FrancophonIA/ELRC3.0 huggingface dataset:
English: Crohn's disease is an inflammatory disease of the gastrointestinal tract.
Croatian: Crohnova bolest je upalna bolest probavnog sustava.
English: De uts chland Takeda GmbH Tel.: +49 (0) 800 825 3325 medinfo@takeda.de
Croatian: Takeda GmbH Tel.: +49 (0) 800 825 3325 medinfo@takeda.de
English: In GEMINI II,
Croatian: Ispitivanje GEMINI II
English: 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.
Croatian: U bolesnika koji su primili 300 mg vedolizumaba kao polusatnu intravensku infuziju u 0. i 2. tjednu, srednja vrijednost najniže serumske koncentracije u 6. tjednu bila je 27,9 µg/ml (SD ± 15,51) kod ulceroznog kolitisa i 26,8 µg/ml (SD ± 17,45) kod Crohnove bolesti.
English: Bronchitis, Gastroenteritis, Upper respiratory tract infection, Influenza, Sinusitis, Pharyngitis
Croatian: Često bronhitis, gastroenteritis, infekcija gornjeg dišnog sustava, gripa, sinusitis, faringitis
English: 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.
Croatian: Pojačani klinički odgovor uočen je u 10. i 14 tjednu u većem udjelu za bolesnike liječene vedolizumabom 16% odnosno 22%, u usporedbi sa bolesnicima koji su primali placebo 7% odnosno 12%.
English: • shingles (herpes zoster)
Croatian: • vaginalna infekcija • herpes zoster
English: Each vial is for single-use only.
Croatian: Svaka je bočica lijeka namijenjena samo za jednokratnu uporabu.
English: trafficking into the CNS as evidenced by the lack of change in the ratio of CD4 +/CD8
Croatian: limfocita u CNS-u što je vidljivo izostankom promjene u omjeru CD4
English: 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).
Croatian: Klinički odgovor temeljem djelomične Mayo ocjene postignut je u 10. i 14. tjednu kod većeg udjela bolesnika liječenih vedolizumabom (32% odnosno 39%) u odnosu na bolesnike koji su primali placebo (15% odnosno 21%).
English: 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.
Croatian: 2Navedeno vrijeme pretpostavlja da se rekonstituirana otopina odmah razrjeđuje u 0,9%-tnoj (9 mg/ml) otopini natrijeva klorida za injekciju i čuva samo u vrećici za infuziju.
English: Do not store any unused portion of the reconstituted solution or infusion solution for reuse.
Croatian: Niti jedan neiskorišteni dio rekonstituirane otopine ili otopine za infuziju nemojte pohranjivati za ponovnu uporabu.
English: Vedolizumab is a gut-selective immunosuppressive biologic.
Croatian: Vedolizumab je biološki imunosupresiv selektivan za crijeva.
English: Beginning at week 6, patients who had achieved clinical response and were receiving corticosteroids were required to begin a corticosteroid-tapering regimen.
Croatian: Počevši od 6. tjedna, od bolesnika koji su uzimali kortikosteroide i postigli klinički odgovor, tražilo se da počnu smanjivati dozu kortikosteroida.
English: The effect of vedolizumab on the pharmacokinetics of commonly co-administered medicinal compounds has not been studied.
Croatian: Učinak vedolizumaba na farmakokinetiku istovremeno primijenjenih čestih lijekova nije ispitan.
English: Adverse Reactions System Organ Class
Croatian: Tablica 1. Nuspojave Klasifikacija organskog sustava
English: Exploratory analysis show clinically meaningful improvements were observed for vedolizumab groups, and the improvements were significantly greater as compared with the placebo group at week 6 and week 52 on EQ-5D and EQ-5D VAS scores, all subscales of IBDQ (bowel symptoms, systemic function, emotional function and social function), and all subscales of SF-36 including the Physical Component Summary (PCS) and Mental Component Summary (MCS).
Croatian: Eksplorativne analize pokazuju da su u 6. i 52. tjednu prema rezultatima upitnika EQ-5D i EQ-5D VAS, svim podljestvicama IBDQ (simptomi na crijevima, sistemska funkcija, emocionana funkcija i društvena funkcija) te svih podljestvica SF-36 uključujući i Sažetak fizičke komponente (PCS) i
English: 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).
Croatian: Primjenu u bolesnika s Crohnovom bolešću potrebno je prekinuti ako se do 14. tjedna liječenja ne utvrdi korist terapije (vidjeti dio 5.1).
English: Possible serious side effects include infusion reactions or allergic reactions (may affect up to 1 in 100 people) and infections (may affect up to 1 in 10 people).
Croatian: Moguće ozbiljne nuspojave uključuju reakcije na infuziju ili alergijske reakcije (mogu se javiti u do 1
English: 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.
Croatian: Analize kliničke remisije u 52. tjednu u bolesnika koji nisu odgovorili na terapiju u 6. tjednu već su odgovor postigli u 10. ili 14. tjednu ukazuju da bolesnici s
English: Reconstituted solution in the vial
Croatian: Rekonstituirana otopina u bočici
English: • There is no clinical trial experience with Entyvio in patients previously treated with natalizumab.
Croatian: • Nema iskustva iz kliničkih ispitivanja s lijekom Entyvio u bolesnika prethodno liječenih natalizumabom.
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.
Croatian: *Skupina koja je primala placebo uključuje one ispitanike koji su primali vedolizumab u 0. i 2. tjednu te su bili randomizirani da primaju placebo od 6. do 52. tjedna.
English: The infections consisted primarily of nasopharyngitis, upper respiratory tract infection, sinusitis, and urinary tract infections.
Croatian: Infekcije su se prvenstveno sastojale od nazofaringitisa, infekcije gornjeg dišnog sustava, sinusitisa te infekcije mokraćnog sustava.
English: Patient numbers were n = 72 for placebo, n = 70 for vedolizumab every eight weeks, and n = 73 for vedolizumab every four weeks
Croatian: Broj bolesnika bio je n = 72 za placebo, n = 70 za vedolizumab svakih osam tjedana i n = 73
English: • pain at the infusion site
Croatian: • bol na mjestu infuzije
English: Immediately withdraw 5 mL (300 mg) of reconstituted Entyvio using a syringe with a 21-25 gauge needle.
Croatian: Odmah izvucite 5 ml (300 mg) rekonstituiranog lijeka Entyvio uporabom štrcaljke s iglom 21G-25G.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 300 mg
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA
English: Unite d Kingdom Takeda UK Ltd Tel.: +44 (0)1628 537 900
Croatian: Takeda UK Ltd Tel.: +44 (0)1628 537 900
English: Treatment 2
Croatian: Liječenje 2
English: • Patient alert card,
Croatian: • Karticu s upozorenjima za bolesnika
English: Clinical remission, week 10 Overall
Croatian: Klinička remisija, 10. tjedan
English: 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.
Croatian: U kontroliranim ispitivanjima GEMINI I i II, stopa ozbiljnih infekcija iznosila je 0,07 po bolesnik-godini u bolesnika liječenih vedolizumabom te 0,06 po bolesnik-godini u bolesnika liječenih placebom.
English: †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.
Croatian: ¶Trajni klinički odgovor: klinički odgovor u tjednima 6. i 52. #Trajna klinička remisija: klinička remisija u tjednima 6. i 52. ♠Klinička remisija bez kortikosteroida: Bolesnici koji su pri uključivanju u ispitivanje koristili peroralne kortikosteroide i počevši od 6. tjedna prekinuli njihovo uzimanje i bili su u kliničkoj remisiji u 52. tjednu.
English: Approximately one-third of patients had failed prior TNFα antagonist therapy.
Croatian: Približno jedna trećina bolesnika nije odgovorila na prethodno liječenje antagonistom TNFα.
English: Такеда България Тел.
Croatian: България Такеда България
English: After reconstitution, each mL contains 60 mg of vedolizumab.
Croatian: Nakon rekonstitucije jedan ml sadrži 60 mg vedolizumaba.
English: • Consider the patient's full medical history, including any prior or concurrent biological medicine use
Croatian: Edukacijski materijal za liječnike treba sadržati sljedeće ključne poruke: • Razmotrite cijelu povijest bolesti bolesnika, uključujući bilo kakvu prethodnu ili istodobnu primjenu biološkog lijeka
English: Efficacy Results for GEMINI II and III Studies at week 6 and week 10
Croatian: Tablica 4. Rezultati djelotvornosti u ispitivanjima GEMINI II i III u 6. i 10. tjednu
English: Powder for concentrate for solution for infusion.
