FrancophonIA/ELRC3.0 huggingface dataset:
English: The Marketing Authorisation Holder (MAH) shall ensure that, prior to launch, all physicians who are expected to prescribe/use Entyvio are provided with a physician pack containing the following:
Danish: Før lancering af lægemidlet skal indehaveren af markedsføringstilladelsen sikre, at alle læger, der forventes at ordinere/bruge Entyvio, forsynes med en lægepakke, der indeholder følgende:
English: Entyvio treatment is not to be initiated in patients with active, severe infections until the infections are controlled, and physicians should consider withholding treatment in patients who develop a severe infection while on chronic treatment with Entyvio.
Danish: Behandling med Entyvio bør ikke initieres hos patienter med aktive, svære infektioner, før infektionerne er under kontrol, og læger bør overveje at pausere behandling hos patienter, som udvikler en svær infektion, mens de er i kronisk behandling med Entyvio.
English: Population pharmacokinetic analyses suggest that while low albumin, higher body weight and prior treatment with anti-TNF drugs may increase vedolizumab clearance, the magnitude of their effects is not considered to be clinically relevant.
Danish: Farmakokinetiske populationsanalyser tyder på, at mens lavt albumin, højere legemsvægt og tidligere behandling med anti-TNF-lægemidler kan øge vedolizumab-clearance, anses deres effekt ikke for at være klinisk relevant.
English: • moderately to severely active Crohn's disease.
Danish: • moderat til svær aktiv Crohns sygdom
English: It is recommended that all patients be brought up to date with all immunisations in agreement with current immunisation guidelines prior to initiating Entyvio therapy.
Danish: Det anbefales, at alle patienter inden påbegyndelse af Entyvio-behandling bringes ajour med alle immuniseringer i overensstemmelse med gældende retningslinjer for immunisering.
English: If a mild to moderate IRR occurs, the infusion rate can be slowed or interrupted and appropriate treatment initiated.
Danish: Hvis der opstår en mild til moderat IRR, kan infusionshastigheden sættes ned eller infusionen afbrydes, og passende behandling påbegyndes.
English: Long-term animal studies with vedolizumab to assess its carcinogenic potential have not been conducted because pharmacologically responsive models to monoclonal antibodies do not exist.
Danish: Der er ikke blevet udført langsigtede dyreforsøg med vedolizumab for at vurdere dets carcinogene potentiale, fordi der ikke findes farmakologisk responsive modeller for monoklonale antistoffer.
English: If latent tuberculosis is diagnosed, appropriate treatment must be started with anti-tuberculosis treatment in accordance with local recommendations, before beginning vedolizumab.
Danish: Hvis der diagnosticeres latent tuberkulose, skal passende antituberkulosebehandling påbegyndes i overensstemmelse med lokale retningslinjer, inden behandlingen med vedolizumab påbegyndes.
English: *p < 0.05 †not statistically significant ‡secondary endpoint to be viewed as exploratory by pre-specified statistical testing procedure §not statistically significant, the other endpoints were therefore not tested statistically ¶n = 157 for placebo and n = 158 for vedolizumab #Sustained clinical remission: clinical remission at weeks 6 and 10 ^Exploratory Endpoint
Danish: *p < 0,05 †ikke statistisk signifikant ‡sekundært endepunkt skal ses som eksplorativt ved forud specificeret statistisk testningsprocedure §ikke statistisk signifikant; de andre endepunkter blev derfor ikke testet statistisk ¶n = 157 for placebo og n = 158 for vedolizumab #Vedholdende klinisk remission: klinisk remission i uge 6 og 10 ^Eksploratorisk endepunkt
English: Vedolizumab does not pass the blood brain barrier after intravenous administration.
Danish: Vedolizumab krydser ikke blod-hjerne-barrieren efter intravenøs administration.
English: Vedolizumab belongs to a group of biological medicines called monoclonal antibodies (MAbs).
Danish: Vedolizumab tilhører en gruppe biologiske lægemidler, der kaldes monoklonale antistoffer (MAb'er).
English: Administration of vedolizumab to pregnant cynomolgus monkeys during most of gestation resulted in no evidence of effects on teratogenicity, prenatal or postnatal development in infants up to 6 months of age.
Danish: Administration af vedolizumab til drægtige cynomolgusaber under det meste af drægtigheden resulterede ikke i nogen tegn på virkninger på teratogenicitet, prænatal eller postnatal udvikling hos unger op til 6 måneder.
English: Patients previously exposed to natalizumab should normally wait a minimum of 12 weeks prior to initiating therapy with Entyvio, unless otherwise indicated by the patient's clinical condition.
Danish: Patienter, som tidligere har været eksponeret for natalizumab, bør normalt vente mindst 12 uger, inden behandling med Entyvio initieres, medmindre patientens kliniske tilstand indikerer andet.
English: Given the lack of binding of vedolizumab to male reproductive tissue in monkey and human, and the intact male fertility observed in β7 integrin-knockout mice, it is not expected that vedolizumab will affect male fertility.
Danish: I betragtning af at vedolizumab ikke binder sig til det mandlige reproduktionsvæv hos aber og mennesker og den intakte mandlige fertilitet observeret hos β7-integrin-knockout-mus, forventes det ikke, at vedolizumab påvirker mandlig fertilitet.
English: Warnings and precautions Talk to your doctor or nurse before being given Entyvio.
Danish: Advarsler og forsigtighedsregler Kontakt lægen eller sundhedspersonalet, før du får Entyvio
English: Rash, Pruritus, Eczema, Erythema, Night sweats, Acne
Danish: Udslæt, pruritus, eksem, erytem, nattesved, acne
English: Most patients continued on vedolizumab after the infection resolved.
Danish: De fleste patienter fortsatte behandlingen med vedolizumab, efter infektionen var behandlet.
English: The effect of vedolizumab on infants is unknown.
Danish: Virkningen af vedolizumab på spædbørn er ukendt.
English: Very common Nasopharyngitis Common
Danish: Meget almindelig Nasofaryngitis Almindelig
English: What you need to know before you are given Entyvio
Danish: Det skal du vide, før du begynder at få Entyvio
English: For all subsequent infusions, patients should be observed for approximately 1 hour following completion of the infusion.
Danish: Ved alle efterfølgende infusioner skal patienter observeres i ca. 1 time efter infusionens afslutning.
English: Vedolizumab is a therapeutic monoclonal antibody and is not expected to bind to plasma proteins.
Danish: Vedolizumab er et terapeutisk, monoklonalt antistof og forventes ikke at binde sig til plasmaproteiner.
English: Vedolizumab exhibited linear pharmacokinetics at serum concentrations greater than 1 mcg/mL.
Danish: Vedolizumab viste lineær farmakokinetik ved serumkoncentrationer, der var højere end 1 mikrog/ml.
English: The plasma protein binding of vedolizumab has not been evaluated.
Danish: Vedolizumabs plasmaproteinbinding er ikke blevet vurderet.
English: 2 weeks after Treatment 1
Danish: 2 uger efter behandling 1
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 300 mg
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 300 mg
English: Very common Arthralgia Common
Danish: Meget almindelig Artralgi Almindelig
English: Tell your doctor immediately if you notice any of the following:
Danish: Fortæl straks lægen det, hvis du bemærker nogen af følgende bivirkninger:
English: White to off-white lyophilised cake or powder.
Danish: Hvide til gullighvide frysetørrede stykker eller pulver.
English: In patients who received vedolizumab at weeks 0 and 2 followed by placebo, no increase in the rate of IRR was seen upon retreatment with vedolizumab after loss of response.
Danish: Hos patienter, som fik vedolizumab i uge 0 og 2 efterfulgt af placebo, blev der ikke set nogen stigning i antallet af IRR ved genbehandling med vedolizumab efter tab af respons.
English: These effects were seen whether or not immunomodulators were also concomitantly administered.
Danish: Disse effekter blev set, uanset om der var samtidig administration af immunmodulerende lægemidler eller ej.
English: Combination treatment, most notably with concomitant corticosteroids, appeared to be more effective in inducing remission in Crohn's disease than vedolizumab alone or with concomitant immunomodulators, which showed a smaller difference from placebo in the rate of remission.
Danish: Kombinationsbehandling, især med samtidig administration af kortikosteroider, lader til at være mere effektiv med hensyn til at inducere remission i Crohns sygdom end vedolizumab alene eller med samtidig administration af immunmodulerende lægemidler, som viste en mindre forskel fra placebo i remissionsraten.
English: In GEMINI I and II controlled studies, 4% of vedolizumab-treated patients and 3% of placebo-treated patients experienced an adverse reaction defined by the investigator as infusion-related reaction (IRR) (see section 4.4).
Danish: I GEMINI I og II kontrollerede studier fik 4 % af vedolizumab-behandlede patienter og 3 % af placebo-behandlede patienter en bivirkning, som investigatoren definerede som en infusionsrelateret reaktion (IRR) (se pkt.
English: Administer the infusion solution over 30 minutes.
Danish: Infusionsopløsningen administreres over 30 minutter.
English: Vedolizumab-exposed subjects had lower seroconversion rates after receiving a killed, oral cholera vaccine.
Danish: Vedolizumab-eksponerede forsøgspersoner havde lavere serokonversionsrater efter at have fået en dræbt, oral koleravaccine.
English: In this open-label extension study, the benefits of vedolizumab treatment as assessed by partial Mayo score, clinical remission, and clinical response were shown for up to 196 weeks.
Danish: I dette open-label forlængelsesstudie blev fordelene ved vedolizumab-behandling vurderet i henhold til partiel Mayo-score, klinisk remission og klinisk respons vist i op til 196 uger.
English: • if you are allergic to vedolizumab or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for vedolizumab eller et af de øvrige indholdsstoffer i dette lægemiddel
English: The effects of Entyvio in pregnant women are not known.
Danish: Entyvios virkning på gravide kvinder er ikke kendt.
English: Corticosteroid-free clinical remission♠
Danish: Kortikosteroidfri klinisk remission♠
English: In clinical studies, infusion-related reactions (IRR) and hypersensitivity reactions have been reported, with the majority being mild to moderate in severity (see section 4.8).
Danish: I kliniske studier er der rapporteret om infusionsrelaterede reaktioner (IRR) og overfølsomhedsreaktioner, hvor de fleste var milde til moderate i sværhedsgrad (se pkt.
English: Treatment (infusion) number
Danish: Behandlings- (infusions-) nummer
English: • Patients treated with Entyvio should be monitored for any new onset or worsening of neurological signs and symptoms such as those listed below: o Progressive weakness on one side of the body or clumsiness of limbs o Disturbance of vision o Changes in thinking, memory, and orientation, leading to confusion and personality changes
Danish: • Patienter, der behandles med Entyvio, skal monitoreres for enhver nyopstået eller forværring af nedenstående neurologiske tegn og symptomer: o Progredierende svaghed i den ene side af kroppen eller klodsethed o Synsforstyrrelser o Forandringer i tankevirksomhed, hukommelse og orienteringsevne, der fører til konfussion og personlighedsforandringer
English: If you forget or miss an appointment to receive the infusion, make another appointment as soon as possible.
Danish: Hvis du har glemt eller ikke får en Entyvio infusion Hvis du har glemt eller ikke har mødt op til en aftale om at få infusionen, skal du aftale en anden tid hurtigst muligt.
English: The two primary endpoints were the proportion of patients in clinical remission (defined as CDAI score ≤ 150 points) at week 6 and the proportion of patients with enhanced clinical response (defined as a ≥ 100-point decrease in CDAI score from baseline) at week 6 (see Table 4).
Danish: De to primære endepunkter var procentdelen af patienter i klinisk remission (defineret som CDAI-score på ≤ 150 point) i uge 6 og procentdelen af patienter med forøget klinisk respons (defineret som et ≥ 100-point fald i CDAI-score fra baseline) i uge 6 (se Tabel 4).
English: Use aseptic technique when preparing Entyvio solution for intravenous infusion.
Danish: Anvend aseptisk teknik, når Entyvio-opløsningen klargøres til intravenøs infusion.
English: Active severe infections such as tuberculosis (TB), sepsis, cytomegalovirus, listeriosis, and opportunistic infections such as Progressive Multifocal Leukoencephalopathy (PML) (see section 4.4).
Danish: Aktive, svære infektioner som f.eks. tuberkulose (TB), sepsis, cytomegalovirus, listeriosis og opportunistiske infektioner som f.eks. progressiv multifokal leukoencefalopati (PML) (se pkt.
English: Vedolizumab did not affect immune surveillance and inflammation of the central nervous system in Experimental Autoimmune Encephalomyelitis in non-human primates, a model of multiple sclerosis.
Danish: Vedolizumab påvirkede ikke immunovervågning og inflammation af centralnervesystemet i eksperimentel autoimmun encefalomyelitis hos ikke-humane primater, en model af multipel sklerose.
English: If this is not possible, reconstituted solution in the vial can be stored for up to 8 hours at 2 °C-8 °C.
Danish: Hvis det ikke er muligt, kan rekonstitueret opløsning i hætteglasset opbevares i op til 8 timer ved 2 °C-8 °C.
English: Population pharmacokinetic analyses indicate that vedolizumab has a total body clearance of approximately 0.157 L/day and a serum half-life of 25 days.
Danish: Populations-farmakokinetiske analyser indikerer, at vedolizumab har total kropsclearance på ca. 0,157 l/dag og en serumhalveringstid på 25 dage.
English: As a precautionary measure, it is preferable to avoid the use of Entyvio during pregnancy unless the benefits clearly outweigh any potential risk to both the mother and foetus.
Danish: For en sikkerheds skyld bør brug af Entyvio undgås under graviditet, medmindre fordelene klart opvejer de potentielle risici for både moder og foster.
English: There are limited amount of data from the use of vedolizumab in pregnant women.
Danish: Der er utilstrækkelige data fra anvendelse af vedolizumab til gravide kvinder.
English: Vedolizumab is a humanised IgG1 monoclonal antibody that binds to the human α4β7 integrin and is produced using recombinant DNA technology in Chinese hamster ovary (CHO) cells.
Danish: Vedolizumab er et humaniseret IgG1 monoklonalt antistof, som binder sig til det humane α4β7 integrin og som produceres ved rekombinant DNA-teknologi i ovarieceller fra kinesiske hamstere (CHO).
English: The effect of vedolizumab on the pharmacokinetics of commonly co-administered medicinal compounds has not been studied.
Danish: Vedolizumabs virkning på de farmakokinetiske egenskaber af almindeligt samtidigt administrerede lægemidler er ikke blevet undersøgt.
English: The efficacy and safety of vedolizumab for the treatment of adult patients with moderately to severely active Crohn's disease (Crohn's Disease Activity Index [CDAI] score of 220 to 450) were evaluated in two studies (GEMINI II and III).
Danish: Vedolizumabs virkning og sikkerhed ved behandlingen af voksne patienter med moderat til svær aktiv Crohns sygdom (Crohns sygdomsaktivitetsindeks- [CDAI] score på 220 til 450) blev vurderet i 2 studier (GEMINI II og III).
English: Population pharmacokinetic analyses showed no effect of age (see section 5.2).
Danish: Populations-farmakokinetiske analyser viste ingen alderseffekt (se pkt.
English: If therapy is interrupted and there is a need to restart treatment with Entyvio, dosing at every four weeks may be considered (see section 5.1).
Danish: Hvis behandlingen afbrydes, og det er nødvendigt at starte behandling med Entyvio igen, kan dosering hver fjerde uge overvejes (se pkt.
English: In a placebo-controlled study of healthy volunteers, a single 750 mg dose of vedolizumab did not lower rates of protective immunity to hepatitis B virus in subjects who were vaccinated intramuscularly with three doses of recombinant hepatitis B surface antigen.
Danish: I et placebo-kontrolleret studie med raske frivillige sænkede en enkelt 750 mg dosis vedolizumab ikke raten af beskyttende immunitet over for hepatitis B-virus hos forsøgspersoner, som blev vaccineret intramuskulært med 3 doser rekombinant hepatitis B-overfladeantigen.
English: Health-related quality of life (HRQOL) was assessed by Inflammatory Bowel Disease Questionnaire (IBDQ), a disease specific instrument, and SF-36 and EQ-5D, which are general measures.
Danish: Helbredsrelateret livskvalitet (HRQOL) blev vurderet ved hjælp af spørgeskemaet om inflammatorisk tarmsygdom (IBDQ), et sygdomsspecifikt instrument samt de almindelige spørgeskemaer, SF-36 og EQ-5D.
English: The GEMINI II Study was a randomised, double-blind, placebo-controlled study evaluating efficacy endpoints at week 6 and week 52.
Danish: GEMINI II studiet var et randomiseret, dobbeltblindet, placebo-kontrolleret forsøg, der vurderede effektendepunkterne i uge 6 og uge 52.
English: Some patients who have experienced a decrease in their response may benefit from an increase in dosing frequency to Entyvio 300 mg every four weeks.
Danish: Nogle patienter, som har oplevet et fald i respons, kan få gavn af en øget doseringshyppighed af Entyvio 300 mg hver 4. uge.
English: • For your first 2 infusions, your doctor or nurse will monitor you closely during the infusion and for approximately 2 hours after you have completed the infusion.
Danish: • Ved de første 2 infusioner vil lægen eller sundhedspersonalet overvåge dig nøje under infusionen og i ca. 2 timer efter infusionens afslutning.
English: Within the system organ classes, adverse reactions are listed under headings of the following frequency categories: very common (≥ 1/10), common (≥ 1/100 to < 1/10),
Danish: Inden for systemorganklasserne er bivirkningerne opstillet under overskrifter af følgende hyppighedskategorier: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10) ikke almindelig (≥ 1/1.000 til < 1/100) samt meget sjælden (< 1/10.000).
English: In controlled and open-label studies in adults with vedolizumab, serious infections have been reported, which include tuberculosis, sepsis (some fatal), salmonella sepsis, listeria meningitis, and cytomegaloviral colitis.
Danish: I kontrollerede studier og open-label studier hos voksne, der fik vedolizumab, er der rapporteret om alvorlige infektioner, bl.a. tuberkulose, sepsis (i nogle tilfælde fatale), salmonella-sepsis, listeria-meningitis og cytomegaloviral colitis.
English: Exploratory analyses examined the effects of concomitant corticosteroids and immunomodulators on induction of remission with vedolizumab.
Danish: Eksploratoriske analyser undersøgte effekterne af samtidig administration af kortikosteroider og immunmodulerende lægemidler på induktion af remission med vedolizumab.
English: • if you have an active severe infection, for example, tuberculosis, blood poisoning, severe gastroenteritis, nervous system infection.
Danish: • hvis du har en aktiv, svær infektion, for eksempel tuberkulose, blodforgiftning, svær mave-tarm-katar, infektion i nervesystemet.
English: Enhanced clinical response was achieved in 29%, 38%, 21%, respectively, and corticosteriod-free clinical remission was achieved in 24%, 16%, 0%, respectively.
Danish: Forøget klinisk respons blev opnået hos hhv. 29 %, 38 % og 21 %, og kortikosteroidfri klinisk remission blev opnået hos hhv. 24 %, 16 % og 0 %.
English: Low levels (< 300 mcg/L) of vedolizumab were detected on post-partum day 28 in the milk of 3 of 11 cynomolgus monkeys treated 100 mg/kg of vedolizumab dosed every 2 weeks and not in any animals that received 10 mg/kg.
Danish: Lave niveauer (< 300 mikrog/l) af vedolizumab blev konstateret på dag 28 postpartum i mælken hos 3 ud af 11 cynomolgusaber, behandlet med 100 mg/kg vedolizumab med en dosis hver 2. uge og ikke på noget dyr, som fik 10 mg/kg.
English: Of those patients who had infusion related reactions, those dosed with vedolizumab had more infusion related reactions with in the first 2 hours as compared to placebo patients with infusion related reactions.
Danish: Af de patienter, der havde infusionsrelaterede reaktioner, havde patienterne, som var blevet behandlet med vedolizumab, flere infusionsrelaterede reaktioner inden for de første 2 timer til sammenligning med infusionsrelaterede reaktioner hos patienter, der havde fået placebo.
English: No specific fertility studies in animals have been performed with vedolizumab.
Danish: Der er ikke udført specifikke fertilitetsstudier med vedolizumab på dyr.
English: • if you experience blurred, loss of or double vision, difficulty speaking, weakness in an arm or a leg, a change in the way you walk or problems with your balance, persistent numbness, decreased sensation or loss of sensation, memory loss or confusion.
Danish: • hvis du oplever sløret syn, synstab eller dobbeltsyn, talebesvær, svaghed i en arm eller et ben, en ændring i din gang eller balanceproblemer, vedvarende følelsesløshed, nedsat følelse eller følelsestab, hukommelsestab eller forvirring.
English: • if you have an infection, or think you have an infection, if you develop chills, shivering, persistent cough or a high fever.
Danish: • hvis du har en infektion eller tror, at du har en infektion, hvis du får kuldegysninger, skælven, vedvarende hoste eller høj feber.
English: This should be taken into consideration, particularly in patients with severe active disease at baseline not previously treated with TNFα antagonists.
Danish: Dette bør tages i betragtning især hos patienter, der har svær aktiv sygdom ved baseline og ikke tidligere er blevet behandlet med TNFα-antagonister (se også pkt.
English: • There is no clinical trial experience with Entyvio in patients previously treated with natalizumab.
Danish: • Der er ingen erfaring fra forsøg med Entyvio for patienter, der tidligere er blevet behandlet med natalizumab.
English: METHOD OF ADMINISTRATION For intravenous use after reconstitution and dilution.
Danish: ADMINISTRATIONSMETODE Til intravenøs anvendelse efter rekonstitution og fortynding.
English: *The placebo group includes those subjects who received vedolizumab at week 0 and week 2, and were randomised to receive placebo from week 6 through week 52.
Danish: *Placebo-gruppen omfatter de forsøgspersoner, som fik vedolizumab i uge 0 og uge 2 og blev randomiseret til at få placebo fra uge 6 til og med uge 52.
English: Vedolizumab 450 mg administered intravenously was not detected in the cerebrospinal fluid of healthy subjects.
Danish: Vedolizumab 450 mg, der blev administreret intravenøst, blev ikke konstateret i cerebrospinalvæsken hos raske forsøgspersoner.
English: Week 6 Efficacy Results of GEMINI I
Danish: Uge 6 Effektresultater fra GEMINI I
English: In clinical trials with vedolizumab at doses ranging from 2 to 10 mg/kg, > 95% saturation of α4β7 receptors on subsets of circulating lymphocytes involved in gut immune surveillance was observed in patients.
Danish: I kliniske forsøg med vedolizumab ved doser fra 2 til 10 mg/kg blev der hos patienter observeret > 95 % mætning af α4β7 receptorer på undergrupper af cirkulerende lymfocytter involveret i tarmimmunovervågning.
English: Vedolizumab should be administered in a healthcare setting equipped to allow management of acute hypersensitivity reactions including anaphylaxis, if they occur.
Danish: Vedolizumab skal administreres i et opsat behandlingsregime, der kan håndtere akutte overfølsomhedsreaktioner inklusive anafylaktiske reaktioner, hvis de forekommer.
English: Week 52 Efficacy Results of GEMINI I
Danish: Uge 52 Effektresultater fra GEMINI I
English: Entyvio passes into breast milk.
Danish: Entyvio udskilles i modermælk.