FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients in Arms A and B were also randomised to receive a GP IIb/IIIa inhibitor either upfront at the time of randomization (prior to angiography) or at the time of PCI.
Slovenian: Bolniki v krakih A in B so bili randomizirani tudi glede tega, ali so prejeli inhibitor GP IIIb/IIIa vnaprej, tj. ob času randomizacije (pred angiografijo), ali v času PCI.
English: • Angina or chest pain
Slovenian: • angina pektoris ali bolečine v prsih
English: Thrombin plays a central role in the thrombotic process, acting to cleave fibrinogen into fibrin monomers and to activate Factor XIII to Factor XIIIa, allowing fibrin to develop a covalently crosslinked framework that stabilises the thrombus.
Slovenian: Trombin ima osrednjo vlogo pri trombotskem procesu, saj fibrinogen cepi na monomere fibrina in aktivira faktor XIII v faktor XIIIa, kar fibrinu omogoča, da razvije kovalentno premreženo ogrodje, ki stabilizira trombus.
English: Caution should be exercised in patients previously treated with lepirudin who had developed lepirudin antibodies.
Slovenian: Bodite pozorni pri bolnikih, ki so bili predhodno zdravljeni z lepirudinom in so razvili protitelesa proti lepirudinu.
English: Unexplained decreases in haematocrit, haemoglobin or blood pressure may indicate haemorrhage.
Slovenian: Nepojasnjeno znižanje hematokrita, hemoglobina ali krvnega tlaka lahko kaže na krvavitev.
English: Driving and using machines the effects of this medicine are known to be short-term.
Slovenian: Znano je, da so učinki tega zdravila kratkotrajni.
English: • subacute bacterial endocarditis
Slovenian: • subakutnim bakterijskim endokarditisom;
English: The following data is based on a clinical study of bivalirudin in 6,000 patients undergoing PCI, half of whom were treated with bivalirudin (REPLACE-2).
Slovenian: Naslednji podatki temeljijo na klinični študiji z bivalirudinom pri 6.000 bolnikih med PCI, od katerih je bila polovica zdravljenih z bivalirudinom (REPLACE-2).
English: Hälsa Pharma GmbH Nikolaus Dürkopp-Str. 4A 33602 Bielefeld GERMANY
Slovenian: Hälsa Pharma GmbH Nikolaus Dürkopp-Str. 4A 33602 Bielefeld Nemčija
English: WHAT YOU NEED TO KNOW BEFORE YOU USE ANGIOX
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Angiox
English: The HORIZONS trial was a prospective, dual arm, single blind, randomised, multi-centre trial to establish the safety and efficacy of bivalirudin in patients with STEMI undergoing a primary PCI strategy with stent implantation with either a slow release paclitaxel-eluding stent (TAXUS™) or an otherwise identical uncoated bare metal stent (Express2™).
Slovenian: Preskušanje HORIZONS je bilo prospektivno, dvojno krako, enojno slepo, randomizirano preskušanje, ki je preverilo varnost in učinkovitost bivalirudina pri bolnikih s STEMI, pri katerih se je izvedla primarna strategija PCI s stenti, ki počasi sproščajo paklitaksel (TAXUS™) ali identičnimi metalnimi stenti brez filma (Express2™).
English: Mannitol, sodium hydroxide 2%
Slovenian: Manitol, 2 % natrijev hidroksid.
English: Rarely this may require surgery to repair the blood vessel in the groin (fistula, pseudoaneurysm) (may affect up to 1 in 1,000 people).
Slovenian: Redko je morda potrebna operacija za popravilo krvnih žil v dimljah (fistula, psevdoanevrizem) (pojavijo se lahko pri največ 1 od 1.000 bolnikov).
English: The most common, (may affect up to 1 in 10 people) serious side effect of treatment with Angiox, is major bleeding which could occur anywhere inside the body (e.g. stomach, digestive system (including vomiting blood or passing blood with the stools), abdomen, lungs, groin, bladder, heart, eye, ear, nose or brain).
Slovenian: Najpogostejši (pojavijo se lahko pri več kot 1 od 10 bolnikov) resni neželeni učinek zdravljenja z zdravilom Angiox je obsežna krvavitev, ki se lahko pojavi kjer koli v telesu (npr. želodcu, prebavnem sistemu (vključno z bruhanjem in krvjo v blatu), trebuhu, pljučih, dimljah, sečnem mehurju, očeh, ušesih, nosu ali možganih).
