natgillin/translations-raw huggingface dataset:
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.
Velike krvavitve, vse na mestu kirurške rane in nobene s smrtnim izidom so opazili pri 8 bolnikih (2,4 %), ki so prejemali fondaparinuks 2,5 mg v primerjavi z 2 bolnikoma (0,6 %), ki sta prejemala placebo.
Hepatic impairment - Following a single, subcutaneous dose of fondaparinux in subjects with moderate hepatic impairment (Child-Pugh Category B), total (i.e., bound and unbound) Cmax and AUC were decreased by 22% and 39%, respectively, as compared to subjects with normal liver function.
Jetrna okvara - Po enkratnem subkutanem odmerku fondaparinuksa se je pri osebah z zmerno okvaro jeter (kategorija B po Child-Pugh-u) skupna (to je vezanega in prostega) vrednost Cmax in AUC zmanjšala, in sicer Cmax za 22 %, AUC pa za 39 % v primerjavi z osebami z normalnim delovanjem jeter.
The solution is a clear and colourless liquid.
Raztopina je bistra in brezbarvna tekočina.
• Prevention of VTE - Patients with body weight <50 kg are at increased risk of bleeding.
• Preprečevanje VTE - Bolniki s telesno maso < 50 kg imajo povečano tveganje za krvavitev.
• Prevention of VTE and Treatment of UA/NSTEMI and STEMI - Dosing adjustment of fondaparinux is not necessary.
• Preprečevanje VTE in zdravljenje UA/NSTEMI in STEMI - Prilagajanje odmerka ni potrebno.
Children and adolescents Arixtra has not been tested in children and adolescents under the age of 17 years.
Pri otrocih in mladostnikih, mlajših od 17 let, uporabe zdravila Arixtra niso raziskovali.
Treatment of unstable angina (UA) or non-ST segment elevation myocardial infarction (NSTEMI) in patients who underwent subsequent PCI with adjunctive UFH
Zdravljenje nestabilne angine pektoris (UA) in miokardnega infarkta brez dviga segmenta ST (NSTEMI) pri bolnikih, ki so imeli opravljeno poznejšo PCI z dodatkom UFH
There are limited clinical data available from patients with creatinine clearance less than 30 ml/min.
Pri bolnikih s kreatininskim očistkom, manjšim od 30 ml/min, so na voljo le omejeni klinični podatki.
• increase in bilirubin (a substance produced by the liver) in the blood
• povečanje vrednosti bilirubina (snovi, ki nastaja v jetrih) v krvi.
Adverse reactions in patients treated for VTE1
Neželeni učinki pri bolnikih, ki so se zdravili zaradi venske trombembolije (VTE)1
Breast-feeding is not recommended during treatment with Arixtra.
Med zdravljenjem z zdravilom Arixtra dojenje ni priporočljivo.
The recommended dose of fondaparinux is 7.5 mg (patients with body weight ≥ 50, ≤ 100kg) once daily administered by subcutaneous injection.
Priporočeni odmerek fondaparinuksa je 7,5 mg (bolniki s telesno maso ≥ 50, ≤ 100 kg) enkrat na dan, apliciran s subkutano injekcijo.
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).
Fondaparinuks je pri hudih ledvičnih okvarah (očistek kreatinina < 30 ml/min) kontraindiciran, pri bolnikih z zmernimi ledvičnimi okvarami (očistek kreatinina 30-50 ml/min) pa ga je treba uporabljati previdno.
Breast-feeding is not recommended during treatment with fondaparinux.
Med zdravljenjem s fondaparinuksom se dojenja ne priporoča.
• Prevention of VTE - Dosing adjustment of fondaparinux is not necessary.
• Preprečevanje VTE - Prilagajanje odmerka ni potrebno.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder:
Imetnik dovoljenja za promet z zdravilom in izdelovalec Imetnik dovoljenja za promet z zdravilom:
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.
Pojavnost simptomatske globoke venske tromboze je bila v obeh skupinah podobna: pojavila se je pri 6 bolnikih (0,4 %), ki so prejemali fondaparinuks in 5 bolnikih (0,3 %), ki so prejemali dalteparin.
The mean age of the patients was 61 years, and approximately 40% were at least 65 years old.
Približno 40 % bolnikov je bilo starih najmanj 65 let.
Store below 25°C.
Shranjujte pod 25°C.
• 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.
• Bolniki pri katerih bo izveden obvod koronarne arterije (CABG) Pri bolnikih s STEMI ali UA/NSTEMI, pri katerih bo izveden obvod koronarne arterije (CABG, “coronary artery bypass graft”), bolnik fondaparinuksa ne sme prejeti 24 ur pred posegom.
