FrancophonIA/ELRC3.0 huggingface dataset:
English: In post-marketing experience, there have also been reports of eosinophilia (eosinophil count >1,500/mm3) without clinical symptoms.
Croatian: Nakon stavljanja lijeka u promet, također su zabilježene pojave eozinofilije (broj eozinofila >1500/mm3) bez kliničkih simptoma.
English: Your doctor may test your blood to check if you have antibodies to the JC virus before you start treatment with TYSABRI.
Croatian: Liječnik može obaviti analizu krvi kako bi provjerio imate li protutijela na JC virus prije nego počne liječenje TYSABRIJEM.
English: Known active malignancies, except for patients with cutaneous basal cell carcinoma.
Croatian: Poznate aktivne zloćudne bolesti, izuzev bolesnika s karcinomom bazalnih stanica kože.
English: • If you have been treated for more than 2 years and you have a lower level of JCV antibodies in your blood.
Croatian: • Ako ste liječeni dulje od 2 godine, a imate nižu razinu protutijela na JC virus u krvi.
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 MS-a.
English: TYSABRI increases the risk of developing encephalitis and meningitis caused by herpes simplex and varicella zoster viruses.
Croatian: TYSABRI povećava rizik od razvoja encefalitisa i meningitisa uzrokovanih herpes simplex i varicella zoster virusima.
English: The analysis explored the effects of selected covariates including body weight, age, gender, hepatic and renal function, and presence of anti-natalizumab antibodies upon pharmacokinetics.
Croatian: Analizom je ispitan utjecaj odabranih kovarijabli poput tjelesne težine, dobi, spola, jetrene i bubrežne funkcije te prisustva anti-natalizumab protutijela na farmakokinetiku.
English: Side effects are listed below by how commonly they have been reported in clinical trials:
Croatian: Nuspojave su navedene niže s obzirom na njihovu učestalost tijekom kliničkih ispitivanja:
English: The Marketing Authorisation Holder must, following discussions and agreement with the National Competent Authorities in each Member State where TYSABRI is marketed, ensure that all physicians who intend to prescribe TYSABRI are provided with a physician pack containing the following elements:
Croatian: Nositelj odobrenja za stavljanje lijeka u promet mora nakon rasprave i dogovora s nacionalnim regulatornim tijelom svake države članice na čijem se tržištu TYSABRI nalazi, osigurati da svi liječnici koji namjeravaju propisati TYSABRI dobiju komplet za liječnika koji sadrži sljedeće elemente: • Sažetak opisa svojstava lijeka i Uputu o lijeku
English: After 2 years all patients should be re-informed about the risk of PML with TYSABRI.
Croatian: Nakon 2 godine sve bolesnike treba ponovno informirati o riziku od PML-a kod primjene TYSABRIJA.
English: • You may not be able to use TYSABRI if you are currently receiving or have previously received medicines that affect your immune system, e.g. mitoxantrone or cyclophosphamide.
Croatian: • Možda nećete moći primijeniti TYSABRI ako trenutno primate ili ste prethodno primali lijekove koji djeluju na Vaš imunološki sustav, npr. mitoksantron ili ciklofosfamid.
English: Pharmacotherapeutic group: Selective immunosuppressive agents, ATC code: L04AA23 Pharmacodynamic effects
Croatian: Farmakoterapijska skupina: Selektivni imunosupresivi, ATK oznaka: L04AA23
English: If you have previously not been treated with immunosuppressants and have received TYSABRI for 2 years or longer, the level of your anti-JCV antibody response may be associated with the risk of getting PML.
Croatian: Ako prethodno niste bili liječeni imunosupresivima, a primali ste TYSABRI 2 ili više godina, razina Vašeg odgovora protutijela na JC virus može biti povezana s rizikom od dobivanja PML-a.
English: What you need to know before you use TYSABRI
Croatian: Što morate znati prije nego počnete primjenjivati TYSABRI
English: Frequencies were defined as follows:
Croatian: Učestalost je definirana kao:
English: The physician should be particularly alert to symptoms suggestive of PML or JCV GCN that the patient may not notice (e.g. cognitive, psychiatric symptoms or cerebellar syndrome).
Croatian: Kliničar treba osobito obratiti pažnju na simptome koji navode na PML ili JCV GCN a koje bolesnik ne primjećuje (npr. kognitivni, psihijatrijski simptomi ili cerebelarni sindrom).
English: If the diluted medicinal product is stored at 2°C - 8°C (do not freeze), allow the solution to warm to room temperature prior to infusion.
Croatian: Ako je razrijeđeni lijek pohranjen na 2°C - 8°C (ne zamrzavati), ostavite otopinu da se zagrije do sobne temperature prije infuzije.
English: Increases from baseline for lymphocytes, monocytes, eosinophils and basophils ranged from 35% to 140% for individual cell types but mean cell counts remained within normal ranges.
Croatian: monocita, eozinofila i bazofila kretalo se u rasponu od 35% do 140% za pojedine vrste stanica, ali je srednji broj stanica ostao u normalnim okvirima.
English: There are no studies on the effects of TYSABRI on the ability to drive and use machines.
Croatian: Ne postoje ispitivanja učinaka TYSABRIJA na sposobnost upravljanja vozilima i strojevima.
English: In a few patients who use TYSABRI, over time the body's natural defence may stop TYSABRI from working properly (the body develops antibodies to TYSABRI).
Croatian: U nekoliko bolesnika koji primjenjuju TYSABRI prirodni tjelesni obrambeni mehanizam može s vremenom zaustaviti djelovanje TYSABRIJA (tijelo stvara protutijela na TYSABRI).
English: PML should be considered as a differential diagnosis in any MS patient taking TYSABRI presenting with neurological symptoms and/or new brain lesions in MRI.
Croatian: PML treba razmotriti kao diferencijalnu dijagnozu u svakog bolesnika s MS-om koji uzima TYSABRI i prezentira neurološke simptomime i/ili nove moždane lezije na MR-u.
English: Biogen Idec Limited, Innovation House, 70 Norden Road, Maidenhead, Berkshire,
Croatian: Biogen Idec Limited, Innovation House, 70 Norden Road, Maidenhead,
English: Only body weight and the presence of anti-natalizumab antibodies were found to influence natalizumab disposition.
Croatian: Utvrđeno je da samo tjelesna težina i prisustvo anti-natalizumab protutijela utječu na uklanjanje natalizumaba.
English: TYSABRI contains the active substance (natalizumab).
Croatian: TYSABRI sadrži djelatnu tvar (natalizumab).
English: Concurrent use of these agents with TYSABRI may increase the risk of infections, including opportunistic infections, and is contraindicated (see section 4.3).
Croatian: Istovremena primjena ovih lijekova s TYSABRIJEM može povećati rizik od infekcija, uključujući oportunističke infekcije, te je stoga kontraindicirana (vidjeti dio 4.3).
English: Cases of asymptomatic PML based on MRI and positive JCV DNA in the cerebrospinal fluid have been reported.
Croatian: Prijavljeni su slučajevi asimptomatskog PML-a na temelju MR-a i pozitivnog JCV DNK-a u cerebrospinalnoj tekućini.
English: Following the repeat intravenous administration of a 300 mg dose of natalizumab to MS patients, the mean maximum observed serum concentration was 110 ± 52 μg/ml.
Croatian: Nakon ponovljene intravenske primjene natalizumaba u dozi od 300 mg u bolesnika s multiplom sklerozom, srednja najveća opažena koncentracija u serumu iznosila je 110 ± 52 μg/ml.
English: Patients should be re-informed about the risk factors for PML, like duration of treatment, immunosuppressant use prior to receiving TYSABRI and the presence of antiJohn Cunningham virus (JCV) antibodies (see section 4.4.
Croatian: Bolesnike je potrebno ponovno uputiti u čimbenike rizika za PML, kao što je trajanje liječenja, liječenje imunosupresivima prije primanja TYSABRIJA i prisutnost protutijela na John Cunningham virus (JCV) (vidjeti dio 4.4.).
