FrancophonIA/ELRC3.0 huggingface dataset:
English: The key secondary endpoint was the change from baseline in the Quantitative MG Scoring System (QMG - a physician reported outcome measure validated in gMG) total score at Week 26.
Danish: Det vigtigste sekundære endepunkt var ændringen fra baseline i Quantitative MG Scoring System (QMG - en lægerapporteret udfaldsmåling valideret i gMG) total score ved uge 26.
English: A total of 7 PNH paediatric patients, with a median weight of 57.2 kg (range of 48.6 to 69.8 kg) and aged from 11 to 17 years (median age : 15.6 years), received Soliris in study M07-005.
Danish: I alt 7 pædiatriske PNH-patienter med en medianvægt på 57,2 kg (interval 48,6 til 69,8 kg) og i alderen fra 11 til 17 år (medianalder 15,6 år) fik Soliris i studie M07-005.
English: These effects were seen among patients within each of the three pre-study RBC transfusion strata (4 - 14 units; 15 - 25 units; > 25 units).
Danish: Disse virkninger sås hos patienter i hvert af de tre strata for erytrocyttransfusion før studiet (hhv. 4-14 portioner, 15-25 portioner og > 25 portioner).
English: Physicians must discuss the benefits and risks of Soliris therapy with patients and provide them with a patient information brochure and a patient safety card.
Danish: Læger skal diskutere fordele og risici ved Soliris-behandling med patienterne og give dem en patientinformationsbrochure og et patientsikkerhedskort.
English: At the last evaluation, 25 of 41 patients (61%) achieved eGFR improvement of ≥ 15 mL/min/1.73 m2 from baseline.
Danish: Ved den sidste evaluering havde 25 ud af 41 patienter (61 %) opnået eGFR-forbedring på ≥ 15 ml/min/1,73 m i forhold til baseline.
English: Parameter aHUS Study C10-004 N = 41
Danish: Parameter aHUS-studie C10-004 N = 41
English: Cases of serious or fatal meningococcal infections have been reported in Soliris-treated patients.
Danish: Tilfælde af alvorlige eller letale meningokokinfektioner er rapporteret hos patienter behandlet med Soliris.
English: Number of patients with prior MG crisis since diagnosis, n (%)
Danish: Antal patienter med tidligere MG-krise siden diagnose, n (%)
English: Primary efficacy endpoints were haemoglobin stabilization (patients who maintained a haemoglobin concentration above the haemoglobin set-point and avoid any RBC transfusion for the entire 26 week period) and blood transfusion requirement.
Danish: De primære endepunkter var hæmoglobinstabilisering (opretholdelse af en hæmoglobinkoncentration over sætpunktet og undgåelse af transfusion af erytrocytter i hele 26 ugers perioden) samt behov for blodtransfusion.
English: The Soliris antibody contains human constant regions and murine complementarity-determining regions grafted onto the human framework light- and heavy-chain variable regions.
Danish: Soliris-antistoffet indeholder dels humane konstante områder, dels murine komplementaritetsbestemmende områder, der er indsat i de variable områder af den humane ramme med lette og tunge kæder.
English: 30 to <40 kg 600 mg weekly x 2 900 mg at week 3; then 900 mg every 2 weeks 20 to <30 kg 600 mg weekly x 2 600 mg at week 3; then 600 mg every 2 weeks 10 to <20 kg 600 mg weekly x 1 300 mg at week 2; then 300 mg every 2 weeks 5 to <10 kg 300 mg weekly x 1 300 mg at week 2; then 300 mg every 3 weeks
Danish: 30 til < 40 kg 600 mg ugentligt x 2 900 mg i uge 3, derefter 900 mg hver 2. uge 20 til < 30 kg 600 mg ugentligt x 2 600 mg i uge 3, derefter 600 mg hver 2. uge 10 til < 20 kg 600 mg ugentligt x 1 300 mg i uge 2, derefter 300 mg hver 2. uge 5 til < 10 kg 300 mg ugentligt x 1 300 mg i uge 2, derefter 300 mg hver 3. uge
English: Your doctor will also want to monitor you closely.
Danish: Lægen vil også ønske at overvåge dig nøje.
English: No specific studies have been performed to evaluate the hepatic, renal, lung, or gastrointestinal routes of excretion/elimination for Soliris.
Danish: Der er ikke udført specifikke studier til vurdering af den hepatiske, renale, pulmonale eller gastrointestinale udskillelse for Soliris.
English: After dilution, the final concentration of the solution to be infused is 5 mg/ml.
Danish: Efter fortynding skal infusionsvæskens endelige koncentration være 5 mg/ml.
English: Baseline characteristics are shown in Table 5.
Danish: Baseline-karakteristika er vist i Tabel 5.
English: In this model, the clearance of Soliris for a typical aHUS patient weighing 70 kg was 0.0139 L/hr and the volume of distribution was 5.6 L. The elimination half-life was 297 h (approximately 12.4 days).
Danish: I denne model var clearance af Soliris hos en typisk aHUS-patient, der vejede 70 kg, 0,0139 l/time, og fordelingsvoluminet var 5,6 l. Eliminationshalveringstiden var 297 timer (ca. 12,4 dage).
English: If severe thrombotic microangiopathy complications occur after Soliris discontinuation, consider reinstitution of Soliris treatment, supportive care with PE/PI, or appropriate organ-specific supportive measures including renal support with dialysis, respiratory support with mechanical ventilation or anticoagulation.
Danish: Hvis der opstår svære komplikationer som følge af trombotisk mikroangiopati efter afbrydelse af Soliris-behandling, skal følgende overvejes: genoptagelse af Soliris-behandlingen; understøttende behandling med PE/PI; eller hensigtsmæssig organspecifik understøttende behandling, herunder understøttelse af nyrefunktionen med dialyse, respiratorisk støtte via mekanisk ventilation eller antikoagulation.
English: Figure 1: Mean changes from baseline in MG-ADL (1A) and QMG (1B) over Studies ECU-MG-301 and ECU-MG-302
Danish: Figur 1: Gennemsnitlige ændringer fra baseline i MG-ADL (1A) og QMG (1B) i studierne ECUMG-301 og ECU-MG-302
English: The clearance and volume of distribution of Soliris are weight dependent, which forms the basis for a weight categorical based dose regimen in paediatric patients (see section 4.2).
Danish: Clearance og fordelingsvolumen for Soliris er vægtafhængigt, hvilket danner grundlag for et dosisregime til pædiatriske patienter baseret på vægtkategorier (se pkt.
English: • Dilute Soliris to a final concentration of 5 mg/ml (initial concentration divided by 2) by adding the appropriate amount of diluent to the infusion bag.
Danish: • Soliris fortyndes til den endelige koncentration på 5 mg/ml (det halve af startkoncentrationen) ved tilsætning af den korrekte mængde fortyndingsvæske til infusionsposen.
English: • relatively few platelets in blood (thrombocytopenia), low level of lymphocytes a specific type of white blood cells (lymphopenia), feeling your heartbeat
Danish: • relativt få blodplader (trombocytopeni), lavt antal lymfocytter (en bestemt type hvide blodlegemer)
English: No clear treatment-related effects or adverse effects were observed in reproductive toxicology studies in mice with a surrogate terminal complement inhibitory antibody, which was utilized to assess the reproductive safety of C5 blockade.
Danish: Der blev ikke iagttaget klare behandlingsrelaterede virkninger eller uønskede virkninger i reproduktionstoksicitetsstudierne hos mus med et surrogatantistof, der hæmmer den terminale komplementaktivering, som blev anvendt til at vurdere reproduktionssikkerheden af C5-blokade.
English: The median time from current thrombotic microangiopathy manifestation to first dose of Soliris was 1 month (range <1 to 16 months).
Danish: Mediantiden fra den aktuelle manifestation af trombotisk mikroangiopati til første Soliris-dosis var 1 måned (interval <1 til 16 måneder).
English: An interim analysis of Study ECU-NMO-302 demonstrates a significant and clinically meaningful reduction in On-trial ARR (as determined by the Treating Physician) on eculizumab treatment, based on the median (min, max) change (-1.829 [-6.38, 1.63], p<0.0001) from historical ARR (24 months prior to screening in Study ECU-NMO-301).
Danish: En interimanalyse af studie ECU-NMO-302 viser en statistisk og klinisk betydningsfuld reduktion i ARR i løbet af studiet (bestemt af den behandlende læge) med eculizumab-behandling, baseret på den mediane (min; maks) ændring (-1,829 [-6,38; 1,63], p<0,0001) fra historisk ARR (24 måneder før screening i studie ECU-NMO-301).
English: PNH patients should be monitored for signs and symptoms of intravascular haemolysis, including serum lactate dehydrogenase (LDH) levels.
Danish: PNH-patienter bør monitoreres for tegn og symptomer på intravaskulær hæmolyse, herunder indholdet i serum af laktatdehydrogenase (LDH).
English: Abbreviations: ARR = adjudicated relapse rate; EDSS = Expanded Disability Status Scale; IST = immunosupressant therapy; Max = maximum; Min = minimum; NMOSD = neuromyelitis optica spectrum disorder; SD = standard deviation.
Danish: Forkortelser: ARR = adjudikeret recidivrate, EDSS = udvidet skala for handicapstatus, IST = immunsuppressiv behandling, Maks = maksimum, Min = minimum, NMOSD = neuromyelitis optica spektrumsygdom, SD = standardafvigelse.
English: 60 minutes prior to each infusion of fresh frozen plasma
Danish: 60 minutter før hver infusion af frisk frosset plasma
English: All patients enrolled in both prospective studies had an ADAMTS-13 level above 5%.
Danish: Alle patienter i de 2 prospektive studier havde et ADAMTS-13-niveau over 5 %.
English: Overall, the efficacy results for these paediatric patients appeared consistent with what was observed in patients enrolled in aHUS pivotal Studies C08-002 and C08-003 (Table 6).
Danish: Samlet set er effektresultaterne for disse pædiatriske patienter i overensstemmelse med, hvad der blev observeret hos patienter, der deltog i de pivotale aHUS-studier C08-002 og C08-003 (tabel 6).
English: Haemolytic activity during the course of the study was effectively blocked in both female and male mice.
Danish: Den hæmolytiske aktivitet blev gennem hele studiet effektivt blokeret hos både hun- og hanmus.
English: Figure 1 presents the change from baseline in both MG-ADL (A) and QMG (B) after 26 weeks of treatment in Study ECU-MG-301 and after 52 weeks of treatment in Study ECU-MG-302.
Danish: Figur 1 viser ændringen fra baseline i både MG-ADL (A) og QMG (B) efter 26 ugers behandling i studie ECU-MG-301 og efter 52 ugers behandling i studie ECU-MG-302.
English: Rash, Pruritus, Alopecia
Danish: Udslæt, pruritus, alopeci
English: • The risk of developing antibodies to eculizumab.
Danish: • risikoen for at udvikle antistoffer mod eculizumab.
English: Pack size of one vial.
Danish: Pakningsstørrelse af ét hætteglas.
English: • The importance of meningococcal vaccination prior to treatment with eculizumab and/or to receive antibiotic prophylaxis.
Danish: • vigtigheden af meningokok-vaccination forud for behandling med eculizumab og/eller at modtage profylaktisk antibiotisk behandling.
English: Eculizumab, the active ingredient in Soliris, is a terminal complement inhibitor that specifically binds to the complement protein C5 with high affinity, thereby inhibiting its cleavage to C5a and C5b and preventing the generation of the terminal complement complex C5b-9.
Danish: Eculizumab, det aktive indholdsstof i Soliris, er en terminal komplementhæmmer, der specifikt bindes til komplementproteinet C5 med høj affinitet og derved blokerer dettes spaltning til C5a og C5b, så dannelsen af det terminale komplementkompleks C5b-9 forhindres.
English: In a NMOSD placebo controlled study, 2/96 (2%) of the Soliris treated patients showed antidrug antibody response post-baseline.
Danish: I et placebokontrolleret studie af NMOSD viste 2/96 (2 %) af patienterne behandlet med Soliris et antilægemiddel-antistofrespons efter baseline.
English: Patients should be provided with information from the Package Leaflet to increase their awareness of potential serious infections and the signs and symptoms of them.
Danish: Oplysninger fra indlægssedlen bør formidles til patienterne, så de er særligt opmærksomme på muligheden for alvorlige infektioner og tegn og symptomer herpå.
English: Soliris is not expected to affect the aplastic component of anaemia in patients with PNH.
Danish: Soliris forventes ikke at påvirke den aplastiske komponent af anæmien hos patienter med PNH.
English: The proportion of clinical responders at Week 26 with no rescue therapy was 59.7% on Soliris compared with 39.7% on placebo (p=0.0229).
Danish: Andelen af personer med klinisk respons ved uge 26 uden nogen nødbehandling var 59,7 % med Soliris sammenlignet med 39,7 % med placebo (p = 0,0229).
English: Gastroesophageal reflux disease, Gingival pain
Danish: Gastroøsofageal reflukssygdom, gingivale smerter
English: No patient required new dialysis with Soliris.
Danish: Ingen patienter havde brug for ny dialyse med Soliris.
English: This medicinal product contains 115 mg sodium per vial.
Danish: Dette lægemiddel indeholder 115 mg natrium pr. hætteglas.
English: Pharmacokinetics and Drug Metabolism
Danish: Farmakokinetik og lægemiddelmetabolisering
English: FACIT-Fatigue score at baseline (median)
Danish: FACIT-træthedsscore ved baseline (median)
English: It is not necessary to protect the diluted solution of Soliris from light during administration to the patient.
Danish: Det er ikke nødvendigt at beskytte den fortyndede opløsning af Soliris mod lys under infusionen.
English: Fifteen severe thrombotic microangiopathy (TMA) complications in 12 patients were observed following treatment discontinuation, and 2 severe TMA complications occurred in an additional 2 patients that received a reduced dosing regimen of Soliris outside of the approved dosing regimen (See Section 4.2).
Danish: Der blev set femten svære komplikationer som følge af trombotisk mikroangiopati (TMA) hos 12 patienter efter behandlingsafbrydelse, og der indtrådte 2 svære komplikationer som følge af TMA hos yderligere 2 patienter, der fik et reduceret doseringsregime af Soliris, der lå uden for det godkendte doseringsregime (se pkt.
English: Use of Soliris in NMOSD treatment has been studied only in the setting of chronic administration and the effect of Soliris discontinuation has not been characterized.
Danish: Brugen af Soliris til behandling af NMOSD er kun blevet undersøgt i et regi med kronisk administration, og virkningen af en afbrydelse af Soliris er ikke blevet karakteriseret.
English: Table 13: Adjudicated On-trial Annualized Relapse Rate - Full Analysis Set Variable
Danish: Tabel 13: Adjudikeret annualiseret recidivrate i løbet af studiet - fuldstændigt analysesæt Variabel
English: If you forget an appointment, please contact your doctor immediately for advice and see section below “If you stop using Soliris”.
Danish: Hvis du har glemt at møde op for at få Soliris Hvis du har glemt at komme til en behandling, skal du straks spørge lægen til råds og læse nedenstående afsnit ”Hvis du holder op med at bruge Soliris”.
English: At least 2 weeks before you start treatment with Soliris, your doctor will administer a vaccine against meningococcal infection if it was not previously administered or if your vaccination is outdated.
Danish: Mindst 2 uger før du begynder at få Soliris, vil din læge administrere en vaccine mod meningokokinfektion, hvis du ikke tidligere er vaccineret, eller hvis din vaccination er for gammel.
English: • hives, redness of the skin, dry skin, red or purple spots under the skin, increased sweating
Danish: • nældefeber, hudrødme, tør hud, røde eller lilla pletter under huden, øget svedtendens
English: Of the 125 patients enrolled in ECU-MG-301, 117 patients subsequently were enrolled in a long-term extension study (Study ECU-MG-302), in which all receive Soliris.
Danish: Ud af de 125 patienter, der indgik i ECU-MG-301, indgik 117 patienter efterfølgende i et langtidsforlængelsesstudie (studie ECU-MG-302), hvor alle fik Soliris.
English: Anaphylactic reaction, Hypersensitivity
Danish: Anafylaktisk reaktion, overfølsomhed
English: From the 195 patients that originated in C04-001, C04-002 and other initial studies, Soliris-treated PNH patients were enrolled in a long term extension study (E05-001).
Danish: Af de 195 patienter, der kom fra C04-001, C04-002 og andre indledende studier, indgik Solirisbehandlede PNH-patienter i et langvarigt forlængelsesstudie (E05-001).
English: The primary analysis of the QMG was a Worst-Rank ANCOVA with a mean rank of 54.7 for Soliris and 70.7 for placebo, based on 125 study patients (p=0.0129).
Danish: Den primære analyse af QMG var en Worst Rank ANCOVA med en gennemsnitlig rangering på 54,7 for Soliris og 70,7 for placebo, baseret på et studie med 125 patienter (p=0,0129).
English: Your doctor will discuss the possible side effects with you and explain the risks.
Danish: Din læge vil diskutere de mulige uønskede virkninger heraf med dig og forklare risiciene.
English: What you need to know before you use Soliris
Danish: Det skal du vide, før du begynder at bruge Soliris
English: (≥1/100 to <1/10)
Danish: Almindelig (≥1/100 til <1/10)
English: • menstrual disorder
Danish: • menstruationsforstyrrelser
English: • sudden and rapid development of extremely high blood pressure, low blood pressure, hot flush, vein disorder
Danish: • pludselig og hurtig udvikling af ekstremt højt blodtryk, lavt blodtryk, hedeture, lidelser relateret til vener (blodårer)
English: When treatment was continued for more than 26 weeks, six additional patients achieved and maintained Complete TMA response due to a decrease in serum creatinine.
Danish: Når behandlingen blev fortsat ud over 26 uger, opnåede og opretholdt yderligere seks patienter et fuldstændigt TMA-respons på grund af reduktion i serum-kreatinin.
English: Antibodies to Soliris were detected in 2% of patients with PNH using an ELISA assay, 3% of patients with aHUS and 2% of patients with NMOSD using the ECL bridging format assay.
Danish: Antistoffer mod Soliris blev konstateret hos 2 % af PNH-patienterne ved en ELISA-analyse, hos 3 % af patienterne med aHUS og hos 2 % af patienterne med NMOSD ved en analyse med ECL-bridging format.
English: Physicians must discuss the benefits and risks of Soliris therapy with patients and provide them with a patient information brochure and a patient safety card (see Package Leaflet for a description).
Danish: Læger skal diskutere fordele og risici ved Soliris-behandling med patienterne og give dem en patientinformationsbrochure og et patientsikkerhedskort (se beskrivelsen i indlægssedlen).
English: Platelet count normalization TMA event-free status Complete TMA response eGFR improvement ≥ 15 mL/min/1.73m2
Danish: Normalisering af trombocyttal TMA-hændelsesfri tilstand Fuldstændig TMA-respons eGFR-forbedring ≥ 15 ml/min/1,73m2
English: Dedicated studies have not been conducted to evaluate the pharmacokinetics of Soliris in special patient populations identified by gender, race, age (geriatric), or the presence of renal or hepatic impairment.
Danish: Der er ikke udført specifikke studier vedrørende farmakokinetikken af Soliris hos særlige patientpopulationer identificeret ud fra køn, race, alder (geriatrisk) eller tilstedeværelse af nedsat nyreeller leverfunktion.
English: Patients in both prospective studies were treated with Soliris for 26 weeks and most patients enrolled into a long-term, open-label extension study.
Danish: Patienterne i de 2 prospektive studier blev behandlet med Soliris i 26 uger, og de fleste patienter fortsatte derefter i et langvarigt, ikkeblindet forlængelsesstudie.
English: Gender - Female (%) History of Aplastic Anaemia or MDS (%) Concomitant Anticoagulants (%) Concomitant Steroids/Immunosuppressant Treatments (%)
Danish: Tidligere aplastisk anæmi eller myelodysplastisk syndrom (%) Samtidig behandling med antikoagulantia (%) Samtidig behandling med steroider/immunosuppressiva (%) Behandling afbrudt
English: In patients with aHUS treated with Soliris, antibodies to Soliris were detected in 3/100 (3%) by the ECL bridging format assay.
Danish: Hos patienter med aHUS i behandling med Soliris blev der detekteret antistoffer mod Soliris hos 3/100 (3 %) i en analyse med ECL-bridging format.
English: Soliris change relative to placebo - LS Mean Difference (95%
Danish: Ændring med Soliris i forhold til placebo - LSgennemsnitlig forskel (95 % CI)
English: Patients less than 18 years of age must be vaccinated against Haemophilus influenzae and pneumococcal infections
Danish: Børn og unge Patienter under 18 år skal være vaccineret imod Haemophilus influenzae og pneumokokinfektioner.
English: At 6 months, patients treated with Soliris with no history of RBC transfusion had significantly (p<0.001) reduced LDH levels (median LDH of 305 U/L; Table 4).
Danish: Efter 6 måneder havde Soliris-behandlede patienter uden RBCtransfusion i anamnesen signifikant (p < 0,001) reducerede LDH-niveauer (median-LDH på 305 E/l; tabel 4).
English: There has been no observed correlation of antibody development to clinical response or adverse events.
Danish: Der er ikke iagttaget sammenhæng mellem antistofdannelse og klinisk respons eller bivirkninger.
English: Patients less than 18 years of age must be vaccinated against Haemophilus influenzae and pneumococcal infections, and strictly need to adhere to the national vaccination recommendations for each age group.
Danish: Patienter under 18 år skal være vaccineret mod Haemophilus influenzae og pneumokokinfektioner og skal nøje overholde de nationale vaccinationsanbefalinger for de respektive aldersgrupper.
English: • The risk of infusion reactions including anaphylaxis and advice on post-infusion monitoring.
Danish: • risikoen for reaktioner som følge af infusion, inklusive anafylaktisk shock, og rådgivning omkring post-infusion monitorering.
English: Complete TMA response was defined as haematologic normalization and a ≥25% reduction in serum creatinine sustained in ≥ 2 consecutive measurements for ≥ 4 weeks.
Danish: Komplet TMA-respons blev defineret som hæmatologisk normalisering og ≥ 25 % reduktion i serum-kreatinin i ≥ 2 på hinanden følgende målinger og opretholdt i ≥ 4 uger.
English: Abscess includes the following group of PTs: Abscess limb, Colonic abscess, Renal abscess, Subcutaneous abscess, Tooth abscess, Hepatosplenic abscess, Perirectal abscess, Rectal abscess.
Danish: a Absces omfatter den følgende gruppe af foretrukne betegnelser: Absces lemmer, kolonabsces, nyreabsces, subkutan absces, tandabsces, hepatosplenisk absces, perirektal absces, rektal absces.
English: Every week for the first four weeks, your doctor will administer an intravenous infusion of diluted
Danish: Hver uge i de første 4 uger vil lægen give dig en intravenøs infusion af fortyndet Soliris.
English: Study ECU-MG-301 (REGAIN) was a 26-week double-blind, randomized, placebo-controlled, multicenter Phase 3 study of Soliris in patients who had failed previous therapies and remain symptomatic.
Danish: Studie ECU-MG-301 (REGAIN) var et 26-ugers, dobbeltblindet, randomiseret, placebokontrolleret, fase 3-multicenterstudie af Soliris hos patienter, hvor tidligere behandlinger havde svigtet, og som fortsat var symptomatiske.
English: Stratified analyses are based on four randomization strata: (i) low EDSS at randomization (<=2.0), (ii) high EDSS (>=2.5 to <=7) and treatment naive at randomization, (iii) high EDSS (>=2.5 to <=7) and continuing on the same IST(s) since last relapse at randomization, (iv) high EDSS (>=2.5 to <=7) and changes in IST(s) since last relapse at randomization.
Danish: (i) lav EDSS ved randomisering (<=2,0), (ii) høj EDSS (>=2,5 til <=7) og behandlingsnaive ved randomisering, (iii) høj EDSS (>=2,5 til <=7) og fortsættelse med samme IST(er) siden det sidste recidiv ved randomisering, (iv) høj EDSS (>=2,5 til <=7) og ændringer i IST(er) siden sidste recidiv ved randomisering.
English: Supplemental dosing is recommended when Soliris is administered to aHUS patients receiving plasma infusion or exchange (see section 4.2).
Danish: Supplerende dosis anbefales, når Soliris administreres til aHUS-patienter, der får plasmainfusion eller plasmaudskiftning (se pkt.
English: Vaccines against serogroups A, C, Y, W 135 and B where available, are recommended in preventing the commonly pathogenic meningococcal serogroups.
Danish: Vacciner mod serogruppe A, C, Y, W 135 og B (hvis tilgængelig) anbefales til forebyggelse af de normalt patogene meningokok-serogrupper.
English: The PNH registry (M07-001) was used to evaluate the efficacy of Soliris in PNH patients with no history of RBC transfusion.
Danish: PNH-registret (M07-001) blev anvendt til at evaluere virkningen af Soliris hos PNH-patienter uden RBC-transfusion i anamnesen.