natgillin/translations-raw huggingface dataset:
These included definite or probable stent thrombosis at study end (0.9% vs 1.8%; HR 0.498; CI 0.364, 0.683); CV death, nonfatal MI, or urgent target vessel revascularisation through 30 days (5.9% vs 7.4%; HR 0.784; CI 0.688,0.894); all cause death, nonfatal MI, or nonfatal stroke through study end (10.2% vs 12.1%; HR 0.831; CI 0.751, 0.919); CV death, nonfatal MI, nonfatal stroke or rehospitalisation for cardiac ischaemic event through study end (11.7% vs 13.8%; HR 0.838; CI 0.762, 0.921).
Hazard Ratio, HR): 0,498; CI: 0,364; 0,683); smrt zbog KV uzroka, nesmrtonosni IM ili hitna revaskularizacija ciljne krvne žile do 30. dana (5,9% u odnosu na 7,4%; HR: 0,784; CI: 0,688; 0,894); smrt zbog bilo kojeg uzroka, nesmrtonosni infarkt miokarda ili nesmrtonosni moždani udar do završetka ispitivanja (10,2% u odnosu na 12,1%; HR: 0,831; CI: 0,751; 0,919); smrt zbog KV uzroka, nesmrtonosni IM, nesmrtonosni moždani udar ili ponovna hospitalizacija zbog srčanog ishemijskog događaja do završetka ispitivanja (11,7% u odnosu na
Patients ≥ 75 years of age have greater sensitivity to bleeding and higher exposure to the active metabolite of prasugrel (see sections 4.4, 4.8, 5.1 and 5.2).
Bolesnici u dobi od ≥ 75 godina skloniji su krvarenju i izloženi su većoj koncentraciji aktivnog metabolita prasugrela (vidjeti dijelove 4.4, 4.8, 5.1 i 5.2).
NAME OF THE MARKETING AUTHORISATION HOLDER Daiichi-Sankyo (Logo)
NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Daiichi-Sankyo (Logo)
An allergic reaction may be recognised as a rash, itching, a swollen face, swollen lips or shortness of breath.
Alergijska reakcija se može prepoznati kao osip, svrbež, oticanje lica, usana ili nedostatak zraka.
• Allergic reaction (rash, itching, swollen lips/tongue, or shortness of breath)
• alergijska reakcija (osip, svrbež, oticanje usana ili jezika, ili nedostatak zraka)
Switching data: Following administration of 75 mg clopidogrel once daily for 10 days, 40 healthy subjects were switched to prasugrel 10 mg once daily with or without a loading dose of 60 mg.
Podaci o prebacivanju: Nakon primjene klopidogrela u dozi od 75 mg jedanput na dan tijekom 10 dana, 40 zdravih ispitanika prebačeno je na prasugrel u dozi od 10 mg jedanput na dan, s udarnom dozom od 60 mg ili bez nje.
The trial's primary outcome measure was the time to first occurrence of cardiovascular (CV) death, non-fatal myocardial infarction (MI), or non-fatal stroke.
Primarna mjera ishoda ovog ispitivanja bilo je vrijeme do prve pojave smrti uzrokovane kardiovaskularnim (KV) događajem, nesmrtonosnog infarkta miokarda (IM) ili nesmrtonosnog moždanog udara.
No dose adjustment is necessary for patients with renal impairment, including patients with end stage renal disease (see section 5.2).
Nije potrebno prilagođavati dozu u bolesnika s oštećenjem bubrega, uključujući i bolesnike u terminalnoj fazi bubrežne bolesti (vidjeti dio 5.2).
Table 2 summarises haemorrhagic and non-haemorrhagic adverse reactions in TRITON, or that were spontaneously reported, classified by frequency and system organ class.
Tablici 2 su sažeto prikazane hemoragijske i nehemoragijske nuspojave u ispitivanju TRITON ili iz spontanih prijava, klasificirane prema učestalosti i organskim sustavima.
Rates of TIMI major bleeding (including life threatening, fatal and ICH) were similar in prasugrel and clopidogrel treated patients.
