FrancophonIA/ELRC3.0 huggingface dataset:
English: The median time on treatment was 13 months and overall treatment duration was up to almost 3 years.
Slovenian: Mediana trajanja zdravljenja je bila 13 mesecev in skupno je zdravljenje trajalo skoraj 3 leta.
English: Due to a reduced extent of absorption an oral bioavailability of 66% was determined for the 20 mg tablet under fasting conditions.
Slovenian: Zaradi zmanjšane stopnje absorpcije je bila ugotovljena biološka uporabnost 66 % za 20 mg tableto na tešče.
English: Patients with elevated biomarkers (troponin or CK-MB) and without a prior stroke/TIA constituted 80% of the study population.
Slovenian: Bolniki s povečanimi vrednostmi biokemičnih označevalcev (troponin ali CK-MB) in brez predhodne možganske kapi/prehodnega ishemičnega napada (TIA) predstavljajo 80 % preizkušane populacije.
English: If you become pregnant while you are taking this medicine, tell your doctor immediately, who will decide how you should be treated.
Slovenian: Če med jemanjem tega zdravila zanosite, morate o tem takoj obvestiti zdravnika, ki se bo odločil o vašem nadaljnjem zdravljenju.
English: It works by blocking a blood clotting factor (factor Xa) and thus reducing the tendency of the blood to form clots.
Slovenian: Deluje tako, da zavre faktor strjevanja krvi (faktor Xa) in tako zmanjša nastajanje krvnih strdkov.
English: Study data indicate that such patients may benefit less from treatment with rivaroxaban (see section 5.1).
Slovenian: Podatki iz študij kažejo, da je za te bolnike zdravljenje z rivaroksabanom lahko manj koristno (glejte poglavje 5.1).
English: • If the first and second characters are BT, the manufacturer is Bayer Bitterfeld GmbH
Slovenian: • Če sta prvi in drugi znak »BT« je proizvajalec Bayer Bitterfeld GmbH
English: Following completion of at least 6 months therapy for DVT or PE
Slovenian: po zaključku vsaj 6-mesečnega zdravljenja GVT ali PE
English: If you have had a major knee operation you will usually take the tablets for 2 weeks.
Slovenian: Če ste imeli velik kirurški poseg na kolenu, boste tablete običajno jemali 2 tedna.
English: Active clinically significant bleeding.
Slovenian: Aktivna klinično pomembna krvavitev.
English: If traumatic puncture occurs the administration of rivaroxaban is to be delayed for 24 hours.
Slovenian: V primeru travmatske punkcije je treba uporabo rivaroksabana odložiti za 24 ur.
English: Taking too much Xarelto increases the risk of bleeding.
Slovenian: Prevelika količina zdravila Xarelto poveča tveganje za krvavitve.
English: Rivaroxaban does not inhibit thrombin (activated factor II) and no effects on platelets have been demonstrated.
Slovenian: Rivaroksaban ne zavira delovanja trombina (aktivirani faktor II) in ne deluje na trombocite.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Xarelto in one or more subsets of the paediatric population in the treatment of thromboembolic events.
Slovenian: Evropska agencija za zdravila je začasno odložila obvezo za predložitev rezultatov kliničnih preskušanj z zdravilom Xarelto v eni ali več podskupin pediatrične populacije pri zdravljenju trombembolij.
English: 1,197 patients continued treatment and prevention of recurrent venous thromboembolism
Slovenian: 1.197 bolnikov z nadaljevalnim zdravljenjem in preprečevanje ponovne venske trombembolije
English: No clinically relevant inter-ethnic differences among Caucasian, African-American, Hispanic, Japanese or Chinese patients were observed regarding rivaroxaban pharmacokinetics and pharmacodynamics.
Slovenian: Razlike med etničnimi skupinami Med belci, Afroameričani, hispani, Japonci in Kitajci niso opazili klinično pomembnih medetničnih razlik v farmakokinetiki in farmakodinamiki rivaroksabana.
English: Adverse reactions like syncope (frequency: uncommon) and dizziness (frequency: common) have been reported (see section 4.8).
Slovenian: Poročali so o neželenih učinkih, kot sta sinkopa (pogostnost: občasno) in omotica (pogostnost: pogosto) (glejte poglavje 4.8).
English: Frequencies are defined as:
Slovenian: Po pogostnosti so neželeni učinki opredeljeni kot sledi:
English: The duration of treatment depends on the individual risk of the patient for venous thromboembolism which is determined by the type of orthopaedic surgery.
Slovenian: Trajanje zaščite je odvisno od tveganja za VTE pri bolniku, kar je določeno z vrsto ortopedskega kirurškega posega.
English: The analysis of the pooled results of the phase III studies corroborated the data obtained in the individual studies regarding reduction of total VTE, major VTE and symptomatic VTE with rivaroxaban 10 mg once daily compared to enoxaparin 40 mg once daily.
Slovenian: Skupna analiza izsledkov iz vseh študij III. faze je potrdila podatke posameznih preskušanj o zmanjšanju pogostnosti vseh VTE, težjih oblik VTE in simptomatskih VTE z rivaroksabanom 10 mg enkrat na dan v primerjavi z enoksaparinom 40 mg enkrat na dan.
English: The safety results in this subgroup of patients undergoing PCI were comparable to the overall safety results.
Slovenian: Izsledki glede varnosti v podskupini bolnikov po perkutanem koronarnem posegu so primerljivi z izsledki glede splošne varnosti.
English: Pharmacokinetic/pharmacodynamic relationship
Slovenian: Farmakokinetično/farmakodinamsko razmerje
English: The recommendation for the use of 15 mg is based on PK modelling and has not been studied in this clinical setting (see sections 4.4, 5.1 and 5.2).
Slovenian: Uporaba priporočenega 15 mg odmerka temelji na farmakokinetičnem modelu in ga niso preučevali v tem kliničnem programu (glejte poglavja 4.4, 5.1 in 5.2).
English: When Xarelto 20 mg tablets are taken together with food increases in mean AUC by 39% were observed when compared to tablet intake under fasting conditions, indicating almost complete absorption and high oral bioavailability.
Slovenian: Če se zdravilo Xarelto 20 mg tablete jemlje skupaj s hrano, so opazili povečanje povprečne AUC za 39 % v primerjavi z jemanjem na tešče, kar kaže na skoraj popolno absorpcijo in visoko biološko uporabnost.
English: These patients also had reduced renal elimination of rivaroxaban, similar to patients with moderate renal impairment.
Slovenian: Pri teh bolnikih je bilo izločanje rivaroksabana skozi ledvice zmanjšano, podobno kot pri bolnikih z zmerno okvaro ledvic.
English: The safety and efficacy of Xarelto in children aged 0 to 18 years have not been established.
Slovenian: Varnost in učinkovitost zdravila Xarelto pri otrocih, starih 0 do 18 let, nista bili dokazani.
English: breathlessness, chest pain or angina pectoris, which may be signs of bleeding.
Slovenian: bolečine v prsnem košu ali angina pektoris, ki so lahko znaki krvavitve.
English: When extended prevention of recurrent DVT and PE is indicated (following completion of at least 6 months therapy for DVT or PE), the recommended dose is 10 mg once daily.
Slovenian: Če je indicirano podaljšano preprečevanje ponovne GVT in PE (po zaključenem vsaj 6-mesečnem zdravljenju GVT ali PE), je priporočeni odmerek 10 mg enkrat na dan.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Xarelto in all subsets of the paediatric population in the prevention of thromboembolic events (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od obveze za predložitev rezultatov kliničnih preskušanj z zdravilom Xarelto za vse skupine pediatrične populacije pri preprečevanju trombembolij (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Table 2: Bleeding* and anaemia events rates in patients exposed to rivaroxaban across the completed phase III studies
Slovenian: Preglednica 2: Pogostnost krvavitev* in anemij pri bolnikih, izpostavljenih rivaroksabanu v zaključenih preskušanjih III. faze
English: Dizziness, headache
Slovenian: driska, bruhanjeA
English: For transesophageal echocardiogram (TEE) guided cardioversion in patients not previously treated with anticoagulants, Xarelto treatment should be started at least 4 hours before cardioversion to ensure adequate anticoagulation (see sections 5.1 and 5.2).
Slovenian: Pri bolnikih s kardioverzijo, vodeno s transezofagealnim ehokardiogramom (TEE), ki predhodno niso bili zdravljeni z antikoagulanti, je treba zdravljenje z zdravilom Xarelto začeti najmanj 4 ure pred kardioverzijo za zagotovitev ustrezne antikoagulacije (glejte poglavji 5.1 in 5.2).
English: The signs, symptoms, and severity (including fatal outcome) will vary according to the location and degree or extent of the bleeding and/or anaemia (see section 4.9 “Management of bleeding”).
Slovenian: Znaki, simptomi in resnost (vključno s smrtnim izidom) so odvisni od mesta, stopnje ali obsežnosti krvavitve in/ali anemije (glejte poglavje 4.9 Ukrepi pri krvavitvah).
English: Rivaroxaban is rapidly absorbed with maximum concentrations (Cmax) appearing 2 - 4 hours after tablet intake.
Slovenian: Absorpcija Rivaroksaban se hitro absorbira in doseže največjo koncentracijo (Cmax) v 2 do 4 urah po zaužitju tablete.
English: Extremes in body weight (< 50 kg or > 120 kg) had only a small influence on rivaroxaban plasma concentrations (less than 25%).
Slovenian: Zelo nizka ali visoka telesna masa (< 50 kg ali > 120 kg) je le malo (manj kot 25 %) vplivala na koncentracije rivaroksabana v plazmi.
English: The median time on treatment was 19 months and overall treatment duration was up to 41 months.
Slovenian: Povprečni čas zdravljenja je bil 19 mesecev; celotno zdravljenje je trajalo do 41 mesecev.
English: Variability in rivaroxaban pharmacokinetics is moderate with inter-individual variability (CV%) ranging from 30% to 40%, apart from on the day of surgery and the following day when variability in exposure is high (70%).
Slovenian: Variabilnost farmakokinetike rivaroksabana je zmerna; interindividualna variabilnost (koeficient variacije %) je od 30 do 40 %, razen na dan kirurškega posega in naslednji dan, ko je variabilnost izpostavljenosti visoka (70 %).
English: The MAH must agree the content and format of the Prescriber Guide together with a communication plan, with the national competent authority in each Member State prior to distribution of the educational pack in their territory.
Slovenian: Imetnik dovoljenja za promet z zdravilom se mora s pristojnim nacionalnim organom v vseh državah članicah dogovoriti glede vsebine in oblike vodnika za predpisovanje in načrta obveščanja pred razdeljevanjem izobraževalnega gradiva v posamezni državi članici.
English: If your doctor thinks that you are at increased risk of developing stomach or bowel ulcers, he may also use a preventative ulcer treatment.
Slovenian: Če zdravnik meni, da pri vas obstaja povečano tveganje za razjede želodca ali črevesja, vam lahko predpiše tudi zdravila za preprečevanje nastanka razjed.
English: DOSE and DOSING SCHEME
Slovenian: ODMEREK in SHEMA ODMERJANJA
English: - Symptomatic bleeding in critical organ (non-fatal)
Slovenian: - Simptomatska krvavitev v kritični organ (brez smrtnega izida)
English: At baseline, the median ejection fraction was 34% (IQR: 28%-38%) and 53% of subjects were NYHA Class III or IV.
Slovenian: Ob randomizaciji je bila mediana iztisnega deleža 34 % (IQR: 28 % - 38 %) in 53 % preiskovancev je bilo razvrščenih v III. ali IV. razred po klasifikaciji NYHA.
English: Patients with a recent acute coronary syndrome a)
Slovenian: Bolniki z nedavnim akutnim koronarnim sindromom a)
English: If you stop taking this medicine, it may increase your risk of having another heart attack or stroke or dying from a disease related to your heart or your blood vessels.
Slovenian: Če prenehate jemati to zdravilo, se bo morda povečalo tveganje za ponovni srčni infarkt, možgansko kap ali za smrt zaradi bolezni, povezane s srcem ali krvnimi žilami.
English: The frequencies of these side effects are very rare (anaphylactic reactions, including anaphylactic shock; may affect up to 1 in 10,000 people) and uncommon (angioedema and allergic oedema; may affect up to 1 in 100 people).
Slovenian: Ti neželeni učinki so zelo redki (anafilaktične reakcije, vključno z anafilaktičnim šokom; pojavijo se lahko pri največ 1 od 10.000 bolnikov) in občasni (angioedem in alergijski edem; pojavijo se lahko pri največ 1 od 100 bolnikov).
English: For patients with moderate or severe renal impairment where the decision has been taken for 15 mg once daily from Day 22 onwards, other pack sizes only containing 15 mg film-coated tablets are available (see dosing instructions in section “Special populations” below).
Slovenian: Za bolnike z zmerno ali hudo okvaro ledvic, pri katerih je bilo določeno odmerjanje 15 mg enkrat na dan od 22. dne dalje, so na voljo druge velikosti pakiranja, ki vsebujejo le 15 mg filmsko obložene tablete (glejte navodila za odmerjanje v spodnjem poglavju Posebne populacije).
English: However, there is currently very limited clinical experience with the use of these medicinal products in individuals receiving rivaroxaban.
Slovenian: Do sedaj je zelo malo izkušenj z uporabo teh zdravil pri bolnikih, ki prejemajo rivaroksaban.
English: To prevent blood clots in the brain (stroke) and other blood vessels in your body: If your heart beat needs to be restored to normal by a procedure called cardioversion, take Xarelto at the times your doctor tells you.
Slovenian: Za preprečevanje krvnih strdkov v možganih (možganska kap) in drugih krvnih žilah v telesu: Če je pri vas potrebno srčni utrip povrniti v normalni srčni ritem s postopkom, ki se imenuje kardioverzija, jemljite zdravilo Xarelto tako, kot vam je svetoval zdravnik.
English: In rats, no effects on male or female fertility were seen.
Slovenian: Pri podganah niso opazili vpliva na plodnost samcev ali samic.
English: Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack.
Slovenian: Preprečevanje možganske kapi in sistemske embolije pri odraslih bolnikih z nevalvularno atrijsko fibrilacijo in enim ali več dejavniki tveganja, kot so kongestivno srčno popuščanje, hipertenzija, starost ≥ 75 let, sladkorna bolezen, predhodna možganska kap ali prehodni ishemični napad.
English: • CAD patients with severe symptomatic heart failure.
Slovenian: • Bolniki s KB s hudim simptomatskim popuščanjem srca.
English: Cardiovascular death
Slovenian: Kardiovaskularna smrt
English: You must take Xarelto together with a meal.
Slovenian: Zdravilo Xarelto jemljite skupaj s hrano.
English: Embryo-foetal toxicity (post-implantation loss, retarded/progressed ossification, hepatic multiple light coloured spots) and an increased incidence of common malformations as well as placental changes were observed at clinically relevant plasma concentrations.
Slovenian: Embriofetalna toksičnost (poimplantacijska izguba, zaostala/progresivna osifikacija, multiple svetlejše lise na površini jeter) in povečana incidenca občasnih malformacij kot tudi spremembe placente so opažali pri klinično pomembnih plazemskih koncentracijah.
English: In a study on male and female fertility in rats no effects were seen (see section 5.3).
Slovenian: V študiji na samcih in samicah podgan niso opazili vpliva na plodnost (glejte poglavje 5.3).
English: In some cases as a consequence of anaemia, symptoms of cardiac ischaemia like chest pain or angina pectoris have been observed.
Slovenian: V nekaterih primerih so kot posledico anemije opazili simptome ishemije srca kot so bolečine v prsnem košu ali angina pektoris.
English: Protamine sulphate and vitamin K are not expected to affect the anticoagulant activity of rivaroxaban.
Slovenian: Ni pričakovati, da bi protaminijev sulfat in vitamin K vplivala na antikoagulacijski učinek rivaroksabana.
English: Treatment was continued with a vitamin K antagonist dose-adjusted to maintain the PT/INR values within the therapeutic range of 2.0 to 3.0.
Slovenian: Nato se je zdravljenje nadaljevalo samo z antagonistom vitamina K v odmerkih, prilagojenih za vzdrževanje vrednosti PČ/INR znotraj terapevtskih vrednosti od 2,0 do 3,0.
English: Due to the pharmacological mode of action, the use of Xarelto may be associated with an increased risk of occult or overt bleeding from any tissue or organ which may result in post haemorrhagic anaemia.
Slovenian: Zaradi farmakološkega načina delovanja lahko uporabo zdravila Xarelto spremlja večje tveganje za prikrite ali očitne krvavitve iz tkiv ali organov, ki lahko povzročijo posthemoragično anemijo.
English: Table 3: All adverse reactions reported in patients in phase III clinical trials or through postmarketing use*
Slovenian: Preglednica 3: Vsi neželeni učinki, o katerih so poročali pri bolnikih v kliničnih preskušanjih III. faze ali v obdobju trženja zdravila*
English: When the recommended dose is 10 mg once daily, no dose adjustment from the recommended dose is necessary.
Slovenian: Če je priporočeni odmerek 10 mg enkrat na dan, odmerka ni treba prilagajati.
English: Stevens-Johnson syndrome/ Toxic Epidermal Necrolysis , DRESS syndrome
Slovenian: Stevens-Johnsonov sindrom/toksična epidermalna nekroliza, sindrom
English: Summary of the safety profile
Slovenian: Povzetek podatkov o varnosti zdravila
English: • If the first and second characters are BX, the manufacturer is Bayer AG
Slovenian: • Če sta prvi in drugi znak »BX« je proizvajalec Bayer AG
English: There are no data in patients with severe hepatic impairment.
Slovenian: Podatkov o bolnikih s hudo okvaro jeter ni.
English: Patients with prior stroke and/or TIA
Slovenian: Bolniki s predhodno možgansko kapjo in/ali TIA
English: Fatal PE/death where PE cannot be ruled out Major or clinically relevant non-major bleeding
Slovenian: Smrtna PE/smrt, pri kateri PE ni mogoče izključiti Velike ali klinično pomembne majhne krvavitve
English: Your doctor has prescribed you Xarelto 10 mg once a day.
Slovenian: Zdravnik vam je predpisal zdravilo Xarelto 10 mg enkrat na dan.
English: Xarelto reduces the risk in adults of having another heart attack or reduces the risk of dying from a disease related to your heart or your blood vessels.
Slovenian: Zdravilo Xarelto pri odraslih zmanjša tveganje za ponovni srčni infarkt ali zmanjša tveganje za smrt zaradi bolezni, povezane s srcem ali krvnimi žilami.
English: Elimination of rivaroxaban from plasma occurs with terminal half-lives of 5 to 9 hours in young individuals, and with terminal half-lives of 11 to 13 hours in the elderly.
Slovenian: Rivaroksaban se iz plazme izloči s končnim razpolovnim časom 5 do 9 ur pri mlajših osebah in s končnim razpolovnim časom 11 do 13 ur pri starejših.
English: The phase III COMPASS study (27,395 patients, 78.0% male, 22.0% female) demonstrated the efficacy and safety of Xarelto for the prevention of a composite of CV death, MI, stroke in patients with CAD or symptomatic PAD at high risk of ischaemic events.
Slovenian: Študija III. faze COMPASS (27.395 bolnikov, 78,0 % moških, 22,0 % žensk) je dokazala učinkovitost in varnost zdravila Xarelto pri preprečevanju dogodkov sestavljenih iz kardiovaskularne smrti, miokardnega infarkta in možganske kapi pri bolnikih s KB ali simptomatsko PAB in visokim tveganjem za ishemične dogodke.
English: The tablets can be taken with or without food (see sections 4.5 and 5.2).
Slovenian: Tablete se lahko jemlje s hrano ali brez nje (glejte poglavji 4.5 in 5.2).
English: The overall combined treatment duration in all studies was up to 21 months.
Slovenian: V vseh kliničnih preskušanjih je skupno trajanje zdravljenja znašalo do 21 mesecev.
English: No pharmacokinetic interaction was observed between warfarin and rivaroxaban.
Slovenian: Farmakokinetičnih interakcij med varfarinom in rivaroksabanom niso opazili.
English: Xarelto is not recommended as an alternative to unfractionated heparin in patients with pulmonary embolism who are haemodynamically unstable or may receive thrombolysis or pulmonary embolectomy since the safety and efficacy of Xarelto have not been established in these clinical situations.
Slovenian: Zdravila Xarelto se ne priporoča kot alternativa nefrakcioniranemu heparinu pri bolnikih s pljučno embolijo, ki so hemodinamsko nestabilni ali bodo morda potrebovali trombolitično terapijo ali pljučno embolektomijo, ker varnost in učinkovitost zdravila Xarelto v teh kliničnih stanjih nista bili dokazani.
English: The tablets are to be taken with food (see section 5.2).
Slovenian: Tablete je treba vzeti skupaj s hrano (glejte poglavje 5.2).
English: - Without overnight stay p = 0.04983
Slovenian: Brez prenočitve p = 0,04983
English: When taking a blood thinner such as Xarelto it is important to be aware of its possible side effects.
Slovenian: Pri uporabi zdravil za redčenje krvi, kot je zdravilo Xarelto, je pomembno, da poznate njegove možne neželene učinke.
English: This treatment initiation pack is only for the first 4 weeks of treatment.
Slovenian: To začetno pakiranje je samo za prve 4 tedne zdravljenja.
English: Haemodynamically unstable PE patients or patients who require thrombolysis or pulmonary embolectomy
Slovenian: Hemodinamsko nestabilni bolniki s PE ali bolniki, ki potrebujejo trombolizo ali pljučno embolektomijo
English: Enoxaparin did not affect the pharmacokinetics of rivaroxaban.
Slovenian: Enoksaparin ni vplival na farmakokinetiko rivaroksabana.
English: The secondary endpoint (composite of cardiovascular events CV death, MI, or stroke) occurred in 41 (5.9%), 36 (5.1%), and 36 (5.2%) subjects in the group 1, group 2 and group 3, respectively.
Slovenian: Sekundarni končni izid, (ki ga sestavljajo kardiovaskularni dogodki: kardiovaskularna smrt, srčni infarkt ali možganska kap), se je pojavil pri 41 (5,9 %), 36 (5,1 %), in 36 (5,2 %) bolnikih v skupini 1, skupini 2 oziroma skupini 3.
English: ♦ You must not stop taking Xarelto without first talking to your doctor as your risk of blood clots may increase.
Slovenian: ♦ Ne prenehajte jemati zdravila, ne da bi se prej posvetovali z zdravnikom, saj se lahko tveganje za nastanek krvnih strdkov poveča.
English: Due to the potential reproductive toxicity, the intrinsic risk of bleeding and the evidence that rivaroxaban passes the placenta, Xarelto is contraindicated during pregnancy (see section 4.3).
Slovenian: Zaradi možnega vpliva na sposobnost razmnoževanja, tveganja za krvavitve in dokazov, da rivaroksaban prehaja skozi placento, je uporaba zdravila Xarelto med nosečnostjo kontraindicirana (glejte poglavje 4.3).
English: Depending on local availability, a consultation with a coagulation expert should be considered in case of major bleedings (see section 5.1).
Slovenian: Odvisno od lokalne dostopnosti zdravniške službe je treba v primeru velikih krvavitev razmisliti o posvetu z zdravnikom, ki ima izkušnje z antikoagulantnim zdravljenjem (glejte poglavje 5.1).
English: The INR is not valid to measure the anticoagulant activity of Xarelto, and therefore should not be used (see section 4.5).
Slovenian: Določanje vrednosti INR ni ustrezno merilo za merjenje antikoagulacijskega učinka zdravila Xarelto, zato se ga ne sme uporabljati (glejte poglavje 4.5).
English: Duration of treatment should be determined for each individual patient based on regular evaluations and should consider the risk for thrombotic events versus the bleeding risks.
Slovenian: Trajanje zdravljenja je treba določiti za vsakega posameznega bolnika na podlagi rednih ocen tveganja za trombotične dogodke v primerjavi s tveganjem za krvavitve.
English: Patients with moderate hepatic impairment were more sensitive to rivaroxaban resulting in a steeper PK/PD relationship between concentration and PT.
Slovenian: Bolniki z zmerno okvaro jeter so bolj občutljivi na rivaroksaban, kar je razvidno iz razmerja PK/PD med koncentracijo in PČ.