FrancophonIA/ELRC3.0 huggingface dataset:
English: Chemical and physical in-use stability has been demonstrated for 24 hours at 2-8°C and subsequently for 8 hours at room temperature.
Danish: Der er påvist kemisk og fysisk holdbarhed i 24 timer ved 2-8°C og efterfølgende i 8 timer ved stuetemperatur.
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.
Danish: 1 Defineret som stigning på ≥1,0 point fra baseline EDSS-score for patienter med en baseline-score på 5,5 eller derunder eller ≥0,5 hvis baseline-scoren er >5,5; Kaplan-Meier-estimater ved uge 120.
English: · Hypersensitivity may be difficult to distinguish from an IRR in terms of symptoms.
Danish: • Det kan være svært at skelne en overfølsomhedsreaktion fra en infusionsrelateret reaktion med hensyn til symptomer.
English: Proportion of patients with No Evidence of Disease Activity (NEDA)
Danish: Andel af patienter uden tegn på sygdomsaktivitet (NEDA)5 Relativ stigning2
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.
Danish: Ocrevus-opløsninger til intravenøs administration forberedes ved at fortynde lægemidlet i en infusionpose indeholdende isotonisk 0,9% natriumchlorid (300 mg/250 ml eller 600 mg/500 ml) til en endelig lægemiddelkoncentration på ca. 1,2 mg/ml.
English: 7.6% Ocrevus vs 12.0% IFN 40% (p=0.0025)7 43 % (p=0.0278)7
Danish: 7,6% Ocrevus vs. 12,0% Interferon-beta-1a 40% (p=0,0025)7 43% (p=0,0278)7
English: See section 4.5 and 5.1.
Danish: Se pkt 4.5 og 5.1.
English: Ocrevus contains the active substance ‘ocrelizumab'.
Danish: Ocrevus indeholder det aktive middel ocrelizumab.
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.
Danish: I det kliniske primær progressiv multipel sclerose-studie oplevede 48,8% af de Ocrevus-behandlede patienter og 42,7% af de patienter, der fik placebo en øvre luftvejsinfektion, og 9,9% af de Ocrevusbehandlede patienter og 9,2% af de patienter, der fik placebo oplevede en nedre luftvejsinfektion.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 300 mg/10 ml
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 300 mg/10 ml
English: Primary efficacy endpoint Proportion of patients with 12 weeks - Confirmed Disability Progression1 (primary endpoint)
Danish: Kliniske endepunkter Vigtige effekt-endepunkt Andel af patienter med 12 ugers bekræftet handicapudvikling1 (primært endepunkt)
English: Annualised Relapse Rate (ARR) (primary endpoint)
Danish: Kliniske endepunkter Årligt antal attakker (primært endepunkt)
English: Patients with mild renal impairment were included in clinical trials.
Danish: Patienter med let nedsat nyrefunktion har været inkluderet i kliniske studier.
English: Your doctor may decide to delay your treatment with Ocrevus or may ask you to stop such medicines before starting treatment with Ocrevus.
Danish: Lægen kan beslutte at udskyde din behandling med Ocrevus eller bede dig om at holde op med at tage den anden medicin, inden du starter behandling med Ocrevus.
English: · Initial Dose
Danish: • Første dosis
English: Common: may affect up to 1 in 10 people · cough · a build-up of thick mucus in the nose, throat or chest.
Danish: • ophobning af tykt slim i næsen, halsen eller brystet.
English: The majority of these decreases reported in Ocrevus treated patients were Grade 1 (<LLN800 cells/mm3) and 2 (between 500 and 800 cells/mm3) in severity.
Danish: Størstedelen af disse indberettede fald i Ocrevus-behandlede patienter var sværhedsgrad 1 (<laveste referencegrænse - 800 celler/mm3) og 2 (mellem 500 og 800 celler/mm3).
English: · 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).
Danish: • Kontakt straks lægen eller sygeplejersken, hvis du oplever ét eller flere af nedenstående tegn på infektion under eller efter behandling med Ocrevus: - feber eller kulderystelser - hoste, der ikke forsvinder - herpes (forkølelsessår, helvedesild eller sår på kønsdelene).
English: The majority of IRRs in both treatment groups were mild to moderate.
Danish: De fleste infusionsrelaterede reaktioner var milde til moderate i begge behandlingsgrupper.
English: Physicians should be vigilant for the early signs and symptoms of PML, which can include any new onset, or worsening of neurological signs or symptoms, as these can be similar to MS disease.
Danish: Lægen bør være særligt opmærksom på tidlige symptomer på progressiv multifokal leukoencefalopati, der kan omfatte debuterende neurologiske symptomer eller forværring af eksisterende neurologiske symptomer, som kan ligne sygdommen multiple sclerose-.
English: The effect on the immune system of these medicines with Ocrevus could be too strong.
Danish: Den samlede virkning af den anden medicin og Ocrevus kan være for skadelig for immunsystemet.
English: · The rate can be increased in 40 mL/hour increments every 30 minutes to a maximum of 200 mL/hour
Danish: • Hastigheden kan øges i trin af 40 ml/time hver 30. minut til maksimalt 200 ml/time
English: 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).
Danish: Ocrevus er et monoklonalt antistof, der cleares via katabolisme (dvs. nedbrydes til peptider og aminosyrer); ændringer i dosis forventes ikke at være nødvendige for patienter med nedsat nyrefunktion (se pkt.
English: 26.7% and 11.9% of Ocrevus treated patients experienced mild and moderate IRRs respectively, 1.4% experienced severe IRRs.
Danish: 26,7 % og 11,9 % af de Ocrevus-behandlede patienter oplevede milde og moderate infusionsrelaterede reaktioner; 1,4 % oplevede svære infusionsrelaterede reaktioner.
English: 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).
Danish: Ocrevus er indiceret til behandling af voksne patienter med attakvis multipel sclerose (RMS) med aktiv sygdom defineret ved kliniske eller ved radiologiske fund (se pkt.
English: 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.
Danish: I kliniske attakvis multipel sclerose-studier oplevede 39,9% af de Ocrevus-behandlede patienter og 33,2% af de interferon-beta-1a-behandlede patienter en øvre luftvejsinfektion, og 7,5% af de Ocrevusbehandlede patienter og 5,2% af de interferon-beta-1a-behandlede patienter oplevede nedre luftvejsinfektion.
English: Do not use the solution if discoloured or if the solution contains foreign particulate matter (see section 3 for a description of the solution).
Danish: Brug ikke opløsningen, hvis den er misfarvet eller hvis opløsningen indeholder fremmede partikler (se pkt.
English: The extent and duration of B-cell depletion was consistent in the PPMS and RMS trials.
Danish: Omfanget og varigheden af B-celledepleteringen var ensartet i primær progressiv- og attakvis multipel sclerose-studier.
English: Patients with known IgE mediated hypersensitivity to ocrelizumab must not be treated (see section 4.3).
Danish: Patienter med kendt IgE-medieret overfølsomhed over for ocrelizumab må ikke behandles (se pkt.
English: Serious infections occurred in 1.3% of patients receiving Ocrevus vs 2.9% of patients receiving interferon beta 1a.
Danish: Alvorlige infektioner sås hos 1,3% af patienterne behandlet med Ocrevus vs. 2,9% af patienterne behandlet med interferon-beta-1a.
English: · In Primary Progressive MS (PPMS), Ocrevus helps to slow down the progression of the disease and reduce deterioration in walking speed.
Danish: • Ved primær progressiv multipel sclerose (PPMS) forsinker Ocrevus sygdommens udvikling og mindsker forværring af ganghastigheden.
English: · Hypotension: As a symptom of IRR, may occur during Ocrevus infusions.
Danish: • Hypotension: Kan forekomme som symptom på infusionsrelateret reaktion under Ocrevusinfusioner.
English: 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).
Danish: Ocrevus er indiceret til behandling af voksne patienter med tidlig primær progressiv multipel sclerose (PPMS) defineret ved sygdomsvarighed, graden af handicap samt radiologiske fund, der er karakteristiske for inflammatorisk aktivitet (se pkt.
English: Table 6 Key Clinical and MRI Endpoints from Study WA25046 (PPMS) Study 3
Danish: Tabel 6 Kliniske og MRI vigtigste-endepunkter fra studie WA25046 (primær progressiv multipel sclerose)
English: How much and how often you will be given Ocrevus
Danish: Størrelsen af dosis af Ocrevus og hvor ofte den skal gives
English: What Ocrevus is used for
Danish: Hvad anvendes Ocrevus til?
English: Patients with primary progressive form of MS
Danish: Patienter med primær progressiv multipel sclerose
English: 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.
Danish: I fase III-studiet med patienter med primær progressiv multipel sclerose fik patienterne 600 mg Ocrevus hver 6. måned som to infusioner af 300 mg, givet med to ugers mellemrum, gennem hele behandlingsperioden.
English: · Ocrevus infusions should not be administered as an intravenous push or bolus.
Danish: • Ocrevus-infusioner må ikke administreres som hurtig intravenøs injektion eller bolus.
English: In case of IRRs during any infusion, see the following adjustments.
Danish: I tilfælde af infusionsrelaterede reaktioner under en infusion foretages nedenstående justeringer.
English: · Patients who experience severe pulmonary symptoms, such as bronchospasm or asthma exacerbation, must have their infusion interrupted immediately and permanently.
Danish: • Hos patienter, der oplever svære pulmonære symptomer, fx bronkospasme eller astmaexacerbation, skal infusionen straks afbrydes og behandlingen seponeres.
English: 20.7% Ocrevus vs 15.6% IFN
Danish: 20,7% Ocrevus vs. 15,6% Interferon-beta-1a
English: It is not known whether Ocrevus can affect your being able to drive or use tools or machines.
Danish: Det vides ikke med sikkerhed om Ocrevus påvirker evnen til at føre motorkøretøj eller bruge maskiner.
English: · The other ingredients are sodium acetate trihydrate, glacial acetic acid, trehalose dihydrate, polysorbate 20 and water for injection.
Danish: • Øvrige indholdsstoffer: natriumacetat trihydrat, iseddikesyre, trehalose dihydrat, polysorbat 20
English: Subsequent doses of Ocrevus thereafter are administered as a single 600 mg intravenous infusion every 6 months (Table 1).
Danish: Efterfølgende doser af Ocrevus administreres derefter som én intravenøs infusion á 600 mg hver 6. måned (Tabel 1).
English: · Infusion Adjustments in case of IRRs In case of IRRs during any infusion, see the following adjustments.
Danish: • Infusionsjusteringer i tilfælde af infusionsrelaterede reaktioner Hvis der under en infusion opstår infusionsrelaterede reaktioner, skal følgende justeringer foretages:
English: Diluted solution for intravenous infusion
Danish: Fortyndet opløsning til intravenøs infusion
English: The initial infusion rate at restart should be half of the infusion rate at the time of onset of the reaction.
Danish: Infusionshastigheden skal initialt være den halve af infusionshastigheden ved reaktionens indtræden.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 300 mg of ocrelizumab in 10 mL at a concentration of 30 mg/mL.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Ét hætteglas indeholder 300 mg ocrelizumab i 10 ml ved en koncentration på 30 mg/ml.
English: The overall safety profile of Ocrevus in Multiple Sclerosis is based on data from patients from pivotal clinical trials in MS (RMS and PPMS).
Danish: Den overordnede sikkerhedsprofil for Ocrevus til multipel sclerose er baseret på data fra patienter i pivotale kliniske studier med multipel sclerose (attakvis multipel sclerose og primær progressiv multipel sclerose).
English: The safety and efficacy of Ocrevus in patients with renal impairment has not been formally studied.
Danish: Sikkerhed og virkning af Ocrevus hos patienter med nedsat leverfunktion er ikke formelt undersøgt.
English: Proportion of patients with at least 12 weeks Confirmed Disability Improvement
Danish: Andel af patienter med mindst 12-ugers bekræftet forbedret handicapudvikling 4
English: 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.
Danish: I det placebo-kontrollerede, kliniske primær progressiv multipel sclerose-studie sås en højere andel af patienter med oral herpes (2,7% vs. 0,8%) i Ocrevus-behandlingsgruppen.
English: · Tell your doctor or nurse straight away if you notice any of these signs of infection: fever or chills cough which does not go away herpes (such as cold sore, shingles and genital sores).
Danish: • Kontakt straks lægen eller sygeplejersken, hvis du opdager ét eller flere af følgende tegn på infektion: feber eller kulderystelser hoste som ikke går over herpes (forkølelssår, helvedsild eller sår på kønsdelene)
English: 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 for 8 hours at room temperature, unless dilution is undertaken in controlled and validated aseptic conditions.
Danish: Hvis den ikke anvendes straks, påhviler ansvaret for opbevaringstid og -forhold brugeren og bør ikke overskride 24 timer ved 2-8°C og efterfølgende i 8 timer ved stuetemperatur, med mindre fortyndingen foretages under kontrollerede og validerede aseptiske forhold.
English: 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.
Danish: • Behandling af svære reaktioner: Relevant udstyr til behandling af svære reaktioner, fx alvorlige infusionsrelaterede reaktioner, overfølsomhedsreaktioner og/eller anafylaktiske reaktioner, skal være tilgængelige.
English: Women should be advised to discontinue breast-feeding during Ocrevus therapy.
Danish: Kvinder skal frarådes at amme mens de er i behandling med Ocrevus.
English: How Ocrevus is given
Danish: Sådan gives Ocrevus
English: Ocrevus is not intended to be used in children and adolescents under 18 years old.
Danish: Ocrevus er ikke beregnet til brug hos børn og unge under 18 år, da effekt og sikkerhed ikke er undersøgt i denne aldersgruppe.
English: In the Phase III studies, between each dose of Ocrevus, up to 5% of patients showed B-cell repletion (> lower limit of normal (LLN) or baseline) at least at one time point.
Danish: Op til 5% af patienterne i fase III-studierne oplevede B-celle-gendannelse (>laveste referencegrænse eller baseline) ved mindst én måling, mellem hver dosis Ocrevus.
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).
Danish: Ocrevus er monoklonalt antistof, der cleares via katabolisme (fremfor levermetabolisme) og ændringer i dosis forventes ikke at være nødvendige for patienter med nedsat leverfunktion (se pkt.
English: IRRs can occur within 24 hours of the infusion.
Danish: Infusionsrelaterede reaktioner kan forekomme inden for 24 timer efter infusionen.
English: · Physicians should alert patients that an IRR can occur within 24 hours of infusion.
Danish: • Lægen skal informere patienterne om, at infusionsrelaterede reaktioner kan opstå inden for 24 timer efter infusion.
English: Ocrevus infusions should not be administered as an intravenous push or bolus.
Danish: Ocrevus-infusioner må ikke administreres som hurtig intravenøs injektion eller bolus.
English: Proportion of patients with 24 weeks - Confirmed Disability Progression1
Danish: Andel af patienter med 24 ugers bekræftet invaliditetsprogression1
English: For guidance regarding posology for patients experiencing IRR symptoms see section 4.2.
Danish: For vejledning i dosering til patienter, der oplever symptomer på infusionsrelaterede reaktioner, se pkt.
English: · The first 600 mg dose of Ocrevus will be given as 2 separate infusions (300 mg each), given
Danish: • Den første 600 mg dose Ocrevus gives som 2 separate infusioner (300 mg hver), med 2 ugers mellemrum.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One vial contains 300 mg ocrelizumab in 10 ml (30 mg/ml).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 hætteglas indeholder 300 mg ocrelizumab i 10 ml (30 mg/ml).
English: This leaflet was last revised in <{MM/YYYY}> Other sources of information
Danish: Denne indlægsseddel blev senest ændret <{MM/ÅÅÅÅ}> <{måned ÅÅÅÅ}.>
English: If a hypersensitivity reaction is suspected during infusion, the infusion must be stopped immediately and permanently.
Danish: Hvis der er mistanke om overfølsomhedsreaktion under infusion, skal infusionen straks afbrydes og behandlingen seponeres permanent.
English: After the infusion
Danish: Efter infusionen
English: Ocrevus 300 mg concentrate for solution for infusion Ocrelizumab
Danish: Ocrevus 300 mg koncentrat til infusionsvæske, opløsning Ocrelizumab
English: · Tell your doctor or nurse straight away if you have any infusion-related reaction (see section 4 for a list of infusion-related reactions).
Danish: • Fortæl det straks til lægen eller sygeplejersken, hvis du har en infusionsrelateret reaktion (se pkt.
English: In the placebo-controlled study in PPMS, infections occurred in 72.2% of patients receiving Ocrevus vs 69.9% of patients receiving placebo.
Danish: I det placebo-kontrollerede primær progressiv multipel sclerose-studie forekom infektioner hos 72,2% af patienterne behandlet med Ocrevus versus 69,9% af patienterne, behandlet med placebo.
English: A risk of PML cannot be ruled-out since John Cunningham (JC) virus infection resulting in PML has been observed in patients treated with anti-CD20 antibodies and other MS therapies, and associated with risk factors (e.g. patient population, polytherapy with immunosuppressants).
Danish: Der er konstateret tilfælde af progressiv multifokal leukoencefalopati hos patienter med John Cunningham (JC)-virus og som har andre risikofaktorer (fx patientpopulation, polyterapi med immunosupprimerende midler) behandlet med anti-CD20 antistoffer og andre multipel sclerose-behandlinger.
English: 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.
Danish: • Præmedicinering for infusionsrelaterede reaktioner Følgende to slags præmedicinering skal gives inden hver Ocrevus-infusion med henblik på at reducere hyppighed og sværhedsgrad af infusionsrelaterede reaktioner: 100 mg intravenøs methylprednisolon (eller tilsvarende) ca. 30 minutter inden hver Ocrevus-infusion antihistamin ca. 30-60 minutter inden hver Ocrevus-infusion
English: · Patients treated with Ocrevus should be observed for at least one hour after the completion of the infusion for any symptom of an IRR.
Danish: • Patienter behandlet med Ocrevus skal observeres i mindst en time efter infusionen er afsluttet for symptomer på infusionsrelaterede reaktioner.
English: Patients should be monitored during the infusion and for at least one hour after the completion of the infusion (see section 4.4).
Danish: Patienten bør monitoreres under infusionen og i mindst en time efter infusionen er afsluttet (se pkt.
English: Keep the vials in the outer carton in order to protect from light.
Danish: Hætteglassene skal opbevares i den ydre karton for at beskytte mod lys.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Ocrevus 300 mg concentrate for solution for infusion ocrelizumab
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Ocrevus 300 mg koncentrat til infusionsvæske, opløsning ocrelizumab
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.
Danish: Hvis en patient oplever en svær infusionsrelateret reaktion (såsom dyspnø) eller et kompleks bestående af rødme, feber og halssmerter, skal infusionen straks afbrydes, og patienten modtage symptomatisk behandling.
English: 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
Danish: Hos patienter behandlet med ocrelizumab øgede en booster vaccine (13-valent pneumokok konjugeret vaccine, 13-PCV) givet 4 uger efter indgivelse af en 23-valent pneumokok polysakkaridvaccine (23PPV) ikke mærkbart responset på 12 serotyper sammenlignet med 23-valent pneumokok polysakkaridvaccine (23-PPV) alene.
English: Blood immunoglobulin G decreased
Danish: Fald i blod- immunglobulin M Fald i blod- immunglobulin G
English: 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]).
Danish: Præspecificeret subgruppeanalyse, som ikke har nok styrke, af det primære endepunkt antyder, at patienter, der er yngre (≤ 45 år) eller med Gd-opladende T1-læsioner ved baseline, får en større fordel af behandlingen (Hazard ratio 0,64 [0,45, 0, 92]), end patienter, der er ældre (> 45 år) eller uden Gdopladende T1-læsioner (Hazard ratio 0,88 [0,62, 1,26]).
English: · Infusion-related reactions are the most common side effect of Ocrevus treatment.
Danish: • De mest almindelige bivirkninger ved behandling med Ocrevus er infusionsrelaterede reaktioner.
English: Patients with mild hepatic impairment were included in clinical trials, and no change in the pharmacokinetics was observed in those patients.
Danish: Der har været inkluderet patienter med let nedsat leverfunktion i de kliniske studier, og der blev ikke set ændringer i Ocrevus' farmakokinetik hos disse patienter.
English: 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.
Danish: I de kontrollerede attakvis multipel sclerose-studier med aktiv komparator forekom infektioner hos 58,5% af patienterne behandlet med Ocrevus versus 52,5% af patienterne behandlet med interferon beta 1a.