natgillin/translations-raw huggingface dataset:
Fondaparinux should be used with caution in patients who have an increased risk of haemorrhage, such as those with congenital or acquired bleeding disorders (e.g. platelet count <50,000/mm3), active ulcerative gastrointestinal disease and recent intracranial haemorrhage or shortly after brain, spinal or ophthalmic surgery and in special patient groups as outlined below.
Fondaparinuks treba primjenjivati uz oprez u bolesnika s povećanim rizikom od krvarenja, poput bolesnika s urođenim ili stečenim poremećajima zgrušavanja krvi (npr. s brojem trombocita <50000/mm3), aktivnom ulcerativnom gastrointestinalnom bolešću i nedavnim intrakranijalnim krvarenjem, ili u bolesnika koji su nedavno imali operaciju mozga, kralježnice ili očiju kao i u dolje navedenim posebnim skupinama bolesnika.
These may affect more than 1 in 100 people treated with Arixtra.
One se mogu javiti u više od 1 na 100 bolesnika liječenih lijekom Arixtra.
Important note
Važne napomene
Insert the full length of the needle at right angles into the skin fold (picture D).
Uvedite iglu okomito (pod kutem od 90°) cijelom dužinom u nabor kože (Slika D).
7.5 mg once a day
7,5 mg jednom na dan preko 100 kg
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.
U bolesnika starijih od 75 godina kojima je potreban ortopedski zahvat i koji su primali fondaparinuks 2,5 mg jednom na dan, procijenjeni klirens iz plazme bio je 1,2 do 1,4 puta manji nego u bolesnika mlađih od 65 godina.
The recommended dose of fondaparinux is 7.5 mg (patients with body weight ≥ 50, ≤ 100kg) once daily administered by subcutaneous injection.
Preporučena doza fondaparinuksa je 7,5 mg (za bolesnike tjelesne težine ≥50 i ≤100 kg) jedanput na dan, primijenjeno supkutanom injekcijom.
• the solution is clear and colourless and doesn't contain particles
• da je otopina bistra i bezbojna i da nema stranih čestica
Fondaparinux provided a significant reduction in the overall rate of VTE compared with placebo [3 patients (1.4%) vs 77 patients (35%), respectively].
Fondaparinuks je omogućio značajno smanjenje ukupnog broja VTE u usporedbi s placebom [3 bolesnika (1,4%) prema 77 bolesnika (35%)].
Treatment of Deep Venous Thrombosis
Liječenje duboke venske tromboze
Prevention of Venous Thromboembolic Events (VTE) in adults undergoing major orthopaedic surgery of the lower limbs such as hip fracture, major knee surgery or hip replacement surgery.
Prevencija venskih tromboembolijskih događaja (VTE) u odraslih osoba koje se podvrgavaju velikom ortopedskom kirurškom zahvatu na donjim ekstremitetima poput operacije frakture kuka, velike operacije koljena ili ugradnje umjetnog kuka.
Dispose of it as your doctor or pharmacist has instructed.
Odložite je prema uputama Vašeg liječnika ili ljekarnika.
Do not use Arixtra:
Nemojte primjenjivati lijek Arixtra:
The 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.
U bolesnika u istim dobnim skupinama koji su primali preporučene doze enoksaparina za liječenje DVT, incidencija krvarenja bila je 2,5%, 3,6%, odnosno 8,3%, dok je u bolesnika koji su primali preporučene doze UFH za liječenje PE ona iznosila 5,5%, 6,6% odnosno 7,4%.
If PCI was performed, patients received either intravenous fondaparinux (fondaparinux patients) or weight adjusted intravenous UFH (enoxaparin patients) as adjunctive therapy, dependent on the timing of the last subcutaneous dose and planned use of GP IIb/IIIa inhibitor.
Ako je provedena perkutana koronarna intervencija, bolesnici su kao dodatnu terapiju dobili ili intravenski fondaparinuks ili intravenski nefrakcionirani heparin, čija je doza bila prilagođena tjelesnoj težini bolesnika, ovisno o vremenu primjene zadnje supkutane doze i planiranoj primjeni inhibitora GP IIb/IIIa.
The most commonly reported serious adverse reactions reported with fondaparinux are bleeding complications (various sites including rare cases of intracranial/ intracerebral and retroperitoneal bleedings) and anaemia.
Najčešće prijavljene ozbiljne nuspojave primjene fondaparinuksa su krvarenje (na različitim mjestima, uključujući i rijetke slučajeve intrakranijalnog/ intracerebralnog i retroperitonealnog krvarenja) i anemija.
• bruising or swelling (oedema)
• modrice ili oticanje (edemi)
Over 8,000 patients (hip fracture - 1,711, hip replacement - 5,829, major knee surgery - 1,367) were studied in controlled Phase II and III clinical studies.
Više od 8000 bolesnika (prijelom kuka - 1711, ugradnja umjetnog kuka - 5829, velika operacija koljena - 1367)
The efficacy findings and results on major bleeding were consistent across prespecified subgroups such as elderly, renally impaired patients, type of concomitant platelet aggregation inhibitors (aspirin, thienopyridines or GP IIb/IIIa inhibitors).
Nalazi djelotvornosti i rezultati velikog krvarenja bili su konzistentni kroz prethodno specificirane podskupine, kao npr. skupine starijih bolesnika, bolesnika s oštećenjem bubrega, skupine prema tipu istodobne primjene inhibitora agregacije trombocita (aspirin, tienopiridini, inhibitori GP IIb/IIIa).
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.
U randomiziranom dvostruko slijepom kliničkom ispitivanju bolesnika s potvrđenom dijagnozom akutne simptomatske DVT, fondaparinuks u dozi od 5 mg (tjelesna težina <50 kg), 7,5 mg (tjelesna težina ≥50 kg, ≤100 kg) ili 10 mg (tjelesna težina >100 kg) primijenjen s.c. jednom na dan uspoređivao se s enoksaparinnatrijem u dozi od 1 mg/kg primijenjenim s.c. dvaput na dan.
The most commonly reported serious adverse reactions reported with fondaparinux are bleeding complications (various sites including rare cases of intracranial/ intracerebral and retroperitoneal bleedings).
Najčešće prijavljene ozbiljne nuspojave primjene fondaparinuksa su krvarenje (na različitim mjestima, uključujući i rijetke slučajeve intrakranijalnog/ intracerebralnog i retroperitonealnog krvarenja).
Talk to your doctor or pharmacist before taking Arixtra:
Posavjetujte se s liječnikom ili ljekarnikom prije prestanka primjene lijeka Arixtra.
Patients under-going urological (other than kidney) or gynaecological surgery, laparoscopic surgery or vascular surgery were not included in the study.
U studiju nisu bili uključeni bolesnici koji su podvrgnuti urološkom (osim bubrega), ginekološkom, vaskularnom niti laparoskopskom operativnom zahvatu.
Initiation of appropriate therapy such as surgical haemostasis, blood replacements, fresh plasma transfusion, plasmapheresis should be considered.
Treba razmotriti primjereno liječenje poput kirurške hemostaze, nadomještanja krvi,
Major bleeding during the initial treatment period was observed in 1.3% of fondaparinux patients, compared to 1.1% with unfractionated heparin.
Veliko krvarenje tijekom početnog razdoblja liječenja zabilježeno je u 1,3% bolesnika na fondaparinuksu, u usporedbi s 1,1% bolesnika koji su primali nefrakcionirani heparin.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PRE-FILLED SYRINGE
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NAPUNJENA ŠTRCALJKA
The pharmacokinetics of fondaparinux has not been studied in patients with severe hepatic impairment (see sections 4.2 and 4.4).
Farmakokinetika fondaparinuksa nije ispitivana u bolesnika s teškim oštećenjem jetre (vidjeti dio 4.2 i
• Prevention of VTE and Treatment of UA/NSTEMI and STEMI - Patients with body weight <50 kg are at increased risk of bleeding.
• Prevencija VTE i liječenje UA/NSTEMI i STEMI - bolesnici tjelesne težine <50 kg imaju povišeni rizik od nastupa krvarenja.
The primary adjudicated endpoint was a composite of death and recurrent MI (re-MI) within 30 days of randomisation.
