natgillin/translations-raw huggingface dataset:
I et randomiseret dobbeltblindt klinisk studie med patienter med den bekræftede diagnose akut symptomatisk DVT blev fondaparinux 5 mg (legemsvægt <50 kg), 7,5 mg (legemsvægt ≥50 kg, ≤100 kg) eller 10 mg (legemsvægt >100 kg) administreret subkutant en gang daglig sammenlignet med enoxaparinnatrium 1 mg/kg subkutant to gange daglig. 
In a randomised, double-blind, clinical trial in patients with a confirmed diagnosis of acute symptomatic DVT, fondaparinux 5 mg (body weight < 50 kg), 7.5 mg (body weight ≥ 50 kg, ≤ 100 kg) or 10 mg (body weight >100 kg) SC once daily was compared to enoxaparin sodium 1 mg/kg SC twice daily.
Endvidere nedsatte fondaparinux signifikant forekomsten af letal PE ifølge bedømmelse [hhv. 0 patienter (0,0 %) versus 5 patienter (1,2 %)]. 
Fondaparinux also significantly reduced the rate of adjudicated fatal PE [0 patients (0.0%) vs 5 patients (1.2%), respectively].
Disse kan forekomme hos op til 1 ud af 1.000 personer, som behandles med Arixtra. 
These may affect up to 1 in every 1000 people treated with Arixtra.
Hvis en patient skal have foretaget perkutan koronarintervention (PCI), skal ufraktioneret heparin (UFH) administreres under PCI i henhold til standardpraksis under hensyntagen til patientens potentielle risiko for blødninger, inklusive tiden fra den sidste fondaparinuxdosis (se pkt. 
If a patient is to undergo percutaneous coronary intervention (PCI), unfractionated heparin (UFH) as per standard 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).
Forebyggelse af tromboemboliske komplikationer hos patienter ved større ortopædkirurgi i underekstremiteterne efter op til 9 dages behandling 
Prevention of Venous Thromboembolic Events (VTE) in patients undergoing major orthopaedic surgery of the lower limbs treated up to 9 days
• Opbevar dette lægemiddel utilgængeligt for børn. 
• Keep this medicine out of the sight and reach of children
På dag 9 var incidensen af svær blødning for fondaparinux og enoxaparin hhv. 2,1 % og 4.1 % (hazard ratio 0,52; 95 % CI, 0,44-0,61; p <0,001). 
At Day 9 the incidence of major bleeding on fondaparinux and enoxaparin was 2.1% and 4.1%, respectively (hazard ratio 0.52, 95% CI, 0.44;0.61, p < 0.001).
• Behandling af superficiel venetrombose - Sikkerheden og virkningen af fondaparinux hos patienter med en legemsvægt på mindre end 50 kg er ikke blevet undersøgt, hvorfor fondaparinux ikke anbefales til disse patienter (se pkt. 
Treatment of superficial-vein thrombosis - The safety and efficacy of fondaparinux in patients with body weight less than 50 kg has not been studied, therefore fondaparinux is not recommended for use in these patients (see section 4.4).
Patienter med svært nedsat leverfunktion, svært nedsat nyrefunktion (kreatininclearance <30 ml/min), lav legemsvægt (<50 kg), aktiv cancer, symptomatisk PE eller tidligere DVT/PE (<6 måneder) eller superficiel venetrombose (<90 dage) blev ekskluderet fra forsøget. 
Patients were excluded if they had severe hepatic impairment, severe renal impairment (creatinine clearance <30ml/min), low body weight (<50kg), active cancer, symptomatic PE or a recent history of DVT/PE (<6 months) or superficial-vein thrombosis (<90 days), or superficial-vein thrombosis associated with sclerotherapy or a complication of an IV line, or they were at high risk of bleeding.
Efter injektionen skal det intravenøse slangesystem skylles godt igennem med saltopløsning for at sikre, at alt aktivt stof er indgivet. 
