FrancophonIA/ELRC3.0 huggingface dataset:
English: Stevens-Johnson syndrome/ Toxic Epidermal Necrolysis , DRESS syndrome
Croatian: Ozbiljne kožne reakcije povezane s primjenom rivaroksabana, uključujući Stevens-Johnsonov sindrom / toksičnu epidermalnu nekrolizu i reakciju na lijek s eozinofilijom i sistemskim simptomima, DRESS
English: CAD/PAD
Croatian: BKA/BPA
English: Please also notify:
Croatian: Molim također obavijestite: Ime i prezime:
English: Each 15 mg film-coated tablet contains 15 mg rivaroxaban.
Croatian: Jedna filmom obložena tableta od 15 mg sadrži 15 mg rivaroksabana.
English: Over 9,500 patients (7,050 in total hip replacement surgery and 2,531 in total knee replacement surgery) were studied in controlled randomised double-blind phase III clinical studies, the RECORD-programme.
Croatian: U fazu III kontroliranih, randomiziranih, dvostruko slijepih kliničkih ispitivanja (program RECORD) uključeno je bilo više od 9500 bolesnika (7050 s totalnom artroplastikom kuka i 2531 s totalnom artroplastikom koljena).
English: Converting patients from the vitamin K antagonist warfarin (INR 2.0 to 3.0) to rivaroxaban (20 mg) or from rivaroxaban (20 mg) to warfarin (INR 2.0 to 3.0) increased prothrombin time/INR (Neoplastin) more than additively (individual INR values up to 12 may be observed), whereas effects on aPTT, inhibition of factor Xa activity and endogenous thrombin potential were additive.
Croatian: Prelazak bolesnika s antagonista vitamina K varfarina (INR 2,0 do 3,0) na rivaroksaban (20 mg) ili s rivaroksabana (20 mg) na varfarin (INR 2,0 do 3,0) produljio je protrombinsko vrijeme/INR (Neoplastin) više nego aditivno (mogu se uočiti pojedinačne vrijednosti INR-a do 12), dok su učinci na aPTV, inhibiciju aktivnosti faktora Xa i endogeni trombinski potencijal bili aditivni.
English: Table 4: Efficacy results from phase III ROCKET AF Study population
Croatian: Tablica 4: Rezultati djelotvornosti iz ispitivanja faze III ROCKET AF Populacija uključena u ispitivanje
English: Use is not recommended in patients with creatinine clearance < 15 ml/min (see sections 4.2 and 5.2).
Croatian: Upotreba se ne preporučuje u bolesnika s klirensom kreatinina < 15 ml/min (vidjeti dijelove 4.2 i 5.2).
English: Body weight No dose adjustment (see section 5.2)
Croatian: Tjelesna težina Dozu ne treba prilagođavati (vidjeti dio 5.2).
English: Xarelto is contraindicated in patients with hepatic disease associated with coagulopathy and clinically relevant bleeding risk including cirrhotic patients with Child Pugh B and C (see sections 4.3 and 5.2).
Croatian: Xarelto je kontraindiciran u bolesnika s bolešću jetre povezanom s koagulopatijom i s klinički značajnim rizikom od krvarenja uključujući bolesnike s cirozom jetre, Child-Pugh stadija B i C (vidjeti dijelove 4.3 i 5.2).
English: Birth date:
Croatian: Datum rođenja: Tjelesna težina:
English: - For the treatment of DVT, treatment of PE and prevention of recurrent DVT and PE: patients should be treated with 15 mg twice daily for the first 3 weeks.
Croatian: Za liječenje duboke venske tromboze, liječenje plućne embolije i prevenciju ponavljajuće duboke venske tromboze i plućne embolije: bolesnike se mora liječiti dozom od 15 mg dvaput na dan prva 3 tjedna.
English: Batch
Croatian: Bayer
English: Rates of major bleeding, recurrent VTE and all-cause mortality for rivaroxaban were 0.7%, 1.4% and 0.5%, respectively.
Croatian: Za rivaroksaban stopa većeg krvarenja bila je 0,7%, ponavljajuće venske tromboembolije 1,4%, a smrtnosti svih uzroka 0,5%.
English: If any of the above apply to you, tell your doctor before taking Xarelto, because the effect of
Croatian: Odnosi li se bilo što od toga na Vas, obavijestite svog liječnika prije nego počnete uzimati Xarelto, jer njegov učinak može biti pojačan.
