natgillin/translations-raw huggingface dataset:
The initial dose should be given 6 hours following surgical closure provided that haemostasis has been established.
Početnu dozu treba dati 6 sati po završetku operacije, pod uvjetom da je uspostavljena odgovarajuća hemostaza.
System organ class MedDRA
Klasifikacija organskih sustava MedDRA
The timing of restarting subcutaneous fondaparinux after sheath removal should be based on clinical judgment.
Vrijeme ponovne supkutane primjene fondaparinuksa nakon vađenja uvodnice treba odrediti prema kliničkoj prosudbi.
Do not administer intramuscularly.
Nemojte ga primijeniti intramuskularno.
Neutralisation of Factor Xa interrupts the blood coagulation cascade and inhibits both thrombin formation and thrombus development.
Neutralizacija faktora Xa prekida kaskadu zgrušavanja krvi, te sprječava i stvaranje trombina i razvoj tromba.
No clinical data on exposed pregnancies are available.
Nema kliničkih podataka o izloženosti lijeku tijekom trudnoće.
This medicinal product contains less than 23 mg of sodium in each dose and therefore is essentially sodium-free.
Ovaj lijek sadržava manje od 23 mg natrija po dozi te se stoga smatra da je bez natrija.
• low number of red blood cells (anaemia)
• smanjenje broja crvenih krvnih stanica (anemija)
If you forget to take Arixtra
Ako ste zaboravili primijeniti lijek Arixtra
Store below 25°C.
Čuvati na temperaturi ispod 25°C.
Sixty-nine percent of the patients underwent surgery for cancer.
69% bolesnika operirano je zbog tumora.
Thus, fondaparinux is not expected to interact with other medicinal products in vivo by inhibition of CYP-mediated metabolism.
Stoga se ne očekuje da bi fondaparinuks ulazio u interakcije s drugim lijekovima in vivo inhibicijom metabolizma posredovanog CYP enzimima.
The primary outcome was a composite of peri-PCI (defined as time of randomisation up to 48 hours post-PCI) adjudicated major or minor bleeding, or major vascular access site complications.
Primarni ishod ispitivanja je bio združeni parametar periproceduralnog (vrijeme definirano kao vrijeme od randomizacije do 48 sati nakon PCI) velikog (obilnijeg) ili manjeg krvarenja, ili značajna komplikacija na mjestu krvožilnog pristupa.
These are patients with refractory or recurrent angina associated with dynamic ST deviation, heart failure, lifethreatening arrhythmias or haemodynamic instability.
To su bolesnici s refraktornom ili rekurentnom anginom udruženom s dinamičkim ST promjenama, zatajenjem srca, po život opasnim aritmijama ili koji su hemodinamski nestabilni.
• Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
• prilikom svake izmjene sustava za upravljanje rizicima, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik,
Outcomes
Ishod
Paediatric population - Fondaparinux is not recommended for use in children below 17 years of age due to a lack of data on safety and efficacy.
Pedijatrijska populacija - ne preporuča se primjena fondaparinuksa u bolesnika mlađih od 17 godina zbog nedostatnih podataka o sigurnosti primjene i djelotvornosti.
Where the instruction for a syringe is different this is clearly stated.
Jasno je naznačeno gdje se upute razlikuju.
Stop taking Arixtra.
Prestanite primjenjivati lijek Arixtra.
Paediatric population - Fondaparinux is not recommended for use in children below 17 years of age due to a lack of data on safety and efficacy (see sections 5.1 and 5.2).
Pedijatrijska populacija - ne preporuča se primjena fondaparinuksa u bolesnika mlađih od 17 godina zbog nedostatnih podataka o sigurnosti primjene i djelotvornosti (vidjeti dio 5.1 i 5.2).
At the 10 mg dose used in interaction studies, fondaparinux did not significantly influence the anticoagulation activity (INR) of warfarin.
Pri dozi od 10 mg koja se koristila u ispitivanjima interakcija, fondaparinuks nije značajno utjecao na antikoagulacijsku aktivnost varfarina (INR).
