FrancophonIA/ELRC3.0 huggingface dataset:
English: Adempas contains the active substance riociguat.
Danish: Adempas indeholder det aktive stof riociguat.
English: Treatment with the established dose should continue unless patients experience signs and symptoms of low blood pressure, in which case the dose should be reduced.
Danish: Behandlingen med den fastlagte dosis bør fortsættes, medmindre patienten oplever tegn og symptomer på lavt blodtryk, i så fald bør dosen reduceres.
English: Further information on Adempas can be found on the Agency's website: ema.europa.eu/en/medicines/human/EPAR/adempas.
Danish: Yderligere information om Adempas findes på agenturets websted under: ema.europa.eu/en/medicines/human/EPAR/adempas.
English: Why is Adempas approved?
Danish: Hvorfor blev Adempas godkendt?
English: For more information about using Adempas, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Adempas, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: Adempas can be used on its own or in combination with other medicines for PAH called ‘endothelin receptor antagonists'.
Danish: Adempas kan anvendes alene eller kombineret med andre lægemidler mod PAH kaldet "endothelin-receptorantagonister".
English: For patients unable to swallow whole tablets, the tablets may be crushed and mixed with water or soft food such as apple sauce.
Danish: Ved patienter, der ikke kan synke hele tabletter, kan tabletterne knuses og blandes med vand eller let flydende fødevarer såsom æblesauce.
English: Regarding safety it considered that side effects of concern, including haemoptysis and pulmonary haemorrhage, have been adequately reflected in the product information and risk management plan.
Danish: Hvad sikkerheden angår mente agenturet, at bivirkninger, herunder hæmoptysis og pulmonal blødning, er blevet tilstrækkeligt afspejlet i produktinformationen og risikostyringsplanen.
English: The Agency therefore decided that Adempas's benefits are greater than its risks and that it can be authorised for use in the EU.
Danish: Agenturet konkluderede derfor, at fordelene ved Adempas opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: What are the risks associated with Adempas?
Danish: Hvilke risici er der forbundet med Adempas?
English: CTEPH and PAH are rare, and Adempas was designated an ‘orphan medicine' (a medicine used in rare diseases) on 20 December 2007.
Danish: CTEPH og PAH er sjældne, og Adempas blev udpeget som "lægemiddel til sjældne sygdomme" den 20. december 2007.
English: Adempas has been shown to be effective at improving the distance patients with CTEPH or PAH could walk in 6 minutes (a way of measuring exercise capacity):
Danish: Adempas har vist sig at være effektivt til at forbedre den distance, som patienterne med CTEPH eller PAH kunne gå på 6 minutter (en måde at måle den fysiske kapacitet på):
English: Adempas is used in patients with functional class II to III CTEPH or PAH.
Danish: Adempas anvendes hos patienter med CTEPH af funktionel klasse II til III eller PAH.
English: Adempas can only be obtained with a prescription and treatment should only be started and monitored by a doctor who has experience in the treatment of CTEPH or PAH.
Danish: Adempas udleveres kun efter recept, og behandlingen bør kun iværksættes og overvåges af en læge med erfaring i behandling af CTEPH eller PAH.
English: The European Medicines Agency considered that Adempas led to significant improvements in exercise capacity in patients with CTEPH or PAH.
Danish: Det Europæiske Lægemiddelagentur fandt, at Adempas medførte betydelige forbedringer i den fysiske kapacitet hos patienter med CTEPH eller PAH.
English: It must also not be used together with medicines called ‘PDE 5 inhibitors' (a class of medicines used for PAH or erectile dysfunction) or with nitrates or nitric oxide donors (often used to treat high blood pressure, chest pain and heart disease, or as recreational drugs).
Danish: Det må heller ikke anvendes sammen med lægemidler, der kaldes "PDE 5-hæmmere" (en gruppe af lægemidler, der anvendes til behandling af PAH eller erektil dysfunktion) eller med nitrat- eller nitrogenoxiddonorer (ofte anvendt til behandling af højt blodtryk, brystsmerter og hjertesygdom eller som rekreative stoffer).
English: The most common side effects with Adempas (which may affect more than 1 in 10 people) are headache, dizziness, dyspepsia (heartburn), peripheral oedema (swelling, especially of the ankles and feet), nausea (feeling sick), diarrhoea and vomiting.
