natgillin/translations-raw huggingface dataset:
Diluted solution in sodium chloride 9 mg/mL (0.9%) solution for injection 
9 mg/ml (0,9 %) raztopino za injiciranje
Excipients: Sucrose, L-histidine, L-histidine monohydrochloride, L-arginine hydrochloride, polysorbate 80. 
Pomožne snovi: saharoza, L-histidin, L-histidinijev klorid, L-argininijev klorid in polisorbat 80.
After reconstitution each mL contains 60 mg of vedolizumab. 
Po rekonstituciji en ml vsebuje 60 mg vedolizumaba.
The effect of vedolizumab on the pharmacokinetics of commonly co-administered medicinal compounds has not been studied. 
Vpliva vedolizumaba na farmakokinetiko pogosto sočasno uporabljenih zdravil niso raziskovali.
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. 
Za kombinirano zdravljenje, predvsem za sočasno zdravljenje s kortikosteroidi, se je izkazalo, da je pri indukciji remisije Crohnove bolezni bolj učinkovito od zdravljenja samo z vedolizumabom ali sočasnega zdravljenja z imunomodulatorji.
Table 2 shows the results from the primary and secondary endpoints evaluated. 
Rezultati ovrednotenih primarnih in sekundarnih opazovanih dogodkov so prikazani v preglednici 2.
• Summary of Product Characteristics and Package Leaflet 
• povzetek glavnih značilnosti zdravila in navodilo za uporabo,
Caution should be exercised when considering the use of Entyvio in these patients. 
Pri odločanju o zdravljenju teh bolnikov z zdravilom Entyvio je potrebna previdnost.
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. 
Pri 3 od 11 opic Cynomolgus, ki so prejemale vedolizumab v odmerku 100 mg/kg na vsaka 2 tedna, so 28. dan po kotitvi v mleku odkrili majhne količine (< 300 μg/l) vedolizumaba, pri živalih, ki so prejemale odmerek 10 mg/kg, pa vedolizumaba v mleku niso odkrili.
Table 3 shows the results from the primary and secondary endpoints evaluated. 
Rezultati ovrednotenih primarnih in sekundarnih opazovanih dogodkov so prikazani v preglednici 3.
In-use stability of the reconstituted solution in the vial has been demonstrated for 8 hours at 2°C-8°C. 
Dokazano je bilo, da je rekonstituirana raztopina v viali pri temperaturi 2 °C-8 °C stabilna 8 ur.
The other ingredients are L-histidine, L-histidine monohydrochloride, L-arginine hydrochloride, sucrose, and polysorbate 80. 
Pomožne snovi so L-histidin, L-histidinijev klorid, L-argininijev klorid, saharoza in polisorbat 80.
Efficacy was regained with no evident increase in adverse reactions or infusion-related reactions during retreatment with vedolizumab (see section 4.8). 
Pri ponovni uvedbi zdravljenja je bila učinkovitost vedolizumaba znova dosežena, brez očitnega povečanja pogostnosti neželenih učinkov ali reakcij, povezanih z infundiranjem (glejte poglavje 4.8).
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. 
Od teh bolnikov je bila klinična remisija v 52. tednu dosežena pri 37 % bolnikov, ki so vedolizumab prejemali na vsakih osem tednov, 35 % bolnikov, ki so vedolizumab prejemali na vsake štiri tedne, in 5 % bolnikov, ki so prejemali placebo.
Therapy for patients with ulcerative colitis should be discontinued if no evidence of therapeutic benefit is observed by week 10 (see section 5.1). 
Če pri bolnikih z ulceroznim kolitisom v 10. tednu ni opaziti znakov terapevtske koristi, je treba prenehati z zdravljenjem (glejte poglavje 5.1).
Anaphylactic reaction, Anaphylactic shock 
Bolezni imunskega sistema zelo redki anafilaktična reakcija, anafilaktični šok
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. 
V študiji GEMINI II je delež klinične remisije pri uporabi brez kortikosteroidov v 6. tednu znašal 10 % (razlika v primerjavi s placebom 2 %, 95 % IZ: -6, 10), pri uporabi skupaj s kortikosteroidi pa 20 % (razlika v primerjavi s placebom 14 %, 95 % IZ: -1, 29).
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. 
Vialo pustite počivati do 20 minut pri sobni temperaturi (20 °C-25 °C), da se vsebina rekonstituira in vsa pena usede.
Appropriate monitoring and medical support measures should be available for immediate use when administering vedolizumab. 