The intravenous tubing should be well flushed with saline after injection to ensure that all of the medicinal product is administered.
I hver gruppe observeredes større blødninger hos 1 patient (0,2 %). 
Major bleedings were observed in 1 patient (0.2%) of each group.
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. 
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.
Incidensen for blødninger hos patienter, der får den anbefalede behandling for DVT eller PE med normal nyrefunktion eller mild, moderat eller svær nedsættelse af nyrefunktionen var henholdsvis 3,0 % (34/1.132), 4,4 % (32/733), 6,6 % (21/318) og 14,5 % (8/55). 
Incidences of bleeding events in patients receiving the recommended regimen in the treatment of DVT or PE with normal renal function, mild renal impairment, moderate renal impairment and severe renal impairment were 3.0 % (34/1,132), 4.4 % (32/733), 6.6% (21/318), and 14.5 % (8/55) respectively.
Nedsat nyrefunktion - Sammenlignet med patienter med normal nyrefunktion (kreatininclearance >80 ml/min), der gennemgik ortopædkirurgi og fik 2,5 mg fondaparinux en gang daglig, 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) undergoing orthopaedic surgery and receiving fondaparinux 2.5 mg once daily, 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).
For patienter, som var blevet behandlet med primær PCI, var incidensen af alvorlig blødning 1,0 % for fondaparinux og 0,4 % i kontrolgruppen. 
For patients receiving primary PCI, the incidence of severe haemorrhage was 1.0% for fondaparinux and 0.4% for controls.
hvis du har risiko for ukontrollerede blødninger på grund af: · mavesår · blødersygdomme 
• if you have a risk of uncontrolled bleeding (haemorrhage) including:
Den første dosis fondaparinux bør ikke gives tidligere end 6 timer efter incisionslukning. 
The first fondaparinux administration should be given not earlier than 6 hours following surgical closure.
Orale antikoagulantia (warfarin), trombocytfunktionshæmmende midler (acetylsalicylsyre), NSAIDs (piroxicam) og digoxin har ingen interaktion med fondaparinux farmakokinetik. 
Oral anticoagulants (warfarin), platelet inhibitors (acetylsalicylic acid), NSAIDs (piroxicam) and digoxin did not interact with the pharmacokinetics of fondaparinux.
• Behandling af superficiel venetrombose - Sikkerheden og virkningen af fondaparinux hos patienter med svært nedsat leverfunktion er ikke blevet undersøgt, hvorfor fondaparinux ikke anbefales til disse patienter (se pkt. 
• Treatment of superficial-vein thrombosis - The safety and efficacy of fondaparinux in patients with severe hepatic impairment has not been studied, therefore fondaparinux is not recommended for use in these patients (see section 4.4).
Fondaparinux nedsatte den generelle forekomst af tromboemboliske komplikationer signifikant sammenlignet med placebo [hhv. 18 patienter (5,6 %) versus 34 patienter (10,5 %)]. 
Fondaparinux significantly reduced the overall rate of VTE compared to placebo [18 patients (5.6%) vs 34 patients (10.5%), respectively].
For patienter, der blev behandlet med primær PCI, var der ikke signifikant forskel i incidensen af død/re-MI efter 30 dage mellem de to grupper [hhv. 6,0 % i fondaparineuxgruppen versus 4,8 % i kontrolgruppen; hazard ratio 1,26; 95 % CI, 0,96; 1,66]. 
In patients treated with primary PCI, the incidence of death/re-MI at Day 30 was not statistically different between the two groups [6.0% in fondaparinux group vs 4.8% in the control group; hazard ratio 1.26, 95% CI, 0.96, 1.66].
