natgillin/translations-raw huggingface dataset:
If you forget or miss an appointment to receive the infusion, make another appointment as soon as possible.
Ako zaboravite ili propustite doći na infuziju, čim prije se dogovorite s liječnikom za drugi termin.
Live vaccines, in particular live oral vaccines, should be used with caution concurrently with Entyvio (see section 4.4).
Živa cjepiva, posebice živa peroralna cjepiva, treba koristiti oprezno kod istovremene primjene lijeka Entyvio (vidjeti dio 4.4).
Vedolizumab does not pass the blood brain barrier after intravenous administration.
Vedolizumab ne prolazi krvno-moždanu barijeru nakon intravenske primjene.
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.
Reakcije povezane s infuzijom (sa simptomima kao što su dispneja, bronhospazam, urtikarija, naleti crvenila, osip te povećan krvni tlak i povećana srčana frekvencija) također su prijavljene u bolesnika liječenih vedolizumabom.
Vedolizumab did not affect immune responses to antigenic challenge in the dermis and muscle (see section 4.4).
Vedolizumab nije utjecao na imunološke odgovore na provokaciju antigenom u dermisu i mišićima (vidjeti dio 4.4).
Entyvio is for single-use only.
Entyvio je namijenjen samo za jednokratnu primjenu.
Age does not impact the vedolizumab clearance in ulcerative colitis and Crohn's disease patients based on the population pharmacokinetic analyses.
Dob ne utječe na klirens vedolizumaba kod bolesnika s ulceroznim kolitisom i Crohnovom bolešću na temelju analiza populacijske farmakokinetike.
Within the system organ classes, adverse reactions are listed under headings of the following frequency categories: very common (≥ 1/10), common (≥ 1/100 to < 1/10),
Unutar klasifikacije organskih sustava, nuspojave su navedene prema sljedećim kriterijima učestalosti: vrlo često (≥ 1/10), često
How to store Entyvio
Kako ćete primati Entyvio
In controlled and open-label studies in adults with vedolizumab, serious infections have been reported, which include tuberculosis, sepsis (some fatal), salmonella sepsis, listeria meningitis, and cytomegaloviral colitis.
U kontroliranim, otvorenim ispitivanjima vedolizumaba u odraslih prijavljene su ozbiljne infekcije koje uključuju tuberkulozu, sepsu (ponekad smrtonosnu), sepsu uzrokovanu salmonelom, meningitis uzrokovan listerijom i kolitis uzrokovan citomegalovirusom.
Rash, Pruritus, Eczema, Erythema, Night sweats, Acne
Često osip, pruritus, ekcem, eritem, noćno znojenje, akne
Other side effects that you may experience while taking Entyvio are listed below.
Druge nuspojave koje možete iskusiti dok uzimate lijek Entyvio navedene su u nastavku.
If a mild to moderate IRR occurs, the infusion rate can be slowed or interrupted and appropriate treatment initiated.
U slučaju blagih do umjerenih RPI, brzina infuzije se može usporiti ili prekinuti te započeti odgovarajuće liječenje.
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.
Preporučuje se da se svi bolesnici odgovarajuće procijepe sukladno važećim smjernicama za imunizaciju prije početka liječenja lijekom
Concomitant stable doses of oral corticosteroids, immunomodulators, and antibiotics were permitted.
Bile su dopuštene istovremene stabilne doze peroralnih kortikosteroida, imunomodulatora i antibiotika.
The plasma protein binding of vedolizumab has not been evaluated.
Vezivanje vedolizumaba na proteine plazme nije ispitano.
Keep this medicine out of the sight and reach of children.
Kako čuvati Entyvio Lijek čuvajte izvan pogleda i dohvata djece.
In patients diagnosed with TB whilst receiving vedolizumab therapy, then vedolizumab therapy should be discontinued until the TB infection has been resolved.
U bolesnika kojima se tuberkuloza dijagnosticira tijekom liječenja vedolizumabom, primjenu vedolizumaba treba prekinuti sve dok se ne izliječi tuberkulozna infekcija.
Vedolizumab-exposed subjects had lower seroconversion rates after receiving a killed, oral cholera vaccine.
Ispitanici izloženi vedolizumabu imali su niže stope serokonverzije nakon primanja umrtvljenih, peroralnih cjepiva protiv kolere.
