natgillin/translations-raw huggingface dataset:
Clinically relevant non major bleeding occurred in 5 (0.3%) fondaparinux patients and 8 (0.5%) placebo patients. 
Klinički značajno manje krvarenje javilo se u 5 bolesnika na fondaparinuksu (0,3%) i 8 bolesnika na placebu (0,5%).
For patients with body weight < 50 kg, the recommended dose is 5 mg. For patients with body weight > 100 kg, the recommended dose is 10 mg. 
Za bolesnike tjelesne težine <50 kg preporučena doza je 5 mg.
Major bleeding was observed in 3.4% of the patients in the fondaparinux group and in 2.4% of the dalteparin group. 
Veliko krvarenje zabilježeno je u 3,4% bolesnika u skupini koja je dobivala fondaparinuks te u 2,4% bolesnika u skupini koja je dobivala dalteparin.
In severe renal impairment (creatinine clearance < 30 ml/min), plasma clearance is approximately 5 times lower than in normal renal function. 
U bolesnika s teškim oštećenjem bubrega (klirens kreatinina <30 ml/min), klirens iz plazme je oko 5 puta manji nego kod normalne bubrežne funkcije.
Oral anticoagulants (warfarin), platelet inhibitors (acetylsalicylic acid), NSAIDs (piroxicam) and digoxin did not interact with the pharmacokinetics of fondaparinux. 
Oralni antikoagulansi (varfarin), inhibitori trombocita (acetilsalicilna kiselina), nesteroidni antireumatici (piroksikam) i digoksin ne ulaze u interakcije s farmakokinetikom fondaparinuksa.
Marketing Authorisation Holder and Manufacturer 
Nositelj odobrenja za stavljanje gotovog lijeka u promet i proizvođač
Patients could be recommended to self-inject the product when they are judged willing and able to do so. Physicians should provide clear instructions for self-injection. 
Bolesnicima se može preporučiti da sami primjenjuju lijek nakon što se procijeni da su voljni i sposobni to učiniti sami.
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. 
U liječenju DVT i PE, u bolesnika koji su primali fondaparinuks u dozi od 5 mg (tjelesna težina <50 kg), 7,5 mg (tjelesna težina 50 - 100 kg) ili 10 mg (tjelesna težina >100 kg), doza prilagođena tjelesnoj težini omogućuje sličnu izloženost u svim težinskim kategorijama.
• reduction or increase in the number of platelets (blood cells necessary for blood clotting) 
• vrućica • smanjenje ili povećanje broja krvnih pločica (krvnih stanica neophodnih za zgrušavanje krvi)
• Prevention of VTE - No dosing adjustment is necessary in patients with either mild or moderate hepatic impairment. 
• Prevencija VTE - nije potrebna prilagodba doziranja u bolesnika s blagim ili umjerenim jetrenim oštećenjem.
Disposal of syringes: 
Odlaganje štrcaljki:
Animal studies are insufficient with respect to effects on toxicity to reproduction because of limited exposure. 
ispitivanja na životinjama nisu dovoljna za ocjenu toksičnog učinka na reprodukciju.
Patients were not included if they had concomitant DVT or superficialvein thrombosis within 3 cm of the sapheno-femoral junction. 
U ispitivanje nisu bili uključeni bolesnici s pratećom DVT ili trombozom površne vene unutar 3 cm od safeno-femoralnog ušća.
• pain and swelling at injection site 
• bol i oticanje na mjestu uboda
Treatment of superficial-vein thrombosis - The safety and efficacy of fondaparinux in patients with body weight less than 50 kg 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 tjelesnom težinom <50 kg nije ispitivana, stoga se njegova primjena ne preporuča u ovoj skupini bolesnika (vidjeti dio 4.4).
Paediatric patients - Fondaparinux has not been investigated in this population for the prevention of VTE or for the treatment of superficial vein thrombosis or acute coronary syndrome (ACS). 
Posebne skupine bolesnika: Pedijatrijska populacija - nije ispitivana primjena fondaparinuksa u djece u prevenciji VTE niti liječenju površinske venske tromboze ili akutnog koronarnog sindroma (ACS).
• internal bleeding in the brain or abdomen 
• unutarnje krvarenje u mozgu ili trbuhu
Patients eligible for fondaparinux 2.5 mg treatment should have acute, symptomatic, isolated, spontaneous superficial-vein thrombosis of the lower limbs, at least 5 cm long and documented by ultrasonographic investigation or other objective methods. 
