natgillin/translations-raw huggingface dataset:
During treatment of VTE, concomitant therapy with vitamin K antagonist should be administered in accordance with the information of Section 4.5.
Med zdravljenjem VTE je potrebno sočasno zdravljenje z antagonistom vitamina K v skladu s podatki v poglavju 4. 5.
Spinal / Epidural anaesthesia In patients receiving fondaparinux for treatment of VTE rather than prophylaxis, spinal/ epidural anaesthesia in case of surgical procedures should not be used.
Spinalna / Epiduralna anestezija Pri bolnikih, ki dobivajo fondaparinuks za zdravljenje VTE, ne za profilakso, uporaba spinalne/ epiduralne anestezije v primeru kirurških postopkov ni dovoljena.
As renal function generally decreases with age, elderly patients may show reduced elimination and increased exposure of fondaparinux (see section 5.2).
Ledvična funkcija s starostjo na splošno upada, zato je lahko pri starejših bolnikih zmanjšano izločanje in povečana izpostavljenost fondaparinuksu (glejte poglavje 5. 2).
The
Incidence krvavitev pri bolnikih na priporočeni shemi 27 zdravljenja DVT ali PE in starih < 65 let, 65- 75 let oziroma > 75 let so bile 3, 0%, 4, 5% oziroma 6, 5%.
26 corresponding incidences in patients receiving the recommended regimen of enoxaparin in the treatment of DVT were 2.5%, 3.6% and 8.3% respectively, while the incidences in patients receiving the recommended regimen of UFH in the treatment of PE were 5.5%, 6.6% and 7.4%, respectively.
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.
Majhna telesna masa 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 previdno uporabljati v dnevnem odmerku 5 mg (glejte poglavji 4. 2 in 5. 2).
Renal impairment The risk of bleeding increases with increasing renal impairment.
Ledvična okvara Nevarnost krvavitve narašča z naraščajočo ledvično okvaro.
Incidences of bleeding events in patients receiving the recommended regimen in the treatment of DVT or PE with normal renal function, mild renal impairment, moderate renal impairment and severe renal impairment were 3.0% (34/ 1,132), 4.4% (32/ 733), 6.6% (21/ 318), and 14.5% (8/ 55) respectively.
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 regimen of enoxaparin in the treatment of DVT were 2.3% (13/ 559), 4.6% (17/ 368), 9.7% (14/ 145) and 11.1% (2/ 18) respectively, and in patients receiving the recommended regimen of unfractionated heparin in the treatment of PE were 6.9% (36/ 523), 3.1% (11/ 352), 11.1% (18/ 162) and 10.7% (3/ 28), respectively.
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 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).
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).
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) (see sections 4.2, 4.3 and 5.2).
Trajanje zdravljenja ne sme preseči trajanja, ovrednotenega med kliničnim preskušanjem (povprečno 7 dni) (glejte poglavja 4. 2, 4. 3 in 5. 2).
After an initial 10 mg daily dose, a reduction of the daily dose to 7.5 mg may be considered, based on pharmacokinetic modelling (see section 4.2).
Po začetnem 10- miligramskem dnevnem odmerku lahko na podlagi farmakokinetičnega modeliranja preudarimo možnost zmanjšanja dnevnega odmerka na 7, 5 mg (glejte poglavje 4. 2).
Severe hepatic impairment The use of fondaparinux should be considered with caution because of an increased risk of bleeding due to a deficiency of coagulation factors in patients with severe hepatic impairment (see section 4.2).
Huda jetrna okvara Uporabo fondaparinuksa je treba skrbno pretehtati zaradi zvečane nevarnosti krvavitve, ki je posledica pomanjkanja koagulacijskih faktorjev pri bolnikih s hudimi okvarami jeter (glejte poglavje 4. 2).
Patients with Heparin Induced Thrombocytopenia Fondaparinux should be used with caution in patients with a history of HIT.
Bolniki s trombocitopenijo, povzročeno s heparinom Pri bolnikih, pri katerih se je kdaj pojavila trombocitopenija, povzročena s heparinom (HIT), je treba fondaparinuks uporabljati previdno.
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, vendar pa so bila pridobljena redka spontana poročila o HIT pri bolnikih, ki so se zdravili s fondaparinuksom.
In clinical studies performed with fondaparinux, oral anticoagulants (warfarin) did not interact with the pharmacokinetics of fondaparinux; at the 10 mg dose used in the interaction studies, fondaparinux did not influence the anticoagulation monitoring (INR) activity of warfarin.
V kliničnih študijah, opravljenih s fondaparinuksom, peroralni antikoagulanti (varfarin) niso medsebojno delovali s farmakokinetiko fondaparinuksa; pri 10- miligramskem odmerku, uporabljanem v študijah medsebojnega delovanja, fondaparinuks ni vplival na spremljano antikoagulantno aktivnost (INR) varfarina.