English: These medicinal products have the potential to cause prolonged immunosuppression, even after dosing is discontinued.
Croatian: Ti lijekovi mogu izazvati produljenu imunosupresiju, čak i nakon prestanka davanja lijeka.
English: In these cases the presence of antibodies should be evaluated and if these remain positive in a confirmatory test after at least 6 weeks, treatment should be discontinued, as persistent antibodies are associated with a substantial decrease in efficacy of TYSABRI and an increased incidence of hypersensitivity reactions (see section 4.8).
Croatian: U tim slučajevima treba ispitati prisutnost protutijela te ako je test na protutijela i dalje pozitivan nakon barem 6 tjedana, liječenje treba prekinuti, jer su perzistirajuća protutijela povezana sa značajnim smanjenjem djelotvornosti TYSABRIJA i povećanom incidencijom reakcija preosjetljivosti (vidjeti dio 4.8).
English: For instructions on dilution of the medicinal product before administration, see section 6.6.
Croatian: Za uputu o razrjeđivanju lijeka prije primjene, vidjeti dio 6.6.
English: These patients may be defined as those who have failed to respond to a full and adequate course (normally at least one year of treatment) of beta-interferon or glatiramer acetate.
Croatian: Te bolesnike je moguće odrediti kao bolesnike koji ne odgovaraju na cjelovito i odgovarajuće liječenje interferonom beta ili glatiramer acetatom (obično najmanje jednu godinu liječenja).
English: The symptoms of MS vary from patient to patient, and you may experience some or none of them.
Croatian: Simptomi MS razlikuju se od bolesnika do bolesnika, a u Vas se mogu javiti neki od simptoma ili niti jedan.
English: PML is a rare infection of the brain.
Croatian: je rijetka infekcija mozga.
English: Hypersensitivity to natalizumab or to any of the excipients listed in section 6.1.
Croatian: Preosjetljivost na natalizumab ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: IRIS occurs in almost all TYSABRI PML patients after withdrawal or removal of the medicinal product, e.g. by plasma exchange (see section 5.2).
Croatian: IRIS se pojavljuje kod gotovo svih bolesnika liječenih TYSABRIJEM sa PML-om nakon ukidanja ili uklanjanja lijeka, npr. izmjenom plazme (vidjeti dio 5.2).
English: If there are signs of treatment-related abnormalities these must return to normal before treatment with natalizumab is started.
Croatian: Ako postoje znakovi abnormalnosti vezani uz liječenje, treba ih ukloniti prije početka liječenja natalizumabom.
English: A benefit-risk evaluation of the use of TYSABRI during pregnancy should take into account the patient's clinical condition and the possible return of disease activity after stopping the medicinal product.
Croatian: Prilikom procjene omjera koristi i rizika primjene TYSABRIJA tijekom trudnoće treba uzeti u obzir kliničko stanje bolesnice i mogući povratak aktivnosti bolesti nakon prekida primjene lijeka.
English: • Adult patients aged 18 years and over with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more Gadolinium enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI.
Croatian: • Odrasli bolesnici od 18 godina starosti i stariji s teškom brzonapredujućom relapsno remitentnom multiplom sklerozom definiranom s 2 ili više onesposobljavajućih relapsa u jednoj godini i s 1 ili više lezija utvrđenih gadolinijem na magnetskoj rezonanci mozga ili sa značajnim povećanjem opterećenja T2 lezijama u odnosu na prethodnu magnetsku rezonancu.
English: Natalizumab is a recombinant humanised anti-α4-integrin antibody produced in a murine cell line by recombinant DNA technology.
Croatian: Natalizumab je rekombinantno humanizirano anti-α4-integrin protutijelo proizvedeno u mišjoj staničnoj liniji tehnologijom rekombinantne DNK.
English: In some instances, the reaction reoccurred when TYSABRI was reintroduced.
Croatian: U nekim slučajevima, reakcija se može ponovo pojaviti kod ponovljene primjene TYSABRIJA.
