FrancophonIA/ELRC3.0 huggingface dataset:
English: * Expanded Disability Status Scale ** Patients who had not been treated with any MS medication in the 2 years prior to randomization.
Croatian: ** Bolesnici koji nisu bili liječeni nijednim lijekom za MS unutar 2 godine prije randomizacije.
English: Ocrevus administration must be delayed in patients with an active infection until the infection is resolved.
Croatian: Primjena lijeka Ocrevus mora se odgoditi u bolesnika koji imaju aktivnu infekciju, sve dok se ona ne povuče.
English: The 600 mg infusions in RMS and the 2 x 300 mg infusions in PPMS demonstrated consistent PK/PD profiles.
Croatian: Infuzije od 600 mg kod RMS-a i infuzije 2 x 300 mg kod PPMS-a pokazale su dosljedne farmakokinetičke/farmakodinamičke profile.
English: No B cell count data have been collected in neonates and infants exposed to ocrelizumab and the potential duration of B-cell depletion in neonates and infants is unknown (see section 4.4).
Croatian: Nisu se prikupljali podaci o broju B-stanica u novorođenčadi i dojenčadi izložene okrelizumabu, pa nije poznato moguće trajanje deplecije B-stanica u novorođenčadi i dojenčadi majki liječenih lijekom Ocrevus (vidjeti dio 4.4).
English: The safety of immunisation with live or live-attenuated vaccines, following Ocrevus therapy has not been studied and vaccination with live-attenuated or live vaccines is not recommended during treatment and not until B-cell repletion (in clinical trials, the median time for B-cell repletion was 72 weeks).
Croatian: Budući da se nije ispitivala sigurnost imunizacije živim ili živim atenuiranim cjepivima nakon liječenja lijekom Ocrevus, ne preporučuje se cijepljenje živim ili živim atenuiranim cjepivima tijekom liječenja kao ni prije nego dođe do oporavka broja B-stanica (u kliničkim je ispitivanjima medijan vremena do oporavka broja B-stanica iznosio 72 tjedna).
English: Patients with relapsing forms of MS Disease history at screening At least two relapses within the prior two years or one relapse within the prior year; EDSS* between 0 and 5.5, inclusive
Croatian: Najmanje dva relapsa unutar prethodne dvije godine ili jedan relaps unutar prethodnih godinu dana; EDSS* između 0 i 5,5
English: No studies have been conducted to investigate the pharmacokinetics of ocrelizumab in children and adolescents <18 years of age.
Croatian: Nisu provedena ispitivanja kojima bi se ocijenila farmakokinetika okrelizumaba u djece i adolescenata u dobi
English: · Hypersensitivity may be difficult to distinguish from an IRR in terms of symptoms.
Croatian: · Simptome preosjetljivosti može biti teško razlikovati od simptoma reakcije na infuziju.
English: *Pre-specified pooled analysis of WA21092 and WA21093
Croatian: *Unaprijed specificirana analiza objedinjenih podataka iz ispitivanja WA21092 i WA21093
English: In the ocrelizumab MS pivotal studies the administration of corticosteroids for the treatment of relapse was not associated with an increased risk of serious infection.
Croatian: pivotalnim ispitivanjima primjene okrelizumaba kod MS-a primjena kortikosteroida za liječenje relapsa nije bila povezana s povećanim rizikom od ozbiljne infekcije.
English: · Tell your doctor or nurse straight away if you experience any signs or symptoms of an infusion-related reaction during the infusion or up to 24 hours after the infusion.
Croatian: · Odmah obavijestite svog liječnika ili medicinsku sestru ako se pojavi bilo koji znak ili simptom reakcije na infuziju tijekom infuzije ili unutar 24 sata nakon nje.
English: If a hypersensitivity reaction is suspected during infusion, the infusion must be stopped immediately and permanently (see ‘Hypersensitivity Reactions' below).
Croatian: Ako se tijekom infuzije posumnja na reakciju preosjetljivosti, infuzija se mora odmah i trajno obustaviti (vidjeti dio „Reakcije preosjetljivosti” u nastavku).
English: A risk of PML cannot be ruled-out since John Cunningham (JC) virus infection resulting in PML has been observed in patients treated with anti-CD20 antibodies and other MS therapies, and associated with risk factors (e.g. patient population, polytherapy with immunosuppressants).
