FrancophonIA/ELRC3.0 huggingface dataset:
English: Physicians should be aware of the potential increased risk of opportunistic infections or infections for which the gut is a defensive barrier (see section 4.8).
Slovenian: Zdravniki se morajo zavedati možnega večjega tveganja za pojav oportunističnih okužb ali okužb za katere črevo predstavlja obrambno pregrado (glejte poglavje 4.8).
English: Although no systemic immunosuppressive effect was noted in healthy subjects the effects on systemic immune system function in patients with inflammatory bowel disease is not known.
Slovenian: Pri zdravih osebah sistemskega zaviranja imunske odzivnosti sicer niso opazili, vendar pa sistemski vplivi na delovanje imunskega sistema pri bolnikih z vnetno črevesno boleznijo niso znani.
English: Some patients who have experienced a decrease in their response may benefit from an increase in dosing frequency to Entyvio 300 mg every four weeks.
Slovenian: Nekaterim bolnikom, katerim se odziv na zdravljenje zmanjša, morda lahko koristi povečanje pogostnosti odmerjanja zdravila Entyvio v odmerku 300 mg na vsake štiri tedne.
English: The use of vedolizumab in lactating women should take into account the benefit of therapy to the mother and potential risks to the infant.
Slovenian: Pri uporabi vedolizumaba pri doječih materah je treba pretehtati prednosti zdravljenja za mater in možnih tveganj za dojenčka.
English: • if you have an active severe infection, for example, tuberculosis, blood poisoning, severe gastroenteritis, nervous system infection.
Slovenian: • če imate hudo aktivno okužbo, na primer tuberkulozo, zastrupitev krvi, hudo vnetje želodca in črevesa (gastroenteritis) ali okužbo živčevja.
English: If PML is suspected, treatment with vedolizumab must be withheld; if confirmed, treatment must be permanently discontinued.
Slovenian: V primeru suma na PML je treba zdravljenje z vedolizumabom zadržati, če pa se sum potrdi, je treba zdravljenje trajno ukiniti.
English: Some integrin antagonists and some systemic immunosuppressive agents have been associated with progressive multifocal leukoencephalopathy (PML), which is a rare and often fatal opportunistic infection caused by the John Cunningham (JC) virus.
Slovenian: Uporaba nekaterih integrinskih zaviralcev in nekaterih zdravil za sistemsko zaviranje imunske odzivnosti je bila povezana s pojavom progresivne multifokalne levkoencefalopatije (PML), redke in pogosto usodne oportunistične okužbe, ki jo povzroča JC virus (John Cunninghamov virus).
English: • blurred vision (loss of sharpness of eyesight)
Slovenian: • zamegljen vid (izguba ostrine vida),
English: The impact on other oral and nasal vaccines is unknown.
Slovenian: Vpliv na druga cepiva za peroralno ali nazalno uporabo ni znan.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 300 mg
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 300 mg
English: You should use adequate contraception during treatment and for at least 4.5 months after the last treatment.
Slovenian: Ženske v rodni dobi morajo med zdravljenjem in še najmanj 4,5 meseca po prejemu zadnjega odmerka zdravila
English: Entyvio should not be given with other biologic medicines that suppress your immune system as the effect of this is not known.
Slovenian: Zdravila Entyvio se ne sme uporabljati skupaj z drugimi biološkimi zdravili, ki zavirajo imunski sistem, saj učinek tega ni znan.
English: Instructions for reconstitution and infusion
Slovenian: Navodila za rekonstitucijo in infundiranje
English: If latent tuberculosis is diagnosed, appropriate treatment must be started with anti-tuberculosis treatment in accordance with local recommendations, before beginning vedolizumab.
Slovenian: Če se ugotovi latentno tuberkulozo, je pred uvedbo zdravljenja z vedolizumabom treba začeti ustrezno protituberkulozno zdravljenje v skladu z lokalnimi priporočili.
English: 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.
Slovenian: V tej odprti podaljšani študiji, so se koristi zdravljenja z vedolizumabom, ovrednotene z delno oceno Mayo, s klinično remisijo in kliničnim odzivom ohranile do 196 tednov.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Entyvio therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Slovenian: Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z zdravilom Entyvio, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
English: • Patients treated with Entyvio should be monitored for any new onset or worsening of neurological signs and symptoms such as those listed below: o Progressive weakness on one side of the body or clumsiness of limbs o Disturbance of vision o Changes in thinking, memory, and orientation, leading to confusion and personality changes
Slovenian: • Bolnike, ki se zdravijo z zdravilom Entyvio, je treba spremljati glede pojava kakršnih koli novih ali poslabšanja že prisotnih nevroloških znakov in simptomov, kot so: o progresivna oslabelost ene strani telesa ali okornost udov, o motnje vida, o spremembe v mišljenju, spominu in orientaciji, ki vodijo do zmedenosti in osebnostnih sprememb.
