FrancophonIA/ELRC3.0 huggingface dataset:
English: Stroke, non-CNS systemic embolism, vascular death and myocardial infarction
Croatian: Moždani udar, sistemska embolija koja nije vezana uz središnji živčani sustav, smrt uzrokovana vaskularnim komplikacijama i infarkt miokarda
English: Posology The recommended dose is 2.5 mg twice daily.
Croatian: Doziranje Preporučena doza je 2,5 mg dvaput na dan.
English: 1.4 per 100 patient years
Croatian: 1,4 na 100 bolesnik godina
English: postoperative anaemia, and wound haemorrhage), contusion, wound secretionA
Croatian: Postproceduralno krvarenje (uključujući postoperativnu anemiju i krvarenje iz rane), kontuzija, sekrecija iz raneA
English: Symptomatic recurrent DVT
Croatian: Simptomatski ponavljajući DVT
English: Embryo-foetal toxicity (post-implantation loss, retarded/progressed ossification, hepatic multiple light coloured spots) and an increased incidence of common malformations as well as placental changes were observed at clinically relevant plasma concentrations.
Croatian: Pri klinički relevantnim koncentracijama u plazmi primijećene su embrio-fetalna toksičnost (postimplantacijski gubitak, usporeno/ubrzano okoštavanje, višestruke svijetle mrlje u jetri), te povećana incidencija čestih malformacija, kao i promjene na posteljici.
English: PVC/PVDC/Aluminium foil blisters in cartons of 5, 10 or 30 film-coated tablets or perforated unit dose blisters in cartons of 10 x 1 or 100 x 1 film-coated tablets.
Croatian: PVC/PVDC/aluminij blisteri u kutijama s po 5, 10 ili 30 filmom obloženih tableta ili perforirani blisteri s jediničnim dozama u kutijama s po 10 x 1 ili 100 x 1 filmom obloženih tableta.
English: The principal safety outcome (major bleeding) occurred in 6 (0.6%)and 4 (0.8%) patients in the rivaroxaban (n = 988) and VKA (n = 499) groups, respectively (RR 0.76; 95% CI 0.21-2.67; safety population).
Croatian: Glavni cilj ispitivanja sigurnosti (veća krvarenja) pojavio se u 6 (0,6%) i 4 (0,8%) bolesnika na rivaroksabanu (n= 988), odnosno VKA (n= 499) (RR 0,76; 95% CI 0,21-2,67; sigurnosna populacija).
English: If your operation involves a catheter or injection into your spinal column (e.g. for epidural or spinal anaesthesia or pain reduction): it is very important to take Xarelto exactly at the times you have been told by your doctor tell your doctor immediately if you get numbness or weakness of your legs or problems with your bowel or bladder after the end of anaesthesia, because urgent care is necessary.
Croatian: - Ako operacija obuhvaća uvođenje katetera ili injekciju u kralježnicu (npr. radi epiduralne ili spinalne anestezije ili smanjenja bola): vrlo je važno da Xarelto točno u ono vrijeme kako Vam je liječnik rekao odmah obavijestite liječnika ako na kraju anestezije osjetite utrnulost ili slabost u nogama ili tegobe s crijevima ili s mokraćnim mjehurom jer je u tom slučaju nužna hitna medicinska skrb.
English: In subjects with mild renal impairment erythromycin (500 mg three times a day) led to a 1.8 fold increase in mean rivaroxaban AUC and 1.6 fold increase in CRmax when compared to subjects with normal renal function.
Croatian: U ispitanika s blagim oštećenjem funkcije bubrega, eritromicin (500 mg tri puta na dan) je doveo do povećanja srednje vrijednosti AUC rivaroksabana 1,8 puta i do povećanja Cmax 1,6 puta u usporedbi s ispitanicima s normalnom funkcijom bubrega.
English: If any of the above apply to you, tell your doctor before you take Xarelto.
Croatian: Odnosi li se bilo što od toga na Vas, obavijestite svog liječnika prije nego počnete uzimati Xarelto.
English: Rivaroxaban pharmacokinetics are approximately linear up to about 15 mg once daily in fasting state.
Croatian: Farmakokinetika rivaroksabana približno je linearna do 15 mg jedanput na dan na prazan želudac.
English: Anaphylactic reactions including anaphylactic shock
Croatian: uključujući anafilaktički šok
English: Table 5: Safety results from phase III ROCKET AF Study population
Croatian: Tablica 5: Rezultati sigurnosti iz ispitivanja faze III ROCKET AF Populacija uključena u ispitivanje
English: Initial treatment Xarelto 15 mg twice a day First 3 weeks Continuous treatment Xarelto 20 mg once a day Week 4 onwards Visit your doctor to ensure continued treatment.
Croatian: Nastavak liječenja Xarelto 20 mg jedanput na dan od 4. tjedna nadalje Obratite se liječniku u svrhu nastavka liječenja
English: Elderly population Increasing age may increase haemorrhagic risk (see section 5.2).
Croatian: S porastom dobi može biti povećan rizik od krvarenja (vidjeti dio 5.2).
English: If you are taking one 20 mg tablet or one 15 mg tablet once a day and have missed a dose, take it as soon as you remember.
Croatian: Ako uzimate jednu tabletu od 20 mg ili jednu tabletu od 15 mg jedanput na dan, a zaboravili ste uzeti dozu, uzmite je čim se sjetite.
English: For the first two days of the conversion period, standard initial dosing of VKA should be used followed by VKA dosing, as guided by INR testing.
Croatian: Tijekom prva dva dana razdoblja prebacivanja mora se koristiti standardno početno doziranje antagonista vitamina K, nakon čega slijedi doziranje antagonista vitamina
English: Clarithromycin (500 mg twice a day), for instance, considered as a strong CYP3A4 inhibitor and moderate P-gp inhibitor, led to a 1.5 fold increase in mean rivaroxaban AUC and a 1.4 fold increase in Cmax.
Croatian: Na primjer, klaritromicin (500 mg dvaput na dan), koji se smatra jakim inhibitorom CYP3A4 i umjerenim inhibitorom P-gp-a, doveo je do povećanja srednje vrijednosti AUC rivaroksabana 1,5 puta, a Cmax 1,4 puta.
English: 22 per 100 patient years
Croatian: 22 na 100 bolesnik godina
English: Patients with CAD/PAD
Croatian: Bolesnici s BKA-om/BPA-om
English: Figure 1: Time to first occurrence of primary efficacy endpoint (CV death, MI or stroke)
Croatian: Slika 1: Vrijeme do pojave primarnog ishoda djelotvornosti (kardiovaskularna smrt, infarkt miokarda ili moždani udar)
English: Tablet film coat: macrogol 3350, hypromellose 2910, titanium dioxide (E 171), iron oxide red (E 172).
Croatian: Film-ovojnica tablete: makrogol 3350, hipromeloza 2910, titanijev dioksid (E171), crveni željezov oksid (E172).
English: Each tablet contains 2.5 mg of rivaroxaban.
Croatian: Jedna tableta sadrži 2,5 mg rivaroksabana.
English: When to start Xarelto
Croatian: Kada početi s lijekom Xarelto
English: Therefore, the use of Xarelto is not recommended in patients receiving concomitant systemic treatment with azole-antimycotics such as ketoconazole, itraconazole, voriconazole and posaconazole or HIV protease inhibitors.
Croatian: Stoga se primjena lijeka Xarelto ne preporučuje u bolesnika koji istodobno sistemski primaju azolne antimikotike poput ketokonazola, itrakonazola, vorikonazola i posakonazola, ili inhibitore HIV proteaza.
