FrancophonIA/ELRC3.0 huggingface dataset:
English: o A stratification of the risk of developing PML based on the identified risk factors and presentation of the PML risk in a given time interval of treatment as well as the cumulative PML risk o PML risk estimates algorithm summarizes PML risk by anti- John Cunningham virus (JCV) antibody status, prior IS use and duration of treatment (by year of treatment) and stratifies this risk by index value when applicable.
Croatian: Liječenje imunosupresivima prije primjene TYSABRIJA o Stratifikacija rizika za pojavu PML-a temeljem identificiranih čimbenika rizika i predstavljanje rizika od PML-a u određenom vremenskom intervalu liječenja, kao i kumulativni rizik za PML o Algoritam procjena rizika od PML-a objedinjuje rizik od PML-a po statusu anti-JohnCunninghamov virus (JCV) antitijela, prethodnoj upotrebi imunosupresiva (IS-a) te trajanju liječenja (u godinama liječenja) te stratificira rizik po vrijednosti indeksa kada je to primjenjivo.
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 radnike nalaze se na kraju ove upute.
English: Patients presenting with eye symptoms such as decreased visual acuity, redness and painful eye should be referred for retinal screening for ARN.
Croatian: Bolesnike kod kojih se javljaju simptomi na oku poput smanjene oštrine vida, crvenilo oka i bol u oku treba uputiti na pregled mrežnice radi utvrđivanja akutne retinalne nekroze.
English: Rare side effects that may affect up to 1 in 1,000 people:
Croatian: Rijetke nuspojave koje se mogu pojaviti u manje od 1 na 1000 osoba:
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: Infekcije uključujući druge oportunističke infekcije 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: Breast-feeding should be discontinued during treatment with TYSABRI.
Croatian: Dojenje treba prekinuti za vrijeme liječenja lijekom TYSABRI.
English: 1 case of herpes meningitis was reported in the meta-analysis.
Croatian: U metaanalizi je zabilježen 1 slučaj herpesnog meningitisa.
English: The pharmacokinetics of natalizumab in patients with renal or hepatic insufficiency has not been studied.
Croatian: Farmakokinetika natalizumaba u bolesnika s bubrežnom ili jetrenom insuficijencijom nije ispitana.
English: No prospective clinical studies have been completed to validate these findings.
Croatian: Ti rezultati nisu validirani prospektivnim kliničkim ispitivanjima.
English: The following steroid regimens have been reported for the treatment of IRIS in the literature:
Croatian: Za liječenje IRIS-a u literaturi su prijavljeni sljedeći režimi primjene steroida:
English: − differentiation between PML and MS
Croatian: - diferencijacija između PML-a i multiple skleroze
English: treatment stratified by prior treatment with immunosuppressants and JCV infection.
Croatian: TYSABRIJEM stratificiran prema prethodnom liječenju imunosupresivima i infekciji JCV-om.
English: Each ml of concentrate contains 20 mg of natalizumab.
Croatian: Jedan ml koncentrata sadrži 20 mg natalizumaba.
English: However, it has recently been suggested that corticosteroids may be useful to treat IRIS, particularly in patients with severe to life-threatening IRIS (Tan et al., 2009, Clifford et al., 2010).
Croatian: IRIS-a, osobito u bolesnika s teškim do po život opasnim IRIS-om (Tan et al., 2009, Clifford et al.,
English: If a woman becomes pregnant while taking TYSABRI, discontinuation of the medicinal product should be considered.
Croatian: Ako žena zatrudni tijekom primanja TYSABRIJA potrebno je razmotriti prekid primjene lijeka.
English: Physicians must evaluate each individual case to determine whether there is evidence of an immunocompromised state prior to commencing treatment with TYSABRI (see section 4.3).
Croatian: Liječnici moraju promotriti svakog bolesnika zasebno kako bi utvrdili da li je stanje bolesnika imunokompromitirano prije početka liječenja TYSABRIJEM (vidjeti dio 4.3).
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 ispitivanjima 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: Interim analysis of results (as of May 2015) from the ongoing TYSABRI Observational Program (TOP), a phase 4, multicentre, single-arm study (n=5770) demonstrated that patients switching from beta interferon (n= 3255) or glatiramer acetate (n= 1384) to TYSABRI showed a sustained, significant decrease in annualised relapse rate (p< 0.0001).
