FrancophonIA/ELRC3.0 huggingface dataset:
English: Soliris was administered as an intravenous infusion over 35 minutes.
Danish: Soliris blev administreret som intravenøs infusion over 35 minutter.
English: • increase of liver enzymes, decrease of the proportion of blood volume that is occupied by red blood cells, decrease in the protein in red blood cells that carries oxygen
Danish: • forhøjet niveau af leverenzymer, nedsat antal røde blodlegemer, nedsat indhold af det protein i de røde blodlegemer, der transporterer ilt
English: 30 ml of concentrate in a vial (Type I glass) with a stopper (butyl, siliconised), and a seal (aluminium) with flip-off cap (polypropylene).
Danish: 30 ml koncentrat i et hætteglas (glas type I) med prop af butylgummi (silikoneret), forsegling (aluminium) og afrivningskapsel (polypropylen).
English: A reduction in intravascular haemolysis as measured by serum LDH levels was sustained for the treatment period and resulted in increased transfusion avoidance, a reduced need for RBC transfusion and less fatigue.
Danish: En reduktion i intravaskulær hæmolyse, målt ved serum-LDH, vedvarede i hele behandlingsperioden og førte til øget undgåelse af transfusion, mindsket behov for erytrocyttransfusion og mindsket træthed.
English: PNH patients receiving Soliris therapy should be similarly monitored for intravascular haemolysis by measuring LDH levels, and may require dose adjustment within the recommended 14±2 day dosing schedule during the maintenance phase (up to every 12 days).
Danish: PNH-patienter i behandling med Soliris bør tilsvarende monitoreres for intravaskulær hæmolyse ved måling af LDH-værdien, og kan have behov for dosisjustering inden for det anbefalede 14±2-dages doseringsskema i vedligeholdelsesfasen (op til hver 12. dag).
English: In a refractory gMG placebo controlled study, none (0/62) of the Soliris treated patients showed antidrug antibody response during the 26 week active treatment.
Danish: I et placebokontrolleret studie af refraktær gMG viste ingen (0/62) af patienterne behandlet med Soliris et antilægemiddel-antistofrespons i løbet af de 26 uger med aktiv behandling.
English: Study C08-003A/B was a prospective, controlled, open-label study which accrued patients with longer term aHUS without apparent evidence of clinical thrombotic microangiopathy manifestations and receiving chronic PE/PI (≥1 PE/PI treatment every two weeks and no more than 3 PE/PI treatments/week for at least 8 weeks before the first dose).
Danish: Studiet C08-003A/B var et prospektivt, kontrolleret, ikke-blindet studie, hvori der deltog patienter med længerevarende aHUS uden synlige tegn på kliniske manifestationer af trombotisk mikroangiopati, som var i kronisk PE/PI-behandling (≥ 1 PE/PI-behandling hver 2. uge og ikke over 3 PE/PI-behandlinger/uge i mindst 8 uger før den første dosis).
English: Table 3: Efficacy Outcomes in C04-001 and C04-002 C04-001
Danish: Tabel 3: Resultater vedrørende virkning i C04-001 og C04-002 C04-001
English: Pharmacodynamic activity measured by free C5 concentrations of <0.5 ug/mL, is correlated with essentially complete blockade of terminal complement activity in PNH, aHUS, refractory gMG and NMOSD patients.
Danish: Den farmakodynamiske aktivitet, målt ved frie C5-koncentrationer på < 0,5 µg/ml, korrelerer med en stort set fuldstændig blokering af den terminale komplementaktivitet hos patienter med PNH, aHUS, refraktær gMG og NMOSD.
English: In patients with NMOSD, uncontrolled terminal complement activation caused by autoantibodies against AQP4 leads to the formation of the MAC and C5a-dependent inflammation which results in astrocyte necrosis and increased permeability of the blood brain barrier, as well as death of the surrounding oligodendrocytes and neurons.
Danish: Hos patienter med NMOSD fører ukontrolleret terminal komplementaktivering forårsaget af autoantistoffer mod AQP4 til dannelsen af MAC- og C5a-afhængig inflammation, hvilket fører til astrocytnekrose og øget permeabilitet af blod-hjerne-barrieren samt død af omgivende oligodendrocytter og neuroner.
