natgillin/translations-raw huggingface dataset:
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. 
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.
· Hypotension: As a symptom of IRR, may occur during Ocrevus infusions. 
• Hipotenzija: med infundiranjem zdravila Ocrevus se lahko pojavi kot simptom z infuzijo povezane reakcije.
B-cell depletion in utero was detected. 
Ugotovili so zmanjšanje števila celic B in utero.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, and embryo-foetal development. 
Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih odmerkih in embriofetalnega razvoja ne kažejo posebnega tveganja za človeka.
The metabolism of Ocrevus has not been directly studied, as antibodies are cleared principally by catabolism (i.e. breakdown into peptides and amino acids). 
Presnove zdravila Ocrevus niso raziskali neposredno, ker se protitelesa odstranijo predvsem s katabolizmom (t.j.
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. 
(23-valentno polisaharidno pnevmokokno cepivo) 4 tedne po cepljenju je bil 71,6 % v skupini z okrelizumabom in 100 % v kontrolni skupini.
· This medicine is to be stored in a refrigerator (2oC - 8oC). 
• Shranjujte v hladilniku (2 do 8 °C).
In PPMS, a decrease in lymphocytes <LLN was observed in 26.3% of Ocrevus treated patients vs 11.7% of placebo-treated patients. 
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.
Key clinical and MRI efficacy results are presented in Table 6 and Figure 2. 
Ključni klinični rezultati učinkovitosti in rezultati učinkovitosti, merjeni z magnetno resonanco, so prikazani v preglednici 6 in na sliki 2.
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. 
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.
Ocrevus is used to treat adults with: · Relapsing forms of multiple sclerosis (RMS) · Early primary progressive multiple sclerosis (PPMS) 
• recidivnimi oblikami multiple skleroze (RMS) • zgodnjo primarno progresivno multiplo sklerozo (PPMS).
IRRs can occur within 24 hours of the infusion. 
Z infuzijo povezane reakcije se lahko pojavijo v 24 urah po infundiranju.
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 
(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.
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. 
Na podlagi maloštevilnih razpoložljivih podatkov (glejte poglavje 5.1 in poglavje 5.2) bolnikom po
Premedication for infusion-related reactions 
• Premedikacija za reakcije, povezane z infuzijo
Blood immunoglobulin G decreased 
Preiskave znižanje imunoglobulinov M v krvi znižanje imunoglobulinov G v krvi
· Patients treated with Ocrevus should be observed for at least one hour after the completion of the infusion for any symptom of an IRR. 
• Bolnike, zdravljene z zdravilom Ocrevus, je treba vsaj eno uro po dokončanju infundiranja opazovati glede morebitnih simptomov z infuzijo povezane reakcije.
For guidance regarding posology for patients experiencing IRR symptoms see section 4.2. 
Glede smernic za odmerjanje pri bolnikih, ki se jim pojavijo simptomi z infuzijo povezanih reakcij, glejte poglavje 4.2.
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. 
Imunski sistem (telesni obrambni sistem) pri multipli sklerozi ne deluje pravilno ter napade zaščitno plast (t.i.
Talk to your doctor before you are given Ocrevus if any of the following apply to you. 
Preden dobite zdravilo Ocrevus, se posvetujte z zdravnikom, če za vas velja kar koli od naslednjega.
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. 
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.
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. 
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.
Percentage change in T2 hyperintense lesion volume, from baseline to Week 120 
Opazovani dogodki z magnetnoresonančnimi posnetki Odstotek spremembe volumna hiperintenzivnih lezij T2 od izhodišča do 120. tedna
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. 
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.
Key clinical and MRI efficacy results are presented in Table 4 and Figure 1. 
Ključni klinični rezultati in rezultati učinkovitosti, merjeni z magnetnoresonančno slikovno diagnostiko, so prikazani v preglednici 4 in na sliki 1.
Study 2: WA21093 (OPERA II) 
Študija 2: WA21093
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. 
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.
Ocrevus is administered as an intravenous infusion. 
Zdravilo Ocrevus se daje v intravenski infuziji.
Figure 1: Kaplan-Meier Plot of Time to Onset of Confirmed Disability Progression Sustained for at Least 12 Weeks with the Initial Event of Neurological Worsening Occurring during the Double-blind Treatment Period (Pooled WA21092 and WA21093 ITT Population)* 
Slika 1: Kaplan-Meierjev prikaz časa do pojava potrjenega napredovanja prizadetosti, ohranjeni vsaj 12 tednov, z začetnim dogodkom nevrološkega poslabšanja med dvojno slepim obdobjem zdravljenja (kumulativna populacija z namenom zdravljenja iz študij WA21092 in
It is not known whether Ocrevus can affect your being able to drive or use tools or machines. 
Vpliv na sposobnost upravljanja vozil in strojev Ni znano, ali lahko zdravilo Ocrevus vpliva na sposobnost upravljanja vozil, orodij in strojev.
· The first 600 mg dose of Ocrevus will be given as 2 separate infusions (300 mg each), given 
• Prvi 600-mg odmerek zdravila Ocrevus boste dobili v 2 ločenih infuzijah (vsako s 300 mg) v presledku 2 tednov.
See sections 4.4 and 4.5. 
Glejte poglavji 4.4 in 4.5.
An updated RMP should be submitted: 
Posodobljen RMP je treba predložiti: • na zahtevo Evropske agencije za zdravila;
See section 4.4 and 5.1. 
Glejte poglavji 4.4 in 5.1.
Treatment groups 
Terapevtski skupini
180 mL/hour. 
30 mg/ml.
The terminal elimination half-life of ocrelizumab was 26 days. 
Terminalni razpolovni čas izločanja okrelizumaba je bil
Each vial contains 300 mg of ocrelizumab in 10 mL at a concentration of 30mg/mL. 
Ena viala vsebuje 300 mg okrelizumaba v 10 ml s koncentracijo 30 mg/ml.
Management of IRRs before the infusion 
Obvladovanje z infuzijo povezanih reakcij pred infundiranjem
In the PPMS clinical trial, 48.8% of Ocrevus treated patients and 42.7% of patients who received placebo experienced an upper respiratory tract infection, and 9.9% of Ocrevus treated patients and 9.2% of patients who received placebo experienced a lower respiratory tract infection. 
V kliničnem preskušanju pri PPMS so se okužbe zgornjih dihal pojavile pri 48,8 % prejemnikov zdravila Ocrevus in pri 42,7 % prejemnikov placeba, okužbe spodnjih dihal pa pri 9,9 % prejemnikov zdravila Ocrevus in pri 9,2 % prejemnikov placeba.
Proportion of patients with 24 weeks - Confirmed Disability Progression1 
Delež bolnikov s 24-tedenskim potrjenim napredovanjem prizadetosti
Defined as decrease of ≥ 1.0 point from the baseline EDSS score for patients with baseline EDSS score ≥ 2 and ≤ 5.5, or ≥0.5 when the baseline score is > 5.5. 
Opredeljeno kot znižanje za ≥ 1,0 točko od izhodiščne ocene EDSS pri bolnikih z izhodiščno oceno EDSS ≥ 2 in ≤ 5,5 oziroma za ≥ 0,5 pri bolnikih z izhodiščno oceno > 5,5.
In active-controlled (RMS) clinical trials, IRR was the most common adverse event in patients treated with Ocrevus with an overall incidence of 34.3% compared with an incidence of 9.9% in the interferon beta-1a treatment group (placebo infusion). 
V kliničnih preskušanjih (RMS), kontroliranih z učinkovino, so bile z infuzijo povezane reakcije najpogostejši neželeni učinek pri bolnikih, zdravljenih z zdravilom Ocrevus; njihova skupna pojavnost je bila pri teh bolnikih 34,3 %, v skupini, zdravljeni z interferonom beta-1a (infuzija placeba), pa 9,9 %.
Due to the potential depletion of B cells in infants of mothers who have been exposed to Ocrevus during pregnancy, it is recommended that vaccination with live or live-attenuated vaccines should be delayed until B-cell levels have recovered; therefore, measuring CD19-positive B-cell levels, in neonates and infants, prior to vaccination is recommended It is recommended that all vaccinations other than live or live-attenuated should follow the local immunisation schedule and measurement of vaccine-induced response titers should be considered to check whether individuals have mounted a protective immune response because the efficacy of the vaccination may be decreased. 
Priporočljivo je, da vsa cepljenja razen živih ali živih oslabljenih sledijo lokalnemu programu cepljenja; ker je lahko učinkovitost cepljenja manjša, je treba razmisliti o meritvah titrov odziva na cepivo, da bi preverili, ali so posamezniki dosegli zaščitni imunski odziv.
Study design 
Načrt študije
Table 1: Dose and Schedule of Ocrevus 
Preglednica 1: Odmerek in razpored uporabe zdravila Ocrevus
Symptoms of MS depend on which part of the central nervous system is affected and can include problems with walking and balance, weakness, numbness, double vision and blurring, poor coordination and bladder problems. 
