FrancophonIA/ELRC3.0 huggingface dataset:
English: Looking at the results of the three studies together, over 18 months, patients who received Rilutek 100 mg/day had an average survival time that was about 2 months longer than the survival time for patients who received placebo.
Danish: Hvis man ser på resultaterne af alle tre undersøgelser under ét over en periode på 18 måneder, overlevede de patienter, der fik 100 mg Rilutek dagligt, i gennemsnit ca. 2 måneder længere end dem, der fik placebo.
English: Why has Rilutek been approved?
Danish: Hvorfor blev Rilutek godkendt?
English: Rilutek is used to extend the patient's life or to delay the need for mechanical ventilation.
Danish: Rilutek anvendes til at forlænge patientens liv eller udskyde tidspunktet, hvor patienten skal i respirator.
English: ALS is a form of motor neuron disease where the nerve cells responsible for sending instructions to the muscles gradually deteriorate, leading to weakness, muscle wasting and paralysis.
Danish: ALS er en sygdom i motorneuronerne, hvor de nerveceller, der sender instruktioner til musklerne, gradvist forringes.
English: What is Rilutek?
Danish: Hvad er Rilutek?
English: What benefit has Rilutek shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, der er ved Rilutek?
English: Rilutek should not be used in patients with any other form of motor neuron disease.
Danish: Rilutek bør ikke anvendes hos patienter med andre sygdomme i motorneuronerne.
English: For the full list of all side effects reported with Rilutek, see the package leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger for Rilutek fremgår af indlægssedlen.
English: Rilutek must not be used in patients who have liver disease or who have abnormally high levels of liver enzymes.
Danish: Rilutek bør ikke anvendes hos patienter med leversygdom eller unormalt højt indhold af leverenzymer i blodet.
English: How has Rilutek been studied?
Danish: Hvordan blev Rilutek undersøgt?
English: The medicine was not more effective than placebo in the late stages of ALS.
Danish: I de sene stadier af ALS virkede lægemidlet ikke bedre end placebo.
English: What is Rilutek used for?
Danish: Hvad anvendes Rilutek til?
English: How is Rilutek used?
Danish: Hvordan anvendes Rilutek?
English: How does Rilutek work?
Danish: Hvordan virker Rilutek?
English: This authorisation was based on the authorisation granted to Stalevo in 2003 (‘informed consent').
Danish: Denne tilladelse byggede på den tilladelse, som blev udstedt for Stalevo i 2003 (‘informeret samtykke').
English: • severely reduced liver function;
Danish: • svært nedsat leverfunktion
English: They should not be used in patients with severe liver problems.
Danish: De bør ikke anvendes hos patienter med svær leversygdom.
English: They should be used with caution in patients with mild to moderately reduced liver function or severely reduced kidney function.
Danish: De bør anvendes med forsigtighed hos patienter med mild til moderat nedsat leverfunktion eller svært nedsat nyrefunktion.
English: All of the tablets contain 200 mg entacapone.
Danish: Alle tabletterne indeholder 200 mg entakapon.
English: The use of combinations of levodopa and carbidopa is well established, having been in use since the mid-1970s.
Danish: Anvendelsen af levodopa og carbidopa i kombination er almindelig anerkendt, da disse har været anvendt siden midten af 1970'erne.
English: • a history of neuroleptic malignant syndrome (a dangerous nervous system disorder usually caused by antipsychotic medicines) or rhabdomyolysis (breakdown of muscle fibres).
Danish: • tidligere malignt neuroleptikasyndrom (en farlig nervesygdom, sædvanligvis forårsaget af antipsykotiske lægemidler) eller rhabdomyolyse (nedbrydning af muskelfibrene).
English: In patients with Parkinson's disease, the cells in the brain that produce dopamine (a substance used to transmit signals between nerve cells that help to control muscle movement) begin to die and the amount of dopamine in the brain decreases.
Danish: Hos patienter med Parkinsons sygdom begynder de celler, der producerer dopamin (et stof, der anvendes til at overføre signaler mellem nerveceller, der hjælper med at styre muskelbevægelser) , at dø, og mængden af dopamin i hjernen falder.
English: Serious side effects which have been reported much less often include gastrointestinal haemorrhage (bleeding in the gut) and angioedema (swelling under the skin of face or limbs).
Danish: Alvorlige bivirkninger, der er blevet indberettet i meget mindre omfang, er gastrointestinale blødninger (blødninger fra tarm) og angioødem (hævelser under huden i ansigtet eller på arme og ben).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Levodopa/Carbidopa/Entacapone Orion on 24 August 2011.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Levodopa/Carbidopa/Entacapone Orion den 24. august 2011.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Levodopa/Carbidopa/Entacapone Orion.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Levodopa/Carbidopa/Entacapone Orion.
English: The maximum daily dose of Levodopa/Carbidopa/Entacapone Orion is 10 tablets, except for the tablets containing 175 mg levodopa and 43.75 mg carbidopa, for which the maximum daily dose is eight tablets, and those containing 200 mg levodopa and 50 mg carbidopa, for which it is seven tablets.
Danish: Den maksimale daglige dosis af Levodopa/Carbidopa/Entacapone Orion er 10 tabletter, undtagen for de tabletter, som indeholder 175 mg levodopa og 43,75 mg carbidopa, hvor den maksimale daglige dosis er otte tabletter, og de tabletter, der indeholder 200 mg levodopa og 50 mg carbidopa, hvor den maksimale daglige dosis er syv tabletter.
English: They are linked with a reduction in the effect of levodopa, when the patient experiences sudden switches between being ‘on' and able to move, and being ‘off' and having difficulty moving about.
Danish: De skyldes 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: Levodopa/Carbidopa/Entacapone Orion is used when these fluctuations cannot be treated with the standard combination alone.
Danish: Levodopa/Carbidopa/Entacapone Orion anvendes, når disse fluktuationer ikke kan behandles med standardkombinationen alene.
English: For more information about treatment with Levodopa/Carbidopa/Entacapone Orion, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Levodopa/Carbidopa/Entacapone Orion, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The CHMP decided that Levodopa/Carbidopa/Entacapone Orion's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Levodopa/Carbidopa/Entacapone Orion opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: Levodopa/Carbidopa/Entacapone Orion is used in patients who are being treated with a combination of levodopa and an inhibitor of dopa decarboxylase (two standard treatments for Parkinson's disease) but are having ‘fluctuations' towards the end of the period between two doses of their medication.
Danish: Levodopa/Carbidopa/Entacapone Orion anvendes hos patienter, der behandles med en kombination af levodopa og en dopa-decarboxylasehæmmer (to standardlægemidler mod Parkinsons sygdom), hos hvem der hen mod slutningen af perioden mellem to doser af medicinen forekommer "fluktuationer".
English: This is a summary of the European public assessment report (EPAR) for Levodopa/Carbidopa/Entacapone Orion.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Levodopa/Carbidopa/Entacapone Orion.
English: The company used some of the data from Comtess/Comtan to support the use of Levodopa/Carbidopa/Entacapone Orion and presented data from the published literature for levodopa and carbidopa.
Danish: Virksomheden anvendte nogle af oplysningerne fra Comtess/Comtan som dokumentation for anvendelsen af Levodopa/Carbidopa/Entacapone Orion og fremlagde også oplysninger fra offentliggjort faglitteratur om levodopa og carbidopa.
English: Each Levodopa/Carbidopa/Entacapone Orion tablet contains one complete dose of levodopa, in seven strengths, with corresponding amounts of carbidopa and entacapone to improve its effectiveness.
Danish: Hver tablet med Levodopa/Carbidopa/Entacapone Orion indeholder en hel dosis levodopa i syv forskellige styrker med tilsvarende mængder af carbidopa og entakapon til at forstærke dens virkning.
English: The studies showed that Levodopa/Carbidopa/Entacapone Orion is bioequivalent to the separate tablets.
Danish: Undersøgelserne viste, at Levodopa/Carbidopa/Entacapone Orion er bioækvivalent med de separate tabletter.
English: The strength of Levodopa/Carbidopa/Entacapone Orion that the patient should use is based on the amount of levodopa they need to control their symptoms.
Danish: Den styrke af Levodopa/Carbidopa/Entacapone Orion, som skal anvendes til patienten, baseres på den mængde levodopa, der er nødvendig til kontrol af patientens symptomer.
English: All of the active substances in Levodopa/Carbidopa/Entacapone Orion work to restore the levels of dopamine in the parts of the brain that control movement and co-ordination.
Danish: De aktive stoffer i Levodopa/Carbidopa/Entacapone Orion genopretter indholdet af dopamin i de dele af hjernen, der styrer bevægelser og koordination.
English: The most common side effects with Levodopa/Carbidopa/Entacapone Orion (seen in more than 1 patient in 10) are dyskinesia (uncontrollable movements), muscle pain, diarrhoea and nausea (feeling sick) and harmless urine discoloration.
Danish: De almindeligste bivirkninger ved Levodopa/Carbidopa/Entacapone Orion (som optræder hos flere end 1 ud af 10 patienter) er dyskinesi (ufrivillige bevægelser), muskelsmerter, diarré, kvalme og harmløs misfarvning af urinen.
English: Levodopa/Carbidopa/Entacapone Orion must not be used in patients with:
Danish: Levodopa/Carbidopa/Entacapone Orion må ikke anvendes til patienter med:
English: Levodopa/Carbidopa/Entacapone Orion tablets should be taken whole, with or without food.
Danish: Levodopa/Carbidopa/Entacapone Orion-tabletter skal tages hele, med eller uden samtidig fødeindtagelse.
English: Levodopa/Carbidopa/Entacapone Orion must not be used in people who are hypersensitive (allergic) to levodopa, carbidopa, entacapone or any of the other ingredients.
Danish: Levodopa/Carbidopa/Entacapone Orion må ikke anvendes til patienter, der er overfølsomme (allergiske) over for levodopa, carbidopa, entakapon eller andre af indholdsstofferne.
English: The company carried out ‘bioequivalence' studies to show that taking Levodopa/Carbidopa/Entacapone Orion produces the same levels of levodopa, carbidopa and entecapone in the blood as taking separate tablets containing entacapone and the combination of levodopa and carbidopa.
Danish: Virksomheden foretog ”bioækvivalens”-undersøgelser til påvisning af, at Levodopa/Carbidopa/Entacapone Orion giver samme koncentration i blodet af levodopa, carbidopa og entakapon, som når de aktive stoffer tages som separate tabletter indeholdende entakapon og tabletter indeholdende en kombination af levodopa og carbidopa.
English: Levodopa/Carbidopa/Entacapone Orion must not be used together with other medicines that belong to the group ‘monoamine oxidase inhibitors' (a type of antidepressant).
Danish: Levodopa/Carbidopa/Entacapone Orion må ikke anvendes samme med andre lægemidler, der tilhører gruppen af monoaminoxidasehæmmere (en form for antidepressiva).
English: The full EPAR for Levodopa/Carbidopa/Entacapone Orion can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: For the full list of all side effects reported with Levodopa/Carbidopa/Entacapone Orion, see the package leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Levodopa/Carbidopa/Entacapone Orion fremgår af indlægssedlen.
English: Other information about Levodopa/Carbidopa/Entacapone Orion
Danish: Andre oplysninger om Levodopa/Carbidopa/Entacapone Orion
English: Levodopa/Carbidopa/Entacapone Orion is used to treat adults with Parkinson's disease.
Danish: Levodopa/Carbidopa/Entacapone Orion anvendes til behandling af Parkinsons sygdom.
English: EPAR summary for the public levodopa/carbidopa/entacapone
Danish: EPAR sammendrag for offentligheden levodopa/carbidopa/entakapon
English: Levodopa/Carbidopa/Entacapone Orion is a medicine that contains three active substances: levodopa, carbidopa and entacapone.
Danish: Levodopa/Carbidopa/Entacapone Orion er et lægemiddel, der indeholder de tre aktive stoffer:
English: Why has Levodopa/Carbidopa/Entacapone Orion been approved?
Danish: Hvorfor blev Levodopa/Carbidopa/Entacapone Orion godkendt?
English: • narrow-angle glaucoma (increased pressure within the eye);
Danish: • snævervinklet grøn stær (for højt væsketryk i øjet),
English: What is the risk associated with Levodopa/Carbidopa/Entacapone Orion?
Danish: Hvilken risiko er der forbundet medLevodopa/Carbidopa/Entacapone Orion?
English: See the summary of product characteristics (also part of the EPAR) for full instructions on how patients should be switched to Levodopa/Carbidopa/Entacapone Orion, and on how the dose is adjusted during treatment.
Danish: Fuldstændige anvisninger for, hvordan patienten skal skifte til Levodopa/Carbidopa/Entacapone Orion, og hvordan dosis skal justeres under behandlingen, fremgår af produktresuméet, der ligeledes er en del af denne EPAR.
English: What is Levodopa/Carbidopa/Entacapone Orion?
Danish: Hvad er Levodopa/Carbidopa/Entacapone Orion?
English: How has Levodopa/Carbidopa/Entacapone Orion been studied?
Danish: Hvordan blev Levodopa/Carbidopa/Entacapone Orion undersøgt?
English: How is Levodopa/Carbidopa/Entacapone Orion used?
Danish: Hvordan anvendes Levodopa/Carbidopa/Entacapone Orion?
English: What is Levodopa/Carbidopa/Entacapone Orion used for?
Danish: Hvad anvendes Levodopa/Carbidopa/Entacapone Orion til?
English: What benefit has Levodopa/Carbidopa/Entacapone Orion shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Levodopa/Carbidopa/Entacapone Orion?
English: How does Levodopa/Carbidopa/Entacapone Orion work?
Danish: Hvordan virker Levodopa/Carbidopa/Entacapone Orion?
English: Invented name Strength Pharmaceutical Form Route of administration
Danish: Lægemiddelform Indgivelsesvej
English: Content Package size
Danish: Pakningsstørrelse
English: You may need to read it again.
Danish: Du kan få brug for at læse det igen.
English: What happens
Danish: Hvad sker der
English: ***No patients are currently evaluable for these endpoints.
Danish: ***Der er på nuværende ingen patienter, som kan evalueres for disse endepunkter.
English: When 20 patients have been treated with 6 months follow-up
Danish: Når 20 patienter er blevet behandlet med 6 måneders opfølgning
English: NR = Not reached.
Danish: NR = ikke nået.
English: Irradiation could lead to inactivation of the product.
Danish: Bestråling kan føre til inaktivering af produktet.
English: o The importance of annual check-ups.
Danish: o Vigtigheden af årlige kontrolundersøgelser.
English: All reactions resolved.
Danish: Alle reaktioner foretog sig.
English: including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Danish: inklusive kommunikationsmedier, distributionsmodaliteter og eventuelle andre aspekter af programmet, med de kompetente nationale myndigheder.
English: This reduces or eliminates the need for blood transfusions.
Danish: Dette reducerer eller eliminerer behovet for blodtransfusioner.
English: *Patients who have not received transfusions in the prior 60 days.
Danish: *Patienter som ikke har fået transfusioner i de sidste 60 dage.
English: A chemotherapy medicine is given for 4 days in a hospital
Danish: En kemoterapimedicin gives i 4 dage på et hospital
English: This information is intended for doctors only.
Danish: Denne information er kun beregnet til læger.
English: - Read the Patient Alert Card carefully and follow the instructions on it.
Danish: - Læs patientkortet omhyggeligt, og følg instruktionerne på det.
English: As this medicine will be given by a qualified doctor, they are responsible for the correct storage of the medicine before and during its use, as well as for its correct disposal.
Danish: Eftersom dette lægemiddel gives af en uddannet læge, er denne ansvarlig for korrekt opbevaring af lægemidlet før og under brugen, samt for korrekt bortskaffelse.
English: The minimum recommended dose is the same for adults and adolescents 12 years of age and older.
Danish: Den minimale anbefalede dosis er den samme for voksne og børn på 12 år eller mere.
English: Hb = Total Hb. WA Hb = Weighted average Hb.
Danish: Hb = total Hb. WA Hb = Vægtet gennemsnit af Hb
English: All patients remain alive at last follow-up.
Danish: Alle patienter var stadig i live ved sidste opfølgning.
English: INFORMATION ON SUPPLIED LOT(S) The following lot(s) was manufactured and included in the shipment:
Danish: OPLYSNINGER OM LEVERET/LEVEREDE LOT(S) Det/de følgende lot(s) blev fremstillet og er inkluderet i forsendelsen:
English: You should also read the package leaflets for these medicines.
Danish: Du bør også læse indlægssedlerne for disse lægemidler.
English: You must get medical attention if you:
Danish: Du skal søge lægehjælp, hvis du:
English: Do not thaw the product until it is ready to be used.
Danish: Undlad at optø produktet, indtil det er klar til brug.
English: Duration of TI
Danish: Varighed af TI
English: Following successful engraftment and achievement of transfusion independence, the effects of the product are expected to be life-long.
Danish: Efter vellykket engraftment og opnåelse af transfusionsuafhængighed, forventes virkningen af produktet at være livslang.
English: This will take place in a hospital and will take less than 30 minutes for each infusion bag.
Danish: Dette vil finde sted på et hospital, og det vil tage under 30 minutter for hver infusionspose.
English: Cardiac T2* at baseline was >20 msec.
Danish: Kardial T2* ved baseline var >20 msek.
English: PATIENT INFORMATION
Danish: PATIENTINFORMATION
English: Non-β0/β0 patients
Danish: Non-β0/β0-patienter
English: Date of first authorisation: 29 May 2019
Danish: Dato for første markedsføringstilladelse: 29. maj 2019
English: The selection of the treatment centres will be conducted in collaboration with national health authorities as appropriate.
Danish: Behandlingscentre vælges i samråd med de relevante nationale sundhedsmyndigheder.
English: Some iron chelators are myelosuppressive.
Danish: Nogle jernkelatorer er myelosuppressive.
English: To recover and be monitored until your doctor is satisfied that it is safe for you to leave the hospital.
Danish: For at du kan få det bedre og blive monitoreret, indtil lægen bedømmer, at det er sikkert for dig at forlade hospitalet.
English: All patients had a Karnofsky performance score ≥80 and the majority had a performance score of 100 at baseline.
Danish: Alle patienter havde en Karnofsky performance score på ≥ 80, og de fleste havde en performance score på 100 ved baseline.
English: It is therefore advised to cryopreserve semen or ova before treatment if possible.
Danish: Det tilrådes derfor at kryopræservere sæd og æg inden behandling, hvis det er muligt.
English: Protocol submission:
Danish: Indsendelse af protokol:
English: • infections which may make you feel warm, chilly, or sweaty
Danish: • infektioner som kan gøre, at du føler dig varm, kold eller svedig
English: Bars represent interquartile ranges.
Danish: Søjler repræsenterer interkvartile intervaller.
English: Risk of insertional oncogenesis
Danish: Risiko for insertion af onkogener
English: • chest pain not due to a heart problem
Danish: • brystsmerter, der ikke skyldes et hjerteproblem
English: The following requirements need to be fulfilled before the product is prescribed, manufactured, dispensed and used:
Danish: Følgende krav skal opfyldes inden ordination, produktion, udlevering og anvendelse af produktet:
English: Given the small patient population and size of cohorts, adverse reactions in the table below do not provide a complete perspective on the nature and frequency of these events.
Danish: På grund af den lille patientpopulation og størrelsen af kohorterne giver bivirkningerne i den nedenstående tabel ikke et fuldstændigt overblik over arten og hyppigheden af disse hændelser.
English: All other bleeding events were nonserious.
Danish: Ingen andre blødningshændelser var alvorlige.
English: These may be signs of a serious liver condition called veno-occlusive disease.
Danish: Disse kan være tegn på en alvorlig leversygdom, der kaldes venookklusiv sygdom.
English: Options may include providing reproductive material for storage in a tissue bank to use at a later time.
Danish: Der kan være en mulighed for at afgive formeringsmateriale til opbevaring i en vævsbank til brug på et senere tidspunkt.
English: • bump your head or have a head injury
Danish: • slår hovedet eller får en skade i hovedet
English: Overall results
Danish: Samlede resultater
English: n/N^ [95% CI]
Danish: n/N^ (%) [95 % KI]
English: No formal drug interaction studies have been performed.
Danish: Der er ikke udført formelle studier af lægemiddelinteraktioner.
English: Do not re-freeze after thawing.
Danish: Må ikke nedfryses igen efter optøning.
English: Effects on male and female fertility have not been evaluated in animal studies.
Danish: Virkninger på mænds og kvinders fertilitet er ikke blevet undersøgt i dyrestudier.
English: Frozen: 1 year at ≤-140°C.
Danish: Frosne: 1 år ved ≤-140 °C.
English: Talk to your doctor if you need to have any vaccinations.
Danish: Tal med din læge, hvis du skal vaccineres.
English: • excess acid in the body not removed by the kidneys
Danish: • overskydende syre i kroppen, som ikke fjernes af nyrerne
English: The educational and controlled distribution programme is aimed at providing information on the safe use of Zynteglo.
Danish: Programmet til undervisning og kontrolleret distribution har til formål at give information om sikker brug af Zynteglo.
English: ^N represents the total number of patients evaluable for TI, defined as patients who have completed their parent study (i.e., 24 months of follow-up), or achieved TI, or will not achieve TI in their parent study.
Danish: ^N repræsenterer det samlede antal patienter, som kan evalueres for TI, hvilket er defineret som patienter, som har fuldført deres hovedstudie (dvs. 24 måneders opfølgning) eller har opnået TI, eller ikke vil opnå TI i deres hovedstudie.
English: Do not use an in-line blood filter or an infusion pump.
Danish: Anvend ikke et in-line-blodfilter eller en infusionspumpe.
English: For women, this may be eggs (oocytes) or ovarian tissue.
Danish: For kvinder kan det være æg (oocytter) eller ovarievæv.
English: Adolescents were excluded from Phase 3 studies if they had a known and available HLA-matched related HSC donor.
Danish: Unge blev ekskluderet fra fase 3-forsøg, hvis de havde en kendt HLA- forligelig HSC-donor til rådighed.
English: Serious events of hepatic VOD occurred in 11.9% of patients following myeloablative conditioning; 80% of these patients did not receive prophylaxis for VOD.
Danish: Alvorlige tilfælde af hepatisk VOD forekom hos 11,9 % af patienter efter myeloablativ konditionering; 80 % af disse patienter modtog ikke profylakse for VOD.
English: • irregular menstruation
Danish: • uregelmæssig menstruation