FrancophonIA/ELRC3.0 huggingface dataset:
English: 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)*
Slovenian: 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
English: It is not known whether Ocrevus can affect your being able to drive or use tools or machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Ni znano, ali lahko zdravilo Ocrevus vpliva na sposobnost upravljanja vozil, orodij in strojev.
English: · The first 600 mg dose of Ocrevus will be given as 2 separate infusions (300 mg each), given
Slovenian: • Prvi 600-mg odmerek zdravila Ocrevus boste dobili v 2 ločenih infuzijah (vsako s 300 mg) v presledku 2 tednov.
English: See sections 4.4 and 4.5.
Slovenian: Glejte poglavji 4.4 in 4.5.
English: An updated RMP should be submitted:
Slovenian: Posodobljen RMP je treba predložiti: • na zahtevo Evropske agencije za zdravila;
English: See section 4.4 and 5.1.
Slovenian: Glejte poglavji 4.4 in 5.1.
English: Treatment groups
Slovenian: Terapevtski skupini
English: 180 mL/hour.
Slovenian: 30 mg/ml.
English: The terminal elimination half-life of ocrelizumab was 26 days.
Slovenian: Terminalni razpolovni čas izločanja okrelizumaba je bil
English: Each vial contains 300 mg of ocrelizumab in 10 mL at a concentration of 30mg/mL.
Slovenian: Ena viala vsebuje 300 mg okrelizumaba v 10 ml s koncentracijo 30 mg/ml.
English: Management of IRRs before the infusion
Slovenian: Obvladovanje z infuzijo povezanih reakcij pred infundiranjem
English: 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.
Slovenian: 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.
English: Proportion of patients with 24 weeks - Confirmed Disability Progression1
Slovenian: Delež bolnikov s 24-tedenskim potrjenim napredovanjem prizadetosti
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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 %.
English: 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.
Slovenian: 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.
English: Study design
Slovenian: Načrt študije
English: Table 1: Dose and Schedule of Ocrevus
Slovenian: Preglednica 1: Odmerek in razpored uporabe zdravila Ocrevus
English: 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.
Slovenian: Obsegajo lahko težave s hojo ali ravnotežjem, šibkost, omrtvelost, dvojen ali zamegljen vid, slabo koordinacijo gibov in težave s sečnim mehurjem.
English: See section 4.5 and 5.1.
Slovenian: Glejte poglavji 4.5 in 5.1.
English: Infusion instructions
Slovenian: Navodila za infundiranje
English: 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.
Slovenian: 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.
English: Single infusion 600 mg in 500 mL · Initiate the infusion at a rate of 40 mL/hour for 30 minutes
Slovenian: Enkratna infuzija 600 mg v 500 ml • Infundiranje začnite s hitrostjo 40 ml/uro za
English: Diluted solution for intravenous infusion
Slovenian: Razredčena raztopina za intravensko infundiranje
English: You will always be given Ocrevus as a drip (intra-venous infusion)
Slovenian: Zdravilo Ocrevus boste vedno dobili kot intravensko infuzijo (kapalno).
English: Table 6 Key Clinical and MRI Endpoints from Study WA25046 (PPMS) Study 3
Slovenian: Ključni klinični opazovani dogodki in opazovani dogodki z magnetnoresonančnimi posnetki v študiji WA25046 (PPMS)
English: Proportion of patients with Gd enhancing T1 lesions Mean EDSS*
Slovenian: Delež bolnikov, ki imajo z gadolinijem obarvane lezije T1
English: Study 1: WA21092 (OPERA I)
Slovenian: Študija 1: WA21092
English: STATEMENT OF ACTIVE SUBSTANCE(S) One vial contains 300 mg ocrelizumab in 10 ml (30 mg/ml).
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena viala vsebuje 300 mg okrelizumaba v 10 ml (30 mg/ml).
English: See section 4.4 ‘Treatment of severely immunocompromised patients' for information about the use of immunosuppressants before, during or after Ocrevus treatment.
Slovenian: Za informacije o uporabi imunosupresivov pred zdravljenjem z zdravilom Ocrevus, med njim in po njem glejte poglavje 4.4, "Zdravljenje imunsko zelo oslabelih bolnikov".