English: Vedolizumab blocks a protein on the surface of white blood cells that cause the inflammation in ulcerative colitis and Crohn's disease, and so the amount of inflammation is reduced.
Slovenian: Vedolizumab blokira beljakovino na površini belih krvnih celic, ki povzročajo vnetje pri ulceroznem kolitisu in Crohnovi bolezni, in posledično zmanjša vnetje.
English: In patients who have responded to treatment with Entyvio, corticosteroids may be reduced and/or discontinued in accordance with standard of care.
Slovenian: Pri bolnikih, ki se odzovejo na zdravljenje z zdravilom Entyvio, se odmerek kortikosteroida morda lahko zmanjša in/ali zdravljenje s kortikosteroidi ukine v skladu s standardnimi smernicami.
English: Live vaccines, in particular live oral vaccines, should be used with caution concurrently with Entyvio (see section 4.4).
Slovenian: Živa cepiva, še posebej živa cepiva za peroralno uporabo, je pri sočasni uporabi z zdravilom Entyvio treba uporabljati previdno (glejte poglavje 4.4).
English: • 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.
Slovenian: • Infuzijo zdravila vam bo dal zdravnik ali medicinska sestra v obliki 30-minutne kapljične infuzije v eno od ven na roki (intravenska infuzija).
English: Patients should be monitored during and after infusion (see section 4.4).
Slovenian: Bolnike je treba nadzirati tako med infundiranjem kot po njem (glejte poglavje 4.4).
English: The patient is to be given a Patient Alert Card (see section 4.2).
Slovenian: Vsak bolnik mora prejeti opozorilno kartico (glejte poglavje 4.2).
English: Vedolizumab does not bind to, nor inhibit function of, the α4β1 and αEβ7 integrins.
Slovenian: Vedolizumab se ne veže na integrina α4β1 in αEβ7 in ne zavira njunih funkcij.
English: Patients should be monitored closely for infections before, during and after treatment.
Slovenian: Bolnike je treba pred uvedbo zdravljenja, med zdravljenjem in po zdravljenju skrbno nadzirati glede okužb.
English: The GEMINI II Study was a randomised, double-blind, placebo-controlled study evaluating efficacy endpoints at week 6 and week 52.
Slovenian: Študija GEMINI II je bila randomizirana, dvojno slepa, s placebom nadzorovana študija, ki je vrednotila opazovane dogodke učinkovitosti v 6. tednu in 52. tednu.
English: If therapy is interrupted and there is a need to restart treatment with Entyvio, dosing at every four weeks may be considered (see section 5.1).
Slovenian: Če je bilo zdravljenje z zdravilom Entyvio prekinjeno in ga je treba znova uvesti, se lahko razmisli o odmerjanju na vsake štiri tedne (glejte poglavje 5.1).
English: Antibodies to vedolizumab may develop during vedolizumab treatment most of which are neutralising.
Slovenian: Pri zdravljenju z vedolizumabom se lahko razvijejo protitelesa proti vedolizumabu, ki so večinoma nevtralizacijska.
English: There was no clinically meaningful difference in clinical remission between treatment groups at these time points.
Slovenian: V teh časovnih točkah se klinična remisija med zdravljenimi skupinami klinično ni pomembneje razlikovala.
English: Entyvio passes into breast milk.
Slovenian: Zdravilo Entyvio prehaja v materino mleko.
English: Induction of remission in Crohn's disease
Slovenian: Indukcija remisije Crohnove bolezni
English: Administer the infusion solution over 30 minutes (see section 4.2).
Slovenian: Raztopino za infundiranje aplicirajte v obliki 30 minutne intravenske infuzije (glejte poglavje 4.2).
English: Administration of vedolizumab to pregnant cynomolgus monkeys during most of gestation resulted in no evidence of effects on teratogenicity, prenatal or postnatal development in infants up to 6 months of age.
Slovenian: Pri dajanju vedolizumaba brejim opicam Cynomolgus med večino obdobja gestacije niso odkrili dokazov o teratogenih učinkih ali vplivov na prenatalni ali postnatalni razvoj mladičev do 6. meseca starosti.
English: All patients should be observed continuously during each infusion.
Slovenian: Med vsakim infundiranjem zdravila je treba vse bolnike neprekinjeno nadzirati.
English: Other medicines and Entyvio Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines.
Slovenian: Obvestite zdravnika ali medicinsko sestro, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: 24 hours2, 3
Slovenian: 24 ur2,3
English: Population pharmacokinetic analyses suggest that while low albumin, higher body weight and prior treatment with anti-TNF drugs may increase vedolizumab clearance, the magnitude of their effects is not considered to be clinically relevant.
Slovenian: Analize populacijske farmakokinetike kažejo, da lahko nizka raven albumina, večja telesna masa in predhodno zdravljenje z zaviralci tumorje nekrotizirajočega faktorja (TNF) povečajo očistek vedolizumaba, vendar pa obseg njihovih učinkov ne velja za klinično pomembnega.
English: Vedolizumab did not affect immune surveillance and inflammation of the central nervous system in Experimental Autoimmune Encephalomyelitis in non-human primates, a model of multiple sclerosis.
Slovenian: Vedolizumab ni vplival na imunski nadzor in vnetje osrednjega živčevja pri eksperimentalnem avtoimunskem encefalomielitisu pri nečloveških primatih, modelu multiple skleroze.
English: Induction of remission in Crohn's disease may take up to 14 weeks in some patients.
Slovenian: Pri nekaterih bolnikih lahko indukcija remisije Crohnove bolezni traja do 14 tednov.
English: Once dissolved, gently invert vial 3 times.
Slovenian: Ko se zdravilo raztopi, vialo 3-krat nežno obrnite.
English: Entyvio is used to treat the signs and symptoms in adults of:
Slovenian: Zdravilo Entyvio uporabljamo pri odraslih za zdravljenje znakov in simptomov:
English: Given the lack of binding of vedolizumab to male reproductive tissue in monkey and human, and the intact male fertility observed in β7 integrin-knockout mice, it is not expected that vedolizumab will affect male fertility.
Slovenian: Zaradi odsotnosti vezave vedolizumaba na moško reproduktivno tkivo pri opicah in človeku in ohranjeni plodnosti samcev, opaženi pri miših z izbitim genom za integrin β7 (“β7 integrin-knockout mice”), vpliva vedolizumaba na moško plodnost ne pričakujemo.
English: As noted in Table 4, although the primary endpoint was not met, exploratory analyses show that clinically meaningful results were observed.
Slovenian: Primarni opazovani dogodek sicer ni bil dosežen, vendar pa eksplorativne analize kažejo klinično pomembne rezultate, kot je razvidno iz preglednice 4.
English: Further treatments
Slovenian: Nadaljnja zdravljenja
English: Therefore, the use of Entyvio in such patients is not recommended.
Slovenian: Uporaba zdravila Entyvio pri teh bolnikih tako ni priporočljiva.
English: A small number of patients have felt dizzy after receiving Entyvio.
Slovenian: Pri majhnem številu bolnikov se je po prejemu zdravila Entyvio pojavila omotica.
English: By binding to α4β7 on certain lymphocytes, vedolizumab inhibits adhesion of these cells to mucosal addressin cell adhesion molecule-1 (MAdCAM-1), but not to vascular cell adhesion molecule-1 (VCAM-1).
Slovenian: Z vezavo na α4β7 na nekaterih limfocitih vedolizumab zavira adhezijo teh celic na mukozno adresinsko celično adhezijsko molekulo-1 (MAdCAM-1-“mucosal addressin cell adhesion molecule-1”), vendar ne za žilno celično adhezijsko molekulo-1 (VCAM-1-“vascular cell adhesion molecule-1”).
English: If you stop using Entyvio You should not stop using Entyvio without talking with your doctor first.
Slovenian: Zdravljenja z zdravilom Entyvio ne smete prekiniti, ne da bi se o tem prej posvetovali s svojim zdravnikom.
English: Therefore, this medicine is not recommended for use during pregnancy unless you and your doctor decide that the benefit to you clearly outweighs the potential risk to yourself and your baby.
Slovenian: Uporaba tega zdravila med nosečnostjo tako ni priporočljiva, razen če skupaj z zdravnikom presodite, da je korist zdravljenja za vas nedvomno večja od možnega tveganja tako za vas kot nerojenega otroka.
English: Vedolizumab did not affect immune responses to antigenic challenge in the dermis and muscle (see section 4.4).
Slovenian: Vedolizumab ni vplival na imunski odziv na antigenski izziv v dermisu in mišici (glejte poglavje 4.4).
English: • sudden, severe allergic reaction which can cause breathing difficulty, swelling, fast heartbeat, sweating, drop in blood pressure, light-headedness, loss of consciousness and collapse (anaphylactic reaction and anaphylactic shock)
Slovenian: • nenadna, huda alergijska reakcija, ki lahko povzroči težave z dihanjem, otekanje, hiter srčni utrip, znojenje, padec krvnega tlaka, omotico, izgubo zavesti in kolaps (anafilaktična reakcija in anafilaktični šok).
English: The European Medicines Agency has deferred the obligation to submit the results of studies with vedolizumab in one or more subsets of the paediatric population in ulcerative colitis and Crohn's disease (see section 4.2 for information on paediatric use).
Slovenian: Pediatrična populacija Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z vedolizumabom za eno ali več podskupin pediatrične populacije z ulceroznim kolitisom in s Crohnovo boleznijo (za informacije o pediatrični uporabi glejte poglavje 4.2).
English: Entyvio treatment should be initiated and supervised by specialist healthcare professionals experienced in the diagnosis and treatment of ulcerative colitis or Crohn's disease (see section 4.4).
Slovenian: Zdravljenje z zdravilom Entyvio mora uvesti in nadzirati zdravnik specialist, ki ima izkušnje z diagnostiko in zdravljenjem ulzeroznega kolitisa ali Crohnove bolezni (glejte poglavje 4.4).
English: Reconstituted solution with uncharacteristic colour or containing particulates must not be administered.
Slovenian: Rekonstituirane raztopine z neznačilno barvo ali vsebnostjo trdnih delcev ne smete aplicirati.
English: Given the known risk of PML development in patients with previous natalizumab exposure, physicians should normally wait 12 weeks after the last natalizumab dose prior to initiating Entyvio treatment.
Slovenian: Glede na to, da pri bolnikih, ki so se predhodno zdravili z natalizumabom, obstaja znano tveganje za razvoj progresivne multifokalne levkoencefalopatije (PML), je pri takšnih bolnikih običajno treba počakati 12 tednov po zadnjem odmerku natalizumaba pred uvedbo zdravljenja z zdravilom Entyvio.
English: If you have any further questions on the use of this medicine, ask your doctor or nurse.
Slovenian: Če imate kakršna koli dodatna vprašanja o uporabi tega zdravila, se posvetujte z zdravnikom ali medicinsko sestro.
English: The effects of Entyvio in pregnant women are not known.
Slovenian: Učinki zdravila Entyvio pri nosečnicah niso znani.
English: There are limited amount of data from the use of vedolizumab in pregnant women.
Slovenian: Nosečnost Podatki o uporabi vedolizumaba pri nosečnicah so omejeni.
English: These data are consistent with investigations in nonhuman primates which did not detect effects on immune surveillance of the CNS.
Slovenian: Ti podatki se skladajo z rezultati preskušanj pri nečloveških primatih, pri katerih niso ugotovili učinkov na imunski nadzor v osrednjem živčevju.
English: As a precautionary measure, it is preferable to avoid the use of Entyvio during pregnancy unless the benefits clearly outweigh any potential risk to both the mother and foetus.
Slovenian: Iz previdnostnih razlogov se je med nosečnostjo uporabi zdravila Entyvio bolje izogibati, razen če koristi zdravljenja jasno prevladajo nad kakršnim koli možnim tveganjem tako za mater kot za plod.
English: No definitive conclusion can be drawn on the male reproductive organs in cynomolgus monkey repeated dose toxicity study.
Slovenian: Dokončnega zaključka o vplivu na moške reproduktivne organe na osnovi študije toksičnosti pri ponavljajočih odmerkih pri opicah Cynomolgus ni mogoče podati.
English: 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),
Slovenian: Pogostnost neželenih učinkov je navedena v skladu z naslednjimi kategorijami pogostnosti: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100) in zelo redki
English: 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).
Slovenian: Primarna opazovana dogodka sta bila delež bolnikov v klinični remisiji (opredeljeno kot indeks CDAI ≤ 150 točk) v 6. tednu in delež bolnikov z okrepljenim kliničnim odzivom (opredeljeno kot zmanjšanje indeksa CDAI za ≥ 100 točk od izhodišča) v 6. tednu (glejte preglednico 4).
English: 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.
Slovenian: V nadzorovanih in odprtih študijah uporabe vedolizumaba pri odraslih so poročila o resnih okužbah vključevala tuberkulozo, sepso (tudi posamezni smrtni primeri), salmonelozno sepso, listeriozni meningitis in citomegalovirusni kolitis.
English: 0 weeks
Slovenian: 0. teden
English: If this is not possible, reconstituted solution in the vial can be stored for up to 8 hours at 2 °C-8 °C.
Slovenian: Če to ni mogoče, lahko rekonstituirano raztopino v viali shranite do 8 ur pri temperaturi 2 °C-8 °C.