Ustrezna oprema in pripomočki ter ustrezno usposobljeno zdravstveno osebje za nadzor in zdravljenje bolnika morajo biti v takšnih primerih nemudoma na voljo.
Patients who failed to demonstrate response at week 6 in GEMINI II were retained in the study and received vedolizumab every four weeks. 
Bolniki brez ugotovljenega odziva v 6. tednu v študiji GEMINI II so ostali v študiji in so prejemali vedolizumab na vsake štiri tedne.
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). 
Če pri bolnikih s Crohnovo boleznijo v 14. tednu ni opaziti znakov terapevtske koristi, se zdravljenja ne sme nadaljevati (glejte poglavje 5.1).
There are no data on the secondary transmission of infection by live vaccines in patients receiving vedolizumab. 
Pri bolnikih, ki so se zdravili z vedolizumabom, ni podatkov o sekundarnem prenosu okužbe z živimi cepivi.
Remove flip-off cap from the vial and wipe with alcohol swab. 
Odstranite zaporko in zamašek viale obrišite z alkoholnim zložencem.
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. 
Razredčeno raztopino, z natrijevim kloridom 9 mg/ml (0,9 %) raztopino za injiciranje, lahko shranjujete največ 12 ur pri sobni temperaturi (do 25 °C) ali največ 24 ur v hladilniku (2 °C-8 °C) ali največ 12 ur pri sobni temperaturi in nato v hladilniku (2 °C-8 °C) do skupnega trajanja shranjevanja 24 ur.
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. 
Bolniki, pri katerih se je odziv na vedolizumab pri zdravljenju na vsakih osem tednov izgubil, so lahko vstopili v odprto podaljšano študijo in so vedolizumab prejemali na vsake štiri tedne.
Do not store any unused portion of the reconstituted solution or infusion solution for reuse. 
Neporabljene rekonstituirane raztopine ali raztopine za infundiranje ne shranjujte za ponovno uporabo.
• blocked nose 
• zamašen nos,
The following information is intended for healthcare professionals only: 
Naslednje informacije so namenjene samo zdravstvenemu osebju: Navodila za rekonstitucijo in infundiranje
Entyvio is for single-use only. 
Zdravilo Entyvio je namenjeno le za enkratno uporabo.
By binding to the α4β7 integrin expressed on gut-homing lymphocytes, vedolizumab exerts an immunosuppressive effect specific to the gut. 
Vedolizumab z vezavo na integrin α4β7, izražen na črevesnih limfocitih, zmanjšuje imunsko odzivnost selektivno v črevesu.
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. 
24-urno obdobje lahko za rekonstituirano raztopino v viali vključuje do 8 ur pri temperaturi 2 °C-8 °C in za razredčeno raztopino v infuzijski vrečki do 12 ur pri temperaturi 20 °C-25 °C, vendar mora biti infuzijska vrečka shranjena v hladilniku (pri temperaturi 2 °C-8 °C) preostanek 24-urnega obdobja.
In these patients, clinical remission was achieved in 46% of patients by 28 weeks and 41% of patients by 52 weeks. 
Pri teh bolnikih je bila klinična remisija v 28. tednu dosežena pri 46 % bolnikov, v 52. tednu pa pri 41 % bolnikov.
• throat infection 
• okužba žrela,
Vedolizumab Every 4 weeks n = 125 
Vedolizumab vsake 4 tedne n = 125
Analyses of week 52 clinical remission in patients who were non-responders at week 6 but achieved response at week 10 or week 14 indicate that non-responder CD patients may benefit from a dose of vedolizumab at week 10. 
6. tednu, ki pa so nato dosegli odziv v 10. tednu ali 14. tednu kažejo, da bolnikom s Crohnovo boleznijo brez odziva lahko koristi odmerek vedolizumaba v 10. tednu.
Muscle spasms, Back pain, Muscular weakness, Fatigue, Pain in the extremity 
Bolezni mišično-skeletnega sistema in vezivnega tkiva zelo pogosti bolečina v sklepih pogosti mišični krči, bolečina v hrbtu, oslabelost mišic, utrujenost, bolečina v okončini
• eczema 
• ekcem,
Treatment 3 
Tretje zdravljenje
This medicine has a minor influence on your ability to drive or use tools or machines. 
Vpliv na sposobnost upravljanja vozil in strojev To zdravilo ima blag vpliv na sposobnost upravljanja vozil in strojev.
Improvements in durable clinical response (47%, 43%, 16%), mucosal healing (42%, 48%, 8%), durable clinical remission (21%, 13%, 3%) and corticosteroid-free clinical remission (23%, 32%, 4%) were seen in the prior TNFα antagonist failure population treated with vedolizumab every eight weeks, vedolizumab every four weeks and placebo, respectively. 
oziroma 16 % bolnikov), celjenja sluznice (pri 42 %, 48 % oziroma 8 % bolnikov), trajne klinične remisije (pri 21 %, 13 % oziroma 3 % bolnikov) in klinične remisije brez uporabe kortikosteroidov (pri 23 %, 32 % oziroma 4 % bolnikov).
Vedolizumab Every 4 weeks n = 154 
Vedolizumab vsake 4 tedne n = 154
The active substance is vedolizumab. 
Učinkovina je vedolizumab.
Vedolizumab exhibited linear pharmacokinetics at serum concentrations greater than 1 mcg/mL. 
Vedolizumab pri koncentracijah v serumu, večjih od 1 μg/ml, kaže linearno farmakokinetiko.
Enhanced clinical response Corticosteroid-free clinical remission§ Durable clinical remission¶ 
Klinična remisija Okrepljen klinični odziv Klinična remisija brez uporabe kortikosteroidov§
Patients should be given the package leaflet and the Patient Alert Card. Posology 
Bolniki morajo prejeti navodilo za uporabo in opozorilno kartico.
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. 
Pri prvih 2 infundiranjih je treba bolnike glede pojava znakov in simptomov akutnih preobčutljivostnih reakcij nadzirati še približno dve uri po koncu infundiranja, pri vseh nadaljnjih infundiranjih pa še približno 1 uro po koncu infundiranja.
How to store Entyvio 
Kako boste prejeli zdravilo Entyvio
Vedolizumab Every 8 weeks n = 154 
Vedolizumab vsakih 8 tednov n = 154
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. 
Pri bolnikih z ulceroznim kolitisom, ki so vedolizumab prejemali na vsakih osem tednov, je povprečna najmanjša serumska koncentracija v stanju dinamičnega ravnovesja znašala 11,2 μg/ml (SD ± 7,24), pri bolnikih, ki so vedolizumab prejemali na vsake štiri tedne, pa 38,3 μg/ml (SD ± 24,43).
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. 
Bolniki, ki so pri zdravljenju z vedolizumabom na vsakih osem tednov izgubili odziv, so se v študiji GEMINI II lahko vključili v odprto podaljšano študijo in so vedolizumab prejemali na vsake štiri tedne.
In-use stability of the diluted solution in sodium chloride 9 mg/mL (0.9%) solution for injection in infusion bag has been demonstrated for 12 hours at 20°C-25°C or 24 hours at 2°C-8°C. 
Razredčeno raztopino, z natrijevim kloridom 9 mg/ml (0,9 %) raztopino za injiciranje, lahko v infuzijski vrečki hranite 12 ur pri temperaturi 20 °C-25 °C ali 24 ur pri temperaturi 2 °C-8 °C.
Takeda Austria GmbH St. Peter-Straße 25 4020 Linz 
A-4020 Linz Avstrija
§Clinical remission: Complete Mayo score of ≤ 2 points and no individual subscore > 1 point 
* p < 0,0001 † p ≤ 0,001 ‡ p < 0,05 § Klinična remisija: celotna ocena Mayo ≤ 2 točk, nobena posamezna podocena > 1 točke ¶ Celjenje sluznice: endoskopska podocena Mayo ≤ 1 točke
Most patients continued on vedolizumab after the infection resolved. 
Po ozdravitvi okužbe se je zdravljenje z vedolizumabom pri večini bolnikov nadaljevalo.
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. 
Pri bolnikih s Crohnovo boleznijo, ki so vedolizumab prejemali na vsakih osem tednov, je povprečna najmanjša serumska koncentracija v stanju dinamičnega ravnovesja znašala 13,0 μg/ml (SD ± 9,08), pri bolnikih, ki so vedolizumab prejemali na vsake štiri tedne, pa 34,8 μg/ml (SD ± 22,55).
In these patients, clinical remission was achieved in 45% of patients by 28 weeks and 36% of patients by 52 weeks. 
Pri teh bolnikih je bila klinična remisija v 28. tednu dosežena pri 45 % bolnikov, v 52. tednu pa pri 36 % bolnikov.
Entyvio 300 mg powder for concentrate for solution for infusion vedolizumab 
Entyvio 300 mg prašek za koncentrat za raztopino za infundiranje vedolizumab
Beginning at week 6, patients who had achieved clinical response and were receiving corticosteroids were required to begin a corticosteroid-tapering regimen. 
ki so dosegli klinični odziv, in so se zdravili s kortikosteroidi, so v 6. tednu morali začeti z režimom zmanjševanja odmerka kortikosteroida.