English: • Adult patients aged 18 years and over with high disease activity despite treatment with a betainterferon or glatiramer acetate.
Croatian: • Odrasli bolesnici od 18 godina starosti i stariji kod kojih je bolest jako aktivna usprkos liječenju interferonom beta ili glatiramer acetatom.
English: Combination with beta-interferons or glatiramer acetate.
Croatian: Kombinacija s interferonima beta ili glatiramer acetatom.
English: In 2-year controlled clinical trials in MS patients, hypersensitivity reactions occurred in up to 4% of patients.
Croatian: U dvogodišnjim kontroliranim kliničkim ispitivanjima na bolesnicima s multiplom sklerozom reakcije preosjetljivosti javile su se u do 4% bolesnika.
English: However, given that dizziness has been commonly reported, patients who experience this adverse reaction should be advised not to drive or use machines until it has resolved.
Croatian: Međutim, uzevši u obzir često zabilježenu omaglicu, bolesnicima koje osjete ovu nuspojavu treba savjetovati da ne upravljaju vozilima niti rade na strojevima dok te smetnje ne prestanu.
English: The MAH shall implement agreed measures for monitoring within a time frame agreed with the National Competent Authorities.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet će primijeniti dogovorene mjere za praćenje u roku dogovorenom s nacionalnim regulatornim tijelom.
English: Persistent antibodies were associated with a substantial decrease in the effectiveness of TYSABRI and an increased incidence of hypersensitivity reactions.
Croatian: Perzistirajuća protutijela dovedena su u svezu sa značajnim smanjenjem djelotvornosti TYSABRIJA i povećanom incidencijom reakcija preosjetljivosti.
English: Natalizumab is a selective adhesion-molecule inhibitor and binds to the α4-subunit of human integrins, which is highly expressed on the surface of all leukocytes, with the exception of neutrophils.
Croatian: Natalizumab selektivno inhibira adhezijske molekule vezanjem za α4-podjedinicu ljudskih integrina, koja je izrazito prisutna na površini svih leukocita osim neutrofila.
English: Do not use this medicine if you notice particles in the liquid and/or the liquid in the vial is discoloured.
Croatian: Ovaj lijek se ne smije upotrijebiti ako primijetite čestice u tekućini i/ili ako je tekućina u bočici promijenila boju.
English: The anti-JCV antibody assay (ELISA) should not be used to diagnose PML.
Croatian: Test na anti-JCV protutijela (ELISA) ne smije se koristiti za dijagnosticiranje PML-a.
English: The diluted medicinal product is to be used as soon as possible and within 8 hours of dilution.
Croatian: Razrijeđeni lijek trebate upotrijebiti što prije i unutar 8 sati nakon razrjeđivanja.
English: Hypersensitivity reactions usually occurred during the infusion or within the 1-hour period after the completion of the infusion (See section 4.4).
Croatian: Reakcije preosjetljivosti uglavnom su se javile tijekom infuzije ili tijekom prvog sata po završetku infuzije (vidjeti dio 4.4).
English: Anti-JCV antibody negative patients may still be at risk of PML for reasons such as a new JCV infection, fluctuating antibody status or a false negative test result.
Croatian: U bolesnika negativnih na anti-JCV protutijela još uvijek može postojati rizik za nastanak PML-a zbog razloga kao što su nova JCV infekcija, promjenjivi status protutijela ili lažno negativni rezultat testa.
English: • Information on PML and IRIS including the risk of developing PML during TYSABRI treatment stratified by prior treatment with immunosuppressants and JC virus infection.
Croatian: • Informacije o PML-u i IRIS-u, uključujući rizik od pojave PML-a tijekom liječenja TYSABRIJEM stratificiran prema prethodnom liječenju imunosupresivima i infekciji JC virusom.
English: No clastogenic or mutagenic effects of natalizumab were observed in the Ames or human chromosomal aberration assays.
Croatian: Klastogeni ili mutageni učinci natalizumaba nisu primijećeni u Amesovom testu ili testovima ljudskih kromosomskih aberacija.
