FrancophonIA/ELRC3.0 huggingface dataset:
English: The population pharmacokinetics estimate of the central volume of distribution was 2.78 L. Peripheral volume and inter-compartment clearance were estimated at 2.68 L and 0.294 L/day.
Danish: Det populations farmakokinetiske estimat af det centrale fordelingsvolumen var 2,78 l. Perifert fordelingsvolumen og inter-kompartmental clearance vurderes at være 2,68 l og 0,294 l/dag.
English: Treatment with Ocrevus leads to rapid depletion of CD19+ B cells in blood by 14 days post treatment (first time-point of assessment) as an expected pharmacologic effect.
Danish: Behandling med Ocrevus medfører hurtig depletering af CD19+ B-celler i blodet, 14 dage efter behandling (første måling), som en forventet farmakologisk virkning.
English: No incompatibilities between Ocrevus and polyvinyl chloride (PVC) or polyolefin (PO) bags and intravenous administration sets have been observed.
Danish: Der er ikke observeret uforligelighed mellem Ocrevus og polyvinylchlorid (PVC)- eller polyolefin (PO)-poser og intravenøse administrationsæt.
English: Patients who have had hepatitis B or are carriers of the hepatitis B virus will have a blood test and will be monitored by a doctor for signs of hepatitis B infection.
Danish: Patienter, der har har haft hepatitis B, eller er bærere af hepatitis B-virus, vil få taget en blodprøve og vil blive overvåget af lægen for tegn på hepatitis B-infektion.
English: Knowledge is limited as to whether concomitant steroid use for symptomatic treatment of relapses is associated with an increased risk of infections in clinical practice.
Danish: Der er begrænset viden om samtidig anvendelse af steroider til symptomatisk behandling af attakker er forbundet med en øget risiko for infektioner i klinisk praksis.
English: All life-threatening infections resolved without discontinuing ocrelizumab.
Danish: Alle livstruende infektioner blev afhjulpet uden seponering af ocrelizumab.
English: Neither carcinogenicity nor mutagenicity studies have been conducted with ocrelizumab.
Danish: Der er ikke gennemført carcinogenicitets- eller mutagenicitetsstudier med ocrelizumab.
English: No studies have been conducted to investigate the pharmacokinetics of ocrelizumab in children and adolescents <18 years of age.
Danish: Der er ikke gennemført studier med henblik på at undersøge farmakokinetikken af ocrelizumab hos børn og unge i aldersgruppen <18 år.
English: The above examples of dose interruption and slowing (for mild/moderate and severe IRRs) will result in a change in the infusion rate and increase the total duration of the infusion, but not the total dose.
Danish: Ovennævnte eksempler på dosisafbrydelse og nedsættelse af infusionshastigheden (for milde/moderate og svære infusionsrelaterede reaktioner) vil medføre en ændring i infusionshastigheden og øge den totale varighed for infusionen, men ikke den totale dosis.
English: The safety and efficacy of Ocrevus in children and adolescents aged 0 to 18 years has not yet been established.
Danish: Sikkerhed og virkning af Ocrevus hos børn og unge i alderen 0-18 år er endnu ikke klarlagt.
English: When the reaction has stopped, the infusion may be continued.
Danish: Når reaktionen er stoppet, kan infusionen måske startes igen.
English: This is because medicines like Ocrevus can cause the hepatitis B virus to become active again.
Danish: Det er fordi lægemidler som Ocrevus kan aktivere hepatitis B-virus og give alvorlige leverproblemer.
English: An increased number of malignancies (including breast cancers) have been observed in clinical trials in patients treated with ocrelizumab, compared to control groups.
Danish: Et øget antal maligniteter (herunder brystkræft) er blevet observeret i kliniske studier hos patienter behandlet med ocrelizumab, sammenlignet med kontrolgrupperne.
English: Constant clearance was estimated at 0.17 L/day, and initial time-dependent clearance at 0.0489 L/day which declined with a half-life of 33 weeks.
Danish: Konstant clearance vurderes at være 0,17 l/dag, og initial tidsafhængig clearance at være 0,0489 l/dag, hvilket var faldende med en halveringstid på 33 uger.
English: · Your doctor may recommend that you are given a seasonal influenza vaccine.
Danish: • Lægen vil måske anbefale dig at blive vaccineret for influenza.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Danish: Læger og sundhedspersonale anmodes om at indberette alle formodede bivirkninger via det nationale rapporteringssystem anført i Appendiks V**.
English: Your doctor will wait until the infection is resolved before giving you Ocrevus.
Danish: Din læge vil vente, indtil infektionen er afhjulpet, før han giver dig Ocrevus.
English: 10 mL concentrate in a glass vial.
Danish: 10 ml koncentrat i hætteglas.
English: Study WA25046 ORATORIO (n=732) Study design
Danish: WA25046 ORATORIO (n=732) Studiedesign
English: Infections included and were not limited to atypical pneumonia and pneumocystis jirovecii pneumonia, varicella pneumonia, tuberculosis, histoplasmosis.
Danish: Infektionerne omfattede og var ikke begrænset til atypisk pneumoni og pneumocystis jirovecii pneumoni, varicella-pneumoni, tuberkulose og histoplasmose.
English: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Danish: For at forbedre sporbarheden af biologiske lægemidler, skal handelsnavn og batchnummer for det administrerede produkt registreres tydeligt (eller angives) i patientens journal.
English: Percentage change in T2 hyperintense lesion volume, from baseline to Week 120
Danish: Procentdel ændring i T2 hyperintenst læsionsvolumen, fra baseline til Uge 120
English: · Your doctor will check if you need any vaccinations before you start treatment with Ocrevus.
Danish: • Lægen vil undersøge om du har brug for at blive vaccineret, inden du starter behandling med Ocrevus.
English: The respiratory tract infections reported in patients treated with Ocrevus were predominately mild to moderate (80 - 90 %).
Danish: De luftvejsinfektioner, der blev indberettet blandt patienter behandlet med Ocrevus var fortrinsvis af mild til moderat sværhedsgrad (80-90%).
English: Reproductive toxicity was observed in pre and post natal development studies (see section 5.3).
Danish: Reproduktionstoksicitet er observeret i præ- og postnatal udviklingstudier (se pkt.
English: MedDRA System Organ Class (SOC)
Danish: MedDRA Systemorgan-klasse
English: These included both active treatment naive and previously treated inadequate responders, as defined by clinical or imaging features.
Danish: Disse omfattede både aktive behandlingsnaive patienter og tidligere behandlede med utilstrækkelig respons, defineret ved kliniske eller radiologiske fund.
English: After administering symptomatic treatment, monitor the patient until the pulmonary symptoms have resolved because initial improvement of clinical symptoms could be followed by deterioration.
Danish: Efter administration af symptomatisk behandling, skal patienten monitoreres indtil de pulmonære symptomer er forsvundet, da initiel forbedring af kliniske symptomer kan afløses af forværring.
English: · From a microbiological point of view, the prepared infusion should be used immediately.
Danish: • Af mikrobiologiske hensyn skal den tilberedte infusion anvendes straks.
English: For subsequent infusions, more severe symptoms than previously experienced, or new severe symptoms, should prompt consideration of a potential hypersensitivity reaction.
Danish: Ved efterfølgende infusioner skal symptomer, der er tiltaget i sværhedsgrad i forhold til tidligere, eller nye, svære symptomer, straks føre til overvejelse om potentiel overfølsomhedsreaktion.
English: Ocrevus also significantly increases the chance of a patient having no evidence of disease activity (brain lesions, relapses and worsening of disability).
Danish: Ocrevus øger også i betydelig grad chancen for, at patienterne ikke oplever tegn på sygdom (hjernelæsioner, attakker og forværring i handicapudviklingen).
English: Ocrevus administration must be delayed in patients with an active infection until the infection is resolved.
Danish: Administration af Ocrevus skal udsættes hos patienter med aktiv infektion, indtil infektionen er væk.
English: Ocrevus has no or negligible influence on the ability to drive and use machines.
Danish: Ocrevus har ingen eller ubetydelig inflydelse på evnen til at føre motorkøretøj eller betjene maskiner.
English: Available pharmacodynamic/toxicological data in animals have shown excretion of ocrelizumab in milk (for details see section 5.3).
Danish: Tilgængelige farmakodynamiske/toksikologiske data fra dyr har vist, at ocrelizumab udskilles i mælk (for detaljer, se pkt.
English: · The product is intended for single use only.
Danish: • Produktet er kun beregnet til éngangsbrug.
English: *Pre-specified pooled analysis of WA21092 and WA21093
Danish: *Præspecificeret poolet analyse af WA21092 og WA21093
English: Very common: may affect more than 1 in 10 people · decrease in specific proteins in the blood (immunoglobulins) which help protect against infection
Danish: Meget almindelig (opleves af mere end 1 ud af 10 patienter) • fald i bestemte proteiner i blodet (immunglobuliner), som beskytter mod infektion
English: One patient with grade 3 (between 500 and 1000 cells/mm3) and one patient with grade 4 (< 500 cells/mm3) neutropenia required specific treatment with granulocyte-colony stimulating factor, and remained on ocrelizumab after the episode.
Danish: En patient med grad 3 (mellem 500 og 1000 celler/mm3) og en patient med grad 4 <500 celler/mm3) neutropeni behøvede specifik behandling med granulocyt-kolonistimulerende faktor og forblev på ocrelizumab efter episoden.
English: If you get any side effects, talk to your doctor or nurse.
Danish: Hvis du oplever bivirkninger, bør du tale med lægen, sygeplejersken eller apoteket.
English: · At the request of the European Medicines Agency; · Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: • når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i benefit/risk-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: Patients who require vaccination should complete their immunisation at least 6 weeks prior to initiation of Ocrevus.
Danish: Patienter med behov for vaccination skal gennemføre immunisering mindst 6 uger inden opstart af Ocrevus.
English: An exploratory analysis identified the following factors associated with risk of serious infections: higher doses of Ocrevus than recommended in MS, other comorbidities, and chronic use of immunosuppressants/corticosteroids.
Danish: En eksplorativ analyse identificerede følgende faktorer associeret med risiko for alvorlige infektioner:højere doser af Ocrevus end de anbefalede til multipel sclerose, anden comorbiditet og kronisk brug af immunsupprimerende midler/kortikosteroider.
English: Measurable levels of ocrelizumab were detected in milk (approximated 0.2% of steady state trough serum levels) during the lactation period.
Danish: Der er påvist målbare niveauer af ocrelizumab i mælken (ca. 0,2% af steady-state niveauet igennem serum) i dieperioden.
English: From a microbiological point of view, the prepared infusion should be used immediately.
Danish: Af mikrobiologiske hensyn skal den tilberedte infusion anvendes straks.
English: · Tell your doctor if you have recently been given any vaccine or might be given a vaccine in the near future.
Danish: • Fortæl det til lægen, hvis du fornylig er blevet vaccineret eller hvis du snart skal vaccineres.
English: Study name
Danish: Studie navn
English: Group A: Ocrevus 600 mg Group B: Placebo, in 2:1 randomisation
Danish: Gruppe A: Ocrevus 600 mg Gruppe B: Placebo, Randomiseret i forholdet 2:1
English: There is limited clinical trial experience with doses higher than the approved intravenous dose of Ocrevus.
Danish: Der er begrænset erfaring fra kliniske studier med doser over den godkendte intravenøse dosis af Ocrevus.
English: · If you are treated with Ocrevus for primary progressive multiple sclerosis, and you have swallowing difficulties, Ocrevus may increase the risk of severe pneumonia.
Danish: • Hvis du bliver behandlet med Ocrevus til primær progressiv multipel sklerose, og du har synkebesvær, kan Ocrevus øge risikoen for alvorlig lungebetændelse.
English: · Talk to your doctor before you are given Ocrevus if you think you have an infection.
Danish: • Tal med din læge, før du får Ocrevus, hvis du tror, du har en infektion.
English: It is recommended to vaccinate patients treated with Ocrevus with seasonal influenza vaccines that are inactivated.
Danish: Det anbefales at vaccinere patienter, der er i behandling med Ocrevus, med inaktiveret sæsonbetonet influenzavaccine.
English: Patients with a history of congestive heart failure (New York Heart Association III & IV) were not studied.
Danish: Patienter med kongestivt hjertesvigt i anamnesen (New York Heart Association III & IV) er ikke undersøgt.
English: Physicians should review the immunisation status of patients being considered for treatment with Ocrevus.
Danish: Lægen skal kontrollere immuniseringsstatus hos de patienter, der overvejes sat i behandling med Ocrevus.
English: Initial Dose (600 mg) divided into 2 infusions
Danish: Første dosis (600 mg) fordelt på 2 infusioner
English: You will be given a total dose of 600 mg of Ocrevus every 6 months.
Danish: Du vil få i alt 600 mg Ocrevus hver 6. måned.
English: Study duration
Danish: Studiet varighed
English: The results of this study show that Ocrevus significantly delays disease progression and reduces deterioration in walking speed compared with placebo.
Danish: Resultaterne af dette studie viser, at Ocrevus i betydelig grad forsinker sygdomsprogression og reducerer forringelse af ganghastighed sammenlignet med placebo.
English: Your doctor may ask you to stop taking your blood pressure medicines for 12 hours before each Ocrevus infusion.
Danish: Lægen kan bede dig om at holde pause med at tage din blodtrykssænkende medicin i 12 timer inden hver Ocrevus-infusion.
English: · Periodic safety update reports
Danish: • Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er)
English: Out of 1311 patients treated with Ocrevus, 12 (~1%) tested positive for treatment-emergent ADAs, of which 2 patients tested positive for neutralising antibodies.
Danish: Ud af 1311 patienter behandlet med Ocrevus, blev 12 (~1%) testet positive for behandlingsudløst anti-lægemiddel antistoffer; ud af disse blev to patienter testet positive for neutraliserende antistoffer.
English: Blood and lymphatic system disorders
Danish: Blod og lymfatiske sygdomme
English: The longest follow up time after the last Ocrevus infusion (Phase II study WA21493, N=51) indicates that the median time to B-cell repletion (return to baseline/LLN whichever occurred first) was 72 weeks (range 27 - 175 weeks).
Danish: Længste opfølgningstid efter sidste Ocrevus-infusion (fase II-studie WA21493, N=51) viser, at mediantid til B-celle-gendannelse (til baseline/laveste referencegrænse, alt efter hvad der forekom først) var 72 uger (27-175 uger).
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.
Danish: Symptomerne på multipel sclerose afhænger af hvilken del af centralnervesystemet, der er ramt, og det kan inkludere problemer med at gå og med balancen, svaghed, følelsesløshed, dobbeltsyn og sløret syn, dårlig koordinationsevne og blæreproblemer.
English: Exploratory result based on complete ITT population.
Danish: Eksplorative resultater baseret på hele Intension To Treat (ITT)populationen.
English: The table 2 summarises the ADRs that have been reported in association with the use of Ocrevus in 1311 patients (3054 patient years) during the controlled treatment periods of MS clinical trials.
Danish: I Tabel 2 opsummeres de bivirkninger, der er indberettet i forbindelse med brug af Ocrevus hos 1311 patienter (3054 patientår) i de kontrollerede behandlingsperioder i multipel sclerose- kliniske studier.
English: Percentage change in brain volume from Week 24 to week 96 Relative reduction in brain volume loss
Danish: Procentdel ændring i hjernevolumen fra Uge 24 til uge 96 Relativt fald i tab af hjernevolumen
English: Pack size of 1 or 2 vials.
Danish: Pakninger med 1 eller 2 hætteglas.
English: Patients in Group B were administered Interferon beta-1a (Rebif) 44 mcg via subcutaneous injection 3 times per week.
Danish: Patienter i Gruppe B fik administreret interferon-beta-1a (Rebif ) 44 mikrogram via subkutan injektion, 3 gange om ugen.
English: 90% of all patients had their B-cells repleted to LLN or baseline by approximately two and a half years after the last infusion.
Danish: 90% af alle patienter havde gendannet B-celler svarende til baseline niveau eller laveste referencegrænse ca. 2,5 år efter sidste infusion.
English: Subsequent Doses (600 mg) once every 6 months
Danish: Efterfølgende doser (600 mg) 1 gang hver 6. måned
English: · In primary progressive MS. the symptoms generally continue to worsen from the start of the disease.
Danish: • I primær progressiv multipel sclerose fortsætter symptomernegenerelt med at forværres fra starten af sygdommen.
English: The infusion should be restarted only after all symptoms have resolved.
Danish: Infusionen må ikke genoptages før alle symptomer er forsvundet.
English: Table 5 Study design, demograhics and baseline characteristics for Study WA25046.
Danish: Tabel 5 Studiedesign, demografiske- og baseline-karakteristika for studie WA25046.
English: Evaluation including Magnetic Resonance Imaging (MRI) scan preferably with contrast (compared with pre-treatment MRI), confirmatory cerebro-spinal fluid (CSF) testing for John Cunningham (JC) Viral Deoxyribonucleic acid (DNA) and repeat neurological assessments, should be considered.
Danish: Evaluering, inklusive Magnectic Resonance Imaging (MRI), helst med kontraststof (til sammenligning med MRI inden behandling), bekræftende cerebrospinalvæske-test (CSF) for John Cunningham (JC)-viral deoxyribonukleinsyre (DNA) og gentagelse af neurologisk vurdering bør overvejes.
English: There are no dedicated PK studies of ocrelizumab in patients ≥55 years due to limited clinical experience (see section 4.2).
Danish: Der er ingen dedikerede farmakokinetiske studier af ocrelizumab hos patienter i aldersgruppen ≥55 år på grund af begrænset klinisk erfaring (se pkt.
English: The overall proportion of patients experiencing a serious infection was similar to comparators (see section 4.8).
Danish: Den samlede andel patienter, der oplevede en alvorlig infektion, var sammenlignelig med komparatorens (se pkt.
English: · Known active malignancies (see section 4.4)
Danish: • Kendte aktive maligniteter (se pkt.
English: · Ocrevus medicinal product must be diluted before administration.
Danish: • Lægemidlet Ocrevus skal fortyndes inden administration.
English: 6.6 Special precautions for disposal and other handling Instructions for dilution
Danish: 6.6 Regler for bortskaffelse og anden håndtering Vejledning i fortynding
English: 1 Symptoms reported as IRRs within 24 hours of the infusion are described below in ‘Infusion-related reactions'.
Danish: 1 Symptomer indberettet som infusionsrelaterede reaktioner inden for 24 timer efter infusionen er beskrivet neden for i afsnittet ‘Infusionsrelaterede reaktioner'.
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.
Danish: 4.8 for information om det systemiske inflammatoriske respons syndrom (SIRS), der forekom hos en patient, der blev behandlet med Ocrevus 2000 mg.
English: 4.5 Interaction with other medicinal products and other forms of interaction No formal drug interaction studies have been performed, as no drug interactions are expected via cytochrome P450 enzymes, other metabolising enzymes or transporters.
Danish: Der er ikke udført interaktionsstudier, da lægemiddelinteraktion ikke forventes via cytokrom P450 enzymer, andre metaboliserende enzymer eller transportører.
English: See under ‘Other medicines and Ocrevus', below for more information.
Danish: Se nedenunder i afsnittet "Brug af anden medicin sammen med Ocrevus" for mere information.
English: · Tell your doctor or nurse straight away if you think your MS is getting worse or if you notice any new symptoms.
Danish: • Kontakt straks lægen eller sygeplejersken, hvis du føler, at din multipel sclerose forværres eller hvis du oplever nye symptomer.
English: Each infusion will last about 2 hours 30 minutes.
Danish: Hver infusion vil tage ca. 2 timer og 30 minutter.
English: Breakdown of the myelin sheath stops the nerves working properly.
Danish: Nedbrydning af myelinskeden forhindrer nerverne i at virke normalt.
English: The maternal doses administered in this study resulted in maximum mean serum concentrations (Cmax) that were 4.5- and 21-fold above those anticipated in the clinical setting.
Danish: De administrerede maternelle doser i dette studie medførte gennemsnitligt maksimale serumkoncentrationer der var 4,5 og 21 gange højere end de, der forventes i klinisk brug.
English: Infections were predominantly mild to moderate in severity and patients recovered with treatment by standard therapies.
Danish: Infektionerne var fortrinsvis af mild til moderat karakter, og patienterne responderede på standardbehandling.
English: Table 3 Study Design, Demographic and Baseline Characteristics Study 1
Danish: Tabel 3 Studiedesign, demografiske- og baseline-karakteristika
English: The metabolism of Ocrevus has not been directly studied, as antibodies are cleared principally by catabolism (i.e. breakdown into peptides and amino acids).
Danish: Metaboliseringen af Ocrevus er ikke direkte undersøgt, da antistoffer principielt cleares ved katabolisme (dvs. nedbrydning til peptider og aminosyrer).
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.
Danish: Reaktivering af hepatitis B-virus, i nogle tilfælde ledsaget af fulminant hepatitis, leversvigt og død, er indberettet hos patienter behandlet med anti-CD20-antistoffer.
English: After treatment with Ocrevus over 2 years, the proportion of patients with positive antibody titers against S. pneumoniae, mumps, rubella and varicella were generally similar to the proportions at baseline.
Danish: Efter behandling med Ocrevus over to år, var andelen af patienter med positive antistof-titer mod S. pneumoniae, fåresyge, røde hunde og skoldkopper generelt svarende til niveauet ved baseline.
English: Sinusitis, bronchitis, oral herpes, gastroenteritis, respiratory tract infection, viral infection, herpes zoster, conjunctivitis, cellulitis
Danish: Sinusitis, bronkitis, oral herpes, gastroenteritis, luftvejsinfektion, viral infektion, herpes zoster, konjunktivitis, cellulitis
English: CD20 is a cell surface antigen found on pre-B cells, mature and memory B cells but not expressed on lymphoid stem cells and plasma cells.
Danish: CD20 er et celleoverflade-antigen, der findes på præ-B-celler samt modne og hukommelses-B-celler, men ikke på lymfestamceller eller plasmaceller.
English: Geometric mean anti-tetanus toxoid specific antibody titers at 8 weeks were 3.74 and 9.81 IU/ml, respectively.
Danish: Det geometriske gennnemsnit af antitetanus toxoid-specifikke antistof-titer ved uge 8 var på henholdsvis 3,74 og 9,81 IE/ml.