Uncommon: nausea, vomiting Rare: abdominal pain, dyspepsia, gastritis, constipation, diarrhoea
Občasni: navzea, bruhanje Redki: abdominalna bolečina, dispepsija, gastritis, konstipacija, driska
At the 10 mg dose used in the interaction studies, fondaparinux did not influence the bleeding time under acetylsalicylic acid or piroxicam treatment, nor the pharmacokinetics of digoxin at steady state.
Pri 10-miligramskem odmerku, uporabljanem v študijah medsebojnega delovanja, fondaparinuks ni vplival na čas krvavitve ob sočasnem zdravljenju z acetilsalicilno kislino ali piroksikamom, niti na farmakokinetiko digoksina v stanju dinamičnega ravnovesja.
System organ class MedDRA
Razvrstitev po organskih sistemih (MedDRA)
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.
Zdravljenje se mora začeti čim prej po postavitvi diagnoze in izključitvi sočasne globoke venske tromboze ali povrhnje venske tromboze, ki je bližje kot 3 cm od safeno-femoralnega spoja.
• Prophylaxis of VTE - Patients with creatinine clearance <50 ml/min are at increased risk of bleeding and VTE and should be treated with caution (see sections 4.2, 4.3 and 5.2).
• Preprečevanje VTE - Pri bolnikih s kreatininskim očistkom < 50 ml/min obstaja povečano tveganje za krvavitve ter VTE in jih moramo obravnavati previdno (glejte poglavja 4.2, 4.3 in 5.2).
Treatment of 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).
• Zdravljenje povrhnje venske tromboze - Varnost in učinkovitost fondaparinuksa pri bolnikih s telesno maso manj kot 50 kg nista raziskani, zato ga pri takšnih bolnikih ni priporočljivo uporabljati (glejte poglavje 4.4).
Platelet inhibitors (acetylsalicylic acid), NSAIDs (piroxicam) and digoxin did not interact with the pharmacokinetics of fondaparinux.
Trombocitni inhibitorji (acetilsalicilna kislina), NSAID (piroksikam) in digoksin niso medsebojno delovali s farmakokinetiko fondaparinuksa.
Instruction for self-administration is mentioned in the Package Leaflet.
Napotki za samoinjiciranje so navedeni v navodilu za uporabo.
In the pivotal UA/NSTEMI clinical trial, treatment with fondaparinux was restarted no earlier than 2 hours after sheath removal.
V ključnem kliničnem preskušanju UA/NSTEMI, zdravljenja s fondaparinuksom niso uvedli prej kot 2 uri po odstranitvi katetra.
• Treatment of UA/NSTEMI and STEMI - For the treatment of UA/NSTEMI and STEMI, there are limited clinical data available on the use of fondaparinux 2.5mg once daily in patients with creatinine clearance between 20 and 30 ml/min.
• Zdravljenje UA/NSTEMI in STEMI - Klinični podatki o uporabi fondaparinuksa v odmerku 2,5 mg enkrat na dan za zdravljenje UA/NSTEMI in STEMI pri bolnikih s kreatininskim očistkom med 20 in 30 ml/min so omejeni.
Major bleeding during treatment occurred in 1 (0.1%) fondaparinux patient and in 1 (0.1%) placebo patient.
Hujše krvavitve so se med zdravljenjem pojavile pri 1 bolniku (0,1 %), ki je prejemal fondaparinuks, in pri 1 bolniku (0,1 %), ki je prejemal placebo.
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.
Pogostnost trombov na vodilnem katetru med PCI je bila 0,1 % (1/1.002) med bolniki, randomiziranimi na "standarni odmerek", in 0,5 % (5/1024) med bolniki, randomiziranimi na "nizek odmerek" UFH.
The primary adjudicated endpoint was a composite of death and recurrent MI (re-MI) within 30 days of randomisation.
Primarni vrednoteni opazovani dogodek je bil sestavljen iz smrtnega izida in ponovitve miokardnega infarkta (re-MI) v 30 dneh po randomizaciji.
Both treatment groups received Vitamin K antagonist therapy usually initiated within 72 hours after the first study drug administration and continued for 90 ± 7 days, with regular dose adjustments to achieve an INR of 2-3.
Obe zdravljeni skupini sta dobivali terapijo z antagonistom vitamina K, navadno uvedeno prej kot 72 ur po prvi aplikaciji proučevanega zdravila, ki se je nadaljevala 90 ± 7 dni, z rednimi popravki odmerka, da so dosegli INR 2-3.
There are different syringes for the 5 mg, 7.5 mg and 10 mg doses.
