natgillin/translations-raw huggingface dataset:
This should be taken into consideration, particularly in patients with severe active disease at baseline not previously treated with TNFα antagonists. 
To je treba upoštevati, še posebej pri bolnikih z močno aktivno boleznijo v izhodišču, ki se predhodno še niso zdravili z zaviralci tumorje nekrotizirajočega faktorja alfa (TNFα).
Concomitant stable doses of oral aminosalicylates, corticosteroids and/or immunomodulators were permitted. 
Dovoljena je bila sočasna uporaba peroralnih aminosalicilatov, kortikosteroidov in/ali imunomodulatorjev v stabilnih odmerkih.
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. 
Uporabo vedolizumaba so raziskovali pri odraslih bolnikih z ulceroznim kolitisom in Crohnovo boleznijo, ki so sočasno uporabljali kortikosteroide, imunomodulatorje (azatioprin, 6-merkaptopurin in metotreksat) ter aminosalicilate.
Entyvio is contraindicated in patients with active tuberculosis (see section 4.3). 
Pri bolnikih z aktivno tuberkulozo je uporaba zdravila Entyvio kontraindicirana (glejte poglavje 4.3).
These effects were seen whether or not immunomodulators were also concomitantly administered. 
Te učinke so opazili tako pri sočasni uporabi imunomodulatorjev kot brez nje.
Immediately withdraw 5 mL (300 mg) of reconstituted Entyvio using a syringe with a 21-25 gauge needle. 
Nemudoma izvlecite 5 ml (300 mg) rekonstituirane raztopine zdravila Entyvio v injekcijsko brizgo s pomočjo injekcijske igle, velikosti 21-25 G.
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. 
Izgled zdravila Entyvio in vsebina pakiranja Zdravilo Entyvio je na voljo v obliki belega do sivobelega praška za koncentrat za raztopino za infundiranje v stekleni viali, zaprti z gumijastim zamaškom in plastično zaporko.
Starting at week 6, patients received 300 mg vedolizumab every eight or four weeks. 
V 6. tednu so bolniki nato začeli s prejemanjem vedolizumaba v odmerku 300 mg na vsakih osem tednov ali na vsake štiri tedne.
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. 
Ves čas, ko je bila rekonstituirana raztopina v viali, je treba odšteti od časa, dovoljenega za shranjevanje raztopine v infuzijski vrečki.
Effects on male and female fertility have not been formally evaluated in animal studies (see section 5.3). 
Pri študijah na živalih vplivov na plodnost samcev in samic niso formalno ovrednotili (glejte poglavje 5.3).
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. 
V s placebom nadzorovani študiji, izvedeni pri zdravih prostovoljcih, enkratni 750-mg odmerek vedolizumaba pri osebah, ki so bile cepljene intramuskularno s tremi odmerki rekombinantnega površinskega antigena virusa hepatitisa B, ni zmanjšal deležev zaščitne imunosti proti virusu hepatitisa B. Pri vedolizumabu izpostavljenih osebah so po prejemu mrtvega peroralnega cepiva proti koleri opazili nižje deleže serokonverzije.
No clinical trial data for concomitant use of vedolizumab with biologic immunosuppressants are available. 
Podatki iz kliničnega preskušanja sočasnega zdravljenja z vedolizumabom in biološkimi zdravili za zaviranje imunske odzivnosti niso na voljo.
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). 
Možni resni neželeni učinki so infuzijske reakcije ali alergijske reakcije (pojavijo se lahko pri največ 1
Ελλάδα 
Celokupno^
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. 
Ulcerozni kolitis Priporočeni režim odmerjanja zdravila Entyvio je 300 mg v obliki intravenske infuzije na ničti, drugi in šesti teden ter nato na vsakih osem tednov.
The plasma protein binding of vedolizumab has not been evaluated. 
Vezave vedolizumaba na plazemske proteine niso vrednotili.
It is a humanised monoclonal antibody that binds specifically to the α4β7 integrin, which is preferentially expressed on gut homing T helper lymphocytes. 
Je humanizirano monoklonsko protitelo, ki se specifično veže na integrin α4β7, ki je izražen predvsem na celicah T pomagalkah v črevesu.
Immunomodulatory medicinal products may increase the risk of malignancy (see section 4.8). 
