natgillin/translations-raw huggingface dataset:
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).
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,
Xarelto contains lactose.
Zdravilo Xarelto vsebuje laktozo.
- 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
- izvidi krvnih preiskav lahko pokažejo povečane vrednosti bilirubina, nekaterih encimov trebušne slinavke ali jetrnih encimov ali povečano število trombocitov
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).
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.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER OF 14 TABLETS FOR 2.5 MG
PRETISNI OMOT S 14 TABLETAMI PO 2,5 MG
- 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))
- 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),
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.
- eno tableto zdravila Xarelto po 15 mg enkrat na dan, če je tveganje za krvavitve večje kot tveganje za nastanek krvnega strdka.
Each film-coated tablet contains 33.92 mg lactose (as monohydrate), see section 4.4.
Ena filmsko obložena tableta vsebuje 33,92 mg laktoze (v obliki laktoze monohidrata), glejte poglavje 4.4.
Xarelto 15 mg (only applicable for outer carton, not applicable for bottle label)
Xarelto 15 mg (samo za škatlo, ne za nalepko za plastenko)
Xarelto 20 mg (only applicable for outer carton, not applicable for bottle label)
Xarelto 20 mg (samo za škatlo, ne za nalepko za plastenko)
There was an increase in rivaroxaban exposure correlated to decrease in renal function, as assessed via creatinine clearance measurements.
Povečanje koncentracije rivaroksabana v plazmi je bilo povezano z zmanjšanim delovanjem ledvic,
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.
anestezijo ali spinalno punkcijo in sočasno uporabo rivaroksabana, je treba upoštevati farmakokinetični profil rivaroksabana.
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
- 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
OUTER CARTON AND LABEL FOR HDPE BOTTLE FOR 20 MG
PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI ŠKATLA IN NALEPKA ZA HDPE PLASTENKE ZA TABLETE PO 20 MG
A 29% and 56% decrease in AUC and Cmax compared to tablet was reported when rivaroxaban granulate is released in the proximal small intestine.
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.
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.
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«
- MI
A,
Each film-coated tablet contains 26.51 mg lactose (as monohydrate), see section 4.4.
Ena filmsko obložena tableta vsebuje 26,51 mg laktoze (v obliki laktoze monohidrata), glejte poglavje 4.4.
Each film-coated tablet contains 21.76 mg lactose (as monohydrate), see section 4.4.
Ena filmsko obložena tableta vsebuje 21,76 mg laktoze (v obliki laktoze monohidrata), glejte poglavje 4.4.
Xareltoa) 3, 6 or 12 months N=2,419
3, 6 ali 12 mesecev n = 2.413
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.
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).
PVC/PVDC/Aluminium foil blisters in cartons of 14 film-coated tablets.
Škatla po 14 filmsko obloženih tablet v pretisnih omotih iz PVC/PVDC/aluminija.
No dose adjustment is necessary in patients with mild renal impairment (creatinine clearance 5080 ml/min) (see section 5.2).
Bolnikom z blago (očistek kreatinina 50 - 80 ml/min) okvaro ledvic odmerka ni treba prilagajati (glejte poglavje 5.2).
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER OF 14 TABLETS FOR 10 MG
PRETISNI OMOT ZA 14 TABLET PO 10 MG
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
♦ 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
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.
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.
Xareltoa) 3, 6 or 12 months N=1,731
Odmerek in trajanje zdravljenja zdravilo Xareltoa) 3, 6 ali 12 mesecev n = 1.731
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)
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)
Xarelto 10 mg (only applicable for outer carton, not applicable for bottle label)
Xarelto 10 mg (samo za škatlo, ne za nalepko za plastenko)
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)).
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)).
PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX) FOR 20 MG
VMESNI KARTON PRI VEČKRATNEM PAKIRANJU ZA TABLETE PO 20 MG (BREZ PODATKOV ZA 'BLUE BOX')
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.
24 ur po zadnjem odmerku zdravila Xarelto, vendar pa pred naslednjim odmerkom zdravila Xarelto.
Each pack of 49 film-coated tablets contains: 42 film-coated tablets of 15 mg rivaroxaban 7 film-coated tablets of 20 mg rivaroxaban
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.
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.
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.
Dosing schedule
Skupni dnevni odmerek
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.
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.
• other gastrointestinal disease without active ulceration that can potentially lead to bleeding complications (e.g. inflammatory bowel disease, oesophagitis, gastritis and gastroesophageal reflux disease)
• druge bolezni prebavil, brez aktivne razjede, ki lahko privedejo do zapletov s krvavitvami (npr.
EU/1/08/472/032 10 x 1 film-coated tablets
EU/1/08/472/032 10 x 1 filmsko obložena tableta
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.
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.
Treatment dose and duration
Mediana trajanja zdravljenja
- 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.
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.
Xarelto 2.5 mg film-coated tablets rivaroxaban
IME ZDRAVILA Xarelto 2,5 mg filmsko obložene tablete rivaroksaban
Xarelto 2.5 mg, twice daily, N=5,115 n (%)
Odmerek zdravila zdravilo Xarelto 2,5 mg, dvakrat na dan, n = 5.115
Table 8: Efficacy and safety results from pooled analysis of phase III Einstein DVT and Einstein PE
Preglednica 8: Izsledki glede učinkovitosti in varnosti iz analize zbranih podatkov iz III. faze kliničnih preskušanj Einstein DVT in Einstein PE
For patients treated for DVT, PE and prevention of recurrence, VKA treatment should be stopped and
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
Xarelto 2.5 mg film-coated tablets
IME ZDRAVILA Xarelto 2,5 mg filmsko obložene tablete
The COMMANDER HF study included 5,022 patients with heart failure and significant coronary artery disease (CAD) following a hospitalization of decompensated heart failure (HF) which were randomly assigned into one of the two treatment groups: rivaroxaban 2.5 mg twice daily (N=2,507) or matching placebo (N=2,515), respectively.