English: Bayer SA-NV Tél/Tel: +32-(0)2-535 63 11
Croatian: Tél/Tel: +32-(0)2-535 63 11
English: 15 mg twice a day
Croatian: 15 mg dvaput na dan 30 mg
English: • Management of overdose situations
Croatian: • Liječenje predoziranja
English: Erythromycin (500 mg three times a day), which inhibits CYP3A4 and P-gp moderately, led to a 1.3 fold increase in mean rivaroxaban AUC and Cmax.
Croatian: Eritromicin (500 mg triput na dan), koji umjereno inhibira CYP3A4 i P-gp, doveo je do povećanja srednje vrijednosti AUC i Cmax rivaroksabana 1,3 puta.
English: The prespecified net clinical benefit (primary efficacy outcome plus major bleeding events) was reported with a HR of 0.67 ((95% CI: 0.47 - 0.95), nominal p value p=0.027) in favour of rivaroxaban.
Croatian: Unaprijed specificirana neto klinička korist (primarni ishod djelotvornosti i veća krvarenja) prijavljena je uz omjer hazarda od 0,67 ((95% CI: 0,47- 0,95), nominalna p vrijednost p=0,027) u korist rivaroksabana.
English: Each tablet contains 15 mg or 20 mg of rivaroxaban.
Croatian: Jedna tableta sadrži 15 mg ili 20 mg rivaroksabana.
English: The incidence of the secondary safety outcome (major bleeding events) was lower in the rivaroxaban group (1.1% (26/2412)) than in the enoxaparin/VKA group (2.2% (52/2405)) with a HR 0.493 (95% CI: 0.308 - 0.789).
Croatian: Incidencija sekundarnog ishoda sigurnosti (veća krvarenja) bila je niža u skupini liječenoj rivaroksabanom (1,1% (26/2412) nego u skupini liječenoj enoksaparinom/ antagonistom vitamina K (2,2% (52/2405)) uz omjer hazarda od 0,493 (95% CI:
English: While patients are on both Xarelto and VKA the INR should not be tested earlier than 24 hours after the previous dose but prior to the next dose of Xarelto.
Croatian: Dok bolesnici istodobno uzimaju Xarelto i antagonist vitamina K INR se ne smije određivati ako je prošlo manje od 24 sata od prethodne doze, nego ga se mora odrediti prije sljedeće doze lijeka Xarelto.
English: Xareltoa) 6 or 12 months N=602
Croatian: 6 ili 12 mjeseci N=602
English: Bayer AB Tel: +46-(0)8-580 223 00
Croatian: Tel: +46-(0)8-580 223 00
English: Within the highest tertile according to centre, the HR with rivaroxaban versus warfarin was 0.69 (95% CI: 0.35 - 1.35).
Croatian: Unutar najvišeg tercila prema centru omjer hazarda s rivaroksabanom u odnosu na varfarin bio je 0,69 (95% CI: 0,35-1,35).
English: In patients with moderate (creatinine clearance 30 - 49 ml/min) or severe (creatinine clearance 1529 ml/min) renal impairment the following dose recommendations apply:
Croatian: U bolesnika s umjereno (klirens kreatinina 30-49 ml/min) ili teško (klirens kreatinina 15-29 ml/min) oštećenom funkcijom bubrega primjenjuju se sljedeće preporuke doza:
English: The dose should not be doubled within the same day to make up for a missed dose.
Croatian: U istom danu ne smiju se uzeti 2 doze kako bi se nadoknadila propuštena doza.
English: Serious skin reactions, including Stevens-Johnson syndrome/toxic epidermal necrolysis and DRESS syndrome, have been reported during post-marketing surveillance in association with the use of rivaroxaban (see section 4.8).
Croatian: (engl. drug reaction with eosinophilia and systemic symptoms) sindrom, prijavljene su tijekom praćenja nakon stavljanja lijeka u promet (vidjeti dio 4.8).
English: In cirrhotic patients with moderate hepatic impairment (classified as Child Pugh B), rivaroxaban mean AUC was significantly increased by 2.3 fold compared to healthy volunteers.
