natgillin/translations-raw huggingface dataset:
Fondaparinux should be used with care in these patients. 
Fondaparinuks treba koristiti uz oprez u tih bolesnika.
• Prevention of VTE - Dosing adjustment of fondaparinux is not necessary. 
• Prevencija VTE - nije potrebna prilagodba doziranja fondaparinuksa.
If you stop the treatment before your doctor told you to, the blood clot may not be treated properly and you may also be at risk of developing a new blood clot in a vein of your leg or in the lung. 
Vam to preporuči liječnik, krvni ugrušak možda neće biti pravilno liječen, a može postojati i veći rizik od nastanka novog ugruška krvi u venama na nozi ili u plućima.
Patients who required thrombolysis or embolectomy or vena cava filter were excluded. 
Isključeni su bolesnici kojima je bila potrebna tromboliza, embolektomija ili uvođenje filtera u venu cavu.
Incidence 
Incidencija
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). 
U liječenju UA/NSTEMI i STEMI - fondaparinuks treba koristiti uz oprez u bolesnika koji se istodobno liječe drugim agensima koji povećavaju rizik od krvarenja (kao što su inhibitori GP IIb/IIIa ili trombolitici).
Animal studies are insufficient with respect to effects on pregnancy, embryo/foetal development, parturition and postnatal development because of limited exposure. 
rezultati ispitivanja na životinjama o utjecaju na trudnoću, embriofetalni razvoj, porod i postnatalni razvoj nisu dovoljni.
• collapse. 
• kolaps
• swelling (oedema) 
• oticanje (edemi)
Gently pinch the skin that has been cleaned to make a fold. 
Očišćenu kožu nježno stisnite da nastane kožni nabor.
Bleeding was a commonly reported event in patients with UA/NSTEMI and STEMI. 
Krvarenje je često prijavljen događaj u bolesnika s UA/NSTEMI i STEMI.
• anxiety or confusion 
• tjeskoba ili smetenost
Arixtra syringe may contain latex 
Arixtra štrcaljka može sadržavati lateks
If you have kidney disease, the dose may be reduced to 1.5 mg once a day. 
Ako patite od bolesti bubrega, liječnik će Vam propisati manju dozu od 1,5 mg jednom na dan.
Other antiplatelet medicinal products (acetylsalicylic acid, dipyridamole, sulfinpyrazone, ticlopidine or clopidogrel), and NSAIDs should be used with caution. 
Ostale antitrombocitne lijekove (acetilsalicilnu kiselinu, dipiridamol, sulfinpirazon, tiklopidin ili klopidogrel) kao i nesteroidne antireumatike treba primjenjivati uz oprez.
The syringe needle shield contains latex. 
Štitnik za iglu sadrži lateks.
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 i obično ne pokazuje križnu reakciju sa serumima bolesnika s trombocitopenijom induciranom heparinom (HIT) tipa II.
The recommended dose is 2.5 mg once a day, injected at about the same time each day. 
Preporučena doza je 2,5 mg jednom na dan, a treba je primijeniti otprilike u isto vrijeme svakog dana.
• leg pain or stomach pain 
• bol u nogama ili u trbuhu
The incidence of symptomatic DVT was similar between treatment groups: 6 patients (0.4%) in the fondaparinux group vs 5 patients (0.3%) in the dalteparin group. 
Incidencija simptomatskih DVT bila je slična u obje skupine: 6 bolesnika (0,4%) u skupini koja je dobivala fondaparinuks, u odnosu na 5 bolesnika (0,3%) u skupini na dalteparinu.
LIST OF EXCIPIENTS Also contains: sodium chloride, water for injections, hydrochloric acid, sodium hydroxide. 
Također sadrži: natrijev klorid, vodu za injekcije, kloridnu kiselinu, natrijev hidroksid.
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 resulting in increased renal clearance of fondaparinux. 
Snižene koncentracije fondaparinuksa u plazmi pripisane su smanjenom vezivanju na ATIII, kao posljedici njegove snižene plazmatske koncentracije u bolesnika s jetrenim oštećenjem, što je rezultiralo povećanim bubrežnim klirensom fondaparinuksa.
A randomised, open-label, clinical trial was conducted in patients with acute symptomatic PE. 
Provedeno je randomizirano otvoreno kliničko ispitivanje u bolesnika s akutnim simptomima plućne embolije.
• Prevention of VTE and Treatment of UA/NSTEMI and STEMI - Dosing adjustment of fondaparinux is not necessary. 
• Prevencija VTE i liječenje UA/NSTEMI i STEMI - nije potrebna prilagodba doziranja fondaparinuksa.
Nervous system disorders Rare: anxiety, somnolence, vertigo, dizziness, headache, confusion 
Poremećaji živčanog sustava Rijetko: anksioznost, somnolencija, vrtoglavica, omaglica, glavobolja, konfuzija
Instruction on self-administration by subcutaneous injection is included in the Package Leaflet. 
Upute za samoinjiciranje supkutanom injekcijom navedene su u uputi o lijeku.
In superficial vein thrombosis patients who are to undergo surgery or other invasive procedures, fondaparinux, where possible, should not be given during the 24 hours before surgery. 
U bolesnika s trombozom površinske vene koji će se podvrgnuti operaciji ili nekom drugom invazivnom zahvatu, fondaparinuks, kada je to moguće, ne treba davati tijekom 24 sata prije zahvata.
The dose should be reduced to 1.5 mg once daily in patients with creatinine clearance in the range of 20 to 50 ml/min (see sections 4.4 and 5.2). 
Dozu treba smanjiti na 1,5 mg jedanput na dan u bolesnika s klirensom kreatinina od 20 do 50 ml/min (vidjeti dio 4.4 i 5.2).
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. 
Pri doziranju jednom na dan, stanje dinamičke ravnoteže razina u plazmi postiže se nakon 3-4 dana, uz porast Cmax i AUC od 1,3 puta.
Treatment of unstable angina or non-ST segment elevation myocardial infarction (UA/NSTEMI) in adultsfor whom urgent (< 120 mins) invasive management (PCI) is not indicated (see sections 4.4 and 5.1). 
Liječenje nestabilne angine pektoris ili infarkta miokarda bez elevacije ST-segmenta (UA/NSTEMI) u odraslih osoba u kojih nije indicirano hitno (< 120 minuta) invazivno liječenje perkutanom koronarnom intervencijom (vidjeti dio 4.4 i 5.1).
STEP BY STEP GUIDE TO USING ARIXTRA 
VODIČ ZA PRIMJENU LIJEKA ARIXTRA PO KORACIMA
• prevent the formation of blood clots in the blood vessels of the legs or lungs after orthopaedic surgery (such as hip or knee surgery) or abdominal surgery 
• za sprječavanje stvaranja ugrušaka krvi u krvnim žilama nogu ili pluća nakon ortopedske operacije, npr. operacije kuka ili koljena, ili nakon operacije u trbušnoj šupljini
Below 50 kg 
Uobičajena doza manje od 50 kg
• 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. 
• Liječenje UA/NSTEMI i STEMI - dostupni su ograničeni klinički podaci o primjeni fondaparinuksa 2,5 mg jedanput na dan u bolesnika s klirensom kreatinina između 20 i 30 ml/min.
Contact your doctor or pharmacist before stopping. 
Posavjetujte se s liječnikom ili ljekarnikom prije prestanka primjene lijeka
In post marketing experience, rare cases of gastritis, constipation, diarrhoea and bilirubinaemia have been reported. 
Nakon stavljanja lijeka u promet prijavljeni su rijetki slučajevi gastritisa, konstipacije, proljeva i bilirubinemije.
Bleeding risk is increased with concomitant administration of fondaparinux and agents that may enhance the risk of haemorrhage (see section 4.4). 
Rizik od krvarenja povećava se istodobnom primjenom fondaparinuksa i lijekova koji mogu povećati rizik od krvarenja (vidjeti dio 4.4).
In patients ≥75 years, fondaparinux should be used with care, as renal function decreases with age (see section 4.4). 
U bolesnika starih ≥75 godina fondaparinuks treba koristiti uz oprez jer se bubrežna funkcija smanjuje s dobi (vidjeti dio 4.4).
One experienced hypertensive encephalopathy accompanied by intracranial bleeding on day 5 of therapy resulting in fondaparinux discontinuation. 
Jedan je bolesnik doživio hipertenzivnu encefalopatiju praćenu intrakranijalnim krvarenjem petog dana liječenja, što je rezultiralo prekidom primjene fondaparinuksa.
The pharmacokinetics of fondaparinux sodium are derived from fondaparinux plasma concentrations quantified via anti factor Xa activity. 
Farmakokinetika fondaparinuksnatrija izvedena je iz koncentracija fondaparinuksa u plazmi, kvantitativno izmjerenih putem aktivnosti anti-Xa.
The safety and efficacy of fondaparinux 2.5 mg has not been studied in the following groups: patients with superficial-vein thrombosis following sclerotherapy or resulting as a complication of an intravenous line, patients with history of superficial-vein thrombosis within the previous 3 months, patients with history of venous thromboembolic disease within the previous 6 months, or patients with active cancer (see section 4.2 and 5.1). 
Sigurnost i djelotvornost primjene fondaparinuksa od 2,5 mg nije bila ispitivana u sljedećim skupinama bolesnika: bolesnici s trombozom površinske vene nakon skleroterapije ili kao posljedicom postavljenog venskog puta, bolesnici s anamnezom tromboze površinske vene unutar posljednja 3 mjeseca, odnosno venske tromboembolije unutar posljednjih 6 mjeseci ili bolesnici s aktivnom malignom bolešću (vidjeti dio 4.2 i 5.1).
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. 
Pri doziranju jednom na dan supkutano, stanje dinamičke ravnoteže razina u plazmi postiže se nakon 3 - 4 dana, uz porast Cmax i AUC od 1,3 puta.
Follow-up therapy with another anticoagulant medicinal product If follow-up treatment is to be initiated with heparin or LMWH, the first injection should, as a general rule, be given one day after the last fondaparinux injection. 
Ako je potrebno daljnje liječenje nastaviti heparinom ili niskomolekularnim heparinom, opće je pravilo da prvu injekciju treba dati jedan dan nakon posljednje injekcije fondaparinuksa.
• Prevention of VTE - Fondaparinux is known to be mainly excreted by the kidney. 
• Profilaksa VTE - Poznato je da se fondaparinuks najvećim dijelom izlučuje putem bubrega.
Oral absorption by the child is however unlikely. 
Međutim, malo je vjerojatno da bi kod dojenčeta moglo doći do peroralne apsorpcije.
In an open-label study, 24 paediatric patients (n=10, age 1 to ≤ 5 years weight range 8-20 kg; n=7, age 6 to ≤ 12 years weight range 17-47 kg and n=7 age 13 to ≤ 18 years weight range 47-130 kg) diagnosed with venous thrombosis at study entry were administered fondaparinux. 
do ≤5 godina, raspon TT 8 - 20 kg; n = 7, dob 6 do ≤12 godina, raspon TT 17 - 47 kg i n = 7, dob 13 do ≤18 godina, raspon TT 47 - 130 kg), kojima je dijagnosticirana venska tromboza na početku ispitivanja.
A randomised, double blind, clinical trial (CALISTO) included 3002 patients with acute symptomatic isolated, spontaneous superficial-vein thrombosis of the lower limbs, at least 5 cm long, confirmed by compression ultrasonography. 
Randomizirano, dvostruko-slijepo kliničko ispitivanje (CALISTO) uključilo je 3002 ispitanika s akutnom simptomatskom, izoliranom, spontano nastalom trombozom površne vene donjih ekstremiteta, u dužini barem 5 cm, a potvrđene kompresijskim ultrazvukom.
If co-administration is essential, close monitoring is necessary. 
Ako je istodobna primjena neophodna, potrebno je pažljivo pratiti bolesnika.
Treatment with fondaparinux was demonstrated to be non-inferior to unfractionated heparin (VTE rates 3.8% and 5.0%, respectively). 
Pokazalo se da liječenje fondaparinuksom nije bilo inferiorno nefrakcioniranom heparinu (stopa VTE 3,8% odnosno
Sites of administration should alternate between the left and the right anterolateral and left and right posterolateral abdominal wall. 
Injekciju treba naizmjenično aplicirati u lijevu i desnu anterolateralnu, te lijevu i desnu posterolateralnu trbušnu stijenku.
• 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). 
• Profilaksa VTE - Bolesnici s klirensom kreatinina <50 ml/min imaju povećan rizik od krvarenja i treba ih liječiti uz oprez (vidjeti dio 4.2, 4.3 i 5.2).
The incidence of each thromboembolic component of the primary outcome was also significantly reduced in fondaparinux patients as follows: symptomatic PE [0 (0%) vs 5 (0.3%) (p=0.031)], symptomatic DVT [3 (0.2%) vs 18 (1.2%); relative risk reduction 83.4% (p<0.001)], symptomatic superficial-vein thrombosis extension [4 (0.3%) vs 51 (3.4%); relative risk reduction 92.2% (p<0.001)], symptomatic superficial-vein thrombosis reoccurrence [5 (0.3%) vs 24 (1.6%); relative risk reduction 79.2% (p<0.001)]. 
Incidencija svake tromboembolijske komponente primarnog ishoda je također značajno smanjena u fondaparinuks skupini bolesnika kako slijedi: simptomatska PE [0 (0%) vs 5 (0,3%) (p=0,031)], simptomatska DVT [3 (0,2%) naspram 18 (1,2%); relativna redukcija rizika od 83,4% (p<0,001)], simptomatsko proširenje (ekstenzija) tromboze površinske vene [4 (0,3%) vs 51 (3,4%); relativna redukcija rizika od 92,2% (p<0,001)], recidiv simptomatske tromboze površinske vene [5 (0,3%) vs 24 (1,6%); relativna redukcija rizika od 79,2% (p<0,001)].
Rare: hypotension 
Rijetko: hipotenzija
Picture D 
Slika D
Consequently, unbound concentrations of fondaparinux are expected to be unchanged in patients with mild to moderate hepatic impairment, and therefore, no dose adjustment is necessary based on pharmacokinetics. 
Posljedično se u bolesnika s blagim do umjerenim oštećenjem funkcije jetre ne očekuje promjena koncentracije slobodnog fondaparinuksa, te na temelju farmakokinetike nije potrebna prilagodba doze.
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). 
Bolesnici s klirensom kreatinina <50 ml/min imaju povećan rizik od krvarenja i treba ih liječiti uz oprez (vidjeti dio 4.2, 4.3 i 5.2).
The incidences of adjudicated guiding catheter thrombus were 0.1% (1/1002) and 0.5% (5/1024), in patients randomised to “standard dose” and “low dose” UFH respectively during PCI. 
Incidencija tromboze u provodnom kateteru je bila 0,1% (1/1002) u bolesnika randomiziranih na “standardnu dozu” UFH, odnosno 0,5% (5/1024) u bolesnika randomiziranih na “nisku dozu” UFH tijekom PCI.
In patients with severe hepatic impairment, fondaparinux should be used with care as this patient group has not been studied (see sections 4.4 and 5.2). 
U bolesnika s teškim oštećenjem jetre fondaparinuks treba koristiti uz oprez, jer njegova primjena u toj skupini bolesnika nije ispitivana (vidjeti dio 4.4 i 5.2).
(2) Npn stands for non-protein-nitrogen such as urea, uric acid, amino acid, etc. 
(1) nisu uzete u obzir pojedinačne nuspojave, osim medicinski relevantnih (2) Npn označava neproteinski dušik, npr. ureu, mokraćnu kiselinu, aminokiseline itd.
Treatment of adults with acute symptomatic spontaneous superficial-vein thrombosis of the lower limbs without concomitant deep-vein thrombosis (see sections 4.2 and 5.1). 
Liječenje odraslih osoba s akutnom spontanom i simptomatskom površinskom venskom trombozom donjih ekstremiteta bez prateće duboke venske tromboze (vidjeti dio 4.2 i 5.1).
At the end of this period, 656 patients were randomised to receive fondaparinux 2.5 mg once daily or placebo for an additional 21 +/- 2 days. 
Na kraju tog razdoblja, 656 bolesnika randomizirano je da u sljedećih 21 +/- 2 dana prima ili fondaparinuks 2,5 mg jednom na dan ili placebo.
Picture 3. 
PRILOG III.
Fondaparinux significantly reduced the overall rate of VTE compared to placebo [18 patients (5.6%) vs 34 patients (10.5%), respectively]. 
Fondaparinuks je značajno smanjio ukupan broj VTE u usporedbi s placebom [18 bolesnika (5,6%) u odnosu na 34 bolesnika (10,5%)].
• Prevention of VTE - Patients with body weight <50 kg are at increased risk of bleeding. 
• Prevencija VTE - bolesnici tjelesne težine <50 kg imaju povišeni rizik od nastupa krvarenja.
In this study, the incidence of total VTE was 4.6% (47/1,027) with fondaparinux, versus 6.1%: (62/1,021) with dalteparin: odds ratio reduction [95%CI] = -25.8% [-49.7%, 9.5%]. 
U ovoj studiji incidencija ukupnih VTE bila je 4,6% (47/1027) u skupini koja je dobivala fondaparinuks, u odnosu na 6,1% (62/1021) u skupini koja je dobivala dalteparin: smanjeni omjer vjerojatnosti izloženosti [95% CI] = -25,8% [-49,7%; 9,5%].
Patients were randomised to receive fondaparinux 2.5 mg once daily or placebo for 45 days in addition to elastic stockings, analgesic and/or topical NSAIDS anti-inflammatory drugs. 
Ispitanici su randomizirani u skupinu koja je primala fondaparinuks 2,5 mg jednom na dan ili placebo tijekom 45 dana, uz primjenu elastičnih čarapa, analgetike i/ili topikalne NSAR.
SC/IV 
Na s.c./i.v.
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). 
Primjena fondaparinuksa je kontraindicirana u bolesnika s teškim oštećenjem bubrega (klirens kreatinina <30 ml/min), a treba je koristiti uz oprez u bolesnika s umjerenim oštećenjem bubrega (klirens kreatinina 30 - 50 ml/min).
In a double-blind clinical study, 2,927 patients were randomised to receive fondaparinux 2.5mg once daily or dalteparin 5,000 IU once daily, with one 2,500 IU preoperative injection and a first 2,500 IU post-operative injection, for 7+2 days. 
U dvostruko slijepom kliničkom ispitivanju, 2927 bolesnika randomizirano je ili u skupinu koja je primala fondaparinuks 2,5 mg jednom na dan ili dalteparin 5000 i.j. jednom na dan, uz jednu injekciju od 2500 i.j. prije operacije i prvu postoperativnu dozu od 2500 i.j., tijekom 7+2 dana.
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. 
OASIS 6 bilo je dvostruko-slijepo, randomizirano ispitivanje sigurnosti primjene i djelotvornosti fondaparinuksa u dozi od 2,5 mg jedanput na dan u odnosu na uobičajeno liječenje [placebo (47%) ili nefrakcionirani heparin (53%)] u otprilike 12000 bolesnika sa STEMI.
Prevention of Venous Thromboembolic Events (VTE) in patients undergoing major orthopaedic surgery of the lower limbs treated up to 9 days 
Prevencija venskih tromboembolijskih događaja (VTE) u bolesnika nakon velikih ortopedskih operacija donjih ekstremiteta, koji su liječeni do 9 dana
Randomised 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 excluded. 
tijekom faze probira, ali su isključeni bolesnici liječeni terapijskom dozom antikoagulansa tijekom više od 24 sata kao i oni s nekontroliranom hipertenzijom.
Arixtra contains sodium 
Arixtra sadrži natrij
Treatment of patients with acute symptomatic spontaneous superficial-vein thrombosis without concomitant Deep-Vein Thrombosis (DVT) 
Liječenje bolesnika s akutnom spontanom i simptomatskom površinskom venskom trombozom bez prateće duboke venske tromboze (DVT)
• Treatment of superficial-vein thrombosis - The safety and efficacy of fondaparinux in patients with severe hepatic impairment has not been studied, therefore fondaparinux is not recommended for use in these patients (see section 4.4). 
• Liječenje površinske venske tromboze - Sigurnost i djelotvornost primjene fondaparinuksa u bolesnika s teškim oštećenjem jetre nije ispitivana, stoga se njegova primjena ne preporuča u ovoj skupini bolesnika (vidjeti dio 4.4).
Patients undergoing major orthopaedic or abdominal surgery The recommended dose of fondaparinux is 2.5 mg once daily administered post-operatively by subcutaneous injection. 
Bolesnici koji se podvrgavaju velikom ortopedskom ili abdominalnom operativnom zahvatu Preporučena doza fondaparinuksa je 2,5 mg jedanput na dan, primijenjeno nakon operacije supkutanom injekcijom.
The safety of fondaparinux 2.5 mg has been evaluated in 3,595 patients undergoing major orthopaedic surgery of the lower limbs treated up to 9 days, in 327 patients undergoing hip fracture surgery treated for 3 weeks following an initial prophylaxis of 1 week, 1,407 patients undergoing abdominal surgery treated up to 9 days, and in 425 medical patients who are at risk for thromboembolic complications treated up to 14 days. 
Sigurnost primjene fondaparinuksa 2,5 mg procijenjena je u 3595 bolesnika nakon velikog ortopedskog kirurškog zahvata donjih ekstremiteta liječenih do 9 dana, u 327 bolesnika nakon operacije prijeloma kuka koji su nakon početne jednotjedne profilakse liječeni tijekom 3 tjedna, u 1407 bolesnika nakon abdominalnog kirurškog zahvata liječenih do 9 dana, u 425 nekirurških bolesnika s rizikom od tromboembolijskih komplikacija liječenih tijekom najviše 14 dana.
• if you have a risk of uncontrolled bleeding (haemorrhage) including: 
• ako imate povećani rizik od velikog nekontroliranog krvarenja,što uključuje: · čir na želucu · poremećaj zgrušavanja krvi
The primary adjudicated endpoint was a composite of death, myocardial infarction (MI) and refractory ischaemia (RI) within 9 days of randomisation. 
Primarna presudna mjera ishoda bila je kombinacija smrtnog ishoda, infarkta miokarda i refraktorne ishemije tijekom 9 dana od randomizacije.
Picture C 
Slika C
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. 
Slično tome, u bolesnika s UA/NSTEMI u po život opasnom stanju koje zahtijeva hitnu revaskularizaciju, također se ne preporuča primjena fondaparinuksa prije i tijekom perkutane koronarne intervencije.
Picture A 
Slika A
The primary efficacy outcome, a composite of symptomatic PE, symptomatic DVT, symptomatic superficial-vein thrombosis extension, symptomatic superficial-vein thrombosis reoccurrence, or Death up to Day 47, was significantly reduced from 5.9% in placebo patients to 0.9% in those receiving fondaparinux 2.5 mg (relative risk reduction: 85.2%; 95% CIs, 73.7% to 91.7% [p<0.001]). 
Primarni ishod djelotvornosti, udruženi događaji simptomatske PE, simptomatske DVT, simptomatskog proširenja tromboze površinske vene, ponovne pojave simptomatske tromboze površinske vene ili smrtnog ishoda do 47-og dana, je značajno smanjen s 5,9% u bolesnika na placebu, na 0,9% u onih koji su primali fondaparinuks 2,5 mg (relativna redukcija rizika: 85,2%; 95% CI, 73,7% do 91,7% [p<0,001]).
These agents include desirudin, fibrinolytic agents, GP IIb/IIIa receptor antagonists, heparin, heparinoids, or Low Molecular Weight Heparin (LMWH). 
U skupinu takvih lijekova ulaze dezirudin, fibrinolitički lijekovi, antagonisti receptora GP IIb/IIIa, heparin, heparinoidi ili niskomolekularni heparin (LMWH).
To avoid the loss of medicinal product when using the pre-filled syringe do not expel the air bubble from the syringe before the injection. 
Kako bi se izbjegao gubitak lijeka, pri uporabi napunjene štrcaljke nemojte istiskivati mjehurić zraka iz štrcaljke prije injiciranja.
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). 
Nema iskustva u podskupini bolesnika koji imaju i veliku tjelesnu težinu (>100 kg) i umjereno oštećenje bubrega (klirens kreatinina 30 - 50 ml/min).
The safety and efficacy of 1.5 mg has not been studied (see section 
Sigurnost i učinkovitost primjene doze od 1,5 mg nije bila proučavana (vidjeti dio 4.4).
Major bleedings, all at surgical site and none fatal, were observed in 8 patients (2.4%) treated with fondaparinux 2.5 mg compared to 2 (0.6%) with placebo. 
Velika krvarenja, sva na mjestu kirurške rane i bez smrtnog ishoda, zabilježena su u 8 bolesnika (2,4%) liječenih fondaparinuksom, u usporedbi s 2 bolesnika (0,6%) na placebu.