Za odmerke 5 mg, 7,5 mg in 10 mg so na voljo različne injekcijske brizge.
The recommended dose is 2.5 mg once a day, injected at about the same time each day.
Priporočeni odmerek je 2,5 mg enkrat na dan v obliki injekcije vsak dan ob istem času.
In patients ≥75 years, fondaparinux should be used with care, as renal function decreases with age (see section 4.4).
Pri bolnikih, starih 75 let ali več, je treba fondaparinuks uporabljati previdno, ker se delovanje ledvic s starostjo zmanjšuje (glejte poglavje 4.4).
Do not dispose of the used syringe in the household waste.
Uporabljene injekcijske brizge ne smete zavreči med gospodinjske odpadke.
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.
Najpogosteje poročani resni neželeni učinki v zvezi s fondaparinuksom so krvavitve (različna mesta krvavitev vključno z redkimi primeri intrakranialnih/intracerebralnih ali retroperitonealnih krvavitev) in anemija.
The most commonly reported serious adverse reactions reported with fondaparinux are bleeding complications (various sites including rare cases of intracranial/ intracerebral and retroperitoneal bleedings).
Najpogosteje poročani resni neželeni učinki v zvezi s fondaparinuksom so krvavitve (različna mesta krvavitev vključno z redkimi primeri intrakranialnih/intracerebralnih ali retroperitonealnih krvavitev) .
• 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.
• Zdravljenje povrhnje venske tromboze - Kliničnih podatkov o uporabi fondaparinuksa za zdravljenje povrhnje venske tromboze pri bolnikih s telesno maso manj kot 50 kg ni.
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%].
Pri bolnikih, ki so v študiji prejemali fondaparinuks je bila pojavnost vseh VTE 4,6-odstotna (47/1.027), pri bolnikih, ki so prejemali dalteparin pa 6,1-odstotna (62/1.021): zmanjšano razmerje obetov (odds ratio) [95 % IZ] = -25,8 % [-49,7 %, 9,5 %].
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.
Primerjali so profilakso s fondaparinuksom 2,5 mg enkrat na dan s pričetkom 6-8 ur po operaciji in enoksaparinom 40 mg enkrat na dan s pričetkom 12 ur pred operacijo ali 30 mg dvakrat na dan s pričetkom 12-24 ur po operaciji.
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.
Preprečevanje venskih trombemboličnih dogodkov (VTE) pri odraslih po velikih ortopedskih kirurških posegih na spodnjih okončinah, kot so operacije zloma kolka, velike operacije kolen ali operacija zamenjave kolka.
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.
Bolniki s povrhnjo vensko trombozo, ki morajo na operacijo ali drug invaziven poseg, naj bi po možnosti ne dobili fondaparinuksa 24 ur pred operacijo.
Animal studies are insufficient with respect to effects on toxicity to reproduction because of limited exposure.
Zaradi omejene izpostavljenosti so študije na živalih nezadostne za oceno toksičnega vpliva na sposobnost razmnoževanja.
Peri-PCI major or minor bleeding, or major vascular access site complications
Večja ali manjša krvavitev v času okrog PCI ali večji zapleti na mestu žilnega
Clinically relevant non major bleeding occurred in 5 (0.3%) fondaparinux patients and 8 (0.5%) placebo patients.
Klinično pomembne krvavitve, ki niso bile hude, so se pojavile pri 5 bolnikih (0,3 %), ki so prejemali fondaparinuks, in pri 8 bolnikih (0,5 %), ki so prejemali placebo.
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 in ponavadi ne reagira navzkrižno s serumi bolnikov s heparinsko trombocitopenijo (HIT) tipa II,
In elderly healthy subjects, pharmacokinetics of fondaparinux is linear in the range of 2 to 8 mg by subcutaneous route.
Pri starejših zdravih osebah je farmakokinetika fondaparinuksa po subkutani uporabi odmerkov od 2 do 8 mg linearna.
Patients with superficial-vein thrombosis
Bolniki s povrhnjo vensko trombozo
• reduction or increase in the number of platelets (blood cells necessary for blood clotting)
• zmanjšanje ali povečanje števila trombocitov (krvnih celic, potrebnih za strjevanje krvi);
Patients were not included if they had concomitant DVT or superficialvein thrombosis within 3 cm of the sapheno-femoral junction.
Bolniki niso bili vključeni, če so imeli sočasno globoko vensko trombozo ali povrhnjo vensko trombozo , ki je bila bližje kot 3 cm od safenofemoralnega spoja.
• Prevention of VTE and Treatment of UA/NSTEMI and STEMI - Patients with body weight <50 kg are at increased risk of bleeding.
