natgillin/translations-raw huggingface dataset:
16 For the prevention of VTE, 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.
16 Neželeni učinki, o katerih so poročali raziskovalci pri preprečevanju VTE 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 organski sistem v padajočem vrstnem redu po resnosti; te neželene učinke moramo interpretirati v povezavi s kirurškim in internističnim posegom.
System organ class MedDRA
17 Neželeni učinki pri bolnikih, ki Neželeni učinki pri Razvrstitev po internističnih bolnikih organskih sistemih (MedDRA)
Rare: post-operative infection
Infekcijske in parazitske bolezni
Uncommon: bleeding (epistaxis, gastrointestinal, haemoptysis, haematuria, haematoma) thrombocytopenia, purpura, thrombocythaemia, platelet abnormal, coagulation disorder
Pogosti: krvavitve (hematom, Pogosti: pooperacijske krvavitve, Bolezni krvi in hematurija, hemoptiza, anemija limfatičnega sistema krvavitve dlesni) Občasni: krvavitve (epistaksa, Občasni: anemija krvavitve v prebavilih, hemoptiza, hematurija, hematom) trombocitopenija, purpura, trombocitemija, nepravilnosti trombocitov, motnje koagulacije
Vascular disorders
Redki: hipotenzija Žilne bolezni
Gastrointestinal disorders
Občasni: dispneja
17 Skin and subcutaneous tissue disorders
Občasni: povečana aktivnost Bolezni jeter, žolčnika in jetrnih encimov, motnje v žolčevodov delovanju jeter Redki: bilirubinemija
In other studies or in post-marketing experience, rare cases of intracranial / intracerebral and retroperitoneal bleedings have been reported.
18 V drugih preskušanjih ali v postmarketinškem obdobju so poročali o redkih primerih intrakranialne/ intracerebralne in retroperitonealne krvavitve.
Bleeding was a commonly reported event in patients with UA/ NSTEMI and STEMI.
Pri bolnikih z UA/ NSTEMI in STEMI so pogosto poročali o krvavitvah.
4.1% (enoxaparin) up to and including Day 9 in the Phase III UA/ NSTEMI study, and the incidence of adjudicated severe haemorrhage by modified TIMI criteria was 1.1% (fondaparinux) vs.
V študiji III. faze UA/ NSTEMI je bila do in vključno z 9. dnem pojavnost večjih krvavitev 2, 1% (fondaparinuks) v primerjavi s 4, 1% (enoksaparin).
1.4% (control [UFH/ placebo]) up to and including Day 9 in the Phase III STEMI study.
V študiji III. faze STEMI je bila do in vključno z 9. dnem pojavnost hujših krvavitev po modificiranih kriterijih TIMI 1, 1% (fondaparinuks) v primerjavi z 1, 4% (kontrola [UFH/ placebo]).
In the Phase III UA/ NSTEMI study, the most commonly reported non-bleeding adverse events (reported in at least 1% of subjects on fondaparinux) were headache, chest pain and atrial fibrillation.
V študiji III. faze UA/ NSTEMI so najpogosteje poročali o naslednjih neželenih učinkih, ki niso bili povezani s krvavitvami (poročila pri najmanj 1% oseb, ki so prejemale fondaparinuks): glavobol, bolečina v prsih in atrijska fibrilacija.
In the Phase III study in STEMI patients, the most commonly reported non-bleeding adverse events (reported in at least 1% of subjects on fondaparinux) were atrial fibrillation, pyrexia, chest pain, headache, ventricular tachycardia, vomiting, and hypotension.
V študiji III. faze pri bolnikih s STEMI so najpogosteje poročali o naslednjih neželenih učinkih, ki niso bili povezani s krvavitvami (poročila pri najmanj 1% oseb, ki so prejemale fondaparinuks): atrijska fibrilacija, zvišana telesna temperatura, bolečina v prsih, glavobol, ventrikularna tahikardija, bruhanje in hipotenzija.
However, rare spontaneous reports of aPTT prolongation have been received.
V odmerku 2, 5 mg, fondaparinuks ne vpliva na rutinske koagulacijske teste v plazmi, kot so merjenje aktiviranega parcialnega tromboplastinskega časa (aPTT), aktiviranega časa nastanka strdka (ACT) ali razmerja protrombinski čas (PT) / internacionalno normalizirano razmerje (INR), niti na čas krvavitve ali fibrinolitično aktivnost, vendar pa so bila pridobljena redka spontana poročila o podaljšanju aPTT.
