FrancophonIA/ELRC3.0 huggingface dataset:
English: The pharmacokinetics of natalizumab in paediatric MS patients or in patients with renal or hepatic insufficiency has not been studied.
Croatian: Farmakokinetika natalizumaba u pedijatrijskih bolesnika s multiplom sklerozom ili u bolesnika s bubrežnom ili jetrenom insuficijencijom nije ispitana.
English: Sodium content in TYSABRI
Croatian: Sadržaj natrija u TYSABRIJU
English: However, in the presence of pro-inflammatory cytokines, VCAM-1 is upregulated on endothelial cells and possibly on glial cells near the sites of inflammation.
Croatian: Međutim, u prisustvu protuupalnih citokina, dolazi do ekspresije VCAM-1 na edotelnim stanicama, a možda i na glija stanicama blizu mjesta upale.
English: Spontaneous cases of serious liver injuries, increased liver enzymes, hyperbilirubinaemia have been reported during the post marketing phase (see section 4.4).
Croatian: Spontane nuspojave ozbiljnih oštećenja jetre, povišenih jetrenih enzima te hiperbilirubinemije bile su prijavljene nakon stavljanja lijeka u promet (vidjeti dio 4.4).
English: Use aseptic technique when preparing TYSABRI solution for intravenous infusion.
Croatian: Koristite aseptičku tehniku za pripremu otopine TYSABRIJA za intravensku (i.v.) infuziju.
English: In 2-year controlled clinical trials in MS patients, an infusion-related event was defined as an adverse event occurring during the infusion or within 1 hour of the completion of the infusion.
Croatian: U dvogodišnjim kontroliranim kliničkim ispitivanjima na bolesnicima s multiplom sklerozom, pojava vezana za infuziju određena je kao nuspojava koja se javlja tijekom infuzije ili do 1 sat po završetku infuzije.
English: Relapse rate
Croatian: Stopa relapsa
English: For further information on anti-JCV antibody testing please see Physician Information and Management Guidelines.
Croatian: Za više informacija o testiranju na anti-JCV protutijela molimo pogledajte Informacije za liječnike i
English: Patients should be instructed that if they develop any infection then they should inform their physician that they are being treated with TYSABRI.
Croatian: Bolesnike treba upozoriti da u slučaju pojave infekcije trebaju reći svom liječniku da primaju TYSABRI.
English: Relapse rate derived variables / MRI-derived variables
Croatian: Varijable dobivene na osnovi stope relapsa / varijable dobivene na osnovi magnetske rezonance
English: In 2-year controlled clinical trials in MS patients, the rate of infection was approximately 1.5 per patient-year in both natalizumab- and placebo-treated patients.
Croatian: U sklopu dvogodišnjih kontroliranih kliničkih ispitivanja na bolesnicima s multiplom sklerozom, stopa infekcija bila je oko 1,5 po bolesniku godišnje, kod bolesnika koji su primali natalizumab kao i kod onih koji su primali placebo.
English: Studies have not been conducted to examine the effects of renal or hepatic impairment.
Croatian: Studije ispitivanja koja bi provjerila učinke oštećenja bubrega ili jetre nisu provedene.
English: Immunisations
Croatian: Imunizacije
English: More frequent MRIs (e.g. on a 3 to 6 monthly basis) using an abbreviated protocol should be considered for patients at higher risk of PML.
Croatian: Treba uzeti u obzir češća MR snimanja (na primjer svakih 3 do 6 mjeseci) uz skraćeni protokol kod bolesnika s visokim rizikom od PML-a.
English: If not used immediately, the diluted solution must be stored at 2˚C - 8˚C and infused within 8 hours of dilution.
Croatian: Ako se ne primijeni odmah, razrijeđenu otopinu treba pohraniti na 2°C - 8°C i primijeniti infuzijom unutar 8 sati nakon razrjeđivanja.
English: Serious, life-threatening, and sometimes fatal cases have been reported in the postmarketing setting in multiple sclerosis patients receiving TYSABRI (see section 4.8).
Croatian: Ozbiljni, po život opasni, a ponekad i fatalni slučajevi prijavljeni su nakon stavljanja lijeka u promet u bolesnika sa multiplom sklerozom koji su primali TYSABRI (vidjeti dio 4.8).
