FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Danish: Patienter med positiv serologi (dvs. negativ for HBsAg og positiv for HB-kerneantistof (HBcAb+); bærere af hepatitis B-virus (positiv for overfladeantigen, HBsAg+)) skal konsultere en leverspecialist inden opstart af behandling og skal monitoreres og håndteres i overensstemmelse med lokale medicinske standarder med henblik på at undgå reaktivering af hepatitis B.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. it is essentially sodium-free.
Danish: Dette produkt indeholder mindre end 1 mmol natrium (23 mg) per dosis, dvs. det er stort set natriumfrit.
English: Any vaccinations should be given at least 6 weeks before you start treatment with Ocrevus.
Danish: Alle nødvendige vacciner skal være givet mindst 6 uger før behandling med Ocrevus starter.
English: You will receive a corticosteroid and an anti-histamine before each infusion and you may also receive medicines to reduce fever.
Danish: Inden hver infusion vil du derfor få kortikosteroid og antihistamin, og muligvis medicin til at reducere feber.
English: Symptoms of IRRs may occur during any infusion, but have been more frequently reported during the first infusion.
Danish: Symptomer på infusionsrelaterede reaktioner kan forekomme under enhver infusion, men er hyppigere indberettet under første infusion.
English: If you are not sure, talk to your doctor before you are given Ocrevus.
Danish: Hvis du er usikker, skal du kontakte lægen inden du får Ocrevus.
English: For storage conditions after dilution of the medicinal product, see section 6.3.
Danish: For opbevaringsforhold efter fortynding af lægemidlet, se pkt.
English: Patients with active HBV (i.e. an active infection confirmed by positive results for HBsAg and anti HB testing) should not be treated with Ocrevus.
Danish: Patienter med aktiv hepatitis B-virus (dvs. aktiv infektion bekræftet ved positiv test for HBsAg og anti-HB) må ikke behandles med Ocrevus.
English: Injury, poisoning and procedura complications
Danish: Traumer, forgiftninger og behandlingskom-likationer
English: A greater proportion of patients in each group experienced IRRs with the first infusion of each dose compared with the second infusion of that dose.
Danish: I begge grupper oplevede en større andel af patienterne infusionsrelaterede reaktioner ved første infusion af hver dosis end ved anden infusion af den pågældende dosis.
English: In MS, the immune system (the body's defence system) works incorrectly and attacks a protective layer (called myelin sheath) around nerve cells and causes inflammation.
Danish: Når man har multipel sclerose, virker immunsystemet (kroppens forsvarssystem) forkert og angriber det beskyttende lag (myelinskede) rundt om nervecellerne og skaber inflammation.
English: * Expanded Disability Status Scale ** Patients who had not been treated with any MS medication in the 2 years prior to randomization.
Danish: * Udvidet skala for invaliditetsstatus (Extended Disability Status Scale) ** DMT: Disease Modifying Treatment - Patienter som ikke havde fået nogen form for multipel sclerose-behandling inden for to år inden randomisering.
English: The pharmacokinetics of ocrelizumab in the MS studies were described by a two compartment model with time-dependent clearance, and with PK parameters typical for an IgG1 monoclonal antibody.
Danish: Ocrelizumabs farmakokinetik i multipel sclerose-studierne er beskrevet ved en 2-kompartmental model med tidsafhængig clearance og med farmakokinetiske parametre typiske for et IgG1 monoklonalt antistof.
English: It is not recommended to use other immunosuppressives concomitantly with Ocrevus except corticosteroids for symptomatic treatment of relapses.
Danish: Det anbefales ikke, at anvende andre immunosupprimerende midler sammen med Ocrevus undtagen kortikosteroider til symptomatisk behandling af attakker.
English: If the infusion-related reaction is life-threatening, your doctor will permanently stop your treatment with Ocrevus.
Danish: Hvis reaktionen på infusionen er livstruende, vil lægen stoppe behandlingen med Ocrevus permanent.
English: If you miss an infusion of Ocrevus
Danish: Hvis du springer en Ocrevus-infusion over
English: The precise mechanisms through which ocrelizumab exerts its therapeutic clinical effects in MS is not fully elucidated but is presumed to involve immunomodulation through the reduction in the number and function of CD20-expressing B cells.
Danish: Den præcise virkningsmekanisme for ocrelizumabs terapeutiske, kliniske effekt på multipel sclerose kendes ikke fuldt ud, men antages at involvere immunmodulering gennem en reducering af antallet og funktionen af B-celler, det udtrykker CD20.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Ocrevus in one or more subsets of the paediatric population in the treatment of multiple sclerosis.
Danish: Det Europæiske Lægemiddelagentur har udskudt kravet om at fremlægge resultaterne af studier med Ocrevus med en eller fleresubgrupper af pædiatriske population med multipel sclerose (se pkt.
English: Ocrevus is associated with IRRs, which may be related to cytokine release and/or other chemical mediators.
Danish: Ocrevus kan være forbundet med infusionsrelaterede reaktioner, som kan have relation til cytokinfrigørelse og/eller andre kemiske mediatorer.
English: · This medicine is not to be used after the expiry date which is stated on the outer carton and the vial label after ‘EXP'.
Danish: • Dette lægemiddel skal ikke bruges efter den udløbsdato, der står på pakningen og hætteglasset efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Upper respiratory tract infection, nasopharyngitis, influenza
Danish: Infektion i øvre luftveje, nasofaryngitis, influenza
English: In the ocrelizumab MS pivotal studies the administration of corticosteroids for the treatment of relapse was not associated with an increased risk of serious infection.
Danish: I ocrelizumab multipel sclerose-pivotalstudierne var administrationen af kortikosteroider til behandling af attakker ikke forbundet med en øget risiko for alvorlig infektion.
English: · In relapsing forms of MS. the patient has repeated attacks of symptoms (relapses).
Danish: • I attakvis multipel sclerose har patienten tilbagevendende anfald af symptomer (attakker).
English: Ocrevus should be prepared by a healthcare professional using aseptic technique.
Danish: Ocrevus skal tilberedes af sundhedsfagligt personale ved brug af aseptisk teknik.
English: Mean number of new and/or enlarging T2 hyperintense lesions per MRI scan
Danish: Gennemsnitligt antal nye og/eller forstørrende T2 hyperintense læsioner per MRI
English: Approximately 1% of the patients in the Ocrevus group had a Grade 3 lymphopenia (between 200 and 500 cells/mm3).
Danish: Ca. 1% af patienterne i Ocrevus-gruppen havde en grad 3 lymfopeni (mellem 200 og 500 celler/mm3).
English: Infusion-related reactions can happen during the infusion or up to 24 hours after the infusion.
Danish: Infusionsrelaterede reaktioner kan opstå under infusionen og i op til 24 timer efter infusionen.
English: Transient peripheral B-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other anti-CD20 antibodies during pregnancy.
Danish: Der er indberettet forbigående perifære fald i B-celleniveauet og lymfocytopeni hos spædbørn født af mødre eksponeret for andre anti-CD20-antistoffer under graviditeten.
English: Ocrevus is a humanised monoclonal antibody of an immunoglobulin G1 subtype and immunoglobulins are known to cross the placental barrier.
Danish: Ocrevus er et humaniseret, monoklonalt antistof af en immunoglobulin G1-subtype, og immunoglobuliner vides at passere placentabarrieren.
English: There is no specific antidote in the event of an overdose; interrupt the infusion immediately and observe the patient for IRRs (see section 4.4).
Danish: Der er ingen specifik antidot i tilfælde af overdosering; afbryd straks infusionen og observer patienten for infusionsrelaterede reaktioner (se pkt.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1231/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/17/1231/001
English: Relative reduction
Danish: Relativ reduktion
English: In other auto-immune conditions, use of Ocrevus concomitantly with immunosuppressive medications (e.g. chronic corticosteroids, non-biologic and biologic disease-modifying antirheumatic drugs [DMARDS], mycophenolate mofetil, cyclophosphamide, azathioprine) resulted in an increase of serious infections, including opportunistic infections.
Danish: Ved andre autoimmune sygdomme, har samtidigt brug af Ocrevus og immunsupprimerende lægemidler (fx kronisk behandling med kortikosteroider, ikke-biologiske og biologiske sygdomsmodificerende antireumatiske lægemidler [DMARDS], mycofenolatmofetil, cyclofosfamid, azathioprin) medført en stigning i alvorlige infektioner, inklusive opportunistiske infektioner.
English: Efficacy and safety of Ocrevus were evaluated in two randomised, double-blind, double-dummy, active comparator-controlled clinical trials (WA21092 and WA21093), with identical design, in patients with relapsing forms of MS (in accordance with McDonald criteria 2010) and evidence of disease activity (as defined by clinical or imaging features) within the previous two years.
Danish: Virkning og sikkerhed af Ocrevus er vurderet i to randomiserede, dobbeltblinde, dobbelt-dummy, aktivt komparator kontrollerede, kliniske studier (WA21092 og WA21093) med identisk design hos patienter med attakvis multipel sclerose (i overensstemmelse med McDonald-kriterier 2010) ogevidens på sygdomsaktivitet (som defineret ved kliniske eller radiologiske fund) inden for de foregående to år.
English: Therefore, withholding of antihypertensive treatments should be considered for 12 hours prior to and throughout each Ocrevus infusion.
Danish: Det bør derfor overvejes at tilbageholde antihypertensiv behandling i 12 timer før og under hver Ocrevus-infusion.
English: · if you are allergic to ocrelizumab or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for ocrelizumab eller et af de øvrige indholdsstoffer i lægemidlet
English: In a pre- and post-natal development study in cynomolgus monkeys, administration of ocrelizumab from gestation day 20 to approximately 5 weeks postpartum was associated with glomerulopathy, lymphoid follicle formation in bone marrow, lymphoplasmacytic renal inflammation, and decreased testicular weight in offspring.
Danish: I et præ- og post-natalt udviklingsstudie med cynomolgusaber var administration af ocrelizumab fra gestationsdag 20 til ca. 5 uger postpartum forbundet med glomerulopati, lymfoid follikeldannelse i knoglemarven, lymfoplasmacytisk nyreinflammation og nedsat testikelvægt hos afkommet.
English: A hypersensitivity reaction may present during any infusion, although typically would not present during the first infusion.
Danish: Der kan opstå overfølsomhedsreaktion under enhver infusion, men ses typisk ikke under den første infusion.
English: There were two cases of moribundityone attributed to weakness due to premature birth accompanied by opportunistic infection and the other to an infective meningoencephalitis involving the cerebellum of the neonate from a maternal dam with an active infection (mastitis).
Danish: Der har været to dødelige tilfælde, ét, der blev tilskrevet svaghed i forbindelse med præmatur fødsel ledsaget af opportunistisk infektion og ét, der blev tilskrevet en infektiøs meningoenfalitis omfattende den neonatales cerebellum og et mødrende ophav med aktiv infektion (mastitis).
English: MRI Endpoints
Danish: MRI-endepunkter
English: · Before you start any other medicines, tell your doctor when you had your last Ocrevus infusion.
Danish: • Inden du får anden medicin, skal du fortælle lægen hvornår du sidst fik en Ocrevus-infusion.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, and embryo-foetal development.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser samt reproduktions- og udviklingstoksicitet.
English: Patients in a severely immunocompromised state must not be treated until the condition resolves (see section 4.3.
Danish: Patienter i en svært immunkompromitteret tilstand må ikke behandles, før tilstanden er afhjulpet (se pkt.
English: One patient, who received 2000 mg of Ocrevus, died of systemic inflammatory response syndrome (SIRS) of unknown etiology, following a magnetic resonance imaging (MRI) examination 12 weeks after the last infusion; an anaphylactoid reaction to the MRI gadolinium-contrast agent could have contributed to the SIRS.
Danish: En patient, som fik 2000 mg Ocrevus, døde af systemisk inflammatorisk respons syndrom af ukendt ætiologi, efter en magnetisk resonans (MR) skanning 12 uger efter den sidste infusion; en anafylaktoid reaktion på MR gadolinium-kontrastmidlet kan have bidraget til det systemiske inflammatoriske respons syndrom.
English: Ocrevus must be permanently discontinued in these patients (see section 4.3).
Danish: Ocrevus skal seponeres permanent hos disse patienter (se pkt.
English: Patients in MS trials (WA21092, WA21093 and WA25046) were tested at multiple time points (baseline and every 6 months post treatment for the duration of the trial) for anti-drug antibodies (ADAs).
Danish: Patienterne i multipel sclerose-studierne (WA21092, WA21093 og WA25046) blev på flere tidspunkter (ved baseline samt hver 6. måned efter behandling igennem hele studiet) testet for antilægemiddel antistoffer.
English: The safety of immunisation with live or live-attenuated vaccines, following Ocrevus therapy has not been studied.
Danish: Sikkerhed ved immunisering med levende eller svækkede, levende vacciner efter behandling med Ocrevus er ikke undersøgt.
English: · Ocrevus may contain fine translucent and/or reflective particles associated with enhanced opalescence.
Danish: • Ocrevus kan indeholde små, transparente og/eller reflekterende partikler, der kan øge farvespillet.
English: · Ocrevus should be prepared by a healthcare professional using aseptic technique.
Danish: • Ocrevus skal forberedes af sundhedsfagligt personale ved brug af aseptisk teknik.
English: No B cell count data have been collected in neonates and infants exposed to ocrelizumab and the potential duration of B-cell depletion in neonates and infants is unknown (see section 4.4).
Danish: Der er ikke indsamlet data om B-celletælling hos nyfødte og spædbørn, som har været eksponeret for ocrelizumab, og varigheden af muligt fald i B-celleniveauet hos nyfødte og spædbørn er ukendt (se pkt.
English: The safety of immunisation with live or live-attenuated vaccines, following Ocrevus therapy has not been studied and vaccination with live-attenuated or live vaccines is not recommended during treatment and not until B-cell repletion (in clinical trials, the median time for B-cell repletion was 72 weeks).
Danish: Sikkerhed ved immunisering med levende eller svækkede, levende vacciner efter behandling med Ocrevus er ikke undersøgt, og vaccination med levende eller svækkede, levende vacciner frarådes under behandlingen og indtil B-celle-niveauet er genoprettet (i kliniske studier var mediantid til Bcelle-niveauet var genoprettet 72 uger).
English: · Subsequent Doses
Danish: • Efterfølgende doser
English: Results of the pre-specified pooled analyses of time to CDP sustained for at least 12 weeks (40% risk reduction for Ocrevus compared to interferon beta-1a (p=0.0006) were highly consistent with the results sustained for at least 24 weeks (40% risk reduction for Ocrevus compared to interferon beta-1a, p=0.0025).
Danish: Resultaterne af de præspecificerede, poolede analyser af tid til bekræftet invaliditetsprogression opretholdt i mindst 12 uger (40% risikoreduktion for Ocrevus sammenlignet med interferon-beta-1a (p=0,0006) var i høj grad konsistente med 24-ugers resultaterne (40% risikoreduktion for Ocrevus sammenlignet med interferon-beta-1a, p=0,0025).
English: Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000
Danish: Hyppighed defineres som: meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1000 til <1/100), sjælden (≥1/10.000 til <1/1000), meget sjælden (<1/10.000).
English: Talk to your doctor before you are given Ocrevus if any of the following apply to you.
Danish: Kontakt lægen, før du får Ocrevus, hvis ét eller flere af følgende punkter gælder for dig.
English: · Infusion-related reactions are the most common side effect of Ocrevus treatment (very common: may affect more than 1 in 10 people).
Danish: • De mest almindelige bivirkninger ved behandling med Ocrevus er infusionsrelatede reaktioner (meget almindelig: opleves af mere end 1 ud af 10 patienter).
English: · if you currently have an infection · if you have been told that you have severe problems with your immune system · if you have cancer
Danish: • hvis du har fået at vide, at du har alvorlige problemer med dit immunsystem
English: HBV screening should be performed in all patients before initiation of treatment with Ocrevus as per local guidelines.
Danish: Alle patienter bør hepatitis B-virus-screenes inden opstart af behandling med Ocrevus, i overenstemmelse med lokale retningslinjer.
English: Analysis of patient populations with differing baseline levels of disease activity, including active and highly active disease, showed that the efficacy of Ocrevus on ARR and 12 week CDP was consistent with the overall population.
Danish: Analyse af patientpopulationer med varierende baselineniveauer af sygdomsaktivitet, inklusive aktiv og højaktiv sygdom, viste, at Ocrevus' effekt på den årlige attakrate (ARR) og bekræftet handicapudvikkling ved uge 12 svarede til den overordnede populations sygdomsaktivitet.
English: Key clinical and MRI efficacy results are presented in Table 6 and Figure 2.
Danish: De vigtigste effektresultater, kliniske og MRI, præsenteres i Tabel 6 og Figur 2.
English: 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.
Danish: På baggrund af de videnskabelige konklusioner for ocrelizumab er CHMP af den opfattelse, at benefit/risk-forholdet for det lægemiddel/de lægemidler, der indeholder ocrelizumab, forbliver uændret under forudsætning af, at de foreslåede ændringer indføres i produktinformationen.
English: Management of IRRs during and after the infusion
Danish: Håndtering af infusionsrelaterede reaktioner under og efter infusionen
English: An increased rate of serious infections was observed during episodes of confirmed total lymphocytes counts decrease in ocrelizumab treated patients.
Danish: Et øget antal af alvorlige infektioner blev observeret under episoder af fald i det totale antal lymfocytter hos patienter behandlet med ocrelizumab.
English: Subsequent Doses
Danish: Efterfølgende doser
English: Caution should be exercised when prescribing Ocrevus taking into consideration the pharmacodynamics of other disease modifying MS therapies.
Danish: Der bør udvises forsigtighed ved ordination af Ocrevus, med hensyn til farmakodynamikken af andre sygdomsmodificerende multipel sclerose-behandlinger.
English: · This medicine is available in packs containing 1 or 2 vials (vials of 10 mL concentrate).
Danish: • fås i pakker med 1 eller 2 hætteglas (hætteglas med 10 ml koncentrat).
English: Your doctor will consider the benefit of you taking Ocrevus against the risk to your baby.
Danish: Lægen beslutter om den gavn du har af Ocrevus opvejer risikoen for barnet.
English: Patients with relapsing forms of MS Disease history at screening At least two relapses within the prior two years or one relapse within the prior year; EDSS* between 0 and 5.5, inclusive
Danish: Patienter med attakvis multipel sclerose Sygdomshistorie ved screening Mindst to attakker inden for de seneste to år eller ét attak inden for det seneste år; EDSS* mellem 0 og 5,5
English: Ocrevus is administered as an intravenous infusion.
Danish: Ocrevus administreres som intravenøs infusion.
English: When initiating Ocrevus after an immunosuppressive therapy or initiating an immunosuppressive therapy after Ocrevus, the potential for overlapping pharmacodynamic effects should be taken into consideration (see section 5.1 Pharmacodynamic effects).
Danish: Når behandling med Ocrevus opstartes efter immunsuppresiv behandling, eller immunsuppresiv behandling opstartes efter behandling med Ocrevus, bør der tages højde for de potentielt overlappende farmakodynamiske virkninger (se pkt.
English: Study design and baseline characteristics of the study population are presented in Table 5.
Danish: Studiets design og studiepopulationens baseline-karakteristika præsenteres i Tabel 5.
English: The adverse drug reactions were consistent with the safety profile for Ocrevus in the pivotal clinical studies.
Danish: Bivirkningerne var i overensstemmelse med Ocrevus' sikkerhedsprofil i de kliniske pivotale studier.
English: Ocrevus medicinal product must be diluted before administration.
Danish: Lægemidlet Ocrevus skal fortyndes inden administration.
English: This reduces inflammation and attacks on the myelin sheath, reduces the chance of having a relapse and slows the progression of your disease.
Danish: Dette mindsker risikoen for inflammation og beskadigelse af myelinskeden og mindsker dermed risikoen for et attak og forsinker udviklingen af sygdommen.
English: The proportion of respiratory tract infections was higher in Ocrevus treated patients compared to interferon beta-1-a and placebo.
Danish: Andelen af luftvejsinfektioner var højere blandt Ocrevus-behandlede patienter end blandt patienter behandlet med interferon-beta-1-a og placebo.
English: Group A: Ocrevus 600 mg Group B: interferon beta-1a 44 mcg S.C. (IFN)
Danish: Gruppe A: Ocrevus 600 mg Gruppe B: interferon-beta-1a 44 mikrogram S.C.
English: Ocrevus treatment should be initiated and supervised by specialised physicians experienced in the diagnosis and treatment of neurological conditions and who have access to appropriate medical support to manage severe reactions such as serious infusion-related reactions (IRRs).
Danish: Behandling med Ocrevus bør initieres og superviseres af specialiserede læger med erfaring i diagnosticering og behandling af neurologiske sygdomme, og som har adgang til relevant medicinsk understøttende behandling til håndtering af svære reaktioner, fx alvorlige infusionsrelaterede reaktioner.
English: · Prior to the start of the intravenous infusion, the content of the infusion bag should be at room temperature to avoid an infusion reaction due to the administration of the solution at low temperatures.
Danish: • Inden den intravenøse infusion påbegyndes, skal indholdet af infusionsposen opnå stuetemperatur for at undgå en infusionsreaktion, der kan forekomme hvis opløsningen administreres ved lave temperaturer.
English: · 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.
Danish: • Kontakt straks lægen eller sygeplejersken, hvis du oplever symptomer på en infusionrelateret reaktion, under infusionen eller op til 24 timer efter infusionen.
English: Keep the vial in the outer carton in order to protect from light Keep the vials in the outer carton in order to protect from light
Danish: Opbevar hætteglasset i den ydre karton for at beskytte mod lys Opbevar hætteglassene i den ydre karton for at beskytte mod lys