At the 10 mg dose used in the interaction studies, fondaparinux did 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
27 4.6 Pregnancy and lactation
4. 6 Nosečnost in dojenje
The safety of fondaparinux has been evaluated in 2,517 patients treated for Venous Thrombo- Embolism and treated with fondaparinux for an average of 7 days.
Varnost fondaparinuksa so ovrednotili pri 2. 517 bolnikih, zdravljenih zaradi venske trombembolije s fondaparinuksom, povprečno 7 dni dolgo.
The most common adverse reactions were bleeding complications (see section 4.4).
Najpogostejši neželeni učinki so bili zapleti s krvavitvami (glejte poglavje 4. 4).
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.
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 organski sistem v padajočem vrstnem redu po resnosti.
Undesirable effects in patients treated for VTE1
Neželeni učinki pri bolnikih, ki so se zdravili zaradi venske trombembolije (VTE) 1
Common: bleeding (gastrointestinal, haematuria, haematoma, epistaxis, haemoptysis, utero-vaginal haemorrhage, haemarthrosis, ocular, purpura, bruise) Uncommon: anaemia, thrombocytopaenia Rare: other bleeding (hepatic, retroperitoneal, intracranial/ intracerebral), thrombocythaemia
Pogosti: krvavitve (gastrointestinalne, hematurija, hematom, epistaksa, hemoptiza, krvavitve iz maternice in nožnice, hemartroza, očesne krvavitve, purpura, modrice)
Immune system disorders
Občasni: anemija, trombocitopenija
Rare: allergic reaction
Redki: druge krvavitve (hepatične, retroperitonealne, intrakranialne/ intracerebralne), trombocitemija
Metabolism and nutrition disorders
Redki: alergijska reakcija Bolezni imunskega sistema
Rare: non-protein-nitrogen (Npn) 2 increased
Presnovne in prehranske Redki: zvišanje vrednosti neproteinskega dušika (Npn) 2 motnje
Nervous system disorders
Občasni: glavobol Bolezni živčevja
Gastrointestinal disorders
Redki: omotica
Hepatobiliary disorders
Občasni: navzea, bruhanje Bolezni prebavil
Uncommon: abnormal liver function
Bolezni jeter, žolčnika in Občasni: nenormalno delovanje jeter žolčevodov
Skin and subcutaneous tissue disorders
Bolezni kože in podkožja Redki: eritemski izpuščaj
General disorders and administration site conditions
Občasni: bolečina, edem Splošne težave in spremembe na mestu Redki: reakcija na mestu injiciranja aplikacije
Pharmacotherapeutic group: antithrombotic agents.
Farmakoterapevtska skupina:
ATC code:
Antitrombotiki Oznaka ATC:
29 Pharmacodynamic effects
30 Farmakodinamični učinki
By binding selectively to antithrombin, fondaparinux potentiates (about 300 times) the innate neutralization of Factor Xa by antithrombin.
S selektivno vezavo na antitrombin fondaparinuks ojača (približno 300- krat) naravno nevtralizacijo faktorja Xa z antitrombinom.
However, rare spontaneous reports of aPTT prolongation have been received.
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 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.
At the 10 mg dose used in interaction studies, fondaparinux did not significantly influence the anticoagulation activity (INR) of warfarin.
Pri 10- miligramskem odmerku, ki so ga uporabljali v študijah medsebojnega delovanja, fondaparinuks ni pomembno vplival na antikoagulacijsko aktivnost (INR) varfarina.
Over 4,874 patients were studied in controlled Phase II and III clinical studies.
V kontroliranih kliničnih študijah faze II in III so proučevali več kot 4. 874 bolnikov.
Treatment of Deep Venous Thrombosis 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 kg) or 10 mg (body weight > 100 kg) SC once daily was compared to enoxaparin sodium 1 mg/ kg SC twice daily.
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 ≥ 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 2,192 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 days, with regular dose adjustments to achieve an INR of 2-3.
Obe zdravljeni skupini sta dobivali terapijo z antagonistom vitamina K, uvedeno prej kot 72 ur po prvi aplikaciji proučevanega zdravila, ki se je nadaljevala 90 ± 7 dni, z rednimi popravki odmerka, da so dosegli INR 2- 3.
Treatment with fondaparinux was demonstrated to be non-inferior to enoxaparin (VTE rates 3.9% and 4.1%, respectively).
Dokazali so, da zdravljenje s 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, compared to 1.2% with enoxaparin.
Večjo krvavitev v začetnem obdobju zdravljenja so opazili pri 1, 1% bolnikov s fondaparinuksom in pri 1, 2% tistih z enoksaparinom.
Treatment of Pulmonary Embolism 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.
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 (5,000 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 of 2,184 patients were treated; for both groups, patients were treated for at least 5 days and up to 22 days (mean 7 days).
Zdravili so vsega skupaj 2. 184 bolnikov; bolnike iz obeh skupin so zdravili vsaj po 5 dni in do 22 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 days, with regular dose adjustments to achieve an INR of 2-3.
Obe zdravljeni skupini sta dobivali terapijo z antagonistom vitamina K, navadno uvedeno prej kot 72 ur po prvi 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 composite of confirmed symptomatic recurrent non-fatal VTE and fatal VTE reported up to Day 97.
Končno stanje primarne učinkovitosti je bilo sestavljeno iz potrjene simptomatske recidivne neletalne VTE in smrtne VTE, o katerih so poročali do
Treatment with fondaparinux was demonstrated to be non-inferior to unfractionated heparin (VTE rates 3.8% and 5.0%, respectively).
Dokazali so, da zdravljenje s fondaparinuksom ni bilo slabše od nefrakcioniranega heparina (pogostosti VTE 3, 8% oziroma 5, 0%).
30 Major bleeding during the initial treatment period was observed in 1.3% of fondaparinux patients, compared to 1.1% with unfractionated heparin.
Večjo krvavitev v začetnem obdobju zdravljenja so opazili pri 1, 3% bolnikov s fondaparinuksom in pri 1, 1% tistih z nefrakcioniranim heparinom.
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 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 masa < 50 kg), 7, 5 mg (telesna masa 50 do vključno 100 kg) in 10 mg (telesna masa > 100 kg) enkrat na dan, za telesno maso prilagojeni odmerki povzročili podobno izpostavljenost po vseh kategorijah telesne mase.
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 fondaparinuksa enkrat na dan, so:
Cmax (mg/ l) - 1.41 (23%), Tmax (h) – 2.4 (8%) and Cmin (mg/ l) -0.52 (45%).
Cmax (mg/ l) – 1, 41 (23%), Tmax (h) – 2, 4 (8%) in Cmin (mg/ l) - 0, 52 (45%).
The associated 5th and 95th percentiles are, respectively, 0.97 and 1.92 for Cmax (mg/ l), and 0.24 and 0.95 for Cmin (mg/ l).
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).
Excretion/ Elimination The elimination half-life (t½) is about 17 hours in healthy young subjects and about 21 hours in healthy elderly subjects.
32 Izločanje Razpolovni čas izločanja (t½) je približno 17 ur pri zdravih mladih osebah in približno 21 ur pri zdravih starejših osebah.
31 Special populations
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 dobivali fondaparinuks v odmerku 2, 5 mg enkrat na dan, je ocenjeni očistek plazme 1, 2 do 1, 4- krat manjši kot pri bolnikih, < 65 let.
Renal impairment - Compared with patients with normal renal function (creatinine clearance > 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 80 ml/ min) and on average 2 times lower in patients with moderate renal impairment (creatinine clearance 30 to 50 ml/ min).
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 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).
32 6.2 Incompatibilities
6. 2 Inkompatibilnosti
Type I glass barrel (1 ml) affixed with a 27 gauge x 12.7 mm needle and stoppered with a chlorobutyl elastomer plunger stopper.
Injekcijska brizga (1 ml) iz stekla tipa I, s pritrjeno injekcijsko iglo G 27 x 12, 7 mm in zaprta z batno zaporko iz klorobutilnega elastomera.
Arixtra 5 mg/ 0.4 ml is available in pack sizes of 2, 7, 10 and 20 pre-filled syringes.
Arixtra 5 mg/ 0, 4 ml je na voljo v pakiranjih z 2, 7, 10 in 20 napolnjenih injekcijskih brizg.
There are two types of syringes: • syringe with a orange plunger and an automatic safety system • syringe with orange plunger and a manual safety system.
Na voljo sta dve vrsti injekcijskih brizg: • injekcijska brizga z oranžnim batom in samodejnim varnostnim sistemom. • injekcijska brizga z oranžnim batom in ročnim varnostnim sistemom.
Arixtra 7.5 mg/ 0.6 ml solution for injection, pre-filled syringe.
Arixtra 7, 5 mg/ 0, 6 ml raztopina za injiciranje, napolnjena injekcijska brizga
Each pre-filled syringe contains 7.5 mg of fondaparinux sodium in 0.6 ml solution for injection.
Vsaka napolnjena injekcijska brizga vsebuje 7, 5 mg natrijevega fondaparinuksa v 0, 6 ml raztopine za injiciranje.
35 Hepatic impairment - No dosing adjustment is necessary in patients with either mild or moderate hepatic impairment.
36 Jetrna okvara - Pri bolnikih z blago ali zmerno okvaro jeter odmerka ni treba prilagajati.
The
Incidence krvavitev pri bolnikih na priporočeni shemi 37 zdravljenja DVT ali PE in starih < 65 let, 65- 75 let oziroma > 75 let so bile 3, 0%, 4, 5% oziroma 6, 5%.
36 corresponding incidences in patients receiving the recommended regimen of enoxaparin in the treatment of DVT were 2.5%, 3.6% and 8.3% respectively, while the incidences in patients receiving the recommended regimen of UFH in the treatment of PE were 5.5%, 6.6% and 7.4%, respectively.
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%.
37 4.6 Pregnancy and lactation
4. 6 Nosečnost in dojenje
39 Pharmacodynamic effects
40 Farmakodinamični učinki
40 Major bleeding during the initial treatment period was observed in 1.3% of fondaparinux patients, compared to 1.1% with unfractionated heparin.
Večjo krvavitev v začetnem obdobju zdravljenja so opazili pri 1, 3% bolnikov s fondaparinuksom in pri 1, 1% tistih z nefrakcioniranim heparinom.
Excretion/ Elimination The elimination half-life (t½) is about 17 hours in healthy young subjects and about 21 hours in healthy elderly subjects.
42 Izločanje Razpolovni čas izločanja (t½) je približno 17 ur pri zdravih mladih osebah in približno 21 ur pri zdravih starejših osebah.
41 Special populations
Posebne skupine bolnikov
42 6.2 Incompatibilities
6. 2 Inkompatibilnosti
Arixtra 7.5 mg/ 0.6 ml is available in pack sizes of 2, 7, 10 and 20 pre-filled syringes.
Arixtra 7, 5 mg/ 0, 6 ml je na voljo v pakiranjih z 2, 7, 10 in 20 napolnjenih injekcijskih brizg.
There are two types of syringes: • syringe with a magenta plunger and an automatic safety system • syringe with magenta plunger and a manual safety system.
Na voljo sta dve vrsti injekcijskih brizg: • injekcijska brizga s škrlatnim batom in samodejnim varnostnim sistemom. • injekcijska brizga s škrlatnim batom in ročnim varnostnim sistemom.
Arixtra 10 mg/ 0.8 ml solution for injection, pre-filled syringe.
Arixtra 10 mg/ 0, 8 ml raztopina za injiciranje, napolnjena injekcijska brizga
Each pre-filled syringe contains 10 mg of fondaparinux sodium in 0.8 ml solution for injection.
Vsaka napolnjena injekcijska brizga vsebuje 10 mg natrijevega fondaparinuksa v 0, 8 ml raztopine za injiciranje.
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).
45 Hepatic impairment - No dosing adjustment is necessary in patients with either mild or moderate hepatic impairment.
46 Jetrna okvara - Pri bolnikih z blago ali zmerno okvaro jeter odmerka ni treba prilagajati.
The
Incidence krvavitev pri bolnikih na priporočeni shemi 47 zdravljenja DVT ali PE in starih < 65 let, 65- 75 let oziroma > 75 let so bile 3, 0%, 4, 5% oziroma 6, 5%.
46 corresponding incidences in patients receiving the recommended regimen of enoxaparin in the treatment of DVT were 2.5%, 3.6% and 8.3% respectively, while the incidences in patients receiving the recommended regimen of UFH in the treatment of PE were 5.5%, 6.6% and 7.4%, respectively.
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%.
47 4.6 Pregnancy and lactation
4. 6 Nosečnost in dojenje
49 Pharmacodynamic effects
50 Farmakodinamični učinki
50 Major bleeding during the initial treatment period was observed in 1.3% of fondaparinux patients, compared to 1.1% with unfractionated heparin.
Večjo krvavitev v začetnem obdobju zdravljenja so opazili pri 1, 3% bolnikov s fondaparinuksom in pri 1, 1% tistih z nefrakcioniranim heparinom.
Excretion/ Elimination The elimination half-life (t½) is about 17 hours in healthy young subjects and about 21 hours in healthy elderly subjects.
52 Izločanje Razpolovni čas izločanja (t½) je približno 17 ur pri zdravih mladih osebah in približno 21 ur pri zdravih starejših osebah.
51 Special populations
Posebne skupine bolnikov
52 6.2 Incompatibilities
6. 2 Inkompatibilnosti
Arixtra 10 mg/ 0.8 ml is available in pack sizes of 2, 7, 10 and 20 pre-filled syringes.
Arixtra 10 mg/ 0, 8 ml je na voljo v pakiranjih z 2, 7, 10 in 20 napolnjenih injekcijskih brizg.
There are two types of syringes: • syringe with a violet plunger and an automatic safety system • syringe with violet plunger and a manual safety system.
Na voljo sta dve vrsti injekcijskih brizg: • injekcijska brizga z vijoličastim batom in samodejnim varnostnim sistemom. • injekcijska brizga z vijoličastim batom in ročnim varnostnim sistemom.
54 ANNEX II
55 DODATEK II