natgillin/translations-raw huggingface dataset:
• Management of overdose situations and haemorrhage 
• postupanje u slučaju predoziranja i krvarenja
The concomitant use of edoxaban with other P-gp inducers (e.g. phenytoin, carbamazepine, phenobarbital or St. John's Wort) may lead to reduced edoxaban plasma concentrations. 
fenitoinom, karbamazepinom, fenobarbitalom ili gospinom travom) može dovesti do smanjene koncentracije edoksabana u plazmi.
• Bruising or bleeding under the skin 
• modrice ili potkožno krvarenje
• other medicines to reduce blood clotting (e.g. heparin, clopidogrel or vitamin K antagonists such as warfarin, acenocoumarol, phenprocoumon or dabigatran, rivaroxaban, apixaban) 
K kao što su varfarin, acenokumarol, fenprokumon ili dabigatran, rivaroksaban, apiksaban)
• Tar-coloured stools 
• stolica boje katrana
Digoxin: Edoxaban 60 mg once daily on days 1 to 14 with coadministration of multiple daily doses of digoxin 0.25 mg twice daily (days 8 and 9) and 0.25 mg once daily (days 10 to 14) increased the Cmax of edoxaban by 17%, with no significant effect on AUC or renal clearance at steady state. 
Digoksin: Edoksaban u dozi od 60 mg jedanput na dan od 1. do 14. dana uz istovremenu primjenu višestrukih dnevnih doza digoksina od 0,25 mg dvaput na dan (8. i 9. dana) i 0,25 mg jedanput na dan
All subjects with symptomatic recurrent VTEc, n (%) 
Svi ispitanici sa simptomatskim recidivirajućim VTE-omc,
The efficacy results for pre-specified major subgroups (with dose reduction as required), including age, body weight, gender, status of renal function, prior stroke or TIA, diabetes and P-gp inhibitors were generally consistent with the primary efficacy results for the overall population studied in the trial. 
Rezultati djelotvornosti za unaprijed određene glavne podskupine (uz sniženje doze prema potrebi), uključujući dob, tjelesnu težinu, spol, status funkcije bubrega, prethodni moždani udar ili TIA, šećerna bolest i inhibitori
Hepatic impairment Roteas is not recommended in patients with severe hepatic impairment (see sections 4.2 and 5.2). 
Roteas se ne preporučuje u bolesnika s teškim oštećenjem funkcije jetre (vidjeti dijelove 4.2 i 5.2).
In the Hokusai-VTE study (Table 10) edoxaban was demonstrated to be non-inferior to warfarin for the primary efficacy outcome, recurrent VTE, which occurred in 130 of 4,118 subjects (3.2%) in the edoxaban group versus 146 of 4,122 subjects (3.5%) in the warfarin group [HR (95% CI): 0.89 (0.70, 1.13); p < 0.0001 for non-inferiority]. 
U ispitivanju Hokusai-VTE (tablica 10), edoksaban se pokazao neinferiornim varfarinu u primarnom ishodu djelotvornosti, recidivirajućem VTE-u, koji je nastao u 130 od 4118 ispitanika (3,2%) u skupini liječenoj edoksabanom naspram 146 od 4122 ispitanika (3,5%) u skupini liječenoj varfarinom [HR
Tell your doctor immediately if you have taken too many Roteas tablets. 
Ako ste uzeli previše tableta Roteasa, odmah obavijestite liječnika.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS UNIT DOSE BLISTER (10 x 1 TABLETS) FOR 15 MG 
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER S JEDINIČNIM DOZAMA (10 x 1 TABLETA)
MARKETING AUTHORISATION NUMBER(S) 15 mg film-coated tablets: EU/1/16/1152/001-002 30 mg film-coated tablets: EU/1/16/1152/003-015 60 mg film-coated tablets: EU/1/16/1152/016-028 
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET 15 mg filmom obložene tablete: EU/1/16/1152/001-002
• Blood in the spit when coughing 
• krv u iskašljaju
The primary safety outcome was a composite of major and CRNM bleeding. 
Primarni ishod sigurnosti bio je kompozitni ishod koji su činila velika i klinički značajna, ali ne velika
Compared to warfarin-treated subjects, the HR in the edoxaban 60 mg group was 0.87 (99% CI: 0.71, 1.07, p = 0.08 for superiority). 
