natgillin/translations-raw huggingface dataset:
b ICH includes primary haemorrhagic stroke, subarachnoid haemorrhage, epi/subdural haemorrhage, and ischaemic stroke with major haemorrhagic conversion.
b ICH uključuje primarni hemoragijski moždani udar, subarahnoidalno krvarenje, epiduralno ili subduralno krvarenje i ishemijski moždani udar s konverzijom u veliko krvarenje.
For subjects presenting with PE (with or without DVT), 47 (2.8%) of edoxaban and 65 (3.9%) of warfarin subjects had a recurrent VTE [HR (95% CI): 0.73 (0.50,
U ispitanika sa slikom PE-a (sa ili bez DVT-a), 47 (2,8%) ispitanika koji su primali edoksaban i 65 (3,9%) ispitanika koji su primali varfarin imalo je recidivirajući VTE [HR (95% CI): 0,73 (0,50, 1,06)].
PHARMACEUTICAL FORM AND CONTENTS 10 film-coated tablets
OBLIK I SADRŽAJ 10 filmom obloženih tableta 10 x 1 filmom obložena tableta
There is neither scientific rationale for benefit nor experience with the use of systemic haemostatics (desmopressin, aprotinin) in individuals receiving edoxaban.
Korist od primjene sistemskih hemostatika (dezmopresina, aprotinina) nema znanstvenu podlogu, a nema niti iskustva s njihovom primjenom u osoba koje primaju edoksaban.
• Coagulation tests such as INR, prothrombin time (PT), or activated partial thromboplastin time
• Testovi koagulacije kao što su INR, protrombinsko vrijeme (PV) ili aktivirano parcijalno tromboplastinsko vrijeme (aPTV) nisu korisne mjere učinka Roteasa.
1.23 × (140-age [years]) × weight [kg] (× 0.85 if female) serum creatinine [µmol/L]
• za kreatinin u µmol/l: 1,23 × (140-dob [godine]) × tjelesna težina [kg] (× 0,85 kod žena) kreatinin u serumu [µmol/l]
• Abnormal liver blood tests
• poremećeni krvni testovi jetrene funkcije
In clinical studies concomitant use of ASA (low dose ≤ 100 mg/day), other antiplatelet agents, and thienopyridines was permitted and resulted in approximately a 2-fold increase in major bleeding in comparison with no concomitant use, although to a similar extent in the edoxaban and warfarin groups (see section 4.4).
≤ 100 mg/dan), drugih antitrombotika i tienopiridina, što je rezultiralo približno dvostrukim povećanjem velikih krvarenja u usporedbi s neistovremenom primjenom, iako u sličnoj mjeri u skupinama koje su primale edoksaban i varfarin (vidjeti dio 4.4).
Parenteral option: Discontinue Roteas and administer a parenteral anticoagulant and VKA at the time of the next scheduled Roteas dose.
Mogućnost parenteralne primjene: Prekinite primjenu Roteasa i primijenite parenteralni antikoagulans i AVK kad bi prema rasporedu bilo vrijeme za sljedeću dozu Roteasa.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR 30 MG
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA ZA 30 MG
NAME OF THE MARKETING AUTHORISATION HOLDER Berlin-Chemie (logo)
Nositelj odobrenja za stavljanje lijeka u promet Berlin-Chemie AG
For the subjects who were dose reduced to 30 mg (predominantly low body weight or renal function) 15 (2.1%) edoxaban and 22 (3.1%) of warfarin subjects had a recurrent VTE [HR (95% CI): 0.69
Od ispitanika kojima je doza snižena na 30 mg (pretežno zbog niske tjelesne težine ili bubrežne funkcije) 15 (2,1%) ispitanika liječenih edoksabanom i 22 (3,1%) ispitanika liječena varfarinom imalo je recidivirajući VTE [HR (95% CI): 0,69 (0,36, 1,34)].
Treatment of DVT, treatment of PE and the prevention of recurrent DVT and PE (VTE) The edoxaban clinical programme for VTE was designed to demonstrate the efficacy and safety of edoxaban in the treatment of DVT and PE, and the prevention of recurrent DVT and PE.
Klinički program ispitivanja edoksabana u liječenju venske tromboembolije (VTE) bio je ustrojen tako da se pokaže djelotvornost i sigurnost edoksabana u liječenju DVT-a i PE-a te prevenciji ponavljajućih
Intraocular haemorrhage
Intraokularno krvarenje
In subgroup analyses, for subjects in the 60 mg treatment group who were dose reduced to 30 mg in the ENGAGE AF-TIMI 48 study (for body weight ≤ 60 kg, moderate renal impairment, or concomitant use of P-gp inhibitors), the event rate was: 2.29% per year for the primary endpoint, compared to the event rate of 2.66% per year for the matching subjects in the warfarin group [HR (95% CI): 0.86 (0.66, 1.13)].
U analizi podskupina, kod ispitanika u skupini liječenoj dozom od 60 mg kojima je doza snižena na 30 mg u ispitivanju ENGAGE AF-TIMI 48 (zbog tjelesne težine ≤ 60 kg, umjerenog oštećenja funkcije bubrega ili istovremene primjene inhibitora P-gp-a), stopa događaja bila je 2,29% godišnje za primarni ishod, u usporedbi sa stopom događaja od 2,66% godišnje za slične ispitanike u skupini liječenoj varfarinom [HR (95% CI): 0,86 (0,66, 1,13)].
Changing from Roteas to parenteral anticoagulants (e.g. heparin) Stop taking Roteas and start the parenteral anticoagulant (e.g. heparin) at the time of the next scheduled dose of Roteas.
Zamjena lijeka Roteas parenteralnim antikoagulansima (npr. heparinom) Prestanite uzimati Roteas i počnite uzimati parenteralni antikoagulans (npr. heparin) u vrijeme kad ste prema rasporedu trebali uzeti sljedeću dozu Roteasa.
In patients with mild to moderate hepatic impairment the recommended dose is 60 mg Roteas once daily (see section 5.2).
Za bolesnike s blagim do umjerenim oštećenjem funkcije jetre, preporučena doza Roteasa je 60 mg jedanput na dan (vidjeti dio 5.2).
60 mg once daily Dose recommendation for patients with one or more of the following clinical factors: Renal Impairment
Preporučena doza za bolesnike s jednim ili više od sljedećih kliničkih čimbenika:
Most patients (85%) should be able to achieve an INR ≥ 2.0 within 14 days of concomitant administration of Roteas and VKA.
trebao postići INR ≥ 2,0 unutar 14 dana od istovremene primjene Roteasa i AVK-a.
Hepatobiliary disorders Blood bilirubin increased
Povišen bilirubin u krvi
• Amiodarone: Co-administration of amiodarone 400 mg once daily with edoxaban 60 mg once daily increased AUC by 40% and Cmax by 66%.
• Amiodaron: Istovremena primjena amiodarona u dozi od 400 mg jedanput na dan s edoksabanom u dozi od 60 mg jedanput na dan povećala je AUC za 40% i Cmax za 66%.
Edoxaban 60 mg (N = 7,012)
Edoksaban 60 mg (N = 7012)
Event rate (%/year)
Stopa događaja (%/god)a
Safety and efficacy of edoxaban have not been established in breast-feeding women.
Dojenje Sigurnost i djelotvornost edoksabana u dojilja nisu ustanovljene.
• Verapamil: Verapamil 240 mg once daily for 11 days with a single concomitant dose of edoxaban 60 mg on Day 10 increased the edoxaban AUC and Cmax by approximately 53%.
• Verapamil: Verapamil u dozi od 240 mg jedanput na dan tijekom 11 dana s jednom istovremeno primijenjenom dozom edoksabana od 60 mg 10. dana, povećao je AUC i Cmax edoksabana za približno 53%.
