natgillin/translations-raw huggingface dataset:
31 6.4 Special precautions for storage
32 6. 4 Posebna navodila za shranjevanje
Type I glass barrel (1 ml) affixed with a 27 gauge x 12.7 mm needle and stoppered with a chlorobutyl elastomer plunger stopper.
t Injekcijska brizga (1 ml) iz stekla tipa I, s pritrjeno injekcijsko iglo G 27 x 12, 7 mm in zaprta z batno
d Quixidar 5 mg/ 0.4 ml is available in pack sizes of 2, 7, 10 and 20 pre-filled syringes with an orange
me zaporko iz klorobutilnega elastomera.
e automatic safety system.
Quixidar 5 mg/ 0, 4 ml je na voljo v pakiranjih z 2, 7, 10 in 20 napolnjenih injekcijskih brizg z oranžnim samodejnim varnostnim sistemom.
ris 6.6 Special precautions for disposal and other handling
pro 6. 6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom
ho The subcutaneous injection is administered in the same way as with a classical syringe.
Subkutano injekcijo se daje na enak način kot s klasično injekcijsko brizgo.
ra Instruction for self-administration is mentioned in the Package Leaflet.
za Parenteralne raztopine moramo pred uporabo pregledati na prisotnost delcev in spremembo barve.
The Quixidar pre-filled syringe has been designed with an automatic needle protection system to
Napotki za samoinjiciranje so navedeni v navodilu za uporabo.
e prevent needle stick injuries following injection. ng Any unused product or waste material should be disposed of in accordance with local requirements.
nja Quixidar napolnjena injekcijska brizga je oblikovana z avtomatičnim sistemom zaščite pred iglo, da preprečimo vbodne poškodbe z iglo po injiciranju. lje Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
This medicinal product is for single use only. lo no
To zdravilo je namenjeno samo za enkratno uporabo. vo
Glaxo Group Ltd Greenford ct
Glaxo Group Ltd Greenford Middlesex eā
United Kingdom ro
UB6 0NN Velika Britanija av
MARKETING AUTHORISATION NUMBERS lP
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET
EU/ 1/ 02/ 207/ 009-011, 018 na
EU/ 1/ 02/ 207/ 009- 011, 018 nim
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION ici
DATUM PRIDOBITVE/ PODALJŠANJA DOVOLJENJA ZA PROMET
21 March 2002 Date of latest renewal:
21. marec 2002 ilo
21 March 2007 ed
21. marec 2007 rav
DATE OF REVISION OF THE TEXT M
DATUM ZADNJE REVIZIJE BESEDILA
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) Zd
Quixidar 7.5 mg/ 0.6 ml solution for injection, pre-filled syringe.
Quixidar 7, 5 mg/ 0, 6 ml raztopina za injiciranje, napolnjena injekcijska brizga
Each pre-filled syringe contains 7.5 mg of fondaparinux sodium in 0.6 ml solution for injection.
t me Vsaka napolnjena injekcijska brizga vsebuje 7, 5 mg natrijevega fondaparinuksa v 0, 6 ml raztopine za injiciranje.
d sodium free.
pro natrija.
e For a full list of excipients, see section 6.1.
Za celoten seznam pomožnih snovi glejte poglavje 6. 1.
ris ho 3.
za 3.
ut The solution is a clear and colourless to slightly yellow liquid.
nja Raztopina je bistra in brezbarvna do rahlo rumenkasta tekočina.
e 4.1 Therapeutic indications ng Treatment of acute Deep Vein Thrombosis (DVT) and treatment of acute Pulmonary Embolism (PE), except in haemodynamically unstable patients or patients who require thrombolysis or pulmonary lo embolectomy. no
Zdravljenje akutne globoke venske tromboze (DVT) in zdravljenje akutne pljučne embolije (PE), razen pri hemodinamsko nestabilnih bolnikih ali bolnikih, pri katerih je potrebna tromboliza ali do
For patients with body weight < 50 kg, the ct
4. 2 Odmerjanje in način uporabe eā
For patients with body weight > 100 kg, the recommended dose is 10 mg. du
Za bolnike s telesno maso > 100 kg je priporočeni odmerek 10 mg. av
Concomitant oral anticoagulation treatment should be initiated ro
Čimprej, navadno pa v prvih 72 urah, je treba uvesti nim
as soon as possible and usually within 72 hours.
sočasno peroralno antikoagulantno zdravljenje.