Unopened vial: Store in a refrigerator (2 °C-8 °C). 
Zaprta viala: Shranjujte v hladilniku (2 °C-8 °C).
Enhanced clinical response was achieved in 29%, 38%, 21%, respectively, and corticosteriod-free clinical remission was achieved in 24%, 16%, 0%, respectively. 
Okrepljen klinični odziv je bil dosežen pri 29 %, 38 %
Caution should be exercised when considering the use of vedolizumab in patients with a controlled chronic severe infection or a history of recurring severe infections. 
Pri bolnikih z nadzorovano hudo kronično okužbo ali anamnezo ponavljajočih se hudih okužb se je treba za zdravljenje z vedolizumabom odločiti po posebej skrbnem in previdnem razmisleku.
Anal Abscess, Anal fissure, Nausea, Dyspepsia, Constipation, Abdominal distension, Flatulence, Haemorrhoids 
Bolezni prebavil pogosti absces zadnjika, fisura ob zadnjiku, navzea, dispepsija, zaprtost, napihnjenost trebuha, flatulenca, hemoroidi
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Entyvio 300 mg powder for concentrate for solution for infusion vedolizumab 
IME ZDRAVILA IN POT(I) UPORABE Entyvio 300 mg prašek za koncentrat za raztopino za infundiranje vedolizumab
Entyvio is given by a doctor or nurse and patients should not need to store or handle Entyvio. 
Bolnikom zdravila Entyvio ni treba shranjevati ali kakor koli z njim rokovati.
In these patients, clinical remission was achieved in 23% of patients at week 28 and 32% of patients at week 52. 
Klinična remisija v 28. tednu je bila dosežena pri 23 % takšnih bolnikov, v 52. tednu pa pri 32 % bolnikov.
Vedolizumab should be administered in a healthcare setting equipped to allow management of acute hypersensitivity reactions including anaphylaxis, if they occur. 
4.4 Posebna opozorila in previdnostni ukrepi Vedolizumab je treba uporabljati v ustrezno opremljenih zdravstvenih ustanovah, kjer je v primeru pojava akutnih preobčutljivostnih reakcij, vključno z anafilaksijo, mogoče nemudoma uvesti ustrezne ukrepe.
Treatment 2 
Drugo zdravljenje
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. 
Pri bolnikih s hudimi aktivnimi okužbami se zdravljenja z zdravilom Entyvio ne sme uvesti vse dokler okužbe niso ustrezno nadzorovane.
Infusion site reaction (including: Infusion site pain and Infusion site irritation), Infusion related reaction, Chills, Feeling cold 
Splošne težave in spremembe na mestu aplikacije pogosti zvišana telesna temperatura občasni reakcija na mestu infundiranja (vključno z bolečino na mestu infundiranja in iritacijo na mestu infundiranja), reakcija, povezana z infundiranjem, mrzlica, občutek mraza
approximately half of patients had previously failed TNFα antagonist therapy. 
GEMINI II se približno polovica bolnikov ni odzvala na predhodno zdravljenje z zaviralcem TNFα.
• Patient alert card, 
• izobraževalno gradivo za zdravnike, • opozorilno kartico za bolnika.
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. 
Z zdravjem povezano kakovost življenja (HRQOL-“Health-related quality of life”) so ovrednotili z za vnetno bolezen črevesa specifičnim vprašalnikom IBDQ (“Inflammatory Bowel Disease
• prickling or tingling 
• mrzlica ali drgetanje,
The risk of malignancy is increased in patients with ulcerative colitis and Crohn's disease. 
Pri bolnikih z ulceroznim kolitisom in s Crohnovo boleznijo je tveganje za novotvorbe večje.
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. 
Za oceno učinkovitosti v 52. tednu so 373 bolnikov iz 1. in 2. kohorte, ki so pri zdravljenju z vedolizumabom dosegli klinični odziv, v 6. tednu randomizirali na dvojno slep način (1:1:1) na enega od naslednjih režimov, ki se je začel v 6. tednu: vedolizumab v odmerku 300 mg na vsakih osem tednov, vedolizumab v odmerku 300 mg na vsake štiri tedne ali placebo na vsake štiri tedne.
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. 
Pri bolnikih, zdravljenih z vedolizumabom, so poročali tudi o reakcijah na mestu injiciranja (s simptomi kot so dispneja, bronhospazem, urtikarija, vročinski oblivi, izpuščaj, zvišan krvni tlak in srčni utrip).
≥ 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. 
Primarni opazovani dogodek je bil delež bolnikov s kliničnim odzivom (opredeljeno kot zmanjšanje celotne oceno Mayo za ≥ 3 točke in ≥ 30 % od izhodiščne vrednosti ob sočasnem zmanjšanju podocene krvavitve iz danke za ≥ 1 točko ali absolutna podocena krvavitve iz danke ≤ 1 točke) v 6. tednu.
NAME OF THE MEDICINAL PRODUCT Entyvio 300 mg powder for concentrate for solution for infusion 
IME ZDRAVILA Entyvio 300 mg prašek za koncentrat za raztopino za infundiranje
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. 
V študiji GEMINI III je delež klinične remisije pri uporabi brez kortikosteroidov v 6. tednu znašal 18 % (razlika v primerjavi s placebom 3 %, 95 % IZ: -7, 13), v 10. tednu pa 22 % (razlika v primerjavi s placebom 8 %, 95 % IZ: -3, 19).
• haemorrhoids 
• koprivnica,
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. 
Zdravilo Entyvio je indicirano za zdravljenje zmerno do močno aktivne Crohnove bolezni pri odraslih bolnikih, če pri predhodnem ustaljenem zdravljenju ali zdravljenju z zaviralcem tumorje nekrotizirajočega faktorja alfa (TNFα) odziv na zdravljenje ni bil zadosten, je izzvenel ali pa bolniki takšnega zdravljenja niso prenašali.
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. 
Zdravilo Entyvio je indicirano za zdravljenje zmerno do močno aktivnega ulceroznega kolitisa pri odraslih bolnikih, če pri predhodnem ustaljenem zdravljenju ali zdravljenju z zaviralcem tumorje nekrotizirajočega faktorja alfa (TNFα) odziv na zdravljenje ni bil zadosten, je izzvenel ali pa bolniki takšnega zdravljenja niso prenašali.
including corticosteroids, immunomodulators, and/or TNFα antagonists (including primary non-responders). 
Vključeni bolniki se niso odzivali na vsaj eno ustaljeno zdravljenje, vključno s kortikosteroidi, imunomodulatorji in/ali zaviralci TNFα (vključno s primarnim neodzivom).
28% receiving vedolizumab every eight weeks, 27% receiving vedolizumab every four weeks, and 13% receiving placebo achieved clinical remission at week 52. 
Od teh bolnikov je bila klinična remisija v 52. tednu dosežena pri 28 % bolnikov, ki so vedolizumab prejemali na vsakih osem tednov, 27 % bolnikov, ki so vedolizumab prejemali na vsake štiri tedne, in 13 % bolnikov, ki so prejemali placebo.
No dose-limiting toxicity was seen in clinical trials. 
V kliničnih preskušanjih niso opazili toksičnih učinkov, ki bi omejevali velikost odmerka.
Treatment 1 
Prvo zdravljenje
Corticosteroid-free clinical remission♠ 
Trajna klinična remisija# Klinična remisija brez uporabe kortikosteroidov♠
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. 
Razen tega pa tudi in vitro na tumorskih celičnih linijah človeškega izvora z izraženim integrinom α4β7 niso ugotovili učinkov vedolizumaba na delež proliferacij ali citotoksičnih učinkov.
• bloated stomach 
• mišični krči,
• stomach flu 
• trebušna gripa,
Immune System Disorders 
Organski sistem
Week 52 Efficacy Results of GEMINI I 
Rezultati učinkovitosti v 52. tednu v študiji GEMINI I Opazovani dogodek
Vedolizumab 
Celokupno
• pneumonia 
• hemoroidi,
Rash, Pruritus, Eczema, Erythema, Night sweats, Acne 
Bolezni kože in podkožja pogosti izpuščaj, srbenje, ekcem, rdečina, nočno znojenje, akna občasni folikulitis
The murine precursor of vedolizumab alleviated gastrointestinal inflammation in colitic cotton-top tamarins, a model of ulcerative colitis. 
Pri tamarinkah ali lisztovih opicah (Saguinus oedipus) s kolitisom, modelu ulceroznega kolitisa, mišji prekurzor vedolizumaba omili gastrointestinalno vnetje.
Vedolizumab does not pass the blood brain barrier after intravenous administration. 
Vedolizumab po intravenski aplikaciji ne prehaja skozi krvno-možgansko pregrado.
Entyvio contains the active substance vedolizumab. 
Učinkovina zdravila Entyvio je vedolizumab.