English: Mean/Median disease duration since diagnosis (years) Patients naive to previous DMT
Slovenian: Povprečno/mediano trajanje od diagnoze (leta) Bolniki, ki predhodno niso prejemali zdravil, ki spreminjajo potek bolezni
English: The diluted infusion solution must be administered using an infusion set with a 0.2 or 0.22 micron in-line filter.
Slovenian: Razredčeno raztopino za infundiranje je treba uporabiti s kompletom za infundiranje, ki ima 0,2- ali
English: Proportion of patients with 12 week Confirmed Disability Progression Risk Reduction (Pooled Analysis Risk Reduction (Individual Studies
Slovenian: Zmanjšanje tveganja (kumulativna analiza Zmanjšanje tveganja (posamezna študija
English: Unopened vial
Slovenian: Rok uporabnosti Neodprta viala
English: IFN 44 mcg (n=418)
Slovenian: IFN 44 µg (n = 418)
English: 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.
Slovenian: 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 %).
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: valentnega pnevmokoknega polisaharida, neoantigena hemocianina iz školjke (keyhole limpet hemocyanin) in sezonskih cepiv proti gripi.
English: Common: may affect up to 1 in 10 people · cough · a build-up of thick mucus in the nose, throat or chest.
Slovenian: • nastajanje goste sluzi v nosu, žrelu ali prsnem košu
English: 7.6% Ocrevus vs 12.0% IFN 40% (p=0.0025)7 43 % (p=0.0278)7
Slovenian: 7,6 % zdravilo Ocrevus v primerjavi z 12,0 % IFN 40 % (p = 0,0025)
English: 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.
Slovenian: 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.
English: Disease history at screening
Slovenian: Anamneza bolezni ob presejanju
English: Initial Dose (600 mg) divided into 2 infusions
Slovenian: (600 mg) razdeljen na
English: · The other ingredients are sodium acetate trihydrate, glacial acetic acid, trehalose dihydrate, polysorbate 20 and water for injection.
Slovenian: • Druge sestavine zdravila so natrijev acetat trihidrat, koncentrirana ocetna kislina,
English: Subsequent doses of Ocrevus thereafter are administered as a single 600 mg intravenous infusion every 6 months (Table 1).
Slovenian: Nadaljnji odmerki Nadaljnje odmerke zdravila Ocrevus je treba dajati v odmerku 600 mg v enkratni intravenski infuziji na 6 mesecev (preglednica 1).
English: After you stop Ocrevus treatment, you may still experience side effects until your B-cells return to normal.
Slovenian: • 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.
English: Patients should be monitored during the infusion and for at least one hour after the completion of the infusion.
Slovenian: Obvladovanje z infuzijo povezanih reakcij med infundiranjem in po njem Bolnike je treba nadzirati med infundiranjem in vsaj še eno uro po koncu infundiranja.
English: Pharmacotherapeutic group: selective immunosuppressants group, ATC code: L04AA36.
Slovenian: Oznaka ATC: L04AA36.
English: 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.
Slovenian: 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.
English: The treatment interval of 6 months (with a minimum of 5 months) for Ocrevus should be maintained between doses (see Table 1).
Slovenian: 6 mesecev (oz. vsaj 5 mesecev) (glejte preglednico 1).
English: Infusion Adjustments in case of IRRs
Slovenian: Prilagoditve infundiranja v primeru z infuzijo povezanih reakcij
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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
English: The overall proportion of patients experiencing a serious infection was similar to comparators (see section 4.8).
Slovenian: Celotni delež bolnikov, ki se jim je pojavila resna okužba, je bil podoben kot s primerjalnimi zdravili
English: Patients with known IgE mediated hypersensitivity to ocrelizumab must not be treated (see section 4.3).
Slovenian: S tem zdravilom se ne sme zdraviti bolnikov, ki imajo znano z IgE posredovano preobčutljivost na okrelizumab (glejte poglavje 4.3).
English: 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.
Slovenian: 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 %.
English: An increased number of malignancies (including breast cancers) have been observed in clinical trials in patients treated with ocrelizumab, compared to control groups.
Slovenian: 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.
