FrancophonIA/ELRC3.0 huggingface dataset:
English: When you receive TYSABRI you might not notice any improvement, but TYSABRI may still be working to prevent your MS becoming worse.
Croatian: Kada počnete primjenjivati TYSABRI možda nećete primijetiti poboljšanje, ali TYSABRI ipak djeluje sprečavanjem pogoršanja MS.
English: A few patients have had an allergic reaction to TYSABRI.
Croatian: Nekoliko je bolesnika imalo alergijsku reakciju na TYSABRI.
English: The predicted time to steady-state was approximately 36 weeks.
Croatian: Predviđeno vrijeme potrebno za uspostavljanje stanja dinamičke ravnoteže bilo je oko 36 tjedana.
English: After 2 years continued therapy should be considered only following a reassessment of the potential for benefit and risk.
Croatian: Nakon 2 godine nastavak liječenja treba uzeti u obzir tek nakon procjene moguće koristi i rizika.
English: Physicians should counsel patients on the importance of uninterrupted dosing, particularly in the early months of treatment (see hypersensitivity).
Croatian: Liječnici trebaju savjetovati bolesnike o važnosti neprekinute primjene, posebice u početnim mjesecima liječenja (vidjeti Preosjetljivost).
English: The following risk factors are associated with an increased risk of PML.
Croatian: Sljedeći rizični čimbenici povezani su s povećanim rizikom od PML-a.
English: The majority of patients did not interrupt natalizumab therapy during infections and recovery occurred with appropriate treatment.
Croatian: Većina bolesnika nije prekidala liječenje natalizumabom tijekom infekcija i oporavak je uslijedio nakon odgovarajućeg liječenja.
English: If you have all three risks described above your chance of getting PML is higher.
Croatian: Ako imate sva tri gore opisana rizika mogućnost da dobijete PML je veća.
English: Will TYSABRI always work?
Croatian: Je li TYSABRI uvijek djelotvoran?
English: At the first sign of any symptoms indicative of the possibility of PML.
Croatian: Pri prvoj naznaci simptoma koji ukazuju na mogućnost PML-a.
English: Therefore, it is recommended that newborns of women exposed to the medicinal product during the third trimester of pregnancy are monitored for potential haematological abnormalities.
Croatian: Stoga se preporučuje da se novorođenčad žena koje su bile izložene lijeku tijekom trećeg tromjesečja trudnoće prati na potencijalne hematološke abnormalnosti.
English: This active ingredient is called a monoclonal antibody.
Croatian: Ova djelatna tvar se naziva monoklonsko protutijelo.
English: • Unusual darkening of the urine.
Croatian: • neuobičajeno tamni urin.
English: Your doctor will check for allergic reactions during the infusion and for 1 hour afterwards.
Croatian: Vaš će liječnik provjeriti ima li alergijskih reakcija tijekom infuzije i 1 sat nakon infuzije.
English: All changes in haematological variables returned to pre-treatment values, usually within 16 weeks of last dose of the medicinal product and the changes were not associated with clinical symptoms.
Croatian: Sve promjene hematoloških varijabli vratile su se na vrijednosti prije liječenja, uglavnom unutar 16 tjedana nakon primjene zadnje doze lijeka i nisu bile povezane s kliničkim simptomima.
English: Of these, 581 patients received a fixed 300 mg dose as monotherapy.
Croatian: Od njih je 581 bolesnik primao fiksnu dozu od 300 mg u obliku monoterapije.
English: It is important that you keep this Alert Card and show it to your partner or caregivers.
Croatian: Važno je da čuvate Karticu s upozorenjima za bolesnika te ju pokažete Vašem partneru ili skrbnicima.
English: Monotherapy; randomised double-blind placebo-controlled parallel-group trial for 120 weeks
Croatian: Monoterapija; randomizirano, dvostruko slijepo ispitivanje kontrolirano paralelnom placebo skupinom u trajanju od 120 tjedana
English: • If your doctor has told you that you have PML (progressive multifocal leukoencephalopathy).
Croatian: • ako Vam je liječnik rekao da imate PML (progresivna multifokalna leukoencefalopatija).