Croatian: Ne može se isključiti rizik od PML-a jer su u bolesnika liječenih anti-CD20 protutijelima i drugim lijekovima za MS primijećeni slučajevi PML-a uzrokovani infekcijom JC (John Cunningham) virusom i povezani s određenim faktorima rizika (npr. populacijom bolesnika, politerapijom imunosupresivima).
English: Age 18-55 years, EDSS of 3.0 to 6.5
Croatian: Dob: 18 - 55; EDSS: 3,0 - 6,5
English: If a hypersensitivity reaction is suspected during infusion, the infusion must be stopped immediately and permanently.
Croatian: Ako se tijekom infuzije posumnja na reakciju preosjetljivosti, infuzija se mora odmah i trajno obustaviti
English: Ocrevus treatment should be initiated and supervised by specialised physicians experienced in the diagnosis and treatment of neurological conditions and who have access to appropriate medical support to manage severe reactions such as serious infusion-related reactions (IRRs).
Croatian: Liječenje lijekom Ocrevus treba započeti i nadzirati liječnik specijalist koji ima iskustva u dijagnosticiranju i liječenju neuroloških bolesti i koji ima pristup odgovarajućoj medicinskoj potpori za zbrinjavanje teških reakcija kao što su ozbiljne reakcije na infuziju.
English: No infusion adjustment is necessary for subsequent new infusions, unless the patient experiences an IRR.
Croatian: Nisu potrebne nikakve prilagodbe kod sljedećih infuzija, osim ako se ne pojavi reakcija na infuziju.
English: · This medicine is to be stored in a refrigerator (2oC - 8oC).
Croatian: · Čuvati lijek u hladnjaku (2°C - 8°C).
English: Efficacy and safety of Ocrevus were evaluated in two randomised, double-blind, double-dummy, active comparator-controlled clinical trials (WA21092 and WA21093), with identical design, in patients with relapsing forms of MS (in accordance with McDonald criteria 2010) and evidence of disease activity (as defined by clinical or imaging features) within the previous two years.
Croatian: dvostruko maskiranim kliničkim ispitivanjima kontroliranima aktivnim usporednim lijekom (WA21092 i WA21093) koja su imala identičan dizajn, a provedena su u bolesnika s relapsirajućim oblicima MS-a (prema McDonaldovim kriterijima iz 2010.) i dokazima aktivnosti bolesti (koja se definirala kliničkim značajkama ili značajkama vidljivima u pretragama oslikavanja) unutar prethodne dvije godine.
English: Type 1 acute hypersensitivity reactions (IgE-mediated) may be clinically indistinguishable from IRR symptoms.
Croatian: Akutne reakcije preosjetljivosti tipa 1 (u kojima posreduje IgE) mogu biti klinički neraspoznatljive od simptoma reakcije na infuziju.
English: See section 4.5 and 5.1 for further information about vaccinations.
Croatian: Vidjeti dijelove 4.5 i 5.1 za više informacija o cijepljenju.
English: · Patients who experience severe pulmonary symptoms, such as bronchospasm or asthma exacerbation, must have their infusion interrupted immediately and permanently.
Croatian: · U bolesnika u kojih se jave teški plućni simptomi, kao što su bronhospazam ili egzacerbacija astme, primjena infuzije mora se odmah i trajno obustaviti.
English: · Physicians should alert patients that an IRR can occur within 24 hours of infusion.
Croatian: · Liječnici moraju upozoriti bolesnike da se reakcija na infuziju može pojaviti unutar 24 sata nakon infuzije.
English: Women should be advised to discontinue breast-feeding during Ocrevus therapy.
Croatian: Ženama treba savjetovati da prekinu dojenje dok se liječe lijekom Ocrevus.
English: Any vaccinations should be given at least 6 weeks before you start treatment with Ocrevus.
Croatian: Sva cjepiva treba primijeniti najmanje 6 tjedana prije početka liječenja lijekom Ocrevus.
English: Data are available on the effects of tetanus toxoid, 23-valent pneumococcal polysaccharide, keyhole limpet hemocyanin neoantigen, and seasonal influenza vaccines in patients receiving Ocrevus.
Croatian: Dostupni su podaci o učincima toksoida tetanusa, 23-valentnog pneumokoknog polisaharidnog cjepiva, neoantigena KLH i sezonskog cjepiva protiv gripe u bolesnika koji primaju Ocrevus.