Naključno so bili razvrščeni v eno od dveh zdravljenih skupin bolnikov: skupino, ki je bila zdravljena z rivaroksabanom 2,5 mg dvakrat na dan (n = 2.507) oziroma skupino, ki je prejemala placebo (n = 2.515).
Talk to your doctor or pharmacist before taking Xarelto.
Pred začetkom jemanja zdravila Xarelto se posvetujte z zdravnikom ali farmacevtom.
For modified ISTH major bleeding, the observed risk increase was HR=2.12 (95% CI 1.5-3.0) in patients ≥75 years (5.2% vs 2.5%) and HR=1.53 (95% CI 1.2-1.9) in patients <75 years (2.6% vs
Za velike krvavitve po prirejenih merilih združenja ISTH je bilo opaženo povečanje razmerja tveganja 2,12 (95 % IZ 1,5 - 3,0) pri bolnikih ≥ 75 let
Body weight No dose adjustment (see section 5.2)
Telesna masa Odmerka ni treba prilagajati (glejte poglavje 5.2)
• The need for intake of the 15 mg and 20 mg tablets with food
• navodila glede zamenjave z drugim zdravilom ali prehod na zdravljenje z rivaroksabanom • pomembnost jemanja tablet po 15 mg oziroma 20 mg skupaj s hrano
See section 2 “Xarelto contains lactose and sodium”.
Zdravilo Xarelto vsebuje laktozo in natrij.
Dose-dependent inhibition of factor Xa activity was observed in humans.
Pri ljudeh je zaviranje faktorja Xa odvisno od odmerka.
Muscle haemorrhage
vaskularna psevdoanevrizmaC
Treatment dose
Nadaljevanje zdravljenja
EU/1/08/472/033 100 x 1 film-coated tablets (PP/Aluminium foil blisters) EU/1/08/472/035 30 film-coated tablets
EU/1/08/472/033 100 x 1 filmsko obložena tableta (pretisni omot iz PP/aluminija) EU/1/08/472/035 30 filmsko obloženih tablet
Increase in transaminases
povečane vrednosti amilazeA
Your doctor will tell you when to start treatment with Xarelto if you have been diagnosed with coronary artery disease or peripheral artery disease.
Če imate diagnozo koronarne bolezni ali periferne arterijske bolezni, vam bo zdravnik svetoval, kdaj začnite zdravljenje z zdravilom Xarelto.
Table 8: Efficacy and safety results from phase III Einstein Extension Study population
Preglednica 8: Izsledki učinkovitosti in varnosti iz III. faze kliničnega preskušanja Einstein Extension
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER OF TREATMENT INITIATION PACK IN WALLET (42 FILM-COATED TABLETS OF 15 MG AND 7 FILM-COATED TABLETS OF 20 MG)
PRETISNI OMOT ZA ZAČETNO PAKIRANJE (ZAČETEK ZDRAVLJENJA) V OVITKU (42 FILMSKO OBLOŽENIH TABLET PO 15 MG IN 7 FILMSKO OBLOŽENIH TABLET PO
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.
Pri bolnikih z nevalvularno atrijsko fibrilacijo, ki so prejemali rivaroksaban za preprečevanje možganske kapi in sistemske embolije, je bil 5/95 percentil za PČ (Neoplastin) 1 do 4 ure po zaužitju tablete (tj. v času največjega učinka) pri bolnikih zdravljenih z odmerkom 20 mg enkrat na dan od 14 do 40 sekund in pri bolnikih z zmerno okvaro ledvic, zdravljenih z odmerkom po 15 mg enkrat na dan od 10 do 50 sekund.
Stroke, non-CNS systemic embolism and vascular death
Možganska kap in sistemska embolija izven osrednjega živčevja Možganska kap in sistemska embolija izven osrednjega živčevja in vaskularna smrt
- if you have an increased risk of bleeding, as could be the case in situations such as: moderate or 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.
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 imate umetno srčno zaklopko - če veste, da imate bolezen, imenovano antifosfolipidni sindrom (bolezen imunskega sistema, zaradi katere imate povečano tveganje za nastanek krvnih strdkov), o tem obvestite zdravnika,
When converting patients from VKAs to Xarelto, INR values will be falsely elevated after the intake of Xarelto.
Vrednosti INR so pri bolnikih, ki prehajajo z zdravljenja z antagonisti vitamina K na zdravljenje z zdravilom Xarelto, lažno povišane po jemanju zdravila Xarelto.
EU/1/08/472/027 56 film-coated tablets
EU/1/08/472/027 56 filmsko obloženih tablet
Table 9: Efficacy and safety results from phase III Einstein Extension Study population
Preglednica 9: Izsledki učinkovitosti in varnosti iz III. faze kliničnega preskušanja Einstein Extension
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.
Škatla po 14, 20, 28, 30, 56, 60, 98, 168 ali 196 filmsko obloženih tablet v pretisnih omotih iz PP/aluminija ali škatla po 10 x 1 ali 100 x 1 filmsko obložena tableta v perforiranih pretisnih omotih za enkratni odmerek ali v večkratnih pakiranjih, ki vsebujejo 100 (10 enot po 10 x 1) filmsko obloženih tablet.
very common (≥ 1/10)
Po pogostnosti so neželeni učinki opredeljeni kot sledi: zelo pogosti (≥ 1/10)
Epistaxis, haemoptysis
holestaza, hepatitis