FrancophonIA/ELRC3.0 huggingface dataset:
English: Roteas has been prescribed at a once-daily dose of:
Croatian: Roteas je propisan jedanput na dan u dozi od:
English: Subcutaneous anticoagulant (i.e.: LMWH, fondaparinux):
Croatian: Supkutani antikoagulans (tj. niskomolekularni heparin (LMWH), fondaparinuks):
English: Safety in patients with NVAF in ENGAGE AF-TIMI 48 The primary safety endpoint was major bleeding.
Croatian: Sigurnost u bolesnika s NVAF-om u ispitivanju ENGAGE AF-TIMI 48 Primarni ishod sigurnosti bilo je veliko krvarenje.
English: • a problem with the blood vessels in the back of your eyes (retinopathy)
Croatian: • tegobe s krvnim žilama u pozadini oka (retinopatija)
English: Warfarin (N = 4,122)
Croatian: Varfarin (N = 4122)
English: Disposition is biphasic.
Croatian: Raspodjela je bifazična.
English: Concomitant administration of higher doses than 100 mg ASA should only be performed under medical supervision.
Croatian: Istovremena primjena ASK-a u dozama višim od 100 mg smije se provoditi samo pod liječničkim nadzorom.
English: There is a potential for inadequate anticoagulation during the transition from Roteas to VKA.
Croatian: Postoji mogućnost neodgovarajuće antikoagulacije tijekom prelaska s Roteasa na AVK.
English: If possible, Roteas should be stopped at least 24 hours before an operation.
Croatian: Po mogućnosti, Roteas treba prestati uzimati najmanje 24 sata prije operacije.
English: The concomitant chronic use of high dose ASA (325 mg) with edoxaban is not recommended.
Croatian: Istovremena kronična primjena visoke doze ASK-a (325 mg) s edoksabanom se ne preporučuje.
English: Discontinue the VKA and start Roteas when the international normalised ratio (INR) is ≤ 2.5.
Croatian: Prekinite primjenu AVK-a i započnite s primjenom Roteasa kad međunarodni normalizirani omjer (INR) bude ≤ 2,5.
English: In healthy subjects, the total clearance is estimated as 22 (± 3) L/hour; 50% is renally cleared (11 L/hour).
Croatian: Procjenjuje se da je ukupni klirens u zdravih ispitanika 22 (± 3) l/sat; 50% se uklanja putem bubrega (11 l/sat).
English: Roteas, like other anticoagulants, is recommended to be used with caution in patients with increased risk of bleeding.
Croatian: Roteas se, kao i druge antikoagulanse, preporučuje primjenjivati s oprezom u bolesnika s povećanim rizikom od krvarenja.
English: A total of 2149 subjects were treated with either edoxaban (N = 1067) or enoxaparin/warfarin (N = 1082).
Croatian: Ukupno 2149 ispitanika liječeno je ili edoksabanom (N = 1067) ili enoksaparinom/varfarinom (N = 1082).
English: Efficacy and safety of edoxaban in the treatment and/or prevention of VTE in patients with active cancer have not been established.
Croatian: Djelotvornost i sigurnost edoksabana u liječenju i/ili prevenciji VTE-a u bolesnika s aktivnim karcinomom nisu ustanovljene.
English: Edoxaban is predominantly absorbed in the upper gastrointestinal (GI) tract.
Croatian: Edoksaban se pretežno apsorbira u gornjem dijelu gastrointestinalnog (GI) trakta.
English: Roteas is not recommended as an alternative to unfractionated heparin in patients with pulmonary embolism who are haemodynamically unstable or may receive thrombolysis or pulmonary embolectomy since the safety and efficacy of edoxaban have not been established in these clinical situations.
Croatian: Roteas se ne preporučuje kao alternativa nefrakcioniranom heparinu u bolesnika s plućnom embolijom koji su hemodinamski nestabilni ili u kojih se može provesti tromboliza ili plućna trombektomija jer sigurnost i djelotvornost edoksabana nisu ustanovljene u tim kliničkim situacijama.
English: • Necessity to carry the Patient alert card with them at all times
Croatian: • potreba da uvijek sa sobom nose Karticu s upozorenjima za bolesnika
English: Edoxaban is absorbed with peak plasma concentrations within 1 - 2 hours.
Croatian: Apsorpcija Edoksaban se apsorbira uz vršne koncentracije u plazmi unutar 1 - 2 sata.
English: Edoxaban is metabolised via hydrolysis (mediated by carboxylesterase 1), conjugation or oxidation by CYP3A4/5 (< 10%).
Croatian: Edoksaban se metabolizira hidrolizom (posredovanom karboksilesterazom 1), konjugacijom ili oksidacijom CYP3A4/5 (< 10%).
English: Rare (may affect up to 1 in 1,000 people):
Croatian: Rijetko (mogu se javiti u najviše 1 na 1000 osoba):
English: You have been prescribed Roteas, an anticoagulant medicine, which thins your blood and helps prevent you from suffering blood clots.
Croatian: Propisana Vam je Roteas, antikoagulantni lijek, koji razrjeđuje krv i pomaže u sprječavanju nastanka krvnih ugrušaka.
English: Edoxaban is a highly selective, direct and reversible inhibitor of factor Xa, the serine protease located in the final common pathway of the coagulation cascade.
Croatian: Edoksaban je visoko selektivan, izravan i reverzibilan inhibitor faktora Xa, serinske proteaze smještene u konačnom zajedničkom putu koagulacijske kaskade.
English: - Film coat:
Croatian: - Film ovojnica:
English: If you stop taking Roteas
Croatian: Ako prestanete uzimati Roteas
English: If a dose of Roteas is missed, the dose should be taken immediately and then be continued the following day with the once-daily intake as recommended.
Croatian: Ako se propusti doza Roteasa, dozu je potrebno uzeti odmah i zatim nastaviti sljedećeg dana s uzimanjem jedanput na dan, kako je preporučeno.
English: The MAH shall ensure that in each Member State where Roteas is marketed, all healthcare professionals who are expected to use Roteas are provided with the following educational material:
Croatian: Nositelj odobrenja za stavljanje lijeka u promet osigurat će da u svakoj državi članici u kojoj je Roteas u prometu, svi zdravstveni djelatnici za koje se očekuje da će primjenjivati lijek Roteas dobiju sljedeći edukacijski materijal: • Sažetak opisa svojstava lijeka
English: The programme is also aimed at ensuring that the healthcare professionals who intend to prescribe Roteas are aware of the Patient alert card and that the card is to be given to and reviewed with all patients treated with Roteas.
Croatian: Cilj tog programa također je osigurati da zdravstveni djelatnici koji namjeravaju propisivati lijek Roteas znaju da postoji Kartica s upozorenjima za bolesnika i da tu karticu treba dati svim bolesnicima koji se liječe lijekom Roteas i zajedno je s njima pregledati.
English: Cardioversion should be performed no later than 12 hours after the dose of Roteas on the day of the procedure.
Croatian: Kardioverziju treba provesti unutar 12 sati nakon primijenjene doze Roteasa na dan postupka.
English: Edoxaban is a substrate for the efflux transporter P-glycoprotein (P-gp), but not a substrate for uptake transporters such as organic anion transporter polypeptide OATP1B1, organic anion transporters OAT1 or OAT3 or organic cation transporter OCT2.
Croatian: Edoksaban je supstrat efluksnog prijenosnika P-glikoproteina (P-gp), ali nije supstrat prijenosnika za unos, kao što su polipeptidni prijenosnik organskih aniona OATP1B1, prijenosnici organskih aniona OAT1 ili OAT3 ili prijenosnik organskih kationa OCT2.
English: In patients with renal impairment the metabolite profile changes and a higher quantity of active metabolites are formed.
Croatian: U bolesnika s oštećenjem funkcije bubrega mijenja se profil metabolita i djelatni metaboliti se stvaraju u većoj količini.
English: Therapy with edoxaban in NVAF patients should be continued long term.
Croatian: Terapija edoksabanom u bolesnika s NVAF-om mora biti dugotrajna.
English: There is no clinically relevant accumulation of edoxaban (accumulation ratio 1.14) with once daily dosing.
Croatian: Nema klinički značajnog nakupljanja edoksabana (omjer nakupljanja 1,14) kod doziranja jedanput na dan.
English: Cartons of 10, 14, 28, 30, 56, 60, 84, 90, 98, 100 film-coated tablets.
Croatian: Kutije s 10, 14, 28, 30, 56, 60, 84, 90, 98, 100 filmom obloženih tableta.
English: ABOUT YOUR TREATMENT
Croatian: O LIJEČENJU
English: For life-threatening bleeding that cannot be controlled with the measures such as transfusion or haemostasis, the administration of a 4-factor prothrombin complex concentrate (PCC) at 50 IU/kg has been shown to reverse the effects of Roteas 30 minutes after completing the infusion.
Croatian: Kod životno opasnog krvarenja koje se ne može kontrolirati pomoću mjera kao što su transfuzija ili hemostaza, pokazalo se da primjena koncentrata protrombinskog kompleksa (PCC) s 4 faktora u dozi od 50 IU/kg poništava učinke Roteasa 30 minuta nakon završetka infuzije.
English: There was a statistically significant interaction between the effect of edoxaban versus warfarin on the main study outcome (stroke/SEE) and renal function (p-value 0.0042; mITT, overall study period).
Croatian: Postojala je statistički značajna interakcija učinka edoksabana naspram varfarina na glavni ishod ispitivanja (moždani udar/SED) i funkciju bubrega (p-vrijednost 0,0042; mITT, cjelokupno trajanje ispitivanja).
English: However, there is limited clinical experience with the use of this product in individuals receiving edoxaban.
Croatian: Međutim, kliničko iskustvo je ograničeno u pogledu primjene ovog pripravka u osoba koje primaju edoksaban.
English: Take special care with Roteas
Croatian: Budite posebno oprezni s lijekom Roteas
English: Renal clearance accounts for approximately 35% of the administered dose.
Croatian: Bubrežnim klirensom uklanja se približno 35% primijenjene doze.
English: Edoxaban showed vaginal haemorrhage at higher doses in rats and rabbits but had no effects in the reproductive performance of parent rats.
Croatian: Reproduktivna toksičnost Edoksaban je u višim dozama izazvao vaginalno krvarenje u štakora i kunića, ali nije imao učinka na reproduktivnu sposobnost roditeljskih štakora.
English: It is recommended to take into account the maintenance dose of VKA and if the patient was previously taking a VKA or to use valid INR driven VKA treatment algorithm, in accordance with local practice.
Croatian: Preporučuje se uzeti u obzir dozu održavanja AVK-a i je li bolesnik prethodno uzimao AVK ili primijeniti valjani algoritam liječenja AVK-om ovisno o INR-u sukladno lokalnoj praksi.
English: You should take the tablet immediately and then continue the following day with the once daily tablet as usual.
Croatian: Trebali biste odmah uzeti tabletu i nastaviti sljedeći dan s uzimanjem tablete jedanput na dan prema uobičajenom rasporedu.
English: Edoxaban vs Warfarin HR (95% CI)b p-valuec
Croatian: Edoksaban naspram varfarinu HR (95% CI)b p-vrijednostc
English: This may include current or recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities.
Croatian: To može uključivati postojeći ili nedavni gastrointestinalni ulkus, prisutnost zloćudnih novotvorina s visokim rizikom od krvarenja, nedavnu ozljedu mozga ili kralježnične moždine, nedavni kirurški zahvat na mozgu, kralježničnoj moždini ili oku, nedavno intrakranijalno krvarenje, potvrđeni ili sumnja na varikozitete jednjaka, arteriovenske malformacije, vaskularne aneurizme ili velike intraspinalne i intracerebralne vaskularne abnormalnosti.
English: If oral medicinal products cannot be taken during or after surgical intervention, consider administering a parenteral anticoagulant and then switch to oral once daily Roteas (see section 4.2).
Croatian: Ako se tijekom ili nakon kirurške intervencije ne mogu uzimati oralni lijekovi, razmotrite primjenu parenteralnog antikoagulansa a zatim ga zamijenite Roteasom koji se uzima peroralno jedanput na dan (vidjeti dio 4.2).
English: b The event rate (%/yr) is calculated as number of events/subject-year exposure.
Croatian: b Stopa događaja (%/god) izračunata je kao broj događaja/izloženost izražena kao ispitanik-godina.
English: Do not stop taking Roteas without talking to your doctor first, because Roteas treats and prevents serious conditions.
Croatian: Nemojte prestati uzimati Roteas a da niste prethodno o tome razgovarali s liječnikom, zato što Roteas liječi i sprječava ozbiljna stanja.
English: Data from animals indicate that edoxaban is secreted into breast milk.
Croatian: Podaci iz ispitivanja na životinjama pokazuju da se edoksaban izlučuje u majčino mlijeko.
English: Due to the pharmacological mode of action, the use of Roteas may be associated with an increased risk of occult or overt bleeding from any tissue or organ which may result in post haemorrhagic anaemia.
Croatian: Zbog njegova načina farmakološkog djelovanja, primjena lijeka Roteas može biti povezana s povećanim rizikom od prikrivenog (okultnog) ili vidljivog krvarenja iz bilo kojeg tkiva ili organa, što može rezultirati posthemoragijskom anemijom.
English: • Abnormal vaginal bleeding, including heavier or prolonged menses
Croatian: • nenormalno krvarenje iz rodnice, uključujući jaču ili dugotrajniju menstruaciju.
English: Edoxaban displays approximately dose-proportional pharmacokinetics for doses of 15 mg to 60 mg in healthy subjects.
Croatian: Edoksaban pokazuje farmakokinetiku približno proporcionalnu dozi u rasponu doza od 15 mg do 60 mg u zdravih ispitanika.
English: Edoxaban can be co-administered with low dose ASA (≤ 100 mg/day).
Croatian: Edoksaban se može primijenjivati istovremeno s niskom dozom ASK-a (≤ 100 mg/dan).
English: Based on these data, when switching from these anticoagulants to edoxaban, the first dose of edoxaban can be initiated at the time of the next scheduled dose of the previous anticoagulant (see section 4.2).
Croatian: Na temelju ovih podataka, kod prebacivanja s tih antikoagulansa na edoksaban, s prvom dozom edoksabana može se započeti u vrijeme kad bi se prema rasporedu davala sljedeća doza prethodnog antikoagulansa (vidjeti dio 4.2).
English: There is no experience with antifibrinolytic agents (tranexamic acid, aminocaproic acid) in individuals receiving edoxaban.
Croatian: Nema iskustva s primjenom antifibrinolitika (traneksamatne kiseline, aminokaproatne kiseline) u osoba koje primaju edoksaban.
English: • severe liver disease
Croatian: • tešku bolest jetre
English: Roteas has no or negligible influence on the ability to drive and use machines.
Croatian: Roteas ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: The efficacy results for pre-specified major subgroups (with dose reduction as required), including age, body weight, gender and status of renal function were consistent with the primary efficacy results for the overall population studied in the trial.
Croatian: Rezultati djelotvornosti u unaprijed određenim glavnim podskupinama (s dozom sniženom po potrebi), uključujući dob, tjelesnu težinu, spol i status funkcije bubrega, bili su sukladni primarnim rezultatima djelotvornosti u ukupne populacije u ovom ispitivanju.
English: • Bleeding in the abdomen
Croatian: • krvarenje u abdomen
English: This exploratory study showed low rates of major and CRNM bleeding and thromboembolism in the two treatment groups in the setting of cardioversion.
Croatian: Ovo eksploratorno ispitivanje pokazalo je niske stope velikih i CRNM krvarenja te tromboembolije kod kardioverzije u obje terapijske skupine.
English: The safety and efficacy of Roteas in children and adolescents less than 18 years of age have not been established.
Croatian: Sigurnost i djelotvornost Roteasa u djece i adolescenata u dobi do 18 godina nisu ustanovljene.
English: *Dose reduction to 30 mg for low body weight ≤ 60 kg or specific concomitant P-glycoprotein (P-gp)
Croatian: *Sniženje doze na 30 mg zbog niske tjelesne težine ≤ 60 kg ili određenih istovremeno primijenjenih inhibitora P-glikoproteina (P-gp)
English: Blood alkaline phosphatase increased
Croatian: Povišena alkalna fosfataza u krvi
English: The majority of subjects in the edoxaban and warfarin groups had cardioversion performed (83.7% and 78.9%, respectively) or were auto-converted (6.6% and 8.6%, respectively).
Croatian: U većine ispitanika u skupinama koje su primale edoksaban i varfarin bila je provedena kardioverzija (83,7% i 78,9%) ili je konverzija nastupila spontano (6,6% i 8,6%).
English: Edoxaban produces rapid onset of pharmacodynamic effects within 1 - 2 hours, which corresponds with peak edoxaban exposure (Cmax).
Croatian: Farmakodinamički učinci edoksabana nastupaju brzo u roku od 1 do 2 sata, što odgovara vršnoj izloženosti edoksabanu (Cmax).
English: • antibiotic medicines (e.g. erythromycin)
Croatian: • antibiotike (npr. eritromicin)
English: Vitamin K Antagonist (VKA)
Croatian: Antagonist vitamina K (AVK)
English: For dabigatran higher aPTT activity was observed after edoxaban administration with prior dabigatran treatment compared to that after treatment with edoxaban alone.
Croatian: Za dabigatran je bila opažena viša aktivnost aPTV-a nakon primjene edoksabana s prethodnim liječenjem dabigatranom u usporedbi s onim nakon liječenja samo edoksabanom.
English: b The HR, two-sided CI are based on the Cox proportional hazards regression model including treatment and the following randomisation stratification factors as covariates: presenting diagnosis (PE with or without DVT, DVT only), baseline risk factors (temporary factors, all others), and the need for 30 mg edoxaban/edoxaban placebo dose at randomisation (yes/no).
Croatian: b HR, dvostrani CI temelje se na Coxovom regresijskom modelu proporcionalnih hazarda uključujući liječenje i sljedeće čimbenike randomizirane stratifikacije kao kovarijance: početna dijagnoza (PE s DVT-om ili bez njega; samo DVT), početni čimbenici rizika (privremeni čimbenici, svi ostali) i potreba za dozom od 30 mg edoksabana/placeba za edoksaban pri randomizaciji (da/ne).
English: When the effects of edoxaban on digoxin PK were also examined, the Cmax of digoxin increased by approximately 28% and AUC by 7%.
Croatian: Kad su se ispitali i učinci edoksabana na farmakokinetiku digoksina, Cmax digoksina bio je povećan za približno 28%, a AUC za 7%.
English: Once an INR ≥ 2.0 is achieved, Roteas should be discontinued.
Croatian: Nakon što se postigne INR ≥ 2,0, primjenu Roteasa treba prekinuti.
English: • Do not stop taking Roteas without consulting your doctor as this can increase your risk of developing a blood clot.
Croatian: • Nemojte prestati uzimati Roteas a da se prethodno niste posavjetovali s liječnikom jer Vam to može povećati rizik od nastanka krvnog ugruška.
English: Gammaglutamyltransferase increased
Croatian: Povišena gamaglutamil transferaza
English: - treat blood clots in the veins of the legs (deep vein thrombosis) and in the blood vessels in the lungs (pulmonary embolism), and to prevent blood clots from re-occurring in the blood vessels in the legs and/or lungs.
Croatian: - liječenje krvnih ugrušaka u venama nogu (duboka venska tromboza) i krvnim žilama pluća (plućna embolija) te za sprječavanje ponovnog nastanka krvnih ugrušaka u krvnim žilama nogu i/ili pluća.
English: The pharmacodynamic effects measured by anti-factor Xa assay are predictable and correlate with the dose and the concentration of edoxaban.
Croatian: Farmakodinamički učinci mjereni anti-faktor Xa testom su predvidljivi i koreliraju s dozom i koncentracijom edoksabana.
English: apixaban or heparin), except when changing anticoagulant treatment or while getting heparin through a venous or arterial line to keep it open - if you have a liver disease which leads to an increased risk of bleeding - if you have uncontrolled high blood pressure - if you are pregnant or breast feeding
Croatian: rivaroksaban, apiksaban ili heparin), osim kod promjene antikoagulacijske terapije ili kod primanja heparina kroz vensku ili arterijsku liniju da bi ostala prohodna - ako imate bolest jetre zbog koje je povećan rizik od krvarenja - ako imate nekotrolirani povišeni krvni tlak - ako ste trudni ili dojite
English: It is recommended that during the first 14 days of concomitant therapy the INR is measured at least 3 times just prior to taking the daily dose of Roteas to minimise the influence of Roteas on INR measurements.
Croatian: preporučuje se izmjeriti INR najmanje 3 puta neposredno prije uzimanja dnevne doze Roteasa, kako bi se minimalizirao utjecaj Roteasa na mjerenje INR-a.