Danish: De hyppigste bivirkninger ved Adempas (som kan forekomme hos mere end 1 ud af 10 personer) er hovedpine, svimmelhed, dyspepsi (halsbrand), perifert ødem (hævelse, især af ankler og fødder), kvalme, diarré og opkastning.
English: As a result, the amount of oxygen that can get into the blood in the lungs is reduced, making physical activity more difficult.
Danish: På den måde reduceres mængden af ilt, som kan komme ind i blodet i lungerne, hvilket vanskeliggør fysisk aktivitet.
English: This helps to lower the blood pressure in the lungs and improve symptoms of CTEPH and PAH.
Danish: Dette sænker blodtrykket i lungerne og bedrer symptomerne på CTEPH og PAH.
English: • Adempas was compared with placebo (a dummy treatment) in one main study in 262 patients with CTEPH who could not be operated, or in whom CTEPH remained or returned after surgery.
Danish: • Adempas blev sammenlignet med placebo (en virkningsløs behandling) i et hovedstudie, der omfattede 262 patienter med CTEPH, som ikke kunne opereres, eller som havde vedvarende eller tilbagevendende CTEPH efter operation.
English: Adempas must not be used in patients with severely reduced liver function, with systolic blood pressure (blood pressure when the heart is contracting) below 95 mmHg before starting treatment, or during pregnancy.
Danish: Adempas må ikke anvendes til patienter, der har svært nedsat leverfunktion, har et systolisk blodtryk (i hjertets sammentrækningsfase) på under 95 mmHg før påbegyndelse af behandling, eller er gravide.
English: The active substance in Adempas, riociguat, stimulates an enzyme called ‘soluble guanylate cyclase' in the blood vessels of the lungs, which causes the blood vessels to relax and widen.
Danish: Det aktive stof i Adempas, riociguat, stimulerer et enzym kaldet "opløseligt guanylatcyklase" i lungernes blodkar, hvilket får blodkarrene til at slappe af og udvide sig.
English: This causes high blood pressure in the vessels taking blood from the heart to the lungs and reduces the blood flow to the lungs.
Danish: Det giver forhøjet blodtryk i de kar, der fører blodet fra hjertet til lungerne og reducerer blodstrømmen til lungerne.
English: CTEPH and PAH are debilitating diseases where there is severe narrowing of the blood vessels of the lungs.
Danish: CTEPH og PAH er invaliderende sygdomme, hvor der sker en alvorlig forsnævring af blodkarrene i lungerne.
English: Serious side effects include haemoptysis (coughing up blood) and pulmonary haemorrhage (bleeding in the lungs).
Danish: Alvorlige bivirkninger omfatter hæmoptyse (opkastning af blod) og pulmonær blødning (blødning i lungerne).
English: Adempas is a medicine that is used to increase the ability to carry out physical activity in adults with the following forms of pulmonary hypertension (high blood pressure in the blood vessels of the lungs):
Danish: Adempas anvendes til at øge den fysiske kapacitet hos voksne med følgende former for pulmonal hypertension (forhøjet blodtryk i lungernes blodkar):
English: • Chronic thromboembolic pulmonary hypertension (CTEPH, where the blood vessels of the lungs are blocked or narrowed with blood clots).
Danish: • Kronisk tromboembolisk pulmonal hypertension (CTEPH, hvor lungernes blodkar er blokerede eller forsnævrede af blodpropper).
English: After 12 weeks, patients treated with Adempas could walk 36 metres further in 6 minutes than patients taking placebo.
Danish: Efter 12 uger kunne de patienter, der blev behandlet med Adempas, gå 36 meter længere på 6 minutter end de patienter, der fik placebo.
English: Before treatment, the patients could walk an average of 347 metres in 6 minutes.
Danish: Inden behandlingen kunne patienterne i gennemsnit gå 347 meter på 6 minutter.
English: Adempas is used to treat patients with CTEPH who cannot be operated on, or in whom CTEPH remains or returns after surgery.
Danish: Adempas anvendes til behandling af patienter med CTEPH, som ikke kan opereres, eller som har vedvarende eller tilbagevendende CTEPH efter operation.
English: Before treatment the patients could walk an average of 363 metres in 6 minutes.
Danish: Inden behandlingen kunne patienterne i gennemsnit gå 363 meter på 6 minutter.