Croatian: U bolesnika s cirozom s umjereno oštećenom funkcijom jetre (Child-Pugh stadija B), srednja vrijednost AUC rivaroksabana značajno se povećala 2,3 puta u usporedbi s onom u zdravih dobrovoljaca.
English: Prevention of VTE in medically ill patients
Croatian: Prevencija VTE u hospitaliziranih nekirurških bolesnika
English: Symptomatic recurrent VTE or major bleeding (net clinical benefit) * p<0.001(superiority) Xarelto 20 mg od vs ASA 100 mg od; HR=0.34 (0.20-0.59) ** p<0.001 (superiority) Xarelto 10 mg od vs ASA 100 mg od; HR=0.26 (0.14-0.47) + Xarelto 20 mg od vs. ASA 100 mg od; HR=0.44 (0.27-0.71), p=0.0009 (nominal) ++ Xarelto 10 mg od vs. ASA 100 mg od; HR=0.32 (0.18-0.55), p<0.0001 (nominal)
Croatian: * p<0,001 (superiornost) Xarelto 20 mg jedanput na dan u odnosu na 100 mg acetilsalicilatne kiseline jedanput na dan; HR=0,34 (0,20-0,59) ** p<0,001 (superiornost) Xarelto 10 mg jedanput na dan u odnosu na 100 mg acetilsalicilatne kiseline jedanput na dan; HR=0,26 (0,14-0,47) + Xarelto 20 mg jedanput na dan u odnosu na 100 mg acetilsalicilatne kiseline jedanput na dan;
English: Τηλ: +30-210-618 75 00
Croatian: Bayer Ελλάς ΑΒΕΕ Τηλ: +30-210-618 75 00
English: Anaemia (incl.
Croatian: Icepharma hf.
English: SIA Bayer Tel: +371-67 84 55 63
Croatian: Tel: +371-67 84 55 63
English: - If you are taking some medicines for treatment of epilepsy (phenytoin, carbamazepine, phenobarbital) St John's Wort (Hypericum perforatum), a herbal product used for depression rifampicin, an antibiotic
Croatian: Ako uzimate neke lijekove za liječenje epilepsije (fenitoin, karbamazepin, fenobarbital) gospinu travu (Hypericum perforatum), biljni pripravak koji se koristi protiv depresije rifampicin, antibiotik
English: platelet count increased)A, Thrombocytopenia
Croatian: Trombocitoza (uključujući povišeni broj trombocita)A, trombocitopenija
English: In the Einstein Extension study (see Table 7) rivaroxaban was superior to placebo for the primary and secondary efficacy outcomes.
Croatian: U ispitivanju Einstein Extension (vidjeti tablicu 7) rivaroksaban je bio superioran placebu kod primarnih i sekundarnih ishoda djelotvornosti.
English: - If you are taking some medicines for fungal infections (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are only applied to the skin ketoconazole tablets (used to treat Cushing's syndrome - when the body produces an excess of cortisol) some medicines for bacterial infections (e.g. clarithromycin, erythromycin) some anti-viral medicines for HIV / AIDS (e.g. ritonavir)
Croatian: Ako uzimate: neke lijekove za gljivične infekcije (npr. flukonazol, itrakonazol, vorikonazol, posakonazol), osim ako ste ih primjenjivali samo na koži tablete ketokonazola (primjenjuju se za liječenje Cushingovog sindroma - kada tijelo stvara previše kortizola) neke lijekove za bakterijske infekcije (npr. klaritromicin, eritromicin) neke antivirusne lijekove za HIV/AIDS (npr. ritonavir)
English: In patients receiving rivaroxaban 2.5 mg twice daily for the prevention of atherothrombotic events in patients with ACS the geometric mean concentration (90% prediction interval) 2 - 4 h and about 12 h after dose (roughly representing maximum and minimum concentrations during the dose interval) was 47 (13 - 123) and 9.2 (4.4 - 18) mcg/l, respectively.
