FrancophonIA/ELRC3.0 huggingface dataset:
English: The MAH shall ensure that in each Member State where Lixiana is marketed, all healthcare professionals who are expected to use Lixiana are provided with the following educational material:
Slovenian: Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo v vsaki državi članici, v kateri se bo tržilo zdravilo Lixiana, vsi zdravstveni delavci, za katere se pričakuje, da bodo uporabljali zdravilo Lixiana, prejeli naslednje izobraževalne materiale:
English: 85276 Pfaffenhofen Germany
Slovenian: 85276 Pfaffenhofen Nemčija
English: For all patients undergoing cardioversion: Confirmation should be sought prior to cardioversion that the patient has taken Lixiana as prescribed.
Slovenian: Za vse bolnike, pri katerih se izvaja kardioverzija: Pred kardioverzijo se je treba prepričati, da je bolnik vzel zdravilo Lixiana, kakor je bilo predpisano.
English: The educational programme is aimed at mitigating the risk of serious bleeds or haemorrhage in patients treated with Lixiana by ensuring prescriber awareness and providing guidance on appropriate patient selection, correct dosing as well as management of the risk.
Slovenian: Cilj izobraževalnega programa je zmanjševanje tveganja resnih krvavitev pri bolnikih, ki se zdravijo z zdravilom Lixiana, in sicer tako, da se zagotovi ozaveščanje zdravnikov, ki predpisujejo zdravilo, in podajanje smernic za ustrezno izbiro bolnikov, pravilno odmerjanje, pa tudi obvladovanje tveganja.
English: If there is a chance that you could become pregnant, use a reliable contraceptive while you are taking Lixiana.
Slovenian: Če obstaja možnost, da bi lahko zanosili, jemljite zanesljivo kontracepcijsko sredstvo, ko jemljete zdravilo Lixiana.
English: • That all patients should be provided with a Patient alert card and be counselled about: The signs or symptoms of bleeding and when to seek attention from a healthcare provider Importance of treatment compliance Necessity to carry the Patient alert card with them at all times The need to inform Health Care Professionals that they are taking Lixiana if they need to have any surgery or invasive procedure
Slovenian: • da morajo vsi bolniki prejeti kartico z opozorili za bolnika in da jim moramo svetovati o: znakih ali simptomih krvavitve in o tem, kdaj je treba poiskati zdravniško pomoč, pomembnosti jemanja zdravila po zdravnikovih navodilih, o potrebi, da imajo kartico z opozorili za bolnika vedno s seboj, o potrebi, da obvestijo zdravstvene delavce, da jemljejo zdravilo Lixiana, če je pri njih potrebna kakršna koli operacija ali invaziven poseg.
English: Lixiana can be taken with or without food.
Slovenian: Zdravilo Lixiana lahko jemljete s hrano ali brez nje.
English: • The signs or symptoms of bleeding and when to seek attention
Slovenian: • o znakih ali simptomih krvavitve in o tem, kdaj je treba poiskati zdravniško pomoč;
English: This method is recommended when assessing patients' CrCL prior to and during Lixiana treatment.
Slovenian: Ta metoda je priporočena pri ocenjevanju CrCL bolnikov pred zdravljenjem z zdravilom Lixiana in med njim.
English: • The need to inform Health Care Professionals that they are taking Lixiana if they need to have any surgery or invasive procedure
Slovenian: • o potrebi, da obvestijo zdravstvene delavce, da jemljejo zdravilo Lixiana, če je pri njih potrebna kakršna koli operacija ali invaziven poseg.
English: After 14 days it is recommended that Lixiana is discontinued and the VKA continued to be titrated to achieve an INR between 2 and 3.
Slovenian: Po 14 dneh je priporočljivo zdravilo Lixiana ukiniti in še naprej titrirati VKA, da se doseže INR med 2 in 3.
English: The safety and efficacy of Lixiana in children and adolescents less than 18 years of age have not been established.
Slovenian: Varnost in učinkovitost zdravila Lixiana pri otrocih in mladostnikih, mlajših od 18 let, nista bili dokazani.
English: If your abnormal heartbeat needs to be restored to normal by a procedure called cardioversion, take Lixiana at the times your doctor tells you to prevent blood clots in the brain and other blood vessels in your body.
Slovenian: Če je vaš nenormalen srčni utrip treba povrniti na normalnega s postopkom, ki mu pravimo kardioverzija, vzemite zdravilo Lixianatakrat, kot vam je naročil zdravnik, da preprečite krvne strdke v možganih in krvnih žilah drugod po vašem telesu.
English: Edoxaban is absorbed with peak plasma concentrations within 1 - 2 hours.
Slovenian: Edoksaban se absorbira z najvišjimi plazemskimi koncentracijami v 1 - 2 urah.
English: Please consult your doctor for a new prescription of Lixiana.
Slovenian: Obrnite se na svojega zdravnika za nov recept za zdravilo Lixiana.
English: Lixiana can be taken with or without food (see section 5.2).
Slovenian: Zdravilo Lixiana se lahko jemlje skupaj s hrano ali brez nje (glejte poglavje 5.2).
English: If you become pregnant while you are taking Lixiana, immediately tell your doctor, who will decide how you should be treated.
Slovenian: Če med jemanjem zdravila Lixiana, zanosite, to nemudoma povejte svojemu zdravniku, ki bo odločil, kako vas bo treba zdraviti.
English: Lixiana has been prescribed at a once-daily dose of:
Slovenian: Zdravilo Lixiana je bilo predpisano v enkratnem dnevnem odmerku:
English: Very common (≥ 1/10), Common (≥ 1/100 to < 1/10), Uncommon (≥ 1/1,000 to < 1/100), Rare (≥ 1/10,000 to < 1/1,000), Very rare (< 1/10,000), not known (cannot be estimated from the available data).
Slovenian: Neželeni učinki so razvrščeni po organskih sistemih in pogostnosti z uporabo naslednjega dogovora: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 to < 1/1.000), zelo redki (< 1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: Safety in patients with NVAF in ENGAGE AF-TIMI 48
Slovenian: Varnost pri bolnikih z NVAF v študiji ENGAGE AF-TIMI 48
English: - prevent blood clots in the brain (stroke) and other blood vessels in the body if you have a form of irregular heart rhythm called nonvalvular atrial fibrillation and at least one additional risk factor.
Slovenian: - za preprečevanje nastanka krvnih strdkov v možganih(možganska kap)in drugih krvnih žilah telesa,čeimajo obliko nerednega srčnega ritma, ki se imenuje nevalvularna atrijska fibrilacija, in vsaj še en dodaten dejavnik tveganja.
English: Lixiana 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 edoxaban have not been established in these clinical situations.
Slovenian: Zdravilo Lixiana ni priporočeno kot alternativa nefrakcioniranemu heparinu pri bolnikih s pljučno embolijo, ki so hemodinamično nestabilni ali bodo morda prejeli trombolizo ali pljučno embolektomijo, saj varnost in učinkovitost edoksabana v teh kliničnih situacijah nista bili ugotovljeni.
English: QR code to be included
Slovenian: Koda QR bo dodana naknadno.
English: The primary efficacy endpoint was the recurrence of symptomatic VTE, defined as the composite of recurrent symptomatic DVT, non-fatal symptomatic PE and fatal PE in subjects during the 12-month study period.
Slovenian: Primarni kriterij učinkovitosti je bil recidiv simptomatskega VTE, po definiciji sestavljen iz recidivne simptomatske GVT, ne-fatalnega simptomatskega PE in fatalnega PE pri preiskovancih med 12-mesečnim obdobjem študije.
English: Clinically Relevant Bleeding (Major and CRNM)b, n (%) n
Slovenian: Klinično pomembna krvavitev (velika in CRNM),b n (%) n
English: A 4 hour haemodialysis session reduced total edoxaban exposures by less than 9%.
Slovenian: Hemodializa 4-urni postopek hemodialize je zmanjšal celotno izpostavljenost edoksabanu za manj kot 9 %.
English: Cardioversion should be performed no later than 12 hours after the dose of Lixiana on the day of the procedure.
Slovenian: Kardioverzijo je treba izvesti največ 12 ur po odmerku zdravila Lixiana na dan posega.
English: If anticoagulation must be discontinued to reduce the risk of bleeding with surgical or other procedures, Lixiana should be stopped as soon as possible and preferably at least 24 hours before the procedure.
Slovenian: Če morate antikoagulacijo prekiniti, da se zmanjša nevarnost krvavitve pri kirurških ali drugih postopkih, zdravilo Lixiana ukinite, takoj ko je to mogoče, po možnosti pa vsaj 24 ur pred postopkom.
English: The programme is also aimed at ensuring that the healthcare professionals who intend to prescribe Lixiana are aware of the Patient alert card and that the card is to be given to and reviewed with all patients treated with Lixiana.
Slovenian: Eden od ciljev programa je tudi zagotoviti, da bodo zdravstveni delavci, ki nameravajo predpisovati zdravilo Lixiana, vedeli za kartico z opozorili za bolnika in da bodo vedeli, da morajo kartico dati vsakemu bolniku, ki se bo zdravil z zdravilom Lixiana, in jo skupaj z njim pregledati.
English: • Prescriber Guide for healthcare professionals
Slovenian: • smernice za predpisovanje za zdravstvene delavce;
English: Prior to initiating Lixiana, liver function testing should be performed.
Slovenian: Pred uvajanjem zdravila Lixiana je treba opraviti testiranje funkcije jeter.
English: For transoesophageal echocardiogram (TEE) guided cardioversion in patients not previously treated with anticoagulants, Lixiana treatment should be started at least 2 hours before cardioversion to ensure adequate anticoagulation (see sections 5.1 and 5.2).
Slovenian: Pri bolnikih, pri katerih se izvaja kardioverzija, vodena s transezofagealno ehokardiografijo (TEE), in ki niso bili predhodno zdravljeni z antikoagulanti, je treba zdravljenje z zdravilom Lixiana začeti vsaj 2 uri pred kardioverzijo, da se zagotovi zadostna antikoagulacija (glejte poglavji 5.1 in 5.2).
English: The majority of subjects in the edoxaban and warfarin groups had cardioversion performed (83.7% and 78.9%, respectively) or were auto-converted (6.6% and 8.6%, respectively).
Slovenian: Pri večini oseb v skupinah z edoksabanomin varfarinom je bila opravljena kardioverzija (83,7 % oziroma 78,9 %) ali pa je pri njih prišlo do samodejne konverzije (6,6 % oziroma 8,6 %).
English: Table 3: List of adverse reactions for NVAF and VTE System Organ Class
Slovenian: Preglednica 3: Seznam neželenih učinkov za NVAF in VTE Organski sistem
English: 1 Post-dose is equivalent to Cmax (post-dose samples were drawn 1 - 3 hours after edoxaban administration)
Slovenian: 1Po odmerku ustreza Cmax (vzorci po odmerku so bili odvzeti 1-3 ure po dajanju edoksabana).
English: • Do not stop taking Lixiana without consulting your doctor as this can increase your risk of developing a blood clot.
Slovenian: • Zdravila Lixiana ne nehajte jemati, ne da bi se prej posvetovali z zdravnikom, saj lahko to zveča vaše tveganje za nastanek krvnega strdka.
English: If you currently take 30 mg (dose reduced) Lixiana:
Slovenian: Če trenutno jemljete 30 mg (zmanjšani odmerek)zdravila Lixiana:
English: Due to the pharmacological mode of action, the use of Lixiana 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 Lixiana spremlja večje tveganje za prikrite ali očitne krvavitve iz tkiv ali organov, ki lahko povzročijo posthemoragično anemijo.
English: What you need to know before you take Lixiana 3.
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Lixiana 3.
English: Edoxaban is predominantly absorbed in the upper gastrointestinal (GI) tract.
Slovenian: Edoksaban se absorbira pretežno v zgornjemgastrointestinalnem (GI) traktu.
English: erythromycin, or ketoconazole.
Slovenian: dronedaron, eritromicin ali ketokonazol.
English: • Recommendations for dose adjustment in at risk populations, including patients with renal or hepatic impairment, low body weight and concomitant use of some P-gp inhibitors
Slovenian: • priporočila za prilaganje odmerjanja pri skupinah bolnikov z zvečanim tveganjem, vključno z bolniki z okvaro ledvic ali jeter, majhno telesno maso in s tistimi, ki sočasno uporabljajo nekatere inhibitorje P-gp;
English: In deciding whether a procedure should be delayed until 24 hours after the last dose of Lixiana, the increased risk of bleeding should be weighed against the urgency of the intervention.
Slovenian: Pri odločanju, ali naj se poseg odloži na čas, ko bo minilo 24 ur od zadnjega odmerka zdravila Lixiana, je treba pretehtati zvečanje tveganja za krvavitve in nujnost posega.
English: Do not take Lixiana:
Slovenian: Ne jemljite zdravilaLixiana:
English: Prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (NVAF) with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack (TIA).
Slovenian: Preprečevanje možganske kapi in sistemske embolije pri odraslih bolnikih z nevalvularno atrijsko fibrilacijo (NVAF - Non-Valvular Atrial Fibrillation) z enim ali več dejavniki tveganja, kot so kongestivno popuščanje srca, hipertenzija, starost ≥ 75 let, sladkorna bolezen, predhodna možganska kap ali prehodna možganska ishemija (TIA - Transient Ischaemic Attack).
English: It is recommended that during the first 14 days of concomitant therapy the INR is measured at least 3 times just prior to taking the daily dose of Lixiana to minimise the influence of Lixiana on INR measurements.
Slovenian: Prvih 14 dni sočasnega zdravljenja je priporočljivo meriti INR vsaj trikrat tik pred jemanjem dnevnega odmerka zdravila Lixiana, da se vpliv zdravila Lixiana na meritve INR kolikor mogoče zmanjša.
English: This exploratory study showed low rates of major and CRNM bleeding and thromboembolism in the two treatment groups in the setting of cardioversion.
Slovenian: Ta raziskovalna študija je pokazala majhno pogostnost velikihkrvavitev, CRNM krvavitev in trombembolije v obeh skupinah zdravljenja v kontekstu kardioverzije.
English: A QR Code and the following text may be printed on the inner lid of the carton: Lixiana should be taken once daily and ideally at the same time every day
Slovenian: Koda QR in naslednje besedilo se lahko natisneta na notranjo stran pokrovčka škatle: Zdravilo Lixiana je treba jemati enkrat na dan, najbolje vsak dan ob istem času.
English: The primary safety endpoint was major bleeding.
Slovenian: Primarni kriterij varnosti je bila velika krvavitev.
English: • When an invasive procedure is required, Lixiana should be stopped at least 24 hours beforehand,
Slovenian: • Če je potreben invaziven poseg, je treba prenehati z uporabo zdravila Lixiana vsaj 24 ur pred njim,
English: The majority of edoxaban treated patients were Caucasians (69.6%) and Asians (21.0%), 3.8% were Black, 5.3% were categorised as Other race.
Slovenian: Večina bolnikov, zdravljenih z edoksabanom, je bila pripadnikov bele (69,6 %) in azijske rase (21,0 %), 3,8 % je bilo črncev, 5,3 % je bilo pripadnikov drugih ras.
English: Lixiana Discontinue the VKA and start Lixiana when the international normalised ratio (INR) is ≤ 2.5.
Slovenian: Lixiana Ukinite VKA in začnite z zdravilom Lixiana, ko bo mednarodno normalizirano razmerje (INR) ≤ 2,5.
English: Like other similar medicines (medicines to reduce blood clotting), Lixiana may cause bleeding which may potentially be life-threatening.
Slovenian: Kot druga podobna zdravila (zdravila, ki zmanjšujejo strjevanje krvi)lahko zdravilo Lixiana povzroči krvavitev, ki je lahko celo smrtno nevarna.
English: Daiichi Sankyo [LOGO]
Slovenian: Daiichi Sankyo [LOGOTIP]
English: • Bleeding from the skin or under the skin
Slovenian: • krvavitve v koži ali pod kožo,
English: • Lixiana may increase the risk of bleeding.
Slovenian: • Zdravilo Lixiana lahko zveča tveganje za krvavitev.
English: • Please read the Patient Information Leaflet found inside each pack of Lixiana.
Slovenian: • Preberite navodila za uporabo zdravila za bolnika, ki ga boste našli v vsakem pakiranju zdravila Lixiana.
English: No dose reduction is required (see section 5.2).
Slovenian: Spol Nikakršno zmanjševanje odmerka ni potrebno (glejte poglavje 5.2).
English: Lixiana has no or negligible influence on the ability to drive and use machines.
Slovenian: Zdravilo Lixiana nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
English: Intravenous unfractionated heparin (UFH): Discontinue the infusion and start Lixiana 4 hours later.
Slovenian: Intravenski nefrakcionirani heparin (INH): Ukinite infuzijo in 4 ure pozneje začnite dajati zdravilo Lixiana.
English: If any of the above apply to you, tell your doctor before taking Lixiana, because the effect of Lixiana may be reduced.
Slovenian: Če se karkoli od naštetega nanaša na vas, se posvetujte z zdravnikom, preden boste začeli jemati zdravilo Lixiana, ker se učinek zdravila Lixiana lahko zmanjša.
English: There may be situations that warrant a change in anticoagulation therapy (Table 2).
Slovenian: Možne so situacije, ko je upravičena sprememba antikoagulantne terapije (preglednica 2).
English: What Lixiana is and what it is used for
Slovenian: Kaj je zdraviloLixiana in za kaj ga uporabljamo
English: b The HR, two-sided CI are based on the Cox proportional hazards regression model including treatment and the following randomisation stratification factors as covariates: presenting diagnosis (PE with or without DVT, DVT only), baseline risk factors (temporary factors, all others), and the need for 30 mg edoxaban/edoxaban placebo dose at randomisation (yes/no).
Slovenian: b HR, dvostranski CI temeljita na Coxovem regresijskem modelu proporcionalnih tveganj, vključno z zdravljenjem in naslednjimi randomizacijskimi stratifikacijskimi dejavniki kot sospremenljivkami: diagnoza ob prvem pregledu (PE z GVT ali brez nje, samo GVT), izhodiščni dejavniki tveganja (začasni dejavniki, vsi drugi) in potreba po odmerku edoksabana 30 mg /edoksabanu placebu ob randomizaciji (da/ne).
English: You have been prescribed Lixiana, an anticoagulant medicine, which thins your blood and helps prevent you from suffering blood clots.
Slovenian: Predpisali so vam zdravilo Lixiana, zdravilo proti strjevanju krvi, ki redči kri in vas pomaga zaščititi pred krvnimi strdki.
English: Lixiana, like other anticoagulants, is recommended to be used with caution in patients with increased risk of bleeding.
Slovenian: Priporočljivo je, da se zdravilo Lixiana, podobno kot drugi antikoagulanti, uporablja previdno pri bolnikih z zvečanim tveganjem za krvavitve.
English: 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 have uncontrolled high blood pressure - if you are pregnant or breast feeding
Slovenian: rivaroksaban, apiksaban ali heparin), razen pri spremembi/zamenjavi antikoagulacijskega zdravljenja ali ko dobivate heparin skozi venski ali arterijskikateterza vzdrževanje prehodnosti katetra, - če imate bolezen jeter, ki lahko zveča tveganje za krvavitve, - če imate nekontroliran visok krvni tlak, - če ste noseči ali dojite.
English: • Bleeding from the nose
Slovenian: • krvavitev iz nosu,
English: It is only indicated in the process of switching from Lixiana 30 mg (patients with one or more clinical factors for increased exposure; see table 1) to VKA, together with an appropriate VKA dose (see table 2, section 4.2).
Slovenian: Indicirano je le v postopku prehoda z zdravila Lixiana 30 mg (bolniki z enim ali več kliničnimi dejavniki za zvečano izpostavljenost; glejte preglednico 1) na VKA, v kombinaciji z ustreznim odmerkom VKA (glejte preglednico 2, poglavje 4.2).
English: OTHER MON, TUE, WED, THU, FRI, SAT, SUN
Slovenian: DRUGI PODATKI PON, TOR, SRE, ČET, PET, SOB, NED
English: Therapy with edoxaban in NVAF patients should be continued long term.
Slovenian: Zdravljenje bolnikov z NVAFz edoksabanomje treba nadaljevati dolgo časa.
English: If you stop taking Lixiana
Slovenian: Če ste prenehali jemati zdravilo Lixiana
English: Vitamin K Antagonist (VKA)
Slovenian: Lixiana antagonist vitamina K (VKA)
English: In animal reproduction studies, rabbits showed increased incidence of gallbladder variations at a dosage of 200 mg/kg which is approximately 65 times the maximum recommended human dose (MRHD) of 60 mg/day based on total body surface area in mg/m2.
Slovenian: V raziskavah reprodukcije pri živalih so kunci kazali zvečano incidenco variacij žolčnika pri odmerku 200 mg/kg, kar je približno 65-kratnik največjega priporočenega odmerka za človeka (MRHD), ki je 60 mg/dan in temelji na celotni telesni površini v mg/m2.
English: • Renal function should be assessed in all patients by calculating the creatinine clearance (CrCL) prior to initiation of treatment with Lixiana to exclude patients with end stage renal disease (i.e. CrCL < 15 mL/min), to use the correct Lixiana dose in patients with CrCL 15 - 50 mL/min (30 mg once daily), in patients with CrCL > 50 mL/min (60 mg once daily) and when deciding on the use of Lixiana in patients with increased creatinine clearance (see section 4.4).
Slovenian: • Pred začetkom zdravljenja z zdravilom Lixiana je treba pri vseh bolnikih oceniti delovanje ledvic prek izračuna očistka kreatinina (CrCL), da izločite bolnike z boleznijo ledvic v končnem stadiju (t. j. CrCL < 15 ml/min) in da uporabite pravilen odmerek zdravila Lixiana pri bolnikih s CrCL 15 - 50 ml/min (30 mg enkrat na dan) in pri bolnikih s CrCL > 50 ml/min (60 mg enkrat na dan), ter takrat, ko se odločate glede uporabe zdravila Lixiana pri bolnikih z zvišanim očistkom kreatinina (glejte poglavje 4.4).
English: 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: Bodite posebno pozorni pri jemanju zdravila Lixiana Če veste, da imate bolezen, imenovano antifosfolipidni sindrom (bolezen imunskega sistema, zaradi katere imate povečano tveganje za nastanek krvnih strdkov), o tem obvestite zdravnika, ki bo presodil, ali je treba zdravljenje spremeniti.
English: If you take more Lixiana than recommended, you may have an increased risk of bleeding.
Slovenian: Če vzamete več zdravila Lixiana, kot je priporočeno, imate lahko zvečano tveganje krvavitev.
English: Do not stop taking Lixiana without talking to your doctor first, because Lixiana treats and prevents serious conditions.
Slovenian: Ne prenehajte jemati zdravila Lixiana, ne da bi se prej posvetovali z zdravnikom, ker zdravilo Lixiana zdravi in preprečuje resne bolezni.
English: For life-threatening bleeding that cannot be controlled with the measures such as transfusion or haemostasis, the administration of a 4-factor prothrombin complex concentrate (PCC) at 50 IU/kg has been shown to reverse the effects of Lixiana 30 minutes after completing the infusion.
Slovenian: Pri smrtno nevarni krvavitvi, ki je ne moremo obvladati s transfuzijo ali hemostazo, so pokazali, da uporaba koncentrata protrombinskega kompleksa s 4 faktorji (PCC) v odmerku 50 i.e./kg nevtralizira učinke zdravila Lixiana 30 minutpo končani infuziji.
English: The duration of therapy for treatment of DVT and PE (venous thromboembolism, VTE), and prevention of recurrent VTE should be individualised after careful assessment of the treatment benefit against the risk for bleeding (see section 4.4).
Slovenian: Trajanje terapije za zdravljenje GVT in PE (venske tromboembolije, VTE) in preprečevanje ponovne VTE se določi individualno po skrbni oceni koristi zdravljenja glede na tveganje za krvavitve(glejte poglavje 4.4).
English: The primary safety endpoint was clinically relevant bleeding (major or clinically relevant non-major).
Slovenian: Primarno končno stanje varnosti je bila klinično pomembna krvavitev (velika ali klinično pomembna, ki ni bila velika).
English: ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
Slovenian: PRILOGAI POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA