natgillin/translations-raw huggingface dataset:
Sixty-nine percent of the patients underwent surgery for cancer.
Kirurški posegi so bili v glavnem opravljeni na kolonu, rektumu, želodcu, jetrih ali žolčnih izvodilih ali pa je bila opravljena holecistektomija.
(62/ 1,021) with dalteparin: odds ratio reduction [95%CI] = -25.8% [-49.7%, 9.5%].
Pri bolnikih, ki so v študiji prejemali fondaparinuks je bila pojavnost vseh VTE 4, 6- odstotna (47/ 1. 027), pri bolnikih, ki so prejemali dalteparin pa 6, 1- odstotna (62/ 1. 021): zmanjšano razmerje obetov (odds ratio) [95% IZ] = - 25, 8% [- 49, 7%, 9, 5%].
The difference in total VTE rates between the treatment groups, which was not statistically significant, was mainly due
Razlika v odstotku pojavnosti vseh VTE med obema skupinama ni bila statistično pomembna.
7 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 fondaparinuks in 5 bolnikih (0, 3%), ki so prejemali dalteparin.
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.
V veliki podskupini bolnikov, ki so bili operirani zaradi tumorja (69% vključenih bolnikov) je bila pojavnost VTE 4, 7% pri bolnikih, ki so prejemali fondaparinuks in 7, 7% pri bolnikih, ki so prejemali dalteparin.
Major bleeding was observed in 3.4% of the patients in the fondaparinux group and in 2.4% of the dalteparin group.
Hujše krvavitve so se pojavile pri 3, 4% bolnikov, ki so prejemali fondaparinuks in pri 2, 4% bolnikov, ki so prejemali dalteparin.
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.
Preprečevanje venskih trombemboličnih dogodkov (VTE) pri internističnih bolnikih, pri katerih obstaja velika nevarnost trombemboličnih zapletov zaradi omejene gibljivosti (imobilizacije) med akutno fazo bolezni V randomiziranem dvojno slepem kliničnem preskusu so zdravili 839 bolnikov s fondaparinuksom v odmerku 2, 5 mg enkrat na dan ali placebom 6 do 14 dni dolgo.
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.
V to študijo so vključili akutno bolne internistične bolnike, stare ≥ 60 let, za katere so pričakovali, da bodo morali ležati vsaj 4 dni dolgo, hospitalizirani pa so bili zaradi kongestivnega popuščanja srca razreda III/ IV po NYHA in/ ali akutne respiracijske bolezni in/ ali akutne infekcijske ali vnetne bolezni.
Fondaparinux significantly reduced the overall rate of VTE compared to placebo [18 patients (5.6%) vs 34 patients (10.5%), respectively].
Fondaparinuks je signifikantno zmanjšal celotno incidenco VTE v primerjavi s placebom [18 bolnikov (5, 6%) proti 34 bolnikom (10, 5%)].
Fondaparinux also significantly reduced the rate of adjudicated fatal PE [0 patients (0.0%) vs 5 patients (1.2%), respectively].
Fondaparinuks je tudi signifikantno zmanjšal pogostost pripisane smrtne PE [0 bolnikov (0, 0%) proti 5 bolnikom (1, 2%)].
Major bleedings were observed in 1 patient (0.2%) of each group.
Večje krvavitve so ugotovili v vsaki skupini pri 1 bolniku (0, 2%).
Absorption After subcutaneous dosing, fondaparinux is completely and rapidly absorbed (absolute bioavailability 100%).
Absorpcija Po subkutani uporabi se fondaparinuks popolno in hitro absorbira (absolutna biološka uporabnost 100%).
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.
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.
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.
Po odmerjanju enkrat na dan je stanje dinamičnega ravnovesja v plazmi doseženo po 3 do 4 dneh, z 1, 3- kratnim povečanjem Cmax in AUC.
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:
Cmax (mg/ l) - 0.39 (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 increased age, fondaparinux steady state plasma concentrations are:
Pri bolnikih z zlomom kolka, povezanim z njihovo višjo starostjo, so plazemske koncentracije fondaparinuksa v stanju dinamičnega ravnovesja:
Distribution The distribution volume of fondaparinux is limited (7-11 litres).
Porazdelitev Volumen porazdelitve fondaparinuksa je majhen (7- 11 litrov).
In vitro, fondaparinux is highly and specifically bound to antithrombin protein with a dose-dependant plasma concentration binding (98.6% to 97.0% in the concentration range from 0.5 to 2 mg/ l).
