FrancophonIA/ELRC3.0 huggingface dataset:
English: 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 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).
Croatian: Međutim, u ovom stratumu, u podskupini bolesnika koja je podvrgnuta trombolizi ili nije reperfundirana (tj. bolesnici koji nisu podvrgnuti primarnoj perkutanoj koronarnoj intervenciji) incidencija smrti/rekurentnog infarkta miokarda tridesetog dana bila je značajno smanjena sa 14,3 % u bolesnika liječenih nefrakcioniranim heparinom na 11,5 % u bolesnika liječenih fondaparinuksom (omjer rizika 0,79; 95% CI, 0,64; 0,98, p = 0,03).
English: In the predefined stratum comparing fondaparinux 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 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).
Croatian: p = 0,003).U prethodno definiranom stratumu u kojem se fondaparinuks uspoređivao s nefrakcioniranim heparinom [bolesnici liječeni primarnom perkutanom koronarnom intervencijom (58,5%), specifičnim fibrinoliticima (13%), nespecifičnim fibrinoliticima (2,6%) i bez reperfuzijskog liječenja (25,9%)], učinci fondaparinuksa i nefrakcioniranog heparina na incidenciju smrti/rekurentnog infarkta miokarda tridesetog dana nisu bili statistički različiti: 8,3% prema 8,7% (omjer rizika 0,94; 95% CI, 0,79; 1,11, p = 0,460).
English: The needle protection system of the Arixtra pre-filled syringes have been designed with a safety system to protect from needle stick injuries following injection.
Croatian: Zaštitni sustav injekcijske igle na Arixtra napunjenim štrcaljkama oblikovan je kao sigurnosni sustav za zaštitu od slučajnog uboda nakon injiciranja.
English: Fondaparinux should be used with caution in patients who have an increased risk of haemorrhage (see section 4.4).
Croatian: Fondaparinuks treba primjenjivati s oprezom u bolesnika koji imaju povišeni rizik od nastanka krvarenja (vidjeti dio 4.4).
English: Since fondaparinux does not bind significantly to plasma proteins other than ATIII, no interaction with other medicinal products by protein binding displacement are expected.
Croatian: Budući da se fondaparinuks ne veže značajno na druge proteine plazme, osim AT III, ne očekuju se interakcije s drugim lijekovima zbog istiskivanja s mjesta vezivanja na proteine.
English: 1: Odds ratio: Low Dose/Standard Dose Note: MI - myocardial infarction.
Croatian: 1: Omjer vjerojatnosti: Niska doza/Standardna doza
English: Adverse reactions in medical patients
Croatian: Nuspojave u nekirurških bolesnika
English: INFORMATION IN BRAILLE arixtra 7.5 mg
Croatian: arixtra 7,5 mg
English: Mean (CV%) steady state pharmacokinetic parameters estimates of fondaparinux in patients undergoing hip replacement surgery receiving fondaparinux 2.5 mg once daily are: Cmax (mg/l) - 0.39 (31%), Tmax (h) - 2.8 (18%) and Cmin (mg/l) -0.14 (56%).
Croatian: Ocjena prosječnih vrijednosti (CV%) farmakokinetičkih parametara za fondaparinuks u stanju dinamičke ravnoteže u bolesnika nakon ugradnje umjetnog kuka, koji su primali fondaparinuks 2,5 mg jednom na dan su: Cmax (mg/l) - 0,39 (31%), Tmax (h) - 2,8 (18%) i Cmin (mg/l) - 0,14 (56%).
English: • internal bleeding in the brain, liver or abdomen
Croatian: • unutarnje krvarenje (u mozgu, jetri ili trbuhu)
English: However, 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).
Croatian: Međutim, treba oprezno razmotriti primjenu fondaparinuksa zbog povećanog rizika od krvarenja uslijed nedostatka faktora koagulacije u bolesnika s teškim oštećenjem jetre (vidjeti dio 4.2).
English: In the pivotal UA/NSTEMI clinical trial, treatment with fondaparinux was restarted no earlier than 2 hours after sheath removal.
Croatian: U pivotalnim kliničkim ispitivanjima UA/NSTEMI, liječenje fondaparinuksom ponovo je uvedeno najranije dva sata nakon vađenja uvodnice.
English: • Subcutaneous administration
Croatian: • Supkutana primjena
English: 6.6 Special precautions for disposal and other handling
Croatian: 6.6 Posebne mjere za zbrinjavanje i druga rukovanje lijekom
English: Uncommon: nausea, vomiting
Croatian: Manje često: mučnina, povraćanje
English: : + 33 (0)1 39177000 aspenmedinfo@professionalinformation.co.uk
Croatian: Tél.: + 33 (0)1 39177000 aspenmedinfo@professionalinformation.co.uk
English: Patients with superficial-vein thrombosis
Croatian: Bolesnici s površinskom venskom trombozom
English: 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).
Croatian: Incidencija smrti/ (re-MI) tridesetog dana bila je značajno smanjena sa 11,1% u kontrolnoj skupini na 9,7% u skupini liječenoj fondaparinuksom (omjer rizika 0,86; 95% CI, 0,77; 0,96, p = 0,008).
English: • rash or itchy skin
Croatian: • osip ili svrbež kože
English: Rare: bilirubinaemia
Croatian: Rijetko: hiperbilirubinemija
English: Paediatric patients - Fondaparinux has not been investigated in this population for the prevention of VTE or for the treatment of superficial vein thrombosis.
Croatian: Pedijatrijska populacija - nije ispitivana primjena fondaparinuksa u djece u prevenciji VTE niti liječenju površinske venske tromboze.
English: • Intravenous administration (first dose in patients with STEMI only) Intravenous administration should be through an existing intravenous line either directly or using a small volume (25 or 50ml) 0.9% saline minibag.
Croatian: Lijek treba intravenski primijeniti kroz postojeću intravensku liniju, ili direktno ili uz mali volumen (25 ili 50 ml) 0,9% fiziološke otopine.
English: Hepatic impairment - No dosing adjustment is necessary in patients with either mild or moderate hepatic impairment.
Croatian: Oštećenje jetre - nije potrebna prilagodba doziranja u bolesnika s blagim ili umjerenim jetrenim oštećenjem.
English: • the expiry date has not passed
Croatian: • da nije istekao rok valjanosti
English: Prevention of VTE and Treatment of UA/NSTEMI and STEMI - No dosing adjustment is necessary in patients with either mild or moderate hepatic impairment.
Croatian: • Prevencija VTE i liječenje UA/NSTEMI i STEMI - nije potrebna prilagodba doziranja u bolesnika s blagim ili umjerenim jetrenim oštećenjem.
English: In severe renal impairment (creatinine clearance <30 ml/min), plasma clearance is approximately 5 times lower than in normal renal function.
Croatian: (klirens kreatinina < 30 ml/min), klirens iz plazme je oko 5 puta manji nego kod normalne bubrežne funkcije.
English: Each pre-filled syringe contains 10 mg of fondaparinux sodium in 0.8 ml solution for injection.
Croatian: Svaka napunjena štrcaljka sadržava 10 mg fondaparinuksnatrija u 0,8 ml otopine za injekciju.
English: 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).
Croatian: Treba oprezno razmotriti primjenu fondaparinuksa zbog povećanog rizika od krvarenja uslijed nedostatka faktora koagulacije u bolesnika s teškim oštećenjem jetre (vidjeti dio 4.2).
English: In this subgroup, the incidence of major bleeding on fondaparinux and enoxaparin at Day 9 was 2.2% and 5.0% respectively (hazard ratio 0.43, 95% CI, 0.33;0.57).
Croatian: U toj je podskupini incidencija velikog krvarenja devetog dana iznosila 2,2%, na fondaparinuks odnosno 5,0% na enoksaparin (omjer rizika 0,43; 95% CI, 0,33; 0,57).
English: Incidences of bleeding events in patients receiving the recommended 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 % (34/1,132), 4.4 % (32/733), 6.6% (21/318), and 14.5 % (8/55) respectively.
Croatian: Incidencija krvarenja u bolesnika koji su primali preporučene doze za liječenje DVT ili PE iznosila je 3,0% (34/1132) u bolesnika s normalnom funkcijom bubrega, 4,4% (32/733) u bolesnika s blagim oštećenjem bubrega, 6,6% (21/318) u bolesnika s umjerenim oštećenjem bubrega i 14,5% (8/55) u bolesnika s teškim oštećenjem bubrega.
English: There are different syringes for the 2.5 mg and 1.5 mg doses.
Croatian: Postoje različite prethodno napunjene štrcaljke koje sadrže doze od 2,5 mg i 1,5 mg lijeka Arixtra.
English: What Arixtra looks like and contents of the pack Arixtra is a clear and colourless to slightly yellow solution for injection.
Croatian: Arixtra je bistra i bezbojna do žućkasta otopina za injekciju.
English: These may affect up to 1 in every 1000 people treated with Arixtra.
Croatian: One se mogu javiti u manje od 1 na 1000 bolesnika liječenih lijekom Arixtra.
English: Presence of superficial-vein thrombosis greater than 3 cm from the sapheno-femoral junction should be confirmed and concomitant DVT should be excluded by compression ultrasound or objective methods prior to initiating treatment of fondaparinux.
Croatian: Prije započinjanja liječenja fondaparinuksom treba potvrditi postojanje površinske venske tromboze udaljene više od 3 cm od safeno-femoralnog ušća i isključiti istovremeno postojanje duboke venske tromboze (DVT) kompresijskim ultrazvukom ili drugom objektivnom metodom.
English: In the predefined stratum comparing fondaparinux to placebo (i.e patients treated with nonfibrin specific lytics (77.3%), no reperfusion (22%), fibrin-specific lytics (0.3%), primary PCI (0.4%), 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).
Croatian: U prethodno definiranom stratumu u kojem se fondaparinuks uspoređivao s placebom (tj. bolesnicima liječenim nespecifičnim fibrinoliticima (77,3%), specifičnim fibrinoliticima (0,3%), primarnom perkutanom koronarnom intervencijom (0,4%), te s onima bez reperfuzijskog liječenja (22%)), incidencija smrti/rekurentnog infarkta miokarda tridesetog dana bila je značajno smanjena sa 14,0% u skupini na placebu na 11,3% (omjer rizika 0,80; 95% CI, 0,69; 0,93,
English: • high number of platelets (blood cells necessary for blood clotting)
Croatian: • povišen broj krvnih pločica (krvnih stanica neophodnih za zgrušavanje krvi)
English: The risk of bleeding increases with increasing renal impairment.
Croatian: Rizik od krvarenja veći je što je oštećenje bubrežne funkcije teže.
English: The syringe needle shield contains latex that has the potential to cause allergic reactions in latex sensitive individuals.
Croatian: Štitnik za iglu sadrži lateks koji ima potencijal uzrokovati alergijske reakcije u osoba osjetljivih na lateks.
English: Don't stop using Arixtra without advice
Croatian: Nemojte samovoljno prestati primjenjivati lijek Arixtra
English: The antithrombotic activity of fondaparinux is the result of antithrombin III (antithrombin) mediated selective inhibition of Factor Xa.
Croatian: Antitrombotsko djelovanje fondaparinuksa rezultat je selektivne inhibicije faktora Xa preko antitrombina III (antitrombin).
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN Keep out of the sight and reach of children.
Croatian: Čuvati izvan pogleda i dohvata djece.
English: In patients undergoing surgery, timing of the first fondaparinux injection requires strict adherence in patients ≥75 years, and/or with body weight <50 kg and/or with renal impairment with creatinine clearance ranging between 20 to 50 ml/min.
Croatian: U bolesnika podvrgnutih operaciji, a koji su stariji od 75 godina i/ili tjelesne težine <50 kg i/ili imaju oštećenje bubrega s klirensom kreatinina 20 - 50 ml/min, treba se strogo pridržavati pravilnog trenutka primjene prve injekcije.
English: Treatment of unstable angina or non-ST segment elevation myocardial infarction (UA/NSTEMI) OASIS 5 was a double-blind, randomised, non-inferiority study with fondaparinux 2.5 mg subcutaneously once daily versus enoxaparin 1 mg/kg subcutaneously twice daily in approximately 20,000 patients with UA/NSTEMI.
Croatian: OASIS 5 bilo je dvostruko slijepo, randomizirano ispitivanje neinferiornosti fondaparinuksa 2,5 mg supkutano jedanput na dan nasuprot enoksaparinu 1 mg/kg supkutano dvaput na dan u otprilike 20000
English: The syringe needle shield may contain latex that has the potential to cause allergic reactions in latex sensitive individuals.
Croatian: Štitnik za iglu može sadržavati lateks koji ima potencijal uzrokovati alergijske reakcije u osoba osjetljivih na lateks.
English: Rare: chest pain, fatigue, hot flushes, leg pain, oedema genital, flushing, syncope
Croatian: Rijetko: bol u prsima, umor, navale vrućine, bolovi u nogama, genitalni edem, crvenilo praćeno osjećajem užarenosti, sinkopa
English: In patients initially not reperfused, the incidence of severe haemorrhage was 1.2% for fondaparinux vs 1.5% for controls.
Croatian: U bolesnika koji inicijalno nisu reperfuzijski liječeni, incidencija velikog krvarenja bila je 1,2% u skupini liječenoj fondaparinuksom, a 1,5% u kontrolnoj skupini.
English: The incidence of all cause mortality at Day 30 was also significantly reduced from 8.9% for the control group to 7.8% in the fondaparinux group (hazard ratio 0.87, 95% CI, 0.77;0.98, p = 0.02).
Croatian: Incidencija mortaliteta svih uzroka tridesetog dana bila je također značajno smanjena s 8,9% u kontrolnoj skupini na 7,8% u skupini liječenoj fondaparinuksom (omjer rizika 0,87; 95% CI, 0,77;
English: What Arixtra looks like and contents of the pack Arixtra is a clear and colourless solution for injection.
Croatian: Arixtra je bistra i bezbojna otopina za injekciju.
English: 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).
Croatian: Na temelju rezultata farmakokinetskog modeliranja može se u toj skupini nakon početne doze od 10 mg na dan razmotriti smanjenje doze na 7,5 mg na dan (vidjeti dio 4.2).
English: If you stop the treatment before your doctor told you to, you are at risk of developing a blood clot in a vein of your leg or lung.
Croatian: Vam to preporuči liječnik, imat ćete veći rizik od nastanka ugruška krvi u venama na nozi ili u plućima.
English: INFORMATION IN BRAILLE arixtra 1.5 mg
Croatian: arixtra 1,5 mg
English: Fondaparinux should be used with caution in elderly patients (see section 4.2).
Croatian: Fondaparinuks treba koristiti uz oprez u starijih bolesnika (vidjeti dio 4.2).
English: Arixtra is available in pack sizes of 2, 7, 10 and 20 pre-filled syringes.
Croatian: Arixtra je dostupna je u pakiranjima s 2, 7, 10 i 20 napunjenih štrcaljki.
English: For prevention of VTE- Agents that may enhance the risk of haemorrhage should not be administered concomitantly with fondaparinux.
Croatian: U prevenciji VTE - lijekovi koji mogu povećati rizik od krvarenja ne smiju se primjenjivati istodobno s fondaparinuksom.
English: Approximately 40% and 17% of patients had mild (creatinine clearance ≥50 to <80 ml/min) or moderate (creatinine clearance ≥30 to <50 ml/min) renal impairment, respectively.
Croatian: Oko 40% bolesnika imalo je blago (klirens kreatinina ≥50 do <80 ml/min), a oko 17% umjereno (klirens kreatinina ≥30 do <50 ml/min) oštećenje bubrega.
English: MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE
English: Rare: abdominal pain
Croatian: Rijetko: bol u abdomenu
English: 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.
Croatian: Oko 40% bolesnika imalo je blago (klirens kreatinina ≥50 do <80 ml/min), a oko 14% umjereno (klirens kreatinina ≥30 do <50 ml/min) oštećenje bubrega.
English: 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 class by decreasing order of seriousness; these adverse reactions should be interpreted within the surgical and medical context.
Croatian: ≥ 1/1000 i < 1/100; rijetko: ≥ 1/10 000 i < 1/1000; vrlo rijetko: <1/10 000) i organskom sustavu od težih prema lakšima; ove nuspojave treba interpretirati u kirurškom i medicinskom kontekstu.
English: Prevention of Venous Thromboembolic Events (VTE) in patients undergoing abdominal surgery who are judged to be at high risk of thromboembolic complications, such as patients undergoing abdominal cancer surgery
Croatian: Prevencija venskih tromboembolijskih događaja (VTE) u bolesnika nakon abdominalnog kirurškog zahvata za koje se procjenjuje da su pod povećanim rizikom od tromboembolijskih komplikacija, npr. bolesnici koji se podvrgavaju abdominalnom kirurškom zahvatu zbog tumora
English: • 7.5 mg fondaparinux sodium in 0.6 ml solution for injection
Croatian: • 7,5 mg fondaparinuksnatrija u 0,6 ml otopine za injekcije
English: By binding selectively to ATIII, fondaparinux potentiates (about 300 times) the innate neutralization of Factor Xa by ATIII.
Croatian: Selektivnim vezanjem na AT III, fondaparinuks pojačava (oko 300 puta) prirodnu neutralizaciju faktora Xa antitrombinom III.
English: Type I glass barrel (1 ml) affixed with a 27 gauge x 12.7 mm needle and stoppered with a bromobutyl or chlorobutyl elastomer plunger stopper.
Croatian: Staklena štrcaljka (1 ml) (staklo tipa I) s gumenim klipom (brombutil ili klorbutil guma) i pričvršćenom injekcijskom iglom (G 27 x 12,7 mm).
English: The needle shield of the pre-filled syringe may contain dry natural latex rubber that has the potential to cause allergic reactions in latex sensitive individuals.
Croatian: Štitnik za iglu na napunjenoj štrcaljki može sadržavati suhu prirodnu lateks gumu koja može izazvati alergijsku reakciju u osoba preosjetljivih na lateks.
English: • after the expiry date shown on the label and carton
Croatian: • ako je istekao rok valjanosti otisnut na pakiranju
English: The solution is a clear and colourless to slightly yellow liquid.
Croatian: Otopina je bistra i bezbojna do žućkasta tekućina.
English: • low number of platelets (blood cells necessary for blood clotting)
Croatian: • smanjenje broja krvnih pločica (krvnih stanica neophodnih za zgrušavanje krvi)
English: METHOD AND ROUTE(S) OF ADMINISTRATION Subcutaneous use
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA
English: This stops a clotting factor Xa (“ten-A”) from working in the blood, and so prevents unwanted blood clots (thromboses) from forming in the blood vessels.
Croatian: Arixtra sadržava fondaparinuksnatrij, sintetički spoj koji ometa djelovanje faktora zgrušavanja Xa („deset-A“) u krvi, te time sprječava nastanak neželjenih krvnih ugrušaka (tromboze) u krvnim žilama.
English: • syringe with yellow plunger and a manual safety system.
Croatian: • štrcaljka s žutim klipom i ručnim sigurnosnim sustavom.
English: In subjects undergoing PCI the incidence of adjudicated guiding catheter thrombus was 1.0% vs. 0.3% in fondaparinux vs. enoxaparin subjects, respectively.
Croatian: U bolesnika podvrgnutih PCI, incidencija tromboze u provodnom kateteru je iznosila 1,0% u fondaparinuks skupini vs 0,3% u enoksaparin skupini.
English: INFORMATION IN BRAILLE arixtra 5 mg
Croatian: arixtra 5 mg
English: Syringe with a manual needle protection system showing security sleeve being pulled over needle AFTER USE
Croatian: Slika 3. Prikaz štrcaljke s ručnim sigurnosnim sustavom za iglu sa zaštitnim valjkom prevučenim preko igle NAKON
English: Common: bleeding (gastrointestinal, haematuria, haematoma, epistaxis, haemoptysis, utero-vaginal haemorrhage, haemarthrosis, ocular, purpura, bruise)
Croatian: Poremećaji krvi i limfnog sustava Često: krvarenje (gastrointestinalno krvarenje, hematurija, hematomi, epistaksa, hemoptiza, uterovaginalno krvarenje, hemartroza, krvarenje u oku, purpura, modrice)
English: INFORMATION IN BRAILLE arixtra 2.5 mg
Croatian: arixtra 2,5 mg
English: • the solution is clear and colourless to slightly yellow and doesn't contain particles
Croatian: • da je otopina bistra i bezbojna do žućkasta te da nema stranih čestica
English: Picture E
Croatian: Slika E
English: Remove the needle shield, by first twisting it (picture B1) and then pulling it in a straight line away from the body of the syringe (picture B2).
Croatian: Skinite štitnik s igle tako da ga najprije zavrnete (slika B1),
English: · recent surgery on the brain, spine or eye
Croatian: · nedavno krvarenje u mozgu (intrakranijalno krvarenje) · nedavnu operaciju na mozgu, kralježnici ili oku
English: 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.
Croatian: U bolesnika u istim skupinama prema bubrežnoj funkciji koji su primali preporučene doze enoksaparina za liječenje DVT, incidencija krvarenja bila je 2,3% (13/559), 4,6% (17/368), 9,7% (14/145) odnosno 11,1% (2/18), dok je u bolesnika koji su primali preporučene doze UFH za liječenje PE ona iznosila
English: • breathlessness
Croatian: • omaglica
English: • if you have very severe kidney disease.
Croatian: • ako imate vrlo tešku bolest bubrega.
English: Uncommon: nausea, vomiting Rare: abdominal pain, dyspepsia, gastritis, constipation, diarrhoea
Croatian: Rijetko: bol u abdomenu, dispepsija, gastritis, konstipacija, proljev
English: No dosage reduction is required for patients with creatinine clearance > 20 ml/min.
Croatian: U bolesnika s klirensom kreatinina >20 ml/min nije potrebno smanjenje doze.
English: • if you have severe liver disease
Croatian: • ako imate vrlo tešku bolest bubrega
English: Type I glass barrel (1 ml) affixed with a 27 gauge x 12.7 mm needle and stoppered with a chlorobutyl elastomer plunger stopper.
Croatian: Staklena štrcaljka (1 ml) (staklo tipa I) s gumenim klipom (klorbutil guma) i pričvršćenom injekcijskom iglom (G 27 x 12,7 mm).
English: Severe hepatic impairment
Croatian: U bolesnika s teškim oštećenjem bubrega
English: The main sites of surgery were colonic/rectal, gastric, hepatic, cholecystectomy or other biliary.
Croatian: Kirurški zahvati bili su uglavnom na debelom crijevu/rektumu, želucu, jetri i žučovodu ili je bila izvedena kolecistektomija.
English: In subjects undergoing primary PCI the incidence of adjudicated guiding catheter thrombus was 1.2% vs 0% in fondaparinux vs. control subjects, respectively.
Croatian: U bolesnika koji su podvrgnuti primarnoj PCI, incidencija tromboze u provodnom kateteru je u fondaparinuks skupini iznosila 1,2% vs 0% u kontrolnih ispitanika.
English: No dosage reduction is required for patients with mild renal impairment (creatinine clearance >50 ml/min).
Croatian: U bolesnika s blagim oštećenjem bubrega (klirens kreatinina >50 ml/min) nije potrebno smanjenje doze.
English: • treat blood clots in blood vessels that are near the surface of the skin of the legs (superficialvein thrombosis).
Croatian: • za liječenje ugrušaka u venama koje se nalaze neposredno ispod površine kože donjih udova
English: Fondaparinux is known to be excreted mainly by the kidney.
Croatian: Poznato je da se fondaparinuks najvećim dijelom izlučuje putem bubrega.
English: Arixtra 7.5 mg/0.6 ml is available in pack sizes of 2, 7, 10 and 20 pre-filled syringes.
Croatian: Arixtra 7,5 mg/0,6 ml dostupna je u pakiranjima s 2, 7, 10 ili 20 napunjenih štrcaljki.
English: Respiratory, thoracic and mediastinal disorders
Croatian: trombocitemija, poremećaji trombocita, poremećaj koagulacije
English: Each pre-filled syringe contains 7.5 mg of fondaparinux sodium in 0.6 ml solution for injection.
Croatian: Jedna napunjena štrcaljka sadržava 7,5 mg fondaparinuksnatrija u 0,6 ml otopine za injekciju.