Croatian: Interim analiza rezultata (od svibnja 2015.) dobivenih u multicentričnom ispitivanju faze 4 s jednom skupinom ispitanika (n = 5770) u programu opažanja za TYSABRI koji je u tijeku pokazala je da se u bolesnika koji prelaze s beta interferona (n = 3255) ili glatirameracetata (n = 1384) na TYSABRI, zadržalo značajno smanjenje godišnje stope relapsa (p < 0,0001).
English: Relapse rate derived variables / MRI-derived variables
Croatian: Varijable dobivene na osnovi stope relapsa / varijable dobivene na osnovi magnetske rezonancije
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 Diagnosis and prognosis of symptomatic and asymptomatic PML
Croatian: o Testiranje na anti-JCV protutijela, učestalost testiranja, tumačenje kvalitativnih i kvantitativnih rezultata, seroprevalencija JCV protutijela i stope serokonverzije tijekom vremena o Dijagnoza i prognoza simptomatskog i asimptomatskog PML-a
English: • Keep alert card with the them after discontinuation • Reporting of side effects
Croatian: • Neka čuvaju karticu upozorenja uza se nakon prekida uzimanja
English: − Pain or redness of the eye(s)
Croatian: − bol ili crvenilo oka (očiju)
English: Consistent with efficacy results observed for patients switching from beta interferon or glatiramer acetate to TYSABRI, for patients switching from fingolimod (n=147) to TYSABRI, a significant decrease in annualised relapse rate (ARR) was observed, which remained stable over 2 years, and mean EDSS scores remained similar from baseline to Year 2.
Croatian: Sukladno rezultatima djelotvornosti opaženim u bolesnika koji su na TYSABRI prelazili s beta interferona ili glatirameracetata, za one u kojih je prijelaz bio s fingolimoda (n = 147) na TYSABRI opaženo je značajno smanjenje godišnje stope relapsa, što je ostalo stabilno 2 godine, a srednje vrijednosti rezultata EDSS ostale su slične od početka do 2. godine.
English: For storage conditions after dilution of the medicinal product see section 6.3.
Croatian: Uvjete čuvanja nakon razrjeđivanja lijeka vidjeti u dijelu 6.3.
English: • Treatment discontinuation form
Croatian: • Obrazac za prekid liječenja
English: It is unknown if patients switching from these therapies to TYSABRI have an increased risk of PML, therefore these patients should be monitored more frequently (i.e. similarly to patients switching from immunosuppressants to TYSABRI).
Croatian: Nije poznato postoji li u bolesnika koji prelaze s tih terapija na TYSABRI povećani rizik od PML-a, stoga te bolesnike treba češće nadzirati (tj. slično kao i bolesnike koji na TYSABRI prelaze s imunosupresivnih lijekova).
English: TYSABRI 300 mg concentrate for solution for infusion
Croatian: TYSABRI 300 mg koncentrat za otopinu za infuziju
English: TYSABRI will be given to you by a doctor experienced in the treatment of MS.
Croatian: TYSABRI će Vam dati liječnik iskusan u liječenju multiple skleroze.
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: In post marketing experience, serious, life-threatening, and sometimes fatal cases of encephalitis and meningitis caused by herpes simplex or varicella zoster have been reported in multiple sclerosis patients receiving TYSABRI.
Croatian: Nakon stavljanja lijeka u promet bilo je prijavljenih ozbiljnih, opasnih po život i ponekad fatalnih slučajeva encefalitisa i meningitisa uzrokovanih herpes simplex ili varicella zoster virusima u bolesnika sa multiplom sklerozom koji su primali TYSABRI.
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 (engl.
English: Symptoms of JCV GCN are similar to PML.
Croatian: Simptomi JCV GCN-a su slični PML-u.
English: When switching from dimethyl fumarate, the washout period should be sufficient for lymphocyte count to recover before treatment with TYSABRI is started.
Croatian: Kada bolesnici prelaze s dimetilfumarata, razdoblje ispiranja lijeka iz organizma treba biti dovoljno dugo da se broj limfocita oporavi prije nego što započne liječenje TYSABRIJEM.
English: • Reminder of the approved dosing; cross reference to EU SmPC
Croatian: Informacije o produljenom intervalu doziranja (EID-u) • Podsjetnik na odobreno doziranje; unakrsna referenca na EU-ov sažetak opisa svojstava lijeka
English: The pharmacokinetics of natalizumab in paediatric MS patients has not been established.
Croatian: Farmakokinetika natalizumaba u pedijatrijskih bolesnika s multiplom sklerozom nije ustanovljena.
