FrancophonIA/ELRC3.0 huggingface dataset:
English: These may affect up to 1 in 100 people treated with Arixtra.
Danish: Disse kan forekomme hos op til 1 ud af 100 personer, som behandles med Arixtra.
English: • increase in the amount of non-protein nitrogen in the blood
Danish: • øget nitrogenindhold i blodet
English: • if you notice any particles in the solution, or if the solution is discoloured
Danish: • hvis du bemærker, at opløsningen indeholder partikler eller er misfarvet.
English: Excipient(s) with known effect: Contains less than 1 mmol of sodium (23 mg) per dose, and therefore is essentially sodium free.
Danish: Hjælpestof, som behandleren skal være opmærksom på: Indeholder under 1 mmol natrium (23 mg) pr. dosis og er derfor for praktiske formål natriumfri.
English: Instruction for self-administration is mentioned in the Package Leaflet.
Danish: Instruktion i selvinjektion findes beskrevet i indlægssedlen.
English: Fondaparinux does not cross-react with sera from patients with heparin-induced thrombocytopaenia.
Danish: Fondaparinux giver normalt ikke krydsreaktion med sera fra patienter med heparin-induceret trombocytopeni (HIT).
English: In patients >75 years undergoing orthopaedic surgery and receiving fondaparinux 2.5 mg once daily, the estimated plasma clearance was 1.2 to 1.4 times lower than in patients <65 years.
Danish: Hos patienter over 75 år, der gennemgik ortopædkirurgi og fik 2,5 mg fondaparinux en gang daglig, blev plasmaclearance vurderet til 1,2 til 1,4 gange lavere end hos patienter under 65 år.
English: Major bleeding was observed in 3.4% of the patients in the fondaparinux group and in 2.4% of the dalteparin group.
Danish: Der blev observeret større blødninger hos 3,4 % af patienterne i fondaparinuxgruppen og hos 2,4 % i dalteparingruppen.
English: Paediatric patients - Fondaparinux has not been investigated in this population for the prevention of VTE or for the treatment of superficial vein thrombosis or acute coronary syndrome (ACS).
Danish: Pædiatriske patienter - Fondaparinux er ikke undersøgt til forebyggelse af VTE eller behandling af superficiel venetrombose eller akut koronarsyndrom (AKS) hos denne patientgruppe.
English: • reduction in potassium in your blood.
Danish: • nedsat indhold af kalium i blodet.
English: Incidence
Danish: Incidens
English: The safety of fondaparinux 2.5 mg has been evaluated in 3,595 patients undergoing major orthopaedic surgery of the lower limbs treated up to 9 days, in 327 patients undergoing hip fracture surgery treated for 3 weeks following an initial prophylaxis of 1 week, 1,407 patients undergoing abdominal surgery treated up to 9 days, and in 425 medical patients who are at risk for thromboembolic complications treated up to 14 days.
Danish: Sikkerheden ved administration af fondaparinux 2,5 mg er evalueret efter op til 9 dages behandling hos 3.595 patienter, der fik foretaget en større ortopædisk operation i underekstremiteterne, hos 327 patienter, der blev opereret for hoftefraktur og blev behandlet i 4 uger efter indgrebet, hos 1.407 patienter, der blev behandlet i op til 9 dage i forbindelse med abdominal kirurgi, samt hos 425 medicinske patienter med risiko for tromboemboliske komplikationer, der blev behandlet i op til 14 dage.
English: • bleeding (for example from an operation site, an existing stomach ulcer, nosebleed, gums)
Danish: • blødninger (fx fra operationsstedet, fra et allerede eksisterende mavesår, næseblod, blå mærker).
English: Initiation of appropriate therapy such as surgical haemostasis, blood replacements, fresh plasma transfusion, plasmapheresis should be considered.
Danish: Man bør overveje at indlede en passende behandling heraf, såsom hæmostase, blodtransfusion, frisk frossen plasma eller plasmaferese.
English: • For prevention of VTE - Agents that may enhance the risk of haemorrhage should not be administered concomitantly with fondaparinux.
Danish: • Til forebyggelse af VTE - Præparater, der kan øge blødningsrisikoen, bør ikke anvendes sammen med fondaparinux.
English: The solution is a clear and colourless liquid.
Danish: Opløsningen er en klar og farveløs væske.
English: Fondaparinux should be used with caution in patients who have an increased risk of haemorrhage, such as those with congenital or acquired bleeding disorders (e.g. platelet count <50,000/mm3), active ulcerative gastrointestinal disease and recent intracranial haemorrhage or shortly after brain, spinal or ophthalmic surgery and in special patient groups as outlined below.
Danish: Fondaparinux bør anvendes med forsigtighed til patienter med øget blødningstendens, herunder patienter med medfødt eller erhvervet blødersygdom (fx trombocyttal <50.000/mm3), aktiv gastrointestinal ulceration og nylig intrakraniel blødning samt kort tid efter hjerne-, ryg- eller øjenkirurgi og til særlige patientgrupper, se nedenfor.
English: The effects on the incidence of MI and RI were not statistically different between the fondaparinux and enoxaparin treatment groups.
Danish: Virkningen af fondaparinux og enoxaparin på MI- og RI-incidensen var ikke statistisk forskellig.
English: Renal impairment - Fondaparinux should be used with caution in patients with moderate renal impairment (see section 4.4).
Danish: Nedsat nyrefunktion - Fondaparinux bør anvendes med forsigtighed til patienter med moderat nedsættelse af nyrefunktionen (se afsnit 4.4).
English: Uncommon: headache Rare: dizziness
Danish: Ikke almindelig: hovedpine Sjælden: svimmelhed
English: The fondaparinux clinical program was designed to demonstrate the efficacy of fondaparinux for the prevention of venous thromboembolic events (VTE), i.e. proximal and distal deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients undergoing major orthopaedic surgery of the lower limbs such as hip fracture, major knee surgery or hip replacement surgery.
Danish: Fondaparinux kliniske forsøgsprogram var tilrettelagt med henblik på at påvise virkningen af fondaparinux til forebyggelse af venøse tromboemboliske komplikationer (VTE), dvs. proksimal og distal DVT og lungeemboli (PE) hos patienter, som skulle have foretaget større ortopædkirurgiske indgreb i underekstremiteterne som fx ved hoftefraktur og knæ- eller hofteledsalloplastik.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Subcutaneous or intravenous use Read the package leaflet before use.
Danish: Subkutan eller intravenøs anvendelse Læs indlægssedlen inden brug
English: In the pivotal STEMI clinical trial, treatment with fondaparinux was restarted no earlier than 3 hours after sheath removal.
Danish: I det tilgrundliggende STEMI-studie blev fondaparinuxbehandlingen ikke genoptaget før tidligst 3 timer efter fjernelsen af sheath.
English: There are different syringes for the 5 mg, 7.5 mg and 10 mg doses.
Danish: mg, 7,5 mg og 10 mg dosis.
English: • Prevention of VTE - Patients with body weight <50 kg are at increased risk of bleeding.
Danish: • Forebyggelse af VTE - Patienter med en legemsvægt <50 kg har en øget blødningsrisiko.
English: In DVT and PE treatment, patients receiving fondaparinux 5 mg (body weight <50 kg), 7.5 mg (body weight 50-100 kg inclusive) and 10 mg (body weight >100 kg) once daily, the body weight-adjusted doses provide similar exposure across all body weight categories.
Danish: Under behandling af DVT og PE hos patienter, der fik fondaparinux 5 mg (legemsvægt <50 kg), 7,5 mg (legemsvægt 50-100 kg begge inklusive) og 10 mg (legemsvægt >100 kg) en gang daglig, gav doserne tilpasset legemsvægt samme eksponering i alle vægtklasser.
English: The incidence of each thromboembolic component of the primary outcome was also significantly reduced in fondaparinux patients as follows: symptomatic PE [0 (0%) vs 5 (0.3%) (p=0.031)], symptomatic DVT [3 (0.2%) vs 18 (1.2%); relative risk reduction 83.4% (p<0.001)], symptomatic superficial-vein thrombosis extension [4 (0.3%) vs 51 (3.4%); relative risk reduction 92.2% (p<0.001)], symptomatic superficial-vein thrombosis reoccurrence [5 (0.3%) vs 24 (1.6%); relative risk reduction 79.2% (p<0.001)].
Danish: Forekomsten af de enkelte tromboemboliske komponenter i det primære effektmål blev også signifikant reduceret hos fondaparinuxpatienterne: symptomatisk PE [0 (0 %) versus 5 (0,3 %) (p=0,031)], symptomatisk DVT [3 (0,2 %) versus 18 (1,2 %); relativ risiko-reduktion 83,4 % (p<0,001)], forlængelse af symptomatisk superficiel venetrombose [4 (0,3 %) versus 51 (3,4 %); relativ risiko-reduktion 92,2 % (p<0,001)], tilbagevendende symptomatisk superficiel venetrombose [5 (0,3 %) versus 24 (1,6 %); relativ risiko-reduktion 79,2 % (p<0,001)].
English: • Treatment of superficial-vein thrombosis - There are no clinical data available for the use of fondaparinux for the treatment of superficial-vein thrombosis in patients with severe hepatic impairment.
Danish: • Behandling af superficiel venetrombose - Der er ingen kliniske data for brug af fondaparinux til behandling af superficiel venetrombose hos patienter med svært nedsat leverfunktion.
English: Rare: dyspnoea, coughing
Danish: Sjælden: dyspnø, hoste
English: Bleeding risk is increased with concomitant administration of fondaparinux and agents that may enhance the risk of haemorrhage (see section 4.4).
Danish: Risikoen for blødninger er øget ved samtidig administration af fondaparinux og andre præparater, der kan øge blødningsrisikoen (se pkt.
English: Paediatric population - Fondaparinux is not recommended for use in children below 17 years of age due to a lack of data on safety and efficacy (see sections 5.1 and 5.2).
Danish: Pædiatrisk population - Fondaparinux bør ikke anvendes til børn under 17 år pga. manglende dokumentation for sikkerhed og virkning (se pkt.
English: • prevent the formation of blood clots in the blood vessels of the legs or lungs after orthopaedic surgery (such as hip or knee surgery) or abdominal surgery
Danish: at forebygge dannelsen af blodpropper i blodkar i benene eller lungerne efter en ortopædisk operation (fx i hofte eller knæ), eller efter en operation i maven.
English: • oozing from operation wound site
Danish: • udsivning fra operationsstedet
English: The most commonly reported serious adverse reactions reported with fondaparinux are bleeding complications (various sites including rare cases of intracranial/ intracerebral and retroperitoneal bleedings) and anaemia.
Danish: De almindeligste alvorlige bivirkninger, der er rapporteret ved brug af fondaparinux, er blødningskomplikationer (forskellige steder, herunder sjældne tilfælde af intrakranielle/intracerebrale og retroperitoneale blødninger) samt anæmi.
English: Fondaparinux neither influenced the INR activity of warfarin, nor the bleeding time under acetylsalicylic acid or piroxicam treatment, nor the pharmacokinetics of digoxin at steady state.
Danish: Fondaparinux udviste ingen indflydelse på warfarins INR-aktivitet eller på blødningstiden ved behandling med acetylsalicylsyre eller piroxicam, ligesom digoxins farmakokinetik ved steady state ikke påvirkedes.
English: Arixtra is a medicine that helps prevent blood clots from forming in the blood vessels (an antithrombotic agent).
Danish: Arixtra er et lægemiddel, som hjælper med at forhindre, at der dannes blodpropper i blodkarrene (et antitrombotisk middel).
English: Paediatric patients - Fondaparinux has not been investigated in this population for the prevention of VTE or for the treatment of superficial vein thrombosis.
Danish: Pædiatriske patienter - Fondaparinux er ikke undersøgt til forebyggelse af VTE eller behandling af superficiel venetrombose hos denne patientgruppe.
English: • reduction or increase in the number of platelets (blood cells necessary for blood clotting)
Danish: • nedsat eller øget antal blodplader (blodplader får blodet til at størkne)
English: The safety of fondaparinux 2.5 mg has been evaluated in: - 3,595 patients undergoing major orthopaedic surgery of the lower limbs treated up to 9 days - 327 patients undergoing hip fracture surgery treated for 3 weeks following an initial prophylaxis of 1 week - 1,407 patients undergoing abdominal surgery treated up to 9 days - 425 medical patients who are at risk for thromboembolic complications treated up to 14 days - 10,057 patients undergoing treatment of UA or NSTEMI ACS - 6,036 patients undergoing treatment of STEMI ACS.
Danish: Sikkerheden ved administration af fondaparinux 2,5 mg er evalueret i: - 3595 patienter, der fik foretaget en større ortopædisk operation i underekstremiteterne og blev behandlet i op til 9 dage - 327 patienter, der blev opereret for hoftefraktur og blev behandlet i 3 uger efter indgrebet, efter en indledende forebyggelsesperiode på 1 uge - 1.407 patienter, der blev behandlet i op til 9 dage i forbindelse med abdominal kirurgi - 425 medicinske patienter med risiko for tromboemboliske komplikationer, der blev behandlet i op til 14 dage - 10057 patienter, der blev behandlet for UA eller NSTEMI AKS - 6036 patienter, der blev behandlet for STEMI AKS.
English: The pharmacokinetics of fondaparinux sodium are derived from fondaparinux plasma concentrations quantified via anti factor Xa activity.
Danish: Farmakokinetikken for fondaparinuxnatrium skyldes fondaparinux plasmakoncentration, der kvantificeres gennem aktiviteten af anti-faktor Xa.
