FrancophonIA/ELRC3.0 huggingface dataset:
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
Croatian: • Bolesnike liječene lijekom Entyvio mora se nadzirati za svaki novi nastup ili pogoršanje neuroloških znakova i simptoma kao što su ovi niže navedeni: o Progresivna slabost na jednoj strani tijela ili nespretni pokreti udova o Smetnje vida o Promjene u razmišljanju, pamćenju i orijentaciji, koje dovode do zbunjenosti i promjene ličnosti
English: • if you have an active severe infection, for example, tuberculosis, blood poisoning, severe gastroenteritis, nervous system infection.
Croatian: • ako imate aktivnu tešku infekciju, na primjer tuberkulozu, trovanje krvi, teški gastroenteritis,
English: • Any patients with new onset or worsening signs and symptoms suggestive of PML should be considered for neurological referral at a center equipped to diagnose PML.
Croatian: • Sve bolesnike s novonastalim ili pogoršanim znakovima i simptomima koji ukazuju na PML treba uputiti na neurološki pregled u centru opremljenom za dijagnosticiranje PML-a.
English: In a pharmacologically responsive species (cynomolgus monkeys), there was no evidence of cellular hyperplasia or systemic immunomodulation that could potentially be associated with oncogenesis in 13- and 26-week toxicology studies.
Croatian: Kod vrsta koje su farmakološki reagirale na liječenje (majmuni roda cynomolgus (makaki majmuni)) nije bilo dokaza stanične hiperplazije ili sustavne imunomodulacije koja bi mogla biti povezana s onkogenezom u 13- i 26- otjednim toksikološkim ispitivanjima.
English: Table 3 shows the results from the primary and secondary endpoints evaluated.
Croatian: Tablica 3 prikazuje rezultate primarnih i sekundarnih ishoda.
English: Vedolizumab is a therapeutic monoclonal antibody and is not expected to bind to plasma proteins.
Croatian: Vedolizumab je terapijsko monoklonsko protutijelo za koje se ne očekuje da će se vezati za proteine plazme.
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.
Croatian: Analize populacijske farmakokinetike ukazuju na to da, iako niske razine albumina, povećana tjelesna težina i prethodno liječenje lijekovima protiv TNF mogu povećati klirens vedolizumaba, jačina njihovih učinaka ne smatra se klinički značajnom.
English: 24 hours2, 3
Croatian: 24 sata2,3
English: Table 2 shows the results from the primary and secondary endpoints evaluated.
Croatian: Tablica 2 prikazuje rezultate primarnih i sekundarnih ishoda.
English: • moderately to severely active ulcerative colitis
Croatian: • umjereno do izrazito aktivnog ulceroznog kolitisa
English: Reconstituted solution with uncharacteristic colour or containing particulates must not be administered.
Croatian: Rekonstituirana otopina nekarakteristične boje ili koja sadrži čestice ne smije se primijeniti.
English: Active severe infections such as tuberculosis (TB), sepsis, cytomegalovirus, listeriosis, and opportunistic infections such as Progressive Multifocal Leukoencephalopathy (PML) (see section 4.4).
Croatian: Aktivne teške infekcije poput tuberkuloze (TB), sepse, citomegalovirusa, listerioze i oportunističkih infekcija poput progresivne multifokalne leukoencefalopatije (PML) (vidjeti dio 4.4).
English: Induction of remission in Crohn's disease
Croatian: Indukcija remisije Crohnove bolesti
English: Your doctor will have to decide if you can still be given Entyvio.
Croatian: Vaš će liječnik morati odlučiti smijete li primati
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.
Croatian: Kao mjera opreza, preporučuje se izbjegavati primjenu lijeka Entyvio tijekom trudnoće, osim kad korist jasno nadilazi bilo koji potencijalni rizik i za majku i za fetus.
English: If you are a woman of childbearing potential, you are advised to avoid becoming pregnant while using Entyvio.
Croatian: Ako ste žena reproduktivne dobi, savjetuje se da izbjegavate trudnoću tijekom primjene lijeka
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Croatian: Ispitivanja na životinjama ne ukazuju na izravan ili neizravan štetan učinak što se tiče reproduktivne toksičnosti (vidjeti dio 5.3).
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.
Croatian: S obzirom da se vedolizumab ne veže na tkivo muških reproduktivnih organa u majmuna i ljudi, te s obzirom na intaktnu plodnost uočenu kod mužjaka miševa s deficitom β7 integrina, utjecaj vedolizumaba na plodnost muškaraca se ne očekuje.
English: No dose adjustment is required in elderly patients.
Croatian: Kod starijih bolesnika nije potrebno prilagođavati dozu.
English: 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).
Croatian: Liječnici trebaju razmotriti premedikaciju (npr. s antihistaminicima, hidrokortizonom i/ili paracetamolom) prije sljedeće infuzije u bolesnika s anamnezom blagih do umjerenih reakcija povezanih s infuzijom vedolizumaba kako bi se smanjili njihovi rizici (vidjeti dio 4.8).
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.
Croatian: Neki bolesnici koji su iskusili smanjenje odgovora mogu imati koristi od povećanja učestalosti doziranja na 300 mg lijeka Entyvio svaka četiri tjedna.
English: Live and oral vaccines
Croatian: Živa i peroralna cjepiva
English: If you stop using Entyvio You should not stop using Entyvio without talking with your doctor first.
Croatian: Nemojte prestati uzimati Entyvio bez savjetovanja s Vašim liječnikom.
English: The recommended dose is 300 mg of Entyvio given as follows (see table below):
Croatian: Preporučena doza iznosi 300 mg lijeka Entyvio dana na sljedeći način (vidjeti tablicu u nastavku):
English: Most infusion related reactions occurred within the first 2 hours.
Croatian: Većina reakcija povezanih s infuzijom dogodila se unutar prva
English: In this open-label extension study, clinical remission and clinical response were observed in patients for up to 196 weeks.
Croatian: U ovom otvorenom nastavku ispitivanja klinička remisija i klinički odgovor zabilježeni su u bolesnika do 196 tjedana.
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).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka vedolizumab u jednoj ili više podskupina pedijatrijske populacije u ulceroznom kolitisu i Crohnovoj bolesti (za informacije o primjeni u djece vidjeti dio 4.2).
English: Efficacy was regained with no evident increase in adverse reactions or infusion-related reactions during retreatment with vedolizumab (see section 4.8).
Croatian: Djelotvornost je ponovo uspostavljena bez očitog porasta nuspojava ili reakcija povezanih s infuzijom tijekom ponovnog liječenja vedolizumabom (vidjeti dio 4.8).
English: Vedolizumab should be administered in a healthcare setting equipped to allow management of acute hypersensitivity reactions including anaphylaxis, if they occur.
Croatian: Vedolizumab treba primijeniti u zdravstvenoj ustanovi koja je opremljena za zbrinjavanje akutnih reakcija preosjetljivosti, uključujući anafilaksiju, za slučaj ako se pojave.
English: Effects on male and female fertility have not been formally evaluated in animal studies (see section 5.3).
Croatian: Učinci na plodnost mužjaka i ženki nisu formalno procijenjeni u ispitivanjima na životinjama (vidjeti dio 5.3).
English: Timing of treatment (infusion)
Croatian: Vremensko određivanje liječenja (infuzija)
English: Entyvio should not be given with other biologic medicines that suppress your immune system as the effect of this is not known.
Croatian: Entyvio se ne smije davati s drugim biološkim lijekovima koji suprimiraju imunološki sustav jer učinak u toj kombinaciji nije poznat.
English: A small number of patients have felt dizzy after receiving Entyvio.
Croatian: Mali broj bolesnika osjetio je omaglicu nakon primanja lijeka Entyvio.
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).
Croatian: Eksplorativne analize podskupina iz kliničkih ispitivanja kod Crohnove bolesti ukazuju da vedolizumab primijenjen u bolesnika bez istovremenog liječenja kortikosteroidima može biti manje djelotvoran u indukciji remisije Crohnove bolesti nego u bolesnika koji već istovremeno uzimaju kortikosteroide (bez obzira na istovremeno uzimanje imunomodulatora; vidjeti dio 5.1).
English: Population pharmacokinetic analyses indicate that vedolizumab has a total body clearance of approximately 0.157 L/day and a serum half-life of 25 days.
Croatian: Analize populacijske farmakokinetike ukazuju da vedolizumab ima ukupni tjelesni klirens od približno 0,157 l/dan i poluživot u serumu od 25 dana.
English: Population pharmacokinetic analyses showed no effect of age (see section 5.2).
Croatian: Populacijske farmakokinetičke analize nisu pokazale utjecaj dobi (vidjeti dio 5.2).
English: 12 hours2
Croatian: 12 sati2
English: The formation of anti-vedolizumab antibodies is associated with increased clearance of vedolizumab and lower rates of clinical remission.
Croatian: Stvaranje anti-vedolizumab protutijela povezano je s povećanim klirensom vedolizumaba i nižim stopama kliničke remisije.
English: Entyvio has minor influence on the ability to drive and use machines, as dizziness has been reported in a small number of patients.
Croatian: Entyvio malo utječe na sposobnost upravljanja vozilima ili rada sa strojevima jer je omaglica zapažena u malom broju bolesnika.
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.
Croatian: Primjena vedolizumaba kod nosećih makaki majmuna tijekom većine gestacije nije dokazala učinke na teratogenost, prenatalni ili postnatalni razvoj u mladunčadi do dobi od 6 mjeseci.
English: Entyvio has not been studied in these patient populations.
Croatian: Entyvio nije ispitivan u ovim populacijama bolesnika.
English: Any time that the reconstituted solution was held in the vial should be subtracted from the time the solution may be held in the infusion bag.
Croatian: Svo vrijeme u kojem se rekonstituirana otopina čuvala u bočici treba oduzeti od vremena u kojem se otopina može čuvati u vrećici za infuziju.
English: Do not hold1
Croatian: Ne čuvati1
English: 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.
Croatian: Kombinirana terapija, najviše s istovremeno primijenjenim kortikosteroidima, čini se djelotvornija u indukciji remisije u Crohnovoj bolesti od vedolizumaba samog ili s istovremeno primjenjivanim imunomodulatorima, koji su pokazali manju razliku u stopi remisije u odnosu na placebo.
English: Most patients continued on vedolizumab after the infection resolved.
Croatian: Većina bolesnika nastavila je liječenje vedolizumabom nakon povlačenja infekcije.
English: Treatment (infusion) number
Croatian: Broj liječenja (infuzije)
English: If this is not possible, reconstituted solution in the vial can be stored for up to 8 hours at 2 °C-8 °C.
Croatian: Ako to nije moguće, rekonstituirana otopina u bočici može se čuvati do 8 sati pri 2 °C-8 °C.
English: Very common Headache Common
Croatian: Vrlo često glavobolja
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.
Croatian: Vedolizumab nije utjecao na imunološki nadzor i upalu središnjeg živčanog sustava kod eksperimentalnog autoimunog encefalomijelitisa u nehumanih primata, modela za multiplu sklerozu.
English: For all subsequent infusions, patients should be observed for approximately 1 hour following completion of the infusion.
Croatian: Za sve naknadne infuzije, bolesnike treba nadzirati približno 1 sat nakon završetka infuzije.
English: 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).
Croatian: U kontroliranim ispitivanjima GEMINI I i GEMINI II, 4% bolesnika liječenih vedolizumabom i 3% bolesnika liječenih placebom imali su nuspojave koje su ispitivači definirali kao reakciju povezanu s infuzijom (RPI) (vidjeti dio 4.4).
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.
Croatian: Prilikom primjene vedolizumaba u žena koje doje potrebno je uzeti u obzir korist liječenja za ženu i potencijalni rizik po dojenče.
English: • if you experience blurred, loss of or double vision, difficulty speaking, weakness in an arm or a leg, a change in the way you walk or problems with your balance, persistent numbness, decreased sensation or loss of sensation, memory loss or confusion.
Croatian: • ako Vam se pojavi zamagljeni vid, gubitak vida ili dvostruka slika, poteškoće u govoru, slabost u ruci ili nozi, promjene u načinu hoda ili problemi s ravnotežom, trajna utrnulost, smanjen osjet ili gubitak osjeta, gubitak pamćenja ili smetenost.
English: In patients who have responded to treatment with Entyvio, corticosteroids may be reduced and/or discontinued in accordance with standard of care.
Croatian: U bolesnika koji su odgovorili na liječenje lijekom Entyvio moguće je smanjiti i/ili prekinuti liječenje kortikosteroidima u skladu sa standardnom skrbi.
English: • For your first 2 infusions, your doctor or nurse will monitor you closely during the infusion and for approximately 2 hours after you have completed the infusion.