Stope značajnih krvarenja prema TIMI kriterijima (uključujući po život opasna, smrtonosna i intrakranijalna krvarenja) bile su slične u bolesnika liječenih prasugrelom i onih liječenih klopidogrelom.
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.
Mikrokristalična celuloza, manitol (E421), umrežena karmelozanatrij, hipromeloza (E464), magnezijev stearat, laktoza hidrat, titanijev dioksid (E171), triacetin (E1518), crveni željezov oksid (samo tablete od 10 mg) (E172), žuti željezov oksid (E172) i talk.
Not Known
Nepoznato
A 5 mg maintenance dose should be used.
Mora se primjenjivati doza održavanja od 5 mg
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.
Ako nakon pažljive procjene koristi i rizika u svakog pojedinog bolesnika liječnik propisivač (vidjeti dio 4.4) ipak ocijeni da je primjena ovog lijeka neophodna u bolesnika u dobnoj skupini ≥ 75 godina, tada se nakon udarne doze od 60 mg mora propisati niža doza održavanja od 5 mg.
The active metabolite's exposure (AUC) has moderate to low between-subject (27%) and within-subject (19%) variability.
Izloženost aktivnom metabolitu (AUC) pokazuje umjerenu do malu interindividualnu (27%) i intraindividualnu (19%) varijabilnost.
Microcrystalline cellulose Mannitol (E421) Croscarmellose sodium Hypromellose (E464) Magnesium stearate
celuloza, mikrokristalična manitol (E421) karmelozanatrij, umrežena hipromeloza (E464) magnezijev stearat
• Haematoma (bleeding under the skin at the site of an injection, or into a muscle, causing swelling)
• krv u mokraći • hematomi (potkožna krvarenja na mjestu davanja injekcije, ili krvarenja u mišić koja uzrokuju oticanje)
It is rapidly hydrolysed in the intestine to a thiolactone, which is then converted to the active metabolite by a single step of cytochrome P450 metabolism, primarily by CYP3A4 and CYP2B6 and to a lesser extent by CYP2C9 and CYP2C19.
On se u tankom crijevu vrlo brzo hidrolizira u tiolakton, koji se potom u jednom koraku, pomoću citokroma P450 - pretežito CYP3A4 i CYP2B6, a u manjoj mjeri CYP2C9 i CYP2C19 - pretvara u aktivni metabolit.
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).
Razlog tomu je povećana izloženost aktivnom metabolitu prasugrela i povećan rizik od krvarenja nakon primjene doze od 10 mg na dan u bolesnika tjelesne težine < 60 kg u usporedbi s bolesnicima tjelesne težine ≥ 60 kg (vidjeti dijelove 4.4, 4,8 i 5.2).
Patients with a history of TIA or a history of ischaemic stroke more than 3 months prior to prasugrel therapy had no reduction in the primary composite endpoint.
U bolesnika koji su imali TIA-u ili ishemijski moždani udar više od 3 mjeseca prije početka liječenja prasugrelom nije došlo do smanjenja objedinjene primarne mjere ishoda.
Τηλ: +30 210 629 4600
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε. Τηλ: +30 210 629 4600
Stroke is an uncommon side effect of Efient in patients who have never had a stroke or transient ischaemic attack (TIA).
Moždani udar je manje česta nuspojava lijeka Efient u bolesnika koji ranije nisu imali moždani udar ni tranzitornu ishemijsku ataku (TIA).
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 farmakodinamičkih/farmakogenomskih ispitivanja provedenih na 720 bolesnika azijskog podrijetla s ACS-om podvrgnutih PCI-u pokazali su da prasugrel dovodi do višeg stupnja inhibicije trombocita nego klopidogrel te da udarna doza prasugrela od 60 mg i doza održavanja od 10 mg predstavlja primjeren režim doziranja za bolesnike azijskog podrijetla koji imaju najmanje 60 kg i mlađi su od 75 godina (vidjeti dio 4.2).
Efient should be given as a single 60 mg loading dose and then continued at a 5 mg once daily dose.
Treba dati jednokratnu udarnu dozu lijeka Efient od 60 mg, a zatim nastaviti liječenje u dozi od 5 mg jedanput na dan.
Patients also received ASA (75 mg to 325 mg once daily).
Bolesnici su primali i ASK (75 mg do 325 mg jedanput na dan).
Ethnicity:
Etničko podrijetlo:
a Centrally adjudicated events defined by the Thrombolysis in Myocardial Infarction (TIMI) Study Group criteria.
a Centralno određeni događaji definirani prema kriterijima ispitivačke skupine za trombolizu u infarktu miokarda (engl.
6.5% (2.3% ICH*)
6,5% (2,3% IKK*)
Concomitant administration with chronic NSAIDs has not been studied.
Nije ispitivana istodobna primjena kod kroničnog liječenja NSAIL-ima.
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 filmom obloženih tableta EU/1/08/503/009 28 filmom obloženih tableta EU/1/08/503/010 30x1 filmom obložena tableta EU/1/08/503/011 56 filmom obloženih tableta EU/1/08/503/012 84 filmom obložene tablete EU/1/08/503/013 90x1 filmom obložena tableta EU/1/08/503/014 98 filmom obložene tablete EU/1/08/503/016 30 filmom obložene tablete
LIST OF EXCIPIENTS Contains lactose.
POPIS POMOĆNIH TVARI Sadrži laktozu.
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).
Plodnost Prasugrel nije utjecao na plodnost mužjaka i ženki štakora koji su primali peroralne doze do izloženosti 240 puta veće od one u ljudi uz primjenu preporučene dnevne doze održavanja (na temelju mg/m2).
Patients randomised to receive prasugrel (60 mg loading dose followed by 10 mg once daily) or clopidogrel (300 mg loading dose followed by 75 mg once daily) were treated for a median of 14.5 months (maximum of 15 months with a minimum of 6 months follow-up).
Bolesnici su randomizirani da primaju prasugrel (udarna doza od 60 mg, a zatim 10 mg jedanput na dan) ili klopidogrel (udarna doza od 300 mg, a zatim 75 mg jedanput na dan) te su liječeni tijekom medijana od 14,5 mjeseci (najviše 15 mjeseci uz najmanje 6 mjeseci praćenja nakon liječenja).
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).
Zbog mogućeg povećanog rizika od krvarenja, istodobna primjena varfarina (ili drugih derivata kumarina) i prasugrela mora se odvijati uz oprez (vidjeti dio 4.4).
Efient was administered without regard to food in TRITON.
Efient se u ispitivanju TRITON primjenjivao neovisno o obroku.
Following a 60 mg loading dose of prasugrel, inhibition of ADP-induced platelet aggregation occurs at 15 minutes with 5 µM ADP and 30 minutes with 20 µM ADP.
Po primjeni udarne doze od 60 mg prasugrela inhibicija ADP-om potaknute agregacije trombocita nastupa nakon 15 minuta uz 5 µm ADP-a, a nakon 30 minuta uz 20 µm ADP-a.
No dose adjustment is necessary in subjects with mild to moderate hepatic impairment (Child Pugh class A and B) (see section 5.2).
Nije potrebno prilagođavati dozu u osoba s blagim do umjerenim oštećenjem jetre (Child-Pugh stadij A i B) (vidjeti dio 5.2).
The observed benefit of prasugrel in patients ≥ 75 years was less than that observed in patients < 75 years.
Korist liječenja prasugrelom u bolesnika u dobi od ≥ 75 godina bila je manja od one u bolesnika mlađih od 75 godina.
More than 98% of subjects had ≥ 20% inhibition of platelet aggregation during maintenance dosing.
U više od 98% ispitanika je tijekom primjene doze održavanja postignuta inhibicija agregacije trombocita od ≥ 20%.
Prasugrel-mediated inhibition of platelet aggregation exhibits low between-subject (9%) and within-subject (12%) variability with both 5 µM and 20 µM ADP.
Prasugrelom posredovana inhibicija agregacije trombocita iskazuje nisku interindividualnu (9%) i intraindividualnu (12%) varijabilnost i uz 5 µm i uz 20 µm ADP-a.