The average duration of administration in clinical trials was 7 days and the clinical experience from treatment beyond 10 days is limited. lP
Povprečno trajanje uporabe v kliničnih preskušanjih je bilo 7 dni, klinične izkušnje z zdravljenjem, ki bi trajalo dlje kot 10 dni, so omejene.
Renal impairment - Fondaparinux should be used with caution in patients with moderate renal impairment (see section 4.4). ed
fondaparinuks uporabljati previdno, ker se delovanje ledvic s starostjo zmanjšuje (glejte poglavje 4. 4). rav
There is no experience in the subgroup of patients with both high body weight (> 100 kg) and moderate renal impairment (creatinine clearance 30-50 ml/ min).
Ledvična okvara - Pri bolnikih z zmernimi okvarami ledvic je treba fondaparinuks uporabljati previdno (glejte poglavje 4. 4).
In this subgroup, after an initial 10 mg daily M
S podskupino bolnikov, ki imajo tako preveliko telesno maso (> 100 kg) kot tudi zmerno okvaro Zd
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 4. 4).
Hepatic impairment - No dosing adjustment is necessary.
34 Jetrna okvara - Prilagajanje odmerjanja ni potrebno.
33 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.
Otroci - Zaradi pomanjkanja podatkov o varnosti in učinkovitosti uporaba fondaparinuksa pri otrocih, mlajših od 17 let, ni priporočljiva.
Method of administration Fondaparinux is administered by deep subcutaneous injection while the patient is lying down.
me Fondaparinuks se injicira globoko pod kožo, medtem ko bolnik leži.
The whole length of the
Da se prepreči izgubo zdravila, pri uporabi napolnjene injekcijske brizge pred injiciranjem ne odstranjujte zračnih mehurčkov.
d needle should be inserted perpendicularly into a skin fold held between the thumb and the forefinger;
Iglo je treba uvesti po celi dolžini navpično v kožno gubo, ki se jo
e the skin fold should be held throughout the injection.
pro drži s palcem in kazalcem; kožno gubo se mora držati ves čas injiciranja.
ris For additional instructions for use and handling and disposal see section 6.6.
Za dodatna navodila za uporabo in ravnanje z zdravilom ter odstranjevanje glejte poglavje 6. 6.
ho 4.3 Contraindications
4. 3 Kontraindikacije
- active clinically significant bleeding
- Preobčutljivost za zdravilno učinkovino ali katerokoli pomožno snov.
- acute bacterial endocarditis
- Sveža klinično pomembna krvavitev.
e ng Fondaparinux is intended for subcutaneous use only.
Fondaparinuks je namenjen samo za subkutano uporabo.
Do not administer intramuscularly.
Ne injicirajte ga intramuskularno. vo Z zdravljenjem hemodinamsko nestabilnih bolnikov s fondaparinuksom so izkušnje omejene.
There is limited experience from treatment with fondaparinux in haemodynamically unstable patients lo and no experience in patients requiring thrombolysis, embolectomy or insertion of a vena cava filter. no
Krvavitev Fondaparinuks moramo uporabljati previdno pri bolnikih s povečanim tveganjem za krvavitev, kot so eā
Haemorrhage 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 ct
bolniki s prirojenimi ali pridobljenimi motnjami strjevanja krvi (npr. število trombocitov < 50. 000/ mm3), bolniki z aktivno ulcerativno gastrointestinalno boleznijo, bolniki po nedavni intrakranialni krvavitvi, bolniki, ki so bili pred kratkim operirani na možganih, hrbtenici ali očeh, in av
ophthalmic surgery and in special patient groups as outlined below. du
zgoraj navedene posebne skupine bolnikov.