English: PML and IRIS (Immune Reconstitution Inflammatory Syndrome)
Croatian: PML i IRIS (upalni sindrom imunološke rekonstitucije)
English: Neurological evaluations were performed every 12 weeks and at times of suspected relapse.
Croatian: Neurološka ispitivanja provedena su svakih 12 tjedana te kod sumnje na relaps.
English: Remove flip-off cap from the vial.
Croatian: Odstranite 'flip-off' kapicu s bočice.
English: These medicines are for MS and cannot be used with TYSABRI (see Using other medicines, below).
Croatian: Ti lijekovi su za MS i ne smiju se primjenjivati s TYSABRIJEM (pogledajte niže: Drugi lijekovi i TYSABRI).
English: The effect of natalizumab on reproduction was evaluated in 5 studies, 3 in guinea pigs and 2 in cynomolgus monkeys.
Croatian: Utjecaj natalizumaba na reprodukciju ocijenjen je u 5 ispitivanja, 3 na zamorcima i 2 na majmunima cynomolgus.
English: Infections, including PML and opportunistic infections
Croatian: Infekcije, uključujući PML i oportunističke infekcije
English: The safety and efficacy of TYSABRI in combination with other immunosuppressive and antineoplastic therapies have not been fully established.
Croatian: Sigurnost i djelotvornost TYSABRIJA u kombinaciji s drugim imunosupresivima i antineoplasticima nisu u potpunosti utvrđene.
English: What TYSABRI is and what is it used for
Croatian: Što je TYSABRI i za što se koristi
English: When the symptoms flare up, it is called a relapse (also known as an exacerbation or an attack).
Croatian: Kad se simptomi bolesti pojačaju govorimo o relapsu (poznatom i kao pogoršanje ili napadaj).
English: The impact of plasma exchange on the restitution of lymphocyte migration and ultimately its clinical usefulness is unknown.
Croatian: Utjecaj izmjene plazme na ponovno uspostavljanje migracije limfocita i krajnja klinička korisnost su nepoznati.
English: Re-testing of anti-JCV antibody negative patients every 6 months is recommended.
Croatian: Ponovno testiranje bolesnika negativnih na anti-JCV protutijela preporuča se svakih 6 mjeseci.
English: Persistent anti-natalizumab antibodies (one positive test reproducible on retesting at least 6 weeks later) developed in approximately 6% of patients.
Croatian: Perzistirajuća anti-natalizumab protutijela (pozitivan test na protutijela reproducibilan i kod ponovnog testiranja najmanje 6 tjedana kasnije) razvila su se u oko 6% bolesnika.
English: • Severe anaemia (decrease in your red blood cells which can make your skin pale and can make you feel breathless or lacking energy)
Croatian: • teška anemija (smanjenje broja crvenih krvnih stanica koje može uzrokovati bljedilo kože i osjećaj nedostatka zraka ili nedostatka energije)
English: • The symptoms of PML may be similar to an MS relapse (e.g. weakness or visual changes).
Croatian: • Simptomi PML-a mogu nalikovati relapsu MS (npr. slabost ili smetnje vida).
English: Anaphylactic/anaphylactoid reactions occurred in less than 1% of patients receiving TYSABRI.
Croatian: Anafilaktičke/anafilaktoidne reakcije javile su se u manje od 1% bolesnika koji su primali TYSABRI.
English: Anti-JCV antibody testing should not be performed during, or for at least two weeks following, plasma exchange due to the removal of antibodies from the serum.
Croatian: Testiranje na anti-JCV protutijela ne smije se provoditi za vrijeme ili najmanje tijekom naredna dva tjedna nakon izmjene plazme zbog odstranjivanja protutijela iz seruma.
English: However, if you experience dizziness, a common side effect, then you should not drive or use machines.