Zdravila, ki spreminjajo imunsko odzivnost, lahko povečajo tveganje za razvoj malignih bolezni (glejte poglavje 4.8).
Entyvio is for intravenous use only. 
Zdravilo Entyvio je namenjeno le za intravensko uporabo.
Approximately one-third of patients had failed prior TNFα antagonist therapy. 
Pri približno eni tretjini bolnikov je bilo predhodno zdravljenje z zaviralcem TNFα neuspešno.
In this open-label extension study, clinical remission and clinical response were observed in patients for up to 196 weeks. 
V tej odprti podaljšani študiji sta se klinična remisija in klinični odziv pri bolnikih ohranila do
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. 
Bolniki s kliničnim odzivom po prejemu vedolizumaba na 0. in 2. teden, ki so nato bili randomizirani na placebo (od 6. do 52. tedna), pri čemer se je klinični odziv izgubil, so lahko vstopili v odprto podaljšano študijo in so vedolizumab prejemali na vsake štiri tedne.
The primary endpoint was the proportion of patients in clinical remission at week 6 in the TNFα antagonist failure subpopulation. 
Primarni opazovani dogodek je bil delež bolnikov v klinični remisiji v 6. tednu v podpopulaciji bolnikov brez odziva na zdravljenje z zaviralcem TNFα.
Vedolizumab is a gut-selective integrin antagonist with no identified systemic immunosuppressive activity (see section 5.1). 
Vedolizumab je za črevo selektiven integrinski zaviralec brez znanega sistemskega zaviranja imunske odzivnosti (glejte poglavje 5.1).
Vedolizumab 450 mg administered intravenously was not detected in the cerebrospinal fluid of healthy subjects. 
Po intravenski aplikaciji vedolizumaba v odmerku 450 mg pri zdravih prostovoljcih vedolizumaba v cerebrospinalni tekočini niso odkrili.
Primary endpoint was the proportion of patients in clinical remission at week 52 (see Table 5). 
Primarni opazovani dogodek je bil delež bolnikov v klinični remisiji v 52. tednu (glejte preglednico 5).
Do not add other medicinal products to the prepared infusion solution or intravenous infusion set. 
V tako pripravljeno raztopino za infundiranje ali set za intravensko infundiranje ne dodajajte drugih zdravil.
• if you have an infection, or think you have an infection, if you develop chills, shivering, persistent cough or a high fever. 
• če imate ali menite, da bi lahko imeli okužbo, če se pojavijo mrzlica, drgetanje, trdovraten kašelj ali zvišana telesna temperatura.
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. 
Entyvio običajno treba počakati najmanj 12 tednov, razen če klinično stanje bolnika ne narekuje drugače.
Patient numbers were n = 72 for placebo, n = 70 for vedolizumab every eight weeks, and n = 73 for vedolizumab every four weeks 
Število bolnikov: n = 72 za placebo, n = 70 za vedolizumab na vsakih osem tednov in n = 73 za vedolizumab na vsake štiri tedne.
Patients who failed to demonstrate response at week 6 remained in the study and received vedolizumab every four weeks. 
Bolniki, pri katerih niso uspeli dokazati odziva v 6. tednu, so ostali v študiji in prejemali vedolizumab na vsake štiri tedne.
Taking into account the PRAC Assessment Report on the PSUR(s) for vedolizumab, the scientific conclusions of the CHMP are as follows: 
Upoštevajoč poročilo Odbora za oceno tveganja na področju farmakovigilance (PRAC) o oceni redno posodobljenih poročil o varnosti zdravila (PSUR) za vedolizumab je Odbor za zdravila za uporabo v humani medicini (CHMP) sprejel naslednje znanstvene zaključke:
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). 
5 ml (300 mg) rekonstituirane raztopine zdravila Entyvio dodajte v 250 ml sterilne raztopine za injiciranje natrijevega klorida 9 mg/ml (0,9 %) in vsebino infuzijske vrečke nežno premešajte (pred dodajanjem zdravila Entyvio iz infuzijske vrečke ni treba odstraniti 5 ml natrijevega klorida 9 mg/ml (0,9 %) raztopine za injiciranje).
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. 
Pri bolnikih, ki so prejemali vedolizumab na 0. in 2. teden nato pa placebo, pri ponovni uvedbi zdravljenja z vedolizumabom po izgubi odziva niso opazili povečanja deleža reakcij, povezanih z infundiranjem.
In patients diagnosed with TB whilst receiving vedolizumab therapy, then vedolizumab therapy should be discontinued until the TB infection has been resolved. 
Pri bolnikih, pri katerih se tuberkulozo ugotovi med zdravljenjem z vedolizumabom, je treba zdravljenje z vedolizumabom prekiniti dokler se tuberkuloza ne razreši.
Therapy should be continued every eight weeks from week 14 in responding patients. 
Pri bolnikih z odzivom je nato zdravljenje od 14. tedna dalje treba nadaljevati na vsakih osem tednov.
• redness and tenderness of hair follicle 
• pordelost in občutljivost lasnega mešička,
There are no data on the effects of vedolizumab on human fertility. 
O vplivu vedolizumaba na plodnost pri človeku ni podatkov.
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). 
Crohnovo boleznijo (indeks aktivnosti Crohnove bolezni [CDAI-“Crohn's Disease Activity Index﻿ od 220 do 450) so vrednotili v dveh študijah (GEMINI II in III).
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. 
Vedolizumab rekonstituirajte s 4,8 ml sterilne vode za injekcije sobne temperature (20 °C-25 °C) s pomočjo injekcijske brizge in injekcijske igle, velikosti 21-25 G.
4.1 Therapeutic indications 
4.1 Terapevtske indikacije Ulcerozni kolitis
Patients showing clinical response at week 6 were required to begin corticosteroid tapering. 
Bolniki, ki so dosegli klinični odziv, so v 6. tednu morali začeti z režimom zmanjševanja odmerka kortikosteroida.
The following listing of adverse reactions is based on clinical trial and post marketing experience and is displayed by system organ class. 
Naslednji seznam neželenih učinkov temelji na izkušnjah iz kliničnega preskušanja in spremljanju zdravila po pridobitvi dovoljenja za promet.
Patient numbers were n = 82 for placebo, n = 82 for vedolizumab every eight weeks, and n = 80 for vedolizumab every four weeks 
Število bolnikov: n = 82 za placebo, n = 82 za vedolizumab na vsakih osem tednov in n = 80 za vedolizumab na vsake štiri tedne.
No dose adjustment is required in elderly patients. 
Pri starostnikih odmerka ni treba prilagajati.
Your doctor will have to decide if you can still be given Entyvio. 
Zdravnik bo presodil, če se kljub temu lahko zdravite z zdravilom Entyvio.
The effect of vedolizumab on infants is unknown. 
Učinek vedolizumaba na dojene novorojence ni znan.
Dose and frequency Treatment with Entyvio is the same for ulcerative colitis and Crohn's disease. 
Odmerek in pogostost Zdravljenje ulceroznega kolitisa in Crohnove bolezni z zdravilom Entyvio je enako.
If a mild to moderate IRR occurs, the infusion rate can be slowed or interrupted and appropriate treatment initiated. 
V primeru pojava blage do zmerne reakcije, povezane z infundiranjem, je treba hitrost infundiranja zdravila zmanjšati ali infundiranje prekiniti in uvesti ustrezno zdravljenje.
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. 
Pri bolnikih, pri katerih so se pojavile reakcije, povezane z infundiranjem, se je več tovrstnih reakcij v prvih dveh urah po infundiranju pojavilo pri bolnikih, ki so prejemali vedolizumab, v primerjavi z bolniki, ki so prejemali placebo.
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. 
V nadzorovanih študijah GEMINI I in II je delež resnih okužb pri bolnikih, ki so se zdravili z vedolizumabom, znašal 0,07 na bolnik-leto, pri bolnikih, ki so prejemali placebo, pa 0,06 na bolnik-leto.
Entyvio is administered as an intravenous infusion over 30 minutes. 
Zdravilo Entyvio je treba aplicirati v obliki 30-minutne intravenske infuzije.
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). 
Klinični odziv z uporabo delnih ocen Mayo je bil v 10. tednu in 14. tednu dosežen pri večjem deležu bolnikov, ki so prejemali vedolizumab (32 % in 39 %), kot pri bolnikih, ki so prejemali placebo (15 % in 21 %).