As for other anticoagulants, fondaparinux should be used with caution in patients who have undergone recent surgery (< 3 days) and only once surgical haemostasis has been established. ro
Tako kot velja za druga antikoagulantna sredstva, je treba fondaparinuks previdno uporabljati pri bolnikih, ki so pred nedavnim (< 3 dni) imeli operacijo, to pa šele po tistem, ko vzpostavimo kirurško nim
Agents that may enhance the risk of haemorrhage should not be administered concomitantly with lP
Sočasno s fondaparinuksom ne smemo uporabljati učinkovin, ki lahko povečajo tveganje za krvavitev.
These agents include desirudin, fibrinolytic agents, GP IIb/ IIIa receptor antagonists, heparin, heparinoids, or Low Molecular Weight Heparin (LMWH).
sočasno zdravljenje z antagonistom vitamina K v skladu s podatki v poglavju 4. 5.
During treatment of VTE, concomitant therapy with vitamin K antagonist should be administered in accordance with the na
Druga antitrombotična zdravila (acetilsalicilna kislina, dipiridamol, sulfinpirazon, tiklopidin ali klopidogrel) rav
information of Section 4.5.
in NSAID moramo uporabljati previdno.
If co- administration is essential, close monitoring is necessary. ici
Če je sočasna uporaba nujna, je potreben skrben nadzor.
Spinal / Epidural anaesthesia ed
Spinalna / Epiduralna anestezija Pri bolnikih, ki dobivajo fondaparinuks za zdravljenje VTE, ne za profilakso, uporaba Zd
M
spinalne/ epiduralne anestezije v primeru kirurških postopkov ni dovoljena.
34 the recommended regimen of UFH in the treatment of PE were 5.5%, 6.6% and 7.4%, respectively.
Ustrezne incidence pri bolnikih, ki so prejemali priporočeno shemo enoksaparina za zdravljenje DVT, so bile 2, 5%, 3, 6% oziroma 8, 3%, medtem ko so bile incidence pri bolnikih na priporočeni shemi UFH za zdravljenje PE, 5, 5%, 6, 6% oziroma 7, 4%.
Low body weight Clinical experience is limited in patients with body weight < 50 kg.
Majhna telesna masa
Renal impairment The risk of bleeding increases with increasing renal impairment.
t Pri bolnikih s telesno maso < 50 kg so klinične izkušnje omejene.
Fondaparinux is known to be
V tej skupini je treba fondaparinuks
Incidences of bleeding events in patients receiving the recommended
me previdno uporabljati v dnevnem odmerku 5 mg (glejte poglavji 4. 2 in 5. 2).
e 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/ 1132), 4.4% (32/ 733), 6.6% (21/ 318),
Znano je, da se fondaparinuks izloča
ris and 14.5% (8/ 55) respectively.
pro večinoma skozi ledvici.
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)
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
ho 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.
za 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).
ut Fondaparinux is contra-indicated in severe renal impairment (creatinine clearance < 30 ml/ min) and
nja 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.
ra should be used with caution in patients with moderate renal impairment (creatinine clearance 30-50 ml/ min).
Trajanje zdravljenja ne sme preseči trajanja, ovrednotenega med kliničnim preskušanjem (povprečno 7 dni) (glejte poglavja 4. 2, 4. 3 in 5. 2).
The duration of treatment should not exceed that evaluated during clinical trial (mean 7 days) (see sections 4.2, 4.3 and 5.2).
S podskupino bolnikov, ki imajo tako preveliko telesno vo
e ng There is no experience in the subgroup of patients with both high body weight (> 100 kg) and moderate renal impairment (creatinine clearance 30-50 ml/ min).
ledvic (očistek kreatinina 30- 50 ml/ min), nimamo nobenih izkušenj.
After an initial 10 mg daily dose, a reduction of the daily dose to 7.5 mg may be considered, lo based on pharmacokinetic modelling (see section 4.2). no
Po začetnem 10- miligramskem dnevnem odmerku lahko na podlagi farmakokinetičnega modeliranja preudarimo možnost zmanjšanja dnevnega odmerka na do
Severe hepatic impairment 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). ct
pomanjkanja koagulacijskih faktorjev pri bolnikih s hudimi okvarami jeter (glejte poglavje 4. 2).
Patients with Heparin Induced Thrombocytopenia Fondaparinux does not bind to platelet factor 4 and does not cross-react with sera from patients with du
Bolniki s trombocitopenijo, povzročeno s heparinom av
Heparin Induced Thrombocytopenia (HIT) type II.
Fondaparinuks se ne veže na trombocitni faktor 4 in ne reagira navzkrižno s serumi bolnikov s trombocitopenijo, povzročeno s heparinom (HIT) tipa II.
The efficacy and safety of fondaparinux have not been formally studied in patients with HIT type II. ro
Učinkovitosti in varnosti fondaparinuksa pri bolnikih s HIT tipa II niso formalno proučevali. nim
4.5 Interaction with other medicinal products and other forms of interaction lP
4. 5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
Bleeding risk is increased with concomitant administration of fondaparinux and agents that may enhance the risk of haemorrhage (see section 4.4). na
Tveganje krvavitve se poveča pri sočasni uporabi fondaparinuksa in učinkovin, ki lahko povečajo tveganje za krvavitev (glejte poglavje 4. 4). ilo
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 ici
V kliničnih študijah, opravljenih s fondaparinuksom, peroralni antikoagulanti (varfarin) niso medsebojno delovali s farmakokinetiko fondaparinuksa; pri 10- miligramskem odmerku, uporabljanem rav
did not influence the anticoagulation monitoring (INR) activity of warfarin. ed
v študijah medsebojnega delovanja, fondaparinuks ni vplival na spremljano antikoagulantno aktivnost (INR) varfarina.
pharmacokinetics of digoxin at steady state.
delovali s farmakokinetiko fondaparinuksa.
4.6 Pregnancy and lactation
36 4. 6 Nosečnost in dojenje
35 Fondaparinux is excreted in rat milk but it is not known whether fondaparinux is excreted in human milk.
Med
No studies on the effect on the ability to drive and to use machines have been performed.
pro Študije o vplivu na sposobnost vožnje in upravljanja s stroji niso bile izvedene.
The most common adverse
za Varnost fondaparinuksa so ovrednotili pri 2. 517 bolnikih, zdravljenih zaradi venske trombembolije s fondaparinuksom, povprečno 7 dni dolgo.
ris reactions were bleeding complications (see section 4.4).
Najpogostejši neželeni učinki so bili zapleti s krvavitvami (glejte poglavje 4. 4).
ho 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
nja Neželeni učinki, o katerih so poročali raziskovalci in za katere je možna vsaj majhna povezava s fondaparinuksom, so navedeni v skupinah glede na pogostnost (zelo pogosti ≥ 1/ 10; pogosti ≥ 1/ 100 do < 1/ 10; občasni ≥ 1/ 1. 000 do < 1/ 100; redki ≥ 1/ 10. 000 do < 1/ 1. 000; zelo redki ≤ 1/ 10. 000) in lje organski sistem v padajočem vrstnem redu po resnosti. vo do eā av nim ilo rav Zd
ut class by decreasing order of seriousness.
