natgillin/translations-raw huggingface dataset:
NAME OF THE MARKETING AUTHORISATION HOLDER Daiichi-Sankyo (Logo)
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Daiichi-Sankyo (Logo)
Table 2: Haemorrhagic and Non-haemorrhagic adverse reactions System Organ
Preglednica 2: Hemoragični in ne-hemoragični neželeni učinki
Efient was administered without regard to food in TRITON.
Zdravilo Efient so v študiji TRITON dajali neodvisno od hrane.
Effects of other medicinal products on Efient
Učinki drugih zdravil na zdravilo Efient
TRITON was a 13,608 patient, multicentre international, randomised, double blind, parallel group study.
TRITON s 13.608 bolniki je bila multicentrična,
In UA/NSTEMI patients, where coronary angiography is performed within 48 hours after admission, the loading dose should only be given at the time of PCI (see sections 4.4, 4.8 and 5.1).
Bolnikom z UA/NSTEMI, pri katerih je koronarna angiografija opravljena v 48 urah po sprejemu, je treba polnilni odmerek dati le v času perkutane koronarne intervencije (glejte poglavja 4.4, 4.8 in 5.1).
• While you are taking Efient:
• Med jemanjem zdravila Efient:
Approximately 68% of the prasugrel dose is excreted in the urine and 27% in the faeces, as inactive metabolites.
Približno 68 % odmerka prasugrela se v obliki neaktivnih presnovkov izloči z urinom in 27 % z blatom.
• A copy of the SPC
• Izvod SPC-ja • S poudarkom na:
EU/1/08/503/008 14 film-coated tablets EU/1/08/503/009 28 film-coated tablets EU/1/08/503/010 30x1 film-coated tablet EU/1/08/503/011 56 film-coated tablets EU/1/08/503/012 84 film-coated tablets EU/1/08/503/013 90x1 film-coated tablet EU/1/08/503/014 98 film-coated tablets EU/1/08/503/016 30 film-coated tablets
EU/1/08/503/008 14 filmsko obloženih tablet EU/1/08/503/009 28 filmsko obloženih tablet EU/1/08/503/010 30x1 filmsko obložena tableta EU/1/08/503/011 56 filmsko obloženih tablet EU/1/08/503/012 84 filmsko obloženih tablet EU/1/08/503/013 90x1 filmsko obložena tableta EU/1/08/503/014 98 filmsko obloženih tablet EU/1/08/503/016 30 filmsko obloženih tablet
Do not take a double dose to make up for a forgotten dose.
Efient naslednji dan. Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
The mean exposure (AUC) of the active metabolite of prasugrel is approximately 30 to 40% higher in healthy subjects and patients with a body weight of < 60 kg compared to those weighing ≥ 60 kg. Prasugrel should be used with caution in patients with a body weight of < 60 kg due to the potential risk of bleeding in this population (see section 4.4).
Srednja izpostavljenost (AUC) aktivnemu presnovku prasugrela je približno 30 do 40 % višja pri zdravih osebah in bolnikih s telesno maso < 60 kg, v primerjavi s tistimi, ki tehtajo ≥ 60 kg. Prasugrel moramo uporabljati previdno pri bolnikih s telesno maso < 60 kg, zaradi možnega tveganja za krvavitev v tej populaciji (glejte poglavje 4.4).
Patients ≥ 75 years old Non-CABG-related TIMI major or minor bleeding rates:
Bolniki, stari ≥ 75 let Stopnje večjih in manjših krvavitev po TIMI, nepovezanih s CABG:
The increase in liver tumours with prasugrel administration in mice is not considered a relevant human risk.
Večje pojavljanje jetrnih tumorjev zaradi dajanja prasugrela pri miših ni ocenjeno kot pomemben dejavnik tveganja za ljudi.
Contents of the pack and other information
Shranjevanje zdravila Efient Vsebina pakiranja in dodatne informacije
EU/1/08/503/001 14 film-coated tablets EU/1/08/503/002 28 film-coated tablets EU/1/08/503/003 30x1 film-coated tablet EU/1/08/503/004 56 film-coated tablets EU/1/08/503/005 84 film-coated tablets EU/1/08/503/006 90x1 film-coated tablet EU/1/08/503/007 98 film-coated tablets EU/1/08/503/015 30 film-coated tablets
EU/1/08/503/001 14 filmsko obloženih tablet EU/1/08/503/002 28 filmsko obloženih tablet EU/1/08/503/003 30x1 filmsko obložena tableta EU/1/08/503/004 56 filmsko obloženih tablet EU/1/08/503/005 84 filmsko obloženih tablet EU/1/08/503/006 90x1 filmsko obložena tableta EU/1/08/503/007 98 filmsko obloženih tablet EU/1/08/503/015 30 filmsko obloženih tablet
• Bleeding from your rectum, blood in your stools or black stools.
• Krvavitev iz danke, kri v blatu ali črno blato
<75 years (N=11672)*
< 75 let (N=11672)*
Do not stop taking Efient without consulting your doctor; if you stop taking Efient too soon, your risk of a heart attack may be higher.
Efient prenehate jemati prezgodaj, je lahko pri vas tveganje za srčno kap večje.
Prasugrel-mediated inhibition of platelet aggregation exhibits low between-subject (9%) and within-subject (12%) variability with both 5 µM and 20 µM ADP.
Zaviranje agregacije trombocitov, inducirano s prasugrelom, kaže majhno variabilnost med osebami (9 %) in pri osebah (12 %) pri obeh, 5 µM ADP in 20 µM
• warfarin (an anti-coagulant),
• klopidogrelom (zdravilom proti trombocitom), • varfarinom (antikoagulantom),
Therapeutic experience with prasugrel is limited in patients with renal impairment (including ESRD) and in patients with moderate hepatic impairment.
Terapevtske izkušnje s prasugrelom so omejene pri bolnikih z okvaro ledvic (vključno s končno ledvično odpovedjo) in pri bolnikih z zmerno okvaro jeter.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeat-dose toxicity, genotoxicity, carcinogenic potential, or toxicity to reproduction.
Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih, genotoksičnosti, kancerogenega potenciala in vpliva na sposobnost razmnoževanja ne kažejo posebnega tveganja za človeka.
Microcrystalline cellulose, mannitol (E421), croscarmellose sodium, hypromellose (E464) magnesium stearate, lactose monohydrate, titanium dioxide (E171), triacetin (E1518), iron oxide red (10 mg tablets only) (E172), iron oxide yellow (E172) and talc.
magnezijev stearat, laktoza monohidrat, titanov dioksid (E171), triacetin (E1518), rdeči železov oksid (samo 10 mg tablete) (E172), rumeni železov oksid (E172) in smukec.
A single intravenous bolus dose of unfractionated heparin (100 U/kg) did not significantly alter the prasugrel-mediated inhibition of platelet aggregation.
Heparin: Enkratni intravenski bolusni odmerek nefrakcioniranega heparina (100 enot/kg) ni značilno spremenil zaviranja agregacije trombocitov, povzročenega s prasugrelom.
Prasugrel 5 mg provided greater antiplatelet effect than clopidogrel 75 mg. Prasugrel should be used with caution in patients ≥ 75 years old and in patients weighing <60 kg (see sections 4.2, 4.4 and 4.8).
Prasugrel 5 mg je omogočil večji antitrombotični učinek kot klopidogrel 75 mg. Prasugrel je treba uporabljati previdno pri bolnikih ≥ 75 let in pri bolnikih, ki tehtajo < 60 kg (glejte poglavja 4.2, 4.4 in
Prasugrel had no effect on fertility of male and female rats at oral doses up to an exposure 240 times the recommended daily human maintenance dose (based on mg/m2).
