natgillin/translations-raw huggingface dataset:
Alvorlige infektioner sås hos 6,2% af patienterne behandlet med Ocrevus vs. 6,7% af patienterne behandlet med placebo.
Serious infections occurred in 6.2% of patients receiving Ocrevus vs 6.7% of patients receiving placebo.
Koncentrat til infusionsvæske, opløsning 300 mg/10 ml
Concentrate for solution for infusion 300 mg/10 ml
Det er vigtigt, fordi Ocrevus kan optages i moderkagen og måske påvirke barnet.
This is because Ocrevus may cross the placenta and affect your baby.
Figur 1 Kaplan-Meier-plot af tid til indtræden af bekræftet handicapudvikling opretholdt i mindst 12 uger, med initial hændelse i form af neurologisk forværring, opstået under den dobbeltblinde behandlingsperiode (poolet WA21092 og WA21093 ITT-population)*
Figure 1: Kaplan-Meier Plot of Time to Onset of Confirmed Disability Progression Sustained for at Least 12 Weeks with the Initial Event of Neurological Worsening Occurring during the Double-blind Treatment Period (Pooled WA21092 and WA21093 ITT Population)*
Hvis dette tåles af patienten, kan infusionshastigheden øges til den oprindelige infusionshastighed.
If tolerated, the infusion rate may then be increased according to the patient's initial infusion rate.
Brug af anden medicin sammen med Ocrevus
Other medicines and Ocrevus
Selv i progressiv multipel sclerose kan sygdomsaktivitet i form af inflammatorisk aktivitet være relateret til radiologiske fund (fx. Gd-opladende T1-læsioner og/eller aktive (nye eller forstørrede) T2-læsioner).
With regard to disease activity, features characteristic of inflammatory activity, even in progressive MS, can be imaging-related, (i.e. T1 Gd-enhancing lesions and/or active [new or enlarging] T2 lesions).
A. FREMSTILLER AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Andel af patienter uden attakker ved 96 uger2
Proportion of patients Relapse free at 96 weeks
• Behandling med Ocrevus bør påbegyndes og superviseres af erfarent sundhedspersonale med adgang til relevant medicinsk understøttende behandling af svære reaktioner, fx alvorlige infusionsrelaterede reaktioner, overfølsomhedsreaktioner og/eller anafylaktiske reaktioner.
· Ocrevus treatment should be initiated and supervised by an experienced healthcare professional with access to appropriate medical support to manage severe reactions such as serious infusionrelated reactions (IRRs), hypersensitivity reactions and/or anaphylactic reactions.
Hvis der under infusionen opstår mistanke om overfølsomhedsreaktion, skal infusionen straks og permanent afbrydes (se ‘Allergiske reaktioner' herunder).
If a hypersensitivity reaction is suspected during infusion, the infusion must be stopped immediately and permanently (see ‘Hypersensitivity Reactions' below).
Patienter skal overvåges under infusionen og i mindst en time efter infusionen.
Patients should be monitored during the infusion and for at least one hour after the completion of the infusion.
• Hastigheden kan øges i trin af 30 ml/time hver 30. minut til maksimalt 180 ml/time.
· The rate can be increased in 30 mL/hour increments every 30 minutes to a maximum of 180 mL/hour.
Inden du får Ocrevus, vil du få anden medicin, der skal forebygge eller mindske risikoen for bivirkninger, bl.a. infusionsrelaterede reaktioner (se pkt.
Medicines you will have before you are given Ocrevus Before you are given Ocrevus, you will receive other medicines to prevent or reduce possible side effects such as infusion-related reactions (see sections 2 and 4 for information about infusion-related reactions).
• Du må ikke blive vaccineret med levende eller svækkede levende vacciner (fx mod tuberkulose eller gul feber), mens du er i behandling med Ocrevus.
· While you are being treated with Ocrevus, you should not be given live or live attenuated vaccines (for example BCG for tuberculosis or vaccines against yellow fever).
• Hver infusion skal gives over ca. 2,5 time
· Each infusion should be given over approximately 2.5 hours
Det bør overvejes at udsætte vaccination med levende eller svækkede levende vacciner hos nyfødte og spædbørn, hvis mødre har fået Ocrevus under graviditeten.
Postponing vaccination with live or live-attenuated vaccines should be considered for neonates and infants born to mothers who have been exposed to Ocrevus in utero.
• Følgende forholdsregler skal tages for patienter, der oplever svære pulmonære symptomer, fx bronkospasme eller astmaexacerbation: Skal permanent have afbrudt infusionen Symptomatisk behandling skal gives - Patienten skal monitoreres indtil de pulmonære symptomer er svundne, da umiddelbar bedring i kliniske symptomer kan afløses af forværring.
During the infusion: · The following measures need to be taken for patients who experience severe pulmonary symptoms, such as bronchospasm or asthma exacerbation: their infusion must be interrupted immediately and permanently symptomatic treatment must be administered the patient must be monitored until the pulmonary symptoms have resolved because initial improvement of clinical symptoms could be followed by deterioration · Hypersensitivity may be difficult to distinguish from an IRR in terms of symptoms.
Fertile kvinder skal anvende prævention under behandling med Ocrevus og i 12 måneder efter sidste infusion af Ocrevus (se nedenfor samt pkt.
Women of child bearing potential should use contraception while receiving Ocrevus and for 12 months after the last infusion of Ocrevus (see below and section 5.1 and 5.2).
Trehalosedihydrat Polysorbat 20
Sodium Acetate Trihydrate Glacial Acetic Acid Trehalose Dihydrate Polysorbate 20
Hvis en intravenøs infusion ikke 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.
Kaplan-Meier-plot over tid til indtræden af bekræftet invaliditetsprogression opretholdt i mindst 12 uger med initial hændelse i form af neurologisk forværring opstået, under den dobbeltblinde behandlingsperiode (WA25046 ITTpopulation)*
Figure 2: Kaplan-Meier Plot of Time to Onset of Confirmed Disability Progression Sustained for at Least 12 Weeks with the Initial Event of Neurological Worsening Occurring during the Double-blind Treatment Period (WA25046 ITT Population)*
Der er påvist kemisk og fysisk holdbarhed 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 for 8 hours at room temperature.
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.
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.
• Det kan være svært at skelne en overfølsomhedsreaktion fra en infusionsrelateret reaktion med hensyn til symptomer.
· Hypersensitivity may be difficult to distinguish from an IRR in terms of symptoms.
Andel af patienter uden tegn på sygdomsaktivitet (NEDA)5 Relativ stigning2
Proportion of patients with No Evidence of Disease Activity (NEDA)
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.
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.
7,6% Ocrevus vs. 12,0% Interferon-beta-1a 40% (p=0,0025)7 43% (p=0,0278)7
7.6% Ocrevus vs 12.0% IFN 40% (p=0.0025)7 43 % (p=0.0278)7
Se pkt 4.5 og 5.1.
See section 4.5 and 5.1.
Ocrevus indeholder det aktive middel ocrelizumab.
Ocrevus contains the active substance ‘ocrelizumab'.
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.
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.
INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 300 mg/10 ml
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 300 mg/10 ml
Kliniske endepunkter Vigtige effekt-endepunkt Andel af patienter med 12 ugers bekræftet handicapudvikling1 (primært endepunkt)
Primary efficacy endpoint Proportion of patients with 12 weeks - Confirmed Disability Progression1 (primary endpoint)
Kliniske endepunkter Årligt antal attakker (primært endepunkt)
Annualised Relapse Rate (ARR) (primary endpoint)
Patienter med let nedsat nyrefunktion har været inkluderet i kliniske studier.
Patients with mild renal impairment were included in clinical trials.
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.
Your doctor may decide to delay your treatment with Ocrevus or may ask you to stop such medicines before starting treatment with Ocrevus.
• Første dosis
· Initial Dose
• ophobning af tykt slim i næsen, halsen eller brystet.
Common: may affect up to 1 in 10 people · cough · a build-up of thick mucus in the nose, throat or chest.
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).
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.
• 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).
· 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).
De fleste infusionsrelaterede reaktioner var milde til moderate i begge behandlingsgrupper.
The majority of IRRs in both treatment groups were mild to moderate.
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-.
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.
Den samlede virkning af den anden medicin og Ocrevus kan være for skadelig for immunsystemet.
The effect on the immune system of these medicines with Ocrevus could be too strong.
• Hastigheden kan øges i trin af 40 ml/time hver 30. minut til maksimalt 200 ml/time
· The rate can be increased in 40 mL/hour increments every 30 minutes to a maximum of 200 mL/hour
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.
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).
26,7 % og 11,9 % af de Ocrevus-behandlede patienter oplevede milde og moderate infusionsrelaterede reaktioner; 1,4 % oplevede svære infusionsrelaterede reaktioner.
26.7% and 11.9% of Ocrevus treated patients experienced mild and moderate IRRs respectively, 1.4% experienced severe IRRs.
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.
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).
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.
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.
Brug ikke opløsningen, hvis den er misfarvet eller hvis opløsningen indeholder fremmede partikler (se pkt.
Do not use the solution if discoloured or if the solution contains foreign particulate matter (see section 3 for a description of the solution).
Omfanget og varigheden af B-celledepleteringen var ensartet i primær progressiv- og attakvis multipel sclerose-studier.
The extent and duration of B-cell depletion was consistent in the PPMS and RMS trials.
Patienter med kendt IgE-medieret overfølsomhed over for ocrelizumab må ikke behandles (se pkt.
Patients with known IgE mediated hypersensitivity to ocrelizumab must not be treated (see section 4.3).
Alvorlige infektioner sås hos 1,3% af patienterne behandlet med Ocrevus vs. 2,9% af patienterne behandlet med interferon-beta-1a.
Serious infections occurred in 1.3% of patients receiving Ocrevus vs 2.9% of patients receiving interferon beta 1a.
• Ved primær progressiv multipel sclerose (PPMS) forsinker Ocrevus sygdommens udvikling og mindsker forværring af ganghastigheden.
· In Primary Progressive MS (PPMS), Ocrevus helps to slow down the progression of the disease and reduce deterioration in walking speed.
• Hypotension: Kan forekomme som symptom på infusionsrelateret reaktion under Ocrevusinfusioner.
· Hypotension: As a symptom of IRR, may occur during Ocrevus infusions.
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.
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).
Tabel 6 Kliniske og MRI vigtigste-endepunkter fra studie WA25046 (primær progressiv multipel sclerose)
Table 6 Key Clinical and MRI Endpoints from Study WA25046 (PPMS) Study 3
Størrelsen af dosis af Ocrevus og hvor ofte den skal gives
How much and how often you will be given Ocrevus
Hvad anvendes Ocrevus til?
What Ocrevus is used for
Patienter med primær progressiv multipel sclerose
Patients with primary progressive form of MS
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.
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.
• Ocrevus-infusioner må ikke administreres som hurtig intravenøs injektion eller bolus.
· Ocrevus infusions should not be administered as an intravenous push or bolus.
I tilfælde af infusionsrelaterede reaktioner under en infusion foretages nedenstående justeringer.
In case of IRRs during any infusion, see the following adjustments.
• Hos patienter, der oplever svære pulmonære symptomer, fx bronkospasme eller astmaexacerbation, skal infusionen straks afbrydes og behandlingen seponeres.
· Patients who experience severe pulmonary symptoms, such as bronchospasm or asthma exacerbation, must have their infusion interrupted immediately and permanently.
20,7% Ocrevus vs. 15,6% Interferon-beta-1a
20.7% Ocrevus vs 15.6% IFN
Det vides ikke med sikkerhed om Ocrevus påvirker evnen til at føre motorkøretøj eller bruge maskiner.
It is not known whether Ocrevus can affect your being able to drive or use tools or machines.
• Øvrige indholdsstoffer: natriumacetat trihydrat, iseddikesyre, trehalose dihydrat, polysorbat 20
· The other ingredients are sodium acetate trihydrate, glacial acetic acid, trehalose dihydrate, polysorbate 20 and water for injection.
Efterfølgende doser af Ocrevus administreres derefter som én intravenøs infusion á 600 mg hver 6. måned (Tabel 1).
Subsequent doses of Ocrevus thereafter are administered as a single 600 mg intravenous infusion every 6 months (Table 1).
• Infusionsjusteringer i tilfælde af infusionsrelaterede reaktioner Hvis der under en infusion opstår infusionsrelaterede reaktioner, skal følgende justeringer foretages:
· Infusion Adjustments in case of IRRs In case of IRRs during any infusion, see the following adjustments.
Fortyndet opløsning til intravenøs infusion
Diluted solution for intravenous infusion
Infusionshastigheden skal initialt være den halve af infusionshastigheden ved reaktionens indtræden.
The initial infusion rate at restart should be half of the infusion rate at the time of onset of the reaction.
KVALITATIV OG KVANTITATIV SAMMENSÆTNING Ét hætteglas indeholder 300 mg ocrelizumab i 10 ml ved en koncentration på 30 mg/ml.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 300 mg of ocrelizumab in 10 mL at a concentration of 30 mg/mL.
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).
The overall safety profile of Ocrevus in Multiple Sclerosis is based on data from patients from pivotal clinical trials in MS (RMS and PPMS).
Sikkerhed og virkning af Ocrevus hos patienter med nedsat leverfunktion er ikke formelt undersøgt.
The safety and efficacy of Ocrevus in patients with renal impairment has not been formally studied.
Andel af patienter med mindst 12-ugers bekræftet forbedret handicapudvikling 4
Proportion of patients with at least 12 weeks Confirmed Disability Improvement
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.
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.
• 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)
· 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).
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.
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.
• Behandling af svære reaktioner: Relevant udstyr til behandling af svære reaktioner, fx alvorlige infusionsrelaterede reaktioner, overfølsomhedsreaktioner og/eller anafylaktiske reaktioner, skal være tilgængelige.
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.
Kvinder skal frarådes at amme mens de er i behandling med Ocrevus.
Women should be advised to discontinue breast-feeding during Ocrevus therapy.
Sådan gives Ocrevus
How Ocrevus is given
Ocrevus er ikke beregnet til brug hos børn og unge under 18 år, da effekt og sikkerhed ikke er undersøgt i denne aldersgruppe.
Ocrevus is not intended to be used in children and adolescents under 18 years old.
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.
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.
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.
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).
Infusionsrelaterede reaktioner kan forekomme inden for 24 timer efter infusionen.
IRRs can occur within 24 hours of the infusion.
• Lægen skal informere patienterne om, at infusionsrelaterede reaktioner kan opstå inden for 24 timer efter infusion.
· Physicians should alert patients that an IRR can occur within 24 hours of infusion.
Ocrevus-infusioner må ikke administreres som hurtig intravenøs injektion eller bolus.
Ocrevus infusions should not be administered as an intravenous push or bolus.
Andel af patienter med 24 ugers bekræftet invaliditetsprogression1
Proportion of patients with 24 weeks - Confirmed Disability Progression1
For vejledning i dosering til patienter, der oplever symptomer på infusionsrelaterede reaktioner, se pkt.
For guidance regarding posology for patients experiencing IRR symptoms see section 4.2.
• Den første 600 mg dose Ocrevus gives som 2 separate infusioner (300 mg hver), med 2 ugers mellemrum.
· The first 600 mg dose of Ocrevus will be given as 2 separate infusions (300 mg each), given
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 hætteglas indeholder 300 mg ocrelizumab i 10 ml (30 mg/ml).
STATEMENT OF ACTIVE SUBSTANCE(S) One vial contains 300 mg ocrelizumab in 10 ml (30 mg/ml).
Denne indlægsseddel blev senest ændret <{MM/ÅÅÅÅ}> <{måned ÅÅÅÅ}.>
This leaflet was last revised in <{MM/YYYY}> Other sources of information
Hvis der er mistanke om overfølsomhedsreaktion under infusion, skal infusionen straks afbrydes og behandlingen seponeres permanent.
If a hypersensitivity reaction is suspected during infusion, the infusion must be stopped immediately and permanently.
Efter infusionen
After the infusion
Ocrevus 300 mg koncentrat til infusionsvæske, opløsning Ocrelizumab
Ocrevus 300 mg concentrate for solution for infusion Ocrelizumab
• Fortæl det straks til lægen eller sygeplejersken, hvis du har en infusionsrelateret reaktion (se pkt.
· Tell your doctor or nurse straight away if you have any infusion-related reaction (see section 4 for a list of infusion-related reactions).
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.
In the placebo-controlled study in PPMS, infections occurred in 72.2% of patients receiving Ocrevus vs 69.9% of patients receiving placebo.