natgillin/translations-raw huggingface dataset:
Xarelto 2.5 mg film-coated tablets are light yellow, round, biconvex and marked with the BAYERcross on one side and “2.5” and a triangle on the other side.
Xarelto 2,5 mg filmom obložene tablete su svijetložute, okrugle, bikonveksne tablete označene BAYER-ovim križićem na jednoj strani, te brojem "2,5" i trokutom na drugoj strani.
Table 9: Efficacy and safety results from phase III Einstein Choice Study population
Tablica 9: Rezultati djelotvornosti i sigurnosti iz ispitivanja faze III Einstein Choice Populacija uključena u ispitivanje
10 mg once daily or 20 mg once daily
Od 22. dana nadalje 20 mg jedanput na dan 20 mg
OUTER CARTON AND LABEL FOR HDPE BOTTLE FOR 15 MG
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM I UNUTARNJEM PAKIRANJU VANJSKA KUTIJA I NALJEPNICA ZA HDPE BOCU ZA 15 MG
- if you are allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6) - if you are bleeding excessively - if you have a disease or condition in an organ of the body that increases the risk of serious bleeding (e.g. stomach ulcer, injury or bleeding in the brain, recent surgery of the brain or eyes) - if you are taking medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), except when changing anticoagulant treatment or while getting heparin through a venous or arterial line to keep it open.
- ako imate bolest ili stanje nekog organa u tijelu koji povećavaju rizik od teškog krvarenja (npr. čir na želucu, ozljedu mozga ili krvarenje u mozgu, nedavni kirurški zahvati na mozgu ili očima) - ako uzimate lijekove za sprječavanje zgrušavanja krvi (npr. varfarin, dabigatran, apiksaban ili heparin), osim kod promjene antikoagulacijskog liječenja ili kod primanja heparina kroz postavljeni venski ili arterijski put da bi ga se održalo otvorenim.
EU/1/08/472/018 28 film-coated tablets
EU/1/08/472/018 28 filmom obloženih tableta
- 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) 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))
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) druge lijekove koji smanjuju stvaranje krvnih ugrušaka (npr. enoksaparin, klopidogrel ili antagoniste vitamina
- if you are allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6) - if you are bleeding excessively - if you have a disease or condition in an organ of the body that increases the risk of serious bleeding (e.g. stomach ulcer, injury or bleeding in the brain, recent surgery of the brain or eyes) - if you are taking medicines to prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), except when changing anticoagulant treatment or while getting heparin through a venous or arterial line to keep it open - if you have a liver disease which leads to an increased risk of bleeding - if you are pregnant or breast-feeding
- ako imate bolest ili stanje nekog organa u tijelu koje povećava rizik od teškog krvarenja (npr. čir na želucu, ozljeda ili krvarenje u mozgu, nedavni kirurški zahvat na mozgu ili očima) - ako uzimate lijekove za sprječavanje zgrušavanja krvi (npr. varfarin, dabigatran, apiksaban ili heparin), osim kod promjene antikoagulacijskog liječenja ili kod primanja heparina kroz venski ili arterijski put da bi ga se održalo otvorenim - ako imate bolest jetre zbog koje je povećan rizik od krvarenja
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 1.75); HR: 0.886 (0.661 - 1.186)
Veće krvarenje 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 1,75); omjer hazarda: 0,886 (0,661 - 1,186)
Xarelto 15 mg film-coated tablets are red, round, biconvex and marked with the BAYER-cross on one side and “15” and a triangle on the other side.
Xarelto 15 mg filmom obložene tablete su crvene, okrugle, bikonveksne tablete označene s BAYERovim križićem na jednoj strani, te brojem «15» i trokutom na drugoj strani.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING WALLET OF TREATMENT INITIATION PACK (42 FILM-COATED TABLETS OF 15 MG AND 7 FILM-COATED TABLETS OF 20 MG) (WITHOUT BLUE BOX)
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA PAKIRANJA ZA POČETAK LIJEČENJA (42 FILMOM OBLOŽENE TABLETE OD 15 MG I 7 FILMOM OBLOŽENIH
10 x 1 film-coated tablets 100 x 1 film-coated tablets
10 filmom obloženih tableta 14 filmom obloženih tableta 28 filmom obloženih tableta 98 filmom obloženih tableta 10 x 1 filmom obložena tableta 100 x 1 filmom obložena tableta
EU/1/08/472/013 42 film-coated tablets
EU/1/08/472/013 42 filmom obloženih tableta
Xarelto 20 mg film-coated tablets are brown-red, round, biconvex and marked with the BAYER-cross on one side and “20” and a triangle on the other.