Vedolizumab is a gut-selective immunosuppressive biologic. 
Vedolizumab je biološko zdravilo za selektivno zaviranje imunske odzivnosti v črevesu.
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). 
V kliničnih študijah so poročali o pojavu reakcij, povezanih z infundiranjem, in o pojavu preobčutljivostnih reakcij, ki pa so bile večinoma blage do zmerne (glejte poglavje 4.8).
Efficacy Results for GEMINI II and III Studies at week 6 and week 10 
Rezultati učinkovitosti v 6. tednu in 10. tednu v študijah GEMINI II in III Študija
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. 
Pri bolnikih, ki so vedolizumab v odmerku 300 mg prejeli v obliki 30-minutne intravenske infuzije na 0. in 2. teden, je povprečna najmanjša koncentracija v serumu v 6. tednu pri bolnikih z ulceroznim kolitisom znašala 27,9 μg/ml (SD ± 15,51), pri bolnikih s Crohnovo boleznijo pa 26,8 μg/ml (SD ± 17,45).
Primary endpoint was the proportion of patients in clinical remission at week 52. 
Primarni opazovani dogodek je bil delež bolnikov v klinični remisiji v 52. tednu.
Once reconstituted, the infusion solution should be used as soon as possible. 
Raztopino za infundiranje morate uporabiti čim prej po rekonstituciji.
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. 
Najpogostejši neželeni učinki, o katerih so poročali, so okužbe (npr. nazofaringitis, okužba zgornjih dihal, bronhitis, gripa in sinusitis), glavobol, navzea, pireksija, utrujenost, kašelj, artralgija.
Entyvio has not been studied in these patient populations. 
Pri teh populacijah bolnikov uporabe zdravila Entyvio niso raziskovali.
Each pack of Entyvio consists of one vial. 
Ena škatla zdravila Entyvio vsebuje eno vialo.
Vedolizumab has been detected in human milk. 
Vedolizumab je bil zaznan v materinem mleku.
Tell your doctor as soon as possible if you notice any of the following: 
Če opazite kar koli od naslednjega, o tem čim prej obvestite svojega zdravnika:
†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. 
¶ Trajni klinični odziv: klinični odziv v 6. in 52. tednu # Trajna klinična remisija: klinična remisija v 6. in 52. tednu ♠ Klinična remisija brez uporabe kortikosteroidov: bolniki, ki so v izhodišču uporabljali peroralne kortikosteroide, nato pa so jih začenši v 6. tednu prenehali jemati in so bili v 52. tednu v klinični remisiji.
METHOD OF ADMINISTRATION For intravenous use after reconstitution and dilution. 
POSTOPEK UPORABE Intravenska uporaba po rekonstituciji in redčenju.
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). 
Pri bolnikih, pri katerih se je pri predhodni aplikaciji zdravila pojavila blaga do zmerna reakcija, povezana z infundiranjem, mora zdravnik presoditi o potrebnosti predhodnega zdravljenja (npr. z antihistaminikom, hidrokortizonom in/ali paracetamolom) pred naslednjo aplikacijo zdravila, da se takšno tveganje zmanjša (glejte poglavje 4.8).
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development. 
5.3 Predklinični podatki o varnosti Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih odmerkih, genotoksičnosti, karcenogenega potenciala, vpliva na sposobnost razmnoževanja in razvoja ne kažejo posebnega tveganja za človeka.
Each vial contains 300 mg of vedolizumab. 
Ena viala vsebuje 300 mg vedolizumaba.
Administer the infusion solution over 30 minutes. 
Raztopino za infundiranje aplicirajte v obliki 30-minutne intravenske infuzije.
Clinical remission, week 10 Overall 
Klinična remisija, 10. teden
Infusion related reactions after vedolizumab infusion are reported in subjects with anti-vedolizumab antibodies. 
O reakcijah, povezanih z infundiranjem, so po infundiranju vedolizumaba poročali pri bolnikih s protitelesi proti vedolizumabu.
Clinical remission Durable clinical response¶ 
Klinična remisija Trajni klinični odziv¶
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). 
V nadzorovanih študijah GEMINI I in II so o neželenem učinku, ki ga je raziskovalec opredelil kot reakcijo, povezano z infundiranjem, poročali pri 4 % bolnikov, ki so prejemali vedolizumab, in 3 % bolnikov, ki so prejemali placebo (glejte poglavje 4.4).
