FrancophonIA/ELRC3.0 huggingface dataset:
English: Active substances strongly inhibiting only one of the rivaroxaban elimination pathways, either CYP3A4 or P-gp, are expected to increase rivaroxaban plasma concentrations to a lesser extent.
Danish: Aktive stoffer, der er stærke hæmmere af kun én af rivaroxabans udskillelsesveje, enten CYP3A4 eller P-gp, forventes kun at øge plasmakoncentrationen af rivaroxaban i mindre udstrækning.
English: 6.8% of patients
Danish: 6,8 % af patienterne
English: common (≥ 1/100 to < 1/10) uncommon (≥ 1/1,000 to < 1/100) rare (≥ 1/10,000 to < 1/1,000) very rare ( < 1/10,000) not known (cannot be estimated from the available data)
Danish: Ikke almindelig (≥ 1/1.000 til < 1/100) Sjælden (≥ 1/10.000 til < 1/1.000) Meget sjælden (< 10.000)
English: Treatment was continued with a vitamin K antagonist dose-adjusted to maintain the PT/INR values within the therapeutic range of 2.0 to 3.0.
Danish: Behandlingen fortsattes med en vitamin-K-antagonist, der dosisjusteredes med henblik på vedligeholdelse af PT/INR-værdier i behandlingsintervallet 2,0 - 3,0.
English: • vascular retinopathy
Danish: ● vaskulær retinopati
English: - For the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation, the recommended dose is 15 mg once daily (see section 5.2).
Danish: Til forebyggelse af apopleksi og systemisk emboli hos patienter med ikke-valvulær atrieflimren er den anbefalede dosis 15 mg én gang dagligt (se pkt.
English: Children and adolescents Xarelto is not recommended for people under 18 years of age.
Danish: Xarelto anbefales ikke til børn og unge under 18 år.
English: • For patients undergoing major hip surgery, a treatment duration of 5 weeks is recommended.
Danish: • Hos patienter, der gennemgår et større hofteindgreb, anbefales en behandlingsvarighed på
English: 10 mg once daily or 20 mg once daily
Danish: 10 mg én gang dagligt eller 20 mg én gang dagligt
English: Haemodynamically unstable PE patients or patients who require thrombolysis or pulmonary embolectomy
Danish: Hæmodynamisk ustabile PE-patienter og patienter, der har behov for trombolyse eller lungeembolektomi
English: In patients with severe renal impairment (creatinine clearance < 30 ml/min) rivaroxaban plasma levels may be significantly increased (1.6 fold on average) which may lead to an increased bleeding risk.
Danish: Hos patienter med svært nedsat nyrefunktion (kreatininclearance < 30 ml/min) kan plasmakoncentrationerne af rivaroxaban være signifikant forhøjet (i gennemsnit 1,6 gange), hvilket kan medføre en øget blødningsrisiko.
English: Both the 2.5 mg twice daily and the 5 mg twice daily regimens of rivaroxaban were effective in further reducing the incidence of CV events on a background of standard antiplatelet care.
Danish: Både behandlingsprogrammerne med 2,5 mg rivaroxaban to gange dagligt og 5 mg to gange dagligt var effektive til at reducere forekomsten af CV-hændelser yderligere på baggrund af standardantitrombocytbehandling.
English: In the pivotal double-blind ATLAS ACS 2 TIMI 51 study, 15,526 patients were randomly assigned in a 1:1:1 fashion to one of three treatment groups: Xarelto 2.5 mg orally twice daily, 5 mg orally twice daily or to placebo twice daily co-administered with ASA alone or with ASA plus a thienopyridine (clopidogrel or ticlopidine).
Danish: I det pivotale dobbeltblindede ATLAS ACS 2 TIMI 51-studie blev 15.526 patienter randomiseret i forholdet 1:1:1 til en af tre behandlingsgrupper: Xarelto 2,5 mg oralt to gange dagligt, 5 mg oralt to gange dagligt eller til placebo to gange dagligt givet samtidig med ASA alene eller med ASA og en thienopyridin (clopidogrel eller ticlopidin).
English: All patients were then randomized 1:1:1 to rivaroxaban 2.5 mg twice daily/ASA 100 mg once daily, to rivaroxaban 5 mg twice daily, or ASA 100 mg once daily alone, and their matching placebos.
Danish: Alle patienter blev dernæst randomiseret i forholdet 1:1:1 til rivaroxaban 2,5 mg to gange dagligt/ASA 100 mg én gang dagligt, rivaroxaban 5 mg to gange dagligt eller ASA 100 mg én gang dagligt alene, og deres matchende placebo.
English: The frequencies of adverse reactions reported with Xarelto are summarised in Table 3 below by system organ class (in MedDRA) and by frequency.
Danish: Hyppighederne af de bivirkninger, der er indberettet for Xarelto, fremgår af tabel 3 nedenfor opdelt efter systemorganklasse (i MedDRA) og hyppighed.
English: Prevention of recurrent DVT and PE
Danish: Forebyggelse af recidiv af DVT og PE
English: Thereafter, when the recommended dose is 20 mg once daily, a reduction of the dose from 20 mg once daily to 15 mg once daily should be considered if the patient's assessed risk for bleeding outweighs the risk for recurrent DVT and PE.
Danish: Derefter, når den anbefalede dosis er 20 mg én gang dagligt, bør en dosisreduktion fra 20 mg én gang dagligt til 15 mg én gang dagligt overvejes, hvis det vurderes, at patientens risiko for blødning vejer tungere end risikoen for recidiverende PE og DVT.
English: Given the limited clinical data available with dronedarone, co-administration with rivaroxaban should be avoided.
Danish: Da der kun er begrænsede kliniske data vedrørende dronedaron, bør det ikke gives sammen med rivaroxaban.
English: 168 film-coated tablets 196 film-coated tablets 10 x 1 film-coated tablets 100 x 1 film-coated tablets 30 film-coated tablets
Danish: 168 filmovertrukne tabletter 196 filmovertrukne tabletter 10 x 1 filmovertrukne tabletter 100 x 1 filmovertrukne tabletter 30 filmovertrukne tabletter
English: 0.70 (0.51, 0.97) p = 0.033** a) modified intent to treat analysis set (intent to treat total analysis set for stent thrombosis) b) vs. placebo; Log-Rank p-value * statistically superior ** nominally significant
Danish: 0,70 (0,51; 0,97) p = 0,033** a) modificeret intent-to-treat-analysesæt (samlet intent-to-treat-analysesæt for stenttrombose) b) vs. placebo, Log-Rank p-værdi * statistisk bedre ** nominelt signifikant
English: Cardiovascular death, MI or stroke 313 (6.1%) 0.84 (0.72, 0.97) p = 0.020*
Danish: Kardiovaskulær død, MI eller apopleksi 313 (6,1 %) 0,84 (0,72; 0,97) p = 0,020*
English: Xarelto 20 mg once daily and Xarelto 10 mg once daily were compared with 100 mg acetylsalicylic acid once daily.
Danish: Xarelto 20 mg én gang dagligt og Xarelto 10 mg én gang dagligt blev sammenlignet med 100 mg acetylsalicylsyre én gang dagligt.
English: In patients converting from Xarelto to VKA, VKA should be given concurrently until the INR is ≥ 2.0.
Danish: Hos patienter, der skifter fra Xarelto til VKA, skal VKA gives sideløbende, indtil INR ≥ 2,0.
English: Dose-dependent inhibition of factor Xa activity was observed in humans.
Danish: Der er set dosisafhængig hæmning af faktor Xa-aktivitet hos mennesker.
English: - For the treatment of DVT, treatment of PE and prevention of recurrent DVT and PE, no dose adjustment from the recommended dose is necessary in patients with mild renal impairment (creatinine clearance 50 - 80 ml/min) (see section 5.2).
Danish: - Til behandling af DVT, behandling af PE og forebyggelse af recidiverende DVT og PE, kræves der ingen dosisjustering af den anbefalede dosis hos patienter med let nedsat nyrefunktion (kreatinclearance 50 - 80 ml/min) (se pkt.
English: Group 1 received rivaroxaban 15 mg once daily (10 mg once daily in patients with creatinine clearance 30 - 49 ml/min) plus P2Y12 inhibitor.
Danish: Gruppe 1 fik rivaroxaban 15 mg én gang dagligt (10 mg én gang dagligt hos patienter med kreatininclearance 30 - 49 ml/min) plus en P2Y12-hæmmer.
English: In addition to the phase III RECORD programme, a post-authorization, non-interventional, open-label cohort study (XAMOS) has been conducted in 17,413 patients undergoing major orthopaedic surgery of the hip or knee, to compare rivaroxaban with other pharmacological thromboprophylaxis (standardof-care) under real-life setting.
Danish: I tillæg til fase III-programmet RECORD er der efter godkendelsen gennemført et åbent ikkeinterventionelt kohortestudie (XAMOS) med 17.413 patienter, der fik foretaget en større ortopædkirurgisk operation af hoften eller knæene, for at sammenligne rivaroxaban med andre farmakologiske tromboprofylakse-behandlinger (standardbehandlinger) i virkelige rammer.
English: 41 months
Danish: 41 måneder
English: These active substances are strong inhibitors of both CYP3A4 and P-gp and therefore may increase rivaroxaban plasma concentrations to a clinically relevant degree (2.6 fold on average) which may lead to an increased bleeding risk (see section 4.5).
Danish: Disse aktive stoffer er stærke hæmmere af både CYP3A4 og P-gp og kan derfor øge rivaroxabans plasmakoncentrationer til et klinisk relevant niveau (i gennemsnit 2,6 gange), hvilket kan resultere i en øget blødningsrisiko (se pkt.
English: Each red film-coated tablet for week 1, 2 and 3 contains 15 mg rivaroxaban.
Danish: Hver rød filmovertrukket tablet for uge 1, 2 og 3 indeholder 15 mg rivaroxaban.
English: Patients undergoing cardioversion
Danish: Patienter, der skal kardioverteres
English: Cerebral and intracranial haemorrhage, syncope
Danish: Cerebral og intrakraniel blødning, synkope
English: The risk of bleedings may be increased in certain patient groups, e.g. those patients with uncontrolled severe arterial hypertension and/or on concomitant treatment affecting haemostasis (see section 4.4 “Haemorrhagic risk”).
Danish: Risikoen for blødning kan være øget hos visse patientgrupper, f.eks. hos patienter med ukontrolleret, svær arteriel hypertension, og/eller som samtidig får anden behandling, der påvirker hæmostasen (se pkt 4.4 ”Blødningsrisiko”).
English: For the first two days of the conversion period, standard initial dosing of VKA should be used followed by VKA dosing, as guided by INR testing.
Danish: I de første to dage af skifteperioden skal standard-initialdosis af VKA benyttes, hvorefter VKA doseres ud fra INR--målinger.
English: Take the tablet every day until your doctor tells you to stop.
Danish: Tag tabletten/erne hver dag, indtil lægen siger, at du skal holde op med at tage dem.
English: How do I take Xarelto?
Danish: Hvordan skal jeg tage Xarelto?
English: Safety and efficacy of Xarelto 2.5 mg twice daily in combination with ASA plus clopidogrel/ticlopidine has only been studied in patients with recent ACS (see section 4.1).
Danish: Xareltos sikkerhed og virkning ved 2,5 mg to gange dagligt i kombination med ASA plus clopidogrel/ticlopidin er kun blevet undersøgt hos patienter med nyligt AKS (se pkt.
English: CYP3A4 and P-gp inhibitors
Danish: CYP3A4- og P-gp-hæmmere
English: Treatment and prevention of recurrent DVT and PE
Danish: Behandling og forebyggelse af recidiv af DVT og PE
English: After combined administration of enoxaparin (40 mg single dose) with rivaroxaban (10 mg single dose) an additive effect on anti-factor Xa activity was observed without any additional effects on clotting tests (PT, aPTT).
Danish: Efter kombineret indtagelse af enoxaparin (enkeltdosis på 40 mg) og rivaroxaban (enkeltdosis på 10 mg) blev der observeret en additiv indvirkning på anti-faktor Xa-aktiviteten uden yderligere indvirkning på koagulationsparametrene (PT, aPTT).
English: The 4-week treatment initiation pack of Xarelto is dedicated to patients who will transition from 15 mg twice daily to 20 mg once daily from Day 22 onwards (see section 6.5).
Danish: Den 4-ugers Xarelto-startpakning er til patienter, der skifter fra 15 mg to gange dagligt til 20 mg én gang dagligt fra dag 22 og frem (se pkt.
English: In Einstein Choice, 3,396 patients with confirmed symptomatic DVT and/or PE who completed 6-12 months of anticoagulant treatment were studied for the prevention of fatal PE or non-fatal symptomatic recurrent DVT or PE.