English: Prior and concurrent use of biological products
Slovenian: Predhodna in sočasna uporaba bioloških zdravil
English: Exploratory subgroup analyses from the clinical trials in Crohn's disease suggested that vedolizumab administered in patients without concomitant corticosteroid treatment may be less effective for induction of remission in Crohn's disease than in those patients already receiving concomitant corticosteroids (regardless of use of concomitant immunomodulators; see section 5.1).
Slovenian: Eksplorativne analize podskupin iz kliničnih preskušanj pri Crohnovi bolezni kažejo, da je indukcija remisije Crohnove bolezni z vedolizumabom pri bolnikih, ki se sočasno ne zdravijo s kortikosteroidi, lahko manj učinkovita kot pri bolnikih, ki se sočasno že zdravijo s kortikosteroidi (ne glede na sočasno zdravljenje z imunomodulatorji, glejte poglavje 5.1).
English: Do not use this medicine if you notice any particles in the liquid or discolouration prior to administration.
Slovenian: Ne uporabljajte tega zdravila, če v tekočini pred aplikacijo opazite kakršne koli trdne delce ali spremembo barve.
English: • shingles (herpes zoster)
Slovenian: • okužba nožnice, • pasovec (herpes zoster).
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.
Slovenian: Študija GEMINI III je bila druga randomizirana, dvojno slepa, s placebom nadzorovana študija, ki je vrednotila učinkovitost v 6. tednu in 10. tednu v podskupini bolnikov, ki se niso odzvali vsaj na eno ustaljeno zdravljenje in na zdravljenje z zaviralcem TNFα (vključno s primarnim neodzivom) pa tudi v celotni populaciji, ki je prav tako vključevala bolnike, ki se niso odzvali na vsaj eno ustaljeno zdravljenje in se predhodno še niso zdravili z zaviralcem TNFα.
English: For all subsequent infusions (after the first two), you will be monitored during the infusion and for approximately 1 hour after you have completed the infusion.
Slovenian: Pri vseh nadaljnjih infuzijah zdravila (po prvih dveh) vas bodo nadzirali med infundiranjem in še približno 1 uro po končanem infundiranju zdravila.
English: Exploratory analyses examined the effects of concomitant corticosteroids and immunomodulators on induction of remission with vedolizumab.
Slovenian: Z eksplorativnimi analizami so raziskali učinke sočasnega zdravljenja s kortikosteroidi in z imunomodulatorji na indukcijo remisije z vedolizumabom.
English: Vedolizumab is a therapeutic monoclonal antibody and is not expected to bind to plasma proteins.
Slovenian: Vedolizumab je terapevtsko monoklonsko protitelo zato vezava na plazemske proteine ni pričakovana.
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.
Slovenian: • če se pojavijo znaki alergijske reakcije ali druge reakcije na infuzijo, kot so sopenje, težko dihanje, koprivnica, srbenje, otekanje ali omotica.
English: 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.
Slovenian: Farmakokinetiko enkratnega in ponavljajočih se odmerkov vedolizumaba so raziskali pri zdravih osebah in bolnikih z zmerno do močno aktivnim ulceroznim kolitisom ali Crohnovo boleznijo.
English: Each pack contains 1 vial.
Slovenian: Pakiranje: škatla z 1 vialo.
English: Your doctor may decide to alter this treatment schedule depending on how well Entyvio works for you.
Slovenian: Zdravnik lahko to shemo zdravljenja spremeni, odvisno od odziva na zdravljenje z zdravilom Entyvio.
English: What Entyvio is and what it is used for What you need to know before you are given Entyvio How Entyvio will be given Possible side effects
Slovenian: Kaj je zdravilo Entyvio in za kaj ga uporabljamo Kaj morate vedeti, preden boste prejeli zdravilo Entyvio Kako boste prejeli zdravilo Entyvio
English: Population pharmacokinetic analyses suggest that co-administration of such agents did not have a clinically meaningful effect on vedolizumab pharmacokinetics.
Slovenian: Analize populacijske farmakokinetike kažejo, da sočasna uporaba teh zdravil ni imela klinično pomembnega vpliva na farmakokinetiko vedolizumaba.
English: 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.
Slovenian: MAdCAM-1 je izražen predvsem na črevesnih endotelijskih celicah in ima pomembno vlogo pri nastanitvi limfocitov T v tkiva v prebavnem traktu.
English: Warnings and precautions Talk to your doctor or nurse before being given Entyvio.
Slovenian: Opozorila in previdnostni ukrepi Pred začetkom uporabe zdravila Entyvio se posvetujte z zdravnikom ali medicinsko sestro.
English: • acne (pimples)
Slovenian: • akna (mozoljavost).