FrancophonIA/ELRC3.0 huggingface dataset:
English: The GEMINI III Study was a second randomised, double-blind, placebo-controlled study that evaluated efficacy at week 6 and week 10 in the subgroup of patients defined as having failed at least one conventional therapy and failed TNFα antagonist therapy (including primary non-responders) as well as the overall population, which also included patients who failed at least one conventional therapy and were naïve to TNFα antagonist therapy.
Danish: GEMINI III studiet var et andet randomiseret, dobbeltblindt, placebo-kontrolleret studie, som vurderede effekten i uge 6 og uge 10 hos undergruppen af patienter, defineret som patienter med manglende respons på mindst én konventionel behandling og manglende respons på TNFαantagonistbehandling (herunder primære non-respondere) samt den generelle population, der også inkluderede patienter med manglende respons på mindst én konventionel behandling og var naive til TNFα-antagonistbehandling.
English: • sudden, severe allergic reaction which can cause breathing difficulty, swelling, fast heartbeat, sweating, drop in blood pressure, light-headedness, loss of consciousness and collapse (anaphylactic reaction and anaphylactic shock)
Danish: • pludselig, alvorlig allergisk reaktion, som kan medføre åndedrætsbesvær, hævelse, hurtig puls, svedudbrud, blodtryksfald, svimmelhed, tab af bevidsthed og besvimelse (anafylaktisk reaktion og anafylaktisk shock)
English: For all subsequent infusions (after the first two), you will be monitored during the infusion and for approximately 1 hour after you have completed the infusion.
Danish: Ved alle efterfølgende infusioner (efter de første 2) vil du blive overvåget under infusionen og i ca. 1 time efter infusionens afslutning.
English: Beginning at week 6, patients who had achieved clinical response and were receiving corticosteroids were required to begin a corticosteroid-tapering regimen.
Danish: Startende i uge 6 skulle patienter, der havde opnået klinisk respons og fik kortikosteroider, begynde et nedtrapningsregime for kortikosteroider.
English: • if you have cancer, tell your doctor.
Danish: • hvis du har kræft, så fortæl lægen det. Din læge skal beslutte, om du stadig må få Entyvio.
English: Vedolizumab is a gut-selective immunosuppressive biologic.
Danish: Vedolizumab er et tarm-selektivt, immunsuppressivt, biologisk lægemiddel.
English: Vedolizumab is a gut-selective integrin antagonist with no identified systemic immunosuppressive activity (see section 5.1).
Danish: Vedolizumab er en tarm-selektiv integrin-antagonist uden identificeret systemisk immunsuppressiv aktivitet (se pkt.
English: By binding to α4β7 on certain lymphocytes, vedolizumab inhibits adhesion of these cells to mucosal addressin cell adhesion molecule-1 (MAdCAM-1), but not to vascular cell adhesion molecule-1 (VCAM-1).
Danish: Ved at binde sig til α4β7 på visse lymfocytter hæmmer vedolizumab adhæsion af disse celler til det mukosale addressin celleadhæsionsmolekyle-1 (MAdCAM-1), men ikke til det vaskulære celleadhæsionsmolekyle-1 (VCAM-1).
English: Caution should be exercised when considering the use of vedolizumab in patients with a controlled chronic severe infection or a history of recurring severe infections.
Danish: Der bør udvises forsigtighed, når det overvejes at bruge vedolizumab hos patienter med en kontrolleret, kronisk, svær infektion eller med gentagne, svære infektioner i anamnesen.
English: Vedolizumab blocks a protein on the surface of white blood cells that cause the inflammation in ulcerative colitis and Crohn's disease, and so the amount of inflammation is reduced.
Danish: Vedolizumab blokerer for et protein på overfladen af de hvide blodlegemer, som forårsager betændelsen i colitis ulcerosa og Crohns sygdommen, og reducerer dermed betændelsen.
English: Anaphylactic reaction, Anaphylactic shock
Danish: Meget sjælden Anafylaktisk reaktion, anafylaktisk shock
English: Clinical remission, week 10 Overall
Danish: Klinisk remission, uge 10 Generelt
English: Vedolizumab has been studied in adult ulcerative colitis and Crohn's disease patients with concomitant administration of corticosteroids, immunomodulators (azathioprine, 6-mercaptopurine, and methotrexate), and aminosalicylates.
Danish: Vedolizumab er blevet undersøgt hos voksne patienter med colitis ulcerosa og Crohns sygdom med samtidig administration af kortikosteroider, immunmodulerende lægemidler (azathioprin, 6-mercaptopurin og methotrexat) og aminosalicylater.
English: Vedolizumab has been detected in human milk.
Danish: Vedolizumab er påvist i human mælk.
English: Population pharmacokinetic analyses suggest that co-administration of such agents did not have a clinically meaningful effect on vedolizumab pharmacokinetics.
Danish: Populations-farmakokinetiske analyser tyder på, at samtidig administration af sådanne lægemidler ikke har nogen klinisk betydningsfuld virkning på vedolizumabs farmakokinetiske egenskaber.
English: Healthcare professionals should monitor patients on vedolizumab for any new onset or worsening of neurological signs and symptoms as outlined in physician education materials, and consider neurological referral if they occur.
Danish: Sundhedspersoner bør monitorere patienter, der får vedolizumab, for enhver nyopstået eller forværring af neurologiske tegn og symptomer, som beskrevet i lægernes undervisningsmaterialer, og evt. overveje henvisning til en neurolog.
English: The infections consisted primarily of nasopharyngitis, upper respiratory tract infection, sinusitis, and urinary tract infections.
Danish: Infektionerne bestod primært af nasofaryngitis, øvre luftvejsinfektion, sinusitis og urinvejsinfektioner.
English: Exploratory subgroup analyses from the clinical trials in Crohn's disease suggested that vedolizumab administered in patients without concomitant corticosteroid treatment may be less effective for induction of remission in Crohn's disease than in those patients already receiving concomitant corticosteroids (regardless of use of concomitant immunomodulators; see section 5.1).
Danish: Eksploratoriske analyser af undergrupper fra de kliniske forsøg af Crohns sygdom antyder, at vedolizumab administreret til patienter uden samtidig behandling med kortikosteroider kan være mindre effektiv for induktion af remission af Crohns sygdom end hos de patienter, der allerede er i samtidig kortikosteroidbehandling (uanset samtidig brug af immunmodulerende lægemidler; se pkt.
English: Entyvio treatment should be initiated and supervised by specialist healthcare professionals experienced in the diagnosis and treatment of ulcerative colitis or Crohn's disease (see section 4.4).
Danish: Entyvio-behandling skal initieres og superviseres af speciallæger med erfaring i diagnosticering og behandling af colitis ulcerosa eller Crohns sygdom (se pkt.
English: In healthy subjects, ulcerative colitis patients, or Crohn's disease patients, vedolizumab does not elevate neutrophils, basophils, eosinophils, B-helper and cytotoxic T lymphocytes, total memory T helper lymphocytes, monocytes or natural killer cells, in the peripheral blood with no leukocytosis observed.
Danish: Hos raske forsøgspersoner, patienter med colitis ulcerosa eller Crohns sygdom forøger vedolizumab ikke neutrofiler, basofiler, eosinofiler, B-hjælpe- og cytotoksiske T-lymfocytter, totale memory-T-hjælpe-lymfocytter, monocytter eller naturlige dræberceller i det perifere blod, og ingen leukocytose er observeret.
English: Analyses of week 52 clinical remission in patients who were non-responders at week 6 but achieved response at week 10 or week 14 indicate that non-responder CD patients may benefit from a dose of vedolizumab at week 10.
Danish: Analyse på patienter i klinisk remission i uge 52, som ikke havde responderet i uge 6, men opnåede respons i uge 10 eller uge 14, indikerede, at de kunne få gavn af en dosis vedolizumab i uge 10.
English: Other medicines and Entyvio Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Entyvio Fortæl lægen eller sundhedspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: Entyvio is for single-use only.
Danish: Entyvio er kun til engangsbrug.