English: • Patients who have all three risk factors for PML (i.e., are anti-JCV antibody positive and have received more than 2 years of TYSABRI therapy, and have received prior immunosuppressant therapy),
Croatian: • Bolesnike koji imaju sva tri čimbenika rizika za PML (tj. pozitivni su na anti-JCV protutijela i primali su terapiju TYSABRIJEM dulje od 2 godine i prethodno su primali imunosupresivnu terapiju),
English: Specifically, natalizumab binds to the α4β1 integrin, blocking the interaction with its cognate receptor, vascular cell adhesion molecule-1 (VCAM-1), and ligands osteopontin, and an alternatively spliced domain of fibronectin, connecting segment-1 (CS-1).
Croatian: Natalizumab se specifično veže za integrin α4β1 te time sprečava njegovu interakciju s receptorom, vaskularnom staničnom adhezijskom molekulom-1 (VCAM-1) i ligandima osteopontinom i veznim segmentom-1 (connecting segment-1,
English: A further mechanism of action of natalizumab may be to suppress ongoing inflammatory reactions in diseased tissues by inhibiting the interaction of α4-expressing leukocytes with their ligands in the extracellular matrix and on parenchymal cells.
Croatian: Daljnji mogući mehanizam djelovanja natalizumaba je sprečavanje upalnih reakcija u oboljelom tkivu inhibicijom interakcije između leukocita koji eksprimiraju α4 i njihovih liganada u izvanstaničnom matriksu i na stanicama parenhima.
English: Other medicines and TYSABRI Tell your doctor if you are taking or have recently taken or might take any other medicines.
Croatian: Obavijestite svog liječnika ako uzimate ili ste nedavno uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: • If you are taking either beta-interferon or glatiramer acetate.
Croatian: • ako primjenjujete bilo interferon beta ili glatiramer acetat.
English: A group of symptoms caused by a serious infection of the brain including: - Changes in personality and behaviour such as confusion, delirium or loss of consciousness, seizures (fits), headache, nausea / vomiting, stiff neck, extreme sensitivity to bright light, fever, rash (anywhere on the body).
Croatian: Promjene u osobnosti i ponašanju, kao što su: smetenost, delirij ili gubitak svijesti, epileptičke napadaje, glavobolju, mučninu / povraćanje, ukočenost vrata, izrazitu osjetljivost na jako svjetlo, vrućicu, osip (bilo gdje na tijelu).
English: The active substance is natalizumab.
Croatian: Djelatna tvar je natalizumab.
English: Some patients may have been exposed to immunosuppressive medicinal products (e.g. mitoxantrone, cyclophosphamide, azathioprine).
Croatian: Neki bolesnici su možda prethodno primali imunosupresive (npr. mitoksantron, ciklofosfamid,
English: RRMS (McDonald criteria)
Croatian: Relapsno-remitentna multipla skleroza (prema McDonaldovim kriterijima)
English: Progressive Multifocal Leukoencephalopathy (PML) Use of TYSABRI has been associated with an increased risk of PML, an opportunistic infection caused by JC virus, which may be fatal or result in severe disability.
Croatian: Primjena TYSABRIJA povezana je s povećanim rizikom od PML-a, oportunističke infekcije uzrokovane JC virusom, koja može biti smrtonosna ili može biti uzrokom teškog invaliditeta.
English: MRI evaluations for T1-weighted gadolinium (Gd)-enhancing lesions and T2-hyperintense lesions were performed annually.
Croatian: Magnetske rezonance za lezije T1 utvrđene gadolinijem (Gd) i za hiperintenzivne lezije T2
English: As such, natalizumab may act to suppress inflammatory activity present at the disease site, and inhibit further recruitment of immune cells into inflamed tissues.
Croatian: Natalizumab time može potisnuti upalni proces na oboljelom mjestu i inhibirati daljnji prodor imunih stanica u upaljena tkiva.
English: TYSABRI is indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following patient groups:
Croatian: 4.1 Terapijske indikacije TYSABRI je indiciran kao imunomodulacijska monoterapija za visoko aktivnu relapsno-remitentnu multiplu sklerozu kod sljedećih skupina bolesnika:
English: Concurrent or prior treatment with immunosuppressants
Croatian: Istovremeno ili prethodno liječenje imunosupresivima
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: How to use TYSABRI
Croatian: Kako primjenjivati TYSABRI
English: Cases of JCV GCN have also been reported during postmarketing use of TYSABRI.
Croatian: Slučajevi JCV GCN-a su također prijavljeni tijekom primjene TYSABRIJA nakon stavljanja lijeka u promet.
English: The symptoms of JCV GCN are similar to PML.
Croatian: Simptomi JCV GCN-a su slični PML-u.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Croatian: U sklopu svake kategorije učestalosti nuspojave su prikazane prema opadajućoj ozbiljnosti.