English: Patients can switch directly from beta interferon or glatiramer acetate to natalizumab providing there are no signs of relevant treatment-related abnormalities e.g. neutropenia.
Croatian: Bolesnici mogu izravno prijeći s interferona beta ili glatiramer acetata na natalizumab, uz uvjet da nema znakova značajnih abnormalnosti vezanih uz liječenje, poput neutropenije.
English: If particles are observed and/or the liquid in the vial is not colourless, clear to slightly opalescent, the vial must not be used.
Croatian: Ako primijetite čestice i/ili ako tekućina u bočici nije bezbojna i bistra do blago opalescentna, bočicu ne smijete upotrijebiti.
English: • You must not use TYSABRI if you are being treated with other medicines to treat your MS, such as beta-interferons or glatiramer acetate.
Croatian: • TYSABRI ne smijete primati ako se liječite drugim lijekovima za liječenje MS, poput interferona beta ili glatiramer acetata.
English: In a randomised, open label study of 60 patients with relapsing MS there was no significant difference in the humoral immune response to a recall antigen (tetanus toxoid) and only slightly slower and reduced humoral immune response to a neoantigen (keyhole limpet haemocyanin) was observed in patients who were treated with TYSABRI for 6 months compared to an untreated control group.
Croatian: U randomiziranom, otvorenom ispitivanju na 60 bolesnika s relapsnom multiplom sklerozom nije opažena značajna razlika između humoralne imunološke reakcije na tetanusni toksoid (recall antigen) i tek malo sporije i smanjene humoralne imunološke reakcije na neoantigen (hemocijanin iz morskih puževa) u bolesnika koji su liječeni TYSABRIJEM tijekom 6 mjeseci u usporedbi s neliječenom kontrolnom skupinom.
English: The mechanism for elimination and results from population pharmacokinetics suggest that dose adjustment would not be necessary in patients with renal or hepatic impairment.
Croatian: Na osnovi mehanizma eliminacije i rezultata populacijske farmakokinetike može se zaključiti da za bolesnike s oštećenjem bubrega ili jetre nije neophodno prilagoditi dozu.
English: Mean number of new or newlyenlarging T2-hyperintense lesions
Croatian: Srednji broj novih ili novorastućih hiperintenzivnih lezija T2
English: Use of these medicinal products soon after the discontinuation of natalizumab may lead to an additive immunosuppressive effect.
Croatian: Primjena ovih lijekova netom nakon prestanka primjene natalizumaba može dovesti do dodatne imunosupresije.
English: If, after approximately 6 months of therapy, persistent antibodies are suspected, either due to reduced efficacy or due to occurrence of infusion-related events, they may be detected and confirmed with a subsequent test 6 weeks after the first positive test.
Croatian: Ako se nakon otprilike 6 mjeseci liječenja posumnja na perzistirajuća protutijela na osnovi smanjene djelotvornosti ili pojave reakcija vezanih za infuziju, protutijela se mogu otkriti i potvrditi daljnjim testiranjem 6 tjedana nakon prvog pozitivnog testa.
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: Ovisno o tome kako se na nacionalnoj razini prate bolesnici koji se trenutno liječe TYSABRIJEM, 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: 1 Progression of disability was defined as at least a 1.0 point increase on the EDSS from a baseline EDSS >=1.0 sustained for 12 or 24 weeks or at least a 1.5 point increase on the EDSS from a baseline EDSS =0 sustained for 12 or 24 weeks.
Croatian: 1 Progresija onesposobljenosti određena je kao povećanje za najmanje 1,0 vrijednost EDSS od početne vrijednosti EDSS >=1,0 u trajanju barem 12 ili 24 tjedna ili kao povećanje za najmanje 1,5 vrijednosti
English: Patients should be monitored as appropriate for impaired liver function, and be instructed to contact their physician in case signs and symptoms suggestive of liver injury occur, such as jaundice and vomiting.
Croatian: Bolesnike je potrebno pratiti kako bi se otkrili znakovi oštećenja jetrene funkcije te ih uputiti da se obrate svom liječniku u slučaju da se pojave znakovi i simptomi koji upućuju na oštećenje jetre, kao što su žutica i povraćanje.
English: Keep the leaflet and Alert Card with you during treatment and for six months after the last dose of TYSABRI, since side effects may occur even after you have stopped treatment.
Croatian: Nosite uz sebe Uputu i Karticu s upozorenjima za bolesnika tijekom liječenja te još šest mjeseci nakon zadnje doze TYSABRIJA, budući se nuspojave mogu javiti i nakon što ste prekinuli liječenje.
English: • Difficulty breathing
Croatian: • otežano disanje
English: In one study in guinea pigs, a small reduction in pup survival was noted.
Croatian: U jednom ispitivanju na zamorcima zabilježeno je malo smanjenje preživljenja mladunčadi.
English: Since patients who have received an initial short exposure to TYSABRI and then had an extended period without treatment are at a higher risk of developing anti-natalizumab antibodies and/or hypersensitivity upon redosing, the presence of antibodies should be evaluated and if these remain positive in a confirmatory test after at least 6 weeks, the patient should not receive further treatment with TYSABRI.
Croatian: Budući da bolesnici, koji su na početku bili kratko izloženi TYSABRIJU a nakon toga imali produženi period bez liječenja, imaju povećani rizik od razvoja protutijela na natalizumab i/ili preosjetljivosti uslijed ponovnog liječenja, mora se ispitati prisutnost protutijela, a ako je test i dalje pozitivan nakon barem 6 tjedana, bolesnik ne smije primiti daljnje liječenje TYSABRIJEM.
English: Elevations in neutrophils were not seen.
Croatian: Povećanje neutrofila nije primijećeno.
English: Retesting low index patients who have no history of prior immunosuppressant use every 6 months once they reach the 2 year treatment point is recommended.
Croatian: Kod bolesnika s niskim indeksom koji u anamnezi nemaju prethodno liječenje imuosupresivima, preporuča se testiranje svakih 6 mjeseci jednom kad dostignu 2 godine liječenja.
English: Gently invert the TYSABRI solution to mix completely.
Croatian: Nježno preokrenite TYSABRI da se potpuno izmiješa.
English: The presence of persistent antinatalizumab antibodies increased natalizumab clearance approximately 3-fold, consistent with reduced serum natalizumab concentrations observed in persistently antibody-positive patients, (see section 4.8).
Croatian: Prisustvo perzistirajućih antinatalizumab protutijela povećalo je klirens natalizumaba oko 3 puta, što je u skladu sa smanjenim koncentracijama natalizumaba u serumu primijećenim u bolesnika koji pokazuju trajno prisustvo protutijela (vidjeti dio 4.8).
English: Disruption of these molecular interactions prevents transmigration of mononuclear leukocytes across the endothelium into inflamed parenchymal tissue.
Croatian: Prekid ovih molekulskih interakcija sprečava prijelaz mononuklearnih leukocita preko endotela uupaljeno tkivo parenhima.
English: The patients were randomised with a 2:1 ratio to receive TYSABRI 300 mg (n = 627) or placebo (n = 315) every 4 weeks for up to 30 infusions.
Croatian: Bolesnici su nasumično raspodijeljeni u omjeru 2:1 u skupinu koja je primala TYSABRI od 300 mg (n = 627) i skupinu koja je primala placebo (n = 315) svaka 4 tjedna do ukupno 30 infuzija.
English: In a study in monkeys, the number of abortions was doubled in the natalizumab 30 mg/kg treatment groups versus matching control groups.
Croatian: U ispitivanju na majmunima broj pobačaja bio je udvostručen u skupinama koje su primale 30 mg/kg natalizumaba u odnosu na kontrolne skupine.
English: Patients who are anti-JCV antibody positive are at an increased risk of developing PML compared to patients who are anti-JCV antibody negative.
Croatian: Bolesnici koji su pozitivni na anti-JCV protutijela imaju povećan rizik od razvoja PML-a u usporedbi s bolesnicima koji su negativni na anti-JCV protutijela.