
English: Injections are usually given in the upper thigh, upper arm, abdomen or buttocks.
Danish: Injektioner gives sædvanligvis i det øvre lår, overarmen, maven eller balden.
English: Ilaris contains the active substance canakinumab.
Danish: Ilaris indeholder det aktive stof canakinumab.
English: Ilaris can only be obtained with a prescription.
Danish: Ilaris udleveres kun efter recept.
English: Serious infections have been observed in patients taking Ilaris.
Danish: Der er indberettet alvorlige infektioner hos patienter, der tager Ilaris.
English: It is not intended to provide practical advice on how to use Ilaris.
Danish: Det er ikke en praktisk vejledning i, hvordan Ilaris bør anvendes.
English: After proper training, patients or their caregivers may inject Ilaris themselves if the doctor deems it appropriate (for gouty arthritis the medicine should always be given by a healthcare professional).
Danish: Efter grundig instruktion kan patienterne selv eller deres omsorgspersoner injicere Ilaris, hvis lægen skønner, at dette er hensigtsmæssigt (mod urinsur gigt skal lægemidlet dog altid administreres af en sundhedsperson).
English: Why is Ilaris approved?
Danish: Hvorfor blev Ilaris godkendt?
English: What is Ilaris and what is it used for?
Danish: Hvad er Ilaris, og hvad anvendes det til?
English: Ilaris treatment also allowed patients to reduce the amount of steroids they take to control inflammation.
Danish: Behandling med Ilaris gjorde det også muligt for patienterne at mindske indtaget af steroider for at begrænse inflammationen.
English: Ilaris is given as a single injection under the skin every 8 weeks for CAPs and every 4 weeks for the other periodic fever syndromes (TRAPS, HIDS/MKD and FMF) and Still's disease.
Danish: Ilaris gives som én injektion under huden hver ottende uge mod CAPS og hver fjerde uge mod andre periodiske febersyndromer (TRAPS, HIDS/MKD og FMF) og Stills sygdom.
English: The risk of developing a new gouty arthritis attack was also reduced with Ilaris (17% with Ilaris versus 37% with triamcinolone acetonide).
Danish: Risikoen for at udvikle et nyt anfald af urinsur gigt blev også reduceret med Ilaris (17 % med Ilaris mod 37 % med triamcinolonacetonid).
English: For information on doses and dose adjustments, see the summary of product characteristics (also part of the EPAR).
Danish: Nærmere oplysninger om dosis og dosisjustering fremgår af produktresuméet (også en del af denne EPAR).
English: In patients taking Ilaris, after 3 days, the pain level was reduced from 74 to 25 (on a standard rating scale from 0 to 100), whereas in patients taking the comparator the pain level was reduced from 74 to 35.
Danish: Hos patienter, som tog Ilaris, blev smerteniveauet mindsket fra 74 til 25 (på en standardskala fra 0 til 100) efter tre dage, mens det hos patienter, som tog sammenligningslægemidlet, blev mindsket fra 74 til 35.
English: − hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency (MKD);
Danish: − hyperimmunoglobulin-D-syndrom (HIDS)/mevalonatkinasemangel (MKD)
English: The company that markets Ilaris will provide doctors who will use Ilaris with educational material containing the prescribing information, the patient reminder card and information for doctors containing important safety information about Ilaris, including precautions to be taken when using the medicine.
Danish: Virksomheden, der markedsfører Ilaris, vil sørge for, at læger, som forventes at bruge Ilaris, får en pakke med ordineringsoplysninger, patientinformationskortet og vigtige sikkerhedsoplysninger til læger om Ilaris, herunder forholdsregler, der skal overholdes ved anvendelsen af lægemidlet.
English: • 4 types of periodic fever syndromes (diseases marked by recurring inflammation and fever) in adults and children aged 2 and above:
Danish: • fire typer af periodisk febersyndrom (sygdomme, som er kendetegnet ved gentagne inflammationer og feber) hos voksne og hos børn i toårsalderen og derover:
English: − cryopyrin-associated periodic syndromes (CAPS);
Danish: − kryopyrinassocierede periodiske syndromer (CAPS)
English: • Gouty arthritis, painful inflammation of the joints caused by deposit of urate crystals (in adults).