Obsegajo lahko težave s hojo ali ravnotežjem, šibkost, omrtvelost, dvojen ali zamegljen vid, slabo koordinacijo gibov in težave s sečnim mehurjem.
See section 4.5 and 5.1. 
Glejte poglavji 4.5 in 5.1.
Infusion instructions 
Navodila za infundiranje
In the active-controlled (RMS) treatment period, a decrease in neutrophils < LNN was observed in 14.7% of Ocrevus patients compared with 40.9% of patients treated with interferon beta-1a. 
Nevtrofilci Med obdobjem zdravljenja (RMS), kontroliranim z učinkovino, so zmanjšanje števila nevtrofilcev pod spodnjo normalno mejo zabeležili pri 14,7 % prejemnikov zdravila Ocrevus in pri 40,9 % prejemnikov interferona beta-1a.
Single infusion 600 mg in 500 mL · Initiate the infusion at a rate of 40 mL/hour for 30 minutes 
Enkratna infuzija 600 mg v 500 ml • Infundiranje začnite s hitrostjo 40 ml/uro za
Diluted solution for intravenous infusion 
Razredčena raztopina za intravensko infundiranje
You will always be given Ocrevus as a drip (intra-venous infusion) 
Zdravilo Ocrevus boste vedno dobili kot intravensko infuzijo (kapalno).
Table 6 Key Clinical and MRI Endpoints from Study WA25046 (PPMS) Study 3 
Ključni klinični opazovani dogodki in opazovani dogodki z magnetnoresonančnimi posnetki v študiji WA25046 (PPMS)
Proportion of patients with Gd enhancing T1 lesions Mean EDSS* 
Delež bolnikov, ki imajo z gadolinijem obarvane lezije T1
Study 1: WA21092 (OPERA I) 
Študija 1: WA21092
STATEMENT OF ACTIVE SUBSTANCE(S) One vial contains 300 mg ocrelizumab in 10 ml (30 mg/ml). 
NAVEDBA ENE ALI VEČ UČINKOVIN Ena viala vsebuje 300 mg okrelizumaba v 10 ml (30 mg/ml).
See section 4.4 ‘Treatment of severely immunocompromised patients' for information about the use of immunosuppressants before, during or after Ocrevus treatment. 
Za informacije o uporabi imunosupresivov pred zdravljenjem z zdravilom Ocrevus, med njim in po njem glejte poglavje 4.4, "Zdravljenje imunsko zelo oslabelih bolnikov".
Mean/Median disease duration since diagnosis (years) Patients naive to previous DMT 
Povprečno/mediano trajanje od diagnoze (leta) Bolniki, ki predhodno niso prejemali zdravil, ki spreminjajo potek bolezni
The diluted infusion solution must be administered using an infusion set with a 0.2 or 0.22 micron in-line filter. 
Razredčeno raztopino za infundiranje je treba uporabiti s kompletom za infundiranje, ki ima 0,2- ali
Proportion of patients with 12 week Confirmed Disability Progression Risk Reduction (Pooled Analysis Risk Reduction (Individual Studies 
Zmanjšanje tveganja (kumulativna analiza Zmanjšanje tveganja (posamezna študija
Unopened vial 
Rok uporabnosti Neodprta viala
IFN 44 mcg (n=418) 
IFN 44 µg (n = 418)
In the placebo-controlled (PPMS) clinical trial, the proportion of Ocrevus patients presenting decreased neutrophils was higher (12.9 %) than placebo patients (10.0 %); among these a higher percentage of patients (4.3%) in the Ocrevus group had Grade 2 or above neutropenia vs 1.3% in the placebo group; approximately 1% of the patients in the Ocrevus group had Grade 4 neutropenia vs 0% in the placebo group. 
V kliničnem preskušanju (PPMS), kontroliranem s placebom, je bil delež prejemnikov zdravila Ocrevus z zmanjšanjem števila nevtrofilcev večji (12,9 %) kot med prejemniki placeba (10,0 %); med temi je imel nevtropenijo 2. stopnje ali več večji delež prejemnikov zdravila Ocrevus (4,3 %) kot prejemnikov placeba (1,3 %).
Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure and death, has been reported in patients treated with anti-CD20 antibodies. 
Pri bolnikih, zdravljenih s protitelesi proti CD20, je bila opisana reaktivacija virusa hepatitisa B (HBV), v nekaterih primerih s posledičnim fulminantnim hepatitisom, odpovedjo jeter in smrtjo.
In RMS, a decrease in lymphocyte < LLN was observed in 20.7% of Ocrevus patients compared with 32.6% of patients treated with interferon beta-1a. 
Limfociti Pri RMS so zmanjšanje števila limfocitov pod spodnjo normalno mejo opažali pri 20,7 % bolnikov, ki so prejemali zdravilo Ocrevus, in pri 32,6 % bolnikov, ki so prejemali interferon beta-1a.
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. 
valentnega pnevmokoknega polisaharida, neoantigena hemocianina iz školjke (keyhole limpet hemocyanin) in sezonskih cepiv proti gripi.
Common: may affect up to 1 in 10 people · cough · a build-up of thick mucus in the nose, throat or chest. 
• nastajanje goste sluzi v nosu, žrelu ali prsnem košu
7.6% Ocrevus vs 12.0% IFN 40% (p=0.0025)7 43 % (p=0.0278)7 
7,6 % zdravilo Ocrevus v primerjavi z 12,0 % IFN 40 % (p = 0,0025)
Solutions of Ocrevus for intravenous administration are prepared by dilution of the drug product into an infusion bag containing isotonic 0.9% sodium chloride (300 mg / 250 mL or 600 mg / 500 mL), to a final drug concentration of approximately 1.2 mg/mL. 
Raztopino zdravila Ocrevus za intravensko infundiranje je treba pripraviti z razredčenjem zdravila v infuzijski vreči, ki vsebuje izotonični 0,9-% natrijev klorid (300 mg/250 ml ali 600 mg/500 ml), tako da je končna koncentracija zdravila približno 1,2 mg/ml.
Disease history at screening 
Anamneza bolezni ob presejanju
Initial Dose (600 mg) divided into 2 infusions 
(600 mg) razdeljen na
· The other ingredients are sodium acetate trihydrate, glacial acetic acid, trehalose dihydrate, polysorbate 20 and water for injection. 
• Druge sestavine zdravila so natrijev acetat trihidrat, koncentrirana ocetna kislina,
Subsequent doses of Ocrevus thereafter are administered as a single 600 mg intravenous infusion every 6 months (Table 1). 
Nadaljnji odmerki Nadaljnje odmerke zdravila Ocrevus je treba dajati v odmerku 600 mg v enkratni intravenski infuziji na 6 mesecev (preglednica 1).
After you stop Ocrevus treatment, you may still experience side effects until your B-cells return to normal. 
• Nekateri neželeni učinki so lahko povezani z majhnim številom celic B. Po koncu zdravljenja z zdravilom Ocrevus boste morda še vedno imeli neželene učinke, dokler število celic B ne postane spet normalno.
Patients should be monitored during the infusion and for at least one hour after the completion of the infusion. 
Obvladovanje z infuzijo povezanih reakcij med infundiranjem in po njem Bolnike je treba nadzirati med infundiranjem in vsaj še eno uro po koncu infundiranja.
Pharmacotherapeutic group: selective immunosuppressants group, ATC code: L04AA36. 
Oznaka ATC: L04AA36.
If a patient experiences a severe IRR (such as dyspnea) or a complex of flushing, fever, and throat pain symptoms, the infusion should be interrupted immediately and the patient should receive symptomatic treatment. 
Če se bolniku pojavi huda z infuzijo povezana reakcija (npr. dispneja) ali skupek simptomov, ki obsega zardevanje, zvišano telesno temperaturo in bolečine v žrelu, je treba infundiranje nemudoma prekiniti in bolnika simptomatsko zdraviti.
The treatment interval of 6 months (with a minimum of 5 months) for Ocrevus should be maintained between doses (see Table 1). 
6 mesecev (oz. vsaj 5 mesecev) (glejte preglednico 1).
Infusion Adjustments in case of IRRs 
Prilagoditve infundiranja v primeru z infuzijo povezanih reakcij
If a patient experiences a mild to moderate IRR (e.g. headache), the infusion rate should be reduced to half the rate at the onset of the event. 
Če se bolniku pojavi blaga do zmerna z infuzijo povezana reakcija (npr. glavobol), je treba hitrost infundiranja zmanjšati na polovico tiste hitrosti, pri kateri je prišlo do reakcije.
Ocrevus is a monoclonal antibody and cleared via catabolism (rather than hepatic metabolism), and a change in dose is not expected to be required for patients with hepatic impairment (see section 5.2). 
Zdravilo Ocrevus je monoklonsko protitelo, ki se odstrani s katabolizmom (ne s presnovo v jetrih), zato ni pričakovati, da bi bilo bolnikom z okvaro jeter odmerek treba prilagoditi
The overall proportion of patients experiencing a serious infection was similar to comparators (see section 4.8). 
Celotni delež bolnikov, ki se jim je pojavila resna okužba, je bil podoben kot s primerjalnimi zdravili
Patients with known IgE mediated hypersensitivity to ocrelizumab must not be treated (see section 4.3). 
S tem zdravilom se ne sme zdraviti bolnikov, ki imajo znano z IgE posredovano preobčutljivost na okrelizumab (glejte poglavje 4.3).
In the placebo-controlled (PPMS) clinical trial, IRR was the most common adverse event in patients treated with Ocrevus with an overall incidence of 40.1% compared with an incidence of 25.5% in the placebo group. 
V kliničnih preskušanjih (PPMS), kontroliranih s placebom, so bile z infuzijo povezane reakcije najpogostejši neželeni učinek pri bolnikih, zdravljenih z zdravilom Ocrevus; njihova skupna pojavnost je bila pri teh bolnikih 40,1 %, pri prejemnikih placeba pa 25,5 %.
An increased number of malignancies (including breast cancers) have been observed in clinical trials in patients treated with ocrelizumab, compared to control groups. 
V kliničnih preskušanjih so med prejemniki okrelizumaba opažali več malignih bolezni (vključno z rakom dojke) kot v kontrolnih skupinah, vendar je bila njihova pojavnost v okviru deleža, pričakovanega za populacijo z multiplo sklerozo.
Infusion 1 300 mg in 250 mL · Initiate the infusion at a rate of 30 mL/hour for 30 minutes 
300 mg v 250 ml • Infundiranje začnite s hitrostjo 30 ml/uro za
Moreover, post-hoc analyses suggested that younger patients with T1 Gd-enhancing lesions at baseline have the better treatment effect (≤ 45 years: HR 0.52 [0.27-1.00]; ≤ 46 years [median age of the 
Poleg tega so analize post-hoc pokazale, da je pri mlajših bolnikih, ki imajo v izhodišču z gadolinijem obarvane lezije T1, učinek zdravljenja boljši: ≤ 45 let: RO 0,52 [0,27-1,00); ≤ 46 let [mediana starost v študiji WA25046]; RO 0,48 [0,25-0,92]; < 51 let: RO 0,53 [0,31-0,89].
If there are signs of a life threatening or disabling IRR during an infusion, such as acute hypersensitivity or acute respiratory distress syndrome the infusion must be stopped immediately and the patient should receive appropriate treatment. 
Če se med infundiranjem pojavijo znaki z infuzijo povezane reakcije, ki ogrozi bolnikovo življenje ali bolnika onesposobi, na primer akutna preobčutljivost ali sindrom akutne dihalne stiske, je treba infundiranje nemudoma prekiniti in bolnika ustrezno zdraviti.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Ocrevus 300 mg concentrate for solution for infusion ocrelizumab 
IME ZDRAVILA IN POT(I) UPORABE Ocrevus 300 mg koncentrat za raztopino za infundiranje okrelizumab i.v.
Defined as an increase of ≥ 1.0 point from the baseline Expanded Disability Status Scale (EDSS) score for patients with baseline score of 5.5 or less, or ≥ 0.5 when the baseline score is > 5.5, Kaplan-Meier estimates at Week 96 
Opredeljeno kot povečanje za ≥ 1,0 točko od izhodiščne ocene EDSS pri bolnikih z izhodiščno oceno 5,5 ali manj oziroma za ≥ 0,5 točke v primeru izhodiščne ocene > 5,5; Kaplan-Meierjeve ocene po 96 tednih.
IFN 44 mcg (n=411) 
IFN 44 µg (n = 411)
Ocrevus 300 mg concentrate for solution for infusion Ocrelizumab 
Ocrevus 300 mg koncentrat za raztopino za infundiranje okrelizumab
· Ocrevus should be prepared by a healthcare professional using aseptic technique. 
Navodila za razredčenje • Zdravilo Ocrevus mora pripraviti zdravstveni delavec; postopek mora biti opravljen aseptično.
Primary Progressive MS 
Primarno progresivna multipla skleroza
· You might get infections more easily with Ocrevus. 
• Med zdravljenjem z zdravilom Ocrevus se vam lahko poveča dovzetnost za okužbe.