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).
Slovenian: 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 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).
English: INFORMATION IN BRAILLE arixtra 1.5 mg
Slovenian: arixtra 1.5 mg
English: How to store Arixtra
Slovenian: Shranjevanje zdravila Arixtra
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).
Slovenian: V tej podskupini je bila pojavnost večjih krvavitev do 9. dne pri bolnikih, ki so prejemali fondaparinuks 2,2 %, pri bolnikih, ki so prejemali enoksaparin pa 5,0 % (razmerje tveganja 0,43, 95 % interval zaupanja, 0,33;0,57).
English: What you need to know before you use Arixtra
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Arixtra Ne uporabljajte zdravila Arixtra:
English: If you get any side effects, talk to your doctor or pharmacist.
Slovenian: Če opazite katerikoli neželeni učinek, se posvetujte s svojim zdravnikom ali s farmacevtom.
English: Sodium chloride Water for injections Hydrochloric acid Sodium hydroxide
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi natrijev klorid voda za injekcije klorovodikova kislina natrijev hidroksid
English: This unlocks the sleeve.
Slovenian: S tem boste odblokirali tulec.
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
Slovenian: Uporabo fondaparinuksa je treba skrbno pretehtati zaradi zvečane nevarnosti krvavitve, ki je posledica pomanjkanja koagulacijskih faktorjev pri bolnikih s hudimi okvarami jeter (glejte poglavje
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).
Slovenian: Do 30. dne se je smrtnost/pojavnost re-MI pomembno 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).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PRE-FILLED SYRINGE
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
English: Fondaparinux should be used with caution in these patients (see section 4.2).
Slovenian: Fondaparinuks moramo pri teh bolnikih uporabljati previdno (glejte poglavje 4.2).
English: • diarrhoea or constipation
Slovenian: • zaspanost ali utrujenost;
English: The syringe needle shield contains latex.
Slovenian: Injekcijska brizga z zdravilom Arixtra vsebuje lateks
English: Syringe automatic system
Slovenian: Injekcijska brizga s samodejnim sistemom
English: Fondaparinux should be used with caution in these patients (see section 4.4).
Slovenian: Fondaparinuks moramo pri teh bolnikih uporabljati previdno (glejte poglavje 4.4).
English: There is limited experience from treatment with fondaparinux in haemodynamically unstable patients and no experience in patients requiring thrombolysis, embolectomy or insertion of a vena cava filter.
Slovenian: Nikakršnih izkušenj ni na voljo z bolniki, pri katerih je potrebna tromboliza, embolektomija ali vstavitev filtra v veno kavo.
English: Parenteral solutions should be inspected visually for particulate matter and discoloration prior to administration.
Slovenian: Parenteralne raztopine moramo pred uporabo pregledati na prisotnost delcev in spremembo barve.
English: Arixtra is available in pack sizes of 2, 7, 10 and 20 pre-filled syringes.
Slovenian: Zdravilo Arixtra je na voljo v pakiranjih z 2, 7, 10 in 20 napolnjenih injekcijskih brizg.
English: The main sites of surgery were colonic/rectal, gastric, hepatic, cholecystectomy or other biliary.
Slovenian: Kirurški posegi so bili v glavnem opravljeni na kolonu, rektumu, želodcu, jetrih ali žolčnih izvodilih ali pa je bila opravljena holecistektomija.
English: Each pre-filled syringe contains 10 mg of fondaparinux sodium in 0.8 ml solution for injection.
Slovenian: Vsaka napolnjena injekcijska brizga vsebuje 10 mg natrijevega fondaparinuksata v 0,8 ml raztopine za injiciranje.
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).
Slovenian: Uporabo fondaparinuksa je treba skrbno pretehtati zaradi zvečane nevarnosti krvavitve, ki je posledica pomanjkanja koagulacijskih faktorjev pri bolnikih s hudimi okvarami jeter (glejte poglavje 4.2).
English: - hypersensitivity to the active substance or to any of the excipients listed in section 6.1 - active clinically significant bleeding - acute bacterial endocarditis - severe renal impairment defined by creatinine clearance < 20 ml/min.
Slovenian: - Sveža klinično pomembna krvavitev - Akutni bakterijski endokarditis - Huda ledvična okvara, opredeljena s kreatininskim očistkom < 20 ml/min.
English: There are different syringes for the 2.5 mg and 1.5 mg doses.
Slovenian: mg in 1,5 mg so na voljo različne injekcijske brizge.