• Preprečevanje VTE in zdravljenje UA/NSTEMI in STEMI - Bolniki s telesno maso < 50 kg imajo povečano tveganje za krvavitev.
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).
Pri bolnikih s kreatininskim očistkom < 50 ml/min obstaja povečano tveganje za krvavitve ter VTE in jih moramo obravnavati previdno (glejte poglavja 4.2, 4.3 in 5.2).
The corresponding incidences in patients receiving the recommended regimen of enoxaparin in the treatment of DVT were 2.3% (13/559), 4.6% (17/368), 9.7% (14/145) and 11.1% (2/18) respectively, and in patients receiving the recommended regimen of unfractionated heparin in the treatment of PE were 6.9% (36/523), 3.1% (11/352), 11.1% (18/162) and 10.7% (3/28), respectively.
Ustrezne incidence pri bolnikih, ki so bili na priporočeni shemi enoksaparina za zdravljenje DVT, so bile 2,3 % (13/559), 4,6 % (17/368), 9,7 % (14/145) oziroma 11,1 % (2/18), pri bolnikih na priporočeni shemi nefrakcioniranega heparina za zdravljenje PE, pa so bile 6,9 % (36/523), 3,1 % (11/352), 11,1 % (18/162) oziroma 10,7 % (3/28).
· stomach ulcer
· želodčno razjedo,
An updated RMP should be submitted: • At the request of the European Medicines Agency;
• na zahtevo Evropske agencije za zdravila;
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 4.2).
Po začetnem 10-miligramskem dnevnem odmerku lahko na podlagi farmakokinetičnega modeliranja preudarimo možnost zmanjšanja dnevnega odmerka na 7,5 mg (glejte poglavje 4.2).
It is supplied in a pre-filled, single-use syringe fitted with a safety system to help prevent needle stick injuries after use.
Na voljo je v napolnjeni injekcijski brizgi za enkratno uporabo, ki je opremljena z varnostnim sistemom za preprečevanje vbodnih poškodb z iglo po uporabi.
Major bleeding was observed in 3.4% of the patients in the fondaparinux group and in 2.4% of the dalteparin group.
Hujše krvavitve so se pojavile pri 3,4 % bolnikov, ki so prejemali fondaparinuks in pri 2,4 % bolnikov, ki so prejemali dalteparin.
In the pivotal STEMI clinical trial, treatment with fondaparinux was restarted no earlier than 3 hours after sheath removal.
V ključnem kliničnem preskušanju STEMI, zdravljenja s fondaparinuksom niso uvedli prej kot 3 ure po odstranitvi katetra.
What Arixtra looks like and contents of the pack Arixtra is a clear and colourless to slightly yellow solution for injection.
Zdravilo Arixtra je bistra in brezbarvna do rahlo rumena raztopina za injiciranje.
Arixtra is a medicine that treats or helps to prevent blood clots from forming in the blood vessels (an antithrombotic agent).
Arixtra je zdravilo, ki ga uporabljamo za zdravljenje ali preprečevanje nastanka krvnih strdkov v krvnih žilah (antitrombotično zdravilo).
• 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.
• Za zdravljenje povrhnje venske tromboze - Fondaparinuks je treba previdno uporabljati pri bolnikih, sočasno zdravljenih z drugimi zdravili, ki povečujejo tveganje krvavitev.
Fondaparinux does not cross-react with sera from patients with heparin-induced thrombocytopaenia.
Fondaparinuks ponavadi ne deluje navzkrižno s serumom bolnikov s heparinom inducirano trombocitopenijo (HIT).
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).
Pediatrični bolniki - Uporabe fondaparinuksa za preprečevanje VTE ali za zdravljenje povrhnje venske tromboze ali akutnega koronarnega sindroma (AKS) pri otrocih niso proučevali.
Oral anticoagulants (warfarin), platelet inhibitors (acetylsalicylic acid), NSAIDs (piroxicam) and digoxin did not interact with the pharmacokinetics of fondaparinux.
Peroralni antikoagulanti (varfarin), zaviralci trombocitov (acetilsalicilna kislina), NSAID (piroksikam) in digoksin niso vstopali v interakcije s farmakokinetiko fondaparinuksa.
Major bleeding during the initial treatment period was observed in 1.3% of fondaparinux patients, compared to 1.1% with unfractionated heparin.
Večjo krvavitev v začetnem obdobju zdravljenja so opazili pri 1,3 % bolnikov s fondaparinuksom in pri 1,1 % tistih z nefrakcioniranim heparinom.
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).
V tej podskupini lahko po začetnem 10-miligramskem dnevnem odmerku na podlagi farmakokinetičnega modeliranja preudarimo možnost zmanjšanja dnevnega odmerka na 7,5 mg (glejte poglavje
Alternate the left and right side of the lower abdominal area at each injection.
Pri dajanju injekcij redno menjavajte levo in desno stran spodnjega predela trebuha.
Take special care with Arixtra: Talk to your doctor or pharmacist before taking Arixtra:
Pred začetkom zdravljenja z zdravilom Arixtra se posvetujte s svojim zdravnikom ali s farmacevtom:
Arixtra contains sodium
Zdravilo Arixtra vsebuje natrij
Major bleedings were observed in 1 patient (0.2%) of each group.
Večje krvavitve so ugotovili v vsaki skupini pri 1 bolniku (0,2 %).
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).
Pri bolnikih s hudo okvaro jeter je treba fondaparinuks uporabljati previdno, saj študije pri tej skupini bolnikov niso bile izvedene (glejte poglavji 4.4 in 5.2).
Therefore, fondaparinux is not recommended for the treatment of superficial-vein thrombosis in these patients (see section 4.2).
Zato fondaparinuks ni priporočljiv za zdravljenje povrhnje venske tromboze pri takšnih bolnikih (glejte poglavje 4.2).
The first fondaparinux administration should be given not earlier than 6 hours following surgical closure.
Prve injekcije fondaparinuksa se ne sme dati prej kot 6 ur po zaključku operacije.
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.
Za zdravljenje povrhnje venske tromboze - Fondaparinuks je treba previdno uporabljati pri bolnikih, sočasno zdravljenih z drugimi zdravili, ki povečujejo tveganje krvavitev.
There are two types of safety syringes used for Arixtra, designed to protect you from needle stick injuries following injection.
Za uporabo zdravila Arixtra sta na voljo dve vrsti varnostnih brizg, ki sta zasnovani tako, da preprečita vbodne poškodbe po injiciranju zdravila.
Other sources of information
Navodilo je bilo revidirano Drugi viri informacij
Treatment with fondaparinux was demonstrated to be non-inferior to enoxaparin (VTE rates 3.9% and 4.1%, respectively).
Dokazali so, da zdravljenje s fondaparinuksom ni bilo slabše od enoksaparina (pogostosti VTE 3,9 % oziroma 4,1 %).
• 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.
• Zdravljenje povrhnje venske tromboze - Kliničnih podatkov o uporabi fondaparinuksa za zdravljenje povrhnje venske tromboze pri bolnikih s hudo okvaro jeter ni.
Since fondaparinux does not bind significantly to plasma proteins other than ATIII, no interaction with other medicinal products by protein binding displacement are expected.
Fondaparinuks se ne veže pomembno na proteine plazme, razen na ATIII, zato ni pričakovati medsebojnega delovanja z drugimi zdravili zaradi izpodrivanja z vezavnih mest na proteinih.
During treatment of VTE, concomitant therapy with vitamin K antagonist should be administered in accordance with the information of Section 4.5.
Med zdravljenjem VTE je potrebno sočasno zdravljenje z antagonistom vitamina K v skladu s podatki v poglavju 4.5.
Gently pinch the skin that has been cleaned to make a fold.
Očiščeno kožo nežno stisnite, da nastane kožna guba.
• If you are not sure what to do, ask your doctor or pharmacist.
• Če ste v dvomih, kaj storiti, se posvetujte s svojim zdravnikom ali s farmacevtom.
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.
V dvojno slepi klinični študiji je bilo 2.927 bolnikov randomiziranih tako, da so 7±2 dni prejemali bodisi fondaparinuks v odmerku 2,5 mg enkrat na dan bodisi 5.000 i.e. dalteparina enkrat na dan. Dalteparin so prejeli tudi pred operacijo (2.500 i.e.) in po operaciji (2.500 i.e.).
Since fondaparinux does not bind significantly to plasma proteins other than antithrombin, no interaction with other medicinal products by protein binding displacement are expected.
Fondaparinuks se ne veže pomembno na proteine plazme, razen na antitrombin, zato ni pričakovati medsebojnega delovanja z drugimi zdravili zaradi izpodrivanja z vezavnih mest na proteinih.
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.
Pri zdravljenju DVT in PE so pri bolnikih, ki so dobivali fondaparinuks v odmerkih 5 mg (telesna masa < 50 kg), 7,5 mg (telesna masa 50 do vključno 100 kg) in 10 mg (telesna masa > 100 kg) enkrat na dan, za telesno maso prilagojeni odmerki povzročili podobno izpostavljenost po vseh kategorijah telesne mase.