English: Relative Increase (Pooled Analysis1) Relative Increase (Individual Studies
Croatian: Relativno povećanje (pojedinačna ispitivanja2)
English: The overall safety profile of Ocrevus in Multiple Sclerosis is based on data from patients from pivotal clinical trials in MS (RMS and PPMS).
Croatian: Ukupan sigurnosni profil lijeka Ocrevus kod multiple skleroze temelji se na podacima prikupljenima u bolesnika koji su sudjelovali u pivotalnim kliničkim ispitivanjima primjene kod MS-a (RMS-a i
English: A minimum interval of 5 months should be maintained between each dose of Ocrevus.
Croatian: Potrebno je održavati interval od najmanje 5 mjeseci između dviju doza lijeka Ocrevus.
English: Measurable levels of ocrelizumab were detected in milk (approximated 0.2% of steady state trough serum levels) during the lactation period.
Croatian: Tijekom razdoblja laktacije u mlijeku su utvrđene mjerljive razine okrelizumaba (približno 0,2% najnižih serumskih vrijednosti u stanju dinamičke ravnoteže).
English: Results of the pre-specified pooled analyses of time to CDP sustained for at least 12 weeks (40% risk reduction for Ocrevus compared to interferon beta-1a (p=0.0006) were highly consistent with the results sustained for at least 24 weeks (40% risk reduction for Ocrevus compared to interferon beta-1a, p=0.0025).
Croatian: Rezultati unaprijed specificiranih analiza objedinjenih podataka o vremenu do potvrđene progresije onesposobljenosti koja se održala tijekom najmanje 12 tjedana (smanjenje rizika za 40% uz Ocrevus u odnosu na interferon beta-1a; p=0,0006) bili su izrazito dosljedni rezultatima za onesposobljenost koja se održala tijekom najmanje 24 tjedna (smanjenje rizika za 40% uz Ocrevus u odnosu na interferon beta-1a; p=0,0025).
English: Ocrevus contains the active substance ‘ocrelizumab'.
Croatian: Ocrevus sadrži djelatnu tvar „okrelizumab”.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 300 mg/10 ml
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 300 mg/10 ml
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e., it is essentially sodium-free.
Croatian: Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) po dozi, tj. zanemarive količine natrija.
English: In active-controlled (RMS) clinical trials, herpes infections were reported more frequently in Ocrevus-treated patients than in interferon-beta-1a treated patients including herpes zoster (2.1% vs 1.0%), herpes simplex, ( 0.7 % vs 0.1 %) oral herpes (3.0% vs 2.2%), genital herpes (0.1% vs 0%) and herpes virus infection (0.1% vs 0%).
Croatian: U kliničkim ispitivanjima kontroliranima aktivnim lijekom (RMS) herpesne infekcije češće su prijavljene u bolesnika liječenih lijekom Ocrevus nego u onih koji su primali interferon beta-1a, a uključivale su herpes zoster (2,1% naspram 1,0%), herpes simpleks (0,7% naspram 0,1%), oralni herpes (3,0% naspram 2,2%), genitalni herpes (0,1% naspram 0%) i infekciju virusom herpesa (0,1% naspram 0%).
English: 90% of all patients had their B-cells repleted to LLN or baseline by approximately two and a half years after the last infusion.
Croatian: U 90% bolesnika zabilježen je oporavak broja B-stanica do DGN-a ili početne vrijednosti tijekom razdoblja do približno dvije i pol godine nakon posljednje infuzije.
English: Respiratory Tract Infections
Croatian: Infekcije dišnih putova
English: Ocrevus is not intended to be used in children and adolescents under 18 years old.
Croatian: Ocrevus nije namijenjen za primjenu u djece i adolescenata mlađih od 18 godina jer se nije ispitivao u toj dobnoj skupini.
English: In a pre- and post-natal development study in cynomolgus monkeys, administration of ocrelizumab from gestation day 20 to approximately 5 weeks postpartum was associated with glomerulopathy, lymphoid follicle formation in bone marrow, lymphoplasmacytic renal inflammation, and decreased testicular weight in offspring.
Croatian: U ispitivanju prenatalnog i postnatalnog razvoja provedenom u makaki majmuna, primjena okrelizumaba od 20. dana gestacije do približno 5 tjedana nakon okota bila je povezana s glomerulopatijom, nastankom limfoidnih folikula u koštanoj srži, limfoplazmocitnom upalom bubrega i smanjenom težinom testisa u mladunčadi.
English: Study 1: WA21092 (OPERA I)
Croatian: 1. ispitivanje: WA21092 (OPERA I)
English: Table 4 Key Clinical and MRI Endpoints from Studies WA21092 and WA21093 (RMS)
Croatian: Tablica 4 Ključne kliničke i MR mjere ishoda iz ispitivanja WA21092 i WA21093 (RMS)
English: Infusion-related reactions can happen during the infusion or up to 24 hours after the infusion.
Croatian: Reakcije na infuziju mogu se javiti tijekom infuzije ili do 24 sata nakon nje.
English: Ocrelizumab is a recombinant humanised anti-CD20 monoclonal antibody produced in Chinese Hamster Ovary cells by recombinant DNA technology.
Croatian: Okrelizumab je rekombinantno humanizirano anti-CD20 monoklonsko protutijelo koje se proizvodi u stanicama jajnika kineskog hrčka tehnologijom rekombinantne DNK.
English: · Premedication: Patients must receive premedication to reduce the frequency and severity of IRRs (see section 4.2.
Croatian: · Premedikacija: Bolesnici moraju primiti premedikaciju radi smanjenja učestalosti i težine reakcija na infuziju (vidjeti dio 4.2).
English: The percentage of patients with seroprotective titers against five influenza strains ranged from 20.0-60.0% and 16.7-43.8% pre-vaccination and at 4 weeks post vaccination from 55.6-80.0% in patients treated with ocrelizumab and 75.0-97.0% in the control group , respectively.
Croatian: Postotak bolesnika sa seroprotektivnim titrima protiv pet sojeva gripe prije cijepljenja kretao se od 20,0% do 60,0% u skupini liječenoj okrelizumabom te od 16,7% do 43,8% u kontrolnoj skupini, dok je 4 tjedna nakon cijepljenja iznosio 55,6 - 80,0% odnosno 75,0 - 97,0%.
English: Therefore, withholding of antihypertensive treatments should be considered for 12 hours prior to and throughout each Ocrevus infusion.
Croatian: Stoga treba razmotriti odgodu primjene antihipertenziva 12 sati prije i tijekom svake infuzije lijeka Ocrevus.
English: Serious infections occurred in 6.2% of patients receiving Ocrevus vs 6.7% of patients receiving placebo.
Croatian: Ozbiljne infekcije javile su se u 6,2% bolesnika koji su primali Ocrevus i 6,7% onih koji su primali placebo.
English: Sodium Acetate Trihydrate Glacial Acetic Acid Trehalose Dihydrate Polysorbate 20
Croatian: natrijev acetat trihidrat ledena acetatna kiselina trehaloza dihidrat polisorbat 20 voda za injekcije
English: Ocrevus must be permanently discontinued in these patients (see section 4.3).
Croatian: U tih se bolesnika liječenje lijekom Ocrevus mora trajno obustaviti (vidjeti dio 4.3).
English: The pharmacokinetics of ocrelizumab in the MS studies were described by a two compartment model with time-dependent clearance, and with PK parameters typical for an IgG1 monoclonal antibody.
Croatian: Farmakokinetika okrelizumaba u ispitivanjima kod MS-a opisana je modelom s dva odjeljka i klirensom ovisnim o vremenu te farmakokinetičkim parametrima karakterističnima za IgG1
English: Infusion instructions
Croatian: Upute za infuziju
English: It is recommended to vaccinate patients treated with Ocrevus with seasonal influenza vaccines that are inactivated.
Croatian: Bolesnike koji se liječe lijekom Ocrevus preporučuje se cijepiti inaktiviranim sezonskim cjepivima protiv gripe.
English: Patients with a history of congestive heart failure (New York Heart Association III & IV) were not studied.
Croatian: Bolesnici s anamnezom kongestivnog zatajivanja srca (NYHA kategorije III i IV) nisu se ispitivali.
English: WA25046 study]; HR 0.48 [0.25-0.92]; <51 years: HR 0.53 [0.31-0.89]).
Croatian: ≤ 46 godina [medijan dobi u ispitivanju WA25046]: HR 0,48 [0,25-0,92]; < 51 godine: HR 0,53
English: The proportion of respiratory tract infections was higher in Ocrevus treated patients compared to interferon beta-1-a and placebo.
Croatian: Udio infekcija dišnih putova bio je veći među bolesnicima liječenima lijekom Ocrevus nego među onima koji su primali interferon beta-1a i placebo.
English: Ocrevus attaches to specific B cells, which are a type of white blood cells that are part of the immune system and play a role in MS. Ocrevus targets and removes those specific B cells.
Croatian: Ocrevus se pričvršćuje za specifične B-stanice - jednu vrstu bijelih krvnih stanica koje su dio imunosnog sustava i imaju ulogu u MS-u.
English: Key clinical and MRI efficacy results are presented in Table 4 and Figure 1.
Croatian: Ključni rezultati za djelotvornost na temelju kliničkih i MR mjera prikazani su u Tablici 4 i na Slici 1.
English: Area under the curve (AUCτ) after the 4th dose of 600 mg ocrelizumab was 3510 µg/mL•day, and mean maximum concentration (Cmax) was 212 µg/mL in RMS (600 mg infusion) and 141 µg/mL in PPMS (300 mg infusions).
Croatian: (AUCτ) nakon 4. doze okrelizumaba od 600 mg iznosilo je 3510 µg/ml•dan, dok je srednja vrijednost najviše koncentracije (Cmax) iznosila 212 µg/ml kod RMS-a (infuzije od 600 mg) i 141 µg/ml kod PPMS-a (infuzije od 300 mg).
English: The first subsequent dose of 600 mg should be administered six months after the first infusion of the initial dose.
Croatian: Prvu sljedeću dozu od 600 mg treba primijeniti šest mjeseci nakon prve infuzije početne doze.
English: The highest dose tested to date in MS patients is 2000 mg, administered as two 1000 mg intravenous infusions separated by 2 weeks (Phase II dose finding study in RRMS).
Croatian: Najveća dosad ispitana doza u bolesnika s MS-om iznosila je 2000 mg, a primijenjena je u dvije intravenske infuzije od 1000 mg u razmaku od 2 tjedna (ispitivanje faze II radi utvrđivanja doze kod RRMS-a).
English: The adverse drug reactions were consistent with the safety profile for Ocrevus in the pivotal clinical studies.
Croatian: Nuspojave su bile u skladu sa sigurnosnim profilom lijeka Ocrevus iz pivotalnih kliničkih ispitivanja.
English: After treatment with Ocrevus over 2 years, the proportion of patients with positive antibody titers against S. pneumoniae, mumps, rubella and varicella were generally similar to the proportions at baseline.
Croatian: Nakon liječenja lijekom Ocrevus tijekom više od 2 godine, udio bolesnika s pozitivnim titrima protutijela na S. pneumoniae, zaušnjake, rubeolu i varičelu u načelu je bio sličan udjelima zabilježenima na početku liječenja.
English: Treatment groups
Croatian: Liječene skupine
English: For the B cell counts, CD19 is used, as the presence of Ocrevus interferes with the recognition of CD20 by the assay.
Croatian: CD19 jer prisutnost lijeka Ocrevus ometa prepoznavanje CD20 u testu.
English: The results of these studies show that Ocrevus significantly suppressed relapses, sub-clinical disease activity measured by MRI, and disease progression compared with interferon beta-1a 44mcg subcutaneous.
Croatian: Rezultati tih ispitivanja pokazuju da je Ocrevus značajno suprimirao relapse, supkliničku aktivnost bolesti utvrđenu MR oslikavanjem i progresiju bolesti u odnosu na interferon beta-1a u supkutanoj dozi od 44 µg.
English: · Infusion-related reactions are the most common side effect of Ocrevus treatment.
Croatian: · Reakcije na infuziju najčešća su nuspojava liječenja lijekom Ocrevus.
English: A greater proportion of patients in each group experienced IRRs with the first infusion of each dose compared with the second infusion of that dose.
Croatian: U obje je skupine veći udio bolesnika doživio reakciju na infuziju kod prve infuzije pojedine doze nego kod druge infuzije te doze.
English: Subsequent doses of Ocrevus thereafter are administered as a single 600 mg intravenous infusion every 6 months (Table 1).
Croatian: Doze lijeka Ocrevus koje slijede nakon toga primjenjuju se u obliku jedne intravenske infuzije od 600 mg svakih 6 mjeseci (Tablica 1).
English: In a randomized open-label study in RMS patients (N=102), the percentage of patients with a positive response to tetanus vaccine at 8 weeks after vaccination was 23.9% in the ocrelizumab group compared to 54.5% in the control group (no disease-modifying therapy except interferon-beta).