I det prædefinerede stratum, som blev anvendt til at sammenligne fondaparinux med UFH (patienter behandlet med primær PCI (58,5 %), fibrinselektive fibrinolytika (13 %), ikke-fibrinselektive fibrinolytika (2,6 %) og ingen reperfusion (25,9 %)), var virkningen af fondaparinux og UFH på incidensen af død/re-MI på dag 30 ikke statistisk forskellig; hhv. 8,3 % versus 8,7 % (hazard ratio 0,94; 95 % CI, 0,79-1,11; p = 0,460). 
In the predefined stratum comparing fondaparinux to UFH (patients treated with primary PCI (58.5%), fibrin-specific lytics (13%), non-fibrin-specific lytics (2.6%) and no reperfusion (25.9%), the effects of fondaparinux and UFH on the incidence of death/re-MI at Day 30 were not statistically different: respectively, 8.3% vs 8.7% (hazard ratio 0.94, 95% CI, 0.79, 1.11 p = 0.460).
Hvis en patient skal have foretaget en ikke-primær PCI, skal der administreres ufraktioneret heparin (UFH) i henhold til standardpraksis under hensyntagen til patientens potentielle risiko for blødninger, inklusive tiden fra den sidste fondaparinuxdosis (se pkt. 
If a patient is to undergo non-primary PCI, unfractionated heparin (UFH) as per standard 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 de doser, der anvendes til behandling, påvirker fondaparinux ikke i klinisk relevant omfang rutine koagulationstest som aktiveret partiel tromboplastintid (aPTT), aktiveret koagulationstid (ACT) eller protrombintid (PT)/International Normalised Ratio (INR) eller fibrinolytisk aktivitet eller kapillærblødningstiden. 
At the doses used for treatment, fondaparinux does not, to a clinically relevant extent, 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.
En opdateret RMP skal fremsendes: 
An updated RMP should be submitted: • At the request of the European Medicines Agency;
Patienter med heparin-induceret trombocytopeni 
Patients with Heparin Induced Thrombocytopenia
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).
Hvis patienten ønsker det og er i stand til det, kan patienten anbefales selv at injicere præparatet. 
Patients could be recommended to self-inject the product when they are judged willing and able to do so. Physicians should provide clear instructions for self-injection.
Patienter, der gennemgår større ortopædisk eller abdominal operation Den anbefalede dosis fondaparinux er 2,5 mg en gang daglig, som indgives postoperativt som subkutan injektion. 
Patients undergoing major orthopaedic or abdominal surgery The recommended dose of fondaparinux is 2.5 mg once daily administered post-operatively by subcutaneous injection.
Fondaparinux medførte en signifikant reduktion af den generelle forekomst af venøse tromboemboliske komplikationer sammenlignet med placebo [henholdsvis 3 patienter (1,4 %) versus 77 patienter (35 %)]. 
Fondaparinux provided a significant reduction in the overall rate of VTE compared with placebo [3 patients (1.4%) vs 77 patients (35%), respectively].
Efter indledning med en startdosis på 10 mg om dagen bør det overvejes at reducere døgndosis til 7,5 mg ud fra farmakokinetisk modellering (se pkt. 
After an initial 10 mg daily dose, a reduction of the daily dose to 7.5 mg may be considered, based on pharmacokinetic modelling (see section 4.2).
Kanylehylsteret indeholder latex. 
The syringe needle shield contains latex.
Trombocytfunktionshæmmere (acetylsalicylsyre), NSAIDs (piroxicam) og digoxin udviste ingen interaktion med fondaparinux farmakokinetik. 
Platelet inhibitors (acetylsalicylic acid), NSAIDs (piroxicam) and digoxin did not interact with the pharmacokinetics of fondaparinux.
• hvis du har en alvorlig nyresygdom. 
• if you have severe kidney disease.
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. 
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.
Fondaparinux bør gives med forsigtighed til patienter ≥75 år, da nyrefunktionen aftager med alderen (se pkt. 
In patients ≥75 years, fondaparinux should be used with care, as renal function decreases with age (see section 4.4).
Den anbefalede dosis af fondaparinux (til patienter med legemsvægt ≥50 kg, ≤100 kg) er 7,5 mg en gang daglig som subkutan injektion. 
The recommended dose of fondaparinux is 7.5 mg (patients with body weight ≥ 50, ≤ 100kg) once daily administered by subcutaneous injection.
Efter indledning med en dosis på 10 mg om dagen bør det hos denne undergruppe overvejes at reducere døgndosis til 7,5 mg ud fra farmakokinetisk modellering (se pkt. 
In this subgroup, after an initial 10 mg daily dose, a reduction of the daily dose to 7.5 mg may be considered, based on pharmacokinetic modelling (see section 4.4).
Fondaparinux i doser ud over det anbefalede niveau kan øge blødningstendensen. 
4.9 Overdose Fondaparinux doses above the recommended regimen may lead to an increased risk of bleeding.
Fondaparinux kliniske forsøgsprogram til forebyggelse af venøse tromboemboliske komplikationer (VTE) var tilrettelagt med henblik på at påvise virkningen af fondaparinux til behandling af DVT og PE. 
The fondaparinux clinical program in treatment of Venous Thromboembolism was designed to demonstrate the efficacy of fondaparinux for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE).
Spørg på apoteket, hvordan du skal bortskaffe medicinrester og injektionssprøjter. 
Ask your pharmacist how to throw away medicines you no longer use.
Præparater, der kan øge blødningsrisikoen, bør ikke anvendes sammen med fondaparinux. 
Agents that may enhance the risk of haemorrhage should not be administered concomitantly with fondaparinux.
Der er ikke observeret nogen speciel fare for mennesker i prækliniske data baseret på traditionelle studier af sikkerhedsfarmakologi, toksikologi med gentagen indgift og gentoksikologi. 
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, and genotoxicity.
UA/NSTEMI- og STEMI-patienter, som skal have foretaget en ikke-primær PCI, bør ikke behandles med fondaparinux som eneste antikoagulans under PCI-proceduren,, da der er øget risiko for kateterrelateret trombose (se pkt. 
In UA/NSTEMI and STEMI patients undergoing non-primary PCI, the use of fondaparinux as the sole anticoagulant during PCI is not recommended due to an increased risk of guiding catheter thrombus (see clinical studies section 5.1).
De primære operationsområder var colon/rektum, ventrikel, lever og galdeblære. 
The main sites of surgery were colonic/rectal, gastric, hepatic, cholecystectomy or other biliary.
Figur D 
Picture D
• Forebyggelse af VTE - Dosisjustering er ikke nødvendig hos patienter med let eller moderat nedsat leverfunktion. 
• Prevention of VTE - No dosing adjustment is necessary in patients with either mild or moderate hepatic impairment.
I fondaparinuxgruppen forekom det primære sammensatte endepunkt blandt 5,8 % af patienterne sammenlignet med 5,7 % blandt de patienter, der blev behandlet med enoxaparin (hazard ratio 1,01; 95 % CI, 0,90-1,13; ensidet-noninferioritets-p-værdi = 0,003). 
Of the patients in the fondaparinux group, 5.8% experienced an event by Day 9 compared to 5.7% for enoxaparin-treated patients (hazard ratio 1.01, 95% CI, 0.90, 1.13, one-sided non-inferiority p value = 0.003).
Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Irland 
Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland Manufacturer:
For patienter som initielt ikke fik reperfusion, var incidensen for alvorlig blødning 1,2 % for fondaparinux versus 1,5 % i kontrolgruppen. 
In patients initially not reperfused, the incidence of severe haemorrhage was 1.2% for fondaparinux vs 1.5% for controls.
Effektparametre og resultater af alvorlig blødning var konsistent mellem de præspecificerede undergrupper, så som ældre patienter med nedsat nyrefunktion og samtidig administration af trombocytaggregationshæmmere (aspirin, thienopyridin). 
The efficacy findings and results on severe haemorrhage were consistent across prespecified subgroups such as elderly, renally impaired patients, type of concomitant platelet aggregation inhibitors (aspirin, thienopyridines).
Fondaparinux antitrombotiske aktivitet skyldes antitrombin III (antitrombin)-medieret selektiv hæmning af Faktor Xa. 
The antithrombotic activity of fondaparinux is the result of antithrombin III (antithrombin) mediated selective inhibition of Factor Xa.
For at undgå tab af det aktive stof fra den fyldte injektionssprøjte skal luftboblen ikke presses ud før injektionen. 
To avoid the loss of medicinal product when using the pre-filled syringe do not expel the air bubble from the syringe before the injection.
Injektionssprøjte med automatisk beskyttelsessystem af nålen 
Syringe with an automatic needle protection system
Under den indledende behandling sås større blødninger hos 1,3 % af de patienter, der fik fondaparinux sammenlignet med 1,1 % af dem, der fik ufraktioneret heparin. 
Major bleeding during the initial treatment period was observed in 1.3% of fondaparinux patients, compared to 1.1% with unfractionated heparin.
• diarré eller forstoppelse 
• diarrhoea or constipation
Effektparametrene og resultaterne vedrørende svær blødning var konsistent mellem de præspecificerede undergrupper, så som ældre patienter med nedsat nyrefunktion og ved samtidig administration af trombocytaggregationshæmmere (aspirin, thienopyridiner eller GP-IIb/IIIahæmmere). 
The efficacy findings and results on major bleeding were consistent across prespecified subgroups such as elderly, renally impaired patients, type of concomitant platelet aggregation inhibitors (aspirin, thienopyridines or GP IIb/IIIa inhibitors).
I det prædefinerede stratum, som blev anvendt til at sammenligne fondaparinux med placebo (dvs. patienter, der blev behandlet med ikke-fibrinselektivt fibrinolytika (77,3), ingen reperfusion (22 %), fibrinselektive fibrinolytika (0,3 %), primær PCI (0,4 %)), var incidensen af død/re-MI efter 30 dage signifikant reduceret fra 14,0 % for placebo til 11,3 % (hazard ratio 0,80; 95 % CI, 0,69-0,93; p = 
In the predefined stratum comparing fondaparinux to placebo (i.e patients treated with nonfibrin specific lytics (77.3%), no reperfusion (22%), fibrin-specific lytics (0.3%), primary PCI (0.4%), the incidence of death/re-MI at Day 30 was significantly reduced from 14.0% on placebo to 11.3% (hazard ratio 0.80, 95% CI, 0.69, 0.93, p = 0.003).
Dosisjustering er ikke nødvendig hos patienter med let nedsat nyrefunktion (kreatininclearance >50 ml/min). 
No dosage reduction is required for patients with mild renal impairment (creatinine clearance >50 ml/min).
For patienter, som fik fibrinolyse, opstod der alvorlige blødninger blandt 1,3 % af fondaparinuxpatienter og 2,0 % af patienterne i kontrolgruppen. 
In patients given a thrombolytic, severe haemorrhage occurred in 1.3% of the fondaparinux patients and in 2.0% of controls.
Under den indledende behandling optrådte større blødninger hos 1,1 % af de patienter, der fik fondaparinux sammenlignet med 1,2 % af dem, der fik enoxaparin. 
Major bleeding during the initial treatment period was observed in 1.1% of fondaparinux patients, compared to 1.2% with enoxaparin.
Ved selektiv binding til ATIII øger fondaparinux ATIII naturlige hæmning af Faktor Xa (ca. 300 gange). 
By binding selectively to ATIII, fondaparinux potentiates (about 300 times) the innate neutralization of Factor Xa by ATIII.