English: Common side effects that may affect up to 1 in 10 people:
Croatian: Česte nuspojave koje se mogu pojaviti u manje od 1 na 10 osoba:
English: Studies have not been conducted to examine the effects of renal or hepatic impairment.
Croatian: Ispitivanja koja bi provjerila učinke oštećenja bubrega ili jetre nisu provedena.
English: • TYSABRI must not be mixed with other medicinal products or diluents.
Croatian: • TYSABRI se ne smije miješati s drugim lijekovima ili otapalima.
English: TYSABRI is contraindicated in combination with other DMTs (see section 4.3).
Croatian: TYSABRI je kontraindiciran u kombinaciji s drugim terapijama koje mijenjaju tijek bolesti (vidjeti dio 4.3).
English: The treatment discontinuation form • Inform patient that PML has been reported up to 6 months after stopping Tysabri
Croatian: • Informirajte bolesnika da je PML prijavljivan i do 6 mjeseci nakon prekida uzimanja lijeka Tysabri
English: Hazard ratio 0.46, CI95% 0.33; 0.64, p<0.001
Croatian: Omjer hazarda 0,46, CI95% 0,33 ; 0,64, p<0,001
English: It is unknown if patients switching from these therapies to TYSABRI have an increased risk of PML, therefore these patients should be monitored more frequently (i.e. similarly to patients switching from immunosuppressants to TYSABRI, see MRI screening for PML).
Croatian: Nije poznato postoji li u bolesnika koji prelaze s tih terapija na TYSABRI povećani rizik od PML-a, stoga te bolesnike treba češće nadzirati (tj. slično kao i bolesnike koji na TYSABRI prelaze s imunosupresivnih lijekova, vidjeti MR probir na PML).
English: In a pre-specified, retrospective analysis of US anti-JCV antibody positive TYSABRI patients (TOUCH registry), the risk of PML was compared between patients treated with the approved dosing interval and patients treated with extended interval dosing as identified in the last 18 months of exposure (EID, average dosing intervals of approximately 6 weeks).
Croatian: antitijelo koji uzimaju TYSABRI (registar TOUCH), rizik od PML-a usporedio se između bolesnika liječenih prema odobrenom intervalu doziranja i bolesnika liječenih prema produljenom intervalu doziranja kako je utvrđeno tijekom zadnjih 18 mjeseci izlaganja (EID, prosječni interval doziranja od otprilike 6 tjedana).
English: Speak to your doctor or nurse immediately if you notice any of the following Symptoms of serious infections including:
Croatian: Odmah razgovarajte sa svojim liječnikom ili medicinskom sestrom ako primijetite bilo što od sljedećeg
English: In anti-JCV antibody positive TYSABRI treated patients who have not used prior immunosuppressants the level of anti-JCV antibody response (index) is associated with the level of risk for PML (i.e. the risk is greater in those with a high antibody index compared to those with a low index).
Croatian: U bolesnika pozitivnih na anti-JCV antitijela liječenih lijekom TYSABRI koji prije nisu uzimali imunosupresive razina odgovora anti-JCV antitijela (indeks) povezana je s razinom rizika od PML-a (tj. rizik je veći u onih s većim indeksom antitijela nego u onih s manjim indeksom).
English: Hazard ratio 0.58, CI95% 0.43; 0.73, p<0.001
Croatian: Omjer hazarda 0,58, CI95% 0,43 ; 0,73, p<0,001
English: The washout period should be sufficient for lymphocyte count to recover before treatment with TYSABRI is started.
Croatian: Razdoblje ispiranja lijeka iz organizma treba biti dovoljno dugo da se broj limfocita oporavi prije nego što započne liječenje TYSABRIJEM.
English: o The recommendation that patients should have MRI scans at the following times:
Croatian: o Preporuka za snimanje bolesnika MR-om po sljedećem rasporedu:
English: • That TYSABRI therapy is to be initiated and continuously supervised by specialised physicians experienced in the diagnosis and treatment of neurological conditions, in centres with timely access to MRI.
Croatian: • Liječenje TYSABRIJEM trebaju započeti i neprekidno nadgledati specijalizirani liječnici s iskustvom u dijagnozi i liječenju neuroloških stanja, u ustanovama gdje postoji stalan pristup uređaju za magnetsku rezonanciju (MR).
English: For further information, refer to the Physician Information and Management Guidelines.
Croatian: Dodatne informacije potražite u Informacijama za liječnike i Smjernicama za liječenje.
English: No cases of PML were identified in the meta-analysis, however, PML has been reported in natalizumab treated paediatric patients in the post-marketing setting.
