natgillin/translations-raw huggingface dataset:
Nedsat nyrefunktion - Fondaparinux må ikke anvendes til patienter med en kreatininclearance < 20 ml/ min.
Renal impairment - Fondaparinux should not be used in patients with creatinine clearance < 20 ml/ min (see section 4.3).
4. 4 og 5. 2).
The dose should be reduced to 1.5 mg once daily in patients with creatinine clearance in the range of 20 to 50 ml/ min (see sections 4.4 and 5.2).
Dosisjustering er ikke påkrævet for patienter med mildt nedsat nyrefunktion (kreatininclearance > 50 ml/ min.).
No dosage reduction is required for patients with mild renal impairment (creatinine clearance > 50 ml/ min).
Nedsat leverfunktion - Dosisjustering er ikke nødvendig for patienter med enten mildt eller moderat nedsat leverfunktion.
Hepatic impairment - No dosing adjustment is necessary in patients with either mild or moderate hepatic impairment.
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).
Børn - Fondaparinux bør ikke anvendes til børn under 17 år p. g. a. manglende dokumentation for sikkerhed og virkning.
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.
Indgivelsesmåde Fondaparinux gives som dyb subkutan injektion, mens patienten ligger ned.
Method of administration Fondaparinux is administered by deep subcutaneous injection while the patient is lying down.
Hele nålens længde bør indføres vertikalt i hudfolden der holdes mellem tommel - og pegefinger; hudfolden bør holdes under hele injektionen.
The whole length of the needle should be inserted perpendicularly into a skin fold held between the thumb and the forefinger; the skin fold should be held throughout the injection.
6. 6.
For additional instructions for use and handling and disposal see section 6.6.
- overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne
- hypersensitivity to the active substance or to any of the excipients
- aktiv klinisk betydende blødning
- active clinically significant bleeding
- akut bakteriel endokardit
- acute bacterial endocarditis
- alvorlig nedsat nyrefunktion defineret ved en kreatininclearance < 20ml/ min
- severe renal impairment defined by creatinine clearance < 20 ml/ min.
Hæmoragi 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.
Haemorrhage 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.
Sådanne præparater omfatter desirudin, fibrinolytika, GP IIb/ IIIa- receptorantagonister, heparin, heparinoider og lavmolekylært heparin.
These agents include desirudin, fibrinolytic agents, GP IIb/ IIIa receptor antagonists, heparin, heparinoids, or Low Molecular Weight Heparin (LMWH).
4. 5.
When required, concomitant therapy with vitamin K antagonist should be administered in accordance with the information of Section 4.5.
3 Spinal - / epiduralanæstesi Ved større ortopædiske operationer er det ikke muligt ved samtidig brug af fondaparinux og spinal - / epiduralanæstesi eller spinalpunktur at udelukke forekomsten af epidurale eller spinale hæmatomer, som kan føre til langvarig eller permanent paralyse.
3 Spinal / Epidural anaesthesia In patients undergoing major orthopaedic surgery, epidural or spinal haematomas that may result in long-term or permanent paralysis cannot be excluded with the concurrent use of fondaparinux and spinal/ epidural anaesthesia or spinal puncture.
Ældre patienter Den ældre befolkning har generelt en øget blødningsrisiko.
Elderly patients The elderly population is at increased risk of bleeding.
5. 2).
As renal function is generally decreasing with age, elderly patients may show reduced elimination and increased exposure of fondaparinux (see section 5.2).
4. 2).
Fondaparinux should be used with caution in elderly patients (see section 4.2).
Lav kropsvægt Patienter med en kropsvægt < 50 kg har en øget blødningsrisiko.
Low body weight Patients with body weight < 50 kg are at increased risk of bleeding.
4. 2).
Fondaparinux should be used with caution in these patients (see section 4.2).
4. 2, 4. 3 og 5. 2).
Patients with creatinine clearance < 50 ml/ min are at increased risk of bleeding and VTE and should be treated with caution (see sections 4.2, 4.3 and 5.2).
Der er kun en begrænset mængde kliniske data tilgængelig for patienter med en kreatininclearance mindre end 30 ml/ min.
