natgillin/translations-raw huggingface dataset:
Hos patienter med hoftefrakturer ses følgende steady state - plasmakoncentrationer, hvilket er forbundet med højere alder:
In hip fracture patients, associated with their increased age, fondaparinux steady state plasma concentrations are:
Fordeling Fondaparinux fordelingsvolumen er begrænset (7- 11 liter).
Distribution The distribution volume of fondaparinux is limited (7-11 litres).
Fondaparinux bindes ikke væsentligt til andre
In vitro, fondaparinux is highly and specifically bound to antithrombin protein with a dose-dependant plasma concentration binding (98.6% to 97.0% in the concentration range from 0.5 to 2 mg/ l).
8 plasmaproteiner, herunder platelet factor 4 (PF4).
Fondaparinux does not bind significantly to other plasma proteins, including platelet factor 4 (PF4).
Metabolisme Selvom en fuldstændig evaluering ikke foreligger, er der ikke fundet tegn på metabolisme af fondaparinux eller dannelse af aktive metabolitter.
Metabolism Although not fully evaluated, there is no evidence of fondaparinux metabolism and in particular no evidence for the formation of active metabolites.
Fondaparinux hæmmer ikke CYP450- enzymer (CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1 og CYP3A4) in vitro.
Fondaparinux does not inhibit CYP450s (CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1 or CYP3A4) in vitro.
Derfor forventes det ikke, at fondaparinux vil interagere med andre lægemidler in vivo gennem hæmning af CYP- medieret metabolisme.
Thus, fondaparinux is not expected to interact with other medicinal products in vivo by inhibition of CYP-mediated metabolism.
21 timer hos raske ældre forsøgspersoner.
Excretion/ Elimination The elimination half-life (t½) is about 17 hours in healthy young subjects and about 21 hours in healthy elderly subjects.
64- 77% af fondaparinux udskilles uændret via nyrerne.
Fondaparinux is excreted to 64 – 77% by the kidney as unchanged compound.
Særlige befolkningsgrupper
8 Special populations
Hos patienter over 75 år, der gennemgik ortopædisk operation, blev plasmaclearance vurderet til 1, 2 til 1, 4 gange lavere end hos patienter under 65 år.
In patients > 75 years undergoing orthopaedic surgery, the estimated plasma clearance was 1.2 to 1.4 times lower than in patients < 65 years.
Nedsat nyrefunktion - Sammenlignet med patienter med normal nyrefunktion (kreatininclearance > 80 ml/ min) er plasmaclearance 1, 2 til 1, 4 gange lavere hos patienter med let nedsat nyrefunktion (kreatininclearance 50- 80 ml/ min) og gennemsnitligt 2 gange lavere hos patienter med moderat nedsat nyrefunktion (kreatininclearance 30- 50 ml/ min).
Renal impairment - Compared with patients with normal renal function (creatinine clearance > 80 ml/ min), plasma clearance is 1.2 to 1.4 times lower in patients with mild renal impairment (creatinine clearance 50 to 80 ml/ min) and on average 2 times lower in patients with moderate renal impairment (creatinine clearance 30 to 50 ml/ min).
5 gange lavere end ved normal nyrefunktion.
In severe renal impairment (creatinine clearance < 30 ml/ min), plasma clearance is approximately 5 times lower than in normal renal function.
Legemsvægt - Plasmaclearance af fondaparinux stiger i takt med legemsvægten (9% for hver 10 kg).
Body weight - Plasma clearance of fondaparinux increases with body weight (9% increase per 10 kg).
Nedsat leverfunktion – Efter subkutan injektion af en enkel dosis fondaparinux til patienter med moderat nedsat leverfunktion (Child- Pugh kategori B) var total (bundet og ubundet) Cmax og AUC reduceret med henholdsvis 22% og 39% sammenlignet med patienter med normal leverfunktion.
Hepatic impairment - Following a single, subcutaneous dose of fondaparinux in subjects with moderate hepatic impairment (Child-Pugh Category B), total (i. e., bound and unbound) Cmax and AUC were decreased by 22% and 39%, respectively, as compared to subjects with normal liver function.
Som følge heraf, forventes koncentrationen af ubundet fondaparinux at forblive uændret hos patienter med mildt til moderat nedsat leverfunktion og dosisjustering er derfor ikke nødvendig (baseret på farmakokinetikken).
