FrancophonIA/ELRC3.0 huggingface dataset:
English: Converting from Vitamin K Antagonists (VKA) to Xarelto For patients treated for prevention of stroke and systemic embolism, VKA treatment should be stopped and Xarelto therapy should be initiated when the International Normalised Ratio (INR) is
Croatian: U bolesnika koji uzimaju lijekove za prevenciju moždanog udara i sistemske embolije, mora se prekinuti liječenje antagonistima vitamina K i početi liječenje lijekom Xarelto kada je međunarodni normalizirani omjer (engl.
English: Hepatic disease associated with coagulopathy and clinically relevant bleeding risk including cirrhotic patients with Child Pugh B and C (see section 5.2).
Croatian: Bolest jetre povezana s koagulopatijom i klinički značajnim rizikom od krvarenja uključujući bolesnike s cirozom jetre, Child-Pugh stadija B i C (vidjeti dio 5.2).
English: Safety and efficacy of Xarelto have not been established in breast-feeding women.
Croatian: Sigurnost i djelotvornost lijeka Xarelto u dojilja nisu ustanovljene.
English: Bayer (logo)
Croatian: Bayer Limited
English: Patients with a recent acute coronary syndrome a)
Croatian: Bolesnici s akutnim koronarnim sindromom
English: Xarelto 15 mg (only applicable for outer carton, not applicable for bottle label)
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Xarelto 15 mg (primjenjivo samo za vanjsku kutiju, nije primjenjivo za naljepnicu za bocu)
English: Your doctor will tell you when to start treatment with Xarelto if you have been diagnosed with coronary artery disease or peripheral artery disease.
Croatian: Ako Vam je dijagnosticirana bolest koronarnih arterija ili bolest perifernih arterija, liječnik će Vam reći kada da počnete liječenje lijekom Xarelto.
English: PP/Aluminium foil blisters in cartons of 14, 20, 28, 30, 56, 60, 98, 168 or 196 film-coated tablets or perforated unit dose blisters in cartons of 10 x 1 or 100 x 1 or in multipacks containing 100 (10 packs of 10 x 1) film-coated tablets.
Croatian: PP/aluminij blisteri u kutijama s po 14, 20, 28, 30, 56, 60, 98, 168 ili 196 filmom obloženih tableta ili perforirani blisteri s jediničnim dozama u kutijama s po 10 x 1 ili 100 x 1 ili u višestrukim pakiranjima koja sadrže 100 (10 pakiranja od 10 x 1) filmom obloženih tableta.
English: Table 7: Efficacy and safety results from pooled analysis of phase III Einstein DVT and Einstein PE
Croatian: Tablica 7: Rezultati djelotvornosti i sigurnosti iz objedinjene analize ispitivanja faze III Einstein DVT i Einstein PE
English: Symptomatic recurrent DVT 18
Croatian: Simptomatski ponavljajući PE 23 Simptomatski ponavljajući DVT 18
English: Enoxaparin/VKAb) 3, 6 or 12 months N=2,413
Croatian: Enoksaparin/ antagonist vitamina Kb) 3, 6 ili 12 mjeseci
English: Cerebral and intracranial haemorrhage, syncope
Croatian: Poremećaji živčanog sustava Omaglica, glavobolja Cerebralno i intrakranijalno krvarenje, sinkopa
English: Each film-coated tablet contains 33.92 mg lactose (as monohydrate), see section 4.4.
Croatian: Jedna filmom obložena tableta sadrži 33,92 mg laktoze (u obliku laktoza hidrata), vidjeti dio 4.4.
English: A prespecified pooled analysis of the outcome of the Einstein DVT and PE studies was conducted (see Table 6).
Croatian: Provedena je unaprijed definirana objedinjena analiza ishoda ispitivanja Einstein DVT i Einstein PE (vidjeti tablicu 6).
English: Uncommon (may affect up to 1 in 100 people) - bleeding into the brain or inside the skull - bleeding into a joint causing pain and swelling - thrombocytopenia (low number of platelets, which are cells that help blood to clot) - allergic reactions, including allergic skin reactions - impaired function of the liver (may be seen in tests performed by your doctor) - blood tests may show an increase in bilirubin, some pancreatic or liver enzymes or in the number of platelets - fainting - feeling unwell - faster heartbeat - dry mouth - hives
Croatian: Manje često (mogu se javiti u do 1 na 100 osoba): - krvarenje u mozak ili unutar lubanje - krvarenje u zglobu koje uzrokuje bol i oticanje - trombocitopenija (smanjen broj trombocita, stanica koje pomažu u zgrušavanju krvi) - alergijske reakcije, uključujući alergijske reakcije kože - oštećenje funkcije jetre (može se vidjeti iz pretraga koje obavlja liječnik) - krvne pretrage mogu pokazati povišene vrijednosti bilirubina, nekih gušteračinih ili jetrenih enzima ili povećan broj trombocita
English: To prevent blood clots in the veins after a hip or knee replacement operation: Take the first tablet 6 - 10 hours after your operation.
Croatian: Prvu tabletu uzmite 6-10 sati nakon operacije.
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 section 4.3).
Croatian: Xarelto je kontraindiciran u bolesnika s bolešću jetre povezanom s koagulopatijom i s klinički značajnim rizikom od krvarenja, uključujući bolesnike s cirozom, Child-Pugh stadija B i C (vidjeti dio
English: A prespecified pooled analysis of the outcome of the Einstein DVT and PE studies was conducted (see Table 7).
Croatian: Provedena je unaprijed definirana objedinjena analiza ishoda ispitivanja Einstein DVT i Einstein PE (vidjeti Tablicu 7).
English: Titanium dioxide (E 171) Iron oxide red (E 172)
Croatian: željezov oksid, crveni (E 172)
English: EU/1/08/472/001-010, EU/1/08/472/022, EU/1/08/472/042-045.
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/08/472/001-010, EU/1/08/472/022, EU/1/08/472/042-045.
English: Within the highest tertile according to centre, the HR with rivaroxaban versus warfarin was 0.642 (95% CI: 0.277 - 1.484).
Croatian: Unutar najvišeg tercila prema centru omjer hazarda s rivaroksabanom u odnosu na varfarin bio je 0,642 (95% CI: 0,277
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS UNIT DOSE BLISTER (10 X 1 TABLETS) FOR 15 MG
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER S JEDINIČNIM DOZAMA (10 X 1 TABLETA) ZA 15 MG
English: If a dose is missed during the once daily treatment phase, the patient should take Xarelto immediately, and continue on the following day with the once daily intake as recommended.
Croatian: Ako propusti uzeti dozu u razdoblju uzimanja lijeka jedanput na dan, bolesnik mora uzeti Xarelto odmah i sljedeći dan nastaviti s uzimanjem doze jedanput na dan kao što je preporučeno.
English: Xarelto 10 mg (only applicable for outer carton, not applicable for bottle label)
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Xarelto 10 mg (primjenjivo samo za vanjsku kutiju, nije primjenjivo za naljepnicu za bocu)
English: Xarelto 10 mg film-coated tablets are light red, round, biconvex and marked with the BAYER-cross on one side and “10” and a triangle on the other side.
Croatian: Xarelto 10 mg filmom obložene tablete su svijetlocrvene boje, okrugle, bikonveksne i označene s BAYER-ovim križićem na jednoj strani, te brojem „10“ i trokutom na drugoj strani.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER OF 14 TABLETS FOR 2.5 MG
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER SA 14 TABLETA ZA 2,5 MG
English: Table 6: Efficacy and safety results from pooled analysis of phase III Einstein DVT and Einstein PE
Croatian: Tablica 6: Rezultati djelotvornosti i sigurnosti iz objedinjene analize ispitivanja faze III Einstein DVT i Einstein PE
English: 100 film-coated tablets
Croatian: OBLIK I SADRŽAJ 100 filmom obloženih tableta
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON OF MULTIPACK (INCLUDING BLUE BOX) FOR 2.5 MG
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA VIŠESTRUKOG PAKIRANJA (UKLJUČUJUĆI PLAVI OKVIR) ZA 2,5
English: Table 6: Safety results from phase III ATLAS ACS 2 TIMI 51 Study population
Croatian: Tablica 6: Rezultati sigurnosti iz ispitivanja faze III ATLAS ACS 2 TIMI 51 Populacija uključena u ispitivanje Bolesnici s nedavnim akutnim koronarnim sindromom a) Terapijska doza
English: Xarelto 15 mg tablets Xarelto 20 mg tablets rivaroxaban
Croatian: NAZIV LIJEKA Xarelto 15 mg tablete Xarelto 20 mg tablete rivaroksaban
English: 06803 Bitterfeld-Wolfen
Croatian: Ortsteil Greppin, Salegaster Chaussee 1 06803 Bitterfeld-Wolfen Njemačka
English: A prespecified pooled analysis of the outcome of the Einstein DVT and PE studies was conducted (see Table 8).
Croatian: Provedena je unaprijed definirana objedinjena analiza ishoda ispitivanja Einstein DVT i Einstein PE (vidjeti tablicu 8).
English: Symptomatic recurrent VTE* 8
Croatian: Simptomatski ponavljajući VTE* 86
English: 20 mg film-coated tablet: brown-red, round biconvex tablets (6 mm diameter, 9 mm radius of curvature) marked with the BAYER-cross on one side and “20” and a triangle on the other side.
Croatian: Filmom obložena tableta od 20 mg: smeđecrvene, okrugle, bikonveksne tablete (promjera 6 mm, polumjera zakrivljenosti 9 mm) označene s BAYER-ovim križićem na jednoj strani, te brojem "20" i trokutom na drugoj strani.
English: In the Einstein PE study (see Table 7) rivaroxaban was demonstrated to be non-inferior to enoxaparin/VKA for the primary efficacy outcome (p=0.0026 (test for non-inferiority); HR: 1.123 (0.749 - 1.684)).
Croatian: U ispitivanju Einstein PE (vidjeti tablicu 7) pokazano je da je rivaroksaban neinferioran u odnosu na enoksaparin/ antagonist vitamina K za primarni ishod djelotvornosti (p= 0,0026 (ispitivanje neinferiornosti); omjer hazarda: 1,123 (0,749 - 1,684)).
English: Table 9: Efficacy and safety results from phase III Einstein Extension Study population
Croatian: Tablica 9: Rezultati djelotvornosti i sigurnosti iz ispitivanja faze III Einstein Extension
English: Xarelto contains the active substance rivaroxaban and is used in adults to: - prevent blood clots in brain (stroke) and other blood vessels in your body if you have a form of irregular heart rhythm called non-valvular atrial fibrillation.
Croatian: Xarelto sadrži djelatnu tvar rivaroksaban i koristi se u odraslih za: - Sprječavanje stvaranja krvnih ugrušaka u mozgu (moždani udar) i drugim krvnim žilama u tijelu ako imate oblik nepravilnog srčanog ritma koji se zove nevalvularna fibrilacija atrija. - liječenje krvnih ugrušaka u venama nogu (duboka venska tromboza) i u krvnim žilama pluća (plućna embolija) i sprječavanje ponovnog pojavljivanja krvnih ugrušaka u krvnim žilama nogu i/ili pluća.
English: They come - in blisters in cartons of 14, 20, 28, 30, 56, 60, 98, 168 or 196 film-coated tablets or - in unit dose blisters in cartons of 10 x 1 or 100 x 1 or - in multipacks comprising 10 cartons, each containing 10 x 1 film-coated tablets or - in bottles of 100 film-coated tablets.
Croatian: - u blisterima u kutijama s po 14, 20, 28, 30, 56, 60, 98, 168 ili 196 filmom obloženih tableta ili - u blisterima s jediničnim dozama u kutijama od 10 x 1 ili 100 x 1 ili - u višestrukim pakiranjima koja sadrže 10 kutija, od kojih svaka sadrži 10 x 1 filmom obloženu tabletu ili - u bocama s po 100 filmom obloženih tableta.
English: In the Einstein PE study (see Table 5) rivaroxaban was demonstrated to be non-inferior to enoxaparin/VKA for the primary efficacy outcome (p=0.0026 (test for non-inferiority); HR: 1.123 (0.749 - 1.684)).
Croatian: U ispitivanju Einstein PE (vidjeti tablicu 5) pokazano je da je rivaroksaban neinferioran u odnosu na enoksaparin/ antagonist vitamina K za primarni ishod djelotvornosti (p= 0,0026 (ispitivanje neinferiornosti); omjer hazarda: 1,123 (0,749 - 1,684)).
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 se podvrgavaju elektivnom kirurškom zahvatu ugradnje umjetnog kuka ili koljena.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER OF 10 TABLETS FOR 2.5 MG
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER S 10 TABLETA ZA 2,5 MG
English: 6.7 per 100 patient years
Croatian: 6,7 na 100 bolesnik-godina
English: Each 15 mg film-coated tablet contains 24.13 mg lactose (as monohydrate), see section 4.4.
Croatian: Jedna filmom obložena tableta od 15 mg sadrži 24,13 mg laktoze (u obliku laktoza hidrata), vidjeti dio 4.4.
English: In the Einstein PE study (see Table 6) rivaroxaban was demonstrated to be non-inferior to enoxaparin/VKA for the primary efficacy outcome (p=0.0026 (test for non-inferiority); HR: 1.123 (0.749 - 1.684)).
Croatian: U ispitivanju Einstein PE (vidjeti Tablicu 6) pokazano je da je rivaroksaban neinferioran u odnosu na enoksaparin/ antagonist vitamina K za primarni ishod djelotvornosti (p= 0,0026 (ispitivanje neinferiornosti); omjer hazarda: 1,123 (0,749 - 1,684)).
English: Table 7: Efficacy and safety results from phase III Einstein Extension Study population
Croatian: Tablica 7: Rezultati djelotvornosti i sigurnosti iz ispitivanja faze III Einstein Extension Populacija uključena u ispitivanje
English: liver injury) - yellowing of the skin and eye (jaundice) localised swelling - collection of blood (haematoma) in the groin as a complication of the cardiac procedure where a catheter is inserted in your leg artery (pseudoaneurysm)
Croatian: - nakupljanje krvi (hematom) u preponi kao komplikacija u srčanom postupku u kojem se uvodi kateter u arteriju noge (pseudoaneurizma)
English: - allergic reactions, including allergic skin reactions - impaired function of the liver (may be seen in tests performed by your doctor) - blood tests may show an increase in bilirubin, some pancreatic or liver enzymes or in the number of platelets - fainting - feeling unwell - faster heartbeat - dry mouth - hives
Croatian: - trombocitopenija (smanjen broj trombocita, stanica koje pomažu u zgrušavanju krvi) - alergijske reakcije, uključujući alergijske reakcije na koži - oštećenje funkcije jetre (može se vidjeti na pretragama koje radi Vaš liječnik) - krvne pretrage mogu pokazati povišene vrijednosti bilirubina, nekih gušteračinih ili jetrenih enzima ili povećan broj trombocita
English: Care is to be taken if patients are treated concomitantly with medicinal products affecting haemostasis such as non-steroidal anti-inflammatory medicinal products (NSAIDs), acetylsalicylic acid and platelet aggregation inhibitors or selective serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine reuptake inhibitors (SNRIs).
Croatian: Nužan je oprez ako su bolesnici istodobno liječeni lijekovima koji utječu na hemostazu, kao što su nesteroidni protuupalni lijekovi (NSAIL), acetilsalicilatna kiselina i inhibitori agregacije trombocita ili selektivni inhibitori ponovne pohrane serotonina (SSRI-jevi) i inhibitori ponovne pohrane serotonina i noradrenalina (SNRI-jevi).
English: - If you are taking
Croatian: - ako ste trudni ili dojite
English: a drug reaction that causes rash, fever, inflammation of internal organs, hematologic abnormalities and systemic illness (DRESS syndrome).