Prasugrel nima učinka na plodnost samcev in samic podgan pri peroralnih odmerkih, ki so do 240-krat večji od izpostavljenosti, pri priporočenem dnevnem vzdrževalnem odmerku pri ljudeh (glede na mg/m2).
In a study in subjects with stable atherosclerosis, the mean AUC of the active metabolite in patients ≥75 years old taking 5 mg prasugrel was approximately half that in patients < 65 years old taking 10 mg prasugrel, and the antiplatelet effect of 5 mg was reduced but was non-inferior compared to 10 mg.
V študiji z bolniki s stabilno aterosklerozo je povprečna AUC aktivnemu presnovku pri bolnikih ≥ 75 let, ki so jemali 5 mg prasugrela, znašala približno polovico AUC pri bolnikih < 65 let, ki so jemali 10 mg prasugrela, antitrombotični učinek 5-mg odmerka pa je bil manjši, vendar ni bil slabši od 10-mg odmerka.
A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE
Clopidogrelb +ASA (N = 4980)
klopidogrelb +ASK (N=4980)
No dose adjustment is necessary in subjects with mild to moderate hepatic impairment (Child Pugh class A and B) (see section 5.2).
Prilagoditev odmerka ni potrebna pri bolnikih z blago do zmerno okvaro jeter (razreda A in B po Child Pugh-u) (glejte poglavje 5.2).
In the large phase 3 clinical trial, the mean estimated exposure (AUC) of the active metabolite was 19% higher in very elderly patients (≥ 75 years of age) compared to subjects < 75 years of age.
V velikem kliničnem preskušanju faze 3, je bila srednja ocenjena izpostavljenost (AUC) aktivnemu presnovku 19 % višja pri zelo starih bolnikih
CV death, nonfatal MI, or nonfatal stroke CV death Nonfatal MI Nonfatal stroke STEMI Primary Composite Outcome Events
CV smrt, ne-smrtni MI ali ne-smrtna možganska kap CV smrt Ne-smrtni MI Ne-smrtna možganska kap STEMI Primarni sestavljeni izidi
Prasugrel is a weak inhibitor of CYP2B6.
Prasugrel je šibek zaviralec CYP2B6.
In a study in subjects with stable atherosclerosis, the mean AUC of the active metabolite in patients <60 kg taking 5 mg prasugrel was 38% lower than in patients ≥60 kg taking 10 mg prasugrel, and the antiplatelet effect of 5 mg was similar to 10 mg.
V študiji z bolniki s stabilno aterosklerozo je bila povprečna AUC aktivnemu presnovku pri bolnikih < 60 kg, ki so jemali 5 mg prasugrela, za 38 % nižja kot pri bolnikih ≥ 60 kg, ki so jemali 10 mg prasugrela, antitrombotični učinek 5-mg odmerka pa je bil podoben 10-mg odmerku.
Efient is unlikely to affect your ability to drive or use machines.
Vpliv na sposobnost upravljanja vozil in strojev Za zdravilo Efient je malo verjetno, da vpliva na vašo sposobnost upravljanja vozil in strojev.
Requiring surgical intervention
Zahteva kirurški poseg
No dose adjustment is necessary for patients with mild to moderate impaired hepatic function (Child Pugh Class A and B).
Prilagoditev odmerka ni potrebna pri bolnikih z blago do zmerno okvaro jeter (razreda A in B po Child Pugh-u).
Specifically, prasugrel did not significantly reduce the frequency of the composite endpoint of cardiovascular (CV) death, myocardial infarction (MI), stroke, urgent revascularization (UR), or glycoprotein (GP) IIb/IIIa inhibitor bailout through 7 days from randomization in subjects receiving prasugrel prior to coronary angiography compared to patients receiving the full loading dose of prasugrel at the time of PCI, and the rate of the key safety objective for all TIMI major bleeding (CABG and non-CABG events) through 7 days from randomization in all treated subjects was significantly higher in subjects receiving prasugrel prior to coronary angiography versus patients receiving the full loading dose of prasugrel at the time of PCI.