Fondaparinux was administered at an initial dose of 0.1 mg/kg subcutaneously once daily and dosing was adjusted to achieve peak fondaparinux sodium concentrations of 0.5 to 1 mg/L after 4 hours.
Fondaparinuks je primijenjen u inicijalnoj dozi od 0,1 mg/kg supkutano jednom dnevno, te je doza prilagođena kako bi se postigla vršna koncentracija fondaparinuksnatrija od 0,5 do 1 mg/l nakon 4 sata.
Similarly, no plasma clearance differences were observed between black and Caucasian patients undergoing orthopaedic surgery.
Isto tako, nisu zabilježene razlike u klirensu iz plazme između crnaca i bijelaca nakon ortopedskih operacija.
Peri-PCI minor bleeding
Peri-PCI manje krvarenje
• prevent the formation of blood clots during and shortly after a period of restricted mobility due to acute illness
• za sprječavanje nastanka ugrušaka tijekom i neposredno nakon razdoblja ograničene pokretljivosti zbog neke akutne bolesti
Rare: hypokalaemia
Rijetko: hipokalijemija
However, rare spontaneous reports of HIT in patients treated with fondaparinux have been received.
Međutim, prijavljeni su rijetka spontana izvješća HIT-a u bolesnika liječenih fondaparinuksom.
Pharmacotherapeutic group: antithrombotic agents.
Farmakoterapijska skupina: antitrombotski lijekovi.
Breast-feeding is not recommended during treatment with fondaparinux.
Ne preporuča se dojenje tijekom liječenja fondaparinuksom.
Minor gastrointestinal bleeding was reported in another patient on day 5 of therapy which resulted in temporary discontinuation of fondaparinux.
Manje gastrointestinalno krvarenje je zabilježeno u drugog bolesnika petog dana liječenja, što je rezultiralo privremenom obustavom primjene fondaparinuksa.
Therefore adjunctive UFH should be used during non-primary PCI according to standard practice (see posology in section 4.2).
Stoga treba primijeniti nefrakcionirani heparin (UFH) tijekom ne-primarne PCI prema standardnoj praksi (vidjeti dio 4.2).
The fondaparinux clinical program in treatment of Venous Thromboembolism was designed to demonstrate the efficacy of fondaparinux for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE).
Klinički program za fondaparinuks u liječenju venske tromboembolije dizajniran je s ciljem da dokaže djelotvornost fondaparinuksa u liječenju duboke venske tromboze (DVT) i plućne embolije (PE).
Inject ALL of the contents of the syringe by pressing down on the plunger as far as it goes (picture E).
Injicirajte CIJELI sadržaj štrcaljke pritišćući klip do kraja. (Slika E).
Excipient(s) with known effect: Contains less than 1 mmol of sodium (23 mg) per dose, and therefore is essentially sodium free.
Pomoćne tvari s poznatim učinkom: sadržava manje od 1 mmol natrija (23 mg) po dozi, tj. zanemarive količine natrija.
There is limited experience from treatment with fondaparinux in haemodynamically unstable patients and no experience in patients requiring thrombolysis, embolectomy or insertion of a vena cava filter.
Ograničeno je kliničko iskustvo primjene fondaparinuksa u hemodinamski nestabilnih bolesnika, a nema iskustva primjene u bolesnika kojima je potrebna tromboliza, embolektomija ili uvođenje filtera u venu cavu.
Efficacy was maintained up to Day 77 and was consistent across all predefined subgroups including patients with varicose veins and patients with superficial-vein thrombosis located below the knee.
Djelotvornost je bila održana do 77. dana i bila je konzistentna unutar svih predefiniranih podskupina uključujući i bolesnike s varikoznim venama i bolesnike s trombozom površinske vene lokaliziranom ispod koljena.
Intravenous administration should be through an existing intravenous line either directly or using a small volume (25 or 50ml) 0.9% saline minibag.
Intravenska primjena treba uslijediti kroz postojeću intravensku liniju ili direktno ili uz mali volumen (25 ili 50 ml) 0,9% fiziološke otopine.
A treatment duration of 6-14 days has been clinically studied in medical patients (see section 5.1).
takvih bolesnika klinički je ispitano liječenje u trajanju od 6-14 dana (vidjeti dio 5.1).
