FrancophonIA/ELRC3.0 huggingface dataset:
English: • You will also find this information in the Patient Alert Card you have been given by your doctor.
Croatian: • Te informacije ćete također naći u Vašoj Kartici s upozorenjima za bolesnika koju ste dobili od svog liječnika.
English: Anti-JCV antibody testing provides supportive information for risk stratification of TYSABRI treatment.
Croatian: Testiranje na anti-JCV protutijela pruža potporne informacije za stratifikaciju rizika liječenja TYSABRIJEM.
English: In post-marketing experience, there have been reports of hypersensitivity reactions which have occurred with one or more of the following associated symptoms: hypotension, hypertension, chest pain, chest discomfort, dyspnoea, angioedema, in addition to more usual symptoms such as rash and urticaria.
Croatian: Nakon stavljanja lijeka u promet izvještavalo se o reakcijama preosjetljivosti povezanim s jednim ili više slijedećih simptoma: hipotenzija, hipertenzija, bol u prsištu, nelagoda u prsištu, dispneja, angioedem kao dodatnim simptomima uz uobičajene, kao što su osip i urtikarija.
English: In patients considered at high risk treatment with TYSABRI should only be continued if the benefits outweigh the risks.
Croatian: Kod bolesnika za koje se smatra da su pod visokim rizikom, liječenje TYSABRIJEM treba nastaviti samo ako su koristi veće od rizika.
English: • Confirmation of patient understanding of the risks of PML and that they have received a copy of the form and a patient alert card
Croatian: • Potvrdu da bolesnik razumije rizik za PML, te da je primio primjerak obrasca i Karticu s upozorenjima za bolesnika
English: • If you are allergic to natalizumab or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte primjenjivati TYSABRI • ako ste alergični na natalizumab ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: You will also find this information in the Patient Alert Card you have been given by your doctor.
Croatian: Ove informacije ćete također naći u Kartici s upozorenjima za bolesnika koju ste dobili od svog liječnika.
English: Natalizumab blocks the interaction of α4β7 integrin with the mucosal addressin cell adhesion molecule-1 (MadCAM-1).
Croatian: Natalizumab sprečava interakciju integrina α4β7 s adhezijskim molekulama-1 MadCAM-1 (mucosal addressin cell adhesion molecule
English: The mean ± SD steady-state clearance was 13.1 ± 5.0 ml/h, with a mean ± SD half-life of 16 ± 4 days.
Croatian: Srednja vrijednost ± SD klirensa u stanju dinamičke ravnoteže bila je 13,1 ± 5,0 ml/h, uz srednju vrijednost ± SD poluvijeka od 16 ± 4 dana.
English: • Yellowing of your skin or the whites of your eyes
Croatian: • žuta boja kože ili bjeloočnica
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Croatian: Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenim člankom 107(c) stavkom 7
English: Disease exacerbations or infusion related events may indicate the development of antibodies against natalizumab.
Croatian: Egzacerbacije bolesti ili pojave vezane za infuziju mogu ukazati na razvoj protutijela na natalizumab.
English: Pack size of one vial per carton.
Croatian: Veličina pakiranja je jedna bočica po kartonskoj kutiji.
English: Hypersensitivity reactions have been associated with TYSABRI, including serious systemic reactions (see section 4.8).
Croatian: Kod primjene TYSABRIJA mogu nastupiti reakcije preosjetljivosti, uključujući ozbiljne sistemske reakcije (vidjeti dio 4.8).
English: TYSABRI is for intravenous use.
Croatian: TYSABRY je za intravensku primjenu.
English: This should be considered if you are on a controlled sodium diet.
Croatian: To treba uzeti u obzir ako ste na dijeti s ograničenim unosom natrija.
English: During treatment with TYSABRI, small reductions in haemoglobin (mean decrease 0.6 g/dl), haematocrit (mean decrease 2%) and red blood cell counts (mean decrease 0.1 x 106/l) were seen.
Croatian: Tijekom liječenja TYSABRIJEM primijećena su mala smanjenja hemoglobina (srednje smanjenje 0,6 g/dl), hematokrita (srednje smanjenje 2%) i broja crvenih krvnih stanica (srednje smanjenje 0,1 x 106/l).
English: Physicians should refer to the Physician Information and Management Guidelines for further information on managing the risk of PML in TYSABRI-treated patients.
Croatian: Liječnici se upućuju na Informacije za liječnike i Smjernice za liječenje za daljnje informacije o zbrinjavanju rizika od PML-a u bolesnika liječenih TYSABRIJEM.
English: If any doubt exists, further evaluation, including MRI scan preferably with contrast (compared with pre-treatment baseline MRI), CSF testing for JC Viral DNA and repeat neurological assessments, should be considered as described in the Physician Information and Management Guidelines (see educational guidance).
Croatian: Ako postoji bilo kakva sumnja treba razmotriti dodatnu procjenu, uključujući MR, najbolje s kontrastom (kojeg treba usporediti s početnim MR-om prije liječenja), pregled cerebrospinalne tekućine na JC virusnu DNK i ponavljanje neuroloških testova, kao što je opisano u Informacijama za liječnike i Smjernicama za liječenje (vidjeti Smjernice za edukaciju).
English: Cases from published literature reported transient mild to moderate thrombocytopenia and anaemia observed in infants born to women exposed to TYSABRI in their third trimester of pregnancy.
Croatian: Slučajevi iz objavljene literature prikazuju prolaznu blagu do umjerenu trombocitopeniju i anemiju uočenu u novorođenčadi žena koje su bile izložene TYSABRIJU u trećem tromjesečju trudnoće.
English: Resources for the management of hypersensitivity reactions should be available.
Croatian: Sredstva za liječenje reakcija preosjetljivosti moraju biti dostupna.
English: No differences in incidence rates or the nature of malignancies between natalizumab- and placebo-treated patients were observed over 2 years of treatment.
Croatian: Nisu primijećene razlike u stopama incidencije ili prirodi zloćudnih bolesti između bolesnika koji su primali natalizumab ili placebo tijekom dvogodišnjeg liječenja.
English: If a patient receiving TYSABRI develops an opportunistic infection, dosing of the medicinal product must be permanently discontinued.
Croatian: Ako bolesnik koji prima TYSABRI razvije oportunističku infekciju, primjenu lijeka mora se trajno prekinuti.
English: The treatment continuation form should contain the elements of the treatment initiation form and, in addition, a statement that the risks of PML increase with duration of treatment and that treatment beyond 24 months carries additional risk.
Croatian: Obrazac za nastavak liječenja treba sadržavati elemente iz obrasca za početak liječenja i dodatno, izjavu da se rizik za PML povećava s povećanjem trajanja liječenja te da liječenje u trajanju duljem od 24 mjeseca nosi dodatni rizik.
English: TYSABRI 300 mg is administered by intravenous infusion once every 4 weeks.
Croatian: Doziranje TYSABRI 300 mg primjenjuje se u obliku intravenske infuzije svaka 4 tjedna.
English: Efficacy as monotherapy has been evaluated in one randomised, double-blind, placebo-controlled study lasting 2 years (AFFIRM study) in relapsing-remitting MS patients who had experienced at least 1 clinical relapse during the year prior to entry and had a Kurtzke Expanded Disability Status Scale (EDSS) score between 0 and 5.
Croatian: Djelotvornost monoterapije ocijenjena je jednim randomiziranim, dvostruko slijepim ispitivanjem kontroliranim placebo skupinom u trajanju od dvije godine (ispitivanje AFFIRM) na bolesnicima s relapsno-remitentnom multiplom sklerozom koji su doživjeli barem 1 klinički relaps u godini prije pristupanja ispitivanju te koji su prema Kurtzkeovoj ljestvici stanja širenja nesposobnosti (Expanded Disability Status Scale, EDSS) ocijenjeni između 0. i 5. stupnja.
English: Over the 2-year duration of the studies, 43.5% of patients treated with natalizumab reported adverse reactions (placebo: 39.6%).
Croatian: Tijekom dvogodišnjeg ispitivanja 43,5% bolesnika koji su primali natalizumab prijavilo je nuspojave (placebo skupina: 39,6%).
English: Some infections other than PML may also be serious and can be due to viruses, bacteria, or other causes.
Croatian: Neke infekcije osim PML-a mogu također biti ozbiljne i mogu ih prouzročiti virusi,
English: In 10% of patients antibodies against natalizumab were detected in 2-year controlled clinical trials in MS patients.
Croatian: U 10% bolesnika s multiplom sklerozom pronađena su protutijela na natalizumab tijekom dvogodišnjih kontroliranih kliničkih ispitivanja.
English: • Physician information about TYSABRI
Croatian: • Informacije za liječnika o TYSABRIJU
English: If a woman becomes pregnant while taking TYSABRI, discontinuation of the medicinal product should be considered.
Croatian: Ako žena zatrudni tijekom uzimanja TYSABRIJA potrebno je razmotriti prekid primjene lijeka.
English: A condition called JCV GCN (JC virus granule cell neuronopathy) is also caused by JC virus and has occurred in some patients who have been given TYSABRI.
Croatian: Stanje koje se naziva JCV GCN (neuronopatija granularnih stanica uzrokovana JC virusom) je također uzrokovano JC virusom i pojavilo se u nekih bolesnika koji su primali TYSABRI.
English: There is no evidence of a specific pattern of birth defects with TYSABRI.
Croatian: Nema dokaza o određenom obrascu prirođenih mana pri primjeni TYSABRIJA.
English: RESULTS Annual relapse rate After one year (primary endpoint) After two years One year
Croatian: Nakon jedne godine (primarni ishod) Nakon dvije godine Jedna godina
English: Insert the syringe needle into the vial through the centre of the rubber stopper and remove 15 ml concentrate for solution for infusion.
Croatian: Umetnite iglu štrcaljke u bočicu kroz središnji dio gumenog čepa i izvucite 15 ml koncentrata za otopinu za infuziju.
English: It is considered unlikely that natalizumab will affect fertility performance in humans following the maximum recommended dose.
Croatian: Mogućnost da bi natalizumab utjecao na plodnost u ljudi kod primjene maksimalne preporučene doze nije vjerojatna.
English: Placebo / Natalizumab 300 mg i.v.
Croatian: Placebo/Natalizumab 300 mg i.v. svaka 4 tjedna
English: Other opportunistic infections have been reported with use of TYSABRI, primarily in patients with Crohn's disease who were immunocompromised or where significant co-morbidity existed, however increased risk of other opportunistic infections with use of the medicinal product in patients without these co-morbidities cannot currently be excluded.
Croatian: Kod primjene TYSABRIJA zabilježene su i neke druge oportunističke infekcije, poglavito u bolesnika s Crohnovom bolešću koji su imunokompromitirani ili u kojih je postojala značajna komorbidnost, međutim, trenutno nije moguće isključiti povećan rizik od drugih oportunističkih infekcija tijekom primjene lijeka u bolesnika u kojih ne postoji komorbiditet.
English: Prescribers should be aware of the possibility that other opportunistic infections may occur during TYSABRI therapy and should include them in the differential diagnosis of infections that occur in TYSABRI-treated patients.
Croatian: Liječnici koji propisuju lijek trebaju imati na umu da postoji mogućnost pojave drugih oportunističkih infekcija tijekom terapije TYSABRIJEM te ih trebaju uključiti u diferencijalnu dijagnozu infekcija koje se javljaju u bolesnika koji primaju TYSABRI.
English: o Description of MRI protocols for baseline, routine screening and in case of PML suspicion o Anti-JCV antibody testing, frequency of testing, interpretation of qualitative and quantitative results, seroprevalence of JCV-antibodies and seroconversion rate over time o Monitoring strategy after discontinuation of TYSABRI treatment o The need to inform patients about the benefits and risk of TYSABRI and provide them with:
Croatian: o Opis MR protokola za početni, rutinski probir i u slučaju sumnje na PML o Testiranje na anti-JCV protutijela, učestalost testiranja, tumačenje kvalitativnih i kvantitativnih rezultata, seroprevalencija JCV protutijela i stope serokonverzije tijekom vremena o Strategija nadziranja nakon prekida liječenja TYSABRIJEM o Bolesnike je potrebno uputiti o koristima i rizicima liječenja TYSABRIJEM te im dati:
English: Before you start treatment with TYSABRI, it is important that you and your doctor have discussed the benefits you would expect to receive from this treatment and the risks that are associated with it.
Croatian: Što morate znati prije nego počnete primjenjivati TYSABRI Prije nego započnete liječenje TYSABRIJEM važno je da s liječnikom razmotrite koristi koje očekujete od ovog liječenja i rizik povezan s tim.
English: In Phase 3 MS clinical trials, concomitant treatment of relapses with a short course of corticosteroids was not associated with an increased rate of infection.
Croatian: U fazi 3 kliničkih ispitivanja multiple skleroze, liječenje relapsa kratkom terapijom kortikosteroidima u kombinaciji s TYSABRIJEM nije bilo povezano s povećanom stopom infekcija.
English: Relapse free
Croatian: Bez relapsa
English: For medicinal products such as interferon and glatiramer acetate, concomitant exposure of this duration was not associated with safety risks in clinical trials.
Croatian: Primjena lijekova poput interferona i glatiramer acetata tijekom razdoblja nakon prestanka primjene natalizumaba nije predstavljala rizik za sigurnost liječenja tijekom kliničkih ispitivanja.
English: Each 15 ml vial of concentrate contains 300 mg natalizumab (20 mg/ml).
Croatian: Jedna bočica od 15 ml koncentrata sadrži 300 mg natalizumaba (20 mg/ml).
English: Therefore the physician must confirm that such patients are not immunocompromised before starting treatment with TYSABRI (see also section
Croatian: Stoga liječnik mora provjeriti da ti bolesnici nisu imunokompromitirani prije početka liječenja TYSABRIJEM (također vidjeti dio 4.4).
English: Testing for serum anti-JCV antibody prior to initiating TYSABRI therapy or in patients receiving the medicinal product with an unknown antibody status is recommended.
Croatian: Testiranje na anti-JCV protutijela u serumu preporuča se prije početka terapije TYSABRIJEM ili u bolesnika s nepoznatim statusom protutijela koji primaju lijek.
English: All changes were observed at doses in excess of the human dose and were reversed upon clearance of natalizumab.
Croatian: Sve promjene primijećene su kod doza viših od ljudske doze te su se povukle nakon uklanjanja natalizumaba iz tijela.
English: Patients and physicians should continue to follow the same monitoring protocol and be alert for any new signs or symptoms that may be suggestive of PML for approximately 6 months following discontinuation of TYSABRI.
Croatian: Bolesnici i liječnici moraju nastaviti slijediti isti plan nadziranja i obraćati pažnju na sve nove znakove ili simptome koji mogu ukazivati na PML tijekom približno 6
English: Mean average steady-state trough natalizumab concentrations over the dosing period ranged from 23 μg/ml to 29 μg/ml.
Croatian: Srednji prosjek najniže koncentracije natalizumaba u stanju dinamičke ravnoteže u razdoblju doziranja bio je u rasponu od 23 μg/ml do 29 μg/ml.
English: Hazard ratio for disability progression was 0.36 (95% CI: 0.17, 0.76) p = 0.008.
Croatian: Omjer rizika od progresije onesposobljenosti bio je 0,36 (95% CI : 0,17, 0,76) p = 0,008.
English: These occurred in 23.1% of MS patients treated with natalizumab (placebo: 18.7%).
Croatian: Ove nuspojave javile su se u 23,1% bolesnika s multiplom sklerozom koji su primali natalizumab (placebo skupina: 18,7%).
English: TYSABRI must not be administered as a bolus injection.
Croatian: TYSABRI se ne smije primijeniti u obliku bolus injekcije.
English: No effects on abortion rates were noted in any other study.
Croatian: Utjecaj na stope pobačaja nije zabilježen u drugim ispitivanjima.
English: These changes were associated with increased splenic extramedullary haematopoiesis, thymic atrophy and decreased hepatic haematopoiesis.
