FrancophonIA/ELRC3.0 huggingface dataset:
English: It is available as a transdermal patch (a patch that delivers a medicine across the skin) and as a gel in a sachet or a metering pump.
Danish: Det fås som et transdermalt plaster (et plaster, der afgiver medicin gennem huden) og som en gel i en pose eller en doseringspumpe.
English: Kentera patches were as effective as tolterodine, with both treatments decreasing the number of episodes by about three per day.
Danish: Kentera-plastre var lige så effektive som tolterodin, der ligeledes mindskede antallet af episoder med ca. tre pr. dag.
English: The main measure of effectiveness was the number of incontinence episodes over either three or seven days.
Danish: Det primære effektmål var antallet af episoder med ufrivillig vandladning i løbet af en periode på enten tre eller syv dage.
English: This helps Kentera to prevent unwanted urination.
Danish: På denne måde er Kentera medvirkende til at forhindre ufrivillig vandladning.
English: This leads to an increase in the amount of urine that the bladder can hold, and to changes in the way the bladder muscles contract as the bladder fills up.
Danish: Dette resulterer i en forøgelse af den mængde urin, som blæren kan indeholde, og ændrer den måde, blæremusklerne trækker sig sammen på, efterhånden som blæren fyldes.
English: After 12 weeks, the average number of incontinence episodes per week had decreased by 19 (about three per day) with Kentera patches, compared with a decrease of 15 episodes with placebo.
Danish: Efter 12 uger var det gennemsnitlige antal episoder med ufrivillig vandladning pr. uge mindsket med 19 (ca. tre pr. dag) med Kentera-plastre sammenlignet med et fald på 15 episoder med placebo.
English: Kentera gel was compared with placebo in one main study in 789 patients with overactive bladders.
Danish: Kentera-gel blev sammenlignet med placebo i én hovedundersøgelse hos 789 patienter med overaktiv blære.
English: The most commonly reported side effect with Kentera gel is dry mouth (seen in between 1 and 10 patients in 100).
Danish: Den hyppigst indberettede bivirkning ved Kentera-gel er mundtørhed (som optræder hos mellem 1 og 10 patienter ud af 100).
English: The gel is applied to dry, intact skin on the abdomen, upper arm, shoulders or thighs.
Danish: intakt hud på mave, overarm, skuldre eller lår.
English: Why has Kentera been approved?
Danish: Hvorfor blev Kentera godkendt?
English: It must not be used in patients with urinary retention (difficulty in passing urine), severe gastro-intestinal conditions (problems with the stomach and gut), uncontrolled narrow-angle glaucoma (increased eye pressure even with treatment) or myasthenia gravis (a disease of the nerves and muscles causing muscle weakness), or in patients at risk of these conditions.
Danish: Det må ikke anvendes til patienter med urinretention (manglende evne til at lade vandet), alvorlige lidelser i mavetarmsystemet (mave/tarmproblemer), ukontrolleret snævervinklet grøn stær (for højt væsketryk i øjet, selv ved behandling) eller myasthenia gravis (en nerve- og muskelsygdom, som medfører muskelsvækkelse) eller til patienter med risiko for at udvikle disse sygdomme.
English: The Committee recommended that the Kentera patch be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for .
English: In the study on the gel, after 12 weeks the average number of daily incontinence episodes, which was initially at 5.4, was reduced by 2.7 episodes per day in patients receiving Kentera gel compared with a drop on average of 2 episodes per day in patients receiving placebo.
Danish: Ved undersøgelsen af gelen var det gennemsnitlige antal daglige episoder med ufrivillig vandladning, der oprindeligt var 5.4, mindsket med 2,7 episoder pr. dag hos patienter, der modtog Kentera-gel, sammenlignet med et fald på 2 episoder i gennemsnit pr. dag hos patienter, der modtog placebo.
English: What is Kentera?
Danish: Hvad er Kentera?
English: For the full list of all side effects reported with Kentera, see the package leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger ved Kentera fremgår af indlægssedlen.
English: The most common side effects with Kentera patches (seen in more than 1 patient in 10) are application site reactions (including itching around the site of patch application).
Danish: Den hyppigste bivirkning ved Kentera-plastre (som optræder hos flere end 1 ud af 10 patienter) er reaktioner på påføringsstedet (herunder kløe omkring det sted, hvor plasteret sidder).
English: Kentera is used to treat urge incontinence (sudden lack of control over urination), increased urinary frequency (need to urinate frequently) and urgency (sudden urge to pass urine) in adults with an overactive bladder (when the bladder muscles contract suddenly).
Danish: Kentera anvendes til behandling af urgeinkontinens (pludselig manglende kontrol over vandladningen), øget vandladningshyppighed og tranginkontinens (pludselig stærk vandladningstrang) hos voksne med overaktiv blære (pludselige sammentrækninger af blæremusklen).
English: During its assessment of the application for Kentera gel, the CHMP concluded that its effectiveness was similar to that of the previously approved patches.
Danish: Under CHMP's vurdering af ansøgningen om Kentera-gel vurderede udvalget, at dens virkning svarede til virkningen af de tidligere godkendte plastre.
English: Kentera transdermal patches were studied in a total of 881 patients, mostly elderly women, with overactive bladders in two main studies.
Danish: Der er udført to hovedundersøgelser af Kentera transdermale plastre hos i alt 881 patienter med overaktiv blære, hovedsagelig ældre kvinder.
English: The patch should be applied to dry, intact skin on the abdomen (tummy), hip, or buttock immediately after it is removed from the protective sachet.
Danish: Plasteret skal påføres på tør, intakt hud på mave, hofte eller balde straks efter, at det er taget ud af den beskyttende pose.
English: What is Kentera used for?
Danish: Hvad anvendes Kentera til?
English: It blocks some receptors in the body called muscarinic M1 and M3 receptors.
Danish: Det blokerer visse receptorer i kroppen kaldet muskarine M1- og M3-receptorer, hvilket i blæren medfører afslappelse af de muskler, der presser urinen ud af blæren.
English: What benefit has Kentera shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Kentera?
English: How has Kentera been studied?
Danish: Hvordan blev Kentera undersøgt?
English: How is Kentera used?
Danish: Hvordan anvendes Kentera?
English: How does Kentera work?
Danish: Hvordan virker Kentera?
English: All active substances are authorised at the level of the Member States.
Danish: Alle aktive stoffer er godkendt på medlemsstatsniveau.
English: - The conditions of the marketing authorisations are set out in Annex IV.
Danish: - Betingelserne for markedsføringstilladelserne fremgår af bilag IV.
English: - Restriction of the maximum dose to 3 mg/day.
Danish: - Den maksimale dosis begrænses til 3 mg/dag.
English: This has been subject to previous reviews leading to risk minimisation measures at national level.
Danish: Dette er tidligere undersøgt, hvilket har medført, at der er taget forholdsregler til at reducere risikoen på nationalt niveau.
English: The majority of reported fibrotic events were not completely reversible although symptomatic improvement occurs for various reasons and indeed occasionally fibrosis may regress.
Danish: Hovedparten af de rapporterede tilfælde af fibrose var ikke fuldstændig reversible, selvom der af forskellige grunde forekommer symptomatiske forbedringer, og fibrosen i visse tilfælde kan regredere.
English: The mechanism of fibrotic reaction induced by ergot alkaloids has not been completely clarified yet.
Danish: Mekanismen for den fibrotiske reaktion, der induceres af ergotalkaloider, er endnu ikke fuldt afklaret.
English: Whether this mechanism also applies to the non-cardiac fibrotic events is unclear.
Danish: Hvorvidt denne mekanisme også gælder for fibrose uden for hjertet er endnu uklart.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF CABERGOLINE AND PERGOLIDE AND ASSOCIATED NAMES (SEE ANNEX I)
Danish: SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF CABERGOLIN OG PERGOLID OG TILKNYTTEDE NAVNE (SE BILAG I)
English: However, most trials did not include echocardiographic monitoring, thus preventing a reliable estimation of incidence rates.
Danish: De fleste undersøgelser omfattede dog ikke ekkokardiografisk overvågning, hvorfor en pålidelig vurdering af incidensen ikke er mulig.
English: The stimulation of the 5-HT2B receptor agonists is considered the most plausible mechanism that induces cardiac valvulopathy, although other mechanisms may be involved.
Danish: Stimuleringen af 5-HT2B-receptorantagonisterne menes at være den mest sandsynlige mekanisme, der inducerer sygdomme i hjerteklapperne, selvom der kan være andre mekanismer involveret.
English: - Strengthening of the contra-indications, warnings and precautions for use, outlining the necessity for patients to be monitored for signs of fibrosis with echocardiography before and during long-term treatment.
Danish: - Skærpelse af kontraindikationer, advarsler og forsigtighedsregler vedrørende brugen, hvoraf det fremgår, at det er nødvendigt at overvåge patienterne for tegn på fibrose ved hjælp af EKG både før og under langtidsbehandling.
English: Four main observational studies looked into the risk of cardiac valvulopathy in patients treated with dopamine agonists for Parkinson's disease (Zanettini et al., NEJM, 2007; Schade et al., NEJM 2007; Yamamoto et al., Neurology 2006; Peralta et al., Movement Disorders 2006).
Danish: Fire vigtige observationsundersøgelser omhandlede risikoen for hjerteklapssygdomme hos patienter, der blev behandlet for Parkinsons syge med dopaminantagonister (Zanettini et al., NEJM, 2007; Schade et al., NEJM 2007; Yamamoto et al., Neurology 2006; Peralta et al., Movement Disorders 2006).
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLETS PRESENTED BY THE EMEA
Danish: BILAG II FAGLIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMÉER OG INDLÆGSSEDLER FREMLAGT AF EMEA
English: The CHMP also recommended that marketing authorisation holders provide a detailed protocol (e.g. drug utilisation studies or survey done by record linkage) for the long term follow-up on the adherence to and effectiveness of the changes to the product information.
Danish: CHMP anbefalede også, at indehaverne af markedsføringstilladelserne fremsender en detaljeret protokol (f.eks. undersøgelser af lægemiddelanvendelse og undersøgelser ved hjælp af record linkage) som en langtidsopfølgning af overholdelsen af og effektiviteten af ændringerne i produktoplysningerne.
English: On 21 June 2007, the UK asked the CHMP, under article 31 of Directive 2001/83/EC, as amended, to review the risk of fibrosis and cardiac valvulopathy associated with the use of all ergot-derived dopamine agonists, and to provide an opinion on whether the marketing authorisations for all products of the class should be maintained, varied, suspended or withdrawn.
Danish: Den 21. juni 2007 anmodede Det Forenede Kongerige i henhold til artikel 31 i direktiv 2001/83/EF, med senere ændringer, CHMP om at undersøge risikoen for fibrose og hjerteklapssygdomme ved brug af alle ergotderiverede dopaminantagonister og afgive udtalelse om, hvorvidt markedsføringstilladelserne for alle produkter i denne klasse bør opretholdes, ændres, suspenderes eller tilbagetrækkes.
English: At its June 2008 meeting, the CHMP concluded that the amount of evidence on the risk of fibrotic events, including valvulopathy, is not equal for all ergot-derived dopamine agonists.
Danish: På mødet i juni 2008 konkluderede CHMP, at beviserne for risikoen for fibrose, herunder klapsygdomme, ikke er ens for alle ergotderiverede dopaminantagonister.
English: Ergot derived dopamine agonists are mainly used to treat Parkinson's disease, either on their own or in combination with other medicines.
Danish: Ergotderiverede dopaminantagonister benyttes hovedsageligt til behandling af Parkinsons syge enten alene eller kombineret med andre lægemidler.
English: GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLETS
Danish: BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMÉ, ETIKETTERING OG INDLÆGSSEDDEL
English: For pergolide and cabergoline, the majority (about two thirds) of case reports of valvulopathy occurred with doses ≥ 3mg / day.
Danish: For pergolid og cabergolin forekom de fleste (ca. to tredjedele) af de rapporterede tilfælde af hjerteklapsygdomme ved doser ≥ 3 mg om dagen.
English: - In view of the available data, the Committee concluded that the risk of fibrosis, including cardiac valvulopathy, is well established for cabergoline and pergolide, and is higher at doses exceeding 3mg/day.
Danish: - På baggrund af de tilgængelige data konkluderede udvalget, at risikoen for fibrose, herunder hjerteklapssygdomme, er veldokumenteret for cabergolin og pergolid, og at de er højere ved doser, der overstiger 3 mg/dag.
English: The CHMP reviewed all of the information made available by marketing authorisation holders (MAH) on the risk of fibrosis and cardiac valvulopathy from clinical trials, observational studies and spontaneous reports.
Danish: CHMP gennemgik alle de oplysninger, der blev gjort tilgængelige af indehaverne af markedsføringstilladelserne, vedrørende risikoen for fibrose og hjerteklapssygdomme, som stammede fra kliniske forsøg, observationsundersøgelser og spontane rapporter.
English: The degree of 5-HT2B receptor agonism varies across ergot derived dopamine agonists and fits well with the difference in incidence rates of fibrotic events for the different ergot-products (C.Hofmann et al., Clin
Danish: Graden af de ergotderiverede dopaminantagonisters 5-HT2B-receptorantagonisme varierer og passer godt med forskellen i incidensraterne af fibrose for de forskellige ergotprodukter (C. Hofmann et al., Clin
English: Cases of fibrotic reactions and valvulopathy have been reported with cabergoline and pergolide during clinical trials (open label study and randomised controlled studies).
Danish: Der er rapporteret tilfælde af fibrotiske reaktioner og klapsygdomme ved brug af cabergolin og pergolid i kliniske undersøgelser (åbne undersøgelser og randomiserede, kontrollerede undersøgelser).
English: The Schade study reported higher adjusted incidence rate ratio (IRR) for symptomatic valvular regurgitation for cabergoline, and pergolide (in particular at doses > 3mg/day), compared to bromocriptine, lisuride, and non ergot derived dopamine agonists pramipexole and ropirinole for which no cases were reported.
Danish: Schade-undersøgelsen rapporterede en højere justeret incidensrate-ratio (IRR) for symptomatisk valvulær regurgitation for cabergolin og pergolid (specielt ved doser > 3 mg/dag) i forhold til bromocriptin, lisurid og de ikke-ergotderiverede dopaminantagonister pramipexol og ropirinol, for hvilke der ingen tilfælde blev rapporteret.
English: - Inclusion of cardiac valvulopathy (including regurgitation) and related disorders (pericarditis and pericardial effusion) as “very common” undesirable effects.
Danish: - Hjerteklapssygdomme (inklusive regurgitation) og tilsvarende sygdomme (perikarditis og perikardieekssudat) skal medtages som ”meget almindelige” bivirkninger.
English: They are also used to treat conditions including hyperprolactinaemia and prolactinoma, and to prevent lactation and migraine.
Danish: De bruges også til behandling af tilstande, der omfatter hyperprolaktinæmi og prolaktinom samt til at forebygge laktation og migræne.
English: In view of the differences in the level risk amongst ergot derived dopamine agonists, the CHMP recommended that a separate opinion is issued for bromocriptine, dihydroergocryptine and lisuride.
Danish: I betragtning af forskellene i risikoniveauet for de ergotderiverede dopaminantagonister anbefalede CHMP, at der afgives en separat udtalelse om bromocriptin, dihydroergocryptin og lisurid.
English: - The CHMP considered the referral made under Article 31 of Directive 2001/83/EC, as amended, for medicinal products containing bromocriptine, cabergoline dihydroergocryptine, lisuride and pergolide,
Danish: - CHMP behandlede indbringelsen i henhold til artikel 31 i direktiv 2001/83/EF, med senere ændringer, for lægemidler indeholdende bromocriptin, cabergolin, dihydroergocryptin, lisurid og pergolid.
English: - The CHMP recommended amendments to the relevant sections of the Summary of product characteristics and Package leaflets of the medicinal products containing cabergoline and pergolide (see Annex III).
Danish: - anbefalede CHMP ændringer i de relevante dele af produktresuméet og indlægssedlen for lægemidler indeholdende cabergolin og pergolid (se Bilag III).
English: As a result, cabergoline and pergolide containing medicinal products are indicated only as 2nd line therapy in Parkinson's disease, and their use is contraindicated for patients with evidence of valve problems.
Danish: Som et resultat heraf er lægemidler, der indeholder cabergolin og pergolid, kun indiceret som andetvalgspræparat til behandling af Parkinsons syge, og brugen af dem er kontraindiceret til patienter med tegn på klapproblemer.
English: Ergot-derived dopamine agonists have been associated with an increased risk of fibrotic disorders and valvular heart disease.
Danish: Ergotderiverede dopaminantagonister er blevet sat i forbindelse med en øget risiko for fibrotiske lidelser og hjerteklapsygdomme.
English: In view of the above, the CHMP recommended the maintenance of the marketing authorisation for cabergoline and pergolide containing medicinal products with amendments to their product information (Summary of product characteristics and Package leaflet), as outlined below.
Danish: I betragtning af ovenstående anbefalede CHMP opretholdelse af markedsføringstilladelsen for lægemidler, der indeholder cabergolin og pergolid, med en ændring af deres produktoplysninger (produktresumé og indlægsseddel), som angivet herunder.
English: Whereas,
Danish: Ud fra følgende betragtninger:
English: Cabergoline and pergolide belong to the class of ergot derived dopamine agonists, which also comprises bromocriptine, dihydroergocryptine and lisuride.
Danish: Cabergolin og pergolid tilhører klassen af ergotderiverede dopaminantagonister, der også omfatter bromocriptin, dihydroergocryptin og lisurid.
English: Data from spontaneous reports indicate that subjects using carbergoline and pergolide are more at risk for fibrotic events and valvulopathy than subjects using bromocriptine, lisuride or dihydroergocryptine.
Danish: Data fra spontane rapporter angiver, at patienter, der bruger cabergolin og pergolid, har større risiko for fibrose og sygdomme i hjerteklapperne end patienter, der bruger bromocriptim, lisurid og dihydroergocryptin.
English: Comparative trials with non-ergot and ergot derived dopamine agonist are scarce.
Danish: Der findes kun få sammenlignende undersøgelser med ikke-ergotderiverede og ergotderiverede dopaminantagonister.
English: The CHMP also noted that these medicines are already indicated only as
Danish: CHMP bemærkede også, at disse lægemidler allerede kun er indicerede som andetvalgspræparat til Parkinsons syge, samt at de er kontraindicerede til patienter med klapsygdomme
English: For carbergoline and pergolide an increased risk of fibrotic events is considered well established.
Danish: Den øgede risiko for fibrose ved brug af cabergolin og pergolid betragtes som veldokumenteret.
English: No cases were reported for bromocriptine, dihydroergocryptine and lisuride by MAHs.
Danish: Indehaverne af markedsføringstilladelserne rapporterede ingen tilfælde i forbindelse med bromocriptin, dihydroergocryptin og lisurid.
English: For bromocriptine, dihydroergocryptine and lisuride an increased risk cannot be excluded based on the amount of evidence available.
Danish: Baseret på de tilgængelige data kan en øget risiko ved brug af bromocriptin, dihydrocryptin og lisuid ikke udelukkes.
English: Strength Pharmaceutical form
Danish: (Særnavn) Navn Styrke Lægemiddelform Administration Emballage Indhold Paknings-størrelse EU/1/06/361/001 Luminity
English: 4 vials
Danish: EU/1/06/361/002 Luminity
English: This allows the infection to be eliminated from the body.
Danish: På den måde kan infektionen fjernes fra kroppen.
English: Date of first authorisation: 26th July 2017
Danish: Dato for første markedsføringstilladelse: 26. juli 2017
English: Appropriate symptomatic treatment should be instituted immediately.
Danish: Der skal straks iværksættes passende symptomatisk behandling.
English: DORA (Part 1)
Danish: DORA (del 1)
English: f. VOYAGE-1 and VOYAGE-2 were Asian regional studies.
Danish: f. VOYAGE-1 og VOYAGE-2 var asiatiske regionale studier
English: Follow the dosing recommendations in Tables 1 and 2.
Danish: Følg doseringsanbefalingerne i tabel 1 og 2.
English: Do not take a double dose (two doses too close together).
Danish: Du må ikke tage en dobbeltdosis (to doser for tæt på hinanden).
English: A risk to the suckling child cannot be excluded.
Danish: En risiko for det diende barn kan ikke udelukkes.
English: Then take the next dose at your usual time.
Danish: Derefter skal du tage den næste dosis på det sædvanlige tidspunkt.
English: • you are taking the following medicines:
Danish: • hvis du tager følgende lægemidler:
English: The risk of failure was, as expected, highest for those exposed to both classes.
Danish: Som forventet var risikoen for behandlingssvigt højest for dem, der var eksponeret for begge klasser.
English: Take the medicine pack with you so that you can show the doctor what you have taken.
Danish: Tag Maviret-pakningen med, så du kan vise lægen, hvad du har taget.
English: Non-interventional post-authorisation safety study (PASS):
Danish: Ikke-interventionel sikkerhedsundersøgelse efter tilladelse til markedsføring (PASS):
English: 8017 JV Zwolle NETHERLANDS
Danish: 8017 JV Zwolle HOLLAND
English: Your doctor will test your blood before, during and after your treatment with Maviret.
Danish: Din læge vil undersøge dit blod før, under og efter din behandling med Maviret.
English: Copovidone (Type K 28)
Danish: Copovidon (type K 28)
English: Number of clinical isolates
Danish: Antal kliniske isolater
English: Metabolism secondary none
Danish: Metabolisering sekundær ingen
English: d. Oxidative metabolites or their byproducts accounted for 26% of radioactive dose.
Danish: d. Oxidative metabolitter eller disses biprodukter udgjorde 26 % af den radioaktive dosis.
English: 47 subjects were enrolled in DORA (Part 1).
Danish: 47 forsøgspersoner deltog i DORA (del 1).
English: Effect of meal (relative to fasting)b
Danish: Effekten af mad (i forhold til faste)b
English: The adverse reactions are listed below by body system organ class and frequency.
Danish: Bivirkningerne er opstillet nedenfor efter systemorganklasse og hyppighed.
English: to prevent blood clots *Your doctor may need to increase the frequency of your blood tests to check how well your blood can clot.
Danish: til forhindring af blodpropper * Din læge kan være nødt til at øge antallet af blodprøver for at kontrollere, hvor godt dit blod størkner.
English: The final study report shall be submitted by:
Danish: Den endelige studierapport skal indsendes senest:
English: NA = not available
Danish: IT = ikke tilgængelig
English: The effects of Maviret during pregnancy are not known.
Danish: Virkningen af Maviret under graviditet kendes ikke.
English: Medicinal product by therapeutic areas/possible mechanism of interaction
Danish: Lægemiddel efter terapeutiske områder/mulig interaktionsmekanisme
English: 6a NA = not available
Danish: 6a IT = ikke tilgængelig
English: Your doctor will tell you how long you need to take Maviret for.
Danish: Lægen vil fortælle dig, hvor længe du skal tage Maviret.
English: The combination of Maviret with tacrolimus should be used with caution.
Danish: Kombinationen af Maviret og tacrolimus bør anvendes med forsigtighed.