natgillin/translations-raw huggingface dataset:
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).
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).
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).
Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000
Kontakt lægen, før du får Ocrevus, hvis ét eller flere af følgende punkter gælder for dig.
Talk to your doctor before you are given Ocrevus if any of the following apply to you.
• De mest almindelige bivirkninger ved behandling med Ocrevus er infusionsrelatede reaktioner (meget almindelig: opleves af mere end 1 ud af 10 patienter).
· Infusion-related reactions are the most common side effect of Ocrevus treatment (very common: may affect more than 1 in 10 people).
• hvis du har fået at vide, at du har alvorlige problemer med dit immunsystem
· if you currently have an infection · if you have been told that you have severe problems with your immune system · if you have cancer
Alle patienter bør hepatitis B-virus-screenes inden opstart af behandling med Ocrevus, i overenstemmelse med lokale retningslinjer.
HBV screening should be performed in all patients before initiation of treatment with Ocrevus as per local guidelines.
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.
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.
De vigtigste effektresultater, kliniske og MRI, præsenteres i Tabel 6 og Figur 2.
Key clinical and MRI efficacy results are presented in Table 6 and Figure 2.
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.
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.
Håndtering af infusionsrelaterede reaktioner under og efter infusionen
Management of IRRs during and after the infusion
Et øget antal af alvorlige infektioner blev observeret under episoder af fald i det totale antal lymfocytter hos patienter behandlet med ocrelizumab.
An increased rate of serious infections was observed during episodes of confirmed total lymphocytes counts decrease in ocrelizumab treated patients.
Efterfølgende doser
Subsequent Doses
Der bør udvises forsigtighed ved ordination af Ocrevus, med hensyn til farmakodynamikken af andre sygdomsmodificerende multipel sclerose-behandlinger.
Caution should be exercised when prescribing Ocrevus taking into consideration the pharmacodynamics of other disease modifying MS therapies.
• fås i pakker med 1 eller 2 hætteglas (hætteglas med 10 ml koncentrat).
· This medicine is available in packs containing 1 or 2 vials (vials of 10 mL concentrate).
Lægen beslutter om den gavn du har af Ocrevus opvejer risikoen for barnet.
Your doctor will consider the benefit of you taking Ocrevus against the risk to your baby.
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
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
Ocrevus administreres som intravenøs infusion.
Ocrevus is administered as an intravenous infusion.
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.
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).
Studiets design og studiepopulationens baseline-karakteristika præsenteres i Tabel 5.
Study design and baseline characteristics of the study population are presented in Table 5.
Bivirkningerne var i overensstemmelse med Ocrevus' sikkerhedsprofil i de kliniske pivotale studier.
The adverse drug reactions were consistent with the safety profile for Ocrevus in the pivotal clinical studies.
Lægemidlet Ocrevus skal fortyndes inden administration.
Ocrevus medicinal product must be diluted before administration.
Dette mindsker risikoen for inflammation og beskadigelse af myelinskeden og mindsker dermed risikoen for et attak og forsinker udviklingen af sygdommen.
This reduces inflammation and attacks on the myelin sheath, reduces the chance of having a relapse and slows the progression of your disease.
Andelen af luftvejsinfektioner var højere blandt Ocrevus-behandlede patienter end blandt patienter behandlet med interferon-beta-1-a og placebo.
The proportion of respiratory tract infections was higher in Ocrevus treated patients compared to interferon beta-1-a and placebo.
Gruppe A: Ocrevus 600 mg Gruppe B: interferon-beta-1a 44 mikrogram S.C.
Group A: Ocrevus 600 mg Group B: interferon beta-1a 44 mcg S.C. (IFN)
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.
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).
• 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.
· 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.
• Kontakt straks lægen eller sygeplejersken, hvis du oplever symptomer på en infusionrelateret reaktion, under infusionen eller op til 24 timer efter infusionen.
· 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.
Opbevar hætteglasset i den ydre karton for at beskytte mod lys Opbevar hætteglassene i den ydre karton for at beskytte mod lys
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
• Ocrevus er en klar til let opaliserende og farveløs til lysebrun opløsning.
· Ocrevus is a clear to slightly opalescent, and colourless to pale brown solution.
De vigtigste og hyppigst indberettede bivirkninger var infusionsrelaterede reaktioner og infektioner.
The most important and frequently reported adverse drug reactions (ADRs) were IRRs and infections.
De vigtigste effektresultater, kliniske som MRI, præsenteres i Tabel 4 og Figur 1.
Key clinical and MRI efficacy results are presented in Table 4 and Figure 1.
Figur 1: Dosis og doseringsskema for Ocrevus
Figure 1: Dose and Schedule of Ocrevus
• Hvis en intravenøs infusion ikke kan gennemføres samme dag, skal overskydende opløsning smides ud.
· In the event an intravenous infusion cannot be completed the same day, the remaining solution should be discarded.
Lægen kan beslutte at udskyde behandlingen med Ocrevus.
Your doctor may decide to delay your treatment with Ocrevus.
Der var ingen rapporter for grad 4 lymfopeni (<200 celler/mm3).
None of the patients was reported with Grade 4 lymphopenia (< 200 cells/mm3).
• 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.
· 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.
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.
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.
Læs produktresumé for yderligere information.
Read the SmPC for additional information.
• Der er påvist kemisk og fysisk stabilitet i 24 timer ved 2-8°C og efterfølgende i 8 timer ved stuetemperatur.
· Chemical and physical in-use stability has been demonstrated for 24 hours at 2-8°C and subsequently 8 hours at room temperature.
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.
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.
Hvis du holder op med at bruge Ocrevus
If you stop Ocrevus treatment
Forekomsten er indenfor baggrundsraten, som forventes for en multipel sclerosepopulation.
The incidence remains within the background rate expected for an MS population.
Ocrelizumab er et rekombinant, humaniseret, anti-CD20 monoklonalt antistof produceret i ovarieceller fra kinesiske hamstere ved rekombinant DNA-teknologi.
Ocrelizumab is a recombinant humanised anti-CD20 monoclonal antibody produced in Chinese Hamster Ovary cells by recombinant DNA technology.
• Præmedicinering: Patienter skal præmedicineres for at mindske hyppigheden og sværhedsgraden af infusionsrelaterede reaktioner (se pkt.
· Premedication: Patients must receive premedication to reduce the frequency and severity of IRRs (see section 4.2.
- infektion i mave og tarm (gastroenteritis) - luftvejsinfektion - virusinfektion - hudinfektion (cellulitis)
infection of the stomach and bowel (gastroenteritis) respiratory tract infection viral infectionskin infection (cellulitis)
Dette opretholdes under behandlingsperioden.CD19 anvendes til B-celle tællingen, da tilstedeværelsen af Ocrevus påvirker genkendelsen af CD20 i testen.
For the B cell counts, CD19 is used, as the presence of Ocrevus interferes with the recognition of CD20 by the assay.
Kønsfordeling (% mænd/% kvinder)
Mean age (years) Age range (years) at inclusion Gender distribution (% male/% female)
• Den fortyndede infusionsopløsning skal administreres med infusionssæt med 0,2 eller 0,22 mikrometer in-line-filter.
· The diluted infusion solution must be administered using an infusion set with a 0.2 or 0.22 micron in-line filter.
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).
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).
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.
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.
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.
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.
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
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.
Incidensen af infusionsrelaterede reaktioner var højest under dosis 1, infusion 1 (27,4 %) og faldt ved efterfølgende doser til <10 % ved dosis 4.
The incidence of IRRs was highest during Dose 1, infusion 1 (27.4%,) and decreased with subsequent doses to <10% at Dose 4.
• 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.
· 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.
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).
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.
• Ved attakvis multipel sclerose (RMS) hjælper Ocrevus med at reducere antallet af attakker betydeligt og bremser betydeligt udviklingen af sygdommen.
· 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.
Nyfødt afkom af hunner eksponeret for ocrelizumab er observeret at have lavt B-celle-niveau i den post-natale fase.
Newborn offspring of maternal animals exposed to ocrelizumab were noted to have depleted B cell populations during the post natal phase.
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.
The impact of treatment-emergent ADAs on safety and efficacy cannot be assessed given the low incidence of ADA associated with Ocrevus.
• Du vil blive fulgt tæt mens du får Ocrevus og i mindst 1 time efter infusionen er færdig.
· You will be closely monitored while you are being given Ocrevus and for at least 1 hour after the infusion has been given.
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.
Patients with mild renal impairment were included in clinical trials and no change in the pharmacokinetics of Ocrevus was observed in those patients.
Incidensen af infusionsrelaterede reaktioner var højest under dosis 1, infusion 1 (27,5%) og faldt over tid til <10% ved dosis 4.
The incidence of IRRs was highest during the Dose 1, infusion 1 (27.5%) and decreased over time to <10% at Dose 4.
Første efterfølgende dosis af 600 mg skal administreres seks måneder efter første infusion af første dosis.
The first subsequent dose of 600 mg should be administered six months after the first infusion of the initial dose.
Inden den intravenøse infusion påbegyndes, bør indholdet af infusionsposen opnå stuetemperatur.
Prior to the start of the intravenous infusion, the content of the infusion bag should be at room temperature.
Justering af infusion er ikke nødvendig ved efterfølgende infusioner, med mindre patienten oplever en infusionsrelateret reaktion.
No infusion adjustment is necessary for subsequent new infusions, unless the patient experiences an IRR.
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).
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).
Det anbefales at kontrollere patientens immunstatus før dosering, da svært immunkompromitterede patienter (e.g med lymfopeni, neutropeni, hypogammaglobulinæmi) ikke må behandles (se pkt.
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).
Brug ikke opløsningen, hvis den er misfarvet eller indeholder fremmede partikler.
Do not use the solution if discoloured or if the solution contains foreign particulate matter.
Det anbefales ikke at ændre dosis af Ocrevus.
No dose reductions of Ocrevus are recommended.
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.
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.
MRI af kraniet viste radiologiske fund, der var karakteristiske for inflammatorisk aktivitet enten ved Gdopladende T1-læsioner eller T2-læsioner.
Cranial MRI showed imaging features characteristic of inflammatory activity either by T1 Gd enhancing lesions or T2 lesions.
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%).
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%).
Ocrelizumab er et rekombinant, humaniseret monoklonalt antistof selektivt målrettet B-celler, der udtrykker CD20.
Ocrelizumab is a recombinant humanised monoclonal antibody that selectively targets CD20-expressing B cells.
Efter celleoverfladebinding, depleterer ocrelizumab selektivt B-celler, der udtrykker CD20, ved antistofafhængig cellulær fagocytose, antistofafhængig cellulær cytotoksicitet, komplementafhængig cytotoksicitet samt apoptose.
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.
Produktet er beregnet til éngangsbrug.
The product is intended for single use only.
Gennemsnitligt antal T1 Gd-opladende læsioner per MRI
Mean number of T1 Gd-enhancing lesions per MRI scan
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.
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.
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).
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).
Lægen vil vurdere om du er i stand til at føre motorkøretøj eller bruge maskiner sikkert.
Your doctor will tell you whether your MS may affect your ability to drive or use tools and machines safely.
Infusionsrelaterede reaktion1
Infusion-related reactions1
Dosisændringer under behandling
Dose Modifications during Treatment
• Hver infusion skal gives over ca. 3,5 time
· Each infusion should be given over approximately 3.5 hours
• Aktivt stof: ocrelizumab.
· The active substance is ocrelizumab.
Der skal gå mindst 5 måneder mellem hver dosis Ocrevus.
A minimum interval of 5 months should be maintained between each dose of Ocrevus.
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.
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.
Tabel 4 Vigtigste kliniske og MRI-endepunkter fra studie WA21092 og WA21093 (attakvis multipel sclerose)
Table 4 Key Clinical and MRI Endpoints from Studies WA21092 and WA21093 (RMS)
Den fortyndede infusionsopløsning skal administreres med infusionssæt med 0,2 eller 0,22 mikrometer in-line-filter.
The diluted infusion solution must be administered using an infusion set with a 0.2 or 0.22 micron in-line filter.
De fleste infusionsrelaterede reaktioner var milde til moderate.
The majority of IRRs were mild to moderate.
Infusionen kan gives langsommere, midlertidigt afbrydes eller afbrydes helt, hvis du får en infusionsrelateret reaktion, afhængigt af hvor alvorlig den er (se pkt.
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).
Første dosis
Initial Dose