English: Infusion 1 300 mg in 250 mL · Initiate the infusion at a rate of 30 mL/hour for 30 minutes
Slovenian: 300 mg v 250 ml • Infundiranje začnite s hitrostjo 30 ml/uro za
English: 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
Slovenian: 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].
English: 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.
Slovenian: 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.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Ocrevus 300 mg concentrate for solution for infusion ocrelizumab
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Ocrevus 300 mg koncentrat za raztopino za infundiranje okrelizumab i.v.
English: 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
Slovenian: 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.
English: IFN 44 mcg (n=411)
Slovenian: IFN 44 µg (n = 411)
English: Ocrevus 300 mg concentrate for solution for infusion Ocrelizumab
Slovenian: Ocrevus 300 mg koncentrat za raztopino za infundiranje okrelizumab
English: · Ocrevus should be prepared by a healthcare professional using aseptic technique.
Slovenian: Navodila za razredčenje • Zdravilo Ocrevus mora pripraviti zdravstveni delavec; postopek mora biti opravljen aseptično.
English: Primary Progressive MS
Slovenian: Primarno progresivna multipla skleroza
English: · You might get infections more easily with Ocrevus.
Slovenian: • Med zdravljenjem z zdravilom Ocrevus se vam lahko poveča dovzetnost za okužbe.
English: NAME OF THE MEDICINAL PRODUCT Ocrevus 300 mg concentrate for solution for infusion
Slovenian: IME ZDRAVILA Ocrevus 300 mg koncentrat za raztopino za infundiranje
English: Ocrevus medicinal product must be diluted before administration.
Slovenian: Zdravilo Ocrevus je treba pred uporabo razredčiti.
English: Roche Pharma AG Emil-Barell-Strasse 1 79639 Grenzach-Whylen Germany
Slovenian: 79639 Grenzach-Whylen Nemčija
English: None of the patients was reported with Grade 4 lymphopenia (< 200 cells/mm3).
Slovenian: 3) in en bolnik z nevtropenijo 4. stopnje (< 500 celic/mm
English: How to store Ocrevus
Slovenian: Kako se daje zdravilo Ocrevus
English: 1 Defined as an increase of ≥ 1.0 point from the baseline 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 120.
Slovenian: (p = 0,0206) 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 120 tednih.
English: Please refer to section 4.8 for information about the Systemic Inflammatory Response Syndrome (SIRS) that occurred in a patient treated with Ocrevus 2000 mg.
Slovenian: Za informacije o sindromu sistemskega vnetnega odziva, ki se je pojavil pri bolniku, zdravljenem z 2000 mg zdravila Ocrevus, glejte poglavje 4.8.
English: Postponing vaccination with live or live-attenuated vaccines should be considered for neonates and infants born to mothers who have been exposed to Ocrevus in utero.
Slovenian: Pri novorojenčkih in dojenčkih, ki so bili izpostavljeni zdravilu Ocrevus in utero, je treba razmisliti o odlogu cepljenja z živimi ali živimi oslabljenimi cepivi.
English: The respiratory tract infections reported in patients treated with Ocrevus were predominately mild to moderate (80 - 90 %).
Slovenian: Okužbe dihal, zabeležene pri prejemnikih zdravila Ocrevus, so bile pretežno blage do zmerne
English: 21,7% and 10.1% of Ocrevus treated patients experienced mild and moderate IRRs respectively, 2.4% experienced severe IRRs and 0.1% experienced lifethreatening IRRs.
Slovenian: Med bolniki, ki so prejemali zdravilo Ocrevus, so se blage z infuzijo povezane reakcije pojavile pri 21,7 % in zmerne pri 10,1 % bolnikov; hude z infuzijo povezane reakcije so se pojavile pri 2,4 % bolnikov, življenjsko ogrožajoče pa pri 0,1 % bolnikov.
English: · Hypersensitivity may be difficult to distinguish from an IRR in terms of symptoms.
Slovenian: • Kar zadeva simptome, je preobčutljivost včasih težko razločiti od z infuzijo povezane reakcije.
English: There is no experience in patients with moderate and severe renal impairment.
Slovenian: Izkušenj pri bolnikih z zmerno in hudo okvaro ledvic ni.
English: Percentage change in Timed 25-Foot Walk from baseline to Week 120 Relative reduction in progression rate of walking time
Slovenian: Odstotek spremembe pri testu hoje na 25 čevljev (7,62 m) od izhodišča do 120. tedna
English: · Hypotension, as a symptom of IRR, may occur during Ocrevus infusions.
Slovenian: • Med infundiranjem zdravila Ocrevus se lahko kot simptom z infuzijo povezanih reakcij pojavi hipotenzija.
English: · Current active infection (see section 4.4) · Patients in a severely immunocompromised state (see section 4.4 ).
Slovenian: • Trenutno aktivna okužba (glejte poglavje 4.4)
English: 2 weeks apart.
Slovenian: 26 dni.
English: · Talk to your doctor before vaccinating your baby.
Slovenian: • Preden daste otroka cepiti, se pogovorite z zdravnikom.
English: Respiratory, thoracic and mediastinal disorders
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora kašelj, katar
English: What Ocrevus contains
Slovenian: Kaj vsebuje zdravilo Ocrevus
English: Transient peripheral B-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other anti-CD20 antibodies during pregnancy.
Slovenian: Pri dojenčkih mater, ki so bile med nosečnostjo izpostavljene drugim protitelesom proti CD20, so poročali o prehodnem zmanjšanju števila perifernih celic B in o limfocitopeniji.
English: Patients with mild renal impairment were included in clinical trials.
Slovenian: V klinična preskušanja so bili vključeni bolniki z blago okvaro ledvic.
English: The following information is intended for healthcare professionals only:
Slovenian: Naslednje informacije so namenjene samo zdravstvenemu osebju: Za dodatne informacije preberite povzetek glavnih značilnosti zdravila.
English: Common: may affect up to 1 in 10 people sinus infection bronchitis (bronchial tube inflammation) herpes infection (cold sore or shingles).
Slovenian: - gripa pogoste: pojavijo se lahko pri do 1 od 10 bolnikov - okužba obnosnih votlin (sinusov)
English: There is no experience in patients with moderate and severe hepatic impairment.
Slovenian: Izkušenj pri bolnikih z zmerno in hudo okvaro jeter ni.
English: Annualised Relapse Rate (ARR) (primary endpoint)
Slovenian: Klinični opazovani dogodki Na leto preračunani delež recidivov (primarni opazovani dogodek)
English: Patients enrolled in the ongoing clinical trials continue to be dosed with 600 mg ocrelizumab every six months after they become 55 and older.
Slovenian: tudi po 55. letu še naprej prejemajo odmerek 600 mg okrelizumaba na šest mesecev.
English: Roche Registration GmbH Emil-Barell-Strasse 1 79639 Grenzach-Wyhlen Germany
Slovenian: D-79639 Grenzach-Wyhlen Nemčija
English: IV after dilution
Slovenian: po razredčenju
English: 26.7% and 11.9% of Ocrevus treated patients experienced mild and moderate IRRs respectively, 1.4% experienced severe IRRs.
Slovenian: Med bolniki, ki so prejemali zdravilo Ocrevus, so se blage z infuzijo povezane reakcije pojavile pri 26,7 % in zmerne pri 11,9 % bolnikov; hude z infuzijo povezane reakcije so se pojavile pri 1,4 % bolnikov.
English: 6.2 Incompatibilities
Slovenian: 2 infundiranji
English: They will watch you closely while you are being given this medicine.
Slovenian: Med dajanjem zdravila vas bodo skrbno opazovali za primer, da bi se vam pojavili kakšni neželeni učinki.
English: Solutions of Ocrevus for intravenous infusion are prepared by dilution of the medicinal product into an infusion bag containing 0.9% sodium chloride, to a final concentration of approximately 1.2 mg/mL.For instructions on dilution of the medicinal product before administration see section 6.6.
Slovenian: Raztopino zdravila Ocrevus za intravensko infundiranje je treba pripraviti tako, da se zdravilo razredči v infuzijski vreči, ki vsebuje 0,9-% natrijev klorid, do končne koncentracije približno 1,2 mg/ml.
English: There is no PK information available in patients with moderate or severe renal impairment.
Slovenian: Informacij o farmakokinetiki pri bolnikih z zmerno ali hudo okvaro ledvic ni.
English: Posology:
Slovenian: Po infundiranju: