natgillin/translations-raw huggingface dataset:
er tromboemboliske komplikationer sammenlignet med placebo [henholdsvis 3 patienter (1, 4%) kontra 77 patienter (35%)].
patients (1.4%) vs 77 patients (35%), respectively].
Størstedelen (70/ 80) af de rapporterede venøse tromboemboliske komplikationer var ikke symptomatiske tilfælde, der blev påvist ved flebografi som dybe venetromboser.
Fondaparinux also provided a lP
ris Fondaparinux medførte også en signifikant reduktion af forekomsten af symptomatiske, venøse tromboemboliske komplikationer (dyb venetrombose og/ eller lungeemboli) [henholdsvis 1 patient (0, 3
Major bleedings, all at surgical site and none fatal, were observed in 8 patients (2.4%) treated with fondaparinux 2.5 mg na
to%) kontra 9 patienter (2, 7%)], herunder to fatale tilfælde af lungeemboli rapporteret i placebogruppen.
compared to 2 (0.6%) with placebo.
au patienter (2, 4%) i behandling med 2, 5mg fondaparinux, mens det blev set hos 2 patienter (0, 6%) i placebogruppen.
Prevention of Venous Thromboembolic Events (VTE) in patients undergoing abdominal surgery ici
Ensure consistent writing of placebogruppen; please check throughout the document.
who are judged to be at high risk of thromboembolic complications, such as patients undergoing abdominal cancer surgery ed
Forebyggelse af tromboemboliske komplikationer (VTE) hos patienter, der gennemgår e abdominalkirurgi, med høj risiko for tromboemboliske komplikatoner, fx ved abdominalcancer er I et dobbeltblindt klinisk forsøg blev 2927 patienter randomiseret til at få fondaparinux 2, 5 mg en gang daglig eller dalteparin 5000 IE en gang daglig, dog 2500 IE præoperativt og 2500 IE postoperativt ng
In a double-blind clinical study, 2927 patients were randomized to receive fondaparinux 2.5mg once daily or dalteparin 5000 IU once daily, with one 2500 IU preoperative injection and a first 2500 IU M
første gang, i 7 + 2 dage.
post-operative injection, for 7+2 days.
Patienter, der blev opereret urologisk (ud over nyrerne), gynækologisk, laparoskopisk eller i kar, var ikke med i forsøget. læ
Patients under-going urological (other than kidney) or gynaecological surgery, laparoscopic surgery or vascular surgery were not included in the study.
Forskellen i den totale forekomst af VTE i de to grupper, som ikke var statistisk signifikant, skyldtes e
(62/ 1021) with dalteparin: odds ratio reduction [95%CI] = -25.8% [-49.7%, 9.5%].
Forekomsten af symptomatisk DVT var den samme i de behandlede grupper, nemlig 6 patienter (0, 4%) i fondaparinuxgruppen over for 5 patienter ikk
The incidence of symptomatic DVT was similar between
(0, 3%) i dalteparingruppen.
6 patients (0.4%) in the fondaparinux group vs 5 patients (0.3%) in the dalteparin group.
I den store subgruppe af patienter, som gennemgik cancerkirurgi (69% af patienterne), var forekomsten af VTE 4, 7% i fondaparinuxgruppen mod 7, 7% i dalteparingruppen. er
In the large subgroup of patients undergoing cancer surgery (69% of the patient population), the VTE rate was 4.7% in the fondaparinux group, versus 7.7% in the dalteparin group.
Der blev observeret større blødninger hos 3, 4% af patienterne i fondaparinuxgruppen over for 2, 4% i dalteparingruppen. et
Major bleeding was observed in 3.4% of the patients in the fondaparinux group and in 2.4% of the dalteparin group.