English: Meningococcal infection includes the following group of PTs: Meningococcal infection, Meningococcal sepsis, Meningitis meningococcal, Neisseria infection.
Danish: b Meningokokinfektion omfatter den følgende gruppe af foretrukne betegnelser: Meningokok-infektion, meningokok-sepsis, meningokok-meningitis, Neisseria-infektion.
English: The pharmacokinetics of eculizumab was evaluated in Study M07-005 in PNH paediatric patients (aged from 11 to less than 18 years) and in Studies C08-002, C08-003, C09-001r and C10-003 in aHUS pediatric patients (aged 2 months to less than 18 years) with body-weight based dose regimen.
Danish: Eculizumabs farmakokinetik blev evalueret i studie M07-005 hos pædiatriske PNH-patienter (i alderen fra 11 år til under 18 år) og i studie C08-002, C08-003, C09-001r og C10-003 hos pædiatriske patienter med aHUS (i alderen fra 2 måneder til under 18 år) med et kropsvægtbaseret dosisregime.
English: A total of 35 patients received PE/PI prior to eculizumab.
Danish: I alt 35 patienter fik PE/PI før eculizumab.
English: Transfer the recommended dose to an infusion bag.
Danish: Den anbefalede dosis overføres til en infusionspose.
English: Due to its mechanism of action, Soliris therapy should be administered with caution to patients with active systemic infections.
Danish: På grund af virkningsmekanismen bør forsigtighed udvises ved anvendelse af Soliris til patienter med aktive systemiske infektioner.
English: The median time from aHUS diagnosis to first dose of Soliris was 14 months (range <1, 110 months).
Danish: Mediantiden fra aHUS-diagnose til første Soliris-dosis var 14 måneder (interval <1 til 110 måneder).
English: • The need for patients to be vaccinated against Neisseria meningitidis two weeks prior to receiving eculizumab and/or to receive antibiotic prophylaxis.
Danish: • behovet for at patienter vaccineres mod Neisseria meningitidis-infektion to uger før de modtager eculizumab og/eller at de modtager profylaktisk antibiotisk behandling.
English: If you experience any of the meningococcal infection symptoms (see section 2 Meningococcal and other Neisseria infections alert), you should immediately inform your doctor.
Danish: 2 Årvågenhed over for meningokokinfektion og andre Neisseria-infektioner), skal du straks informere lægen.
English: Change from baseline at 12 weeks of LDH Value (U/L)
Danish: Ændring fra baseline efter 12 uger i LDHværdi (E/l)
English: When maternal exposure to the antibody occurred during organogenesis, two cases of retinal dysplasia and one case of umbilical hernia were observed among 230 offspring born to mothers exposed to the higher antibody dose (approximately 4 times the maximum recommended human Soliris dose, based on a body weight comparison); however, the exposure did not increase foetal loss or neonatal death.
Danish: Ved maternel eksponering for antistoffet under organogenesen blev der iagttaget to tilfælde af retinal dysplasi og ét tilfælde af umbilikalhernie blandt 230 unger af hunner, der blev eksponeret for den høje antistofdosis (ca. 4 gange den anbefalede maksimale humane Soliris-dosis, baseret på kropsvægt).
English: The adjudicated on-trial annualized relapse rate (ARR) ratio (95% CI) for eculizumab compared with placebo was 0.045 (0.013, 0.151), representing a 95.5% relative reduction in adjudicated On-trial ARR for patients treated with eculizumab compared with placebo (p<0.0001) (Table 13).
Danish: Forholdet mellem den adjudikerede annualiserede recidivrate (ARR) i løbet af studiet (ARR) (95 % CI) for eculizumab sammenlignet med placebo var 0,045 (0,013; 0,151), hvilket udgør en 95,5 % relativ reduktion i adjudikeret ARR i løbet af studiet for patienter i behandling med eculizumab sammenlignet med placebo (p<0,0001) (tabel 13).
English: When immunosuppressant and anticholinesterase therapies are decreased or discontinued, patients should be monitored closely for signs of disease exacerbation.
Danish: Når behandlinger med immunsuppressive midler og anticholinesterase reduceres eller seponeres, skal patienterne overvåges nøje for tegn på sygdomsforværring.
English: Table 9: Patient Demographic and Characteristics in Study ECU-MG-301
Danish: Tabel 9: Patientdemografi og karakteristika i studie ECU-MG-301
English: • The risk of infusion reactions with eculizumab, including anaphylaxis, and the need for clinical monitoring post-infusion.
Danish: • risikoen for reaktioner som følge af infusion, inklusive anafylaktisk shock, og behovet for klinisk post-infusion monitorering.
English: Any prior ventilator support since diagnosis,
Danish: Tidligere ventilatorstøtte siden diagnose, n
English: • Transfer the recommended dose to an infusion bag.
Danish: • Den anbefalede dosis overføres til en infusionspose.
English: Animal reproduction studies have not been conducted with eculizumab (see section 5.3).
Danish: Der er ikke udført dyrereproduktionsstudier med eculizumab (se pkt.
English: • serious allergic reaction which causes difficulty in breathing or dizziness (anaphylactic reaction),
Danish: • alvorlig allergisk reaktion, der forårsager vejrtrækningsbesvær eller svimmelhed (anafylaktisk reaktion), overfølsomhed
English: Withdrawal of immunosuppressant and anticholinesterase therapies during Soliris treatment for refractory gMG was not assessed in the placebocontrolled studies.
Danish: Seponering af behandlinger med immunsuppressive midler og anticholinesterase under behandling med Soliris for refraktær gMG blev ikke vurderet i de placebokontrollerede studier.
English: In patients with NMOSD, their eye nerve and spinal cord are attacked and damaged by the immune system which can lead to blindness in one or both eyes, weakness or paralysis in the legs or arms, painful spasms, loss of sensation, and markedly impaired activities of daily living.
Danish: Hos patienter med NMOSD angribes og beskadiges øjennerverne og rygmarven af kroppens eget immunsystem, hvilket kan føre til blindhed i det ene eller i begge øjne, svaghed eller lammelse i arme og ben, smertefulde spasmer, følelsesløshed og markant hæmning af dagligdags aktiviteter.
English: If you have any of these symptoms, contact your doctor.
Danish: Kontakt lægen, hvis du får nogen af disse symptomer.
English: In all clinical studies, the most serious adverse reaction was meningococcal sepsis which is a common presentation of meningococcal infections in patients treated with Soliris (see section 4.4).
Danish: I alle kliniske studier var den alvorligste bivirkning meningokoksepsis, som er et almindeligt symptom på meningokokinfektioner hos patienter behandlet med Soliris (se pkt.
English: When treatment was continued for more than 26 weeks, two additional patients achieved and maintained Complete TMA response due to normalization of LDH (1 patient) and a decrease in serum creatinine (2 patients).
Danish: Når behandlingen blev fortsat ud over 26 uger, opnåede og opretholdt yderligere to patienter et fuldstændigt TMA-respons på grund af normalisering af LDH (1 patient) og reduktion i serum-kreatinin (2 patienter).
English: Study ECU-NMO-301 was a double-blind, randomized, placebo-controlled, multi-center, Phase 3 study of Soliris in patients with NMOSD.
Danish: Studie ECU-NMO-301 var et dobbeltblindet, randomiseret, placebokontrolleret fase 3 multicenterstudie af Soliris hos patienter med NMOSD.
English: Soliris (eculizumab) has not been studied for the treatment of acute relapses in NMOSD patients.
Danish: Soliris (eculizumab) er ikke blevet undersøgt til behandling af akutte recidiver hos NMOSD-patienter.
English: Allergic reactions Soliris contains a protein and proteins can cause allergic reactions in some people.
Danish: Proteiner kan hos nogle fremkalde allergiske reaktioner.
English: Table 5: Patient Demographics and Characteristics in C08-002A/B and C08-003A/B
Danish: Tabel 5: Patientdemografi og karakteristika i C08-002A/B og C08-003A/B Parameter
English: One hundred and eighteen (118) of the 125 (94%) patients completed the 26-week treatment period and 117 (94%) patients subsequently enrolled in Study ECU-MG-302, an open-label, multi-center long-term safety and efficacy extension study in which all patients received Soliris treatment.
Danish: Et hundrede og atten (118) af de 125 (94 %) patienter gennemførte den 26ugers behandlingsperiode, og 117 (94 %) patienter indgik efterfølgende i studie ECU-MG-302, et åbent multicenter-forlængelsesstudie til vurdering af langtidssikkerhed og -virkning, hvor alle patienterne fik behandling med Soliris.
English: (N = 143)
Danish: I alt (N = 143)
English: Haemolysis*, Abnormal clotting factor, Red blood cell agglutination, Coagulopathy
Danish: Hæmolyse*, abnorm koagulationsfaktor, agglutination af røde blodlegemer, koagulopati
English: P - Value Mean (SD) Wilcoxon Signed Rank
Danish: Wilcoxon Signed Rank
English: Meningococcal and other Neisseria infections alert Soliris treatment may reduce your natural resistance to infections, especially against certain organisms that cause meningococcal infection (severe infection of the linings of the brain and sepsis) and other Neisseria infections including disseminated gonorrhea.
Danish: Årvågenhed over for meningokok- og andre Neisseria-infektioner Soliris kan svække din naturlige modstandskraft over for infektioner, især med visse organismer, der er årsag til meningokokinfektion (svær hjernehindebetændelse og blodforgiftning) og andre Neisseriainfektioner, herunder dissemineret gonorré.
English: Baseline characteristics are shown in Table 2.
Danish: Baseline-karakteristika er vist i tabel 2.
English: Table 4: Efficacy Outcomes (LDH level and FACIT-Fatigue) in Patients with PNH with No History of Transfusion in M07-001
Danish: Tabel 4: Effektresultater (LDH-niveau og FACIT-træthedsscore) hos PNH-patienter uden transfusion i anamnesen i PNH-register M07-001
English: 2 to <12 years (n=10)
Danish: 2 til <12 år (n=10)
English: In the non-controlled study C04-002 (SHEPHERD), PNH patients with at least one transfusion in the prior 24 months and at least 30,000 platelets/microliter received Soliris over a 52-week period.
Danish: I det ikke-kontrollerede studie C04-002 (SHEPHERD) blev PNH-patienter, der havde fået mindst én transfusion de foregående 24 måneder og havde et trombocyttal på mindst 30 000/μl, behandlet med Soliris i en periode på 52 uger.
English: If you experience any of the following symptoms, you should immediately inform your doctor: - headache with nausea or vomiting - headache with a stiff neck or back - fever - rash - confusion - severe muscle aches combined with flu-like symptoms
Danish: Hvis du kommer ud for nogen af nedenstående symptomer, skal du straks henvende dig til lægen: hovedpine med kvalme eller opkastning hovedpine med nakke- eller rygstivhed feber udslæt omtågethed stærk muskelømhed samtidig med influenzalignende symptomer lysfølsomhed.
English: The primary endpoint for Study ECU-MG-301 was the change from baseline in the MG Activities of Daily Living Profile (MG-ADL - a patient reported outcome measure validated in gMG) total score at Week 26.
Danish: Det primære endepunkt for studie ECU-MG-301 var ændringen fra baseline i MG-Activities of Daily Living-profilen (MG-ADL - en patientrapporteret udfaldsmåling valideret i gMG) total score ved uge 26.
English: Soliris is produced in a murine myeloma (NS0 cell line) expression system and purified by affinity and ion exchange chromatography.
Danish: Soliris produceres i et ekspressionssystem for murint myelom (NS0 cellelinje) og renses ved affinitetsog ionbytningskromatografi.
English: Prior to initiating Soliris therapy, it is recommended that PNH, aHUS, refractory gMG and NMOSD patients initiate immunizations according to current immunization guidelines.
Danish: Før iværksættelse af Soliris-behandling anbefales det, at PNH-, aHUS-, refraktær gMG- og NMOSDpatienter påbegynder vaccination i henhold til de gældende retningslinjer.
English: A total of 15 paediatric patients (aged 2 months to 12 years) received Soliris in aHUS Study C09-001r.
Danish: I alt 15 pædiatriske patienter (i alderen 2 måneder til 12 år) fik Soliris i aHUS-studiet C09-001r.
English: • Inspect visually Soliris solution for particulate matter and discolouration.
Danish: • Opløsningen inspiceres visuelt for partikler og misfarvning.
English: Compared to placebo-treated patients, Soliris-treated patients had reduced annualized rates of hospitalizations (0.04 for Soliris versus 0.31 for placebo), of intravenous corticosteroid administrations to treat acute relapses (0.07 for Soliris versus 0.42 for placebo), and of plasma exchange treatments (0.02 for Soliris versus 0.19 for placebo).
Danish: Sammenlignet med patienter, der fik placebo, havde patienter, der fik Soliris, reducerede annualiserede rater af indlæggelse (0,04 for Soliris vs. 0,31 for placebo) af intravenøse kortikosteroidadministrationer for at behandle akutte recidiver (0,07 for Soliris vs. 0,42 for placebo), og for behandling med plasmaudskiftning (0,02 for Soliris vs. 0,19 for placebo).
English: Four of the five patients who required dialysis at study entry were able to discontinue dialysis for the duration of Soliris treatment, and one patient developed a new dialysis requirement.
Danish: 4 af de 5 patienter, der havde behov for dialyse ved studiets begyndelse, kunne ophøre med dialysebehandling under Soliris-behandlingen; 1 patient udviklede behov for dialyse.
English: Primary endpoints included platelet count change from baseline in study C08-002A/B and thrombotic microangiopathy (TMA) event-free status in study C08-003A/B.
Danish: Primære endepunkter omfattede ændring af trombocyttallet i forhold til baseline i studie C08-002A/B og TMA-hændelsesfri tilstand i studie C08-003A/B.
English: A total of 10 patients received PE/PI prior to eculizumab.
Danish: I alt 10 patienter fik PE/PI før eculizumab.
English: Age at MG Diagnosis (years),
Danish: Varighed af MG (år),
English: Longer term treatment with Soliris (median 52 weeks ranging from 15 to 126 weeks) was associated with an increased rate of clinically meaningful improvements in adult patients with aHUS.
Danish: Længerevarende behandling med Soliris (median: 52 uger; interval: fra 15 uger til 126 uger) var forbundet med en øget forekomst af klinisk betydningsfulde forbedringer hos voksne patienter med aHUS.
English: • The diluted solution should be allowed to warm to room temperature [18°C - 25°C] prior to administration by exposure to ambient air.
Danish: • Den fortyndede opløsning skal henstå, til den er nået op på rumtemperatur (18 °C - 25 °C), før den administreres.
English: PE/PI Event-Free Status, n (%) New Dialysis Event-Free Status, n (%)
Danish: PE/PI-hændelsesfri tilstand, n (%) 'Ny dialyse'-hændelsesfri tilstand, n (%)
English: Normalization of platelet count All patients, n (%) (95% CI) Patients with abnormal baseline, n/n (%) TMA event-free status, n (%) (95% CI) TMA intervention rate Daily preeculizumab rate, median (min, max) Daily duringeculizumab rate, median (min, max) P-value
Danish: Normalisering af trombocyttal Alle patienter, n (%) (95 % CI) Patienter med unormal baseline, n/n (%) TMA-hændelsesfri tilstand, n (%) (95 % CI) Forekomst af TMAintervention Daglige værdier før eculizumab, median (min., maks.)
English: Supplemental Soliris Dose
Danish: Tidspunkt for supplerende Soliris-dosis
English: Table 14: Efficacy Outcomes in Paediatric PNH Study M07-005
Danish: Tabel 14: Effektresultater i det pædiatriske PNH-studie M07-005
English: Mean clearance was 0.31 ± 0.12 mL/hr/kg, mean volume of distribution was 110.3 ± 17.9 mL/kg, and mean elimination half-life was 11.3 ± 3.4 days.
Danish: Den gennemsnitlige clearance var 0,31 ± 0,12 ml/h/kg, det gennemsnitlige fordelingsvolumen 110,3 ± 17,9 ml/kg og den gennemsnitlige halveringstid 11,3 ± 3,4 dage.
English: Children and adolescents with PNH or aHUS and who are under 40 kg weight require a lower dose based on how much they weigh.
Danish: Børn og unge med PNH eller aHUS, som vejer under 40 kg, kræver en mindre dosis, baseret på deres vægt.
English: The efficacy of eculizumab treatment in paediatric PNH patients appears to be consistent with that observed in adult PNH patients enrolled in PNH pivotal Studies (C04-001 and C04-002) (Table 3 and
Danish: Virkningen af eculizumab-behandling hos pædiatriske PNH-patienter synes at være i overensstemmelse med, hvad der er observeret hos voksne PNH-patienter, der indgik i de pivotale PNH-studier (C04-001 og C04-002) (tabel 3 og 14).
English: For adult aHUS, refractory gMG and NMOSD patients and paediatric aHUS patients supplemental dosing of Soliris is required in the setting of concomitant PE/PI (plasmapheresis or plasma exchange, or fresh frozen plasma infusion):
Danish: For voksne patienter med Ahus, refraktær gMG og NMOSD og pædiatriske patienter med aHUS er supplerende Soliris-doser påkrævet ved samtidig plasmaferese/plasmaudskiftning eller infusion af frisk frosset plasma (PE/PI):
English: Time from NMOSD initial clinical presentation to first dose of study drug (years)
Danish: Tid fra første kliniske præsentation af NMOSD til den første dosis studielægemiddel (år)
English: Longer term treatment with Soliris (median 55 weeks ranging from 1day to 107 weeks) was associated with an increased rate of clinically meaningful improvements in paediatric and adolescent patients with aHUS.
Danish: Længerevarende behandling med Soliris (median: 55 uger; interval: fra 1 dag til 107 uger) var forbundet med en øget forekomst af klinisk betydningsfulde forbedringer hos pædiatriske og unge patienter med aHUS.
English: The aHUS, refractory gMG and NMOSD dosing regimen for adult patients (≥18 years of age) consists of a 4 week initial phase followed by a maintenance phase:
Danish: Dosisregimet til voksne patienter med aHUS, refraktær gMG og NMOSD (≥ 18 år) består af en 4-ugers startfase efterfulgt af en vedligeholdelsesfase:
English: Despite Soliris re-initiation following discontinuation, progression to end stage renal disease occurred in one patient.
Danish: Trods genopstart af Soliris efter behandlingsafbrydelse oplevede én patient progression til dialysekrævende nyresygdom i slutstadiet.
English: Through data cut-off (October 12, 2012), with median duration of Soliris therapy of 44 weeks (range: 1 dose to 88
Danish: Til og med data-afslutning (12. oktober, 2012), med median Soliris-behandlingsvarighed på ca. 44 uger (interval: 1 dosis til 88 uger).
English: Soliris treatment is recommended to continue for the patient's lifetime, unless the discontinuation of Soliris is clinically indicated (see section 4.4).
Danish: Det anbefales, at behandlingen med Soliris fortsættes i hele patientens levetid, medmindre der er klinisk indikation for afbrydelse (se pkt.
English: C5 expression in the human tissue panel examined in this study is consistent with published reports of C5 expression, as C5 has been reported in smooth muscle, striated muscle, and renal proximal tubular epithelium.
Danish: C5-ekspressionen i de undersøgte humane væv er forenelig med publicerede beskrivelser af C5-ekspression, da C5 er beskrevet både i glatmuskulatur, tværstribet muskulatur og epitel fra de proksimale nyretubuli.
English: Soliris is a recombinant humanised monoclonal IgG2/4k antibody that binds to the human C5 complement protein and inhibits the activation of terminal complement.
Danish: Soliris er et rekombinant, humaniseret, monoklonalt IgG2/4κ-antistof, der bindes til humant komplementprotein C5 og hæmmer den terminale komplementaktivering.
English: Table 12: Patient Disease history and Baseline Characteristics in Study ECU-NMO-301 Variable
Danish: Tabel 12: Patientens anamnese og baseline-karakteristika i studie ECU-NMO-301 Variabel
English: In Study ECU-MG-301, a clinical responder in the QMG total score was defined as having at least a 5point improvement.
Danish: I studie ECU-MG-301 blev en person med klinisk respons i QMG total score defineret som en person med en forbedring på mindst 5 point.
English: In the PNH Registry, patients treated with Soliris were observed to have a reduction in haemolysis and associated symptoms.
Danish: PNH-registret viste, at de patienter, der blev behandlet med Soliris, oplevede en reduktion i hæmolyse og dermed forbundne symptomer.
English: • spontaneous penile erection
Danish: • spontan peniserektion