FrancophonIA/ELRC3.0 huggingface dataset:
English: EU/1/08/472/030 168 film-coated tablets
Slovenian: EU/1/08/472/030 168 filmsko obloženih tablet
English: Table 4: Efficacy results from phase III ATLAS ACS 2 TIMI 51 Study population
Slovenian: Preglednica 4: Izsledki glede učinkovitosti v kliničnem preskušanju III. faze ATLAS TIMI 51
English: When to start Xarelto
Slovenian: Kdaj morate začeti jemati zdravilo Xarelto
English: No clinically significant pharmacokinetic or pharmacodynamic interactions were observed when rivaroxaban was co-administered with 500 mg acetylsalicylic acid.
Slovenian: Med sočasno uporabo rivaroksabana in acetilsalicilne kisline (500 mg) niso opazili klinično pomembnega farmakokinetičnega ali farmakodinamičnega medsebojnega delovanja.
English: ASA 100 mg od N=9126 n (Cum.risk %)
Slovenian: acetilsalicilna kislina 100 mg enkrat na dan n = 9.126 n (%
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS UNIT DOSE BLISTER (10 X 1 TABLETS) FOR 20 MG
Slovenian: PRETISNI OMOT ZA ENKRATNI ODMEREK (10 X 1 TABLETA) PO 20 MG
English: Each film-coated tablet contains 15 mg rivaroxaban.
Slovenian: Ena filmsko obložena tableta vsebuje 15 mg rivaroksabana.
English: Xarelto 20 mg film-coated tablets rivaroxaban This medicine is subject to additional monitoring.
Slovenian: Xarelto 15 mg filmsko obložene tablete Xarelto 20 mg filmsko obložene tablete rivaroksaban Za to zdravilo se izvaja dodatno spremljanje varnosti.
English: Xarelto contains the active substance rivaroxaban and is used in adults to: - 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.
Slovenian: Zdravnik vam je to zdravilo predpisal, ker ste po kirurškem posegu bolj ogroženi za nastanek krvnih strdkov, - zdravljenje krvnih strdkov v venah vaših nog (globoka venska tromboza) in v krvnih žilah vaših pljuč (pljučna embolija) ter za preprečevanje ponovnega nastanka krvnih strdkov v krvnih žilah vaših nog in/ali pljučih (pljučna embolija).
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).
Slovenian: Bolnikom z blago (očistek kreatinina 50 - 80 ml/min) ali zmerno (očistek kreatinina 30 - 49 ml/min)
English: Enoxaparin/VKAb) 3, 6 or 12 months N=2,413
Slovenian: enoksaparin/AVKb) 3, 6 ali 12 mesecev n = 2.413
English: hepatocellular injury (inflamed liver incl.
Slovenian: hepatitis (vključno s hepatocelularno poškodbo)
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
Slovenian: EU/1/08/472/004 100 x 1 filmsko obložena tableta (pretisni omot iz PVC/PVDC/aluminija) EU/1/08/472/005 5 filmsko obloženih tablet
English: 06803 Bitterfeld-Wolfen
Slovenian: Ortsteil Greppin, Salegaster Chaussee 1 06803 Bitterfeld-Wolfen
English: Renal impairment
Slovenian: odpoved ledvic/
English: - Stroke
Slovenian: bruhanje
English: 569 days.
Slovenian: 3,9 let.
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).
Slovenian: Primarni izid za oceno varnosti (velike krvavitve) se je pojavil pri 6 (0,6 %) bolnikih v skupini, ki je prejemala rivaroksaban (n = 988), in pri 4 bolnikih (0,8 %) v skupini, ki je prejemala antagoniste vitamina K (n = 499) (razmerje tveganja 0,76; 95 % interval zaupanja 0,.21 - 2,67; varnostna populacija).
English: Xarelto 2.5 mg bid in combination with ASA 100 mg od, N=9152 n (Cum.
Slovenian: 2,5 mg dvakrat na dan v kombinaciji z acetilsalicilno kislino 100 mg enkrat na dan n = 9.152
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.
Slovenian: 15 mg filmsko obložena tableta: rdeče, okrogle bikonveksne tablete (6 mm premera, 9 mm polmer ukrivljenosti), na eni strani označene z oznako BAYER (križ) in na drugi strani s številko »15« in trikotnikom.
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).
Slovenian: Uporaba zdravila Xarelto je kontraindicirana pri bolnikih z boleznijo jeter, ki imajo hkrati motnje koagulacije in klinično pomembno tveganje za krvavitve, vključno z bolniki z jetrno cirozo razreda Child-Pugh B in C (glejte poglavji 4.3 in 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 section 4.3).
Slovenian: Uporaba zdravila Xarelto je kontraindicirana pri bolnikih z boleznijo jeter, ki imajo hkrati motnje koagulacije in klinično pomembno tveganje za krvavitve, vključno z bolniki z jetrno cirozo razreda Child-Pugh B in C (glejte poglavje 4.3).
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS UNIT DOSE BLISTER (10 X 1 TABLETS) FOR 15 MG
Slovenian: PRETISNI OMOT ZA ENKRATNI ODMEREK (10 X 1 TABLETA) PO 15 MG
English: Major and non-major clinically relevant bleeding events
Slovenian: Velike in klinično pomembne majhne krvavitve
English: 40 mg od 12 ± 2 days p
Slovenian: 12 ± 2 dni p vse VTE
English: Xarelto 10 mg tablets rivaroxaban
Slovenian: Xarelto 10 mg tablete rivaroksaban
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).
Slovenian: O vnaprej določeni čisti klinični koristi zdravljenja (primarni izid učinkovitosti in velike krvavitve) analize zbranih podatkov so poročali z razmerjem tveganja 0,771 ((95 % IZ: 0,614 - 0,967), nominalna vrednost p = 0,0244).
English: 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.
Slovenian: Zdravilo Xarelto 2,5 mg filmsko obložene tablete so svetlo rumene, okrogle, bikonveksne in na eni strani označene z oznako BAYER (križ) in na drugi s številko »2.5« in trikotnikom.
English: Xarelto 2.5 mg twice daily in combination with ASA 100 mg once daily was superior to ASA 100 mg, in the reduction of the primary composite outcome of CV death, MI, stroke (see Table 7 and Figure 2).
Slovenian: Zdravljenje z zdravilom Xarelto 2,5 mg dvakrat na dan v kombinaciji z acetilsalicilno kislino 100 mg enkrat na dan se je pri zmanjšanju primarnega sestavljenega končnega izida (kardiovaskularna smrt,
English: Xarelto contains lactose.
Slovenian: Zdravilo Xarelto vsebuje laktozo.
English: - 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
Slovenian: - izvidi krvnih preiskav lahko pokažejo povečane vrednosti bilirubina, nekaterih encimov trebušne slinavke ali jetrnih encimov ali povečano število trombocitov
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).
Slovenian: Če bolniki sočasno prejemajo zdravila, ki vplivajo na hemostazo, npr. nesteroidna protivnetna zdravila (NSAID), acetilsalicilno kislino, zaviralce agregacije trombocitov ali selektivne zaviralce ponovnega privzema serotonina (SSRI - Selective Serotonin Reuptake Inhibitors) in zaviralce ponovnega privzema serotonina in noradrenalina (SNRI - Serotonin Norepinephrine Reuptake Inhibitors), je potrebna previdnost.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER OF 14 TABLETS FOR 2.5 MG
Slovenian: PRETISNI OMOT S 14 TABLETAMI PO 2,5 MG
English: Bayer S.p.A. Tel: +39-02-3978 1
Slovenian: Tel: +39-02-3978 1
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) 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))
Slovenian: - Če jemljete katero od zdravil proti glivičnim okužbam (npr. flukonazol, itrakonazol, vorikonazol, posakonazol), razen če jih uporabljate samo na koži, tablete ketokonazola (ki se uporabljajo za zdravljenje Cushingovega sindroma - stanje, ko v telesu nastaja preveč kortizola) katero od zdravil proti bakterijskim okužbam (npr. klaritromicin, eritromicin), nekatera zdravila za zdravljenje okužb z virusom HIV/AIDS (npr. ritonavir), druga zdravila proti strjevanju krvi (npr. enoksaparin, klopidogrel ali antagoniste vitamina K, kot sta varfarin in acenokumarol),
English: If you have kidney problems, your doctor may decide to reduce the dose for the treatment after 3 weeks to one tablet Xarelto 15 mg once a day if the risk for bleeding is greater than the risk for having another blood clot.