Clinical studies
19 Klinične študije
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.
Primerjali so profilakso s fondaparinuksom 2, 5 mg enkrat na dan, s pričetkom 6- 8 ur po operaciji in enoksaparinom 40 mg enkrat na dan s pričetkom 12 ur pred operacijo ali 30 mg dvakrat na dan s pričetkom 12- 24 ur po operaciji.
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.
V preskušanjih fondaparinuksa v primerjavi s 40 mg enoksaparina enkrat na dan s pričetkom 12 ur pred operacijo so opazili v skupini bolnikov, ki je prejemala fondaparinuks v priporočenem odmerku, 2, 8% velikih krvavitev v primerjavi z 2, 6% v skupini bolnikov z enoksaparinom.
19 to a reduction of asymptomatic distal DVT.
V glavnem je bila posledica redkejše asimptomatske distalne globoke venske tromboze (DVT).
6 patients (0.4%) in the fondaparinux group vs 5 patients (0.3%) in the dalteparin group.
Pojavnost simptomatske globoke venske tromboze je bila v obeh skupinah podobna: pojavila se je pri 6 bolnikih (0, 4%), ki so prejemali 20 fondaparinuks in 5 bolnikih (0, 3%), ki so prejemali dalteparin.
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.
Pri približno 20. 000 bolnikih z UA/ NSTEMI je primerjala uporabo fondaparinuksa v odmerku 2, 5 mg subkutano enkrat na dan in enoksaparina v odmerku 1 mg/ kg subkutano dvakrat na dan.
All patients received standard medical treatment for UA/ NSTEMI, with 34% of patients undergoing PCI and 9% undergoing CABG.
Vsi bolniki so bili standardno zdravljeni za UA/ NSTEMI, PCI je bila izvedena pri 34% bolnikov, CABG pa pri 9% bolnikov.
The mean treatment duration was 5.5 days in the fondaparinux group and 5.2 days in the enoxaparin group.
V skupini, ki je prejemala fondaparinuks, je zdravljenje v povprečju trajalo 5, 5 dni, v skupini, ki je prejemala enoksaparin pa 5, 2 dni.
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.
Če je bila izvedena PCI, so bolniki dodatno intravensko prejeli bodisi fondaparinuks (bolniki, ki so prejemali fondaparinuks) bodisi nefrakcionirani heparin, prilagojen na telesno maso (bolniki, ki so prejemali enoksaparin), odvisno od časa zadnje aplikacije subkutanega odmerka in predvidene uporabe zaviralca GP IIb/ IIIa.
The mean age of the patients was 67 years, and approximately 60% were at least 65 years old.
Povprečna starost bolnikov je bila 67 let, približno 60% bolnikov je bilo starih najmanj 65 let.
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.
Približno 40% bolnikov je imelo blago ledvično okvaro (kreatininski očistek ≥ 50 do < 80 ml/ min), približno 17% bolnikov pa zmerno ledvično okvaro (kreatininski očistek ≥ 30 do < 50 ml/ min).
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).
V skupini s fondaparinuksom se je dogodek do 9. dne pojavil pri 5, 8 bolnikov, v skupini, ki je prejemala enoksaparin pa pri 5, 7% bolnikov (razmerje tveganja 1, 01, 95% interval zaupanja, 0, 90; 1, 13, enostranska neinferiorna p vrednost = 0, 003).
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).
Do 30. dne se je smrtnost iz kateregakoli vzroka pomembno zmanjšala – s 3, 5% pri enoksaparinu na 2, 9% pri fondaparinuksu (razmerje tveganja 0, 83, 95% interval zaupanja, 0, 71; 0, 97, p = 0, 02).
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).
Do 9. dne je bila pojavnost večje krvavitve pri fondaparinuksu 2, 1%, pri enoksaparinu pa 4, 1% (razmerje tveganja 0, 52, 95% interval zaupanja, 0, 44; 0, 61, p < 0, 001).
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).
Pri v naprej določenih podskupinah, kot so starostniki, bolniki z okvaro ledvic, vrsta sočasnega zaviralca agregacije trombocitov (acetilsalicilna kislina, tienopiridini, zaviralci GP IIb/ IIIa) sta bili učinkovitost in pojavnost večjih krvavitev konsistentni.
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).
Pri podskupini bolnikov, ki so se zdravili s fondaparinuksom ali enoksaparinom in pri katerih je bila izvedena PCI, so o smrtnem izidu/ MI/ RI v 9 dneh po randomizaciji poročali pri 8, 8% bolnikov, ki so prejemali fondaparinuks in 8, 2% bolnikov, ki so prejemali enoksaparin (razmerje tveganja 1, 08, 95% interval zaupanja, 0, 92; 1, 27).
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).
V tej podskupini je bila pojavnost večjih krvavitev do 9. dne pri 21 bolnikih, ki so prejemali fondaparinuks 2, 2%, pri bolnikih, ki so prejemali enoksaparin pa 5, 0% (razmerje tveganja 0, 43, 95% interval zaupanja, 0, 33; 0, 57).
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.
Zdravljenje miokardnega infarkta z dvigom segmenta ST (STEMI) OASIS 6 je bila dvojno slepa, randomizirana študija, ki je vrednotila varnost in učinkovitost fondaparinuksa v odmerku 2, 5 mg enkrat na dan v primerjavi z običajnim zdravljenjem (placebo (47%) ali UFH (53%)) pri približno 12. 000 bolnikih s STEMI.
All patients received standard treatments for STEMI, including primary PCI (31%),
Vsi bolnikih so bili standardno zdravljeni za STEMI, vključno s primarno PCI (31%), trombolitiki (45%) ali brez reperfuzije (24%).
Of the patients treated with a thrombolytic, 84% were treated with a non-fibrin specific agent (primarily streptokinase).
84% s trombolitikom zdravljenjih bolnikov se je zdravilo s fibrinsko nespecifičnim zdravilom (predvsem streptokinazo).
The mean treatment duration was 6.2 days on fondaparinux.
Zdravljenje s fondaparinuksom je v povprečju trajalo 6, 2 dni.
The mean age of the patients was 61 years, and approximately 40% were at least 65 years old.
Približno 40% bolnikov je bilo starih najmanj 65 let.
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.
Približno 40% bolnikov je imelo blago ledvično okvaro (kreatininski očistek ≥ 50 do < 80 ml/ min), približno 14% bolnikov pa zmerno ledvično okvaro (kreatininski očistek ≥ 30 do < 50 ml/ min).
The primary adjudicated endpoint was a composite of death and recurrent MI (re-MI) within 30 days of randomisation.
Primarni vrednoteni opazovani dogodek je bil sestavljen iz smrtnega izida in ponovitve miokardnega infarkta (re- MI) v 30 dneh po randomizaciji.
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).
Do 30. dne se je smrtnost/ pojavnost re- MI pomembno zmanjšala z 11, 1% v kontrolni skupini na 9, 7% v skupini, ki je prejemala fondaparinuks (razmerje tveganja 0, 86, 95% interval zaupanja, 0, 77; 0, 96, p = 0, 008).
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).
Pri v naprej določenih skupinah pri katerih so fondaparinuks primerjali s placebom (to je bolniki, ki so se zdravili s fibrinsko nespecifičnimi litiki (77, 3%), brez reperfuzije (22%), fibrinsko specifičnimi litiki (0, 3%) primarno PCI (0, 4%)) se je smrtnost/ pojavnost re- MI do 30. dne pomembno zmanjšala s 14, 0% pri placebu na 11, 3% (razmerje tveganja 0, 80, 95% interval zaupanja, 0, 69; 0, 93, p = 0, 003).
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).
Pri v naprej določeni skupini, pri kateri so fondaparinuks primerjali z UFH (bolniki, zdravljeni s primarno PCI (58, 5%), fibrinsko specifičnimi litiki (13%), fibrinsko nespecifičnimi litiki (2, 6) in brez reperfuzije (25, 9)), se učinka fondaparinuksa in UFH na zmanjšanje smrtnosti/ pojavnosti re- MI do 30. dne nista statistično pomembno razlikovala, in sicer sta bila 8, 3% za fondaparinuks in 8, 7% za UFH (razmerje tveganja 0, 94, 95% interval zaupanja, 0, 79; 1, 11 p = 0, 460).
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).
