FrancophonIA/ELRC3.0 huggingface dataset:
English: Following administration of Ondexxya and cessation of a major bleed, re-anticoagulation should be considered to prevent thrombotic events due to the patient's underlying medical condition.
Croatian: Nakon primjene Ondexxye i zaustavljanja većeg krvarenja, potrebno je razmotriti ponovno započinjanje primjene antikoagulantnih lijekova radi prevencije trombotičkih događaja uvjetovanih podležećim zdravstvenim stanjem bolesnika.
English: The effects of andexanet alfa can be measured through pharmacodynamic markers, including anti-FXa activity, and free fraction of available FXa inhibitor as well as through restoration of thrombin generation.
Croatian: Učinci andeksaneta alfa mogu se mjeriti pomoću farmakodinamičkih biljega, uključujući anti-FXa aktivnost, slobodne frakcije raspoloživog inhibitora FXa kao i pomoću oporavka stvaranja trombina.
English: All PK studies were conducted using a former drug substance generation.
Croatian: Sva farmakokinetička ispitivanja provedena su korištenjem ranije generacije djelatne tvari lijeka.
English: Administration using an intravenous bag 1.
Croatian: Primjena pomoću vrećice za intravensku infuziju 1.
English: Table 2: Summary of dosing for reversal of apixaban
Croatian: Tablica 2: Sažetak doziranja za reverziju apiksabana
English: The most frequently observed adverse reactions were mild or moderate infusion-related reactions (see table 4) comprising symptoms such as flushing, feeling hot, cough, dysgeusia, and dyspnoea occurring within a few minutes to a few hours of the infusion.
Croatian: Najčešće opažene nuspojave bile su blage ili umjerene reakcije povezane s infuzijom (vidjeti tablicu 4) koje su uključivale simptome poput navala crvenila, osjećaja vrućine, kašlja, disgeuzije i dispneje koji su se javljali nekoliko minuta do nekoliko sati od početka infuzije.
English: Andexanet alfa does not need to be brought to room temperature before reconstitution or administration to the patient.
Croatian: Andeksanet alfa nije potrebno zagrijati na sobnu temperaturu prije rekonstitucije ili primjene bolesniku.
English: Fertility There are no data on the effects of andexanet alfa on human fertility.
Croatian: Plodnost Nema podataka o učincima andeksaneta alfa na plodnost u ljudi.
English: • effects on blood clotting markers: some markers which affect blood clotting were increased for a little while and then returned to normal.
Croatian: - učinci na biljege zgrušavanja: razine nekih biljega koji utječu na zgrušavanje bile su povišene kratko vrijeme i potom se vratile na normalne vrijednosti.
English: Do not use if opaque particles or discolouration are present.
Croatian: Ne koristiti ako su prisutne neprozirne čestice i promjena boje.
English: Powder for solution for infusion White to off-white lyophilized powder
Croatian: OBLIK Prašak za otopinu za infuziju Bijeli do gotovo bijeli liofilizirani prašak.
English: Non-cardiovascular deaths (n=27) included: respiratory failure (n=5), infection/sepsis (n=5), accident/trauma (n=2), cancer (n=1), and other/non-vascular cause (n=14).
Croatian: Nekardiovaskularni uzroci smrti (n = 27) uključivali su: respiratorno zatajenje (n = 5), infekciju/sepsu (n = 5), nesretni slučaj/traumu (n = 2), rak (n = 1) i druge/nevaskularne uzroke (n = 14).
English: Table 3: Summary of dosing for reversal of rivaroxaban
Croatian: Tablica 3: Sažetak doziranja za reverziju rivaroksabana
English: List of possible side effects
Croatian: Popis mogućih nuspojava
English: 400 mg at a target rate of 30 mg/min
Croatian: 400 mg s ciljnom brzinom primjene od 30 mg/min
English: The active site serine was substituted with alanine, rendering the molecule unable to cleave and activate prothrombin, and the gamma-carboxyglutamic acid (Gla) domain was removed to eliminate the ability of the protein to assemble into the prothrombinase complex, thus removing any anti-coagulant effects.
Croatian: Serin na aktivnom mjestu zamijenjen je alaninom što onemogućuje molekuli cijepanje protrombina i njegovu aktivaciju, a domena gama-karboksiglutamatne kiseline je odstranjena kako bi se uklonila sposobnost proteina da se ugradi u kompleks protrombinaze, čime se uklanja svaki antikoagulacijski učinak.
English: The predominant mechanism of action is the binding and sequestration of the FXa inhibitor, although there may be a minor contribution from the inhibition of tissue factor pathway inhibitor (TFPI) activity through binding to TFPI.
Croatian: Prevladavajući mehanizam djelovanja je vezivanje i sekvestracija inhibitora FXa, iako u manjoj mjeri tome može pridonositi i inhibicija aktivnosti inhibitora puta tkivnog faktora (engl. tissue factor pathway inhibitor - TFPI) do koje dolazi vezanjem na TFPI.
English: Reversal of rivaroxaban
Croatian: Reverzija rivaroksabana
English: Laboratory parameters as antiFXa activity, endogenous thrombotic potential (ETP), or markers of thrombosis might not be reliable for guidance.
Croatian: Laboratorijski parametri, poput anti-FXa aktivnosti, endogenog trombotičkog potencijala (ETP) ili biljega tromboze, mogu biti nepouzdani kao vodiči u liječenju.
English: Andexanet alfa is a specific reversal agent for FXa inhibitors.
Croatian: Andeksanet alfa je specifični agens za reverziju inhibitora FXa.
English: Dose-dependent increases in coagulation markers F1+2, TAT, and D-dimers after administration of andexanet alfa were observed, but these markers were not measured in patients enrolled in the ANNEXA-4 study, and their relevance in bleeding patients is not known.
Croatian: Zabilježeni su o dozi ovisni porasti razine biljega koagulacije F1+2, TAT i D-dimera nakon primjene andeksaneta alfa, međutim ti biljezi nisu mjereni u bolesnika uključenih u ispitivanje ANNEXA-4, a njihova važnost u bolesnika s krvarenjem nije poznata.
English: The anti-FXa activity returned to the placebo levels and above approximately two hours after the end of a bolus or infusion dependent on dosage.
Croatian: Anti-Fxa aktivnost vratila se na razine kakve je imala nakon primjene placeba i više otprilike dva sata nakon završetka primjene bolusa ili infuzije, ovisno o dozi.
English: From a microbiological point of view, once opened, the product should be used immediately.
Croatian: S mikrobiološke točke gledišta, nakon otvaranja lijek se mora odmah primijeniti.
English: Compared with patients recruited in North America, EU patients were significantly older (79.0 years vs. 76.3 years), more frequently had ICH as index event (72.9% vs. 59.0%) and more ICHs were intraparenchymal (54.9% vs. 34.4%).
Croatian: U usporedbi s bolesnicima uključenim u ispitivanje u Sjevernoj Americi, bolesnici u Europskoj uniji bili su značajno stariji (79,0 godina naspram 76,3 godine), imali su češće intrakranijalno krvarenje kao pokazatelj događaja (72,9% naspam 59,0%) i češće je intrakranijalno krvarenje bilo intraparenhimalno (54,9% naspram 34,4%).
English: • If you have any further questions, ask your doctor or nurse.
Croatian: - Ako imate dodatnih pitanja, obratite se liječniku ili medicinskoj sestri.
English: The volume of distribution at steady state (Vdss) and volume of distribution (Vd) at sub-therapeutic levels decreased with dose, consistent with the saturation of a high-affinity compartment, likely to reflect binding to endothelial cell bound TFPI, the only endogenous molecule known to bind andexanet alfa.
Croatian: Volumen distribucije u stanju dinamičke ravnoteže (Vdss) i volumen distribucije (Vd) pri subterapijskim razinama opadao je s dozom, dosljedno saturaciji odjeljka visokog afiniteta, što vjerojatno odražava vezivanje na TFPI vezan na endotelne stanice, jedine endogene molekule za koju se zna da vezuje andeksanet alfa.
English: To reduce this risk, resumption of anticoagulant therapy should be considered as soon as medically appropriate after completion of treatment.
Croatian: Da bi se smanjio ovaj rizik, potrebno je razmotriti ponovno uvođenje antikoagulacijske terapije čim to bude medicinski opravdano nakon dovršenja liječenja.
English: Once reconstituted, Ondexxya is for immediate use.
Croatian: Nakon rekonstitucije Ondexxya se mora odmah primijeniti.
English: In the ANNEXA-4 study, 36 (10.3%) patients experienced a total of 42 thromboembolic events: cerebrovascular accident (CVA) (15/42; 35.7%), deep venous thrombosis (13/42; 33.1%), acute myocardial infarction (8/42; 19.0%), pulmonary embolism (5/42; 11.9%), and transient ischaemic attack (1/42; 2.4%).
Croatian: U ispitivanju ANNEXA-4 36 (10,3%) bolesnika imalo je ukupno 42 tromboembolijska događaja: cerebrovaskularni incident (CVI) (15/42; 35,7%), duboku vensku trombozu (13/42; 33,1%), akutni infarkt miokarda (8/42; 19,0%), plućnu emboliju (5/42; 11,9%) i tranzitornu ishemičku ataku (1/42; 2,4%).
English: In order to further confirm the efficacy and safety, the MAH should submit an updated PK/PD model using all previously incorporated data (from studies 11-501, 12-502, 14503, 14-504, and 14-506) as well as newly incorporated data from study 16-512 (PKPD study of Generation 2 andexanet versus Generation 1), study 16-508 (PK-PD study of andexanet in individuals of Japanese ethnicity), and study 14-505 (ANNEXA-4).
Croatian: U cilju daljnje potvrde djelotvornosti i sigurnosti nositelj odobrenja mora podnijeti ažurirani farmakokinetički/farmakodinamički model koristeći podatke prethodno uključene u ispitivanja (iz ispitivanja 11-501, 12-502, 14-503, 14-504 i 14-506)kao i novouključene podatke iz ispitivanja 16-512 (Farmakokinetičkofarmakodinamičko ispitivanje 2. generacije andeksaneta u usporedbi s 1. generacijom), ispitivanja 16-508 (Farmakokinetičko-farmakodinamičko ispitivanje andeksaneta u ispitanika koji su etnički Japanci) i ispitivanja 14-505 (ANNEXA-4).
English: There is no clinical experience with overdose of andexanet alfa.
Croatian: Nema kliničkih iskustava s predoziranjem andeksanetom alfa.
English: Thirty-six of 352 patients with complete 30-day safety follow up (10.3%) had thrombotic events, including venous thromboembolism (VTE), myocardial infarction (MI), and stroke.
Croatian: Trideset šest od 352 bolesnika koji su dovršili praćenje sigurnosti primjene lijeka tijekom 30 dana (10,3 %) imalo je trombotičke događaje, uključujući vensku tromboemboliju, infarkt miokarda i moždani udar.
English: To prevent the inadvertent transfer of air, be careful to hold the syringe needle up, and do not set the syringe down between multiple withdrawals from vials.
Croatian: 4. Kako bi se spriječilo nehotično uštrcavanje zraka, potrebno je pažljivo držati iglu štrcaljke prema gore i ne spuštati štrcaljku između dva odvojena navlačenja iz bočice.
English: Hepatic impairment: Based on the existing data on clearance of andexanet alfa, no dose adjustment is recommended.
Croatian: Oštećenje funkcije jetre: Na temelju postojećih podataka o klirensu andeksaneta alfa, ne preporučuje se prilagođavanje doze.
English: To reduce this risk, resumption of anticoagulant therapy should be considered as soon as medically appropriate.
Croatian: Da bi se smanjio ovaj rizik, ponovno uvođenje antikoagulacijske terapije potrebno je razmotriti čim to bude medicinski opravdano.
English: After reconstitution, each mL of solution contains 10 mg of andexanet alfa.
Croatian: Nakon rekonstitucije jedan ml otopine sadrži 10 mg andeksaneta alfa.
English: EU/1/18/1345/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/18/1345/001
English: In order to further confirm the posology of Ondexxya, the MAH should submit the results of a comparative PK study with Generation 1, process 3, and Generation 2 material (study 19-514).
Croatian: U cilju daljnje potvrde doziranja Ondexxye, nositelj odobrenja mora podnijeti rezultate usporednog farmakokinetičkog ispitivanja 1. generacije, proces 3. s 2. generacijom djelatne tvari (ispitivanje 19-514).
English: What Ondexxya is and what it is used for
Croatian: Što je Ondexxya i za što se koristi
English: Your doctor may give you an antihistamine medicine to help with any side effects (see section 4).
Croatian: Liječnik Vam može dati antihistaminik koji će Vam olakšati nuspojave (pogledajte dio 4).
English: In clinical trials of patients with life-threatening bleeding, fever and stroke may affect up to 1 in 10 people; transient ischaemic attack (TIA), heart attack, and blood clots in the legs or lungs may affect up to 1 in 100 people (uncommon side effects).
Croatian: U kliničkim ispitivanjima u bolesnika s po život opasnim krvarenjima primijećene nuspojave bile su vrućica i moždani udar, koji se mogu javiti u do 1 na 10 osoba; tranzitorna ishemijska ataka (prolazni napadaj sličan moždanom udaru), srčani udar i krvni ugrušci u nogama ili plućima koji se mogu javiti u do 1 na 100 osoba (manje česte nuspojave)..
English: Preliminary data suggest higher risk of thrombosis for patients receiving the higher dose of andexanet, previous lower dose of the anti-FXa inhibitor, and patients on rivaroxaban.
Croatian: Preliminarni podaci upućuju na viši rizik za nastanak tromboze u bolesnika koji primaju višu dozu andeksaneta, koji su ranije primali nižu dozu inhibitora FXa, i bolesnika koji primaju rivaroksaban.
English: Vial (unopened) Two years stored at 2°C to 8°C.
Croatian: Dvije godine čuvana na 2 °C do 8 °C.
English: Timing of last dose before Ondexxya initiation
Croatian: Vrijeme proteklo od posljednje doze prije početka primjene Ondexxye
English: The posology was confirmed in a study in patients with acute major bleeding.
Croatian: Doziranje je potvrđeno u ispitivanju u bolesnika s velikim akutnim krvarenjem.
English: Discard all used syringes, needles, and vials, including any unused portion of reconstituted solution.
Croatian: 7. Bacite sve upotrijebljene štrcaljke, igle i bočice, uključujući neiskorišteni dio rekonstituirane otopine.
English: Thrombotic events
Croatian: Tromboembolijski događaji
English: In the clinical trials in healthy subjects administered an FXa inhibitor and then receiving andexanet alfa, no serious or severe adverse reactions were reported.
Croatian: U kliničkim ispitivanjima sa zdravim ispitanicima kojima je primjenjivan FXa inhibitor a koji su zatim primili andeksanet alfa nisu zabilježene ozbiljne ili teške nuspojave.
English: Therefore, dose adjustment is not considered needed for patients with hepatic impairment.
Croatian: Stoga se ne smatra potrebnim prilagođavati dozu u bolesnika s oštećenom funkcijom jetre.
English: Use of andexanet alfa in conjunction with other supportive measures Andexanet alfa can be used in conjunction with standard haemostatic supportive measures, which should be considered as medically appropriate.
Croatian: Andeksanet alfa se može primjenjivati u kombinaciji sa standardnim hemostatskim potpornim mjerama, koje se smatraju medicinski opravdanim.
English: The 30-day mortality rates were 16.2% (37/229) in patients presenting with ICH, 12.8% (12/94) with GI bleeding, and 17.9% (5/28) with other types of bleeding.
Croatian: Stopa smrtnosti u 30-dnevnom razdoblju bila je 16,2% (37/229) u bolesnika s intrakranijalnim krvarenjem, 12,8% (12/94) u bolesnika s krvarenjem iz gastrointestinalnog trakta i 17,9% (5/28) u bolesnika s drugim oblicima krvarenja.
English: Diphenhydramine may be administered.
Croatian: Može se primijeniti i difenhidramin.
English: For these patients, median anti-FXa activity at baseline was 149.7 ng/mL for patients taking apixaban, and 211.8 ng/mL for patients taking rivaroxaban.
Croatian: U tih bolesnika medijan početne vrijednosti aktivnosti anti-FXa bio je 149,7 ng/ml za bolesnike koji su uzimali apiksaban, odnosno 211,8 ng/ml za bolesnike koji su uzimali rivaroksaban.
English: There are no data from the use of andexanet alfa in pregnant women.
Croatian: Nema podataka o primjeni andeksaneta alfa u trudnica.
English: The bolus and infusion are prepared in separate large volume syringes.
Croatian: Bolus i infuzija pripremaju se u zasebnim štrcaljkama velikog volumena.
English: Table 4 provides the list of adverse reactions from clinical studies of healthy subjects treated with andexanet alfa.
Croatian: Tablica 4 prikazuje popis nuspojava opaženih u kliničkim ispitivanjima sa zdravim ispitanicima liječenima andeksanetom alfa.
English: Aseptic technique during the reconstitution procedure should be used.
Croatian: Za vrijeme postupka rekonstitucije potrebno je koristiti aseptičnu tehniku.
English: Dosage recommendations have been defined from the effects of andexanet alfa in healthy volunteers administered a direct FXa inhibitor and from the ability to reverse the levels of anti-FXa activity.
Croatian: Preporuke o doziranju određene su na temelju učinaka andeksaneta alfa u zdravih dobrovoljaca koji su primili direktni inhibitor FXa i na temelju njegove sposobnosti da poništi razinu anti-FXa aktivnosti.
English: In the healthy subject trials, elevations > 2 x ULN in D-dimer and prothrombin fragments F1+2 were frequently observed.
Croatian: U ispitivanjima sa zdravim ispitanicima, učestalo je opaženo povišenje > 2 x gornje granice normalnih vrijednosti za D-dimer i protrombinske fragmente F1+2.
English: If you suffer side effects when you are being given Ondexxya by infusion (drip), your doctor may decide to slow down or pause your treatment.
Croatian: Ako razvijete nuspojave dok primate Ondexxyu u infuziji, Vaš liječnik može odlučiti usporiti brzinu primjene ili privremeno prekinuti infuziju.
English: From a microbiological point of view, once reconstituted, the product should be used immediately.
Croatian: S mikrobiološke točke gledišta, jednom rekonstituirani lijek mora se odmah primijeniti.
English: It will not reverse the effects of non-FXa inhibitors.
Croatian: Lijek neće poništiti učinke lijekova koji nisu inhibitori FXa.
English: No neutralising antibodies or antibodies to factor X or FXa were detected.
Croatian: Nisu utvrđena neutralizirajuća antitijela ili antitijela na FX i FXa.
English: This is based on the specific anticoagulant medicine you take as well as on the dose and the time since your last dose of anticoagulant medicine.
Croatian: To će ovisiti o specifičnom lijeku protiv zgrušavanja krvi koji uzimate, kao i o dozi i vremenu kad ste posljednji puta uzeli lijek protiv zgrušavanja.
English: FXa inhibitors did not affect andexanet alfa pharmacokinetics at therapeutic levels.
Croatian: Inhibitori FXa nisu djelovali na farmakokinetiku andexaneta alfa u terapijskim razinama.
English: Submission of the final CSR by 30 June
Croatian: Podnošenje konačnog izvješća o kliničkom ispitivanju do 30. lipnja
English: Bolus strengths of andexanet alfa being necessary to achieve mean unbound apixaban (400 mg bolus) and unbound rivaroxaban concentrations (800 mg bolus) below the anticipated respective threshold for no anticoagulant effect were twice as high for rivaroxaban (20 mg QD) compared to apixaban (5 mg BID), due to the differential PK characteristics and dose levels of respective FXa inhibitor.
Croatian: Jačina bolusa andeksaneta alfa koja je bila potrebna da bi se postigla srednja vrijednost koncentracije nevezanog apiksabana (bolus 400 mg) i nevezanog rivaroksabana (bolus 800 mg) niža od predviđenog praga za postizanje odsutnosti antikoagulacijskog učinka bila je dvostruko viša za rivaroksaban (20 mg dnevno) u usporedbi s apiksabanom (5 mg dvaput dnevno) zbog različitih farmakokinetičkih karakteristika i razina doze odnosnog inhibitora FXa.
English: Administration of andexanet alfa as a bolus followed by continuous infusion resulted in a sustained decrease in anti-FXa activity.
Croatian: Primjena andeksaneta alfa kao bolusa nakon kojeg je slijedila kontinuirana infuzija imala je za posljedicu kontinuirano smanjivanje anti-FXa aktivnosti.
English: In prospective, randomized, placebo-controlled, dose-ranging studies in healthy subjects, the dose and dose regimen of andexanet alfa required to reverse anti-FXa activity and restore thrombin generation for FXa inhibitors (apixaban or rivaroxaban) were determined.
Croatian: U prospektivnom, randomiziranom, placebom kontroliranom ispitivanju za određivanje doze andeksaneta alfa u zdravih ispitanika, utvrđena je doza i režim doziranja za reverziju anti-FXa aktivnosti i oporavak stvaranja trombina za inhibitore FXa (apiksaban ili rivaroksaban).
English: The safety has been evaluated in clinical trials including 247 healthy subjects administered an FXa inhibitor, as well as in 352 patients in a Phase IIIb/IV trial (ANNEXA-4), who had acute major bleeding and were under treatment with an FXa inhibitor (mostly apixaban and rivaroxaban).
Croatian: Sigurnost primjene procijenjena je u kliničkim ispitivanjima koja su uključila 247 zdravih ispitanika koji su primili inhibitor FXa i 352 bolesnika u fazi IIIb/IV ispitivanja (ANNEXA-4), koji su imali veliko akutno krvarenje, a liječeni su inhibitorom FXa (većinom apiksabanom i rivaroksabanom).
English: Repeat steps 1 and 2 as necessary to transfer the complete volume of the bolus and the infusion into an IV bag.
Croatian: 3. Ponoviti korake 1 i 2 ako je potrebno dok se sav volumen bolusa i infuzije prebaci u vrećicu za i.v. infuziju.
English: Administration using an intravenous bag
Croatian: Primjena pomoću vrećice za intravensku infuziju
English: FXa inhibitor
Croatian: Inhibitor FXa
English: In both, Study 14-503 and Study 14-504, treatment with andexanet alfa also resulted in a statistically significant increase in thrombin generation in healthy subjects anticoagulated with apixaban or rivaroxaban versus placebo (p < 0.0001).
Croatian: I u ispitivanju 14-503 i u ispitivanju 14-504 terapija andeksanetom alfa rezultirala je i statistički značajnim porastom stvaranja trombina u zdravih ispitanika koji su kao antikoagulans primili apiksaban ili rivaroksaban u usporedbi s placebom (p < 0,0001).
English: Transient ischaemic attack uncommon
Croatian: Tranzitorna ishemijska ataka manje često
English: Administer the reconstituted solution at the appropriate rate.
Croatian: Rekonstituiranu otopinu primjenjujte odgovarajućom brzinom.
English: Most patients had previously received either apixaban (194/352; 55.1%) or rivaroxaban (128/352; 36.4%), and experienced either an ICH (230/352; 65.3%) or a gastrointestinal (GI) bleed (94/352; 26.7%).
Croatian: Većina je bolesnika prethodno primala apiksaban (194/352; 55,1%) odnosno rivaroksaban (128/352; 36,4%) i imala je ili intrakranijalno krvarenje (230/352; 65,3%) ili krvarenje u gastrointestinalnom traktu
English: Push the plunger down to slowly inject the 20 mL of water for injections into the vial, directing the stream toward the inside wall of the vial to minimise foaming.
Croatian: Pritiskom na klip štrcaljke polako istisnuti 20 ml vode za injekciju u bočicu, usmjeravajući mlaz prema unutarnjoj stijenci bočice kako bi se smanjilo stvaranje pjene.
English: • Large (60 mL or larger) sterile syringe.
Croatian: • Velika sterilna štrcaljka (60 ml ili veća).
English: Frequency in bleeding patients
Croatian: Učestalost u bolesnika s krvarenjem
English: Based on the existing data on clearance, no dose adjustment is recommended.
Croatian: Na temelju postojećih podataka o klirensu, ne preporučuje se prilagođavanje doze.
English: Ondexxya contains the active ingredient andexanet alfa.
Croatian: Ondexxya sadrži djelatnu tvar andeksanet alfa.
English: Andexanet alfa binds direct FXa inhibitors with high affinity, making them unavailable to exert their anticoagulant effects.
Croatian: Andeksanet alfa se velikim afinitetom vezuje na direktne inhibitore FXa i tako onemogućuje njihov antikoagulantni učinak.
English: Do not breast-feed your child while you are taking this medicine.
Croatian: Dok primate ovaj lijek nemojte dojiti.
English: Factor Xa inhibitors are given to prevent clots in your blood vessels.
Croatian: Inhibitori faktora Xa daju se radi sprječavanja nastanka ugruška u krvnim žilama.
English: Prepare the bolus and infusion in separate large volume syringes.
Croatian: 2. Bolus i infuziju pripremite u zasebnim štrcaljkama velikog volumena.