FrancophonIA/ELRC3.0 huggingface dataset:
English: They are linked with a reduction in the effects of levodopa, when the patient experiences sudden switches between being ‘on' and able to move, and being ‘off' and having difficulties moving about.
Danish: Fluktuationer forekommer, når behandlingens virkning aftager og symptomerne vender tilbage De er forbundet med den aftagende virkning af levodopa, der for patienten medfører pludselige skift mellem "on-perioder" hvor patienten er i stand til at bevæge sig, og "off-perioder", hvor patienten har vanskeligt ved at bevæge sig.
English: How has Comtan been studied?
Danish: Hvordan blev Comtan undersøgt?
English: What benefit has Comtan shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Comtan?
English: How is Comtan used?
Danish: Hvordan anvendes Comtan?
English: How does Comtan work?
Danish: Hvordan virker Comtan?
English: See the Summary of Product Characteristics (also part of the EPAR) for full details.
Danish: Fuldstændige oplysninger herom fremgår af produktresuméet, der ligeledes er en del af denne EPAR.
English: Comtan has been studied in a total of 376 patients with Parkinson's disease, in two six-month studies that measured the effects of adding Comtan or placebo (a dummy medicine) to the patient's combination of levodopa and carbidopa or levodopa and benserazide.
Danish: Comtan blev undersøgt hos i alt 376 patienter med Parkinsons sygdom i to undersøgelser af seks måneders varighed.
English: * Antigenic mass ELISA units.
Danish: (stamme Gr-01-005) * Antigen masse ELISA-enheder.
English: - L. interrogans serogroup Canicola serovar Portland-vere (strain Ca-12-000)
Danish: L. interogans serogruppe Canicola serovar Portland-vere 3550-7100 E* (stamme Ca-12-000)
English: - L. kirschneri serogroup Grippotyphosa serovar Dadas (strain Gr-01-005)
Danish: (stamme As-05-073) L. kirschneri serogruppe Grippotyphosa serovar Dadas
English: - L. interrogans serogroup Icterohaemorrhagiae serovar Copenhageni (strain Ic-02-001)
Danish: L. interogans serogruppe Icterohaemorrhagiae serovar
English: - L. interrogans serogroup Australis serovar Bratislava (strain As-05-073)
Danish: Copenhageni (stramme Ic-02-001) L. interrogans serogruppe Australis serovar Bratislava
English: List of the names, pharmaceutical form(s), strength(s) of the medicinal product(s), route(s) of administration, applicant in the Member States
Danish: Fortegnelse over lægemidlernes navne, lægemiddelform(er), styrke(r), indgivelsesvej(e), ansøger i medlemsstaterne
English: United Kingdom TEVA Pharma B.V. Computerweg 10,
Danish: Storbritannien TEVA Pharma B.V.
English: Belgium TEVA Pharma B.V. Computerweg 10,
Danish: Computerweg 10,
English: Mikrogramm Weichkapseln
Danish: 1 mikrogram
English: Ocular use vial (glass)
Danish: Øjendråber, opløsning Til okulær anvendelse Flaske (glas)
English: EMA Number
Danish: Navn
English: The second eye should be treated at least 6 days after the first.
Danish: Det andet øje bør behandles mindst seks dage efter det første.
English: The improvement in patients' vision was maintained for at least three years.
Danish: Forbedringen i patienternes syn blev opretholdt i mindst tre år.
English: Luxturna (voretigene neparvovec)
Danish: Luxturna (voretigen neparvovec)
English: The type of virus used in this medicine (adeno-associated virus) does not cause disease in humans.
Danish: Den type virus, der anvendes i dette lægemiddel (adeno-associeret virus), medfører ikke sygdom hos mennesker.
English: This is a type of medicine that works by delivering genes into the body.
Danish: Denne type lægemiddel virker ved at levere gener til kroppen.
English: Luxturna will only be available from centres where the educational programme is in place.
Danish: Luxturna vil kun være tilgængeligt på centre, hvor uddannelsesprogrammet er implementeret.
English: As for all medicines, data on the use of Luxturna are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Luxturna løbende overvåget.
English: This was considered an important clinical benefit, taking into account the lack of authorised treatments for this progressive, degenerative condition.
Danish: Dette blev betragtet som en stor klinisk fordel i betragtning af manglen på godkendte behandlinger for denne progressive, degenerative sygdom.
English: Other information about Luxturna
Danish: Andre oplysninger om Luxturna
English: Patients were considered to have passed the test if they completed the route within 3 minutes and bumped into no more than 3 obstacles.
Danish: Patienterne bestod testen, hvis de gennemførte ruten inden for tre minutter og ikke stødte ind i mere end tre forhindringer.
English: What is Luxturna and what is it used for?
Danish: Hvad er Luxturna, og hvad anvendes det til?
English: What measures are being taken to ensure the safe and effective use of Luxturna?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Luxturna?
English: The safety of Luxturna was considered acceptable and side effects manageable.
Danish: Sikkerheden ved Luxturna blev anset for acceptabel, og bivirkningerne håndterbare.
English: This helps the cells in the retina to function better, slowing down the progression of the disease.
Danish: Dette hjælper cellerne i nethinden med at fungere bedre og sinker sygdommens udvikling.
English: Side effects reported with Luxturna are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Luxturna vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: Therefore, the European Medicines Agency decided that Luxturna's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved Luxturna opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: An overview of Luxturna and why it is authorised in the EU
Danish: En oversigt over Luxturna, og hvorfor det er godkendt i EU
English: For more information about using Luxturna, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Luxturna, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: Why is Luxturna authorised in the EU?
Danish: Hvorfor blev Luxturna godkendt i EU?
English: Inherited retinal dystrophy is rare, and Luxturna was designated an ‘orphan medicine' (a medicine used in rare diseases) for two forms of the disease on various dates (retinitis pigmentosa: 28 July 2015; Leber's congenital amaurosis: 2 April 2012).
Danish: Nedarvet retinal dystrofi er sjældent, og Luxturna blev udpeget som "lægemiddel til sjældne sygdomme" for to former af sygdommen på forskellige datoer (retinitis pigmentosa: 28. juli 2015; Lebers kongenitte amaurose: 2. april 2012).
English: After one year of treatment, patients treated with Luxturna improved their scores by 1.8 points, while patients who were not given Luxturna improved their scores by 0.2 points, meaning that patients treated with Luxturna were able to move better along the route.
Danish: Efter et års behandling forbedrede de patienter, der blev behandlet med Luxturna, deres resultater med 1,8 point, mens de patienter, som ikke fik Luxturna, forbedrede deres resultater med 0,2 point, hvilket viste, at de patienter, der blev behandlet med Luxturna, bedre kunne navigere ruten.
English: In addition, the company will have to follow-up all patients who received Luxturna in the main studies for 15 years, in order to characterise the long-term effectiveness and safety of the medicine, and establish a registry to collect long-term safety data in patients treated with Luxturna.
Danish: Endvidere vil virksomheden skulle følge op på alle patienter, som fik Luxturna i hovedstudiet, i 15 år for at fastlægge langtidseffekten og sikkerheden af lægemidlet, og den skal føre et register for at indsamle data om langtidssikkerheden hos patienter, som er blevet behandlet med Luxturna.
English: Patients should start receiving immunosuppressant medicines (medicines that reduce the activity of the immune system, the body's natural defences) 3 days before Luxturna is injected into the first eye, to lower the risk of the medicine being rejected by the body, and this treatment should continue for 14 days after injection.
Danish: Patienterne bør begynde at tage lægemidler, der undertrykker immunforsvaret (kroppens naturlige forsvar), tre dage før Luxturna indsprøjtes i det første øje, for at mindske risikoen for, at kroppen afviser lægemidlet, og denne behandling bør fortsætte i 14 dage efter indsprøjtning.
English: Luxturna must not be used in patients with eye infection or inflammation.
Danish: Luxturna må ikke anvendes hos patienter med øjeninfektion eller øjenbetændelse.
English: An information package for patients and their carers will also be provided.
Danish: Patienter og deres omsorgspersoner vil også modtage en patientinformationspakke.
English: Further information on Luxturna can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/luxturna.
Danish: Yderligere information om Luxturna findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/luxturna.
English: Further information on the orphan designations can be found on the European Medicines Agency's website ema.europa.eu/medicines/human/orphandesignations.
Danish: Yderligere oplysninger om lægemidler til sjældne sygdomme kan findes på Det Europæiske Lægemiddelagenturs websted under: ema.europa.eu/medicines/human/orphan-designations.
English: The main measure of effectiveness was how well patients performed in a mobility test, where they were required to navigate a route with turns and obstacles under various light settings.
