natgillin/translations-raw huggingface dataset:
anaesthesia in case of surgical procedures should not be used.
spinalne/ epiduralne anestezije v primeru kirurških postopkov ni dovoljena.
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.
Incidence krvavitev pri bolnikih na priporočeni shemi zdravljenja DVT ali PE in starih < 65 let, 65- 75 let oziroma > 75 let so bile 3, 0%, 4, 5% oziroma
25 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.
Ustrezne incidence pri bolnikih, ki so prejemali priporočeno shemo enoksaparina za zdravljenje DVT, so bile 2, 5%, 3, 6% oziroma 8, 3%, medtem ko so bile incidence pri bolnikih na priporočeni shemi UFH za zdravljenje PE, 5, 5%, 6, 6% oziroma 7, 4%.
Low body weight Clinical experience is limited in patients with body weight < 50 kg.
t Pri bolnikih s telesno maso < 50 kg so klinične izkušnje omejene.
Fondaparinux should be used with caution at a daily dose of 5 mg in this population (see sections 4.2 and 5.2).
V tej skupini je treba fondaparinuks
Renal impairment
me previdno uporabljati v dnevnem odmerku 5 mg (glejte poglavji 4. 2 in 5. 2).
d The risk of bleeding increases with increasing renal impairment.
Ledvična okvara Nevarnost krvavitve narašča z naraščajočo ledvično okvaro.
Fondaparinux is known to be
Znano je, da se fondaparinuks izloča
e excreted mainly by the kidney.
pro večinoma skozi ledvici.
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
Incidence krvavitev pri bolnikih, ki so prejemali priporočeno shemo za zdravljenje DVT ali PE in so imeli normalno ledvično funkcijo, blago ledvično okvaro, zmerno ledvično okvaro oziroma hudo ledvično okvaro, so bile 3, 0% (34/ 1132), 4, 4% (32/ 733), 6, 6% (21/ 318) oziroma 14, 5% (8/ 55).
The corresponding incidences in patients receiving the recommended
Ustrezne incidence pri bolnikih, ki so bili na priporočeni shemi enoksaparina za zdravljenje DVT, so bile 2, 3% (13/ 559), 4, 6% (17/ 368), 9, 7% (14/ 145) oziroma
ho 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),
za 11, 1% (2/ 18), pri bolnikih na priporočeni shemi nefrakcioniranega heparina za zdravljenje PE, pa so bile 6, 9% (36/ 523), 3, 1% (11/ 352), 11, 1% (18/ 162) oziroma 10, 7% (3/ 28).
ra 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).
nja Fondaparinuks je pri hudih ledvičnih okvarah (očistek kreatinina < 30 ml/ min) kontraindiciran, pri bolnikih z zmernimi ledvičnimi okvarami (očistek kreatinina 30- 50 ml/ min) pa ga je treba uporabljati previdno.
The duration of treatment should not exceed that evaluated during clinical trial (mean 7 days)
Trajanje zdravljenja ne sme preseči trajanja, ovrednotenega med kliničnim preskušanjem (povprečno 7 dni) (glejte poglavja 4. 2, 4. 3 in 5. 2).
e (see sections 4.2, 4.3 and 5.2). ng 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).
ledvic (očistek kreatinina 30- 50 ml/ min), nimamo nobenih izkušenj.
Fondaparinux should be used with care in these lo patients.
Pri teh bolnikih je treba fondaparinuks previdno uporabljati.
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). no
Po začetnem 10- miligramskem dnevnem odmerku lahko na podlagi farmakokinetičnega modeliranja preudarimo možnost zmanjšanja dnevnega odmerka na do
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). ct du
pomanjkanja koagulacijskih faktorjev pri bolnikih s hudimi okvarami jeter (glejte poglavje 4. 2).
Patients with Heparin Induced Thrombocytopenia Fondaparinux does not bind to platelet factor 4 and does not cross-react with sera from patients with Heparin Induced Thrombocytopenia (HIT) type II.
