natgillin/translations-raw huggingface dataset:
The safety of edoxaban has been evaluated in two Phase 3 studies including 21,105 patients with NVAF (ENGAGE AF-TIMI 48 study), and 8,292 patients with VTE (DVT and PE) (Hokusai-VTE study).
Sigurnost edoksabana procijenjena je u dva ispitivanja faze 3 koja su uključila 21 105 bolesnika s NVAF-om (ispitivanje ENGAGE AF-TIMI 48) te 8292 bolesnika s VTE-om (DVT i PE) (ispitivanje Hokusai-VTE).
HR (95% CI) All Bleeding n
HR (95% CI) CRNM krvarenje n
The effect on prothrombin time (PT) and other coagulation biomarkers (e.g. anti-FXa, aPTT) was measured.
Mjerio se učinak na protrombinsko vrijeme (PV) i druge biološke biljege koagulacije (npr. anti-FXa, aPTV).
These include acetylsalicylic acid (ASA), P2Y12 platelet inhibitors, other antithrombotic agents, fibrinolytic therapy, selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs), and chronic nonsteroidal anti-inflammatory drugs (NSAIDs) (see section 4.5).
Među njima su acetilsalicilatna kiselina (ASK), inhibitori trombocitnog receptora P2Y12, drugi antitrombotički lijekovi, fibrinolitička terapija, selektivni inhibitori ponovne pohrane serotonina (SSRI) i/ili inhibitori ponovne pohrane serotonina i noradrenalina (SNRI) i kronična primjena nesteroidnih protuupalnih lijekova (NSAR) (vidjeti dio 4.5).
• some medicines for fungal infections (e.g. ketoconazole)
• neke lijekove protiv gljivičnih infekcija (npr. ketokonazol)
Although treatment with edoxaban does not require routine monitoring, the effect on anticoagulation can be estimated by a calibrated quantitative anti-Factor Xa assay which may be useful in exceptional situations where knowledge of edoxaban exposure may help to inform clinical decisions, e.g. overdose and emergency surgery (see also section 4.4).
Iako liječenje edoksabanom ne zahtijeva rutinsko praćenje, učinak na antikoagulaciju može se procijeniti kalibriranim kvantitativnim anti-faktor Xa testom, koji može biti koristan u iznimnim situacijama kada poznavanje izloženosti edoksabanu može pomoći kao informacija kod donošenja kliničkih odluka, npr. kod predoziranja i hitnih kirurških zahvata (vidjeti također dio 4.4).
Keep this medicine out of the sight and reach of children.
Kako čuvati Roteas Ovaj lijek čuvajte izvan pogleda i dohvata djece.
Phone number, practice stamp:
Telefonski broj, žig ordinacije:
Unchanged edoxaban is the predominant form in plasma.
Edoksaban se u plazmi pretežno nalazi u nepromijenjenom obliku.
Co-administration of edoxaban with the P-gp inducer rifampicin led to a decrease in mean edoxaban AUC and a shortened half-life, with possible decreases in its pharmacodynamic effects.
Induktori P-gp-a Istodobna primjena edoksabana s induktorom P-gp-a rifampicinom dovela je do smanjenja srednje vrijednosti AUC-a i skraćenog poluvijeka edoksabana, uz moguće slabljenje njegovih farmakodinamičkih učinaka.
Discontinue dabigatran, rivaroxaban or apixaban and start Roteas at the time of the next dose of the oral anticoagulant (see section 5.1).
Prekinite primjenu dabigatrana, rivaroksabana ili apiksabana i započnite s primjenom Roteasa u vrijeme sljedeće doze oralnog antikoagulansa (vidjeti dio 5.1).
Acetylsalicylic acid (ASA): Co-administration of ASA (100 mg or 325 mg) and edoxaban increased bleeding time relative to either medicine alone.
Acetilsalicilatna kiselina (ASK): Istovremena primjena ASK-a (100 mg ili 325 mg) i edoksabana produljila je vrijeme krvarenja u odnosu na ono kod odvojene primjene ta dva lijeka.
However, a calibrated anti-Factor Xa assay may help inform clinical decisions.
Međutim, kalibrirani test za određivanje anti-faktora Xa može dati korisnu informaciju kod donošenja kliničke odluke.
Co-administration of low dose ASA (≤ 100 mg) did not affect the peak or total exposure of edoxaban either after single dose or at steady-state.
Istovremena primjena niske doze ASK-a (≤ 100 mg) nije utjecala na vršnu ili ukupnu izloženost edoksabanu bilo nakon jedne doze, bilo u stanju dinamičke ravnoteže.
How to take Roteas
Kako uzimati Roteas
Co-administration of high dose ASA (325 mg) increased the steady state Cmax and AUC of edoxaban by 35% and 32%, respectively.
Istovremena primjena visoke doze ASK-a (325 mg) povećala je Cmax i AUC edoksabana u stanju dinamičke ravnoteže za 35% odnosno 32%.
The risk of bleedings may be increased in certain patient groups e.g. those patients with uncontrolled severe arterial hypertension and/or on concomitant treatment affecting haemostasis (see Haemorrhagic risk in section 4.4).
Rizik od krvarenja može u određenih skupina bolesnika biti povećan, npr. u bolesnika s jakom, nekontroliranom arterijskom hipertenzijom i/ili u onih koji istodobno primaju druge lijekove koji utječu na hemostazu (vidjeti „Rizik od krvarenja“ u dijelu 4.4).
Anticoagulants, antiplatelets, NSAIDs and SSRIs/SNRIs Anticoagulants: Co-administration of edoxaban with other anticoagulants is contraindicated due to increased risk of bleeding (see section 4.3).
Antikoagulansi, antitrombotici, NSAR-ovi i SSRI-jevi/SNRI-jevi Antikoagulansi: Istovremena primjena edoksabana s drugim antikoagulansima kontraindicirana je zbog povećanog rizika od krvarenja (vidjeti dio 4.3).
SSRIs/SNRIs: As with other anticoagulants the possibility may exist that patients are at increased risk of bleeding in case of concomitant use with SSRIs or SNRIs due to their reported effect on platelets (see section 4.4).
SSRI-jevi/SNRI-jevi: Kao i s drugim antikoagulansima, može postojati mogućnost povećanog rizika od krvarenja u bolesnika u slučaju istodobne primjene sa SSRI-jevima i SNRI-jevima zbog njihovog zabilježenog učinka na trombocite (vidjeti dio 4.4).
In the warfarin group, the median TTR (time in therapeutic range, INR 2.0 to 3.0) was 65.6%.
U skupini koja je primala varfarin, medijan TTR (vrijeme u terapijskom rasponu, INR od 2,0 do 3,0) iznosio je 65,6%.
Edoxaban and initial parenteral anticoagulant should not be administered simultaneously.
Edoksaban se ne smije primijeniti istovremeno s početnim parenteralnim antikoagulansom.
In case of emergency, please contact: Name:
Datum rođenja: U hitnom slučaju, molimo da se obratite:
15 mg and 60 mg film-coated tablets: Iron oxide yellow (E172) 15 mg and 30 mg film-coated tablets: Iron oxide red (E172)
15 mg i 60 mg filmom obložene tablete: željezov oksid, žuti (E172) 15 mg i 30 mg filmom obložene tablete: željezov oksid, crveni (E172)
In the warfarin group, the median TTR (time in therapeutic range, INR 2.0 to 3.0) was 68.4%.
U skupini liječenoj varfarinom, medijan TTR (vrijeme u terapijskom rasponu, INR 2,0 do 3,0) iznosio je 68,4%.
PVC/Aluminium perforated unit dose blisters of 10 x 1, 50 x 1 and 100 x 1 film-coated tablets.
PVC/aluminij perforirani blisteri s jediničnim dozama od 10 x 1, 50 x 1 i 100 x 1 filmom obložena tableta.
After accounting for body weight, gender had no additional clinically significant effect on edoxaban pharmacokinetics in a population pharmacokinetic analysis of the Phase 3 study in NVAF (ENGAGE AF-TIMI 48).
Kad se u obzir uzela tjelesna težina, spol nije imao dodatni klinički značajni učinak na farmakokinetiku edoksabana u analizi populacijske farmakokinetike u glavnom ispitivanju faze 3 kod NVAF-a (ENGAGE AF-TIMI 48).
Edoxaban is a substrate for the efflux transporter P-gp.
Edoksaban je supstrat efluksnog prijenosnika P-gp-a.
Depending on local availability, a consultation with a coagulation expert should be considered in case of major bleedings.
U slučaju velikih krvarenja, potrebno je razmotriti savjetovanje sa stručnjakom za koagulaciju, ovisno o lokalnoj dostupnosti.
• anti-inflammatory and pain-relieving medicines (e.g. naproxen or acetylsalicylic acid)
• protuupalne lijekove i lijekove protiv bolova (npr. naproksen ili acetilsalicilatnu kiselinu)
Periodic hepatic monitoring is recommended for patients on Roteas treatment beyond 1 year.
Povremeno praćenje jetrene funkcije preporučuje se u bolesnika koji se liječe Roteasom dulje od
Gender No dose reduction is required (see section 5.2).
Spol Nije potrebno sniženje doze (vidjeti dio 5.2).
Early administration of activated charcoal may be considered in case of edoxaban overdose to reduce absorption.
U slučaju predoziranja edoksabanom može se razmotriti rana primjena aktivnog ugljena da bi se smanjila apsorpcija.
Although treatment with edoxaban does not require routine monitoring, the effect on anticoagulation can be estimated by a calibrated quantitative anti-Factor Xa assay which may help to inform clinical decisions in particular situations as, e.g. overdose and emergency surgery (see also section 5.2).
Iako liječenje edoksabanom ne zahtijeva rutinsko praćenje, učinak na antikoagulaciju može se procijeniti kalibriranim kvantitativnim anti-faktor Xa testom, čiji rezultat može pomoći kao informacija u kliničkim odlukama u određenim situacijama, npr. kod predoziranja i hitnog kirurškog zahvata (vidjeti također dio 5.2).
A specific anticoagulant reversal agent for edoxaban is not available (see section 4.9).
Specifični antidot koji poništava antikoagulacijski učinak edoksabana nije dostupan (vidjeti dio 4.9).
• Bleeding from the skin or under the skin
• krvarenje iz kože ili potkožno
After taking renal function and body weight into account, age had no additional clinically significant effect on edoxaban pharmacokinetics in a population pharmacokinetic analysis of the pivotal Phase 3 study in NVAF (ENGAGE AF-TIMI 48).
Kad su u obzir uzeti funkcija bubrega i tjelesna težina, dob nije imala dodatni klinički značajn učinak na farmakokinetiku edoksabana u analizi populacijske farmakokinetike u glavnom ispitivanju faze 3 kod NVAF-a (ENGAGE AF-TIMI 48).
In the clinical studies mucosal bleedings (e.g. epistaxis, gastrointestinal, genitourinary) and anaemia were seen more frequently during long term edoxaban treatment compared with VKA treatment.
U kliničkim ispitivanjima krvarenja iz sluznice (npr. epistaksa, gastrointestinalno, genitourinarno krvarenje) i anemija zabilježeni su češće tijekom dugotrajnog liječenja edoksabanom u usporedbi s liječenjem AVK-om.
They come in blisters in cartons of 10 film-coated tablets or unit dose blisters in cartons of 10 x 1 filmcoated tablets.
Dolaze u blisterima u kutijama s 10 filmom obloženih tableta ili blisterima s jediničnim dozama u kutijama s 10 x 1 filmom obloženom tabletom.
The signs, symptoms, and severity (including fatal outcome) will vary according to the location and degree or extent of the bleeding and/or anaemia (see section 4.9 Management of bleeding).
varirat će ovisno o mjestu i stupnju ili opsegu krvarenja i/ili anemije (vidjeti dio 4.9 „Liječenje krvarenja“).
No specific studies with edoxaban in humans have been conducted to evaluate effects on fertility.
Nisu provedena posebna ispitivanja kojima bi se ocijenili učinci edoksabana na plodnost u ljudi.
Haemodialysis A 4 hour haemodialysis session reduced total edoxaban exposures by less than 9%.
Četverosatna hemodijaliza smanjila je ukupnu izloženost edoksabanu za manje od 9%.
Edoxaban Anti-FXa activity pre-dose (IU/mL)2 Median [2.5 - 97.5% range] Prevention of stroke and systemic embolism: NVAF 30 mg QD ≥ 30 to ≤ 50 60 mg QD*
Medijan [raspon: 2,5 - 97,5%] Prevencija moždanog udara i sistemske embolije: NVAF 30 mg QD ≥ 30 do ≤ 50
Warfarin (N = 7,012)
Varfarin (N = 7012)
Concomitant use of edoxaban with ciclosporin, dronedarone, erythromycin, or ketoconazole requires dose reduction to 30 mg once daily.
Kod istovremene primjene edoksabana s ciklosporinom, dronedaronom, eritromicinom ili ketokonazolom potrebno je smanjiti dozu na 30 mg jedanput na dan.
Edoxaban 60 mg was non-inferior to warfarin for the primary efficacy endpoint of stroke or SEE (upper limit of the 97.5% CI of the HR was below the pre-specified non-inferiority margin of 1.38) (Table 4).
60 mg bio je neinferioran varfarinu u primarnom ishodu djelotvornosti, što je bio moždani udar ili SED (gornja granica 97,5% CI HR-a bila je ispod unaprijed određene margine neinferiornosti od 1,38) (tablica 4).
Platelet inhibitors: In ENGAGE AF-TIMI 48 concomitant use of thienopyridines (e.g. clopidogrel) monotherapy was permitted and resulted in increased clinically relevant bleeding although with a lower risk of bleeding on edoxaban compared to warfarin (see section 4.4).
Inhibitori agregacije trombocita: U ispitivanju ENGAGE AF-TIMI 48 bila je dopuštena istovremena primjena monoterapije tienopiridinima (npr. klopidogrelom), što je rezultiralo povećanim klinički značajnim krvarenjem, iako je rizik od krvarenja bio manji kod primjene edoksabana nego varfarina (vidjeti dio 4.4).
Elderly No dose reduction is required (see section 5.2).
Nije potrebno sniženje doze (vidjeti dio 5.2).
Edoxaban 60 mg (30 mg dose reduced) resulted in a lower rate of cardiovascular mortality compared to warfarin [HR (95% CI): 0.86 (0.77, 0.97)].
Edoksaban u dozi od 60 mg (sniženoj dozi od 30 mg) snizio je stopu kardiovaskularnog mortaliteta u usporedbi s varfarinom [HR (95% CI): 0,86 (0,77, 0,97)].
erythromycin, or ketoconazole, the recommended dose is one 30 mg tablet once daily.
dronedaron, eritromicin ili ketokonazol, preporučena doza je jedna tableta od 30 mg jedanput na dan.
The use of edoxaban with other P-gp inhibitors including HIV protease inhibitors has not been studied.
Primjena edoksabana s drugim inhibitorima P-gp-a uključujući inhibitore proteaze HIV-a nije ispitana.
In pharmacokinetic (PK) studies, concomitant administration of edoxaban with the P-gp inhibitors: ciclosporin, dronedarone, erythromycin, ketoconazole, quinidine, or verapamil resulted in increased plasma concentrations of edoxaban.
U farmakokinetičkim (PK) je ispitivanjima istovremena primjena edoksabana s inhibitorima P-gp-a: ciklosporinom, dronedaronom, eritromicinom, ketokonazolom, kinidinom ili verapamilom rezultirala povišenim koncentracijama edoksabana u plazmi.
There is very limited experience on the use of edoxaban with dual antiplatelet therapy or fibrinolytic agents.
Iskustvo s primjenom edoksabana s dvojnom antitrombocitnom terapijom ili fibrinoliticima vrlo je ograničeno.
Injury, poisoning and procedural complications Surgical site haemorrhage
Ozljede, trovanja i proceduralne komplikacije Krvarenje na mjestu kirurškog zahvata
In clinical pharmacology studies, healthy subjects received rivaroxaban 20 mg once daily, dabigatran 150 mg twice daily, or apixaban 5 mg twice daily, followed by a single dose of edoxaban 60 mg on Day 4.
U kliničkim farmakološkim ispitivanjima, zdravi su ispitanici primali rivaroksaban u dozi od 20 mg jedanput na dan, dabigatran u dozi od 150 mg dvaput na dan ili apiksaban u dozi od 5 mg dvaput na dan, nakon čega je slijedila jedna doza edoksabana od 60 mg 4. dana.
If there is a chance that you could become pregnant, use a reliable contraceptive while you are taking Roteas.
Ako postoji mogućnost da zatrudnite dok uzimate
Haemodialysis does not significantly contribute to edoxaban clearance (see section 5.2).
Hemodijaliza ne pridonosi značajno klirensu edoksabana (vidjeti dio 5.2).
Prosthetic heart valves and moderate to severe mitral stenosis Edoxaban has not been studied in patients with mechanical heart valves, in patients during the first 3 months after implantation of a bioprosthetic heart valve, with or without atrial fibrillation, or in patients with moderate to severe mitral stenosis.
Edoksaban nije ispitan u bolesnika s mehaničkim srčanim zaliscima, bolesnika tijekom prva 3 mjeseca nakon implantacije bioprostetičkog srčanog zaliska, s atrijskom fibrilacijom ili bez nje ili u bolesnika s umjerenom do teškom mitralnom stenozom.
Continuous adequate anticoagulation should be ensured during any transition to an alternate anticoagulant.
Tijekom svakog prelaska na neki drugi antikoagulans potrebno je osigurati neprekidnu odgovarajuću antikoagulaciju.
a The primary efficacy endpoint is adjudicated symptomatic recurrent VTE (i.e., the composite endpoint of DVT, non-fatal PE, and fatal PE).
a Primarni ishod djelotvornosti je simptomatski recidivirajući VTE prema procjeni (tj. kompozitni ishod koji uključuje DVT, PE bez smrtnog ishoda i PE sa smrtnim ishodom).
Tables 7, 8 and 9 show major, fatal and intracranial bleedings, respectively, by creatinine clearance category in NVAF patients in ENGAGE AF-TIMI 48.
Tablice 7, 8 i 9 pokazuju velika krvarenja, krvarenja sa smrtnim ishodom odnosno intrakranijalna krvarenja prema kategoriji klirensa kreatinina u bolesnika s NVAF-om u ispitivanju ENGAGE AF
In particular for patients that are triple positive (for lupus anticoagulant, anticardiolipin antibodies, and anti-beta 2glycoprotein I antibodies), treatment with DOACs could be associated with increased rates of recurrent thrombotic events compared with vitamin K antagonist therapy.
Posebice se ne preporučuju u bolesnika koji su trostruko pozitivni (na lupus antikoagulans, antikardiolipinska antitijela i anti-beta2-glikoprotein-I antitijela), u kojih bi liječenje direktno djelujućim oralnim antikoagulansima moglo biti povezano s povećanom stopom rekurentnih trombotskih događaja u usporedbi s terapijom antagonistima vitamina K.
Edoxaban 60 mg (30 mg Dose Reduced) (N = 4,118)
Edoksaban 60 mg (doza snižena na 30 mg) (N = 4118)
As a result of FXa inhibition, edoxaban also prolongs clotting time in tests such as prothrombin time (PT), and activated partial thromboplastin time (aPTT).
Kao rezultat inhibicije faktora Xa, edoksaban također produljuje vrijeme zgrušavanja na pretragama kao što su protrombinsko vrijeme (PV) i aktivirano parcijalno tromboplastinsko vrijeme (aPTV).
Increased post-implantation pregnancy losses occurred in rats at 300 mg/kg/day (approximately 49 times the MRHD) and in rabbits at 200 mg/kg/day (approximately 65 times the MRHD) respectively.
Povećani postimplantacijski gubici opaženi su u štakora pri dozi od 300 mg/kg/dan (približno 49 puta većoj od MRHD) te u kunića pri dozi od 200 mg/kg/dan (približno 65 puta većoj od MRHD).
A multicentre, prospective, randomised, open-label study with blinded endpoint evaluation (ENSUREAF) was conducted which randomised 2199 subjects (oral anticoagulant naïve and pre-treated) with non-valvular atrial fibrillation scheduled for cardioversion, to compare edoxaban 60 mg once daily with enoxaparin/warfarin to maintain a therapeutic INR of 2.0 to 3.0 (randomised 1:1), mean TTR on warfarin was 70.8%.
Provedeno je multicentrično, prospektivno, randomizirano, otvoreno ispitivanje s maskiranom procjenom ishoda (ENSURE-AF) u kojem je randomizirano 2199 ispitanika (oni koji prethodno nisu bili liječeni peroralnim antikoagulansima i oni koji su već liječeni) s nevalvularnom fibrilacijom atrija planiranih za kardioverziju, kako bi se usporedila primjena edoksabana u dozi od 60 mg jednom dnevno s enoksaparinom/varfarinom radi održavanja terapijskog INR-a od 2,0 do 3,0 (randomizirani 1:1), srednja vrijednost TTR-a uz varfarin bila je 70,8%.
Oral option: For patients currently on a 60 mg dose, administer a Roteas dose of 30 mg once daily together with an appropriate VKA dose.
Mogućnost oralne primjene: U bolesnika koji trenutno uzimaju dozu od 60 mg primijenite Roteas u dozi od 30 mg jedanput na dan zajedno s odgovarajućom dozom AVK-a.
- if you are allergic to edoxaban or any of the other ingredients of this medicine (listed in section 6) - if you are actively bleeding - if you have a disease or condition that increases the risk of serious bleeding
Nemojte uzimati Roteas: - ako ste alergični na edoksaban ili neki drugi sastojak ovog lijeka (naveden u dijelu 6) - ako aktivno krvarite
Retroperitoneal haemorrhage
Retroperitonealno krvarenje
Phone no:
Ime: Broj telefona:
During the overall study period in the ITT population (analysis set to show superiority), adjudicated stroke or SEE occurred in 296 subjects in the edoxaban 60 mg group (1.57% per year), and 337 subjects in the warfarin group (1.80% per year).
Tijekom cjelokupnog trajanja ispitivanja u ITT populaciji (skupina za analizu kojom bi se pokazala superiornost), moždani udar ili SED su, prema procjeni, nastali u 296 ispitanika u skupini liječenoj edoksabanom od 60 mg (1,57% godišnje) i 337 ispitanika u skupini liječenoj varfarinom (1,80% godišnje).
No dose reduction is required for concomitant use of amiodarone, quinidine or verapamil (see section
Nije potrebno sniženje doze kod istovremene primjene amiodarona, kinidina ili verapamila (vidjeti dio 4.5).
inhibitors 1 Post-dose is equivalent to Cmax (post-dose samples were drawn 1 - 3 hours after edoxaban administration) 2 Pre-dose is equivalent to Cmin
1 „Nakon doze“ odgovara vrijednosti Cmax (uzorci nakon doze uzeti su 1 - 3 sata poslije primjene edoksabana)
Assessment of renal function:
Posebne populacije Procjena funkcije bubrega:
They come in blisters in cartons of 10, 14, 28, 30, 56, 60, 84, 90, 98 or 100 film-coated tablets or unit dose blisters in cartons of 10 x 1, 50 x 1, or 100 x 1 film-coated tablets.
Dolaze u blisterima u kutijama s 10, 14, 28, 30, 56, 60, 84, 90, 98 ili 100 filmom obloženih tableta ili blisterima djeljivima na jedinične doze u kutijama s 10 x 1, 50 x 1 ili 100 x 1 filmom obloženom tabletom.
NVAF and VTE indications) patients with body weight ≤ 60 kg had a 50% edoxaban dose reduction and had similar efficacy and less bleeding when compared to warfarin.
U kliničkim ispitivanjima faze 3 (u indikacijama NVAF i VTE), bolesnicima s tjelesnom težinom ≤ 60 kg doza edoksabana bila je snižena za 50% i imala je sličnu djelotvornost, a bilo je i manje krvarenja u usporedbi s varfarinom.
Musculoskeletal and connective tissue disorders Intramuscular haemorrhage (no compartment syndrome)
Poremećaji mišićno-koštanog sustava i vezivnog tkiva Intramuskularno krvarenje (bez sindroma odjeljka)
The use of Roteas with other P-gp inhibitors including HIV protease inhibitors has not been studied.
Primjena Roteasa s drugim inhibitorima P-gp-a uključujući inhibitore proteaze HIV-a nije ispitana.
diabetes mellitus, prior stroke or transient ischaemic attack (TIA).
dob ≥ 75 godina, šećerna bolest, pretrpljeni moždani udar ili tranzitorna ishemijska ataka (TIA).
15 mg film-coated tablets:
15 mg filmom obložene tablete:
In a pre-specified subgroup analysis of PE subjects 447 (30.6%) and 483 (32.2%) of edoxaban and warfarin treated subjects, respectively, were identified as having PE and NT-proBNP ≥ 500 pg/mL.
U unaprijed određenoj analizi podskupine ispitanika s PE, za 447 (30,6%) ispitanika liječenih edoksabanom i 483 (32,2%) ispitanika liječenih varfarinom ustanovljeno je da imaju PE i NT-proBNP ≥ 500 pg/ml.
Your doctor will tell you to reduce your dose of Roteas to a 15 mg tablet once daily and to take it together with a vitamin K antagonist (e.g. warfarin).
Liječnik će Vam reći da snizite dozu Roteasa na 15 mg jedanput na dan i da je uzmete zajedno s antagonistom vitamina K (npr. varfarin).
Your doctor will tell you to reduce your dose of Roteas to a 30 mg tablet once daily and to take it together with a vitamin K antagonist (e.g. warfarin).
Liječnik će Vam reći da snizite dozu Roteasa na 30 mg jedanput na dan i da je uzmete zajedno s antagonistom vitamina K (npr. varfarinom).
Cartons of 10 film-coated tablets.
Kutije s 10 filmom obloženih tableta.
> 50 to ≤ 70 > 70 to ≤ 90 > 90 to ≤ 110 > 110 to ≤ 130
> 50 do ≤ 70 > 70 do ≤ 90 > 90 do ≤ 110 > 110 do ≤ 130
PVC/Aluminium perforated unit dose blisters of 10 x 1 film-coated tablets.
PVC/aluminij perforirani blisteri s jediničnim dozama od 10 x 1 filmom obložena tableta.
OTHER MON, TUE, WED, THU, FRI, SAT, SUN
DRUGO Pon, Uto, Sri, Čet, Pet, Sub, Ned
Blood and lymphatic system disorders Anaemia
Poremećaji krvi i limfnog sustava
Secondary efficacy endpoints included: Composite of stroke, SEE, and cardiovascular (CV) mortality; major adverse cardiovascular event (MACE), which is the composite of non-fatal MI, non-fatal stroke, non-fatal SEE, and death due to CV cause or bleeding; composite of stroke, SEE, and all-cause mortality.
SED-a i kardiovaskularnog (KV) mortaliteta; veliki štetni kardiovaskularni događaj (MACE), koji je kompozitna mjera sastavljena od infarkta miokarda bez smrtnog ishoda, moždanog udara bez smrtnog ishoda, SED-a bez smrtnog ishoda i smrti zbog KV uzroka ili krvarenja; kompozitnu mjeru sastavljenu od moždanog udara, SED-a i mortaliteta bilo kojeg uzroka.