English: - If your doctor has prescribed medicines known as P-gp inhibitors: ciclosporin, dronedarone,
Croatian: - Ako Vam je liječnik propisao lijekove koji su poznati inhibitori P-gp-a: ciklosporin,
English: If you forget to take Roteas
Croatian: Ako ste zaboravili uzeti Roteas
English: In ENGAGE AF-TIMI 48 study in NVAF, efficacy and safety results were similar for subjects with and without concomitant amiodarone use.
Croatian: U ispitivanju ENGAGE AF-TIMI 48 kod NVAF-a, rezultati za djelotvornost i sigurnost bili su slični kod ispitanika koji su istovremeno primali amiodaron i onih koji ga nisu primali.
English: In rats, no effects on male or female fertility were seen.
Croatian: U štakora nisu opaženi učinci na plodnost mužjaka ili ženki.
English: Haemorrhagic complications may present as weakness, paleness, dizziness, headache or unexplained swelling, dyspnoea, and unexplained shock.
Croatian: Komplikacije zbog krvarenja mogu se očitovati kao slabost, bljedilo, omaglica, glavobolja ili neobjašnjivo oticanje, dispneja i neobjašnjeni šok.
English: For transoesophageal echocardiogram (TEE) guided cardioversion in patients not previously treated with anticoagulants, Roteas treatment should be started at least 2 hours before cardioversion to ensure adequate anticoagulation (see sections 5.1 and 5.2).
Croatian: Kada je postupak kardioverzije vođen transezofagealnom ehokardiografijom (engl. transoesophageal echocardiogram, TEE) u bolesnika koji nisu prethodno liječeni antikoagulansima, liječenje Roteasom potrebno je početi najmanje 2 sata prije postupka kardioverzije kako bi se osigurala odgovarajuća antikoagulacija (vidjeti dijelove 5.1 i 5.2).
English: Following the switch to edoxaban on Day 4 the PT was equivalent to Day 3 of rivaroxaban and apixaban.
Croatian: Nakon prebacivanja na edoksaban 4. dana, protrombinsko vrijeme bilo je jednako onome 3. dana kod rivaroksabana i apiksabana.
English: HR (97.5% CI) p-value for non-inferiorityc
Croatian: HR (97,5% CI) p-vrijednost za neinferiornostc
English: • When an invasive procedure is required, Roteas should be stopped at least 24 hours beforehand,
Croatian: • Kad je potreban invazivni postupak, primjenu Roteasa treba prekinuti najmanje 24 sata prije i primijeniti odgovarajući oprez.
English: • St John's Wort, a herbal product used for anxiety and mild depression
Croatian: • gospinu travu, biljni pripravak koji se primjenjuje kod tjeskobe i blage depresije
English: Therefore, edoxaban should only be used in patients with NVAF and high creatinine clearance after a careful evaluation of the individual thromboembolic and bleeding risk.
Croatian: Stoga se u bolesnika s NVAF-om i visokim klirensom kreatinina edoksaban smije primjenjivati samo nakon pažljive procjene rizika od tromboembolije i krvarenja u pojedinog bolesnika.
English: Should a bleeding complication arise in a patient receiving edoxaban, the next edoxaban administration should be delayed or treatment should be discontinued as appropriate.
Croatian: Ako u bolesnika nastupi krvarenje kao komplikacija primanja edoksabana, potrebno je odgoditi primjenu sljedeće doze edoksabana ili po potrebi prekinuti liječenje.
English: a The event rate (%/yr) is calculated as number of events/subject-year exposure.
Croatian: a Stopa događaja (%/god) izračunata je kao broj događaja/izloženost izražena kao ispitanik-godina.
English: If you currently take 30 mg (dose reduced) Roteas:
Croatian: Ako trenutno uzimate Roteas u dozi od 30 mg (sniženu dozu):
English: b Primary Safety Endpoint: Clinically relevant bleeding (composite of major and clinically relevant non-major bleeding).
Croatian: b Primarni ishod sigurnosti: klinički značajno krvarenje (kompozitni ishod koji čine veliko i klinički značajno, ali ne veliko krvarenje).
English: The adverse reactions are classified by System Organ Class and frequency, using the following convention:
Croatian: Nuspojave su prikazane prema klasifikaciji organskih sustava i učestalosti prema sljedećoj konvenciji: