FrancophonIA/ELRC3.0 huggingface dataset:
English: Every 8 weeks
Danish: Hver 8. uge
English: ¶Durable clinical remission: Clinical remission at ≥ 80% of study visits including final visit (week 52)
Danish: ¶Vedvarende klinisk remission: Klinisk remission ved ≥ 80 % af studiebesøg, herunder sidste besøg (uge 52)
English: 3 This period may include up to 12 hours at 20 °C-25 °C.
Danish: 3 Dette tidsrum kan omfatte op til 12 timer ved 20 °C-25 °C.
English: • Your doctor will also give you a Patient Alert Card for you to keep with you at all times.
Danish: • Lægen vil også give dig et patientinformationskort, som du altid skal have på dig.
English: trafficking into the CNS as evidenced by the lack of change in the ratio of CD4 +/CD8
Danish: transport i centralnervesystemet (CNS), hvilket ses ved manglende ændring i forholdet af CD4 +/CD8
English: Entyvio should not be given with other biologic medicines that suppress your immune system as the effect of this is not known.
Danish: Entyvio bør ikke gives sammen med andre biologiske lægemidler, som undertrykker immunsystemet, da virkningen heraf ikke er kendt.
English: Entyvio has not been studied in these patient populations.
Danish: Entyvio er ikke blevet undersøgt hos disse patientpopulationer.
English: You should use adequate contraception during treatment and for at least 4.5 months after the last treatment.
Danish: Du skal anvende sikker kontraception under behandlingen og i mindst 4½ måned efter den sidste behandling.
English: Doses up to 10 mg/kg (approximately 2.5 times the recommended dose) have been administered in clinical trials.
Danish: Doser på op til 10 mg/kg (ca. 2,5 gange den anbefalede dosis) er blevet administreret i kliniske forsøg.
English: No dose adjustment is required in elderly patients.
Danish: Dosisjustering er ikke nødvendig hos ældre patienter.
English: Do not hold1
Danish: Må ikke gemmes1
English: Most infusion related reactions occurred within the first 2 hours.
Danish: De fleste infusionsrelaterede reaktioner forekom inden for de første 2 timer.
English: Patients receiving vedolizumab treatment may continue to receive non-live vaccines.
Danish: Patienter, der får vedolizumab-behandling, kan fortsætte med at få ikke-levende vacciner.
English: The Physican's Educational Material should contain the following key messages:
Danish: Undervisningsmaterialet til læger skal indeholde følgende hovedelementer:
English: Do not vigorously shake or invert.
Danish: Må ikke rystes kraftigt eller vendes på hovedet.
English: Efficacy Results for GEMINI II at week 52 Placebo n = 153*
Danish: Effektresultater for GEMINI II i uge 52 Placebo n = 153*
English: • Consider the patient's full medical history, including any prior or concurrent biological medicine use
Danish: • Overvej patientens fulde anamnese, herunder evt. tidligere eller samtidig brug af biologiske lægemidler
English: Once reconstituted, the infusion solution should be used as soon as possible.
Danish: Efter rekonstitution af infusionsopløsningen skal den anvendes snarest muligt.
English: A small number of patients have felt dizzy after receiving Entyvio.
Danish: Et lille antal patienter har oplevet svimmelhed efter at have fået Entyvio.
English: If you have previously taken natalizumab (a medicine used to treat multiple sclerosis) or rituximab (a medicine used to treat certain types of cancer and rheumatoid arthritis), tell your doctor, who will decide if you can be given Entyvio.
Danish: Hvis du tidligere har brugt natalizumab (et lægemiddel, der anvendes til at behandle multipel sklerose) eller rituximab (et lægemiddel, der anvendes til at behandle visse typer kræft og leddegigt), skal du fortælle det til lægen, så denne kan beslutte, om du må få Entyvio.
English: Therapy should be continued every eight weeks from week 14 in responding patients.
Danish: Behandlingen bør fortsættes hver 8. uge fra uge 14 hos responderende patienter.