Croatian: Metaanaliza nije pokazala slučajeve PML-a, međutim,tijekom praćenja nakon stavljanja lijeka u promet, zabilježeni su slučajevi PML-a u pedijatrijskih bolesnika liječenih natalizumabom.
English: • Progressive multifocal leukoencephalopathy (PML)
Croatian: • progresivna multifokalna leukoencefalopatija (PML)
English: Following clinical diagnosis of ARN, discontinuation of TYSBABRI should be considered in these patients.
Croatian: Nakon kliničke dijagnoze akutne retinalne nekroze potrebno je razmotriti prekid primjene TYSABRIJA tih bolesnika.
English: • Sore throat and runny or blocked up nose
Croatian: • grlobolja i nos koji curi ili je začepljen • drhtanje
English: sodium phosphate, monobasic, monohydrate; sodium phosphate, dibasic, heptahydrate; sodium chloride; polysorbate 80 (E433) and water for injections.
Croatian: natrijev dihidrogenfosfat hidrat, natrijev hidrogenfosfat heptahidrat, natrijev klorid, polisorbat 80 (E433) i voda za injekcije.
English: Based on how patients treated with TYSABRI are currently monitored at national level, the Marketing Authorisation Holder (MAH) shall discuss and agree with the National Competent Authorities measures to enhance further this monitoring (e.g. registries, post-marketing surveillance studies) as appropriate.
Croatian: nositelj odobrenja za stavljanje lijeka u promet će prema potrebi raspraviti i usuglasiti mjere za daljnje poboljšanje praćenja s nacionalnim regulatornim tijelom (npr. registri, ispitivanja praćenja nakon stavljanja lijeka u promet).
English: Your doctor can decide whether TYSABRI is not working properly for you by testing your blood and will stop TYSABRI, if necessary.
Croatian: Liječnik će nakon pretraga krvi odlučiti je li TYSABRI djelotvoran te će po potrebi prekinuti liječenje TYSABRIJEM.
English: Uncommon side effects that may affect up to 1 in 100 people:
Croatian: Manje česte nuspojave koje se mogu pojaviti u manje od 1 na 100 osoba:
English: Resources for the management of hypersensitivity reactions and access to MRI should be available.
Croatian: Sredstva za zbrinjavanje reakcija preosjetljivosti kao i pristup uređaju za magnetsku rezonanciju moraju biti dostupni.
English: • You must not use TYSABRI if you are being treated with other medicines to treat your MS disease
Croatian: • TYSABRI ne smijete primati ako se liječite drugim lijekovima za liječenje multiple skleroze.
English: Patients with a treatment history of immunosuppressant medications are at increased risk for PML.
Croatian: Bolesnici koji su prije liječeni imunosupresivnim lijekovima pod povećanim su rizikom od pojave
English: The treatment reported in these cases included anti-viral therapy and in some cases, surgery (see section 4.4).
Croatian: Liječenje zabilježeno u tim slučajevima uključivalo je antivirusnu terapiju, a u nekim slučajevima operaciju
English: Irrespective of the presence or absence of PML risk factors, heightened clinical vigilance for PML should be maintained in all patients treated with TYSABRI and for 6 months following discontinuation of therapy.
Croatian: Neovisno o prisutnosti ili odsutnosti rizičnih faktora za PML, u svih bolesnika liječenih lijekom
English: Following discontinuation of fingolimod, lymphocyte count progressively returns to normal range within 1 to 2 months after stopping therapy.
Croatian: Nakon prekida liječenja fingolimodom, broj limfocita progresivno se vraća u normalan raspon unutar
English: In anti-JCV antibody positive patients, extended interval dosing of TYSABRI (average dosing interval of approximately 6 weeks) is suggested to be associated with a lower PML risk compared to approved dosing.
Croatian: Extended Interval Dosing) TYSABRIJA (uz prosječni interval doziranja od otprilike 6 tjedana) sugerira da je povezan s nižim rizikom od PML-a u usporedbi s odobrenim doziranjem.
English: The symptoms of JCV GCN are similar to PML.
Croatian: Simptomi JCV GCN-a slični su simptomima PML-a.
English: o Patients, their partners and care givers are advised of symptoms that may be indicative of early PML and the need for counseling on the need to be vigilant for these symptoms while on TYSABRI treatment, and also for approximately 6 months after the last dose of TYSABRI (PML has also been reported up to 6 months following the last dose of TYSABRI in patients who did not have findings suggestive of PML at the time of discontinuation).
