natgillin/translations-raw huggingface dataset:
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. 
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.
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. 
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.
Blandt disse patienter opnåede 37 %, der fik vedolizumab hver 8. uge, 35 %, der fik vedolizumab hver 4. uge, og 5 %, der fik placebo, klinisk remission i uge 52. 
Among these patients, 37% receiving vedolizumab every eight weeks, 35% receiving vedolizumab every four weeks, and 5% receiving placebo achieved clinical remission at week 52.
Det primære endepunkt var procentdelen af patienter i klinisk remission i uge 52 (se Tabel 5). 
Primary endpoint was the proportion of patients in clinical remission at week 52 (see Table 5).
Antallet af patienter var n = 82 for placebo, n = 82 for vedolizumab hver 8. uge og n = 80 for vedolizumab hver 4. uge 
Patient numbers were n = 82 for placebo, n = 82 for vedolizumab every eight weeks, and n = 80 for vedolizumab every four weeks
2 Dette tidsrum er under antagelse af, at den rekonstituerede opløsning straks fortyndes i natriumchlorid 9 mg/ml (0,9 %) injektionsvæske, opløsning og kun opbevares i infusionsposen. 
2 This time assumes the reconstituted solution is immediately diluted in the sodium chloride 9 mg/mL (0.9%) solution for injection and held in the infusion bag only.
MAdCAM-1 eksprimeres hovedsagelig på tarmens endotelceller og spiller en kritisk rolle i ekstravasation af T-lymfocytter til væv i mave-tarm-kanalen. 
MAdCAM-1 is mainly expressed on gut endothelial cells and plays a critical role in the homing of T lymphocytes to tissues within the gastrointestinal tract.
• rødme af huden 
• itching of the skin
Det primære endepunkt var procentdelen af patienter i klinisk remission i uge 52. 
Primary endpoint was the proportion of patients in clinical remission at week 52.
Behandling for patienter med colitis ulcerosa skal seponeres, hvis der ikke observeres tegn på terapeutisk gavn i uge 10 (se pkt. 
Therapy for patients with ulcerative colitis should be discontinued if no evidence of therapeutic benefit is observed by week 10 (see section 5.1).
Én alvorlig bivirkning i form af en IRR blev rapporteret hos en patient med Crohns sygdom under den anden infusion (de rapporterede symptomer var dyspnø, bronkospasme, urticaria, blussen, udslæt samt forhøjet blodtryk og hjertefrekvens); bivirkningen forsvandt efter afbrydelse af infusionen og behandling med antihistamin og intravenøs hydrokortison. 
One serious adverse reaction of IRR was reported in a Crohn's disease patient during the second infusion (symptoms reported were dyspnoea, bronchospasm, urticaria, flushing, rash, and increased blood pressure and heart rate) and was successfully managed with discontinuation of infusion and treatment with antihistamine and intravenous hydrocortisone.
GEMINI II studiet Klinisk remission, uge 6 Generelt 
GEMINI II Study Clinical remission, week 6 Overall
Behandlingen for patienter med Crohns sygdom bør seponeres, hvis der ikke observeres tegn på terapeutisk gavn i uge 14 (se pkt. 
Therapy for patients with Crohn's disease should be discontinued if no evidence of therapeutic benefit is observed by week 14 (see section 5.1).
Kør ikke motorkøretøj, og lad være med at arbejde med værktøj eller betjene maskiner, hvis du er svimmel. 
If you feel dizzy, do not drive or use tools or machines.
6.6 for instruktioner angående rekonstitution og fortynding af lægemidlet før administration. 
For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6.
Den kliniske remissionsrate i GEMINI II i uge 6 var 10 % (forskel fra placebo 2 %, 95 % CI: -6, 10) ved administration uden kortikosteroider sammenlignet med 20 % (forskel fra placebo 14 %, 95 % CI: -1, 29) ved samtidig administration af kortikosteroider. 
Clinical remission rate in GEMINI II at week 6 was 10% (difference from placebo 2%, 95% CI: -6, 10) when administered without corticosteroids compared to 20% (difference from placebo 14%, 95% CI: -1, 29) when administered with concomitant corticosteroids.