Danish: • urinsur gigt, smertefuld inflammation i leddene forårsaget af aflejring af uratkrystaller (hos voksne).
English: What are the risks associated with Ilaris?
Danish: Hvilke risici er der forbundet med Ilaris?
English: For more information about treatment with Ilaris, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Ilaris, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Studies have shown that Ilaris is effective at reducing symptoms or relapses in patients with periodic fever syndromes, Still's disease and gouty arthritis.
Danish: Undersøgelser har vist, at Ilaris er effektivt til at mindske symptomer eller tilbagefald hos patienter med periodiske febersyndromer, Stills sygdom og urinsur gigt.
English: A study in 84 patients with childhood Still's disease (also known as systemic juvenile idiopathic arthritis, SJIA) found that Ilaris was more effective than placebo at reducing symptoms of arthritis: around 84% of patients who received Ilaris achieved the required reduction in symptoms, compared with about 10% of patients who received placebo.
Danish: Af en undersøgelse hos 84 patienter med Stills sygdom hos børn (også kaldet systemisk juvenil idiopatisk arthritis (SJIA)) fremgik det, at Ilaris var mere effektivt end placebo til at mindske symptomerne på arthritis: Ca. 84 % af de patienter, der fik Ilaris, opnåede den krævede reduktion i symptomer sammenlignet med ca. 10 % af de patienter, som fik placebo.
English: Three studies involving 220 adults and children 2 years and older showed that Illaris was effective at reducing relapses of CAPS symptoms after a 24-week treatment period.
Danish: Af tre undersøgelser hos 220 voksne og børn i alderen 2 år og derover fremgik det, at Ilaris var effektivt til at nedbringe de tilbagevendende symptomer på CAPS efter en behandlingsperiode på 24 uger.
English: In a second study in childhood Still's disease (177 patients), the risk of experiencing a disease flare was reduced by 64% with Ilaris, compared with placebo.
Danish: En anden undersøgelse af Stills sygdom hos børn (177 patienter) viste, at risikoen for at opleve en sygdomsopblussen blev reduceret med 64 % med Ilaris sammenlignet med placebo.
English: Because of the similarities between childhood Still's disease and the adult form (adult-onset Still's disease, AOSD), Ilaris is expected to have similar benefits in adults.
Danish: På grund af lighederne mellem Stills sygdom hos børn og Stills sygdom hos voksne (AOSD), forventes fordelene ved Ilaris at være de samme for voksne som for børn.
English: In the two other CAPS studies, which did not compare Ilaris with any other treatment, 85% of patients on Ilaris had no relapses at all.
Danish: Af de to andre CAPS-undersøgelser, hvor Ilaris ikke blev sammenlignet med andre behandlinger, fremgik det, at 85 % af de patienter, der fik Ilaris, helt undgik tilbagefald.
English: A fourth study in 181 patients with other periodic fever syndromes found that Ilaris was more effective than placebo in achieving a response (symptoms resolved with no new flare ups).
Danish: Af en fjerde undersøgelse hos 181 patienter med andre periodiske febersyndromer fremgik det, at Ilaris var mere effektivt end placebo til at afføde en respons (symptomer løst uden tilbagefald).
English: In one of the studies, none of the patients with CAPS who received Ilaris during the 24-week treatment period had a relapse, compared with 81% of patients who received placebo (a dummy treatment).
Danish: I en af undersøgelserne oplevede ingen af de patienter med CAPS, som fik Ilaris i behandlingsperioden på 24 uger, tilbagefald, mod 81 % af de patienter, som fik placebo (en virkningsløs behandling).
English: In patients with gouty arthritis, a single injection is given on-demand to treat gouty arthritis attacks.
Danish: Hos patienter med urinsur gigt gives én injektion, efter anmodning, mod anfald af urinsur gigt.
English: Two studies involving 454 patients with gouty arthritis showed that Ilaris was more effective than another anti-inflammatory medicine triamcinolone acetonide at reducing pain.
Danish: Af to undersøgelser hos 454 patienter med urinsur gigt fremgik det, at Ilaris var mere effektivt til reducere smerte end triamcinolonacetonid, et andet antiinflammatorisk lægemiddel.