Do not break or crush the tablet.
Tablete se ne smiju drobiti niti lomiti.
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.
U bolesnika s akutnim koronarnim sindromom (engl. acute coronary syndrome, ACS) podvrgnutih PCI-u, prerani prekid primjene bilo kojeg antitrombocitnog lijeka, uključujući Efient, može povećati rizik od tromboze, infarkta miokarda ili smrti kao komplikacije bolesnikove osnovne bolesti.
Patients ≥ 75 years were at increased risk of bleeding, including fatal (see sections 4.2, 4.4,
Bolesnici u dobi od ≥ 75 godina imali su povećan rizik od krvarenja, uključujući i ona smrtonosna (vidjeti dijelove 4.2, 4.4 i 4.8).
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 filmom obloženih tableta EU/1/08/503/002 28 filmom obloženih tableta EU/1/08/503/003 30x1 filmom obložena tableta EU/1/08/503/004 56 filmom obloženih tableta EU/1/08/503/005 84 filmom obložene tablete EU/1/08/503/006 90x1 filmom obložena tableta EU/1/08/503/007 98 filmom obloženih tableta EU/1/08/503/015 30 filmom obloženih tableta
Similar or higher inhibition of platelet aggregation was observed with prasugrel.
Uočena je slična ili jača inhibicija agregacije trombocita uz primjenu prasugrela.
a 10 mg prasugrel; 5 mg prasugrel if ≥75 years of age
a10 mg prasugrela; 5 mg prasugrela ako je dob ≥ 75 godina
Although not studied in specific interaction studies, Efient has been co-administered in the phase 3 clinical trial with low molecular weight heparin, bivalirudin, and GP IIb/IIIa inhibitors (no information available regarding the type of GP IIb/IIIa inhibitor used) without evidence of clinically significant adverse interactions.
Iako nisu provedena specifična ispitivanja interakcija, Efient se u fazi III kliničkog ispitivanja primjenjivao s heparinom male molekulske mase, bivalirudinom i inhibitorima GPIIb/IIIa (nema podataka o vrsti
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).
Populacija svih bolesnika s ACS-om: Efient je bio djelotvorniji od klopidogrela u smanjenju broja objedinjenih događaja primarne mjera ishoda kao i unaprijed definiranih događaja koji su činili sekundarne mjere ishoda, uključujući trombozu stenta (vidjeti Tablicu 3).
In TRITON, for every 1000 patients treated with Efient, there were 22 fewer patients with myocardial infarction, and 5 more with non-CABG-related TIMI major haemorrhages, compared with patients treated with clopidogrel.
U ispitivanju TRITON je na svakih 1000 bolesnika liječenih lijekom Efient broj bolesnika s infarktom miokarda bio manji za 22, dok se broj onih sa značajnim krvarenjem (prema TIMI) nevezanim uz CABG povećao za 5 u usporedbi s bolesnicima liječenima klopidogrelom.
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.
Svakodnevna istodobna primjena ranitidina (blokatora H2-receptora) odnosno lanzoprazola (inhibitora protonske pumpe) s prasugrelom nije dovela do promjene AUC-a i tmax aktivnog metabolita prasugrela, ali je snizila njegov Cmax za 14% odnosno 29%.
• “non steroidal anti inflammatory drugs” for pain and fever (such as ibuprofen, naproxen, etoricoxib).
• nesteroidnim protuupalnim lijekovima protiv bolova i vrućice (poput ibuprofena, naproksena,
Atorvastatin (80 mg daily) did not alter the pharmacokinetics of prasugrel and its inhibition of platelet aggregation.
Atorvastatin (80 mg na dan) nije promijenio farmakokinetiku prasugrela ni njegovu inhibiciju agregacije trombocita.
Efient, which contains the active substance prasugrel, belongs to a group of medicines called antiplatelet agents.
Što je Efient i za što se koristi Efient, koji sadrži djelatnu tvar prasugrel, pripada skupini lijekova koji se nazivaju antitrombocitni lijekovi.
Prasugrel did not inhibit CYP2C9, as it did not affect the pharmacokinetics of S-warfarin.
Lijekovi koji se metaboliziraju putem CYP2C9: Prasugrel nije inhibirao CYP2C9 jer nije utjecao na farmakokinetiku S-varfarina.
The active metabolite is further metabolised to two inactive compounds by S-methylation or conjugation with cysteine.
Aktivni metabolit se S-metilacijom ili konjugacijom s cisteinom dalje metabolizira u dva neaktivna spoja.
INFORMATION IN BRAILLE Efient 10 mg
16. PODACI NA BRAILLEOVOM PISMU Efient 10 mg
The rate of study drug discontinuation due to adverse events was 7.2% for prasugrel and 6.3% for clopidogrel.
Stopa bolesnika u kojih je zbog nuspojava prekinuta primjena ispitivanog lijeka bila je 7,2% kod primjene prasugrela te 6,3% kod primjene klopidogrela.
MARKETING AUTHORISATION NUMBER(S) Efient 5 mg:
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Efient 5 mg:
Prasugrel is not detected in plasma following oral administration.
Prasugrel nije utvrđen u plazmi nakon peroralne primjene.
• Low blood platelet count
• malen broj krvnih pločica
Rates of major bleeding were similar in patients treated with 5 mg prasugrel and those treated with 75 mg clopidogrel.
Stope značajnih krvarenja bile su slične u bolesnika liječenih prasugrelom u dozi od 5 mg i onih liječenih klopidogrelom u dozi od 75 mg.
Pharmacokinetics and pharmacodynamics of prasugrel in patients with severe hepatic impairment have not been studied.
Nisu ispitivane farmakokinetika i farmakodinamika prasugrela u bolesnika s teškim oštećenjem jetre.
Also contact your doctor immediately if you notice any of the following:
Isto tako, odmah se obratite liječniku ako primijetite neke od sljedećih simptoma:
• warfarin (an anti-coagulant),
• klopidogrelom (antitrombocitni lijek) • varfarinom (antikoagulans)
All of the above may be signs of a stroke.
Sve to mogu biti znakovi moždanog udara.
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).
Efient je u kombinaciji s acetilsalicilatnom kiselinom (ASK) indiciran za sprečavanje aterotrombotskih događaja u odraslih bolesnika s akutnim koronarnim sindromom (tj. nestabilnom anginom, infarktom miokarda bez elevacije ST-spojnice [engl. unstable angina, non-ST segment elevation myocardial infarction, UA/NSTEMI] ili infarktom miokarda s elevacijom ST-spojnice [engl.
A single intravenous bolus dose of unfractionated heparin (100 U/kg) did not significantly alter the prasugrel-mediated inhibition of platelet aggregation.
Jedna doza nefrakcioniranog heparina (100 U/kg) u obliku intravenske bolusne injekcije nije značajno promijenila prasugrelom posredovanu inhibiciju agregacije trombocita.
Pharmacokinetics of prasugrel and its inhibition of platelet aggregation were similar in subjects with mild to moderate hepatic impairment compared to healthy subjects.
Farmakokinetika prasugrela i njegova inhibicija agregacije trombocita bile su podjednake u ispitanika s blagim do umjerenim oštećenjem jetre i zdravih ispitanika.
In a study of 276 ACS patients managed with PCI, switching from an initial loading dose of 600 mg clopidogrel or placebo administered upon presentation to the hospital prior to coronary angiography to a 60 mg loading dose of prasugrel administered at the time of percutaneous coronary intervention, resulted in a similar increased inhibition of platelet aggregation for the 72 hour duration of the study.
276 bolesnika s ACS-om podvrgnutih PCI-u, prebacivanje s početne udarne doze od 600 mg klopidogrela ili placeba, primijenjene u trenutku primitka u bolnicu prije koronarne angiografije, na udarnu dozu od 60 mg prasugrela, primijenjenu u vrijeme perkutane koronarne intervencije, dovelo je do podjednakog povećanja inhibicije agregacije trombocita tijekom razdoblja od 72 sata, koliko je trajalo ispitivanje.
