FrancophonIA/ELRC3.0 huggingface dataset:
English: Furthermore, according to the published literatures in paediatric patients with GIST, the calculated starting dose ranged from 16.6 mg/m to 36 mg/m increased to doses as high as 40.4 mg/m
Danish: Desuden var det beregnede startdosisinterval ifølge publicerede data 16,6 mg/m 2 til 36 mg/m 2 og steg til doser helt op til 40,4 mg/m 2 (måtte ikke overstige en totaldosis på 50
English: A Phase 1 dose-escalation study of oral sunitinib was conducted in 35 patients comprised of 30 paediatric patients (aged 3 years to 17 years) and 5 young adult patients (aged: 18 years to 21 years), with refractory solid tumours, the majority of whom were enrolled with a primary diagnosis of brain tumour.
Danish: Et fase 1-dosiseskaleringsstudie med oral sunitinib blev udført hos 35 patienter, herunder 30 pædiatriske patienter (i alderen 3-17 år) og 5 unge voksne patienter (i alderen 18-21 år) med refraktære solide tumorer, hvoraf de fleste blev inkluderet med en hjernetumor som primær diagnose.
English: Gastroduodenal carcinomas, an increased incidence of background haemangiosarcomas, and/or gastric mucosal hyperplasia were observed at doses of ≥ 25 mg/kg/day following 1- or 6-months duration (≥ 7.3 times the AUC in patients administered the recommended daily dose RDD).
Danish: Der er set gastroduodenale karcinomer, øget forekomst af baggrunds-hæmangiosarkomer og/eller hyperplasi af ventrikelslimhinden efter 1 eller 6 måneders behandling med doser på >25 mg/kg/dag (>7,3 gange AUC hos patienter behandlet med de anbefalede daglige doser [ADD]).
English: The most serious adverse reactions associated with sunitinib, some fatal, are renal failure, heart failure, pulmonary embolism, gastrointestinal perforation, and haemorrhages (e.g., respiratory tract, gastrointestinal, tumour, urinary tract, and brain haemorrhages).
Danish: De alvorligeste bivirkninger forbundet med sunitinib (hvoraf nogle har været letale) er nyresvigt, hjertesvigt, lungeemboli, gastrointestinal perforation og blødninger (f.eks. blødninger i luftvejene, gastrointestinale blødninger, tumorblødninger, blødninger i urinvejene og hjerneblødning).
English: Limited information is available on the continued use of sunitinib in patients with fistulae (see section 4.8).
Danish: Der er begrænset viden om fortsat sunitinibbehandling af patienter med fistler (se pkt.
English: Primary TTP (weeks) Interim 27.3 (16.0, 32.1) 6.4 (4.4, 10.0) 0.329 (0.233, 0.466) < 0.001 Final
Danish: Primært TTP (uger) Interim 27,3 (16,0-32,1) 6,4 (4,4-10,0) 0,329 (0,233-0,466) <0,001 Slut Sekundært PFS (uger) Interim 24,1 (11,1-28,3) 6,0 (4,4-9,9) 0,333 (0,238-0,467) <0,001 Slut ORR (%) Interim 6,8 (3,7-11,1)
English: QTc interval prolongation was investigated in a trial in 24 patients, ages 20-87 years, with advanced malignancies.
Danish: I et studie hos 24 patienter, i alderen 20-87 år med avanceret malign sygdom, er forlængelse af QTcintervallet undersøgt.
English: Patients who presented with cardiac events within 12 months prior to sunitinib administration, such as myocardial infarction (including severe/unstable angina), coronary/peripheral artery bypass graft, symptomatic congestive heart failure (CHF), cerebrovascular accident or transient ischaemic attack, or pulmonary embolism were excluded from all sunitinib clinical studies.
Danish: Patienter, som havde haft hjertehændelser inden for 12 måneder før sunitinib-behandling, som f.eks. myokardieinfarkt (inklusive alvorlig/ustabil angina), koronar/perifer arterie bypass operation,
English: Sutent 12.5 mg hard capsules Sutent 25 mg hard capsules Sutent 37.5 mg hard capsules Sutent 50 mg hard capsules sunitinib
Danish: Sutent 12,5 mg hårde kapsler Sutent 25 mg hårde kapsler Sutent 37,5 mg hårde kapsler Sutent 50 mg hårde kapsler sunitinib
English: Tell your doctor if you develop cough, chest pain, sudden onset of shortness of breath, or coughing up blood.