Croatian: U randomiziranom otvorenom ispitivanju provedenom u bolesnika s RMS-om (N=102) postotak bolesnika s pozitivnim odgovorom na cjepivo protiv tetanusa 8 tjedana nakon cijepljenja iznosio je 23,9% u skupini liječenoj okrelizumabom i 54,5% u kontrolnoj skupini (nije se primjenjivala terapija koja modificira tijek bolesti osim interferona-beta).
English: · It is important to continue your treatment for as long as you and your doctor decide that it is helping you.
Croatian: Ako prekinete liječenje lijekom Ocrevus · Važno je da nastavite liječenje dok god Vi i Vaš liječnik budete smatrali da Vam lijek pomaže.
English: Ocrevus should be prepared by a healthcare professional using aseptic technique.
Croatian: Upute za razrjeđivanje Ocrevus treba pripremiti zdravstveni radnik primjenom aseptičke tehnike.
English: Key clinical and MRI efficacy results are presented in Table 6 and Figure 2.
Croatian: Ključni rezultati za djelotvornost na temelju kliničkih i MR mjera prikazani su u Tablici 6 i na Slici 2.
English: Keep the vial in the outer carton in order to protect from light Keep the vials in the outer carton in order to protect from light
Croatian: Bočicu čuvati u vanjskom pakiranju radi zaštite od svjetlosti Bočice čuvati u vanjskom pakiranju radi zaštite od svjetlosti
English: · Subsequent Doses
Croatian: · Sljedeće doze
English: 180 mL/hour.
Croatian: 1,2 mg/ml.
English: The following side effects have been reported with Ocrevus:
Croatian: Kod primjene lijeka Ocrevus prijavljene su sljedeće nuspojave:
English: METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use For intravenous use after dilution Do not shake the vial
Croatian: NAČIN I PUT(EVI) PRIMJENE Prije uporabe pročitajte uputu o lijeku Za intravensku primjenu nakon razrjeđivanja Nemojte tresti bočicu
English: The incidence of IRRs was highest during the Dose 1, infusion 1 (27.5%) and decreased over time to <10% at Dose 4.
Croatian: Incidencija reakcija na infuziju bila je najviša tijekom 1. infuzije 1. doze (27,5%), a s vremenom je pala na < 10% pri 4. dozi.
English: Study 2: WA21093 (OPERA II)
Croatian: 2. ispitivanje: WA21093 (OPERA II)
English: Your doctor may decide to delay your treatment with Ocrevus.
Croatian: Liječnik će možda odlučiti odgoditi liječenje lijekom Ocrevus.
English: Table 6 Key Clinical and MRI Endpoints from Study WA25046 (PPMS) Study 3
Croatian: Tablica 6 Ključne kliničke i MR mjere ishoda iz ispitivanja WA25046 (PPMS)
English: Ocrevus is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features (see section 5.1).
Croatian: Ocrevus je indiciran za liječenje odraslih bolesnika s relapsirajućim oblicima multiple skleroze (RMS) koji imaju aktivnu bolest definiranu kliničkim značajkama ili značajkama vidljivima u pretragama oslikavanja (vidjeti dio 5.1).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1231/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/17/1231/001
English: · Chemical and physical in-use stability has been demonstrated for 24 hours at 2-8°C and subsequently 8 hours at room temperature.
Croatian: · Dokazana je kemijska i fizikalna stabilnost tijekom 24 sata na temperaturi od 2°C do 8°C, a nakon toga tijekom 8 sati na sobnoj temperaturi.
English: Breakdown of the myelin sheath stops the nerves working properly.
Croatian: Razgradnja mijelinske ovojnice onemogućuje normalan rad živaca.
English: Grounds for the variation to the terms of the marketing authorisation(s) On the basis of the scientific conclusions for ocrelizumab the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing ocrelizumab is unchanged subject to the proposed changes to the product information.
Croatian: Na temelju znanstvenih zaključaka za okrelizumab, CHMP smatra da je omjer koristi i rizika lijeka(ova) koji sadrži(e) okrelizumab nepromijenjen, uz predložene izmjene informacija o lijeku.
English: Figure 1: Dose and Schedule of Ocrevus
Croatian: Slika 1: Doza i raspored primjene lijeka Ocrevus