natgillin/translations-raw huggingface dataset:
Lægen kan bede dig om at holde pause med at tage din blodtrykssænkende medicin i 12 timer inden hver Ocrevus-infusion.
Your doctor may ask you to stop taking your blood pressure medicines for 12 hours before each Ocrevus infusion.
• Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er)
· Periodic safety update reports
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.
Out of 1311 patients treated with Ocrevus, 12 (~1%) tested positive for treatment-emergent ADAs, of which 2 patients tested positive for neutralising antibodies.
Blod og lymfatiske sygdomme
Blood and lymphatic system disorders
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).
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).
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.
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.
Eksplorative resultater baseret på hele Intension To Treat (ITT)populationen.
Exploratory result based on complete ITT population.
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.
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.
Procentdel ændring i hjernevolumen fra Uge 24 til uge 96 Relativt fald i tab af hjernevolumen
Percentage change in brain volume from Week 24 to week 96 Relative reduction in brain volume loss
Pakninger med 1 eller 2 hætteglas.
Pack size of 1 or 2 vials.
Patienter i Gruppe B fik administreret interferon-beta-1a (Rebif ) 44 mikrogram via subkutan injektion, 3 gange om ugen.
Patients in Group B were administered Interferon beta-1a (Rebif) 44 mcg via subcutaneous injection 3 times per week.
90% af alle patienter havde gendannet B-celler svarende til baseline niveau eller laveste referencegrænse ca. 2,5 år efter sidste infusion.
90% of all patients had their B-cells repleted to LLN or baseline by approximately two and a half years after the last infusion.
Efterfølgende doser (600 mg) 1 gang hver 6. måned
Subsequent Doses (600 mg) once every 6 months
• I primær progressiv multipel sclerose fortsætter symptomernegenerelt med at forværres fra starten af sygdommen.
· In primary progressive MS. the symptoms generally continue to worsen from the start of the disease.
Infusionen må ikke genoptages før alle symptomer er forsvundet.
The infusion should be restarted only after all symptoms have resolved.
Tabel 5 Studiedesign, demografiske- og baseline-karakteristika for studie WA25046.
Table 5 Study design, demograhics and baseline characteristics for Study WA25046.
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.
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.
Der er ingen dedikerede farmakokinetiske studier af ocrelizumab hos patienter i aldersgruppen ≥55 år på grund af begrænset klinisk erfaring (se pkt.
There are no dedicated PK studies of ocrelizumab in patients ≥55 years due to limited clinical experience (see section 4.2).
Den samlede andel patienter, der oplevede en alvorlig infektion, var sammenlignelig med komparatorens (se pkt.
The overall proportion of patients experiencing a serious infection was similar to comparators (see section 4.8).
• Kendte aktive maligniteter (se pkt.
· Known active malignancies (see section 4.4)
• Lægemidlet Ocrevus skal fortyndes inden administration.
· Ocrevus medicinal product must be diluted before administration.
6.6 Regler for bortskaffelse og anden håndtering Vejledning i fortynding
6.6 Special precautions for disposal and other handling Instructions for dilution
1 Symptomer indberettet som infusionsrelaterede reaktioner inden for 24 timer efter infusionen er beskrivet neden for i afsnittet ‘Infusionsrelaterede reaktioner'.
1 Symptoms reported as IRRs within 24 hours of the infusion are described below in ‘Infusion-related reactions'.
4.8 for information om det systemiske inflammatoriske respons syndrom (SIRS), der forekom hos en patient, der blev behandlet med Ocrevus 2000 mg.
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.
Der er ikke udført interaktionsstudier, da lægemiddelinteraktion ikke forventes via cytokrom P450 enzymer, andre metaboliserende enzymer eller transportører.
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.
Se nedenunder i afsnittet "Brug af anden medicin sammen med Ocrevus" for mere information.
See under ‘Other medicines and Ocrevus', below for more information.
• Kontakt straks lægen eller sygeplejersken, hvis du føler, at din multipel sclerose forværres eller hvis du oplever nye symptomer.
· Tell your doctor or nurse straight away if you think your MS is getting worse or if you notice any new symptoms.
Hver infusion vil tage ca. 2 timer og 30 minutter.
Each infusion will last about 2 hours 30 minutes.
Nedbrydning af myelinskeden forhindrer nerverne i at virke normalt.
Breakdown of the myelin sheath stops the nerves working properly.
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.
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.
Infektionerne var fortrinsvis af mild til moderat karakter, og patienterne responderede på standardbehandling.
Infections were predominantly mild to moderate in severity and patients recovered with treatment by standard therapies.
Tabel 3 Studiedesign, demografiske- og baseline-karakteristika
Table 3 Study Design, Demographic and Baseline Characteristics Study 1
Metaboliseringen af Ocrevus er ikke direkte undersøgt, da antistoffer principielt cleares ved katabolisme (dvs. nedbrydning til peptider og aminosyrer).
The metabolism of Ocrevus has not been directly studied, as antibodies are cleared principally by catabolism (i.e. breakdown into peptides and amino acids).
Reaktivering af hepatitis B-virus, i nogle tilfælde ledsaget af fulminant hepatitis, leversvigt og død, er indberettet hos patienter behandlet med anti-CD20-antistoffer.
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.
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.
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.
Sinusitis, bronkitis, oral herpes, gastroenteritis, luftvejsinfektion, viral infektion, herpes zoster, konjunktivitis, cellulitis
Sinusitis, bronchitis, oral herpes, gastroenteritis, respiratory tract infection, viral infection, herpes zoster, conjunctivitis, cellulitis
CD20 er et celleoverflade-antigen, der findes på præ-B-celler samt modne og hukommelses-B-celler, men ikke på lymfestamceller eller plasmaceller.
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.
Det geometriske gennnemsnit af antitetanus toxoid-specifikke antistof-titer ved uge 8 var på henholdsvis 3,74 og 9,81 IE/ml.
Geometric mean anti-tetanus toxoid specific antibody titers at 8 weeks were 3.74 and 9.81 IU/ml, respectively.
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.
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.
Dette produkt indeholder mindre end 1 mmol natrium (23 mg) per dosis, dvs. det er stort set natriumfrit.
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. it is essentially sodium-free.
Alle nødvendige vacciner skal være givet mindst 6 uger før behandling med Ocrevus starter.
Any vaccinations should be given at least 6 weeks before you start treatment with Ocrevus.
Inden hver infusion vil du derfor få kortikosteroid og antihistamin, og muligvis medicin til at reducere feber.
You will receive a corticosteroid and an anti-histamine before each infusion and you may also receive medicines to reduce fever.
Symptomer på infusionsrelaterede reaktioner kan forekomme under enhver infusion, men er hyppigere indberettet under første infusion.
Symptoms of IRRs may occur during any infusion, but have been more frequently reported during the first infusion.
Hvis du er usikker, skal du kontakte lægen inden du får Ocrevus.
If you are not sure, talk to your doctor before you are given Ocrevus.
For opbevaringsforhold efter fortynding af lægemidlet, se pkt.
For storage conditions after dilution of the medicinal product, see section 6.3.
Patienter med aktiv hepatitis B-virus (dvs. aktiv infektion bekræftet ved positiv test for HBsAg og anti-HB) må ikke behandles med Ocrevus.
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.
Traumer, forgiftninger og behandlingskom-likationer
Injury, poisoning and procedura complications
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.
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.
Når man har multipel sclerose, virker immunsystemet (kroppens forsvarssystem) forkert og angriber det beskyttende lag (myelinskede) rundt om nervecellerne og skaber inflammation.
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.
* 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.
* Expanded Disability Status Scale ** Patients who had not been treated with any MS medication in the 2 years prior to randomization.
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.
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.
Det anbefales ikke, at anvende andre immunosupprimerende midler sammen med Ocrevus undtagen kortikosteroider til symptomatisk behandling af attakker.
It is not recommended to use other immunosuppressives concomitantly with Ocrevus except corticosteroids for symptomatic treatment of relapses.
Hvis reaktionen på infusionen er livstruende, vil lægen stoppe behandlingen med Ocrevus permanent.
If the infusion-related reaction is life-threatening, your doctor will permanently stop your treatment with Ocrevus.
Hvis du springer en Ocrevus-infusion over
If you miss an infusion of Ocrevus
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.
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.
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.
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.
Ocrevus kan være forbundet med infusionsrelaterede reaktioner, som kan have relation til cytokinfrigørelse og/eller andre kemiske mediatorer.
Ocrevus is associated with IRRs, which may be related to cytokine release and/or other chemical mediators.
• 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.
· This medicine is not to be used after the expiry date which is stated on the outer carton and the vial label after ‘EXP'.
Infektion i øvre luftveje, nasofaryngitis, influenza
Upper respiratory tract infection, nasopharyngitis, influenza
I ocrelizumab multipel sclerose-pivotalstudierne var administrationen af kortikosteroider til behandling af attakker ikke forbundet med en øget risiko for alvorlig infektion.
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.
• I attakvis multipel sclerose har patienten tilbagevendende anfald af symptomer (attakker).
· In relapsing forms of MS. the patient has repeated attacks of symptoms (relapses).
Ocrevus skal tilberedes af sundhedsfagligt personale ved brug af aseptisk teknik.
Ocrevus should be prepared by a healthcare professional using aseptic technique.
Gennemsnitligt antal nye og/eller forstørrende T2 hyperintense læsioner per MRI
Mean number of new and/or enlarging T2 hyperintense lesions per MRI scan
Ca. 1% af patienterne i Ocrevus-gruppen havde en grad 3 lymfopeni (mellem 200 og 500 celler/mm3).
Approximately 1% of the patients in the Ocrevus group had a Grade 3 lymphopenia (between 200 and 500 cells/mm3).
Infusionsrelaterede reaktioner kan opstå under infusionen og i op til 24 timer efter infusionen.
Infusion-related reactions can happen during the infusion or up to 24 hours after the infusion.
Der er indberettet forbigående perifære fald i B-celleniveauet og lymfocytopeni hos spædbørn født af mødre eksponeret for andre anti-CD20-antistoffer under graviditeten.
Transient peripheral B-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other anti-CD20 antibodies during pregnancy.
Ocrevus er et humaniseret, monoklonalt antistof af en immunoglobulin G1-subtype, og immunoglobuliner vides at passere placentabarrieren.
Ocrevus is a humanised monoclonal antibody of an immunoglobulin G1 subtype and immunoglobulins are known to cross the placental barrier.
Der er ingen specifik antidot i tilfælde af overdosering; afbryd straks infusionen og observer patienten for infusionsrelaterede reaktioner (se pkt.
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).
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/17/1231/001
MARKETING AUTHORISATION NUMBER(S) EU/1/17/1231/001
Relativ reduktion
Relative reduction
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.
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.
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.
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.
Det bør derfor overvejes at tilbageholde antihypertensiv behandling i 12 timer før og under hver Ocrevus-infusion.
Therefore, withholding of antihypertensive treatments should be considered for 12 hours prior to and throughout each Ocrevus infusion.
• hvis du er allergisk over for ocrelizumab eller et af de øvrige indholdsstoffer i lægemidlet
· if you are allergic to ocrelizumab or any of the other ingredients of this medicine (listed in section 6).
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.
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.
Der kan opstå overfølsomhedsreaktion under enhver infusion, men ses typisk ikke under den første infusion.
A hypersensitivity reaction may present during any infusion, although typically would not present during the first infusion.
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).
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).
MRI-endepunkter
MRI Endpoints
• Inden du får anden medicin, skal du fortælle lægen hvornår du sidst fik en Ocrevus-infusion.
· Before you start any other medicines, tell your doctor when you had your last Ocrevus infusion.
Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser samt reproduktions- og udviklingstoksicitet.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, and embryo-foetal development.
Patienter i en svært immunkompromitteret tilstand må ikke behandles, før tilstanden er afhjulpet (se pkt.
Patients in a severely immunocompromised state must not be treated until the condition resolves (see section 4.3.
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.
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.
Ocrevus skal seponeres permanent hos disse patienter (se pkt.
Ocrevus must be permanently discontinued in these patients (see section 4.3).
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.
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).
Sikkerhed ved immunisering med levende eller svækkede, levende vacciner efter behandling med Ocrevus er ikke undersøgt.
The safety of immunisation with live or live-attenuated vaccines, following Ocrevus therapy has not been studied.
• Ocrevus kan indeholde små, transparente og/eller reflekterende partikler, der kan øge farvespillet.
· Ocrevus may contain fine translucent and/or reflective particles associated with enhanced opalescence.
• Ocrevus skal forberedes af sundhedsfagligt personale ved brug af aseptisk teknik.
· Ocrevus should be prepared by a healthcare professional using aseptic technique.
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.
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).
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).
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).
• Efterfølgende doser
· Subsequent Doses