Natančneje, prasugrel ni bistveno zmanjšal pogostnosti sestavljenega opazovanega dogodka srčnožilne (CV) smrti, miokardnega infarkta (MI), možganske kapi, urgentne revaskularizacije (UR) ali reševalnega zdravljenja z zaviralci glikoproteina (GP) IIb/IIIa v obdobju 7 dni od randomizacije pri bolnikih, ki so prejeli prasugrel pred koronarno angiografijo, v primerjavi z bolniki, ki so prejeli poln polnilni odmerek prasugrela v času perkutane koronarne intervencije; stopnja ključnih z varnostjo povezanih dogodkov za vse večje krvavitve po
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).
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).
Do not take Efient - If you are allergic (hypersensitive) to prasugrel or any of the other ingredients of Efient.
- Če ste alergični (preobčutljivi) na prasugrel ali katerokoli sestavino zdravila Efient.
cLife-threatening is a subset of TIMI Major bleeding and includes the types indented below.
c Smrtno nevarna krvavitev je podskupina večje krvavitve po TIMI in vključuje tipe, navedene spodaj.
• A rash, itching, or a swollen face, swollen lips/tongue, or shortness of breath.
• izpuščaj, srbenje, ali otekel obraz, otekle ustnice/jezik ali težko dihanje.
Also contact your doctor immediately if you notice any of the following:
Svojega zdravnika prav tako nemudoma obvestite, če opazite karkoli od naslednjega:
What you need to know before you take Efient
Kaj morate vedeti, preden boste vzeli zdravilo Efient Ne jemljite zdravila Efient
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).
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.
Nonfatal MI
Ne-smrtni MI
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.
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
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).
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).
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.
Zato se za zaviralce CYP3A, kot so azolski antimikotiki, zaviralci HIV proteaze, klaritromicin, telitromicin, verapamil, diltiazem, indinavir,
Body weight:
Telesna masa:
≥75 years (N=2060)**
≥ 75 let (N=2060) **
Renal impairment:
Okvara ledvic:
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.
- jemanje nekaterih vrst zdravil (glejte ‘Jemanje drugih zdravil' spodaj) - načrtovan kirurški poseg (vključno z nekaterimi zobozdravstvenimi posegi) v naslednjih sedmih dneh.
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.
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.
Efient, which contains the active substance prasugrel, belongs to a group of medicines called antiplatelet agents.
Kaj je zdravilo Efient in za kaj ga uporabljamo Efient, ki vsebuje zdravilno učinkovino prasugrel, spada v skupino zdravil, imenovanih zdravila proti trombocitom.
Thrombocytopaenia Thrombotic thrombocytopaenic purpura (TTP) -see section 4.4
Bolezni krvi in limfatičnega sistema anemija trombocitpenija trombotična trombocitopenična purpura (TTP)glejte poglavje 4.4
Patients had ACS with moderate to high risk UA, NSTEMI, or STEMI and were managed with PCI.
Bolniki, ki so imeli PCI, so imeli ACS z zmernim do visokim tveganjem za UA, NSTEMI ali STEMI.
Skin and subcutaneous tissue disorders
Bolezni kože in podkožja izpuščaj ekhimoza
<75 years (N=7180)**
< 75 let (N=7180)**
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.
mora z jemanjem zdravila Efient prekiniti najmanj 7 dni pred kirurškim posegom.
≥75 years (N=1785)*
≥ 75 let (N=1785)*
and 4.8).
4.2, 4.8 in 5.1).
Contact your doctor immediately if you notice any of the following:
Svojega zdravnika takoj obvestite, če opazite karkoli od naslednjega:
Requiring inotropes Requiring surgical intervention Requiring transfusion (≥ 4
Zahteva transfuzijo (≥ 4 enote)
Microcrystalline cellulose Mannitol (E421) Croscarmellose sodium Hypromellose (E464) Magnesium stearate
Natrijev karmelozat, premreženi Hipromeloza (E464) Magnezijev stearat
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).
