natgillin/translations-raw huggingface dataset:
Der blev observeret større blødninger hos 3, 4% af patienterne i fondaparinuxgruppen over for 2, 4% i dalteparingruppen.
Major bleeding was observed in 3.4% of the patients in the fondaparinux group and in 2.4% of the dalteparin group.
Forsøget omfattede akut syge patienter i aldersgruppen ≥60 år, som forventedes at skulle holde sengen i mindst 4 dage, og som var indlagt på grund af kronisk hjerteinsufficiens (NYHA- klasse III/ IV) og/ eller akut respirationssygdom og/ eller akut infektiøs eller inflammatorisk sygdom.
This study included acutely ill medical patients, aged ≥ 60 years, expected to require bed rest for at least four days, and hospitalized for congestive heart failure NYHA class III/ IV and/ or acute respiratory illness and/ or acute infectious or inflammatory disease.
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.
Alle patienter fik medicinsk UA/ NSTEMI- standardbehandling, 34% fik foretaget PCI, og 9% fik foretaget CABG.
All patients received standard medical treatment for UA/ NSTEMI, with 34% of patients undergoing PCI and 9% undergoing CABG.
Den gennemsnitlige behandlingsvarighed var 5, 5 dage i gruppen, som fik fondaparinux, og 5, 2 dage i gruppen, som fik enoxaparin.
The mean treatment duration was 5.5 days in the fondaparinux group and 5.2 days in the enoxaparin group.
Hvis der blev foretaget PCI, fik patienterne enten intravenøs fondaparinux (fondaparinuxpatienter) eller vægtbaseret intravenøs UFH (enoxaparinpatienter) som tillægsbehandling, afhængig af tidspunktet for den sidste subkutane dosis og planlagt administration af GP- IIb/ IIIa- hæmmere.
If PCI was performed, patients received either intravenous fondaparinux (fondaparinux patients) or weight adjusted intravenous UFH (enoxaparin patients) as adjunctive therapy, dependent on the timing of the last subcutaneous dose and planned use of GP IIb/ IIIa inhibitor.
Ca.
The mean age of the patients was 67 years, and approximately 60% were at least 65 years old.
17% havde moderat nedsat nyrefunktion (kreatinclearance ≥ 30 og < 50 ml/ min.).
Approximately 40% and 17% of patients had mild (creatinine clearance ≥ 50 to < 80 ml/ min) or moderate (creatinine clearance ≥ 30 to < 50 ml/ min) renal impairment, respectively.
I fondaparinuxgruppen forekom det primære sammensatte endpoint blandt 5, 8% af patienterne sammenlignet med 5, 7% blandt de patienter der blev behandlet med enoxaparin (hazard rate 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).
På dag 30 reducerede fondaparinux signifikant den samlede mortalitetsincidens fra 3, 5% for enoxaparin til 2, 9% (hazard rate 0, 83; 95% CI 0, 71- 0, 97; p = 0, 02).
By Day 30, the incidence of all cause mortality was significantly reduced from 3.5% on enoxaparin to 2.9% on fondaparinux (hazard ratio 0.83, 95% CI, 0.71; 0.97, p = 0.02).
Effekten af fondaparinux og enoxaparin på MI - og RI- incidensen var ikke statistisk forskellig.
The effects on the incidence of MI and RI were not statistically different between the fondaparinux and enoxaparin treatment groups.
2, 1% og 4. 1% (hazard rate 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).
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/ IIIa - hæmmere).
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).
8, 8% og 8, 2% 9 dage efter randomiseirngen (hazard rate 1, 08; 95% CI 0, 92- 1, 27).
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).
2, 2% og 5, 0% (hazard rate 0, 43; 95% CI 0, 33- 0, 57) for fondaparinux og enoxaparin.
In this subgroup, the incidence of major bleeding on fondaparinux and enoxaparin at Day 9 was 2.2% and 5.0% respectively (hazard ratio 0.43, 95% CI, 0.33; 0.57).
Behandling af ST segment elevations myokardieinfarkt (STEMI) OASIS 6 var en dobbeltblindet, randomiseret undersøgelse til vurdering af sikkerhed og effekt ved subkutan administration af fondaparinux 2, 5 mg én gang daglig versus sædvanlig behandling (placebo (47%) eller UFH (53%)) blandt ca.
Treatment of ST segment elevation myocardial infarction (STEMI) OASIS 6 was a double blind, randomised study assessing the safety and efficacy of fondaparinux 2.5 mg once daily, versus usual care (placebo (47%) or UFH (53%) in approximately 12,000 patients with STEMI.
12. 000 patienter med STEMI.
All patients received standard treatments for STEMI, including primary PCI (31%),
Alle patienter modtog standardbehandling for STEMI, i form af primær PCI (31%), fibrinolyse (45%) eller ingen reperfusion (24%).
20 thrombolytics (45%) or no reperfusion (24%).
Af de patienter, som blev behandlet med fibrinolyse, blev 84% behandlet med et ikke- fibrinselektivt
Of the patients treated with a thrombolytic, 84% were treated with a non-fibrin specific agent (primarily streptokinase).
behandlingsvarighed var 6, 2 dage for fondaparinux.
The mean treatment duration was 6.2 days on fondaparinux.
40% var mindst 65 år eller ældre.
The mean age of the patients was 61 years, and approximately 40% were at least 65 years old.
14% havde moderat nedsat nyrefunktion (kreatininclearence ≥ 30 til < 50 ml/ min.).
Approximately 40% and 14% of patients had mild (creatinine clearance ≥ 50 to < 80 ml/ min) or moderate (creatinine clearance ≥ 30 to < 50 ml/ min) renal impairment, respectively.
Det primære sammensatte endpoint var død og reinfarkt (re- MI) senest 30 dage efter randomisering.
The primary adjudicated endpoint was a composite of death and recurrent MI (re-MI) within 30 days of randomisation.
Fondaparinux reducerede incidensen af død/ re- MI efter 30 dage signifikant, fra 11, 1% i kontrolgruppen til 9, 7% i fondaparinuxgruppen (hazard rate 0, 86; 95% CI 0, 77- 0, 96; p = 0, 008).
The incidence of death/ re-MI at Day 30 was significantly reduced from 11.1% for the control group to 9.7% for the fondaparinux group (hazard ratio 0.86, 95% CI, 0.77, 0.96, p = 0.008).
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 rate 0, 80; 95% CI 0, 69- 0, 93; p = 0, 003).
In the predefined stratum comparing fondaparinux to placebo (i. e patients treated with non- fibrin 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).
8, 3% versus 8, 7% (hazard rate 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).
For undergruppen i dette stratum, som enten fik fibrinolyse eller ingen reperfusion (dvs. de patienter, som ikke fik foretaget primær PCI), var incidensen for død/ re- MI efter 30 dage signifikant reduceret fra 14, 3% for UFH til 11, 5% for fondaparinux (hazard rate 0, 79; 95% CI 0, 64- 0, 98; p = 0, 03).
However, in this stratum, in the subgroup of indicated population undergoing thrombolysis or no reperfusion (i. e patients not undergoing primary PCI), the incidence of death/ re-MI at Day 30 was significantly reduced from 14.3% on UFH to 11.5% with fondaparinux (hazard ratio 0.79, 95% CI, 0.64, 0.98, p = 0.03).
Den samlede mortalitetsincidens efter 30 dage var ligeledes signifikant reduceret fra 8, 9% for kontrolgruppen til 7, 8% i fondaparinuxgruppen (hazard rate 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).
Hos patienter, som blev revaskulariseret med fibrinolytika, reducerede fondaparinux incidensen af død/ re- MI signifikant efter 30 dage fra 13, 6% for kontrolgruppen til 10, 9% (hazard rate 0, 79; 95% CI 0, 68- 0, 93; p= 0, 003).
In patients who were revascularised with a thrombolytic, fondaparinux significantly reduced the incidence of death/ re-MI at Day 30 from 13.6% for the control group to 10.9% (hazard ratio 0.79, 95%CI, 0.68; 0.93, p = 0.003).
Blandt patienter, som initielt ikke fik reperfusion, reducerede fondaparinux incidensen af død/ re- MI signifikant efter 30 dage fra 15% for kontrolgruppen til 12. 1% for fondaparinux- gruppen (hazard rate 0, 79; 95% CI 0, 65 - 097; p = 0, 023).
