natgillin/translations-raw huggingface dataset:
OTHER <MON, TUE, WED, THU, FRI, SAT, SUN>
<PON, UTO, SRI, ČET, PET, SUB, NED>
The reduction in stent thrombosis with Efient was observed both early and beyond 30 days for both bare metal and drug eluting stents.
Smanjenje broja tromboza stenta kod primjene lijeka Efient opaženo je i u ranoj fazi liječenja kao nakon više od 30 dana, a odnosilo se kako na čiste metalne tako i na stentove koji izlučuju lijek.
The use of Efient in patients ≥ 75 years of age is generally not recommended.
Primjena lijeka Efient općenito se ne preporučuje u bolesnika u dobi od ≥ 75 godina.
Patients taking Efient should also take ASA daily (75 mg to 325 mg).
Bolesnici koji uzimaju Efient moraju svakodnevno uzimati i acetilsalicilatnu kiselinu (u dozi od 75 mg do 325 mg).
Of those patients, the rate of CABG-related TIMI major or minor bleeding was 14.1% for the prasugrel group and 4.5% in the clopidogrel group.
U tih je bolesnika udio značajnih ili manjih krvarenja (prema TIMI kriterijima) vezanih uz CABG bio 14,1% u skupini koja je primala prasugrel te 4,5% u skupini koja je primala klopidogrel.
Prasugrel-mediated inhibition of platelet aggregation was also similar in patients with ESRD who required haemodialysis compared to healthy subjects, although Cmax and AUC of the active metabolite decreased 51% and 42%, respectively, in ESRD patients.
Prasugrelom posredovana inhibicija agregacije trombocita podjednaka je i u bolesnika u terminalnoj fazi bubrežne bolesti kojima je potrebna hemodijaliza u usporedbi sa zdravim ispitanicima, iako je u bolesnika u terminalnoj fazi bubrežne bolesti Cmax aktivnog metabolita bio 51%, a AUC 42% niži.
Of these, bleeding was the most common adverse reaction for both drugs leading to study drug discontinuation (2.5% for prasugrel and 1.4% for clopidogrel).
Najčešća nuspojava koja je bila razlogom prekida primjene obaju lijekova bilo je krvarenje (2,5% kod primjene prasugrela i 1,4% kod primjene klopidogrela).
Switching directly to prasugrel 60 mg loading dose resulted in the most rapid onset of higher platelet inhibition.
Izravnim prebacivanjem na udarnu dozu od 60 mg postignut je najbrži nastup pojačane inhibicije agregacije trombocita.
Prasugrel is an inhibitor of platelet activation and aggregation through the irreversible binding of its active metabolite to the P2Y12 class of ADP receptors on platelets.
Prasugrel inhibira aktivaciju i agregaciju trombocita ireverzibilnim vezivanjem aktivnog metabolita na ADP receptore tipa P2Y12 na trombocitima.
(see sections 4.2 and 4.4).
(vidjeti dio 4.4).
Clopidogrelb +ASA (N = 4980)
Klopidogrelb +ASK (N = 4980)
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).
U dvogodišnjem istraživanju na štakorima, uz izloženost prasugrelu koja je bila i do 75 puta veća od preporučene terapijske izloženosti u ljudi (na temelju izloženosti aktivnog i glavnih cirkulirajućih metabolita u plazmi), nije uočena pojava tumora povezana s primjenom lijeka.
How to store Efient
Kako čuvati Efient
• Skin rash
• kožni osip
All of the above may be signs of bleeding, the most common side effect with Efient.
Sve to mogu biti znakovi krvarenja, koje je najčešća nuspojava liječenja lijekom Efient.
The efficacy of prasugrel was independent of the ASA dose (75 mg to 325 mg once daily).
Djelotvornost prasugrela nije ovisila o dozi ASK-a (75-325 mg jedanput na dan).
Contact your doctor immediately if you notice any of the following:
Odmah se obratite liječniku ako primijetite neki od sljedećih simptoma:
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).
Doza održavanja od 10 mg se ne preporučuje (vidjeti dijelove 4.2 i 4.8).
• A rash, itching, or a swollen face, swollen lips/tongue, or shortness of breath.