Zaradi možnega povečanega tveganja za krvavitev, moramo previdno dajati sočasno varfarin (ali druge kumarinske derivate) in prasugrel (glejte poglavje 4.4).
There is limited therapeutic experience in patients with renal impairment (see section 4.4).
Terapevtske izkušnje pri bolnikih z okvaro ledvic so omejene (glejte poglavje 4.4).
CV death, nonfatal MI, or nonfatal stroke CV death
CV smrt, ne-smrtni MI ali ne-smrtna možganska kap
Prasugrel is a prodrug and is rapidly metabolised in vivo to an active metabolite and inactive metabolites.
Prasugrel je predzdravilo ki se hitro presnavlja in vivo v aktivni presnovek in neaktivne presnovke.
Prasugrel did not inhibit CYP2C9, as it did not affect the pharmacokinetics of S-warfarin.
Zdravila, ki se presnavljajo s CYP2C9: Prasugrel ne zavira CYP2C9, kot tudi ne vpliva na farmakokinetiko S-varfarina.
including oral anticoagulants, clopidogrel, non-steroidal anti-inflammatory drugs (NSAIDs), and fibrinolytics.
• 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.
Because of the potential for increased risk of bleeding, warfarin and Efient should be co-administered with caution (see section 4.4).
Zaradi možnega povečanega tveganja za krvavitev, moramo previdno dajati sočasno varfarin in zdravilo Efient (glejte poglavje 4.4).
Uncommon side effects (may affect up to 1 in 100 people)
• Modrice Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov)
No dosage adjustment is necessary for patients with renal impairment, including patients with end stage renal disease (ESRD).
Prilagoditev odmerka ni potrebna pri bolnikih z okvaro ledvic, vključno z bolniki s končno ledvično odpovedjo.
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).
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.
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.
Rifampicin (600 mg na dan), močan induktor CYP3A in CYP2B6 ter induktor CYP2C9, CYP2C19 in
9.0% (1.0% fatal)
9,0 % (1,0 % smrtno)
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.
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.
In the All ACS population, analysis of each of the secondary endpoints showed a significant benefit (p < 0.001) for prasugrel versus clopidogrel.
V celotni ACS populaciji je analiza vsakega od sekundarnih ciljev kazala signifikantno korist
• 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).
• 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«)
• Blood in stools
• Kri v blatu
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.
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.
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).
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
Efient 5 mg: Each tablet contains 5 mg of prasugrel (as hydrochloride).
Efient 5 mg: Ena tableta vsebuje 5 mg prasugrela (v obliki klorida).
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Daiichi Sankyo Europe GmbH
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Daiichi Sankyo Europe GmbH
10.1% (0% fatal)
10,1 % (0 % smrtno)
Marketing Authorisation Holder Daiichi Sankyo Europe GmbH Zielstattstrasse 48
IMETNIK DOVOLJENJA ZA PROMET Daiichi Sankyo Europe GmbH Zielstattstrasse 48
a 10 mg prasugrel; 5 mg prasugrel if ≥75 years of age
a 10 mg prasugrela; 5 mg prasugrela, če ≥ 75 let.
2.0% (0.1% fatal) a
2,0 % (0,1 % smrtno) a
a 10 mg prasugrel; 5 mg prasugrel if <60 kg
a 10 mg prasugrela; 5 mg prasugrela, če < 60 kg.
Efient 10 mg: Each tablet contains 10 mg of prasugrel (as hydrochloride).
Efient 10 mg: Ena tableta vsebuje 10 mg prasugrela (v obliki klorida).
Tell your doctor promptly if you notice any of the following:
Svojega zdravnika nemudoma obvestite, če opazite karkoli od naslednjega:
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').
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«).