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).
Metabolism Although not fully evaluated, there is no evidence of fondaparinux metabolism and in particular no evidence for the formation of active metabolites.
Presnova Čeprav ni v celoti ovrednotena, ni dokazov za presnovo fondaparinuksa in zlasti ne za tvorbo aktivnih metabolitov.
Excretion/ Elimination The elimination half-life (t½) is about 17 hours in healthy young subjects and about 21 hours in healthy elderly subjects.
Izločanje Razpolovni čas izločanja (t½) je približno 17 ur pri zdravih mladih osebah in približno 21 ur pri zdravih starejših osebah.
Fondaparinux is excreted to 64 – 77% by the kidney as unchanged compound.
Fondaparinuks se izloča preko ledvic, 64 – 77% v nespremenjeni obliki.
8 Special populations
Posebne skupine bolnikov
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.
Renal impairment - Compared with patients with normal renal function (creatinine clearance > 80 ml/ min), plasma clearance is 1.2 to 1.4 times lower in patients with mild renal impairment (creatinine clearance 50 to 80 ml/ min) and on average 2 times lower in patients with 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) 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).
In severe renal impairment (creatinine clearance < 30 ml/ min), plasma 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.
Race - Pharmacokinetic differences due to race have not been studied prospectively.
9 Rasa - Prospektivno farmakokinetičnih razlik med rasami niso raziskovali.
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 10 kg).
Hepatic impairment - Following a single, subcutaneous dose of fondaparinux in subjects with moderate hepatic impairment (Child-Pugh Category B), total (i. e., bound and unbound) Cmax and AUC were decreased by 22% and 39%, respectively, as compared to subjects with normal liver function.
Jetrna okvara – Po enkratnem subkutanem odmerku fondaparinuksa se je pri osebah z zmerno okvaro jeter (kategorija B po Child- Pugh- u) skupna (to je vezanega in prostega) vrednost Cmax in AUC zmanjšala, in sicer Cmax za 22%, AUC pa za 39% v primerjavi z osebami z normalnim delovanjem jeter.
The pharmacokinetics of fondaparinux has not been studied in patients with severe hepatic impairment (see sections 4.2 and 4.4).
Pri bolnikih s hudo okvaro jeter farmakokinetike fondaparinuksa niso raziskovali (glejte poglavji 4. 2 in 4. 4).
9 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 bromobutyl or 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 bromobutilnega ali klorobutilnega elastomera.
Arixtra is available in pack sizes of 2, 7, 10 and 20 pre-filled syringes.
Arixtra je na voljo v pakiranjih z 2, 7, 10 in 20 napolnjenih injekcijskih brizg.
There are two types of syringes: • syringe with a yellow plunger and an automatic safety system • syringe with yellow plunger and a manual safety system.
10 • injekcijska brizga z rumenim batom in ročnim varnostnim sistemom.
The needle protection system of the Arixtra pre-filled syringes have been designed with a safety system to protect from needle stick injuries following injection.
Ta varnostni sistem omogoča zaščito pred vbodom z iglo po injiciranju.
21 March 2002
21. marec 2002 Datum zadnjega podaljšanja dovoljenja za promet:
Arixtra 2.5 mg/ 0.5 ml solution for injection, pre-filled syringe.
Arixtra 2, 5 mg/ 0, 5 ml raztopina za injiciranje, napolnjena injekcijska brizga
Each pre-filled syringe (0.5 ml) contains 2.5 mg of fondaparinux sodium.
Ena napolnjena injekcijska brizga (0, 5 ml) vsebuje 2, 5 mg natrijevega fondaparinuksa.
Treatment of unstable angina or non-ST segment elevation myocardial infarction (UA/ NSTEMI) in patients for whom urgent (< 120 mins) invasive management (PCI) is not indicated (see sections 4.4 and 5.1).
Zdravljenje nestabilne angine pektoris ali miokardnega infarkta brez dviga segmenta ST (UA/ NSTEMI; “ unstable angina/ non- ST segment elevation myocardial infarction ”) pri bolnikih, pri katerih ni indicirano urgentno (< 120 minut) invazivno zdravljenje (PCI) (glejte poglavji 4. 4 in 5. 1).
Treatment of ST segment elevation myocardial infarction (STEMI) in patients who are managed with thrombolytics or who initially are to receive no other form of reperfusion therapy.