Vendar pa se je v tej podskupini pri bolnikih, pri katerih je bila izvedena tromboliza ali reperfuzija ni bila izvedena (to je bolniki pri katerih ni bila izvedena primarna PCI) smrtnost/ pojavnost re- MI do 30. dne pomembno zmanjšala s 14, 3% pri UFH na 11, 5% pri fondaparinuksu (razmerje tveganja 0, 79, 95 interval zaupanja, 0, 64; 0, 98, p = 0, 03).
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).
Do 30. dne se je pomembno zmanjšala tudi smrtnost iz kateregakoli vzroka – z 8, 9% v kontrolni skupini na 7, 8% v skupini, ki je prejemala fondaparinuks (razmerje tveganja 0, 87, 95% interval zaupanja, 0, 77; 0, 98, p = 0, 02).
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).
Pri bolnikih, pri katerih je bila opravljena revaskularizacija s trombolitikom, je fondaparinuks do 30. dne pomembno zmanjšal smrtnost/ pojavnost re- MI iz 13, 6% v kontrolni skupini na 10, 9% (razmerje tveganja 0, 79, 95% interval zaupanja, 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).
Pri bolnikih, pri katerih ni bila opravljena začetna reperfuzija, je fondaparinuks pomembno zmanjšal smrtnost/ pojavnost re- MI do 30. dne iz 15% v kontrolni skupini na 12, 1% (razmerje tveganja 0, 79, 95% interval zaupanja, 0, 65; 0, 97, p = 0, 023).
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].
Pri bolnikih, pri katerih je bila opravljena primarna PCI niso opazili statistično pomembne razlike pri smrtnosti/ pojavnosti re- MI do 30. dne med obema skupinama [6, 0% v skupini, ki je prejemala fondaparinuks v primerjavi s 4, 8% v kontrolni skupini; razmerje tveganja 1, 26, 95% interval zaupanja, 0, 96, 1, 66].
By Day 9, 1.1% of patients treated with fondaparinux and 1.4% of control patients experienced a severe haemorrhage.
Hujša krvavitev se je do 9. dne pojavila pri 1, 1% bolnikov, ki so se zdravili s fondaparinuksom in 1, 4% bolnikov v kontrolni skupini.
In patients given a thrombolytic, severe haemorrhage occurred in 1.3% of the fondaparinux patients and in 2.0% of controls.
Pri bolnikih, ki so prejeli trombolitik, se je hujša krvavitev pojavila pri 1, 3% bolnikov, ki so prejemali fondaparinuks in 2, 0% bolnikov v kontrolni skupini.
In patients initially not reperfused, the incidence of severe haemorrhage was 1.2% for fondaparinux vs 1.5% for controls.
Pri bolnikih, pri katerih ni bila opravljena začetna reperfuzija je bila pojavnost hujše krvavitve 1, 2% za fondaparinuks v primerjavi z 1, 5% za kontrolo.
For patients receiving primary PCI, the incidence of severe haemorrhage was 1.0% for fondaparinux and 0.4% for controls.
Pri bolnikih, pri katerih je bila izvedena primarna PCI, je bila pojavnost hujše krvavitve 1, 0% pri fondaparinuksu in 0, 4% pri kontroli.
5.2 Pharmacokinetic properties
22 5. 2 Farmakokinetične lastnosti
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.
Po subkutanem odmerku enkrat na dan je stanje dinamičnega ravnovesja v plazmi doseženo po 3 do 4 dneh, z 1, 3- kratnim povečanjem Cmax in AUC.
21 Mean (CV%) steady state pharmacokinetic parameters estimates of fondaparinux in patients undergoing hip replacement surgery receiving fondaparinux 2.5 mg once daily are:
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 fondaparinuksa so:
In patients > 75 years undergoing orthopaedic surgery, the estimated plasma clearance was 1.2 to 1.4 times lower than in patients < 65 years.
Pri bolnikih, > 75 let, z ortopedskimi operacijami, je ocenjeni očistek plazme 1, 2 do 1, 4- krat manjši kot pri bolnikih, < 65 let.
Race - Pharmacokinetic differences due to race have not been studied prospectively.
23 Rasa - Prospektivno farmakokinetičnih razlik med rasami niso raziskovali.
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
Nižje koncentracije fondaparinuksa v plazmi so pripisali manjši vezavi na ATIII zaradi nižjih koncentracij ATIII v plazmi pri osebah z okvaro jeter in zaradi tega večjemu ledvičnemu očistku fondaparinuksa.
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.
Če se fondaparinuks doda v minibag z 0, 9% fiziološko raztopino, je najbolje, da se ga infundira takoj, vendar pa se ga pri sobni temperaturi lahko shranjuje do 24 ur.
Arixtra is available in pack sizes of 2, 7, 10 and 20 pre-filled syringes.
24 Arixtra je na voljo v pakiranjih z 2, 7, 10 in 20 napolnjenih injekcijskih brizg.
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.
Na voljo sta dve vrsti injekcijskih brizg: • injekcijska brizga z modrim batom in samodejnim varnostnim sistemom. • injekcijska brizga z modrim batom in ročnim varnostnim sistemom.
Intravenous administration should be through an existing intravenous line either directly or using a small volume (25 or 50ml) 0.9% saline minibag.
Pri intravenski aplikaciji je treba zdravilo aplicirati preko obstoječe intravenske linije, bodisi neposredno bodisi v manjšem volumnu 0, 9% fiziološke raztopine (25 ali 50 ml) v minibagu.
23 Instruction on self-administration by subcutaneous injection is included in the Package Leaflet.
Napotki za subkutano samoinjiciranje so navedeni v navodilu za uporabo.
21 March 2002 Date of latest renewal:
21. marec 2002 Datum zadnjega podaljšanja dovoljenja za promet:
Arixtra 5 mg/ 0.4 ml solution for injection, pre-filled syringe.
Arixtra 5 mg/ 0, 4 ml raztopina za injiciranje, napolnjena injekcijska brizga
Each pre-filled syringe contains 5 mg of fondaparinux sodium in 0.4 ml solution for injection.
Vsaka napolnjena injekcijska brizga vsebuje 5 mg natrijevega fondaparinuksa v 0, 4 ml raztopine za injiciranje.
The solution is a clear and colourless to slightly yellow liquid.
Raztopina za injiciranje Raztopina je bistra in brezbarvna do rahlo rumenkasta tekočina.
The recommended dose of fondaparinux is 7.5 mg (patients with body weight ≥ 50, ≤ 100kg) once daily administered by subcutaneous injection.
Priporočeni odmerek fondaparinuksa je 7, 5 mg (bolniki s telesno maso ≥ 50, ≤ 100 kg) enkrat na dan, apliciran s subkutano injekcijo.
In patients ≥ 75 years, fondaparinux should be used with care, as renal function decreases with age (see section 4.4).
Pri bolnikih, starih 75 let ali več, je treba fondaparinuks uporabljati previdno, ker se delovanje ledvic s starostjo zmanjšuje (glejte poglavje 4. 4).
Renal impairment - Fondaparinux should be used with caution in patients with moderate renal impairment (see section 4.4).
Ledvična okvara - Pri bolnikih z zmernimi okvarami ledvic je treba fondaparinuks uporabljati previdno (glejte poglavje 4. 4).
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).
S podskupino bolnikov, ki imajo tako preveliko telesno maso (> 100 kg) kot tudi zmerno okvaro ledvic (očistek kreatinina 30- 50 ml/ min), nimamo nobenih izkušenj.
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).
V tej podskupini lahko po začetnem 10- miligramskem dnevnem odmerku na podlagi farmakokinetičnega modeliranja preudarimo možnost zmanjšanja dnevnega odmerka na 7, 5 mg (glejte poglavje 4. 4).
Fondaparinux should not be used in patients with severe renal impairment (creatinine clearance < 30 ml/ min) (see section 4.3).
Pri bolnikih s hudo ledvično okvaro (očistek kreatinina < 30 ml/ min) fondaparinuksa ne smemo uporabljati (glejte poglavje 4. 3).
25 Hepatic impairment - No dosing adjustment is necessary in patients with either mild or moderate hepatic impairment.
26 Jetrna okvara - Pri bolnikih z blago ali zmerno okvaro jeter odmerka ni treba prilagajati.
- severe renal impairment defined by creatinine clearance < 30 ml/ min.
- Huda ledvična okvara (kreatininski očistek < 30 ml/ min).
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.
Tako kot velja za druga antikoagulantna sredstva, je treba fondaparinuks previdno uporabljati pri bolnikih, ki so pred nedavnim (< 3 dni) imeli operacijo, to pa šele po tistem, ko vzpostavimo kirurško hemostazo.