FrancophonIA/ELRC3.0 huggingface dataset:
English: The main measure of effectiveness was based on how many patients had a ‘complete response', which was defined as no vomiting, retching or dry heaves and no need for any other medication to control nausea and vomiting 25 to 120 hours after the start of chemotherapy (delayed phase).The study also looked at how many patients achieved a complete response in the first 24 hours after chemotherapy (acute phase).
Danish: Det primære mål for virkning blev baseret på, hvor mange patienter der opnåede "komplet respons" defineret som ingen opkastning eller opkastningsfornemmelser og intet behov for andre lægemidler mod kvalme og opkastning 25-120 timer efter påbegyndelse af kemoterapien (forsinket fase).Det blev også undersøgt, hvor mange patienter der opnåede komplet respons i de første 24 timer efter kemoterapi (akut fase).
English: A fourth study has been carried out with Emend (125 mg capsules or 125 mg oral solution) in 307 children from 6 months to 17 years of age, where Emend, taken with ondansetron (with or without dexamethasone), was compared with ondansetron alone (with or without dexamethasone).
Danish: Der er også gennemført en fjerde undersøgelse af Emend (125 mg-kapsler eller 125 mg oral suspension) hos 307 børn mellem 6 måneder og 17 år, hvor Emend i kombination med ondansentron (med eller uden dexamethason) blev sammenlignet med ondansentron alene (med eller uden dexamethason).
English: Emend makes chemotherapy more tolerable for the patient.
Danish: Emend gør, at patienterne bedre kan tåle kemoterapien.
English: What benefit has Emend shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Emend?
English: Two doses of Emend (40 and 125 mg as capsules) were compared with ondansetron given as an injection.
Danish: To doser af Emend (40 mg- og 125 mg-kapsler) blev sammenlignet med ondansetron givet som injektion.
English: At a dose of 80, 125 and 165 mg, the other side effects seen in between 1 and 10 patients in 100 are headache, hiccups, constipation, dyspepsia (indigestion), loss of appetite, and fatigue (tiredness).
Danish: Ved en dosis på 80, 125 og 165 mg er de øvrige bivirkninger, som optræder hos mellem 1 og 10 patienter ud af 100, hovedpine, hikke, forstoppelse, dyspepsi (fordøjelsesbesvær), appetitløshed og træthed.
English: What is Emend used for?
Danish: Hvad anvendes Emend til?
English: In PONV, two studies were carried out in a total of 1,727 adult patients, most of whom were women undergoing gynaecological operations.
Danish: 727 voksne patienter, hvoraf de fleste var kvinder, som fik foretaget gynækologiske operationer.
English: Emend 165 mg capsules were compared with the authorised intravenous medicine Ivemend 150 mg. Ivemend contains a substance called fosaprepitant which is converted in the body into aprepitant.
Danish: Emend 165 mg-kapsler blev sammenlignet med det allerede godkendte intravenøse lægemiddel Ivemend 150 mg. Ivemend indeholder et stof kaldet fosaprepitant, som omdannes til aprepitant i kroppen.
English: It is available as capsules (40, 80, 125 and 165 mg) and as a powder to be made up into an oral (by mouth) suspension (125 mg).
Danish: Det fås som kapsler (40, 80, 125 og 165 mg) og som et pulver, der blandes til en suspension, som indtages gennem munden (125 mg).
English: In the study in children, around 51% (77 out of 152) of children given Emend with ondansetron had a complete response 25 to 120 hours after beginning chemotherapy, compared with 26% (39 out of 150) of children given ondansetron alone.
Danish: I undersøgelsen hos børn opnåede ca. 51 % (77 ud af 152) af de børn, der fik Emend med ondansetron, komplet respons 25-120 timer efter påbegyndelse af kemoterapi sammenlignet med 26 % (39 ud af 150) af de børn, der fik ondansetron alene.
English: Emend 165 mg capsules were shown to be bioequivalent to Ivemend 150 mg, which means that like Ivemend it can also be used to prevent nausea and vomiting caused by chemotherapy.
Danish: Emend 165 mg-kapsler viste sig at være bioækvivalent med Ivemend 150 mg, hvilket betyder, at det ligesom Ivemend kan anvendes til at forebygge kvalme og opkastning forårsaget af kemoterapi.
English: In PONV, Emend was as effective as ondansetron.
Danish: I forbindelse med postoperativ kvalme og opkastning var Emend lige så effektivt som ondansetron.
English: Emend 80, 125 and 165 mg capsules are used in adults; children from 12 years of age may be given the 80- or 125-mg capsules and children between 6 months and 12 years of age are given the oral suspension.
Danish: Kapsler med 80, 125 og 165 mg Emend anvendes til voksne; børn fra 12 år og opefter kan få 80- eller 125 mg-kapsler, og børn mellem 6 måneder og 12 år behandles med en suspension til indtagelse gennem munden.
English: In chemotherapy, the usual dose of Emend in adults and children from 12 years of age is one 125 mg capsule by mouth one hour before the start of chemotherapy.
Danish: Ved kemoterapi er den normale dosis af Emend for voksne og børn fra 12 år én 125 mg-kapsel, som indtages gennem munden én time, før kemoterapien påbegyndes.
English: Emend is an antiemetic, a medicine that prevents nausea (feeling sick) and vomiting.
Danish: Emend er et antiemetikum (et lægemiddel, der modvirker kvalme og opkastning).
English: It is used with chemotherapy that is a moderate or high trigger of nausea and vomiting such as cisplatin, cyclophosphamide, doxorubicin or epirubicin.
Danish: Det anvendes sammen med kemoterapeutiske lægemidler, der i mellemhøj til høj grad medfører kvalme og opkastning, herunder cisplatin, ciclofosfamid, doxorubicin og epirubicin.
English: For the full list of restrictions with Emend, see the package leaflet.
Danish: Den fuldstændige liste over begrænsninger ved Emend fremgår af indlægssedlen.
English: Looking at the results of both studies together, 55% of the patients (298 out of 541) taking Emend capsules at a dose of 40 mg had a complete response, compared with 49% of the patients who received ondansetron (258 out of 526).
Danish: Når man ser nærmere på de samlede resultater af de to undersøgelser, opnåede 55 % af de patienter (298 ud af 541), der fik en Emend-dosis på 40 mg, komplet respons sammenlignet med 49 % af de patienter, der fik ondansetron (258 ud af 526).
English: How has Emend been studied?
Danish: Hvordan blev Emend undersøgt?
English: In the study of chemotherapy that is a moderate trigger of nausea and vomiting, 51% of the patients taking Emend had no nausea or vomiting (220 out of 433), compared with 43% of the patients who did not take it (180 out of 424).
Danish: I undersøgelsen af kemoterapi som moderat udløser af kvalme og opkastning led 51 % af de patienter, som fik Emend, ikke af kvalme eller opkastning (220 ud af 433) sammenlignet med 43 % af de patienter, som ikke fik Emend (180 ud af 424).
English: Looking at the results of the two cisplatin studies taken together, 68% of the patients taking Emend had no nausea or vomiting over five days (352 out of 520), compared with 48% of the patients who did not take it (250 out of 523).
Danish: Sammenlagt viser resultaterne af de to undersøgelser med cisplatin, at 68 % af de patienter, som fik Emend, ikke led af kvalme eller opkastning i fem dage (352 ud af 520) sammenlignet med 48 % af de patienter, som ikke fik cisplatin (250 ud af 523).
English: For the full list of all side effects reported with Emend, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Emend fremgår af indlægssedlen.
English: How is Emend used?
Danish: Hvordan anvendes Emend?
English: How does Emend work?
Danish: Hvordan virker Emend?
English: In PONV, the usual dose is one 40 mg capsule given to adults within the three hours before the patient is anaesthetised (‘put to sleep').
Danish: Ved behandling af postoperativ kvalme og opkastning hos voksne er den almindelige dosis én 40 mg kapsel, som gives tre timer, før patienten bedøves.
English: EU/1/17/1232/001 Miglustat Gen.Orph
Danish: EU/1/17/1232/001 Miglustat Gen.Orph 100 mg Kapsel, hård
English: Blister (OPA/alu/PVC) 84 capsules
Danish: Blisterpakning (OPA/alu/PVC)
English: 100 mg Capsule, hard
Danish: 84 kapsler
English: 19 April 2012
Danish: Den 19. april 2012
English: The applicant requested a re-examination of the opinion.
Danish: Ansøgeren anmodede om en fornyet overvejelse af udtalelsen.
English: The company that applied for the authorisation is Allos Therapeutics Limited.
Danish: Den virksomhed, der har indgivet ansøgningen, er Allos Therapeutics Limited.
English: Moreover, there was no clear improvement seen in the condition of the patients, as the study looked at the patients' response to treatment but did not further allow the Committee to assess the effect on overall survival (how long the patients lived) or progression free survival (how long the patients lived without their disease getting worse).
Danish: Desuden blev der ikke iagttaget nogen klar bedring af patienternes tilstand, da undersøgelsen vedrørte patienternes reaktion på behandlingen, men ikke derudover gav udvalget mulighed for at vurdere virkningen på den samlede overlevelse (hvor længe patienterne levede) eller progressionsfri overlevelse (hvor længe patienterne levede uden at sygdommen blev værre).
English: The main measure of effectiveness was based on the proportion of patients who responded to treatment.
Danish: Behandlingens virkning blev hovedsagelig målt på den andel af patienterne, der reagerede på behandlingen.
English: The effects of Folotyn were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Folotyn blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Folotyn can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Danish: Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Folotyn findes på EMA's websted under: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: During the re-examination in April 2012, the CHMP's concerns were not resolved.
Danish: Ved den fornyede overvejelse i april 2012 blev CHMP's vigtigste betænkeligheder ikke afklaret.
English: In this study, Folotyn was not compared with any other treatment.
Danish: I undersøgelsen blev Folotyn ikke sammenlignet med noget andet lægemiddel.
English: Folotyn is a medicine that contains the active substance pralatrexate.
Danish: Folotyn er et lægemiddel, der indeholder det aktive stof pralatrexat.
English: What is Folotyn?
Danish: Hvad er Folotyn?
English: Response to treatment ranged from having improvements in the disease to having no sign of cancer.
Danish: Reaktionen på behandlingen spændte fra bedring af sygdommen til fravær af tegn på kræft.
English: Refusal of the marketing authorisation for Folotyn (pralatrexate) EMA/CHMP/255106/2012
Danish: Afslag på ansøgningen om markedsføringstilladelse for Folotyn (pralatrexat) EMA/CHMP/255106/2012
English: Refusal of the marketing authorisation for Folotyn (pralatrexate)
Danish: Afslag på ansøgningen om markedsføringstilladelse for Folotyn (pralatrexat)
English: Patients were given Folotyn together with vitamin B12 and folic acid supplements (to compensate for the deficiency in these vitamins that may occur during Folotyn treatment).
Danish: Patienterne fik Folotyn sammen med tilskud af vitamin B12 og folsyre (for at kompensere for den mangel på disse vitaminer, der kan optræde ved behandling med Folotyn ).
English: In January 2012, the CHMP was concerned that the main study was designed in a way that did not allow the Committee to assess the benefit of the medicine, particularly since Folotyn was not compared with any other treatment or placebo (a dummy treatment) in another group of patients.
Danish: I januar 2012 var CHMP betænkelig ved, at hovedundersøgelsen var tilrettelagt på en måde, der ikke gav udvalget mulighed for at vurdere fordelen ved lægemidlet, især fordi Folotyn ikke blev sammenlignet med nogen anden behandling eller med placebo (virkningsløs behandling) hos en anden gruppe patienter.
English: What was Folotyn expected to be used for?
Danish: Hvad forventedes Folotyn anvendt til?
English: The company presented the results of one main study involving a total of 115 adults with peripheral Tcell lymphoma which kept coming back or did not respond to previous treatments.
Danish: Virksomheden fremlagde resultaterne af en hovedundersøgelse med i alt 115 voksne patienter, der havde perifert T-cellelymfom, som blev ved med at vende tilbage og ikke reagerede på de foregående behandlinger.
English: After considering the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 19 April 2012.
Danish: Efter at have gennemgået begrundelsen for anmodningen foretog CHMP en fornyet overvejelse af den første udtalelse og fastholdt den 19. april 2012 afslaget på ansøgningen om markedsføringstilladelse.
English: Therefore, at that point in time, the CHMP was of the opinion that the benefits of Folotyn did not outweigh its risks and recommended that it be refused marketing authorisation.
Danish: Derfor fandt CHMP på daværende tidspunkt, at fordelene ved Folotyn ikke er større end risiciene, og anbefalede afslag på ansøgning om markedsføringstilladelse.
English: How is Folotyn expected to work?
Danish: Hvordan forventes Folotyn at virke?
English: In the body, it is expected to take the place of folic acid and attach to an enzyme called dihydrofolate reductase (DHFR).
Danish: I organismen forventes den at indtage folsyrens plads og bindes til enzymet dihydrofolatreduktase (DHFR).
English: It was to be available as a solution for infusion (drip into a vein).
Danish: Det var meningen, at det skulle leveres som en infusionsvæske, opløsning (til indgivelse gennem et drop).
English: On 19 January 2012, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Folotyn, intended for the treatment of peripheral T-cell lymphoma.
Danish: Den 19. januar 2012 vedtog Udvalget for Lægemidler til Mennesker (CHMP) en negativ udtalelse, der anbefalede afslag på ansøgningen om markedsføringstilladelse for lægemidlet Folotyn, der er bestemt til behandling af perifert T-cellelymfom.
English: The company informed the CHMP that there are no consequences on patients currently included in clinical trials or compassionate use programmes with Folotyn.
Danish: Virksomheden har til CHMP oplyst, at beslutningen ikke vil få konsekvenser for patienter, der på nuværende tidspunkt deltager i kliniske undersøgelser eller programmer for anvendelse med særlig udleveringstilladelse for Folotyn.
English: expected to block the enzyme's activity, inhibiting the division of the cancer cells and eventually killing them.
Danish: Pralatrexat forventedes at bindes til DHFR og derved blokere enzymets aktivitet, så kræftcellernes deling hæmmes, og de til sidst dør.
English: DHFR is necessary for the production of new DNA, which is required for cells to divide and multiply.
Danish: DHFR er nødvendig for at cellerne kan danne nyt dna, når de
English: The CHMP was of the opinion that there was insufficient evidence to establish the benefits of Folotyn in the treatment of peripheral T-cell lymphoma.
Danish: Det var CHMP's opfattelse, at der ikke var tilstrækkelig dokumentation for fordelene ved Folotyn til behandling af perifert T-cellelymfom.
English: Folotyn was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 13 April 2007 for the treatment of peripheral T-cell lymphoma.
Danish: Den 13. april 2007 blev Folotyn udpeget som "lægemiddel til sjældne sygdomme" til behandling af perifert T-cellelymfom.
English: In particular, the Committee considered that the data submitted by the applicant were insufficient to establish the benefits of Folotyn in the treatment of peripheral T-cell lymphoma.
Danish: Det var således CHMP's opfattelse, at de af ansøgeren forelagte data ikke er tilstrækkelige til at dokumentere fordelene ved Folotyn til behandling af perifert T-cellelymfom.
English: Folotyn was expected to be used to treat adults with peripheral T-cell lymphoma, which is a cancer of a type of white blood cell called T-cells.
Danish: Folotyn forventedes anvendt til behandling af voksne med perifert T-cellelymfom.
English: Pralatrexate is an ‘antimetabolite' medicine.
Danish: Folotyn er en stofskiftehæmmer.
English: Modigraf is taken twice a day, usually in the morning and evening.
Danish: Modigraf tages to gange dagligt, sædvanligvis morgen og aften.
English: One study involved 28 children who were given the medicine for up to one year.
Danish: En undersøgelse omfattede 28 børn, som fik lægemidlet i op til et år.
English: This means that it reduces the activity of the immune system (the body's natural defences).
Danish: Det betyder, at det dæmper aktiviteten i immunsystemet (kroppens naturlige forsvar).
English: Doses are calculated based on the patient's weight.
Danish: Dosis beregnes på grundlag af patientens vægt.
English: In the second study, the difference between the total number of rejections for the two medicine combinations was not considered to be relevant.
Danish: I den anden undersøgelse blev differencen mellem det samlede antal afstødninger for hver af de to lægemiddelkombinationer ikke anset for relevant.
English: Other information about Modigraf:
Danish: Andre oplysninger om Modigraf:
English: In the first study, 79% of patients given Modigraf (22 out of 28) did not have organ rejection.
Danish: I den første undersøgelse havde 79 % af de patienter, der fik Modigraf (22 ud af 28), ikke organafstødning.
English: Tacrolimus has been available in the European Union (EU) for preventing organ rejection since the mid-1990's.
Danish: Tacrolimus har været godkendt i Den Europæiske Union (EU) til forebyggelse af organafstødning siden midten af 1990'erne.
English: The Committee recommended that Modigraf be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Modigraf.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Modigraf to Astellas Pharma Europe B.V. on 15 May 2009.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Modigraf til Astellas Pharma Europe B.V.
English: The full EPAR for Modigraf can be found here.
Danish: Den fuldstændige EPAR for Modigraf findes her.
English: Modigraf was not compared with any other medicine.
Danish: Modigraf blev ikke sammenlignet med et andet lægemiddel.
English: Because tacrolimus has been in use for many years, the company presented results of studies from the scientific literature on the effectiveness of tacrolimus in organ transplantation.
Danish: Da tacrolimus har været anvendt i mange år, fremlagde virksomheden undersøgelsesresultater fra faglitteraturen om effekten af tacrolimus ved organtransplantation.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) MODIGRAF EPAR summary for the public
Danish: EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) MODIGRAF EPAR - sammendrag for offentligheden
English: It is available as sachets (0.2 mg and 1 mg) containing granules that are made up into an oral suspension.
Danish: Det leveres i breve (0,2 mg og 1 mg) indeholdende granulat, hvoraf der fremstilles en oral suspension.
English: The second study involved 185 children who were given either Modigraf with corticosteroids (a group of immunosuppressant medicine) or a combination of other immunosuppressant medicines (cicosporin, azathioprine and corticosteroids) for one year.
Danish: Den anden undersøgelse omfattede 185 børn, som fik enten Modigraf med corticosteroider (en gruppe af immunsuppressive lægemidler) eller en kombination af andre immunsuppressive lægemidler (ciclosporin, azathioprin og corticosteroider) i et år.
English: Doctors should monitor the levels of tacrolimus in the blood to check that they stay within predefined ranges.
Danish: Lægen bør overvåge blodets indhold af tacrolimus for at sikre, at det ligger inden for det fastlagte område.
English: Tacrolimus acts on some special cells in the immune system called T-cells that are primarily responsible for attacking the transplanted organ (organ rejection).
Danish: Tacrolimus virker på særlige celler i immunsystemet kaldet T-celler, der er de hovedansvarlige for angrebet på det transplanterede organ (organafstødning).
English: Modigraf can also be used to treat organ rejection when other immunosuppressive medicines are not effective.
Danish: Modigraf kan også anvendes til behandling af organafstødning, når andre immunsuppressive lægemidler ikke virker.
English: Modigraf is a medicine that contains the active substance tacrolimus.
Danish: Modigraf er et lægemiddel, der indeholder det aktive stof tacrolimus.
English: Modigraft was studied in two main studies in children who had had a liver transplant.
Danish: Modigraf blev undersøgt i to hovedundersøgelser af børn, som havde fået en levertransplantation.
English: It also looked at the number of organ rejections in patients that did not respond to corticosteroids.
Danish: Man så også nærmere på antallet af organafstødninger hos patienter, som ikke reagerede på corticosteroider.
English: Modigraf is for long-term use.
Danish: Modigraf er beregnet til langtidsbehandling.
English: Modigraf also offered the possibility of giving more exact doses and may be more easily administered to young children.
Danish: Modigraf gjorde det også muligt at give mere nøjagtige doser og var nemmere at give til mindre børn.
English: However, the Modigraf combination was more effective than the other combination at preventing organ rejections that could not be treated by corticosteroids.
Danish: Modigrafkombinationen var dog mere effektiv end de øvrige kombinationer til forebyggelse af organafstødninger, som ikke kunne behandles med corticosteroider.
English: For the full list of all side effects reported with Modigraf, see the Package Leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Modigraf fremgår af indlægssedlen.
English: The Committee for Medicinal Products for Human Use (CHMP) was of the opinion that in terms of effectiveness and safety, Modigraf was similar to other tacrolimus medicines available as capsules.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) var af den opfattelse, at Modigraf med hensyn til virkning og sikkerhed lignede andre tacrolimus-lægemidler, der kunne fås som kapsler.
English: Treatment with Modigraf should only be prescribed by doctors who have experience in the management of transplant patients.
Danish: Modigraf bør kun ordineres af en læge med erfaring i behandling af transplantationspatienter.
English: Modigraf should not be used in people who may be hypersensitive (allergic) to tacrolimus or any of the other ingredients or to other macrolides (medicines with a similar structure to tacrolimus).
Danish: Modigraf må ikke anvendes til personer, som kan være overfølsomme (allergiske) over for tacrolimus eller andre af indholdsstofferne eller over for andre macrolider (lægemidler med en struktur, der ligner strukturen i tacrolimus).
English: The most common side effects with Modigraf (seen in more than 1 patient in 10) are diabetes, hyperglycaemia (high blood glucose), hyperkalaemia (high blood potassium), insomnia (difficulty sleeping), headache, tremor (shaking), hypertension (high blood pressure), diarrhoea, nausea (feeling sick), abnormal liver function test (abnormal level of liver enzymes), and kidney problems.
Danish: De hyppigste bivirkninger ved Modigraf (som optræder hos flere end 1 ug af 10 patienter) er diabetes, hyperglycæmi (forhøjet glukoseindhold i blodet), hyperkalæmi (forhøjet kaliumindhold i blodet), søvnbesvær, hovedpine, tremor (rysten), hypertension (forhøjet blodtryk), diarré, kvalme, unormal leverfunktionstest (unormalt indhold af leverenzymer) og nyreproblemer.