FrancophonIA/ELRC3.0 huggingface dataset:
English: Prior to randomization, all patients underwent an initial observation period to confirm the need for RBC transfusion and to identify the haemoglobin concentration (the "set-point") which would define each patient's haemoglobin stabilization and transfusion outcomes.
Danish: Før randomisering gennemgik alle patienter en indledende observationsperiode til bekræftelse af behovet for transfusion af erytrocytter og til fastlæggelse af den hæmoglobinkoncentration (det "sætpunkt"), der for hver patient beskriver resultatet hvad angår hæmoglobinstabilisering og transfusion.
English: The primary endpoint for Study ECU-NMO-301 was the time to first on-trial relapse as adjudicated by an independent committee who were blinded to treatment.
Danish: Det primære endepunkt i studie ECU-NMO-301 var tiden til første recidiv i studiet, adjudikeret af en uafhængig komité, som var blindet med hensyn til behandlingen.
English: Meningococcal disease due to any serogroup may occur.
Danish: Infektion med meningokokker af enhver serogruppe kan forekomme.
English: In the open-label extension trial (Study ECU-MG-302), physicians had the option to adjust background immunosuppressant therapies.
Danish: I det åbne forlængelsesstudie (studie ECU-MG-302) havde lægerne mulighed for at justere immunsuppressiv baggrundsbehandling.
English: No overall differences in safety were reported between elderly (≥ 65 years) and younger refractory gMG
Danish: Der er ikke rapporteret nogen generel forskel i sikkerheden mellem ældre (≥ 65 år) og yngre patienter med refraktær gMG (< 65 år) (se pkt.
English: Total number of patients reporting clinical deterioration n (%) Total number of patients requiring rescue therapy n (%)
Danish: Totale antal patienter, der rapporterede klinisk forværring n (%) Totale antal patienter, der havde behov for nødbehandling n (%)
English: Soliris is a clear and colorless solution.
Danish: Soliris er en klar, farveløs opløsning.
English: The most common adverse reaction was headache, (occurred mostly in the initial phase of dosing), and the most serious adverse reaction was meningococcal sepsis.
Danish: Den mest almindelige bivirkning var hovedpine (forekom hovedsageligt i opstartsfasen af doseringen), og den mest alvorlige bivirkning var meningokoksepsis.
English: • Statement that the patient is receiving eculizumab.
Danish: • meddelelse om at patienten er i behandling med eculizumab.
English: • Initial Phase:
Danish: • Startfase:
English: - If you are allergic to eculizumab, proteins derived from mouse products, other monoclonal antibodies, or any of the other ingredients of this medicine (listed in section 6).
Danish: - hvis du er allergisk over for eculizumab, proteiner udvundet fra mus, andre monoklonale antistoffer eller et af de øvrige indholdsstoffer i Soliris (angivet i punkt 6).
English: Soliris-treated patients experienced similar improvement in time to first adjudicated on-trial relapse with or without concomitant IST treatment.
Danish: Solirisbehandlede patienter oplevede tilsvarende forbedringer i tiden til første adjudikerede recidiv i studiet med eller uden samtidig IST-behandling.
English: Drug interaction studies have not been conducted with eculizumab in patients treated with IVIg.
Danish: Der er ikke udført lægemiddelinteraktionsstudier med eculizumab hos patienter i behandling med IVIg.
English: Mean (SD) Median
Danish: Gennemsnit (SD) Median
English: Very common: may affect more than 1 in 10 people: headache.
Danish: Meget almindelige (kan forekomme hos flere end 1 ud af 10 patienter): hovedpine
English: Instructions for Use for Healthcare Professionals Handling Soliris
Danish: Anvisninger til læger og sundhedspersonale Håndtering af Soliris
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/ .
Danish: Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: In PNH clinical studies, 16 patients discontinued the Soliris treatment regimen.
Danish: I de kliniske studier vedrørende PNH fik 16 patienter afbrudt Soliris-behandlingsregimet.
English: Basedow's disease
Danish: Basedows sygdom
English: Serious haemolysis was not observed.