Xarelto 20 mg filmom obložene tablete su smeđecrvene, okrugle, bikonveksne tablete označene s BAYER-ovim križićem na jednoj strani, te brojem "20" i trokutom na drugoj strani.
Dosing recommendations before and after invasive procedures and surgical intervention If an invasive procedure or surgical intervention is required, Xarelto 2.5 mg should be stopped at least 12 hours before the intervention, if possible and based on the clinical judgement of the physician.
Ako je potreban invazivni postupak ili kirurški zahvat, Xarelto 2,5 mg se mora prekinuti najmanje 12 sati prije zahvata, ako je to moguće i na temelju kliničke procjene liječnika.
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 International Normalised Ratio (INR) is ≤ 2.5.
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 međunarodni normalizirani omjer (engl.International Normalised Ratio, INR)
Day 1 to 21: 15 mg 1 tablet twice a day (one 15 mg tablet in the morning and one in the evening) together with food.
Od 1.do 21. dana: tableta od 15 mg dvaput na dan (jedna tableta od 15 mg ujutro i jedna navečer) s hranom.
EU/1/08/472/044 98 film-coated tablets
EU/1/08/472/044 98 filmom obloženih tableta
PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX) FOR 10 MG
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU UNUTARNJA KUTIJA VIŠESTRUKOG PAKIRANJA (BEZ PLAVOG OKVIRA) ZA 10 MG
Xarelto 10 mg film-coated tablets rivaroxaban
Xarelto 10 mg filmom obložene tablete rivaroksaban
Prevention of atherothrombotic events in patients after an ACS
Prevencija aterotrombotskih događaja u bolesnika s BKA-om
EU/1/08/472/025-035, EU/1/08/472/041, EU/1/08/472/046-047
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/08/472/025-035, EU/1/08/472/041, EU/1/08/472/046-047.
In Einstein Extension 1,197 patients with DVT or PE were studied for the prevention of recurrent DVT and PE.
U ispitivanju Einstein Extension proučavana je prevencija ponavljajuće duboke venske tromboze i plućne embolije u 1197 bolesnika s dubokom venskom trombozom ili plućnom embolijom.
Do not take Xarelto and tell your doctor if any of these apply to you.
Odnosi li se bilo što od toga na Vas, nemojte uzimati Xarelto i obavijestite o tome svog liječnika.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON OF MULTIPACK (INCLUDING BLUE BOX) FOR 15 MG
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA VIŠESTRUKOG PAKIRANJA (UKLJUČUJUĆI PLAVI OKVIR) ZA 15
Light yellow, round biconvex tablets (6 mm diameter, 9 mm radius of curvature) marked with the BAYER-cross on one side and "2.5" and a triangle on the other side.
Svijetložute, okrugle, bikonveksne tablete (promjera 6 mm, polumjera zakrivljenosti 9 mm) označene s BAYER-ovim križićem na jednoj strani, te brojem "2,5" i trokutom na drugoj strani.
EU/1/08/472/016 100 x 1 film-coated tablets (PP/Aluminium foil blisters) EU/1/08/472/038 10 film-coated tablets
EU/1/08/472/016 100 x 1 filmom obložena tableta (blisteri od PP/aluminijska folija) EU/1/08/472/038 10 filmom obložena tableta
Xarelto 15 mg tablets rivaroxaban
NAZIV LIJEKA Xarelto 15 mg tablete rivaroksaban
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER OF 10 TABLETS FOR 15 MG
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER S 10 TABLETA ZA 15 MG
Critical organ bleeding*
Smrt zbog krvarenja* Krvarenje iz kritičnog organa * Intrakranijalno krvarenje* 55
EU/1/08/472/008 100 x 1 film-coated tablets (PP/Aluminium foil blisters) EU/1/08/472/009 10 x 1 film-coated tablets
EU/1/08/472/008 100 x 1 filmom obložena tableta (blisteri od PP/aluminijska folija) EU/1/08/472/009 10 x 1 filmom obložena tableta
EU/1/08/472/020 10 x 1 film-coated tablets
EU/1/08/472/020 10 x 1 filmom obložena tableta
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER OF 14 TABLETS FOR 10 MG
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER S 14 TABLETA ZA 10 MG
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER OF 14 TABLETS FOR 15 MG
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER SA 14 TABLETA ZA 15 MG
EU/1/08/472/007 30 film-coated tablets
EU/1/08/472/007 30 filmom obloženih tableta
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON OF MULTIPACK (INCLUDING BLUE BOX) FOR 20 MG
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA VIŠESTRUKOG PAKIRANJA (UKLJUČUJUĆI PLAVI OKVIR) ZA 20
EU/1/08/472/015 10 x 1 film-coated tablets
EU/1/08/472/015 10 x 1 filmom obložena tableta
Feeling unwell (incl.