For intravenous use after reconstitution and dilution. 
Intravenska uporaba po rekonstituciji in redčenju.
No formal studies have been conducted to examine the effects of either renal or hepatic impairment on the pharmacokinetics of vedolizumab. 
Formalne študije, ki bi ovrednotile vpliv okvare ledvic ali jeter na farmakokinetiko vedolizumaba, niso bile izvedene.
Enhanced clinical response, week 6 Overall^ 
Okrepljen klinični odziv, 6. teden
No specific fertility studies in animals have been performed with vedolizumab. 
Posebne študije o vplivu vedolizumaba na plodnost pri živalih niso bile izvedene.
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. 
Koristen učinek vedolizumaba na klinični odziv, remisijo in celjenje sluznice so opazili tako pri bolnikih, ki se predhodno še niso zdravili z zaviralcem TNFα, kot tudi pri bolnikih, ki se na predhodno zdravljenje z zaviralcem TNFα niso odzvali.
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. 
Za vrednotenje opazovanih dogodkov v 6. tednu so 374 bolnikov randomizirali na dvojno slep način (3:2) na prejemanje vedolizumaba v odmerku 300 mg ali placeba na 0. teden in 2. teden.
Storage Condition Refrigerator (2°C-8°C) 
Pogoji shranjevanja V hladilniku (2 °C-8 °C)
Once the mild or moderate IRR subsides, continue the infusion. 
Ko blaga ali zmerna reakcija, povezana z infundiranjem, izzveni, se infundiranje zdravila lahko nadaljuje.
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. 
V nadzorovanih študijah GEMINI I in II je delež okužb pri bolnikih, zdravljenih z vedolizumabom, znašal 0,85 na bolnik-leto (“patient-year”), pri bolnikih, ki so prejemali placebo, pa 0,70 na bolnik-leto.
†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. 
§ Klinična remisija brez uporabe kortikosteroidov: bolniki, ki so v izhodišču uporabljali peroralne kortikosteroide, nato pa so jih začenši v 6. tednu prenehali jemati in so bili v 52. tednu v klinični remisiji.
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. 
Bolnike (n = 416), od tega približno 75 % bolnikov brez odziva na zdravljenje z zaviralcem TNFα, so randomizirali na dvojno slep način (1:1) na prejemanje vedolizumaba v odmerku 300 mg ali placeba na 0., 2. in 6. teden.
The infections consisted primarily of nasopharyngitis, upper respiratory tract infection, sinusitis, and urinary tract infections. 
Okužbe so bile predvsem nazofaringitis, okužba zgornjih dihal, sinuzitis in okužbe sečil.
Tell your doctor immediately if you notice any of the following: 
Če opazite kar koli od naslednjega, o tem nemudoma obvestite svojega zdravnika:
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. 
Okrepljen klinični odziv v 10. tednu in 14. tednu so opazili pri večjem deležu bolnikov, ki so prejemali vedolizumab (16% in 22%), kot pri bolnikih, ki so prejemali placebo (7 % in 12 %).
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. 
Bolnike (n = 368) so randomizirali na dvojno slep način (3:2) na dva odmerka vedolizumaba 300 mg ali placeba na 0. teden in 2. teden.
The recommended dose is 300 mg of Entyvio given as follows (see table below): 
Priporočeni odmerek zdravila Entyvio je 300 mg. Prejeli ga boste na naslednji način (glejte preglednico v nadaljevanju): Številka zdravljenja (infuzije)
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. 
Priporočljivo je, da so pred uvedbo zdravljenja z zdravilom Entyvio, vsi bolniki cepljeni z vsemi cepivi v skladu z veljavnimi smernicami za cepljenje.
L-histidine monohydrochloride L-arginine hydrochloride sucrose polysorbate 80 
L-histidinijev klorid L-argininijev klorid saharoza polisorbat 80
4.7 Effects on ability to drive and use machines 
4.7 Vpliv na sposobnost vožnje in upravljanja strojev Zdravilo Entyvio ima blag vpliv na sposobnost vožnje in upravljanja strojev.
Vedolizumab Every 8 weeks n = 122 
Vedolizumab vsakih 8 tednov n = 122