Consequently, unbound concentrations of fondaparinux are expected to be unchanged in patients with mild to moderate hepatic impairment, and therefore, no dose adjustment is necessary based on pharmacokinetics.
4. 2 og 4. 4).
The pharmacokinetics of fondaparinux has not been studied in patients with severe hepatic impairment (see sections 4.2 and 4.4).
9 5. 3 Prækliniske sikkerhedsdata
5.3 Preclinical safety data
Natriumchlorid Vand til injektionsvæsker Saltsyre Natriumhydroxid
Sodium chloride Water for injections Hydrochloric acid Sodium hydroxide
6. 2 Uforligeligheder
9 6.2 Incompatibilities
Type I- glascylinder (1 ml), hvorpå er monteret en kanyle 27 gauge og længde 12, 7 mm tilproppet med en bromobutyl eller chlorobutyl elastomerprop.
Type I glass barrel (1 ml) affixed with a 27 gauge x 12.7 mm needle and stoppered with a bromobutyl or chlorobutyl elastomer plunger stopper.
Der findes to typer injektionssprøjter: • Injektionsspøjte med et gult stempel og et automatisk sikkerhedssystem • Injektionssprøjte med et gult stempel og et manuelt sikkerhedssystem
There are two types of syringes: • syringe with a yellow plunger and an automatic safety system • syringe with yellow plunger and a manual safety system.
Første MT:
Date of first authorisation:
21. marts 2002 Fornyelse af MT:
21 March 2002
Yderligere information om dette lægemiddel er tilgængelig på Det europæiske Lægemiddelagenturs (EMEAs) hjemmeside http: // www. emea. europa. eu /
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
Arixtra 2, 5 mg/ 0, 5 ml injektionsvæske, opløsning, fyldt injektionssprøjte.
Arixtra 2.5 mg/ 0.5 ml solution for injection, pre-filled syringe.
Hver fyldt injektionssprøjte (0, 5 ml) indeholder 2, 5 mg fondaparinuxnatrium.
Each pre-filled syringe (0.5 ml) contains 2.5 mg of fondaparinux sodium.
Indeholder under 1 mmol natrium (23 mg) pr. dosis og er derfor for praktiske formål natriumfri.
Contains less than 1 mmol of sodium (23 mg) per dose, and therefore is essentially sodium free.
5. 1).
Prevention of Venous Thromboembolic Events (VTE) in patients undergoing abdominal surgery who are judged to be at high risk of thromboembolic complications, such as patients undergoing abdominal cancer surgery (see section 5.1).
4. 4 og 5. 1).
Treatment of unstable angina or non-ST segment elevation myocardial infarction (UA/ NSTEMI) in patients for whom urgent (< 120 mins) invasive management (PCI) is not indicated (see sections 4.4 and 5.1).
12 tromboemboliske komplikationer 9 dage efter operationen.
Experience shows that in patients undergoing hip fracture surgery, the risk of VTE continues beyond 9 days after surgery.
Medicinske patienter med høj risiko for tromboemboliske komplikationer ud fra en individuel risikovurdering Den anbefalede dosis fondaparinux er 2, 5 mg én gang daglig, der indgives som subkutan injektion.
12 Medical patients who are at high risk for thromboembolic complications based on an individual risk assessment The recommended dose of fondaparinux is 2.5 mg once daily administered by subcutaneous injection.
Behandling af ustabil angina/ non- ST segment elevations myokardieinfarkt (UA/ NSTEMI) Den anbefalede fondaparinuxdosis er 2, 5 mg daglig, administreret som subkutan injektion.
Treatment of unstable angina/ non- ST segment elevation myocardial infarction (UA/ NSTEMI) The recommended dose of fondaparinux is 2.5 mg once daily, administered by subcutaneous injection.
4. 4).
If a patient is to undergo percutaneous coronary intervention (PCI), unfractionated heparin (UFH) as per local practice should be administered during PCI, taking into account the patient’ s potential risk of bleeding, including the time since the last dose of fondaparinux (see section 4.4).
I det tilgrundlæggende UA/ NSTEMI- studie blev fondaparinuxbehandlingen ikke genoptaget før tidligst 2 timer efter fjernelsen af sheath.