English: If you have Crohn's disease you will first be given other medicines.
Danish: Hvis du har Crohns sygdom, vil du først blive behandlet med andre lægemidler.
English: Therefore, this medicine is not recommended for use during pregnancy unless you and your doctor decide that the benefit to you clearly outweighs the potential risk to yourself and your baby.
Danish: Derfor anbefales dette lægemiddel ikke til brug under graviditeten, medmindre du og din læge beslutter, at fordelen for dig klart opvejer den mulige risiko for dig og dit barn.
English: This leaflet is available in formats suitable for the blind or partially sighted patient and can be requested from respective local representative of the Marketing Authorisation Holder.
Danish: Denne indlægsseddel er tilgængelig i formater, der egner sig for blinde og svagsynede og kan rekvireres fra den pågældende lokale repræsentant for indehaveren af markedsføringstilladelsen.
English: • if you are not feeling any better as vedolizumab may take up to 14 weeks to work in some patients with very active Crohn's disease.
Danish: • hvis du ikke har fået det bedre, da det kan tage op til 14 uger, før vedolizumab virker hos nogle patienter med meget aktiv Crohns sygdom.
English: The recommended dose is 300 mg of Entyvio given as follows (see table below):
Danish: Den anbefalede dosis er 300 mg Entyvio, der indgives som følger (se nedenstående tabel):
English: Other live vaccines may be administered concurrently with vedolizumab only if the benefits clearly outweigh the risks.
Danish: Andre levende vacciner må kun gives samtidigt med vedolizumab, hvis fordelene klart opvejer risiciene.
English: Live vaccines, in particular live oral vaccines, should be used with caution concurrently with Entyvio (see section 4.4).
Danish: Levende vacciner, især levende orale vacciner, bør anvendes med forsigtighed sammen med Entyvio (se pkt.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid eller planlægger at blive gravid, skal du spørge din læge til råds, før du begynder behandlingen med dette lægemiddel.
English: Overall, results from the clinical program to date do not suggest an increased risk for malignancy with vedolizumab treatment; however, the number of malignancies was small and long-term exposure was limited.
Danish: Generelt tyder resultaterne fra det kliniske program til dato ikke på, at der er øget risiko for malignitet ved vedolizumab-behandling; antallet af maligniteter var dog lille, og den langsigtede eksponering var begrænset.
English: The treatment interruption period in clinical trials extended up to one year.
Danish: I kliniske forsøg strakte behandlingsafbrydelsesperioden sig op til 1 år.
English: Vedolizumab did not affect CD4
Danish: Vedolizumab påvirkede ikke CD4
English: Do not use this medicine if you notice any particles in the liquid or discolouration prior to administration.
Danish: Anvend ikke lægemidlet, hvis der bemærkes partikler i væsken eller misfarvning før administrationen.
English: In patients who have responded to treatment with Entyvio, corticosteroids may be reduced and/or discontinued in accordance with standard of care.
Danish: Hos patienter, som har responderet på behandling med Entyvio, kan kortikosteroider reduceres og/eller seponeres i overensstemmelse med standardbehandling.
English: Therefore, the use of Entyvio in such patients is not recommended.
Danish: Derfor anbefales brugen af Entyvio til sådanne patienter ikke.
English: These data are consistent with investigations in nonhuman primates which did not detect effects on immune surveillance of the CNS.
Danish: Disse data er i overensstemmelse med undersøgelser i ikke-humane primater, hvor der ikke blev konstateret effekt på immunovervågning af CNS.
English: • blurred vision (loss of sharpness of eyesight)
Danish: • sløret syn (tab af evne til at se skarpt)
English: • pain at the infusion site
Danish: • smerter på infusionsstedet
English: These may all be symptoms of a serious and potentially fatal brain condition known as progressive multifocal leukoencephalopathy (PML).
Danish: Alle disse kan være symptomer på en alvorlig og potentielt fatal hjernetilstand kaldet progressiv multifokal leukoencefalopati (PML).
English: Serum CRP change from baseline to week 6, median (mcg/mL) Overall‡
Danish: CRP-ændring i serum fra baseline til uge 6, median (µg/ml) Generelt‡
English: Vedolizumab does not bind to, nor inhibit function of, the α4β1 and αEβ7 integrins.
Danish: Vedolizumab binder sig ikke til og hæmmer heller ikke funktionen af α4β1 og αEβ7 integriner.
English: Induction of remission in Crohn's disease
Danish: Induktion af remission af Crohns sygdom
English: Caution should be exercised when considering the use of Entyvio in these patients.
Danish: Der bør udvises forsigtighed, når det overvejes at anvende Entyvio til disse patienter.
English: • The infusion will be given to you, by your doctor or nurse, through a drip in one of the veins in your arm (intravenous infusion) over about 30 minutes.
Danish: • Infusionen bliver givet til dig af lægen eller sundhedspersonalet gennem et drop i en vene i armen (intravenøs infusion) i løbet af ca. 30 minutter.
English: Based on plausible mechanism and available number of spontaneous reports of herpes zoster, the PRAC concluded that the product information should be updated with herpes zoster as a new adverse drug reaction with frequency uncommon.
Danish: På baggrund af den plausible mekanisme og det tilgængelige antal spontane indberetninger om herpes zoster er PRAC nået til den konklusion, at produktinformationen skal opdateres med herpes zoster som en ny bivirkning med hyppigheden ikke almindelig.
English: • Physician's Educational Material
Danish: • Undervisningsmateriale til læger
English: Entyvio is contraindicated in patients with active tuberculosis (see section 4.3).
Danish: Entyvio er kontraindiceret hos patienter med aktiv tuberkulose (se pkt.
English: Most infusion related reactions were not serious and occurred during the infusion or within the first hour after infusion is completed.
Danish: De fleste infusionsrelaterede reaktioner var ikke alvorlige og forekom under infusionen eller inden for den første time efter infusionens afslutning.
English: If you are a woman of childbearing potential, you are advised to avoid becoming pregnant while using Entyvio.
Danish: Hvis du er kvinde i den fertile alder, rådes du til at undgå at blive gravid, mens du får Entyvio.
English: The safety and efficacy of vedolizumab in children aged 0 to 17 years old have not been established.
Danish: Vedolizumabs sikkerhed og virkning hos børn i alderen 0 til 17 år er ikke klarlagt.
English: • acne (pimples)
Danish: • acne (filipenser)
English: There was no clinically meaningful difference in clinical remission between treatment groups at these time points.
Danish: På disse tidspunkter var der ingen klinisk betydningsfuld forskel i klinisk remission mellem behandlingsgrupperne.
English: Instructions for reconstitution and infusion
Danish: Vejledning til rekonstitution og infusion
English: Do not add other medicinal products to the prepared infusion solution or intravenous infusion set.
Danish: Tilsæt ikke andre lægemidler til den tilberedte infusionsopløsning eller det intravenøse infusionssæt.
English: 24 hours2, 3
Danish: 24 timer2, 3
English: Taking into account the PRAC Assessment Report on the PSUR(s) for vedolizumab, the scientific conclusions of the CHMP are as follows:
Danish: Under hensyntagen til PRAC's vurderingsrapport om PSUR'en/PSUR'erne for vedolizumab er CHMP nået frem til følgende videnskabelige konklusioner:
English: Observed IRRs generally resolved with no or minimal intervention following the infusion.
Danish: Observerede IRR'er forsvandt som regel uden nogen eller kun minimal intervention efter infusionen.
English: Some integrin antagonists and some systemic immunosuppressive agents have been associated with progressive multifocal leukoencephalopathy (PML), which is a rare and often fatal opportunistic infection caused by the John Cunningham (JC) virus.
Danish: Nogle integrin-antagonister og nogle systemiske immunsuppressive midler er blevet associeret med progressiv multifokal leukoencefalopati (PML), som er en sjælden og ofte dødelig opportunistisk infektion forårsaget af John Cunningham (JC) virus.