Subjects in the edoxaban treatment group received 30 mg once daily if one or more of the following clinical factors were present: moderate renal impairment (CrCL 30 - 50 mL/min), low body weight (≤ 60 kg) or concomitant use of specific P-gp inhibitors.
Ispitanici u skupini koja je liječena edoksabanom primali su 30 mg jednom dnevno ako je bio prisutan jedan ili više sljedećih kliničkih faktora: umjereno oštećenje funkcije bubrega (CrCL 30 - 50 ml/min), mala tjelesna težina (≤ 60 kg) ili istovremena primjena specifičnih inhibitora P-gp-a.
• bleeding disorders
Krvožilni poremećaji
• Ketoconazole: Ketoconazole 400 mg once daily for 7 days with a single concomitant dose of edoxaban 60 mg on Day 4, increased edoxaban AUC and Cmax by 87% and 89%, respectively.
• Ketokonazol: Ketokonazol u dozi od 400 mg jedanput na dan tijekom 7 dana s jednom istovremeno primijenjenom dozom edoksabana od 60 mg 4. dana, povećao je AUC edoksabana za 87%, a Cmax za 89%.
The primary efficacy outcome consisted of a composite of all stroke, SEE, MI and CV mortality.
Primarni ishod djelotvornosti bio je kompozitni ishod koji su činili svi moždani udari, sistemski embolijski događaji (SEE), infarkt miokarda (MI) i kardiovaskularna (CV) smrtnost.
Oral/Pharyngeal haemorrhage
Oralno/faringealno krvarenje
Continued anticoagulant therapy is important in patients with NVAF and VTE.
U bolesnika s NVAF-om i VTE-om važno je nastaviti s antikoagulacijskom terapijom.
In subgroup analyses, for subjects who were dose reduced to 30 mg in the Hokusai-VTE study for body weight ≤ 60 kg, moderate renal impairment, or concomitant use of P-gp inhibitors, 58 (7.9%) of edoxaban 30 mg dose reduced subjects and 92 (12.8%) of warfarin subjects had a major bleeding or CRNM event [HR (95%): 0.62 (0.44, 0.86)].
U analizi podskupina, od ispitanika u ispitivanju Hokusai-VTE kojima je doza snižena na 30 mg zbog tjelesne težine ≤ 60 kg, umjerenog oštećenja funkcije bubrega ili istovremene primjene inhibitora P-gp-a, 58 (7,9%) ispitanika liječenih dozom edoksabana sniženom na 30 mg i 92 (12,8%) ispitanika liječena varfarinom imalo je veliko krvarenje ili CRNM događaj [HR (95%): 0,62 (0,44, 0,86)].
Adjudicated efficacy cardiovascular mortality per renal subgroups (edoxaban vs. warfarin): CrCL 30 to ≤ 50 mL/min [HR (95% CI): 0.80 (0.65, 0.99)]; CrCL > 50 to < 80 mL/min [HR (95% CI): 0.75 (0.62, 0.90)]; CrCL ≥ 80 mL/min [HR (95% CI): 1.16 (0.92, 1.46)].
Podaci pripisane djelotvornosti za kardiovaskularni mortalitet u podskupinama prema bubrežnoj funkciji (edoksaban naspram varfarin): CrCL od 30 do ≤ 50 ml/min [HR (95% CI): 0,80 (0,65, 0,99)]; CrCL od > 50 do < 80 ml/min [HR (95% CI): 0,75 (0,62, 0,90)]; CrCL ≥ 80 ml/min [HR (95% CI):
Roteas should be used with caution in patients with mild to moderate hepatic impairment (see section 4.4).
Roteas se mora primjenjivati s oprezom u bolesnika s blagim ili umjerenim oštećenjem funkcije jetre (vidjeti dio 4.4).
• rivaroxaban
• rivaroksaban
• Bleeding in the brain
• krvarenje u mozak
Common (may affect up to 1 in 10 people):
Često (mogu se javiti u najviše 1 na 10 osoba): • bol u trbuhu
• Quinidine: Quinidine 300 mg once daily on Days 1 and 4 and three times daily on Days 2 and 3, with a single concomitant dose of edoxaban 60 mg on Day 3, increased edoxaban AUC over 24 hours by 77% and Cmax by 85%, respectively.
• Kinidin: Kinidin u dozi od 300 mg jedanput na dan 1. i 4. dana te tri puta na dan 2. i 3. dana s jednom istovremeno primijenjenom dozom edoksabana od 60 mg 3. dana, povećao je AUC edoksabana tijekom 24 sata za 77%, a Cmax za 85%.
Table 5: Number of Ischaemic Strokes/SEE by creatinine clearance category in ENGAGE AFTIMI 48, mITT Analysis Set Overall Study CrCL subgroup (mL/min)
Tablica 5: Broj ishemijskih moždanih udara/SED-a prema kategoriji klirensa kreatinina u ispitivanju ENGAGE AF-TIMI 48, analiziran u mITT u cjelokupnom ispitivanju Podskupina prema CrCL (ml/min)
In subgroup analyses, for subjects in the 60 mg treatment group who were dose reduced to 30 mg in the ENGAGE AF-TIMI 48 study for body weight ≤ 60 kg, moderate renal impairment, or concomitant use of P-gp inhibitors, 104 (3.05% per year) of edoxaban 30 mg dose reduced subjects and 166 (4.85% per year) of warfarin dose reduced subjects had a major bleeding event [HR (95% CI): 0.63 (0.50,
U analizi podskupina, od ispitanika u terapijskoj skupini liječenoj dozom od 60 mg kojima je doza snižena na 30 mg u ispitivanju ENGAGE AF-TIMI 48 zbog tjelesne težine ≤ 60 kg, umjerenog oštećenja funkcije bubrega ili istovremene primjene inhibitora P-gp, njih 104 (3,05% godišnje) kojima je doza edoksabana snižena na 30 mg i njih 166 (4,85% godišnje) kojima je snižena doza varfarina imalo je veliko krvarenje [HR (95% CI): 0,63 (0,50, 0,81)].
Discontinue subcutaneous anticoagulant and start Roteas at the time of the next scheduled subcutaneous anticoagulant dose.
Prekinite primjenu supkutanog antikoagulansa i započnite s primjenom Roteasa kad bi prema rasporedu bilo vrijeme za sljedeću dozu supkutanog antikoagulansa.
≤ 60 kg
ZA 60 MG
> 50 to ≤ 70 2,093 148 3.31 2,106 171 3.77 0.88 (0.71, 1.10) > 70 to ≤ 90 1,661 108 2.88 1,703 119 3.08 0.93 (0.72, 1.21) > 90 to ≤ 110 927 29
> 50 do ≤ 70 2093 148 3,31 2106 171 3,77 0,88 (0,71, 1,10) > 70 do ≤ 90 1661 108 2,88 1703 119 3,08 0,93 (0,72, 1,21) > 90 do ≤ 110 927 29
Table 9: Number of Intracranial Bleeding Events by creatinine clearance category in ENGAGE AF-TIMI 48, Safety Analysis On-Treatmenta CrCL subgroup (mL/min)
Tablica 9: Broj intrakranijalnih krvarenja prema kategoriji klirensa kreatinina u ispitivanju ENGAGE AF-TIMI 48, analiza sigurnosti tijekom liječenjaa Podskupina prema CrCL (ml/min)
Management of bleeding
Zbrinjavanje krvarenja
Nervous system disorders Dizziness
Poremećaji živčanog sustava
Stroke and SEE occurred in fewer subjects in the edoxaban 60 mg treatment group than in the warfarin group (1.57% and 1.80% per year, respectively), with a HR of 0.87 (99% CI: 0.71, 1.07, p = 0.0807 for superiority).
Moždani udar i SED nastali su u manjeg broja ispitanika u skupini liječenoj edoksabanom u dozi od 60 mg nego u skupini liječenoj varfarinom (1,57% odnosno 1,80% godišnje), uz HR od 0,87 (99%
• 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.