English: − tumour necrosis factor receptor associated periodic syndrome (TRAPS);
Danish: − tumornekrosefaktorreceptorassocieret periodisk syndrom (TRAPS)
English: • Still's disease, a rare disease causing inflammation of joints as well as rash and fever (in adults and children aged 2 and above);
Danish: • Stills sygdom, en sjælden sygdom, der forårsager inflammation i leddene og udslæt og feber (hos voksne og hos børn i toårsalderen og derover)
English: For the full list of all side effects reported with Ilaris, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Ilaris fremgår af indlægssedlen.
English: For practical information about using Ilaris, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Ilaris, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: This messenger is involved in causing inflammation and is found in high levels in patients with periodic fever syndromes, Still's disease and gouty arthritis.
Danish: Dette signalmolekyle er en medvirkende årsag til inflammationstilstande og findes i høje koncentrationer hos patienter med periodiske febersyndromer, Stills sygdom og urinsur gigt.
English: What benefits of Ilaris have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Ilaris?
English: How is Ilaris used?
Danish: Hvordan anvendes Ilaris?
English: How does Ilaris work?
Danish: Hvordan virker Ilaris?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ilaris 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 Ilaris.
English: Gouty arthritis
Danish: Urinsur gigt
English: This is a summary of the European public assessment report (EPAR) for Bemfola.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Bemfola.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Bemfola on 27 March 2014.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Bemfola den 27. marts 2014.
English: What is Bemfola and what is it used for?
Danish: Hvad er Bemfola, og hvad anvendes det til?
English: Other information about Bemfola
Danish: Andre oplysninger om Bemfola
English: The full EPAR and risk management plan summary for Bemfola can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR og en sammenfatning af risikohåndteringsplanen for Bemfola findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: A risk management plan has been developed to ensure that Bemfola is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Bemfola anvendes så risikofrit som muligt.
English: Bemfola is given by injection under the skin once a day.
Danish: Bemfola gives ved injektion under huden én gang dagligt.
English: The dose of Bemfola and how often it is given depend on why it is being used and on the patient's response to treatment.
Danish: Dosis af Bemfola og hvor ofte det gives, afhænger af, hvorfor det anvendes, og hvordan behandlingen virker.
English: This means that Bemfola is similar to a biological medicine (also known as the ‘reference medicine') that is already authorised in the European Union (EU).
Danish: Det vil sige, at Bemfola svarer til et biologisk lægemiddel (“referencelægemidlet”), som allerede er godkendt i Den Europæiske Union (EU).
English: What measures are being taken to ensure the safe and effective use of Bemfola?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Bemfola?
English: This is called ‘ovarian hyperstimulation syndrome'.
Danish: Dette kaldes “ovarielt hyperstimulationssyndrom”.
English: The Committee recommended that Bemfola be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Bemfola.
English: It is not intended to provide practical advice on how to use Bemfola.
Danish: Det er ikke en praktisk vejledning i, hvordan Bemfola bør anvendes.
English: What are the risks associated with Bemfola?
Danish: Hvilke risici er der forbundet med Bemfola?
English: The medicine can only be obtained with a prescription and treatment should be started under the supervision of a doctor who has experience in the treatment of fertility problems
Danish: fås kun på recept, og behandlingen bør iværksættes under overvågning af en læge med erfaring i behandling af fertilitetsproblemer.
English: Why is Bemfola approved?
Danish: Hvorfor blev Bemfola godkendt?
English: The most common side effects with Bemfola (which may affect more than 1 in 10 people) are reactions at the injection site (pain, redness, bruising, swelling or irritation).
Danish: De hyppigste bivirkninger ved Bemfola (som kan forekomme hos flere end 1 ud af 10 behandlede) er reaktioner på injektionsstedet (smerte, rødme, blå mærker, hævelse eller irritation).
English: • men who have hypogonadotrophic hypogonadism (a rare hormone deficiency disease).
Danish: • mænd med hypogonadotrop hypogonadisme (en sjælden hormonmangelsygdom).
English: The main measure of effectiveness was the number of eggs collected.
Danish: Behandlingens virkning blev hovedsagelig bedømt ved antallet af udtagne æg.
English: Bemfola was compared with GONAL-f in one main study involving 372 women who were undergoing assisted reproductive techniques.
Danish: Bemfola er blevet sammenlignet med GONAL-f i én hovedundersøgelse med deltagelse af 372 kvinder, der var i behandling for fertilitetsproblemer.