Croatian: Učestalost ove nuspojave je vrlo rijetka (u do 1 na 10 000). - reakcija na lijek koja uzrokuje osip, vrućicu, upalu unutarnjih organa, hematološke promjene i sustavnu bolest (DRESS sindrom).
English: OUTER CARTON AND LABEL FOR HDPE BOTTLE FOR 20 MG
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM I UNUTARNJEM PAKIRANJU VANJSKA KUTIJA I NALJEPNICA ZA HDPE BOCU ZA 20 MG
English: Xarelto 2.5 mg film-coated tablets rivaroxaban
Croatian: Xarelto 2,5 mg filmom obložene tablete rivaroksaban
English: Stroke, non-CNS systemic embolism and vascular death
Croatian: Moždani udar, sistemska embolija koja nije vezana uz središnji živčani sustav i smrt uzrokovana vaskularnim komplikacijama
English: Table 4: Efficacy results from phase III ATLAS ACS 2 TIMI 51 Study population
Croatian: Tablica 4: Rezultati djelotvornosti iz ispitivanja faze III ATLAS ACS 2 TIMI 51 Populacija uključena u ispitivanje Bolesnici s nedavnim akutnim koronarnim sindromom a)
English: Each film-coated tablet contains 26.51 mg lactose (as monohydrate), see section 4.4.
Croatian: Jedna filmom obložena tableta sadrži 26,51 mg laktoze (u obliku laktoza hidrata), vidjeti dio 4.4.
English: Table 8: Efficacy and safety results from phase III Einstein Choice Study population
Croatian: Tablica 8: Rezultati djelotvornosti i sigurnosti iz ispitivanja faze III Einstein Choice Populacija uključena u ispitivanje
English: For the initial treatment of acute PE 15 mg rivaroxaban was administered twice daily for three weeks.
Croatian: Za početno liječenje akutne plućne embolije primjenjivao se rivaroksaban od 15 mg dvaput na dan kroz tri tjedna, a nakon toga rivaroksaban od 20 mg jedanput na dan.
English: UAB Bayer Tel: +370-5-233 68 68
Croatian: Tel: +370-5-233 68 68
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX) FOR 20 MG
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU UNUTARNJA KUTIJA VIŠESTRUKOG PAKIRANJA (BEZ PLAVOG OKVIRA) ZA 20 MG
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER OF 14 TABLETS FOR 20 MG
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER SA 14 TABLETA ZA 20 MG
English: Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.
Croatian: Liječenje duboke venske tromboze (DVT), plućne embolije (PE) i prevencija njihovog ponovnog javljanja od 1. do 21. dana: 30
English: Care is to be taken if patients are treated concomitantly with medicinal products affecting haemostasis such as non-steroidal anti-inflammatory medicinal products (NSAIDs), acetylsalicylic acid (ASA) and platelet aggregation inhibitors or selective serotonin reuptake inhibitors (SSRIs) and serotonin norepinephrine reuptake inhibitors (SNRIs).
Croatian: Nužan je oprez ako su bolesnici istodobno liječeni lijekovima koji utječu na hemostazu, kao što su nesteroidni protuupalni lijekovi (NSAIL), acetilsalicilatna kiselina (ASK) i inhibitori agregacije trombocita ili selektivni inhibitori ponovne pohrane serotonina (SSRI-jevi) i inhibitori ponovne pohrane serotonina i noradrenalina (SNRI-jevi).
English: From Day 22: 20 mg 1 tablet once a day (taken at same time each day) together with food.
Croatian: Od 22. dana nadalje: tableta od 20 mg jedanput na dan (uzeta svaki dan u isto vrijeme) s hranom.
English: No dose adjustment is necessary in patients with mild renal impairment (creatinine clearance 5080 ml/min) or moderate renal impairment (creatinine clearance 30 - 49 ml/min) (see section 5.2).
Croatian: 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: Day 1 to 21: One 15 mg tablet twice a day (one 15 mg tablet in the morning and one in the evening) together with food.
Croatian: Od 1. do 21. dana: 1 tableta od 15 mg dvaput na dan (jedna tableta od 15 mg ujutro i jedna tableta navečer) s hranom.
English: Each film-coated tablet contains 2.5 mg rivaroxaban.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna filmom obložena tableta sadrži 2,5 mg rivaroksabana.
English: Xarelto 20 mg tablets rivaroxaban
Croatian: NAZIV LIJEKA Xarelto 20 mg tablete rivaroksaban
English: Xarelto 2.5 mg film-coated tablets
Croatian: NAZIV LIJEKA Xarelto 2,5 mg filmom obložene tablete
English: Major bleeding events a) Rivaroxaban 15 mg twice daily for 3 weeks followed by 20 mg once daily b) Enoxaparin for at least 5 days, overlapped with and followed by VKA * p < 0.0001 (non-inferiority to a prespecified HR of 2.0); HR: 0.680 (0.443 - 1.042), p=0.076 (superiority)
Croatian: Veća krvarenja a) Rivaroksaban 15 mg dvaput na dan kroz 3 tjedna, te potom 20 mg jedanput na dan b) Enoksaparin kroz najmanje 5 dana, uz preklapanje i nastavak s antagonistom vitamina K * p < 0,0001 (neinferiornost prema unaprijed određenom omjeru hazarda od 2,0); omjer hazarda: 0,680 (0,443-1,042), p=0,076 (superiornost)
English: Each film-coated tablet contains 21.76 mg lactose (as monohydrate), see section 4.4.
Croatian: Jedna filmom obložena tableta sadrži 21,76 mg laktoze (u obliku laktoza hidrata), vidjeti dio 4.4.
English: OUTER CARTON AND LABEL FOR HDPE BOTTLE FOR 10 MG
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM I UNUTARNJEM PAKIRANJU VANJSKA KUTIJA I NALJEPNICA ZA HDPE BOCU ZA 10 MG
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX) FOR 15 MG
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU UNUTARNJA KUTIJA VIŠESTRUKOG PAKIRANJA (BEZ PLAVOG OKVIRA) ZA 15 MG
English: Xarelto 15 mg film-coated tablets rivaroxaban
Croatian: Xarelto 15 mg filmom obložena tableta rivaroksaban
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER OF 10 TABLETS FOR 20 MG
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER S 10 TABLETA ZA 20 MG
English: EU/1/08/472/004 100 x 1 film-coated tablets (PVC/PVDC/Aluminium foil blisters) EU/1/08/472/005 5 film-coated tablets
Croatian: EU/1/08/472/004 100 x 1 filmom obložena tableta (blisteri od PVC/PVDC/aluminijska folija) EU/1/08/472/005 5 filmom obloženih tableta
English: Table 10: Efficacy and safety results from phase III Einstein Choice Study population
Croatian: Tablica 10: Rezultati djelotvornosti i sigurnosti iz ispitivanja faze III Einstein Choice Populacija uključena u ispitivanje
English: EU/1/08/472/043 28 film-coated tablets
Croatian: EU/1/08/472/043 28 filmom obloženih tableta
English: No dose adjustment is necessary in patients with mild renal impairment (creatinine clearance 5080 ml/min) (see section 5.2).
Croatian: U bolesnika s blago oštećenom funkcijom bubrega (klirens kreatinina 50 - 80 ml/min) dozu ne treba prilagođavati (vidjeti dio 5.2).
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 you are older than 75 years you weigh 60 kg or less you have a coronary artery disease with severe symptomatic heart failure - 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: poremećaja s krvarenjem vrlo visokog krvnog tlaka, koji nije kontroliran lijekovima bolesti želuca ili crijeva koje 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 ste stariji od 75 godina ako imate tjelesnu težinu 60 kilograma ili manje ako imate bolest koronarnih arterija s teškim simptomatskim zatajivanjem srca - 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.
English: Localised oedemaA
Croatian: Lokalizirani edemiA
English: Xarelto 10 mg tablets rivaroxaban
Croatian: NAZIV LIJEKA Xarelto 10 mg tablete rivaroksaban