English: • high number of platelets (blood cells necessary for blood clotting)
Slovenian: • zvišanje števila trombocitov (krvnih celic, potrebnih za strjevanje krvi);
English: • if you have a risk of uncontrolled bleeding (haemorrhage) including: · stomach ulcer · bleeding disorders · recent bleeding into the brain (intracranial bleeding) · recent surgery on the brain, spine or eye
Slovenian: · nedavno možgansko krvavitvijo (znotrajlobanjska krvavitev), · nedavno operacijo na možganih, hrbtenici ali očeh;
English: • oozing from operation wound site
Slovenian: • izcedek iz rane na mestu operacije;
English: Treatment of superficial-vein thrombosis
Slovenian: Zdravljenje povrhnje venske tromboze
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.
Slovenian: Približno 40 % bolnikov je imelo blago ledvično okvaro (kreatininski očistek ≥ 50 do < 80 ml/min), približno 17 % bolnikov pa zmerno ledvično okvaro (kreatininski očistek ≥ 30 do < 50 ml/min).
English: No dosage reduction is required for patients with mild renal impairment (creatinine clearance >50 ml/min).
Slovenian: Bolnikom z blago okvaro ledvic (očistek kreatinina > 50 ml/min) odmerka ni treba zmanjšati.
English: • if you have severe liver disease
Slovenian: • če imate hudo jetrno bolezen;
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.
Slovenian: 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 organski sistem v padajočem vrstnem redu po resnosti; te neželene učinke moramo interpretirati v povezavi s kirurškim in internističnim posegom.
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
Slovenian: Preprečevanje venskih trombemboličnih dogodkov (VTE) po kirurških posegih v trebušni votlini pri bolnikih, pri katerih obstaja povečano tveganje za pojav trombemboličnih zapletov, npr. bolniki po resekciji tumorja v trebušni votlini
English: The antithrombotic activity of fondaparinux is the result of antithrombin III (antithrombin) mediated selective inhibition of Factor Xa.
Slovenian: Antitrombotični učinek fondaparinuksa je rezultat selektivne inhibicije faktorja Xa preko antitrombina III (antitrombin).
English: Renal impairment - Fondaparinux should be used with caution in patients with moderate renal impairment (see section 4.4).
Slovenian: Ledvična okvara - Pri bolnikih z zmernimi okvarami ledvic je treba fondaparinuks uporabljati previdno (glejte poglavje 4.4).
English: INFORMATION IN BRAILLE arixtra 2.5 mg
Slovenian: arixtra 2.5 mg
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.
Slovenian: Približno 40 % 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).
English: Contact your doctor or pharmacist for advice as soon as possible because of the increased risk of bleeding.
Slovenian: Zaradi večje možnosti za pojav krvavitev se čim prej posvetujte s svojim zdravnikom ali s farmacevtom.
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.
Slovenian: • Preprečevanje VTE in zdravljenje UA/NSTEMI in STEMI - Pri bolnikih z blago ali zmerno okvaro jeter odmerka ni treba prilagajati.
English: Picture E
Slovenian: Slika E
English: For the prevention of VTE, 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.
Slovenian: Neželeni učinki, o katerih so poročali raziskovalci pri preprečevanju VTE 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 organski sistem v padajočem vrstnem redu po resnosti; te neželene učinke moramo interpretirati v povezavi s kirurškim in internističnim posegom.
English: The antithrombotic activity of fondaparinux is the result of antithrombin III (ATIII) mediated selective inhibition of Factor Xa.
Slovenian: Antitrombotični učinek fondaparinuksa je rezultat selektivne inhibicije faktorja Xa preko antitrombina III (ATIII).
English: Each pre-filled syringe contains 7.5 mg of fondaparinux sodium in 0.6 ml solution for injection.
Slovenian: Vsaka napolnjena injekcijska brizga vsebuje 7,5 mg natrijevega fondaparinuksata v 0,6 ml raztopine za injiciranje.
English: Medicinal product subject to medical prescription.
Slovenian: Predpisovanje in zdaja zdravila je le na recept.
English: • 7.5 mg fondaparinux sodium in 0.6 ml solution for injection
Slovenian: • 7,5 mg natrijevega fondaparinuksata v 0,6 ml raztopine za injiciranje.
English: INFORMATION IN BRAILLE arixtra 5 mg
Slovenian: arixtra 5 mg
English: These may affect up to 1 in every 1000 people treated with Arixtra.
Slovenian: Pojavijo se lahko pri do 1 od 1.000 bolnikov, ki se zdravijo z zdravilom Arixtra:
English: • If you get any side effects, talk to your doctor or pharmacist.
Slovenian: • Če opazite katerikoli neželeni učinek, se posvetujte s svojim zdravnikom ali s farmacevtom.
English: • bruising or swelling (oedema)
Slovenian: • nastanek modric ali oteklin (edemi);
English: Each pre-filled syringe contains 5 mg of fondaparinux sodium in 0.4 ml solution for injection.
Slovenian: Vsaka napolnjena injekcijska brizga vsebuje 5 mg natrijevega fondaparinuksata v 0,4 ml raztopine za injiciranje.
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).
Slovenian: Vendar pa moramo uporabo fondaparinuksa skrbno obravnavati, ker obstaja pri bolnikih s hudimi jetrnimi okvarami povečano tveganje za krvavitve zaradi pomanjkanja faktorjev koagulacije (glejte poglavje 4.2).
English: The needle shield of the pre-filled syringe contains dry natural latex rubber that has the potential to cause allergic reactions in latex sensitive individuals.
Slovenian: Ščitnik igle na napolnjeni injekcijski brizgi vsebuje suho naravno gumo iz lateksa, ki lahko osebam, občutljivim na lateks, povzroči alergijsko reakcijo.
English: The incidence of each thromboembolic component of the primary outcome was also significantly reduced in fondaparinux patients as follows: symptomatic PE [0 (0%) vs 5 (0.3%) (p=0.031)], symptomatic DVT [3 (0.2%) vs 18 (1.2%); relative risk reduction 83.4% (p<0.001)], symptomatic superficial-vein thrombosis extension [4 (0.3%) vs 51 (3.4%); relative risk reduction 92.2% (p<0.001)], symptomatic superficial-vein thrombosis reoccurrence [5 (0.3%) vs 24 (1.6%); relative risk reduction 79.2% (p<0.001)].
Slovenian: Pri bolnikih, ki so prejemali fondaparinuks, se je značilno zmanjšala tudi incidenca vsake posamezne komponente primarnega opazovanega dogodka: simptomatske pljučne embolije [0 (0 %) v primerjavi s 5 (0,3 %), p = 0,031], simptomatske globoke venske tromboze [3 (0,2 %) v primerjavi z 18 (1,2 %), zmanjšanje relativnega tveganja 83,4 % (p < 0,001)],
English: Hepatic impairment - No dosing adjustment is necessary in patients with either mild or moderate hepatic impairment.
Slovenian: Jetrna okvara - Pri bolnikih z blago ali zmerno okvaro jeter odmerka ni treba prilagajati.
English: Peri-PCI minor bleeding
Slovenian: Večja krvavitev v času okrog PCI Manjša krvavitev v času okrog PCI
English: • Treatment of UA/NSTEMI and STEMI - Fondaparinux should not be used in patients with creatinine clearance < 20 ml/min (see section 4.3).
Slovenian: • Zdravljenje UA/NSTEMI in STEMI - Fondaparinuksa se ne sme uporabljati pri bolnikih s kreatininskim očistkom < 20 ml/min (glejte poglavje 4.3).
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.
Slovenian: Zdravilo Arixtra vsebuje sintetično učinkovino, imenovano natrijev fondaparinuksat, ki zavre delovanje faktorja strjevanja krvi Xa (“deset-A”) v krvi in tako prepreči razvoj neželenih krvnih strdkov (trombozo) v krvnih žilah.
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).
Slovenian: Do 30. dne se je pomembno zmanjšala tudi smrtnost iz kateregakoli vzroka - z 8,9 % v kontrolni skupini na 7,8 % v skupini, ki je prejemala fondaparinuks (razmerje tveganja 0,87, 95
English: METHOD OF ADMINISTRATION EXPIRY DATE
Slovenian: DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
English: Common: post-operative haemorrhage, anaemia Uncommon: bleeding (epistaxis, gastrointestinal, haemoptysis, haematuria, haematoma) thrombocytopenia, purpura, thrombocythaemia, platelet abnormal, coagulation disorder
Slovenian: Občasni: krvavitve (epistaksa, krvavitve v prebavilih, hemoptiza, hematurija, hematom) trombocitopenija, purpura, trombocitemija, nepravilnosti trombocitov, motnje koagulacije
English: The dose should be reduced to 1.5 mg once daily in patients with creatinine clearance in the range of 20 to 50 ml/min (see sections 4.4 and 5.2).
Slovenian: Bolnikom z očistkom kreatinina od 20 do 50 ml/min je treba odmerek zmanjšati na 1,5 mg enkrat na dan (glejte poglavji 4.4 in 5.2).