English: What benefits of Adempas have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Adempas?
English: After 16 weeks, patients treated with Adempas could walk on average 46 metres further in 6 minutes than patients taking placebo.
Danish: Efter 16 uger kunne de patienter, der fik Adempas, i gennemsnit gå 46 meter længere på 6 minutter end de patienter, der fik placebo.
English: For the full list of side effects with Adempas, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger ved Adempas fremgår af indlægssedlen.
English: How is Adempas used?
Danish: Hvordan anvendes Adempas?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Adempas 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 Adempas.
English: • Pulmonary arterial hypertension (PAH, where the walls of the blood vessels of the lungs are thickened and the vessels become narrowed).
Danish: • Pulmonal arteriel hypertension (PAH, hvor karvæggene i lungerne fortykkes, så karrene bliver forsnævrede).
English: In patients taking certain medicines, including some medicines for HIV infection,
Danish: Til patienter, der får visse lægemidler, herunder en række lægemidler til behandling af hiv infektion, tuberkulose eller svampeinfektioner, kan lægen anbefale en lavere startdosis.
English: How does Adempas work?
Danish: Hvordan virker Adempas?
English: Strength Pharmaceutical Form
Danish: Paknings-størrelse
English: Wakix should always be used at the lowest effective dose.
Danish: Wakix bør altid anvendes med den laveste effektive dosis.
English: Wakix is available as tablets (4.5 and 18 mg).
Danish: Wakix fås som tabletter (4,5 og 18 mg).
English: Serious but rare side effects are abnormal loss of weight and spontaneous abortion.
Danish: Alvorlige, men sjældne bivirkninger er unormalt vægttab og spontan abort.
English: This is a summary of the European public assessment report (EPAR) for Wakix.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Wakix.
English: Some patients also have episodes of severe muscle weakness (cataplexy) that can cause collapse.
Danish: Nogle patienter oplever også episoder med svær muskelslaphed (katapleksi), der kan føre til kollaps.
English: The safety profile of Wakix is considered acceptable, with no major safety concerns identified.
Danish: Wakix' sikkerhedsprofil vurderes at være acceptabel, idet der ikke er identificeret nogen væsentlige sikkerhedsrisici.
English: The most common side effects with Wakix (which may affect up to 1 in 10 people) are insomnia (difficulty sleeping), headache, nausea (feeling sick), anxiety, irritability, dizziness, depression, tremor, sleep disorders, tiredness, vomiting, vertigo (a spinning sensation) and dyspepsia (heartburn).
Danish: De hyppigste bivirkninger ved Wakix (som kan optræde hos op til 1 ud af 10 personer) er søvnløshed, hovedpine, kvalme, angst, irritabilitet, svimmelhed, depression, skælven, søvnforstyrrelser, træthed, opkastning, svimmelhed og dyspepsi (halsbrand).
English: A risk management plan has been developed to ensure that Wakix is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Wakix anvendes så sikkert som muligt.
English: In addition, Wakix works differently from currently available treatments and therefore offers an alternative treatment option.
Danish: Desuden fungerer Wakix på en anden måde end de behandlinger, der hidtil er blevet anvendt, og giver dermed en alternativ behandlingsmulighed.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) therefore decided that Wakix's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede derfor, at fordelene ved Wakix opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: Wakix contains the active substance pitolisant.
Danish: Wakix indeholder det aktive stof pitolisant.
English: Other information about Wakix
Danish: Andre oplysninger om Wakix
English: Because the number of patients with narcolepsy is low, the disease is considered ‘rare', and Wakix was designated an ‘orphan medicine' (a medicine used in rare diseases) on 10 July 2007.
Danish: Da antallet af patienter med narkolepsi er lavt, betragtes sygdommen som "sjælden", og Wakix blev udpeget som "lægemiddel til sjældne sygdomme" den 10. juli 2007.
English: Results from this study also showed a decrease in the number of cataplexy attacks.
Danish: Resultaterne fra denne undersøgelse viste også et fald i antallet af muskelslaphedsanfald.
English: In addition, the company that markets Wakix will carry out an observational study to collect information on the safety of the medicine when used in medical practice.
Danish: Derudover skal den virksomhed, der markedsfører Wakix, gennemføre en observationsundersøgelse med henblik på at indsamle oplysninger om lægemidlets sikkerhed ved brug i medicinsk praksis.
English: Wakix has been investigated in 2 main studies involving a total of 261 adults with narcolepsy, the majority of whom also had cataplexy.
Danish: Wakix er blevet undersøgt i 2 hovedundersøgelser med i alt 261 voksne med narkolepsi, hvoraf størstedelen også havde muskelslaphedsanfald.
English: During the first week of treatment, the recommended dose is 9 mg per day, taken in the morning during breakfast.
Danish: I den første uge af behandlingen er den anbefalede daglige dosis 9 mg, der tages sammen med morgenmåltidet.
English: In patients with moderately reduced liver function or with kidney problems, the maximum dose should be 18 mg per day.
Danish: Hos patienter med moderat nedsat leverfunktion eller nyreproblemer bør den maksimale dosis være 18 mg dagligt.
English: Wakix is a medicine used to treat adults with narcolepsy.
Danish: Wakix er et lægemiddel til behandling af voksne med narkolepsi.
English: This increases the activity of certain brain cells called ‘histamine neurons', which are important for keeping the body awake.
Danish: Derved øges aktiviteten af bestemte hjerneceller, de såkaldte "histaminneuroner", der spiller en vigtig rolle for at holde kroppen vågen.
English: What measures are being taken to ensure the safe and effective use of Wakix?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Wakix?
English: Narcolepsy is a long-term sleep disorder which affects the brain's ability to regulate the normal sleep-wake cycle.
Danish: Narkolepsi er en kronisk søvnsygdom, der påvirker hjernens evne til at regulere den normale cyklus mellem søvn og vågenhed.
English: During the second week of treatment, the dose can be increased to 18 mg per day or decreased to 4.5 mg per day.
Danish: I den anden uge af behandlingen kan dosen sættes op til 18 mg dagligt eller sænkes til 4,5 mg dagligt.
English: What is Wakix and what is it used for?
Danish: Hvad er Wakix, og hvad anvendes det til?
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Wakix, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Wakix, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: The full EPAR and risk management plan summary for Wakix can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR og resuméet af risikostyringsplanen for Wakix findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The studies compared Wakix with placebo (a dummy treatment).
Danish: I undersøgelserne blev Wakix sammenlignet med placebo (en uvirksom behandling).
English: When looking at sleepiness with an objective test called Maintenance of Wakefulness Test or MWT, the results of the two studies together showed that Wakix significantly improved wakefulness compared with placebo.
Danish: Når man vurderer søvnigheden med en objektiv test, den såkaldte MWT-test til måling af, i hvor høj grad vågenheden opretholdes, viste resultaterne fra de to undersøgelser tilsammen, at Wakix gav en væsentlig forbedring af vågenheden sammenholdt med placebo.
English: Wakix must not be used in patients with severely reduced liver function and in women who are breastfeeding.
Danish: Wakix må ikke anvendes hos patienter med svært nedsat leverfunktion eller hos kvinder, som ammer.
English: Wakix can only be obtained with a prescription and treatment should be started by a doctor experienced in the treatment of sleep disorders.
Danish: Lægemidlet Wakix udleveres kun efter recept, og behandlingen bør iværksættes af en læge med erfaring i behandling af søvnsygdomme.
English: It is not intended to provide practical advice on how to use Wakix.
Danish: Det er ikke en praktisk vejledning i, hvordan Wakix bør anvendes.
English: Why is Wakix approved?
Danish: Hvorfor blev Wakix godkendt?
English: This is a standard scale used in patients with narcolepsy which ranges from 0 to 24.
Danish: Det er en standardskala fra 0 til 24, der bruges til patienter med narkolepsi.
English: The second study, however, did not show a difference between Wakix and placebo at reducing sleepiness or cataplexy.
Danish: Den anden undersøgelse viste imidlertid ikke nogen forskel mellem Wakix og placebo med hensyn til at reducere søvnigheden eller muskelslaphedsanfaldene.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Wakix can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Danish: Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Wakix findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: The active substance in Wakix, pitolisant, works by attaching to receptors in the brain called ‘histamine H3 receptors'.
Danish: Det virksomme stof i Wakix, pitolisant, virker ved at binde til de såkaldte "histamin H3-receptorer" i hjernen.
English: Wakix is used in patients with or without cataplexy.
Danish: Wakix anvendes hos patienter med eller uden muskelslaphedsanfald.
English: The main measure of effectiveness was based on how sleepy patients felt during daytime, assessed using the Epworth Sleepiness Scale or ESS.
Danish: Det primære mål for virkning var baseret på, hvor søvnige patienterne følte sig i dagtimerne vurderet ved hjælp af Epworth-skalaen til måling af søvnighed.
English: The overall data available demonstrate that Wakix has a positive effect on the two major symptoms of narcolepsy, excessive daytime sleepiness and cataplexy.
Danish: De samlede tilgængelige oplysninger viser, at Wakix har en positiv effekt på de to vigtigste symptomer på narkolepsi, som er voldsom søvnighed om dagen og muskelsvaghedsanfald.
English: For more information about treatment with Wakix, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Wakix, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: In a further study in 105 patients with narcolepsy and cataplexy, Wakix was also more effective than placebo at reducing the number of cataplexy attacks per week: the number of cataplexy attacks decreased from around 9 to around 3 per week in patients taking Wakix, while it remained at around 7 per week in patients taking placebo.
Danish: I en anden undersøgelse af 105 patienter med narkolepsi og muskelsvaghedsanfald var Wakix også mere effektivt end placebo med hensyn til at reducere antallet af muskelsvaghedsanfald pr. uge: Antallet af muskelsvaghedsanfald faldt fra ca. 9 til ca. 3 om ugen hos de patienter, der fik Wakix, mens de patienter, der fik placebo, stadig fik ca. 7 anfald om ugen.
English: What are the risks associated with Wakix?
Danish: Hvilke risici er der forbundet med Wakix?
English: The first study showed that Wakix was more effective than placebo at reducing daytime sleepiness: patients taking Wakix had an average reduction of 3 points more in the ESS scale than those taking placebo after 8 weeks of treatment.
Danish: Den første undersøgelse viste, at Wakix var mere effektivt end placebo til at reducere søvnighed om dagen: Efter 8 ugers behandling havde de patienter, der fik Wakix, en gennemsnitlig reduktion på 3 trin mere på Epworth-skalaen end de patienter, der fik placebo.
English: the dose may be further increased to the maximum dose of 36 mg per day.
Danish: I den tredje uge af behandlingen kan dosen hæves yderligere til maksimalt 36 mg dagligt.
English: This leads to symptoms such as an irresistible urge to sleep, even at inappropriate times and places, and disturbed night-time sleep.
Danish: Symptomerne er bl.a. overdreven trang til at sove, uanset tid og sted, samt søvnforstyrrelser om natten.
English: For the full list of all side effects reported with Wakix, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Wakix fremgår af indlægssedlen.
English: For practical information about using Wakix, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Wakix, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: How is Wakix used?
Danish: Hvordan anvendes Wakix?
English: What benefits of Wakix have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Wakix?
English: How does Wakix work?
Danish: Hvordan virker Wakix?
English: 0.6 ml (10 mg/ml) 1 pre-filled syringe
Danish: 0.6 ml (10 mg/ml) 1 fyldt injektionssprøjte
English: 31 July 2014
Danish: Den 31. juli 2014
English: The final opinion was converted into a Decision by the European Commission on 31 July 2014.
Danish: Den endelige udtalelse blev den 31. juli 2014 omarbejdet til en beslutning af Europa-Kommissionen.
English: Article 35 of Directive 2001/82/EC, as amended
Danish: Artikel 35 i direktiv 2001/82/EF, som ændret.
English: The referral started on 6 November 2013.
Danish: Indbringelsesproceduren blev indledt den 6. november 2013.
English: International non-proprietary name (INN): tylosin
Danish: Internationalt fællesnavn (INN): tylosin
English: The Committee appointed E. Persson as rapporteur and A. Wachnik-Święcicka as co-rapporteur.
Danish: Som rapportør og medrapportør udpegede udvalget hhv. E. Persson og A. Wachnik-Święcicka.
English: The CVMP was requested to consider whether tylosin is still effective against swine dysentery (caused by Brachyspira hyodysenteriae) and whether the treatment durations beyond three weeks are justified.
Danish: CVMP blev anmodet om at tage stilling til, om tylosin fortsat er effektivt mod svinedysenteri (forårsaget af Brachyspira hyodysenteriae), og om en behandlingsvarighed på mere end tre uger er begrundet.