Ca. en -tredjedel af patienterne havde manglende respons på tidligere TNFα-antagonistbehandling. 
Approximately one-third of patients had failed prior TNFα antagonist therapy.
Kanylen stikkes ned midt gennem proppen på hætteglasset, og væskestrømmen rettes mod hætteglassets side for at undgå for stor skumdannelse. 
Insert the needle into the vial through the centre of the stopper and direct the stream of liquid to the wall of the vial to avoid excessive foaming.
Muskelkramper, rygsmerter, muskelsvaghed, træthed, smerter i ekstremiteter 
Muscle spasms, Back pain, Muscular weakness, Fatigue, Pain in the extremity
Entyvio er indiceret til behandling af voksne patienter med moderat til svær aktiv Crohns sygdom, som har haft utilstrækkelig respons eller mistet respons på eller var intolerante over for enten konventionel behandling eller en tumor nekrose faktor alfa (TNFα)-antagonist. 
Entyvio is indicated for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor-alpha (TNFα) antagonist.
Museforstadiet af vedolizumabs lindrede den gastrointestinale inflammation hos hvidtoppede tamariner med colitis, en model af colitis ulcerosa. 
The murine precursor of vedolizumab alleviated gastrointestinal inflammation in colitic cotton-top tamarins, a model of ulcerative colitis.
GEMINI III studiet Klinisk remission, uge 6 Generelt‡ 
GEMINI III Study Clinical remission, week 6 Overall‡
Fortyndet opløsning i natriumchlorid 9 mg/ml (0,9 %) injektionsvæske, opløsning 
Diluted solution in sodium chloride 9 mg/mL (0.9%) solution for injection
Der er ligeledes rapporteret reaktioner på injektionsstedet (med symptomer såsom dyspnø, bronkospasmer, urticaria, rødmen, udslæt og forhøjet blodtryk og hjerterytme) hos patienter, der blev behandlet med vedolizumab. 
Injection site reactions (with symptoms such as dyspnea, bronchospasm, urticaria, flushing, rash, and increased blood pressure and heart rate) have also been reported in patients treated with vedolizumab.
Patienter (n = 416), som inkluderede ca. 75 % patienter med manglende respons på TNFα-antagonistbehandling, blev randomiseret på en dobbeltblind måde (1:1) til at få enten vedolizumab 300 mg eller placebo i uge 0, 2 og 6. 
Patients (n = 416), which included approximately 75% TNFα antagonist failures patients, were randomised in a double-blind fashion (1:1) to receive either vedolizumab 300 mg or placebo at weeks 0, 2, and 6.
• rødme og ømhed ved hårsække 
• redness and tenderness of hair follicle
Rekonstitueret opløsning i hætteglasset 
Reconstituted solution in the vial
Hos patienter med Crohns sygdom var de gennemsnitlige steady-state koncentrationer af serum hhv. 13,0 mikrog/ml (SD ± 9,08) og 34,8 mikrog/ml (SD ± 22,55). 
In patients with Crohn's disease mean steady-state serum trough concentrations were 13.0 mcg/mL (SD ± 9.08) and 34.8 mcg/mL (SD ± 22.55), respectively.
Forøget klinisk respons Kortikosteroidfri klinisk remission§ Vedvarende klinisk remission¶ 
Enhanced clinical response Corticosteroid-free clinical remission§ Durable clinical remission¶
Der foreligger ingen data fra kliniske forsøg vedrørende samtidig brug af vedolizumab og biologiske immunsuppressive lægemidler. 
No clinical trial data for concomitant use of vedolizumab with biologic immunosuppressants are available.
Der er rapporteret infusionsrelaterede reaktioner efter infusion af vedolizumab hos patienter med anti-vedolizumab-antistoffer. 
Infusion related reactions after vedolizumab infusion are reported in subjects with anti-vedolizumab antibodies.
Hjælpestoffer: Saccharose, L-histidin, L-histidinmonohydrochlorid, L-argininhydrochlorid, polysorbat 80. 
Excipients: Sucrose, L-histidine, L-histidine monohydrochloride, L-arginine hydrochloride, polysorbate 80.
I GEMINI III i uge 6 og 10 var de kliniske remissionsrater hhv. 18 % (forskel fra placebo 3 %, 95 % CI: -7, 13) og 22 % (forskel fra placebo 8 %, 95 % CI: -3, 19) ved administration uden kortikosteroider sammenlignet med 20 % (forskel fra placebo 11%, 95 % CI: 2, 20) og 35 % (forskel fra placebo 23 %, 95 % CI: 12, 33) ved samtidig administration af kortikosteroider. 
In GEMINI III at week 6 and 10 the respective clinical remission rates were 18% (difference from placebo 3%, 95% CI: -7, 13) and 22% (difference from placebo 8%, 95% CI: -3, 19) when administered without corticosteroids compared to 20% (difference from placebo 11%, 95% CI: 2, 20) and 35% (difference from placebo 23%, 95% CI: 12, 33) respectively when administered with concomitant corticosteroids.
L-histidinmonohydrochlorid L-argininhydrochlorid Saccharose 
L-histidine monohydrochloride L-arginine hydrochloride sucrose polysorbate 80
• oppustet mave 
• bloated stomach
Ved vurderingen af uge 6 endepunkterne var 374 patienter randomiseret på en dobbeltblind måde (3:2) til at få vedolizumab 300 mg eller placebo i uge 0 og uge 2. 
For the evaluation of the week 6 endpoints, 374 patients were randomised in a double-blind fashion (3:2) to receive vedolizumab 300 mg or placebo at week 0 and week 2.
Entyvio er indiceret til behandling af voksne patienter med moderat til svær aktiv colitis ulcerosa, som har haft utilstrækkelig respons eller mistet respons på eller var intolerante over for enten konventionel behandling eller en tumor nekrose faktor alfa (TNFα)-antagonist. 
Entyvio is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor-alpha (TNFα) antagonist.
Øvrige indholdsstoffer: L-histidin, L-histidin-monohydrochlorid, L-arginin-hydrochlorid, saccharose og polysorbat 80. 
The other ingredients are L-histidine, L-histidine monohydrochloride, L-arginine hydrochloride, sucrose, and polysorbate 80.
Patienter skal forsynes med indlægssedlen og patientinformationskortet. 
Patients should be given the package leaflet and the Patient Alert Card. Posology
Patienter (n = 368) blev randomiseret på en dobbeltblindet måde (3:2) til at få 2 doser vedolizumab 300 mg eller placebo i uge 0 og uge 2. 
Patients (n = 368) were randomised in a double-blind fashion (3:2) to receive two doses of vedolizumab 300 mg or placebo at week 0 and week 2.
Behandlingen med Entyvio er den samme for colitis ulcerosa og Crohns sygdom. 
Dose and frequency Treatment with Entyvio is the same for ulcerative colitis and Crohn's disease.
Forbedret klinisk respons, uge 6 Generelt^ 
Enhanced clinical response, week 6 Overall^
†p < 0,0001 ‡p < 0,001 §p < 0,05 ¶Vedvarende klinisk respons: Klinisk respons i uge 6 og 52 #Vedvarende klinisk remission: Klinisk remission i uge 6 og 52 ♠Kortikosteroidfri klinisk remission: Patienter, der brugte orale kortikosteroider ved baseline, men var holdt op med at bruge kortikosteroider fra uge 6 og var i klinisk remission i uge 52. 
†p < 0.0001 ‡p < 0.001 §p < 0.05 ¶Durable clinical response: Clinical response at weeks 6 and 52 #Durable clinical remission: Clinical remission at weeks 6 and 52 ♠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.
Klinisk respons på partiel Mayo-score blev opnået i uge 10 og uge 14 af større procentdele af vedolizumab-patienter (hhv. 32 % og 39 %) sammenlignet med placebo-patienter (hhv. 15 % og 
Clinical response using partial Mayo scores was achieved at week 10 and week 14 by greater proportions of vedolizumab patients (32% and 39%, respectively) compared with placebo patients (15% and 21%, respectively).