Croatian: • Za prve dvije infuzije, liječnik ili medicinska sestra će Vas pomno nadzirati tijekom infuzije i približno 2 sata nakon dovršetka infuzije.
English: The recommended dose regimen of Entyvio is 300 mg administered by intravenous infusion at zero, two and six weeks and then every eight weeks thereafter.
Croatian: Preporučeno doziranje lijeka Entyvio je 300 mg primijenjenih intravenskom infuzijom u nultom, drugom i šestom tjednu, te svakih osam tjedana nakon toga.
English: Patients previously exposed to natalizumab should normally wait a minimum of 12 weeks prior to initiating therapy with Entyvio, unless otherwise indicated by the patient's clinical condition.
Croatian: Bolesnici prethodno izloženi natalizumabu trebali bi pričekati najmanje 12 tjedana prije početka liječenja lijekom Entyvio, osim ako bolesnikovo kliničko stanje ne iziskuje drugačije.
English: Of those patients who had infusion related reactions, those dosed with vedolizumab had more infusion related reactions with in the first 2 hours as compared to placebo patients with infusion related reactions.
Croatian: Od onih bolesnika koji su imali reakcije povezane s infuzijom, oni koji su primili vedolizumab imali su više reakcija povezanih s infuzijom unutar prva 2 sata u usporedbi s bolesnicima koji su primali placebo te su doživjeli s infuzijom povezane reakcije.
English: Vedolizumab does not bind to, nor inhibit function of, the α4β1 and αEβ7 integrins.
Croatian: Vedolizumab se ne veže na integrine α4β1 i αEβ7 niti inhibira njihovu funkciju.
English: In a placebo-controlled study of healthy volunteers, a single 750 mg dose of vedolizumab did not lower rates of protective immunity to hepatitis B virus in subjects who were vaccinated intramuscularly with three doses of recombinant hepatitis B surface antigen.
Croatian: U placebom kontroliranim ispitivanjima na zdravim dobrovoljcima, pojedinačna doza od 750 mg vedolizumaba nije smanjila stopu zaštitne imunosti na virus hepatitisa B u ispitanika koji su cijepljeni intramuskularno s tri doze rekombinantnog površinskog antigena B.
English: Exploratory analyses examined the effects of concomitant corticosteroids and immunomodulators on induction of remission with vedolizumab.
Croatian: Eksplorativne analize istražile su djelovanje istovremene primjene kortikosteroida i imunomodulatora na indukciju remisije s vedolizumabom.
English: Patients with Crohn's disease, who have not shown a response may benefit from a dose of Entyvio at week 10 (see section 4.4).
Croatian: Bolesnici s Crohnovom bolešću kod kojih nije zabilježen odgovor mogu imati koristi od doze lijeka Entyvio u 10. tjednu (vidjeti dio 4.4).
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).
Croatian: Vezanjem na α4β7 na određenim limfocitima vedolizumab inhibira adheziju tih stanica na mukozno adresinsku staničnu adhezijsku molekulu-1 (MAdCAM-1), ali ne i na vaskularnu staničnu adhezijsku molekulu-1 (VCAM-1).
English: The patient is to be given a Patient Alert Card (see section 4.2).
Croatian: Bolesnik mora dobiti Karticu s upozorenjima za bolesnika (vidjeti dio 4.2).
English: Vedolizumab 450 mg administered intravenously was not detected in the cerebrospinal fluid of healthy subjects.
Croatian: Vedolizumab 450 mg primijenjen intravenski nije detektiran u cerebrospinalnoj tekućini zdravih ispitanika.
English: For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3.
Croatian: Za uvjete čuvanja nakon rekonstitucije i razrjeđivanja lijeka, vidjeti dio 6.3.
English: Vedolizumab exhibited linear pharmacokinetics at serum concentrations greater than 1 mcg/mL.
Croatian: Vedolizumab je iskazao linearnu farmakokinetiku pri serumskim koncentracijama većim od 1 µg/ml.
English: In contrast, vedolizumab inhibited an immune response to a gastrointestinal antigenic challenge in healthy human volunteers (see section 4.4).
Croatian: Nasuprot tome, vedolizumab je inhibirao imunološki odgovor na gastrointestinalnu provokaciju antigenom u ljudskih zdravih dobrovoljaca (vidjeti dio 4.4).
English: This medicine has a minor influence on your ability to drive or use tools or machines.
Croatian: Ovaj lijek može imati mali utjecaj na sposobnost upravljanja vozilima ili rada sa alatima i strojevima.
English: The following listing of adverse reactions is based on clinical trial and post marketing experience and is displayed by system organ class.
Croatian: Sljedeći popis nuspojava temelji se na iskustvu iz kliničkih ispitivanja i praćenju lijeka nakon stavljanja u promet, a prikazan je prema klasifikaciji organskih sustava.
English: Doses up to 10 mg/kg (approximately 2.5 times the recommended dose) have been administered in clinical trials.
Croatian: U kliničkim su ispitivanjima primjenjivane doze do 10 mg/kg (približno 2,5 puta preporučena doza).
English: Population pharmacokinetic analyses suggest that co-administration of such agents did not have a clinically meaningful effect on vedolizumab pharmacokinetics.
Croatian: Farmakokinetičke populacijske analize ukazuju da istovremena primjena takvih lijekova nije imala klinički značajan učinak na farmakokinetiku vedolizumaba.
English: Entyvio is contraindicated in patients with active tuberculosis (see section 4.3).
Croatian: Entyvio je kontraindiciran u bolesnika s aktivnom tuberkulozom (vidjeti dio 4.3).
English: Entyvio treatment is not to be initiated in patients with active, severe infections until the infections are controlled, and physicians should consider withholding treatment in patients who develop a severe infection while on chronic treatment with Entyvio.
Croatian: Liječenje lijekom Entyvio ne smije se započinjati u bolesnika s aktivnim, teškim infekcijama sve dok se infekcije ne stave pod kontrolu, a liječnici trebaju razmotriti odgodu liječenja u bolesnika koji su razvili tešku infekciju dok su na kroničnom liječenju lijekom Entyvio.
English: 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.
Croatian: Potreban je oprez kad se razmatra primjena vedolizumaba u bolesnika s kontroliranom kroničnom teškom infekcijom ili anamnezom povratnih teških infekcija.
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).
Croatian: Liječenje lijekom Entyvio treba započeti i nadzirati liječnik specijalist s iskustvom u dijagnosticiranju i liječenju ulceroznog kolitisa ili Crohnove bolesti (vidjeti dio 4.4).
English: Entyvio is used to treat the signs and symptoms in adults of:
Croatian: Entyvio se koristi u odraslih bolesnika za liječenje znakova i simptoma:
English: Administer the infusion solution over 30 minutes.
Croatian: Otopinu za infuziju primijenite tijekom 30 minuta.
English: Powder for concentrate for solution for infusion in Type 1 glass vial (20 mL) fitted with rubber stopper and aluminium crimp protected by a plastic cap.
Croatian: Prašak za koncentrat za otopinu za infuziju u staklenoj bočici tipa 1 (20 ml) opremljen gumenim čepom i aluminijskim prstenom zaštićenim plastičnim zatvaračem.
English: Vedolizumab belongs to a group of biological medicines called monoclonal antibodies (MAbs).
Croatian: Vedolizumab pripada skupini bioloških lijekova zvanih monoklonska protutijela.
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)
Croatian: • iznenadna teška alergijska reakcija koja može prouzročiti poteškoće s disanjem, oticanje, ubrzane otkucaje srca, znojenje, pad krvnog tlaka, ošamućenost, gubitak svijesti i kolaps (anafilaktička reakcija i anafilaktički šok)
English: Entyvio is given by a doctor or nurse and patients should not need to store or handle Entyvio.
Croatian: Entyvio primjenjuju liječnik ili medicinska sestra te bolesnici ne trebaju čuvati Entyvio niti rukovati njime.
English: If latent tuberculosis is diagnosed, appropriate treatment must be started with anti-tuberculosis treatment in accordance with local recommendations, before beginning vedolizumab.
Croatian: Ako je dijagnosticirana latentna tuberkuloza, potrebno je prije početka liječenja vedolizumabom započeti odgovarajuće antituberkulozno liječenje sukladno lokalnim preporukama.
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.
Croatian: Vedolizumab blokira protein na površini bijelih krvnih stanica koji uzrokuje upalu kod ulceroznog kolitisa i Crohnove bolesti, te smanjuje razmjere upale.