In this open-label extension study, the benefits of vedolizumab treatment as assessed by partial Mayo score, clinical remission, and clinical response were shown for up to 196 weeks.
U otvorenom nastavku ispitivanja korist liječenja vedolizumabom, procijenjena po djelomičnoj Mayo ocjeni, kliničkoj remisiji i kliničkom odgovoru, bila je prisutna do 196. tjedna.
There are no data on the effects of vedolizumab on human fertility.
Nema podataka o utjecaju vedolizumaba na plodnost u ljudi.
Once dissolved, gently invert vial 3 times.
Kad se otopi, lagano preokrenite bočicu tri puta.
Vedolizumab is a gut-selective integrin antagonist with no identified systemic immunosuppressive activity (see section 5.1).
Vedolizumab je antagonist integrina selektivan za crijeva bez utvrđene sustavne imunosupresivne aktivnosti (vidjeti dio 5.1).
Vedolizumab is a humanised IgG1 monoclonal antibody that binds to the human α4β7 integrin and is produced using recombinant DNA technology in Chinese hamster ovary (CHO) cells.
Vedolizumab je humanizirano monoklonsko protutijelo IgG1 koje se veže za ljudski integrin α4β7, proizvedeno u stanicama jajnika kineskog hrčka tehnologijom rekombinantne DNK.
The active substance is vedolizumab.
Djelatna tvar je vedolizumab.
Appropriate monitoring and medical support measures should be available for immediate use when administering vedolizumab.
Oprema za praćenje i primjenu medicinskih potpornih mjera treba biti spremna kad se primjenjuje vedolizumab.
The effects of Entyvio in pregnant women are not known.
Učinci lijeka Entyvio u trudnih žena nisu poznati.
Do not add other medicinal products to the prepared infusion solution or intravenous infusion set.
Ne dodajte druge lijekove u pripremljenu otopinu za infuziju ili komplet za intravensku infuziju.
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.
Niske razine (< 300 µg/l) vedolizumaba uočene su 28. dan nakon okota u mlijeku 3 od 11 ženki makaki majmuna koje su svaka dva tjedna primale 100 mg/kg vedolizumaba, ali ne i u životinja koje su primale 10 mg/kg.
MAdCAM-1 is mainly expressed on gut endothelial cells and plays a critical role in the homing of T lymphocytes to tissues within the gastrointestinal tract.
MAdCAM-1 je uglavnom prisutna na endotelnim stanicama crijeva i igra ključnu ulogu u naseljavanju T limfocita u tkiva probavnog trakta.
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.
Neka bočica odstoji do 20 minuta na sobnoj temperaturi (20 °C-25 °C) kako bi se omogućila rekonstitucija i slijeganje pjene; bočicu se za to vrijeme smije vrtiti i provjeravati otapanje.
• The infusion will be given to you, by your doctor or nurse, through a drip in one of the veins in your arm (intravenous infusion) over about 30 minutes.
• Infuziju će Vam dati liječnik ili medicinska sestra, kapanjem u jednu od vena u Vašoj ruci
Enrolled patients had failed at least one conventional therapy, including corticosteroids, immunomodulators, and/or the TNFα antagonist infliximab (including primary non-responders).
Uključeni bolesnici nisu odgovorili na barem jednu standardnu terapiju, uključujući kortikosteroide, imunomodulatore i/ili antagonist TNFα infliksimab (uključujući i bolesnike bez odgovora na primarno liječenje).
The efficacy and safety of vedolizumab for the treatment of adult patients with moderately to severely active ulcerative colitis (Mayo score 6 to 12 with endoscopic sub score ≥ 2) was demonstrated in a randomised, double-blind, placebo-controlled study evaluating efficacy endpoints at week 6 and week 52 (GEMINI I).
Djelotvornost i sigurnost vedolizumaba u liječenju odraslih bolesnika s umjereno do izrazito aktivnim ulceroznim kolitisom (Mayo ocjena 6 do 12, endoskopski podrezultat ≥ 2) dokazane su u randomiziranom, dvostruko slijepom, placebom kontroliranom ispitivanju u kojem su ocijenjeni ishodi učinkovitosti u 6. i 52. tjednu (GEMINI I).
No clinical trial data for concomitant use of vedolizumab with biologic immunosuppressants are available.
Nema podataka iz kliničkih ispitivanja o istodobnoj primjeni vedolizumaba s biološkim imunosupresivima.
Before starting treatment with vedolizumab, patients must be screened for tuberculosis according to the local practice.
Prije početka liječenja vedolizumabom bolesnike treba probrati na tuberkulozu sukladno lokalnim preporukama.
Muscle spasms, Back pain, Muscular weakness, Fatigue, Pain in the extremity
Često mišićni spazmi, bolovi u leđima, mišićna slabost, umor, bol u ekstremitetima
If a severe IRR, anaphylactic reaction, or other severe reaction occurs, administration of Entyvio must be discontinued immediately and appropriate treatment initiated (e.g., epinephrine and antihistamines) (see section 4.3).
Kod ozbiljnih RPI, anafilaktičkih reakcija ili drugih teških reakcija, primjenu lijeka Entyvio treba odmah prekinuti te započeti odgovarajuće liječenje (npr. adrenalin i antihistaminici) (vidjeti dio 4.3).
In-use stability of the reconstituted solution in the vial has been demonstrated for 8 hours at 2°C-8°C.
Stabilnost rekonstituirane otopine u primjeni u bočici dokazana je tijekom 8 sati pri 2 °C-8 °C.
Treatment 1
Liječenje 1
These data are consistent with investigations in nonhuman primates which did not detect effects on immune surveillance of the CNS.
Ovi su podatci dosljedni s ispitivanjima kod nehumanih primata u kojima nisu zabilježeni učinci na imunološki nadzor središnjeg živčanog sustava.
No definitive conclusion can be drawn on the male reproductive organs in cynomolgus monkey repeated dose toxicity study.
Ne može se donijeti konačan zaključak o reproduktivnim organima mužjaka kod ispitivanja toksičnosti ponovljene doze na makaki majmunima.
White to off-white lyophilised cake or powder.
Prašak za koncentrat za otopinu za infuziju Bijeli do gotovo bijeli liofilizirani kolačić ili prašak.
Healthcare professionals should monitor patients on vedolizumab for any new onset or worsening of neurological signs and symptoms as outlined in physician education materials, and consider neurological referral if they occur.
Zdravstveni radnici moraju u bolesnika koji primaju vedolizumab pratiti pojavu ili pogoršanje neuroloških znakova i simptoma kako je to opisano u edukativnim materijalima za liječnika, te uputiti bolesnika neurologu ako se oni pojave.
Do not freeze the reconstituted solution in the vial or the diluted solution in the infusion bag.
Ne zamrzavati rekonstituiranu otopinu u bočici ili razrijeđenu otopinu u vrećici za infuziju.
Patient numbers were n = 82 for placebo, n = 82 for vedolizumab every eight weeks, and n = 80 for vedolizumab every four weeks
Brojevi bolesnika bili su n = 82 za placebo, n = 82 za vedolizumab svakih osam tjedana i n = 80 za vedolizumab svaka četiri tjedna
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).
Dodajte 5 ml (300 mg) rekonstituiranog lijeka Entyvio u 250 ml sterilne 0,9%-tne (9 mg/ml) otopine natrijeva klorida za injekciju i lagano promiješajte vrećicu za infuziju (ne morate izvući 5 ml 0,9%-tne (9 mg/ml) otopine natrijeva klorida za injekciju iz vrećice za infuziju prije dodavanja lijeka Entyvio).
Do not use this medicine if you notice any particles in the liquid or discolouration prior to administration.
Nemojte upotrebljavati ovaj lijek ako prije primjene uočite čestice u tekućini ili promjenu boje.
In clinical trials with vedolizumab at doses ranging from 2 to 10 mg/kg, > 95% saturation of α4β7 receptors on subsets of circulating lymphocytes involved in gut immune surveillance was observed in patients.
U kliničkim ispitivanjima vedolizumaba u dozama od 2 do 10 mg/kg kod bolesnika je uočeno zasićenje receptora α4β7 veće od 95% na podskupinu cirkulirajućih limfocita uključenih u imunološki nadzor crijeva.
Grounds for the variation to the terms of the Marketing Authorisation(s) On the basis of the scientific conclusions for vedolizumab the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing vedolizumab is unchanged subject to the proposed changes to the product information.
Na temelju znanstvenih zaključaka za vedolizumab, CHMP smatra da je omjer koristi i rizika lijeka(ova) koji sadrži(e) vedolizumab nepromijenjen, uz predložene izmjene informacija o lijeku.