Croatian: Međutim, ako osjetite omaglicu, čestu nuspojavu, tada ne smijete upravljati vozilima ili strojevima.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with TYSABRI in one or more subsets of the paediatric population in multiple sclerosis (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove je odgodila obvezu podnošenja rezultata ispitivanja lijeka TYSABRI u jednoj ili više podskupina pedijatrijske populacije s multiplom sklerozom (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Body weight was found to influence clearance in a less-thanproportional manner, such that a 43% change in body weight resulted in a 31% to 34% change in clearance.
Croatian: Tjelesna težina utječe na klirens gotovo linearno, na način da je promjena tjelesne težine za 43% dovela do promjene klirensa za 31% do 34%.
English: This is because patients who received one or two doses of TYSABRI and then had a gap in treatment of three months or more, were more likely to have an allergic reaction when resuming treatment.
Croatian: To je zato što bolesnici, koji su primili jednu ili dvije doze TYSABRIJA i zatim imali razmak u liječenju od tri ili više mjeseci, imaju veću vjerojatnost dobiti alergijsku reakciju kod nastavka liječenja.
English: • Patient details, signature and date
Croatian: • Podatke o bolesniku, potpis i datum
English: • If you have an active cancer (unless it is a type of skin cancer called basal cell carcinoma).
Croatian: • ako imate aktivni tumor (osim ako se radio o vrsti tumora kože koji se zove karcinom bazalnih stanica).
English: TYSABRI can also have other side effects.
Croatian: TYSABRI može imati i druge nuspojave.
English: Tell your doctor immediately if you have, or think you have, any sort of infection (see side effects).
Croatian: Odmah obavijestite svog liječnika ako imate ili mislite da imate bilo kakvu vrstu infekcije (vidjeti nuspojave).
English: Each vial is for single-use only.
Croatian: Svaka bočica namijenjena je za jednokratnu uporabu.
English: The risk of PML with TYSABRI is higher:
Croatian: Rizik za PML kod liječenja TYSABRIJEM je veći:
English: The risk for hypersensitivity was greatest with early infusions and in patients re-exposed to TYSABRI following an initial short exposure (one or two infusions) and extended period (three months or more) without treatment.
Croatian: Rizik od preosjetljivosti je bio najveći kod početnih infuzija i kod bolesnika ponovno izloženih TYSABRIJU nakon početne kratke izloženosti (jedna ili dvije infuzije) i produženog perioda (tri mjeseca ili više) bez liječenja.
English: Data on the safety and efficacy of natalizumab at 2 years were generated from controlled, doubleblind studies.
Croatian: Podaci o sigurnosti i djelotvornosti natalizumaba prikupljeni su iz dvogodišnjih kontroliranih dvostruko slijepih ispitivanja.
English: Anaemia and haemolytic anaemia
Croatian: Anemija i hemolitička anemija
English: • Unusual infections (so-called “Opportunistic infections”)
Croatian: • neuobičajene infekcije (tzv. “oportunističke infekcije”)
English: These reactions usually occurred during the infusion or up to 1 hour after completion of the infusion.
Croatian: Te reakcije uglavnom su se javljale tijekom infuzije ili do 1 sat nakon završetka infuzije.
English: PML is associated with an uncontrolled increase of the JC virus in the brain, although the reason for this increase in some patients treated with TYSABRI is unknown.
Croatian: PML je povezana s nekontroliranim povećanjem broja JC virusa u mozgu, iako je razlog za to povećanje u nekih bolesnika liječenih TYSABRIJEM nepoznat.
English: After dilution (see section 6.6), the infusion is to be administered over approximately 1 hour and patients are to be observed during the infusion and for 1 hour after the completion of the infusion for signs and symptoms of hypersensitivity reactions.
Croatian: Nakon razrjeđivanja (vidjeti dio 6.6), infuziju treba primijeniti u trajanju od približno 1 sata, a bolesnike treba pratiti tijekom infuzije i 1 sat nakon završetka infuzije s obzirom na pojavu znakova i simptoma reakcija preosjetljivosti.
English: Infections including other opportunistic infections
Croatian: Infekcije uključujući druge oportunističke infekcije
English: Symptoms might arise that you might not become aware of by yourself, such as changes in mood or behaviour, memory lapses, speech and communication difficulties, which your doctor may need to investigate further to rule out PML.
