FrancophonIA/ELRC3.0 huggingface dataset:
English: Results of a pharmacodynamic/pharmacogenomic study in 720 Asian ACS PCI patients demonstrated that higher levels of platelet inhibition are achieved with prasugrel compared to clopidogrel, and that prasugrel 60-mg loading dose/10-mg maintenance dose is an appropriate dose regimen in Asian subjects who weigh at least 60 kg and are less than 75 years of age (see section 4.2).
Slovenian: Rezultati farmakodinamske/farmakogenomske študije pri bolnikih azijskega porekla z akutnim koronarnim sindromom, zdravljenim s perkutano koronarno intervencijo, so pokazali, da pri prasugrelu pride do večjega zaviranja trombocitov kot pri klopidogrelu in da je začetni odmerek 60 mg/vzdrževalni odmerek 10 mg ustrezen režim odmerjanja pri preiskovancih azijskega porekla, s telesno maso vsaj 60 kg in so mlajši od 75 let (glejte poglavje 4.2).
English: Do not take Efient - If you are allergic (hypersensitive) to prasugrel or any of the other ingredients of Efient.
Slovenian: - Če ste alergični (preobčutljivi) na prasugrel ali katerokoli sestavino zdravila Efient.
English: cLife-threatening is a subset of TIMI Major bleeding and includes the types indented below.
Slovenian: c Smrtno nevarna krvavitev je podskupina večje krvavitve po TIMI in vključuje tipe, navedene spodaj.
English: • A rash, itching, or a swollen face, swollen lips/tongue, or shortness of breath.
Slovenian: • izpuščaj, srbenje, ali otekel obraz, otekle ustnice/jezik ali težko dihanje.
English: Also contact your doctor immediately if you notice any of the following:
Slovenian: Svojega zdravnika prav tako nemudoma obvestite, če opazite karkoli od naslednjega:
English: What you need to know before you take Efient
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Efient Ne jemljite zdravila Efient
English: Because of the potential for increased risk of bleeding, chronic NSAIDs (including COX-2 inhibitors) and Efient should be coadministered with caution (see section 4.4).
Slovenian: Zaradi možnega povečanega tveganja za krvavitev, je pri sočasni uporabi NSAIDs (vključno z zaviralci COX-2) in zdravila Efient (glejte poglavje 4.4) potrebna previdnost.
English: Nonfatal MI
Slovenian: Ne-smrtni MI
English: Daily co-administration of ranitidine (an H2 blocker) or lansoprazole (a proton pump inhibitor) did not change the prasugrel active metabolite's AUC and Tmax, but decreased the Cmax by 14% and 29%, respectively.
Slovenian: Zdravila, ki višajo želodčni pH: Dnevno sočasno dajanje ranitidina (blokator H2) ali lanzoprazola (zaviralec protonske črpalke) ni spremenilo AUC in tmax aktivnega presnovka prasugrela, ampak je zmanjšalo Cmax za 14 % oziroma
English: Efient, co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with acute coronary syndrome (i.e. unstable angina, non-ST segment elevation myocardial infarction [UA/NSTEMI] or ST segment elevation myocardial infarction [STEMI]) undergoing primary or delayed percutaneous coronary intervention (PCI).
Slovenian: nestabilna angina pektoris, miokardni infarkt brez elevacije ST spojnice [non-ST segment elevation myocardial infarction, UA/NSTEMI] ali miokardni infarkt z elevacijo ST spojnice [ST segment elevation myocardial infarction, STEMI], ki imajo primarno ali odloženo perkutano koronarno intervencijo (percutaneous coronary intervention, PCI).
English: Therefore, CYP3A inhibitors such as azol antifungals, HIV protease inhibitors, clarithromycin, telithromycin, verapamil, diltiazem, indinavir, ciprofloxacin, and grapefruit juice are not anticipated to have a significant effect on the pharmacokinetics of the active metabolite.
Slovenian: Zato se za zaviralce CYP3A, kot so azolski antimikotiki, zaviralci HIV proteaze, klaritromicin, telitromicin, verapamil, diltiazem, indinavir,
English: Body weight:
Slovenian: Telesna masa:
English: Clopidogrel 75 mg
Slovenian: prasugrel 5 mg klopidogrel 75 mg
English: ≥75 years (N=2060)**
Slovenian: ≥ 75 let (N=2060) **
English: Renal impairment:
Slovenian: Okvara ledvic:
English: Your doctor should prescribe a daily dose of 5 mg of Efient if you weigh less than 60 kg - renal (kidney) disease or moderate liver problems - taking certain types of medicines (see ‘Taking other medicines' below) - planned surgery (including some dental procedures) in the next seven days.
Slovenian: - jemanje nekaterih vrst zdravil (glejte ‘Jemanje drugih zdravil' spodaj) - načrtovan kirurški poseg (vključno z nekaterimi zobozdravstvenimi posegi) v naslednjih sedmih dneh.
English: In patients ≥60 kg and age <75 years, non-CABG-related TIMI major or minor bleeding rates were 3.6% for prasugrel and 2.8% for clopidogrel; rates for fatal bleeding were 0.2% for prasugrel and 0.1% for clopidogrel.
Slovenian: nepovezanih s CABG, 3,6 % za prasugrel in 2,8 % za klopidogrel; stopnje smrtnih krvavitev so bile 0,2 % za prasugrel in 0,1 % za klopidogrel.
English: • Periodic Safety Update Reports
Slovenian: Redno posodobljena poročila o varnosti zdravila (PSUR)
English: Efient, which contains the active substance prasugrel, belongs to a group of medicines called antiplatelet agents.
Slovenian: Kaj je zdravilo Efient in za kaj ga uporabljamo Efient, ki vsebuje zdravilno učinkovino prasugrel, spada v skupino zdravil, imenovanih zdravila proti trombocitom.
English: Thrombocytopaenia Thrombotic thrombocytopaenic purpura (TTP) -see section 4.4
Slovenian: Bolezni krvi in limfatičnega sistema anemija trombocitpenija trombotična trombocitopenična purpura (TTP)glejte poglavje 4.4
English: Patients had ACS with moderate to high risk UA, NSTEMI, or STEMI and were managed with PCI.
Slovenian: Bolniki, ki so imeli PCI, so imeli ACS z zmernim do visokim tveganjem za UA, NSTEMI ali STEMI.
English: Skin and subcutaneous tissue disorders
Slovenian: Bolezni kože in podkožja izpuščaj ekhimoza
English: <75 years (N=7180)**
Slovenian: < 75 let (N=7180)**
English: Statins:
Slovenian: Statini:
English: If a patient is to undergo elective surgery, and an antiplatelet effect is not desired, Efient should be discontinued at least 7 days prior to surgery.
Slovenian: mora z jemanjem zdravila Efient prekiniti najmanj 7 dni pred kirurškim posegom.
English: ≥75 years (N=1785)*
Slovenian: ≥ 75 let (N=1785)*
English: and 4.8).
Slovenian: 4.2, 4.8 in 5.1).
English: Contact your doctor immediately if you notice any of the following:
Slovenian: Svojega zdravnika takoj obvestite, če opazite karkoli od naslednjega:
English: Requiring inotropes Requiring surgical intervention Requiring transfusion (≥ 4
Slovenian: Zahteva transfuzijo (≥ 4 enote)
English: Microcrystalline cellulose Mannitol (E421) Croscarmellose sodium Hypromellose (E464) Magnesium stearate
Slovenian: Natrijev karmelozat, premreženi Hipromeloza (E464) Magnezijev stearat
English: Because of the potential for increased risk of bleeding, warfarin (or other coumarin derivatives) and prasugrel should be co-administered with caution (see section 4.4).
Slovenian: Zaradi možnega povečanega tveganja za krvavitev, moramo previdno dajati sočasno varfarin (ali druge kumarinske derivate) in prasugrel (glejte poglavje 4.4).
English: There is limited therapeutic experience in patients with renal impairment (see section 4.4).
Slovenian: Terapevtske izkušnje pri bolnikih z okvaro ledvic so omejene (glejte poglavje 4.4).
English: CV death, nonfatal MI, or nonfatal stroke CV death
Slovenian: CV smrt, ne-smrtni MI ali ne-smrtna možganska kap
English: Prasugrel is a prodrug and is rapidly metabolised in vivo to an active metabolite and inactive metabolites.
Slovenian: Prasugrel je predzdravilo ki se hitro presnavlja in vivo v aktivni presnovek in neaktivne presnovke.
English: Prasugrel did not inhibit CYP2C9, as it did not affect the pharmacokinetics of S-warfarin.
Slovenian: Zdravila, ki se presnavljajo s CYP2C9: Prasugrel ne zavira CYP2C9, kot tudi ne vpliva na farmakokinetiko S-varfarina.
English: including oral anticoagulants, clopidogrel, non-steroidal anti-inflammatory drugs (NSAIDs), and fibrinolytics.
Slovenian: • s sočasnim dajanjem zdravil, ki lahko povečajo tveganje za krvavitev, vključno s peroralnimi antikoagulanti, klopidogrelom, nesteroidnimi protivnetnimi zdravili (non-steroidal anti-inflammatory drugs, NSAIDs) in fibrinolitiki.
English: Because of the potential for increased risk of bleeding, warfarin and Efient should be co-administered with caution (see section 4.4).
Slovenian: Zaradi možnega povečanega tveganja za krvavitev, moramo previdno dajati sočasno varfarin in zdravilo Efient (glejte poglavje 4.4).
English: Uncommon side effects (may affect up to 1 in 100 people)
Slovenian: • Modrice Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov)
English: No dosage adjustment is necessary for patients with renal impairment, including patients with end stage renal disease (ESRD).
Slovenian: Prilagoditev odmerka ni potrebna pri bolnikih z okvaro ledvic, vključno z bolniki s končno ledvično odpovedjo.
English: No compound-related tumours were observed in a 2-year rat study with prasugrel exposures ranging to greater than 75 times the recommended therapeutic exposures in humans (based on plasma exposures to the active and major circulating human metabolites).
Slovenian: V 2-letnih študijah pri podganah, pri izpostavitvah prasugrelu v obsegu do večjih od 75-kratnih priporočenih terapevtskih izpostavitev pri ljudeh (na osnovi plazemske izpostavitve aktivnemu in pomembnejšim krožečim humanim presnovkom), niso opazili tumorjev, povezanih z zdravilno učinkovino.
English: Rifampicin (600 mg daily), a potent inducer of CYP3A and CYP2B6, and an inducer of CYP2C9, CYP2C19, and CYP2C8, did not significantly change the pharmacokinetics of prasugrel.
Slovenian: Rifampicin (600 mg na dan), močan induktor CYP3A in CYP2B6 ter induktor CYP2C9, CYP2C19 in
English: 9.0% (1.0% fatal)
Slovenian: 9,0 % (1,0 % smrtno)
English: Mean steady-state inhibition of platelet aggregation was 74% and 69% respectively for 5 µM ADP and 20 µM ADP, and was achieved following 3 to 5 days of administration of the 10 mg prasugrel maintenance dose preceded by a 60 mg loading dose.
Slovenian: ADP oziroma 69 % pri 20 µM ADP ter je bilo doseženo po 3 do 5 dneh dajanja 10 mg vzdrževalnega odmerka prasugrela, ki je sledil 60 mg polnilnemu odmerku.
English: In the All ACS population, analysis of each of the secondary endpoints showed a significant benefit (p < 0.001) for prasugrel versus clopidogrel.
Slovenian: V celotni ACS populaciji je analiza vsakega od sekundarnih ciljev kazala signifikantno korist
English: • Fever and bruising under the skin that may appear as red pinpoint dots, with or without unexplained extreme tiredness, confusion, yellowing of the skin or eyes (jaundice).