Arixtra should not be prescribed to pregnant women unless clearly necessary.
Trudnoća i dojenje Arixtra se ne smije propisivati trudnicama osim u slučaju jasne potrebe.
A total of 2,192 patients were treated; for both groups, patients were treated for at least 5 days and up to 26 days (mean 7 days).
Ukupno je liječeno 2192 bolesnika; liječenje je trajalo najmanje 5, a najviše 26 dana (prosječno 7 dana).
• reduction in potassium in your blood.
• smanjenje razine kalija u krvi.
Low body weight
Mala tjelesna težina
Immune system disorders Rare: allergic reaction (including very rare reports of angioedema, anaphylactoid/anaphylactic reaction)
Poremećaji imunološkog sustava Rijetko: alergijska reakcija (uključujući vrlo rijetke prijave angioedema, anafilaktoidnih/anafilaktičkih reakcija)
The majority (70/80) of the recorded VTE events were venographically detected non-symptomatic cases of DVT.
(70/80) zabilježenih VTE bili su venografski detektirani asimptomatski slučajevi DVT.
· bleeding disorders
Krvožilni poremećaji
Fondaparinux also provided a significant reduction in the rate of symptomatic VTE (DVT, and / or PE) [1 (0.3%) vs 9 (2.7%) patients, respectively] including two fatal PE reported in the placebo group.
Fondaparinuks je također omogućio značajno smanjenje broja simptomatskih VTE (DVT i/ili PE) [1 (0,3%) naspram 9 (2,7%) bolesnika] uključujući dva slučaja plućne embolije sa smrtnim ishodom u skupini na placebu.
The incidence of adjudicated major bleeding was 2.1% (fondaparinux) vs. 4.1% (enoxaparin) up to and including Day 9 in the Phase III UA/NSTEMI study, and the incidence of adjudicated severe haemorrhage by modified TIMI criteria was 1.1% (fondaparinux) vs. 1.4% (control [UFH/placebo]) up to and including Day 9 in the Phase III STEMI study.
Incidencija presudnih velikih krvarenja iznosila je 2,1% za fondaparinuks, a 4,1% za enoksaparin do uključivo devetog dana u UA/NSTEMI studiji faze III, dok je incidencija presudne teške hemoragije prema modificiranim TIMI kriterijima bila 1,1% za fondaparinuks, a 1,4% u kontrolnoj skupini (nefrakcionirani heparin/placebo) do uključivo devetog dana u STEMI studiji faze III.
Clinical studies
Klinička ispitivanja
Elderly patients - Renal function may decrease with age and thus, the elimination capacity for fondaparinux may be reduced in elderly.
Stariji bolesnici - bubrežna funkcija može slabiti s dobi, te stoga starije osobe mogu imati smanjeni kapacitet izlučivanja.
Between 50 kg and 100 kg
5 mg jednom na dan između 50 kg i 100 kg
Fondaparinux must not be administered intramuscularly.
Fondaparinuks se ne smije primijeniti intramuskularno.
Fondaparinux 2.5 mg once daily started 6-8 hours postoperatively was compared with enoxaparin 40 mg once daily started 12 hours before surgery, or 30 mg twice daily started 12-24 hours after surgery.
Fondaparinuks u dozi od 2,5 mg jednom na dan s početkom 6-8 sati nakon operacije uspoređivao se s enoksaparinom 40 mg jednom na dan s početkom 12 sati prije operacije, ili 30 mg dvaput na dan s početkom 12-24 sata nakon operacije.
The safety of fondaparinux has been evaluated in 2,517 patients treated for Venous ThromboEmbolism and treated with fondaparinux for an average of 7 days.
Sigurnost primjene fondaparinuksa procijenjena je u 2517 bolesnika liječenih fondaparinuksom zbog venske tromboembolije tijekom prosječno 7 dana.
Do not try to remove this air bubble before making the injection - you may lose some of the medicine if you do.
Nemojte pokušavati odstraniti taj mjehurić prije injiciranja kako ne biste izgubili i dio lijeka.
Fondaparinux may be restarted at least 6 hours post-operatively provided haemostasis has been achieved.