English: Additional anti-platelet therapy utilised in the study included acetylsalicylic acid and clopidogrel.
Slovenian: Dodatna antitrombocitna terapija, ki so jo uporabljali v študiji, je vključevala uporabo acetilsalicilne kisline in klopidogrela.
English: Normal renal function (≥ 90ml/min) Mild renal impairment (60-89 ml/min) Moderate renal impairment (30-59 ml/min) Severe renal impairment (10-29 ml/min) Dialysis dependent patients (off-dialysis)
Slovenian: Normalna ledvična funkcija (≥90 ml/min) Blaga ledvična okvara (60 -89 ml/min) Zmerna ledvična okvara (30 -59 ml/min) Huda ledvična okvara (10 -29 ml/min) Dializni bolniki (ne med dializo)
English: There are no or limited data from the use of bivalirudin in pregnant women.
Slovenian: Ni podatkov o uporabi bivalirudina pri nosečnicah oziroma so ti omejeni.
English: The intravenous infusion may continue at this dose for up to 4 hours after the PCI and for STEMI patients (those with a severe type of heart attack) it should continue at this dose for up to 4 hours.
Slovenian: Intravensko infundiranje tega odmerka se lahko nadaljuje največ 4 ure po PCI, medtem ko je pri bolnikih s STEMI (tistih s hudim srčnim infarktom) treba nadaljevati s tem odmerkom največ 4 ure.
English: Patients can be started on Angiox 30 minutes after discontinuation of unfractionated heparin given intravenously, or 8 hours after discontinuation of low molecular weight heparin given subcutaneously.
Slovenian: Bolniki lahko začnejo prejemati zdravilo Angiox 30 minut po prekinitvi intravenskega dajanja nefrakcioniranega heparina ali 8 ur po prekinitvi subkutanega dajanja heparina z nizkomolekularno maso.
English: The dosing cards will contain the following key information:
Slovenian: Kartice za odmerjanje vsebujejo spodnje ključne informacije:
English: The bolus dose should be administered by a rapid intravenous push to ensure that the entire bolus reaches the patient before the start of the procedure.
Slovenian: Bolusni odmerek je treba dati s hitrim intravenskim vbrizgom, da celotni bolusni odmerek doseže bolnika pred začetkom postopka.
English: Although most bleeding associated with bivalirudin occurs at the site of arterial puncture in patients undergoing PCI, haemorrhage can occur at any site during therapy.
Slovenian: Čeprav do krvavitve zaradi bivalirudina večinoma pride na mestu arterijske punktacije pri bolnikih med PCI, lahko med terapijo pride do krvavitve na kateremkoli mestu.
English: Adverse reactions for bivalirudin from HORIZONS, ACUITY, REPLACE-2 trials and post-marketing experience are listed by system organ class in Table 1.
Slovenian: Neželeni učinki bivalirudina iz preskušanj HORIZONS, ACUITY, REPLACE-2 in izkušenj v obdobju trženja so navedeni v preglednici 1 po organskih sistemih.
English: This may, rarely, result in a stroke or be fatal.
Slovenian: To lahko v redkih primerih privede do možganske kapi ali smrti.
English: A total of 356 (7.7%) of patients randomised to Arm C also received a GP IIb/IIIa inhibitor.
Slovenian: Skupaj 356 (7,7 %) bolnikov, ki so bili randomizirani v krak C, je prav tako prejelo inhibitor GP IIb/IIIa.
English: • Tabulated information on dosing by body weight of patient.
Slovenian: • Informacije o odmerjanju glede na telesno maso bolnika v preglednicah.
English: Angiox should be administered by a physician experienced in either acute coronary care or in coronary intervention procedures.
Slovenian: Zdravilo Angiox naj daje zdravnik, ki ima izkušnje bodisi z zdravljenjem akutnega koronarnega sindroma ali s postopki koronarne intervencije.
English: Pharmacotherapeutic group: antithrombotic agents, Direct thrombin inhibitors, ATC code: B01AE06.
Slovenian: 5.1 Farmakodinamične lastnosti Farmakoterapevtska skupina: antitrombotiki, direktni zaviralci trombina, oznaka ATC: B01AE06.
English: Angiox can be used in conjunction with a GP IIb/IIIa inhibitor.
Slovenian: Zdravilo Angiox lahko uporabljate v kombinaciji z zaviralcem GP IIb/IIIa.