Slovenian: • vročino, podkožne modrice, ki lahko izgledajo kot rdeče pike, z ali brez nepojasnjene hude utrujenosti, zmedenosti, porumenitve kože in oči (zlatenica) (glejte poglavje 2 »Kaj morate vedeti, preden boste vzeli zdravilo Efient«)
English: • Blood in stools
Slovenian: • Kri v blatu
English: If, after a careful individual benefit/risk evaluation by the prescribing physician (see section 4.4), treatment is deemed necessary in the patients age group ≥ 75 years, then following a 60 mg loading dose a reduced maintenance dose of 5 mg should be prescribed.
Slovenian: o Če je po skrbni oceni lečečega zdravnika glede posameznikove koristi/tveganja zdravljenje v starostni skupini ≥ 75 let potrebno, mora biti po enkratnemu 60 mg polnilnemu odmerku predpisan nižji vzdrževalni odmerek 5 mg. o Bolniki s telesno maso < 60 kg morajo jemati nižji vzdrževalni odmerek 5 mg.
English: In a 30-day study (ACCOAST) in 4033 patients with NSTEMI with elevated troponin who were scheduled for coronary angiography followed by PCI within 2 to 48 hours after randomization, subjects who received prasugrel 30 mg loading dose on average 4 hours prior to coronary angiography followed by a 30 mg loading dose at the time of PCI (n=2037) had an increased risk of non-CABG peri-procedural bleeding and no additional benefit compared to patients receiving a 60 mg loading dose at the time of PCI (n=1996).
Slovenian: V 30-dnevni študiji (ACCOAST) s 4033 bolniki z NSTEMI s povišanim troponinom, pri katerih je bila predvidena koronarna angiografija, ki ji je sledila perkutana koronarna intervencija v obdobju 2 do 48 ur po randomizaciji, so bolniki, ki so prejeli 30-mg polnilni odmerek prasugrela v povprečju 4 ure pred koronarno angiografijo, ki mu je sledil 30-mg polnilni odmerek v času perkutane koronarne intervencije (n=2037), imeli povečano tveganje za krvavitev ob postopku, ki ni bila povezana s
English: Efient 5 mg: Each tablet contains 5 mg of prasugrel (as hydrochloride).
Slovenian: Efient 5 mg: Ena tableta vsebuje 5 mg prasugrela (v obliki klorida).
English: Eli Lilly Norge A.S. Tlf: +47 22 88 18 00
Slovenian: Tlf: +47 22 88 18 00
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Daiichi Sankyo Europe GmbH
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Daiichi Sankyo Europe GmbH
English: 10.1% (0% fatal)
Slovenian: 10,1 % (0 % smrtno)
English: Marketing Authorisation Holder Daiichi Sankyo Europe GmbH Zielstattstrasse 48
Slovenian: IMETNIK DOVOLJENJA ZA PROMET Daiichi Sankyo Europe GmbH Zielstattstrasse 48
English: a 10 mg prasugrel; 5 mg prasugrel if ≥75 years of age
Slovenian: a 10 mg prasugrela; 5 mg prasugrela, če ≥ 75 let.
English: 2.0% (0.1% fatal) a
Slovenian: 2,0 % (0,1 % smrtno) a
English: a 10 mg prasugrel; 5 mg prasugrel if <60 kg
Slovenian: a 10 mg prasugrela; 5 mg prasugrela, če < 60 kg.
English: Efient 10 mg: Each tablet contains 10 mg of prasugrel (as hydrochloride).
Slovenian: Efient 10 mg: Ena tableta vsebuje 10 mg prasugrela (v obliki klorida).
English: Tell your doctor promptly if you notice any of the following:
Slovenian: Svojega zdravnika nemudoma obvestite, če opazite karkoli od naslednjega:
English: You should tell your doctor immediately if you develop a medical condition called Thrombotic Thrombocytopaenic Purpura (or TTP) that includes fever and bruising under the skin that may appear as red pinpoint dots, with or without unexplained extreme tiredness, confusion, yellowing of the skin or eyes (jaundice) (see section 4 ‘Possible side effects').
Slovenian: To stanje se kaže z vročino, podkožnimi modricami, ki lahko izgledajo kot rdeče pike, z ali brez nepojasnjene hude utrujenosti, zmedenosti, porumenitve kože in oči (zlatenica) (glejte poglavje 4 »Možni neželeni učinki«).
English: In patients with acute coronary syndrome (ACS) who are managed with PCI, premature discontinuation of any antiplatelet agent, including Efient, could result in an increased risk of thrombosis, myocardial infarction or death due to the patient's underlying disease.
Slovenian: Pri bolnikih z akutnim koronarnim sindromom (acute coronary syndrome, ACS), ki je zdravljen s PCI, lahko predhodna prekinitev kakršnegakoli zdravila proti trombocitom, vključno z zdravilom Efient,
English: A treatment of up to 12 months is recommended unless the discontinuation of Efient is clinically indicated (see sections 4.4 and 5.1).
Slovenian: Priporoča se zdravljenje do 12 mesecev, razen, če je prekinitev zdravila Efient klinično indicirana
English: Heparin:
Slovenian: Digoksin:
English: e ICH=intracranial haemorrhage.
Slovenian: e ICH=intracranial haemorrhage, intrakranialna krvavitev.
English: Vascular Disorders Haematoma Respiratory, thoracic and mediastinal disorders
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora epistaksa hemoptiza
English: Retroperitoneal haemorrhage Rectal haemorrhage Haematochezia Gingival bleeding
Slovenian: Bolezni prebavil gastrointestinalna krvavitev retroperitonealna krvavitev rektalna krvavitev hematohezija krvavitev iz dlesni
English: +ASA (N = 6741)
Slovenian: +ASK (N=6716)
English: Bleeding Risk Associated with Timing of Loading Dose in NSTEMI In a clinical trial of NSTEMI patients (the ACCOAST study), where patients were scheduled to undergo coronary angiography within 2 to 48 hours after randomization, a prasugrel loading dose given on average 4 hours prior to coronary angiography increased the risk of major and minor peri-procedural bleeding compared with a prasugrel loading dose at the time of PCI.
Slovenian: V kliničnem preskušanju bolnikov z NSTEMI (študija ACCOAST), v kateri je bila za bolnike predvidena koronarna angiografija v obdobju 2 do 48 ur po randomizaciji, je polnilni odmerek prasugrela, dan v povprečju 4 ure pred koronarno angiografijo, povečal tveganje za večjo ali manjšo krvavitev ob postopku v primerjavi s polnilnim odmerkom prasugrela v času perkutane koronarne intervencije.
English: +ASA (N = 1740)
Slovenian: +ASK (N=1736)
English: In healthy subjects, patients with stable atherosclerosis, and patients with ACS receiving Efient, there was no relevant effect of genetic variation in CYP3A5, CYP2B6, CYP2C9, or CYP2C19 on the pharmacokinetics of prasugrel or its inhibition of platelet aggregation.
Slovenian: zaradi genetske variacije CYP3A5, CYP2B6, CYP2C9 ali CYP2C19 ni bilo pomembnega učinka na farmakokinetiko prasugrela ali njegovo zaviranje agregacije trombocitov.
English: Efient 10 mg film-coated tablets Efient 5 mg film-coated tablets Prasugrel
Slovenian: Efient 10 mg filmsko obložene tablete Efient 5 mg filmsko obložene tablete
English: f Clinically overt bleeding associated with a fall in haemoglobin of ≥3 g/dL but <5 g/dL.
Slovenian: f Klinično očitna krvavitev, povezana s padcem hemoglobina ≥ 3 g/dl vendar < 5 g/dl.
English: The efficacy of prasugrel was independent of the ASA dose (75 mg to 325 mg once daily).
Slovenian: Učinkovitost prasugrela je bila neodvisna od odmerka ASK (75 mg do
English: Effects of Efient on other medicinal products Digoxin:
Slovenian: Učinki zdravila Efient na druga zdravila
English: There is limited therapeutic experience in patients with mild and moderate hepatic dysfunction (see section 4.4).
Slovenian: Terapevtske izkušnje pri bolnikih z blago in zmerno okvaro jeter so omejene (glejte poglavje 4.4).
English: Talk to your doctor before taking Efient.
Slovenian: Pred začetkom jemanja zdravila Efient se posvetujte z zdravnikom.
English: Platelet aggregation gradually returned to baseline values after treatment in 7 to 9 days after administration of a single 60 mg loading dose of prasugrel and in 5 days following discontinuation of maintenance dosing at steady-state.
Slovenian: Po zdravljenju, v 7 do 9 dneh po dajanju enkratnega 60 mg polnilnega odmerka prasugrela in v 5 dneh po prekinitvi vzdrževalnega odmerjanja v stanju dinamičnega ravnovesja, se je agregacija trombocitov postopno vrnila na osnovne vrednosti.
English: * ICH=intracranial haemorrhage.
Slovenian: d ICH=intracranial haemorrhage, intrakranialna krvavitev.
English: 3.0% (0.5% fatal)
Slovenian: 3,0 % (0,5 % smrtno)
English: c Any intracranial haemorrhage or any clinically overt bleeding associated with a fall in haemoglobin ≥5 g/dL.
Slovenian: c Vsaka intrakranialna krvavitev ali klinično očitna krvavitev, povezana s padcem hemoglobina ≥ 5 g/dl.
English: 2.2% (0.2% fatal) a
Slovenian: 2,2 % (0,2 % smrtno) a
English: 3.8% (0.2% fatal)
Slovenian: 3,8 % (0,2 % smrtno)
English: Efient contains lactose
Slovenian: Zdravilo Efient vsebuje laktozo.
English: Lactose monohydrate Hypromellose (E464) Titanium dioxide (E171) Triacetin (E1518)
Slovenian: Titanov dioksid (E171)
English: Bleeding
Slovenian: Krvavitev
English: Increased frequency (3-fold) and severity of bleeding may occur in patients undergoing CABG surgery within 7 days of discontinuation of prasugrel (see section 4.8).
Slovenian: V obdobju 7 dni po prekinitvi prasugrela se pri bolnikih, ki so imeli kirurški poseg aortokoronarnega obvoda (Coronary Artery Bypass Graft, CABG), lahko pojavita povečana pogostnost (3-krat) in resnost krvavitve (glejte poglavje 4.8).
English: In clinical pharmacology studies, after adjusting for body weight, the AUC of the active metabolite was approximately 19% higher in Chinese, Japanese, and Korean subjects compared to that of Caucasians, predominantly related to higher exposure in Asian subjects < 60 kg.
Slovenian: približno 19 % višji pri kitajskih, japonskih in korejskih preiskovancih, v primerjavi z AUC pri belcih, zlasti zaradi višje izpostavljenosti pri azijskih osebah < 60 kg. Razlik v izpostavljenosti pri kitajskih, japonskih in korejskih preiskovancih ni bilo.
English: How to store Efient
Slovenian: Shranjevanje zdravila Efient
English: Non-Coronary Artery Bypass Graft (CABG) related bleeding In TRITON, the frequency of patients experiencing a non-CABG related bleeding event is shown in Table 1.
Slovenian: V študiji TRITON je pogostnost bolnikov, ki so imeli krvavitev, nepovezano s CABG, prikazana v
English: • Spontaneous bleeding from the eye, rectum, gums or in the abdomen around the internal organs
Slovenian: • Alergijske reakcije (izpuščaj, srbenje, otekle ustnice/jezik ali težko dihanje) • Spontana krvavitev iz očesa, danke, dlesni ali v trebuh okrog notranjih organov
English: The benefits and risks of prasugrel should be carefully considered in patients in whom the coronary anatomy has not been defined and urgent CABG is a possibility.