In the pivotal UA/ NSTEMI clinical trial, treatment with fondaparinux was restarted no earlier than 2 hours after sheath removal.
Behandling af ST segment elevations myokardieinfarkt (STEMI) Den anbefalede fondaparinuxdosis er 2, 5 mg daglig.
Treatment of ST segment elevation myocardial infarction (STEMI) The recommended dose of fondaparinux is 2.5 mg once daily.
4. 4).
If a patient is to undergo non-primary PCI, unfractionated heparin (UFH) as per local practice should be administered during PCI, taking into account the patient’ s potential risk of bleeding, including the time since the last dose of fondaparinux (see section 4.4).
I det tilgrundlæggende STEMI- studie blev fondaparinuxbehandlingen ikke genoptaget før tidligst 3 timer efter fjernelsen af sheath.
In the pivotal STEMI clinical trial, treatment with fondaparinux was restarted no earlier than 3 hours after sheath removal.
For STEMI - eller UA/ NSTEMI- patienter, som skal have foretaget koronararteriebypass- operation (CABG- operation), bør fondaparinux om muligt ikke gives i de 24 timer umiddelbart før operationen, og det kan genoptages 48 timer efter operationen.
In STEMI or UA/ NSTEMI patients who are to undergo coronary artery bypass graft (CABG) surgery, fondaparinux where possible, should not be given during the 24 hours before surgery and may be restarted 48 hours post-operatively.
Forebyggelse af VTE efter operation Hos patienter, der gennemgår en operation, skal tidspunktet for første injektion af fondaparinux overholdes nøje hos de af patienterne der er ≥75 år og/ eller har en legemsvægt < 50 kg og/ eller med nedsat nyrefunktion med kreatininclearance i intervallet 20- 50 ml/ min.
Prevention of VTE following Surgery In patients undergoing surgery, timing of the first fondaparinux injection requires strict adherence in patients ≥ 75 years, and/ or with body weight < 50 kg and/ or with renal impairment with creatinine clearance ranging between 20 to 50 ml/ min.
(se pkt.
Renal impairment • Prophylaxis of VTE - Fondaparinux should not be used in patients with creatinine clearance < 20 ml/ min (see section 4.3).
4. 3).
• Treatment of UA/ NSTEMI and STEMI - fondaparinux should not be used in patients with creatinine clearance < 20 ml/ min (see section 4.3).
Dosisreduktion er ikke påkrævet for patienter med en kreatininclearance > 20 ml/ min.
No dosage reduction is required for patients with creatinine clearance > 20 ml/ min.
13 Nedsat leverfunktion - Dosisjustering er ikke nødvendig for patienter med enten mildt eller moderat nedsat leverfunktion.
13 Hepatic impairment - No dosing adjustment is necessary in patients with either mild or moderate hepatic impairment.
Indgivelsesmåde • Subkutan administration Fondaparinux gives som dyb subkutan injektion, mens patienten ligger ned.
Method of administration • Subcutaneous administration Fondaparinux is administered by deep subcutaneous injection while the patient is lying down.
Hele nålens længde bør indføres vinkelret i hudfolden der holdes mellem tommel - og pegefinger; hudfolden bør holdes under hele injektionen.
The whole length of the needle should be inserted perpendicularly into a skin fold held between the thumb and the forefinger; the skin fold should be held throughout the injection.
Intravenøs administration (første dosis for patienter, der kun har STEMI) Intravenøs administration skal gives direkte i en eksisterende intravenøs adgang eller ved anvendelse af en lille (25 eller 50 ml) minipose med 0, 9% saltopløsning.
• Intravenous administration (first dose in patients with STEMI only) Intravenous administration should be through an existing intravenous line either directly or using a small volume (25 or 50ml) 0.9% saline minibag.
Ved brug af miniposer skal infusionen gives over 1- 2 minutter.
If administered via a minibag, the infusion should be given over 1 to 2 minutes.
- alvorlig nedsat nyrefunktion defineret ved en kreatininclearance < 20ml/ min.
- severe renal impairment defined by creatinine clearance < 20 ml/ min.
For at undgå VTE bør præparater, der kan øge blødningsrisikoen, ikke anvendes sammen med fondaparinux.
For prevention of VTE, agents that may enhance the risk of haemorrhage should not be administered concomitantly with fondaparinux.
4. 5.
When required, concomitant therapy with vitamin K antagonist should be administered in accordance with the information of section 4.5.
GP- IIb/ IIIa - hæmmere eller fibrinolytika).
For treatment of UA/ NSTEMI and STEMI, fondaparinux should be used with caution in patients who are being treated concomitantly with other agents that increase the risk of haemorrhage (such as GPIIb/ IIIa inhibitors or thrombolytics).
PCI og risiko for ledekateter- trombose STEMI- patienter, som gennemgår primær PCI, bør ikke behandles med fondaparinux før og under
14 PCI and risk of guiding catheter thrombus In STEMI patients undergoing primary PCI, the use of fondaparinux prior to and during PCI is not recommended.
Tilsvarende bør UA/ NSTEMI- patienter med livstruende lidelser, der kræver akut revaskularisering, ikke behandles med fondaparinux hverken før eller under PCI- proceduren.
Similarly, in UA/ NSTEMI patients with life threatening conditions that require urgent revascularisation, the use of fondaparinux prior to and during PCI is not recommended.
Det drejer sig om patienter med behandlingsrefraktær eller tilbagevendende angina og ledsagende dynamiske ST- forandringer, hjerteinsufficiens, livstruende arytmi eller hæmodynamisk ustabilitet.
These are patients with refractory or recurrent angina associated with dynamic ST deviation, heart failure, life- threatening arrhythmias or haemodynamic instability.
4. 2).
In UA/ NSTEMI and STEMI patients undergoing non-primary PCI, the use of fondaparinux as the sole anticoagulant during PCI is not recommended, therefore UFH should be used according to local practice (see section 4.2).
Der er begrænsede data vedrørende brugen af UFH under ikke- primær PCI til patienter, som også er i behandling med fondaparinux (se pkt.
There are limited data on the use of UFH during non-primary PCI in patients treated with fondaparinux (see section 5.1).
Hos patienter, som fik foretaget ikke- primær PCI 6- 24 timer efter sidste fondaparinuxdosis, var den mediane UFH- dosis 8. 000 IE, og incidensen af svær blødning var 2% (2/ 98).
In those patients who underwent non-primary PCI 6-24 hours after the last dose of fondaparinux, the median dose of UFH was 8,000 IU and the incidence of major bleeding was 2% (2/ 98).
Hos patienter, som fik foretaget en ikke- primær PCI mindre end 6 timer efter sidste fondaparinuxdosis, var den mediane UFH- dosis 5. 000 IE, og incidensen af svær blødning var 4, 1% (2/ 49).
In those patients who underwent non-primary PCI < 6 hours after the last dose of fondaparinux, the median dose of UFH was 5,000 IU and the incidence of major bleeding was 4.1% (2/ 49).
Sammenlignet med en kontrolgruppe har kliniske undersøgelser vist en lav, men forøget risiko for ledekateter- trombose hos patienter, der gennemgår PCI og behandles med fondaparinux som antikoagulans.
Clinical trials have shown a low but increased risk of guiding catheter thrombus in patients treated with fondaparinux for anticoagulation during PCI compared to control.
Incidensen i forbindelse med ikke- primær PCI var for UA/ NSTEMI 1% versus 0, 3% (fondaparinux versus enoxaparin), og ved primær PCI hos STEMI- patienter var incidensen 1, 2% versus 0% (fondaparinux versus kontrolgruppe).
Incidences in non-primary PCI in UA/ NSTEMI were 1.0% vs 0.3% (fondaparinux vs. enoxaparin) and in primary PCI in STEMI were 1.2% vs 0% (fondaparinux vs. control).
Spinal - / epiduralanæstesi Ved større ortopædiske operationer er det ikke muligt ved samtidig brug af fondaparinux og spinal - / epiduralanæstesi eller spinalpunktur at udelukke forekomsten af epidurale eller spinale hæmatomer, som kan føre til langvarig eller permanent paralyse.
Spinal / Epidural anaesthesia In patients undergoing major orthopaedic surgery, epidural or spinal haematomas that may result in long-term or permanent paralysis cannot be excluded with the concurrent use of fondaparinux and spinal/ epidural anaesthesia or spinal puncture.
4. 2, 4. 3 og 5. 2).
• Prophylaxis of VTE - Patients with creatinine clearance < 50 ml/ min are at increased risk of bleeding and VTE and should be treated with caution (see sections 4.2, 4.3 and 5.2).
• Behandling af UA/ NSTEMI og STEMI - Der findes kun en begrænset mængde kliniske data vedrørende behandling af UA/ NSTEMI og STEMI med 2, 5 mg fondaparinux daglig til patienter med kreatininclearance mellem 20 og 30 ml/ min.
• Treatment of UA/ NSTEMI and STEMI - For the treatment of UA/ NSTEMI and STEMI, there are limited clinical data available on the use of fondaparinux 2.5mg once daily in patients with creatinine clearance between 20 and 30 ml/ min.
4. 3).
Therefore the physician should determine if the benefit of treatment outweighs the risk (see sections 4.2 and 4.3).
15 Patienter med heparin- induceret trombocytopeni Fondaparinux bør anvendes med forsigtighed til patienter med HIT i anamnesen.
15 Patients with Heparin Induced Thrombocytopenia Fondaparinux should be used with caution in patients with a history of HIT.
De udførte dyreforsøg er utilstrækkelige med hensyn til virkningerne for graviditetens og/ eller embryoets/ fostrets udvikling, fødslen og den postnatale udvikling på grund af begrænset eksponering.
Animal studies are insufficient with respect to effects on pregnancy, embryo/ foetal development, parturition and postnatal development because of limited exposure.
Sikkerheden ved administration af fondaparinux 2, 5 mg er evalueret i:
The safety of fondaparinux 2.5 mg has been evaluated in:
- 3595 patienter, der fik foretaget en større ortopædisk operation i underekstremiteterne og blev
- 3,595 patients undergoing major orthopaedic surgery of the lower limbs treated up to 9 days
- 327 patienter, der blev opereret for hoftefraktur og blev behandlet i 3 uger efter indgrebet, efter
- 327 patients undergoing hip fracture surgery treated for 3 weeks following an initial prophylaxis
en indledende forebyggelsesperiode på 1 uge
of 1 week
- 1. 407 patienter, der blev behandlet i op til 9 dage i forbindelse med abdominal kirurgi
- 1,407 patients undergoing abdominal surgery treated up to 9 days
- 425 medicinske patienter med risiko for tromboemboliske komplikationer, der blev behandlet i
- 425 medical patients who are at risk for thromboembolic complications treated up to 14 days
- 10057 patienter, der blev behandlet for UA eller NSTEMI AKS
- 10,057 patients undergoing treatment of UA or NSTEMI ACS
- 6036 patienter, der blev behandlet for STEMI AKS.
- 6,036 patients undergoing treatment of STEMI ACS.
Betydningen af disse bivirkninger bør fortolkes ud fra den kirurgiske og medicinsk kontekst.
16 For the prevention of VTE, the adverse reactions reported by the investigator as at least possibly related to fondaparinux are presented within each frequency grouping (very common ≥ 1/ 10; 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) and system organ class by decreasing order of seriousness; these adverse reactions should be interpreted within the surgical and medical context.
Sjælden: postoperativ sårinfektion
Common: post-operative haemorrhage, anaemia
Blod - og lymfesystem
Common: bleeding (haematoma, haematuria,
Almindelig: postoperativ blødning, anæmi Ikke almindelig: blødninger (epistaxis, gastrointestinale blødninger, hæmoptyse, hæmaturi, hæmatom), trombocytopeni, purpura, trombocytæmi, trombocytabnormitet, koagulations- forstyrrelse
Uncommon: bleeding (epistaxis, gastrointestinal, haemoptysis, haematuria, haematoma) thrombocytopenia, purpura, thrombocythaemia, platelet abnormal, coagulation disorder
Almindelig: blødninger (hæmatom, hæmaturi, hæmoptyse, gingival blødning) Ikke almindelig: anæmi
haemoptysis, gingival bleeding) Uncommon: anaemia
Den bivirkningsprofil, som blev rapporteret i AKS- programmet, stemmer overens med de bivirkninger, som er identificeret ved forebyggelse af VTE.
The adverse event profile reported in the ACS program is consistent with the adverse drug reactions identified for VTE prophylaxis.
Der blev jænvligt rapporteret om blødninger blandt patienter med UA/ NSTEMI og STEMI.
4.1% (enoxaparin) up to and including Day 9 in the Phase III UA/ NSTEMI study, and the incidence of adjudicated severe haemorrhage by modified TIMI criteria was 1.1% (fondaparinux) vs.
Incidensen af erklæret svær blødning var 2, 1% (fondaparinux) versus 4, 1% (enoxaparin) til og med dag 9 i fase III- undersøgelsen for UA/ NSTEMI, og incidensen af erklæret svær blødning ifølge modificerede TIMI- kriterier var 1, 1% (fondaparinux) versus 1, 4% (kontrol [UFH/ placebo]) til og med dag 9 i fase III- undersøgelsen for STEMI.
1.4% (control [UFH/ placebo]) up to and including Day 9 in the Phase III STEMI study.
I fase III- undersøgelsen for UA/ NSTEMI var de hyppigst rapporterede bivirkninger udover blødning (der blev rapporteret hos mindst 1% af alle patienter, som fik fondaparinux) hovedpine, brystsmerter og atrieflimren.
In the Phase III UA/ NSTEMI study, the most commonly reported non-bleeding adverse events (reported in at least 1% of subjects on fondaparinux) were headache, chest pain and atrial fibrillation.
17 I fase III- undersøgelsen med STEMI- patienter var de hyppigst rapporterede bivirkninger udover blødning (der blev rapporteret hos mindst 1% af alle patienter, som fik fondaparinux), atrieflimren, feber, brystsmerter, hovedpine, ventrikulær takykardi, opkastning og hypotension.
In the Phase III study in STEMI patients, the most commonly reported non-bleeding adverse events (reported in at least 1% of subjects on fondaparinux) were atrial fibrillation, pyrexia, chest pain, headache, ventricular tachycardia, vomiting, and hypotension.
I 2, 5 mg dosis påvirker fondaparinux ikke rutine- koagulationstest som aktiveret partiel tromboplastintid (aPTT), aktiveret koagulationstid (ACT) eller protrombintid (PT) / International Normalised Ratio (INR) eller fibrinolytisk aktivitet eller kapillærblødningstiden.
18 At the 2.5 mg dose, fondaparinux does not affect routine coagulation tests such as activated partial thromboplastin time (aPTT), activated clotting time (ACT) or prothrombin time (PT)/ International Normalised Ratio (INR) tests in plasma nor bleeding time or fibrinolytic activity.
Over 8. 000 patienter (hoftefraktur: n=1711; hoftealloplastik: n=5829; større knæoperationer: n=1367) blev inkluderet i kontrollerede kliniske fase II - og III- studier.
Over 8,000 patients (hip fracture – 1,711, hip replacement – 5,829, major knee surgery – 1,367) were studied in controlled Phase II and III clinical studies.
En analyse af de samlede data fra disse studier fandt, at det anbefalede dosisregime af fondaparinux vs. enoxaparin medfører et signifikant fald (54% - med 95% konfidensinterval, 44% - 63%) i forekomsten af tromboemboliske komplikationer vurderet frem til dag 11 efter indgrebet.
In a pooled analysis of these studies, the recommended dose regimen of fondaparinux versus enoxaparin was associated with a significant decrease (54% [95% CI, 44%; 63%]) in the rate of VTE evaluated up to day 11 after surgery, irrespective of the type of surgery performed.
Forekomsten af proksimal dyb venetrombose
The majority of endpoint events were diagnosed by a prescheduled venography and consisted mainly of distal DVT, but the incidence of proximal DVT was also significantly reduced.
Forekomsten af symptomatiske tromboemboliske komplika - tioner inklusive lungeemboli var ikke signifikant forskellig i behandlingsgrupperne.
The incidence of symptomatic VTE, including PE was not significantly different between treatment groups.
Der blev observeret større blødninger ved operationsstedet, heraf ingen fatale, hos 8 patienter (2, 4%) i behandling med 2, 5mg fondaparinux, mens det blev set hos 2 patienter (0, 6%) i behandling med placebo.
Major bleedings, all at surgical site and none fatal, were observed in 8 patients (2.4%) treated with fondaparinux 2.5 mg compared to 2 (0.6%) with placebo.