English: • Prevention of VTE and Treatment of UA/NSTEMI and STEMI - Patients with body weight <50 kg are at increased risk of bleeding.
Danish: • Forebyggelse af VTE og behandling af UA/NSTEMI og STEMI - Patienter med en legemsvægt <50 kg har en øget blødningsrisiko.
English: There are different syringes for the 2.5 mg and 1.5 mg doses.
Danish: 2,5 mg og 1,5 mg dosis.
English: Experience shows that in patients undergoing hip fracture surgery, the risk of VTE continues beyond 9 days after surgery.
Danish: Erfaringen viser, at for patienter der har fået foretaget hoftefrakturkirurgi, er der fortsat risiko for tromboemboliske komplikationer 9 dage efter operationen.
English: In the subgroup of patients treated with fondaparinux or enoxaparin who underwent PCI, 8.8% and 8.2% of patients respectively, experience death/MI/RI within 9 days of randomisation (hazard ratio 1.08, 95% CI, 0.92;1.27).
Danish: I undergruppen af patienter, der blev behandlet med fondaparinux eller enoxaparin, og som fik foretaget PCI, var incidensen af død/MI/RI hhv. 8,8 % og 8,2 % 9 dage efter randomiseringen (hazard ratio 1,08; 95 % CI, 0,92-1,27).
English: Gently pinch the skin that has been cleaned to make a fold.
Danish: Efter rensning nives let i huden, så der dannes en hudfold.
English: 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.
Danish: 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.
English: Fondaparinux also significantly reduced the rate of adjudicated fatal PE [0 patients (0.0%) vs 5 patients (1.2%), respectively].
Danish: Endvidere nedsatte fondaparinux signifikant forekomsten af letal PE ifølge bedømmelse [hhv. 0 patienter (0,0 %) versus 5 patienter (1,2 %)].
English: These may affect up to 1 in every 1000 people treated with Arixtra.
Danish: Disse kan forekomme hos op til 1 ud af 1.000 personer, som behandles med Arixtra.
English: 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).
Danish: 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.
English: Prevention of Venous Thromboembolic Events (VTE) in patients undergoing major orthopaedic surgery of the lower limbs treated up to 9 days
Danish: Forebyggelse af tromboemboliske komplikationer hos patienter ved større ortopædkirurgi i underekstremiteterne efter op til 9 dages behandling
English: • Keep this medicine out of the sight and reach of children
Danish: • Opbevar dette lægemiddel utilgængeligt for børn.
English: 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).
Danish: 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).
English: 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).
Danish: • 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.
English: 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.
Danish: 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.
English: The intravenous tubing should be well flushed with saline after injection to ensure that all of the medicinal product is administered.
Danish: Efter injektionen skal det intravenøse slangesystem skylles godt igennem med saltopløsning for at sikre, at alt aktivt stof er indgivet.
English: Major bleedings were observed in 1 patient (0.2%) of each group.
Danish: I hver gruppe observeredes større blødninger hos 1 patient (0,2 %).
English: 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.
Danish: 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.
English: 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.
Danish: 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).
English: 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).
Danish: 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).
English: For patients receiving primary PCI, the incidence of severe haemorrhage was 1.0% for fondaparinux and 0.4% for controls.
Danish: For patienter, som var blevet behandlet med primær PCI, var incidensen af alvorlig blødning 1,0 % for fondaparinux og 0,4 % i kontrolgruppen.
English: • if you have a risk of uncontrolled bleeding (haemorrhage) including:
Danish: hvis du har risiko for ukontrollerede blødninger på grund af: · mavesår · blødersygdomme
English: The first fondaparinux administration should be given not earlier than 6 hours following surgical closure.
Danish: Den første dosis fondaparinux bør ikke gives tidligere end 6 timer efter incisionslukning.
English: Oral anticoagulants (warfarin), platelet inhibitors (acetylsalicylic acid), NSAIDs (piroxicam) and digoxin did not interact with the pharmacokinetics of fondaparinux.
Danish: Orale antikoagulantia (warfarin), trombocytfunktionshæmmende midler (acetylsalicylsyre), NSAIDs (piroxicam) og digoxin har ingen interaktion med fondaparinux farmakokinetik.
English: • 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).
Danish: • 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.
English: Fondaparinux significantly reduced the overall rate of VTE compared to placebo [18 patients (5.6%) vs 34 patients (10.5%), respectively].
Danish: Fondaparinux nedsatte den generelle forekomst af tromboemboliske komplikationer signifikant sammenlignet med placebo [hhv. 18 patienter (5,6 %) versus 34 patienter (10,5 %)].
English: 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].
Danish: 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].
English: 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).
Danish: 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).
English: 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).
Danish: 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.