English: • The most frequent serious and fatal adverse reactions are major haemorrhage (access site and non access-site bleeding, including intracranial haemorrhage) and hypersensitivity, including anaphylactic shock.
Slovenian: • Najpogostejši resni in smrtni neželeni učinki so večje krvavitve (krvavitev na mestu aplikacije in izven mesta aplikacije, vključno z možgansko krvavitvijo) in preobčutljivost, vključno z anafilaktičnim šokom.
English: Thrombin also activates Factors V and VIII, promoting further thrombin generation, and activates platelets, stimulating aggregation and granule release.
Slovenian: Trombin aktivira tudi faktorja V in VIII ter s tem pospeši nadaljnjo tvorbo trombina in aktivira krvne ploščice, s čimer stimulira agregacijo in sprostitev granul.
English: In cases of overdose, treatment with bivalirudin should be immediately discontinued and the patient monitored closely for signs of bleeding.
Slovenian: V primeru prekomernega odmerjanja nemudoma prekinite zdravljenje z bivalirudinom in temeljito preverite, ali bolnik kaže znake krvavitve.
English: TIMI major bleeding was defined as intracranial bleeding or a decrease in haemoglobin concentration ≥5 g/dl.
Slovenian: Večja krvavitev TIMI je bila opredeljena kot intrakranialna krvavitev ali kot zmanjšanje koncentracije hemoglobina za ≥ 5 g/dl.
English: Angiox is available in cartons containing 10 vials.
Slovenian: Zdravilo Angiox je na razpolago v škatlah, ki vsebujejo 10 vial.
English: • active bleeding or increased risk of bleeding because of haemostasis disorders and/or irreversible coagulation disorders
Slovenian: • aktivno krvavitvijo ali povečanim tveganjem za krvavitve zaradi motenj hemostaze ali trajnih
English: - The active substance is bivalirudin.
Slovenian: - Zdravilna učinkovina je bivalirudin.
English: The pharmacokinetics of bivalirudin have not been studied in patients with hepatic impairment but are not expected to be altered because bivalirudin is not metabolized by liver enzymes such as cytochrome P-450 isozymes.
Slovenian: Farmakokinetika bivalirudina ni bila preučena pri bolnikih z okvarjenimi jetri, vendar se verjetno ne bo spremenila, ker bivalirudina ne presnavljajo jetrni encimi, kot so izoencimi citokroma P-450.
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH
Slovenian: A. IZDELOVALEC (IZDELKOVALCI) , ODGOVOREN
English: Angiox is supplied as a lyophilised powder in 10 ml single use glass vials (Type 1) closed with a butyl rubber stopper and sealed with a crimped aluminum seal.
Slovenian: Zdravilo Angiox je dobavljeno kot liofiliziran prašek v 10 ml steklenih vialah (Tip 1) za enkratno uporabo, zaprtih z butilnim gumijastim zamaškom in nabranim aluminijastim zamaškom.
English: Angiox is intended for intravenous use.
Slovenian: Zdravilo Angiox je namenjeno intravenski uporabi.
English: The safety and efficacy of a bolus dose of bivalirudin without the subsequent infusion has not been evaluated and is not recommended even if a short PCI procedure is planned.
Slovenian: Varnost in učinkovitost bolusnega odmerka bivalirudina brez poznejše infuzije niso ocenjevali in ni priporočen, tudi če se načrtuje kratek postopek PCI.
English: The primary metabolite resulting from the cleavage of Arg3-Pro4 bond of the Nterminal sequence by thrombin is not active because of the loss of affinity to the catalytic active site of thrombin.
Slovenian: Osnovni presnovek, ki nastane kot posledica cepitve vezi Arg3-Pro4 N-terminalnega zaporedja s trombinom ni aktiven zaradi izgube afinitete do katalitično aktivnega mesta trombina.
English: • Thrombosis (blood clot) is an uncommon side effect (may affect up to 1 in 100 people) which may result in serious or fatal complications such as heart attack.
Slovenian: • Tromboza (krvni strdek), občasen neželen učinek (pojavi se lahko pri največ 1 od 100 bolnikov), ki ima lahko za posledice resne zaplete, kakršen je srčni infarkt.
English: Single bolus doses of bivalirudin up to 7.5 mg/kg have also been reported.
Slovenian: Poročali so tudi o enkratnih bolusnih odmerkih z do 7,5 mg/kg bivalirudina.
English: The solution should be a clear to slightly opalescent, colourless to slightly yellow solution.
Slovenian: Raztopina bi morala biti bistra do rahlo svetlikajoča, brezbarvna do rahlo rumena.
English: For patients starting with percutaneous coronary intervention (PCI) the recommended dose is:
Slovenian: Za bolnike, ki začenjajo s perkutano koronarno intervencijo (PCI) je priporočeni odmerek:
English: Angiox contains bivalirudin, a direct and specific thrombin inhibitor that binds both to the catalytic site and the anion-binding exosite of fluid-phase and clot-bound thrombin.
Slovenian: Zdravilo Angiox vsebuje bivalirudin, neposreden in specifičen trombinski inhibitor, ki se veže tako na katalitično mesto kot na anionsko zunanje vezavno mesto prostega in na strdek vezanega trombina.
English: Increased awareness due to high bleeding risk should be exercised in the elderly because of age-related decrease in renal function.
Slovenian: Pri starejši populaciji je potrebno biti pozoren zaradi tveganja za povečano krvavitev zaradi s starostjo povezanega slabšega delovanja ledvic.
English: Patients must be observed carefully for symptoms and signs of bleeding during treatment particularly if bivalirudin is combined with another anticoagulant (see section 4.5).
Slovenian: Med zdravljenjem bodite pozorni na simptome in znake krvavitve pri bolnikih, še posebej, če bivalirudin kombinirate z drugim antikoagulacijskim zdravilom (glejte poglavje 4.5).
English: INR increased d
Slovenian: Povečan INR
English: • a known hypersensitivity to the active substance or to any of the excipients listed in section 6.1,
Slovenian: • znano preobčutljivostjo na bivalirudin, katerokoli pomožno snov, navedeno v poglavju 6.1, ali
English: Based on the short half-life of bivalirudin (25 minutes), failure to initiate an infusion following the Angiox bolus will result in a plasma concentration that is below the required level within minutes
Slovenian: Zaradi kratkega razpolovnega časa bivalirudina (25 minut) lahko izpustitev infuzije, po bolusu zdravila Angiox, v nekaj minutah povzroči plazemske koncentracije, ki so pod zahtevano ravnjo.
English: Data from 366 patients indicates that the ACT is unaffected by concomitant treatment with a GP IIb/IIIa inhibitor.
Slovenian: Podatki 366 bolnikov kažejo, da sočasno zdravljenje z zaviralcem GP IIb/IIIa ne vpliva na ACT.
English: • In patients receiving warfarin, INR is increased by administration of bivalirudin.
Slovenian: • Pri bolnikih, ki prejemajo varfarin, se z uporabo bivalirudina INR poveča.
English: Angiox is for injection, followed by infusion (drip), into a vein (never into a muscle).
Slovenian: Zdravilo Angiox je namenjeno injiciranju, ki mu sledi infundiranje (kapljično) v veno (nikoli v mišico).
English: The ACT value is positively correlated with the dose and plasma concentration of bivalirudin administered.
Slovenian: Vrednost ACT je v pozitivni povezavi z odmerkom in koncentracijo danega bivalirudina.
English: In vitro studies have also shown that bivalirudin prolongs the activated partial thromboplastin time (aPTT) thrombin time (TT) and pro-thrombin time (PT) of normal human plasma in a concentrationdependent manner and that bivalirudin does not induce a platelet aggregation response against sera from patients with a history of Heparin-Induced Thrombocytopenia/Thrombosis Syndrome (HIT/HITTS).
Slovenian: Študije in vitro kažejo tudi, da bivalirudin od koncentacije odvisno podaljša aktivirani parcialni tromboplastinski čas (aTPČ), trombinski čas (TČ) in protrombinski čas (PČ) normalne človeške plazme in da bivalirudin ne povzroča agregacije krvnih ploščic kot odziv na serum pri bolnikih s heparinsko povzročenim sindromom trombocitopenije/tromboze (HIT/HITTS - »Heparin-Induced Thrombocytopenia/Thrombosis Syndrom«) v anamnezi.
English: Heparin-induced thrombocytopenia (HIT) and heparin-induced thrombocytopenia-thrombosis syndrome (HIT/HITTS)
Slovenian: Heparinsko povzročena trombocitopenija (HIT - »»Heparin-Induced Thrombocytopenia«) in heparinsko povzročeni sindrom trombocitopenije/tromboze (HIT/HITTS - »Heparin-Induced Thrombocytopenia/Thrombosis Syndrom«)
English: Prolonged post PCI infusions of bivalirudin at recommended doses have not been associated with an increased rate of bleeding (see section 4.2).
Slovenian: Podaljšane infuzije bivalirudina po PCI v priporočenih odmerkih niso bile povezane s povečano pogostostjo krvavitev (glejte poglavje 4.2).
English: The pharmacodynamic effects of bivalirudin may be assessed using measures of anticoagulation including the ACT.
Slovenian: Farmakodinamične učinke bivalirudina lahko ocenimo s pomočjo merjenja antikoagulacije z ACT.
English: Acute stent thrombosis (<24 hours) has been observed in patients with STEMI undergoing primary PCI and has been managed by Target Vessel Revascularisation (TVR) (see sections 4.8 and 5.1).
Slovenian: Akutna tromboza stenta (< 24 ur) se pojavlja pri bolnikih s STEMI, pri katerih se izvaja primarna PCI in je bila izvedena revaskularizacija prizadete žile (TVR) (glejte poglavji 4.8 in 5.1).
English: Your warfarin blood test result (INR test) may be affected by Angiox.
Slovenian: Zdravilo Angiox lahko vpliva na vaš krvni izvid varfarina (INR test).
English: Hypersensitivity, including anaphylactic reaction and shock, including reports with fatal outcome
Slovenian: Bolezni imunskega sistema preobčutljivost, vključno z anafilaktično reakcijo in šokom, vključno s poročili o smrtnem
English: The systemic clearance of bivalirudin decreases with glomerular filtration rate (GFR).
Slovenian: Telesni očistek bivalirudina se zmanjšuje s stopnjo glomerularne filtracije (GFR - »glomerular filtration rate«).
English: This increased risk of acute stent thrombosis was observed during the first 4 hours following the end of the procedure among patients who either discontinued the infusion of bivalirudin at the end of the procedure or received a continued infusion at the reduced dose of 0.25 mg/kg/h (see section 4.2).
Slovenian: To povečano tveganje za akutno trombozo stenta so opazili v prvih 4 urah po koncu postopka pri bolnikih, ki so prekinili infuzijo bivalirudina na koncu postopka ali nadaljevali infuzijo z zmanjšanim odmerkom 0,25 mg/kg/h (glejte poglavje 4.2).
English: The clearance of bivalirudin is similar in patients with normal renal function and those with mild renal impairment.
Slovenian: Očistek bivalirudina je podoben pri bolnikih z normalno ledvično funkcijo in blago ledvično okvaro.
English: It is, therefore, unlikely to affect your ability to drive or to use machines.
Slovenian: Zaradi tega je verjetnost vpliva na vaše sposobnosti upravljanja vozil in strojev majhna.
English: The reconstituted/diluted solution will be a clear to slightly opalescent, colourless to slightly yellow solution.
Slovenian: Rekonstituirana/razredčena raztopina bo bistra do rahlo opalescentna, brezbarvna do rahlo rumene barve.
English: Acute stent thrombosis
Slovenian: Akutna tromboza stenta
English: The steady-state volume of distribution is 0.1 l/kg.
Slovenian: Volumen porazdelitve v stanju dinamičnega ravnovesja je 0,1 l/kg.
English: The binding of bivalirudin to thrombin, and therefore its activity, is reversible as thrombin slowly cleaves the bivalirudin, Arg3-Pro4, bond, resulting in recovery of thrombin active site function.
Slovenian: Vezava bivalirudina na trombin in njegova aktivnost je reverzibilna, saj trombin počasi cepi bivalirudinijevo vez Arg3-Pro4, kar povzroči povrnitev funkcije aktivnega mesta trombina.
English: The other ingredients are mannitol and sodium hydroxide 2% (for pH adjustment)
Slovenian: Drugi sestavini zdravila sta manitol in 2 % raztopina natrijevega hidroksida (za uravnavanje pH)
English: Thrombocytopenia was reported in 10 bivalirudin-treated patients participating in the ACUITY study (0.1%).
Slovenian: O trombocitopeniji so poročali pri 10 bolnikih, ki so jih zdravili z bivalirudinom, ki so sodelovali v študiji ACUITY (0,1 %).
English: Angiox has no or negligible influence on the ability to drive and use machines.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Zdravilo Angiox nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
English: The REPLACE-2 Trial (Patients undergoing PCI)
Slovenian: Preskušanje REPLACE-2 (Bolniki med PCI)
English: The safety and efficacy of a bolus without subsequent infusion dose of ANGIOX has not been evaluated and is not recommended even if a short PCI procedure is planned.
Slovenian: Varnost in učinkovitost bolusa brez naknadne infuzije odmerka zdravila ANGIOX ni bila ocenjena in ni priporočena, tudi če se načrtuje krajši poseg PCI.
English: The infusion dose should be initiated immediately after the bolus dose is administered, ensuring delivery to the patient prior to the procedure, and continued uninterrupted for the duration of the procedure.
Slovenian: Odmerek infuzije je treba sprožiti takoj po bolusnem odmerku, zagotoviti, da infundirani odmerek doseže bolnika pred postopkom, ter zagotoviti neprekinjeno dajanje med trajanjem postopka.
English: What Angiox looks like and contents of the pack
Slovenian: Izgled zdravila Angiox in vsebina pakiranja
English: • Angiox must be administered as a bolus dose followed immediately by an intravenous infusion, even if a short PCI procedure is planned.
Slovenian: • Zdravilo Angiox je treba dati kot bolusni odmerek, ki mu takoj sledi intravenska infuzija, tudi če se načrtuje krajši poseg PCI.
English: All patients received acetylsalicylic acid and clopidogrel with twice as many patients (approximately 64%) receiving a 600mg loading dose of clopidogrel than a 300mg loading dose of clopidogrel.
Slovenian: Vsi bolniki so prejeli acetilsalicilno kislino in klopidogrel, pri čemer je 600 mg začetni odmerek klopidogrela prejelo dvakrat toliko bolnikov (približno 64 %) kot 300 mg začetni odmerek klopidogrela.
English: Dose adjustments for this age group should be on the basis of renal function, see section 4.2.
Slovenian: Prilagoditev odmerkov za to starostno skupino mora biti odvisna od ledvične funkcije; glejte poglavje
English: Patients should remain for at least 24 hours in a facility capable of managing ischaemic complications and should be carefully monitored following primary PCI for signs and symptoms consistent with myocardial ischaemia.
Slovenian: Bolniki morajo vsaj 24 ur ostati v oskrbi, kjer jih lahko oskrbijo, če pride do ishemičnih zapletov in kjer jih po primarni PCI pozorno spremljajo glede znakov in simptomov, ki kažejo na miokardno ishemijo.
English: Intra-procedural thrombus formation has been observed during gamma brachytherapy procedures with Angiox.
Slovenian: Med gama brahiterapevtskimi postopki z zdravilom Angiox je bila med postopkom opažena tvorba trombusa.
English: Pharmacokinetic parameters for bivalirudin in patients with normal and impaired
Slovenian: Farmakokinetični parametri za bivalirudin pri bolnikih z normalno in okvarjeno ledvično funkcijo.
English: Cases of overdose of up to 10 times the recommended dose have been reported in clinical trials.
Slovenian: V kliničnih preskušanjih so poročali o primerih prevelikih odmerkov, ki so bili do 10-krat višji od priporočenega odmerka.
English: - After dilution (mixing of 5 ml of the reconstituted solution into an infusion bag [total volume of
Slovenian: - Po nadalnjem redčenju (5 ml rekonstituirane raztopine se v infuzijski vrečki [skupni volumen 50
English: Once the ACT value is greater than 225 seconds, no further monitoring is required provided the 1.75 mg/kg/h infusion dose is properly administered.
Slovenian: Ko vrednost ACT preseže 225 sekund, nadaljnji nadzor ni potreben, če je infuzijski odmerek 1,75 mg/kg/h dan pravilno.
English: Very common side effects (may affect more than 1 in 10 people): • Minor bleeding
Slovenian: Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov): • manjša krvavitev
English: This medicine contains less than 23 mg of sodium per vial, which means that it is essentially “sodiumfree”.
Slovenian: Zdravilo Angiox vsebuje manj kot 23 mg natrija na vialo, to dejansko pomeni, da je »brez natrija«.
English: • In the ImproveR registry bolus dosing (without subsequent infusion) was observed in EU clinical practice.
Slovenian: • V klinični praksi EU so poročali dajanju bolusa (brez naknadne infuzije).