Croatian: Mogu se javiti simptomi kojih sami niste svjesni, kao što su promjene raspoloženja ili ponašanja, smetnje pamćenja, problemi u govoru i komunikaciji, koje liječnik mora dodatno ispitati kako bi isključio sumnju na PML.
English: A “non-responder” could also be defined as a patient with an unchanged or increased relapse rate or ongoing severe relapses, as compared to the previous year.
Croatian: Bolesnika koji nije odgovorio na terapiju također je moguće definirati kao bolesnika sa nepromijenjenom ili povećanom stopom relapsa ili s teškim relapsima koji su u tijeku, u usporedbi s proteklom godinom.
English: The interaction between α4β1 and its targets is an important component of pathological inflammation in the brain and disruption of these interactions leads to reduced inflammation.
Croatian: Interakcija između α4β1 i njegovih meta važan je dio patološke upale u mozgu i prekidom ovih interakcija dolazi do smanjenja upale.
English: Do not use this medicine after the expiry date stated on the label and carton.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici i kutiji.
English: Following reconstitution of the immune system in immunocompromised patients with PML improved outcome has been seen.
Croatian: Nakon obnavljanja imunološkog sustava u imunokompromitiranih bolesnika s PML-om primijećen je poboljšani ishod bolesti.
English: For the estimation of PML risk in the different patient subgroups, please refer to the Physician Information and Management Guidelines.
Croatian: Za procjenu PML rizika u različitih podskupina bolesnika, molimo pogledajte Informaciju za liječnike i Smjernice za liječenje.
English: To be taken into consideration by patients on a controlled sodium diet.
Croatian: To treba uzeti u obzir kod bolesnika na dijeti s kontroliranim natrijem.
English: No case of overdose has been reported.
Croatian: Nije zabilježen slučaj predoziranja.
English: If PML or JCV GCN is suspected, further dosing must be suspended until PML has been excluded.
Croatian: Ako se sumnja na PML ili JCV GCN, mora se prekinuti daljnje doziranje sve dok nije otklonjena sumnja na PML.
English: It is given as a drip into a vein (by intravenous infusion), usually in your arm.
Croatian: Daje se putem infuzije u venu (drip), uglavnom u ruku.
English: TYSABRI stops the cells that cause inflammation from going into your brain.
Croatian: TYSABRI sprječava da stanice koje uzrokuju upalu uđu u Vaš mozak.
English: IRIS is thought to result from the restoration of immune function in patients with PML, which can lead to serious neurological complications and may be fatal.
Croatian: Misli se da je IRIS rezultat ponovne uspostave imunološke funkcije u bolesnika sa PML-om, što može dovesti do ozbiljnih neuroloških komplikacija i može biti smrtonosno.
English: Keep the vial in the outer carton in order to protect from light.
Croatian: Čuvati bočicu u vanjskoj kutiji radi zaštite od svjetlosti.
English: Do not use if it is discoloured or if foreign particles are seen.
Croatian: Nemojte ga upotrijebiti ako je boja promijenjena ili ako su vidljive čestice.
English: This was the result of a high incidence of abortions in treated groups in the first cohort that was not observed in the second cohort.
Croatian: To je bio rezultat visoke incidencije pobačaja u prvoj skupini majmuna koji su primali lijek, a koja nije primijećena u drugoj skupini.
English: These symptoms may be caused by an infection of the brain (encephalitis) or its covering layer (meningitis).
Croatian: Ove simptome može uzrokovati infekcija mozga (encefalitis) ili njegove ovojnice (meningitis).
English: If herpes encephalitis or meningitis occurs, the medicinal product should be discontinued, and appropriate treatment for herpes encephalitis or meningitis should be administered.
Croatian: Ako se pojave herpesni encefalitis ili meningitis, liječenje treba prekinuti i provesti odgovarajuće liječenje herpesnog encefalitisa ili meningitisa.
English: Data from clinical trials, a prospective pregnancy registry, post-marketing cases and available literature do not suggest an effect of TYSABRI exposure on pregnancy outcomes.