Danish: Der blev ikke iagttaget alvorlig hæmolyse.
English: Must be diluted before use.
Danish: Skal fortyndes inden brug.
English: Do not use Soliris
Danish: Brug ikke Soliris
English: The MAH shall send annually to prescribers or pharmacists who prescribe/dispense eculizumab, a reminder in order that prescriber/pharmacist checks if a (re)-vaccination against Neisseria meningitidis is needed for his/her patients on eculizumab.
Danish: Indehaveren af markedsføringstilladelsen skal årligt sende en påmindelse til læger og farmaceuter, som ordinerer/udleverer eculizumab, så læger/farmaceuter kontrollerer, om en (re-) vaccination imod Neisseria meningitidis er nødvendig for de patienter, som de har i behandling med eculizumab.
English: Treatment discontinuation for NMOSD:
Danish: Afbrydelse af behandling mod NMOSD:
English: Soliris should be prepared for administration by a qualified healthcare professional using aseptic technique.
Danish: Soliris skal klargøres til administration af uddannet medicinsk personale ved brug af aseptisk teknik.
English: TMA-event free status was defined as the absence for at least 12 weeks of the following: decrease in platelet count of > 25% from baseline, PE/PI, and new dialysis.
Danish: TMA-hændelsesfri blev defineret som mindst 12 ugers fravær af følgende: fald i trombocyttal på > 25% i forhold til baseline, PE/PI-behandling og ny dialyse.
English: Furthermore, 74% of the patients without a history of transfusion and treated with Soliris experienced clinically meaningful improvements in FACIT-Fatigue score (i.e., increase by 4 points or more) and 84% in EORTC fatigue score (i.e., decrease by 10 points or more).
Danish: Desuden oplevede 74 % af de transfusionsnaive patienter, der blev behandlet med Soliris, klinisk betydningsfulde forbedringer i FACIT-træthedsscoren (dvs. en stigning på 4 point eller mere), og 84 % oplevede en forbedring i EORTC-træthedsscoren (dvs. et fald på 10 point eller mere).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton Label
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Kartonetiket
English: Monitoring may be insufficient to predict or prevent severe thrombotic microangiopathy complications in patients with aHUS after discontinuation of Soliris.
Danish: Monitorering kan være utilstrækkelig til at forudsige eller forebygge svære komplikationer som følge af trombotisk mikroangiopati hos patienter med aHUS efter afbrydelse af Soliris-behandling.
English: If you use this medicine to treat aHUS, refractory gMG or NMOSD For adults:
Danish: Hvis du bruger dette lægemiddel til behandling af aHUS, refraktær gMG eller NMOSD Voksne:
English: After 3 weeks of Soliris treatment, patients reported less fatigue and improved health-related quality of life.
Danish: Efter tre ugers behandling med Soliris berettede patienterne om mindsket træthed og forbedret helbredsrelateret livskvalitet.
English: Anticoagulant therapy Treatment with Soliris should not alter anticoagulant management.
Danish: Antikoagulationsbehandling Behandling med Soliris skulle ikke kræve ændret antikoagulationsbehandling.
English: Headache Dizziness, Dysgeusia
Danish: Svimmelhed, dysgeusi
English: The patient should be monitored for one hour following infusion.
Danish: Patienten skal monitoreres i en time efter infusionen.
English: • sleep disorder, abnormal dreams
Danish: • søvnforstyrrelser, unormale drømme
English: Soliris has no or negligible influence on the ability to drive and use machines.
Danish: Soliris påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Soliris contains the active substance eculizumab and it belongs to a class of medicines called monoclonal antibodies.
Danish: Soliris indeholder det aktive stof eculizumab, der tilhører en gruppe lægemidler, der kaldes monoklonale antistoffer.
English: • Soliris should only be administered via intravenous infusion.
Danish: • Soliris må kun administreres ved intravenøs infusion.
English: 5.3 Preclinical safety data The specificity of eculizumab for C5 in human serum was evaluated in two in vitro studies.
Danish: Specificiteten af eculizumab for C5 i humant serum blev bestemt i to in vitro-studier.
English: Chronic intravenous human immunoglobulin (IVIg) treatment may interfere with the endosomal neonatal Fc receptor (FcRn) recycling mechanism of monoclonal antibodies such as eculizumab and thereby decrease serum eculizumab concentrations.
Danish: Kronisk behandling med intravenøst humant immunoglobulin (IVIg) kan påvirke den endosomale neonatale Fc-receptor (FcRn)-medierede recirkuleringsmekanisme for monoklonale antistoffer, såsom eculizumab, og dermed nedsætte koncentrationen af eculizumab i serum.
English: Percentage of patients with stabilized Haemoglobin levels at end of study
Danish: Procentdel patienter, hos hvem hæmoglobin stabiliseredes ved studiets slutning
English: - If you have a meningococcal infection.
Danish: - hvis du har en meningokokinfektion.
English: Thrombotic microangiopathy (TMA) complications have been observed as early as 4 weeks and up to 127 weeks following discontinuation of Soliris treatment in some patients.
Danish: Der er set komplikationer som følge af trombotisk mikroangiopati (TMA) efter bare 4 uger og op til 127 uger efter afbrydelse af Soliris-behandling hos visse patienter.
English: Discontinuation of the therapy should be considered in a patient who shows no evidence of therapeutic benefit by 12 weeks.
Danish: Det bør overvejes at seponere behandlingen hos en patient, hvor der ikke er evidens for en terapeutisk fordel efter 12 uger.
English: Dosing for paediatric patients <40 kg is based on paediatric patients with aHUS.
Danish: Doseringen til pædiatriske patienter <40 kg er baseret på pædiatriske patienter med aHUS.
English: The haemoglobin set-point was less than or equal to 9 g/dL in patients with symptoms and was less than or equal to 7 g/dL in patients without symptoms.
Danish: Sætpunktet for hæmoglobin var højst 9 g/dl hos patienter med symptomer og højst 7 g/dl hos patienter uden symptomer.
English: This medicinal product contains 5 mmol sodium per vial.
Danish: Dette lægemiddel indeholder 5 mmol natrium pr. hætteglas.
English: • disease with thyroid overactivity (Basedow's disease)
Danish: • sygdom med overaktiv skjoldbruskkirtel (Basedows sygdom)
English: Pharmacokinetic Parameters
Danish: Farmakokinetiske parametre
English: In aHUS clinical studies, 61 patients (21 paediatric patients) discontinued Soliris treatment with a median follow-up period of 24 weeks.
Danish: I kliniske aHUS-studier afbrød 61 patienter (21 pædiatriske patienter) behandlingen med Soliris med en gennemsnitlig opfølgningsperiode på 24 uger.
English: Fertility No specific study of eculizumab on fertility has been conducted.
Danish: Fertilitet Der er ikke udført specifikke fertilitetsstudier med eculizumab.
English: All patients sustained a reduction in intravascular haemolysis over a total Soliris exposure time ranging from 10 to 54 months.
Danish: Alle patienter bevarede en reduktion i intravaskulær hæmolyse i hele Soliris-behandlingsperioden, som varede mellem 10 og 54 måneder.
English: LDH AUC (U/L x Day)
Danish: LDH-AUC (E/l x dag)
English: In refractory gMG placebo-controlled studies, no antidrug antibodies were observed.
Danish: I placebokontrollerede studier af refraktær gMG blev der ikke observeret nogen antilægemiddel-antistoffer.
English: Serious infections with Neisseria species (other than Neisseria meningitidis), including disseminated gonococcal infections, have been reported.
Danish: Alvorlige infektioner med Neisseria-arter (udover Neisseria meningitidis), herunder disseminerede gonokokinfektioner, er blevet indberettet.
English: Haemolysis was monitored mainly by the measurement of serum LDH levels, and the proportion of PNH RBCs was monitored by flow cytometry.
Danish: Hæmolyse blev hovedsagelig monitoreret ved bestemmelse af serum-LDH, og andelen af PNH-erytrocytter blev monitoreret ved flowcytometri.
English: Nine of the 11 patients who required dialysis at baseline no longer required dialysis after Study Day 15 of eculizumab treatment.
Danish: Ni ud af 11 patienter, der havde behov for dialyse ved baseline, havde ikke længere brug for dialyse efter studiedag 15 med eculizumabbehandling.
English: • Risk of substantial disease exacerbation or relapse following eculizumab discontinuation (refractory gMG and NMOSD)
Danish: • risikoen for en betydelig sygdomsforværring eller recidiv efter afbrydelse af eculizumab (refraktær gMG og NMOSD)
English: In a 26 week toxicity study performed in mice with a surrogate antibody directed against murine C5, treatment did not affect any of the toxicity parameters examined.
Danish: I et 26 uger langt toksicitetsstudie med mus med et surrogat-antistof mod murint C5 havde behandlingen ingen indflydelse på nogen af de undersøgte toksicitetsparametre.
English: Other medicines and Soliris Tell your doctor or pharmacist if you are using or have recently used or might use any other medicines.
Danish: Brug af anden medicin sammen med Soliris Fortæl altid lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: A significant effect on the time to first adjudicated On-trial Relapse was observed for eculizumab compared with placebo (relative risk reduction 94%; hazard ratio 0.058; p<0.0001) (Figure 2).
Danish: En signifikant virkning på tiden til det første adjudikerede recidiv i studiet blev observeret for eculizumab sammenlignet med placebo (relativ risikoreduktion 94 %, hazard ratio 0,058; p<0,0001) (figur 2).
English: Your doctor will discuss the possible side effects and risks with you.
Danish: Din læge vil diskutere de mulige bivirkninger og risici med dig.
English: Soliris must be administered by a healthcare professional and under the supervision of a physician experienced in the management of patients with haematological, renal, neuromuscular or neuroinflammatory disorders.
Danish: Soliris skal gives af sundhedspersoner under supervision af en læge med erfaring i behandling af patienter med hæmatologiske, renale, neuromuskulære eller neuroinflammatoriske sygdomme.
English: Treatment discontinuation for refractory gMG:
Danish: Afbrydelse af behandling mod refraktær gMG:
English: No unexpected tissue cross-reactivity was observed.
Danish: Der blev ikke iagttaget uventet krydsreaktivitet over for andre væv.
English: The PNH dosing regimen for adult patients (≥18 years of age) consists of a 4-week initial phase followed by a maintenance phase:
Danish: Dosisregimet ved PNH til voksne patienter (≥18 år) består af en 4 ugers startfase efterfulgt af en vedligeholdelsesfase:
English: Reconstitution and dilution should be performed in accordance with good practices rules, particularly for the respect of asepsis.
Danish: Anvisninger: Rekonstituering og fortynding skal udføres i henhold til god praksis, specielt hvad angår aseptik.
English: Twenty-two (22) (17.6%) elderly refractory gMG patients (> 65 years of age) were treated with Soliris in the clinical trials.
Danish: 22 (17,6 %) ældre patienter med refraktær gMG (> 65 år) blev behandlet med Soliris i kliniske studier.
English: The distribution of changes from Baseline to End of Study on other secondary endpoints favored eculizumab treatment over placebo across all neurologic disability (EDSS score [nominal p=0.0597] and mRS [nominal p=0.0154]), functional disability (HAI [nominal p=0.0002]) and quality of life (EQ-5D VAS [nominal p=0.0309] and EQ-5D Index [nominal p= 0.0077]) measures.
Danish: Fordelingen af ændringer fra baseline til studiets afslutning for andre sekundære endepunkter favoriserede eculizumab-behandling over placebo for alle neurologiske handicap (EDSS-score [nominel p = 0,0597] og målinger af mRS [nominel p = 0,0154]), funktionelt handicap (HAI [nominel p = 0,0002]) og livskvalitet (EQ-5D VAS [nominel p = 0,0309] og EQ-5D-indeks [nominel p = 0,0077]).
English: What is Soliris
Danish: Hvad er Soliris
English: The safety and efficacy of Soliris in PNH patients with haemolysis were assessed in a randomized, double-blind, placebo-controlled 26 week study (C04-001).
Danish: Sikkerheden og virkningen af Soliris hos PNH-patienter med hæmolyse blev vurderet i et randomiseret, placebokontrolleret 26 ugers dobbeltblindet studie (C04-001).
English: The MAH shall agree the details of a controlled drug distribution system and educational material including a patient safety card with each National Competent Authority and must implement such programmes nationally to ensure that:
Danish: Indehaveren af markedsføringstilladelsen skal aftale de nærmere enkeltheder i et kontrolleret udleveringssystem og uddannelsesmaterialet, inklusive et patientsikkerhedskort, med den ansvarlige nationale myndighed og gennemføre et nationalt program, der sikrer at:
English: In PNH placebo controlled studies low antibody responses have been reported with a frequency (3.4%) similar to that of placebo (4.8%).
Danish: I placebokontrollerede studier af PNH er der rapporteret om lave antistofresponser med en hyppighed (3,4 %) svarende til placebobehandlede patienters (4,8 %).
English: If the infusion is slowed, the total infusion time may not exceed two hours in adults and adolescents (aged 12 years to under 18 years) and four hours in children aged less than 12 years.
Danish: Hvis infusionshastigheden nedsættes, må den samlede infusionsvarighed ikke overstige 2 timer hos voksne og unge (i alderen 12 år til under 18 år), og 4 timer hos børn under 12 år.
English: Treatment for meningococcal infection while travelling If you are travelling in a remote region where you are unable to contact your doctor or in which you find yourself temporarily unable to receive medical treatment, your doctor can make arrangements to issue, as a preventive measure, a prescription for an antibiotic to counter Neisseria meningitidis that you keep with you.
Danish: Hvis du rejser til afsides rejsemål, hvor du ikke kan kontakte en læge eller midlertidigt ikke kan få lægehjælp, kan din læge som forebyggende foranstaltning skrive en recept til dig på et antibiotikum mod Neisseria meningitidis.
English: Adverse reactions reported at a very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100) or rare (≥1/10,000 to <1/1,000) frequency with eculizumab, are listed by system organ class and preferred term.
Danish: De bivirkninger af eculizumab, der blev rapporteret med en hyppighed svarende til meget almindelige (≥1/10), almindelige (≥1/100 til <1/10), ikke almindelige (≥1/1.000 til < 1/100) eller sjældne (≥1/10.000 til <1/1.000), er opført iht.
English: Soliris is composed of two 448 amino acid heavy chains and two 214 amino acid light chains and has a molecular weight of approximately 148 kDa.
Danish: Soliris består af to tunge kæder med 448 aminosyrer og to lette kæder med 214 aminosyrer.
English: 2) Failed at least one immunosuppressant therapy and required chronic plasma exchange or IVIg to control symptoms, ie, patients require PE or IVIg on a regular basis for the management of muscle weakness at least every 3 months over previous 12 months.
Danish: 2) Svigtet behandling med mindst én immunsuppressiv behandling og påkrævet kronisk plasmaudskiftning eller IVIg for at kontrollere symptomerne, dvs. patienterne har haft behov for regelmæssig PE eller IVIg til behandling af muskelsvaghed mindst hver 3. måned i løbet af de seneste 12 måneder.
English: NMOSD History Age at NMOSD Initial Clinical Presentation (years)
Danish: NMOSD-anamnese Alder ved første kliniske præsentation af NMOSD (år)
English: Treatment with eculizumab at the proposed dosing regimen in the paediatric population was associated with a reduction of intravascular haemolysis as measured by serum LDH level.
Danish: Behandling med eculizumab ved det foreslåede doseringsregime hos den pædiatriske population var forbundet med en reduktion af intravaskulær hæmolyse, målt ved serum-LDH.
English: In atypical Haemolytic Uremic Syndrome (aHUS), refractory generalized Myasthenia Gravis (gMG) and Neuromyelitis Optica Spectrum Disorder (NMOSD):
Danish: Atypisk hæmolytisk uræmisk syndrom (aHUS), refraktær generaliseret myasthenia gravis (gMG) og neuromyelitis optica spektrumsygdom (NMOSD):
English: If the infusion is slowed, the total infusion time may not exceed two hours in adults and adolescents and four hours in children aged less than 12.
Danish: Hvis infusionshastigheden nedsættes, må den samlede infusionsvarighed ikke overstige 2 timer hos voksne og unge og 4 timer hos børn under 12 år.
English: Paraesthesia, Tremor Syncope
Danish: Paræstesi, tremor Synkope
English: Table 16: Efficacy Outcomes in Paediatric Patients in Study C09-001r according to duration of current severe clinical thrombotic microangiopathy (TMA) manifestation Duration of current severe clinical TMA manifestation
Danish: Tabel 16: Effektresultater hos pædiatriske patienter i studiet C09-001r i forhold til varigheden af den aktuelle svære kliniske manifestation af trombotiske mikroangiopati (TMA) Varighed af den aktuelle svære kliniske TMA-manifestation
English: Abbreviations: ARR = annualized relapse rate; CI = confidence interval.
Danish: Forkortelser: ARR = annualiseret recidivrate; CI = konfidensinterval.
English: Abbreviations: CI = confidence interval; EDSS = Expanded Disability Status Scale; IST = immunosuppressive therapy
Danish: Forkortelser: CI = konfidensinterval, EDSS = udvidet skala for handicapstatus, IST = immunsuppressiv behandling
English: If an adverse event occurs during the administration of Soliris, the infusion may be slowed or stopped at the discretion of the physician.
Danish: Hvis der opstår en uønsket reaktion under administration af Soliris, kan infusionshastigheden nedsættes eller infusionen standses efter lægens skøn.
English: Table 10: ECU-MG-301 Efficacy Outcomes Change from Baseline to Week 26
Danish: Tabel 10: ECU-MG-301 - Ændring i effektresultater fra baseline til uge 26
English: Body weight was a significant covariate resulting in a lower eculizumab clearance in pediatric patients requiring body weight based dosing in pediatric patients.
Danish: Kropsvægt var en signifikant kovariat, der førte til en lavere eculizumab-clearance hos pædiatriske patienter, så dosering i henhold til legemsvægt er nødvendig hos pædiatriske patienter.
English: Patients that were previously treated with Soliris in Study ECU-MG-301 continued to demonstrate a sustained effect of Soliris on all measures (MG-ADL, QMG, MGC and MG-QoL15) over an additional 52 weeks of treatment with Soliris.
Danish: Patienter, der tidligere blev behandlet med Soliris i studie ECU-MG-301, viste fortsat en vedvarende virkning af Soliris på alle målinger (MG-ADL, QMG, MGC og MG-QoL15) i løbet af de yderligere 52 ugers behandling med Soliris.
English: Weight was a significant covariate resulting in a lower eculizumab clearance 0.0105 L/h in the adolescent PNH patients.
Danish: Vægt var en signifikant kovariat, som førte til en lavere eculizumab-clearance på 0,010 l/time hos unge PNH-patienter.
English: PNH patients were also treated with Soliris in a single arm 52 week study (C04-002), and in a long term extension study (E05-001).
Danish: PNH-patienter blev desuden behandlet med Soliris i et 52 ugers studie med én enkelt arm (C04-002) og i et langvarigt forlængelsesstudie (E05-001).
English: • Diluted solution of Soliris may be stored at 2°C - 8°C for up to 24 hours prior to administration.
Danish: • Den fortyndede opløsning af Soliris kan før indgift opbevares ved 2 °C til 8 °C i indtil 24 timer.
English: An observational non-interventional Registry in patients with PNH (M07-001) was also initiated to characterize the natural history of PNH in untreated patients and the clinical outcomes during Soliris treatment.
Danish: Der blev også iværksat et ikke-intervenerende observationsregister over patienter med PNH (M07-001) med henblik på at karakterisere det naturlige forløb af PNH hos ubehandlede patienter og de kliniske resultater under behandling med Soliris.