natgillin/translations-raw huggingface dataset:
Once reconstituted, the infusion solution should be used as soon as possible.
Raztopino za infundiranje morate uporabiti čim prej po rekonstituciji.
The most commonly reported adverse reactions are infections (such as nasopharyngitis, upper respiratory tract infection, bronchitis, influenza and sinusitis), headache, nausea, pyrexia, fatigue, cough, arthralgia.
Najpogostejši neželeni učinki, o katerih so poročali, so okužbe (npr. nazofaringitis, okužba zgornjih dihal, bronhitis, gripa in sinusitis), glavobol, navzea, pireksija, utrujenost, kašelj, artralgija.
Entyvio has not been studied in these patient populations.
Pri teh populacijah bolnikov uporabe zdravila Entyvio niso raziskovali.
Each pack of Entyvio consists of one vial.
Ena škatla zdravila Entyvio vsebuje eno vialo.
Vedolizumab has been detected in human milk.
Vedolizumab je bil zaznan v materinem mleku.
Tell your doctor as soon as possible if you notice any of the following:
Če opazite kar koli od naslednjega, o tem čim prej obvestite svojega zdravnika:
†p < 0.0001 ‡p < 0.001 §p < 0.05 ¶Durable clinical response: Clinical response at weeks 6 and 52 #Durable clinical remission: Clinical remission at weeks 6 and 52 ♠Corticosteroid-free clinical remission: Patients using oral corticosteroids at baseline who had discontinued corticosteroids beginning at week 6 and were in clinical remission at week 52.
¶ Trajni klinični odziv: klinični odziv v 6. in 52. tednu # Trajna klinična remisija: klinična remisija v 6. in 52. tednu ♠ Klinična remisija brez uporabe kortikosteroidov: bolniki, ki so v izhodišču uporabljali peroralne kortikosteroide, nato pa so jih začenši v 6. tednu prenehali jemati in so bili v 52. tednu v klinični remisiji.
METHOD OF ADMINISTRATION For intravenous use after reconstitution and dilution.
POSTOPEK UPORABE Intravenska uporaba po rekonstituciji in redčenju.
Physicians should consider pre-treatment (e.g., with antihistamine, hydrocortisone and/or paracetamol) prior to the next infusion for patients with a history of mild to moderate IRR to vedolizumab, in order to minimize their risks (see section 4.8).
Pri bolnikih, pri katerih se je pri predhodni aplikaciji zdravila pojavila blaga do zmerna reakcija, povezana z infundiranjem, mora zdravnik presoditi o potrebnosti predhodnega zdravljenja (npr. z antihistaminikom, hidrokortizonom in/ali paracetamolom) pred naslednjo aplikacijo zdravila, da se takšno tveganje zmanjša (glejte poglavje 4.8).
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development.
5.3 Predklinični podatki o varnosti Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih odmerkih, genotoksičnosti, karcenogenega potenciala, vpliva na sposobnost razmnoževanja in razvoja ne kažejo posebnega tveganja za človeka.
Each vial contains 300 mg of vedolizumab.
Ena viala vsebuje 300 mg vedolizumaba.
Administer the infusion solution over 30 minutes.
Raztopino za infundiranje aplicirajte v obliki 30-minutne intravenske infuzije.
Clinical remission, week 10 Overall
Klinična remisija, 10. teden
Infusion related reactions after vedolizumab infusion are reported in subjects with anti-vedolizumab antibodies.
O reakcijah, povezanih z infundiranjem, so po infundiranju vedolizumaba poročali pri bolnikih s protitelesi proti vedolizumabu.
Clinical remission Durable clinical response¶
Klinična remisija Trajni klinični odziv¶
In GEMINI I and II controlled studies, 4% of vedolizumab-treated patients and 3% of placebo-treated patients experienced an adverse reaction defined by the investigator as infusion-related reaction (IRR) (see section 4.4).
V nadzorovanih študijah GEMINI I in II so o neželenem učinku, ki ga je raziskovalec opredelil kot reakcijo, povezano z infundiranjem, poročali pri 4 % bolnikov, ki so prejemali vedolizumab, in 3 % bolnikov, ki so prejemali placebo (glejte poglavje 4.4).
For intravenous use after reconstitution and dilution.
Intravenska uporaba po rekonstituciji in redčenju.
No formal studies have been conducted to examine the effects of either renal or hepatic impairment on the pharmacokinetics of vedolizumab.
Formalne študije, ki bi ovrednotile vpliv okvare ledvic ali jeter na farmakokinetiko vedolizumaba, niso bile izvedene.
Enhanced clinical response, week 6 Overall^
Okrepljen klinični odziv, 6. teden
No specific fertility studies in animals have been performed with vedolizumab.
Posebne študije o vplivu vedolizumaba na plodnost pri živalih niso bile izvedene.
The beneficial effect of vedolizumab on clinical response, remission and mucosal healing was observed both in patients with no prior TNFα antagonist exposure as well as in those who had failed prior TNFα antagonist therapy.
Koristen učinek vedolizumaba na klinični odziv, remisijo in celjenje sluznice so opazili tako pri bolnikih, ki se predhodno še niso zdravili z zaviralcem TNFα, kot tudi pri bolnikih, ki se na predhodno zdravljenje z zaviralcem TNFα niso odzvali.
For the evaluation of the week 6 endpoints, 374 patients were randomised in a double-blind fashion (3:2) to receive vedolizumab 300 mg or placebo at week 0 and week 2.
Za vrednotenje opazovanih dogodkov v 6. tednu so 374 bolnikov randomizirali na dvojno slep način (3:2) na prejemanje vedolizumaba v odmerku 300 mg ali placeba na 0. teden in 2. teden.
Storage Condition Refrigerator (2°C-8°C)
Pogoji shranjevanja V hladilniku (2 °C-8 °C)
Once the mild or moderate IRR subsides, continue the infusion.
Ko blaga ali zmerna reakcija, povezana z infundiranjem, izzveni, se infundiranje zdravila lahko nadaljuje.
In GEMINI I and II controlled studies, the rate of infections was 0.85 per patient-year in the vedolizumab-treated patients and 0.70 per patient-year in the placebo-treated patients.
V nadzorovanih študijah GEMINI I in II je delež okužb pri bolnikih, zdravljenih z vedolizumabom, znašal 0,85 na bolnik-leto (“patient-year”), pri bolnikih, ki so prejemali placebo, pa 0,70 na bolnik-leto.
†p < 0.001 ‡p < 0.05 §Corticosteroid-free clinical remission: Patients using oral corticosteroids at baseline who had discontinued corticosteroids beginning at week 6 and were in clinical remission at week 52.
§ Klinična remisija brez uporabe kortikosteroidov: bolniki, ki so v izhodišču uporabljali peroralne kortikosteroide, nato pa so jih začenši v 6. tednu prenehali jemati in so bili v 52. tednu v klinični remisiji.
Patients (n = 416), which included approximately 75% TNFα antagonist failures patients, were randomised in a double-blind fashion (1:1) to receive either vedolizumab 300 mg or placebo at weeks 0, 2, and 6.
Bolnike (n = 416), od tega približno 75 % bolnikov brez odziva na zdravljenje z zaviralcem TNFα, so randomizirali na dvojno slep način (1:1) na prejemanje vedolizumaba v odmerku 300 mg ali placeba na 0., 2. in 6. teden.
The infections consisted primarily of nasopharyngitis, upper respiratory tract infection, sinusitis, and urinary tract infections.
Okužbe so bile predvsem nazofaringitis, okužba zgornjih dihal, sinuzitis in okužbe sečil.
Tell your doctor immediately if you notice any of the following:
Če opazite kar koli od naslednjega, o tem nemudoma obvestite svojega zdravnika:
Enhanced clinical response was observed at week 10 and week 14 for greater proportions of vedolizumab patients 16% and 22%, respectively, compared with placebo patients 7% and 12%, respectively.
Okrepljen klinični odziv v 10. tednu in 14. tednu so opazili pri večjem deležu bolnikov, ki so prejemali vedolizumab (16% in 22%), kot pri bolnikih, ki so prejemali placebo (7 % in 12 %).
Patients (n = 368) were randomised in a double-blind fashion (3:2) to receive two doses of vedolizumab 300 mg or placebo at week 0 and week 2.
Bolnike (n = 368) so randomizirali na dvojno slep način (3:2) na dva odmerka vedolizumaba 300 mg ali placeba na 0. teden in 2. teden.
The recommended dose is 300 mg of Entyvio given as follows (see table below):
Priporočeni odmerek zdravila Entyvio je 300 mg. Prejeli ga boste na naslednji način (glejte preglednico v nadaljevanju): Številka zdravljenja (infuzije)
It is recommended that all patients be brought up to date with all immunisations in agreement with current immunisation guidelines prior to initiating Entyvio therapy.
Priporočljivo je, da so pred uvedbo zdravljenja z zdravilom Entyvio, vsi bolniki cepljeni z vsemi cepivi v skladu z veljavnimi smernicami za cepljenje.
L-histidine monohydrochloride L-arginine hydrochloride sucrose polysorbate 80
L-histidinijev klorid L-argininijev klorid saharoza polisorbat 80
4.7 Effects on ability to drive and use machines
4.7 Vpliv na sposobnost vožnje in upravljanja strojev Zdravilo Entyvio ima blag vpliv na sposobnost vožnje in upravljanja strojev.
Vedolizumab Every 8 weeks n = 122
Vedolizumab vsakih 8 tednov n = 122
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.