natgillin/translations-raw huggingface dataset:
*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.
*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.
The infections consisted primarily of nasopharyngitis, upper respiratory tract infection, sinusitis, and urinary tract infections.
Infekcije su se prvenstveno sastojale od nazofaringitisa, infekcije gornjeg dišnog sustava, sinusitisa te infekcije mokraćnog sustava.
Patient numbers were n = 72 for placebo, n = 70 for vedolizumab every eight weeks, and n = 73 for vedolizumab every four weeks
Broj bolesnika bio je n = 72 za placebo, n = 70 za vedolizumab svakih osam tjedana i n = 73
• pain at the infusion site
• bol na mjestu infuzije
Immediately withdraw 5 mL (300 mg) of reconstituted Entyvio using a syringe with a 21-25 gauge needle.
Odmah izvucite 5 ml (300 mg) rekonstituiranog lijeka Entyvio uporabom štrcaljke s iglom 21G-25G.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 300 mg
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA
Treatment 2
Liječenje 2
• Patient alert card,
• Karticu s upozorenjima za bolesnika
Clinical remission, week 10 Overall
Klinička remisija, 10. tjedan
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.
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.
†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 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.
Approximately one-third of patients had failed prior TNFα antagonist therapy.
Približno jedna trećina bolesnika nije odgovorila na prethodno liječenje antagonistom TNFα.
After reconstitution, each mL contains 60 mg of vedolizumab.
Nakon rekonstitucije jedan ml sadrži 60 mg vedolizumaba.
• Consider the patient's full medical history, including any prior or concurrent biological medicine use
Edukacijski materijal za liječnike treba sadržati sljedeće ključne poruke: • Razmotrite cijelu povijest bolesti bolesnika, uključujući bilo kakvu prethodnu ili istodobnu primjenu biološkog lijeka
Efficacy Results for GEMINI II and III Studies at week 6 and week 10
Tablica 4. Rezultati djelotvornosti u ispitivanjima GEMINI II i III u 6. i 10. tjednu
Powder for concentrate for solution for infusion.
Prašak za koncentrat za otopinu za infuziju
Luxe mbourg/Luxemburg Takeda Belgium Tel/Tél: +32 2 464 06 11 takeda-belgium@takeda.com
Takeda Belgium Tel./Tél.: +32 2 464 06 11 takeda-belgium@takeda.com
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.
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.
• redness and tenderness of hair follicle
• crvenilo i osjetljivost vlasišta
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.
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.
Dose and frequency Treatment with Entyvio is the same for ulcerative colitis and Crohn's disease.
Liječenje lijekom Entyvio jednako je za ulcerozni kolitis i Crohnovu bolest.
No dose-limiting toxicity was seen in clinical trials.
U kliničkim ispitivanjima nije opažena toksičnost koja bi zahtijevala ograničenje doze.
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.
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.
Entyvio contains the active substance vedolizumab.
Entyvio sadrži djelatnu tvar vedolizumab.
Therapy for patients with ulcerative colitis should be discontinued if no evidence of therapeutic benefit is observed by week 10 (see section 5.1).
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).
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.
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.
: +47 6676 3030 infonorge@takeda.com
Tlf.: +47 6676 3030 infonorge@takeda.com
Very common Nasopharyngitis Common
Vrlo često nazofaringitis
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.
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.
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).
Crohnovom bolešću (indeks aktivnosti Crohnove bolesti [CDAI] 220 do 450) ispitane su u dva ispitivanja (GEMINI II i III).
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 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.
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.
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).
This should be taken into consideration, particularly in patients with severe active disease at baseline not previously treated with TNFα antagonists.
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).
Primary endpoint was the proportion of patients in clinical remission at week 52.
Primarni ishod bio je omjer bolesnika u kliničkoj remisiji u 52. tjednu.
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.
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.
Enhanced clinical response, week 6 Overall^
Pojačani klinički odgovor, 6. tjedan
• if you experience signs of an allergic reaction or other reaction to the infusion such as wheezing, difficulty breathing, hives, itching, swelling or dizziness.
• ako Vam se pojave znakovi alergijske reakcije ili drugih reakcija na infuziju poput piskanja,
Entyvio is for intravenous use only.
Način primjene Entyvio je namijenjen isključivo za intravensku primjenu.
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.
Bolesnici (n = 368) su dvostruko slijepo randomizirani (3:2) za primanje dvije doze vedolizumaba 300 mg ili placeba u 0. i 2. tjednu.
Serum CRP change from baseline to week 6, median (mcg/mL) Overall‡
Promjena razine serumskog C- reaktivnog proteina u odnosu na vrijednosti prije ispitivanja do 6. tjedna, medijan (µg/mL) Ukupno‡
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.
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.
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.
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).
Vedolizumab Every 8 weeks n = 122
Vedolizumab svakih 8 tjedana n = 122
Tell your doctor if you are breast-feeding or planning to breast-feed.
Obratite se svom liječniku ako dojite ili ako namjeravate dojiti.
The other ingredients are L-histidine, L-histidine monohydrochloride, L-arginine hydrochloride, sucrose, and polysorbate 80.
Drugi sastojci (pomoćne tvari) su L-histidin, L-histidinklorid, L-argininklorid, saharoza i polisorbat 80.
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.
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%,
Patients showing clinical response at week 6 were required to begin corticosteroid tapering.
Od bolesnika koji su uzimali kortikosteroide i u 6. tjednu su pokazivali klinički odgovor tražilo se da počnu smanjivati dozu kortikosteroida.
Anaphylactic reaction, Anaphylactic shock
Poremećaji imunološkog sustava Vrlo rijetko anafilaktička reakcija, anafilaktički šok
Storage Condition Refrigerator (2 °C-8 °C)
Hladnjak (2 °C-8 °C)
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.
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.
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.
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
• prickling or tingling
• zimicu ili drhtavicu
28% receiving vedolizumab every eight weeks, 27% receiving vedolizumab every four weeks, and 13% receiving placebo achieved clinical remission at week 52.
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.
Excipients: Sucrose, L-histidine, L-histidine monohydrochloride, L-arginine hydrochloride, polysorbate 80.
Pomoćne tvari: saharoza, L-histidin, L-histidinklorid, L-argininklorid, polisorbat 80.
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.
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.
Entyvio 300 mg powder for concentrate for solution for infusion vedolizumab
Entyvio 300 mg prašak za koncentrat za otopinu za infuziju vedolizumab
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.
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
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.
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.
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.
instrumentom specifičnim za bolest, te upitnicima SF-36 i EQ-5D koji se smatraju općom mjerom.
Adverse Reaction(s)
Nuspojava(e)
• high fever or rash
• povišenu temperaturu ili osip
Remove flip-off cap from the vial and wipe with alcohol swab.
Uklonite zatvarač s bočice i obrišite čep alkoholnom vatom.
Patients should be given the package leaflet and the Patient Alert Card. Posology
Bolesnici moraju dobiti Uputu o lijeku i Karticu s upozorenjima za bolesnika.
Patients who failed to demonstrate response at week 6 remained in the study and received vedolizumab every four weeks.
Bolesnici kod kojih nije postignut odgovor na liječenje u 6. tjednu nastavili su ispitivanje, te su primali vedolizumab svaka četiri tjedna.
The murine precursor of vedolizumab alleviated gastrointestinal inflammation in colitic cotton-top tamarins, a model of ulcerative colitis.
Mišji prekursor vedolizumaba ublažio je upalu u probavnom sustavu kod kolitičnih majmuna vrste pinč tamarina koji služe kao model za ulcerozni kolitis.
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.
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.
What Entyvio contains
Kako Entyvio izgleda i sadržaj pakiranja
Table 4.
PRILOG IV.
In these patients, clinical remission was achieved in 25% of patients at week 28 and week 52.
Kod tih bolesnika klinička remisija postignuta je kod 25% bolesnika u 28. tjednu i 52. tjednu.
• sinus infection
• infekcija sinusa
Anal Abscess, Anal fissure, Nausea, Dyspepsia, Constipation, Abdominal distension, Flatulence, Haemorrhoids
Poremećaji probavnog sustava Često analni apsces, analna fisura, mučnina, dispepsija, konstipacija, abdominalna distenzija, flatulencija, hemoroidi
There are limited amount of data from the use of vedolizumab in pregnant women.
Podaci o primjeni vedolizumaba u trudnica su ograničeni.
†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.
§Klinička remisija bez kortikosteroida: Bolesnici koji su pri uključivanju u ispitivanje koristili peroralne kortikosteroide i koji su počevši od 6. tjedna prekinuli liječenje kortikosteroidima, te su bili u kliničkoj remisiji u 52. tjednu.
Each vial contains 300 mg of vedolizumab.
Svaka bočica sadrži 300 mg vedolizumaba.
≥ 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 ishod bio je udio bolesnika s kliničkim odgovorom (definiran kao smanjenje ukupne Mayo ocjene za ≥ 3 boda i ≥ 30% od početnih vrijednosti s popratnim smanjenjem podrezultata rektalnog krvarenja od ≥ 1 boda ili apsolutnim podrezultatom rektalnog krvarenja od ≤ 1 boda) u 6. tjednu.
• throat and mouth yeast infection
• gljivična infekcija grla i usta
Diluted solution in sodium chloride 9 mg/mL (0.9%) solution for injection
Razrijeđena otopina u 0,9%-tnoj (9 mg/ml)
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.
Bolesnici koji su izgubili odgovor na vedolizumab pri liječenju svakih osam tjedana u ispitivanju GEMINI II, mogli su ući u otvoreni nastavak ispitivanja i primati vedolizumab svaka četiri tjedna.
• throat infection
• infekcija grla
Sustained clinical remission#,¶ Overall
Održana klinička remisija#¶
Takeda Austria GmbH St. Peter-Straße 25 4020 Linz
A-4020 Linz Austrija
Vedolizumab Every 4 weeks n = 154
Vedolizumab svaka 4 tjedna n = 154
In these patients, clinical remission was achieved in 46% of patients by 28 weeks and 41% of patients by 52 weeks.
Kod tih bolesnika klinička remisija postignuta je kod 46% bolesnika u 28 tjedana te kod 41% bolesnika u
Patients who failed to demonstrate response at week 6 in GEMINI II were retained in the study and received vedolizumab every four weeks.
Bolesnici koji nisu postigli odgovor u 6. tjednu u ispitivanju GEMINI II zadržani su u ispitivanju te su primali vedolizumab svaka četiri tjedna.
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.
52. tjednu, 461 bolesnik iz kohorte 1 i 2 koji su liječeni vedolizumabom i koji su postigli klinički odgovor (definiran kao smanjenje od ≥ 70 bodova u rezultatu CDAI u odnosu na vrijednosti prije početka ispitivanja) u 6. tjednu, dvostruko slijepo su randomizirani (1:1:1) u jedan od sljedećih režima počevši od 6. tjedna: vedolizumab 300 mg svakih osam tjedana, vedolizumab 300 mg svaka četiri tjedna ili placebo svaka četiri tjedna.
Vedolizumab Every 8 weeks n = 154
Vedolizumab svakih 8 tjedana n = 154
Therapy should be continued every eight weeks from week 14 in responding patients.
Kod bolesnika koji postignu odgovor, liječenje je od 14. tjedna potrebno nastaviti svakih osam tjedana.
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.
Bolesnici koji su izgubili odgovor na vedolizumab pri liječenju svakih osam tjedana mogli su ući u otvoreni nastavak ispitivanja i primati vedolizumab svaka četiri tjedna.
There is insufficient information on what effect this may have on your baby.
Nema dovoljno podataka o učinku vedolizumaba na dojenčad.
Infusion related reactions after vedolizumab infusion are reported in subjects with anti-vedolizumab antibodies.
U ispitanika s anti-vedolizumab protutijelima su nakon primjene infuzije vedolizumaba prijavljene reakcije povezane s infuzijom.
Vedolizumab Every 4 weeks n = 125
Vedolizumab svakih 4 tjedna n = 125
If you get any side effects, talk to your doctor or nurse.
Prije nego što dobijete Entyvio razgovarajte sa svojim liječnikom ili medicinskom sestrom.
§Clinical remission: Complete Mayo score of ≤ 2 points and no individual subscore > 1 point
*p < 0,0001 †p ≤ 0,001 ‡p < 0,05 §Klinička remisija: Ukupna Mayo ocjena ≤ 2 boda i bez individualnog podrezultata > 1 boda ¶Cijeljenje sluznice: Mayo endoskopski podrezultat ≤ 1 boda
• redness of skin
• crvenilo kože
Vedolizumab reduces gastrointestinal inflammation in UC and CD patients.
Vedolizumab smanjuje gastrointestinalnu upalu kod bolesnika s ulceroznim kolitisom i Crohnovom bolešću.
The following information is intended for healthcare professionals only:
Sljedeće informacije namijenjene su samo zdravstvenim radnicima: Upute za rekonstituciju i infuziju 1.
• chills or shivering
• peckanje ili trnci
Week 52 Efficacy Results of GEMINI I
Tablica 5. Rezultati djelotvornosti u ispitivanju GEMINI II u 52. tjednu
• blocked nose
• začepljen nos
: +358 20 746 5000 infoposti@takeda.com
Puh./Tel.: +358 20 746 5000 infoposti@takeda.com
Vedolizumab has been detected in human milk.
Zabilježena je prisutnost vedolizumaba u majčinom mlijeku.
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.
Eksplorativne analize pokazale su da su u ispitivanju GEMINI II uočena klinički značajna poboljšanja uz vedolizumab primijenjen svaka četiri tjedna i svakih osam tjedana i ta su poboljšanja bila znatno veća u usporedbi sa skupinom koja je primala placebo od početka do 52. tjedna prema ljestvicama
Unopened vial: Store in a refrigerator (2 °C-8 °C).
Neotvorena bočica: Čuvati u hladnjaku (2 ˚C-8 ˚C).