Danish: Virkningen blev hovedsagelig bedømt på, hvor godt patienterne klarede sig i en mobilitetstest, hvor de skulle navigere en rute med sving og forhindringer under forskellige lysforhold.
English: Luxturna contains the active substance voretigene neparvovec and is a type of advanced therapy medicine called a ‘gene therapy product'.
Danish: Luxturna indeholder det aktive stof voretigen neparvovec og er et lægemiddel til avanceret terapi, som kaldes et "genterapiprodukt".
English: What are the risks associated with Luxturna?
Danish: Hvilke risici er der forbundet med Luxturna?
English: Additionally, 13 of the 21 patients (62%) treated with Luxturna passed the mobility test at the lowest light level of 1 lux (similar to conditions of a poorly lit pavement at night), while none of the patients not given the medicine were able to do so.
Danish: Endvidere bestod 13 ud af de 21 patienter (62 %), der blev behandlet med Luxturna, mobilitetstesten ved de dårligste lysforhold på 1 lux (svarende til et fortov med ringe belysning om aftenen), mens dette ikke var tilfældet for nogen af de patienter, der ikke blev behandlet med lægemidlet.
English: The company that markets Luxturna will set up an educational programme and prepare educational material aimed at doctors and pharmacists expected to use and handle Luxturna, in order to ensure the correct use of the medicine and minimise the risks associated with the medicine and its administration.
Danish: Virksomheden, der markedsfører Luxturna vil iværksætte et uddannelsesprogram og udarbejde undervisningsmateriale til læger og farmaceuter, som forventes at anvende Luxturna, for at sikre, at lægemidlet anvendes korrekt, og mindske risiciene i forbindelse med lægemidlet og indgivelsen heraf.
English: RPE65 is responsible for the production of an enzyme called all-trans retinyl isomerase, which is necessary for the normal functioning of retinal cells.
Danish: RPE65 er ansvarligt for produktionen af et enzym kaldet all-trans-retinol-isomerase, som er nødvendigt for, at cellerne i nethinden kan fungere normalt.
English: Luxturna can only be obtained with a prescription and treatment should be given by a surgeon experienced in performing eye surgery.
Danish: Luxturna udleveres kun efter recept, og behandlingen bør udføres af en kirurg med erfaring i at foretage øjenoperationer.
English: Luxturna is a medicine that is used to treat adults and children with loss of vision due to inherited retinal dystrophy, a rare genetic disorder of the retina (the light sensitive membrane at the back of the eye).
Danish: Luxturna er et lægemiddel, der anvendes til behandling af voksne og børn med synstab som følge af nedarvet retinal dystrofi, en sjælden genetisk sygdom i nethinden (den lysfølsomme hinde bagest i øjet).
English: Luxturna is given as a single injection into the back of each eye, under the retina.
Danish: Luxturna gives som en enkelt indsprøjtning bagest i hvert øje under nethinden.
English: Luxturna has been shown to improve patients' vision and ability to move around obstacles, particularly in dim light, and is expected to improve their quality of life.
Danish: Det er blevet påvist, at Luxturna forbedrer patienternes syn og evne til at undgå forhindringer, særlig ved lav belysning, og lægemidlet forventes at øge patienternes livskvalitet.
English: Luxturna can only be used while patients still have enough functioning cells left in the retina and when the disease is caused by mutations (changes) in the gene RPE65.
Danish: Luxturna kan udelukkende anvendes, når patienterne stadig har nok fungerende celler tilbage i nethinden, og når sygdommen skyldes ændringer (mutationer) i genet RPE65.
English: Luxturna consists of a virus that contains normal copies of the RPE65 gene.
Danish: Luxturna består af et virus, som indeholder normale kopier af genet RPE65.
English: Luxturna was investigated in one main study involving 31 patients with inherited retinal dystrophy due to RPE65 mutations.
Danish: Luxturna blev undersøgt i et hovedstudie, som omfattede 31 patienter med nedarvet retinal dystrofi forårsaget af RPE65-mutationer.
English: The most common side effects with Luxturna (which may affect more than 1 in 20 people) are conjunctival hyperaemia (increased blood supply to the eye, leading to redness of the eye), cataract (clouding of the lens of the eye) and increased pressure inside the eye. For the full list of side effects of Luxturna, see the package leaflet.