Primarna presudna mjera ishoda bila je kombinacija smrtnog ishoda i rekurentnog infarkta miokarda (re-MI) tijekom 30 dana od randomizacije.
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 Kod velikih ortopedskih kirurških zahvata, pri istodobnoj primjeni fondaparinuksa i spinalne/epiduralne anestezije ili spinalne punkcije ne može se isključiti mogućnost nastanka epiduralnih ili spinalnih hematoma koji mogu uzrokovati dugotrajnu ili trajnu paralizu bolesnika.
The first fondaparinux administration should be given not earlier than 6 hours following surgical closure.
Prva injekcija fondaparinuksa se ne smije dati prije nego je prošlo 6 sati od završetka operativnog zahvata.
• The other ingredient(s) are sodium chloride, water for injections, and hydrochloric acid and/or sodium hydroxide to adjust the pH (see section 2).
• Drugi sastojci su natrijev klorid, voda za injekcije, kloridna kiselina i/ili natrijev hidroksid za podešavanje pH (pogledajte dio 2).
All patients received standard treatments for STEMI, including primary PCI (31%), thrombolytics (45%) or no reperfusion (24%).
Svi su bolesnici primili standardno liječenje za STEMI, uključujući primarnu perkutanu koronarnu intervenciju (PCI) (31%),
Fondaparinux does not cross-react with sera from patients with heparin-induced thrombocytopaenia.
Fondaparinuks obično ne pokazuje križnu reakciju sa serumima bolesnika s heparinom induciranom trombocitopenijom (HIT).
In the subgroup of patients treated with fondaparinux or enoxaparin who underwent PCI, 8.8% and 8.2% of patients respectively, experience death/MI/RI within 9 days of randomisation (hazard ratio 1.08, 95% CI, 0.92;1.27).
U podskupinama bolesnika liječenih fondaparinuksom ili enoksaparinom koji su bili podvrgnuti perkutanoj koronarnoj intervenciji, 8,8% odnosno 8,1% bolesnika doživjelo je smrt, infarkt miokarda ili refraktornu ishemiju tijekom 9 dana od randomizacije (omjer rizika 1,08; 95% CI, 0,92; 1,27).
Arixtra is a medicine that treats or helps to prevent blood clots from forming in the blood vessels (an antithrombotic agent).
Arixtra je lijek koji služi liječenju ili pomaže pri sprječavanju stvaranja ugrušaka u krvnim žilama (lijek iz skupine antitrombotika).
In elderly healthy subjects, pharmacokinetics of fondaparinux is linear in the range of 2 to 8 mg by subcutaneous route.
U zdravih starijih osoba farmakokinetika fondaparinuksa primijenjenog supkutano je linearna u rasponu 2 do 8 mg.
Prevention of Venous Thromboembolic Events (VTE) in adults undergoing abdominal surgery who are judged to be at high risk of thromboembolic complications, such as patients undergoing abdominal cancer surgery (see section 5.1).
Prevencija venskih tromboembolijskih događaja (VTE) u odraslih osoba koje se podvrgavaju abdominalnom kirurškom zahvatu kod kojih se procjenjuje da postoji visoki rizik nastanka tromboembolijskih komplikacija, kao što su bolesnici koji se podvrgavaju abdominalnom kirurškom zahvatu zbog tumora (vidjeti dio 5.1).
The intravenous tubing should be well flushed with saline after injection to ensure that all of the medicinal product is administered.
Nakon injekcije sistem za intravensku primjenu treba dobro isprati fiziološkom otopinom kako bi se osigurala potpuna primjena lijeka.
Uncommon: anaemia, thrombocytopaenia
Manje često: anemija, trombocitopenija
Patients were excluded if they had severe hepatic impairment, severe renal impairment (creatinine clearance <30ml/min), low body weight (<50kg), active cancer, symptomatic PE or a recent history of DVT/PE (<6 months) or superficial-vein thrombosis (<90 days), or superficial-vein thrombosis associated with sclerotherapy or a complication of an IV line, or they were at high risk of bleeding.
(kreatinin klirens <30 ml/min), malom tjelesnom težinom (<50 kg), aktivnom malignom bolešću, simptomatskom PE ili anamnezom nedavno preboljele DVT/PE (<6 mjeseci), trombozom površinske vene (<90 dana), ili pak trombozom površinske vene kao posljedicom skleroterapije ili postavljenog venskog puta ili koji su imali povišeni rizik od krvarenja.
The efficacy findings and results on severe haemorrhage were consistent across prespecified subgroups such as elderly, renally impaired patients, type of concomitant platelet aggregation inhibitors (aspirin, thienopyridines).
Nalazi djelotvornosti i rezultati obzirom na veliko krvarenje bili su konzistentni kroz prethodno specificirane podskupine, kao npr. skupine starijih bolesnika, bolesnika s oštećenjem bubrega, skupine prema tipu istodobne primjene inhibitora agregacije trombocita (aspirin, tienopiridini).
The fondaparinux clinical program was designed to demonstrate the efficacy of fondaparinux for the prevention of venous thromboembolic events (VTE), i.e. proximal and distal deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients undergoing major orthopaedic surgery of the lower limbs such as hip fracture, major knee surgery or hip replacement surgery.
Klinički program za fondaparinuks dizajniran je s ciljem da dokaže djelotvornost fondaparinuksa u prevenciji venskih tromboembolijskih događaja (VTE), tj. proksimalne i distalne duboke venske tromboze (DVT) i plućne embolije (PE) u bolesnika nakon velikih ortopedskih operacija donjih ekstremiteta poput prijeloma kuka, velike operacije koljena ili ugradnje umjetnog kuka.
Arixtra is a medicine that helps prevent blood clots from forming in the blood vessels (an antithrombotic agent).
Arixtra je lijek koji pomaže pri sprječavanju stvaranja ugrušaka u krvnim žilama (lijek iz skupine antitrombotika).
Slide the sleeve up the body of the syringe until it locks into position over the needle.
Povucite valjak preko štrcaljke dok ne zatvori iglu.
In the pivotal STEMI clinical trial, treatment with fondaparinux was restarted no earlier than 3 hours after sheath removal.
U pivotalnim kliničkim ispitivanjima STEMI, liječenje fondaparinuksom ponovo je uvedeno najranije tri sata nakon vađenja uvodnice.
In UA/NSTEMI and STEMI patients undergoing non-primary PCI, the use of fondaparinux as the sole anticoagulant during PCI is not recommended due to an increased risk of guiding catheter thrombus (see clinical studies section 5.1).
U bolesnika s UA/NSTEMI i STEMI koji su podvrgnuti neprimarnoj perkutanoj koronarnoj intervenciji, ne preporuča se primjena fondaparinuksa kao jedinog antikoagulansa tijekom perkutane koronarne intervencije, zbog povećanog rizika od tromboze u provodnom kateteru (vidjeti dio 5.1).
In a study of 3235 high-risk UA/NSTEMI patients scheduled for angiography and treated with openlabel fondaparinux (OASIS 8/FUTURA), the 2026 patients indicated for PCI were randomised to receive one of two double-blind dose regimens of adjunctive UFH.
U ispitivanju koje je uključivalo 3235 visoko rizičnih bolesnika s UA/NSTEMI koji su bili predviđeni za angiografiju i liječeni fondaparinuksom (otvorena faza ispitivanja) (OASIS 8/FUTURA), 2026
• bleeding (for example from an operation site, an existing stomach ulcer, nosebleed, bruising)
• krvarenje (na primjer na mjestu kirurškog reza, krvarenje postojećeg čira želuca, krvarenje iz nosa, stvaranje modrica)
Platelet inhibitors (acetylsalicylic acid), NSAIDs (piroxicam) and digoxin did not interact with the pharmacokinetics of fondaparinux.
Inhibitori trombocita (acetilsalicilna kiselina), nesteroidni antireumatici (piroksikam) i digoksin ne ulaze u interakcije s farmakokinetikom fondaparinuksa.
In hip fracture patients, associated with their increased age, fondaparinux steady state plasma concentrations are: Cmax (mg/l) - 0.50 (32%), Cmin (mg/l) - 0.19 (58%).
U bolesnika s frakturom kuka povezanom s njihovom starijom životnom dobi, koncentracije fondaparinuksa u plazmi u stanju dinamičke ravnoteže su: Cmax (mg/l) - 0,50 (32%), Cmin (mg/l)
Treatment should be initiated as soon as possible following diagnosis and after exclusion of concomitant DVT or superficial-vein thrombosis within 3 cm from the sapheno-femoral junction.
Liječenje treba započeti što je moguće prije nakon postavljanja dijagnoze i nakon što je isključena prateća duboka venska tromboza ili površinska venska tromboza unutar 3 cm od safeno-femoralnog ušća.
Major bleeding during treatment occurred in 1 (0.1%) fondaparinux patient and in 1 (0.1%) placebo patient.
Veliko krvarenje pojavilo se u jednog bolesnika na fondaparinuksu (0,1%) i u jednog na placebu (0,1%).
To avoid the loss of medicinal product when using the prefilled syringe do not expel the air bubble from the syringe before the injection.
Kako bi se izbjegao gubitak lijeka, pri uporabi štrcaljke nemojte istiskivati mjehurić zraka prije injiciranja.
By binding selectively to antithrombin, fondaparinux potentiates (about 300 times) the innate neutralization of Factor Xa by antithrombin.
Selektivnim vezanjem na antitrombin, fondaparinuks pojačava (oko 300 puta) prirodnu neutralizaciju faktora Xa antitrombinom.
• Treatment of superficial-vein thrombosis - There are no clinical data available for the use of fondaparinux for the treatment of superficial-vein thrombosis in patients with severe hepatic impairment.
• Liječenje površinske venske tromboze - nema kliničkih podataka o primjeni fondaparinuksa u liječenju bolesnika s površinskom venskom trombozom i teškim oštećenjem jetre.
By Day 30, the incidence of all cause mortality was significantly reduced from 3.5% on enoxaparin to 2.9% on fondaparinux (hazard ratio 0.83, 95% CI, 0.71;0.97, p = 0.02).
Do tridesetog dana incidencija mortaliteta svih uzroka bila je značajno smanjena sa 3,5% na enoksaparinu do 2,9% na fondaparinuksu (omjer rizika 0,83; 95% CI, 0,71; 0,97; p = 0,02).
Fondaparinux also significantly reduced the rate of adjudicated fatal PE [0 patients (0.0%) vs 5 patients (1.2%), respectively].
Fondaparinuks je također značajno smanjio broj slučajeva plućne embolije sa smrtnim ishodom [0 bolesnika (0,0%) prema 5 bolesnika (1,2%)].
At the doses used for treatment, fondaparinux does not, to a clinically relevant extent, affect routine coagulation tests such as activated partial thromboplastin time (aPTT), activated clotting time (ACT) or prothrombin time (PT)/International Normalised Ratio (INR) tests in plasma nor bleeding time or fibrinolytic activity.
Pri terapijskim dozama fondaparinuks ne utječe u klinički značajnoj mjeri na rutinske testove koagulacije, poput aktiviranog parcijalnog tromboplastinskog vremena (APTV), aktiviranog vremena zgrušavanja, na protrombinsko vrijeme (PV)/internacionalni normalizirani omjer (INR) u plazmi, kao niti na vrijeme krvarenja i fibrinolitičko djelovanje.
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).
Oštećenje funkcije bubrega - u usporedbi s bolesnicima s normalnom funkcijom bubrega (klirens kreatinina > 80 ml/min), klirens iz plazme je 1,2 do 1,4 puta manji u bolesnika s blagim oštećenjem bubrega (klirens kreatinina 50 do 80 ml/min), a prosječno 2 puta manji u bolesnika s umjerenim oštećenjem bubrega (klirens kreatinina 30 do 50 ml/min).
How to store Arixtra
Kako primjenjivati lijek Arixtra
• Treatment of superficial-vein thrombosis - There are no clinical data available for the use of fondaparinux for the treatment of superficial-vein thrombosis in patients with body weight less than 50kg.
• Liječenje površinske venske tromboze - nema kliničkih podataka o primjeni fondaparinuksa u liječenju bolesnika s površinskom venskom trombozom i tjelesnom težinom <50 kg.
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