Danish: Fortæl det til lægen, hvis du får hoste, smerter i brystet, pludseligt åndedrætsbesvær eller hoster blod op.
English: You should not breast-feed during treatment with Sutent.
Danish: Du må ikke amme, når du tager Sutent.
English: Pulmonary haemorrhage* Respiratory failure*
Danish: Pulmonal blødning Respirationssvigt
English: Stomatitiso Abdominal painp
Danish: Stomatitis Abdominalsmerter Opkastning Diarré
English: m Acute myocardial infarction, myocardial infarction, and silent myocardial infarction.
Danish: Akut myokardieinfarkt, myokardieinfarkt og tavst myokardieinfarkt Orofaryngeale og faryngolaryngeale smerter
English: Cardiac failure congestive Myocardial infarctionm,* Cardiac failure* Cardiomyopathy*
Danish: Kronisk venstresidig hjerteinsufficiens Myokardieinfarkt m,*
English: • Abnormal blood tests including pancreatic and liver enzymes.
Danish: • Unormale blodprøveresultater fx for bugspytkirtel- og leverenzymer.
English: Tell your doctor if you experience altered frequency or absence of urination which may be symptoms of kidney failure.
Danish: Fortæl det til lægen, hvis dit vandladningsmønster ændrer sig eller vandladningen ophører, det kan være symptomer på nyresvigt.
English: Patients who develop thyroid dysfunction should be treated as per standard medical practice.
Danish: Thyroideadysfunktion skal behandles efter gældende medicinsk praksis.
English: Cases of overdose have been reported; some cases were associated with adverse reactions consistent with the known safety profile of sunitinib.
Danish: I nogle tilfælde var bivirkningerne i overenstemmelse med sunitinibs kendte sikkerhedsprofil.
English: Cases of pyoderma gangrenosum, generally reversible after discontinuation of sunitinib, have been reported (see also section 4.4).
Danish: Der er rapporteret tilfælde af gangrænøs pyoderma , der generelt var reversibel efter seponering af behandlingen (se også pkt.
English: You should avoid drinking grapefruit juice while on treatment with Sutent.
Danish: Sutent bør ikke tages sammen med grapefrugtjuice.
English: Hyperthyroidism was reported in no sunitinib-treated patients and 1 (1.0%) patient receiving standard of care.
Danish: Der sås ikke hypertyreose hos patienter i behandling med sunitinib, men 1 (1,0%) patient i standardbehandling fik hypertyreose.
English: Bisphosphonates are medicines used to prevent bone complications that may have been given for another medical condition.
Danish: Bisfosfonater er medicin til forebyggelse af knogleskørhed.
English: - If you have or have had blood disease, bleeding problems, or bruising.
Danish: - Hvis du har eller har haft sygdomme i blodet, blødningstendens eller tendens til blå mærker.
English: A Phase 2 open-label study was conducted in 29 patients comprised of 27 paediatric patients (aged 3 years to 16 years) and 2 young adult patients (aged 18 years to 19 years) with HGG or ependymoma.
Danish: Et ublindet fase 2-studie blev udført hos 29 patienter, herunder 27 pædiatriske patienter (i alderen 3 til 16 år) og 2 unge voksne patienter (i alderen 18 til 19 år) med gliom af høj grad eller ependymom.
English: Serious infections, with or without neutropenia, including some with a fatal outcome, have been reported.
Danish: Der er set alvorlige inf ektioner, med eller uden neutropeni, inklusive letale tilfælde.
English: - Printing ink: shellac, propylene glycol, potassium hydroxide, black iron oxide (E172).
Danish: Trykkeblæk: shellac, propylenglycol, kaliumhydroxid, sort jernoxid (E172).
English: Your doctor should do blood tests to check your liver function before and during treatment with Sutent, and as clinically indicated.
Danish: Lægen vil tage blodprøver før og under behandlingen med Sutent, og hvis det ellers er nødvendigt.
English: Fatal events other than those listed in section 4.4 above or in section 4.8 below that were considered possibly related to sunitinib included multi-system organ failure, disseminated intravascular coagulation, peritoneal haemorrhage, adrenal insufficiency, pneumothorax, shock, and sudden death.
Danish: 4.8 nedenfor og som betragtes mulig relateret til sunitinib, omfatter multiorgansvigt, dissemineret intravaskulær koagulation, peritoneal blødning, adrenal insufficiens, pneumothorax, shock og pludselig død af ukendt årsag.