Forebyggelse af tromboemboliske komplikationer hos medicinske patienter med høj risiko for tromboemboliske komplikationer på grund af immobilisering under akut sygdom idl
Prevention of Venous Thromboembolic Events (VTE) in medical patients who are at high risk for thromboembolic complications due to restricted mobility during acute illness
I et randomiseret, dobbeltblindt klinisk forsøg blev 839 patienter behandlet med fondaparinux 2, 5 mg en gang daglig i 6- 14 dag.
d In a randomised double-blind clinical trial, 839 patients were treated with fondaparinux 2.5 mg once
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 m
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
hjerteinsufficiens (NYHA- klasse III/ IV) og/ eller akut respirationssygdom og/ eller akut infektiøs eller inflammatorisk sygdom.
ris class III/ IV and/ or acute respiratory illness and/ or acute infectious or inflammatory disease.
Fondaparinux nedsatte den generelle forekomst af tromboemboliske ge
Fondaparinux significantly reduced the overall rate of VTE compared to placebo [18 patients (5.6%)
18 patienter (5, 6% og 34 patienter (10, 5%)].
ho vs 34 patients (10.5%), respectively].
I hver Læ
Fondaparinux also significantly reduced the rate of adjudicated fatal PE [0 patients (0.0%) vs 5 patients (1.2%), respectively].
gruppe observeredes større blødninger hos 1 patient (0, 2%).
Major bleedings were observed in 1 patient (0.2%) of each group.
Behandling af ustabil angina eller non- ST segment elevations myokardieinfarkt (UA/ NSTEMI) OASIS 5 var en dobbeltblindet, randomiseret, noninferioritetsundersøgelse af fondaparinux 2, 5 mg
ut Treatment of unstable angina or non-ST segment elevation myocardial infarction (UA/ NSTEMI)
18 subkutant én gang daglig versus enoxaparin 1 mg/ kg subkutant to gange daglig til ca.
ra 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.
20. 000 patienter med UA/ NSTEMI.
All patients received standard medical treatment for UA/ NSTEMI,
Alle patienter fik medicinsk UA/ NSTEMI- standardbehandling, 34% fik foretaget PCI, og 9% fik foretaget CABG.
e 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 ng 5.5 days in the fondaparinux group and 5.2 days in the enoxaparin group.
lg patienterne enten intravenøs fondaparinux (fondaparinuxpatienter) eller vægtbaseret intravenøs UFH (enoxaparinpatienter) som tillægsbehandling, afhængig af tidspunktet for den sidste subkutane dosis
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 lo subcutaneous dose and planned use of GP IIb/ IIIa inhibitor.
40% af patienterne havde let nedsat nyrefunktion (kreatininclearance ≥ 50 og < 80 ml/ min.), og ca.
Approximately 40% and 17% of patients had no
17% havde moderat nedsat nyrefunktion (kreatinclearance ≥ 30 og < 50
mild (creatinine clearance ≥ 50 to < 80 ml/ min) or moderate (creatinine clearance ≥ 30 to < 50 ml/ min) renal impairment, respectively.
til ml/ min.).
The primary adjudicated endpoint was a composite of death, myocardial infarction (MI) and refractory ct
et Det primære sammensatte endpoint var død, myokardieinfarkt (MI) og refraktær iskæmi (RI) senest 9 dage efter randomisering.
ischaemia (RI) within 9 days of randomisation.
I fondaparinuxgruppen forekom det primære sammensatte endpoint blandt
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, du
er 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).
95% CI, 0.90, 1.13, one-sided non-inferiority p value = 0.003). ro
ris 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
The effects on the incidence of lP
to enoxaparin på MI - og RI- incidensen var ikke statistisk forskellig.
MI and RI were not statistically different between the fondaparinux and enoxaparin treatment groups.
au På dag 9 var incidensen af svær blødning for fondaparinux og enoxaparin hhv.
At Day 9 the incidence of major bleeding on fondaparinux and enoxaparin was 2.1% and 4.1%, na
2, 1% og 4. 1% (hazard rate 0, 52; 95% CI 0, 44- 0, 61; p < 0, 001).
respectively (hazard ratio 0.52, 95% CI, 0.44; 0.61, p < 0.001).
Effektparametrene og resultaterne vedrørende svær blødning var konsistent mellem de e præspecificerede undergrupper, så som ældre, patienter med nedsat nyrefunktion og ved samtidig er administration af trombocytaggregationshæmmere (aspirin, thienopyridiner eller GP- IIb/ IIIa - hæmmere). ng
such as elderly, renally impaired patients, type of concomitant platelet aggregation inhibitors (aspirin, thienopyridines or GP IIb/ IIIa inhibitors). ed
8, 8% og 8, 2% 9 dage efter randomiseirngen (hazard læ
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 M
rate 1, 08; 95% CI 0, 92- 1, 27).
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. e
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).
12. 000 patienter med STEMI.
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 12000 patients with STEMI.
Alle patienter modtog standardbehandling for STEMI, i form af primær PCI (31%), fibrinolyse (45%) eller ingen er
All patients received standard treatments for STEMI, including primary PCI (31%), 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
streptokinase).
19 treated with a non-fibrin specific agent (primarily streptokinase).
40 et
The mean age of the patients was 61 years, and approximately 40% were at least 65 years old.
14% havde moderat nedsat nyrefunktion idl
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.
(kreatininclearence ≥ 30 til < 50 ml/ min.).
The primary adjudicated endpoint was a composite of death and recurrent MI (re-MI) within 30 days of randomisation.
Det primære sammensatte endpoint var død og reinfarkt (re- MI) senest 30 dage efter randomisering. m
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).
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). ge
In the predefined stratum comparing fondaparinux to placebo (i. e patients treated with non-
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%), fibrinselektivt fibrinolytika (0, 3%), primær PCI (0, 4%)), var incidensen af død/ re- MI efter 30 dage Læ
d fibrin specific lytics (77.3%), no reperfusion (22%), fibrin-specific lytics (0.3%), primary PCI (0.4%)),
signifikant reduceret fra 14, 0% for placebo til 11, 3% (hazard rate 0, 80; 95% CI 0, 69- 0, 93; p = 0, 003).
e 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).
I det prædefinerede stratum, som sammenlignede fondaparinux med UFH (patienter behandlet med
In the predefined stratum comparing fondaparinux
19 primær PCI (58, 5%), fibrinselektivt fibrinolytika (13%), ikke- fibrinselektivt fibrinolytika (2, 6%) og ingen reperfusion (25, 9%)), var effekten af fondaparinux og UFH på incidensen af død/ re- MI på dag 30 ikke statistisk forskellig; hhv.
ris 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
8, 3% versus 8, 7% (hazard rate 0, 94; 95% CI 0, 79- 1, 11; p = 0, 460).
ho 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,
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
lg 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).
ut 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).
sa 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
til Forskellen i mortalitet var signifikant i stratum 1 (sammenlignet med placebo) men ikke i stratum 2 (sammenlignet med UFH).
e difference in mortality was statistically significant in stratum 1 (placebo comparator) but not in ng stratum 2 (UFH comparator).
Den mortalitetsgevinst, der blev observeret i fondaparinuxgruppen blev
The mortality benefit shown in the fondaparinux group was maintained until the end of follow-up at Day 180. lo 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, no
et opretholdt til slutningen af opfølgningsperioden ved dag 180.
95%CI, 0.68; 0.93, p = 0.003).
er 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).
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).
Blandt patienter, som initielt ikke fik reperfusion, reducerede fondaparinux
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 ct
For patienter, som var blevet
group vs 4.8% in the control group; hazard ratio 1.26, 95% CI, 0.96, 1.66)]. du
to behandlet med primær PCI, var der ikke signifikant forskel i incidensen af død/ re- MI efter 30 dage mellem de to grupper (hhv.
By Day 9, 1.1% of patients treated with fondaparinux and 1.4% of control patients experienced a severe haemorrhage.
6, 0% i fondaparineuxgruppen versus 4, 8% i kontrolgruppen (hazard rate
In patients given a thrombolytic, severe haemorrhage occurred in 1.3% of the ro
au 1, 26; 95% CI 0, 96- 1, 66)).
fondaparinux patients and in 2.0% of controls.
På dag 9 var incidensen af alvorlig blødning 1, 1% for patienter, som var blevet behandlet med fondaparinux og 1, 4% for patienter i kontrolgruppen.
In patients initially not reperfused, the incidence of severe haemorrhage was 1.2% for fondaparinux vs 1.5% for controls.
For patienter, som var blevet behandlet med primær PCI, ng
For patients receiving primary lP
var incidensen af alvorlig blødning 1, 0% for fondaparinux og 0, 4% i kontrolgruppen.
PCI, the incidence of severe haemorrhage was 1.0% for fondaparinux and 0.4% for controls.
Effektparametre og resultater af alvorlig blødning var konsistent mellem de præspecificerede læ
The efficacy findings and results on severe haemorrhage were consistent across prespecified na
undergrupper, så som ældre, patienter med nedsat nyrefunktion og i forbindelse med anden samtidig trombocytfunktionshæmmende behandling (aspirin, thienopyridin). e
subgroups such as elderly, renally impaired patients, type of concomitant platelet aggregation inhibitors (aspirin, thienopyridines). ici
5. 2 Farmakokinetiske egenskaber ikk
5.2 Pharmacokinetic properties ed
Efter en enkelt subkutan injektion af 2, 5 mg fondaparinux til unge raske forsøgspersoner opnås den maksimale plasmakoncentration (gennemsnitlig Cmax = 0, 34 mg/ l) 2 timer er
Following a single subcutaneous injection of fondaparinux 2.5 mg to young healthy subjects, M
efter indgift.
peak plasma concentration (mean Cmax = 0.34 mg/ l) is obtained 2 hours post-dosing.
Plasmakoncentrationer på halvdelen af de gennemsnitlige Cmax- værdier indtræffer 25 minutter efter indgift. et
Plasma concentrations of half the mean Cmax values are reached 25 minutes post-dosing.
Ved en daglig subkutan dosis opnås steady state- plasmakoncentration efter 3- 4 dage idl
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.
Cmax (mg/ l) – 0, 39 (31%), Tmax (h) – ge
20 Mean (CV%) steady state pharmacokinetic parameters estimates of fondaparinux in patients undergoing hip replacement surgery receiving fondaparinux 2.5 mg once daily are:
2, 8 (18%) og Cmin (mg/ l) – 0, 14 (56%).
Cmax (mg/ l) - 0.39 (31%), Tmax (h) - 2.8 (18%) and Cmin (mg/ l) -0.14 (56%).
Læ
Cmax (mg/ l) - 0.50 (32%), Cmin (mg/ l) - 0.19 (58%).
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
Fondaparinux bindes ikke væsentligt til andre
Fondaparinux does not bind
20 plasmaproteiner, herunder platelet factor 4 (PF4).
e significantly to other plasma proteins, including platelet factor 4 (PF4).
Da fondaparinux ikke bindes til andre plasmaproteiner end ATIII, er der ingen forventning om interaktion med andre lægemidler i form af proteinbindingssubstitution.
ris Since fondaparinux does not bind significantly to plasma proteins other than ATIII, no interaction with other medicinal products by protein binding displacement are expected.
lg Metabolisme
ho Metabolism Although not fully evaluated, there is no evidence of fondaparinux metabolism and in particular no
sa Selvom en fuldstændig evaluering ikke foreligger, er der ikke fundet tegn på metabolisme af fondaparinux eller dannelse af aktive metabolitter.
ut evidence for the formation of active metabolites.
til Fondaparinux hæmmer ikke CYP450- enzymer (CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1 og CYP3A4) in vitro.
ra Fondaparinux does not inhibit CYP450s (CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1 or CYP3A4) in vitro.
et Udskillelse/ elimination
e Excretion/ Elimination
17 timer hos raske unge forsøgspersoner og ca.
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. lo Special populations no
ris Særlige befolkningsgrupper:
Paediatric patients - Fondaparinux has not been investigated in this population.
to Pædiatriske patienter - Fondaparinux er ikke undersøgt i denne patientgruppe.
Elderly patients - Renal function may decrease with age and thus, the elimination capacity for ct
au Ældre patienter - Nyrefunktionen kan aftage med alderen, og derfor kan eliminationen af fondaparinux være reduceret hos ældre.
fondaparinux may be reduced in elderly.
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. e er 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 ng
In patients > 75 years undergoing orthopaedic surgery, the estimated plasma clearance was 1.2 to 1.4 times lower than in patients < 65 years. du
(kreatininclearance 50- 80 ml/ min) og gennemsnitligt 2 gange lavere hos patienter med moderat nedsat nyrefunktion (kreatininclearance 30- 50 ml/ min).
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 lP
Ved svært nedsat nyrefunktion (kreatininclearance < 30 ml/ min) er plasmaclearance ca.
moderate renal impairment (creatinine clearance 30 to 50 ml/ min).
Værdierne for læ
In severe renal impairment (creatinine clearance < 30 ml/ min), plasma clearance is approximately 5 times lower than in normal renal function.
terminal halveringstid var 29 timer hos patienter med moderat nedsat nyrefunktion, og 72 timer hos patienter med svært nedsat nyrefunktion.
Associated terminal half-life values were 29 h in moderate and 72 h in patients with na
Køn - Der blev ikke observeret kønsspecifikke forskelle efter justering for legemsvægt. e ikk
Gender - No gender differences were observed after adjustment for body weight. ici
Race - Forskelle i farmakokinetik, som kan tilskrives race, er ikke undersøgt prospektivt.
However, studies ed
Imidlertid påviste studier med asiatiske (japanske), raske forsøgspersoner ingen forskel i den farmakokinetiske profil ved sammenligning med kaukasiske, raske forsøgspersoner.
performed in Asian (Japanese) healthy subjects did not reveal a different pharmacokinetic profile compared to Caucasian healthy subjects.
Der blev heller ikke observeret forskelle i plasmaclearance mellem sorte og kaukasiske patienter, som gennemgik ortopædkirurgi. er
M
Legemsvægt - Plasmaclearance af fondaparinux stiger i takt med legemsvægten (9% for hver 10 kg). et
Body weight - Plasma clearance of fondaparinux increases with body weight (9% increase per 10 kg).
Nedsat leverfunktion - Farmakokinetikken af fondaparinux er ikke evalueret hos patienter med nedsat leverfunktion. idl
Hepatic impairment - Fondaparinux pharmacokinetics has not been evaluated in hepatic impairment.
5. 3 Prækliniske sikkerhedsdata m
21 5.3 Preclinical safety data
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.
Læ
Animal studies are insufficient with respect to effects on toxicity to reproduction because of limited exposure.
21 Natriumchlorid Vand til injektionsvæsker Saltsyre
Sodium chloride Water for injections
lg Natriumhydroxid
e
sa 6. 2 Uforligeligheder
d
Da der ikke foreligger undersøgelser vedrørende eventuelle uforligeligheder, må denne medicin ikke
ris Hydrochloric acid Sodium hydroxide
til blandes med andre lægemidler.
ho 6.2 Incompatibilities
6. 3 Opbevaringstid
ut In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
et 2 år.
ra 6.3 Shelf life
er Hvis fondaparinuxnatrium tilsættes en minipose 0, 9% saltopløsning bør infusionen ideelt set gives
e 2 years. ng 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. lo 6.4 Special precautions for storage no
ris straks, men den kan opbevares ved stuetemperatur i op til 24 timer.
Do not freeze.
6. 4 Særlige opbevaringsforhold
6.5 Nature and contents of container ct