natgillin/translations-raw huggingface dataset:
Having reviewed all available data, the CHMP considered that CMS and colistin represent a crucial therapeutic option in the armamentarium available to prescribers in the context of the treatment of infections caused by multi-drug resistant Gram-negative pathogens. 
Ko je odbor CHMP pregledal vse razpoložljive podatke, je menil, da NKM in kolistin predstavljata ključno terapevtsko možnost, ki je na voljo predpisovalcem za zdravljenje okužb, ki jih povzročajo multirezistentni gramnegativni patogeni.
• the CHMP considered that colistimethate sodium and colistin represent a crucial therapeutic option in the context of the treatment of infections caused by multi-drug resistant Gramnegative pathogens, 
• odbor CHMP je menil, da natrijev kolistimetat in kolistin predstavljata ključno terapevtsko možnost za zdravljenje okužb, ki jih povzročajo multirezistentni gramnegativni patogeni;
• the CHMP considered that the risks of nephrotoxicity and neurotoxicity observed with colistin for parenteral use should be balanced against the risk of the underlying disease and the high mortality from the treated conditions and that it can be satisfactorily mitigated by warnings and recommendations in the SmPC, 
• odbor CHMP je menil, da je treba tveganja nefrotoksičnosti in nevrotoksičnosti, ki so jih opazili pri kolistinu za parenteralno uporabo, pretehtati glede na tveganje osnovne bolezni in veliko umrljivost zaradi zdravljenih stanj ter da jih je mogoče zadovoljivo zmanjšati z opozorili in priporočili v povzetku glavnih značilnosti zdravila;
• the CHMP made extensive revisions to the SmPC to reflect current pharmacokinetic and pharmacodynamic data, including an update of the EUCAST breakpoints and the list of susceptible species, 
• odbor CHMP je temeljito pregledal in popravil povzetke glavnih značilnosti zdravila, da odražajo trenutne farmakokinetične in farmakodinamične podatke, vključno s posodobitvijo mejnih vrednosti po EUCAST in seznamom občutljivih vrst;
In conclusion, the CHMP is of the opinion that the benefit-risk of the polymyxin-based products included in the scope of this procedure remains positive, provided that changes, as applicable, are made to their product information as set out in Annex III to the opinion. 
V svojem sklepu je odbor CHMP menil, da razmerje med tveganji in koristmi zdravil, ki vsebujejo polimiksine in so vključena v ta postopek, ostaja pozitivno, če se v informacije o zdravilu vnesejo spremembe, navedene v Prilogi III k temu mnenju, kot je primerno.
The posology and method of administration section was also revised in its entirety, for all patient subpopulations, in order to define the optimal treatment regimens for achieving plasma concentrations above the critical minimal inhibitory concentrations. 
Da bi opredelili optimalne režime zdravljenja za doseganje koncentracij v plazmi, večjih od kritičnih minimalnih inhibitornih koncentracij, so spremenili tudi celotni poglavji o odmerjanju in načinu uporabe za vse podskupine bolnikov.
Strength Pharmaceutical Form Route of Administration 
Številka EU ime jakost farmacevtska oblika pot uporabe ovojnina
These are your last remaining tablets. 
To so zadnje tablete, ki jih še imate.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 19 June 2015 
Datum prve odobritve: 19. junij 2015
The Patient alert card should contain the following key safety messages: 
Kartica z opozorili za bolnika mora vsebovati naslednja ključna varnostna sporočila:
INFORMATION FOR HEALTHCARE PROFESSIONALS 
INFORMACIJE ZA ZDRAVSTVENE DELAVCE
PRESCRIBER INFORMATION For more information or in case of emergency, please contact: Physician's name: 
INFORMACIJE O PREDPISOVALCU Za več informacij ali v nujnem primeru se obrnite na: Ime zdravnika:
Prior to launch of Lixiana in each Member State, the Marketing Authorisation Holder (MAH) must agree the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority. 