There are limited clinical data available from patients with creatinine clearance less than 30 ml/ min.
Alvorligt nedsat leverfunktion Dosisjustering af fondaparinux er ikke nødvendig.
Severe hepatic impairment Dosing adjustment of fondaparinux is not necessary.
4. 2).
However, 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).
Patienter med heparin- induceret trombocytopeni Fondaparinux bør anvendes med forsigtighed til patienter med HIT i anamnesen.
Patients with Heparin Induced Thrombocytopenia Fondaparinux should be used with caution in patients with a history of HIT.
Fondaparinux binder ikke til trombocytfaktor 4, og giver ikke krydsreaktion med sera fra patienter med heparin- induceret trombocytopeni type II (HIT II).
Fondaparinux does not bind to platelet factor 4 and does not cross-react with sera from patients with Heparin Induced Thrombocytopenia (HIT) type II.
4. 4).
Bleeding risk is increased with concomitant administration of fondaparinux and agents that may enhance the risk of haemorrhage (see section 4.4).
I interaktionsstudier var fondaparinux- dosis (10 mg) højere end anbefalet for de aktuelle indikationer.
The fondaparinux dose (10 mg) in the interaction studies was higher than the dose recommended for the present indications.
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.
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.
Hvis der er behov for opfølgende behandling med vitamin K- antagonist, skal behandlingen med fondaparinux fortsættes, indtil den tilsigtede værdi for INR nås.
If follow up treatment with a Vitamin K antagonist is required, treatment with fondaparinux should be continued until the target INR value has been reached.
De udførte dyreforsøg er utilstrækkelige med hensyn til virkningerne for graviditetens og/ eller embryoets/ fostrets
Animal studies are insufficient with respect to effects on pregnancy, embryo/ foetal development, parturition and postnatal
4 udvikling, fødslen og den postnatale udvikling på grund af begrænset eksponering.
4 development because of limited exposure.
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.
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.
- < 1/ 10; ikke almindelig ≥ 1/ 1. 000 - < 1/ 100; sjælden ≥ 1/ 10. 000 - < 1/ 1. 000; meget sjælden <
The adverse reactions reported by the investigator as at least possibly related to fondaparinux are presented within each frequency grouping (very common ≥ 1/ 10; common: ≥ 1/ 100 to < 1/ 10; uncommon: ≥ 1/ 1,000 to < 1/ 100; rare: ≥ 1/ 10,000 to < 1/ 1,000; very rare < 1/ 10,000) and system organ class by decreasing order of seriousness; these adverse reactions should be interpreted within the surgical and medical context.
5 Systemorganklasse MedDRA
System organ class MedDRA
Bivirkninger hos patienter i større ortopædisk operation i underekstremiteterne og eller abdominal kirurgi
Undesirable effects in patients undergoing major orthopaedic surgery of lower limbs and/ or abdominal surgery
Almindelig: postoperativ blødning, anæmi Ikke almindelig: blødninger (epistaxis, gastrointestinale blødninger, hæmoptyse, hæmaturi, hæmatom), trombocytopeni, purpura, trombocytæmi, trombocytabnormitet, koagulationsforstyrrelse
Common: post-operative haemorrhage, anaemia Uncommon: bleeding (epistaxis, gastrointestinal, haemoptysis, haematuria, haematoma) thrombocytopenia, purpura, thrombocythaemia, platelet abnormal, coagulation disorder
Almindelig: blødninger (hæmatom, hæmaturi, hæmoptyse, gingival blødning) Ikke almindelig: anæmi
Common: bleeding (haematoma, haematuria, haemoptysis, gingival bleeding) Uncommon: anaemia
Sjælden: allergiske reaktioner
Immune system disorders Rare: allergic reaction
Metabolisme og ernæring Sjælden: hypokaliæmi Nervesystemet
Metabolism and nutrition Rare: hypokalaemia disorders