English: In MS, lesions are believed to occur when activated T-lymphocytes cross the blood-brain barrier (BBB).
Croatian: Smatra se da lezije kod multiple skleroze nastaju kada aktivirani T-limfociti prijeđu krvnomoždanu barijeru.
English: Rare side effects that may affect up to 1 in 1,000 people:
Croatian: Rijetke nuspojave koje se mogu javiti u manje od 1 na 1000 osoba:
English: You should discuss with your doctor whether you choose to breast-feed or to use TYSABRI.
Croatian: S liječnikom ćete odlučiti da li dojiti ili primjenjivati TYSABRI.
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 Diagnosis and prognosis of symptomatic and asymptomatic PML differentiation between PML and MS
Croatian: 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 Dijagnoza i prognoza simptomatskog i asimptomatskog PML-a diferencijacija između PML-a i multiple skleroze o Algoritam zbrinjavanja PML-a o Preporuka za snimanje bolesnika MR-om po sljedećem rasporedu:
English: Mean number of T1-hypointense lesions
Croatian: Srednji broj hipointenzivnih lezija T1
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.
Croatian: Kod bolesnika liječenih TYSABRIJEM koji su pozitivni na anti-JCV protutijela i koji nisu prethodno uzimali imunosupresive, razina odgovora (indeks) anti-JCV protutijela je povezana s razinom rizika od PML-a.
English: Physicians must discuss the benefits and risks of TYSABRI therapy with the patient and provide them with a Patient Alert Card.
Croatian: Liječnici moraju razgovarati s bolesnikom o koristima i rizicima terapije TYSABRIJEM te im dati Karticu s upozorenjem za bolesnika.
English: Current evidence suggests that the risk of PML is low at an index equal to or below 0.9 and increases substantially above 1.5 for patients who have been on treatment with TYSABRI for longer than 2 years (see the Physician Information and Management Guidelines for further information).
Croatian: Trenutni dokazi upućuju na to da je rizik od PML-a nizak ako je indeks jednak ili manji od 0,9 i znatno se povećava iznad 1,5 za bolesnike koji su bili na liječenju TYSABRIJEM dulje od 2 godine
English: o Infusion reactions o Hypersensitivity reactions o Antibody formation
Croatian: o Reakcije vezane za infuziju o Reakcije preosjetljivosti o Stvaranje protutijela
English: TYSABRI must not be mixed with other medicinal products or diluents.
Croatian: TYSABRI se ne smije miješati s drugim lijekovima ili otopinama za razrjeđivanje.
English: Natalizumab is excreted in human milk.
Croatian: Natalizumab se izlučuje u majčino mlijeko.
English: • Immunosuppressant use prior to receiving TYSABRI.
Croatian: • Liječenje imunosupresivima prije primanja TYSABRIJA.
English: In cases of significant liver injury TYSABRI should be discontinued.
Croatian: slučajevima značajne ozljede jetre potrebno je prekinuti terapiju TYSABRIJEM.
English: • Sore throat and runny or blocked up nose
Croatian: • grlobolja i nos koji curi ili je začepljen
English: TYSABRI contains sodium
Croatian: TYSABRI sadrži natrij
English: No studies on the effects on the ability to drive and use machines have been performed with TYSABRI.
Croatian: Ispitivanja o utjecaju TYSABRIJA na sposobnost upravljanja vozilima i rada sa strojevima nisu provedene.
English: Progressive multifocal leukoencephalopathy (PML).
Croatian: Progresivna multifokalna leukoencefalopatija (PML).
English: PHARMACEUTICAL FORM Concentrate for solution for infusion.
Croatian: OBLIK Koncentrat za otopinu za infuziju.
English: Immunosuppressant treatment prior to the use of TYSABRI
Croatian: Liječenje imunosupresivima prije primjene TYSABRIJA
English: • Prescriber name, signature and date
Croatian: • Podatke o liječniku koji je lijek propisao, potpis i datum
English: The nature of the infections was generally similar in natalizumab- and placebo-treated patients.
Croatian: Priroda infekcija bila je slična u bolesnika koji su primali natalizumab odnosno placebo.
English: In such cases where TYSABRI therapy was discontinued the elevated eosinophil levels resolved.
Croatian: U takvim slučajevima kada je terapija TYSABRIJEM prekinuta povišene razine ezinofila su se vratile na normalne vrijednosti.
English: MedDRA System Organ Class Adverse reaction
Croatian: MedDRA - klasifikacija organskih sustava
English: LIST OF EXCIPIENTS 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: Additional infusion-related reactions associated with persistent antibodies included rigors, nausea, vomiting and flushing (see section 4.4).
Croatian: Perzistirajuća protutijela također dovode do reakcija vezanih za infuziju, kao što su tresavica, mučnina, povraćanje i crvenilo uz osjećaj vrućine (vidjeti dio 4.4).
English: When diluted (see section 6.6), the solution for infusion contains approximately 2.6 mg/ml of natalizumab.
Croatian: Nakon razrjeđivanja (vidjeti dio 6.6) otopina za infuziju sadrži približno 2,6 mg/ml natalizumaba.
English: Adverse reactions reported with natalizumab with an incidence of 0.5% greater than reported with placebo are shown below.
Croatian: U nastavku su prikazane nuspojave vezane za natalizumab s incidencijom većom od 0,5% u odnosu na placebo.
English: Hazard ratio 0.46, CI95% 0.33; 0.64, p<0.001
Croatian: Omjer rizika 0,46, CI95% 0,33 ; 0,64, p<0,001
English: Leukocyte migration across the BBB involves interaction between adhesion molecules on inflammatory cells and endothelial cells of the vessel wall.
Croatian: Prijelaz leukocita preko krvno-moždane barijere uključuje interakciju između adhezijskih molekula na upalnim stanicama i endotelnim stanicama stjenke krvnih žila.
English: Common side effects that may affect up to 1 in 10 people:
Croatian: Česte nuspojave koje se mogu javiti u manje od 1 na 10 osoba:
English: • If you have antibodies to the JC virus in your blood.
Croatian: • ako u krvi imate protutijela na JC virus.
English: TYSABRI contains 2.3 mmol (or 52 mg) sodium per vial of medicinal product.
Croatian: TYSABRI sadrži 2,3 mmol (ili 52 mg) natrija po bočici lijeka.
English: − Prolonged dizziness
Croatian: − dugotrajnu omaglicu
English: Colourless, clear to slightly opalescent solution.
Croatian: Bezbojna, bistra do blago opalescentna otopina.
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 rezonancu moraju biti dostupni.
English: Monitoring for development of IRIS, which has occurred within days to several weeks after plasma exchange in TYSABRI treated patients with PML, and appropriate treatment of the associated inflammation during recovery from PML should be undertaken (see the Physician Information and Management Guidelines for further information).
Croatian: U bolesnika sa PML-om, liječenih TYSABRIJEM, potrebno je praćenje razvoja IRIS-a, koji se može pojaviti unutar nekoliko dana ili tjedana nakon izmjene plazme i poduzimanje prikladnog liječenja prateće upale tijekom oporavka od PML-a (za daljnje informacije vidjeti Informacije za liječnike i Smjernice za liječenje).
English: Progressive Multifocal Leukoencephalopathy (PML)
Croatian: Progresivna multifokalna leukoencefalopatija (PML)
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 rezonancu (MR).
English: If a patient develops PML the dosing of TYSABRI must be permanently discontinued.
Croatian: Ako se u bolesnika javi PML liječenje TYSABRIJEM se mora trajno prekinuti.
English: Hazard ratio 0.58, CI95% 0.43; 0.73, p<0.001
Croatian: Omjer rizika 0,58, CI95% 0,43 ; 0,73, p<0,001
English: MRI screening for PML
Croatian: MR probir na PML
English: Patients who have experienced a hypersensitivity reaction must be permanently discontinued from treatment with TYSABRI.
Croatian: Bolesnici kod kojih se pojavi reakcija preosjetljivosti moraju trajno prekinuti liječenje
English: When diluted in 100 ml sodium chloride 9 mg/ml (0.9%) the medicinal product contains 17.7 mmol (or 406 mg) sodium.
Croatian: Kada je razrijeđen u 100 ml otopine natrijeva klorida od 9 mg/ml (0,9%), lijek sadrži 17,7 mmol (ili 406 mg) natrija.
English: • That the aim of the treatment initiation form is to provide patients with information on PML and IRIS
Croatian: Obrazac za početak liječenja treba sadržavati sljedeće elemente: • Da je svrha obrasca za početak liječenja pružiti bolesniku informacije o PML i IRIS-u
English: Keep this medicine out of the sight and reach of children.
Croatian: Kako čuvati TYSABRI Lijek čuvajte izvan pogleda i dohvata djece.
English: When diluted in 100 ml sodium chloride 9 mg/ml (0.9%) this medicinal product contains 17.7 mmol (or 406 mg) sodium per dose.
Croatian: Kada je razrijeđen u 100 ml natrijeva klorida 9 mg/ml (0,9%) taj lijek sadrži 17,7 mmol (ili 406 mg) natrija po dozi.
English: Rate ratio 0.32 CI95% 0.26 ; 0.40
Croatian: Omjer stope relapsa 0,32 CI95% 0,26 ; 0,40
English: TYSABRI 300 mg concentrate for solution for infusion natalizumab
Croatian: TYSABRI 300 mg koncentrat za otopinu za infuziju natalizumab
English: Warnings and precautions Talk to your doctor before using TYSABRI.
Croatian: Obratite se svom liječniku prije nego primijenite TYSABRI.
English: In studies conducted in mice, growth and metastasis of melanoma and lymphoblastic leukaemia tumour cells was not increased by the administration of natalizumab.
Croatian: U ispitivanjima na miševima primjena natalizumaba nije dovela do povećanja i metastaziranja tumorskih stanica melanoma i limfoblastičke leukemije.
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.
English: Uncommon side effects that may affect up to 1 in 100 people:
Croatian: Manje česte nuspojave koje se mogu javiti u manje od 1 na 100 osoba:
English: Proportion progressed1(24-week confirmation)
Croatian: Udio progresije bolesti1 (potvrđeno nakon 24 tjedna; primarni ishod)
English: 6.6 Special precautions for disposal and other handling
Croatian: 6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom Upute za upotrebu:
English: The highest incidence of adverse reactions identified from placebo-controlled trials in multiple sclerosis patients with natalizumab given at the recommended dose, are reported as dizziness, nausea, urticaria and rigors associated with infusions.
Croatian: Najveća incidencija nuspojava uočenih u placebo kontroliranim ispitivanjima kod bolesnika s multiplom sklerozom s natalizumabom u preporučenoj dozi, prijavljena je za omaglicu, mučninu,
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 PML (progresivna multifokalna leukoencefalopatija).
English: Relapses in previous 12 months, median (range)
Croatian: Medijan vremena od postavljanja dijagnoze u godinama (raspon) Medijan broja relapsa u prethodnih 12 mjeseci (raspon)
English: every 4 weeks
Croatian: 4 godine
English: If an opportunistic infection is suspected, dosing with TYSABRI is to be suspended until such infections can be excluded through further evaluations.
Croatian: primjenu TYSABRIJA treba prekinuti sve dok se daljnjim procjenama ne isključi mogućnost takvih infekcija.
English: Consistent with the pharmacological activity of natalizumab, altered trafficking of lymphocytes was seen as white blood cell increases as well as increased spleen weights in most in vivo studies.
Croatian: U skladu s farmakološkim djelovanjem natalizumaba, u ispitivanjima in vivo primijećeno je promijenjeno kretanje limfocita kako se povećavao broj bijelih krvnih stanica i kako se povećavala težina slezene.
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 počnete primjenjivati TYSABRI i kada primjenjujete TYSABRI dulje od dvije godine morate raspraviti s Vašim liječnikom je li TYSABRI najprikladnije liječenje za Vas.
English: Natalizumab showed no effects on in vitro assays of α4-integrin-positive tumour line proliferation or cytotoxicity.
Croatian: Natalizumab nije imao utjecaja na ispitivanja in vitro proliferacije α4
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 se s liječnikom da ju 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: Instructions for use:
Croatian: 15. UPUTE ZA UPORABU
English: Presence of anti-JC virus antibodies Level of the antibody response (index) for patients without a history of immunosuppressant treatment
Croatian: Razina odgovora protutijela (indeks) za bolesnike bez imunosupresivnog liječenja u anamnezi
English: In patients with PML a reaction known as IRIS (Immune Reconstitution Inflammatory Syndrome) is likely to occur after treatment for PML, as TYSABRI is removed from your body.
Croatian: U bolesnika s PML-om, nakon liječenja PML-a, zbog uklanjanja TYSABRIJA iz tijela najvjerojatnije će se javiti reakcija poznata kao IRIS (upalni sindrom imunološke rekonstitucije).
English: Inspect the TYSABRI vial for particles prior to dilution and administration.
Croatian: Provjerite sadrži li TYSABRI bočica čestice prije razrjeđivanja i primjene.
English: − Headache
Croatian: − glavobolju
English: Stopping TYSABRI therapy
Croatian: Prekid terapije TYSABRIJEM
English: Infusion reactions
Croatian: Reakcije vezane za infuziju