Croatian: U bolesnika koji primaju rivaroksaban 2,5 mg dvaput na dan za prevenciju aterotrombotskih događaja u bolesnika s akutnim koronarnim sindromom, geometrijska srednja vrijednost koncentracije (90 % interval predviđanja) 2 do 4 h i oko 12 sati nakon doze bila je 47 (13-123) i 9,2 (4,4-18) mikrograma/l (što ugrubo predstavlja maksimalne i minimalne koncentracije tijekom intervala doziranja)
English: Symptomatic recurrent DVT 14
Croatian: Simptomatski ponavljajući DVT 14
English: Time period
Croatian: Razdoblje
English: In the Einstein Extension study (see Table 9) rivaroxaban was superior to placebo for the primary and secondary efficacy outcomes.
Croatian: U ispitivanju Einstein Extension (vidjeti tablicu 9) rivaroksaban je bio superioran placebu kod primarnih i sekundarnih ishoda djelotvornosti.
English: Table 7: Efficacy results from phase III COMPASS Study
Croatian: Tablica 7: Rezultati djelotvornosti iz ispitivanja faze III COMPASS Ispitivana populacija
English: a) intention-to-treat analysis set, primary analyses b) vs. ASA 100 mg; Log-Rank p-value bid: twice daily; CI: confidence interval; Cum.
Croatian: a) analiza skupine bolesnika planirane za liječenje, primarne analize b) naspram ASK 100 mg; log-rang p-vrijednost
English: Treatment and prevention of recurrent DVT and PE
Croatian: Liječenje i prevencija ponavljajuće duboke venske tromboze (DVT) i plućne embolije (PE)
English: Icepharma hf. Sími: +354-540 80 00
Croatian: Sími: +354-540 80 00
English: In patients receiving rivaroxaban for treatment of acute DVT 20 mg once daily the geometric mean concentration (90% prediction interval) 2 - 4 h and about 24 h after dose (roughly representing maximum and minimum concentrations during the dose interval) was 215 (22 - 535) and 32 (6239) mcg/l, respectively.
Croatian: U bolesnika koji primaju 20 mg rivaroksabana jedanput na dan za liječenje akutne duboke venske tromboze (DVT) geometrijska srednja vrijednost koncentracije (90% interval predviđanja) 2-4 h i oko 24 h nakon doze bila je 215 (22-535) i 32 (6-239) mikrograma/l (što ugrubo predstavlja maksimalne i minimalne koncentracije tijekom intervala doziranja).
English: Prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation The Xarelto clinical programme was designed to demonstrate the efficacy of Xarelto for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation.
Croatian: Klinički program za Xarelto osmišljen je kako bi pokazao djelotvornost lijeka Xarelto u prevenciji moždanog udara i sistemske embolije u bolesnika s nevalvularnom fibrilacijom atrija.
English: Rare (may affect up to 1 in 1,000 people) - bleeding into a muscle - cholestasis (decreased bile flow), hepatitis incl.
Croatian: Rijetko (mogu se javiti u do 1 na 1000 osoba): - krvarenje u mišiće - kolestaza (smanjen protok žuči), hepatitis koji uključuje oštećenje jetrenih stanica (upala jetre,
English: Treatment was continued with a vitamin K antagonist dose-adjusted to maintain the PT/INR values within the therapeutic range of 2.0 to 3.0.
Croatian: K kako bi se vrijednosti PV/INR održale unutar terapijskog raspona od 2,0 do 3,0.
English: Prevention of atherothrombotic events in patients with CAD/PAD
Croatian: Prevencija aterotrombotskih događaja u bolesnika s BKA-om/BPA-om
English: Xareltoa) 3, 6 or 12 months N=4,150
Croatian: 3, 6 ili 12 mjeseci N=4150
English: EU/1/08/472/017-021, EU/1/08/472/024, EU/1/08/472/037, EU/1/08/472/039, EU/1/08/472/049.
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/08/472/017-021, EU/1/08/472/024, EU/1/08/472/037, EU/1/08/472/039, EU/1/08/472/049.
English: No clinically significant pharmacokinetic or pharmacodynamic interactions were observed when rivaroxaban was co-administered with midazolam (substrate of CYP3A4), digoxin (substrate of P-gp), atorvastatin (substrate of CYP3A4 and P-gp) or omeprazole (proton pump inhibitor).
Croatian: Pri istodobnoj primjeni rivaroksabana s midazolamom (supstrat CYP3A4), digoksinom (supstrat P-gpa), atorvastatinom (supstrat CYP3A4 i P-gp-a) ili omeprazolom (inhibitor protonske pumpe) nisu uočene klinički značajne farmakokinetičke ni farmakodinamičke interakcije.
English: Xareltoa) 3, 6 or 12 months N=2,419
Croatian: 3, 6 ili 12 mjeseci N=2419
English: • Specialist Cohort Event Monitoring (SCEM) ACS Study With the submission of the last final study report from the programme, the MAH should provide an overview and discussion of the results from all studies of the programme in view of ACS patients.
Croatian: U sklopu podnošenja posljednjeg završnog izvješća iz programa ispitivanja, nositelj odobrenja treba dostaviti pregled i raspravu o rezultatima svih ispitivanja iz programa, a vezano uz bolesnike s akutnim koronarnim sindromom.
English: Acute limb ischaemia a) intention to treat analysis set, primary analyses b) vs. ASA 100 mg; Log-Rank p-value * The reduction in the primary efficacy outcome was statistically superior.
Croatian: Smrtnost od svih uzroka Akutna ishemija ekstremiteta a) analiza skupine bolesnika planirane za liječenje, primarne analize b) naspram ASK 100 mg; log-rang p-vrijednost
English: 10 x 1 film-coated tablets.
Croatian: OBLIK I SADRŽAJ 10 x 1 filmom obložena tableta.
English: Information for health care providers:
Croatian: Uputa o lijeku: Informacije za korisnika
English: Fatal PE/death where PE cannot be ruled out Major or clinically relevant non-major bleeding
Croatian: PE sa smrtnim ishodom/smrt za koju se ne može isključiti PE Veća ili klinički značajna manja krvarenja
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR 2.5 MG
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA ZA 2,5 MG
English: Xarelto 2.5 mg bid in combination with ASA 100 mg od
Croatian: XARELTO 2,5 mg bid, ASK 100 mg od ASK 100 mg od
English: Increase in transaminases
Croatian: Poremećaji jetre i žuči Povišene transaminaze
English: The primary safety endpoint, clinically significant bleeding events, occurred in 109 (15.7%), 117 (16.6%), and 167 (24.0%) subjects in group 1, group 2 and group 3, respectively (HR 0.59; 95% CI 0.47-0.76; p<0.001, and HR 0.63; 95% CI 0.50-0.80; p<0.001, respectively).
Croatian: Primarni ishod sigurnosti, klinički značajna krvarenja, javila su se u 109 (15,7%) ispitanika u prvoj skupini , u 117 (16,6%) u drugoj skupini te u 167 (24,0%) ispitanika u trećoj skupini (prva skupina u odnosu na treću skupinu HR 0,59; 95% CI 0,47-0,76; p< 0,001; druga skupina u odnosu na treću skupinu HR 0,63; 95% CI 0,50-0,80; p<0,001) . Sekundarni ishod (kompozitni ishod kardiovaskularne smrti, infarkta miokarda ili moždanog udara) javio se u 41 (5,9%) ispitanika u prvoj skupini, u 36 (5,1%) u drugoj skupini te u 36 (5,2%) u trećoj skupini.
English: In the Einstein Extension study (see Table 8) rivaroxaban was superior to placebo for the primary and secondary efficacy outcomes.
