FrancophonIA/ELRC3.0 huggingface dataset:
English: Constipation, Dyspepsia, Abdominal distension
Danish: Obstipation, dyspepsi, abdominal distension
English: Data from 143 patients in one controlled study (Study ECU-NMO-301) and from 119 patients who continued in one open-label extension trial (Study ECU-NMO-302) were used to evaluate the efficacy and safety of Soliris in the treatment of patients with NMOSD.
Danish: Data fra 143 patienter i et kontrolleret studie (studie ECU-NMO-301) og fra 119 patienter, som fortsatte i et åbent forlængelsesstudie (studie ECU-NMO-302), blev anvendt til at evaluere virkning og sikkerhed ved Soliris ved behandling af patienter med NMOSD.
English: • abnormal leakage of the infused drug out of the vein, infusion site abnormal sensation, feeling hot
Danish: • unormal udsivning af det infunderede lægemiddel fra blodåren, unormal fornemmelse på infusionsstedet, varmefornemmelse
English: Treatment Discontinuation for aHUS
Danish: Afbrydelse af aHUS-behandlingen
English: Soliris reduced signs of complement-mediated TMA activity, as shown by an increase in mean platelet counts from baseline to 26 weeks.
Danish: Soliris reducerede tegn på komplementmedieret TMAaktivitet, vist ved en stigning i det gennemsnitlige trombocyttal fra baseline til 26 uger.
English: • infusion related reaction
Danish: • reaktioner i forbindelse med infusionen
English: In Paroxysmal Nocturnal Haemoglobinuria (PNH):
Danish: Paroksystisk nokturn hæmoglobinuri (PNH):
English: - If you have not been vaccinated against meningococcal infection unless you take antibiotics to reduce the risk of infection until 2 weeks after you have been vaccinated .
Danish: - hvis du ikke er vaccineret mod meningokok-infektion, medmindre du tager antibiotika i 2 uger efter, du er blevet vaccineret, for at nedsætte risikoen for infektion.
English: Pre-treatment LDH levels (median, U/L) Free Haemoglobin at baseline (median, mg/dL)
Danish: LDH-niveau før behandling (median, E/l) Fri hæmoglobin ved baseline (median, mg/dl)
English: Change from baseline at 12 weeks in Plasma Free Haemoglobin (mg/dL) Change from baseline Type III RBC clone size (Percent of aberrant cells) Change from baseline at 12 weeks of PedsQLTM4.0 Generic Core scale (patients) 10.5 (6.66)
Danish: Ændring fra baseline efter 12 uger i frit hæmoglobin i plasma (mg/dl) Ændring fra baseline i type III RBCklonstørrelse (procent abnorme celler) Ændring fra baseline efter 12 uger i PedsQLTM4.0 Generic Core-skala (patienter)
English: In refractory gMG patients, uncontrolled terminal complement activation causes membrane attack complex (MAC) dependent lysis and C5a-dependent inflammation at the Neuromuscular Junction (NMJ) leading to failure of neuromuscular transmission.
Danish: Hos patienter med refraktær gMG forårsager ukontrolleret terminal komplementaktivering membranangrebskompleks (MAC)-afhængig lysis og C5a-afhængig inflammation i de neuromuskulære synapser, hvilket fører til svigtende neuromuskulær transmission.
English: Haematologic normalization was defined as normalization of platelet counts and LDH levels sustained for ≥2 consecutive measurements for ≥4 weeks.
Danish: Hæmatologiske normalisering blev defineret som normalisering af trombocyttal og LDH-niveauer i ≥ 2 på hinanden følgende målinger og opretholdt i ≥ 4 uger.
English: Driving and using machines Soliris has no or negligible influence on the ability to drive and use machines.
Danish: Trafik- og arbejdssikkerhed Soliris påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Table 9 presents the baseline characteristics of the refractory gMG patients enrolled in Study ECU-MG
Danish: Tabel 9 viser baseline-karakteristika for patienterne med refraktær gMG, der indgik i studie ECU-MG
English: All physicians who intend to prescribe Soliris must ensure they are familiar with the physician's guide to prescribing.
Danish: Læger, som påtænker at ordinere Soliris, skal læse instruktionsfolderen vedrørende ordination.
English: To reduce the risk of infection, all patients must be vaccinated at least 2 weeks prior to receiving Soliris unless the risk of delaying Soliris therapy outweighs the risks of developing a meningococcal infection.
Danish: For at mindske infektionsrisikoen skal alle patienter vaccineres mindst 2 uger, før de får Soliris, medmindre risikoen ved at udskyde behandling med Soliris opvejer risici for udvikling af meningokokinfektion.
English: In paediatric patients with shorter duration of current severe clinical thrombotic microangiopathy (TMA) manifestation prior to eculizumab, there was TMA control and improvement of renal function with eculizumab treatment (Table 15).
Danish: Hos pædiatriske patienter med kortere varighed af den aktuelle svære kliniske manifestation af trombotisk mikroangiopati (TMA) før behandling med eculizumab sås kontrol af TMA og en forbedring af nyrefunktionen ved eculizumab-behandling (tabel 15).
English: In TRIUMPH, study patients treated with Soliris had significantly reduced (p< 0.001) haemolysis resulting in improvements in anaemia as indicated by increased haemoglobin stabilization and reduced need for RBC transfusions compared to placebo treated patients (see Table 3).
Danish: I TRIUMPH-studiet fik de patienter, der blev behandlet med Soliris, signifikant mindre hæmolyse (p < 0,001) med deraf følgende bedring i anæmien, udtrykt ved øget hæmoglobinstabilisering og mindre behov for transfusioner af erytrocytter, end placebobehandlede patienter (se tabel 3).
English: Soliris can block the body's inflammatory response, and its ability to attack and destroy its own eye nerves and spinal cord, thereby reducing symptoms of the disease and impact of the disease on the activities of daily living.
Danish: Soliris kan blokere kroppens betændelsesrespons og dens evne til at angribe og ødelægge dens egne øjennerver og rygmarven, hvorved symptomerne på sygdommen og sygdommens påvirkning af dagligdags aktiviteter reduceres.
English: Hypersensitivity to eculizumab, murine proteins or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for eculizumab, murine proteiner eller over for et eller flere af hjælpestofferne anført i pkt.
English: Change in platelet count through week 26 (109/L)
Danish: Ændring i trombocyttal til og med uge 26 (109/l)
English: • kidney disorder, difficulties or pain when urinating (dysuria), blood in urine
Danish: • nyreproblemer, vandladningsbesvær eller smerter ved vandladning, blod i urinen
English: Median Duration of complete TMA response, weeks (range)1
Danish: Median varighed af fuldstændigt TMA-respons, uger (interval)1
English: Table 2: Patient Demographics and Characteristics in C04-001 and C04-002 C04-001
Danish: Tabel 2: Demografiske data og karakteristika for patienterne i C04-001 og C04-002 C04-001
English: In paediatric patients with longer duration of current severe clinical TMA manifestation prior to eculizumab, there was TMA control with eculizumab treatment.
Danish: Hos pædiatriske patienter med længere varighed af den aktuelle svære kliniske TMA-manifestation før behandling med eculizumab sås kontrol af TMA ved eculizumab-behandling.
English: When Soliris treatment was continued for more than 26 weeks, three additional patients (63% of patients in total) achieved Complete TMA response and four additional patients (98% of patients in total) achieved hematologic normalization.
Danish: Da Soliris-behandlingen blev fortsat i mere end 26 uger, var der yderligere tre patienter (63 % af patienterne i alt), der opnåede fuldstændigt TMA-respons, og yderligere fire patienter (98 % af patienterne i alt), der opnåede hæmatologisk normalisering.
English: If your child is below the age of vaccination or if you are not vaccinated at least 2 weeks before you start treatment with Soliris, your doctor will prescribe antibiotics to reduce the risk of infection until 2 weeks after you have been vaccinated.
Danish: Hvis dit barn er for lille til at blive vaccineret, eller hvis du ikke er vaccineret mindst 2 uger før, du starter behandling med Soliris, vil din læge ordinere antibiotika i 2 uger efter, du er blevet vaccineret, for at nedsætte risikoen for infektion.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Soliris in one or more subsets of the paediatric population in the treatment of NMOSD (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Soliris i en eller flere undergrupper af den pædiatriske population ved behandling af NMOSD (se pkt.
English: Atypical Haemolytic Uremic Syndrome
Danish: Atypisk hæmolytisk uræmisk syndrom
English: Supportive safety data were obtained from 30 completed and one ongoing clinical studies that included 1,503 patients exposed to eculizumab in complement-mediated disease populations, including PNH, aHUS, refractory gMG and NMOSD.
Danish: Understøttende sikkerhedsdata blev opnået fra 30 afsluttede og et igangværende kliniske studier, som omfattede 1.503 patienter, der blev eksponeret for eculizumab, i komplement-medierede sygdomspopulationer, herunder PNH, aHUS, refraktær gMG og NMOSD.
English: In order to qualify for enrolment, patients were required to have a platelet count < lower limit of normal range (LLN), evidence of haemolysis such as an elevation in serum LDH, and serum creatinine above the upper limits of normal, without the need for chronic dialysis.
Danish: For at indgå i studiet skulle patienterne have et trombocyttal < nedre grænse for normalområdet (lower limit of normal range, LLN), bevis for hæmolyse, såsom forhøjet serum-LDH, og serum-kreatinin over den øvre normalgrænse uden behov for kronisk dialyse.
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 1 vial of 30 ml (10 mg/ml)
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Koncentrat til infusionsvæske, opløsning 1 hætteglas á 30 ml (10 mg/ml)
English: Twenty of the 24 patients who required dialysis at baseline were able to discontinue dialysis during Soliris treatment.
Danish: 20 ud af de 24 patienter, der fik dialyse ved baseline, kunne undvære dialyse under behandlingen med Soliris.
English: In Study ECU-MG-301, a clinical responder in the MG-ADL total score was defined as having at least a 3-point improvement.
Danish: I studie ECU-MG-301 blev en person med klinisk respons i MG-ADL total score defineret som en person med en forbedring på mindst 3 point.
English: Severe thrombotic microangiopathy complications post discontinuation can be identified by (i) any two, or repeated measurement of any one, of the following: a decrease in platelet count of 25% or more as compared to either baseline or to peak platelet count during Soliris treatment; an increase in serum creatinine of 25% or more as compared to baseline or to nadir during Soliris treatment; or, an increase in serum LDH of 25% or more as compared to baseline or to nadir during Soliris treatment; or (ii) any one of the following: a change in mental status or seizures; angina or dyspnoea; or thrombosis.
Danish: Svære komplikationer som følge af trombotisk mikroangiopati efter behandlingsafbrydelse kan identificeres ved (1) to eller flere målinger af et af følgende: et fald i trombocyttallet på 25 % eller mere i forhold til enten baseline eller det maksimale trombocyttal under Soliris-behandlingen; en stigning i serum-kreatinin på 25 % eller mere i forhold til baseline eller nadir under Solirisbehandlingen; en stigning i serum-LDH på 25 % eller mere i forhold til baseline eller nadir under Soliris-behandlingen; eller (2) et af følgende: en ændring i mental tilstand eller krampeanfald; angina eller dyspnø; trombose.
English: If serious haemolysis occurs after Soliris discontinuation, consider the following procedures/treatments: blood transfusion (packed RBCs), or exchange transfusion if the PNH RBCs are >50% of the total RBCs by flow cytometry; anticoagulation; corticosteroids; or reinstitution of Soliris.
Danish: Opstår der alvorlig hæmolyse efter afbrydelse af Soliris, bør følgende procedurer/behandlinger overvejes: blodtransfusion (pakkede erytrocytter), udskiftningstransfusion hvis PNH-erytrocytter udgør > 50 % af den samlede mængde erytrocytter ifølge flowcytometri, antikoagulationsbehandling, kortikosteroider, genoptagelse af Soliris-behandlingen.
English: PRBC transfused during treatment (median)
Danish: Pakkede erytrocytter transfunderet under behandlingen (median)
English: Alanine aminotransferase increased, Aspartate aminotransferase increased, Gammaglutamyltransferase increased, Haematocrit decreased,
Danish: Forhøjet alaninaminotransferase, forhøjet aspartataminotransferase, forhøjet gammaglutamyltransferase, fald i hæmatokrit, fald i hæmoglobin
English: Paediatric PNH and aHUS patients with body weight ≥ 40 kg are treated with the adult dosing recommendations, respectively.
Danish: Pædiatriske PNH- og aHUS-patienter med en kropsvægt ≥ 40 kg behandles i henhold til med de respektive doseringsanbefalinger til voksne.
English: Neuromyelitis Optica Spectrum Disorder
Danish: Neuromyelitis optica spektrumsygdom
English: Dilute Soliris to a final concentration of 5 mg/ml by addition to the infusion bag using sodium chloride 9 mg/ml (0.9%) solution for injection, sodium chloride 4.5 mg/ml (0.45%) solution for injection, or 5% dextrose in water, as the diluent.
Danish: Soliris fortyndes til den endelige koncentration på 5 mg/ml ved tilsætning af natriumchlorid 9 mg/ml (0,9%) injektionsvæske, opløsning, natriumchlorid 4,5 mg/ml (0,45%) injektionsvæske, opløsning eller 5 % glucoseopløsning.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Soliris in one or more subsets of the paediatric population in the treatment of refractory gMG (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Soliris i en eller flere undergrupper af den pædiatriske population ved behandling af refraktær gMG (se pkt.
English: Fatigue and health-related quality of life were relevant secondary endpoints.
Danish: Relevante sekundære endepunkter omfattede træthed og helbredsrelateret livskvalitet.
English: Each vial of Soliris contains 300 mg of active ingredient in 30 ml of product solution.
Danish: Hvert hætteglas med Soliris indeholder 300 mg af det aktive stof i 30 ml opløsning med produktet.
English: Meningococcal Infection
Danish: Meningokokinfektion
English: In Study ECU-MG-301, gMG patients with a positive serologic test for anti-AChR antibodies, MGFA (Myasthenia Gravis Foundation of America) clinical classification class II to IV and MG-ADL total score
Danish: I studie ECU-MG-301 blev gMG-patienter med en positiv serologisk test for anti-AChR-antistoffer, MGFA (Myasthenia Gravis Foundation of America) klinisk klassifikation klasse II til IV og MG-ADL total score ≥6 randomiseret til enten Soliris (n = 62) eller placebo (n = 63).
English: Hematologic Normalization, n (%) Median duration of hematologic normalization, weeks (range) 1
Danish: Hæmatologisk normalisering, n (%) Median varighed af hæmatologisk normalisering, uger (interval)1
English: Serious haemolysis is identified by serum LDH levels greater than the pre-treatment level, along with any of the following: greater than 25% absolute decrease in PNH clone size (in the absence of dilution due to transfusion) in one week or less; a haemoglobin level of <5 g/dL or a decrease of >4 g/dL in one week or less; angina; change in mental status; a 50% increase in serum creatinine level; or thrombosis.
Danish: Alvorlig hæmolyse er kendetegnet ved serum-LDHværdier, der er højere end før behandlingen og er ledsaget af et eller flere af følgende tegn: et absolut fald på mere end 25 % i PNH-klonstørrelse (uden at fortynding pga. transfusion medregnes) i løbet én uge eller mindre, et hæmoglobinindhold, der er < 5 g/dl eller er faldet > 4 g/dl i løbet af én uge eller mindre, angina, ændret mentaltilstand, 50 % stigning i serumkreatinin, eller trombose.
English: Rare: may affect up to 1 in 1,000 people:
Danish: Sjældne (kan forekomme hos op til 1 ud af 1.000 patienter):
English: Extravasation, Infusion site paraesthesia, Feeling hot
Danish: Ekstravasation, paræstesier ved infusionsstedet, varmefornemmelse
English: weeks.
Danish: 4 uger.
English: The second population PK model was applied to the multiple dose PK data from 22 paediatric aHUS patients receiving the recommended Soliris regimen in aHUS C10-003.
Danish: Den anden populationsfarmakokinetiske model blev anvendt på farmakokinetiske data efter gentagne doser fra 22 pædiatriske aHUS-patienter, der fik det anbefalede dosisregime med Soliris i aHUS C10003.
English: In Study C10-003, patients who enrolled in the study were required to have a platelet count < lower limit of normal range (LLN), evidence of haemolysis such as an elevation in serum LDH above the upper limits of normal and serum creatinine level ≥97 percentile for age without the need for chronic dialysis.
Danish: I studie C10-003 skulle patienter, som indgik i studiet, have et trombocyttal < nedre grænse for normalområdet (LLN), bevis for hæmolyse såsom forhøjet serum-LDH over den øvre normalgrænse og serum-kreatininniveau ≥97 percentil for alder, uden behov for kronisk dialyse.
English: The most serious side effect was meningococcal sepsis.
Danish: Den alvorligste bivirkning var blodforgiftning forårsaget af meningokokker.
English: EU/1/07/393/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/07/393/001
English: − The active substance is eculizumab (300 mg/30 ml in a vial corresponding to 10 mg/ml).
Danish: Aktivt stof: eculizumab (300 mg/30 ml i et hætteglas svarende til 10 mg/ml).
English: The corresponding elimination half-life remained almost unchanged within a range of 349 to 378 h (approximately 14.5 to 15.8 days).
Danish: De tilhørende værdier for fordelingsvolumen var hhv. 5,23, 2,76 og 1,21 l. Den tilhørende eliminationshalveringstid forblev næsten uændret inden for et interval på 349 til 378 t (ca. 14,5 til 15,8 dage).
English: Number of PE/PI sessions for current clinical TMA manifestation, median (min, max)
Danish: Antal PE/PI-behandlinger for aktuel klinisk TMA-manifestation, median (min., maks.)
English: <12 years (n=15)
Danish: <12 år (n=15)
English: Use of Soliris in refractory gMG treatment has been studied only in the setting of chronic administration.
Danish: Brugen af Soliris til behandling af refraktær gMG er kun blevet undersøgt i et regi med kronisk administration.
English: Patients received meningococcal vaccination prior to receipt of Soliris.
Danish: Patienterne fik meningokokvaccine før administration af Soliris.
English: Septic shock, Peritonitis, Lower respiratory tract infection, Fungal infection, Viral a, infection, Abscess Cellulitis, Influenza, Gastrointestinal infection, Cystitis, Infection, Sinusitis,
Danish: Meningokokinfektionb, sepsis, septisk shock, peritonitis, infektion i nedre luftveje, svampeinfektion, virusinfektion, absces a, cellulitis, influenza, gastrointestinal infektion, cystitis, infektion, sinusitis
English: LDH level at baseline (median , U/L)
Danish: LDH-niveau ved baseline (median, E/l)
English: Additionally, all patients must be vaccinated against meningococcal infections at least 2 weeks prior to receiving Soliris unless the risk of delaying Soliris therapy outweighs the risks of developing a meningococcal infection.
Danish: Desuden skal alle patienter vaccineres mod meningokok-infektioner mindst to uger før, de får Soliris, medmindre risikoen ved at udskyde behandling med Soliris opvejer risiciene for udvikling af meningokokinfektion.
English: A second population PK analysis with a standard 1 compartmental model was conducted on the multiple dose PK data from 37 aHUS patients receiving the recommended Soliris regimen in studies C08-002A/B
Danish: En anden populationsfarmakokinetisk analyse, som anvendte en standard 1-kompartmentmodel, blev udført på baggrund af farmakokinetiske data vedrørende multiple doser hos 37 aHUS-patienter, der fik den anbefalede Soliris-behandling i studierne C08-002A/B og C08-003A/B.
English: Patients enrolled in aHUS C10-003 had an ADAMTS-13 level above 5%.
Danish: Patienter, der indgik i aHUS C10-003, havde et ADAMTS-13-niveau over 5 %.
English: Sepsis is a common presentation of meningococcal infections in patients treated with Soliris (see section 4.8).
Danish: Sepsis er et almindeligt symptom på meningokokinfektioner hos patienter behandlet med Soliris (se pkt.
English: Cases of thrombotic microangiopathy complication have been reported in the setting of missed or delayed Soliris dose in aHUS clinical trials (see also Section 4.4).
Danish: Komplikationer som følge af trombotisk mikroangiopati er rapporteret ved manglende eller forsinket Soliris-dosis i kliniske aHUS-studier (se også pkt.
English: In 40 patients with PNH, a 1-compartmental model was used to estimate pharmacokinetic parameters after multiple doses.
Danish: Hos 40 patienter med PNH blev de farmakokinetiske parametre for flergangsdosering bestemt ved hjælp af en en-kompartment model.
English: RMP presented in Module 1.8.2 of the Marketing Authorisation, and any agreed subsequent updates of the
Danish: Indehaveren af markedsføringstilladelsen skal udføre de påkrævede aktiviteter og foranstaltninger vedrørende lægemiddelovervågning, som er beskrevet i den godkendte RMP, der fremgår af modul 1.8.2 i markedsføringstilladelsen, og enhver efterfølgende godkendt opdatering af RMP.
English: Body Weight
Danish: Patientens kropsvægt
English: The final volume of a 5 mg/ml diluted solution is 60 ml for 300 mg doses, 120 ml for 600 mg doses, 180 ml for 900 mg doses and 240 ml for 1,200 mg doses.
Danish: Det endelige volumen af den fortyndede opløsning med 5 mg/ml er 60 ml til en dosis på 300 mg, 120 ml til en dosis på 600 mg, 180 ml til en dosis på 900 mg og 240 ml til en dosis på 1.200 mg.
English: Data from 139 patients in two prospective controlled studies (Studies C08-001 and ECU-MG-301), and one open-label extension trial (Study ECU-MG-302) were used to evaluate the efficacy of Soliris in the treatment of patients with refractory gMG.
Danish: Data fra 139 patienter i to prospektive, kontrollerede studier (studie C08-001 og ECU-MG-301) og et åbent forlængelsesstudie (studie ECU-MG-302) blev anvendt til at evaluere virkningen af Soliris til behandling af patienter med refraktær gMG.
English: Adverse reactions reported in patients with disease other than PNH, aHUS, refractory gMG or NMOSD were similar to those reported in patients with PNH, aHUS, refractory gMG or NMOSD (see Table 1 above).
Danish: De bivirkninger, der blev rapporteret hos patienter med anden sygdom end PNH, aHUS, refraktær gMG eller NMOSD, var de samme som dem, der blev rapporteret hos patienter med PNH, aHUS, refraktær gMG eller NMOSD (se tabel 1 ovenfor).
English: Immunosuppressant and anticholinesterase therapies Patients in refractory gMG clinical trials continued treatment with immunosuppressant and anticholinesterase therapies while on Soliris treatment.
Danish: Behandlinger med immunsuppressive midler og anticholinesterase Patienter i kliniske studier af refraktær gMG fortsatte behandlingen med immunsuppressive midler og anticholinesterase, mens de fik behandling med Soliris.
English: When Soliris treatment was continued for more than 26 weeks, one additional patient (68% of patients in total) achieved Complete TMA Response and two additional patients (91% of patients in total)
Danish: Da Soliris-behandlingen blev fortsat i mere end 26 uger, opnåede yderligere én patient (68 % af patienterne i alt) fuldstændigt TMA-respons, og yderligere to patienter (91 % af patienterne i alt) hæmatologisk normalisering.
English: <2 years (n=5)
Danish: <2 år (n=5)
English: Sodium as chloride, phosphate dibasic, phosphate monobasic, polysorbate 80 and water for injections.
Danish: Dinatriumphosphat; natriumdihydrogenphosphat, natriumchlorid; polysorbat 80 og vand til injektionsvæsker.
English: Diarrhoea, Vomiting, Nausea, Abdominal pain
Danish: Diarré, opkastning, kvalme, abdominalsmerter