Croatian: Te promjene bile su povezane s povećanom ekstramedularnom hematopoezom u slezeni, atrofijom timusa i smanjenom jetrenom hematopoezom.
English: • Information for medical or healthcare professionals on how to prepare and administer TYSABRI is provided at the end of this leaflet.
Croatian: • Podaci o pripremi i primjeni TYSABRIJA za medicinske i zdravstvene djelatnike nalaze se na kraju ove Upute.
English: After one year After two years
Croatian: Nakon jedne godine Nakon dvije godine Onesposobljenost
English: The clinician should evaluate the patient to determine if the symptoms are indicative of neurological dysfunction and, if so, whether these symptoms are typical of MS or possibly suggestive of PML or JCV GCN.
Croatian: Kliničar treba procijeniti bolesnika kako bi utvrdio da li simptomi ukazuju na neurološku disfunkciju te da li su svojstveni za multiplu sklerozu ili možda ukazuju na PML ili JCV GCN.
English: In the sub-group of patients indicated for treatment of rapidly evolving relapsing remitting MS (patients with 2 or more relapses and 1 or more Gd+ lesion), the annualised relapse rate was 0.282 in the TYSABRI treated group (n = 148) and 1.455 in the placebo group (n = 61) (p <0.001).
Croatian: U podskupini bolesnika u kojih je postojala indikacija za liječenje brzonapredujuće relapsnoremitentne multiple skleroze (bolesnici s dva ili više relapsa i jednom ili više lezija utvrđenih gadolinijem) godišnja stopa relapsa iznosila je 0,282 za skupinu koja je primala TYSABRI (n = 148) i 1,455 za skupinu koja je primala placebo (n = 61) (p <0,001).
English: The rate of defects corresponds to the defect rates reported in other pregnancy registries involving MS patients.
Croatian: Ta stopa mana odgovara stopi mana prijavljenih u drugim registrima trudnoća koji uključuju bolesnice s multiplom sklerozom.
English: However, the risk of hypersensitivity reactions should be considered for every infusion administered.
Croatian: Međutim, kod svake primijenjene infuzije treba uzeti u obzir rizik od reakcija preosjetljivosti.
English: Cases of PML have been reported from clinical trials, post-marketing observational studies and postmarketing passive surveillance.
Croatian: Slučajevi PML-a prijavljeni su u kliničkim ispitivanjima, opservacijskim ispitivanjima nakon stavljanja lijeka u promet i pasivnom praćenju nakon stavljanja lijeka u promet.
English: The effect of plasma exchange on natalizumab clearance and pharmacodynamics was evaluated in a study of 12 MS patients.
Croatian: Utjecaj izmjene plazme na klirens natalizumaba i farmakodinamiku bio je ocjenjivan u ispitivanju na 12 bolesnika s multiplom sklerozom.
English: Breast-feeding should be discontinued during treatment with TYSABRI.
Croatian: Dojenje treba prekinuti tijekom liječenja TYSABRIJEM.
English: Reductions in female guinea pig fertility were observed in one study at doses in excess of the human dose; natalizumab did not affect male fertility.
Croatian: Smanjenje plodnosti ženki zamorca primijećeno je u jednom ispitivanju kod doza viših od ljudskih doza; natalizumab nije utjecao na plodnost mužjaka.
English: The efficacy of re-administration has not been established, for safety see section 4.4.
Croatian: Djelotvornost ponovljene primjene lijeka nije utvrđena, a za sigurnost ponovljene primjene lijeka vidjeti dio 4.4.
English: • Treatment initiation and treatment continuation forms
Croatian: • Obrasce za početak i nastavak liječenja • Obrazac za prekid liječenja
English: Short courses of steroids used to treat relapses were not associated with increased infections in clinical trials.
Croatian: Kratkotrajna primjena steroida za liječenje relapsa nije dovela do povećanja infekcija tijekom kliničkih ispitivanja.
English: No information on the severity of the relapses before inclusion of patients in the study is available.
Croatian: Podaci o težini relapsa prije uključenja bolesnika u ispitivanje nisu dostupni.
English: Some patients with a past medical history of an abnormal liver test have experienced an exacerbation of abnormal liver test while on TYSABRI.
Croatian: Neki bolesnici, koji su u svojoj anamnezi imali abnormalne jetrene testove, doživjeli su egzacerbaciju abnormalnih testova jetre dok su primali TYSABRI.
English: In clinical trials, herpes infections (Varicella-Zoster virus, Herpes-simplex virus) occurred slightly more frequently in natalizumab-treated patients than in placebo-treated patients.
Croatian: U kliničkim ispitivanjima, herpes infekcije (Varicella-Zoster virus, Herpes-simplex virus) su se pojavljivale neznatno učestalije u bolesnika koji su primali natalizumab u odnosu na bolesnike koji su primali placebo.
English: After 2 years of treatment, patients should be reinformed about the risks of TYSABRI, especially the increased risk of Progressive Multifocal Leukoencephalopathy (PML), and should be instructed together with their caregivers on early signs and symptoms of PML.
Croatian: Nakon 2 godine liječenja, bolesnike je potrebno ponovno uputiti u rizike liječenja TYSABRIJEM, osobito u povećan rizik od progresivne multifokalne leukoencefalopatije (PML), te bolesnike i njihove njegovatelje treba uputiti na rane znakove i simptome PML-a.
English: Platelet counts were also reduced in offspring born to mothers treated with natalizumab until parturition, however there was no evidence of anaemia in these offspring.
Croatian: Broj trombocita također je bio smanjen u mladunčadi majki koje su primale natalizumab sve do poroda, no nije bilo znakova anemije.
English: Due to this increased risk of developing PML, the benefits and risks of TYSABRI treatment should be individually reconsidered by the specialist physician and the patient; patients must be monitored at regular intervals throughout and should be instructed together with their caregivers on early signs and symptoms of PML.
Croatian: Uslijed tog povećanog rizika od razvoja PML-a, koristi i rizici liječenja TYSABRIJEM trebaju biti ponovno razmotreni za pojedinog bolesnika od strane liječnika specijalista i bolesnika; bolesnike se mora pratiti u redovitim intervalima tijekom liječenja i treba ih podučiti zajedno sa njihovim njegovateljima o ranim znakovima i simptomima PML-a.
English: Anti-JCV antibody testing
Croatian: Testiranje na anti-JCV protutijela
English: In placebo-controlled trials in 1,617 MS patients treated with natalizumab for up to 2 years (placebo: 1,135), adverse events leading to discontinuation of therapy occurred in 5.8% of patients treated with natalizumab (placebo: 4.8%).
Croatian: U placebom kontroliranim ispitvanjima na 1617 bolesnika s multiplom sklerozom koji su primali natalizumab do 2 godine (1135 bolesnika je primalo placebo), u 5,8% bolesnika koji su primali natalizumab (placebo skupina: 4,8%) došlo je do nuspojava koje su uzrokovale prekid liječenja.
English: Given that efficacy may be reduced or the incidence of hypersensitivity or infusion-related reactions may be increased in a patient with persistent antibodies, treatment should be discontinued in patients who develop persistent antibodies.
Croatian: Budući da u bolesnika s perzistirajućim protutijelima djelotvornost lijeka može biti smanjena, dok incidencija reakcija preosjetljivosti ili reakcija vezanih uz infuziju može biti povećana, liječenje treba prekinuti u bolesnika koji su razvili perzistirajuća protutijela.
English: Opportunistic infections were also detected in MS patients treated with TYSABRI as a monotherapy (see section 4.8).
Croatian: Oportunističke infekcije uočene su i u bolesnika s multiplom sklerozom koji su primali TYSABRI kao monoterapiju (vidjeti dio 4.8).
English: A study in pregnant cynomolgus monkeys demonstrated natalizumab-related changes in the foetus that included mild anaemia, reduced platelet counts, increased spleen weights and reduced liver and thymus weights.
Croatian: Ispitivanje na trudnim majmunima cynomolgus ukazalo je na promjene u fetusu vezane za natalizumab poput blage anemije, smanjenog broja trombocita, povećane težine slezene te smanjene težine jetre i timusa.