60 mg iznosio je 0,87 (99% CI: 0,71, 1,07; p = 0,08 za superiornost).
Body weight For patients with body weight ≤ 60 kg, the recommended dose is 30 mg Roteas once daily (see section 
Za bolesnike s tjelesnom težinom ≤ 60 kg, preporučena doza Roteasa je 30 mg jedanput na dan (vidjeti dio 5.2).
Roteas should be used with caution in patients with mild or moderate hepatic impairment (see section 
Roteas se mora primjenjivati s oprezom u bolesnika s blagim ili umjerenim oštećenjem funkcije jetre
• Erythromycin: Erythromycin 500 mg four times daily for 8 days with a single concomitant dose of edoxaban 60 mg on Day 7 increased the edoxaban AUC and Cmax by 85% and 68%, respectively. 
• Eritromicin: Eritromicin u dozi od 500 mg četiri puta na dan tijekom 8 dana s jednom istovremeno primijenjenom dozom edoksabana od 60 mg 7. dana, povećao je AUC edoksabana za 85%, a Cmax za 68%.
Roteas 15 mg film-coated tablets are orange, round-shaped (6.7 mm diameter) and debossed with “DSC L15” on one side. 
Roteas 15 mg filmom obložene tablete su narančaste i okrugle (6,7 mm u promjeru) s utisnutom oznakom „DSC L15“ na jednoj strani.
In patients with severe hepatic impairment Roteas is not recommended (see sections 4.4 and 5.2). 
Za bolesnike s teškim oštećenjem funkcije jetre, Roteas se ne preporučuje (vidjeti dijelove 4.4 i 5.2).
For NVAF and VTE the recommended dose is 30 mg edoxaban once daily in patients with one or more of the following clinical factors: 
Za NVAF i VTE preporučena doza je 30 mg edoksabana jedanput na dan u bolesnika s jednim ili više sljedećih kliničkih čimbenika: • umjereno ili teško oštećenje funkcije bubrega (klirens kreatinina (CrCL) 15 - 50 ml/min)
In patients with mild renal impairment (CrCL > 50 - 80 mL/min), the recommended dose is 60 mg Roteas once daily. 
Za bolesnike s blagim oštećenjem funkcije bubrega (CrCL > 50 - 80 ml/min), preporučena doza
Protamine sulfate and vitamin K are not expected to affect the anticoagulant activity of edoxaban. 
Ne očekuje se da će protamin sulfat i vitamin
Roteas 15 mg: hypromellose (E464), macrogol 8000, titanium dioxide (E171), talc, carnauba wax, iron oxide red (E172), iron oxide yellow (E172). 
Roteas 15 mg: hipromeloza (E464), makrogol 8000, titanijev dioksid (E171), talk, karnauba vosak, željezov oksid crveni (E172), željezov oksid žuti (E172).
PATIENT ALERT CARD 
KARTICA S UPOZORENJIMA ZA BOLESNIKA KARTICA S UPOZORENJIMA ZA BOLESNIKA
15 mg film-coated tablet: Orange, round-shaped film-coated tablets (6.7 mm diameter) debossed with “DSC L15”. 
Filmom obložene tablete od 15 mg: narančaste, okrugle filmom obložene tablete (6,7 mm u promjeru) s utisnutom oznakom „DSC L15“.
• Dronedarone: Dronedarone 400 mg twice daily for 7 days with a single concomitant dose of edoxaban 60 mg on Day 5 increased edoxaban AUC and Cmax by 85% and 46%, respectively. 
• Dronedaron: Dronedaron u dozi od 400 mg dvaput na dan tijekom 7 dana s jednom istovremeno primijenjenom dozom edoksabana od 60 mg 5. dana, povećao je AUC edoksabana za 85%, a Cmax za 46%.
The primary efficacy outcome occurred in 14 (3.1%) and 30 (6.2%) of edoxaban and warfarin subjects, respectively [HR (95% CI): 0.50 (0.26, 0.94)]. 
30 (6,2%) ispitanika liječenih varfarinom [HR (95% CI): 0,50 (0,26, 0,94)].
Roteas 15 mg: Each tablet contains 15 mg edoxaban (as tosilate). 