Bolesnici kojima je indicirana primjena fondaparinuksa od 2,5 mg su bolesnici s akutnom, simptomatskom, izoliranom, spontanom trombozom površinske vene donjih ekstremiteta, koja zahvaća venu u dužini od barem 5 cm, a potvrđena je ultrazvukom ili nekom drugom objektivnom metodom.
• For prevention of VTE - Agents that may enhance the risk of haemorrhage should not be administered concomitantly with fondaparinux. 
• U prevenciji VTE - lijekovi koji mogu povećati rizik od krvarenja ne smiju se primjenjivati istodobno s fondaparinuksom.
Since fondaparinux does not bind significantly to plasma proteins other than antithrombin, no interaction with other medicinal products by protein binding displacement are expected. 
Budući da se fondaparinuks ne veže značajno na druge proteine plazme, osim na antitrombin, ne očekuju se interakcije s drugim lijekovima zbog istiskivanja s mjesta vezanja na proteine.
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). 
U bolesnika koji su revaskularizirani trombolitikom fondaparinuks je značajno smanjio incidenciju smrti/rekurentnog infarkta miokarda tridesetog dana s 13,6% u kontrolnoj skupini na 10,9% (omjer rizika 0,79; 95% CI, 0,68; 0,93, p = 0,003).
In a pooled analysis of these studies, the recommended dose regimen of fondaparinux versus enoxaparin was associated with a significant decrease (54% [95% CI, 44 %; 63%]) in the rate of VTE evaluated up to day 11 after surgery, irrespective of the type of surgery performed. 
U skupnoj analizi tih studija, fondaparinuks je u preporučenoj shemi doziranja u usporedbi s enoksaparinom bio povezan sa značajnim smanjenjem (54% - [95% CI, 44 %; 63%]) stope VTE
Breast-feeding is not recommended during treatment with Arixtra. 
Arixtra ne preporuča se dojenje.
• Patients who are to undergo coronary artery bypass graft (CABG) surgery 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. 
U bolesnika sa STEMI ili UA/NSTEMI koji se podvrgavaju operaciji ugradnje koronarne premosnice, fondaparinuks ne treba davati tijekom 24 sata prije operacije, ako je to moguće, a u terapiju se ponovo može uvesti 48 sati nakon zahvata.
There are different syringes for the 5 mg, 7.5 mg and 10 mg doses. 
Postoje različite prethodno napunjene štrcaljke koje sadrže doze od 5 mg, 7,5 mg i 10 mg lijeka Arixtra.
Uncommon: rash, pruritus 
Manje često: osip, pruritus
If a patient is to undergo percutaneous coronary intervention (PCI), unfractionated heparin (UFH) as per standard 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). 
Ako se bolesnik podvrgava neprimarnoj perkutanoj koronarnoj intervenciji, tijekom zahvata u skladu sa standardnom praksom treba primijeniti nefrakcionirani heparin i pritom razmotriti potencijalni rizik od krvarenja, uključujući i vrijeme proteklo od posljednje doze fondaparinuksa (vidjeti dio 4.4).
Major bleeding during the initial treatment period was observed in 1.1% of fondaparinux patients, compared to 1.2% with enoxaparin. 
Veliko krvarenje tijekom početnog razdoblja liječenja zabilježeno je u 1,1% bolesnika na fondaparinuksu, u usporedbi s 1,2% bolesnika na enoksaparinu.
Syringe with an automatic needle protection system 
Štrcaljka s automatskim sigurnosnim sustavom za iglu
• For treatment of superficial-vein thrombosis- Fondaparinux should be used with caution in patients who are being treated concomitantly with other medicinal products that increase the risk of haemorrhage. 
• U liječenju površinske venske tromboze - Fondaparinuks treba primjenjivati s oprezom u bolesnika koji se istovremeno liječe s drugim preparatima koji povećavaju rizik od krvarenja.
Incidences of bleeding events in patients receiving the recommended regimen in the treatment of DVT or PE and aged <65 years, 65-75 and >75 years were 3.0 %, 4.5 % and 6.5 %, respectively. 
Incidencija krvarenja u bolesnika koji su primali preporučene doze za liječenje DVT ili PE bila je 3% u dobnoj skupini <65 godina, 4,5% u bolesnika starih 65-75 godina, te 6,5% u starijih od 75
Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland Manufacturer: 
Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Irska
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. 
Nuspojave koje su ispitivači prijavili kao barem moguće povezane s fondaparinuksom navedene su u skupinama prema učestalosti pojavljivanja (vrlo često: ≥ 1/10; često: ≥1/100 i < 1/10; manje često:
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). 
Na temelju farmakokinetskih modela, u toj se podskupini može razmotriti smanjenje dnevne doze s početnih 10 mg na 7,5 mg dnevno (vidjeti dio 4.4.)
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]. 
U bolesnika podvrgnutih primarnoj perkutanoj koronarnoj intervenciji, incidencija smrti/rekurentnog infarkta miokarda tridesetog dana nije bila statistički različita između dvije skupine (6,0% u skupini liječenoj fondaparinuksom prema 4,8% u kontrolnoj skupini; omjer rizika 1,26; 95% CI, 0,96; 1,66).
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). 
U skupini liječenoj fondaparinuksom, 5,8% bolesnika je doživjelo jedan događaj do devetog dana u odnosu na 5,7% bolesnika liječenih enoksaparinom (omjer rizika 1,01; 95% CI, 0,90; 1,13; p = 0,003).
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). 
Deveti dan je incidencija velikog krvarenja iznosila 2,1% na fondaparinuksu, odnosno 4,1% na enoksaparinu (omjer rizika 0,52; 95% CI, 0,44; 0,61, p < 0,001).
Agents that may enhance the risk of haemorrhage should not be administered concomitantly with fondaparinux. 
Lijekovi koji mogu povećati rizik od krvarenja ne smiju se primjenjivati istodobno s fondaparinuksom.
• pain 
• bolovi
Treatment of superficial-vein thrombosis 
Liječenje površinske venske tromboze
In STEMI patients undergoing primary PCI, the use of fondaparinux prior to and during PCI is not recommended. 
U bolesnika sa STEMI koji su podvrgnuti primarnoj perkutanoj koronarnoj intervenciji, primjena fondaparinuksa prije i tijekom perkutane koronarne intervencije se ne preporuča.
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu 
Detaljnije informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove:
For treatment of superficial-vein thrombosis - Fondaparinux should be used with caution in patients who are being treated concomitantly with other medicinal products that increase the risk of haemorrhage. 
U liječenju površinske venske tromboze - Fondaparinuks treba primjenjivati s oprezom u bolesnika koji se istovremeno liječe s drugim preparatima koji povećavaju rizik od krvarenja.
• if you notice any particles in the solution, or if the solution is discoloured 
• ako u otopini primijetite strane čestice ili promjenu boje • ako primijetite da je štrcaljka oštećena
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). 
Međutim, u ovom stratumu, u podskupini bolesnika koja je podvrgnuta trombolizi ili nije reperfundirana (tj. bolesnici koji nisu podvrgnuti primarnoj perkutanoj koronarnoj intervenciji) incidencija smrti/rekurentnog infarkta miokarda tridesetog dana bila je značajno smanjena sa 14,3 % u bolesnika liječenih nefrakcioniranim heparinom na 11,5 % u bolesnika liječenih fondaparinuksom (omjer rizika 0,79; 95% CI, 0,64; 0,98, p = 0,03).
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). 
p = 0,003).U prethodno definiranom stratumu u kojem se fondaparinuks uspoređivao s nefrakcioniranim heparinom [bolesnici liječeni primarnom perkutanom koronarnom intervencijom (58,5%), specifičnim fibrinoliticima (13%), nespecifičnim fibrinoliticima (2,6%) i bez reperfuzijskog liječenja (25,9%)], učinci fondaparinuksa i nefrakcioniranog heparina na incidenciju smrti/rekurentnog infarkta miokarda tridesetog dana nisu bili statistički različiti: 8,3% prema 8,7% (omjer rizika 0,94; 95% CI, 0,79; 1,11, p = 0,460).
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. 
Zaštitni sustav injekcijske igle na Arixtra napunjenim štrcaljkama oblikovan je kao sigurnosni sustav za zaštitu od slučajnog uboda nakon injiciranja.
Fondaparinux should be used with caution in patients who have an increased risk of haemorrhage (see section 4.4). 
Fondaparinuks treba primjenjivati s oprezom u bolesnika koji imaju povišeni rizik od nastanka krvarenja (vidjeti dio 4.4).
Since fondaparinux does not bind significantly to plasma proteins other than ATIII, no interaction with other medicinal products by protein binding displacement are expected. 
Budući da se fondaparinuks ne veže značajno na druge proteine plazme, osim AT III, ne očekuju se interakcije s drugim lijekovima zbog istiskivanja s mjesta vezivanja na proteine.
1: Odds ratio: Low Dose/Standard Dose Note: MI - myocardial infarction. 
1: Omjer vjerojatnosti: Niska doza/Standardna doza
Adverse reactions in medical patients 
Nuspojave u nekirurških bolesnika
Mean (CV%) steady state pharmacokinetic parameters estimates of fondaparinux in patients undergoing hip replacement surgery receiving fondaparinux 2.5 mg once daily are: Cmax (mg/l) - 0.39 (31%), Tmax (h) - 2.8 (18%) and Cmin (mg/l) -0.14 (56%). 
Ocjena prosječnih vrijednosti (CV%) farmakokinetičkih parametara za fondaparinuks u stanju dinamičke ravnoteže u bolesnika nakon ugradnje umjetnog kuka, koji su primali fondaparinuks 2,5 mg jednom na dan su: Cmax (mg/l) - 0,39 (31%), Tmax (h) - 2,8 (18%) i Cmin (mg/l) - 0,14 (56%).
• internal bleeding in the brain, liver or abdomen 
• unutarnje krvarenje (u mozgu, jetri ili trbuhu)
However, 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). 
Međutim, treba oprezno razmotriti primjenu fondaparinuksa zbog povećanog rizika od krvarenja uslijed nedostatka faktora koagulacije u bolesnika s teškim oštećenjem jetre (vidjeti dio 4.2).
In the pivotal UA/NSTEMI clinical trial, treatment with fondaparinux was restarted no earlier than 2 hours after sheath removal. 
U pivotalnim kliničkim ispitivanjima UA/NSTEMI, liječenje fondaparinuksom ponovo je uvedeno najranije dva sata nakon vađenja uvodnice.
• Subcutaneous administration 
• Supkutana primjena
6.6 Special precautions for disposal and other handling 
6.6 Posebne mjere za zbrinjavanje i druga rukovanje lijekom
Uncommon: nausea, vomiting 
Manje često: mučnina, povraćanje
: + 33 (0)1 39177000 aspenmedinfo@professionalinformation.co.uk 
Tél.: + 33 (0)1 39177000 aspenmedinfo@professionalinformation.co.uk
Patients with superficial-vein thrombosis 
Bolesnici s površinskom venskom trombozom
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). 
Incidencija smrti/ (re-MI) tridesetog dana bila je značajno smanjena sa 11,1% u kontrolnoj skupini na 9,7% u skupini liječenoj fondaparinuksom (omjer rizika 0,86; 95% CI, 0,77; 0,96, p = 0,008).
• rash or itchy skin 
• osip ili svrbež kože
Rare: bilirubinaemia 
Rijetko: hiperbilirubinemija
Paediatric patients - Fondaparinux has not been investigated in this population for the prevention of VTE or for the treatment of superficial vein thrombosis. 
Pedijatrijska populacija - nije ispitivana primjena fondaparinuksa u djece u prevenciji VTE niti liječenju površinske venske tromboze.
• 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. 
Lijek treba intravenski primijeniti kroz postojeću intravensku liniju, ili direktno ili uz mali volumen (25 ili 50 ml) 0,9% fiziološke otopine.
Hepatic impairment - No dosing adjustment is necessary in patients with either mild or moderate hepatic impairment. 
Oštećenje jetre - nije potrebna prilagodba doziranja u bolesnika s blagim ili umjerenim jetrenim oštećenjem.
• the expiry date has not passed 
• da nije istekao rok valjanosti
Prevention of VTE and Treatment of UA/NSTEMI and STEMI - No dosing adjustment is necessary in patients with either mild or moderate hepatic impairment. 
• Prevencija VTE i liječenje UA/NSTEMI i STEMI - nije potrebna prilagodba doziranja u bolesnika s blagim ili umjerenim jetrenim oštećenjem.
In severe renal impairment (creatinine clearance <30 ml/min), plasma clearance is approximately 5 times lower than in normal renal function. 
