FrancophonIA/ELRC3.0 huggingface dataset:
English: The incidence of IRRs was highest during the Dose 1, infusion 1 (27.5%) and decreased over time to <10% at Dose 4.
Slovenian: Pojavnost z infuzijo povezanih reakcij je bila največja pri 1. infundiranju 1. odmerka (27,5 %) in se je sčasoma zmanjšala na < 10 % pri 4. odmerku.
English: Study design and baseline characteristics of the study population are presented in Table 5.
Slovenian: Načrt študije in izhodiščne značilnosti raziskovane populacije so prikazani v preglednici 5.
English: Patients in a severely immunocompromised state must not be treated until the condition resolves (see section 4.3.
Slovenian: Imunsko zelo oslabelih bolnikov se ne sme zdraviti, dokler takšno stanje ne mine (glejte poglavje 4.3).
English: Ocrevus infusions should not be administered as an intravenous push or bolus.
Slovenian: Infuzij zdravila Ocrevus se ne sme dati s forsirano intravensko aplikacijo ali kot bolus.
English: Very common: may affect more than 1 in 10 people · decrease in specific proteins in the blood (immunoglobulins) which help protect against infection
Slovenian: • zmanjšanje koncentracije specifičnih beljakovin v krvi (imunoglobulinov), ki pomagajo varovati pred okužbami
English: · If you get any side effects, talk to your doctor or nurse.
Slovenian: • Če opazite katerega koli izmed neželenih učinkov, se posvetujte z zdravnikom ali medicinsko sestro.
English: Infections included and were not limited to atypical pneumonia and pneumocystis jirovecii pneumonia, varicella pneumonia, tuberculosis, histoplasmosis.
Slovenian: Med takšnimi okužbami so bile atipična pljučnica in pljučnica zaradi Pneumocystis jirovecii, pljučnica zaradi virusa varicelle, tuberkuloza, histoplazmoza, a ne le te.
English: · In relapsing forms of MS. the patient has repeated attacks of symptoms (relapses).
Slovenian: • Pri recidivnih oblikah multiple skleroze imajo bolniki ponavljajoče napade simptomov
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Slovenian: Odlaganje neuporabljenih zdravil/zdravil, ki jim je potekel rok uporabnosti Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
English: In the active-controlled studies in RMS, infections occurred in 58.5% of patients receiving Ocrevus vs 52.5% of patients receiving interferon beta 1a.
Slovenian: V študijah RMS, kontroliranih z učinkovino, so se okužbe pojavile pri 58,5 % bolnikov, ki so prejemali zdravilo Ocrevus, in pri 52,5 % bolnikov, ki so prejemali interferon beta-1a.
English: The safety and efficacy of Ocrevus in patients with renal impairment has not been formally studied.
Slovenian: Varnost in učinkovitost zdravila Ocrevus pri bolnikih z okvaro ledvic nista formalno raziskani.
English: If you stop Ocrevus treatment
Slovenian: Če ste prenehali uporabljati zdravilo Ocrevus
English: A hypersensitivity reaction may present during any infusion, although typically would not present during the first infusion.
Slovenian: Preobčutljivostne reakcije se lahko pojavijo med katerim koli infundiranjem, a praviloma ne med prvim infundiranjem.
English: Patients with positive serology (i.e. negative for HBsAg and positive for HB core antibody (HBcAb +); carriers of HBV (positive for surface antigen, HBsAg+) should consult liver disease experts before start of treatment and should be monitored and managed following local medical standards to prevent hepatitis B reactivation.
Slovenian: Bolniki s pozitivnimi serološkimi izvidi (tj. negativni za HBsAg in pozitivni za protitelesa proti jedrnemu antigenu HB (HBcAb+) ali nosilci HBV (pozitivni za površinski antigen, HBsAg+)) se morajo pred začetkom zdravljenja posvetovati s specialistom za jetrne bolezni.
English: The majority of IRRs were mild to moderate.
Slovenian: Večina z infuzijo povezanih reakcij je bila blagih do zmernih.
English: In the placebo-controlled (PPMS) clinical trial, a higher proportion of patients with oral herpes (2.7% vs 0.8%) were observed in the Ocrevus treatment arm.
Slovenian: V kliničnem preskušanju (PPMS), kontroliranem s placebom, so v terapevtski skupini z zdravilom Ocrevus zabeležili večji delež bolnikov z oralnim herpesom (2,7 % v primerjavi z 0,8 %).
English: · Each infusion should be given over approximately 2.5 hours.
Slovenian: • Vsako infundiranje mora trajati približno 2,5 ure.
English: NEDA defined as absence of protocol defined relapses, 12-week Confirmed Disability Progression (CDP), and any MRI activity (either Gd-enhancing T1 lesions, or new or enlarging T2 lesions) during the whole 96-week treatment.
Slovenian: 12-tedenskega potrjenega napredovanja prizadetosti (CDP - Confirmed Disability Progression) in kakršne koli magnetnoresonančne aktivnosti (z gadolinijem obarvanih lezij T1 ali novih/povečanih lezij T2) med celotnim 96tedenskim zdravljenjem.
English: Ocrevus is a monoclonal antibody and cleared via catabolism (i.e. breakdown into peptides and amino acids), and a change in dose is not expected to be required for patients with renal impairment (see section 5.2).
Slovenian: Zdravilo Ocrevus je monoklonsko protitelo, ki se odstrani s katabolizmom (tj. z razgradnjo v peptide in aminokisline), zato ni pričakovati, da bi bilo bolnikom z okvaro ledvic odmerek treba prilagoditi (glejte poglavje 5.2).
English: The incidence of IRRs was highest during Dose 1, infusion 1 (27.4%,) and decreased with subsequent doses to <10% at Dose 4.
Slovenian: Pojavnost z infuzijo povezanih reakcij je bila največja pri 1. infundiranju 1. odmerka (27,4 %) in se je pri nadaljnjih odmerkih zmanjšala na < 10 % pri 4. odmerku.
English: Individual benefit risk should be considered in patients with known risk factors for malignancies and in patients who are being actively monitored for recurrence of malignancy.
Slovenian: Pri bolnikih z znanimi dejavniki tveganja za maligne bolezni in bolnikih, aktivno nadzorovanih zaradi ponovitve maligne bolezni, je treba individualno pretehtati korist in tveganje.
English: Ocrevus administration must be delayed in patients with an active infection until the infection is resolved.
Slovenian: Pri bolnikih z aktivno okužbo je treba uporabo zdravila Ocrevus odložiti, dokler okužba ne mine.
English: · you have ever had hepatitis B or are a carrier of the hepatitis B virus.
Slovenian: • ste kdaj imeli hepatitis B ali če ste nosilec virusa hepatitisa B. Zdravila, kot je zdravilo Ocrevus, namreč lahko povzročijo, da postane virus hepatitisa B spet aktiven.
English: Table 5 Study design, demograhics and baseline characteristics for Study WA25046.
Slovenian: Načrt študije, demografske in izhodiščne značilnosti v študiji WA25046 Ime študije
English: METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use For intravenous use after dilution Do not shake the vial
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA Pred uporabo preberite priloženo navodilo za intravensko uporabo po razredčenju
English: See section 4.5 and 5.1 for further information about vaccinations.
Slovenian: Za nadaljnje informacije glede cepljenj glejte poglavji 4.5 in 5.1.
English: Ocrelizumab is a recombinant humanised anti-CD20 monoclonal antibody produced in Chinese Hamster Ovary cells by recombinant DNA technology.
Slovenian: Okrelizumab je rekombinantno humanizirano monoklonsko protitelo proti CD20, pridobljeno s tehnologijo rekombinantne DNA v celicah jajčnika kitajskega hrčka.
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%).
Slovenian: V kliničnih preskušanjih (RMS), kontroliranih z učinkovino, so o herpetičnih okužbah pogosteje poročali med prejemniki zdravila Ocrevus kot med prejemniki interferona beta-1a; to vključuje herpes zoster (2,1 % v primerjavi z 1,0 %), herpes simpleks (0,7 % v primerjavi z 0,1 %), oralni herpes
English: Patients with mild renal impairment were included in clinical trials and no change in the pharmacokinetics of Ocrevus was observed in those patients.