Croatian: Podaci iz kliničkih ispitivanja, registra za prospektivno praćenje trudnoća, slučajeva nakon stavljanja lijeka u promet i dostupne literature ne ukazuju da izloženost TYSABRIJU ima učinak na ishod trudnoće.
English: Patients with increased risk for opportunistic infections, including immunocompromised patients (including those currently receiving immunosuppressive therapies or those immunocompromised by prior therapies, e.g. mitoxantrone or cyclophosphamide, see also sections 4.4 and 4.8).
Croatian: Bolesnici s povećanim rizikom od oportunističkih infekcija, uključujući imunokompromitirane bolesnike (uključujući bolesnike koji trenutno primaju terapiju imunosupresivima ili koji su imunokompromitirani uslijed prethodnih terapija, npr. mitoksantronom ili ciklofosfamidom, vidjeti također dijelove 4.4 i 4.8).
English: Before initiation of treatment with TYSABRI, a recent (usually within 3 months) MRI should be available as a reference, and be repeated at least on a yearly basis.
Croatian: Prije početka liječenja TYSABRIJEM, mora biti dostupan nedavni (obično unutar 3 mjeseca) MR kao referentni nalaz, koji treba ponavljati barem jednom godišnje.
English: All physicians who intend to prescribe TYSABRI must ensure they are familiar with the Physician Information and Management Guidelines.
Croatian: Svi kliničari koji namjeravaju propisati TYSABRI, moraju dobro poznavati Informaciju za liječnike i Smjernice za liječenje.
English: MRI (0-2 years) Median % change in T2hyperintense lesion volume
Croatian: Magnetska rezonanca (0-2 godine) Medijan % promjene volumena hiperintenzivnih lezija T2
English: 15 ml concentrate in a vial (type I glass) with a stopper (bromobutyl rubber) and a seal (aluminium) with a flip-off cap.
Croatian: 15 ml koncentrata u bočici (staklo tipa I) s čepom (od bromobutilne gume) i zatvaračem (od aluminija) s ‘flip-off' kapicom.
English: • Confirmation that the doctor has discussed the risks of PML and the risk of IRIS if treatment is discontinued following suspicion of PML
Croatian: • Potvrdu da je liječnik razgovarao o riziku za PML i riziku za IRIS ako se liječenje prekine nakon sumnje na PML
English: A population pharmacokinetics analysis was conducted on samples from over 1,100 MS patients receiving doses ranging from 3 to 6 mg/kg natalizumab.
Croatian: Analiza populacijske farmakokinetike provedena je na uzorcima od preko 1100 bolesnika s multiplom sklerozom koji su primali doze u rasponu od 3 do 6 mg/kg natalizumaba.
English: • The presence of anti-JCV antibodies.
Croatian: • Prisustvo anti-JCV protutijela.
English: 4.5 Interaction with other medicinal products and other forms of interaction TYSABRI is contraindicated in combination with beta-interferons or glatiramer acetate (see section
Croatian: 4.5 Interakcije s drugim lijekovima i drugi oblici interakcija TYSABRI je kontraindiciran u kombinaciji s interferonima beta ili glatiramer acetatom (vidjeti dio
English: If a decision is made to stop treatment with natalizumab, the physician needs to be aware that natalizumab remains in the blood, and has pharmacodynamic effects (e.g increased lymphocyte counts) for approximately 12 weeks following the last dose.
Croatian: Ako se donese odluka o prekidu liječenja natalizumabom, liječnik treba biti svjestan toga da natalizumab ostaje u krvi i ispoljava farmakodinamski učinak (npr. povećan broj limfocita) tijekom približno 12 tjedana nakon zadnje doze.
English: Any unused medicinal product or waste material must be disposed of in accordance with local requirements.
Croatian: Neiskorišteni lijek ili otpadni materijal valja zbrinuti sukladno lokalnim propisima.
English: • If you do not have antibodies to the JC virus in your blood OR
Croatian: • Ako nemate protutijela na JC virus u krvi ILI
English: Once the clinician has excluded PML and/or JCV GCN (if necessary, by repeating clinical, imaging and/or laboratory investigations if clinical suspicion remains), dosing of TYSABRI may resume.