• osip, svrbež, oticanje lica, oticanje usana ili jezika ili nedostatak zraka.
Therefore, statins that are substrates of CYP3A are not anticipated to have an effect on the pharmacokinetics of prasugrel or its inhibition of platelet aggregation.
Stoga se ne predviđa da će statini koji su supstrati CYP3A utjecati na farmakokinetiku prasugrela ili na inhibiciju agregacije trombocita ovim lijekom.
Common side effects (may affect up to 1 in 10 people)
Česte nuspojave (mogu se javiti u do 1 na 10 osoba):
Clopidogrelb +ASA (N = 1736)
Klopidogrelb +ASK (N = 1736)
The benefit was primarily due to a significant decrease in non-fatal MI (see Table 3).
Korist se primarno temeljila na značajnom smanjenju broja nesmrtonosnih infarkta miokarda (vidjeti
• Blood in stools
• krv u stolici
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.
U ispitivanju u kojem su sudjelovali ispitanici sa stabilnom aterosklerozom, srednja vrijednost AUC-a aktivnog metabolita u bolesnika u dobi od ≥ 75 godina liječenih prasugrelom u dozi od 5 mg bila je približno dvostruko manja nego u bolesnika mlađih od 65 godina liječenih prasugrelom u dozi od 10 mg, dok je antitrombocitni učinak doze od 5 mg bio manji, ali ne i inferioran u odnosu na dozu od 10 mg.
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.
U ispitivanju u kojem su sudjelovali ispitanici sa stabilnom aterosklerozom, srednja vrijednost AUC-a aktivnog metabolita u bolesnika tjelesne težine < 60 kg koji su uzimali prasugrel u dozi od 5 mg bila je 38% niža nego u bolesnika tjelesne težine ≥ 60 kg koji su uzimali prasugrel u dozi od 10 mg, dok je antitrombocitni učinak doze od 5 mg bio podjednak učinku doze od 10 mg.
Injury, poisoning and procedural complications
Ozljede, trovanja i proceduralne komplikacije kontuzija postproceduralno krvarenje potkožni hematom
Do not take Efient - If you are allergic (hypersensitive) to prasugrel or any of the other ingredients of Efient.
- ako ste alergični (preosjetljivi) na prasugrel ili neki drugi sastojak lijeka Efient.
As in the < 75 years old and ≥60 kg patients treated with 10 mg prasugrel, there was no difference between 5 mg prasugrel and 75 mg clopidogrel in CV outcomes.
Kao i u bolesnika u dobi od < 75 godina i onih tjelesne težine ≥ 60 kg koji su uzimali dozu prasugrela od 10 mg, nije primijećena razlika između prasugrela u dozi od 5 mg i klopidogrela u dozi od 75 mg kada su u pitanju kardiovaskularni ishodi.
1.2% (0% ICH*)
1,2% (0% IKK*)
Primary Individual Outcome Events
Objedinjeni događaji iz primarne mjere ishoda:
Therapeutic experience with prasugrel is limited in patients with renal impairment (including ESRD) and in patients with moderate hepatic impairment.
Ograničeno je terapijsko iskustvo s prasugrelom u bolesnika s oštećenjem bubrega (uključujući one u terminalnoj fazi bubrežne bolesti) te u bolesnika s umjerenim oštećenjem jetre.
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PRILOG II. A. PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE LIJEKA U PROMET
Uncommon side effects (may affect up to 1 in 100 people)
Manje česte nuspojave (mogu se javiti u do 1 na 100 osoba):
Statins:
Statini:
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).
U 30-dnevnom ispitivanju (ACCOAST) u 4033 bolesnika s NSTEMI i povišenim razinama troponina, koji su bili podvrgnuti koronarnoj angiografiji, a zatim i perkutanoj koronarnoj intervenciji, unutar 2 do 48 sati nakon randomizacije, ispitanici koji su primili udarnu dozu prasugrela od 30 mg u prosjeku 4 sata prije koronarne angiografije te zatim udarnu dozu od 30 mg u vrijeme perkutane koronarne intervencije (n=2037) imali su povećan rizik od krvarenja nevezanog za CABG tijekom postupka, a nisu imali nikakve dodatne koristi u odnosu na bolesnike koji su primili udarnu dozu od 60 mg u vrijeme perkutane koronarne intervencije (n=1996).
• 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).
• vrućicu i potkožne modrice koje se mogu pojaviti kao okrugle, crvene točkice veličine vrška pribadače, a mogu, ali ne moraju, biti popraćene neobjašnjivim izrazitim umorom, smetenošću, žutilom kože ili očiju (žutica) (vidjeti dio 2 'Što morate znati prije nego počnete uzimati Efient')
Patients < 60 kg Non-CABG-related TIMI major or minor bleeding rates:
Bolesnici tjelesne težine < 60 kg Stope značajnih odnosno manjih krvarenja (prema TIMI kriterijima) nevezanih uz CABG:
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), snažan induktor CYP3A i CYP2B6 te induktor CYP2C9, CYP2C19 i
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).
U bolesnika s UA/NSTEMI, u kojih se koronarna angiografija provodi unutar 48 sati nakon primitka u bolnicu, udarna doza smije se dati samo u vrijeme perkutane koronarne intervencije (vidjeti dijelove 4.4, 4.8 i 5.1).
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.
- ako uzimate određene vrste lijekova (vidjeti ‘Drugi lijekovi i Efient' u nastavku) - ako imate zakazanu operaciju (uključujući i neke stomatološke zahvate) u sljedećih 7 dana.
2.2% (0.2% fatal) a
2,2% (0,2% smrtonosna)a
9.0% (1.0% fatal)
9,0% (1,0% smrtonosna)
Patients ≥60 kg and age <75 years
Bolesnici tjelesne težine ≥ 60 kg i mlađi od 75 godina
0.9% (0.2% ICH*)
0,9% (0,2% IKK*)
• Bleeding from a needle puncture site
• krvarenje na mjestu uboda iglom
There is limited therapeutic experience in patients with renal impairment (see section 4.4).
Terapijsko iskustvo u bolesnika s oštećenjem bubrega je ograničeno (vidjeti dio 4.4).
o If, after a careful individual benefit/risk evaluation by the prescribing physician,
o ako nakon pažljive procjene koristi i rizika u svakog pojedinog bolesnika liječnik propisivač ocijeni da je primjena ovog lijeka neophodna u bolesnika u dobnoj skupini
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER OF 10 mg FILM-COATED TABLETS
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Vascular Disorders Haematoma Respiratory, thoracic and mediastinal disorders
Krvožilni poremećaji hematom Poremećaji dišnog sustava, prsišta i sredoprsja epistaksa hemoptiza
Clopidogrelb +ASA (N = 6716)
Klopidogrel b +ASK (N = 6716)
Gastrointestinal haemorrhage
Tablični prikaz nuspojava
Primary Composite Outcome Events Cardiovascular (CV) death, non fatal MI, or non fatal stroke
Objedinjeni događaji iz primarne mjere ishoda: smrt zbog kardiovaskularnog (KV) uzroka, nesmrtonosni IM, ili nesmrtonosni moždani udar
including oral anticoagulants, clopidogrel, non-steroidal anti-inflammatory drugs (NSAIDs), and fibrinolytics.
• koji istodobno primaju lijekove koji mogu povećati rizik od krvarenja, uključujući oralne antikoagulanse, klopidogrel, nesteroidne protuupalne lijekove (NSAIL) i fibrinolitike
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.
TIMI kriterijima) nevezanih uz CABG iznosila je 3,6% uz prasugrel te 2,8% uz klopidogrel, dok je stopa smrtonosnih krvarenja bila 0,2% uz prasugrel i 0,1% uz klopidogrel.
CV death, nonfatal MI, or nonfatal stroke CV death Nonfatal MI Nonfatal stroke STEMI Primary Composite Outcome Events
smrt zbog KV uzroka, nesmrtonosni IM, nesmrtonosni moždani udar smrt zbog KV uzroka nesmrtonosni IM nesmrtonosni moždani udar STEMI
1.0% (0.3% ICH*)
1,0% (0,3% IKK*)
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER OF 5 mg FILM-COATED TABLETS
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER ZA 5 mg FILMOM OBLOