FrancophonIA/ELRC3.0 huggingface dataset:
English: Ramelteon was expected to be used to treat primary insomnia (difficulty falling and staying asleep, and poor quality of sleep) in patients aged 18 years or over.
Danish: Ramelteon forventedes anvendt til behandling af primær søvnløshed (vanskeligt ved at falde i søvn og sove og dårlig søvnkvalitet) hos patienter på 18 år og derover.
English: The effectiveness of Ramelteon was compared with that of placebo (a dummy treatment) in a total of about 5,400 patients.
Danish: Virkningen af Ramelteon blev sammenlignet med virkningen af placebo (en uvirksom behandling) hos i alt ca. 5 400 patienter.
English: When other aspects of sleep were considered, Ramelteon did not have any effect.
Danish: Hvis man så på andre søvnaspekter, havde Ramelteon ikke nogen effekt.
English: only one of the three studies carried out in the natural setting was there a difference in the time taken to fall asleep between patients taking Ramelteon and those taking placebo.
Danish: Endvidere var der kun i en af de tre undersøgelser, som blev gennemført i naturlige omgivelser, en forskel i den tid, det tog at falde i søvn, mellem patienter, der fik Ramelteon og patienter, der fik placebo.
English: On 19 September 2008, Takeda Global Research & Development Centre (Europe) Ltd. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Ramelteon, for the treatment of primary insomnia in adult patients.
Danish: Den 19. september 2008 meddelte Takeda Global Research & Development Centre (Europe) Ltd. officielt Udvalget for Humanmedicinske Lægemidler (CHMP), at firmaet ønsker at tilbagetrække sin ansøgning om markedsføringstilladelse for Ramelteon til behandling af primær søvnløshed hos voksne patienter.
English: The Committee was also concerned that the company had not demonstrated the long-term effectiveness of Ramelteon.
Danish: Udvalget havde også betænkeligheder ved, at firmaet ikke havde påvist en langsigtet effekt af Ramelteon.
English: Ramelteon is a medicine that contains the active substance ramelteon.
Danish: Ramelteon er et lægemiddel, der indeholder det aktive stof ramelteon.
English: Ramelteon was expected to work in the same way as melatonin in promoting sleep.
Danish: Det forventedes, at Ramelteon ville virke på samme måde som melatonin med hensyn til at befordre søvn.
English: The active substance in Ramelteon, ramelteon, is a melatonin-receptor agonist.
Danish: Det aktive stof i Ramelteon, ramelteon, er en melatoninreceptoragonist.
English: The CHMP was concerned that the company had not demonstrated the effectiveness of Ramelteon, which was measured by looking at only one aspect of insomnia, the time to fall asleep.
Danish: CHMP var betænkelig ved, at firmaet ikke havde påvist effekten af Ramelteon, som kun var målt ved at se på et enkelt aspekt af søvnløshed, nemlig den tid, det tog at falde i søvn.
English: What was Ramelteon expected to be used for?
Danish: Hvad forventedes Ramelteon anvendt til?
English: Therefore, at the time of the withdrawal, the CHMP's view was that a benefit of Ramelteon had not been sufficiently demonstrated and any benefits did not outweigh the identified risks.
Danish: På tilbagetrækningstidspunktet var det derfor CHMP's opfattelse, at fordelene ved Ramelteon ikke var blevet tilstrækkeligt påvist, og at de eventuelle fordele ikke opvejede de påviste risici.
English: This means that it works by attaching itself to the receptors that melatonin normally attaches to. Melatonin is a naturally occurring hormone that is involved in co-ordinating the body's sleep cycle by acting on receptors in specific areas of the brain.
Danish: Melatonin er et naturligt forekommende hormon, som medvirker til at koordinere kroppens søvncyklus via indvirkning på receptorerne i bestemte områder af hjernen.
English: Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had given a negative opinion and did not recommend a marketing authorisation for Ramelteon for the treatment of primary insomnia in adult patients.
Danish: Efter gennemgang af de foreliggende oplysninger og firmaets besvarelse af CHMP's spørgsmål havde CHMP på tilbagetrækningstidspunktet afgivet en negativ udtalelse og anbefalede ikke udstedelse af markedsføringstilladelse for Ramelteon til behandling af primær søvnløshed hos voksne patienter.
English: What are the consequences of the withdrawal for patients in clinical trials or compassionate use programmes using Ramelteon?
Danish: Hvilke konsekvenser har tilbagetræningen for patienter, der deltager i kliniske undersøgelser med Ramelteon eller i programmer for anvendelse af Ramelteon med særlig udleveringstilladelse?
English: The company informed the CHMP that there are no ongoing clinical trials or compassionate use programs with Ramelteon in the European Union.
Danish: Firmaet har over for CHMP oplyst, at der på nuværende tidspunkt ikke gennemføres kliniske undersøgelser eller programmer for anvendelse af Ramelteon med særlig udleveringstilladelse i Den Europæiske Union.
English: How is Ramelteon expected to work?
Danish: Hvordan forventedes Ramelteon at virke?
English: This procedure usually takes 3-4 hours.
Danish: Denne proces tager normalt 3-4 timer.
English: This may be due to a number of reasons, for example, if there is:
Danish: Det kan skyldes forskellige forhold, f.eks.:
English: The medicinal product should be used immediately.
Danish: Lægemidlet skal anvendes med det samme.
English: Abbreviations: CI = confidence interval.
Danish: Forkortelser: KI = konfidensinterval.
English: The most severe side effects are described below:
Danish: De alvorligste bivirkninger er beskrevet her:
English: c p-value based on a log-rank test.
Danish: c p-værdi baseret på en log-rank-test.
English: To provide data from the observational US-based registry (PROCEED, Study P10-3)
Danish: Tilvejebringe data fra det USA-baserede observationsregister (PROCEED, studie P10-3)
English: It should not be given to children or adolescents under the age of 18 years.
Danish: Lægemidlet må ikke gives til børn og unge under 18 år.
English: In the insulated container 18 hours.
Danish: I den isolerede beholder 18 timer
English: • not enough of the right type of cells to manufacture the medicine.
Danish: • at der ikke er nok af den rigtige type celler til at fremstille produktet.
English: It is very important that you arrive on time for your appointments.
Danish: Det er meget vigtigt, at du kommer til tiden, når du har en aftale.
English: Microbiological testing
Danish: Mikrobiologiske test
English: <1/1,000), very rare (<1/10,000), and not known (cannot be estimated from the available data).
Danish: (< 1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Older people No dose adjustment is required in the elderly population.
Danish: Ældre Dosisjustering er ikke nødvendig hos den ældre population.
English: You will be monitored before and during the infusion.
Danish: Du bliver overvåget før og under infusionen.
English: If this happens, do not drive or use any tools or machines until you feel better.
Danish: Hvis det sker, må du ikke køre bil eller betjene værktøj eller maskiner, før du får det bedre.
English: Infections due to contaminated product also occurred in some patients.
Danish: Infektioner som følge af kontamineret produkt forekom også hos nogle patienter.
English: • The expiration date and time have passed.
Danish: • Hvis udløbsdatoen og -tidspunktet er overskredet.
English: Overall survival was not a study endpoint but a pre-specified analysis.
Danish: Samlet overlevelse var ikke et effektmål for studiet, men en foruddefineret analyse.
English: Patients should be advised of this possibility prior to initiating treatment.
Danish: Patienterne skal informeres om denne mulighed, inden de starter behandlingen.
English: A small number of these patients discontinued treatment as a result.
Danish: Et lille antal af disse patienter stoppede behandlingen af denne grund.
English: All patients had baseline testosterone levels < 50 ng/mL.
Danish: Alle patienter havde baseline-testosteronniveau < 50 ng/ml.
English: These patients should be closely monitored for signs and symptoms of infection.
Danish: Sådanne patienter skal overvåges nøje for tegn og symptomer på infektion.
English: Overall survival Median, months (95% CI) Hazard ratio (95% CI)
Danish: Gennemsnitlig samlet overlevelse, måneder (95 %-KI) Hazard ratio (95 %-KI)
English: The physician should monitor and/or treat the patient as appropriate.
Danish: Lægen skal overvåge og/eller behandle patienten efter behov.
English: Submission of study protocol with first PSUR
Danish: Indsendelse af forsøgsprotokol med den første PSUR
English: Some have resulted in hospitalization.
Danish: Nogle af disse reaktioner har ført til hospitalsindlæggelse.
English: The median age was 71, 90% of the patients were Caucasian, and all had a life expectancy of at least 6 months.
Danish: Medianalderen var 71 år, 90 % af patienterne var kaukasere, og de havde alle en forventet levetid på mindst 6 måneder.
English: Some patients developed infection, including sepsis.
Danish: Nogle patienter udviklede infektioner, herunder sepsis.
English: Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden du får lægemidlet, da den indeholder vigtige oplysninger.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/867/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/13/867/001
English: Table 2 Summary of overall survival (all patients as randomized) IMPACT
Danish: Tabel 2 Oversigt over samlet overlevelse (alle patienter, som var randomiseret) IMPACT
English: ▼ This medicine is subject to additional monitoring.
Danish: ▼ Dette lægemiddel er underlagt supplerende overvågning.
English: Once the infusion is complete you will be observed and monitored for at least 30-60 minutes, after which, you may go home.
Danish: Når infusionen er færdig, vil du være under observation i mindst 30-60 minutter, hvorefter du kan tage hjem igen.
English: Do not use a cell filter for infusion.
Danish: Brug ikke et cellefilter til infusion.
English: This peripheral delivery system is commonly used in clinical practice for the transfusion of blood components.
Danish: Dette system til perifer indgift bruges hyppigt i klinisk praksis til transfusion af blodkomponenter.
English: It is recommended that the minimum interval between leukapheresis procedures should not be less than 2 weeks.
Danish: Det anbefales, at intervallet mellem leukafereseprocedurerne er minimum 2 uger.
English: This may be due to release criteria not being met during manufacturing, the expiration time being exceeded, or the patient being unable to meet the scheduled infusion time.
Danish: Dette kan skyldes, at frigivelseskriterierne ikke er blevet overholdt i fremstillingsprocessen, at udløbsdatoen er overskredet, eller at patienten ikke kan overholde det planlagte infusionstidspunkt.
English: This testing is a legal requirement and is to ensure that your blood cells can be safely handled by the healthcare professionals involved in your treatment.
Danish: Disse undersøgelser er et lovkrav og skal sikre, at dine blodceller kan håndteres sikkert af det sundhedspersonale, der deltager i din behandling.
English: In addition to antigen presenting cells (APCs), the final product thus contains T cells, B cells, natural killer (NK) cells, and other cells.
Danish: Ud over APC'er (antigenpræsenterende celler) indeholder det færdige produkt således Tceller, B-celler, natural killer (NK)-celler og andre celler.
English: Conventional reproductive and development toxicity studies are not considered relevant given the nature and the intended clinical use of this autologous cell therapy product.
Danish: Konventionelle studier af reproduktions- og udviklingstoksicitet anses ikke for relevante ud fra karakteren af og den tilsigtede kliniske brug af dette autologe celleterapiprodukt.
English: In case of using premedication, the status of the patient and possible contraindications/interactions should be taken into account.
Danish: Ved præmedicinering skal der tages hensyn til patientens status og eventuelle kontraindikationer/interaktioner.
English: Figure 1 Kaplan-Meier overall survival curve, IMPACT study
Danish: Kaplan-Meier-kurve for samlet overlevelse, IMPACT-studiet
English: Table 1 Adverse reactions from clinical studies and post-marketing reports System organ class
Danish: Tabel 1 Bivirkninger i kliniske studier og rapporter efter markedsføring Systemorganklasse
English: A machine is used to take blood from one arm, extract the white blood cells and return the rest of the blood to you, usually in the other arm.
Danish: Der benyttes en maskine, der tager blod fra den ene arm, udtrækker de hvide blodceller og giver dig resten af blodet tilbage, normalt i den anden arm.
English: * Primarily associated with the leukapheresis procedure
Danish: * Primært i forbindelse med leukafereseproceduren.
English: In 95.1% of patients reporting acute infusion reactions, the events were mild or moderate.
Danish: Hos 95,1 % af de patienter, der indberettede akutte infusionsreaktioner, var bivirkningerne lette eller moderate.
English: Your doctor may decide that Provenge is not suitable for you due to one or more of these conditions.
Danish: Din læge kan beslutte, at det ikke vil være hensigtsmæssigt at behandle dig med Provenge på grund af en eller flere af ovennævnte tilstande.
English: Small clumps of cellular material should disperse with gentle manual mixing.
Danish: Små klumper af cellemateriale skal dispergeres ved forsigtig manual blanding.
English: The first infusion of Provenge will be given approximately 3 days after the cell collection and will last approximately 1 hour (see also section 2 “Warnings and precautions”).
Danish: Den første Provenge-infusion vil blive givet ca. 3 dage efter celleopsamlingen og vil vare ca. 1 time (se også "Advarsler og forsigtighedsregler" i afsnit 2).
English: These measures will help to protect the environment.
Danish: Derved sikres det også, at der bliver taget hensyn til miljøet.
English: No data are available for these patients.
Danish: Der er ingen data for disse patienter.
English: It is important that you read the entire content of this procedure prior to administering Provenge.
Danish: Det er vigtigt, at du læser hele procedurebeskrivelsen inden administration af Provenge.
English: A cell filter should not be used.
Danish: Der må ikke bruges cellefilter.
English: The doses of paracetamol and antihistamine given should be in accordance with local practice.
Danish: Paracetamol- og antihistamindoserne skal være i overensstemmelse med lokal praksis.
English: The number of cells in Provenge does not exceed the number of cells from the leukapheresis.
Danish: Antallet af celler in Provenge overstiger ikke antallet af celler fra leukaferesen.
English: The incidence of severe reactions was greater following the second infusion (2.1% vs. 0.8% following the first infusion), and decreased to 1.3% following the third infusion.
Danish: Incidensen af svære bivirkninger var højere efter den anden infusion (2,1 % mod 0,8 % efter første infusion) og faldt til 1,3 % efter den tredje infusion.
English: NL-6229 EV, Maastricht The Netherlands
Danish: NL-6229 EV, Maastricht Nederlandene
English: You can also report any side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: Du kan også indberette bivirkninger direkte til Sundhedsstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: Pharmacotherapeutic group: Immunostimulants, other immunostimulants, ATC code: L03AX17.
Danish: Farmakoterapeutisk klassifikation: Immunstimulanter, andre immunstimulanter, ATC-kode: L03AX17.
English: Citrate toxicity*
Danish: Citrattoksicitet*
English: After removal from the insulated container
Danish: Efter fjernelse fra den isolerede beholder
English: The final (7-day incubation) sterility test results will not be available at the time of infusion.
Danish: De endelige testresultater for sterilitet (7 dages inkubation) er ikke tilgængelige på infusionstidspunktet.
English: If you need a vaccination whilst receiving Provenge, you should first discuss this with your doctor.
Danish: Hvis du har behov for at blive vaccineret samtidig med, at du bliver behandlet med Provenge, skal du først tale med din læge om det.
English: There are no known instances of overdose from either a single infusion or a full course of therapy with Provenge.
Danish: Der er ingen kendte forekomster af overdosering, hverken i forbindelse med en enkelt infusion eller med et fuldt behandlingsforløb med Provenge.
English: Final study report by 31 December 2020
Danish: Endelig studierapport 31. december
English: This procedure will take 3 to 4 hours (see section “Steps before Provenge treatment” below).
Danish: Denne opsamling tager 3 til 4 timer (se afsnittet "Inden behandlingen med Provenge" nedenfor).
English: The second step is to send your collected cells to a special manufacturing centre where they are mixed with an antigen to make them ready for your infusion.
Danish: Det andet trin består i at sende de opsamlede celler til et særligt forarbejdningscenter, hvor de blandes med et antigen og gøres klar til infusion.
English: Educational materials
Danish: Undervisningsmateriale
English: Each leukapheresis was followed approximately 3 days later by infusion of Provenge or control.
Danish: Hver leukaferese blev ca. 3 dage senere efterfulgt af infusion af Provenge eller kontrol.
English: Provenge is designed to stimulate the immune system.
Danish: Provenge er beregnet til at stimulere immunsystemet.
English: Provenge contains sodium and potassium This medicine contains:
Danish: Provenge indeholder natrium og kalium Dette lægemiddel indeholder:
English: Since this medicine will be given by a qualified doctor or nurse, they are responsible for the correct disposal of the product.
Danish: Da lægemidlet gives af en læge eller sygeplejerske, er det hans eller hendes ansvar at bortskaffe produktet på den rigtige måde.
English: You may also be given other medicines if needed.
Danish: Det kan være, du også får anden medicin, hvis der er behov for det.
English: No interaction studies have been performed with Provenge.
Danish: Der er ikke udført interaktionsstudier med Provenge.
English: In addition, your blood will be tested for specific viruses (for example HIV-1, HIV-2, hepatitis B and hepatitis C).
Danish: Derudover bliver dit blod undersøgt for specifikke virusser (f.eks. HIV-1, HIV-2, hepatitis B og hepatitis C).
English: Thirty-five percent of patients had undergone radical prostatectomy, 54% had received local radiotherapy, and 82% had received combined androgen blockade.
Danish: 35 % af patienterne havde gennemgået radikal prostatektomi, 54 % havde fået lokal strålebehandling, og 82 % havde fået kombineret androgen blokade.
English: Each Provenge infusion comprises the maximum number of cells that can be manufactured from a single leukapheresis procedure.
Danish: Hver Provenge-infusion indeholder det maksimale antal celler, der kan fremstilles ud fra en enkelt leukafereseprocedure.
English: The clinical significance is uncertain.
Danish: Den kliniske betydning heraf kendes ikke.
English: Summary of Product Characteristics (SmPC) 2.
Danish: Produktresumé (SPC) 2.
English: • Provenge is infused over a period of approximately 60 minutes through a large bore needle appropriate for transfusion of red blood cells.
Danish: • Provenge-infusionsvæsken skal infunderes i løbet af ca. 60 minutter gennem en kanyle med stort hul, der er egnet til transfusion af røde blodceller.
English: Citrate is generally the preferred anticoagulant used during leukapheresis and can result in hypocalcaemia.
Danish: Citrat er generelt den foretrukne antikoagulans til brug i forbindelse med leukaferese og kan medføre hypokalcæmi.
English: These immune cells are then mixed with an antigen (a protein, which is able to stimulate your immune system) at a specific manufacturing facility.
Danish: Disse immunceller er derefter blevet blandet med et antigen (et protein, der stimulerer dit immunsystem) på et særligt forarbejdningscenter.
English: Provenge should be infused intravenously over a period of approximately 60 minutes.
Danish: Provenge skal infunderes intravenøst i løbet af ca. 60 minutter.
English: Your blood will be tested before it is collected (see section “Tests” below).
Danish: Dit blod bliver testet, før det opsamles (se afsnittet "Blodprøver").
English: A total of 512 patients were randomised in a 2:1 ratio to receive Provenge (n=341) or control (n=171).
Danish: I alt blev 512 patienter randomiseret i forholdet 2:1 til at få Provenge (n = 341) eller kontrol (n = 171).
English: The most common reactions (≥ 20%) were chills, fever, and fatigue.
Danish: De hyppigste reaktioner (≥ 20 %) var kulderystelser, feber og træthed.
English: Fevers and chills generally resolved within 2 days (71.9% and 89.0%, respectively).
Danish: Feber og kulderystelser var normalt overstået på 2 dage (i henholdsvis 71,9 % og 89,0 % af tilfældene).
English: Do not remove the top insulated lid and do not open the insulated box until both of the following have occurred:
Danish: Fjern ikke det øverste isolerede låg, og luk ikke den isolerede beholder op, før følgende to ting er sket:
English: If the final results show that your medicine was not sterile, your doctor will be notified and you will be monitored closely for any signs of infection and will be treated accordingly.
Danish: Hvis de endelige testresultater viser, at medicinen ikke var steril, vil lægen få besked, og du vil blive overvåget nøje for eventuelle tegn på infektion og om nødvendigt få behandling.
English: Provenge should be delayed in patients with active systemic infection until resolution.
Danish: Provenge-behandling skal udsættes hos patienter med aktive systemiske infektioner indtil resolution.
English: Dispersion for infusion.
Danish: Dispersion til infusion.
English: Dose and course of treatment
Danish: Dosis og behandlingsforløb
English: Patients should be observed for at least 30 minutes following each infusion.
Danish: Patienten skal observeres i mindst 30 minutter efter hver infusion.
English: Appropriate medical therapy should be administered as needed.
Danish: Passende medicinsk behandling skal gives efter behov.
English: All physicians who intend to prescribe Provenge must review the educational materials and sign the training verification form.
Danish: Alle læger, der har til hensigt at ordinere Provenge, skal gennemgå undervisningsmaterialet og underskrive undervisningscertificerings-formularen.
English: Your doctor or nurse will confirm that your details (name and date of birth) correspond to the details provided with the Provenge container.
Danish: Lægen eller sundhedspersonalet vil bekræfte, at dine personoplysninger (navn og fødselsdato) svarer til det, der står på Provenge-beholderen.
English: Each Provenge bag contains one individual infusion treatment and the container will only be opened when you are ready to receive your treatment.
Danish: Hver pose indeholder Provenge til én personlig infusionsbehandling, og beholderen bliver først åbnet, når du er klar til at få behandling.
English: Your treatment will involve at least 6 visits to the cell collection site and/or clinic.
Danish: Din behandling vil omfatte mindst 6 besøg på den klinik eller afdeling, hvor der foretages blodcelleopsamling.
English: Supportive studies
Danish: Understøttende studier
English: Neither endpoint met statistical significance.
Danish: Ingen af effektmålene nåede statistisk signifikans.
English: Following randomization, patients from both treatment groups underwent a series of 3 leukapheresis procedures (at approximately 2 week intervals, range 1 to 15 weeks).
Danish: Efter randomisering gennemgik patienter fra begge behandlingsgrupper 3 leukafereseprocedurer (med ca. 2 ugers mellemrum, intervalområde: 1 til 15 uger).