Fondaparinuks se može ponovo uvesti barem 6 sati nakon zahvata pod uvjetom da je postignuta odgovarajuća hemostaza.
The solution is a clear and colourless liquid.
Otopina je bistra i bezbojna tekućina.
In patients receiving fondaparinux for treatment of VTE rather than prophylaxis, spinal/epidural anaesthesia in case of surgical procedures should not be used.
U bolesnika koji primaju fondaparinuks za liječenje VTE, a ne za profilaksu, u slučaju kirurškog zahvata ne smije se koristiti spinalna/epiduralna anestezija.
In subjects randomized to the “standard dose UFH” or the “low dose UFH” regimen the median dose of UFH was 85 U/kg and 50 U/kg, respectively.
U ispitanika randomiziranih na “standardnu dozu UFH” ili “nisku dozu UFH” medijan doze nefrakcioniranog heparina je iznosio 85 j/kg, odnosno 50 j/kg.
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.
Nakon pojedinačne supkutane injekcije fondaparinuksa od 2,5 mg mladim zdravim osobama, vršna koncentracija u plazmi (prosječni Cmax = 0,34 mg/l) postiže se 2 sata nakon primjene doze.
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.
U velikoj podskupini bolesnika operiranih zbog tumora (69% svih bolesnika) stopa VTE bila je 4,7% u skupini koja je dobivala fondaparinuks u odnosu na 7,7% u skupini koja je dobivala dalteparin.
In the Phase III UA/NSTEMI study, the most commonly reported non-bleeding adverse events (reported in at least 1% of subjects on fondaparinux) were headache, chest pain and atrial fibrillation.
U studiji faze III u bolesnika s UA/NSTEMI, najčešće prijavljene nuspojave koje nisu bile povezane s krvarenjem (prijavljene u najmanje 1% bolesnika na fondaparinuksu) bile su glavobolja, bol u prsima i fibrilacija atrija.
The primary efficacy endpoint was the composite of confirmed symptomatic recurrent non-fatal VTE and fatal VTE reported up to Day 97.
Primarna mjera ishoda djelotvornosti bila je kombinacija potvrđenih simptomatskih rekurentnih VTE bez smrtnog ishoda, te VTE sa smrtnim ishodom prijavljenih do 97.
Prevention of Venous Thromboembolic Events (VTE) in adult medical patients who are judged to be at high risk for VTE and who are immobilised due to acute illness such as cardiac insufficiency and/or acute respiratory disorders, and/or acute infectious or inflammatory disease.
Prevencija venskih tromboembolijskih događaja (VTE) u odraslih nekirurških bolesnika za koje se procjenjuje da postoji visoki rizik nastanka VTE i koji su nepokretni zbog akutne bolesti, npr. srčane insuficijencije i/ili akutnih respiratornih bolesti i/ili akutnih zaraznih ili upalnih bolesti.
The mortality rates were low and similar between the treatments groups with 2 (0.1%) deaths in the fondaparinux group versus 1 (0.1%) death in the placebo group.
Stopa smrtnosti je bila niska i slična između ispitivanih skupina, s 2 smrti (0,1%) u fondaparinuks skupini naprama 1 smrti (0,1%) u placebo skupini.
Adverse reactions in patients undergoing major orthopaedic surgery of lower limbs and/or abdominal surgery
Nuspojave u bolesnika s velikom ortopedskom operacijom na donjim ekstremitetima i/ili abdominalnim kirurškim zahvatom
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, fondaparinuks se, ovisno o koncentraciji odgovarajuće doze u plazmi, u velikoj mjeri i specifično veže za antitrombinski protein (98,6% do 97,0% u rasponu koncentracije od 0,5 do 2 mg/l).
If they do, you must not use Arixtra.
U takvim situacijama, ne smijete koristiti lijek Arixtra
By Day 9, 1.1% of patients treated with fondaparinux and 1.4% of control patients experienced a severe haemorrhage.
Do devetog dana je 1,1% bolesnika liječenih fondaparinuksom i 1,4% bolesnika u kontrolnoj skupini doživjelo veliko krvarenje.
In studies versus enoxaparin 40 mg once daily started 12 hours before surgery, major bleeding was observed in 2.8% of fondaparinux patients treated with the recommended dose, compared to 2.6% with enoxaparin.
U ispitivanjima fondaparinuksa u usporedbi s 40 mg enoksaparina jednom na dan s početkom 12 sati prije operacije, veliko krvarenje zabilježeno je u 2,8% bolesnika koji su primali preporučenu dozu fondaparinuksa, u odnosu na 2,6% koji su primali enoksaparin.
PHARMACEUTICAL FORM AND CONTENTS Solution for injection, 2 pre-filled syringes with an automatic safety system Solution for injection, 7 pre-filled syringes with an automatic safety system Solution for injection, 10 pre-filled syringes with an automatic safety system Solution for injection, 20 pre-filled syringes with an automatic safety system Solution for injection, 2 pre-filled syringes with a manual safety system Solution for injection, 10 pre-filled syringes with a manual safety system Solution for injection, 20 pre-filled syringes with a manual safety system
Otopina za injekciju, 2 napunjene štrcaljke sa automatskim sigurnosnim sustavom Otopina za injekciju, 7 napunjenih štrcaljki sa automatskim sigurnosnim sustavom Otopina za injekciju, 10 napunjenih štrcaljki sa automatskim sigurnosnim sustavom Otopina za injekciju, 20 napunjenih štrcaljki sa automatskim sigurnosnim sustavom
Alternate the left and right side of the lower abdominal area at each injection.
Injekcije primijenite naizmjence na lijevu i desnu stranu donjeg dijela trbuha.
During treatment of VTE, concomitant therapy with vitamin K antagonist should be administered in accordance with the information of Section 4.5.
Tijekom liječenja VTE, istodobno liječenje antagonistom vitamina K treba primijeniti u skladu s podacima u Poglavlju 4.5.
The effects on the incidence of MI and RI were not statistically different between the fondaparinux and enoxaparin treatment groups.
Učinci na incidenciju infarkta miokarda ili refraktorne ishemije nisu bili statistički različiti između skupina liječenih fondaparinuksom i enoksaparinom.
In the Phase III study in STEMI patients, the most commonly reported non-bleeding adverse events (reported in at least 1% of subjects on fondaparinux) were atrial fibrillation, pyrexia, chest pain, headache, ventricular tachycardia, vomiting, and hypotension.
U studiji faze III u bolesnika sa STEMI, najčešće prijavljene nuspojave koje nisu bile povezane s krvarenjem (prijavljene u najmanje 1% bolesnika na fondaparinuksu) bile su fibrilacija atrija, porast tjelesne temperature, bol u prsima, glavobolja, ventrikularna tahikardija, povraćanje i hipotenzija.
As renal function is generally decreasing with age, elderly patients may show reduced elimination and increased exposure of fondaparinux (see section 5.2).
Budući da bubrežna funkcija općenito opada s dobi, stariji bolesnici mogu imati smanjeno izlučivanje i povećanu izloženost fondaparinuksu (vidjeti dio 5.2).
There are two types of safety syringes used for Arixtra, designed to protect you from needle stick injuries following injection.
Postoje dva tipa sigurnosnih štrcaljki koje se koriste s lijekom Arixtra, dizajniranih da Vas zaštite od slučajnog uboda iglom nakon injiciranja.
The first dose of fondaparinux is administered intravenously and subsequent doses are administered by subcutaneous injection.
Prva doza fondaparinuksa primijenjuje se intravenski, a sljedeće doze supkutanom injekcijom.
In clinical studies performed with fondaparinux, oral anticoagulants (warfarin) did not interact with the pharmacokinetics of fondaparinux; at the 10 mg dose used in the interaction studies, fondaparinux did not influence the anticoagulation monitoring (INR) activity of warfarin.
U kliničkim ispitivanjima s fondaparinuksom, oralni antikoagulansi (varfarin) nisu pokazali interakciju s farmakokinetikom fondaparinuksa; pri dozi od 10 mg koja se koristila u ispitivanjima interakcija, fondaparinuks nije utjecao na antikoagulacijsku aktivnost varfarina (INR).
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.