(klirens kreatinina < 30 ml/min), klirens iz plazme je oko 5 puta manji nego kod normalne bubrežne funkcije.
Each pre-filled syringe contains 10 mg of fondaparinux sodium in 0.8 ml solution for injection. 
Svaka napunjena štrcaljka sadržava 10 mg fondaparinuksnatrija u 0,8 ml otopine za injekciju.
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). 
Treba oprezno razmotriti primjenu fondaparinuksa zbog povećanog rizika od krvarenja uslijed nedostatka faktora koagulacije u bolesnika s teškim oštećenjem jetre (vidjeti dio 4.2).
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). 
U toj je podskupini incidencija velikog krvarenja devetog dana iznosila 2,2%, na fondaparinuks odnosno 5,0% na enoksaparin (omjer rizika 0,43; 95% CI, 0,33; 0,57).
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. 
Incidencija krvarenja u bolesnika koji su primali preporučene doze za liječenje DVT ili PE iznosila je 3,0% (34/1132) u bolesnika s normalnom funkcijom bubrega, 4,4% (32/733) u bolesnika s blagim oštećenjem bubrega, 6,6% (21/318) u bolesnika s umjerenim oštećenjem bubrega i 14,5% (8/55) u bolesnika s teškim oštećenjem bubrega.
There are different syringes for the 2.5 mg and 1.5 mg doses. 
Postoje različite prethodno napunjene štrcaljke koje sadrže doze od 2,5 mg i 1,5 mg lijeka Arixtra.
What Arixtra looks like and contents of the pack Arixtra is a clear and colourless to slightly yellow solution for injection. 
Arixtra je bistra i bezbojna do žućkasta otopina za injekciju.
These may affect up to 1 in every 1000 people treated with Arixtra. 
One se mogu javiti u manje od 1 na 1000 bolesnika liječenih lijekom Arixtra.
Presence of superficial-vein thrombosis greater than 3 cm from the sapheno-femoral junction should be confirmed and concomitant DVT should be excluded by compression ultrasound or objective methods prior to initiating treatment of fondaparinux. 
Prije započinjanja liječenja fondaparinuksom treba potvrditi postojanje površinske venske tromboze udaljene više od 3 cm od safeno-femoralnog ušća i isključiti istovremeno postojanje duboke venske tromboze (DVT) kompresijskim ultrazvukom ili drugom objektivnom metodom.
In the predefined stratum comparing fondaparinux to placebo (i.e patients treated with nonfibrin 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). 
U prethodno definiranom stratumu u kojem se fondaparinuks uspoređivao s placebom (tj. bolesnicima liječenim nespecifičnim fibrinoliticima (77,3%), specifičnim fibrinoliticima (0,3%), primarnom perkutanom koronarnom intervencijom (0,4%), te s onima bez reperfuzijskog liječenja (22%)), incidencija smrti/rekurentnog infarkta miokarda tridesetog dana bila je značajno smanjena sa 14,0% u skupini na placebu na 11,3% (omjer rizika 0,80; 95% CI, 0,69; 0,93,
• high number of platelets (blood cells necessary for blood clotting) 
• povišen broj krvnih pločica (krvnih stanica neophodnih za zgrušavanje krvi)
The risk of bleeding increases with increasing renal impairment. 
Rizik od krvarenja veći je što je oštećenje bubrežne funkcije teže.
The syringe needle shield contains latex that has the potential to cause allergic reactions in latex sensitive individuals. 
Štitnik za iglu sadrži lateks koji ima potencijal uzrokovati alergijske reakcije u osoba osjetljivih na lateks.
Don't stop using Arixtra without advice 
Nemojte samovoljno prestati primjenjivati lijek Arixtra
The antithrombotic activity of fondaparinux is the result of antithrombin III (antithrombin) mediated selective inhibition of Factor Xa. 
Antitrombotsko djelovanje fondaparinuksa rezultat je selektivne inhibicije faktora Xa preko antitrombina III (antitrombin).
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN Keep out of the sight and reach of children. 
Čuvati izvan pogleda i dohvata djece.
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. 
U bolesnika podvrgnutih operaciji, a koji su stariji od 75 godina i/ili tjelesne težine <50 kg i/ili imaju oštećenje bubrega s klirensom kreatinina 20 - 50 ml/min, treba se strogo pridržavati pravilnog trenutka primjene prve injekcije.