English: - For the treatment of DVT, treatment of PE and prevention of recurrent DVT and PE, no dose adjustment from the recommended dose is necessary in patients with mild renal impairment (creatinine clearance 50 - 80 ml/min) (see section 5.2).
Croatian: Za liječenje duboke venske tromboze, liječenje plućne embolije i prevenciju ponavljajuće duboke venske tromboze i plućne embolije, u bolesnika s blago (klirens kreatinina od 50 do 80 ml/min) oštećenom funkcijom bubrega nije potrebna prilagodba preporučene doze (vidjeti dio 5.2).
English: For the initial 3 week treatment of acute DVT 15 mg rivaroxaban was administered twice daily.
Croatian: Za prva 3 tjedna liječenja akutne duboke venske tromboze primjenjivao se rivaroksaban od 15 mg dvaput na dan, a nakon toga rivaroksaban od 20 mg jedanput na dan.
English: Within the highest quartile according to centre, the Hazard Ratio (HR) with rivaroxaban versus warfarin was 0.74 (95% CI, 0.49 - 1.12).
Croatian: Unutar najvišeg kvartila prema centru omjer hazarda s rivaroksabanom u odnosu na varfarin iznosio je 0,74 (95% CI, 0,49 do 1,12).
English: EU/1/08/472/011-016, EU/1/08/472/023, EU/1/08/472/036, EU/1/08/472/038, EU/1/08/472/048.
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/08/472/011-016, EU/1/08/472/023, EU/1/08/472/036, EU/1/08/472/038, EU/1/08/472/048.
English: DOSE and DOSING SCHEME
Croatian: DOZIRANJE i REŽIM DOZIRANJA:
English: Each 20 mg film-coated tablet contains 20 mg rivaroxaban.
Croatian: Jedna filmom obložena tableta od 20 mg sadrži 20 mg rivaroksabana.
English: Not known
Croatian: - nesvjestica
English: DAY 22 DAY 23 DAY 24 DAY 25 DAY 26 DAY 27 DAY 28
Croatian: 22. DAN 23. DAN 24.
English: In the enoxaparin/VKA group, there was no clear relation between the level of mean centre TTR (Time in Target INR Range of 2.0 - 3.0) in the equally sized tertiles and the incidence of the recurrent VTE (P=0.932 for interaction).
Croatian: U skupini s enoksaparinom/antagonistom vitamina K nije bilo jasnog odnosa između razine srednjeg centralnog vremena unutar terapijskog raspona (vrijeme u ciljnom INR rasponu od 2,0-3,0) u tercilima jednakih veličina i incidencije ponavljajuće venske tromboembolije (P=0,932 za interakciju).
English: If an invasive procedure or surgical intervention is required, Xarelto 10 mg should be stopped at least 24 hours before the intervention, if possible and based on the clinical judgement of the physician.
Croatian: Ako je potreban invazivni postupak ili kirurški zahvat, Xarelto 10 mg se mora prestati uzimati najmanje 24 sata prije zahvata, ako je to moguće i na temelju kliničke procjene liječnika.
English: Тел: +359-(0)2-424 72 80
Croatian: Байер България ЕООД Тел: +359-(0)2-424 72 80
English: In the enoxaparin/VKA group, there was no clear relation between the level of mean centre TTR (Time in Target INR Range of 2.0 - 3.0) in the equally sized tertiles and the incidence of the recurrent VTE (p=0.082 for interaction).
Croatian: U skupini s enoksaparinom/antagonistom vitamina K nije bilo jasnog odnosa između razine srednjeg centralnog vremena unutar terapijskog raspona (vrijeme u ciljnom INR rasponu od 2,0-3,0) u tercilima jednakih veličina i incidencije ponavljajuće venske tromboembolije (P=0,082 za interakciju).
English: Hazard Ratio (HR) (95% CI) pvalue b)
Croatian: n (%) omjer hazarda (95 % CI) p-vrijednost b)
English: The prespecified net clinical benefit (primary efficacy outcome plus major bleeding events) of the pooled analysis was reported with a HR of 0.771 ((95% CI: 0.614 - 0.967), nominal p value p = 0.0244).
Croatian: Unaprijed specificirana neto klinička korist (primarni ishod djelotvornosti i veća krvarenja) objedinjene analize prijavljena je uz omjer hazarda od 0,771 ((95% CI: 0,614- 0,967), nominalna p vrijednost p = 0,0244).
English: ▪ 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 za depresiju rifampicin, antibiotik
English: Each pack of 49 film-coated tablets contains: 42 film-coated tablets of 15 mg rivaroxaban 7 film-coated tablets of 20 mg rivaroxaban
Croatian: Svako pakiranje od 49 filmom obloženih tableta sadrži: 42 filmom obložene tablete od 15 mg rivaroksabana.
English: Xareltoa) 3, 6 or 12 months N=1,731
Croatian: 3, 6 ili 12 mjeseci N=1731
English: Prevention of VTE in adult patients undergoing elective hip or knee replacement surgery
Croatian: Prevencija VTE u odraslih bolesnika podvrgnutih elektivnom kirurškom zahvatu zamjene kuka ili koljena
English: Each brown-red film-coated tablet for week 4 contains 20 mg rivaroxaban.
Croatian: Jedna smeđecrvena filmom obložena tableta za 4. tjedan sadrži 20 mg rivaroksabana.
English: Weight:
Croatian: Tjelesna težina
English: Bayer plc Tel: +44-(0) 118 206 3000
Croatian: Tel: +44-(0) 118 206 3000
English: Converting from Xarelto to Vitamin K antagonists (VKA) There is a potential for inadequate anticoagulation during the transition from Xarelto to VKA.
Croatian: Prelazak bolesnika s lijeka Xarelto na antagoniste vitamina K (VKA) Postoji mogućnost za neadekvatnu antikoagulaciju tijekom prelaska s lijeka Xarelto na antagoniste vitamina K. Tijekom prelaska na zamjenski antikoagulans potrebno je osigurati neprekidnu adekvatnu antikoagulaciju.
English: 20 mg once a day taken at same time each day
Croatian: Promjena doze Xarelto 20 mg 20 mg jedanput na dan uzeti svaki dan u isto vrijeme
English: Bayer Limited Tel: +353-(0)1-2999 313
Croatian: Tel: +353-(0)1-2999 313
English: In the Einstein Choice study (Table 9) Xarelto 20 mg and 10 mg were both superior to 100 mg acetylsalicylic acid for the primary efficacy outcome.
Croatian: U ispitivanju Einstein Choice (tablica 9) Xarelto 20 mg i Xarelto 10 mg bili su superiorni acetilsalicilatnoj kiselini od 100 mg za primarni ishod djelotvornosti.
English: Bayer d. o. o. Tel: +386-(0)1-58 14 400
Croatian: Tel: +386-(0)1-58 14 400
English: other medicines to reduce blood clotting (e.g. enoxaparin, clopidogrel or vitamin K antagonists such as warfarin and acenocoumarol) anti-inflammatory and pain relieving medicines (e.g. naproxen or acetylsalicylic acid) dronedarone, a medicine to treat abnormal heart beat some medicines to treat depression (selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs))
Croatian: K kao što su varfarin i acenokumarol) protuupalne lijekove i lijekove protiv boli (npr. naproksen ili acetilsalicilatnu kiselinu) dronedaron, lijek za liječenje abnormalnog srčanog ritma ▪ neke lijekove za liječenje depresije (selektivne inhibitore ponovne pohrane serotonina (SSRI-jevi) ili inhibitore ponovne pohrane serotonina i noradrenalina (SNRI-jevi)
English: Gender No dose adjustment (see section 5.2)
Croatian: Dozu ne treba prilagođavati (vidjeti dio 5.2)
English: Prevention of venous thromboembolism in medically ill patients
Croatian: Prevencija venske tromboembolije (VTE) u hospitaliziranih nekirurških bolesnika
English: - if you have a liver disease which leads to an increased risk of bleeding - if you are pregnant or breast-feeding
Croatian: - ako imate bolest jetre zbog koje je povećan rizik od krvarenja
English: 95% CI, 0.66 - 0.96; P<0.001 for non-inferiority).
Croatian: P<0,001 za neinferiornost; P=0,117 za superiornost).
English: In the Einstein Choice study (see Table 8) Xarelto 20 mg and 10 mg were both superior to 100 mg acetylsalicylic acid for the primary efficacy outcome.
Croatian: U ispitivanju Einstein Choice (tablica 8) Xarelto 20 mg i Xarelto 10 mg bili su superiorni acetilsalicilatnoj kiselini od 100 mg za primarni ishod djelotvornosti.
English: Bayer S.p.A. Tel: +39-02-3978 1
Croatian: Tel: +39-02-3978 1
English: OUTER CARTON AND LABEL FOR HDPE BOTTLE FOR 2.5 MG
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM I UNUTARNJEM PAKIRANJU VANJSKA KUTIJA I NALJEPNICA ZA HDPE BOCU ZA 2,5 MG
English: Each 20 mg film-coated tablet contains 21.76 mg lactose (as monohydrate), see section 4.4.
Croatian: Jedna filmom obložena tableta od 20 mg sadrži 21,76 mg laktoze (u obliku laktoza hidrata), vidjeti dio 4.4.
English: Bayer OÜ Tel: +372-655 85 65
Croatian: Tel: +372-655 85 65
English: Xarelto 15 mg film-coated tablets Xarelto 20 mg film-coated tablets
Croatian: Xarelto 15 mg filmom obložene tablete Xarelto 20 mg filmom obložene tablete
English: This was followed by 20 mg rivaroxaban once daily.
Croatian: Preporučena doza je 10 mg rivaroksabana peroralno jedanput na dan.
English: A: observed in prevention of VTE in adult patients undergoing elective hip or knee replacement surgery
Croatian: A: opaženo kod prevencije VTE-a u odraslih bolesnika koji se podvrgavaju elektivnom kirurškom zahvatu zamjene kuka ili koljena
English: - if you have an increased risk of bleeding, as could be the case in situations such as: severe kidney disease, since your kidney function may affect the amount of medicine that works in your body if you are taking other medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), when changing anticoagulant treatment or while getting heparin through a venous or arterial line to keep it open (see section “Other medicines and Xarelto”) bleeding disorders very high blood pressure, not controlled by medical treatment diseases of your stomach or bowel that might result in bleeding, e.g. inflammation of the bowels or stomach, or inflammation of the oesophagus (gullet), e.g. due to gastroesophageal reflux disease (disease where stomach acid goes upwards into the oesophagus) a problem with the blood vessels in the back of your eyes (retinopathy) a lung disease where your bronchi are widened and filled with pus (bronchiectasis), or previous bleeding from your lung - if you have a prosthetic heart valve - if you know that you have a disease called antiphospholipid syndrome (a disorder of the immune system that causes an increased risk of blood clots), tell your doctor who will decide if the treatment may need to be changed.
Croatian: Budite posebno oprezni s lijekom Xarelto - ako imate povećan rizik od krvarenja, što može biti slučaj kod: teške bolesti bubrega, s obzirom na to da Vaša funkcija bubrega može utjecati na količinu lijeka koji djeluje u Vašem tijelu ako uzimate druge lijekove za sprječavanje zgrušavanja krvi (npr. varfarin, dabigatran, apiksaban ili heparin) kod promjene antikoagulacijskog liječenja ili dok primate heparin kroz postavljeni venski ili arterijski put da bi ga se održalo otvorenim (pogledajte dio „Drugi lijekovi i Xarelto“) poremećaja s krvarenjem vrlo visokog krvnog tlaka, koji nije kontroliran lijekovima bolesti želuca ili crijeva koja mogu rezultirati krvarenjem, npr. upala crijeva ili želuca, ili upala jednjaka npr. zbog gastroezofagealne refluksne bolesti (bolest gdje se želučana kiselina vraća gore u jednjak) tegoba s krvnim žilama u očnoj pozadini (retinopatija) bolesti pluća kada su bronhiji prošireni i ispunjeni gnojem (bronhiektazije), ili prethodnog krvarenja u plućima - ako imate umjetni srčani zalistak - ako znate da imate bolest koja se naziva antifosfolipidni sindrom (poremećaj imunološkog sustava koji uzrokuje povećani rizik od nastanka krvnih ugrušaka), obavijestite o tome svog liječnika koji će odlučiti postoji li potreba za izmjenom terapije. - ako Vaš liječnik ocijeni da Vam je krvni tlak nestabilan ili ako je planirano drugo liječenje ili kirurški zahvat da bi se odstranio krvni ugrušak iz pluća
English: From Day 22: One 20 mg tablet once a day (taken at same time each day).
Croatian: Od 22. dana nadalje: 1 tableta od 20 mg jedanput na dan (uzeta svaki dan u isto vrijeme).
English: XARELTO 2.5 mg twice daily Placebo
Croatian: Xarelto 2,5 mg, dvaput na dan,
English: When converting patients from VKAs to Xarelto, International Normalised Ratio (INR) values will be falsely elevated after the intake of Xarelto.
Croatian: International Normalised Ratio, INR) lažno će se povećati nakon uzimanja lijeka Xarelto.
English: Xarelto 2.5 mg tablets rivaroxaban
Croatian: Xarelto 2,5 mg tablete rivaroksaban
English: In the Einstein Choice study (see Table 10) Xarelto 20 mg and 10 mg were both superior to 100 mg acetylsalicylic acid for the primary efficacy outcome.
Croatian: U ispitivanju Einstein Choice (tablica 10) Xarelto 20 mg i Xarelto 10 mg bili su superiorni acetilsalicilatnoj kiselini od 100 mg za primarni ishod djelotvornosti.
English: Day 1 to 21: One 15 mg tablet twice a day (one 15 mg tablet in the morning and one in the evening).
Croatian: Od 1. do 21. dana: 1 tableta od 15 mg dvaput na dan (jedna tableta od 15 mg ujutro i jedna tableta navečer).
English: 15 mg film-coated tablet: red, round biconvex tablets (6 mm diameter, 9 mm radius of curvature) marked with the BAYER-cross on one side and “15” and a triangle on the other side.
Croatian: Filmom obložena tableta od 15 mg: crvene, okrugle, bikonveksne tablete (promjera 6 mm, polumjera zakrivljenosti 9 mm) označene s BAYER-ovim križićem na jednoj strani, te brojem "15" i trokutom na drugoj strani.
English: In ACS patients, efficacy and safety of Xarelto 2.5 mg have been investigated in combination with the antiplatelet agents ASA alone or ASA plus clopidogrel/ticlopidine.
Croatian: 4.4 Posebna upozorenja i mjere opreza pri uporabi Djelotvornost i sigurnost lijeka Xarelto u dozi od 2,5 mg u bolesnika s akutnim koronarnim sindromom ispitivane su u kombinaciji s antitrombocitnim lijekovima: samo ASK-om ili ASK-om uz dodatak klopidogrela/tiklopidina.
English: Xarelto 20 mg (only applicable for outer carton, not applicable for bottle label)
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Xarelto 20 mg (primjenjivo samo za vanjsku kutiju, nije primjenjivo za naljepnicu za bocu)
English: A prospective, randomised, open-label, multicentre, exploratory study with blinded endpoint evaluation (X-VERT) was conducted in 1504 patients (oral anticoagulant naive and pre-treated) with non-valvular atrial fibrillation scheduled for cardioversion to compare rivaroxaban with dose-adjusted VKA (randomised 2:1), for the prevention of cardiovascular events.
Croatian: U 1504 bolesnika (oni koji su prvi put na oralnom antikoagulansu i oni koji su prethodno liječeni oralnim antikoagulansom) s nevalvularnom fibrilacijom atrija u kojih je bila dogovorena kardioverzija, provedeno je prospektivno, randomizirano, otvoreno, multicentrično, eksploracijsko ispitivanje sa zaslijepljenom evaluacijom cilja (X-VERT), da bi se usporedili rivaroksaban i VKA s prilagođenom dozom (randomizirani 2:1) za prevenciju kardiovaskularnih događaja.
English: 168 film-coated tablets 196 film-coated tablets 10 x 1 film-coated tablets 100 x 1 film-coated tablets 30 film-coated tablets
Croatian: 14 filmom obloženih tableta 20 filmom obloženih tableta 28 filmom obloženih tableta 56 filmom obloženih tableta 60 filmom obloženih tableta 98 filmom obloženih tableta 168 filmom obloženih tableta 196 filmom obloženih tableta 10 x 1 filmom obložena tableta 100 x 1 filmom obložena tableta 30 filmom obloženih tableta
English: Use is not recommended in patients with creatinine clearance < 15 ml/min (see sections 4.4 and 5.2).
Croatian: Ne preporučuje se primjena lijeka u bolesnika s klirensom kreatinina < 15 ml/min (vidjeti dijelove 4.4 i 5.2).
English: In the per-protocol population on treatment, stroke or systemic embolism occurred in 188 patients on rivaroxaban (1.71% per year) and 241 on warfarin (2.16% per year) (HR 0.79;
Croatian: Kod ispitanika uključenih prema protokolu ispitivanja, moždani udar ili sistemska embolija dogodila se kod 188 bolesnika na rivaroksabanu (1,71% godišnje) i 241 s varfarinom (2,16% godišnje) (HR 0,79; 95% CI, 0,66-0,96; P<0,001 za neinferiornost).