Slovenian: Bolniki z blago okvaro ledvic so bili vključeni v klinična preskušanja in pri teh bolnikih niso opazili sprememb farmakokinetike zdravila Ocrevus.
English: After dilution, Ocrevus is administered as an intravenous infusion through a dedicated line.
Slovenian: Po razredčenju se zdravilo Ocrevus daje kot intravenska infuzija po namenski intravenski liniji.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 300 mg/10 ml
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 300 mg/10 ml
English: There were no life-threatening IRRs.
Slovenian: Življenjsko ogrožajočih z infuzijo povezanih reakcij ni bilo.
English: · Ocrevus medicinal product must be diluted before administration.
Slovenian: • Zdravilo Ocrevus je treba pred uporabo razredčiti.
English: Before the infusion: · Management of severe reactions: Appropriate resources for the management of severe reactions such as serious IRR, hypersensitivity reactions and/or anaphylactic reactions should be available.
Slovenian: • Obvladovanje hudih reakcij: na voljo mora biti vse potrebno za obvladovanje hudih reakcij, na primer resnih z infuzijo povezanih reakcij, preobčutljivostnih reakcij in/ali anafilaktičnih reakcij.
English: Clear to slightly opalescent, and colourless to pale brown solution.
Slovenian: Bistra do rahlo opalescentna in brezbarvna do bledorjava raztopina.
English: · Tell your doctor or nurse straight away if you have any of these signs of infection during or after Ocrevus treatment: fever or chills cough that does not go away herpes (such as cold sore, shingles or genital sores).
Slovenian: • Zdravniku ali medicinski sestri morate takoj povedati, če med zdravljenjem ali po njem opazite katerega koli od naslednjih znakov okužbe: zvišano telesno temperaturo ali mrzlico kašelj, ki ne mine herpes (na primer herpes na ustnici, pasovec ali herpes na spolovilih)
English: Caution should be exercised when prescribing Ocrevus taking into consideration the pharmacodynamics of other disease modifying MS therapies.
Slovenian: V primeru predpisovanja zdravila Ocrevus je potrebna previdnost in upoštevati je treba farmakodinamiko drugih imunomodulirajočih zdravil za zdravljenje multiple skleroze.
English: Preclinical data reveal no special hazards for humans based on studies of male and female fertility in cynomologous monkeys.
Slovenian: Predklinični podatki na osnovi študij plodnosti samcev in samic opic cynomolgus ne kažejo posebnih tveganj za človeka.
English: · Each infusion should be given over approximately 3.5 hours
Slovenian: • Vsako infundiranje mora trajati približno 3,5 ure.
English: · After dilution, Ocrevus is administered as an intravenous infusion through a dedicated line.
Slovenian: • Po razredčenju se zdravilo Ocrevus daje kot intravenska infuzija po namenski intravenski liniji.
English: Patients who have had hepatitis B or are carriers of the hepatitis B virus will have a blood test and will be monitored by a doctor for signs of hepatitis B infection.
Slovenian: Pred zdravljenjem z zdravilom Ocrevus bo zdravnik preveril, ali vas ogroža okužba s hepatitisom B. Bolniki, ki so imeli hepatitis B ali so nosilci virusa hepatitisa B, bodo opravili preiskavo krvi in zdravnik jih bo spremljal glede znakov okužbe s hepatitisom B.
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
Slovenian: Vsaj dva recidiva v zadnjih dveh letih ali en recidiv v zadnjem letu; EDSS* od 0 do vključno 5,5
English: With regard to disease activity, features characteristic of inflammatory activity, even in progressive MS, can be imaging-related, (i.e. T1 Gd-enhancing lesions and/or active [new or enlarging] T2 lesions).
Slovenian: Značilnosti, ki opredeljujejo vnetno aktivnost, so lahko glede na aktivnost bolezni celo pri progresivni multipli sklerozi potrjene s slikovno diagnostiko (tj. z gadolinijem obarvanimi lezijami T1 in/ali aktivnimi [novimi ali naraščajočimi]
English: Name and address of the manufacturer responsible for batch release
Slovenian: Ime in naslov izdelovalca, odgovornega za sproščanje serij Roche Pharma AG
English: · The active substance is ocrelizumab.
Slovenian: • Učinkovina je okrelizumab.
English: If PML is suspected, dosing with Ocrevus must be withheld.
Slovenian: V primeru suma na PML je treba uporabo zdravila Ocrevus zadržati.
English: Figure 1: Dose and Schedule of Ocrevus
Slovenian: Slika 1: Odmerek in razpored uporabe zdravila Ocrevus
English: In particular tell your doctor if: · you have ever taken, are taking or are planning to take medicines that affect the immune system - such as chemotherapy, immunosuppressants or other medicines used to treat MS.
Slovenian: • če ste kdaj jemali, trenutno jemljete, ali nameravate jemati zdravila, ki vplivajo na imunski sistem, na primer kemoterapijo, imunosupresivna zdravila ali druga zdravila, ki se uporabljajo za zdravljenje multiple skleroze.
English: Ocrevus will be stored by the healthcare professionals at the hospital or clinic under the following conditions: · This medicine is to be kept out of the sight and reach of children.
Slovenian: Zdravilo Ocrevus bo shranjevalo zdravstveno osebje v bolnišnici ali ambulanti v naslednjih pogojih:
English: Approximately 1% of the patients in the Ocrevus group had a Grade 3 lymphopenia (between 200 and 500 cells/mm3).
Slovenian: Približno 1 % bolnikov v skupini z zdravilom Ocrevus je imel limfopenijo 3. stopnje (med 200 in 500 celic/mm Nobeden od bolnikov ni imel limfopenije 4. stopnje (< 200 celic/mm
English: Table 4 Key Clinical and MRI Endpoints from Studies WA21092 and WA21093 (RMS)
Slovenian: Ključni klinični opazovani dogodki in opazovani dogodki z magnetnoresonančnimi posnetki v študijah WA21092 in WA21093 (RMS)
English: infection of the stomach and bowel (gastroenteritis) respiratory tract infection viral infectionskin infection (cellulitis)
Slovenian: - okužba s herpesom (herpes na ustnici ali pasovec) - okužba želodca in črevesa (gastroenteritis) - okužba dihal - virusna okužba - okužba kože (celulitis)
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.
Slovenian: Učinkovitost in varnost zdravila Ocrevus so ocenili v dveh randomiziranih, dvojno slepih, z učinkovino kontroliranih kliničnih preskušanjih z vzporednim placebom (WA21092 in WA21093), ki sta imeli enak načrt in sta zajeli bolnike z recidivnimi oblikami multiple skleroze (v skladu z
English: Ocrevus should be prepared by a healthcare professional using aseptic technique.
Slovenian: Zdravilo Ocrevus mora pripraviti zdravstveni delavec; postopek mora biti opravljen aseptično.
English: What Ocrevus is and what it is used for
Slovenian: Kaj vsebuje navodilo Kaj je zdravilo Ocrevus in za kaj ga uporabljamo
English: The majority of the neutrophil decreases were transient (only observed once for a given patient treated with Ocrevus) and were Grade 1 (<1500 cells/mm3) and 2 (between 1000 and 1500 cells/mm3) in severity.
Slovenian: Večinoma je bilo zmanjšanje števila nevtrofilcev prehodno (ugotovljeno le enkrat pri posameznem bolniku, zdravljenem z zdravilom Ocrevus), po izrazitosti pa je bilo 1. stopnje (< 1500 celic/mm
English: This is because of a very rare and life-threatening brain infection, called ‘progressive multifocal leukoencephalopathy' (PML), which can cause symptoms similar to those of MS. PML can occur in patients taking medicines like Ocrevus, and other medicines used for treating MS. Tell your partner or carer about your Ocrevus treatment.
Slovenian: To je potrebno zaradi zelo redke in življenjsko ogrožajoče okužbe možganov, ki jo imenujemo progresivna multifokalna levkoencefalopatija (PML) in ki lahko povzroči simptome, podobne simptomom multiple skleroze.
English: · Hypotension: As a symptom of IRR, may occur during Ocrevus infusions.
Slovenian: • Hipotenzija: med infundiranjem zdravila Ocrevus se lahko pojavi kot simptom z infuzijo povezane reakcije.
English: B-cell depletion in utero was detected.
Slovenian: Ugotovili so zmanjšanje števila celic B in utero.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, and embryo-foetal development.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih odmerkih in embriofetalnega razvoja ne kažejo posebnega tveganja za človeka.
English: The metabolism of Ocrevus has not been directly studied, as antibodies are cleared principally by catabolism (i.e. breakdown into peptides and amino acids).
Slovenian: Presnove zdravila Ocrevus niso raziskali neposredno, ker se protitelesa odstranijo predvsem s katabolizmom (t.j.
English: Positive response to ³5 serotypes in 23-PPV at 4 weeks after vaccination was 71.6% in the ocrelizumab group and 100% in the control group.
Slovenian: (23-valentno polisaharidno pnevmokokno cepivo) 4 tedne po cepljenju je bil 71,6 % v skupini z okrelizumabom in 100 % v kontrolni skupini.
English: · This medicine is to be stored in a refrigerator (2oC - 8oC).
Slovenian: • Shranjujte v hladilniku (2 do 8 °C).
English: In PPMS, a decrease in lymphocytes <LLN was observed in 26.3% of Ocrevus treated patients vs 11.7% of placebo-treated patients.
Slovenian: Pri PPMS so zmanjšanje števila limfocitov pod spodnjo normalno mejo opažali pri 26,3 % bolnikov, ki so prejemali zdravilo Ocrevus, in pri 11,7 % bolnikov, ki so prejemali placebo.
English: Key clinical and MRI efficacy results are presented in Table 6 and Figure 2.
Slovenian: Ključni klinični rezultati učinkovitosti in rezultati učinkovitosti, merjeni z magnetno resonanco, so prikazani v preglednici 6 in na sliki 2.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the healthcare professional and would normally not be longer than 24 hours at 2°C - 8°C and subsequently 8 hours at room temperature.
Slovenian: Če ni uporabljeno takoj, so čas shranjevanja med uporabo in pogoji pred uporabo odgovornost zdravstvenega delavca; čas običajno ne sme preseči 24 ur na temperaturi od 2 do 8 °C in nadaljnjih 8 ur na sobni temperaturi.
English: Ocrevus is used to treat adults with: · Relapsing forms of multiple sclerosis (RMS) · Early primary progressive multiple sclerosis (PPMS)
Slovenian: • recidivnimi oblikami multiple skleroze (RMS) • zgodnjo primarno progresivno multiplo sklerozo (PPMS).
English: IRRs can occur within 24 hours of the infusion.
Slovenian: Z infuzijo povezane reakcije se lahko pojavijo v 24 urah po infundiranju.
English: Efficacy and safety of Ocrevus were also evaluated in a randomised, double-blind, placebo-controlled clinical trial in patients with primary progressive MS (Study WA25046) who were early in their disease course according to the main inclusion criteria, i.e. ages 18-55 years, inclusive; EDSS at screening from 3.0 to 6.5 points; disease duration from the onset of MS symptoms less than 10 years in patients with an EDSS at screening ≤5.0 or less than 15 years in patients with an EDSS at screening
Slovenian: (študija WA25046), ki so bili v zgodnji fazi bolezni, kot je bilo opredeljeno z glavnimi merili za vključitev, tj. starost od 18 do 55 let (vključno), EDSS ob presejanju od 3,0 do 6,5 točke, trajanje bolezni od pojava simptomov multiple skleroze manj kot 10 let med bolniki s presejalnim EDSS ≤ 5,0 ali manj kot 15 let med bolniki s presejalnim EDSS > 5,0.
English: Based on the limited data available (see section 5.1 and section 5.2), no posology adjustment is needed in patients over 55 years of age.
Slovenian: Na podlagi maloštevilnih razpoložljivih podatkov (glejte poglavje 5.1 in poglavje 5.2) bolnikom po
English: Premedication for infusion-related reactions
Slovenian: • Premedikacija za reakcije, povezane z infuzijo
English: Blood immunoglobulin G decreased
Slovenian: Preiskave znižanje imunoglobulinov M v krvi znižanje imunoglobulinov G v krvi
English: · Patients treated with Ocrevus should be observed for at least one hour after the completion of the infusion for any symptom of an IRR.
Slovenian: • Bolnike, zdravljene z zdravilom Ocrevus, je treba vsaj eno uro po dokončanju infundiranja opazovati glede morebitnih simptomov z infuzijo povezane reakcije.
English: For guidance regarding posology for patients experiencing IRR symptoms see section 4.2.
Slovenian: Glede smernic za odmerjanje pri bolnikih, ki se jim pojavijo simptomi z infuzijo povezanih reakcij, glejte poglavje 4.2.
English: In MS, the immune system (the body's defence system) works incorrectly and attacks a protective layer (called myelin sheath) around nerve cells and causes inflammation.
Slovenian: Imunski sistem (telesni obrambni sistem) pri multipli sklerozi ne deluje pravilno ter napade zaščitno plast (t.i.
English: Talk to your doctor before you are given Ocrevus if any of the following apply to you.
Slovenian: Preden dobite zdravilo Ocrevus, se posvetujte z zdravnikom, če za vas velja kar koli od naslednjega.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2-8°C and subsequently 8 hours at room temperature, unless dilution undertaken in controlled and validated aseptic conditions.
Slovenian: Če ni uporabljena takoj, so čas shranjevanja med uporabo in pogoji pred uporabo odgovornost uporabnika; čas običajno ne sme presegati 24 ur pri temperaturi od 2-8 °C in nadalje 8 ur pri sobni temperaturi, razen če je razredčenje opravljeno v nadzorovanih in validiranih aseptičnih pogojih.
English: The initial 600 mg dose is administered as two separate intravenous infusions; first as a 300 mg infusion, followed 2 weeks later by a second 300 mg infusion.
Slovenian: Začetni odmerek 600 mg je treba dati v dveh ločenih intravenskih infuzijah: najprej infuzijo 300 mg, ki ji čez 2 tedna sledi druga infuzija 300 mg.
English: Percentage change in T2 hyperintense lesion volume, from baseline to Week 120
Slovenian: Opazovani dogodki z magnetnoresonančnimi posnetki Odstotek spremembe volumna hiperintenzivnih lezij T2 od izhodišča do 120. tedna
English: Across the RMS and PPMS trials, symptoms associated with IRRs included, but are not limited to: pruritus, rash, urticaria, erythema, flushing, hypotension, pyrexia, fatigue, headache, dizziness, throat irritation, oropharyngeal pain, dyspnoea, pharyngeal or laryngeal oedema, nausea, tachycardia.
Slovenian: V preskušanjih pri RMS in PPMS so simptomi, ki so spremljali z infuzijo povezane reakcije, obsegali srbenje, izpuščaj, urtikarijo, eritem, zardevanje, hipotenzijo, zvišano telesno temperaturo, utrujenost, glavobol, omotico, draženje žrela, orofaringealno bolečino, dispnejo, edem žrela ali grla, navzeo, tahikardijo, a ne le teh.
English: Key clinical and MRI efficacy results are presented in Table 4 and Figure 1.
Slovenian: Ključni klinični rezultati in rezultati učinkovitosti, merjeni z magnetnoresonančno slikovno diagnostiko, so prikazani v preglednici 4 in na sliki 1.
English: Study 2: WA21093 (OPERA II)
Slovenian: Študija 2: WA21093
English: In the RMS clinical trials, 39.9% of Ocrevus treated patients and 33.2% interferon beta-1-a treated patients experienced an upper respiratory tract infection and 7.5% of Ocrevus treated patients and 5.2% of interferon beta-1-a treated patients experienced a lower respiratory tract infection.
Slovenian: V kliničnih preskušanjih pri RMS so se okužbe zgornjih dihal pojavile pri 39,9 % prejemnikov zdravila Ocrevus in pri 33,2 % prejemnikov interferona beta-1a, okužbe spodnjih dihal pa pri 7,5 % prejemnikov zdravila Ocrevus in pri 5,2 % prejemnikov interferona beta-1a.
English: Ocrevus is administered as an intravenous infusion.
Slovenian: Zdravilo Ocrevus se daje v intravenski infuziji.