natgillin/translations-raw huggingface dataset:
Treatment of ST segment elevation myocardial infarction (STEMI) OASIS 6 was a double blind, randomised study assessing the safety and efficacy of fondaparinux 2.5 mg once daily, versus usual care (placebo (47%) or UFH (53%)) in approximately 12000 patients with STEMI.
Zdravljenje miokardnega infarkta z dvigom segmenta ST (STEMI) OASIS 6 je bila dvojno slepa, randomizirana študija, ki je vrednotila varnost in učinkovitost fondaparinuksa v odmerku 2, 5 mg enkrat na dan v primerjavi z običajnim zdravljenjem (placebo
All patients received standard treatments for STEMI, including primary PCI (31%), thrombolytics (45%) or no reperfusion (24%).
me zdravljeni za STEMI, vključno s primarno PCI (31%), trombolitiki (45%) ali brez reperfuzije (24%).
Of the patients treated with a thrombolytic, 84% were
84% s trombolitikom zdravljenjih bolnikov se je zdravilo s fibrinsko nespecifičnim zdravilom (predvsem streptokinazo).
The mean age of the patients was 61 years, and approximately 40% were at least 65 years old.
Povprečna starost bolnikov je bila 61 let.
Approximately 40% and 14% of patients had mild (creatinine clearance ≥ 50 to < 80 ml/ min) or moderate (creatinine clearance ≥ 30 to < 50 ml/ min) renal impairment, respectively.
Približno 40%
The primary adjudicated endpoint was a composite of death and recurrent MI (re-MI) within 30 days of randomisation.
pro bolnikov je imelo blago ledvično okvaro (kreatininski očistek ≥ 50 do < 80 ml/ min), približno 14% bolnikov pa zmerno ledvično okvaro (kreatininski očistek ≥ 30 do < 50 ml/ min).
The incidence of death/ re-MI at Day 30 was significantly reduced from 11.1% for the control group to 9.7% for the fondaparinux group (hazard ratio 0.86, 95% CI, 0.77, 0.96, p = 0.008).
Primarni vrednoteni opazovani dogodek je bil sestavljen iz smrtnega izida in ponovitve miokardnega infarkta (re- MI) v 30 dneh po randomizaciji.
In the predefined stratum comparing fondaparinux to placebo (i. e patients treated with non-
Do 30. dne se je smrtnost/ pojavnost re- MI pomembno
e the incidence of death/ re-MI at Day 30 was significantly reduced from 14.0% on placebo to 11.3% (hazard ratio 0.80, 95% CI, 0.69, 0.93, p = 0.003).
za zmanjšala z 11, 1% v kontrolni skupini na 9, 7% v skupini, ki je prejemala fondaparinuks (razmerje tveganja 0, 86, 95% interval zaupanja, 0, 77; 0, 96, p = 0, 008).
In the predefined stratum comparing fondaparinux
Pri v naprej določenih skupinah pri katerih so fondaparinuks primerjali s placebom (to je bolniki, ki so se zdravili s fibrinsko
ris to UFH (patients treated with primary PCI (58.5%), fibrin-specific lytics (13%), non-fibrin-specific lytics (2.6%) and no reperfusion (25.9%)), the effects of fondaparinux and UFH on the incidence of
nja nespecifičnimi litiki (77, 3%), brez reperfuzije (22%), fibrinsko specifičnimi litiki (0, 3%) primarno PCI (0, 4%)) se je smrtnost/ pojavnost re- MI do 30. dne pomembno zmanjšala s 14, 0% pri placebu na 11, 3% (razmerje tveganja 0, 80, 95% interval zaupanja, 0, 69; 0, 93, p = 0, 003).
ho death/ re-MI at Day 30 were not statistically different: respectively, 8.3% vs 8.7% (hazard ratio 0.94, 95% CI, 0.79, 1.11 p = 0.460).
Pri v naprej določeni skupini, pri kateri so fondaparinuks primerjali z UFH (bolniki, zdravljeni s primarno PCI (58, 5%), lje fibrinsko specifičnimi litiki (13%), fibrinsko nespecifičnimi litiki (2, 6) in brez reperfuzije (25, 9)), se učinka fondaparinuksa in UFH na zmanjšanje smrtnosti/ pojavnosti re- MI do 30. dne nista statistično vo pomembno razlikovala, in sicer sta bila 8, 3% za fondaparinuks in 8, 7% za UFH (razmerje tveganja 0, 94, 95% interval zaupanja, 0, 79; 1, 11 p = 0, 460).