Danish: De hyppigste bivirkninger ved Luxturna (som optræder hos mere end 1 ud af 20 patienter) er konjunktival hyperæmi (øget blodforsyning til øjnene, som medfører røde øjne), grå stær (sløring af linsen i øjet) og forhøjet tryk i øjet.
English: When Luxturna is injected into the eye the virus carries the RPE65 gene into the retinal cells and enables them to produce the missing enzyme.
Danish: Når Luxturna indsprøjtes i øjet, overfører virusset genet RPE65 ind i cellerne i nethinden, hvilket gør det muligt for cellerne at danne det manglende enzym.
English: How is Luxturna used?
Danish: Hvordan anvendes Luxturna?
English: What benefits of Luxturna have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Luxturna?
English: How does Luxturna work?
Danish: Hvordan virker Luxturna?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Luxturna 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 Luxturna.
English: See section 4.3.
Danish: Se punkt 4.3.
English: OTHER SPECIAL WARNING(S):
Danish: ANDRE SÆRLIGE ADVARSLER:
English: See situations in which this product should never be used in section 2.
Danish: Se punkt 2 for situationer, hvor dette lægemiddel aldrig må anvendes.
English: Annex III Amendments to relevant sections of the Product Information
Danish: Bilag III Ændringer til relevante afsnit i produktinformationen
English: SEE ALL CONTRAINDICATIONS IN THE SMPC.
Danish: SE ALLE KONTRAINDIKATIONER I PRODUKTRESUMÉET.
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Danish: Produktinformationen kan efterfølgende opdateres af de kompetente myndigheder i medlemsstaterne i samråd med referencemedlemsstaten og i henhold til procedurerne i direktiv 2001/83/EF, kapitel 4, afsnit III.
English: These amendments to the relevant sections of the Summary of Product Characteristics and package leaflet are the outcome of the referral procedure.
Danish: Nedenstående ændringer til de relevante afsnit i produktresuméet og indlægssedlen er resultatet af henvisningsproceduren.
English: MAHs of HES solution for infusion should amend the product information (insertion, replacement or deletion of the text, as appropriate) to reflect the wording as provided below, and in conjunction to the Scientific conclusions:
Danish: Indehavere af markedsføringstilladelse for HES-opløsning til infusion bør ændre produktinformationen (ved tilføjelse, erstatning eller sletning af tekst, alt efter hvad der er relevant), så den afspejler nedenstående ordlyd, jf. de videnskabelige konklusioner:
English: [This statement below should be strongly emphasised (e.g. capitalized, bold letters or use of colours), the visual details of the warning on the outer and immediate packaging should be agreed with NCAs and be subject to a user test taking into account the "Guideline on the Readability of the labelling and package leaflet on medicinal products for human use" within 1 month from the Commission Decision.]
Danish: Advarslens visuelle detaljer på den ydre og på den indre emballage bør aftales med de nationale kompetente myndigheder og underkastes en brugertest senest 1 måned efter Kommissionens beslutning, idet der tages hensyn til "Guideline on the Readability of the labelling and package leaflet on medicinal products for human use".]
English: Warning Do not use in sepsis (severe generalised infection), renal impairment, or critically ill patients.
Danish: Advarsel Må ikke anvendes ved sepsis (alvorlig generaliseret infektion), nedsat nyrefunktion eller til kritisk syge patienter.
English: PACKAGE LEAFLET [This statement below should be added in a black box at the top of the package leaflet.]
Danish: INDLÆGSSEDDEL [Nedenstående bør tilføjes i en sort boks øverst i indlægssedlen.]
English: SUMMARY OF PRODUCT CHARACTERISTICS [This statement below should be added in a black box at the top of the SmPC.]
Danish: PRODUKTRESUMÉ [Nedenstående bør tilføjes i en sort boks øverst i produktresuméet.]
English: Contraindications Do not use in sepsis, renal impairment, or critically ill patients.
Danish: Kontraindikationer Må ikke anvendes ved sepsis, nedsat nyrefunktion eller til kritisk syge patienter.
English: DO NOT USE IN SEPSIS, RENAL IMPAIRMENT, OR CRITICALLY ILL PATIENTS.
Danish: MÅ IKKE ANVENDES VED SEPSIS, NEDSAT NYREFUNKTION ELLER TIL KRITISK SYGE PATIENTER.
English: Without ergosterol, the fungus dies or is prevented from spreading.
Danish: Uden ergosterol dør svampen eller den forhindres i at sprede sig.