Croatian: Nakon što je liječnik isključio PML i/ili JCV GCN (ako je to potrebno, ponovljenim kliničkim, slikovnim i/ili laboratorijskim pretragama u slučaju da ostaje klinička sumnja), primjena TYSABRIJA može se nastaviti.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/06/346/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/06/346/001
English: Continued therapy must be carefully reconsidered in patients who show no evidence of therapeutic benefit beyond 6 months
Croatian: Nastavak liječenja treba pažljivo razmotriti u bolesnika u kojih nije vidljivo poboljšanje nakon liječenja u trajanju od 6 mjeseci.
English: • TYSABRI must be diluted before it is given to you.
Croatian: • TYSABRI se mora razrijediti prije primjene.
English: Care should be taken with patients who have previously received immunosuppressants to allow sufficient time for immune function recovery to occur.
Croatian: Pažnja je potrebna u bolesnika koji su prethodno primali imunosupresive jer treba proći dovoljno vremena da se ponovno uspostavi normalna imunološka funkcija.
English: • If your doctor tells you that you have a serious problem with your immune system (due to disease for example, HIV or due to a medicine you are taking or have previously taken, e.g. mitoxantrone or cyclophosphamide).
Croatian: • ako Vam liječnik kaže da imate ozbiljne probleme s imunološkim sustavom (zbog bolesti npr. HIV-a ili zbog lijeka kojeg primjenjujete ili ste prethodno primjenjivali, npr. mitoksantron, ciklofosfamid).
English: • Date treatment started
Croatian: • Datum početka liječenja
English: Starting other therapies during this interval will result in a concomitant exposure to natalizumab.
Croatian: Započinjanje druge terapije u ovom razdoblju će stoga dovesti do istovremene izloženosti natalizumabu.
English: Proportion progressed1(12-week confirmation; primary outcome)
Croatian: Udio progresije bolesti1 (potvrđeno nakon 12 tjedana; primarni ishod)
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of concentrate contains 20 mg of natalizumab.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedan ml koncentrata sadrži 20 mg natalizumaba.
English: In cynomolgus monkeys treated with natalizumab until parturition, low levels of natalizumab were detected in the breast milk of some animals.
Croatian: U majmuna cynomolgus koji su primali natalizumab sve do poroda, niske razine natalizumaba pronađene su u majčinom mlijeku nekih životinja.
English: Your doctor may repeat this blood test while you are on TYSABRI treatment to check if anything has changed.
Croatian: Vaš liječnik može ponoviti ovaj krvni test dok ste na liječenju TYSABRIJEM radi provjere da se što nije promijenilo.
English: The duration of treatment with TYSABRI prior to onset ranged from a few months to several years (see section 4.4).
Croatian: Liječenje TYSABRIJEM prije pojave te bolesti trajalo je nekoliko mjeseci do nekoliko godina (vidjeti dio 4.4).
English: Patients are to be observed during the infusion and for 1 hour after the completion of the infusion (see section 4.8).
Croatian: Bolesnike treba promatrati tijekom infuzije i sat vremena nakon infuzije (vidjeti dio 4.8).
English: Symptoms can include; walking problems, numbness in the face, arms or legs, problems seeing things, tiredness, feeling off-balance or light headed, bladder and bowel problems, difficulty in thinking and concentrating, depression, acute or chronic pain, sexual problems, and stiffness and muscle spasms.
Croatian: Simptomi mogu uključivati; poteškoće u hodanju, obamrlost lica, ruku ili nogu, problemi s vidom, umor, osjećaj neravnoteže ili vrtoglavice, problemi s mjehurom i crijevima, poteškoće u razmišljanju i koncentraciji, depresija, akutna ili kronična bol, seksualni problemi te ukočenost i grčevi mišića.
English: Short courses of corticosteroids can be used in combination with TYSABRI.
Croatian: Kratkotrajna primjena kortikosteroida stoga se može koristiti u kombinaciji s TYSABRIJEM.