• If you have any further questions, ask your doctor or nurse.
• Ako imate dodatnih pitanja, obratite se svom liječniku ili medicinskoj sestri.
The two primary endpoints were the proportion of patients in clinical remission (defined as CDAI score ≤ 150 points) at week 6 and the proportion of patients with enhanced clinical response (defined as a ≥ 100-point decrease in CDAI score from baseline) at week 6 (see Table 4).
Dva primarna ishoda bila su udio bolesnika u kliničkoj remisiji (definiran kao rezultat CDAI ≤ 150 bodova) u 6. tjednu i udio bolesnika s pojačanim kliničkim odgovorom (definiran kao smanjenje od ≥ 100 bodova na rezultatu CDAI u odnosu na vrijednosti prije početka ispitivanja) u 6. tjednu (vidjeti tablicu 4).
Enhanced clinical response was achieved in 29%, 38%, 21%, respectively, and corticosteriod-free clinical remission was achieved in 24%, 16%, 0%, respectively.
Pojačani klinički odgovor postignut je u 29%, 38% odnosno 21% bolesnika, a klinička remisija bez kortikosteroida postignuta je kod 24%, 16% odnosno 0% bolesnika.
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.
Rekonstituirajte vedolizumab sa 4,8 ml sterilne vode za injekcije na sobnoj temperaturi (20 °C-25 °C) koristeći štrcaljku s iglom veličine 21G-25G.
The single and multiple dose pharmacokinetics of vedolizumab have been studied in healthy subjects and in patients with moderate to severely active ulcerative colitis or Crohn's disease.
Farmakokinetika pojedinačne i uzastopnih doza vedolizumaba ispitana je na zdravim dobrovoljcima te u bolesnika s umjereno do izrazito aktivnim ulceroznim kolitisom ili Crohnovom bolešću.
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.
Vedolizumab je ispitan u odraslih bolesnika s ulceroznim kolitisom i Crohnovom bolešću uz istovremenu primjenu kortikosteroida, imunomodulatora (azatioprin, 6-merkaptopurin i metotreksat)
The risk of malignancy is increased in patients with ulcerative colitis and Crohn's disease.
Rizik malignih bolesti povećan je u bolesnika s ulceroznim kolitisom i Crohnovom bolešću.
It is a humanised monoclonal antibody that binds specifically to the α4β7 integrin, which is preferentially expressed on gut homing T helper lymphocytes.
To je humanizirano monoklonsko protutijelo koje se specifično veže na integrin α4β7 koji je pretežno prisutan na pomagačkim T limfocitima u crijevima.
No formal studies have been conducted to examine the effects of either renal or hepatic impairment on the pharmacokinetics of vedolizumab.
Nisu provedena službena ispitivanja procjene učinaka oštećenja bubrega ili jetre na farmakokinetiku vedolizumaba.
Primary endpoint was the proportion of patients in clinical remission at week 52 (see Table 5).
Primarni ishod bio je omjer bolesnika u kliničkoj remisiju u 52. tjednu (vidjeti tablicu 5).
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.
Entyvio je bijeli do gotovo bijeli prašak za koncentrat za otopinu za infuziju koji se isporučuje u staklenoj bočici s gumenim čepom i plastičnim zatvaračem.
Infusion site reaction (including: Infusion site pain and Infusion site irritation), Infusion related reaction, Chills, Feeling cold
Manje često reakcija na mjestu primjene infuzije (uključujući: bol na mjestu infuzije i nadraženost mjesta infuzije), reakcije povezane s infuzijom, zimica, osjećaj hladnoće
Once the mild or moderate IRR subsides, continue the infusion.
Nakon što se smire blage ili umjerene reakcije povezane s infuzijom, nastavite s infuzijom.
The primary endpoint was the proportion of patients in clinical remission at week 6 in the TNFα antagonist failure subpopulation.
Primarni ishod bio je udio bolesnika u kliničkoj remisiji u 6. tjednu u subpopulaciji bolesnika koji nisu reagirali na antagonist TNFα.
Clinical remission Durable clinical response¶
Klinička remisija Trajni klinički odgovor¶
Insert the needle into the vial through the centre of the stopper and direct the stream of liquid to the wall of the vial to avoid excessive foaming.
Umetnite iglu u bočicu kroz središte čepa i usmjerite mlaz tekućine prema stijenci bočice kako biste izbjegli prekomjerno pjenjenje.
No specific fertility studies in animals have been performed with vedolizumab.
Na životinjama nisu provedena ispitivanja plodnosti s vedolizumabom.
• if you are not feeling any better as vedolizumab may take up to 14 weeks to work in some patients with very active Crohn's disease.
• ako se ne osjećate bolje budući da u nekih bolesnika s vrlo aktivnom Crohnovom bolesti vedolizumab može početi djelovati tek nakon 14 tjedana.
Entyvio passes into breast milk.
Entyvio se izlučuje u majčino mlijeko.
The GEMINI II Study was a randomised, double-blind, placebo-controlled study evaluating efficacy endpoints at week 6 and week 52.
Ispitivanje GEMINI II bilo je randomizirano, dvostruko slijepo, placebom kontrolirano ispitivanje za procjenu ishoda djelotvornosti u 6. i 52. tjednu.
Very rare side effects (may affect up to 1 in 10,000 people)
Vrlo rijetke nuspojave (mogu se javiti u do 1 na 10 000 osoba)
L-histidine monohydrochloride L-arginine hydrochloride sucrose polysorbate 80
L-histidin L-histidinklorid L-argininklorid saharoza polisorbat 80
Treatment 3
Liječenje 3
Respiratory tract infection, Vulvovaginal candidiasis, Oral candidiasis, Herpes zoster
Manje često infekcija dišnog sustava, vulvovaginalna kandidijaza, oralna kandidijaza, herpes zoster
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.
U bolesnika koji su primali vedolizumab u tjednima 0. i 2., nakon čega je primjenjen placebo, nije uočeno povećanje stope RPI nakon ponovnog liječenja vedolizumabom nakon gubitka odgovora.
Crohn's disease is an inflammatory disease of the gastrointestinal tract.
Crohnova bolest je upalna bolest probavnog sustava.
In GEMINI II,
Ispitivanje GEMINI II
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.
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.
Bronchitis, Gastroenteritis, Upper respiratory tract infection, Influenza, Sinusitis, Pharyngitis
Često bronhitis, gastroenteritis, infekcija gornjeg dišnog sustava, gripa, sinusitis, faringitis
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.
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%.
• shingles (herpes zoster)
• vaginalna infekcija • herpes zoster
Each vial is for single-use only.
Svaka je bočica lijeka namijenjena samo za jednokratnu uporabu.
trafficking into the CNS as evidenced by the lack of change in the ratio of CD4 +/CD8
limfocita u CNS-u što je vidljivo izostankom promjene u omjeru CD4
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).
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%).
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.
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.
Do not store any unused portion of the reconstituted solution or infusion solution for reuse.
Niti jedan neiskorišteni dio rekonstituirane otopine ili otopine za infuziju nemojte pohranjivati za ponovnu uporabu.
Vedolizumab is a gut-selective immunosuppressive biologic.
Vedolizumab je biološki imunosupresiv selektivan za crijeva.
Beginning at week 6, patients who had achieved clinical response and were receiving corticosteroids were required to begin a corticosteroid-tapering regimen.
Počevši od 6. tjedna, od bolesnika koji su uzimali kortikosteroide i postigli klinički odgovor, tražilo se da počnu smanjivati dozu kortikosteroida.
The effect of vedolizumab on the pharmacokinetics of commonly co-administered medicinal compounds has not been studied.
Učinak vedolizumaba na farmakokinetiku istovremeno primijenjenih čestih lijekova nije ispitan.
Adverse Reactions System Organ Class
Tablica 1. Nuspojave Klasifikacija organskog sustava
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).
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
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).
Primjenu u bolesnika s Crohnovom bolešću potrebno je prekinuti ako se do 14. tjedna liječenja ne utvrdi korist terapije (vidjeti dio 5.1).
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).
Moguće ozbiljne nuspojave uključuju reakcije na infuziju ili alergijske reakcije (mogu se javiti u do 1
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.
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
Reconstituted solution in the vial
Rekonstituirana otopina u bočici
• There is no clinical trial experience with Entyvio in patients previously treated with natalizumab.
• Nema iskustva iz kliničkih ispitivanja s lijekom Entyvio u bolesnika prethodno liječenih natalizumabom.