However, in this stratum, in the subgroup of indicated population undergoing thrombolysis or no reperfusion (i. e patients not undergoing primary PCI), the incidence of
Vendar pa se je v tej podskupini pri bolnikih, pri katerih je bila izvedena tromboliza ali reperfuzija ni bila izvedena (to je bolniki pri katerih ni bila do
ut death/ re-MI at Day 30 was significantly reduced from 14.3% on UFH to 11.5% with fondaparinux (hazard ratio 0.79, 95% CI, 0.64, 0.98, p = 0.03).
izvedena primarna PCI) smrtnost/ pojavnost re- MI do 30. dne pomembno zmanjšala s 14, 3% pri UFH na 11, 5% pri fondaparinuksu (razmerje tveganja 0, 79, 95 interval zaupanja, 0, 64; 0, 98, p = 0, 03).
The
Do 30. dne se je pomembno zmanjšala tudi smrtnost iz kateregakoli vzroka – z 8, 9% v kontrolni eā
e difference in mortality was statistically significant in stratum 1 (placebo comparator) but not in ng stratum 2 (UFH comparator).
skupini na 7, 8% v skupini, ki je prejemala fondaparinuks (razmerje tveganja 0, 87, 95% interval zaupanja, 0, 77; 0, 98, p = 0, 02).
The mortality benefit shown in the fondaparinux group was maintained until the end of follow-up at Day 180. lo In patients who were revascularised with a thrombolytic, fondaparinux significantly reduced the incidence of death/ re-MI at Day 30 from 13.6% for the control group to 10.9% (hazard ratio 0.79, no
Korist fondaparinuksa pri av
Among patients initially not reperfused, the incidence of death/ re-MI at Day 30 was significantly reduced from 15% for the control group to 12.1% for the fondaparinux group (hazard ratio 0.79, 95% CI, 0.65; 0.97, p = 0.023).
zmanjšanju umrljivosti se je ohranila do konca spremljanja na 180. dan.
In patients treated with primary PCI, the incidence of death/ re-MI at Day 30 was not statistically different between the two groups [6.0% in fondaparinux ct
Pri bolnikih, pri katerih je bila opravljena revaskularizacija s trombolitikom, je fondaparinuks do 30. dne pomembno zmanjšal smrtnost/ pojavnost re- MI iz 13, 6% v kontrolni skupini na 10, 9% nim
group vs 4.8% in the control group; hazard ratio 1.26, 95% CI, 0.96, 1.66)]. du
(razmerje tveganja 0, 79, 95% interval zaupanja, 0, 68; 0, 93, p = 0, 003).
By Day 9, 1.1% of patients treated with fondaparinux and 1.4% of control patients experienced a severe haemorrhage.
Pri bolnikih, pri katerih ni bila opravljena začetna reperfuzija, je fondaparinuks pomembno zmanjšal smrtnost/ pojavnost re- MI do 30. dne iz 15% v kontrolni skupini na 12, 1% (razmerje tveganja 0, 79, 95% interval zaupanja, 0, 65; 0, 97, p = 0, 023).
In patients given a thrombolytic, severe haemorrhage occurred in 1.3% of the ro
Pri bolnikih, pri katerih je bila opravljena primarna PCI niso opazili statistično pomembne razlike pri smrtnosti/ pojavnosti re- MI do 30. dne med obema skupinama [6, 0% v skupini, ilo
fondaparinux patients and in 2.0% of controls.
ki je prejemala fondaparinuks v primerjavi s 4, 8% v kontrolni skupini; razmerje tveganja 1, 26, 95% interval zaupanja, 0, 96, 1, 66]. rav
In patients initially not reperfused, the incidence of severe haemorrhage was 1.2% for fondaparinux vs 1.5% for controls.
Hujša krvavitev se je do 9. dne pojavila pri 1, 1% bolnikov, ki so se zdravili s fondaparinuksom in 1, 4% bolnikov v kontrolni skupini.
For patients receiving primary lP
Pri Zd
PCI, the incidence of severe haemorrhage was 1.0% for fondaparinux and 0.4% for controls.
bolnikih, pri katerih ni bila opravljena začetna reperfuzija je bila pojavnost hujše krvavitve 1, 2% za fondaparinuks v primerjavi z 1, 5% za kontrolo.
The efficacy findings and results on severe haemorrhage were consistent across prespecified na
Pri bolnikih, pri katerih je bila izvedena primarna PCI, je bila pojavnost hujše krvavitve 1, 0% pri fondaparinuksu in 0, 4% pri kontroli.
subgroups such as elderly, renally impaired patients, type of concomitant platelet aggregation inhibitors (aspirin, thienopyridines). ici
Pri v naprej določenih podskupinah, kot so starostniki, bolniki z okvaro ledvic, vrsta sočasnega zaviralca agregacije trombocitov (acetilsalicilna kislina, tienopiridini) sta bili učinkovitost in pojavnost hujših krvavitev konsistentni.
5.2 Pharmacokinetic properties ed
21 5. 2 Farmakokinetične lastnosti
Following a single subcutaneous injection of fondaparinux 2.5 mg to young healthy subjects, M
Po enkratni subkutani injekciji 2, 5 mg fondaparinuksa mladim zdravim osebam je največja
peak plasma concentration (mean Cmax = 0.34 mg/ l) is obtained 2 hours post-dosing.
Polovična
Plasma concentrations of half the mean Cmax values are reached 25 minutes post-dosing.
me vrednost povprečne vrednosti Cmax v plazmi je dosežena v 25 minutah po odmerjanju.
Following once daily subcutaneous dosing, steady state of plasma levels is obtained after 3 to 4 days with a 1.3-fold increase in Cmax and AUC.
pro doseženo po 3 do 4 dneh, z 1, 3- kratnim povečanjem Cmax in AUC.
20 Mean (CV%) steady state pharmacokinetic parameters estimates of fondaparinux in patients undergoing hip replacement surgery receiving fondaparinux 2.5 mg once daily are:
Ocena povprečnih vrednosti (CV%) farmakokinetičnih parametrov za fondaparinuks v stanju dinamičnega ravnovesja pri bolnikih po kirurški zamenjavi kolka, ki so prejemali enkrat na dan 2, 5 mg fondaparinuksa so:
Cmax (mg/ l) - 0.39 (31%), Tmax (h) - 2.8 (18%) and Cmin (mg/ l) -0.14 (56%).
Pri
In hip fracture patients, associated with their increased age, fondaparinux steady state plasma concentrations are:
za bolnikih z zlomom kolka, povezanim z njihovo višjo starostjo, so plazemske koncentracije fondaparinuksa v stanju dinamičnega ravnovesja:
Distribution The distribution volume of fondaparinux is limited (7-11 litres).
nja Porazdelitev Volumen porazdelitve fondaparinuksa je majhen (7- 11 litrov).
ris Since fondaparinux does not bind significantly to plasma proteins other than ATIII, no interaction with other medicinal products by protein binding displacement are expected.
In vitro se fondaparinuks v veliki meri in specifično veže na antitrombinski protein z deležem vezave, ki je v smislu odvisnosti od odmerka odvisna od koncentracije v plazmi (98, 6% do 97, 0% v razponu koncentracije od 0, 5 do 2 mg/ l). lje Fondaparinuks se ne veže pomembno na druge proteine plazme, vključno s faktorjem 4 (PF4). vo 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. do
ho Metabolism Although not fully evaluated, there is no evidence of fondaparinux metabolism and in particular no
Presnova Čeprav ni v celoti ovrednotena, ni dokazov za presnovo fondaparinuksa in zlasti ne za tvorbo aktivnih metabolitov. eā
ra Fondaparinux does not inhibit CYP450s (CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1 or CYP3A4) in vitro.
Fondaparinuks in vitro ne zavira CYP450 (CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1 ali CYP3A4).
Thus, fondaparinux is not expected to interact with other medicinal products in vivo by inhibition of CYP-mediated metabolism.
Zato ni pričakovati, da bi fondaparinuks medsebojno deloval z drugimi zdravili in vivo z zaviranjem metabolizma preko CYP. av
The elimination half-life (t½) is about 17 hours in healthy young subjects and about 21 hours in healthy elderly subjects.
Izločanje Razpolovni čas izločanja (t½) je približno 17 ur pri zdravih mladih osebah in približno 21 ur pri zdravih starejših osebah.
Fondaparinux is excreted to 64 – 77% by the kidney as unchanged compound. lo Special populations no
Fondaparinuks se izloča preko ledvic, 64 – 77% v nespremenjeni obliki. nim
Paediatric patients - Fondaparinux has not been investigated in this population.
Posebne skupine bolnikov
Elderly patients - Renal function may decrease with age and thus, the elimination capacity for ct
Otroci - Uporabe fondaparinuksa pri otrocih niso proučevali. ilo
fondaparinux may be reduced in elderly.
Starejši bolniki - Delovanje ledvic lahko s starostjo upada, zato je lahko pri starejših zmanjšana zmogljivost izločanja fondaparinuksa.
In patients > 75 years undergoing orthopaedic surgery, the estimated plasma clearance was 1.2 to 1.4 times lower than in patients < 65 years. du
Pri bolnikih, > 75 let z ortopedskimi operacijami, je ocenjeni rav
Renal impairment - Compared with patients with normal renal function (creatinine ro
očistek plazme 1, 2 do 1, 4- krat manjši kot pri bolnikih, < 65 let.
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 lP
Okvara ledvic - V primerjavi z bolniki z normalnim delovanjem ledvic (kreatininski očistek > 80 ml/ min) je pri bolnikih z blago okvaro delovanja ledvic (kreatininski očistek 50 do Zd
moderate renal impairment (creatinine clearance 30 to 50 ml/ min).
80 ml/ min) plazemski očistek 1, 2 do 1, 4 - krat manjši in v povprečju 2- krat manjši pri bolnikih z zmerno okvaro delovanja ledvic (kreatininski očistek 30 do 50 ml/ min).
Associated terminal half-life values were 29 h in moderate and 72 h in patients with na
Pripadajoče vrednosti končnega razpolovnega časa so 29 h pri zmerni okvari in 72 h pri bolnikih s hudo okvaro ledvic.
Gender - No gender differences were observed after adjustment for body weight. ici
Spol - Po izenačenju glede na telesno maso razlik med spoloma niso opazili.
Race - Pharmacokinetic differences due to race have not been studied prospectively.
22 Rasa - Prospektivno farmakokinetičnih razlik med rasami niso raziskovali.
performed in Asian (Japanese) healthy subjects did not reveal a different pharmacokinetic profile compared to Caucasian healthy subjects.
Vendar raziskave z zdravimi osebami v Aziji (Japonci) niso razkrile drugačnega farmakokinetičnega profila, kot ga imajo zdravi Kavkazijci.
M
Podobno niso opazili razlik v plazemskem očistku med temnopoltimi in kavkaškimi bolniki po ortopedskih operacijah.
Body weight - Plasma clearance of fondaparinux increases with body weight (9% increase per 10 kg).
t Telesna masa - Plazemski očistek fondaparinuksa se povečuje s telesno maso (9% povečanje na
21 5.3 Preclinical safety data
pro 5. 3 Predklinični podatki o varnosti
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
6.
nja 6.
Sodium chloride Water for injections
6. 1 Seznam pomožnih snovi lje natrijev klorid voda za injekcije vo klorovodikova kislina natrijev hidroksid do
ho 6.2 Incompatibilities
6. 2 Inkompatibilnosti
ut In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Zaradi pomanjkanja študij kompatibilnosti zdravila ne smemo mešati z drugimi zdravili. eā
ra 6.3 Shelf life
6. 3 Rok uporabnosti
e 2 years. ng If fondaparinux sodium is added to a 0.9% saline minibag it should ideally be infused immediately, but can be stored at room temperature for up to 24 hours. lo 6.4 Special precautions for storage no
Če se fondaparinuks doda v minibag z 0, 9% fiziološko raztopino, je najbolje, da se ga infundira takoj, vendar pa se ga pri sobni temperaturi lahko shranjuje do 24 ur. nim
6.5 Nature and contents of container ct
6. 5 Vrsta ovojnine in vsebina ilo
Type I glass barrel (1 ml) affixed with a 27 gauge x 12.7 mm needle and stoppered with a bromobutyl du
Injekcijska brizga (1 ml) iz stekla tipa I, s pritrjeno injekcijsko iglo G 27 x 12, 7 mm in zaprta z batno rav
or chlorobutyl elastomer plunger stopper. ro
zaporko iz bromobutilnega ali klorobutilnega elastomera.
Not all pack sizes may be marketed. lP
Zd
6.6 Special precautions for disposal and other handling na
6. 6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom
Intravenous administration should be through an existing intravenous line either directly or using a small volume (25 or 50ml) 0.9% saline minibag. ici
Pri intravenski aplikaciji je treba zdravilo aplicirati preko obstoječe intravenske linije, bodisi neposredno bodisi v manjšem volumnu 0, 9% fiziološke raztopine (25 ali 50 ml) v minibagu.
Parenteral solutions should be inspected visually for particulate matter and discoloration prior to ed
23 Parenteralne raztopine moramo pred uporabo pregledati na prisotnost delcev in spremembo barve.
M
Napotki za subkutano samoinjiciranje so navedeni v navodilu za uporabo.
Any unused product or waste material should be disposed of in accordance with local requirements.
t me Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
Glaxo Group Ltd Greenford Middlesex UB6 0NN United Kingdom
pro Glaxo Group Ltd Greenford Middlesex UB6 0NN
d 8.
nja 8.
e EU/ 1/ 02/ 207/ 001-004
EU/ 1/ 02/ 207/ 001- 004 lje 9.
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
DATUM PRIDOBITVE/ PODALJŠANJA DOVOLJENJA ZA PROMET vo Datum pridobitve dovoljenja za promet:
21 March 2007
21. marec 2007 do
DATE OF REVISION OF THE TEXT
DATUM ZADNJE REVIZIJE BESEDILA eā
e Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu ct du ro lP na ici ed M
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu /. av nim ilo rav Zd
Quixidar 5 mg/ 0.4 ml solution for injection, pre-filled syringe.
Quixidar 5 mg/ 0, 4 ml raztopina za injiciranje, napolnjena injekcijska brizga
Each pre-filled syringe contains 5 mg of fondaparinux sodium in 0.4 ml solution for injection.
t me Vsaka napolnjena injekcijska brizga vsebuje 5 mg natrijevega fondaparinuksa v 0, 4 ml raztopine za injiciranje.
Contains less than 1 mmol of sodium (23 mg) per dose, and therefore is essentially
Vsebuje manj kot 1 mmol natrija (23 mg) na odmerek, kar v bistvu pomeni brez
e sodium free.
pro natrija.
ris For a full list of excipients, see section 6.1.
Za celoten seznam pomožnih snovi glejte poglavje 6. 1.
ut Solution for injection.
Raztopina za injiciranje
The solution is a clear and colourless to slightly yellow liquid.
nja Raztopina je bistra in brezbarvna do rahlo rumenkasta tekočina.
ra 4.
4. 1
CLINICAL PARTICULARS
KLINIČNI PODATKI Terapevtske indikacije
e 4.1
vo
Treatment of acute Deep Vein Thrombosis (DVT) and treatment of acute Pulmonary Embolism (PE), lo except in haemodynamically unstable patients or patients who require thrombolysis or pulmonary 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
4.2 Posology and method of administration
pljučna embolektomija.
The recommended dose of fondaparinux is 7.5 mg (patients with body weight ≥ 50, ≤ 100kg) once ct
4. 2 Odmerjanje in način uporabe eā
For patients with body weight < 50 kg, the du
Priporočeni odmerek fondaparinuksa je 7, 5 mg (bolniki s telesno maso ≥ 50, ≤ 100 kg) enkrat na dan, apliciran s subkutano injekcijo.
recommended dose is 5 mg.
Za bolnike s telesno maso < 50 kg je priporočeni odmerek 5 mg.
For patients with body weight > 100 kg, the recommended dose is 10 mg.
Za bolnike s telesno maso > 100 kg je priporočeni odmerek 10 mg. av
Treatment should be continued for at least 5 days and until adequate oral anticoagulation is established ro
Zdravljenje se mora nadaljevati vsaj 5 dni in dokler se ne vzpostavi primerna peroralna antikoagulacija (internacionalno normalizirano razmerje 2 do 3).
(International Normalised Ratio 2 to 3).
sočasno peroralno antikoagulantno zdravljenje.
The average duration of administration in clinical lP
Povprečno trajanje uporabe v kliničnih preskušanjih je bilo 7 dni, klinične izkušnje z zdravljenjem, ki bi trajalo dlje kot 10 dni, so omejene.
Special populations na
Posebne skupine bolnikov
In patients ≥ 75 years, fondaparinux should be used with care, as renal function decreases with age (see section 4.4). ici
Pri bolnikih, starih 75 let ali več, je treba ilo
Renal impairment - Fondaparinux should be used with caution in patients with moderate renal ed
fondaparinuks uporabljati previdno, ker se delovanje ledvic s starostjo zmanjšuje (glejte poglavje 4. 4). rav
impairment (see section 4.4).
Ledvična okvara - Pri bolnikih z zmernimi okvarami ledvic je treba fondaparinuks uporabljati previdno (glejte poglavje 4. 4).
There is no experience in the subgroup of patients with both high body weight (> 100 kg) and moderate M
S podskupino bolnikov, ki imajo tako preveliko telesno maso (> 100 kg) kot tudi zmerno okvaro Zd
renal impairment (creatinine clearance 30-50 ml/ min).
ledvic (očistek kreatinina 30- 50 ml/ min), nimamo nobenih izkušenj.
24 Hepatic impairment - No dosing adjustment is necessary.
25 Jetrna okvara - Prilagajanje odmerjanja ni potrebno.
Method of administration Fondaparinux is administered by deep subcutaneous injection while the patient is lying down.
t Način uporabe
d posterolateral abdominal wall.
me Fondaparinuks se injicira globoko pod kožo, medtem ko bolnik leži.
To avoid the loss of medicinal product when using the pre-filled
Mesto injiciranja je treba izmenjavati med levo in desno anterolateralno in levo in desno posterolateralno stranjo trebušne stene.
e syringe do not expel the air bubble from the syringe before the injection.
Da se prepreči izgubo zdravila, pri uporabi napolnjene injekcijske brizge pred injiciranjem ne odstranjujte zračnih mehurčkov.
The whole length of the 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
ris the skin fold should be held throughout the injection.
pro drži s palcem in kazalcem; kožno gubo se mora držati ves čas injiciranja.
ho 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.
ut
za
ra
nja
e 4.4
4. 4
Do not administer intramuscularly. lo There is limited experience from treatment with fondaparinux in haemodynamically unstable patients no
Ne injicirajte ga intramuskularno. vo Z zdravljenjem hemodinamsko nestabilnih bolnikov s fondaparinuksom so izkušnje omejene.
and no experience in patients requiring thrombolysis, embolectomy or insertion of a vena cava filter.
vstavitev filtra v veno kavo.
Haemorrhage Fondaparinux should be used with caution in patients who have an increased risk of haemorrhage, ct
Krvavitev Fondaparinuks moramo uporabljati previdno pri bolnikih s povečanim tveganjem za krvavitev, kot so eā
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 du
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. ro
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. lP
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
These agents include desirudin, fibrinolytic agents, GP IIb/ IIIa receptor antagonists, na
Med zdravljenjem VTE je potrebno ilo
During treatment of VTE, concomitant therapy with vitamin K antagonist should be administered in accordance with the information of Section 4.5.
sočasno zdravljenje z antagonistom vitamina K v skladu s podatki v poglavju 4. 5.
Other antiplatelet medicinal products (acetylsalicylic acid, dipyridamole, ici
Druga antitrombotična zdravila (acetilsalicilna kislina, dipiridamol, sulfinpirazon, tiklopidin ali klopidogrel) rav
sulfinpyrazone, ticlopidine or clopidogrel), and NSAIDs should be used with caution.
in NSAID moramo uporabljati previdno.
If co- administration is essential, close monitoring is necessary. ed
Če je sočasna uporaba nujna, je potreben skrben nadzor.
Spinal / Epidural anaesthesia In patients receiving fondaparinux for treatment of VTE rather than prophylaxis, spinal/ epidural M
Spinalna / Epiduralna anestezija Pri bolnikih, ki dobivajo fondaparinuks za zdravljenje VTE, ne za profilakso, uporaba Zd