natgillin/translations-raw huggingface dataset:
Proportion of patients with at least 12 weeks Confirmed Disability Improvement 
Delež bolnikov z vsaj 12-tedenskim potrjenimi izboljšanjem prizadetosti4
· The rate can be increased in 40 mL/hour increments every 30 minutes to a maximum of 200 mL/hour 
• Hitrost je mogoče na 30 minut povečevati po 40 ml/uro do največ 200 ml/uro.
Pre-specified non-powered subgroup analysis of the the primary endpoint suggests that patients who are younger or those with T1 Gd-enhancing lesions at baseline receive a greater treatment benefit than patients who are older or without T1 Gd-enhancing lesions (≤ 45 years: HR 0.64 [0.45, 0.92], >45 years: HR 0.88 [0.62, 1.26]; with T1 Gd-enhancing lesions at baseline: HR 0.65 [0.40-1.06], without T1 Gd-enhancing lesions at baseline: HR 0.84 [0.62-1.13]). 
Vnaprej načrtovana analiza (za katero ni bila izbrana ustrezna statistična moč) primarnega opazovanega dogodka po podskupinah kaže, da zdravljenje bolj koristi mlajšim bolnikom in bolnikom, ki imajo v izhodišču z gadolinijem obarvane lezije T1, kakor starejšim bolnikom in bolnikom, ki v izhodišču nimajo z gadolinijem obarvanih lezij T1 (≤ 45 let: RO 0,64 [0,45; 0,92], > 45 let: RO 0,88 [0,62; 1,26]; z gadolinijem obarvane lezije v izhodišču: RO 0,65 [0,40-1,06], brez z gadolinijem obarvanih lezij T1 v izhodišču: RO 0,84 [0,62-1,13]).
In patients treated with ocrelizumab a booster vaccine (13-PCV) given 4 weeks after 23-PPV did not markedly enhance the response to 12 serotypes 
Pri bolnikih, zdravljenih z okrelizumabom, obnovitveno cepivo 13-PCV (13-valentno konjugirano pnevmokokno cepivo), dano 4 tedne po cepivu 23-PPV, ni znatno izboljšalo odziva na 12 serotipov, skupnih s cepivom 23-PPV.
Mean age (years) Age range (years) at inclusion Gender distribution (% male/% female) 
Porazdelitev spolov (% moških/% žensk)
The two following premedications must be administered prior to each Ocrevus infusion to reduce the frequency and severity of IRRs: -100 mg intravenous methylprednisolone (or an equivalent) approximately 30 minutes prior to each Ocrevus infusion; -antihistamine approximately 30-60 minutes prior to each Ocrevus infusion; In addition, premedication with an antipyretic (e.g. paracetamol) may also be considered approximately 30-60 minutes prior to each Ocrevus infusion. 
Pred vsakim infundiranjem zdravila Ocrevus je treba za zmanjšanje pogostnosti in izrazitosti z infuzijo povezanih reakcij uporabiti naslednji premedikaciji: 100 mg metilprednizolona (ali ekvivalent) intravensko približno 30 minut pred vsakim infundiranjem zdravila Ocrevus; antihistaminik približno 30 do 60 minut pred vsakim infundiranjem zdravila Ocrevus; Poleg tega pride v poštev tudi premedikacija z antipiretikom (npr. s paracetamolom), in sicer približno 30 do 60 minut pred vsakim infundiranjem zdravila Ocrevus.
· Ocrevus is a clear to slightly opalescent, and colourless to pale brown solution. 
• Zdravilo Ocrevus je bistra do rahlo opalescentna in brezbarvna do bledorjava raztopina.
During the infusion: · The following measures need to be taken for patients who experience severe pulmonary symptoms, such as bronchospasm or asthma exacerbation: their infusion must be interrupted immediately and permanently symptomatic treatment must be administered the patient must be monitored until the pulmonary symptoms have resolved because initial improvement of clinical symptoms could be followed by deterioration · Hypersensitivity may be difficult to distinguish from an IRR in terms of symptoms. 
• Pri bolnikih, ki se jim pojavijo hudi pljučni simptomi, na primer bronhospazem ali poslabšanje astme, je treba izvesti naslednje ukrepe: nemudoma in trajno je treba prekiniti infundiranje; začeti je treba simptomatsko zdravljenje; bolnika je treba nadzirati, dokler pljučni simptomi ne minejo, saj lahko uvodnemu izboljšanju kliničnih simptomov sledi poslabšanje.
No studies have been conducted to investigate the pharmacokinetics of ocrelizumab in children and adolescents <18 years of age. 
Študij farmakokinetike okrelizumaba pri otrocih in mladostnikih, starih < 18 let, niso izvedli.
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). 
Zdravilo Ocrevus je indicirano za zdravljenje odraslih bolnikov z recidivnimi oblikami multiple skleroze (RMS), ki imajo klinično ali s slikovno diagnostiko opredeljeno aktivno bolezen (glejte poglavje 5.1).
This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e., it is essentially sodium-free. 
To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni “brez natrija”.
· Ocrevus treatment should be initiated and supervised by an experienced healthcare professional with access to appropriate medical support to manage severe reactions such as serious infusionrelated reactions (IRRs), hypersensitivity reactions and/or anaphylactic reactions. 
• Zdravljenje z zdravilom Ocrevus mora uvesti in nadzorovati usposobljen zdravnik, ki ima dostop do ustrezne medicinske podpore, potrebne za obvladanje hudih reakcij, kot so na primer resne z infuzijo povezane reakcije, preobčutljivostne reakcije in/ali anafilaktične reakcije.
*Pre-specified pooled analysis of WA21092 and WA21093 
Vnaprej določena kumulativna analiza študij WA21092 in WA21093
Amount of Ocrevus to be administered 
Količina zdravila Ocrevus, ki jo je treba uporabiti
If you miss an infusion of Ocrevus 
Če ste izpustili infuzijo zdravila Ocrevus
The safety of immunisation with live or live-attenuated vaccines, following Ocrevus therapy has not been studied. 
Varnost cepljenja z živimi ali oslabljenimi živimi cepivi po zdravljenju z zdravilom Ocrevus ni raziskana.
An increased rate of serious infections was observed during episodes of confirmed total lymphocytes counts decrease in ocrelizumab treated patients. 
Med obdobji potrjenega zmanjšanja celotnega števila limfocitov so pri bolnikih, ki so prejemali okrelizumab, opažali večji delež resnih okužb.
Chemical and physical in-use stability has been demonstrated for 24 hours at 2-8°C and subsequently for 8 hours at room temperature. 
Kemijska in fizikalna stabilnost med uporabo sta dokazani do 24 ur pri temperaturi od 2 do 8 °C in nadalje 8 ur pri sobni temperaturi.
· Ocrevus infusions should not be administered as an intravenous push or bolus. 
• Infuzij zdravila Ocrevus se ne sme dati s forsirano intravensko aplikacijo ali kot bolus.
Serious infections occurred in 1.3% of patients receiving Ocrevus vs 2.9% of patients receiving interferon beta 1a. 
Resne okužbe so se pojavile pri 1,3 % bolnikov, ki so prejemali zdravilo Ocrevus, in pri 2,9 % bolnikov, ki so prejemali interferon beta-1a.
In controlled trials there were no fatal IRRs. 
V kontroliranih preskušanjih ni bilo z infuzijo povezanih reakcij s smrtnim izidom.
Cranial MRI showed imaging features characteristic of inflammatory activity either by T1 Gd enhancing lesions or T2 lesions. 
Kranialni magnetnoresonančni posnetki so pokazali značilnosti, ki opredeljujejo vnetno aktivnost, bodisi z gadolinijem obarvanimi lezijami T1 bodisi z lezijami T2.
The following infections have been seen in patients treated with Ocrevus in MS: - Very common: may affect more than 1 in 10 people upper respiratory tract infection flu. 
• Pri bolnikih, ki so za zdravljenje multiple skleroze prejemali zdravilo Ocrevus, so opažali naslednje okužbe: zelo pogoste: pojavijo se lahko pri več kot 1 od 10 bolnikov - okužba zgornjih dihal
Figure 2: 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 (WA25046 ITT Population)* 
Slika 2: Kaplan-Meierjev prikaz časa do pojava potrjenega napredovanja prizadetosti, ohranjeni vsaj 12 tednov, z začetnim dogodkom nevrološkega poslabšanja med dvojno slepim obdobjem zdravljenja (populacija z namenom zdravljenja iz študije WA25046)*
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. it is essentially sodium-free. 
To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni "brez natrija".
Patients receiving Ocrevus (Group A) were given 600 mg every 6 months (Dose 1 as 2 x 300 mg intravenous infusions, administered 2 weeks apart, and subsequent doses were administered as a single 600 mg intravenous infusion). 
Bolniki, ki so prejemali zdravilo Ocrevus (skupina A), so dobivali 600 mg na 6 mesecev (1. odmerek kot intravenski infuziji 2 x 300 mg, dani v presledku 2 tednov, nadaljnje odmerke pa so dajali v eni intravenski infuziji 600 mg).
During the Phase 3 PPMS study, patients received 600 mg Ocrevus every 6 months as two 300 mg infusions, given two weeks apart, throughout the treatment period. 
V študiji faze III pri PPMS so bolniki med celotnim obdobjem zdravljenja prejemali zdravilo Ocrevus na 6 mesecev v odmerku 600 mg v obliki dveh 300-mg infuzij, uporabljenih v presledku dveh tednov.
Taking into account the PRAC Assessment Report on the PSUR(s) for ocrelizumab, the scientific conclusions of CHMP are as follows: 
Upoštevajoč poročilo Odbora za oceno tveganja na področju farmakovigilance (PRAC) o oceni rednih posodobljenih poročil o varnosti zdravila (PSUR) za okrelizumab je Odbor za zdravila za uporabo v humani medicini (CHMP) sprejel naslednje znanstvene zaključke:
Therefore, withholding of antihypertensive treatments should be considered for 12 hours prior to and throughout each Ocrevus infusion. 
Zato je treba razmisliti o začasni prekinitvi antihipertenzivne terapije v 12 urah pred infundiranjem zdravila Ocrevus in med njegovim infundiranjem.
The incidence of IRRs was highest during the Dose 1, infusion 1 (27.5%) and decreased over time to <10% at Dose 4. 
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.
Study design and baseline characteristics of the study population are presented in Table 5. 
Načrt študije in izhodiščne značilnosti raziskovane populacije so prikazani v preglednici 5.
Patients in a severely immunocompromised state must not be treated until the condition resolves (see section 4.3. 
Imunsko zelo oslabelih bolnikov se ne sme zdraviti, dokler takšno stanje ne mine (glejte poglavje 4.3).
Ocrevus infusions should not be administered as an intravenous push or bolus. 
Infuzij zdravila Ocrevus se ne sme dati s forsirano intravensko aplikacijo ali kot bolus.
Very common: may affect more than 1 in 10 people · decrease in specific proteins in the blood (immunoglobulins) which help protect against infection 
• zmanjšanje koncentracije specifičnih beljakovin v krvi (imunoglobulinov), ki pomagajo varovati pred okužbami
· If you get any side effects, talk to your doctor or nurse. 
• Če opazite katerega koli izmed neželenih učinkov, se posvetujte z zdravnikom ali medicinsko sestro.
Infections included and were not limited to atypical pneumonia and pneumocystis jirovecii pneumonia, varicella pneumonia, tuberculosis, histoplasmosis. 
Med takšnimi okužbami so bile atipična pljučnica in pljučnica zaradi Pneumocystis jirovecii, pljučnica zaradi virusa varicelle, tuberkuloza, histoplazmoza, a ne le te.
· In relapsing forms of MS. the patient has repeated attacks of symptoms (relapses). 
• Pri recidivnih oblikah multiple skleroze imajo bolniki ponavljajoče napade simptomov
Any unused medicinal product or waste material should be disposed of in accordance with local requirements. 
Odlaganje neuporabljenih zdravil/zdravil, ki jim je potekel rok uporabnosti Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
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. 
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.
The safety and efficacy of Ocrevus in patients with renal impairment has not been formally studied. 
Varnost in učinkovitost zdravila Ocrevus pri bolnikih z okvaro ledvic nista formalno raziskani.
If you stop Ocrevus treatment 
Če ste prenehali uporabljati zdravilo Ocrevus
A hypersensitivity reaction may present during any infusion, although typically would not present during the first infusion. 
Preobčutljivostne reakcije se lahko pojavijo med katerim koli infundiranjem, a praviloma ne med prvim infundiranjem.
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. 
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.
The majority of IRRs were mild to moderate. 
Večina z infuzijo povezanih reakcij je bila blagih do zmernih.
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. 
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 %).
· Each infusion should be given over approximately 2.5 hours. 
• Vsako infundiranje mora trajati približno 2,5 ure.
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. 
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.
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). 
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).
The incidence of IRRs was highest during Dose 1, infusion 1 (27.4%,) and decreased with subsequent doses to <10% at Dose 4. 
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.
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. 
Pri bolnikih z znanimi dejavniki tveganja za maligne bolezni in bolnikih, aktivno nadzorovanih zaradi ponovitve maligne bolezni, je treba individualno pretehtati korist in tveganje.
Ocrevus administration must be delayed in patients with an active infection until the infection is resolved. 
Pri bolnikih z aktivno okužbo je treba uporabo zdravila Ocrevus odložiti, dokler okužba ne mine.
· you have ever had hepatitis B or are a carrier of the hepatitis B virus. 
• 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.
Table 5 Study design, demograhics and baseline characteristics for Study WA25046. 
Načrt študije, demografske in izhodiščne značilnosti v študiji WA25046 Ime študije
METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use For intravenous use after dilution Do not shake the vial 
POSTOPEK IN POT(I) UPORABE ZDRAVILA Pred uporabo preberite priloženo navodilo za intravensko uporabo po razredčenju
See section 4.5 and 5.1 for further information about vaccinations. 
Za nadaljnje informacije glede cepljenj glejte poglavji 4.5 in 5.1.
Ocrelizumab is a recombinant humanised anti-CD20 monoclonal antibody produced in Chinese Hamster Ovary cells by recombinant DNA technology. 
Okrelizumab je rekombinantno humanizirano monoklonsko protitelo proti CD20, pridobljeno s tehnologijo rekombinantne DNA v celicah jajčnika kitajskega hrčka.
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%). 
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
Patients with mild renal impairment were included in clinical trials and no change in the pharmacokinetics of Ocrevus was observed in those patients. 
Bolniki z blago okvaro ledvic so bili vključeni v klinična preskušanja in pri teh bolnikih niso opazili sprememb farmakokinetike zdravila Ocrevus.
After dilution, Ocrevus is administered as an intravenous infusion through a dedicated line. 
Po razredčenju se zdravilo Ocrevus daje kot intravenska infuzija po namenski intravenski liniji.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 300 mg/10 ml 
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 300 mg/10 ml
There were no life-threatening IRRs. 
Življenjsko ogrožajočih z infuzijo povezanih reakcij ni bilo.
· Ocrevus medicinal product must be diluted before administration. 
• Zdravilo Ocrevus je treba pred uporabo razredčiti.
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. 
• 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.
Clear to slightly opalescent, and colourless to pale brown solution. 
Bistra do rahlo opalescentna in brezbarvna do bledorjava raztopina.
· 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). 
• 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)
Caution should be exercised when prescribing Ocrevus taking into consideration the pharmacodynamics of other disease modifying MS therapies. 
V primeru predpisovanja zdravila Ocrevus je potrebna previdnost in upoštevati je treba farmakodinamiko drugih imunomodulirajočih zdravil za zdravljenje multiple skleroze.
Preclinical data reveal no special hazards for humans based on studies of male and female fertility in cynomologous monkeys. 
Predklinični podatki na osnovi študij plodnosti samcev in samic opic cynomolgus ne kažejo posebnih tveganj za človeka.
· Each infusion should be given over approximately 3.5 hours 
• Vsako infundiranje mora trajati približno 3,5 ure.
· After dilution, Ocrevus is administered as an intravenous infusion through a dedicated line. 
• Po razredčenju se zdravilo Ocrevus daje kot intravenska infuzija po namenski intravenski liniji.
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. 
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.
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 
Vsaj dva recidiva v zadnjih dveh letih ali en recidiv v zadnjem letu; EDSS* od 0 do vključno 5,5
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). 
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]
Name and address of the manufacturer responsible for batch release 
Ime in naslov izdelovalca, odgovornega za sproščanje serij Roche Pharma AG
· The active substance is ocrelizumab. 
• Učinkovina je okrelizumab.
If PML is suspected, dosing with Ocrevus must be withheld. 
V primeru suma na PML je treba uporabo zdravila Ocrevus zadržati.
Figure 1: Dose and Schedule of Ocrevus 
Slika 1: Odmerek in razpored uporabe zdravila Ocrevus
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. 
• 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.
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. 
Zdravilo Ocrevus bo shranjevalo zdravstveno osebje v bolnišnici ali ambulanti v naslednjih pogojih:
Approximately 1% of the patients in the Ocrevus group had a Grade 3 lymphopenia (between 200 and 500 cells/mm3). 
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
Table 4 Key Clinical and MRI Endpoints from Studies WA21092 and WA21093 (RMS) 
Ključni klinični opazovani dogodki in opazovani dogodki z magnetnoresonančnimi posnetki v študijah WA21092 in WA21093 (RMS)
infection of the stomach and bowel (gastroenteritis) respiratory tract infection viral infectionskin infection (cellulitis) 
- okužba s herpesom (herpes na ustnici ali pasovec) - okužba želodca in črevesa (gastroenteritis) - okužba dihal - virusna okužba - okužba kože (celulitis)
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. 
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
Ocrevus should be prepared by a healthcare professional using aseptic technique. 
Zdravilo Ocrevus mora pripraviti zdravstveni delavec; postopek mora biti opravljen aseptično.
What Ocrevus is and what it is used for 
Kaj vsebuje navodilo Kaj je zdravilo Ocrevus in za kaj ga uporabljamo
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. 
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