Fondaparinuks se ne veže na trombocitni faktor 4 in ne reagira navzkrižno s serumi bolnikov s trombocitopenijo, povzročeno s heparinom (HIT) tipa II.
been formally studied in patients with HIT type II. lP
Učinkovitosti in varnosti fondaparinuksa pri bolnikih s HIT tipa II niso formalno proučevali. nim
Bleeding risk is increased with concomitant administration of fondaparinux and agents that may na
Tveganje krvavitve se poveča pri sočasni uporabi fondaparinuksa in učinkovin, ki lahko povečajo tveganje za krvavitev (glejte poglavje 4. 4). ilo
In clinical studies performed with fondaparinux, oral anticoagulants (warfarin) did not interact with ici
V kliničnih študijah, opravljenih s fondaparinuksom, peroralni antikoagulanti (varfarin) niso medsebojno delovali s farmakokinetiko fondaparinuksa; pri 10- miligramskem odmerku, uporabljanem rav
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. ed
v študijah medsebojnega delovanja, fondaparinuks ni vplival na spremljano antikoagulantno aktivnost (INR) varfarina.
Platelet inhibitors (acetylsalicylic acid), NSAIDs (piroxicam) and digoxin did not interact with the pharmacokinetics of fondaparinux.
Trombocitni inhibitorji (acetilsalicilna kislina), NSAID (piroksikam) in digoksin niso medsebojno Zd
not influence the bleeding time under acetylsalicylic acid or piroxicam treatment, nor the pharmacokinetics of digoxin at steady state.
Pri 10- miligramskem odmerku, uporabljanem v študijah medsebojnega delovanja, fondaparinuks ni vplival na čas krvavitve ob sočasnem zdravljenju z acetilsalicilno kislino ali piroksikamom, niti na farmakokinetiko digoksina v stanju dinamičnega ravnovesja.
26 4.6 Pregnancy and lactation
27 4. 6 Nosečnost in dojenje
Fondaparinux is excreted in rat milk but it is not known whether fondaparinux is excreted in human milk.
Med
Breast-feeding is not recommended during treatment with fondaparinux.
me zdravljenjem s fondaparinuksom se dojenja ne priporoča.
ris No studies on the effect on the ability to drive and to use machines have been performed.
pro Študije o vplivu na sposobnost vožnje in upravljanja s stroji niso bile izvedene.
ho 4.8 Undesirable effects
4. 8 Neželeni učinki
ut Embolism and treated with fondaparinux for an average of 7 days.
za Varnost fondaparinuksa so ovrednotili pri 2. 517 bolnikih, zdravljenih zaradi venske trombembolije s fondaparinuksom, povprečno 7 dni dolgo.
ra 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;
nja Neželeni učinki, o katerih so poročali raziskovalci in za katere je možna vsaj majhna povezava s fondaparinuksom, so navedeni v skupinah glede na pogostnost (zelo pogosti ≥ 1/ 10; pogosti ≥ 1/ 100 do < 1/ 10; občasni ≥ 1/ 1. 000 do < 1/ 100; redki ≥ 1/ 10. 000 do < 1/ 1. 000; zelo redki ≤ 1/ 10. 000) in lje organski sistem v padajočem vrstnem redu po resnosti. vo do eā av nim ilo rav Zd
e 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. ng lo no ct du ro lP na ici ed M
28 Neželeni učinki pri bolnikih, ki so se zdravili Organski sistemi po zaradi venske trombembolije (VTE) 1 MedDRA
Undesirable effects in patients treated for VTE1
Pogosti: krvavitve (gastrointestinalne, hematurija, Bolezni krvi in hematom, epistaksa, hemoptiza, krvavitve iz limfatičnega sistema maternice in nožnice, hemartroza, očesne
Blood and lymphatic system disorders
t krvavitve, purpura, modrice)
d Uncommon: anaemia, thrombocytopaenia
me Občasni: anemija, trombocitopenija
e Rare: other bleeding (hepatic, retroperitoneal,
Redki: druge krvavitve (hepatične,
ris intracranial/ intracerebral), thrombocythaemia
pro retroperitonealne, intrakranialne/ intracerebralne), trombocitemija
Rare: allergic reaction
Redki: alergijska reakcija Bolezni imunskega
Metabolism and nutrition disorders
za sistema
e Rare: dizziness
Redki: omotica
Gastrointestinal ng Uncommon: nausea, vomiting disorders lo Hepatobiliary disorders Uncommon: abnormal liver function no
lje
Rare: rash erythematous
Občasni: navzea, bruhanje vo
ct
Bolezni jeter, žolčnika in žolčevodov
General disorders and administration site
Občasni: nenormalno delovanje jeter do
du
Bolezni kože in podkožja Redki: eritemski izpuščaj
Uncommon: pain, oedema, Rare: reaction at injection site
Občasni: bolečina, edem Splošne težave in eā
conditions ro
spremembe na mestu Redki: reakcija na mestu injiciranja aplikacije av
(2) Npn stands for non-protein-nitrogen such as urea, uric acid, amino acid, etc. lP
(2) Npn pomeni neproteinski dušik, kot na primer sečnina, sečna kislina, aminokisline, ipd. nim
4.9 Overdose na
4. 9 Preveliko odmerjanje
There is no known antidote to fondaparinux. ici
Antidota za fondaparinuks ne poznamo. ilo
Initiation of appropriate therapy such as surgical haemostasis, blood ed
Presoditi moramo o primerni terapiji, kot je kirurška hemostaza, rav
M
nadomeščanje krvi, transfuzija sveže plazme in plazmafereza.