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS UNIT DOSE BLISTER (10 x 1 TABLETS) FOR 2.5 MG
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER S JEDINIČNIM DOZAMA (10 x 1 TABLETA) ZA 2,5 MG
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR 10 MG
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA ZA 10 MG
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX) FOR 2.5 MG
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU UNUTARNJA KUTIJA VIŠESTRUKOG PAKIRANJA (BEZ PLAVOG OKVIRA) ZA 2,5 MG
English: Among all randomised patients analysed according to ITT, primary events occurred in 269 on rivaroxaban (2.12% per year) and 306 on warfarin (2.42% per year) (HR 0.88; 95% CI, 0.74 - 1.03; P<0.001 for non-inferiority; P=0.117 for superiority).
Croatian: Intention to treat), primarni događaji dogodili su se u 269 bolesnika na rivaroksabanu (2,12% godišnje) i 306 s varfarinom (2,42% godišnje) (HR 0,88; 95% CI, 0,74-1,03;
English: Table 8: Efficacy and safety results from pooled analysis of phase III Einstein DVT and Einstein PE
Croatian: Tablica 8: Rezultati djelotvornosti i sigurnosti iz objedinjene analize ispitivanja faze III Einstein DVT i Einstein PE
English: Xarelto 15 mg Xarelto 20 mg film-coated tablets rivaroxaban
Croatian: Xarelto 15 mg Xarelto 20 mg filmom obložene tablete rivaroksaban
English: Prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery
Croatian: Prevencija venske tromboembolije (VTE) u odraslih bolesnika koji su podvrgnuti elektivnom kirurškom zahvatu zamjene kuka ili koljena
English: and additionally a predefined pooled analysis of the Einstein DVT and Einstein PE studies was conducted.
Croatian: Provedena je unaprijed definirana objedinjena analiza ishoda ispitivanja Einstein DVT i Einstein PE
English: Converting from Vitamin K Antagonists (VKA) to Xarelto For patients treated for DVT, PE and prevention of recurrence, VKA treatment should be stopped and Xarelto therapy should be initiated once the INR is ≤ 2.5.
Croatian: U bolesnika koji se liječe zbog duboke venske tromboze, plućne embolije ili uzimaju lijekove za prevenciju ponovnog javljanja, mora se prekinuti liječenje antagonistima vitamina K i početi liječenje lijekom Xarelto kada je INR ≤ 2,5.
English: Do not start taking Xarelto if you know you are at risk of bleeding, without first discussing this with your doctor.
Croatian: Ne započinjite uzimati Xarelto bez prethodnog dogovora s liječnikom ako znate da ste izloženi povećanom riziku od krvarenja.
English: No clinically significant pharmacokinetic or pharmacodynamic interactions were observed when rivaroxaban was co-administered with 500 mg acetylsalicylic acid.
Croatian: Kad se rivaroksaban primijenio istodobno s 500 mg acetilsalicilatne kiseline, nisu uočene klinički značajne farmakokinetičke ni farmakodinamičke interakcije.
English: Use is not recommended in patients with creatinine clearance < 15 ml/min.
Croatian: Ne preporučuje se primjena lijeka Xarelto u bolesnika s klirensom kreatinina < 15 ml/min.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS UNIT DOSE BLISTER (10 X 1 TABLETS) FOR 20 MG
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER S JEDINIČNIM DOZAMA (10 X 1 TABLETA) ZA 20 MG
English: From Day 22: One 20 mg tablet once a day (taken at same time each day) together with food.
Croatian: Od 22. dana nadalje: jedna tableta od 20 mg jedanput na dan (uzeta svaki dan u isto vrijeme) s hranom.
English: If a dose is missed the patient should take Xarelto immediately and continue on the following day with the once daily intake as recommended.
Croatian: Ako propusti dozu, bolesnik mora odmah uzeti Xarelto, a potom od idućega dana nastaviti uzimati lijek jedanput na dan kao što mu je preporučeno.
English: In Einstein Choice, 3,396 patients with confirmed symptomatic DVT and/or PE who completed 6-12 months of anticoagulant treatment were studied for the prevention of fatal PE or non-fatal symptomatic recurrent DVT or PE.
Croatian: U ispitivanju Einstein Choice, ispitivana je prevencija plućne embolije sa smrtnim ishodom ili simptomatske ponavljajuće duboke venske tromboze ili plućne embolije bez smrtnog ishoda u 3396 bolesnika s potvrđenom simptomatskom dubokom venskom trombozom i/ili plućnom embolijom koji su završili 6 do 12 mjeseci antikoagulacijskog liječenja.
English: How to store Xarelto
Croatian: Kako čuvati Xarelto