Among patients initially not reperfused, the incidence of death/ re-MI at Day 30 was significantly reduced from 15% for the control group to 12.1% for the fondaparinux group (hazard ratio 0.79, 95% CI, 0.65; 0.97, p = 0.023).
6, 0% i fondaparineuxgruppen versus 4, 8% i kontrolgruppen; hazard rate 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].
For patienter, som fik fibrinolyse, opstod der alvorlige blødninger blandt 1. 3% af fondaparinuxpatienter og 2, 0% af patienterne i kontrolgruppen.
By Day 9, 1.1% of patients treated with fondaparinux and 1.4% of control patients experienced a severe haemorrhage.
For patienter som initielt ikke fik reperfusion, var incidensen for alvorlig blødning 1, 2% for fondaparinux versus 1, 5% i kontrolgruppen.
In patients given a thrombolytic, severe haemorrhage occurred in 1.3% of the fondaparinux patients and in 2.0% of controls.
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.
Ved en daglig subkutan dosis opnås steady state- plasmakoncentration efter 3- 4 dage med en 1, 3 gange øget Cmax og AUC.
Following once daily subcutaneous dosing, steady state of plasma levels is obtained after 3 to 4 days with a 1.3-fold increase in Cmax and AUC.
Estimaterne for middel- steady state (Coefficient Variation (CV)) famakokinetiske parametre for hoftealloplastik- patienter, der får fondaparinux 2, 5 mg daglig, er:
21 Mean (CV%) steady state pharmacokinetic parameters estimates of fondaparinux in patients undergoing hip replacement surgery receiving fondaparinux 2.5 mg once daily are:
21 Fordeling Fondaparinux fordelingsvolumen er begrænset (7- 11 liter).
Distribution The distribution volume of fondaparinux is limited (7-11 litres).
In vitro bindes fondaparinux med høj affinitet og specifikt til ATIII- protein, [hvilket giver en plasmakoncentrationsbinding] (98, 6- 97, 0% i koncentrationsintervallet fra 0, 5 til 2 mg/ l).
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).
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.
Den lave plasmakoncentration af fondaparinux er forklaret med en reduceret binding til ATIII og sekundært til den lave ATIII plasmakoncentration hos patienter med nedsat leverfunktion, der resulterer i en øget renalclearance af fondaparinux.
The lower plasma concentrations of fondaparinux were attributed to reduced binding to ATIII secondary to the lower ATIII plasma concentrations in subjects with hepatic impairment thereby
22 pkt.
22 resulting in increased renal clearance of fondaparinux.
Hvis fondaparinuxnatrium tilsættes en minipose med 0, 9% saltopløsning bør infusionen ideelt set gives straks, men den kan opbevares ved stuetemperatur i op til 24 timer.
If fondaparinux sodium is added to a 0.9% saline minibag it should ideally be infused immediately, but can be stored at room temperature for up to 24 hours.
Der findes to typer injektionssprøjter: • Injektionssprøjte med et blåt stempel og et automatisk sikkerhedssystem • Injektionssprøjte med et blåt stempel og et manuelt sikkerhedssystem
There are two types of syringes: • syringe with a blue plunger and an automatic safety system • syringe with blue plunger and a manual safety system.
Intravenøs administration bør ske i en eksisterende intravenøs linje enten direkte eller ved brug af en lille (25 eller 50 ml) minipose med 0, 9% saltopløsning
Intravenous administration should be through an existing intravenous line either directly or using a small volume (25 or 50ml) 0.9% saline minibag.
Instruktion i subkutan selvinjektion findes beskrevet i indlægssedlen.
23 Instruction on self-administration by subcutaneous injection is included in the Package Leaflet.
23 De fyldte Arixtra injektionssprøjter er forsynet med et system til beskyttelse af kanylen, som beskytter mod skader pga. nålestik efter injektionen.
The needle protection system of the Arixtra pre-filled syringes have been designed with a safety system to protect from needle stick injuries following injection.
21. marts 2002 Fornyelse af MT:
21 March 2002 Date of latest renewal:
Arixtra 5 mg/ 0, 4 ml injektionsvæske, opløsning, fyldt injektionssprøjte.
Arixtra 5 mg/ 0.4 ml solution for injection, pre-filled syringe.
Hver fyldt injektionssprøjte indeholder 5 mg fondaparinuxnatrium i 0, 4 ml injektionsvæske.
Each pre-filled syringe contains 5 mg of fondaparinux sodium in 0.4 ml solution for injection.
Den anbefalede dosis af fondaparinux (til patienter med legemsvægt ≥50 kg, ≤100 kg) er 7, 5 mg én 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.
Til patienter, der vejer < 50 kg, er den anbefalede dosis 5 mg.
For patients with body weight < 50 kg, the recommended dose is 5 mg.
Til patienter, der vejer > 100 kg, er den anbefalede dosis 10 mg.
For patients with body weight > 100 kg, the recommended dose is 10 mg.
Behandlingen fortsættes i mindst 5 dage, og indtil peroral antikoagulation er tilfredsstillende (INR - værdier, international normaliseret ratio, 2- 3).
Treatment should be continued for at least 5 days and until adequate oral anticoagulation is established (International Normalised Ratio 2 to 3).
Nedsat nyrefunktion - Fondaparinux bør anvendes med forsigtighed til patienter med moderat nedsættelse af nyrefunktionen (se afsnit 4. 4).
Renal impairment - Fondaparinux should be used with caution in patients with moderate renal impairment (see section 4.4).
Der er ingen erfaringer med den undergruppe af patienter, som både har høj legemsvægt (> 100 kg) og moderat nedsættelse af nyrefunktionen (kreatininclearance 30- 50 ml/ min).
There is no experience in the subgroup of patients with both high body weight (> 100 kg) and moderate renal impairment (creatinine clearance 30-50 ml/ min).
4. 4).
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).
4. 3).
Fondaparinux should not be used in patients with severe renal impairment (creatinine clearance < 30 ml/ min) (see section 4.3).
Nedsat leverfunktion - Dosisjustering er ikke nødvendig for patienter med enten mildt eller moderat nedsat leverfunktion.
25 Hepatic impairment - No dosing adjustment is necessary in patients with either mild or moderate hepatic impairment.
25 4. 4 og 5. 2).
In patients with severe hepatic impairment, fondaparinux should be used with care as this patient group has not been studied (see sections 4.4 and 5.2).
- alvorlig nedsat nyrefunktion (kreatininclearance < 30 ml/ min).
- severe renal impairment defined by creatinine clearance < 30 ml/ min.
Der er begrænsede erfaringer med behandling af hæmodynamisk ustabile patienter med fondaparinux, og ingen erfaringer med patienter, der kræver trombolyse, embolektomi eller indlæggelse af vena cava- filter.
There is limited experience from treatment with fondaparinux in haemodynamically unstable patients and no experience in patients requiring thrombolysis, embolectomy or insertion of a vena cava filter.
Hvad angår andre antikoagulantia, bør fondaparinux anvendes med forsigtighed til nyopererede patienter (< 3 dage), og først når der er tilfredsstillende kirurgisk hæmostase.
As for other anticoagulants, fondaparinux should be used with caution in patients who have undergone recent surgery (< 3 days) and only once surgical haemostasis has been established.
Under behandling af venøse tromboemboliske komplikationer bør samtidig behandling med vitamin K- antagonister gives efter behov i henhold til oplysningerne i pkt.
During treatment of VTE, concomitant therapy with vitamin K antagonist should be administered in accordance with the information of Section 4.5.
4. 5 Anden trombocythæmmende medicin (acetylsalicylsyre, dipyramidol, sulfinpyrazon, ticlopidin eller clopidogrel) samt NSAIDs bør anvendes med forsigtighed.
Other antiplatelet medicinal products (acetylsalicylic acid, dipyridamole, sulfinpyrazone, ticlopidine or clopidogrel), and NSAIDs should be used with caution.
Spinal - / epiduralanæstesi Spinal - / epiduralanæstesi bør ikke anvendes til patienter, der får fondaparinux til behandling af venøse tromboemboliske komplikationer og ikke som profylakse.
Spinal / Epidural anaesthesia In patients receiving fondaparinux for treatment of VTE rather than prophylaxis, spinal/ epidural anaesthesia in case of surgical procedures should not be used.
Ældre patienter Ældre har generelt en øget blødningsrisiko.
Elderly patients The elderly population is at increased risk of bleeding.
5. 2).
As renal function generally decreases with age, elderly patients may show reduced elimination and increased exposure of fondaparinux (see section 5.2).
Incidensen for blødninger hos patienter i aldersgruppen < 65 år, 65- 75 år og > 75 år, der fik den anbefalede behandling med fondaparinux for dyb venetrombose eller lungeemboli, 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.
Den tilsvarende incidens hos patienter, der fik den anbefalede behandling med enoxaparin
The
26 for dyb venetrombose, var henholdsvis 2, 5%, 3, 6% og 8, 3%, mens incidensen hos patienter, der fik den anbefalede behandling med ufraktioneret heparin for lungeemboli var henholdsvis 5, 5%, 6, 6% og 7, 4%.
26 corresponding incidences in patients receiving the recommended regimen of enoxaparin in the treatment of DVT were 2.5%, 3.6% and 8.3% respectively, while the incidences in patients receiving the recommended regimen of UFH in the treatment of PE were 5.5%, 6.6% and 7.4%, respectively.
Lav legemsvægt Der er begrænsede kliniske erfaringer hos patienter, der vejer < 50 kg.
Low body weight Clinical experience is limited in patients with body weight < 50 kg.
5. 2).
Fondaparinux should be used with caution at a daily dose of 5 mg in this population (see sections 4.2 and 5.2).
Nedsat nyrefunktion Blødningsrisikoen øges med øget nedsættelse af nyrefunktionen.
Renal impairment The risk of bleeding increases with increasing renal impairment.
Incidensen for blødninger hos patienter, der får den anbefalede behandling for dyb venetrombose eller lungeemboli med normal nyrefunktion eller mild, moderat eller svær nedsættelse af nyrefunktionen var henholdsvis 3, 0% (34/ 1132), 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.
De tilsvarende incidenser hos patienter, der får den anbefalede behandling for DVT med enoxaparin var 2, 3% (13/ 559), 4, 6% (17/ 368), 9, 7% (14/ 145) henholdsvis 11, 1% (2/ 18), mens indicensen hos patienter, der fik den anbefalede behandling med ufraktioneret heparin mod lungeemboli var henholdsvis 6, 9% (36/ 523), 3, 1% (11/ 352), 11, 1% (18/ 162) og 10, 7% (3/ 28).
The corresponding incidences in patients receiving the recommended regimen of enoxaparin in the treatment of DVT were 2.3% (13/ 559), 4.6% (17/ 368), 9.7% (14/ 145) and 11.1% (2/ 18) respectively, and in patients receiving the recommended regimen of unfractionated heparin in the treatment of PE were 6.9% (36/ 523), 3.1% (11/ 352), 11.1% (18/ 162) and 10.7% (3/ 28), respectively.
Fondaparinux er kontraindiceret ved svært nedsat nyrefunktion (kreatininclearance < 30 ml/ min) og bør anvendes med forsigtighed til patienter med moderat nedsat nyrefunktion (kreatininclearance 30 - 50 ml/ min).
Fondaparinux is contra-indicated in severe renal impairment (creatinine clearance < 30 ml/ min) and should be used with caution in patients with moderate renal impairment (creatinine clearance 30-50 ml/ min).
5. 2).
The duration of treatment should not exceed that evaluated during clinical trial (mean 7 days) (see sections 4.2, 4.3 and 5.2).
Der er ingen erfaringer med den undergruppe af patienter, som både har høj legemsvægt (> 100 kg) og moderat nedsat nyrefunktion (kreatininclearance 30- 50 ml/ min).
There is no experience in the subgroup of patients with both high body weight (> 100 kg) and moderate renal impairment (creatinine clearance 30-50 ml/ min).
4. 2).
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).
4. 2).
Severe hepatic impairment The use of fondaparinux should be considered with caution because of an increased risk of bleeding due to a deficiency of coagulation factors in patients with severe hepatic impairment (see section 4.2).
I interaktionsstudier udviste en dosis på 10 mg fondaparinux ingen indflydelse på antikoagulationskontrol med warfarin målt som INR- aktivitet.
In clinical studies performed with fondaparinux, oral anticoagulants (warfarin) did not interact with the pharmacokinetics of fondaparinux; at the 10 mg dose used in the interaction studies, fondaparinux did not influence the anticoagulation monitoring (INR) activity of warfarin.
27 4. 6 Graviditet og amning
27 4.6 Pregnancy and lactation