Slovenian: Pri bolnikih, pri katerih srčna anatomija ni določena in je možen nujni CABG, je treba skrbno razmisliti o koristih in tveganjih prasugrela.
English: • Haematoma (bleeding under the skin at the site of an injection, or into a muscle, causing swelling)
Slovenian: • Hematom (podkožna krvavitev na mestu injiciranja ali v mišico, ki povzroča oteklino) • Nizek hemoglobin ali nizko število rdečih krvnih celic (anemija)
English: This is due to an increase in exposure to the active metabolite of prasugrel, and an increased risk of bleeding in patients with body weight < 60 kg when given a 10 mg once daily dose compared with patients ≥ 60 kg (see sections 4.4, 4.8 and 5.2).
Slovenian: Zdravilo Efient moramo dati kot enkratni 60 mg polnilni odmerek in nato nadaljevati s 5 mg odmerkom enkrat na dan. 10 mg vzdrževalni odmerek ni priporočljiv, in sicer zaradi večje izpostavljenosti aktivnemu presnovku prasugrela in povečanemu tveganju za krvavitev ob prejemanju 10 mg odmerka enkrat na dan pri bolnikih, ki tehtajo < 60 kg, v primerjavi z bolniki ≥ 60 kg (glejte poglavja 4.4, 4.8 in 5.2).
English: Prasugrel must not be used in patients with severe hepatic impairment (see section 4.
Slovenian: Prasugrela ne smemo uporabljati pri bolnikih s hudo okvaro jeter (glejte poglavje 4.3).
English: eClinically overt bleeding associated with a fall in haemoglobin of ≥3 g/dL but <5 g/dL.
Slovenian: e Klinično očitna krvavitev, povezana s padcem hemoglobina ≥ 3 g/dl vendar < 5 g/dl.
English: 1.6% (0.2% fatal)
Slovenian: 1,6 % (0,2 % smrtno)
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Efient 10 mg:
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA
English: Immune system disorders
Slovenian: Organski sistem Pogosti
English: The maximum inhibition by prasugrel of ADP-induced platelet aggregation is 83% with 5 µM ADP and 79% with 20 µM ADP, in both cases with 89% of healthy subjects and patients with stable atherosclerosis achieving at least 50% inhibition of platelet aggregation by 1 hour.
Slovenian: Maksimalno zaviranje agregacije trombocitov, inducirane z ADP, s prasugrelom je 83 % pri 5 µM ADP in 79 % pri 20 µM ADP.
English: Nonfatal stroke
Slovenian: Okvara ledvic
English: Rare side effects (may affect up to 1 in 1,000 people)
Slovenian: Redki neželeni učinki (pojavijo se lahko pri največ 1 od 1.000 bolnikov) • Nizko število trombocitov
English: Each tablet contains 10 mg prasugrel (as hydrochloride).
Slovenian: Ena tableta vsebuje 10 mg prasugrela (v obliki klorida).
English: Clopidogrelb +ASA (N = 6716)
Slovenian: prasugrelb +ASK (N=6741)
English: This effect is likely to be of clinical concern only when prasugrel is co-administered with medicinal products for which CYP2B6 is the only metabolic pathway and have a narrow therapeutic window (e.g. cyclophosphamide, efavirenz).
Slovenian: CYP2B6 in imajo ozko terapevtsko širino (npr. ciklofosfamid, efavirenz).
English: Clopidogrelb +ASA (N = 1736)
Slovenian: prasugrelb +ASK (N=1740)
English: Bleeding risk
Slovenian: Smrtno nevarnac
English: 2.9% (0.1% fatal)
Slovenian: 2,9 % (0,1 % smrtno)
English: 6.9% (0.1% fatal)
Slovenian: 6,9 % (0,1 % smrtno)