natgillin/translations-raw huggingface dataset:
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
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.