FrancophonIA/ELRC3.0 huggingface dataset:
English: In most PNH patients, eculizumab serum concentrations of approximately 35 microgram/mL are sufficient for essentially complete inhibition of terminal complement-mediated intravascular haemolysis.
Danish: Hos de fleste PNH-patienter er en eculizumab-serumkoncentration på ca. 35 μg/ml tilstrækkelig til at bevirke stort set fuldstændig hæmning af den terminale komplementmedierede intravaskulære hæmolyse.
English: • The diluted solution of Soliris should be administered by intravenous infusion over 25 to 45 minutes in adults and 1-4 hours in paediatric patients via gravity feed, a syringe-type pump, or an infusion pump.
Danish: • Den fortyndede opløsning af Soliris administreres ved intravenøs infusion i løbet af 25-45 minutter hos voksne og 1-4 timer hos pædiatriske patienter enten ved naturligt indløb, med en pumpe af sprøjtetypen eller med en infusionspumpe.
English: All patients treated with Soliris when administered as recommended demonstrated rapid and sustained reduction in terminal complement activity.
Danish: Hos alle patienter, som blev behandlet med Soliris som anbefalet, sås en hurtig og vedvarende reduktion i den terminale komplementaktivitet.
English: Renal function, as measured by eGFR, was improved and maintained during Soliris therapy.
Danish: Nyrefunktionen, målt som estimeret GFR (eGFR), blev forbedret og opretholdt under Solirisbehandlingen.
English: PK parameters are consistent across PNH, aHUS, refractory gMG and NMOSD patient populations.
Danish: Farmakokinetiske parametre er overensstemmende i alle PNH-, aHUS-, refraktær gMG- og NMOSDpatientpopulationer.
English: • Risk of substantial disease exacerbation or relapse (in refractory gMG and NMOSD) following discontinuation/postponement of eculizumab administrations and recommendation to consult the prescriber before discontinuing/postponing eculizumab administrations.
Danish: • risikoen for betydelig sygdomsforværring eller recidiv (ved refraktær gMG og NMOSD) efter afbrydelse/udsættelse af administration af eculizumab og anbefaling om at konsultere den ordinerende læge før afbrydelse/udsættelse af administration af eculizumab.
English: Treatment Discontinuation for PNH
Danish: Afbrydelse af PNH-behandlingen
English: Most Recent Soliris Dose
Danish: Seneste Solirisdosis
English: There was an un-vaccinated patient diagnosed with idiopathic membranous glomerulonephropathy who experienced meningococcal meningitis.
Danish: Meningokokmeningitis forekom hos én uvaccineret patient med diagnosticeret idiopatisk membranøs glomerulonefritis.
English: • spasm of mouth muscle
Danish: • sammentrækninger i mundmuskulaturen
English: After completion of the initial 26-week treatment period, most patients elected to continue on chronic dosing.
Danish: Efter den indledende 26-ugers behandlingsperiode var gennemført, valgte de fleste patienter at fortsætte med kronisk dosering.
English: After completion of the initial 26week treatment period, most patients elected to continue on chronic dosing.
Danish: Efter den indledende 26 ugers behandlingsperiode var gennemført, valgte de fleste patienter at fortsætte med kronisk dosering.
English: Thrombocytopenia, Lymphopenia
Danish: Leukopeni, anæmi Trombocytopeni, lymfopeni
English: Change From Baseline QMG Total Score
Danish: Baseline QMG-score
English: TMA Event-free Status, n (%) 95% CI
Danish: TMA-hændelsesfri tilstand, n (%) 95% CI
English: The use of effective contraception during treatment and up to 5 months after treatment should be considered in women who are able to get pregnant.
Danish: For kvinder, der kan blive gravide, skal det overvejes at bruge sikker prævention under behandlingen og i op til 5 måneder efter behandlingen.
English: Depression, Anxiety, Mood swings
Danish: Depression, angst, humørsvingninger
English: Reduction in terminal complement activity and an increase in platelet count relative to baseline were observed after commencement of Soliris.
Danish: Reduktion i terminal komplementaktivitet og stigning i trombocyttallet i forhold til baseline blev observeret efter Soliris blev påbegyndt.
English: Plasmapheresis or plasma exchange
Danish: Plasmaferese/plasmauds kiftning
English: In aHUS patients, uncontrolled terminal complement activation and the resulting complement-mediated thrombotic microangiopathy are blocked with Soliris treatment.
Danish: Hos aHUS-patienter blokeres ukontrolleret terminal komplementaktivering og deraf følgende komplementmedieret trombotisk mikroangiopati ved behandling med Soliris.
English: The dosing regimen in paediatric patients and adolescents weighing less than 40 kg was defined based on a pharmacokinetic (PK) simulation that identified the recommended dose and schedule based on body weight (see section 4.2).
Danish: Dosisregimet til pædiatriske patienter og unge, der vejede under 40 kg, blev beregnet på baggrund af farmakokinetisk ekstrapolering, der fastsatte den anbefalede dosis og behandlingsplan iht.
English: FACIT-Fatigue (effect size) * Results from study C04-002 refer to pre- versus post-treatment comparisons.
Danish: * I resultaterne fra studiet C04-002 sammenlignes værdierne før og efter behandlingen.
English: Table 18: Efficacy Outcomes in Prospective aHUS Study C10-003
Danish: Tabel 18: Effektresultater i det prospektive aHUS-studie C10-003
English: Adjusted adjudicated ARR
Danish: Justeret adjudikeret ARRa
English: Treatment monitoring aHUS patients should be monitored for signs and symptoms of thrombotic microangiopathy (TMA) (see section 4.4 aHUS laboratory monitoring).
Danish: Patienter med aHUS bør monitoreres for tegn og symptomer på trombotisk mikroangiopati (TMA) (se pkt.
English: Children and adolescents with PNH or aHUS and who are 40 kg weight and over are treated with the adult dosing.
Danish: Børn og unge med PNH og aHUS, som vejer 40 kg og derover, skal have samme dosis som voksne.
English: TMA Event-Free Status, n (%)
Danish: TMA-hændelsesfri tilstand, n (%)
English: • muscle cramp, muscle aches, back and neck pain, bone pain, joint swelling, pain in the limbs (arms and legs)
Danish: • muskelkramper, muskelsmerter, ryg- og nakkesmerter, knoglesmerter, hævede led, smerter i arme og ben
English: Accelerated hypertension, Hypotension, Hot flush, Vein disorder
Danish: Hypertension Hurtig udvikling af hypertension, hypotension, hedeture, lidelser relateret til vener
English: Table 6 summarizes the efficacy results for aHUS Study C08-003A/B.
Danish: I tabel 6 opsummeres effektresultaterne fra aHUS-studiet C08-003A/B.
English: Haematologic normalization, n (%) (95% CI)
Danish: Hæmatologisk normalisering, n (%) (95% CI)
English: Soliris has not been evaluated in paediatric patients with NMOSD.
Danish: Soliris er ikke blevet evalueret til pædiatriske patienter med NMOSD.
English: Complete TMA response, n (%)
Danish: Fuldstændigt TMA-respons, n (%)
English: NAME OF THE MEDICINAL PRODUCT Soliris 300 mg concentrate for solution for infusion
Danish: LÆGEMIDLETS NAVN Soliris 300 mg koncentrat til infusionsvæske, opløsning
English: Renal function, as measured by median eGFR, increased during Soliris therapy.
Danish: Nyrefunktionen, målt som median eGFR, blev forbedret under Soliris-behandlingen.
English: As a result, patients with complement-mediated diseases, including PNH, aHUS, refractory gMG and NMOSD may experience increased signs and symptoms of their underlying disease, such as haemolysis (PNH), TMA (aHUS), MG exacerbation (refractory gMG) or relapse (NMOSD).
Danish: Som følge heraf kan patienter med komplementmedierede sygdomme, herunder PNH, aHUS, refraktær gMG og NMOSD, opleve øgede tegn og symptomer på deres underliggende sygdom, såsom hæmolyse (PNH), TMA (aHUS), forværring af MG (refraktær gMG) eller recidiv (NMOSD).
English: Marketing Authorisation Holder: Alexion Europe SAS 103-105 rue Anatole France 92300 Levallois-Perret France
Danish: Indehaveren af markedsføringstilladelsen: Alexion Europe SAS 103-105 rue Anatole France 92300 Levallois-Perret Frankrig
English: Patients with eGFR improvement
Danish: *En patient opnåede eGFR-forbedring efter nyretransplantation
English: Table 7: Baseline Characteristics of Patients Enrolled in aHUS Study C10-004
Danish: Tabel 7: Baseline-karakteristika for patienter, der indgik i aHUS-studie C10-004
English: When immunosuppressant therapy is decreased or discontinued, patients should be monitored closely for signs and symptoms of potential NMOSD relapse.
Danish: Når den immunsuppressive behandling reduceres eller seponeres, skal patienterne overvåges nøje for tegn på et muligt NMOSD-recidiv.
English: 002A/B C08-003A/B, C10-004) one in paediatric and adolescent patients (C10-003 ) and 30 patients in one retrospective study (C09-001r) were used to evaluate the efficacy of Soliris in the treatment of aHUS.
Danish: Data fra fire prospektive, kontrollerede studier med 100 patienter, tre med voksne og unge patienter (C08-002A/B C08-003A/B, C10-004), et med pædiatriske og unge patienter (C10-003) samt 30 patienter i et retrospektivt studie (C09-001r) blev anvendt til at evaluere virkningen af Soliris ved behandling af aHUS.
English: As a result, patients with complement-mediated diseases, including PNH, aHUS, refractory gMG and NMOSD, may experience increased signs and symptoms of their underlying disease, such as haemolysis (PNH), TMA (aHUS), MG exacerbation (refractory gMG) or relapse (NMOSD).
Danish: Som følge heraf kan patienter med komplementmedierede sygdomme, herunder PNH, aHUS, refraktær gMG og NMOSD, opleve øgede tegn og symptomer på deres underliggende sygdom, såsom hæmolyse (PNH), TMA (aHUS), MGforværringer (refraktær gMG) eller recidiv (NMOSD).
English: In all aHUS patients, eculizumab serum concentrations of approximately 50 - 100 microgram/mL are sufficient for essentially complete inhibition of terminal complement activity.
Danish: Hos alle aHUS-patienter er en eculizumab-serumkoncentration på omkring 50-100 µg/ml tilstrækkelig til så godt som fuldstændig hæmning af den terminale komplementaktivitet.
English: All aHUS patients treated with Soliris when administered as recommended demonstrated rapid and sustained reduction in terminal complement activity.
Danish: Hos alle aHUS-patienter, som blev behandlet med Soliris som anbefalet, sås en hurtig og vedvarende reduktion i den terminale komplementaktivitet.
English: Table 8: Efficacy Outcomes in Prospective aHUS Study C10-004
Danish: Tabel 8: Effektresultater i det prospektive aHUS-studie C10-004
English: A reduction in terminal complement activity and an increase in platelet count relative to baseline were observed after commencement of Soliris.
Danish: Der blev observeret en reduktion i den terminale komplementaktivitet og en stigning i trombocyttal i forhold til baseline efter påbegyndelse af Soliris-behandling.
English: Renal function, as measured by eGFR, was improved during Soliris therapy.
Danish: Nyrefunktionen, målt ved eGFR, blev forbedret i løbet af behandlingen med Soliris.
English: • Maintenance phase: 1,200 mg of Soliris administered via a 25 - 45 minute intravenous infusion for the fifth week, followed by 1,200 mg of Soliris administered via a 25 - 45 minute intravenous infusion every 14 ± 2 days (see section 5.1).
Danish: • Vedligeholdelsesfase: 1.200 mg Soliris givet som intravenøs infusion over 25-45 minutter den 5. uge, efterfulgt af 1.200 mg Soliris givet som intravenøs infusion over 25-45 minutter hver 14. dag ± 2 dage (se pkt.
English: Soliris has not been evaluated in paediatric patients with refractory gMG.
Danish: Soliris er ikke blevet evalueret hos pædiatriske patienter med refraktær gMG.
English: Chronic administration of Soliris results in immediate, complete, and sustained inhibition of terminal complement activity.
Danish: Kronisk administration af Soliris fører til øjeblikkelig, fuldstændig og vedvarende hæmning af terminal komplementaktivitet.
English: Common: may affect up to 1 in 10 people:
Danish: Almindelige (kan forekomme hos op til 1 ud af 10 patienter):
English: Uncommon: may affect up to 1 in 100 people:
Danish: Ikke almindelige (kan forekomme hos op til 1 ud af 100 patienter):
English: • Do not administer Soliris as an intravenous push or bolus injection.
Danish: • Soliris må ikke administreres som en intravenøs bolusinjektion.
English: In all studies, the dose of eculizumab was 600 mg every 7 ± 2 days for 4 weeks, followed by 900 mg 7 ± 2 days later, then 900 mg every 14 ± 2 days for the study duration.
Danish: I alle studierne blev eculizumab givet i en dosis på 600 mg hver 7 ± 2 dage i 4 uger, efterfulgt af 900 mg 7 ± 2 dage senere, derefter 900 mg hver 14 ± 2 dage i hele studiets varighed.
English: Baseline LDH (U/L) median (min, max )
Danish: Baseline-LDH (E/l) median (min.; maks.)
English: Baseline platelet count (x 109/L), median ( min, max)
Danish: Baseline-trombocyttal (x 109/l), median (min.; maks.)
English: In PNH patients, pharmacodynamic activity correlates directly with eculizumab serum concentrations and maintenance of trough levels above ≥ 35 microgram/mL results in essentially complete blockade of haemolytic activity in the majority of PNH patients.
Danish: Hos PNH-patienter korrelerer den farmakodynamiske aktivitet direkte med serumkoncentrationerne af eculizumab, og ved opretholdelse af dalkoncentrationer ≥ 35 μg/ml opnås stort set fuldstændig blokering af den hæmolytiske aktivitet hos størstedelen af PNH-patienterne.
English: In aHUS Study C08-002A/B, responses to Soliris were similar in patients with and without identified mutations in genes encoding complement regulatory factor proteins.
Danish: I aHUS-studiet C08-002A/B var respons på Soliris ens hos patienter med og uden identificerede mutationer i de gener, der koder for de proteiner, der er regulatorer af komplementsystemet.
English: What Soliris looks like and contents of the pack Soliris is presented as a concentrate for solution for infusion (30 ml in a vial - pack size of 1).
Danish: Soliris er et koncentrat til infusionsvæske, opløsning (30 ml i et hætteglas - pakningsstørrelse 1 stk.).
English: In aHUS Study C08-003A/B, responses to Soliris were similar in patients with and without identified mutations in genes encoding complement regulatory factor proteins.
Danish: I aHUS-studiet C08-003A/B var respons på Soliris ens hos patienter med og uden identificerede mutationer i de gener, der koder for de proteiner, der er regulatorer af komplementsystemet.
English: For 1,200 mg doses, use 120 ml of Soliris and add
Danish: Til en dosis på 1.200 mg anvendes 120 ml Soliris og 120 ml fortyndingsvæske.
English: The treatment will be given by your doctor or other health care provider by infusing a dilution of the Soliris vial from a drip bag through a tube directly into one of your veins.
Danish: Du vil få en fortyndet opløsning af indholdet i hætteglasset med Soliris som infusion fra en dropflaske gennem en slange direkte i en vene.
English: • Diluents are Sodium chloride 9 mg/ml (0.9%) solution for injection, Sodium chloride 4.5 mg/ml
Danish: • Som fortyndingsvæske anvendes natriumchlorid 9 mg/ml (0,9%) injektionsvæske, opløsning, natriumchlorid 4,5 mg/ml (0,45%) injektionsvæske, opløsning eller 5 % glucoseopløsning.
English: In aHUS patients, pharmacodynamic activity correlates directly with eculizumab serum concentrations and maintenance of trough levels of approximately 50-100 microgram/ml results in essentially complete blockade of terminal complement activity in all aHUS patients.
Danish: Hos aHUS-patienter korrelerer den farmakodynamiske aktivitet direkte med serumkoncentrationen af eculizumab, og ved opretholdelse af dalkoncentrationer ≥ 50-100 µg/ml opnås stort set fuldstændig blokering af den terminale komplementaktivitet hos alle aHUS-patienterne.
English: Ensure that your current meningococcal vaccination is up to date.
Danish: Hvis du allerede er vaccineret, skal du sikre dig, at din gamle meningokokvaccination stadig giver dig beskyttelse.
English: Table 7 summarizes the key baseline clinical and diseaserelated characteristics of patients enrolled in aHUS C10-004.
Danish: Tabel 7 opsummerer de primære kliniske og sygdomsrelaterede baselinekarakteristika for patienter, der indgik i aHUS C10-004.
English: • In the fifth week, your doctor will administer an intravenous infusion of diluted Soliris at a dose of 1,200 mg (4 vials of 30 ml) over a 25 - 45 minute period.
Danish: • I den 5. uge vil lægen give dig en intravenøs infusion af fortyndet Soliris i en dosis på 1.200 mg (4 hætteglas a 30 ml).
English: • In the fifth week, your doctor will administer an intravenous infusion of diluted Soliris at a dose of 900 mg (3 vials of 30 ml) over a 25 - 45 minute period.
Danish: • I den 5. uge giver lægen dig en intravenøs infusion af fortyndet Soliris i en dosis på 900 mg (3 hætteglas a 30 ml).
English: Table 17 summarizes the key baseline clinical and disease-related characteristics of patients enrolled in aHUS Study C10-003.
Danish: Tabel 17 opsummerer de primære baseline kliniske og sygdomsrelaterede karakteristika for patienter, der indgik i aHUS-studie C10-003.
English: Soliris has not been studied in paediatric patients with refractory gMG or NMOSD.
Danish: Soliris er ikke blevet undersøgt hos pædiatriske patienter med refraktær Gmg eller NMOSD.
English: For 900 mg doses, use 90 ml of Soliris and add 90 ml of diluent.
Danish: Til en dosis på 900 mg anvendes 90 ml Soliris og 90 ml fortyndingsvæske.
English: ≥15 mL/min/1.73 m2, n (%)
Danish: Patienter med eGFR-forbedring ≥15 ml/min/1,73 m2, n (%)
English: For 300 mg doses, use 30 ml of Soliris (10 mg/ml)
Danish: Til en dosis på 300 mg anvendes 30 ml Soliris (10 mg/ml) og 30 ml fortyndingsvæske.
English: Interrupting or stopping treatment with Soliris may cause your NMOSD to worsen and relapse to happen.
Danish: Hvis du holder op med at bruge Soliris mod NMOSD Hvis du afbryder eller stopper behandlingen med Soliris, kan din NMOSD forværres, og der kan opstå tilbagefald.
English: In PNH patients, uncontrolled terminal complement activation and the resulting complement-mediated intravascular haemolysis are blocked with Soliris treatment.
Danish: Hos PNH-patienter blokeres ukontrolleret terminal komplementaktivering og den deraf følgende komplementmedierede intravaskulære hæmolyse ved behandling med Soliris.
English: Spontaneous penile erection,
Danish: Spontan peniserektion
English: For children and adolescents with PNH and aHUS aged less than 18 years:
Danish: Børn og unge med PNH og aHUS under 18 år: Kropsvægt
English: Meningococcal infection symptoms
Danish: Symptomer ved meningokokinfektion
English: In Studies ECU-MG301 and ECU-MG-302, the dose of Soliris in adult refractory gMG patients was 900 mg every 7 ± 2 days for 4 weeks, followed by 1200 mg at Week 5± 2 days, then 1,200 mg every 14 ± 2 days for the study duration.
Danish: I studie ECU-MG301 og ECU-MG-302 var dosis af Soliris hos voksne patienter med refraktær gMG 900 mg hver 7. dag ± 2 dage i 4 uger, efterfulgt af 1.200 mg ved uge 5 ± 2 dage, dernæst 1.200 mg hver 14. dag ± 2 dage i løbet af hele studiet.
English: C08-002A/B C08-003A/B
Danish: C08-002A/B
English: 300 mg per each plasmapheresis or plasma exchange session
Danish: 300 mg 300 mg for hver plasmaferese /plasmaudskiftning
English: Clearance values of Soliris in paediatric aHUS patients were 10.4, 5.3, and 2.2 mL/hr with body weight of 70, 30, and 10 kg, respectively; and the corresponding volume of distribution values were 5.23, 2.76, and 1.21 L, respectively.
Danish: Clearance-værdier for Soliris hos pædiatriske aHUS-patienter var 10,4, 5,3 og 2,2 ml/t ved en kropsvægt på hhv. 70, 30 og 10 kg.
English: Efficacy Parameter aHUS Study C10-004 (N = 41)
Danish: Effektparameter aHUS-studie C10-004 (N = 41) Efter 26 uger
English: n (%)
Danish: Kvinder, n (%)
English: Patients in aHUS C10-003 received Soliris for a minimum of 26 weeks.
Danish: Patienterne i aHUS C10-003 fik Soliris i mindst 26 uger.
English: Patients who discontinue Soliris treatment should be carefully monitored for signs and symptoms of disease exacerbation.
Danish: Patienter, der afbryder behandlingen med Soliris, skal overvåges nøje for tegn og symptomer på en sygdomsforværring.
English: Infrequent antibody responses have been detected in Soliris-treated patients across all clinical studies.
Danish: Blandt Soliris-behandlede patienter i samtlige kliniske studier er der konstateret antistofdannelse i nogle få tilfælde.
English: Table 8 summarizes the efficacy results for aHUS study C10-004.
Danish: Tabel 8 opsummerer effektresultaterne for aHUS-studie C10-004.
English: Change From Baseline MG-ADL Total Score
Danish: Gennemsnit (min, max) Baseline MG-ADL-score
English: Chest discomfort, Asthenia, Chest pain, Infusion site pain, Chills
Danish: Ubehag i brystet, asteni, smerter i brystet, smerte ved infusionsstedet, kulderystelser
English: For 600 mg doses, use 60 ml of Soliris and add 60 ml of diluent.
Danish: Til en dosis på 600 mg anvendes 60 ml Soliris og 60 ml fortyndingsvæske.
English: 600 mg per each plasmapheresis or plasma exchange session
Danish: ≥600 mg 600 mg for hver plasmaferese /plasmaudskiftning
English: Your doctor will want to monitor you closely.
Danish: Din læge vil da ønske at holde dig under nøje observation.
English: The posology of Soliris for PNH patients less than 40kg weight is based on the posology used for patients with aHUS and who weigh less than 40kg.
Danish: Soliris er ikke blevet undersøgt hos patienter med PNH, som vejer under 40 kg. Doseringen af Soliris til PNH-patienter med en vægt under 40 kg er baseret på den anvendte dosering til patienter med aHUS, som vejer under 40 kg.
English: Dyspnoea, Epistaxis, Throat irritation, Nasal congestion, Rhinorrhoea
Danish: Dyspnø, epistaxis, irritation i svælget, nasal kongestion, rinoré
English: In the eculizumab NMOSD clinical development program, the dose of Soliris in adult patients with NMOSD was 900 mg every 7 ± 2 days for 4 weeks, followed by 1200 mg at Week 5 ± 2 days, then 1200 mg every 14 ± 2 days for the study duration.
Danish: I det eculizumab-kliniske udviklingsprogram for NMOSD var dosis af Soliris hos voksne patienter med NMOSD 900 mg hver 7 ± 2 dage i 4 uger, efterfulgt af 1.200 mg ved uge 5 ± 2 dage, dernæst 1.200 mg hver 14 ± 2 dage i løbet af hele studiet.
English: In aHUS C10-004, mean (±SD) platelet count increased from 119 ± 66 x109/L at baseline to 200 ± 84 x109/L by one week; this effect was maintained through 26 weeks (mean platelet count (±SD) at week 26: 252 ± 70 x109/L).
Danish: I aHUS C10004 steg det gennemsnitlige (±SD) trombocyttal fra 119 ± 66 x 109/l ved baseline til 200 ± 84 x 109/l efter 1 uge.
English: • inflammation of the skin, skin color disorder
Danish: • betændelseslignende reaktion (inflammation) i huden, misfarvning af huden
English: Patients who discontinue Soliris treatment should be carefully monitored for signs and symptoms of potential NMOSD relapse.
Danish: Patienter, der afbryder behandlingen med Soliris, skal overvåges nøje for tegn og symptomer på et muligt NMOSDrecidiv.
English: and C08-003A/B.
Danish: C08-003A/B
English: eGFR improvement ≥15 mL/min/ 1.73•m2, n (%) Change in eGFR ( ≥15 mL/min/1.73•m2) at 26
Danish: eGFR-forbedring ≥15 ml/min/ 1,73•m2, n (%) Ændring i eGFR ( ≥15 ml/min/1,73•m2) efter 26 uger, median (interval) Forbedring af kronisk nyreinsufficiens med ≥1 trin, n (%)
English: Rate ratio (eculizumab/placebo) 95% CI
Danish: Rate-ratio (eculizumab/placebo)
English: Time from current clinical TMA manifestation until first study dose (months), median ( min, max)
Danish: Tid fra aktuel klinisk TMA-manifestation indtil den første studiedosis (måneder), median (min.; maks.)
English: Free Haemoglobin at end of study (median, mg/dL)
Danish: Frit hæmoglobin ved studiets slutning (median, mg/dl) Træthed (FACIT) (virkningens størrelse)
English: Eculizumab can block the body's inflammatory response, and its ability to attack and destroy its own vulnerable blood and kidney cells.
Danish: Eculizumab kan blokere for kroppens reaktion på betændelsestilstande og dens evne til at angribe og ødelægge sine egne blodlegemer og nyreceller.