FrancophonIA/ELRC3.0 huggingface dataset:
English: The safety and efficacy of Efient in children below age 18 has not been established.
Slovenian: Varnost in učinkovitost zdravila Efient pri otrocih, mlajših od 18 let, nista bili dokazani.
English: Subjects with diabetes had significant reductions in the primary and all secondary composite endpoints.
Slovenian: Osebe z diabetesom so imele signifikantno znižanje primarnih in vseh sekundarnih sestavljenih ciljev študije.
English: Tell your doctor if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription, dietary supplements and herbal remedies.
Slovenian: Obvestite zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo, tudi če ste ga dobili brez recepta, prehranska dopolnila ali zeliščna sredstva.
English: You may also have had one or more stents placed to keep open a blocked or narrowed artery supplying blood to the heart.
Slovenian: Morda imate tudi enega ali več žilnih opornic, ki razširjajo zamašeno ali zožano arterijo, ki oskrbuje srce s krvjo.
English: • Blood in urine
Slovenian: • Kri v urinu
English: Ethnicity:
Slovenian: Narodnost:
English: The active metabolite's exposure (AUC) increases proportionally over the therapeutic dose range.
Slovenian: Izpostavljenost (AUC) aktivnemu presnovku se povečuje sorazmerno z razponom terapevtskega odmerka.
English: Inhibitors of CYP3A:
Slovenian: Zaviralci CYP3A:
English: Distribution Active metabolite binding to human serum albumin (4% buffered solution) was 98%.
Slovenian: Porazdelitev Vezava aktivnega presnovka na humani serumski albumin (v 4 % pufrski raztopini) je bila 98 %.
English: Patients ≥ 75 years in whom the benefit with prasugrel was more evident included those with diabetes, STEMI, higher risk of stent thrombosis, or recurrent events.
Slovenian: Bolniki ≥ 75 let, pri katerih je bila korist zdravljenja s prasugrelom bolj očitna, so vključevali tiste z diabetesom, STEMI, večjim tveganjem za trombozo žilne opornice ali ponovljenimi dogodki.
English: You have been prescribed Efient because you have already had a heart attack or unstable angina and you have been treated with a procedure to open blocked arteries in the heart.
Slovenian: Zdravilo Efient so vam predpisali, ker ste že imeli srčni infarkt ali nestabilno angino pektoris in so vas zdravili s postopkom, s katerim so odprli zamašene arterije v srcu.
English: Event
Slovenian: Dogodek
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila: http://www.ema.europa.eu
English: You should tell your doctor before taking Efient if any of the situations mentioned below apply to you:
Slovenian: Povejte svojemu zdravniku preden vzamete zdravilo Efient, če se katerokoli izmed spodnjih stanj nanaša na vas:
English: Your doctor may wish you to stop taking Efient temporarily due to the increased risk of bleeding
Slovenian: Vaš zdravnik vam bo morda naročil, da začasno prenehate jemati zdravilo Efient, zaradi povečanega tveganja za krvavitev.
English: For the 14, 28, 56 84 and 98 tablet pack sizes, you can check the day on which you last took a tablet of Efient by referring to the calendar printed on the blister.
Slovenian: Pri velikostih pakiranja tablet po 14, 28, 56, 84 in 98 lahko preverite tudi dan, ko ste zadnjič vzeli tableto zdravila Efient, glede na koledar, ki je natisnjen na pretisnem omotu.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali s farmacevtom, preden vzamete to zdravilo.
English: Table 1: Incidence of Non-CABG related bleedinga (% Patients)
Slovenian: Preglednica 1: Incidenca krvavitev, nepovezanih s CABGa (% bolnikov)
English: No dose adjustment is recommended based on ethnicity alone.
Slovenian: Prilagoditev odmerka na osnovi same narodnosti ni potrebna.
English: Excipient(s) with known effect
Slovenian: Pomožna(e) snov(i) z znanim učinkom:
English: At a very high dose (> 240 times the recommended daily human maintenance dose on a mg/m2 basis) that caused effects on maternal body weight and/or food consumption, there was a slight decrease in offspring body weight (relative to controls).
Slovenian: Pri zelo visokem odmerku (> 240 krat priporočeni dnevni vzdrževalni odmerek za ljudi na osnovi mg/m2), ki je povzročil učinke na telesno maso breje samice in/ali uživanje hrane, je bil opazen rahel upad telesne mase mladičev (glede na kontrolo).
English: Symptomatic ICHe
Slovenian: Simptomatska ICHe
English: • Uncontrollable bleeding, for example from a cut.
Slovenian: • Nenadzorovana krvavitev, na primer od ureza
English: Store in the original package in order to protect from air and moisture.
Slovenian: Shranjujte v originalni ovojnini za zagotovitev zaščite pred zrakom in vlago.
English: Gender: In healthy subjects and patients, the pharmacokinetics of prasugrel are similar in men and women.
Slovenian: Spol: Pri zdravih osebah in bolnikih je farmakokinetika prasugrela podobna pri moških in ženskah.
English: Pharmacotherapeutic group: Platelet aggregation inhibitors excluding heparin, ATC code: B01AC22.
Slovenian: Farmakoterapevtska skupina: Zaviralci agregacije trombocitov brez heparina, oznaka ATC: B01AC22.
English: • Small red bruises on the skin (ecchymoses)
Slovenian: • Kožni izpuščaj • Majhne rdeče modrice na koži (ekhimoza)
English: In the phase 3 clinical trial these patients were at greater risk of bleeding, including fatal bleeding, compared to patients <75 years of age.
Slovenian: V kliničnem preskušanju faze 3 so imeli ti bolniki večje tveganje za krvavitev, vključno s krvavitvijo s smrtnim izidom, v primerjavi z bolniki < 75 let starosti.
English: All of the above may be signs of bleeding, the most common side effect with Efient.
Slovenian: Vse zgoraj našteto so lahko znaki krvavitve, najpogostejšega neželenega učinka z zdravilom Efient.
English: Your doctor will also tell you to take acetylsalicylic acid- (s)he will tell you the exact dose to take (usually between 75 mg and 325 mg daily).
Slovenian: Vaš zdravnik vam bo tudi naročil, da jemljite acetilsalicilno kislino - povedal vam bo natančno kakšen odmerek morate vzeti (običajno med 75 mg in 325 mg dnevno).
English: Animal studies have shown excretion of prasugrel in breast milk.
Slovenian: Študije na živalih so pokazale izločanje prasugrela v mleko samic.
English: No (N=13090)
Slovenian: Ne (N=13090)
English: Efient is available in packs of 14, 28, 30, 56, 84, 90 and 98 tablets.
Slovenian: Zdravilo Efient je na voljo v pakiranjih po 14, 28, 30, 56, 84, 90 in 98 tablet.
English: No data are available on the reversal of the pharmacological effect of prasugrel; however, if prompt correction of prolonged bleeding time is required, platelet transfusion and/or other blood products may be considered.
Slovenian: Podatkov o izničenju farmakološkega učinka prasugrela, ni; vendar, če je potreben takojšnji popravek podaljšanega časa krvavitve, lahko razmislimo o transfuziji trombocitov in/ali drugih zdravil iz krvi.
English: What Efient is and what it is used for What you need to know before you take Efient How to take Efient
Slovenian: Kaj je zdravilo Efient in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Efient Kako jemati zdravilo Efient
English: 4.5 Interaction with other medicinal products and other forms of interaction
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Varfarin:
English: Prasugrel Prior to Coronary Angiographya (N=2037)
Slovenian: Prasugrel pred koronarno angiografijoa (N=2037)
English: In these patients the 10 mg maintenance dose is not recommended.
Slovenian: Pri teh bolnikih 10 mg vzdrževalni odmerek ni priporočen.
English: For patients with active bleeding for whom reversal of the pharmacological effects of Efient is required, platelet transfusion may be appropriate.
Slovenian: Za bolnike z aktivno krvavitvijo, za katere je potrebno izničenje farmakoloških učinkov zdravila Efient, je lahko primerna transfuzija trombocitov.
English: Clots in arteries supplying blood to the heart may also reduce the blood supply, causing unstable angina (a severe chest pain).