Roteas 15 mg: Jedna tableta sadrži 15 mg edoksabantosilata.
Discontinue Roteas and start the parenteral anticoagulant at the time of the next scheduled dose of Roteas. 
Prekinite primjenu Roteasa i započnite s primjenom parenteralnog antikoagulansa kad bi prema rasporedu bilo vrijeme za sljedeću dozu Roteasa.
Reproductive system and breast disorders Vaginal haemorrhage1 
Vaginalno krvarenje1
Started on: 
Početak liječenja:
Eye disorders Conjunctival/Scleral haemorrhage 
Konjunktivalno/skleralno krvarenje
Management should be individualised according to the severity and location of the haemorrhage. 
Liječenje treba prilagoditi pojedinom bolesniku sukladno težini i mjestu krvarenja.
60 mg film-coated tablet: Yellow, round-shaped film-coated tablets (10.5 mm diameter) debossed with “DSC L60”. 
Filmom obložene tablete od 60 mg: žute, okrugle filmom obložene tablete (10,5 mm u promjeru) s utisnutom oznakom „DSC L60“.
Urticaria 
Svrbež
Discontinue Roteas and start the non-VKA anticoagulant at the time of the next scheduled dose of Roteas. 
Prekinite primjenu Roteasa i započnite s primjenom antikoagulansa koji nije AVK kad bi prema rasporedu bilo vrijeme za sljedeću dozu Roteasa.
Package leaflet: Information for the user Roteas 15 mg film-coated tablets 
Uputa o lijeku: Informacija za korisnika Roteas 15 mg filmom obložene tablete Roteas 30 mg filmom obložene tablete Roteas 60 mg filmom obložene tablete edoksaban
Roteas 60 mg: hypromellose (E464), macrogol 8000, titanium dioxide (E171), talc, carnauba wax, iron oxide yellow (E172). 
Roteas 60 mg: hipromeloza (E464), makrogol 8000, titanijev dioksid (E171), talk, karnauba vosak, željezov oksid žuti (E172).
Table 5 shows ischaemic strokes/SEE by creatinine clearance category in NVAF patients in ENGAGE AF-TIMI 48. 
Tablica 5 pokazuje ishemijske moždane udare/SED prema kategoriji klirensa kreatinina u bolesnika s
30 mg film-coated tablet: Pink, round-shaped film-coated tablets (8.5 mm diameter) debossed with “DSC L30”. 
Filmom obložene tablete od 30 mg: ružičaste, okrugle filmom obložene tablete (8,5 mm u promjeru) s utisnutom oznakom „DSC L30“.
Roteas 30 mg: hypromellose (E464), macrogol 8000, titanium dioxide (E171), talc, carnauba wax, iron oxide red (E172). 
Roteas 30 mg: hipromeloza (E464), makrogol 8000, titanijev dioksid (E171), talk, karnauba vosak, željezov oksid crveni (E172).
Each 15 mg film-coated tablet contains 15 mg edoxaban (as tosilate). 
Jedna filmom obložena tableta od 15 mg sadrži 15 mg edoksabana (u obliku tosilata).
Pharmocokinetic/pharmacodynamic relationship(s) PT, INR, aPTT and Anti-factor Xa correlate linearly with edoxaban concentrations. 
PT, INR, aPTT i anti-faktor Xa linearno koreliraju s koncentracijama edoksabana.
Roteas 60 mg film-coated tablets are yellow, round-shaped (10.5 mm diameter) and debossed with “DSC L60” on one side. 
Roteas 60 mg filmom obložene tablete su žute i okrugle (10,5 mm u promjeru) s utisnutom oznakom „DSC L60“ na jednoj strani.
Ciclosporin, dronedarone, erythromycin, ketoconazole 
eritromicina i ketokonazola.
Roteas 30 mg film-coated tablets are pink, round-shaped (8.5 mm diameter) and debossed with “DSC L30” on one side. 
Roteas 30 mg filmom obložene tablete su ružičaste i okrugle (8,5 mm u promjeru) s utisnutom oznakom „DSC L30“ na jednoj strani.
Roteas 30 mg: Each tablet contains 30 mg edoxaban (as tosilate). 
Roteas 30 mg: Jedna tableta sadrži 30 mg edoksabantosilata.
Roteas film-coated tablets edoxaban 
Roteas filmom obložene tablete edoksaban
Roteas 60 mg once daily is recommended during concomitant use with the following P-gp inhibitors: 
Tijekom istovremene primjene sa sljedećim inhibitorima P-gp-a, preporučuje se primijeniti Roteas u dozi od 60 mg jedanput na dan:
Each 30 mg film-coated tablet contains 30 mg edoxaban (as tosilate). 
Jedna filmom obložena tableta od 30 mg sadrži 30 mg edoksabana (u obliku tosilata).
Roteas 60 mg: Each tablet contains 60 mg edoxaban (as tosilate). 
Roteas 60 mg: Jedna tableta sadrži 60 mg edoksabantosilata.
First Stroke/SEEa n Event Rate (%/yr)b 
Stopa događaja (%/god)b
Roteas 60 mg film-coated tablets 
Roteas 60 mg filmom obložene tablete edoksaban
Each 60 mg film-coated tablet contains 60 mg edoxaban (as tosilate). 
Jedna filmom obložena tableta od 60 mg sadrži 60 mg edoksabana (u obliku tosilata).
Prevention of stroke and systemic embolism The recommended dose is 60 mg edoxaban once daily. 
Preporučena doza je 60 mg edoksabana jedanput na dan.
Roteas 15 mg: Tablet core: mannitol (E421), pregelatinised starch, crospovidone, hydroxypropylcellulose, magnesium stearate (E470b). 
Roteas 15 mg: Jezgra tablete: manitol (E421), prethodno geliran škrob, krospovidon, hidroksipropilceluloza, magnezijev stearat (E470b).
Changing from Roteas to non-VKA oral anticoagulants (dabigatran, rivaroxaban, or apixaban) Stop taking Roteas and start the non-VKA anticoagulant (e.g. dabigatran, rivaroxaban, or apixaban) at the time of the next scheduled dose of Roteas. 
Prestanite uzimati Roteas i počnite uzimati antikoagulans koji nije antagonist vitamina K (npr. dabigatran, rivaroksaban ili apiksaban) u vrijeme kad ste prema rasporedu trebali uzeti sljedeću dozu Roteasa.
EU/1/16/1152/016 10 film-coated tablets EU/1/16/1152/017 14 film-coated tablets EU/1/16/1152/018 28 film-coated tablets EU/1/16/1152/019 30 film-coated tablets EU/1/16/1152/020 56 film-coated tablets EU/1/16/1152/021 60 film-coated tablets EU/1/16/1152/022 84 film-coated tablets EU/1/16/1152/023 90 film-coated tablets EU/1/16/1152/024 98 film-coated tablets EU/1/16/1152/025 100 film-coated tablets EU/1/16/1152/026 10 x 1 film-coated tablets EU/1/16/1152/027 50 x 1 film-coated tablets EU/1/16/1152/028 100 x1 film-coated tablets 
EU/1/16/1152/023 90 filmom obloženih tableta EU/1/16/1152/024 98 filmom obloženih tableta EU/1/16/1152/025 100 filmom obloženih tableta EU/1/16/1152/026 10 x 1filmom obložena tableta EU/1/16/1152/027 50 x 1 filmom obložena tableta EU/1/16/1152/028 100 x 1 filmom obložena tableta
Roteas 60 mg: Tablet core: mannitol (E421), pregelatinised starch, crospovidone, hydroxypropylcellulose, magnesium stearate (E470b). 
Roteas 60 mg: Jezgra tablete: manitol (E421), prethodno geliran škrob, krospovidon, hidroksipropilceluloza, magnezijev stearat (E470b).
Intra-articular haemorrhage 
Intraartikularno krvarenje
≥ 30 to ≤ 50 1,302 63 > 50 to ≤ 70 2,093 85 > 70 to ≤ 90 1,661 45 > 90 to ≤ 110 927 27 > 110 to ≤ 130 497 14 
≥ 30 do ≤ 50 1302 63 > 50 do ≤ 70 2093 85 > 70 do ≤ 90 1661 45 > 90 do ≤ 110 927 27 > 110 do ≤ 130 497 14
Roteas 30 mg: Tablet core: mannitol (E421), pregelatinised starch, crospovidone, hydroxypropylcellulose, magnesium stearate (E470b). 
Roteas 30 mg: Jezgra tablete: manitol (E421), prethodno geliran škrob, krospovidon, hidroksipropilceluloza, magnezijev stearat (E470b).
The reduction in fatal bleeds was also significant for the edoxaban 60 mg treatment group compared with the warfarin group (0.21%, and 0.38%) [HR (95% CI): 0.55 (0.36, 0.84); p = 0.0059 for superiority], primarily because of the reduction in fatal ICH bleeds [HR (95% CI): 0.58 (0.35, 0.95); p = 0.0312]. 
0,38%) [HR (95% CI): 0,55 (0,36, 0,84); p = 0,0059 za superiornost], prvenstveno zbog smanjenja intrakranijalnih krvarenja sa smrtnim ishodom [HR (95% CI): 0,58 (0,35, 0,95); p = 0,0312].
Prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation 
4.1 Terapijske indikacije Prevencija moždanog udara i sistemske embolije u odraslih bolesnika s nevalvularnom fibrilacijom atrija (NVAF) s jednim ili više čimbenika rizika, kao što su kongestivno zatajenje srca, hipertenzija,
EU/1/16/1152/003 10 film-coated tablets EU/1/16/1152/004 14 film-coated tablets EU/1/16/1152/005 28 film-coated tablets EU/1/16/1152/006 30 film-coated tablets EU/1/16/1152/007 56 film-coated tablets EU/1/16/1152/008 60 film-coated tablets EU/1/16/1152/009 84 film-coated tablets EU/1/16/1152/010 90 film-coated tablets EU/1/16/1152/011 98 film-coated tablets EU/1/16/1152/012 100 film-coated tablets EU/1/16/1152/013 10 x 1 film-coated tablets EU/1/16/1152/014 50 x 1 film-coated tablets EU/1/16/1152/015 100 x1 film-coated tablets 
EU/1/16/1152/003 10 filmom obloženih tableta EU/1/16/1152/004 14 filmom obloženih tableta EU/1/16/1152/005 28 filmom obloženih tableta EU/1/16/1152/006 30 filmom obloženih tableta EU/1/16/1152/007 56 filmom obloženih tableta EU/1/16/1152/008 60 filmom obloženih tableta EU/1/16/1152/009 84 filmom obložene tablete
• Ciclosporin: Concurrent administration of a single dose of ciclosporin 500 mg with a single dose of edoxaban 60 mg increased edoxaban AUC and Cmax by 73% and 74%, respectively. 
30 mg jedanput na dan: • Ciklosporin: Istovremena primjena jedne doze ciklosporina od 500 mg s jednom dozom edoksabana od 60 mg povećala je AUC edoksabana za 73%, a Cmax za 74%.
Your doctor will decide if you should be treated with Roteas and if you should be kept under observation. 
Roteasom i trebate li biti pod nadzorom.
Roteas 30 mg film-coated tablets 
Roteas 30 mg filmom obložene tablete edoksaban
The secondary composite endpoint of recurrent VTE and all-cause mortality occurred in 138 subjects (3.4%) in the edoxaban group and 158 subjects (3.9%) in the warfarin group [HR (95% CI): 0.87 
138 ispitanika (3,4%) u skupini liječenoj edoksabanom i 158 ispitanika (3,9%) u skupini liječenoj varfarinom [HR (95% CI): 0,87 (0,70, 1,10)].
There was a significant risk reduction in favour of the edoxaban 60 mg treatment group compared with the warfarin group in major bleeding (2.75%, and 3.43% per year, respectively) [HR (95% CI): 0.80 (0.71, 0.91); p = 0.0009], ICH (0.39%, and 0.85% per year, respectively) [HR (95% CI): 0.47 (0.34, 0.63); p < 0.0001], and other types of bleeding (Table 6). 
CI): 0,80 (0,71, 0,91); p = 0,0009], intrakranijalno krvarenje (0,39% odnosno 0,85% godišnje) [HR (95% CI): 0,47 (0,34, 0,63); p < 0,0001] i drugih vrsta krvarenja (tablica 6).
Procedural haemorrhage 
Proceduralno krvarenje
Edoxaban 30 mg once daily was used for subjects with one or more of the following clinical factors: moderate renal impairment (CrCL 30 - 50 mL/min); body weight ≤ 60 kg; concomitant use of specific P-gp inhibitors. 
Edoksaban u dozi od 30 mg jedanput na dan primjenjivao se u ispitanika s jednim ili više od sljedećih kliničkih čimbenika: umjereno oštećenje funkcije bubrega (CrCL 30 - 50 ml/min); tjelesna težina
≥ 30 to ≤ 50 1,302 16 > 50 to ≤ 70 2,093 19 > 70 to ≤ 90 1,661 17 > 90 to ≤ 110 927 5 > 110 to ≤ 130 497 2 
≥ 30 do ≤ 50 1302 16 > 50 do ≤ 70 2093 19 > 70 do ≤ 90 1661 17 > 90 do ≤ 110 927 5 > 110 do ≤ 130 497 2
Major Bleeding n Event rate (%/yr)a HR (95% CI) p-value ICHb n Event rate (%/yr)a HR (95% CI) Fatal Bleeding n Event rate (%/yr)a HR (95% CI) CRNM Bleeding n Event rate (%/yr)a HR (95% CI) Any Confirmed Bleedingc n Event rate (%/yr)a HR (95% CI) Abbreviations: ICH = Intracranial Haemorrhage, HR = Hazard Ratio versus warfarin, CI = Confidence Interval, CRNM = Clinically Relevant Non-Major, n = number of subjects with events, N = number of subjects in Safety population, yr = year. 
HR (95% CI) Prvi SED n (%/god)a HR (95% CI) Kratice: HR = omjer hazarda naspram varfarinu, CI = interval pouzdanosti, n = broj događaja, mITT = modificirano planirano liječenje, N = broj ispitanika u mITT populaciji, SED = sistemski embolijski događaj, god = godina a Jedan ispitanik može biti prikazan u većem broju redova.
• Feeling sick 
• glavobolja • svrbež
Berlin-Chemie AG Glienicker Weg 125 12489 Berlin Germany 
Berlin-Chemie Menarini Hrvatska d.o.o. Tel : +385 1 4821 361
• Blood in the urine 
• krv u mokraći
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER OF 14 FILM-COATED TABLETS FOR 30 MG 
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER S 14 FILMOM OBLOŽENIH
NAME OF THE MEDICINAL PRODUCT Roteas 15 mg film-coated tablets edoxaban 
Roteas 15 mg filmom obložene tablete edoksaban
Changing from non-VKA oral anticoagulants (dabigatran, rivaroxaban, or apixaban) to Roteas Stop taking the previous medicines (e.g. dabigatran, rivaroxaban, or apixaban) and start Roteas at the time of the next scheduled dose. 
Prestanite uzimati prethodne lijekove (npr. dabigatran, rivaroksaban ili apiksaban) i počnite uzimati Roteas u vrijeme kad ste prema rasporedu trebali uzeti sljedeću dozu.
Respiratory, thoracic and mediastinal disorders Epistaxis 
Poremećaji dišnog sustava, prsišta i sredoprsja
The average exposure to edoxaban 60 mg (including 30 mg dose reduced) was 2.5 years among 7,012 patients in ENGAGE AF-TIMI 48 and 251 days among 4,118 patients in Hokusai-VTE. 
2,5 godina kod 7012 bolesnika u ispitivanju ENGAGE AF-TIMI 48 i 251 dan kod 4118 bolesnika u ispitivanju Hokusai-VTE.
The duration of therapy for treatment of DVT and PE (venous thromboembolism, VTE), and prevention of recurrent VTE should be individualised after careful assessment of the treatment benefit against the risk for bleeding (see section 4.4). 
VTE-a treba biti prilagođeno pojedinom bolesniku nakon pažljive procjene koristi od liječenja u odnosu na rizik od krvarenja (vidjeti dio 4.4).
Investigations Liver function test abnormal 
Poremećeni nalazi pretraga jetrenih funkcija
• Guidance on switching from or to Roteas treatment 
• smjernice za zamjenu drugog lijeka Roteasom i obrnuto
• apixaban 
• koprivnjača
Reproductive toxicology 
Žene reproduktivne dobi
• Other types of bleeding 
• poremećaj krvarenja
Cardiac disorders Pericardial haemorrhage 
Makroskopska hematurija/uretralno krvarenje
Intravenous unfractionated heparin (UFH): Discontinue the infusion and start Roteas 4 hours later. 
Prekinite infuziju i započnite s primjenom Roteasa nakon 4 sata.
From 
U
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER OF 10 FILM-COATED TABLETS FOR 15 MG 
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER S 10 FILMOM OBLOŽENIH
• Headache 
• omaglica
First SEE n (%/yr)a 
n (%)
In patients with end stage renal disease (ESRD) (CrCL < 15 mL/min) or on dialysis, the use of Roteas is not recommended (see sections 4.4 and 5.2). 
Za bolesnike u završnom stadiju bubrežne bolesti (ESRD) (CrCL < 15 ml/min) ili na dijalizi, primjena
Talk to your doctor or pharmacist before taking Roteas, 
Obratite se svom liječniku ili ljekarniku prije nego uzmete Roteas: - ako imate povećan rizik od krvarenja, što bi moglo biti u slučaju da imate neko od sljedećih stanja:
Therefore, the possibility of haemorrhage is to be considered in evaluating the condition in any anticoagulated patient. 
Stoga, pri procjeni stanja svakog bolesnika koji uzima antikoagulans potrebno je uzeti u obzir i mogućnost krvarenja.
Fertility 
Urtikarija
Table 8: Number of Fatal Bleeding Events by creatinine clearance category in ENGAGE AFTIMI 48, Safety Analysis On-Treatmenta CrCL subgroup (mL/min) 
Tablica 8: Broj krvarenja sa smrtnim ishodom prema kategoriji klirensa kreatinina u ispitivanju ENGAGE AF-TIMI 48, analiza sigurnosti tijekom liječenjaa
The primary safety endpoint was clinically relevant bleeding (major or clinically relevant non-major). 
Sigurnost primjene u bolesnika s VTE-om (DVT i PE) u ispitivanju Hokusai-VTE Primarni ishod sigurnosti primjene bilo je klinički značajno krvarenje (veliko krvarenje ili klinički značajno, ali ne veliko).
Table 12: Edoxaban Anti-FXa activity by creatinine clearance Edoxaban Dose 
Tablica 12: Inhibicijsko djelovanje edoksabana na faktor Xa prema klirensu kreatinina Doza edoksabana CrCL (ml/min)
Uncommon (may affect up to 1 in 100 people): 
Manje često (mogu se javiti u najviše 1 na 100 osoba): • druge vrste krvarenja
≥ 30 to ≤ 50 1,302 9 > 50 to ≤ 70 2,093 8 > 70 to ≤ 90 1,661 10 > 90 to ≤ 110 927 2 > 110 to ≤ 130 497 1 
> 50 do ≤ 70 2093 8 > 70 do ≤ 90 1661 10 > 90 do ≤ 110 927 2 > 110 do ≤ 130 497 1
Hydroxypropylcellulose Magnesium stearate (E470b) 
Jezgra tablete: manitol (E421) prethodno geliran škrob krospovidon hidroksipropilceluloza magnezijev stearat (E470b)
Subdural haemorrhage 
Subduralno krvarenje
Upper GI haemorrhage 
Prijavljivanje nuspojava
In stable angina, these symptoms occur during physical effort. 
Pri stabilnoj angini ti se simptomi javljaju za vrijeme fizičkog napora.
The full EPAR for Ivabradine Accord can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Cjeloviti EPAR za lijek Ivabradine Accord nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect. 
Dva su lijeka bioekvivalentna kada u tijelu proizvode jednake razine djelatne tvari pa se stoga očekuje i da imaju jednak učinak.
The recommended starting dose is 5 mg twice a day with meals, which the doctor may increase to 7.5 mg twice a day or decrease to 2.5 mg (half a 5-mg tablet) twice a day depending on the patient's heart rate and symptoms. 
Preporučena početna doza je 5 mg dva puta dnevno uz obroke, što liječnik može povećati na 7,5 mg dva puta dnevno ili smanjiti na 2,5 mg (polovicu tablete od 5 mg) dva puta dnevno, ovisno o pulsu i simptomima bolesnika.