Zdravljenje miokardnega infarkta z dvigom segmenta ST (STEMI; “ ST segment elevation myocardial infarction ” pri bolnikih, ki so prejeli trombolitik ali bolnikih, pri katerih v začetku ni bila izvedena druga oblika reperfuzijskega zdravljenja.
Experience shows that in patients undergoing hip fracture surgery, the risk of VTE continues beyond 9 days after surgery.
Izkušnje kažejo, da traja pri bolnikih po
12 Medical patients who are at high risk for thromboembolic complications based on an individual risk assessment The recommended dose of fondaparinux is 2.5 mg once daily administered by subcutaneous injection.
Internistični bolniki, pri katerih obstaja velika nevarnost trombemboličnih zapletov na podlagi individualne ocene tveganja Priporočeni odmerek fondaparinuksa je 2, 5 mg enkrat na dan s subkutano injekcijo.
A treatment duration of 6-14 days has been clinically studied in medical patients (see section 5.1).
Zdravljenje bolnikov v trajanju od 6- 14 dni je bilo klinično preučeno (glejte poglavje 5. 1).
Treatment of unstable angina/ non- ST segment elevation myocardial infarction (UA/ NSTEMI) The recommended dose of fondaparinux is 2.5 mg once daily, administered by subcutaneous injection.
Zdravljenje nestabilne angine pektoris/ miokardnega infarkta brez dviga segmenta ST (UA/ NSTEMI) Priporočeni odmerek fondaparinuksa je 2, 5 mg enkrat na dan v obliki subkutane injekcije.
If a patient is to undergo percutaneous coronary intervention (PCI), unfractionated heparin (UFH) as per local practice should be administered during PCI, taking into account the patient’ s potential risk of bleeding, including the time since the last dose of fondaparinux (see section 4.4).
Če bo pri bolniku opravljena perkutana koronarna intervencija (PCI, “ percutaneous coronary intervention ”), mora bolnik med PCI prejeti nefrakcionirani heparin (UFH, “ unfractionated heparin ”) v skladu z lokalno prakso, pri čemer je treba upoštevati možno tveganje za pojav krvavitev, vključno s časom, ko je bolnik prejel zadnji odmerek fondaparinuksa (glejte poglavje 4. 4).
In the pivotal UA/ NSTEMI clinical trial, treatment with fondaparinux was restarted no earlier than 2 hours after sheath removal.
V ključnem kliničnem preskušanju UA/ NSTEMI, zdravljenja s fondaparinuksom niso uvedli prej kot 2 uri po odstranitvi katetra.
Treatment of ST segment elevation myocardial infarction (STEMI) The recommended dose of fondaparinux is 2.5 mg once daily.
Zdravljenje miokardnega infarkta z dvigom segmenta ST (STEMI) Priporočeni odmerek fondaparinuksa je 2, 5 mg enkrat na dan.
If a patient is to undergo non-primary PCI, unfractionated heparin (UFH) as per local practice should be administered during PCI, taking into account the patient’ s potential risk of bleeding, including the time since the last dose of fondaparinux (see section 4.4).
Če bo pri bolniku opravljena neprimarna PCI, mora bolnik med PCI prejeti nefrakcionirani heparin (UHF) v skladu z lokalno prakso, pri čemer je treba upoštevati možno tveganje za pojav krvavitev, vključno s časom, ko je bolnik prejel zadnji odmerek fondaparinuksa (glejte poglavje 4. 4).
In STEMI or UA/ NSTEMI patients who are to undergo coronary artery bypass graft (CABG) surgery, fondaparinux where possible, should not be given during the 24 hours before surgery and may be restarted 48 hours post-operatively.
Zdravljenje s fondaparinuksom se lahko ponovno uvede šele 48 ur po operaciji.
Prevention of VTE following Surgery In patients undergoing surgery, timing of the first fondaparinux injection requires strict adherence in patients ≥ 75 years, and/ or with body weight < 50 kg and/ or with renal impairment with creatinine clearance ranging between 20 to 50 ml/ min.
Preprečevanje VTE po operaciji Pri bolnikih z operacijami, starih ≥ 75 let in/ ali težkih < 50 kg in/ ali z ledvično okvaro s kreatininskim očistkom v razponu od 20 do 50 ml/ min, se je treba strogo držati pravilnega časa prve injekcije fondaparinuksa.
Renal impairment • Prophylaxis of VTE - Fondaparinux should not be used in patients with creatinine clearance < 20 ml/ min (see section 4.3).
Ledvična okvara • Preprečevanje VTE - Fondaparinuksa se ne sme uporabljati pri bolnikih, ki imajo kreatininski očistek < 20 ml/ min (glejte poglavje 4. 3).
• Treatment of UA/ NSTEMI and STEMI - fondaparinux should not be used in patients with creatinine clearance < 20 ml/ min (see section 4.3).
• Zdravljenje UA/ NSTEMI in STEMI - Fondaparinuksa se ne sme uporabljati pri bolnikih s kreatininskim očistkom < 20 ml/ min (glejte poglavje 4. 3).
No dosage reduction is required for patients with creatinine clearance > 20 ml/ min.
Pri bolnikih s kreatininskim očistkom > 20 ml/ min odmerka ni treba prilagajati.
13 Hepatic impairment - No dosing adjustment is necessary in patients with either mild or moderate hepatic impairment.
13 Jetrna okvara – Pri bolnikih z blago ali zmerno okvaro jeter odmerka ni treba prilagajati.
Method of administration • Subcutaneous administration Fondaparinux is administered by deep subcutaneous injection while the patient is lying down.
Način uporabe • Subkutana uporaba Fondaparinuks se injicira globoko pod kožo, medtem ko bolnik leži.
• Intravenous administration (first dose in patients with STEMI only) Intravenous administration should be through an existing intravenous line either directly or using a small volume (25 or 50ml) 0.9% saline minibag.
• Intravenska uporaba (le prvi odmerek pri bolnikih s STEMI) 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.
When required, concomitant therapy with vitamin K antagonist should be administered in accordance with the information of section 4.5.
Kadar so nujni, moramo uvesti sočasno terapijo z antagonisti vitamina K, skladno s podatki v poglavju 4. 5.
For treatment of UA/ NSTEMI and STEMI, fondaparinux should be used with caution in patients who are being treated concomitantly with other agents that increase the risk of haemorrhage (such as GPIIb/ IIIa inhibitors or thrombolytics).
Pri zdravljenju UA/ NSTEMI in STEMI, je treba fondaparinuks uporabljati previdno pri bolnikih, ki se sočasno zdravijo z drugimi zdravili, ki povečajo tveganje za krvavitve (kot so zaviralci GPIIb/ IIIa ali trombolitiki).
14 PCI and risk of guiding catheter thrombus In STEMI patients undergoing primary PCI, the use of fondaparinux prior to and during PCI is not recommended.
14 PCI in tveganje za tromb vodilnega katetra Pri bolnikih s STEMI, pri katerih bo opravljena primarna PCI, uporabe fondaparinuksa pred in med PCI ne priporočamo.
Similarly, in UA/ NSTEMI patients with life threatening conditions that require urgent revascularisation, the use of fondaparinux prior to and during PCI is not recommended.
Tudi pri ogroženih bolnikih z UA/ NSTEMI, ki zahtevata urgentno revaskularizacijo, uporabe fondaparinuksa pred in med PCI ne priporočamo.
In UA/ NSTEMI and STEMI patients undergoing non-primary PCI, the use of fondaparinux as the sole anticoagulant during PCI is not recommended, therefore UFH should be used according to local practice (see section 4.2).
Pri bolnikih z UA/ NSTEMI in STEMI pri katerih bo opravljena neprimarna PCI, uporabe fondaparinuksa kot edinega antigoagulanta med PCI ne priporočamo, zato je treba uporabljati nefrakcionirani heparin v skladu z lokalno prakso (glejte poglavje 4. 2).
There are limited data on the use of UFH during non-primary PCI in patients treated with fondaparinux (see section 5.1).
Podatki o uporabi nefrakcioniranega heparina med neprimarno PCI pri bolnikih, ki se zdravijo s fondaparinuksom, so omejeni (glejte poglavje 5. 1).
In those patients who underwent non-primary PCI 6-24 hours after the last dose of fondaparinux, the median dose of UFH was 8,000 IU and the incidence of major bleeding was 2% (2/ 98).
Pri bolnikih pri katerih je bila neprimarna PCI opravljena 6- 24 ur po aplikaciji zadnjega odmerka fondaparinuksa je bil povprečni odmerek nefrakcioniranega heparina 8. 000 i. e., pojavnost večjih krvavitev pa 2% (2/ 98).
In those patients who underwent non-primary PCI < 6 hours after the last dose of fondaparinux, the median dose of UFH was 5,000 IU and the incidence of major bleeding was 4.1% (2/ 49).
Pri bolnikih, pri katerih je bila opravljena neprimarna PCI < 6 ur po zadnjem odmerku fondaparinuksa, je bil povprečni odmerek nefrakcioniranega heparina 5. 000 i. e., pojavnost večjih krvavitev pa 4, 1% (2/ 49).
Incidences in non-primary PCI in UA/ NSTEMI were 1.0% vs 0.3% (fondaparinux vs. enoxaparin) and in primary PCI in STEMI were 1.2% vs 0% (fondaparinux vs. control).
Pri neprimarni PCI pri bolnikih z UA/ NSTEMI je bila pojavnost 1, 0% v primerjavi z 0, 3% (fondaparinuks v primerjavi z enoksaparinom), pri primarni PCI pri bolnikih s STEMI pa 1, 2% v primerjavi z 0% (fondaparinuks v primerjavi s kontrolo).
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.
Spinalna / Epiduralna anestezija Pri bolnikih z večjimi ortopedskimi operacijami, epiduralnih ali spinalnih hematomov, ki lahko povzročijo dolgotrajno ali trajno paralizo, pri sočasni uporabi fondaparinuksa in spinalne/ epiduralne anestezije ali spinalne punkcije ne moremo izključiti.
• Prophylaxis of VTE - 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).
• Preprečevanje VTE - Pri bolnikih s kreatininskim očistkom < 50 ml/ min obstaja povečano tveganje za krvavitve ter VTE in jih moramo obravnavati previdno (glejte poglavja 4. 2, 4. 3 in 5. 2).
• Treatment of UA/ NSTEMI and STEMI - For the treatment of UA/ NSTEMI and STEMI, there are limited clinical data available on the use of fondaparinux 2.5mg once daily in patients with creatinine clearance between 20 and 30 ml/ min.
• Zdravljenje UA/ NSTEMI in STEMI - Klinični podatki o uporabi fondaparinuksa v odmerku 2, 5 mg enkrat na dan za zdravljenje UA/ NSTEMI in STEMI pri bolnikih s kreatininskim očistkom med 20 in 30 ml/ min so omejeni.
Therefore the physician should determine if the benefit of treatment outweighs the risk (see sections 4.2 and 4.3).
Zdravnik mora zato presoditi, če korist zdravljenja upravičuje morebitno tveganje (glejte poglavji 4. 2 in 4. 3).
Severe hepatic impairment Dosing adjustment of fondaparinux is not necessary.
15 Huda jetrna okvara Prilagajanje odmerka ni potrebno.
15 Patients with Heparin Induced Thrombocytopenia Fondaparinux should be used with caution in patients with a history of HIT.
Bolniki s trombocitopenijo, povzročeno s heparinom (heparinska trombocitopenija) Pri bolnikih, pri katerih se je kdaj pojavila heparinska trombocitopenija (HIT), je treba fondaparinuks uporabljati previdno.
Animal studies are insufficient with respect to effects on pregnancy, embryo/ foetal development, parturition and postnatal development because of limited exposure.
Zaradi omejene izpostavljenosti izsledki študij na živalih o vplivu na nosečnost, embrio- fetalni razvoj, porod in postnatalni razvoj niso zadostni.
The safety of fondaparinux 2.5 mg has been evaluated in:
Varnost fondaparinuksa 2, 5 mg so ocenjevali pri:
- 3,595 patients undergoing major orthopaedic surgery of the lower limbs treated up to 9 days
- 3. 595 bolnikih po veliki ortopedski operaciji na spodnjih okončinah, ki so se zdravili do 9 dni.
- 327 patients undergoing hip fracture surgery treated for 3 weeks following an initial prophylaxis
- 327 bolnikih po operaciji zaradi zloma kolka, ki so po začetni enotedenski profilaksi prejemali
of 1 week
zdravilo še 3 tedne.
- 1,407 patients undergoing abdominal surgery treated up to 9 days
- 1. 407 bolnikih po opravljenem kirurškem posegu v trebušni votlini, ki so se zdravili do 9 dni.
- 425 medical patients who are at risk for thromboembolic complications treated up to 14 days
- 425 internističnih bolnikih s tveganjem trombemboličnih zapletov, zdravljenih do 14 dni dolgo.
- 10,057 patients undergoing treatment of UA or NSTEMI ACS
- 10. 057 bolnikih, ki so se zdravili zaradi akutnega koronarnega sindroma (UA ali NSTEMI).
- 6,036 patients undergoing treatment of STEMI ACS.
- 6. 036 bolnikih, ki so se zdravili zaradi akutnega koronarnega sindroma (STEMI).