Slovenian: Strdki v arterijah, ki oskrbujejo srce s krvjo, tudi lahko zmanjšajo dotok krvi, s čimer povzročijo nestabilno angino pektoris (huda bolečina v prsih).
English: All of the above may be signs of a stroke.
Slovenian: Vse zgoraj našteto so lahko znaki možganske kapi.
English: A 5 mg maintenance dose should be used.
Slovenian: Uporabiti moramo 5 mg vzdrževalni odmerek.
English: *TRITON study in ACS patients undergoing PCI **TRILOGY-ACS study in patients not undergoing PCI (see 5.1):
Slovenian: **Študija TRILOGY-ACS pri bolnikih, ki niso imeli PCI (glejte 5.1):
English: • Bleeding after surgery
Slovenian: • Krvavitev po operaciji
English: In patients with acute coronary syndrome, in whom morphine cannot be withheld and fast P2Y12 inhibition is deemed crucial, the use of a parenteral P2Y12 inhibitor may be considered.
Slovenian: Pri bolnikih z akutnim koronarnim sindromom, pri katerih dajanja morfina ni mogoče prekiniti in je hitro zaviranje P2Y12 ključnega pomena, lahko pride v poštev uporaba parenteralnega zaviralca P2Y12.
English: The rate of study drug discontinuation due to adverse events was 7.2% for prasugrel and 6.3% for clopidogrel.
Slovenian: Stopnja prekinitve jemanja preiskovanega zdravila zaradi neželenih učinkov je bila 7,2 % za prasugrel in 6,3 % za klopidogrel.
English: • with a propensity to bleed (e.g. due to recent trauma, recent surgery, recent or recurrent gastrointestinal bleeding, or active peptic ulcer disease)
Slovenian: • z nagnjenostjo za krvavitev (npr. zaradi nedavne poškodbe, nedavnega kirurškega posega, nedavne ali ponovljene gastrointestinalne krvavitve ali aktivni peptični ulkus).
English: Inducers of cytochromes P450:
Slovenian: Induktorji citokroma P450:
English: Overall, no new safety findings were identified for prasugrel as monotherapy in this patient population.
Slovenian: Na splošno niso v tej populaciji bolnikov odkrili nobenih novih varnostnih spoznanj za prasugrel v monoterapiji.
English: The use of Efient in patients ≥ 75 years of age is generally not recommended.
Slovenian: Uporaba zdravila Efient pri bolnikih, starih ≥ 75 let, na splošno ni priporočena.
English: In the phase 3 clinical trial (TRITON) key exclusion criteria included an increased risk of bleeding; anaemia; thrombocytopaenia; a history of pathological intracranial findings.
Slovenian: V kliničnem preskušanju faze 3 (TRITON) so izključitveni kriteriji vključevali povečano tveganje za krvavitev; anemijo; trombocitopenijo; patološke intrakranialne ugotovitve v anamnezi.
English: The clinical study protocol provided for all patients to receive aspirin and a daily maintenance dose of prasugrel.
Slovenian: Protokol klinične študije je omogočal, da so vsi bolniki prejeli acetilsalicilno kislino in dnevni vzdrževalni odmerek prasugrela.
English: In patients with or without a history of TIA or stroke, the incidence of stroke in the phase 3 clinical trial was as follows (see section 4.4):
Slovenian: Pri bolnikih, ki so bili z ali brez TIA ali možganski kapi v anamnezi, je bila pogostnost možganske kapi v kliničnem preskušanju faze 3 naslednja (glejte poglavje 4.4):
English: More than 98% of subjects had ≥ 20% inhibition of platelet aggregation during maintenance dosing.
Slovenian: Več kot 98 % oseb je imelo ≥ 20 % zaviranje agregacije trombocitov med vzdrževalnim odmerjanjem.
English: Administration of the 60 mg prasugrel loading dose in the fasted state may provide most rapid onset of action (see section 5.2).
Slovenian: Dajanje 60 mg polnilnega odmerka prasugrela v stanju stradanja lahko nudi najhitrejši začetek delovanja (glejte poglavje 5.2).