PHARMACOLOGICAL PROPERTIES
FARMAKOLOŠKE LASTNOSTI Zd
28 Pharmacodynamic effects
29 Farmakodinamični učinki
Neutralisation of Factor Xa interrupts the blood coagulation cascade and inhibits both thrombin formation and thrombus development.
Nevtralizacija faktorja Xa prekine kaskado strjevanja krvi
Fondaparinux does not inactivate thrombin (activated Factor II) and has no effects on platelets.
Fondaparinuks ne deaktivira trombina (aktivirani
d At the doses used for treatment, fondaparinux does not, to a clinically relevant extent, affect routine
me faktor II) in nima učinka na trombocite.
e 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
V odmerkih, ki se uporabljajo pri zdravljenju, fondaparinuks ne vpliva, v klinično pomembnem obsegu, na rutinske koagulacijske teste v plazmi, kot so merjenje aktiviranega parcialnega
ris fibrinolytic activity.
pro tromboplastinskega časa (aPTT), aktiviranega časa nastanka strdka (ACT) ali razmerja protrombinski čas (PT) / internacionalno normalizirano razmerje (INR), niti na čas krvavitve ali fibrinolitično aktivnost.
At the 10 mg dose used in interaction studies, fondaparinux did not significantly influence the anticoagulation activity (INR) of
Pri 10- miligramskem odmerku, ki so ga uporabljali v študijah medsebojnega delovanja, fondaparinuks ni pomembno vplival na antikoagulacijsko aktivnost (INR) varfarina.
Fondaparinux does not cross-react with sera from patients with heparin-induced thrombocytopaenia.
za Fondaparinuks ne deluje navzkrižno s serumom bolnikov s heparinom inducirano trombocitopenijo.
ut Clinical studies
nja Klinične študije
ra The fondaparinux clinical program in treatment of Venous Thromboembolism was designed to demonstrate the efficacy of fondaparinux for the treatment of deep vein thrombosis (DVT) and
Klinični program za fondaparinuks pri zdravljenju venske trombembolije je bil oblikovan, da bi dokazal učinkovitost fondaparinuksa za zdravljenje globoke venske tromboze (DVT) in pljučne lje embolije (PE).
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 no
V kontroliranih kliničnih študijah faze II in III so proučevali več kot 4. 874 bolnikov. vo Zdravljenje globoke venske tromboze V randomiziranem, dvojno slepem kliničnem preskušanju pri bolnikih s potrjeno diagnozo akutne simptomatske DVT so fondaparinuks v odmerkih 5 mg (telesna masa < 50 kg), 7, 5 mg (telesna masa do
kg) or 10 mg (body weight > 100 kg) SC once daily was compared to enoxaparin sodium 1 mg/ kg SC twice daily.
≥ 50 kg, ≤ 100 kg) ali 10 mg (telesna masa > 100 kg) s. c. enkrat na dan primerjali z natrijevim enoksaparinatom v odmerku 1 mg/ kg s. c. dvakrat na dan.
A total of 2192 patients were treated; for both groups, patients were treated for at least 5 days and up to 26 days (mean 7 days).
Zdravili so vsega skupaj 2. 192 bolnikov; bolnike iz obeh skupin so zdravili vsaj po 5 dni in do 26 dni dolgo (povprečno po 7 dni).
Both treatment groups received Vitamin K antagonist therapy usually initiated within 72 hours after the first study drug administration and continued for 90 ± 7 ct
Obe zdravljeni skupini sta dobivali terapijo z antagonistom vitamina K, uvedeno prej kot 72 ur po prvi eā
days, with regular dose adjustments to achieve an INR of 2-3.
aplikaciji proučevanega zdravila, ki se je nadaljevala 90 ± 7 dni, z rednimi popravki odmerka, da so dosegli INR 2- 3.
The primary efficacy endpoint was the du
Dokazali so, da zdravljenje s av
Treatment with fondaparinux was demonstrated to be non-inferior to enoxaparin (VTE rates 3.9% and 4.1%, respectively). ro
fondaparinuksom ni bilo slabše od enoksaparina (pogostosti VTE 3, 9% oziroma 4, 1%).
Major bleeding during the initial treatment period was observed in 1.1% of fondaparinux patients, lP
Večjo krvavitev v začetnem obdobju zdravljenja so opazili pri 1, 1% bolnikov s fondaparinuksom in nim
Treatment of Pulmonary Embolism na
pri 1, 2% tistih z enoksaparinom.
A randomised, open-label, clinical trial was conducted in patients with acute symptomatic PE.
Zdravljenje pljučne embolije Randomizirano, odprto klinično preskušanje so opravili pri bolnikih z akutno simptomatsko PE.
Randomised ici
Bolnike, pri katerih so bili potrebni tromboliza ali embolektomija ali filter v veni kavi, so ilo
patients could have been pre-treated with UFH during the screening phase but patients treated for more than 24 hours with therapeutic dose of anticoagulant or with uncontrolled hypertension were ed
Randomizirani bolniki so smeli biti predhodno zdravljeni z UFH med presejalno fazo, bolnike, ki so bili več kot 24 ur zdravljeni s terapevtskim odmerkom antikoagulantnega sredstva, in rav
excluded.
tiste z neobvladano hipertenzijo, pa so izključili.
Fondaparinux 5 mg (body weight< 50 kg), 7.5 mg (body weight ≥ 50kg, ≤ 100 kg) or 10 mg (body weight > 100 kg) SC once daily was compared to unfractionated heparin IV bolus (5000 IU) followed by a continuous IV infusion adjusted to maintain 1.5– 2.5 times aPTT control value..
Primerjali so fondaparinuks v odmerkih 5 mg (telesna masa < 50 kg), 7, 5 mg (telesna masa > 50 kg, ≤ 100 kg) ali 10 mg (telesna masa > 100 kg) s. c. enkrat na dan z i. v. bolusom nefrakcioniranega heparina (5. 000 i. e.), ki mu je sledila neprekinjena i. v. infuzija, prilagojena tako, da se je vzdrževala 1, 5- 2, 5- kratna kontrolna vrednost aPTT.
A total M
Zdravili so Zd
of 2184 patients were treated; for both groups, patients were treated for at least 5 days and up to 22 days (mean 7 days).
vsega skupaj 2. 184 bolnikov; bolnike iz obeh skupin so zdravili vsaj po 5 dni in do 22 dni dolgo (povprečno po 7 dni).
29 Major bleeding during the initial treatment period was observed in 1.3% of fondaparinux patients, compared to 1.1% with unfractionated heparin.
30 Večjo krvavitev v začetnem obdobju zdravljenja so opazili pri 1, 3% bolnikov s fondaparinuksom in pri 1, 1% tistih z nefrakcioniranim heparinom.
The pharmacokinetics of fondaparinux sodium are derived from fondaparinux plasma concentrations quantified via anti factor Xa activity.
me kvantitativno izmerjenih z aktivnostjo proti faktorju Xa.
After subcutaneous dosing, fondaparinux is completely and rapidly absorbed (absolute bioavailability
pro Absorpcija Po subkutani uporabi se fondaparinuks popolno in hitro absorbira (absolutna biološka uporabnost 100%).
Plasma
Po enkratni subkutani injekciji 2, 5 mg fondaparinuksa mladim zdravim osebam je največja koncentracija v plazmi (povprečna Cmax = 0, 34 mg/ l) dosežena v 2 urah po odmerjanju.
ho concentrations of half the mean Cmax values are reached 25 minutes post-dosing.
Polovična vrednost povprečne vrednosti Cmax v plazmi je dosežena v 25 minutah po odmerjanju.
In elderly healthy subjects, pharmacokinetics of fondaparinux is linear in the range of 2 to 8 mg by
za Pri starejših zdravih osebah je farmakokinetika fondaparinuksa po subkutani uporabi odmerkov od 2 do 8 mg linearna.
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.
nja 3 do 4 dneh, z 1, 3- kratnim povečanjem Cmax in AUC.
Cmax (mg/ l) - 0.39
Ocena povprečnih vrednosti (CV%) farmakokinetičnih parametrov za fondaparinuks v stanju dinamičnega ravnovesja pri bolnikih po kirurški zamenjavi kolka, ki so prejemali enkrat na dan 2, 5 mg lje fondaparinuksa so:
e (31%), Tmax (h) - 2.8 (18%) and Cmin (mg/ l) -0.14 (56%).
Cmax (mg/ l) – 0, 39 (31%), Tmax (h) – 2, 8 (18%) in Cmin (mg/ l) – 0, 14 (56%).
In hip fracture patients, associated with their ng increased age, fondaparinux steady state plasma concentrations are:
Pri bolnikih z zlomom kolka, povezanim z njihovo višjo starostjo, so plazemske koncentracije vo fondaparinuksa v stanju dinamičnega ravnovesja:
Cmax (mg/ l) - 0.50 (32%), Cmin (mg/ l) - 0.19 (58%). lo 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 no
Cmax (mg/ l) – 0, 50 (32%), Cmin (mg/ l) – 0, 19 (58%).
doses provide similar exposure across all body weight categories.
Pri zdravljenju DVT in PE so pri bolnikih, ki so dobivali fondaparinuks v odmerkih 5 mg (telesna do
The mean (CV%) steady state pharmacokinetic parameters estimates of fondaparinux in patients with VTE receiving the fondaparinux proposed dose regimen once daily are:
Srednje (CV%) ocene farmakokinetičnih parametrov za fondaparinuks v stanju dinamičnega ravnovesja pri bolnikih z VTE, ki so prejemali predlagano shemo odmerjanja eā
Cmax (mg/ l), and 0.24 and 0.95 for Cmin (mg/ l). du
Ustrezna 5. in 95. percentil sta 0, 97 in 1, 92 za Cmax (mg/ l) in 0, 24 in 0, 95 za Cmin (mg/ l). av
Fondaparinux does not bind lP
In vitro se fondaparinuks v veliki meri in specifično veže na antitrombinski protein z deležem vezave, ki je v smislu odvisnosti od odmerka odvisna od koncentracije v plazmi (98, 6% do 97, 0% v razponu koncentracije od 0, 5 do 2 mg/ l). nim
significantly to other plasma proteins, including platelet factor 4 (PF4).
Fondaparinuks se ne veže pomembno na druge proteine plazme, vključno s trombocitnim faktorjem 4 (PF4).
Since fondaparinux does not bind significantly to plasma proteins other than antithrombin, no na
Fondaparinuks se ne veže pomembno na proteine plazme, razen na antitrombin, zato ni pričakovati medsebojnega delovanja z drugimi zdravili zaradi izpodrivanja z vezavnih mest na proteinih. ilo
Metabolism ici
Presnova rav
Although not fully evaluated, there is no evidence of fondaparinux metabolism and in particular no evidence for the formation of active metabolites. ed
Čeprav ni v celoti ovrednotena, ni dokazov za presnovo fondaparinuksa in zlasti ne za tvorbo aktivnih metabolitov.
Fondaparinux does not inhibit CYP450s (CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1 or CYP3A4) in vitro.
Fondaparinuks in vitro ne zavira CYP450 (CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, Zd
products in vivo by inhibition of CYP-mediated metabolism.
Zato ni pričakovati, da bi fondaparinuks medsebojno deloval z drugimi zdravili in vivo z zaviranjem metabolizma preko CYP.
30 Special populations
31 Posebne skupine bolnikov
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.
Pri bolnikih, > 75 let, ki so imeli ortopedsko operacijo in so
A similar pattern is observed in DVT and PE treatment patients.
t dobivali fondaparinuks v odmerku 2, 5 mg enkrat na dan, je ocenjeni očistek plazme 1, 2 do 1, 4- krat
d Renal impairment - Compared with patients with normal renal function (creatinine clearance
Podoben vzorec opazujejo pri zdravljenih bolnikih z DVT in PE.
e > 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
Okvara ledvic - V primerjavi z bolniki z normalnim delovanjem ledvic (kreatininski očistek > 80 ml/ min), ki so imeli ortopedsko operacijo in so dobivali fondaparinuks v odmerku 2, 5 mg
In severe renal impairment (creatinine clearance < 30 ml/ min), plasma
pro enkrat na dan, je pri bolnikih z blago okvaro delovanja ledvic (kreatininski očistek 50 do 80 ml/ min) plazemski očistek 1, 2 do 1, 4 - krat manjši in v povprečju 2- krat manjši pri bolnikih z zmerno okvaro delovanja ledvic (kreatininski očistek 30 do 50 ml/ min).
ho clearance is approximately 5 times lower than in normal renal function.
Pri hudi okvari delovanja ledvic (kreatininski očistek < 30 ml/ min), je plazemski očistek približno 5- krat manjši kot pri normalnem delovanju ledvic.
Associated terminal half-life values were 29 h in moderate and 72 h in patients with severe renal impairment.
Pripadajoče vrednosti končnega razpolovnega časa so 29 h pri zmerni okvari in 72 h pri bolnikih s
ut Body weight - Plasma clearance of fondaparinux increases with body weight (9% increase per 10 kg).
Telesna masa - Plazemski očistek fondaparinuksa se povečuje s telesno maso (9% povečanje na
ra Gender - No gender differences were observed after adjustment for body weight.
nja 10 kg).
e Race - Pharmacokinetic differences due to race have not been studied prospectively.
Spol - Po izenačenju glede na telesno maso razlik med spoloma niso opazili. lje Rasa - Prospektivno farmakokinetičnih razlik med rasami niso raziskovali.
However, studies ng performed in Asian (Japanese) healthy subjects did not reveal a different pharmacokinetic profile compared to Caucasian healthy subjects.
Vendar raziskave z zdravimi osebami v Aziji (Japonci) niso razkrile drugačnega farmakokinetičnega profila, kot ga imajo vo zdravi belci.
Similarly, no plasma clearance differences were observed between black and Caucasian patients undergoing orthopaedic surgery. lo Hepatic impairment - Fondaparinux pharmacokinetics has not been evaluated in hepatic impairment. no
Podobno niso opazili razlik v plazemskem očistku med temnopoltimi in belopoltimi bolniki po ortopedskih operacijah. do
5.3 Preclinical safety data
Jetrna okvara - Farmakokinetika fondaparinuksa pri jetrnih okvarah ni bila ovrednotena.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety ct
5. 3 Predklinični podatki o varnosti eā
pharmacology and genotoxicity.
Predklinični podatki na osnovi običajnih študij farmakološke varnosti in genotoksičnosti ne kažejo posebnega tveganja za človeka.
The repeated dose and reproduction toxicity studies did not reveal any special risk but did not provide adequate documentation of safety margins due to limited exposure du
Študije s ponavljajočimi odmerki in študije reproduktivne toksičnosti niso razkrile nikakršnega posebnega tveganja, zaradi omejene izpostavljenosti pri raziskovani živalski av
in the animal species. ro
vrsti pa niso zadostno dokumentirale varnostnih mej.
PHARMACEUTICAL PARTICULARS lP
FARMACEVTSKI PODATKI nim
6.1 List of excipients na
6. 1 Seznam pomožnih snovi
Sodium chloride Water for injections Hydrochloric acid ici
natrijev klorid voda za injekcije ilo
Sodium hydroxide ed
klorovodikova kislina natrijev hidroksid rav
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal M
Zaradi pomanjkanja študij kompatibilnosti zdravila ne smemo mešati z drugimi zdravili.
products.
Zd