English: Arixtra 7.5 mg/0.6 ml is available in pack sizes of 2, 7, 10 and 20 pre-filled syringes.
Slovenian: Zdravilo Arixtra 7,5 mg/0,6 ml je na voljo v pakiranjih z 2, 7, 10 in 20 napolnjenih injekcijskih brizg.
English: These may affect up to 1 in 100 people treated with Arixtra.
Slovenian: Pojavijo se lahko pri do 1 od 100 bolnikov, ki se zdravijo z zdravilom Arixtra:
English: The dose should be reduced to 1.5 mg once daily in patients with creatinine clearance in the range of 20 to 50 ml/min (see sections 4.2 and 5.2).
Slovenian: Bolnikom z očistkom kreatinina od 20 do 50 ml/min je treba odmerek zmanjšati na 1,5 mg enkrat na dan (glejte poglavji 4.2 in 5.2).
English: • The active substance is 1.5 mg fondaparinux sodium in 0.3 ml solution for injection
Slovenian: • Zdravilna učinkovina je 1,5 mg natrijevega fondaparinuksata v 0,3 ml raztopine za injiciranje.
English: Discard the needle shield.
Slovenian: Ščitnik igle zavrzite.
English: Patients under-going urological (other than kidney) or gynaecological surgery, laparoscopic surgery or vascular surgery were not included in the study.
Slovenian: V študijo niso bili vključeni bolniki pri katerih je bil opravljen kirurški poseg na sečilih (vse razen ledvic), ženskih spolovilih, žilah ali laparoskopski poseg.
English: In subjects undergoing primary PCI the incidence of adjudicated guiding catheter thrombus was 1.2% vs 0% in fondaparinux vs. control subjects, respectively.
Slovenian: Pri preiskovancih z opravljeno primarno PCI je bila pogostnost tromba na vodilnem katetru 1,2 % med preiskovanci, ki so prejemali fondaparinuks, in 0 % med preiskovanci v kontrolni skupini.
English: The recommended dose of fondaparinux is 2.5 mg once daily administered by subcutaneous injection.
Slovenian: Priporočeni odmerek fondaparinuksa je 2,5 mg enkrat na dan s subkutano injekcijo.
English: Prevention of Venous Thromboembolic Events (VTE) in patients undergoing hip fracture surgery treated for up to 24 days following an initial prophylaxis of 1 week In a randomised double-blind clinical trial, 737 patients were treated with fondaparinux 2.5 mg once daily for 7 +/- 1 days following hip fracture surgery.
Slovenian: V naključnem dvojno slepem kliničnem preskušanju so 737 bolnikov zdravili s fondaparinuksom v odmerku 2,5 mg enkrat na dan 7 dni +/- 1 dan po operaciji zloma kolka.
English: By Day 9, 1.1% of patients treated with fondaparinux and 1.4% of control patients experienced a severe haemorrhage.
Slovenian: 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.
English: MedDRA
Slovenian: Dojenje
English: • Prevention of VTE - Fondaparinux should not be used in patients with creatinine clearance <20 ml/min (see section 4.3).
Slovenian: • Preprečevanje VTE - Fondaparinuksa se ne sme uporabljati pri bolnikih, ki imajo kreatininski očistek < 20 ml/min (glejte poglavje 4.3).
English: Arixtra 10 mg/0.8 ml is available in pack sizes of 2, 7, 10 and 20 pre-filled syringes.
Slovenian: Zdravilo Arixtra 10 mg/0,8 ml je na voljo v pakiranjih z 2, 7, 10 in 20 napolnjenih injekcijskih brizg.
English: Arixtra syringe may contain latex
Slovenian: Injekcijska brizga z zdravilom Arixtra lahko vsebuje lateks
English: Arixtra 5 mg/0.4 ml is available in pack sizes of 2, 7, 10 and 20 pre-filled syringes.
Slovenian: Zdravilo Arixtra 5 mg/0,4 ml je na voljo v pakiranjih z 2, 7, 10 in 20 napolnjenih injekcijskih brizg.
English: Dispose of it as your doctor or pharmacist has instructed.
Slovenian: Injekcijsko brizgo zavrzite v skladu z navodili svojega zdravnika ali farmacevta.
English: Arixtra 7.5 mg/0.6 ml solution for injection Arixtra 10 mg/0.8 ml solution for injection fondaparinux sodium
Slovenian: Navodilo za uporabo Arixtra 5 mg/0,4 ml raztopina za injiciranje Arixtra 7,5 mg/0,6 ml raztopina za injiciranje Arixtra 10 mg/0,8 ml raztopina za injiciranje natrijev fondaparinuksat
English: Prevention of Venous Thromboembolic Events (VTE) in medical patients who are at high risk for thromboembolic complications due to restricted mobility during acute illness In a randomised double-blind clinical trial, 839 patients were treated with fondaparinux 2.5 mg once daily or placebo for 6 to 14 days.
Slovenian: V randomiziranem dvojno slepem kliničnem preskusu so zdravili 839 bolnikov s fondaparinuksom v odmerku 2,5 mg enkrat na dan ali placebom 6 do 14 dni dolgo.
English: • 5 mg fondaparinux sodium in 0.4 ml solution for injection
Slovenian: • 5 mg natrijevega fondaparinuksata v 0,4 ml raztopine za injiciranje.
English: Arixtra is a medicine that helps prevent blood clots from forming in the blood vessels (an antithrombotic agent).
Slovenian: Arixtra je zdravilo, ki pomaga preprečevati nastajanje krvnih strdkov v krvnih žilah
English: • syringe with a orange plunger and an automatic safety system
Slovenian: • injekcijska brizga z oranžnim batom in samodejnim varnostnim sistemom.
English: The timing of restarting subcutaneous fondaparinux after sheath removal should be based on clinical judgment.
Slovenian: Klinik naj presodi o času ponovne uvedbe subkutanega zdravljenja s fondaparinuksom po odstranitvi katetra.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe (0.8 ml) contains 10 mg fondaparinux sodium.
Slovenian: Ena napolnjena injekcijska brizga (0,8 ml) vsebuje 10 mg natrijevega fondaparinuksata.
English: The recommended dose of fondaparinux is 2.5 mg once daily, administered by subcutaneous injection.
Slovenian: Priporočeni odmerek fondaparinuksa je 2,5 mg enkrat na dan, injiciran subkutano.
English: Fondaparinux should be used with caution in elderly patients (see section 4.2).
Slovenian: Pri starejših bolnikih moramo fondaparinuks uporabljati previdno (glejte poglavje 4.2).
English: EU/1/02/206/005-008 EU/1/02/206/024 EU/1/02/206/025 EU/1/02/206/026
Slovenian: EU/1/02/206/024 EU/1/02/206/025 EU/1/02/206/026
English: Arixtra 10 mg/0.8 ml solution for injection, pre-filled syringe.
Slovenian: Arixtra 10 mg/0,8 ml raztopina za injiciranje, napolnjena injekcijska brizga
English: - hypersensitivity to the active substance or to any of the excipients listed in section 6.1 - active clinically significant bleeding - acute bacterial endocarditis - severe renal impairment defined by creatinine clearance < 30 ml/min.
Slovenian: - Sveža klinično pomembna krvavitev - Akutni bakterijski endokarditis - Huda ledvična okvara (kreatininski očistek < 30 ml/min).
English: Severe hepatic impairment
Slovenian: Huda jetrna okvara
English: → Tell your doctor if you think any of these applies to you.
Slovenian: → Če menite, da se karkoli od navedenega nanaša na vas, o tem obvestite svojega zdravnika.
English: If they do, you must not use Arixtra.
Slovenian: V teh primerih zdravila Arixtra ne smete uporabljati.
English: • syringe with orange plunger and a manual safety system.
Slovenian: • injekcijska brizga z oranžnim batom in ročnim varnostnim sistemom.
English: Arixtra 7.5 mg/0.6 ml solution for injection, pre-filled syringe.
Slovenian: Arixtra 7,5 mg/0,6 ml raztopina za injiciranje, napolnjena injekcijska brizga
English: • dizziness
Slovenian: • zasoplost;
English: In subjects undergoing PCI the incidence of adjudicated guiding catheter thrombus was 1.0% vs. 0.3% in fondaparinux vs. enoxaparin subjects, respectively.
Slovenian: Pri preiskovancih z opravljeno PCI je bila pogostnost tromba na vodilnem katetru 1,0 % med preiskovanci, ki so prejemali fondaparinuks, in 0,3 % med preiskovanci, ki so prejemali enoksaparin.
English: Uncommon: chest pain
Slovenian: Občasni: bolečine v prsih
English: NAME OF THE MEDICINAL PRODUCT Arixtra 10 mg/0.8 ml solution for injection fondaparinux sodium
Slovenian: Arixtra 10 mg/0,8 ml raztopina za injiciranje natrijev fondaparinuksat
English: • syringe with a yellow plunger and an automatic safety system
Slovenian: • injekcijska brizga z rumenim batom in samodejnim varnostnim sistemom.