English: Approximately 98% of patients (in each of the treatment groups) received antithrombins (heparin, low molecular weight heparin, bivalirudin, or other agent) directly in support of PCI.
Slovenian: Približno 98 % bolnikov (v vsaki skupini zdravljenja) je prejelo antitrombine (heparin, nizko molekularni heparin, bivalirudin ali druga zdravila) neposredno, kot podporo PCI.
English: The active metabolite is further metabolised to two inactive compounds by S-methylation or conjugation with cysteine.
Slovenian: Aktivni presnovek se nato nadalje presnovi v dve neaktivni spojini, z S-metilizacijo ali s konjugacijo s cisteinom.
English: If given together with Efient these medicines may increase the risk of bleeding.
Slovenian: Če jih jemljete skupaj z zdravilom Efient, lahko ta zdravila povečajo tveganje za krvavitev.
English: Overdose of Efient may lead to prolonged bleeding time and subsequent bleeding complications.
Slovenian: Preveliko odmerjanje zdravila Efient lahko vodi v podaljšan čas krvavitve in nadaljnje zaplete zaradi krvavitve.
English: Patients ≥ 75 years old
Slovenian: Bolniki, stari ≥ 75 let
English: Likewise, prasugrel did not significantly alter the effect of heparin on measures of coagulation.
Slovenian: Podobno prasugrel ni značilno spremenil učinka heparina na merila koagulacije.
English: Yes (N=518)
Slovenian: Da (N=518)
English: Your doctor will also give you acetylsalicylic acid (e.g. aspirin), another antiplatelet agent.
Slovenian: Vaš zdravnik vam bo predpisal tudi acetilsalicilno kislino (npr. aspirin), drugo zdravilo proti trombocitom.
English: The most common site of spontaneous bleeding was the gastrointestinal tract (1.7% rate with prasugrel and 1.3% rate with clopidogrel); the most frequent site of provoked bleeding was the arterial puncture site (1.3% rate with prasugrel and 1.2% with clopidogrel).
Slovenian: Najpogostejše mesto spontane krvavitve je bil prebavni trakt (1,7 % stopnja pri prasugrelu in 1,3 % stopnja pri klopidogrelu); najpogostejše mesto povzročene krvavitve je bilo mesto arterijskega vboda (1,3 % stopnja pri prasugrelu in 1,2 % stopnja pri klopidogrelu).
English: Embryo-foetal developmental toxicology studies in rats and rabbits showed no evidence of malformations due to prasugrel.
Slovenian: Toksikološke študije razvoja ploda-zarodka pri podganah in zajcih niso podale dokazov o malformacijah zaradi prasugrela.
English: The higher risk for bleeding events in subjects treated with prasugrel persisted up to 7 days from the most recent dose of study drug.
Slovenian: Večje tveganje za krvavitve pri osebah, zdravljenih s prasugrelom je bilo prisotno še do 7 dni od zadnjega odmerka preiskovanega zdravila.
English: Prasugrel is expected to have no or negligible influence on the ability to drive and use machines.
Slovenian: Pričakuje se, da prasugrel nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
English: Primary Composite Outcome Events
Slovenian: Primarni sestavljeni izidi
English: Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
Slovenian: Predklinične učinke so opazili samo pri izpostavljenosti, ki je močno presegala največjo izpostavljenost pri človeku, kar kaže na majhen pomen za klinično uporabo.
English: Requiring transfusion (≥4 units) TIMI Minor bleedinge aOther standard therapies were used as appropriate.
Slovenian: Zahteva transfuzijo (≥ 4 enote) Manjša krvavitev po TIMIe a Ostala standardna zdravljenja so bila ustrezno uporabljena.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines webportal.
Slovenian: Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7)
English: Do not crush or break the tablet.
Slovenian: Tablet ne drobite in ne lomite.
English: The superior efficacy was accompanied by an increase in major bleeding (see sections 4.4 and 4.8).
Slovenian: Superiorno učinkovitost je spremljalo povečano pojavljanje večje krvavitve (glejte poglavji 4.4 in 4.8).
English: Although a pharmacodynamic interaction with ASA leading to an increased risk of bleeding is possible, the demonstration of the efficacy and safety of prasugrel comes from patients concomitantly treated with ASA.
Slovenian: Čeprav je možna farmakodinamična interakcija z ASK, ki vodi v povečano tveganje za krvavitev, so dokazi o učinkovitosti in varnosti prasugrela pridobljeni pri bolnikih, ki so bili sočasno zdravljeni z ASK.
English: Tablet Core:
Slovenian: Jedro tablete:
English: If you have been told by a doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Slovenian: Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se pred uporabo tega zdravila posvetujte s svojim zdravnikom.
English: Elderly:
Slovenian: Starejši:
English: Although uncommon, severe bleeding can be life-threatening.
Slovenian: Čeprav le občasno, je huda krvavitev lahko smrtno nevarna.
English: In a study of healthy subjects, AUC of the active metabolite was unaffected by a high fat, high calorie meal, but Cmax was decreased by 49% and the time to reach Cmax (Tmax) was increased from 0.5 to 1.5 hours.
Slovenian: V študiji pri zdravih osebah je bila AUC aktivnega presnovka nespremenjena pri obroku z veliko maščob in kalorij, vendar se je Cmax znižal za 49 % in čas do dosega Cmax (tmax) je bil podaljšan z 0,5 na 1,5 ure.
English: Other therapies, such as heparin and GPIIb/IIIa inhibitors, were administered at the discretion of the physician.
Slovenian: Druge terapije, kot je heparin in zaviralci GPIIb/IIIa, so bile uporabljene po odločitvi zdravnika.
English: Study TADO tested the use of prasugrel (n=171) vs placebo (n=170) in patients, ages 2 to less than 18 years of age, with sickle cell anaemia for reduction of vaso occlusive crisis in a phase III study.
Slovenian: V študiji TADO so proučevali uporabo prasugrela (n=171) v primerjavi s placebom (n=170) pri bolnikih, starih med 2 do manj kot 18 let, z anemijo srpastih celic, za zmanjšanje vazookluzivne krize v študiji III. faze.
English: Efient showed superior efficacy compared to clopidogrel in reducing the primary composite outcome events as well as the pre-specified secondary outcome events, including stent thrombosis (see Table 3).
Slovenian: Zdravilo Efient je pokazalo superiorno učinkovitost v primerjavi s klopidogrelom pri znižanju primarnih sestavljenih izidov kot tudi pred-določenih sekundarnih izidov, vključno s trombozo žilne opornice (glejte Preglednico 3).
English: The benefits associated with prasugrel were independent of the use of other acute and long-term cardiovascular therapies, including heparin/low molecular weight heparin, bivalirudin, intravenous GPIIb/IIIa inhibitors, lipid-lowering medicinal products, beta-blockers, and angiotensin converting enzyme inhibitors.
Slovenian: Koristi, povezane s prasugrelom, so bile neodvisne od uporabe drugih akutnih in dolgotrajnih srčnožilnih terapij, vključno s heparinom/nizko molekularnim heparinom, bivalirudinom, intravenskimi zaviralci GPIIb/IIIa, zdravili za znižanje lipidov, beta-blokatorji in zaviralci encima angiotenzin konvertaze.
English: 14 film-coated tablets 28 film-coated tablets 30x1 film-coated tablet 56 film-coated tablets 84 film-coated tablets 90x1 film-coated tablet 98 film-coated tablets 30 film-coated tablets
Slovenian: 14 filmsko obloženih tablet 28 filmsko obloženih tablet 30x1 filmsko obložena tableta 56 filmsko obloženih tablet 84 filmsko obloženih tablet 90x1 filmsko obložena tableta 98 filmsko obloženih tablet 30 filmsko obloženih tablet
English: The observed benefit of prasugrel in patients ≥ 75 years was less than that observed in patients < 75 years.
Slovenian: Opazovane koristi prasugrela pri bolnikih ≥ 75 let so bile manjše, kot pri bolnikih < 75 let.
English: In a 30 month study (TRILOGY-ACS) in 9326 patients with UA/NSTEMI ACS medically managed without revascularisation (non-licensed indication), prasugrel did not significantly reduce the frequency of the composite endpoint of CV death, MI or stroke compared to clopidogrel.
Slovenian: V 30-mesečni študiji (TRILOGY-ACS) pri 9326 bolnikih z UA/NSTEMI ACS, ki je bila medicinsko obravnavana brez revaskularizacije (neregistrirana indikacija), prasugrel ni bistveno znižal pogostnosti sestavljenega opazovanega dogodka CV smrti, MI ali možganske kapi v primerjavi s klopidogrelom.
English: Fatal Symptomatic ICHd
Slovenian: Smrtna Simptomatska ICHd
English: Only take other medicines while you are on Efient if your doctor tells you that you can.
Slovenian: Medtem, ko jemljete zdravilo Efient, vzemite druga zdravila samo, če vam zdravnik pove, da jih smete.
English: Efient can be concomitantly administered with medicinal products metabolised by cytochrome P450 enzymes (including statins), or medicinal products that are inducers or inhibitors of cytochrome P450 enzymes.
Slovenian: Zdravilo Efient lahko sočasno dajemo z zdravili, ki se presnavljajo z encimi citokroma P450 (vključno s statini) ali zdravili, ki so induktorji ali zaviralci encimov citokroma P450.
English: If prescribed, a lower maintenance dose of 5 mg should be used; the 10 mg maintenance dose is not recommended (see sections 4.2 and 4.8).
Slovenian: Če zdravilo predpišemo, moramo uporabiti nižji vzdrževalni odmerek 5 mg; 10 mg vzdrževalni odmerek ni priporočen (glejte poglavji 4.2 in 4.8).
English: When a blood vessel is damaged, for example if it is cut, platelets clump together to help form a blood clot (thrombus).
Slovenian: Ko je krvna žila poškodovana, na primer ob ureznini, se trombociti združijo skupaj, da pomagajo tvoriti krvni strdek (tromb).
English: Efient reduces the chances of you having a further heart attack or stroke or of dying from one of these atherothrombotic events.
Slovenian: Zdravilo Efient zmanjša možnost, da bi prišlo do naslednjega srčnega infarkta ali možganske kapi ali da bi umrli zaradi enega izmed teh aterotrombotičnih dogodkov.
English: OTHER <MON, TUE, WED, THU, FRI, SAT, SUN>
Slovenian: <PON, TOR, SRE, ČET, PET, SOB, NED>
English: If you weigh less than 60 kg or are more than 75 years of age, the dose is 5 mg Efient per day.
Slovenian: Če tehtate manj kot 60 kg ali če ste starejši od 75 let, boste jemali odmerek 5 mg na dan.
English: No clinical study has been conducted in pregnant or breast-feeding women.
Slovenian: Kliničnih študij pri nosečnicah in doječih ženskah niso opravili.
English: If you take more Efient than you should
Slovenian: Če ste vzeli večji odmerek zdravila Efient, kot bi smeli
English: Since platelets participate in the initiation and/or evolution of thrombotic complications of atherosclerotic disease, inhibition of platelet function can result in the reduction of the rate of cardiovascular events such as death, myocardial infarction, or stroke.
Slovenian: Ker trombociti sodelujejo pri začetku in/ali razvoju trombotičnih komplikacij aterosklerotične bolezni, lahko zaviranje delovanja trombocitov vodi v zmanjšanje stopnje srčnožilnih dogodkov kot so smrt, miokardni infarkt ali možganska kap.
English: The use of oral anticoagulants, non-study antiplatelet medicinal products and chronic NSAIDs was not allowed in TRITON.
Slovenian: Uporaba peroralnih antikoagulantov, ne-preiskovanih zdravil proti trombocitom in kronično zdravljenje z NSAIDs v študiji TRITON niso bili dovoljeni.
English: Therefore, the use of Efient in patients at increased risk of bleeding should only be considered when the benefits in terms of prevention of ischaemic events are deemed to outweigh the risk of serious bleedings.
Slovenian: Zato moramo o uporabi zdravila Efient pri bolnikih s povečanim tveganjem za krvavitev razmisliti, kadar menimo, da koristi v smislu preprečevanja ishemičnih dogodkov pretehtajo tveganje za resne krvavitve.