English: The duration of treatment depends on the severity of the disease and the patient's response.
Danish: Behandlingens varighed afhænger af sygdommens sværhedsgrad og patientens respons.
English: It works by preventing the formation of ergosterol, which is an important part of fungal cell walls.
Danish: Det virker ved at forhindre dannelsen af ergosterol, som er en vigtig del af svampecellevæggene.
English: Further information on Poxaconazole AHCL can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/posaconazole-ahcl.
Danish: Yderligere information vedrørende Posaconazole AHCL findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/posaconazole-ahcl.
English: • chromoblastomycosis and mycetoma (long-term fungal infections of the skin or the tissue just below the skin, usually caused by fungal spores infecting wounds due to thorns or splinters),
Danish: • chromoblastomykose og mycetom (langvarige svampeinfektioner i huden eller vævet lige under huden, som normalt forårsages af svampesporer, der inficerer sår efter torne eller splinter)
English: Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Noxafil, and do not need to be repeated for Posaconazole AHCL.
Danish: Der er allerede foretaget studier over det aktive stofs fordele og risici ved godkendt brug med referencelægemidlet, Noxafil, og de behøver ikke at blive gentaget for Posaconazole AHCL.
English: Posaconazole AHCL is available as an oral suspension (40 mg/ml) which is taken with a meal or nutritional supplement.
Danish: Posaconazole AHCL fås som en oral suspension (40 mg/ml), der tages sammen med et måltid eller et kosttilskud.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Posaconazole AHCL has been shown to have comparable quality and to be bioequivalent to Noxafil.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at det i overensstemmelse med EU's krav er påvist, at Posaconazole AHCL er af sammenlignelig kvalitet og er bioækvivalent med Noxafil.
English: It is used in patients whose infection is severe or in patients with weakened immune systems, when medicines applied topically (directly on the thrush) are unlikely to work.
Danish: Det anvendes hos patienter med svær infektion eller svækket immunforsvar, når det ikke forventes, at lægemidler til topisk anvendelse (direkte på trøsken) vil virke.
English: Side effects reported with Posaconazole AHCL are carefully evaluated and any necessary action taken to protect patients.
Danish: De indberettede bivirkninger ved Posaconazole AHCL vurderes omhyggeligt, og der træffes de nødvendige forholdsregler for at beskytte patienterne.
English: Because Posaconazole AHCL is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Posaconazole AHCL er et generisk lægemiddel og er bioækvivalent med referencelægemidlet, anses dets fordele og risici for at være de samme som for referencelægemidlet.
English: Posaconazole AHCL is an antifungal medicine used to treat adults with the following fungal diseases, when treatments with other antifungal medicines (amphotericin B, itraconazole or fluconazole) cannot be tolerated or have failed:
Danish: Posaconazole AHCL er et svampemiddel, der anvendes til behandling af voksne med følgende svampesygdomme, når behandling med andre svampemidler (amphotericin B, itraconazol eller fluconazol) ikke tåles eller ikke har virket:
English: This means that Posaconazole AHCL contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Noxafil.
Danish: Det betyder, at Posaconazole AHCL indeholder det samme aktive stof og virker på samme måde som et "referencelægemiddel", som allerede er godkendt i EU, og som hedder Noxafil.
English: Posaconazole AHCL is also used to prevent invasive fungal infections in patients whose immune system is weakened because of treatments they are receiving for blood or bone marrow cancers or medicines used in haematopoietic stem cell transplantation (a procedure where the patient's bone marrow is replaced by stem cells from a donor to form new bone marrow).
Danish: Posaconazole AHCL anvendes også til at forhindre invasive svampeinfektioner hos patienter, hvis immunsystem er svækket på grund af igangværende behandling for blodkræft eller knoglemarvskræft eller behandling med lægemidler, der anvendes i hæmatopoietisk stamcelletransplantation (en procedure, hvor patientens knoglemarv erstattes af stamceller fra en donor for at danne ny knoglemarv).
English: Posaconazole AHCL can only be obtained with a prescription and treatment should be started by a doctor who has experience in managing fungal infections or in treating patients at high risk of invasive fungal infections.
Danish: Posaconazole AHCL fås kun på recept, og behandlingen bør iværksættes af en læge med erfaring i håndtering af svampeinfektioner eller behandling af patienter med høj risiko for invasive svampeinfektioner.