Lad hætteglasset stå i op til 20 minutter ved stuetemperatur (20 °C-25 °C) for at give tid til rekonstitution, og så eventuelt skum kan lægge sig; i dette tidsrum kan hætteglasset hvirvles rundt og undersøges, for at se om alt pulver er opløst. 
Let the vial sit for up to 20 minutes at room temperature (20 °C-25 °C), to allow for reconstitution and for any foam to settle; the vial can be swirled and inspected for dissolution during this time.
Hvert hætteglas er kun til engangsbrug. 
Each vial is for single-use only.
Hver pakning med Entyvio indeholder 1 hætteglas. 
Each pack of Entyvio consists of one vial.
Hos patienter med colitis ulcerosa var de gennemsnitlige steady-state koncentrationer af serum hhv. 11,2 mikrog/ml (SD ± 7,24) og 38,3 mikrog/ml (SD ± 24,43). 
In patients with ulcerative colitis, mean steady-state serum trough concentrations were 11.2 mcg/mL (SD ± 7.24) and 38.3 mcg/mL (SD ± 24.43), respectively.
Patienter med manglende respons i uge 6, forblev i studiet og fik vedolizumab hver 4. uge. 
Patients who failed to demonstrate response at week 6 remained in the study and received vedolizumab every four weeks.
Analabsces, analfissur, kvalme, dyspepsi, obstipation, abdominal distension, flatulens, hæmorider 
Anal Abscess, Anal fissure, Nausea, Dyspepsia, Constipation, Abdominal distension, Flatulence, Haemorrhoids
Forøget klinisk respons blev observeret i uge 10 og uge 14 af større procentdele af vedolizumab-patienter (hhv. 16 % og 22 %) sammenlignet med placebo-patienter (hhv. 7 % og 12 %). 
Enhanced clinical response was observed at week 10 and week 14 for greater proportions of vedolizumab patients 16% and 22%, respectively, compared with placebo patients 7% and 12%, respectively.
Virkningen blev opnået igen uden tydelig stigning i bivirkninger eller infusionsrelaterede reaktioner under gentagen behandling med vedolizumab (se pkt. 
Efficacy was regained with no evident increase in adverse reactions or infusion-related reactions during retreatment with vedolizumab (see section 4.8).
I modsætning hertil hæmmede vedolizumab immunrespons over for en gastrointestinal antigen-belastning hos raske, frivillige forsøgspersoner (se pkt. 
In contrast, vedolizumab inhibited an immune response to a gastrointestinal antigenic challenge in healthy human volunteers (see section 4.4).
• smerter i lemmerne 
• pain in the limb
Klinisk remission Vedvarende klinisk respons¶ 
Clinical remission Durable clinical response¶
I GEMINI I fik to kohorter af patienter vedolizumab i uge 0 og uge 2: patienter i kohorte 1 blev randomiseret til at få enten vedolizumab 300 mg eller placebo på en dobbeltblind måde, og patienter i kohorte 2 blev behandlet med open-label vedolizumab 300 mg. For at vurdere effekten i uge 52 blev 373 patienter fra kohorte 1 og 2, som var blevet behandlet med vedolizumab og havde opnået klinisk respons i uge 6, randomiseret på en dobbeltblind måde (1:1:1) til et af følgende regimer, der begyndte i uge 6: vedolizumab 300 mg hver 8. uge, vedolizumab 300 mg hver 4. uge eller placebo hver 4. uge. 
In GEMINI I, two cohorts of patients received vedolizumab at week 0 and week 2: cohort 1 patients were randomised to receive either vedolizumab 300 mg or placebo in a double-blind fashion, and cohort 2 patients were treated with open-label vedolizumab 300 mg. To evaluate efficacy at week 52, 373 patients from cohort 1 and 2 who were treated with vedolizumab and had achieved clinical response at week 6 were randomised in a double-blind fashion (1:1:1) to one of the following regimens beginning at week 6: vedolizumab 300 mg every eight weeks, vedolizumab 300 mg every four weeks, or placebo every four weeks.
LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Entyvio 300 mg pulver til koncentrat til infusionsvæske, opløsning. 