English: Sunitinib treatment in rats during organogenesis resulted in developmental effects at  5 mg/kg/day consisting of increased incidence of foetal skeletal malformations, predominantly characterised as retarded ossification of thoracic/lumbar vertebrae and occurred at plasma exposure levels 5.5 times the systemic exposure in humans.
Danish: I rotter med plasmakoncentrationer 5,5 gange højere end human eksponering medfører sunitinib-behandling ved >5 mg/kg/dag under organogenesen en forøget forekomst af skeletforandringer hos fostrene, fortrinsvis forsinket ossifikation af bryst- og lændehvirvlerne.
English: Sutent can cause abnormality of your heart rhythm.
Danish: Sutent kan give forstyrrelser i hjerterytmen.
English: Uncommon: may affect up to 1 in 100 people
Danish: Ikke almindelige: forekommer hos op til 1 ud af 100 personer
English: Check with your doctor if you are not sure.
Danish: Fortæl det til din læge, hvis du ammer.
English: Interim Final
Danish: OS (uger) Interim Slut
English: In a Phase 2 study in cytokine-refractory MRCC patients, 0.9% of patients experienced treatment-related fatal myocardial infarction and in the Phase 3 study in treatment-naïve MRCC patients, 0.6% of patients on the IFN- arm and 0% of patients on the sunitinib arm experienced fatal cardiac events.
Danish: I fase 3-studiet hos behandlingsnaive mRCC-patienter oplevede 0,6% af patienterne i IFN-α-armen og 0% af patienterne i sunitinib-armen letale hjertehændelser.
English: Co-administration of sunitinib with potent CYP3A4 inducers, such as rifampicin, should be avoided (see sections 4.4 and 4.5).
Danish: Samtidig anvendelse af sunitinib og potente CYP3A4-induktorer, som f.eks. rifampin bør undgås (se pkt.
English: • Excessive reaction to an allergen including hay fever, skin rash, itchy skin, hives, swelling of body parts, and trouble breathing.
Danish: • Voldsom reaktion på allergifremkaldende stoffer, herunder høfeber, hududslæt, kløende hud,
English: Brunner's glands carcinoma occurred in the duodenum at ≥ 1 mg/kg/day in females and at 3 mg/kg/day in males, and mucous cell hyperplasia was evident in the glandular stomach at 3 mg/kg/day in males, which occurred at ≥ 0.9, 7.8, and 7.8 times the AUC in patients administered the RDD, respectively.
Danish: Brunnerkirtelkarcinom i duodenum sås ved >1 mg/kg/dag hos hunrotter, ved 3 mg/kg/dag hos hanrotter og slimhindehyperplasi var tydelig i maveslimhinden ved 3 mg/kg/dag hos hanrotter, ved henholdsvis >0,9, 7,8 og 7,8 gange AUC hos patienter behandlet med ADD. Human relevans af neoplastiske fund set i mus (rasH2 transgene) og karcinogenicitetsstudier i rotter efter behandling med sunitinib er uklar.
English: Sutent 37.5 mg hard capsules
Danish: Sutent 37,5 mg hårde kapsler
English: Hepatic dysfunction has been reported and may include Liver Function Test abnormalities, hepatitis, or liver failure (see section 4.4).
Danish: Disse kan omfatte unormale leverfunktionstest, hepatitis eller leversvigt (se pkt.
English: • Haemorrhoids, pain in the rectum, gingival bleeding, difficulty in swallowing or inability to swallow.
Danish: • Hæmorider, smerter i endetarmen, blødende tandkød, synkebesvær.
English: Cardiovascular events, including heart failure, cardiomyopathy, left ventricular ejection fraction decline to below the lower limit of normal, myocarditis, myocardial ischaemia and myocardial infarction, some of which were fatal, have been reported in patients treated with sunitinib.
Danish: Hos patienter behandlet med sunitinib er der set kardiovaskulære hændelser, inklusive hjertesvigt, kardiomyopati, fald i venstre ventrikels ejektionsfraktion til under den nedre referenceværdi, myokarditis,og myokardieiskæmi og myokardieinfarkt; disse hændelser var i nogle tilfælde letale.
English: Cases of pulmonary embolism with fatal outcome have been observed in postmarketing surveillance.
Danish: Der er set letale tilfælde af lungeemboli efter markedsaføring.
English: Treatment-naïve mRCC summary of efficacy endpoints (ITT population)
Danish: Tabel 3 - Sammenfatning af effekt-endepunkter for behandlingsnaiv mRCC (ITT-populationen) Sammenfatning af progression-fri overlevelse
English: Reversal of the effects of TMA has been observed after treatment discontinuation (see section 4.8).
Danish: Det er set, at virkningerne af TMA reverseres efter behandlingsophør (se pkt.
English: - If you have had a recent problem with blood clots in your veins and/or arteries (types of blood vessels), including stroke, heart attack, embolism, or thrombosis.
Danish: - Hvis du for nylig har haft problemer med blodpropper, inklusive slagtilfælde og hjertetilfælde.
English: Pericardial effusion Electrocardiogram QT prolonged
Danish: Hjertesvigt Kardiomyopati Perikardieeffusion Forlænget QTinterval i ekg
English: Furthermore, based on an integrated population PK analysis of pooled data from the 3 paediatric studies (2 paediatric solid tumour studies and 1 paediatric GIST study; ages: 6 years to 11 years and 12 years to 17 years), baseline body surface area (BSA) was a significant covariate on apparent clearance of sunitinib and its active metabolite.
Danish: Derudover var legemsoverfladeareal (BSA), ved baseline en signifikant kovariant på den tilsyneladende clearance af sunitinib og dets aktive metabolit, hvilket var baseret på en integreret farmakokinetisk populationsanalyse af samlede data fra 3 pædiatriske studier (2 pædiatriske studier med solide tumorer og 1 pædiatrisk GIST studie; alder: 6-11 år og 12-17 år).
English: BLISTER - 37.5 MG CAPSULES
Danish: BLISTER - 37,5 MG KAPSLER
English: Muscular weakness
Danish: Muskuloskeletale smerter
English: Skin and tissue disorders
Danish: Hud- og vævslidelser
English: Sutent 12.5 mg hard capsules
Danish: Sutent 12,5 mg hårde kapsler
English: BLISTER - 12.5 MG CAPSULES
Danish: BLISTER - 12,5 MG KAPSLER
English: - If you have or have had pancreatic or gallbladder disorders.
Danish: - Hvis du har eller har haft problemer med bugspytkirtlen eller galdeblæren.
English: Contact your doctor immediately if symptoms of infection occur around a skin injury, including fever, pain, redness, swelling, or drainage of pus or blood.
Danish: Du skal omgående kontakte din læge, hvis du får symptomer på infektion omkring en hudskade, herunder feber, smerter, rødme, hævelse eller sivning af pus eller blod.Dette forsvinder sædvanligvis, når behandlingen ophører.
English: Blood TSH increase was reported in 1 (0.9%) patient on sunitinib and no patients on standard of care.
Danish: Der sås forhøjet TSH i blodet hos 1 (0,9%) patient på sunitinib, men ikke hos patienter i standardbehandling.
English: Sutent 50 mg hard capsules
Danish: Sutent 50 mg hårde kapsler
English: z Amylase and amylase increased.
Danish: Ansigtsødem, ødem og perifert ødem Amylase og forhøjet amylase
English: Core radiology assessment was discontinued after the primary endpoint had been met. At the final analysis, the ORR as determined by the investigator's assessment was 46% (95% CI: 41%, 51%) for the sunitinib arm and 12.0% (95% CI: 9%, 16%) for the IFN-α arm (p<0.001).
Danish: Ved den afsluttende analyse var ORR 46% (95% CI: 41%-51%) i sunitinib-armen og 12% (95% CI: 9%16%) i IFN-α-armen (p<0,001), baseret på investigators vurderinger.
English: Red iron oxide (E172) Titanium dioxide (E171)
Danish: Rød jernoxid (E172) Titandioxid (E171)
English: Sutent 25 mg hard capsules
Danish: Sutent 25 mg hårde kapsler
English: It may be taken with or without food.
Danish: Administration Sutent er til oral brug, og kan tages med eller uden mad.
English: • Decreased in the amount of blood pumped by the heart.
Danish: • Hjertet pumper mindre blod rundt i kroppen.
English: If you might get pregnant, you should use a reliable method of contraception during treatment with Sutent.
Danish: Hvis du er i den fødedygtige alder, skal du bruge sikker prævention, mens du tager Sutent.
English: • Yellow skin/skin discoloration, excess pigmentation of the skin, hair colour change, rash on the palms of the hands and soles of the feet, rash, dryness of the skin.
Danish: • Gulfarvning af huden/misfarvning af huden, mørkfarvning af huden, ændring af hårfarve,
English: Blood TSH increase was reported in 12 (5.0%) patients on sunitinib and no patients on capecitabine.
Danish: Der sås forhøjet TSH i blodet hos 12 (5,0%) patienter på sunitinib, men ikke hos patienter på capecitabin.
English: OS data were not mature at the time of the study closure [20.6 months (95% CI: 20.6, NR) for the sunitinib arm compared to NR (95% CI: 15.5, NR) for the placebo arm, hazard ratio: 0.409 (95% CI: 0.187, 0.894), p-value=0.0204].
Danish: OS-data var endnu ikke tilgængelige ved studiets afslutning [20,6 måneder (95% CI 20,6; NR (ikke nået)) i sunitinib-gruppen sammenlignet med NR (95% CI 15,5; NR) i placebo-gruppen, hazard ratio:
English: If you take more Sutent than you should
Danish: Hvis du har taget for meget Sutent
English: A Phase 3, randomised, multi-centre, international study evaluating the efficacy and safety of sunitinib compared with IFN- in treatment-naïve MRCC patients was conducted.
Danish: Behandlingsnaiv metastaserende renalcellekarcinom Der er udført et fase 3 randomiseret, multicenter, international studie, der evaluerede effekt og sikkerhed af sunitinib sammenlignet med interferon IFN-α på behandlingsnaive mRCC-patienter.
English: The other ingredients are: - Capsule content: mannitol (E421), croscarmellose sodium, povidone (K-25), and magnesium stearate.
Danish: Kapselindhold: mannitol (E421), croscarmellosenatrium, povidon (K-25) og magnesiumstearat.
English: Co-administration of sunitinib with potent CYP3A4 inhibitors, such as ketoconazole, should be avoided (see sections 4.4 and 4.5).
Danish: Samtidig anvendelse af sunitinib og potente CYP3A4-hæmmere, som f.eks. ketoconazol, bør undgås (se pkt.
English: Tell your doctor if you have severe abdominal pain, fever, nausea, vomiting, blood in your stool, or changes in bowel habits.
Danish: Fortæl det til lægen, hvis du har kraftige mavesmerter, feber, kvalme, opkastning, blod i afføringen eller ændrede afføringsvaner
English: Neutropoenia Thrombocytopoenia Anaemia
Danish: Neutropeni Trombocytopeni Anæmi
English: e Cellulitis and skin infection.
Danish: Cellulitis og hudinfektion
English: BLISTER - 25 MG CAPSULES
Danish: BLISTER - 25 MG KAPSLER
English: Co-administration with medicinal products that are BCRP inhibitors In vitro, sunitinib is a substrate of the efflux transporter BCRP.
Danish: Sunitinib er et substrat for effluxtransporteren BCRP in vitro.
English: Periorbital oedema Eyelid oedema Lacrimation increased
Danish: Periorbitalt ødem Øjenlågsødem Øget tåresekretion
English: o Stomatitis and aphtous stomatitis.
Danish: Stomatitis og aftøs stomatitis p
English: Impaired wound healing Cases of impaired wound healing have been reported during sunitinib therapy.
Danish: Dårlig sårheling Der er set tilfælde af dårlig sårheling under behandling med sunitinib.
English: BLISTER - 50 MG CAPSULES
Danish: BLISTER - 50 MG KAPSLER
English: Similarly, among 57 patients in the sunitinib arm (including 28 with 1 prior systemic therapy and 29 with 2 or more prior systemic therapies) and 61 patients in the placebo arm (including 25 with 1 prior systemic therapy and 36 with 2 or more prior systemic therapies), the hazard ratio for PFS was 0.456 (95% CI: 0.264, 0.787), p=0.0036.
Danish: Ligeledes var hazard ratio for PFS 0,456 (95% CI: 0,264 - 0,787), p = 0,0036 blandt 57 sunitinib-behandlede patienter (inklusive 28 med 1 forudgående systemisk behandling og 29 med 2 forudgående systemiske behandlinger) og 61 placebo-behandlede patienter (inklusive 25 med 1 forudgående systemisk behandling og 36 med 2 forudgående systemiske behandlinger).
English: - Capsule shell: gelatin, red iron oxide (E172), and titanium dioxide (E171).
Danish: Kapselskal: gelatine, rød jernoxid (E172) og titandioxid (E171).
English: Medicinal products that may decrease sunitinib plasma concentrations Effect of CYP3A4 inducers
Danish: Lægemidler, som kan nedsætte plasmakoncentrationen af sunitinib:
English: Deep vein thrombosis Hot flush
Danish: Dyb venetrombose Hedeture
English: Tell your doctor if you develop fever, fatigue, tiredness, bruising, bleeding, swelling, confusion, vision loss, and seizures.
Danish: Fortæl det til din læge, hvis du får feber, oplever udmattethed, træthed eller forvirring, får blå mærker eller blødning, hævelser, synstab eller kramper.
English: If this is not possible, the dose of sunitinib may need to be reduced to a minimum of 37.5 mg daily for GIST and MRCC or 25 mg daily for pNET, based on careful monitoring of tolerability.
Danish: Hvis dette ikke er muligt, kan det være nødvendigt at nedsætte dosis af sunitinib til minimum 37,5 mg dagligt ved GIST og mRCC eller 25 mg dagligt ved pNET med omhyggelig monitorering af tolerabilitet.
English: Medicinal products that may increase sunitinib plasma concentrations Effect of CYP3A4 inhibitors
Danish: Lægemidler, som kan øge plasmakoncentrationen af sunitinib:
English: For GIST and MRCC, dose modifications in 12.5 mg steps may be applied based on individual safety and tolerability.
Danish: På baggrund af individuel sikkerhed og tolerabilitet kan dosis justeres med en dosisøgning på 12,5 mg ad gangen ved GIST og mRCC.
English: In rats, embryo-foetal mortality was evident as significant reductions in the number of live foetuses, increased numbers of resorptions, increased postimplantation loss, and total litter loss in 8 of 28 pregnant females at plasma exposure levels 5.5 times the systemic exposure in humans.
Danish: Der er observeret embryo-føtal mortalitet hos rotter, hvor der ved plasmakoncentrationer 5,5 gange højere end human eksponering ses signifikant fald i antal levende fostre, forøget antal resorptioner, forøget postimplantationstab og tab af hele kuldet hos 8/28 drægtige hunner.
English: Hyperthyroidism was reported in 4 (1.7%) patients on sunitinib and no patients on capecitabine.
Danish: Der sås hypertyreose hos 4 (1,7%) patienter i behandling med sunitinib, men ikke hos patienter i behandling med capecitabin.
English: None of these events in the Phase 3 studies were fatal, but rare fatal haematological events, including haemorrhage associated with thrombocytopenia and neutropenic infections, have been reported during postmarketing surveillance.
Danish: Ved overvågning efter markedsføring er der rapporteret om sjældne letale hæmatologiske tilfælde, inklusive blødning i forbindelse med trombocytopeni og neutropeniske infektioner.
English: The difference in overall survival (OS) was statistically in favour of sunitinib [hazard ratio (HR): 0.491; (95% CI: 0.290, 0.831)]; the risk of death was 2 times higher in patients in the placebo arm compared to the sunitinib arm.
Danish: Forskellen i den samlede overlevelse (OS) var statistisk til fordel for sunitinib (hazard ratio (HR): 0,491: 95% (CI: 0,290 - 0,831)).
English: • Dizziness.
Danish: • Vægttab.
English: Systemic exposures after a single dose of sunitinib were similar in subjects with mild or moderate (Child-Pugh Class A and B) hepatic impairment compared to subjects with normal hepatic function.
Danish: Hos forsøgspersoner med mildt eller moderat nedsat leverfunktion (Child-Pugh klasse A og B) er systemisk eksponering efter en enkeltdosis sunitinib den samme som hos patienter med svært nedsat leverfunktion (Child-Pugh klasse A og B).
English: • An enlargement and weakening of a blood vessel wall or a tear in a blood vessel wall
Danish: • En udvidelse og svækkelse af en blodårevæg eller en rift i en blodårevæg (aneurismer og arterielle dissektioner).
English: • Damage to the smallest blood vessels known as thrombotic microangiopathy (TMA).
Danish: • Trombotisk mikroangiopati (TMA), en sygdom hvor der er beskadigelse på de mindste blodkar.
English: Cases of renal impairment, renal failure and/or acute renal failure, in some cases with fatal outcome, have been reported (see section 4.8).
Danish: Der er set tilfælde af nedsat nyrefunktion, nyresvigt og/eller akut nyresvigt, der i nogle tilfælde var letale (se pkt.