Croatian: U ispitivanju Einstein Extension (vidjeti tablicu 8) rivaroksaban je bio superioran placebu kod primarnih i sekundarnih ishoda djelotvornosti.
English: Fatal bleeding event
Croatian: Krvarenje sa smrtnim ishodom
English: If you are taking one 20 mg tablet once a day and have missed a dose, take it as soon as you remember.
Croatian: Ako uzimate jednu tabletu od 20 mg jedanput na dan, a zaboravili ste uzeti dozu, uzmite je čim se sjetite.
English: If a dose is missed the patient should take Xarelto immediately and then continue the following day with once daily intake as before.
Croatian: Ako propusti dozu, bolesnik mora odmah uzeti Xarelto, a potom od idućeg dana nastaviti uzimati lijek jedanput na dan kao i ranije.
English: In Einstein DVT 3,449 patients with acute DVT were studied for the treatment of DVT and the prevention of recurrent DVT and PE (patients who presented with symptomatic PE were excluded from this study).
Croatian: U ispitivanju Einstein DVT ispitivano je liječenje duboke venske tromboze i prevencija ponavljajuće duboke venske tromboze i plućne embolije (bolesnici sa simptomatskom plućnom embolijom nisu uključeni u ovo ispitivanje) na 3449 bolesnika s akutnom dubokom venskom trombozom.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR UNIT PACK FOR 15 MG
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA ZA JEDINIČNO PAKIRANJE ZA 15 MG
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR UNIT PACK FOR 20 MG
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA ZA JEDINIČNO PAKIRANJE ZA 20 MG
English: Each tablet contains 10 mg of rivaroxaban.
Croatian: Jedna tableta sadrži 10 mg rivaroksabana.
English: 2.5 per 100 patient years
Croatian: 2,5 na 100 bolesnik godina
English: If you are taking one 15 mg tablet twice a day and have missed a dose, take it as soon as you remember.
Croatian: Ako uzimate jednu tabletu od 15 mg dvaput na dan, a zaboravili ste uzeti dozu, uzmite ju čim se sjetite.
English: Major and non-major clinically relevant bleeding events
Croatian: Veća i manja klinički značajna krvarenja
English: - For the prevention of VTE in adult patients undergoing elective hip or knee replacement surgery, no dose adjustment is necessary in patients with mild renal impairment (creatinine clearance 50 - 80 ml/min) or moderate renal impairment (creatinine clearance 30- 49 ml/min) (see section 5.2).
Croatian: Za prevenciju venske tromboembolije (VTE) u odraslih bolesnika koji se podvrgavaju elektivnom kirurškom zahvatu ugradnje umjetnog kuka ili koljena, u bolesnika s blago (klirens kreatinina od 50 do 80 ml/min) ili umjereno (klirens kreatinina od 30 do 49 ml/min) oštećenom funkcijom bubrega nije potrebna prilagodba doze (vidjeti dio 5.2).
English: Treatment of DVT, PE and prevention of recurrent DVT and PE The Xarelto clinical programme was designed to demonstrate the efficacy of Xarelto in the initial and continued treatment of acute DVT and PE and prevention of recurrence.
Croatian: Klinički program za lijek Xarelto bio je osmišljen da se dokaže djelotvornost lijeka Xarelto u početnom i kontinuiranom liječenju akutne duboke venske tromboze i plućne embolije te prevenciji ponovnog javljanja.
English: Patients with recent acute coronary syndrome undergoing PCI a)
Croatian: Populacija uključena u ispitivanje Bolesnici s nedavnim akutnim koronarnim sindromom koji su podvrgnuti perkutanoj koronarnoj intervenciji a)
English: How to take Xarelto
Croatian: Kako uzimati Xarelto
English: Treatment of deep vein thrombosis (DVT), pulmonary embolism (PE) and prevention of recurrence
Croatian: Liječenje duboke venske tromboze, plućne embolije i prevencija njihovog ponovnog javljanja