English: Pharmacotherapeutic group: immunosuppressants, selective immunosuppressants, ATC code: L04AA33
Danish: Farmakoterapeutisk klassifikation: immunsuppressive lægemidler, selektive immunsuppressive lægemidler, ATC-kode: L04AA33
English: Entyvio is administered as an intravenous infusion over 30 minutes.
Danish: Entyvio administreres som intravenøs infusion over 30 minutter.
English: For the first two infusions, they should also be observed for approximately 2 hours following completion of the infusion for signs and symptoms of acute hypersensitivity reactions.
Danish: Ved de første to infusioner skal de også observeres i ca. 2 timer efter infusionens afslutning for tegn og symptomer på akutte overfølsomhedsreaktioner.
English: Possible serious side effects include infusion reactions or allergic reactions (may affect up to 1 in 100 people) and infections (may affect up to 1 in 10 people).
Danish: Blandt mulige alvorlige bivirkninger er infusionsrelaterede reaktioner, allergiske reaktioner (kan forekomme hos op til 1 ud af 100 personer) og infektioner (kan forekomme hos op til 1 ud af 10 personer).
English: Although no systemic immunosuppressive effect was noted in healthy subjects the effects on systemic immune system function in patients with inflammatory bowel disease is not known.
Danish: Selv om ingen systemisk immunsuppressiv virkning er bemærket hos raske personer, er virkningerne på det systemiske immunsystems funktion hos patienter med inflammatorisk tarmsygdom ikke kendt.
English: If PML is suspected, treatment with vedolizumab must be withheld; if confirmed, treatment must be permanently discontinued.
Danish: Hvis der er mistanke om PML, skal behandlingen med vedolizumab seponeres; hvis sygdommen bekræftes, skal behandlingen seponeres permanent.
English: Antibodies to vedolizumab may develop during vedolizumab treatment most of which are neutralising.
Danish: Der kan udvikles antistoffer mod vedolizumab under behandling med vedolizumab, og de fleste af disse er neutraliserende.
English: Timing of treatment (infusion)
Danish: Tidspunkt for behandlingen (infusionen)
English: Gently swirl the vial for at least 15 seconds.
Danish: Hætteglasset hvirvles forsigtigt rundt i mindst 15 sekunder.
English: • moderately to severely active ulcerative colitis
Danish: • moderat til svær aktiv colitis ulcerosa
English: In this open-label extension study, clinical remission and clinical response were observed in patients for up to 196 weeks.
Danish: I dette open-label forlængelsesstudie blev der observeret klinisk remission og klinisk respons hos patienter i op til 196 uger.
English: Women of childbearing potential should use adequate contraception to prevent pregnancy and to continue its use for at least 18 weeks after the last treatment.
Danish: Kvinder i den fertile alder skal anvende sikker kontraception for at undgå graviditet under behandlingen og fortsætte i mindst 18 uger efter den sidste behandling.
English: Physicians should be aware of the potential increased risk of opportunistic infections or infections for which the gut is a defensive barrier (see section 4.8).
Danish: Læger skal være opmærksomme på den potentielle øgede risiko for opportunistiske infektioner eller infektioner, som tarmen er beskyttelsesbarriere mod (se pkt.
English: In a pharmacologically responsive species (cynomolgus monkeys), there was no evidence of cellular hyperplasia or systemic immunomodulation that could potentially be associated with oncogenesis in 13- and 26-week toxicology studies.
Danish: Hos en farmakologisk responsiv dyreart (cynomolgus aber) var der ingen tegn på cellulær hyperplasi eller systemisk immunmodulation, som potentielt kunne associeres med oncogenese i 13- og 26-ugers toksikologiske studier.
English: Immunomodulatory medicinal products may increase the risk of malignancy (see section 4.8).
Danish: Immunmodulerende lægemidler kan muligvis øge risikoen for malignitet (se pkt.
English: The recommended dose regimen of Entyvio is 300 mg administered by intravenous infusion at zero, two and six weeks and then every eight weeks thereafter.
Danish: Det anbefalede dosisregime for Entyvio er 300 mg administreret ved intravenøs infusion i uge 0, 2 og 6 og så hver 8. uge derefter.
English: The use of vedolizumab in lactating women should take into account the benefit of therapy to the mother and potential risks to the infant.
Danish: Beslutningen om at bruge vedolizumab til kvinder, der ammer, skal tage højde for de terapeutiske fordele for moderen og de potentielle risici for barnet.
English: Given the known risk of PML development in patients with previous natalizumab exposure, physicians should normally wait 12 weeks after the last natalizumab dose prior to initiating Entyvio treatment.
Danish: Givet den kendte risiko for at udvikle PML hos patienter, der tidligere har været eksponeret for natalizumab, bør læger normalt vente 12 uger efter den sidste dosis af natalizumab, inden behandling med Entyvio initieres.
English: No dose-limiting toxicity was seen in clinical trials.
Danish: Der blev ikke observeret nogen dosis-begrænsende toksicitet i kliniske forsøg.
English: If you have ulcerative colitis, you will first be given other medicines.
Danish: Hvis du har colitis ulcerosa, vil du først blive behandlet med andre lægemidler.
English: The exact elimination route of vedolizumab is not known.
Danish: Den nøjagtige eliminationsvej for vedolizumab er ikke kendt.
English: 0 weeks
Danish: 0 uge
English: Solution should be clear or opalescent, colourless to light yellow and free of visible particulates.
Danish: Opløsningen skal være klar eller opaliserende, farveløs til lysegul og fri for synlige partikler.
English: Entyvio has minor influence on the ability to drive and use machines, as dizziness has been reported in a small number of patients.
Danish: Entyvio påvirker evnen til at føre motorkøretøj og betjene maskiner i mindre grad, idet svimmelhed er indrapporteret hos et lille antal patienter.
English: 6 weeks after Treatment 1
Danish: 6 uger efter behandling 1
English: Patients should be monitored during and after infusion (see section 4.4).
Danish: Patienterne skal monitoreres under og efter infusionen (se pkt.
English: Entyvio is given by a doctor or nurse and patients should not need to store or handle Entyvio.
Danish: Entyvio gives af en læge eller sundhedspersonale, så det skulle ikke være nødvendigt for patienter at opbevare eller håndtere Entyvio.
English: The following listing of adverse reactions is based on clinical trial and post marketing experience and is displayed by system organ class.
Danish: Følgende tabel over bivirkninger er baseret på erfaringerne fra kliniske studier samt erfaringer efter markedsføring og vises efter systemorganklasse.
English: If a severe IRR, anaphylactic reaction, or other severe reaction occurs, administration of Entyvio must be discontinued immediately and appropriate treatment initiated (e.g., epinephrine and antihistamines) (see section 4.3).
Danish: Hvis der opstår en svær IRR, anafylaktisk reaktion eller anden svær reaktion, skal administrationen af Entyvio straks ophøre, og passende behandling påbegyndes (f.eks. epinefrin og antihistaminer) (se pkt.
English: Once the mild or moderate IRR subsides, continue the infusion.
Danish: Når den milde eller moderate IRR først er stilnet af, kan infusionen fortsætte.
English: in cerebrospinal fluid pre- and post-vedolizumab administration in healthy human volunteers.
Danish: i cerebrospinalvæsken præ- og postvedolizumab administration hos raske, frivillige forsøgspersoner.
English: If you stop using Entyvio You should not stop using Entyvio without talking with your doctor first.
Danish: Hvis du holder op med at få Entyvio Inden du holder op med at få Entyvio, skal du først tale med din læge.
English: This medicine has a minor influence on your ability to drive or use tools or machines.
Danish: Dette lægemiddel kan i mindre grad påvirke evnen til at køre motorkøretøj, arbejde med værktøj og betjene maskiner.
English: (see also section 5.1.)
Danish: (angivet i punkt 6)
English: Tell your doctor as soon as possible if you notice any of the following:
Danish: Fortæl snarest muligt lægen, hvis du bemærker nogen af følgende bivirkninger:
English: The formation of anti-vedolizumab antibodies is associated with increased clearance of vedolizumab and lower rates of clinical remission.
Danish: Dannelsen af anti-vedolizumab-antistoffer er forbundet med øget clearance af vedolizumab og nedsatte rater af klinisk remission.
English: Physicians should consider pre-treatment (e.g., with antihistamine, hydrocortisone and/or paracetamol) prior to the next infusion for patients with a history of mild to moderate IRR to vedolizumab, in order to minimize their risks (see section 4.8).
Danish: Læger bør overveje præmedicinering (f.eks. med antihistamin, hydrokortison og/eller paracetamol) inden den næste infusion for patienter med mild til moderat IRR over for vedolizumab i anamnesen for at minimere deres risici (se pkt.
English: There are no data on the effects of vedolizumab on human fertility.
Danish: Der foreligger ingen data om vedolizumabs virkning på human fertilitet.
English: Entyvio is for intravenous use only.
Danish: Entyvio er kun til intravenøs brug.
English: Table 2 shows the results from the primary and secondary endpoints evaluated.
Danish: Tabel 2 viser resultaterne fra de primære og sekundære endepunkter, der blev vurderet.
English: Further treatments
Danish: Yderligere behandlinger
English: Furthermore, no effects were found of vedolizumab on the proliferative rate or cytotoxicity of a human tumour cell line expressing the α4β7 integrin in vitro.
Danish: Endvidere konstateredes der ingen virkninger af vedolizumab på proliferationsraten eller cytotoksiciteten af en human tumorcellelinje, der eksprimerede α4β7-integrinet in vitro.
English: Efficacy Results for GEMINI II and III Studies at week 6 and week 10
Danish: Effektresultater for GEMINI II og III studier i uge 6 og uge 10 Studie
English: Takeda Austria GmbH St. Peter-Straße 25 4020 Linz
Danish: Takeda Austria GmbH St. Peter-Straβe 25 A-4020 Linz Østrig
English: Before starting treatment with vedolizumab, patients must be screened for tuberculosis according to the local practice.
Danish: Inden behandling med vedolizumab påbegyndes, skal patienter screenes for tuberkulose i henhold til lokale retningslinjer.
English: Entyvio contains the active substance vedolizumab.
Danish: Entyvio indeholder det aktive stof vedolizumab.
English: Effects on male and female fertility have not been formally evaluated in animal studies (see section 5.3).
Danish: Virkninger på mandlig og kvindelig fertilitet er ikke blevet formelt vurderet i dyreforsøg (se pkt.
English: There are no data on the secondary transmission of infection by live vaccines in patients receiving vedolizumab.
Danish: Der foreligger ingen data om den sekundære infektionsoverførsel af levende vacciner hos patienter, der får vedolizumab.
English: Table 3 shows the results from the primary and secondary endpoints evaluated.
Danish: Tabel 3 viser resultaterne fra de primære og sekundære endepunkter, der blev vurderet.
English: Starting at week 6, patients received 300 mg vedolizumab every eight or four weeks.
Danish: Startende i uge 6 fik patienter 300 mg vedolizumab hver 8. eller 4. uge.
English: Reconstituted solution with uncharacteristic colour or containing particulates must not be administered.
Danish: Rekonstitueret opløsning med ukarakteristisk farve eller med partikler må ikke administreres.
English: Sustained clinical remission#,¶ Overall
Danish: Vedholdende klinisk remission#,¶ Generelt
English: Population pharmacokinetic analyses indicate that the distribution volume of vedolizumab is approximately 5 litres.
Danish: Populations-farmakokinetiske analyser indikerer, at vedolizumabs fordelingsvolumen er ca. 5 liter.