Following administration of a 900 mg loading dose of clopidogrel (with ASA), 56 subjects with ACS were treated for 14 days with either prasugrel 10 mg once daily or clopidogrel 150 mg once daily, and then switched to either clopidogrel 150 mg or prasugrel 10 mg for another 14 days.
Nakon primjene udarne doze klopidogrela od 900 mg (uz ASK), 56 ispitanika s akutnim koronarnim sindromom je 14 dana liječeno ili prasugrelom u dozi od 10 mg jedanput na dan ili klopidogrelom u dozi od 150 mg jedanput na dan, a nakon toga su tijekom sljedećih 14 dana prebačeni na klopidogrel u dozi od 150 mg odnosno prasugrel u dozi od 10 mg.
The MAH should provide educational material to all physicians who may be involved in treating patients with prasugrel.
MAH mora sve liječnike koji bi mogli biti uključeni u liječenje bolesnika prasugrelom opskrbiti edukacijskim materijalom.
For patients who received their last dose of thienopyridine within 4 to 7 days prior to CABG, the frequencies decreased to 11.3% (9 of 80 patients) in the prasugrel group and 3.4% (3 of 89 patients) in the clopidogrel group.
7 dana prije CABG-a, učestalost se smanjila na 11,3% (9 od 80 bolesnika) u skupini koja je primala prasugrel, odnosno na 3,4% (3 od 89 bolesnika) u skupini koja je primala klopidogrel.
Skin and subcutaneous tissue disorders
Poremećaji kože i potkožnog tkiva osip ekhimoza
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.
Korist od primjene prasugrela bila je primjetnija u bolesnika u dobi od ≥ 75 godina koji su imali šećernu bolest, STEMI, povećan rizik od tromboze stenta te onih u kojih su se kardiovaskularni događaji ponavljali.
Rare side effects (may affect up to 1 in 1,000 people)
Rijetke nuspojave (mogu se javiti u do 1 na 1000 osoba):
INFORMATION IN BRAILLE Efient 5 mg
16. PODACI NA BRAILLEOVOM PISMU Efient 5 mg
Table 2: Haemorrhagic and Non-haemorrhagic adverse reactions System Organ
Tablica 2: Hemoragijske i nehemoragijske nuspojave Organski sustav Često
Clopidogrel +ASA
Klopidogrel +ASK
• Subcutaneous haematoma (bleeding under the skin causing a swelling)
• potkožni hematom (potkožno krvarenje koje uzrokuje oticanje)
The use of oral anticoagulants, non-study antiplatelet medicinal products and chronic NSAIDs was not allowed in TRITON.
U ispitivanju TRITON nije bila dozvoljena primjena oralnih antikoagulansa, antiagregacijskih lijekova koji nisu bili predmet ispitivanja kao ni kronična primjena NSAIL-a.
It is unknown whether prasugrel is excreted in human breast milk.
Nije poznato izlučuje li se prasugrel u majčino mlijeko u ljudi.
* ICH=intracranial haemorrhage.
* IKK = intrakranijalno krvarenje.
See leaflet for further information.
Za dodatne informacije pročitati uputu o lijeku.
This medicinal product does not require any special temperature storage conditions.
6.4 Posebne mjere pri čuvanju lijeka Lijek ne zahtijeva čuvanje na određenoj temperaturi.
Elderly:
Starije osobe:
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.
Agregacija trombocita se nakon liječenja postupno vratila na početne vrijednosti, i to za 7 do 9 dana nakon primjene jednokratne udarne doze prasugrela od 60 mg, odnosno za 5 dana nakon prekida primjene doze održavanja u stanju dinamičke ravnoteže.
Patients with STEMI within 12 hours of symptoms and planned for primary PCI could be randomised without knowledge of coronary anatomy.
Bolesnike koji su imali STEMI i u kojih je planiran PCI, moglo se randomizirati unutar 12 sati od pojave simptoma i bez prethodnog određivanja anatomije koronarnih krvnih žila.
Clopidogrel
Klopidogrel