FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients experiencing these adverse reactions should not drive or use machines.
Slovenian: Bolniki, pri katerih se pojavijo ti neželeni učinki, ne smejo voziti ali upravljati strojev.
English: Bayer Portugal, Lda.
Slovenian: Portugal Bayer Portugal, Lda.
English: The treatment duration was up to 12 months depending on the individual randomisation date (median: 351 days).
Slovenian: Zdravljenje je trajalo do 12 mesecev, odvisno od individualnega dneva randomizacije (mediana: 351 dni).
English: When should I seek advice from my health care provider?
Slovenian: Kdaj naj se posvetujem z zdravnikom?
English: Doctor's phone: Doctor's stamp:
Slovenian: Telefon zdravnika: Žig zdravnika:
English: The volume of distribution is moderate with Vss being approximately 50 litres.
Slovenian: Volumen porazdelitve je zmerno velik; Vss je približno 50 litrov.
English: If neurological compromise is noted, urgent diagnosis and treatment is necessary.
Slovenian: Ob nastopu nevrološke simptomatike je potrebna takojšnja diagnostična obravnava in zdravljenje.
English: Birth date:
Slovenian: Datum rojstva:
English: Therefore, concomitant administration of strong CYP3A4 inducers should be avoided unless the patient is closely observed for signs and symptoms of thrombosis.
Slovenian: Zato se je treba sočasni uporabi močnih induktorjev CYP3A4 izogibati, razen če se bolnika skrbno spremlja glede znakov in simptomov tromboze.
English: The treatment duration was for 3, 6 or 12 months depending on the clinical judgement of the investigator.
Slovenian: Zdravljenje je trajalo 3, 6 ali 12 mesecev, odvisno od klinične presoje raziskovalca.
English: ** In the COMPASS study, there is a low anaemia incidence as a selective approach to adverse event collection was applied
Slovenian: ** V študiji COMPASS je nizka incidenca anemije, ker je bil uporabljen selektivni pristop k zbiranju neželenih dogodkov.
English: The recommendation is also based on limited non-clinical data.
Slovenian: Priporočila temeljijo tudi na omejenem številu predkliničnih podatkov.
English: Treatment duration median [interquartile range]
Slovenian: Mediana trajanja zdravljenja [interkvartilni razpon]
English: KM % Patients with events
Slovenian: % KM bolniki z dogodki
English: The risk may also be increased by traumatic or repeated epidural or spinal puncture.
Slovenian: Tveganje lahko povečajo tudi travmatska punkcija ali ponavljajoče epiduralne ali spinalne punkcije.
English: The manufacturer can be identified by the batch number printed on the side flap of the carton and on each blister or bottle:
Slovenian: Proizvajalca je mogoče identificirati na podlagi številke serije, ki je natisnjena na stranski ploskvi škatle in na vsakem pretisnem omotu ali plastenki:
English: Data on efficacy in this population are limited (see sections 4.2 and 5.1).
Slovenian: Podatki o učinkovitosti pri tej populaciji so omejeni (glejte poglavji 4.2 in 5.1).
English: Corresponding increases in pharmacodynamic effects were more pronounced.
Slovenian: Povečanje farmakodinamičnih učinkov je bilo bolj izrazito.
English: If the procedure cannot be delayed the increased risk of bleeding should be assessed against the urgency of the intervention.
Slovenian: Če postopka ni mogoče odložiti, je treba pretehtati povečanje tveganja za krvavitve in nujnost posega.
English: As incidence of adverse reactions did not increase and no new adverse reaction was identified, COMPASS study data were not included for frequency calculation in this table.
Slovenian: Ker se incidenca neželenih učinkov ni povečala in niso opazili nobenega novega neželenega učinka, podatki iz študije COMPASS niso bili upoštevani pri izračunu pogostnosti v tej preglednici.
English: • Patient Alert Cards [Text included in Annex III]
Slovenian: • opozorilno kartico za bolnika (besedilo je vključeno v Prilogo III)
English: The educational pack is aimed at increasing awareness about the potential risk of bleeding during treatment with Xarelto and providing guidance on how to manage that risk.
Slovenian: Izobraževalno gradivo je namenjeno povečanju ozaveščenosti o možnem tveganju za krvavitve med zdravljenjem z zdravilom Xarelto in daje navodila za obvladovanje tega tveganja.
English: sun as symbol moon as symbol
Slovenian: Ned simbol sonca simbol lune
English: All-cause death
Slovenian: Smrt zaradi vseh vzrokov
English: Rare cases of overdose up to 600 mg have been reported without bleeding complications or other adverse reactions.
Slovenian: Poročali so o redkih primerih prevelikega odmerjanja z odmerki do 600 mg brez zapletov s krvavitvijo ali brez drugih neželenih učinkov.
English: • Recommendations for dose reduction in at risk populations
Slovenian: • priporočila o zmanjšanju odmerka pri populacijah s povečanim tveganjem
English: Other medicines / conditions:
Slovenian: Druga zdravila/bolezni:
English: The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Slovenian: Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnih sprejetih posodobitvah RMP.
English: An additional retrospective analysis showed a nominally significant reduction in the incidence rates of stent thrombosis compared with placebo (see Table 4).
Slovenian: Dodatna retrospektivna analiza je pokazala nominalno pomembno zmanjšanje incidence tromboze stenta v primerjavi s placebom (glejte preglednico 4).
English: Lesion or condition, if considered to be a significant risk for major bleeding.
Slovenian: Poškodbe ali stanja, za katere se meni, da predstavljajo pomembno tveganje za velike krvavitve.
English: - if you have a liver disease which leads to an increased risk of bleeding - if you are pregnant or breast-feeding
Slovenian: - če imate bolezen jeter, ki lahko poveča tveganje za krvavitve, - če ste noseči ali dojite.
English: Do not take Xarelto and tell your doctor if any of these apply to you.
Slovenian: Ne vzemite zdravila Xarelto in obvestite zdravnika, če kaj od naštetega velja za vas.
English: Do not take more than two 15 mg tablets in a single day.
Slovenian: Ne vzemite več kot dveh tablet po 15 mg v enem dnevu.
English: For all patients, confirmation should be sought prior to cardioversion that the patient has taken Xarelto as prescribed.
Slovenian: Pri vseh bolnikih je treba pred kardioverzijo pridobiti potrditev, da je bolnik jemal zdravilo Xarelto tako, kot je predpisano.
English: Patients appear to be at highest risk for these reactions early in the course of therapy: the onset of the reaction occurring in the majority of cases within the first weeks of treatment.
Slovenian: Zdi se, da je pri bolnikih tveganje za te reakcije največje na začetku zdravljenja, v večini primerov se reakcije pojavijo v prvih tednih zdravljenja.
English: If you miss a dose, take your next dose at the usual time.
Slovenian: Če izpustite odmerek, vzemite naslednji odmerek ob običajnem času.
English: Treatment with Xarelto is not recommended for these patients.
Slovenian: Zdravljenja z zdravilom Xarelto se pri teh bolnikih ne priporoča.
English: - you have been diagnosed with a high risk of getting a blood clot due to a coronary artery disease or peripheral artery disease which causes symptoms.
Slovenian: - imate ugotovljeno visoko tveganje za nastanek krvnega strdka zaradi koronarne bolezni ali periferne arterijske bolezni, ki povzroča simptome.
English: 39 days
Slovenian: 39 dni
English: Therefore, Xarelto is to be used with caution in these patients.
Slovenian: Zato je treba zdravilo Xarelto pri teh bolnikih uporabljati previdno.
English: Patients with events
Slovenian: bolniki z dogodki
English: Paediatric population Safety and efficacy have not been established for children and adolescents up to 18 years.
Slovenian: Pediatrična populacija Varnost in učinkovitost pri otrocih in mladostnikih do 18 let nista bili dokazani.
English: Thus, the results were consistent with the results of the pivotal randomised studies.
Slovenian: Izsledki so bili skladni z izsledki ključnih randomiziranih študij.
English: No clinically relevant interaction with food was observed (see section 4.2).
Slovenian: Klinično pomembnih interakcij s hrano niso opazili (glejte poglavje 4.2).
English: Do not take more than one tablet in a single day to make up for a forgotten dose.
Slovenian: Ne vzemite več kot ene tablete v enem dnevu, da bi s tem nadomestili pozabljeni odmerek.
English: C: observed as uncommon in prevention of atherothrombotic events in patients after an ACS (following percutaneous coronary intervention) * A pre-specified selective approach to adverse event collection was applied.
Slovenian: C: opazili občasno pri preprečevanju aterotrombotičnih dogodkov pri bolnikih po AKS (po perkutanem koronarnem posegu) * Uporabljen je bil predhodno določen selektivni pristop k zbiranju neželenih dogodkov.
English: Rivaroxaban has a half-life of approximately 5 to 13 hours (see section 5.2).
Slovenian: Razpolovni čas rivaroksabana je približno 5 do 13 ur (glejte poglavje 5.2).
English: Given the predictable, dose-proportional pharmacokinetic profile of rivaroxaban, the bioavailability results from this study are likely applicable to lower rivaroxaban doses.
Slovenian: Glede na predvidljiv, z odmerkom sorazmerni farmakokinetični profil rivaroksabana, je verjetno, da rezultati biološke uporabnosti iz te študije veljajo tudi za manjše odmerke rivaroksabana.
English: Should a bleeding complication arise in a patient receiving rivaroxaban, the next rivaroxaban administration should be delayed or treatment should be discontinued as appropriate.
Slovenian: Če se pri bolniku, ki prejema rivaroksaban, pojavi krvavitev, je treba naslednji odmerek rivaroksabana odložiti ali prekiniti zdravljenje, kot je ustrezno.
English: The readout for PT is to be done in seconds, because the INR is only calibrated and validated for coumarins and cannot be used for any other anticoagulant.
Slovenian: Protrombinski čas je treba odčitati v nekaj sekundah, kajti INR je kalibriran in validiran samo za kumarine in se ga ne more uporabljati za meritve učinkov drugih antikoagulacijskih zdravil.
English: 4,832 patients with an acute symptomatic PE
Slovenian: 4.832 bolnikov z akutno simptomatsko PE
English: Data from animals indicate that rivaroxaban is secreted into milk.
Slovenian: Podatki pri živalih kažejo, da se rivaroksaban izloča v mleko.
English: Unbound AUC was increased 2.6 fold.
Slovenian: Nevezana AUC je bila povečana 2,6-krat.
English: Take Xarelto around the same time every day (for example, one tablet in the morning and one in the evening).
Slovenian: Zdravilo Xarelto vzemite vsak dan ob približno istem času (na primer eno tableto zjutraj in eno zvečer).
English: Patients must have had symptomatic HF for at least 3 months and left ventricular ejection fraction (LVEF) of ≤40% within one year of enrollment.
Slovenian: Bolniki so morali imeti simptomatsko srčno popuščanje najmanj 3 mesece in iztisni delež levega prekata (LVEF - left ventricular ejection fraction) ≤ 40 % v enem letu pred vključitvijo.
English: • The use of coagulation tests and their interpretation
Slovenian: • opis ukrepov pri prevelikem odmerjanju • uporaba koagulacijskih testov in njihova interpretacija
English: In contrast, the 3-factor PCC had a greater and more rapid overall effect on reversing changes in endogenous thrombin generation than the 4-factor PCC (see section 4.9).
Slovenian: Vendar pa ima 3-faktorski PCC večji in hitrejši celokupni vpliv na tvorbo endogenega trombina kot 4-faktorski PCC (glejte poglavje 4.9).
English: • uncontrolled severe arterial hypertension
Slovenian: • neurejeno hudo arterijsko hipertenzijo,
English: Pharmacokinetic data in patients
Slovenian: Farmakokinetični podatki za bolnike
English: Pharmacotherapeutic group: Antithrombotic agents, direct factor Xa inhibitors, ATC code: B01AF01 Mechanism of action
Slovenian: Farmakoterapevtska skupina: antitrombotiki, direktni zaviralci faktorja Xa, oznaka ATC: B01AF01
English: Due to limited absorption a ceiling effect with no further increase in average plasma exposure is expected at supratherapeutic doses of 50 mg rivaroxaban or above.
Slovenian: Zaradi omejene absorpcije se pričakuje plato učinek brez nadaljnjega povečanja povprečne izpostavljenosti v plazmi pri supraterapevtskih odmerkih po 50 mg rivaroksabana ali več.
English: Xarelto has minor influence on the ability to drive and use machines.
Slovenian: Zdravilo Xarelto ima blag vpliv na sposobnost vožnje in upravljanja strojev.
English: Major intracranial bleeding p = 0.59858
Slovenian: Velika intrakranialna krvavitev p = 0,59858
English: 3,449 patients with symptomatic acute deep vein thrombosis
Slovenian: 3.449 bolnikov s simptomatsko akutno globoko vensko trombozo
English: Several sub-groups of patients, as detailed below, are at increased risk of bleeding.
Slovenian: Pri številnih podskupinah bolnikov, ki so podrobno opredeljene v nadaljevanju, obstaja povečano tveganje za krvavitve.
English: Any bleeding
Slovenian: Katera koli krvavitev
English: Patients with CAD/PAD a)
Slovenian: Bolniki s KB/PAB a)
English: It should be noted that Xarelto can contribute to an elevated INR.
Slovenian: Treba je poudariti, da lahko zdravilo Xarelto vpliva na povišanje vrednosti INR.
English: If you have difficulty swallowing the tablet whole, talk to your doctor about other ways to take Xarelto.
Slovenian: Če imate težave pri požiranju cele tablete, se z zdravnikom pogovorite o drugih načinih jemanja zdravila Xarelto.
English: • Details of populations potentially at higher risk of bleeding
Slovenian: • podroben opis populacij, pri katerih obstaja povečano tveganje za krvavitve
English: In patients with mild and moderate heart failure the treatment effects for the COMPASS study subgroup were similar to those of the entire study population (see section CAD/PAD).
Slovenian: Pri bolnikih z blagim in zmernim srčnim popuščanjem so bili učinki zdravljenja v podskupini študije COMPASS podobni učinkom v celotni preizkušani populaciji (glejte poglavje KB/PAB).
English: The 3-factor PCC reduced mean Neoplastin PT values by approximately 1.0 second within 30 minutes, compared to reductions of approximately 3.5 seconds observed with the 4-factor PCC.
Slovenian: 3-faktorski PCC je zmanjšal srednje vrednosti PČ (Neoplastin) za približno 1,0 sekundo v 30 minutah v primerjavi s približno 3,5 sekund, ki so jih opazili pri 4-faktorskem PCC.
English: Few ACS patients with a prior stroke or TIA have been studied but the limited efficacy data available indicate that these patients do not benefit from treatment.
Slovenian: Preučevali so nekaj bolnikov z AKS, ki so predhodno imeli možgansko kap ali TIA, vendar malo podatkov o učinkovitosti, ki so na voljo, kaže da tem bolnikom zdravljenje ne koristi.
English: The safety of rivaroxaban has been evaluated in thirteen phase III studies including 53,103 patients exposed to rivaroxaban (see Table 1).
Slovenian: Varnost rivaroksabana so ocenili v trinajstih kliničnih preskušanjih III. faze, v katera je bilo vključenih 53.103 bolnikov, ki so prejemali rivaroksaban (glejte preglednico 1).
English: After intravenous administration of a 1 mg dose the elimination half-life is about 4.5 hours.
Slovenian: Po intravenski uporabi 1 mg odmerka je razpolovni čas izločanja 4,5 ur.
English: Results for secondary endpoints as tested in hierarchical order in the ITT analysis are displayed in Table 4.
Slovenian: Sekundarni končni izidi, preskušani po hierarhičnem vrstnem redu v ITT
English: 23% of patients
Slovenian: 23 % bolnikov
English: Treatment in combination with other antiplatelet agents, e.g. prasugrel or ticagrelor, has not been studied and is not recommended.
Slovenian: Zdravljenja v kombinaciji z drugimi antitrombotiki, npr. prasugrel ali tikagrelor, niso preučevali in se ga ne priporoča.
English: Transfusion of 2 or more units of packed red blood cells or whole blood*
Slovenian: Transfuzija dveh ali več enot koncentriranih eritrocitov ali polne krvi*
English: Bayer Bitterfeld GmbH Ortsteil Greppin, Salegaster Chaussee 1 06803 Bitterfeld-Wolfen Germany
Slovenian: Bayer Bitterfeld GmbH Ortsteil Greppin, Salegaster Chaussee 1 06803 Bitterfeld-Wolfen Nemčija
English: To ensure optimal protection from blood clots, never skip a dose.
Slovenian: Za zagotovitev največje možne zaščite pred nastajanjem krvnih strdkov nikoli ne izpustite ali pozabite vzeti odmerka zdravila.
English: Xarelto can be initiated or continued in patients who may require cardioversion.
Slovenian: Zdravilo Xarelto se lahko uvede ali z zdravljenjem nadaljuje pri bolnikih, pri katerih je potrebna kardioverzija.
English: • Final Study Reports submitted by Q4 2020
Slovenian: • Predložitev končnih poročil o študijah do 4. četrtletja 2020.
English: Also the first secondary endpoint (all-cause death, MI or stroke) was reduced significantly.
Slovenian: Tudi prvi sekundarni opazovani izid (smrt zaradi vseh vzrokov, miokardni infarkt ali možganska kap) se je pomembno zmanjšal.
English: In the pre- and postnatal study in rats, reduced viability of the offspring was observed at doses that were toxic to the dams.
Slovenian: V pre- in postnatalnih študijah na podganah so pri odmerkih, ki so bili toksični za samice, opazili zmanjšano sposobnost preživetja plodov.
English: The MAH shall also provide a Patient Alert Card in each medicine pack, the text of which is included in Annex III.
Slovenian: Imetnik dovoljenja za promet z zdravilom bo opozorilno kartico za bolnika priložil v vsako pakiranje zdravila; besedilo je vključeno v Prilogo III.
English: Einstein DVT, PE and Extension used the same pre-defined primary and secondary efficacy outcomes.
Slovenian: V kliničnih preskušanjih Einstein DVT, PE in Extension so uporabili enake predhodno opredeljene primarne in sekundarne izide učinkovitosti.
English: What Xarelto is and what it is used for
Slovenian: Kaj je zdravilo Xarelto in za kaj ga uporabljamo
English: Doctor's name:
Slovenian: Ime in priimek zdravnika:
English: What should I know about Xarelto?
Slovenian: Kaj moram vedeti o zdravilu Xarelto?
English: - Bleeding leading to hospitalisation (non-fatal, not in critical organ, not requiring reoperation)
Slovenian: - Krvavitev, zaradi katere je potrebna hospitalizacija (brez smrtnega izida, ne v kritični organ, ponovni kirurški poseg ni potreben)
English: 8,281 patients with an acute symptomatic DVT or PE
Slovenian: 8.281 bolnikov z akutno simptomatsko GVT ali PE
English: If there is a chance that you could become pregnant, use a reliable contraceptive while you are taking Xarelto.
Slovenian: Če obstaja možnost, da bi lahko zanosili, morate med jemanjem zdravila Xarelto uporabljati zanesljivo kontracepcijsko metodo.
English: Patients are to be frequently monitored for signs and symptoms of neurological impairment (e.g. numbness or weakness of the legs, bowel or bladder dysfunction).
Slovenian: Bolnike je treba stalno nadzorovati glede znakov in simptomov nevrološke okvare (npr. omrtvelosti ali šibkosti nog ter motenega delovanja črevesja ali mehurja).
English: Nevertheless, there may be individuals with a more pronounced pharmacodynamic response.
Slovenian: Kljub temu je lahko farmakodinamični odziv pri nekaterih posameznikih izrazitejši.
English: If you forget to take a dose you can take two 15 mg tablets at the same time to get a total of two tablets (30 mg) on one day.
Slovenian: Če ste pozabili vzeti odmerek, lahko vzamete dve tableti po 15 mg hkrati, to je skupaj dve tableti (30 mg) na dan.
English: If you have had a major hip operation you will usually take the tablets for 5 weeks.
Slovenian: Če ste imeli velik kirurški poseg na kolku, boste tablete običajno jemali 5 tednov.
English: Your doctor may decide to keep you under closer observation or change how you should be treated.
Slovenian: Zdravnik se lahko odloči, da vas bo natančno nadzoroval ali da bo spremenil vaše zdravljenje.
English: Swallow the tablet(s) preferably with water.
Slovenian: Najbolje je, če tableto(-e) zaužijete z vodo.
English: Transfusion of 4 or more units of blood over a 48 hour period a) safety population, on treatment b) vs. placebo; Log-Rank p-value * statistically significant
Slovenian: Transfuzija 4 ali več enot krvi v obdobju 48 ur a) populacija iz študije varnosti, med zdravljenjem b) v primerjavi s placebom; p-vrednost Log-Rank
English: Extension of treatment beyond 12 months should be done on an individual patient basis as experience up to 24 months is limited (see section 5.1).
Slovenian: Podaljšanje zdravljenja na več kot 12 mesecev je treba pretehtati pri vsakem bolniku, ker je izkušenj z zdravljenjem, daljšim od 24 mesecev, malo (glejte poglavje 5.1).
English: Like other similar medicines (antithrombotic agents), Xarelto may cause bleeding which may potentially be life threatening.
Slovenian: Tako kot druga podobna zdravila (antitrombotiki) lahko tudi zdravilo Xarelto povzroči krvavitve, ki so lahko življenjsko ogrožajoče.
English: Spinal/epidural anaesthesia or puncture
Slovenian: Spinalna/epiduralna anestezija ali punkcija
English: If you get Xarelto after an acute coronary syndrome, your doctor may tell you to also take clopidogrel or ticlopidine.
Slovenian: Če boste zdravilo Xarelto prejeli po akutnem koronarnem sindromu, vam bo zdravnik morda svetoval, da jemljite tudi klopidogrel ali tiklopidin.
English: Component of a multipack, can't be sold separately.
Slovenian: Enota v večkratnem pakiranju, prodaja posameznih enot ni možna.
English: Subjects without a continuous need for treatment with a proton pump inhibitor were randomized to pantoprazole or placebo.
Slovenian: Osebe, pri katerih ni potrebe za neprekinjeno zdravljenje z zaviralci protonske črpalke so randomizirali v skupini, ki sta prejemali pantoprazol ali placebo.
English: Therefore, administration of rivaroxaban distal to the stomach should be avoided since this can result in reduced absorption and related rivaroxaban exposure.
Slovenian: Zato se je treba dajanju rivaroksabana za želodcem izogibati, saj lahko to povzroči manjšo absorpcijo in s tem povezano manjšo izpostavljenost rivaroksabanu.
English: No dose adjustment (see sections 4.4 and 5.2) The risk of bleeding increases with increasing age (see section 4.4).
Slovenian: Odmerka ni treba prilagajati (glejte poglavji 4.4 in 5.2) Tveganje za krvavitve se povečuje s starostjo (glejte poglavje 4.4).
English: - if your doctor determines that your blood pressure is unstable or another treatment or surgical procedure to remove the blood clot from your lungs is planned.
Slovenian: - če je zdravnik potrdil, da je vaš krvni tlak nestabilen ali če je načrtovano drugo zdravljenje ali kirurški poseg za odstranitev krvnega strdka iz vaših pljuč.
English: This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ”sodiumfree”.
Slovenian: To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na tableto, kar v bistvu pomeni »brez natrija«.
English: Take the next tablet on the following day and then carry on taking one tablet once a day.
Slovenian: Naslednjo tableto vzemite naslednji dan, potem pa nadaljujte z jemanjem ene tablete enkrat na dan.
English: These observations in clinical practice are consistent with the established safety profile in this indication.
Slovenian: Ta opažanja v vsakdanji klinični praksi potrjujejo dokazan varnostni profil za to indikacijo.
English: The risk of these events may be increased by the post-operative use of indwelling epidural catheters or the concomitant use of medicinal products affecting haemostasis.
Slovenian: Tveganje za te zaplete se poveča pri pooperativni uporabi epiduralnih katetrov ali sočasnem jemanju zdravil, ki vplivajo na hemostazo.
English: The relationship between rivaroxaban concentration and factor Xa activity was best described by an Emax model.
Slovenian: Razmerje med koncentracijo rivaroksabana in aktivnostjo faktorja Xa je najbolje opisana z modelom Emax.
English: Fatal PE/death where PE cannot be ruled out
Slovenian: Smrtna PE/smrt, pri kateri PE ni mogoče izključiti