English: • wheezing or difficulty breathing
Danish: • pibende vejrtrækning eller åndenød
English: It is a humanised monoclonal antibody that binds specifically to the α4β7 integrin, which is preferentially expressed on gut homing T helper lymphocytes.
Danish: Det er et humaniseret monoklonalt antistof, der binder sig specifikt til α4β7 integrinet, som fortrinsvis eksprimeres på T-hjælper lymfocytter målrettet mod tarmen.
English: • Any patients with new onset or worsening signs and symptoms suggestive of PML should be considered for neurological referral at a center equipped to diagnose PML.
Danish: • Det bør overvejes at henvise patienter med nyopstået eller forværring af tegn og symptomer der typder på PML til neurologisk undersøgelse på en klinik, der er udstyret til at diagnosticere PML.
English: Concomitant stable doses of oral corticosteroids, immunomodulators, and antibiotics were permitted.
Danish: Samtidig behandling med fast dosis af orale kortikosteroider, immunmodulatorer og antibiotika var tilladt.
English: In patients diagnosed with TB whilst receiving vedolizumab therapy, then vedolizumab therapy should be discontinued until the TB infection has been resolved.
Danish: Hos patienter, der diagnosticeres med TB, mens de får behandling med vedolizumab, skal behandlingen med vedolizumab seponeres, indtil TB-infektionen er behandlet.
English: The primary endpoint was the proportion of patients in clinical remission at week 6 in the TNFα antagonist failure subpopulation.
Danish: Det primære endepunkt var procentdelen af patienter i klinisk remission i uge 6 i subpopulationen, som ikke havde opnået respons på TNFα-antagonistbehandling.
English: No definitive conclusion can be drawn on the male reproductive organs in cynomolgus monkey repeated dose toxicity study.
Danish: Der kan ikke drages nogen afgørende konklusion fra toksicitetsstudiet med gentagne doser vedrørende mandlige reproduktionsorganer hos cynomolgusaber.
English: How Entyvio will be given
Danish: Sådan indgives Entyvio
English: Treatment 1
Danish: Behandling 1
English: Patients with Crohn's disease, who have not shown a response may benefit from a dose of Entyvio at week 10 (see section 4.4).
Danish: Patienter med Crohns sygdom, som ikke har udvist respons, kan nyde gavn af en dosis Entyvio i uge 10 (se pkt.
English: Patients showing clinical response at week 6 were required to begin corticosteroid tapering.
Danish: Patienter med klinisk respons i uge 6 skulle begynde nedtrapning af kortikosteroider.
English: Grounds for the variation to the terms of the Marketing Authorisation(s) On the basis of the scientific conclusions for vedolizumab the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing vedolizumab is unchanged subject to the proposed changes to the product information.
Danish: På baggrund af de videnskabelige konklusioner for vedolizumab er CHMP af den opfattelse, at benefit/risk-forholdet for det lægemiddel/de lægemidler, der indeholder vedolizumab, forbliver uændret under forudsætning af, at de foreslåede ændringer indføres i produktinformationen.
English: †p < 0.001 ‡p < 0.05 §Corticosteroid-free clinical remission: Patients using oral corticosteroids at baseline who had discontinued corticosteroids beginning at week 6 and were in clinical remission at week 52.
Danish: †p < 0,001 ‡p < 0,05 §Kortikosteroid-fri klinisk remission: Patienter, der brugte orale kortikosteroider ved baseline, men var holdt op med at tage kortikosteroider i uge 6 og var i klinisk remission i uge 52.
English: Tell your doctor if you are breast-feeding or planning to breast-feed.
Danish: Fortæl det til lægen, hvis du ammer eller planlægger at begynde at amme.
English: Infusion site reaction (including: Infusion site pain and Infusion site irritation), Infusion related reaction, Chills, Feeling cold
Danish: Ikke almindelig Reaktion på infusionsstedet (herunder: smerter og irritation på infusionsstedet), infusionsrelateret reaktion, kuldegysninger, patienten fryser
English: Ulcerative colitis is an inflammatory disease of the large bowel.
Danish: Colitis ulcerosa er en betændelsessygdom i tyktarmen.
English: 12 hours2
Danish: 12 timer2
English: Inhibiting the interaction of α4β7 with MAdCAM-1 with vedolizumab prevents transmigration of gut-homing memory T helper lymphocytes across the vascular endothelium into parenchymal tissue in nonhuman primates and induced a reversible 3-fold elevation of these cells in peripheral blood.
Danish: Når interaktionen af α4β7 med MAdCAM-1 hæmmes med vedolizumab, forhindres transmigrationen af memory-T-hjælper lymfocytter modrettet mod tarmen over det vaskulære endotel ind i parenkymvævet hos ikke-humane primater og fremkalder en reversibel 3-foldig forøgelse af disse celler i perifert blod.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with vedolizumab in one or more subsets of the paediatric population in ulcerative colitis and Crohn's disease (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med vedolizumab i en eller flere undergrupper af den pædiatriske population ved colitis ulcerosa og Crohns sygdom (se pkt.
English: No vedolizumab clinical trial data are available for patients previously treated with natalizumab or rituximab.
Danish: Der foreligger ingen data fra kliniske forsøg med vedolizumab for patienter, der tidligere er blevet behandlet med natalizumab eller rituximab.
English: Enrolled patients had failed at least one conventional therapy, including corticosteroids, immunomodulators, and/or the TNFα antagonist infliximab (including primary non-responders).
Danish: De inkluderede patienter havde manglende respons på mindst én konventionel behandling, herunder kortikosteroider, immunmodulerende lægemidler og/eller TNFα-antagonisten infliximab (herunder primære non-respondere).
English: Improvements in durable clinical response (47%, 43%, 16%), mucosal healing (42%, 48%, 8%), durable clinical remission (21%, 13%, 3%) and corticosteroid-free clinical remission (23%, 32%, 4%) were seen in the prior TNFα antagonist failure population treated with vedolizumab every eight weeks, vedolizumab every four weeks and placebo, respectively.
Danish: Forbedringer i vedvarende klinisk respons (47 %, 43 %, 16 %), mucosaheling (42 %, 48 %, 8 %), vedvarende klinisk remission (21 %, 13 %, 3 %) og kortikosteroidfri klinisk remission (23 %, 32 %, 4 %) blev set hos populationen, som tidligere havde manglende respons på TNFα-antagonistbehandling og som blev behandlet med hhv. vedolizumab hver 8. uge, vedolizumab hver 4. uge og placebo.
English: Patients who achieved a clinical response after receiving vedolizumab at week 0 and 2 and were then randomised to placebo (for 6 to 52 weeks) and lost response were allowed to enter the open-label extension study and receive vedolizumab every four weeks.
Danish: Patienter, som opnåede klinisk respons efter at have fået vedolizumab i uge 0 og 2 og så blev randomiseret til placebo (i 6 til 52 uger) og mistede respons, fik lov til at indgå i det open-label forlængelsesstudie og få vedolizumab hver 4. uge.
English: In GEMINI I and II controlled studies, the rate of serious infections was 0.07 per patient year in vedolizumab-treated patients and 0.06 per patient year in placebo-treated patients.
Danish: I GEMINI I og II kontrollerede studier var raten af alvorlige infektioner 0,07 pr. patientår hos vedolizumab-behandlede patienter og 0,06 pr. patientår hos placebo-behandlede patienter.
English: Powder for concentrate for solution for infusion in Type 1 glass vial (20 mL) fitted with rubber stopper and aluminium crimp protected by a plastic cap.
Danish: Pulver til koncentrat til infusionsvæske, opløsning i hætteglas (type 1 glas) (20 ml) monteret med gummiprop og aluminiumforsegling beskyttet med plasthætte.
English: Treatment 3
Danish: Behandling 3
English: The single and multiple dose pharmacokinetics of vedolizumab have been studied in healthy subjects and in patients with moderate to severely active ulcerative colitis or Crohn's disease.
Danish: Vedolizumabs farmakokinetik ved enkeltdoser og multiple doser er blevet undersøgt hos raske forsøgspersoner og hos patienter med moderat til svær aktiv colitis ulcerosa eller Crohns sygdom.
English: Concomitant stable doses of oral aminosalicylates, corticosteroids and/or immunomodulators were permitted.
Danish: Samtidig behandling med fast dosis af orale aminosalicylater, kortikosteroider og/eller immunmodulerende lægemidler var tilladt.
English: Exploratory analysis show clinically meaningful improvements were observed for vedolizumab groups, and the improvements were significantly greater as compared with the placebo group at week 6 and week 52 on EQ-5D and EQ-5D VAS scores, all subscales of IBDQ (bowel symptoms, systemic function, emotional function and social function), and all subscales of SF-36 including the Physical Component Summary (PCS) and Mental Component Summary (MCS).
Danish: Eksploratorisk analyse viser, at klinisk betydningsfulde forbedringer blev observeret for vedolizumab-grupperne, og forbedringerne var signifikant større i sammenligning med placebo-gruppen i uge 6 og uge 52 på EQ-5D- og EQ-5D VAS-scorer, alle subskalaer af IBDQ (tarmsymptomer, systemisk funktion, mental funktion og social funktion) og alle subskalaer af SF-36, herunder på den fysiske helbredskomponent (PCS) og den mentale helbredskomponent (MCS).
English: The efficacy and safety of vedolizumab for the treatment of adult patients with moderately to severely active ulcerative colitis (Mayo score 6 to 12 with endoscopic sub score ≥ 2) was demonstrated in a randomised, double-blind, placebo-controlled study evaluating efficacy endpoints at week 6 and week 52 (GEMINI I).
Danish: Vedolizumabs virkning og sikkerhed ved behandlingen af voksne patienter med moderat til svær aktiv colitis ulcerosa (Mayo-score 6 til 12 med endoskopi-subscore på ≥ 2) blev påvist i et randomiseret, dobbeltblindet, placebo-kontrolleret studie, der vurderende effektendepunkterne i uge 6 og uge 52 (GEMINI I).
English: • if you experience signs of an allergic reaction or other reaction to the infusion such as wheezing, difficulty breathing, hives, itching, swelling or dizziness.
Danish: • hvis du oplever tegn på en allergisk reaktion eller anden reaktion på infusionen, f.eks. pibende vejrtrækning, åndenød, nældefeber, kløe, hævelse eller svimmelhed.
English: Prior and concurrent use of biological products
Danish: Tidligere og samtidig brug af biologiske lægemidler
English: Treatment 2
Danish: Behandling 2
English: 24 hours2,3
Danish: 24 timer2,3
English: The active substance is vedolizumab.
Danish: Aktivt stof: Vedolizumab.
English: The patient is to be given a Patient Alert Card (see section 4.2).
Danish: Patienten skal forsynes med et patientinformationskort (se pkt.
English: Vedolizumab did not affect immune responses to antigenic challenge in the dermis and muscle (see section 4.4).
Danish: Vedolizumab påvirkede ikke immunrespons over for antigen-belastning i dermis og muskler (se pkt.
English: The beneficial effect of vedolizumab on clinical response, remission and mucosal healing was observed both in patients with no prior TNFα antagonist exposure as well as in those who had failed prior TNFα antagonist therapy.
Danish: Den gavnlige virkning af vedolizumab på klinisk respons, remission og mucosaheling blev observeret både hos patienter uden tidligere TNFαantagonist-eksponering og hos patienter med manglende respons på tidligere TNFαantagonist-behandling.
English: Administer the infusion solution over 30 minutes (see section 4.2).
Danish: Infusionsopløsningen administreres over 30 minutter (se pkt.
English: Any time that the reconstituted solution was held in the vial should be subtracted from the time the solution may be held in the infusion bag.
Danish: Tidsrum, hvor den rekonstituerede opløsning har været opbevaret i hætteglasset, skal trækkes fra det tidsrum, i hvilket opløsningen må opbevares i infusionsposen.
English: By binding to the α4β7 integrin expressed on gut-homing lymphocytes, vedolizumab exerts an immunosuppressive effect specific to the gut.
Danish: Ved at binde sig til α4β7-integrinet eksprimeret på lymfocytter målrettet mod tarmen, udviser vedolizumab en immunsuppressiv virkning, der er specifik for tarmene.
English: In GEMINI I and II controlled studies, the rate of infections was 0.85 per patient-year in the vedolizumab-treated patients and 0.70 per patient-year in the placebo-treated patients.
Danish: I GEMINI I og II kontrollerede studier var raten af infektioner 0,85 pr. patientår hos vedolizumab-behandlede patienter og 0,70 pr. patientår hos placebo-behandlede patienter.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Entyvio therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Danish: Det skal besluttes, om du skal ophøre med at amme eller stoppe med at tage Entyvio, idet der tages højde for fordelene ved amning for dit barn i forhold til fordelene ved behandlingen for dig.
English: M anufacture r Delpharm Novara S.r.l.
Danish: Fre ms tille r Delpharm Novara S.r.l.
English: Patient numbers were n = 72 for placebo, n = 70 for vedolizumab every eight weeks, and n = 73 for vedolizumab every four weeks
Danish: Antallet af patienter var n = 72 for placebo, n = 70 for vedolizumab hver 8. uge og n = 73 for vedolizumab hver 4. uge
English: • Patient alert card,
Danish: • Patientinformationskort
English: In-use stability of the reconstituted solution in the vial has been demonstrated for 8 hours at 2°C-8°C.
Danish: senere anvendelse af den rekonstituerede opløsning i hætteglasset er påvist i 8 timer ved 2 °C-8 °C.
English: Immediately withdraw 5 mL (300 mg) of reconstituted Entyvio using a syringe with a 21-25 gauge needle.
Danish: Træk straks 5 ml (300 mg) af det rekonstituerede Entyvio op ved hjælp af en sprøjte med en 21-25 G (gauge) kanyle.
English: Add the 5 mL (300 mg) of reconstituted Entyvio to 250 mL of sterile sodium chloride 9 mg/mL (0.9%) solution for injection, and gently mix the infusion bag (5 mL of sodium chloride 9 mg/mL (0.9%) solution for injection does not have to be withdrawn from the infusion bag prior to adding Entyvio).
Danish: Tilsæt de 5 ml (300 mg) af det rekonstituerede Entyvio til 250 ml steril natriumchlorid 9 mg/ml (0,9 %) injektionsvæske, opløsning, og bland forsigtigt i infusionsposen (5 ml natriumchlorid 9 mg/ml (0,9 %) injektionsvæske, opløsning behøver ikke trækkes op fra infusionsposen før tilsætningen af Entyvio).
English: In patients administered 300 mg vedolizumab as a 30 minute intravenous infusion on weeks 0 and 2, mean serum trough concentrations at week 6 were 27.9 mcg/mL (SD ± 15.51) in ulcerative colitis and 26.8 mcg/mL (SD ± 17.45) in Crohn's disease.
Danish: Hos patienter, administreret med 300 mg vedolizumab som en 30-minutters intravenøs infusion i uge 0 og 2, var de gennemsnitlige koncentrationer af serum i uge 6 på 27,9 mikrog/ml (SD ± 15,51) ved colitis ulcerosa og 26,8 mikrog/ml (SD ± 17,45) ved Crohns sygdom.
English: Exploratory analysis showed clinically meaningful improvements were observed for the vedolizumab every four weeks and every eight weeks groups in GEMINI II and the improvements were significantly greater as compared with the placebo group from baseline to week 52 on EQ-5D and EQ-5D VAS scores, total IBDQ score, and IBDQ subscales of bowel symptoms and systemic function.
Danish: Eksploratoriske analyser viser, at der blev observeret klinisk betydningsfulde forbedringer for grupperne, der fik vedolizumab hver 4. uge og hver 8. uge i GEMINI II, og at forbedringerne var signifikant større sammenlignet med placebo-gruppen fra baseline til uge 52 på EQ-5D- og EQ-5D VAS-scorer, total IBDQ-score og IBDQ-subskalaer af tarmsymptomer og systemisk funktion.