Loše osjećanje (uključujući malaksalost)
EU/1/08/472/049 14 film-coated tablets
EU/1/08/472/049 14 filmom obloženih tableta
Each film-coated tablet contains 24.13 mg lactose (as monohydrate), see section 4.4.
Jedna filmom obložena tableta sadrži 24,13 mg laktoze (u obliku laktoza hidrata), vidjeti dio 4.4.
Light red, round biconvex tablets (6 mm diameter, 9 mm radius of curvature) marked with the BAYER-cross on one side and "10" and a triangle on the other side.
Svijetlocrvene, okrugle, bikonveksne tablete (promjera 6 mm, polumjera zakrivljenosti 9 mm) označene s BAYER-ovim križićem na jednoj strani, te brojem "10" i trokutom na drugoj strani.
Mean follow-up was
* Nominalno značajno
- if your doctor determines that your blood pressure is unstable or another treatment or surgical procedure to remove the blood clot from your lungs is planned
- 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
EU/1/08/472/021 100 x 1 film-coated tablets (PP/Aluminium foil blisters) EU/1/08/472/039 10 film-coated tablets
EU/1/08/472/021 100 x 1 filmom obložena tableta (blisteri od PP/aluminijska folija) EU/1/08/472/039 10 filmom obloženih tableta
Contact your doctor immediately if you have taken too many Xarelto tablets.
Ako uzmete previše tableta Xarelto, odmah se obratite liječniku.
EU/1/08/472/006 10 film-coated tablets
EU/1/08/472/006 10 filmom obloženih tableta
Total VTE 18 (1.1%) 58 (3.7%) < 0.001 17 (2.0%) 81 (9.3%) < 0.001 79 (9.6%) 166 (18.9%) < 0.001 Major
- infarkt miokarda 178 (1,9%) 2,46% 205 (2,2%) 2,94% 0,86 (0,70; 1,05) p = 0,14458
Xarelto 10 mg film-coated tablets
NAZIV LIJEKA Xarelto 10 mg filmom obložene tablete
EU/1/08/472/003 30 film-coated tablets
EU/1/08/472/003 30 filmom obloženih tableta
EU/1/08/472/048 14 film-coated tablets
EU/1/08/472/048 14 filmom obloženih tableta
Common (may affect up to 1 in 10 people) - reduction in red blood cells which can make the skin pale and cause weakness or breathlessness - bleeding in the stomach or bowel, urogenital bleeding (including blood in the urine and heavy menstrual bleeding), nose bleed, bleeding in the gum - bleeding into the eye (including bleeding from the whites of the eyes) - bleeding into tissue or a cavity of the body (haematoma, bruising) - coughing up blood - bleeding from the skin or under the skin - bleeding following an operation - oozing of blood or fluid from surgical wound - swelling in the limbs - pain in the limbs - impaired function of the kidneys (may be seen in tests performed by your doctor) - fever - stomach ache, indigestion, feeling or being sick, constipation, diarrhoea - low blood pressure (symptoms may be feeling dizzy or fainting when standing up) - decreased general strength and energy (weakness, tiredness), headache, dizziness - rash, itchy skin - blood tests may show an increase in some liver enzymes
- bol u udovima - oštećenje funkcije bubrega (može se vidjeti iz pretraga koje obavlja liječnik) - vrućica - bol u trbuhu, probavne tegobe, mučnina ili povraćanje, zatvor, proljev - nizak krvni tlak (simptomi mogu biti osjećaj omaglice ili nesvjestica prilikom ustajanja) - smanjenje opće snage i energije (slabost, umor), glavobolja, omaglica - osip, svrbež kože - krvne pretrage mogu pokazati povišene vrijednosti nekih enzima jetre
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON OF MULTIPACK (INCLUDING BLUE BOX) FOR 10 MG
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA VIŠESTRUKOG PAKIRANJA (UKLJUČUJUĆI PLAVI OKVIR) ZA 10
Non-major clinically relevant bleeding events
Manja klinički značajna krvarenja
Pain in extremityA Haemarthrosis
Society on Thrombosis and Haemostasis)
- treat blood clots in the veins of your legs (deep vein thrombosis) and in the blood vessels of your lungs (pulmonary embolism), and to prevent blood clots from re-occurring in the blood vessels of your legs and/or lungs.
Liječnik Vam je propisao ovaj lijek jer ste nakon operacije izloženi većem riziku od stvaranja krvnih ugrušaka. - 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.
EU/1/08/472/012 28 film-coated tablets
EU/1/08/472/012 28 filmom obloženih tableta
No clinically relevant prolongation of bleeding time was observed after concomitant administration of rivaroxaban (15 mg) and 500 mg naproxen.
Nakon istodobne primjene rivaroksabana (15 mg) s naproksenom u dozi od 500 mg nije uočeno klinički značajno produljenje vremena krvarenja.
Xarelto 20 mg film-coated tablets
NAZIV LIJEKA Xarelto 20 mg filmom obložene tablete
Common (may affect up to 1 in 10 people) - reduction in red blood cells which can make the skin pale and cause weakness or breathlessness - bleeding in the stomach or bowel, urogenital bleeding (including blood in the urine and heavy menstrual bleeding), nose bleed, bleeding in the gum - bleeding into the eye (including bleeding from the whites of the eyes) - bleeding into tissue or a cavity of the body (haematoma, bruising) - coughing up blood - bleeding from the skin or under the skin - bleeding following an operation - oozing of blood or fluid from surgical wound- swelling in the limbs - pain in the limbs - impaired function of the kidneys (may be seen in tests performed by your doctor) - fever - stomach ache, indigestion, feeling or being sick, constipation, diarrhoea - low blood pressure (symptoms may be feeling dizzy or fainting when standing up) - decreased general strength and energy (weakness, tiredness), headache, dizziness - rash, itchy skin - blood tests may show an increase in some liver enzymes
- bol u udovima - oštećena funkcija bubrega (može se vidjeti na testovima koje provodi Vaš liječnik) - vrućica - bol u trbuhu, probavne tegobe, mučnina ili povraćanje, zatvor, proljev - nizak krvni tlak (simptomi mogu biti osjećaj omaglice ili nesvjestice prilikom ustajanja) - smanjenje opće snage i energije (slabost, umor), glavobolja, omaglica - osip, svrbež kože - krvne pretrage mogu pokazati povišene vrijednosti nekih jetrenih enzima
Dosing recommendations before and after invasive procedures and surgical intervention If an invasive procedure or surgical intervention is required, Xarelto 15 mg/ Xarelto 20 mg should be stopped at least 24 hours before the intervention, if possible and based on the clinical judgement of the physician.
Ako je potreban invazivni postupak ili kirurški zahvat Xarelto 15 mg/ Xarelto 20 mg se mora prestati uzimati najmanje 24 sata prije zahvata, ako je to moguće i na temelju kliničke procjene liječnika.
Xarelto 20 mg film-coated tablets rivaroxaban
Xarelto 20 mg filmom obložene tablete rivaroksaban
They come in blisters in cartons of 10, 14, 28, 42 or 98 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.
- u blisterima u kutijama s po 10, 14, 28, 42 ili 98 filmom obloženih tableta ili - u blisterima s jediničnim dozama u kutijama od 10 x 1 ili 100 x 1 ili - u višestrukim pakiranjima od 10 kutija od kojih svaka sadrži 10 x 1 filmom obloženu tabletu ili - u bocama sa 100 filmom obloženih tableta.
In patients receiving rivaroxaban for treatment of DVT and PE and prevention of recurrence, the 5/95 percentiles for PT (Neoplastin) 2 - 4 hours after tablet intake (i.e. at the time of maximum effect) for 15 mg rivaroxaban twice daily ranged from 17 to 32 s and for 20 mg rivaroxaban once daily from 15 to 30 s. At trough (8 - 16 h after tablet intake) the 5/95 percentiles for 15 mg twice daily ranged from 14 to 24 s and for 20 mg once daily (18 - 30 h after tablet intake) from 13 to 20 s. In patients with non-valvular atrial fibrillation receiving rivaroxaban for the prevention of stroke and systemic embolism, the 5/95 percentiles for PT (Neoplastin) 1 - 4 hours after tablet intake (i.e. at the time of maximum effect) in patients treated with 20 mg once daily ranged from 14 to 40 s and in patients with moderate renal impairment treated with 15 mg once daily from 10 to 50 s. At trough (16 - 36 h after tablet intake) the 5/95 percentiles in patients treated with 20 mg once daily ranged from 12 to 26 s and in patients with moderate renal impairment treated with 15 mg once daily from 12 to 26 s.
U bolesnika koji boluju od nevalvularne fibrilacije atrija i koji rivaroksaban dobivaju za prevenciju moždanog udara i sistemske embolije, trajanje PV-a (Neoplastin) 1-4 sati nakon uzimanja tablete (tj. u vrijeme maksimalnog učinka) u bolesnika koji dobivaju 20 mg lijeka jedanput na dan u 5% slučajeva je manje od 14 s, a u 5% slučajeva dulje od 40 s, a u bolesnika s umjereno oštećenom funkcijom bubrega koji dobivaju 15 mg lijeka na dan u 5% slučajeva je manje od 10 s, a u 5% slučajeva dulje od 50 s.
PP/Aluminium foil blisters in cartons of 10, 14, 28, 42 or 98 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) filmcoated tablets.
PP/aluminij blisteri u kutijama s po 10, 14, 28, 42 ili 98 filmom obloženih tableta ili perforirani blisteri s jediničnim dozama u kutijama od po 10 x 1, 100 x 1 ili višestruka pakiranja koja sadrže 100 (10 pakiranja od 10 x 1) filmom obloženih tableta.
They come in blisters in cartons of 5, 10, 14, 28, 30 or 98 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.
- u kutijama s po 5, 10, 14, 28, 30 ili 98 filmom obloženih tableta ili - u blisterima s jediničnim dozama u kutijama od 10 x 1 ili 100 x 1 ili - u višestrukim pakiranjima od 10 kutija od kojih svaka sadrži 10 x 1 filmom obloženu tabletu ili - u bocama s po 100 filmom obloženih tableta.
PP/Aluminium foil blisters in cartons of 5, 10, 14, 28, 30 or 98 film-coated tablets or perforated unit dose blisters in cartons of 10 x 1, 100 x 1, or in multipacks containing 100 (10 packs of 10 x 1) filmcoated tablets.
PP/aluminij blisteri u kutijama s po 5, 10, 14, 28, 30 ili 98 filmom obloženih tableta ili perforirani blisteri s jediničnim dozama u kutijama s po 10 x 1, 100 x 1 ili višestrukim pakiranjima koja sadrže 100 (10 pakiranja s po 10 x 1) filmom obloženih tableta.
EU/1/08/472/010 10 x 1 film-coated tablets
EU/1/08/472/010 10 x 1 filmom obložena tableta
Treatment dose and duration after surgery
Doza i trajanje liječenja nakon zahvata rivaroksaba n
EU/1/08/472/019 98 film-coated tablets
EU/1/08/472/019 98 filmom obloženih tableta
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.
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.
Prior to neuraxial intervention the physician should consider the potential benefit versus the risk in anticoagulated patients or in patients to be anticoagulated for thromboprophylaxis.
U bolesnika koji primaju antikoagulanse ili će ih primati za tromboprofilaksu, liječnik mora prije neuroaksijalne intervencije razmotriti potencijalnu korist u odnosu na rizik.
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)
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 do 12), dok su učinci na aPTV, inhibiciju aktivnosti faktora Xa i endogeni trombinski potencijal bili aditivni.
uncommon cases of generalised pruritus), rash, ecchymosis, cutaneous and subcutaneous haemorrhage
Poremećaji kože i potkožnog tkiva Svrbež (uključujući manje česte slučajeve generaliziranog svrbeža), osip, ekhimoza, kožno i potkožno krvarenje
EU/1/08/472/014 98 film-coated tablets
EU/1/08/472/014 98 filmom obloženih tableta
Converting from Vitamin K Antagonists (VKA) to Xarelto When converting patients from VKAs to Xarelto, International Normalised Ratio (INR) values could be falsely elevated after the intake of Xarelto.
International Normalised Ratio, INR) mogu biti lažno povećane nakon uzimanja lijeka Xarelto.
EU/1/08/472/042 14 film-coated tablets
EU/1/08/472/042 14 filmom obloženih tableta
Xarelto 15 mg film-coated tablets
NAZIV LIJEKA Xarelto 15 mg filmom obložene tablete
SC Bayer SRL Tel: +40-(0)21-528 59 00
Tel: +40-(0)21-528 59 00
PP/Aluminium foil blisters in cartons of 10, 14, 28 or 98 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) filmcoated tablets.
PP/aluminij blisteri u kutijama s po 10, 14, 28 ili 98 filmom obloženih tableta ili perforirani blisteri s jediničnim dozama u kutijama od po 10 x 1, 100 x 1 ili višestruka pakiranja koja sadrže 100 (10 pakiranja od 10 x 1) filmom obloženih tableta.