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Entyvio 300 mg powder for concentrate for solution for infusion vedolizumab
Entyvio indeholder: 
What Entyvio contains
I GEMINI II deltog to kohorter af patienter, som fik vedolizumab i uge 0 og 2: Patienter i kohorte 1 blev randomiseret til at få enten vedolizumab 300 mg eller placebo på en dobbeltblindet måde, og patienter i kohorte 2 blev behandlet med open-label vedolizumab 300 mg. For at vurdere virkningen i uge 52 blev 461 patienter fra kohorte 1 og 2, som var blevet behandlet med vedolizumab og havde opnået klinisk respons (defineret som et ≥ 70-point fald i CDAI-score fra baseline) i uge 6, randomiseret på en dobbeltblindet måde (1:1:1) til ét af følgende regimer, der begyndte i uge 6: vedolizumab 300 mg hver 8. uge, vedolizumab 300 mg hver 4. uge eller placebo hver 4. uge. 
GEMINI II contained two cohorts of patients that received vedolizumab at weeks 0 and 2: cohort 1 patients were randomised to receive either vedolizumab 300 mg or placebo in a double-blind fashion, and cohort 2 patients were treated with open-label vedolizumab 300 mg. To evaluate efficacy at week 52, 461 patients from cohorts 1 and 2, who were treated with vedolizumab and had achieved clinical response (defined as a ≥ 70-point decrease in CDAI score from baseline) at week 6, were randomised in a double-blind fashion (1:1:1) to one of the following regimens beginning at week 6: vedolizumab 300 mg every eight weeks, vedolizumab 300 mg every four weeks, or placebo every four weeks.
Blandt disse patienter opnåede 28 %, der fik vedolizumab hver 8. uge, 27 %, der fik vedolizumab hver 4. uge, og 13 %, der fik placebo, klinisk remission i uge 52. 
28% receiving vedolizumab every eight weeks, 27% receiving vedolizumab every four weeks, and 13% receiving placebo achieved clinical remission at week 52.
Når pulveret er opløst, vendes hætteglasset forsigtigt på hovedet 3 gange. 
Once dissolved, gently invert vial 3 times.
Patienter, som ikke havde opnået respons i uge 6 i GEMINI II, forblev i studiet og fik vedolizumab hver 4. uge. 
Patients who failed to demonstrate response at week 6 in GEMINI II were retained in the study and received vedolizumab every four weeks.
De mest almindeligt rapporterede bivirkninger er infektioner (såsom nasofaryngitis, infektion i de øvre luftveje, bronkitis, influenza og sinusitis), hovedpine, kvalme, feber, træthed, hoste, ledsmerter. 
The most commonly reported adverse reactions are infections (such as nasopharyngitis, upper respiratory tract infection, bronchitis, influenza and sinusitis), headache, nausea, pyrexia, fatigue, cough, arthralgia.
• tilstoppet næse 
• blocked nose
Entyvio er et hvidt til gullighvidt pulver til koncentrat til infusionsvæske, opløsning, i et hætteglas med gummiprop og plasthætte. 
What Entyvio looks like and contents of the pack Entyvio is a white to off-white powder for concentrate for solution for infusion provided in a glass vial with a rubber stopper and a plastic cap.
α4β7 integrinet eksprimeres på en separat undergruppe af memory-T-hjælperlymfocytter, som fortrinsvis migrerer ind i mave-tarm-kanalen og forårsager betændelse, som er karakteristisk for colitis ulcerosa og Crohns sygdom. 
The α4β7 integrin is expressed on a discrete subset of memory T helper lymphocytes which preferentially migrate into the gastrointestinal (GI) tract and cause inflammation that is characteristic of ulcerative colitis and Crohn's disease, both of which are chronic inflammatory immunologically mediated conditions of the GI tract.
Vedolizumab Hver 8. uge n = 122 
Vedolizumab Every 8 weeks n = 122
KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hvert hætteglas indeholder 300 mg vedolizumab. 
QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 300 mg of vedolizumab.
En periode på 24 timer kan omfatte op til 8 timer ved 2 °C-8 °C for den rekonstituerede opløsning i hætteglasset og op til 12 timer ved 20 °C-25 °C for den fortyndede opløsning i infusionsposen, men infusionsposen skal opbevares i køleskab (2 °C-8 °C) i resten af perioden på 24 timer. 
A 24 hour period may include up to 8 hours at 2°C-8°C for reconstituted solution in the vial and up to 12 hours at 20°C-25°C for diluted solution in the infusion bag but the infusion bag must be stored in the refrigerator (2°C-8°C) for the rest of the 24 hour period.
Patienter, som havde mistet respons på vedolizumab, da de blev behandlet hver 8. uge, fik lov til at indgå i et open-label forlængelsesstudie og få vedolizumab hver 4. uge. 
Patients who lost response to vedolizumab when treated every eight weeks were allowed to enter an open-label extension study and receive vedolizumab every four weeks.
• kløende hud 
• redness of skin
Det primære endepunkt var procentdelen af patienter med klinisk respons (defineret som en reduktion af det totale Mayo-score på ≥ 3 point og ≥ 30 % fra baseline ledsaget af et fald i rektal-blødning-subscore på ≥ 1 point eller en absolut-rektal-blødning-subscore på ≤ 1 point) i uge 6. 
≥ 3 points and ≥ 30% from baseline with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point) at week 6.
Efter rekonstitution indeholder hver ml 60 mg vedolizumab. 
After reconstitution each mL contains 60 mg of vedolizumab.
Klinisk respons Klinisk remission§ Mucosaheling¶ 
Clinical response Clinical remission§ Mucosal healing¶
*p < 0,0001 †p ≤ 0,001 ‡p < 0,05 §Klinisk remission: Total Mayo-score på ≤ 2 point, uden individuel subscore > 1 point ¶Mucosaheling: Mayo-endoskopi-subscore på ≤ 1 point 
§Clinical remission: Complete Mayo score of ≤ 2 points and no individual subscore > 1 point
Fortyndet opløsning i natriumchlorid 9 mg/ml (0,9 %) injektionsvæske, opløsning kan opbevares op til 12 timer ved stuetemperatur (ikke over 25 °C) eller op til 24 timer i køleskab (2 °C-8 °C), eller op til 12 timer ved stuetemperatur og i køleskab (2 °C-8 °C) op til i alt 24 timer. 
Diluted solution in sodium chloride 9 mg/mL (0.9%) solution for injection can be stored up to 12 hours at a room temperature of not above 25 °C, or up to 24 hours in a refrigerator (2 °C-8 °C), or for up to 12 hours at room temperature and in a refrigerator (2 °C-8 °C), up to a combined total of 24 hours.
I GEMINI II havde ca. halvdelen af patienter tidligere haft manglende respons på TNFα-antagonistbehandling. 
approximately half of patients had previously failed TNFα antagonist therapy.
Patienter, som havde mistet respons på vedolizumab, da de blev behandlet hver 8. uge i GEMINI II, fik lov til at indgå i et open-label forlængelsesstudie og fik vedolizumab hver 4. uge. 
Patients who lost response to vedolizumab when treated every eight weeks in GEMINI II were allowed to enter an open-label extension study and received vedolizumab every four weeks.
Crohns sygdom er en betændelsessygdom i mave-tarm-kanalen. 
Crohn's disease is an inflammatory disease of the gastrointestinal tract.
Hvert hætteglas indeholder 300 mg vedolizumab. 
Each vial contains 300 mg of vedolizumab.
Vedolizumab reducerer den gastrointestinale inflammation hos patienter med colitis ulcerosa og Crohns sygdom. 
Vedolizumab reduces gastrointestinal inflammation in UC and CD patients.
Før fortynding skal den rekonstituerede opløsning undersøges visuelt for partikler og misfarvning. 
Inspect the reconstituted solution visually for particulate matter and discolouration prior to dilution.
Vedolizumab rekonstitueres med 4,8 ml sterilt vand til injektionsvæske ved stuetemperatur (20 °C-25 °C). 
Reconstitute vedolizumab with 4.8 mL of sterile water for injections at room temperature (20 °C-25 °C), using a syringe with a 21-25 gauge needle.