37 Neželeni učinki pri bolnikih, ki so se zdravili Organski sistemi po zaradi venske trombembolije (VTE) 1 MedDRA
ra
Pogosti: krvavitve (gastrointestinalne, hematurija, Bolezni krvi in hematom, epistaksa, hemoptiza, krvavitve iz limfatičnega sistema maternice in nožnice, hemartroza, očesne
System organ class MedDRA
t krvavitve, purpura, modrice)
Undesirable effects in patients treated for VTE1
me Občasni: anemija, trombocitopenija
e Blood and lymphatic system disorders ng Common: bleeding (gastrointestinal, haematuria, haematoma, epistaxis, haemoptysis, utero-vaginal haemorrhage, haemarthrosis, ocular, purpura, lo bruise) Uncommon: anaemia, thrombocytopaenia no
Redki: druge krvavitve (hepatične,
Rare: other bleeding (hepatic, retroperitoneal, intracranial/ intracerebral), thrombocythaemia ct
pro retroperitonealne, intrakranialne/ intracerebralne), trombocitemija
disorders
za sistema
nutrition disorders lP
nja
Uncommon: headache Rare: dizziness
Občasni: glavobol
na
Redki: omotica
ici
lje
Uncommon: nausea, vomiting
Občasni: navzea, bruhanje vo
Hepatobiliary disorders Uncommon: abnormal liver function ed
Bolezni jeter, žolčnika in žolčevodov
Skin and subcutaneous tissue disorders
Občasni: nenormalno delovanje jeter do
Rare: rash erythematous
Bolezni kože in podkožja Redki: eritemski izpuščaj
General disorders and administration site conditions
Občasni: bolečina, edem Splošne težave in eā
Uncommon: pain, oedema, Rare: reaction at injection site
spremembe na mestu Redki: reakcija na mestu injiciranja aplikacije av
(2) Npn stands for non-protein-nitrogen such as urea, uric acid, amino acid, etc.
(2) Npn pomeni neproteinski dušik, kot na primer sečnina, sečna kislina, aminokisline, ipd. nim
36 4.9 Overdose
4. 9 Preveliko odmerjanje
There is no known antidote to fondaparinux.
Antidota za fondaparinuks ne poznamo. ilo
Initiation of appropriate therapy such as surgical haemostasis, blood replacements, fresh plasma transfusion, plasmapheresis should be considered.
Presoditi moramo o primerni terapiji, kot je kirurška hemostaza, rav
PHARMACOLOGICAL PROPERTIES
nadomeščanje krvi, transfuzija sveže plazme in plazmafereza.
e
5.
ris 5.1 Pharmacodynamic properties
5. 1 Farmakodinamične lastnosti
ho Pharmacotherapeutic group: antithrombotic agents.
Farmakoterapevtska skupina:
ut Pharmacodynamic effects
38 Farmakodinamični učinki
ra Fondaparinux is a synthetic and selective inhibitor of activated Factor X (Xa).
Fondaparinuks je sintetični in selektivni zaviralec aktiviranega faktorja X (Xa).
By binding selectively to antithrombin, fondaparinux potentiates (about 300 times) the
S selektivno vezavo na antitrombin fondaparinuks ojača (približno 300- krat) naravno nevtralizacijo faktorja Xa z antitrombinom.
e innate neutralization of Factor Xa by antithrombin.
t in zavre tako tvorbo trombina kot razvoj trombusa.
Neutralisation of Factor Xa interrupts the blood ng coagulation cascade and inhibits both thrombin formation and thrombus development.
me faktor II) in nima učinka na trombocite.
Fondaparinux does not inactivate thrombin (activated Factor II) and has no effects on platelets. lo 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) no
V odmerkih, ki se uporabljajo pri zdravljenju, fondaparinuks ne vpliva, v klinično pomembnem obsegu, na rutinske koagulacijske teste v plazmi, kot so merjenje aktiviranega parcialnega
or prothrombin time (PT)/ International Normalised Ratio (INR) tests in plasma nor bleeding time or fibrinolytic activity.
pro tromboplastinskega časa (aPTT), aktiviranega časa nastanka strdka (ACT) ali razmerja protrombinski čas (PT) / internacionalno normalizirano razmerje (INR), niti na čas krvavitve ali fibrinolitično aktivnost.
At the 10 mg dose used in interaction studies, fondaparinux did not significantly influence the anticoagulation activity (INR) of warfarin. ct
Pri 10- miligramskem odmerku, ki so ga uporabljali v študijah medsebojnega delovanja, fondaparinuks ni pomembno vplival na antikoagulacijsko aktivnost (INR) varfarina.
Fondaparinux does not cross-react with sera from patients with heparin-induced thrombocytopaenia. du
za Fondaparinuks ne deluje navzkrižno s serumom bolnikov s heparinom inducirano trombocitopenijo.
Clinical studies ro
nja Klinične študije
The fondaparinux clinical program in treatment of Venous Thromboembolism was designed to lP
Klinični program za fondaparinuks pri zdravljenju venske trombembolije je bil oblikovan, da bi dokazal učinkovitost fondaparinuksa za zdravljenje globoke venske tromboze (DVT) in pljučne lje embolije (PE).
Over 4874 patients were studied in controlled Phase II and III clinical studies. na
V kontroliranih kliničnih študijah faze II in III so proučevali več kot 4. 874 bolnikov. vo Zdravljenje globoke venske tromboze V randomiziranem, dvojno slepem kliničnem preskušanju pri bolnikih s potrjeno diagnozo akutne simptomatske DVT so fondaparinuks v odmerkih 5 mg (telesna masa < 50 kg), 7, 5 mg (telesna masa do
Treatment of Deep Venous Thrombosis In a randomised, double-blind, clinical trial in patients with a confirmed diagnosis of acute ici
≥ 50 kg, ≤ 100 kg) ali 10 mg (telesna masa > 100 kg) s. c. enkrat na dan primerjali z natrijevim enoksaparinatom v odmerku 1 mg/ kg s. c. dvakrat na dan.
Both treatment groups received Vitamin K antagonist therapy usually initiated within 72 hours after the first study drug administration and continued for 90 ± 7 M
Obe zdravljeni skupini sta dobivali terapijo z antagonistom vitamina K, uvedeno prej kot 72 ur po prvi eā
The primary efficacy endpoint was the composite of confirmed symptomatic recurrent non-fatal VTE and fatal VTE reported up to Day 97.
Dokazali so, da zdravljenje s av
Treatment with fondaparinux was demonstrated to be non-inferior to enoxaparin (VTE rates 3.9% and 4.1%, respectively).
fondaparinuksom ni bilo slabše od enoksaparina (pogostosti VTE 3, 9% oziroma 4, 1%).
Major bleeding during the initial treatment period was observed in 1.1% of fondaparinux patients, compared to 1.2% with enoxaparin.
Večjo krvavitev v začetnem obdobju zdravljenja so opazili pri 1, 1% bolnikov s fondaparinuksom in nim
37 Treatment of Pulmonary Embolism A randomised, open-label, clinical trial was conducted in patients with acute symptomatic PE.
Zdravljenje pljučne embolije Randomizirano, odprto klinično preskušanje so opravili pri bolnikih z akutno simptomatsko PE.
Patients who required thrombolysis or embolectomy or vena cava filter were excluded.
Bolnike, pri katerih so bili potrebni tromboliza ali embolektomija ali filter v veni kavi, so ilo
Randomised patients could have been pre-treated with UFH during the screening phase but patients treated for more than 24 hours with therapeutic dose of anticoagulant or with uncontrolled hypertension were excluded.
Randomizirani bolniki so smeli biti predhodno zdravljeni z UFH med presejalno fazo, bolnike, ki so bili več kot 24 ur zdravljeni s terapevtskim odmerkom antikoagulantnega sredstva, in rav
A total
Zdravili so Zd
d of 2184 patients were treated; for both groups, patients were treated for at least 5 days and up to 22
vsega skupaj 2. 184 bolnikov; bolnike iz obeh skupin so zdravili vsaj po 5 dni in do 22 dni dolgo (povprečno po 7 dni).
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
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.
Treatment with
Končno stanje primarne učinkovitosti je bilo sestavljeno iz potrjene simptomatske recidivne neletalne VTE in smrtne VTE, o katerih so poročali do 97. dne.
ho fondaparinux was demonstrated to be non-inferior to unfractionated heparin (VTE rates 3.8% and 5.0%, respectively).
Dokazali so, da zdravljenje s fondaparinuksom ni bilo slabše od nefrakcioniranega heparina (pogostosti VTE 3, 8% oziroma 5, 0%).