• døsighed eller træthed 
• drowsiness or tiredness
Arixtra injektionssprøjter kan indeholde latex 
Arixtra syringe may contain latex
Injektionssprøjte med et manuelt sikkerhedssystem, hvor en sikkerhedsmanchet bliver trukket hen over nålen efter brug. 
Syringe with a manual needle protection system showing security sleeve being pulled over needle AFTER USE
Den samlede mortalitetsincidens efter 30 dage var ligeledes signifikant reduceret fra 8,9 % for kontrolgruppen til 7,8 % i fondaparinuxgruppen (hazard ratio 0,87; 95 % CI, 0,77-0,98; p = 0,02). 
The incidence of all cause mortality at Day 30 was also significantly reduced from 8.9% for the control group to 7.8% in the fondaparinux group (hazard ratio 0.87, 95% CI, 0.77;0.98, p = 0.02).
ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) 
METHOD AND ROUTE(S) OF ADMINISTRATION Subcutaneous use
Forebyggelse af venøse tromboemboliske komplikationer (VTE) hos voksne, som gennemgår abdominalkirurgi, og som skønnes at have høj risiko for tromboemboliske komplikationer, fx patienter med abdominalcancer (se pkt. 
Prevention of Venous Thromboembolic Events (VTE) in adults 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).
Fondaparinux antitrombotiske aktivitet skyldes antitrombin III (ATIII)-medieret selektiv hæmning af Faktor Xa. 
The antithrombotic activity of fondaparinux is the result of antithrombin III (ATIII) mediated selective inhibition of Factor Xa.
Forebyggelse af venøse tromboemboliske komplikationer (VTE) hos voksne i forbindelse med større ortopædkirurgiske indgreb i underekstremiteterne som fx ved hoftefraktur og knæ- eller hofteledsalloplastik. 
Prevention of Venous Thromboembolic Events (VTE) in adults undergoing major orthopaedic surgery of the lower limbs such as hip fracture, major knee surgery or hip replacement surgery.
Af hensyn til miljøet må du ikke smide medicinrester i afløbet, toilettet eller skraldespanden. 
Do not throw away any medicines or syringes via wastewater or household waste.
meget sjældne tilfælde af angioødem, anafylaktoid/anafylaktisk reaktion) 
Rare: allergic reaction (including very rare reports of angioedema, anaphylactoid/anaphylactic reaction)
Hæmning af Faktor Xa standser koagulationsprocessen, hvorved trombinsyntese og trombedannelse reduceres. 
Neutralisation of Factor Xa interrupts the blood coagulation cascade and inhibits both thrombin formation and thrombus development.
OASIS 5 var en dobbeltblindet, randomiseret, noninferioritetsundersøgelse af fondaparinux 2,5 mg subkutant en gang daglig versus enoxaparin 1 mg/kg subkutant to gange daglig til ca. 20.000 patienter med UA/NSTEMI. 
Treatment of unstable angina or non-ST segment elevation myocardial infarction (UA/NSTEMI) OASIS 5 was a double-blind, randomised, non-inferiority study with fondaparinux 2.5 mg subcutaneously once daily versus enoxaparin 1 mg/kg subcutaneously twice daily in approximately 20,000 patients with UA/NSTEMI.
Incidensen for blødninger hos patienter i aldersgruppen <65 år, 65-75 år og >75 år, der fik den anbefalede behandling med fondaparinux for DVT eller PE, var henholdsvis 3,0 %, 4,5 % og 6,5 %. 
Incidences of bleeding events in patients receiving the recommended regimen in the treatment of DVT or PE and aged <65 years, 65-75 and >75 years were 3.0 %, 4.5 % and 6.5 %, respectively.
Fondaparinux bør ikke anvendes til patienter med svært nedsat nyrefunktion (kreatininclearance <30 ml/min) (se pkt. 
Fondaparinux should not be used in patients with severe renal impairment (creatinine clearance < 30 ml/min) (See section 4.3).
Behandling af dyb venetrombose 
Treatment of Deep Venous Thrombosis