FrancophonIA/ELRC3.0 huggingface dataset:
English: · Ocrevus is a clear to slightly opalescent, and colourless to pale brown solution.
Danish: • Ocrevus er en klar til let opaliserende og farveløs til lysebrun opløsning.
English: The most important and frequently reported adverse drug reactions (ADRs) were IRRs and infections.
Danish: De vigtigste og hyppigst indberettede bivirkninger var infusionsrelaterede reaktioner og infektioner.
English: Key clinical and MRI efficacy results are presented in Table 4 and Figure 1.
Danish: De vigtigste effektresultater, kliniske som MRI, præsenteres i Tabel 4 og Figur 1.
English: Figure 1: Dose and Schedule of Ocrevus
Danish: Figur 1: Dosis og doseringsskema for Ocrevus
English: · In the event an intravenous infusion cannot be completed the same day, the remaining solution should be discarded.
Danish: • Hvis en intravenøs infusion ikke kan gennemføres samme dag, skal overskydende opløsning smides ud.
English: Your doctor may decide to delay your treatment with Ocrevus.
Danish: Lægen kan beslutte at udskyde behandlingen med Ocrevus.
English: None of the patients was reported with Grade 4 lymphopenia (< 200 cells/mm3).
Danish: Der var ingen rapporter for grad 4 lymfopeni (<200 celler/mm3).
English: · Medicines that affect your immune system : 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.
Danish: • Lægemidler, som påvirker dit immunsystem: hvis du tager, har tidligere taget eller planlægger at tage, medicin der påvirker immunsystemet, fx kemoterapi, immunsupprimerende midler eller anden medicin til behandling af multipel sclerose.
English: They might notice symptoms of PML that you do not, such as memory lapses, trouble thinking, difficulty walking, sight loss, changes in the way you talk, which your doctor may need to investigate.
Danish: Måske opdager de symptomer på progressiv multifokal leukoencefalopati (PML), du ikke selv opdager, fx hukommelsestab, koncentrationsbesvær, gangbesvær, nedsat syn, at du taler på en anden måde, som din læge måske skal undersøge.
English: Read the SmPC for additional information.
Danish: Læs produktresumé for yderligere information.
English: · Chemical and physical in-use stability has been demonstrated for 24 hours at 2-8°C and subsequently 8 hours at room temperature.
Danish: • Der er påvist kemisk og fysisk stabilitet i 24 timer ved 2-8°C og efterfølgende i 8 timer ved stuetemperatur.
English: The results of these studies show that Ocrevus significantly suppressed relapses, sub-clinical disease activity measured by MRI, and disease progression compared with interferon beta-1a 44mcg subcutaneous.
Danish: Resultaterne af disse studier viser, at Ocrevus i betydelig grad reducerer antallet af attakker, subklinisk sygdomsaktivitet målt ved MRI samt sygdomsprogression sammenlignet med interferon-beta1a 44 mikrogram S.C.
English: If you stop Ocrevus treatment
Danish: Hvis du holder op med at bruge Ocrevus
English: The incidence remains within the background rate expected for an MS population.
Danish: Forekomsten er indenfor baggrundsraten, som forventes for en multipel sclerosepopulation.
English: Ocrelizumab is a recombinant humanised anti-CD20 monoclonal antibody produced in Chinese Hamster Ovary cells by recombinant DNA technology.
Danish: Ocrelizumab er et rekombinant, humaniseret, anti-CD20 monoklonalt antistof produceret i ovarieceller fra kinesiske hamstere ved rekombinant DNA-teknologi.
English: · Premedication: Patients must receive premedication to reduce the frequency and severity of IRRs (see section 4.2.
Danish: • Præmedicinering: Patienter skal præmedicineres for at mindske hyppigheden og sværhedsgraden af infusionsrelaterede reaktioner (se pkt.
English: infection of the stomach and bowel (gastroenteritis) respiratory tract infection viral infectionskin infection (cellulitis)
Danish: - infektion i mave og tarm (gastroenteritis) - luftvejsinfektion - virusinfektion - hudinfektion (cellulitis)
English: For the B cell counts, CD19 is used, as the presence of Ocrevus interferes with the recognition of CD20 by the assay.
Danish: Dette opretholdes under behandlingsperioden.CD19 anvendes til B-celle tællingen, da tilstedeværelsen af Ocrevus påvirker genkendelsen af CD20 i testen.
English: Mean age (years) Age range (years) at inclusion Gender distribution (% male/% female)
Danish: Kønsfordeling (% mænd/% kvinder)
English: · The diluted infusion solution must be administered using an infusion set with a 0.2 or 0.22 micron in-line filter.
Danish: • Den fortyndede infusionsopløsning skal administreres med infusionssæt med 0,2 eller 0,22 mikrometer in-line-filter.
English: Area under the curve (AUCτ) after the 4th dose of 600 mg ocrelizumab was 3510 µg/mL•day, and mean maximum concentration (Cmax) was 212 µg/mL in RMS (600 mg infusion) and 141 µg/mL in PPMS (300 mg infusions).
Danish: Arealet under kurven (AUCτ) efter 4. dosis af 600 mg ocrelizumab var 3510 µg/ml•dag, og den gennemsnitlige maksimale koncentration var 212 µg/ml i attakvis multipel sclerose-studierne (600 mg infusion) og 141 µg/ml i primær progressiv multipel sclerose-studiet (300 mg infusioner).
English: 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.
Danish: Ocrevus binder sig til specifikke B-celler, som er en type hvide blodlegemer, som er en del af immpunsystemet og som spiller en rolle i multipel sclerose.
English: Study 1: WA21092 (OPERA I)
Danish: Studie 1: WA21092 (OPERA I)
English: The overall exposure (AUC over the 24 weeks dosing interval) was identical in the 2 x 300 mg in PPMS and 1 x 600 mg in RMS studies, as expected given an identical dose was administered.
Danish: Den overordnede eksponering (AUC over doseringsintervallet på 24 uger) var identisk for 2 x 300 mg i primær progressiv multipel sclerose-studiet og 1 x 600 mg i attakvis multipel sclerose-studierne, hvilket var forventeligt idet de administrerede doser var identiske.
English: 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.
Danish: Symptomer kan blandt andet være: kløende hud udslæt nældefeber rødme af huden irritation eller smerter i halsen åndenød hævelse af halsen rødmen af ansigtet lavt blodtryk feber træthedsfornemmelse hovedpine svimmelhed føle sig syg (kvalme) hjertebanken
English: The incidence of IRRs was highest during Dose 1, infusion 1 (27.4%,) and decreased with subsequent doses to <10% at Dose 4.
Danish: Incidensen af infusionsrelaterede reaktioner var højest under dosis 1, infusion 1 (27,4 %) og faldt ved efterfølgende doser til <10 % ved dosis 4.
English: · If you have an infusion-related reaction, you will be given medicines to treat it and the infusion may need to be slowed down or stopped.
Danish: • Hvis du får en infusionsrelateret reaktion, vil du få medicin for at behandle den; måske vil lægen skrue ned for hastigheden eller stoppe infusionen helt.
English: 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.
Danish: De fleste tilfælde af fald i neutrofilocytter var forbigående (kun set én gang per patient behandlet med Ocrevus) og af sværhedsgrad 1 (<1500 celler/mm3) og 2 (mellem 1000 og 1500 celler/mm3).
English: · In Relapsing forms of MS (RMS),Ocrevus helps to significantly reduce the number of attacks (relapses) and significantly slow down the progression of the disease.
Danish: • Ved attakvis multipel sclerose (RMS) hjælper Ocrevus med at reducere antallet af attakker betydeligt og bremser betydeligt udviklingen af sygdommen.
English: Newborn offspring of maternal animals exposed to ocrelizumab were noted to have depleted B cell populations during the post natal phase.
Danish: Nyfødt afkom af hunner eksponeret for ocrelizumab er observeret at have lavt B-celle-niveau i den post-natale fase.
English: The impact of treatment-emergent ADAs on safety and efficacy cannot be assessed given the low incidence of ADA associated with Ocrevus.
Danish: Betydningen af behandlingsudløste anti-lægemiddel antistoffer for sikkerheden og virkningen kan, på grund af den lave incidens af anti-lægemiddel-antistoffer i forbindelse med Ocrevus, ikke vurderes.
English: · You will be closely monitored while you are being given Ocrevus and for at least 1 hour after the infusion has been given.
Danish: • Du vil blive fulgt tæt mens du får Ocrevus og i mindst 1 time efter infusionen er færdig.
English: Patients with mild renal impairment were included in clinical trials and no change in the pharmacokinetics of Ocrevus was observed in those patients.
Danish: Der har været inkluderet patienter med let nedsat nyrefunktion i de kliniske studier, og der blev ikke set ændringer i Ocrevus' farmakokinetik hos disse patienter.
English: Study 2: WA21093 (OPERA II)
Danish: Studie 2: WA21093 (OPERA II)
English: The incidence of IRRs was highest during the Dose 1, infusion 1 (27.5%) and decreased over time to <10% at Dose 4.
Danish: Incidensen af infusionsrelaterede reaktioner var højest under dosis 1, infusion 1 (27,5%) og faldt over tid til <10% ved dosis 4.
English: The first subsequent dose of 600 mg should be administered six months after the first infusion of the initial dose.
Danish: Første efterfølgende dosis af 600 mg skal administreres seks måneder efter første infusion af første dosis.
English: Prior to the start of the intravenous infusion, the content of the infusion bag should be at room temperature.
Danish: Inden den intravenøse infusion påbegyndes, bør indholdet af infusionsposen opnå stuetemperatur.
English: No infusion adjustment is necessary for subsequent new infusions, unless the patient experiences an IRR.
Danish: Justering af infusion er ikke nødvendig ved efterfølgende infusioner, med mindre patienten oplever en infusionsrelateret reaktion.
English: In a randomized open-label study in RMS patients (N=102), the percentage of patients with a positive response to tetanus vaccine at 8 weeks after vaccination was 23.9% in the ocrelizumab group compared to 54.5% in the control group (no disease-modifying therapy except interferon-beta).
Danish: I et randomiseret åbent studie hos patienter med attakvis multipel sclerose (n = 102) var den procentvise andel af patienter med et positivt respons på stivkrampevaccine 8 uger efter vaccinationen på 23,9 % i gruppen behandlet med ocrelizumab sammenlignet med 54,5 % i kontrolgruppen (ingen sygdomsmodificerende behandling bortset fra interferon-beta).
English: It is recommended to verify the patient's immune status before dosing since severely immunocompromised patients (e.g. with lymphopenia, neutropenia, hypogammaglobulinemia) should not be treated (see sections 4.3 and 4.8).
Danish: Det anbefales at kontrollere patientens immunstatus før dosering, da svært immunkompromitterede patienter (e.g med lymfopeni, neutropeni, hypogammaglobulinæmi) ikke må behandles (se pkt.
English: Do not use the solution if discoloured or if the solution contains foreign particulate matter.
Danish: Brug ikke opløsningen, hvis den er misfarvet eller indeholder fremmede partikler.
English: No dose reductions of Ocrevus are recommended.
Danish: Det anbefales ikke at ændre dosis af Ocrevus.
English: The frequency of grade 4 (life-threatening) and grade 5 (fatal) infections was low in all treatment groups, but in PPMS it was higher with Ocrevus compared with placebo for life-threatening (1.6% vs 0.4%) and fatal (0.6% vs 0%) infections.
Danish: Hyppigheden af grad 4 (livstruende) og grad 5 (dødelige) infektioner var lav i alle behandlingsgrupper, men i PPMS behandlingsgruppen var hyppigheden af livstruende (1,6% vs. 0,4%) og dødelige (0,6 % vs. 0%) infektioner højere med Ocrevus sammenlignet med placebo behandlingsgruppen.
English: Cranial MRI showed imaging features characteristic of inflammatory activity either by T1 Gd enhancing lesions or T2 lesions.
Danish: MRI af kraniet viste radiologiske fund, der var karakteristiske for inflammatorisk aktivitet enten ved Gdopladende T1-læsioner eller T2-læsioner.
English: 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%).
Danish: I de kontrollerede attakvis multipel sclerose-studier med aktiv komparator var der flere indberetninger af herpesinfektion blandt Ocrevus-behandlede patienter end blandt interferon-beta-1a-behandlede patienter, inklusive 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%) og herpesvirusinfektion (0,1% vs. 0%).
English: Ocrelizumab is a recombinant humanised monoclonal antibody that selectively targets CD20-expressing B cells.
Danish: Ocrelizumab er et rekombinant, humaniseret monoklonalt antistof selektivt målrettet B-celler, der udtrykker CD20.
English: Following cell surface binding, ocrelizumab selectively depletes CD20-expressing B cells through antibody-dependent cellular phagocytosis (ADCP), antibody-dependent cellular cytotoxicity (ADCC), complement-dependent cytotoxicity (CDC), and apoptosis.
Danish: Efter celleoverfladebinding, depleterer ocrelizumab selektivt B-celler, der udtrykker CD20, ved antistofafhængig cellulær fagocytose, antistofafhængig cellulær cytotoksicitet, komplementafhængig cytotoksicitet samt apoptose.
English: The product is intended for single use only.
Danish: Produktet er beregnet til éngangsbrug.
English: Mean number of T1 Gd-enhancing lesions per MRI scan
Danish: Gennemsnitligt antal T1 Gd-opladende læsioner per MRI
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.
Danish: I det placebo-kontrollerede kliniske studie (primær progressiv multipel sclerose) var andelen af Ocrevus-patienter med fald i neutrofilocytter højere (12,9%) end for placebo-patienter (10,0%) ; blandt disse havde en højere procentdel af patienterne (4,3%) i Ocrevus-gruppen neutropeni af grad 2 eller højere versus 1,3% i placebo-gruppen; ca. 1% af patienterne i Ocrevus-gruppen havde grad 4 neutropeni versus 0% i placebo-gruppen.
English: 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).
Danish: Den højeste testede dosis hos multipel sclerose-patienter til dato er 2000 mg, administreret som to intravenøse infusioner af 1000 mg, med to ugers mellemrum (fase II dosistitreringsstudier i attakvis multipel sklerose).
English: Your doctor will tell you whether your MS may affect your ability to drive or use tools and machines safely.
Danish: Lægen vil vurdere om du er i stand til at føre motorkøretøj eller bruge maskiner sikkert.
English: Infusion-related reactions1
Danish: Infusionsrelaterede reaktion1
English: Dose Modifications during Treatment
Danish: Dosisændringer under behandling
English: · Each infusion should be given over approximately 3.5 hours
Danish: • Hver infusion skal gives over ca. 3,5 time
English: · The active substance is ocrelizumab.
Danish: • Aktivt stof: ocrelizumab.
English: A minimum interval of 5 months should be maintained between each dose of Ocrevus.
Danish: Der skal gå mindst 5 måneder mellem hver dosis Ocrevus.
English: 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.
Danish: Positivt respons på ≥ 5 serotyper hos 23-valent pneumokok polysakkaridvaccine (23-PPV) ved 4 uger efter vaccination var på 71,6 % i gruppen behandlet med ocrelizumab og 100 % i kontrolgruppen.
English: Table 4 Key Clinical and MRI Endpoints from Studies WA21092 and WA21093 (RMS)
Danish: Tabel 4 Vigtigste kliniske og MRI-endepunkter fra studie WA21092 og WA21093 (attakvis multipel sclerose)
English: The diluted infusion solution must be administered using an infusion set with a 0.2 or 0.22 micron in-line filter.
Danish: Den fortyndede infusionsopløsning skal administreres med infusionssæt med 0,2 eller 0,22 mikrometer in-line-filter.
English: The majority of IRRs were mild to moderate.
Danish: De fleste infusionsrelaterede reaktioner var milde til moderate.
English: The infusion may be slowed, temporarily stopped or permanently stopped if you have an infusion-related reaction, depending on how serious it is (see sections 2 and 4 for information about infusion-related reactions).
Danish: Infusionen kan gives langsommere, midlertidigt afbrydes eller afbrydes helt, hvis du får en infusionsrelateret reaktion, afhængigt af hvor alvorlig den er (se pkt.
English: Initial Dose
Danish: Første dosis
English: Serious infections occurred in 6.2% of patients receiving Ocrevus vs 6.7% of patients receiving placebo.
Danish: Alvorlige infektioner sås hos 6,2% af patienterne behandlet med Ocrevus vs. 6,7% af patienterne behandlet med placebo.
English: Concentrate for solution for infusion 300 mg/10 ml
Danish: Koncentrat til infusionsvæske, opløsning 300 mg/10 ml
English: This is because Ocrevus may cross the placenta and affect your baby.
Danish: Det er vigtigt, fordi Ocrevus kan optages i moderkagen og måske påvirke barnet.
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)*
Danish: Figur 1 Kaplan-Meier-plot af tid til indtræden af bekræftet handicapudvikling opretholdt i mindst 12 uger, med initial hændelse i form af neurologisk forværring, opstået under den dobbeltblinde behandlingsperiode (poolet WA21092 og WA21093 ITT-population)*
English: If tolerated, the infusion rate may then be increased according to the patient's initial infusion rate.
Danish: Hvis dette tåles af patienten, kan infusionshastigheden øges til den oprindelige infusionshastighed.
English: Other medicines and Ocrevus
Danish: Brug af anden medicin sammen med Ocrevus
English: 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).
Danish: Selv i progressiv multipel sclerose kan sygdomsaktivitet i form af inflammatorisk aktivitet være relateret til radiologiske fund (fx. Gd-opladende T1-læsioner og/eller aktive (nye eller forstørrede) T2-læsioner).
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
English: Proportion of patients Relapse free at 96 weeks
Danish: Andel af patienter uden attakker ved 96 uger2
English: · 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.
Danish: • Behandling med Ocrevus bør påbegyndes og superviseres af erfarent sundhedspersonale med adgang til relevant medicinsk understøttende behandling af svære reaktioner, fx alvorlige infusionsrelaterede reaktioner, overfølsomhedsreaktioner og/eller anafylaktiske reaktioner.
English: If a hypersensitivity reaction is suspected during infusion, the infusion must be stopped immediately and permanently (see ‘Hypersensitivity Reactions' below).
Danish: Hvis der under infusionen opstår mistanke om overfølsomhedsreaktion, skal infusionen straks og permanent afbrydes (se ‘Allergiske reaktioner' herunder).
English: Patients should be monitored during the infusion and for at least one hour after the completion of the infusion.
Danish: Patienter skal overvåges under infusionen og i mindst en time efter infusionen.
English: · The rate can be increased in 30 mL/hour increments every 30 minutes to a maximum of 180 mL/hour.
Danish: • Hastigheden kan øges i trin af 30 ml/time hver 30. minut til maksimalt 180 ml/time.
English: Medicines you will have before you are given Ocrevus Before you are given Ocrevus, you will receive other medicines to prevent or reduce possible side effects such as infusion-related reactions (see sections 2 and 4 for information about infusion-related reactions).
Danish: Inden du får Ocrevus, vil du få anden medicin, der skal forebygge eller mindske risikoen for bivirkninger, bl.a. infusionsrelaterede reaktioner (se pkt.
English: · While you are being treated with Ocrevus, you should not be given live or live attenuated vaccines (for example BCG for tuberculosis or vaccines against yellow fever).
Danish: • Du må ikke blive vaccineret med levende eller svækkede levende vacciner (fx mod tuberkulose eller gul feber), mens du er i behandling med Ocrevus.
English: · Each infusion should be given over approximately 2.5 hours
Danish: • Hver infusion skal gives over ca. 2,5 time
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.
Danish: Det bør overvejes at udsætte vaccination med levende eller svækkede levende vacciner hos nyfødte og spædbørn, hvis mødre har fået Ocrevus under graviditeten.
English: 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.
Danish: • Følgende forholdsregler skal tages for patienter, der oplever svære pulmonære symptomer, fx bronkospasme eller astmaexacerbation: Skal permanent have afbrudt infusionen Symptomatisk behandling skal gives - Patienten skal monitoreres indtil de pulmonære symptomer er svundne, da umiddelbar bedring i kliniske symptomer kan afløses af forværring.
English: Women of child bearing potential should use contraception while receiving Ocrevus and for 12 months after the last infusion of Ocrevus (see below and section 5.1 and 5.2).
Danish: Fertile kvinder skal anvende prævention under behandling med Ocrevus og i 12 måneder efter sidste infusion af Ocrevus (se nedenfor samt pkt.
English: Sodium Acetate Trihydrate Glacial Acetic Acid Trehalose Dihydrate Polysorbate 20
Danish: Trehalosedihydrat Polysorbat 20
English: In the event an intravenous infusion cannot be completed the same day, the remaining solution should be discarded.
Danish: Hvis en intravenøs infusion ikke gennemføres samme dag, skal overskydende opløsning smides ud.
English: 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)*
Danish: Kaplan-Meier-plot over tid til indtræden af bekræftet invaliditetsprogression opretholdt i mindst 12 uger med initial hændelse i form af neurologisk forværring opstået, under den dobbeltblinde behandlingsperiode (WA25046 ITTpopulation)*