Pred prihodom zdravila Lixiana na trg vsake države članice se mora imetnik dovoljenja za promet z zdravilom dogovoriti o vsebini in obliki izobraževalnega programa, vključno s komunikacijskimi mediji, načini distribucije in vsemi drugimi vidiki programa, s pristojnim nacionalnim organom.
• Allergic reaction 
• alergijska reakcija,
A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from therapy. 
Odločiti se je treba ali prenehati z dojenjem ali prenehati oz. vzdržati se zdravljenja.
Discontinuation for surgery and other interventions 
Ukinitev zaradi operacije in drugih posegov
Signature of physician: 
Podpis zdravnika:
The same information is also available on the following URL: www.dspatient.eu. 
Te informacije so na voljo tudi na naslednji povezavi: www.dspatient.eu.
Overall list of possible side effects: 
Celoten seznam možnih neželenih učinkov:
Vaginal bleeds were reported commonly in women under the age of 50 years, while it was uncommon in women over the age of 50 years. 
O vaginalnih krvavitvah so poročali pogosto pri ženskah, mlajših od 50 let, in občasno pri ženskah, starejših od 50 let.
Do not take Lixiana if you are pregnant or breast-feeding. 
Ne jemljite zdravila Lixiana, če ste noseči ali dojite.
- if you have an increased risk of bleeding, as could be the case if you have any of the following conditions: 
- če imate zvečano tveganje krvavitve, kar bi bilo možno, če imate katero od naslednjih bolezni:
Do not stop taking Lixiana unless advised by your doctor. 
Ne prenehajte jemati zdravila Lixiana, razen če vam to svetuje zdravnik.
Lixiana 15 mg is not indicated as monotherapy, as it may result in decreased efficacy. 
Zdravilo Lixiana 15 mg ni indicirano za monoterapijo, saj bi lahko prišlo do zmanjšane učinkovitosti.
Most patients (85%) should be able to achieve an INR ≥ 2.0 within 14 days of concomitant administration of Lixiana and VKA. 
Večina bolnikov (85 %) bi morala biti sposobna doseči INR ≥ 2,0 v 14 dneh sočasnega zdravljenja z zdravilom Lixiana in VKA.
Lixiana is used in adults to: 
Zdravilo Lixiana se pri odraslih uporablja:
Take as recommended by your doctor: 
Zdravilo jemljite tako, kot vam je priporočil zdravnik:
85276 Pfaffenhofen, Bayern Germany 
85276 Pfaffenhofen, Bayern Nemčija
30 mg once daily 
60 mg enkrat na dan*
What Lixiana is and what it is used for 2. 
Kaj je zdravilo Lixiana in za kaj ga uporabljamo 2.
The method used to estimate renal function (CrCL in mL/min) during the clinical development of Lixiana was the Cockcroft-Gault method. 
Metoda, uporabljena za oceno delovanja ledvic (CrCL v ml/min) med kliničnim razvojem zdravila Lixiana,je bila Cockcroft-Gaultova metoda.
• endstage kidney disease or if you are on dialysis 
• končni stadij bolezni ledvic ali če ste na dializi,
Table 10: Efficacy Results from the Hokusai-VTE Study - mITT population, overall study period 
Preglednica 10: Rezultati učinkovitosti iz študije Hokusai-VTE - populacija mITT, celotno obdobje študije
• For creatinine in µmol/L: 
• Za kreatinin vµmol/l:
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: 
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:
85276 Pfaffenhofen Germany 
85276 Pfaffenhofen Nemčija
For all patients undergoing cardioversion: Confirmation should be sought prior to cardioversion that the patient has taken Lixiana as prescribed. 
Za vse bolnike, pri katerih se izvaja kardioverzija: Pred kardioverzijo se je treba prepričati, da je bolnik vzel zdravilo Lixiana, kakor je bilo predpisano.
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. 
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.
If there is a chance that you could become pregnant, use a reliable contraceptive while you are taking Lixiana. 
Če obstaja možnost, da bi lahko zanosili, jemljite zanesljivo kontracepcijsko sredstvo, ko jemljete zdravilo Lixiana.
• 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 
• 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.
Lixiana can be taken with or without food. 
Zdravilo Lixiana lahko jemljete s hrano ali brez nje.
• The signs or symptoms of bleeding and when to seek attention 
• o znakih ali simptomih krvavitve in o tem, kdaj je treba poiskati zdravniško pomoč;
This method is recommended when assessing patients' CrCL prior to and during Lixiana treatment. 
Ta metoda je priporočena pri ocenjevanju CrCL bolnikov pred zdravljenjem z zdravilom Lixiana in med njim.
• The need to inform Health Care Professionals that they are taking Lixiana if they need to have any surgery or invasive procedure 
• o potrebi, da obvestijo zdravstvene delavce, da jemljejo zdravilo Lixiana, če je pri njih potrebna kakršna koli operacija ali invaziven poseg.
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. 
Po 14 dneh je priporočljivo zdravilo Lixiana ukiniti in še naprej titrirati VKA, da se doseže INR med 2 in 3.
The safety and efficacy of Lixiana in children and adolescents less than 18 years of age have not been established. 
Varnost in učinkovitost zdravila Lixiana pri otrocih in mladostnikih, mlajših od 18 let, nista bili dokazani.
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. 
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.
Edoxaban is absorbed with peak plasma concentrations within 1 - 2 hours. 
Edoksaban se absorbira z najvišjimi plazemskimi koncentracijami v 1 - 2 urah.
Please consult your doctor for a new prescription of Lixiana. 
Obrnite se na svojega zdravnika za nov recept za zdravilo Lixiana.
Lixiana can be taken with or without food (see section 5.2). 
Zdravilo Lixiana se lahko jemlje skupaj s hrano ali brez nje (glejte poglavje 5.2).
If you become pregnant while you are taking Lixiana, immediately tell your doctor, who will decide how you should be treated. 
Če med jemanjem zdravila Lixiana, zanosite, to nemudoma povejte svojemu zdravniku, ki bo odločil, kako vas bo treba zdraviti.
Lixiana has been prescribed at a once-daily dose of: 
Zdravilo Lixiana je bilo predpisano v enkratnem dnevnem odmerku:
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). 
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).
Safety in patients with NVAF in ENGAGE AF-TIMI 48 
Varnost pri bolnikih z NVAF v študiji ENGAGE AF-TIMI 48
- 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. 
- 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.
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. 
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.
QR code to be included 
Koda QR bo dodana naknadno.
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. 
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.
Clinically Relevant Bleeding (Major and CRNM)b, n (%) n 
Klinično pomembna krvavitev (velika in CRNM),b n (%) n
A 4 hour haemodialysis session reduced total edoxaban exposures by less than 9%. 
Hemodializa 4-urni postopek hemodialize je zmanjšal celotno izpostavljenost edoksabanu za manj kot 9 %.
Cardioversion should be performed no later than 12 hours after the dose of Lixiana on the day of the procedure. 
Kardioverzijo je treba izvesti največ 12 ur po odmerku zdravila Lixiana na dan posega.
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. 
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.
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. 
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.
• Prescriber Guide for healthcare professionals 
• smernice za predpisovanje za zdravstvene delavce;
Prior to initiating Lixiana, liver function testing should be performed. 
Pred uvajanjem zdravila Lixiana je treba opraviti testiranje funkcije jeter.
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). 
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).
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). 
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 %).
Table 3: List of adverse reactions for NVAF and VTE System Organ Class 
Preglednica 3: Seznam neželenih učinkov za NVAF in VTE Organski sistem
1 Post-dose is equivalent to Cmax (post-dose samples were drawn 1 - 3 hours after edoxaban administration) 
1Po odmerku ustreza Cmax (vzorci po odmerku so bili odvzeti 1-3 ure po dajanju edoksabana).
• Do not stop taking Lixiana without consulting your doctor as this can increase your risk of developing a blood clot. 
• Zdravila Lixiana ne nehajte jemati, ne da bi se prej posvetovali z zdravnikom, saj lahko to zveča vaše tveganje za nastanek krvnega strdka.
If you currently take 30 mg (dose reduced) Lixiana: 
Če trenutno jemljete 30 mg (zmanjšani odmerek)zdravila Lixiana:
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. 
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.
What you need to know before you take Lixiana 3. 
Kaj morate vedeti, preden boste vzeli zdravilo Lixiana 3.
Edoxaban is predominantly absorbed in the upper gastrointestinal (GI) tract. 
Edoksaban se absorbira pretežno v zgornjemgastrointestinalnem (GI) traktu.
erythromycin, or ketoconazole. 
dronedaron, eritromicin ali ketokonazol.
• 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 
• 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;
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. 
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.
Do not take Lixiana: 
Ne jemljite zdravilaLixiana:
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). 
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).
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. 
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.
This exploratory study showed low rates of major and CRNM bleeding and thromboembolism in the two treatment groups in the setting of cardioversion. 
Ta raziskovalna študija je pokazala majhno pogostnost velikihkrvavitev, CRNM krvavitev in trombembolije v obeh skupinah zdravljenja v kontekstu kardioverzije.
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 
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.
The primary safety endpoint was major bleeding. 
Primarni kriterij varnosti je bila velika krvavitev.
• When an invasive procedure is required, Lixiana should be stopped at least 24 hours beforehand, 
• Če je potreben invaziven poseg, je treba prenehati z uporabo zdravila Lixiana vsaj 24 ur pred njim,
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. 
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.
Lixiana Discontinue the VKA and start Lixiana when the international normalised ratio (INR) is ≤ 2.5. 
Lixiana Ukinite VKA in začnite z zdravilom Lixiana, ko bo mednarodno normalizirano razmerje (INR) ≤ 2,5.
Like other similar medicines (medicines to reduce blood clotting), Lixiana may cause bleeding which may potentially be life-threatening. 
Kot druga podobna zdravila (zdravila, ki zmanjšujejo strjevanje krvi)lahko zdravilo Lixiana povzroči krvavitev, ki je lahko celo smrtno nevarna.
Daiichi Sankyo [LOGO] 
Daiichi Sankyo [LOGOTIP]
• Bleeding from the skin or under the skin 
• krvavitve v koži ali pod kožo,
• Lixiana may increase the risk of bleeding. 
• Zdravilo Lixiana lahko zveča tveganje za krvavitev.
• Please read the Patient Information Leaflet found inside each pack of Lixiana. 
• Preberite navodila za uporabo zdravila za bolnika, ki ga boste našli v vsakem pakiranju zdravila Lixiana.
No dose reduction is required (see section 5.2). 
Spol Nikakršno zmanjševanje odmerka ni potrebno (glejte poglavje 5.2).
Lixiana has no or negligible influence on the ability to drive and use machines. 
Zdravilo Lixiana nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
Intravenous unfractionated heparin (UFH): Discontinue the infusion and start Lixiana 4 hours later. 
Intravenski nefrakcionirani heparin (INH): Ukinite infuzijo in 4 ure pozneje začnite dajati zdravilo Lixiana.
If any of the above apply to you, tell your doctor before taking Lixiana, because the effect of Lixiana may be reduced. 
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.
There may be situations that warrant a change in anticoagulation therapy (Table 2). 
Možne so situacije, ko je upravičena sprememba antikoagulantne terapije (preglednica 2).
What Lixiana is and what it is used for 
Kaj je zdraviloLixiana in za kaj ga uporabljamo
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). 
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).
You have been prescribed Lixiana, an anticoagulant medicine, which thins your blood and helps prevent you from suffering blood clots. 
Predpisali so vam zdravilo Lixiana, zdravilo proti strjevanju krvi, ki redči kri in vas pomaga zaščititi pred krvnimi strdki.