Croatian: Prašak za koncentrat za otopinu za infuziju
English: Luxe mbourg/Luxemburg Takeda Belgium Tel/Tél: +32 2 464 06 11 takeda-belgium@takeda.com
Croatian: Takeda Belgium Tel./Tél.: +32 2 464 06 11 takeda-belgium@takeda.com
English: 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.
Croatian: U kontroliranim ispitivanjima GEMINI I i II, stopa infekcija iznosila je 0,85 po bolesnik-godini u bolesnika liječenih vedolizumabom te 0,70 po bolesnik-godini u bolesnika liječenih placebom.
English: • redness and tenderness of hair follicle
Croatian: • crvenilo i osjetljivost vlasišta
English: 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.
Croatian: Bolesnici koji su postigli klinički odgovor nakon primanja vedolizumaba u 0. i 2. tjednu i potom su randomizirani u skupinu koja je primala placebo (od 6. do 52. tjedna) te su izgubili odgovor na liječenje, mogli su ući u otvoreni nastavak ispitivanja i primati vedolizumab svaka četiri tjedna.
English: Dose and frequency Treatment with Entyvio is the same for ulcerative colitis and Crohn's disease.
Croatian: Liječenje lijekom Entyvio jednako je za ulcerozni kolitis i Crohnovu bolest.
English: No dose-limiting toxicity was seen in clinical trials.
Croatian: U kliničkim ispitivanjima nije opažena toksičnost koja bi zahtijevala ograničenje doze.
English: 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.
Croatian: Povoljni učinak vedolizumaba na klinički odgovor, remisiju i cijeljenje sluznice uočen je i kod bolesnika koji nisu prethodno uzimali antagoniste TNFα kao i kod onih s neuspješnom prethodnom terapijom TNFα antagonistima.
English: Entyvio contains the active substance vedolizumab.
Croatian: Entyvio sadrži djelatnu tvar vedolizumab.
English: Therapy for patients with ulcerative colitis should be discontinued if no evidence of therapeutic benefit is observed by week 10 (see section 5.1).
Croatian: Liječenje lijekom Entyvio u bolesnika s ulceroznim kolitisom potrebno je prekinuti ako se do 10. tjedna liječenja ne utvrdi korist terapije (vidjeti dio 5.1).
English: 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.
Croatian: Razrijeđena otopina u 0,9%-tnoj (9 mg/ml) otopini natrijeva klorida za injekciju može se čuvati do 12 sati na sobnoj temperaturi ne višoj od 25 °C ili do 24 sata u hladnjaku (2 ˚C-8 ˚C) ili, kombinirano, do 12 sati na sobnoj temperaturi i u hladnjaku (2 ˚C-8˚C) preostalo vrijeme do ukupno 24 sata.
English: : +47 6676 3030 infonorge@takeda.com
Croatian: Tlf.: +47 6676 3030 infonorge@takeda.com
English: Very common Nasopharyngitis Common
Croatian: Vrlo često nazofaringitis
English: 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.
Croatian: Bolesnici (n = 416), među kojima približno 75 % njih nije odgovorilo na terapiju antagonistima TNFα, su dvostruko slijepo randomizirani (1:1) za primanje ili vedolizumaba 300 mg ili placeba u 0., 2. i 6. tjednu.
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).
Croatian: Crohnovom bolešću (indeks aktivnosti Crohnove bolesti [CDAI] 220 do 450) ispitane su u dva ispitivanja (GEMINI II i III).
English: 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.
Croatian: Za procjenu ishoda u 6. tjednu, 374 bolesnika su dvostruko-slijepo randomizirana (3:2) za primanje vedolizumaba 300 mg ili placeba u 0. i 2. tjednu.
English: 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.
Croatian: U bolesnika s Crohnovom bolešću, srednja vrijednost najniže ravnotežne serumske koncentracije bila je 13,0 µg/ml (SD ± 9,08) odnosno 34,8 µg/ml (SD ± 22,55).
English: This should be taken into consideration, particularly in patients with severe active disease at baseline not previously treated with TNFα antagonists.
Croatian: To se mora uzeti u obzir, posebno u bolesnika s izrazito aktivnom bolesti na početku koja nije prethodno liječena TNFα antagonistima. (vidjeti također dio 5.1).
English: Primary endpoint was the proportion of patients in clinical remission at week 52.
Croatian: Primarni ishod bio je omjer bolesnika u kliničkoj remisiji u 52. tjednu.
English: 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.
Croatian: Stabilnost razrijeđene otopine u primjeni u 0,9%-tnoj (9 mg/ml) otopini natrijeva klorida za injekciju u vrećici za infuziju dokazana je tijekom 12 sati pri 20 °C-25 °C ili 24 sata pri 2 °C-8 °C.
English: Enhanced clinical response, week 6 Overall^
Croatian: Pojačani klinički odgovor, 6. tjedan
English: • if you experience signs of an allergic reaction or other reaction to the infusion such as wheezing, difficulty breathing, hives, itching, swelling or dizziness.
Croatian: • ako Vam se pojave znakovi alergijske reakcije ili drugih reakcija na infuziju poput piskanja,
English: Entyvio is for intravenous use only.
Croatian: Način primjene Entyvio je namijenjen isključivo za intravensku primjenu.
English: 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.
Croatian: Bolesnici (n = 368) su dvostruko slijepo randomizirani (3:2) za primanje dvije doze vedolizumaba 300 mg ili placeba u 0. i 2. tjednu.
English: Serum CRP change from baseline to week 6, median (mcg/mL) Overall‡
Croatian: Promjena razine serumskog C- reaktivnog proteina u odnosu na vrijednosti prije ispitivanja do 6. tjedna, medijan (µg/mL) Ukupno‡
English: 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.
Croatian: onih koji su primali vedolizumab svakih osam tjedana, 35% onih koji su primali vedolizumab svaka četiri tjedna, te 5% onih koji su primali placebo postiglo je kliničku remisiju u 52. tjednu.
English: 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.
Croatian: U bolesnika s ulceroznim kolitisom, srednja vrijednost najniže ravnotežne serumske koncentracije bila je 11,2 µg/ml (SD ± 7,24) odnosno 38,3 µg/ml (SD ± 24,43).
English: Vedolizumab Every 8 weeks n = 122
Croatian: Vedolizumab svakih 8 tjedana n = 122
English: Tell your doctor if you are breast-feeding or planning to breast-feed.
Croatian: Obratite se svom liječniku ako dojite ili ako namjeravate dojiti.
English: The other ingredients are L-histidine, L-histidine monohydrochloride, L-arginine hydrochloride, sucrose, and polysorbate 80.
Croatian: Drugi sastojci (pomoćne tvari) su L-histidin, L-histidinklorid, L-argininklorid, saharoza i polisorbat 80.
English: 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.
Croatian: 95%-tni interval pouzdanosti: -7, 13) i 22% (razlika u odnosu na placebo 8%, 95%-tni interval pouzdanosti: - 3, 19) kad se terapija primjenjivala bez kortikosteroida u usporedbi s 20% (razlika u odnosu na placebo 11%, 95%-tni interval pouzdanosti: 2, 20) i 35% (razlika u odnosu na placebo 23%,
English: Patients showing clinical response at week 6 were required to begin corticosteroid tapering.
Croatian: Od bolesnika koji su uzimali kortikosteroide i u 6. tjednu su pokazivali klinički odgovor tražilo se da počnu smanjivati dozu kortikosteroida.
English: Anaphylactic reaction, Anaphylactic shock
Croatian: Poremećaji imunološkog sustava Vrlo rijetko anafilaktička reakcija, anafilaktički šok
English: Storage Condition Refrigerator (2 °C-8 °C)
Croatian: Hladnjak (2 °C-8 °C)
English: 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.
Croatian: 10% (razlika u odnosu na placebo bila je 2%, 95%-tni interval pouzdanosti: -6, 10) kad se terapija primjenjivala bez kortikosteroida u usporedbi sa 20% (razlika u odnosu na placebo 14%, 95%-tni interval pouzdanosti: -1, 29) uz istovremenu primjenu kortikosteroida.
English: The GEMINI III Study was a second randomised, double-blind, placebo-controlled study that evaluated efficacy at week 6 and week 10 in the subgroup of patients defined as having failed at least one conventional therapy and failed TNFα antagonist therapy (including primary non-responders) as well as the overall population, which also included patients who failed at least one conventional therapy and were naïve to TNFα antagonist therapy.
Croatian: Ispitivanje GEMINI III bilo je drugo randomizirano, dvostruko slijepo, placebom kontrolirano kliničko ispitivanje za ocjenu učinkovitosti u 6. i 10. tjednu na podskupini bolesnika koji su definirani kao oni koji nisu odgovorili na barem jedno standardno liječenje i na liječenje antagonistima TNFα
English: • prickling or tingling
Croatian: • zimicu ili drhtavicu
English: 28% receiving vedolizumab every eight weeks, 27% receiving vedolizumab every four weeks, and 13% receiving placebo achieved clinical remission at week 52.
Croatian: Od ovih bolesnika, 28% onih koji su primali vedolizumab svakih osam tjedana, 27% onih koji su primali vedolizumab svaka četiri tjedna, te 13% onih koji su primali placebo postiglo je kliničku remisiju u 52. tjednu.
English: Excipients: Sucrose, L-histidine, L-histidine monohydrochloride, L-arginine hydrochloride, polysorbate 80.
Croatian: Pomoćne tvari: saharoza, L-histidin, L-histidinklorid, L-argininklorid, polisorbat 80.
English: 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.
Croatian: Entyvio je indiciran za liječenje odraslih bolesnika s umjereno do izrazito aktivnom Crohnovom bolesti koji nisu postigli odgovarajući odgovor ili su izgubili odgovor ili na standardnu terapiju ili na antagoniste faktora nekroze tumora alfa (TNFα), te onih koji takvu terapiju nisu podnosili.
English: Entyvio 300 mg powder for concentrate for solution for infusion vedolizumab
Croatian: Entyvio 300 mg prašak za koncentrat za otopinu za infuziju vedolizumab
English: 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.
Croatian: Integrin α4β7 je izražen na izdvojenom podskupu memorijskih pomagačkih T limfocita koji pretežno migriraju u probavni (GI) sustav i uzrokuju upalu koja je karakteristična za ulcerozni kolitis i
English: 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.
Croatian: Razdoblje od 24 sata može uključivati do 8 sati pri 2 °C-8 °C za rekonstituiranu otopinu u bočici i do 12 sati pri 20 °C-25 °C za razrijeđenu otopinu u vrećici za infuziju, ali vrećica za infuziju mora biti pohranjena u hladnjaku (2 °C-8 °C) tijekom preostalog dijela razdoblja od 24 sata.
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.
Croatian: instrumentom specifičnim za bolest, te upitnicima SF-36 i EQ-5D koji se smatraju općom mjerom.
English: Adverse Reaction(s)
Croatian: Nuspojava(e)
English: • high fever or rash
Croatian: • povišenu temperaturu ili osip
English: Remove flip-off cap from the vial and wipe with alcohol swab.
Croatian: Uklonite zatvarač s bočice i obrišite čep alkoholnom vatom.
English: Patients should be given the package leaflet and the Patient Alert Card. Posology
Croatian: Bolesnici moraju dobiti Uputu o lijeku i Karticu s upozorenjima za bolesnika.
English: Patients who failed to demonstrate response at week 6 remained in the study and received vedolizumab every four weeks.
Croatian: Bolesnici kod kojih nije postignut odgovor na liječenje u 6. tjednu nastavili su ispitivanje, te su primali vedolizumab svaka četiri tjedna.
English: The murine precursor of vedolizumab alleviated gastrointestinal inflammation in colitic cotton-top tamarins, a model of ulcerative colitis.
Croatian: Mišji prekursor vedolizumaba ublažio je upalu u probavnom sustavu kod kolitičnih majmuna vrste pinč tamarina koji služe kao model za ulcerozni kolitis.
English: 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.
Croatian: Entyvio je indiciran za liječenje odraslih bolesnika s umjereno do izrazito aktivnim ulceroznim kolitisom koji nisu postigli odgovarajući odgovor ili su izgubili odgovor ili na standardnu terapiju ili na antagoniste faktora nekroze tumora alfa (TNFα), te onih koji takvu terapiju nisu podnosili.
English: What Entyvio contains
Croatian: Kako Entyvio izgleda i sadržaj pakiranja
English: Table 4.
Croatian: PRILOG IV.