natgillin/translations-raw huggingface dataset:
Evaluation including Magnetic Resonance Imaging (MRI) scan preferably with contrast (compared with pre-treatment MRI), confirmatory cerebro-spinal fluid (CSF) testing for John Cunningham (JC) Viral Deoxyribonucleic acid (DNA) and repeat neurological assessments, should be considered.
Razmisliti je treba o ovrednotenju, vključno s magnetnoresonančnimi posnetki, po možnosti s kontrastom (v primerjavi z magnetnoresonančnimi posnetki pred zdravljenjem), potrditvenim testiranjem cerebrospinalnega likvorja za deoksiribonukleinsko kislino (DNA) virusa John Cunningham in ponavljajočimi nevrološkimi ocenami.
Your doctor may decide to delay your treatment with Ocrevus.
Zdravnik se lahko odloči za odlog zdravljenja z zdravilom Ocrevus.
Grounds for the variation to the terms of the marketing authorisation(s) On the basis of the scientific conclusions for ocrelizumab the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing ocrelizumab is unchanged subject to the proposed changes to the product information.
Na podlagi znanstvenih zaključkov za okrelizumab odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil, ki vsebujejo okrelizumab, nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
Study WA25046 ORATORIO (n=732) Study design
Študija WA25046 ORATORIO (n = 732)
Ocrevus must be permanently discontinued in these patients (see section 4.3).
Pri takšnih bolnikih je treba uporabo zdravila Ocrevus trajno ukiniti (glejte poglavje 4.3).
What Ocrevus looks like and contents of the pack
Izgled zdravila Ocrevus in vsebina pakiranja
Symptoms can include, but are not limited to: itchy skin rash hives redness of the skin throat irritation or pain shortness of breath swelling of the throat flushing low blood pressure fever feeling tired headache feeling dizzy feeling sick (nausea) fast heart beat.
Nekateri od možnih simptomov so: srbeča koža izpuščaj koprivnica pordelost kože draženje žrela ali boleče žrelo kratka sapa oteklost žrela zardevanje nizek krvni tlak zvišana telesna temperatura občutek utrujenosti glavobol omotica siljenje na bruhanje (navzea)
Concentrate for solution for infusion 300 mg/10 ml
koncentrat za raztopino za infundiranje 300 mg/10 ml
Ocrevus is a humanised monoclonal antibody of an immunoglobulin G1 subtype and immunoglobulins are known to cross the placental barrier.
Zdravilo Ocrevus je humanizirano monoklonsko protitelo podvrste imunoglobulinov G1; za imunoglobuline je znano, da prehajajo skozi placentno pregrado.
Table 2 ADRs reported with Ocrevus (in RMS or PPMS)
Neželeni učinki, zabeleženi z zdravilom Ocrevus (pri RMS ali PPMS)
Ocrevus contains sodium
Zdravilo Ocrevus vsebuje natrij
Your doctor may decide to delay your treatment with Ocrevus, or may decide you cannot receive Ocrevus if: · you have an infection.
Zdravnik se lahko odloči za odlog zdravljenja z zdravilom Ocrevus, ali presodi, da ne morete dobivati zdravila Ocrevus, če:
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALEC BIOLOŠKE UČINKOVINE IN IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ
· Tell your doctor or nurse straight away if you experience any signs or symptoms of an infusion-related reaction during the infusion or up to 24 hours after the infusion.
• Zdravniku ali medicinski sestri morate takoj povedati, če se vam med infundiranjem zdravila ali do 24 ur po infundiranju pojavijo kakšni znaki ali simptomi z infuzijo povezanih reakcij.
Ocrevus is indicated for the treatment of adult patients with early primary progressive multiple sclerosis (PPMS) in terms of disease duration and level of disability, and with imaging features characteristic of inflammatory activity (see section 5.1).
Zdravilo Ocrevus je indicirano za zdravljenje odraslih bolnikov z zgodnjo primarno progresivno multiplo sklerozo (PPMS) glede na trajanje bolezni in stopnjo prizadetosti ter s slikovno diagnostiko opredeljenimi značilnostmi vnetne aktivnosti (glejte poglavje 5.1).
The adverse drug reactions were consistent with the safety profile for Ocrevus in the pivotal clinical studies.
Neželeni učinki zdravila so se skladali z varnostnimi značilnostmi zdravila Ocrevus v ključnih kliničnih študijah.
Ocrelizumab is a recombinant humanised monoclonal antibody that selectively targets CD20-expressing B cells.
Okrelizumab je rekombinantno humanizirano monoklonsko protitelo, selektivno usmerjeno na celice B, ki imajo izražen CD20.
· It is supplied as a concentrate for solution for infusion.
• Na voljo je kot koncentrat za raztopino za infundiranje.
If you are not sure, talk to your doctor before you are given Ocrevus.
Če ste negotovi, se posvetujte z zdravnikom, preden dobite zdravilo Ocrevus.
If a hypersensitivity reaction is suspected during infusion, the infusion must be stopped immediately and permanently.
V primeru suma na preobčutljivostno reakcijo med infundiranjem je treba infundiranje nemudoma in trajno končati.
Serious infections occurred in 6.2% of patients receiving Ocrevus vs 6.7% of patients receiving placebo.
Resne okužbe so se pojavile pri 6,2 % bolnikov, ki so prejemali zdravilo Ocrevus, in pri 6,7 % prejemnikov placeba.
Study design and baseline characteristics of the study population are summarised in Table 3.
Načrt študij in izhodiščne značilnosti raziskovanih populacij so povzeti v preglednici 3.
These reactions may present as pruritus, rash, urticaria, erythema, throat irritation, oropharyngeal pain, dyspnoea, pharyngeal or laryngeal oedema, flushing, hypotension, pyrexia, fatigue, headache, dizziness, nausea and tachycardia (see section 4.8).
Te reakcije se lahko pokažejo kot srbenje, izpuščaj, urtikarija, eritem, draženje žrela, orofaringealna bolečina, dispneja, edem žrela ali grla, zardevanje, hipotenzija, zvišana telesna temperatura, utrujenost, glavobol, omotica, navzea in tahikardija (glejte poglavje 4.8).
Subsequent Doses
Nadaljnji odmerki
IRR profiles per infusion were also similar, independent of whether the 600 mg dose was administered as a single 600 mg infusion or as two 300 mg infusions separated by two weeks (see sections 4.8 and 5.2), but due to overall more infusions with the 2 x 300 mg regimen, the total number of IRRs were higher.
Podobne so bile tudi značilnosti z infuzijo povezanih reakcij na infundiranje, neodvisno od tega, ali je bil 600-mg odmerek uporabljen v eni 600-mg infuziji ali v dveh 300-mg infuzijah v presledku dveh tednov (glejte poglavji 4.8 in 5.2), toda zaradi v celoti večjega števila infuzij po shemi 2 x 300 mg je bilo celotno število z infuzijo povezanih reakcij pri tej skupini večje.
· Chemical and physical in-use stability has been demonstrated for 24 hours at 2-8°C and subsequently 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.
The highest dose tested to date in MS patients is 2000 mg, administered as two 1000 mg intravenous infusions separated by 2 weeks (Phase II dose finding study in RRMS).
Največji doslej preskušeni odmerek pri bolnikih z multiplo sklerozo je 2000 mg, uporabljen v obliki dveh 1000-mg intravenskih infuzij v presledku 2 tednov (študija faze II za določitev odmerka pri recidivno-remitentni multipli sklerozi (RRMS)).
Ocrevus attaches to specific B cells, which are a type of white blood cells that are part of the immune system and play a role in MS. Ocrevus targets and removes those specific B cells.
Zdravilo Ocrevus se veže na posebne celice B, vrsto belih krvnih celic, ki so del imunskega sistema in igrajo vlogo pri multipli sklerozi.
In the placebo-controlled study in PPMS, infections occurred in 72.2% of patients receiving Ocrevus vs 69.9% of patients receiving placebo.
V študijah PPMS, kontroliranih s placebom, so se okužbe pojavile pri 72,2 % bolnikov, ki so prejemali zdravilo Ocrevus, in pri 69,9 % bolnikov, ki so prejemali placebo.
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.