Sjælden: uro, somnolens, vertigo, svimmelhed, hovedpine, konfusion
Nervous system disorders Rare: anxiety, somnolence, vertigo, dizziness, headache, confusion
Vaskulære sygdomme
5 Vascular disorders
Luftveje, thorax og mediastinum
Respiratory, thoracic and Rare: dyspnoea, coughing mediastinal disorders
Sjælden: dyspnø, hoste
Uncommon: dyspnoea
Ikke almindelig: dyspnø
Gastrointestinal Uncommon: nausea, vomiting disorders Rare: abdominal pain, dyspepsia, gastritis, constipation, diarrhoea
Mave- tarmkanalen
Hepatobiliary disorders
Ikke almindelig: kvalme, opkastning Sjælden: mavesmerter, dyspepsi, gastritis, obstipation, diaré
Uncommon: hepatic enzymes increased, hepatic function abnormal Rare: bilirubinaemia
Lever og galdeveje
Uncommon: rash, pruritus
Ikke almindelig: forhøjet levertal, abnorm leverfunktion Sjælden: bilirubinæmi
Uncommon: rash, pruritus
Hud og subkutane væv Almene symptomer og reaktioner på administrationsstedet
General disorders and administration site conditions
Ikke almindelig: udslæt, kløe Ikke almindelig: ødem, perifert ødem, feber, sårsekretion Sjælden: brystsmerter, træthed, rødme, hedeture, smerte i ben, genitale ødemer, synkope
Uncommon: oedema, oedema peripheral, fever, wound secretion Rare: chest pain, fatigue, hot flushes, leg pain, oedema genital, flushing, syncope
Ikke almindelig: udslæt, kløe Ikke almindelig: brystsmerter
Uncommon: chest pain
B01AX05.
B01AX05
6 Farmakodynamiske virkninger
Pharmacodynamic effects
Fondaparinux antitrombotiske aktivitet skyldes antitrombin III (ATIII) - medieret selektiv hæmning af Faktor Xa.
Fondaparinux is a synthetic and selective inhibitor of activated Factor X (Xa).
Ved selektiv binding til ATIII øger fondaparinux ATIII naturlige hæmning af Faktor Xa (ca.
The antithrombotic activity of fondaparinux is the result of antithrombin III (ATIII) mediated selective inhibition of Factor Xa.
300 gange).
By binding selectively to ATIII, fondaparinux potentiates (about 300 times) the innate neutralization of Factor Xa by ATIII.
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.
6 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.
Der er dog set sjældne spontane tilfælde af aPTT- forlængelse.
However, rare spontaneous reports of aPTT prolongation have been received.
Fondaparinux giver ikke krydsreaktion med sera fra patienter med heparin- induceret trombocytopeni.
Fondaparinux does not cross-react with sera from patients with heparin-induced thrombocytopaenia.
Forebyggelse af tromboemboliske komplikationer hos patienter ved større ortopædkirurgi i underekstremiteterne efter op til 9 dages behandling Fondaparinux kliniske forsøgsprogram var tilrettelagt med henblik på at påvise effekten af fondaparinux til forebyggelse af venøse tromboemboliske komplikationer (VTE), dvs. proksimal og distal dyb venetrombose og lungeemboli hos patienter, som skulle have foretaget større ortopædkirurgiske indgreb i underekstremiteterne som fx ved hoftefraktur og knæ - eller hofteleds - alloplastik.
Prevention of Venous Thromboembolic Events (VTE) in patients undergoing major orthopaedic surgery of the lower limbs treated up to 9 days 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.
Over 8. 000 patienter (hoftefraktur: n=1711; hoftealloplastik: n=5829; større knæoperationer: n=1367) blev inkluderet i kontrollerede kliniske fase II- og III- studier.
Over 8,000 patients (hip fracture – 1,711, hip replacement – 5,829, major knee surgery – 1,367) were studied in controlled Phase II and III clinical studies.
Fondaparinux 2, 5 mg en gang daglig med første administration 6- 8 timer postoperativt blev sammenlignet med enoxaparin 40 mg en gang daglig med første administration 12 timer før kirurgi, eller 30 mg to gange daglig med første administration 12- 24 timer efter kirurgi.
Fondaparinux 2.5 mg once daily started 6-8 hours postoperatively was compared with enoxaparin 40 mg once daily started 12 hours before surgery, or 30 mg twice daily started 12-24 hours after surgery.
En analyse af de samlede data fra disse studier fandt, at det anbefalede dosisregime af fondaparinux vs. enoxaparin medfører et signifikant fald (54% - med 95% konfidensinterval, 44% - 63%) i forekomsten af tromboemboliske komplikationer vurderet frem til dag 11 efter indgrebet, uanset den udførte type kirurgi.
In a pooled analysis of these studies, the recommended dose regimen of fondaparinux versus enoxaparin was associated with a significant decrease (54% [95% CI, 44%; 63%]) in the rate of VTE evaluated up to day 11 after surgery, irrespective of the type of surgery performed.
Forekomsten af proksimal dyb venetrombose blev dog ligeledes reduceret signifikant.
The majority of endpoint events were diagnosed by a prescheduled venography and consisted mainly of distal DVT, but the incidence of proximal DVT was also significantly reduced.
I studier, hvor fondaparinux blev sammenlignet med enoxaparin 40 mg en gang daglig med første administration 12 timer før indgrebet, blev der observeret større blødninger hos 2, 8% af de patienter, der fik fondaparinux i den anbefalede dosering, mens der blev set 2, 6% i enoxaparingruppen.
In studies versus enoxaparin 40 mg once daily started 12 hours before surgery, major bleeding was observed in 2.8% of fondaparinux patients treated with the recommended dose, compared to 2.6% with enoxaparin.
Forebyggelse af tromboemboliske komplikationer hos patienter opereret for hoftefraktur med efterfølgende profylakse givet 7 dage plus op til 24 dage I et randomiseret, dobbeltblindt klinisk forsøg blev 737 patienter behandlet med fondaparinux 2, 5 mg en gang daglig i 7 ± 1 dag efter operation for hoftefraktur.
Prevention of Venous Thromboembolic Events (VTE) in patients undergoing hip fracture surgery treated for up to 24 days following an initial prophylaxis of 1 week In a randomised double-blind clinical trial, 737 patients were treated with fondaparinux 2.5 mg once daily for 7 +/ - 1 days following hip fracture surgery.
Efter denne periode blev 656 patienter randomiseret til behandling med fondaparinux 2, 5 mg en gang daglig eller placebo i yderligere 21 ± 2 dage.
At the end of this period, 656 patients were randomised to receive fondaparinux 2.5 mg once daily or placebo for an additional 21 +/ - 2 days.
Fondaparinux medførte en signifikant reduktion af den generelle forekomst af venøse tromboemboliske komplikationer sammenlignet med placebo [henholdsvis 3 patienter (1, 4%) kontra 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].
Størstedelen (70/ 80) af de rapporterede venøse tromboemboliske komplikationer var ikke symptomatiske tilfælde, der blev påvist ved flebografi som dybe venetromboser.
The majority (70/ 80) of the recorded VTE events were venographically detected non-symptomatic cases of DVT.
Fondaparinux medførte også en signifikant reduktion af forekomsten af symptomatiske, venøse tromboemboliske komplikationer (dyb venetrombose og/ eller lungeemboli) [henholdsvis 1 patient (0, 3%) kontra 9 patienter (2, 7%)], herunder to fatale tilfælde af lungeemboli rapporteret i placebogruppen.
Fondaparinux also provided a significant reduction in the rate of symptomatic VTE (DVT, and / or PE) [1 (0.3%) vs 9 (2.7%) patients, respectively] including two fatal PE reported in the placebo group.
7 behandling med placebo.
Major bleedings, all at surgical site and none fatal, were observed in 8 patients (2.4%) treated with fondaparinux 2.5 mg compared to 2 (0.6%) with placebo.
Forebyggelse af tromboemboliske komplikationer (VTE) hos patienter, der gennemgår abdominalkirurgi, med høj risiko for tromboemboliske komplikatoner, fx ved abdominalcancer I et dobbeltblindt klinisk forsøg blev 2. 927 patienter randomiseret til at få fondaparinux 2, 5 mg en gang daglig eller dalteparin 5. 000 IE en gang daglig, dog 2. 500 IE præoperativt og 2. 500 IE postoperativt første gang, i 7 + 2 dage.
Prevention of Venous Thromboembolic Events (VTE) in patients undergoing abdominal surgery who are judged to be at high risk of thromboembolic complications, such as patients undergoing abdominal cancer surgery In a double-blind clinical study, 2,927 patients were randomized to receive fondaparinux 2.5mg once daily or dalteparin 5,000 IU once daily, with one 2,500 IU preoperative injection and a first 2,500 IU post-operative injection, for 7+2 days.
De primære operationsområder var colon/ rektum, ventrikel, lever og galdeblære.
The main sites of surgery were colonic/ rectal, gastric, hepatic, cholecystectomy or other biliary.
69% var cancerkirurgi.
Sixty-nine percent of the patients underwent surgery for cancer.
I dette forsøg var forekomsten af VTE i alt 4, 6% (47/ 1. 027) med fondaparinux over for 6, 1% (62/ 1. 021) med dalteparin: odds risikoreduktion 25, 8% med 95% konfidensinterval - 49, 7% - 9, 5%.
(62/ 1,021) with dalteparin: odds ratio reduction [95%CI] = -25.8% [-49.7%, 9.5%].
Forskellen i den totale forekomst af VTE i de to grupper, som ikke var statistisk signifikant, skyldtes hovedsageligt en reduktion i asymptomatisk distal DVT.
The difference in total VTE rates between the treatment groups, which was not statistically significant, was mainly due
Forekomsten af symptomatisk DVT var den samme i de behandlede grupper, nemlig 6 patienter (0, 4%) i fondaparinuxgruppen over for 5 patienter (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.
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 hos 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.
Forebyggelse af tromboemboliske komplikationer hos medicinske patienter med høj risiko for tromboemboliske komplikationer på grund af immobilisering under akut sygdom I et randomiseret, dobbeltblindt klinisk forsøg blev 839 patienter behandlet med fondaparinux 2, 5 mg en gang daglig i 6- 14 dag.
Prevention of Venous Thromboembolic Events (VTE) in medical patients who are at high risk for thromboembolic complications due to restricted mobility during acute illness In a randomised double-blind clinical trial, 839 patients were treated with fondaparinux 2.5 mg once daily or placebo for 6 to 14 days.
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.
18 patienter (5, 6% og 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].
0 patienter (0, 0%) og 5 patienter (1, 2%)].
Fondaparinux also significantly reduced the rate of adjudicated fatal PE [0 patients (0.0%) vs 5 patients (1.2%), respectively].
I hver gruppe observeredes større blødninger hos 1 patient (0, 2%).
Major bleedings were observed in 1 patient (0.2%) of each group.
Absorption Efter subkutan indgift absorberes fondaparinux fuldstændigt og hurtigt med en absolut biotilgængelighed på 100%.
Absorption After subcutaneous dosing, fondaparinux is completely and rapidly absorbed (absolute bioavailability 100%).
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 efter indgift.
Following a single subcutaneous injection of fondaparinux 2.5 mg to young healthy subjects, 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.
Plasma concentrations of half the mean Cmax values are reached 25 minutes post-dosing.
Hos ældre raske forsøgspersoner, fandtes fondaparinux farmakokinetik lineær i området 2- 8 mg ved subkutan indgift.
In elderly healthy subjects, pharmacokinetics of fondaparinux are linear in the range of 2 to 8 mg by subcutaneous route.
Ved en daglig dosis opnås steady state- plasmakoncentration efter 3- 4 dage med en 1, 3 gange øget Cmax og AUC.
Following once daily 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)) farmakokinetiske parametre for hoftealloplastik- patienter, der får fondaparinux 2, 5 mg daglig, er:
Mean (CV%) steady state pharmacokinetic parameters estimates of fondaparinux in patients undergoing hip replacement surgery receiving fondaparinux 2.5 mg once daily are:
Cmax (mg/ l) – 0, 39 (31%), Tmax (h) – 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%).