Slovenian: - eno tableto zdravila Xarelto po 15 mg enkrat na dan, če je tveganje za krvavitve večje kot tveganje za nastanek krvnega strdka.
English: Each film-coated tablet contains 33.92 mg lactose (as monohydrate), see section 4.4.
Slovenian: Ena filmsko obložena tableta vsebuje 33,92 mg laktoze (v obliki laktoze monohidrata), glejte poglavje 4.4.
English: Xarelto 15 mg (only applicable for outer carton, not applicable for bottle label)
Slovenian: Xarelto 15 mg (samo za škatlo, ne za nalepko za plastenko)
English: Xarelto 20 mg (only applicable for outer carton, not applicable for bottle label)
Slovenian: Xarelto 20 mg (samo za škatlo, ne za nalepko za plastenko)
English: Xarelto 20 mg tablets rivaroxaban
Slovenian: Xarelto 20 mg tablete rivaroksaban
English: There was an increase in rivaroxaban exposure correlated to decrease in renal function, as assessed via creatinine clearance measurements.
Slovenian: Povečanje koncentracije rivaroksabana v plazmi je bilo povezano z zmanjšanim delovanjem ledvic,
English: To reduce the potential risk of bleeding associated with the concurrent use of rivaroxaban and neuraxial (epidural/spinal) anaesthesia or spinal puncture, consider the pharmacokinetic profile of rivaroxaban.
Slovenian: anestezijo ali spinalno punkcijo in sočasno uporabo rivaroksabana, je treba upoštevati farmakokinetični profil rivaroksabana.
English: 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
Slovenian: - bolečine v okončinah - moteno delovanje ledvic (kar se lahko ugotovi s preiskavami, ki jih opravi zdravnik) - zvišana telesna temperatura - bolečine v želodcu, prebavne motnje, slabost ali bruhanje, zaprtje, driska - nizek krvni tlak (simptomi so lahko občutek vrtoglavice ali omedlevice pri vstajanju) - splošna oslabelost in pomanjkanje energije (oslabelost, utrujenost), glavobol, omotica - osip, srbenje kože - izvidi krvnih preiskav lahko pokažejo povečane vrednosti nekaterih jetrnih encimov
English: OUTER CARTON AND LABEL FOR HDPE BOTTLE FOR 20 MG
Slovenian: PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI ŠKATLA IN NALEPKA ZA HDPE PLASTENKE ZA TABLETE PO 20 MG
English: A 29% and 56% decrease in AUC and Cmax compared to tablet was reported when rivaroxaban granulate is released in the proximal small intestine.
Slovenian: Pri sproščanju rivaroksabana iz granulata v zgornjem delu tankega črevesa so poročali o zmanjšanju AUC za 29 % in Cmax za 56 % v primerjavi s tableto.
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.
Slovenian: 20 mg filmsko obložena tableta: rjavordeče, okrogle bikonveksne tablete (6 mm premera, 9 mm polmer ukrivljenosti), na eni strani označene z oznako BAYER (križ) in na drugi strani s številko »20«
English: - MI
Slovenian: A,
English: Each film-coated tablet contains 26.51 mg lactose (as monohydrate), see section 4.4.
Slovenian: Ena filmsko obložena tableta vsebuje 26,51 mg laktoze (v obliki laktoze monohidrata), glejte poglavje 4.4.
English: Each film-coated tablet contains 21.76 mg lactose (as monohydrate), see section 4.4.
Slovenian: Ena filmsko obložena tableta vsebuje 21,76 mg laktoze (v obliki laktoze monohidrata), glejte poglavje 4.4.
English: Xareltoa) 3, 6 or 12 months N=2,419
Slovenian: 3, 6 ali 12 mesecev n = 2.413
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.
Slovenian: Vnaprej določena čista klinična korist zdravljenja (primarni izid učinkovitosti in velike krvavitve) je bila v korist rivaroksabana z razmerjem tveganja 0,67 ((95 % IZ: 0,47 - 0,95), nominalna vrednost p = 0,027).
English: PVC/PVDC/Aluminium foil blisters in cartons of 14 film-coated tablets.
Slovenian: Škatla po 14 filmsko obloženih tablet v pretisnih omotih iz PVC/PVDC/aluminija.
English: No dose adjustment is necessary in patients with mild renal impairment (creatinine clearance 5080 ml/min) (see section 5.2).
Slovenian: Bolnikom z blago (očistek kreatinina 50 - 80 ml/min) okvaro ledvic odmerka ni treba prilagajati (glejte poglavje 5.2).
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER OF 14 TABLETS FOR 10 MG
Slovenian: PRETISNI OMOT ZA 14 TABLET PO 10 MG
English: Tell your health care provider straight away if you have any signs or symptoms of bleeding such as the following: ♦ pain ♦ swelling or discomfort ♦ headache, dizziness or weakness ♦ unusual bruising, nosebleeds, bleeding of gums, cuts that take a long time to stop bleeding ♦ menstrual flow or vaginal bleeding that is heavier than normal ♦ blood in your urine which may be pink or brown, red or black stools ♦ coughing up blood, or vomiting blood or material that looks like coffee grounds
Slovenian: ♦ menstrualne krvavitve ali krvavitve iz nožnice, ki so močnejše kot običajno ♦ kri v seču, ki je zato lahko rožnat ali rjavkast, rdeče ali črno blato ♦ izkašljevanje ali bruhanje krvi ali vsebine, podobne kavni usedlini
English: The use of pantoprazole 40 mg once daily in addition to antithrombotic study medication in patients with no clinical need for a proton pump inhibitor showed no benefit in the prevention of upper gastrointestinal events (i.e. composite of upper gastrointestinal bleeding, upper gastrointestinal ulceration, or upper gastrointestinal obstruction or perforation); the incidence rate of upper gastrointestinal events was 0.39/100 patient-years in the pantoprazole 40 mg once daily group and 0.44/100 patient-years in the placebo once daily group.
Slovenian: razjede v zgornjem delu prebavil, obstrukcijo ali perforacijo zgornjega dela prebavil); incidenca dogodkov v zgornjem delu prebavil je bila 0,39/100 bolnikov-let v skupini, ki je prejemala 40 mg pantoprazola enkrat na dan in 0,44/100 bolnikov-let v skupini, ki je prejemala placebo enkrat na dan.
English: Xareltoa) 3, 6 or 12 months N=1,731
Slovenian: Odmerek in trajanje zdravljenja zdravilo Xareltoa) 3, 6 ali 12 mesecev n = 1.731
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)
Slovenian: Velike krvavitve a) rivaroksaban v odmerku 15 mg dvakrat na dan 3 tedne, nato pa odmerek po 20 mg enkrat na dan b) enoksaparin vsaj 5 dni, sočasno zdravljenje z AVK in enoksaparinom in nadaljevanje zdravljenja z AVK * p < 0,0001 (neinferiornost glede na predhodno opredeljeno razmerje tveganja 2,0); razmerje tveganja: 0,680 (0,443 - 1,042), p = 0,076 (superiornost)
English: Xarelto 10 mg (only applicable for outer carton, not applicable for bottle label)
Slovenian: Xarelto 10 mg (samo za škatlo, ne za nalepko za plastenko)
English: In the Einstein DVT study (see Table 4) rivaroxaban was demonstrated to be non-inferior to enoxaparin/VKA for the primary efficacy outcome (p < 0.0001 (test for non-inferiority); Hazard Ratio (HR): 0.680 (0.443 - 1.042), p=0.076 (test for superiority)).
Slovenian: V kliničnem preskušanju Einstein DVT (glejte preglednico 4) se je v primarnem izidu učinkovitosti pokazalo, da je rivaroksaban neinferioren zdravljenju z enoksaparinom/antagonisti vitamina K (p < 0,0001 (test neinferiornosti); razmerje tveganja (HR - Hazard Ratio): 0,680 (0,443 - 1,042), p = 0,076 (test superiornosti)).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX) FOR 20 MG
Slovenian: VMESNI KARTON PRI VEČKRATNEM PAKIRANJU ZA TABLETE PO 20 MG (BREZ PODATKOV ZA 'BLUE BOX')
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.
Slovenian: 24 ur po zadnjem odmerku zdravila Xarelto, vendar pa pred naslednjim odmerkom zdravila Xarelto.
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
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA Eno pakiranje po 49 filmsko obloženih tablet vsebuje: 42 filmsko obloženih tablet po 15 mg rivaroksabana, 7 filmsko obloženih tablet po 20 mg rivaroksabana.
English: In individuals with mild, moderate and severe renal impairment the overall inhibition of factor Xa activity was increased by a factor of 1.5, 1.9 and 2.0 respectively as compared to healthy volunteers; prolongation of PT was similarly increased by a factor of 1.3, 2.2 and 2.4 respectively.
Slovenian: Pri bolnikih z blago okvaro ledvic je bilo zavrtje aktivnosti faktorja Xa 1,5-krat, pri bolnikih z zmerno okvaro 1,9-krat in pri bolnikih s hudo okvaro 2,0-krat večje kot pri zdravih prostovoljcih.
English: Dosing schedule
Slovenian: Skupni dnevni odmerek
English: 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.
Slovenian: Zdravilo Xarelto 20 mg filmsko obložene tablete so rjavordeče, okrogle, bikonveksne in na eni strani označene z oznako BAYER (križ) in na drugi s številko »20« in trikotnikom.
English: • other gastrointestinal disease without active ulceration that can potentially lead to bleeding complications (e.g. inflammatory bowel disease, oesophagitis, gastritis and gastroesophageal reflux disease)
Slovenian: • druge bolezni prebavil, brez aktivne razjede, ki lahko privedejo do zapletov s krvavitvami (npr.
English: EU/1/08/472/032 10 x 1 film-coated tablets
Slovenian: EU/1/08/472/032 10 x 1 filmsko obložena tableta
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.
Slovenian: Zdravilo Xarelto 10 mg filmsko obložene tablete so svetlo rdeče, okrogle, bikonveksne in na eni strani označene z oznako BAYER (križ) in na drugi s številko »10« in trikotnikom.
English: Treatment dose and duration
Slovenian: Mediana trajanja zdravljenja
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.
Slovenian: motnje strjevanja krvi zelo visok krvni tlak, ki ni urejen z zdravili bolezen želodca ali črevesja, ki lahko povzroči krvavitve, npr. vnetje črevesne ali želodčne sluznice, vnetje požiralnika (ezofagusa) zaradi npr. gastroezofagealne refluksne bolezni (bolezni, pri kateri se vsebina želodca vrača nazaj v požiralnik) težave z ožiljem na očesnem ozadju (retinopatija) bolezen pljuč, pri kateri so bronhiji razširjeni in napolnjeni z gnojnim izmečkom (bronhiektazije) ali predhodne krvavitve v pljučih če ste starejši kot 75 let če tehtate 60 kg ali manj če imate koronarno bolezen s hudim simptomatskim popuščanjem srca.
English: Xarelto 2.5 mg film-coated tablets rivaroxaban
Slovenian: IME ZDRAVILA Xarelto 2,5 mg filmsko obložene tablete rivaroksaban
English: Xarelto 2.5 mg, twice daily, N=5,115 n (%)
Slovenian: Odmerek zdravila zdravilo Xarelto 2,5 mg, dvakrat na dan, n = 5.115
English: Table 8: Efficacy and safety results from pooled analysis of phase III Einstein DVT and Einstein PE
Slovenian: Preglednica 8: Izsledki glede učinkovitosti in varnosti iz analize zbranih podatkov iz III. faze kliničnih preskušanj Einstein DVT in Einstein PE
English: For patients treated for DVT, PE and prevention of recurrence, VKA treatment should be stopped and
Slovenian: Pri bolnikih, ki za zdravljenje GVT, PE in preprečevanje ponovne GVT in PE jemljejo antagoniste vitamina K, je treba zdravljenje z antagonisti vitamina K prenehati in uvesti zdravljenje z zdravilom
English: Xarelto 2.5 mg film-coated tablets
Slovenian: IME ZDRAVILA Xarelto 2,5 mg filmsko obložene tablete