Danish: I Einstein Choice blev 3.396 patienter med bekræftet symptomatisk DVT og/eller PE, som havde gennemførte 6-12 måneders behandling med antikoagulantia, undersøgt for forebyggelse af dødelig PE eller ikke-dødelig symptomatisk recidiverende DVT eller PE.
English: • CAD/PAD Patients taking Xarelto 2.5 mg twice daily should also take a daily dose of 75 - 100 mg ASA.
Danish: • Koronararteriesygdom (CAD) /perifer arteriesygdom (PAD) Patienter, der tager Xarelto 2,5 mg to gange dagligt, bør også tage en daglig dosis af 75 - 100 mg ASA.
English: 8,281 patients with an acute symptomatic DVT or PE
Danish: 8,281 patienter med akut symtomatisk DVT eller PE
English: The phase III COMPASS study (27,395 patients, 78.0% male, 22.0% female) demonstrated the efficacy and safety of Xarelto for the prevention of a composite of CV death, MI, stroke in patients with CAD or symptomatic PAD at high risk of ischaemic events.
Danish: Koronararteriesygdom (CAD) /perifer arteriesygdom (PAD) Fase III COMPASS-studiet (27.395 patienter, 78,0 % mænd, 22,0 % kvinder) påviste Xareltos virkning og sikkerhed til at forebygge sammensatte tilfælde af CV-død, MI, apopleksi hos patienter med koronararteriesygdom (CAD) eller symptomatisk perifer arteriesygdom (PAD) med høj risiko for iskæmiske hændelser.
English: Treatment with Xarelto after an acute coronary syndrome should be started as soon as possible after stabilisation of the acute coronary syndrome, at the earliest 24 hours after admission to hospital and at the time when parenteral (via injection) anticoagulation therapy would normally be stopped.
Danish: Behandlingen med Xarelto efter et akut koronarsyndrom skal starte så hurtigt som muligt efter stabilisering af det akutte koronarsyndrom, tidligst 24 timer efter indlæggelse på hospitalet og på det tidspunkt, hvor parenteral (via injektion) antikoagulationsbehandling normalt ville blive stoppet.
English: Microcrystalline cellulose Croscarmellose sodium Lactose monohydrate Hypromellose 2910
Danish: Mikrokrystallinsk cellulose Natriumcroscarmellose Lactosemonohydrat Hypromellose 2910
English: The recommended dose is one 2.5 mg tablet twice a day.
Danish: Den anbefalede dosis er én 2,5 mg tablet to gange dagligt.
English: Platelet aggregation inhibitors should be discontinued as suggested by the manufacturer's prescribing information.
Danish: Trombocytfunktionshæmmere skal seponeres som foreslået i fabrikantens produktresumé.
English: 2,531 patients undergoing total knee replacement surgery
Danish: 2.531 patienter, der fik foretaget knæledsalloplastik
English: Prevention of VTE in adult patients undergoing elective hip or knee replacement surgery The recommended dose is 10 mg rivaroxaban taken orally once daily.
Danish: Forebyggelse af VTE hos voksne patienter, der gennemgår planlagt hofteleds- eller knæledsalloplastik Den anbefalede dosis er 10 mg rivaroxaban indtaget oral én gang dagligt.
English: Day 1 - 21: 30 mg Day 22 and onwards: 20 mg
Danish: Dag 1 - 21: 30 mg Fra og med dag 22: 20 mg
English: Elderly patients exhibited higher plasma concentrations than younger patients, with mean AUC values being approximately 1.5 fold higher, mainly due to reduced (apparent) total and renal clearance.
Danish: Ældre patienter havde højere plasmakoncentrationer end yngre patienter, idet deres gennemsnitlige AUC-værdier var cirka 1,5 gange højere.
English: You have been given Xarelto because - you have been diagnosed with an acute coronary syndrome (a group of conditions that includes heart attack and unstable angina, a severe type of chest pain) and have been shown to have had an increase in certain cardiac blood tests.
Danish: Du får Xarelto, da - du har fået stillet diagnosen akut koronarsyndrom (en samlet betegnelse for akut opstået hjertesygdom som hjerteanfald og ustabil angina pectoris, som giver alvorlige smerter i brystet), og da du har en unomal stigning i visse blodprøveresultater med relevans for hjertet.
English: Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack.
Danish: Forebyggelse af apopleksi og systemisk emboli hos voksne patienter med ikke-valvulær atrieflimren med én eller flere risikofaktorer som f.eks. kongestiv hjerteinsufficiens, hypertension, alder ≥ 75 år, diabetes mellitus, tidligere apopleksi eller transitorisk cerebral iskæmi (TCI/TIA).
English: C: observed as uncommon in prevention of atherothrombotic events in patients after an ACS (following percutaneous coronary intervention) * A pre-specified selective approach to adverse event collection was applied.
Danish: C Iagttaget som ikke almindelig ved forebyggelse af aterotrombotiske hændelser efter akut koronarsyndrom (efter perkutan koronarintervention) * Der blev benyttet en præspecificeret selektiv metode for indsamlingen af bivirkninger.
English: HDPE bottles with a PP screw cap containing 100 film-coated tablets.
Danish: HDPE-beholdere med et PP-skruelåg, der indeholder 100 filmovertrukne tabletter.
English: The crushed tablet should be administered in a small amount of water via a gastric tube after which it should be flushed with water (see section 5.2).
Danish: Den knuste tablet bør administreres i en smule vand via en mavesonde, hvorefter sonden skylles med vand (se pkt.
English: Patients taking Xarelto 2.5 mg twice daily should also take a daily dose of 75 - 100 mg ASA or a daily dose of 75 - 100 mg ASA in addition to either a daily dose of 75 mg clopidogrel or a standard daily dose of ticlopidine.
Danish: Patienter, der tager Xarelto 2,5 mg to gange dagligt, bør også tage en daglig dosis på 75 - 100 mg ASA eller en daglig dosis af 75 - 100 mg ASA i tillæg til enten en daglig dosis på 75 mg clopidogrel eller en daglig standarddosis af ticlopidin.
English: Converting patients from the vitamin K antagonist warfarin (INR 2.0 to 3.0) to rivaroxaban (20 mg) or from rivaroxaban (20 mg) to warfarin (INR 2.0 to 3.0) increased prothrombin time/INR (Neoplastin) more than additively (individual INR values up to 12 may be observed), whereas effects on aPTT, inhibition of factor Xa activity and endogenous thrombin potential were additive.
Danish: Skift af patienter fra vitamin K-antagonisten warfarin (INR 2,0-3,0) til rivaroxaban (20 mg) eller fra rivaroxaban (20 mg) til warfarin (INR 2,0-3,0) øgede protrombintiden/INR (Neoplastin) mere end additivt (der kan forekomme individuelle INR-værdier på op til 12), hvorimod virkningerne på aPTT, hæmning af faktor Xa-aktiviteten og endogent trombinpotentiale var additive.
English: Do not stop taking Xarelto without talking to your doctor first, because Xarelto treats and prevents serious conditions.
Danish: Du må ikke holde op med at tage Xarelto uden først at have talt med din læge, da Xarelto behandler og forebygger alvorlige tilstande.
English: Hepatic impairment, Increased bilirubin, increased blood alkaline phosphataseA, increased GGTA
Danish: Nedsat leverfunktion, forhøjet bilirubin, forhøjet basisk serumfosfataseA, forhøjet GGTA
English: Patients with high risk triple positive antiphospholipid syndrome In an investigator sponsored, randomized open-label multicenter study with blinded endpoint adjudication, rivaroxaban was compared to warfarin in patients with a history of thrombosis, diagnosed with antiphospholipid syndrome and at high risk for thromboembolic events (positive for all 3 antiphospholipid tests: lupus anticoagulant, anticardiolipin antibodies, and anti-beta 2-glycoprotein I antibodies).
Danish: Højrisikopatienter med tredobbelt positiv antifosfolipidsyndrom I et åbent, investigator-sponseret, randomiseret multicenterstudie med blindet bedømmelse af endepunkter blev rivaroxaban sammenlignet med warfarin hos patienter med tidligere trombose, der var diagnosticerede med antifosfolipidsyndrom, og som havde høj risiko for tromboemboliske hændelser (positive for alle 3 antifosfolipidtest: lupus antikoagulans, antikardiolipin-antistoffer og anti-beta 2-glykoprotein I-antistoffer).
English: - Bleeding into the surgical site requiring reoperation (nonfatal, not in critical organ)
Danish: - Blødning ind i operationsstedet, som kræver gentagen operation (ikke-dødelig, ikke i kritisk organ)
English: Rivaroxaban 10 mg once daily (od) started no sooner than 6 hours post-operatively was compared with enoxaparin 40 mg once daily started 12 hours pre-operatively.
Danish: Der blev foretaget en sammenligning mellem indtagelse af 10 mg rivaroxaban én gang dagligt tidligst 6 timer efter operationen og 40 mg enoxaparin givet én gang dagligt, startende 12 timer før operationen.
English: The activated partial thromboplastin time (aPTT) and HepTest are also prolonged dose-dependently; however, they are not recommended to assess the pharmacodynamic effect of rivaroxaban.
Danish: Den aktiverede partielle tromboplastintid (aPTT) og Heptest forlænges også i forhold til dosis, men de anbefales ikke til vurdering af rivaroxabans farmakodynamiske effekt.
English: Prevention of VTE in adult patients undergoing elective hip or knee replacement surgery The rivaroxaban clinical programme was designed to demonstrate the efficacy of rivaroxaban for the prevention of VTE, i.e. proximal and distal deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients undergoing major orthopaedic surgery of the lower limbs.
Danish: Forebyggelse af VTE hos voksne patienter, der gennemgår planlagt hofteleds- eller knæledsalloplastik Det kliniske program for rivaroxaban har til formål at påvise rivaroxabans effekt på forebyggelsen af venøs tromboemboli (VTE), dvs. proksimal og distal dyb venetrombose (DVT) og lungeemboli (PE) hos patienter, der gennemgår større ortopædkirurgiske indgreb i underekstremiteterne.
English: FeverA, peripheral oedema, decreased general strength and energy (incl.
Danish: FeberA, perifert ødem, nedsat generel styrke og energi (herunder træthed og asteni)
English: Plasma protein binding in humans is high at approximately 92% to 95%, with serum albumin being the main binding component.
Danish: Plasmaproteinbindingen hos mennesker er høj og ligger omkring 92 - 95 %.
English: The incidence rates for the primary safety outcome (major or clinically relevant non-major bleeding events) as well as the secondary safety outcome (major bleeding events) were similar for both treatment groups.
Danish: Frekvenserne for det primære sikkerhedsendepunkt (større eller klinisk relevante mindre blødninger) samt det sekundære sikkerhedsendepunkt (større blødninger) var ens for de to behandlingsgrupper.
English: As with other anticoagulants the possibility may exist that patients are at increased risk of bleeding in case of concomitant use with SSRIs or SNRIs due to their reported effect on platelets.
Danish: Som ved andre antikoagulantia kan der være risiko for, at patienter har øget blødningsrisiko ved samtidig brug af SSRI- og SNRI-præparater på grund af den rapporterede virkning på trombocytter for disse lægemidler.
English: The incidence rates for the principal safety outcome (major and non-major clinically relevant bleeding events) were similar for both treatment groups (see Table 5).
Danish: Frekvenserne af det primære sikkerhedsendepunkt (større og mindre klinisk relevante blødninger) var ens for de to behandlingsgrupper (se tabel 5).
English: When neuraxial anaesthesia (spinal/epidural anaesthesia) or spinal/epidural puncture is employed, patients treated with antithrombotic agents for prevention of thromboembolic complications are at risk of developing an epidural or spinal haematoma which can result in long-term or permanent paralysis.
Danish: I forbindelse med neuraksial anæstesi (spinal/epiduralanæstesi) eller spinal/epiduralpunktur, har patienter, som får antitrombotika til forebyggelse af tromboemboliske komplikationer, risiko for at udvikle epiduralt eller spinalt hæmatom, hvilket kan føre til langvarig eller permanent paralyse.
English: Critical organ bleeding*
Danish: Kritisk organblødning* 91
English: Not known (frequency cannot be estimated from the available data) - kidney failure after a severe bleeding - increased pressure within muscles of the legs or arms after a bleeding, which leads to pain, swelling, altered sensation, numbness or paralysis (compartment syndrome after a bleeding)
Danish: Ikke kendt (kan ikke estimeres ud fra forhåndenværende data) nyresvigt efter en alvorlig blødning øget tryk i muskler i ben eller arme efter en blødning, hvilket kan medføre smerter, hævelse, ændret følelse, følelsesløshed eller lammelse (kompartmentsyndrom efter en blødning)