Croatian: Općenito, čini se da na prevalenciju anti-JCV antitijela nisu utjecali prethodna upotreba imunosupresiva, prethodna izloženost lijeku TYSABRI ili trajanje izlaganja lijeku TYSABRI. o Bolesnici, njihovi partneri i skrbnici dobili su savjete o simptomima koji mogu upućivati na rani PML i potrebi za savjetovanjem o potrebi praćenja tih simptoma tijekom liječenja lijekom TYSABRI te približno 6 mjeseci nakon zadnje doze tog lijeka (PML je prijavljivan i do 6 mjeseci nakon zadnje doze lijeka TYSABRI u bolesnika koji nisu imali nalaze koji bi upućivali na PML u vrijeme prekida uzimanja).
English: • If you have antibodies to the JC virus in your blood.
Croatian: • ako u krvi imate protutijela na JC virus
English: During extended pre-registration trials, two cases of PML were reported in MS patients and a full safety evaluation revealed one further case in a clinical trial patient with Crohn's Disease.
Croatian: PML-a, a potpunom sigurnosnom procjenom otkriven je još jedan dodatni slučaj bolesnika s Crohnovom bolešću koji je sudjelovao u kliničkom ispitivanju.
English: o Confirmation that TYSABRI should be permanently discontinued if PML is confirmed.
Croatian: o Potvrda trajnog prekida liječenja lijekom TYSABRI u slučaju potvrde PML-a.
English: If you miss your usual dose of TYSABRI, arrange with your doctor to receive it as soon as you can. You can then continue to receive your dose of TYSABRI every 4 weeks.
Croatian: Ako propustite primiti uobičajenu dozu TYSABRIJA, dogovorite s liječnikom da je što prije primite.
English: - Keep this leaflet and the Patient Alert Card. You may need to read them again.
Croatian: - Sačuvajte ovu uputu i Karticu s upozorenjima za bolesnika.
English: You should discuss with your doctor if TYSABRI is the most suitable treatment for you before you start taking TYSABRI and when you have been taking TYSABRI for more than two years.
Croatian: Prije nego što počnete primati TYSABRI i kada primate TYSABRI dulje od dvije godine,
English: There have been cases of a rare brain infection called PML (progressive multifocal leukoencephalopathy) that have occurred in patients who have been given TYSABRI.
Croatian: U nekih bolesnika koji su primali TYSABRI zabilježeni su slučajevi rijetke infekcije mozga koja se zove progresivna multifokalna leukoencefalopatija (PML).
English: When diluted the solution for infusion contains approximately 2.6 mg/ml of natalizumab.
Croatian: otopina za infuziju sadrži približno 2,6 mg/ml natalizumaba.
English: Biogen Netherlands B.V. Prins Mauritslaan 13
Croatian: Biogen Netherlands B.V.
English: − Impaired vision
Croatian: − oštećenje vida
English: • Reminder no to take any other long-term medicines for MS while receiving Tysabri
Croatian: • Podsjetnik na to da se uz Tysabri ne uzima nikakva druga dugotrajna terapija lijekovima za MS
English: TYSABRI therapy is to be initiated and continuously supervised by specialised physicians experienced in the diagnosis and treatment of neurological conditions, in centres with timely access to MRI.
Croatian: Liječenje TYSABRIJEM trebaju započeti i neprekidno nadgledati specijalizirani liječnici s iskustvom u dijagnozi i liječenju neuroloških stanja, u ustanovama gdje postoji stalan pristup uređaju za snimanje magnetskom rezonancijom (MR).
English: Package leaflet: Information for the patient TYSABRI 300 mg concentrate for solution for infusion natalizumab This medicine is subject to additional monitoring.
Croatian: Uputa o lijeku: Informacije za bolesnika TYSABRI 300 mg koncentrat za otopinu za infuziju natalizumab
English: The limited sample size and shorter duration of TYSABRI exposure for this subgroup of patients should be considered when interpreting these data.
Croatian: Kod interpretacije tih rezultata u ovoj podskupini bolesnika treba uzeti u obzir ograničenu veličinu uzorka i kraće trajanje izloženosti lijeku TYSABRI.
English: • Add the 15 ml concentrate for solution for infusion to 100 ml sodium chloride 9 mg/ml (0.9%) solution for injection.
Croatian: • Dodajte 15 ml koncentrata za otopinu za infuziju u 100 ml 0,9%-tne (9 mg/ml) otopine natrijevog klorida za injekcije.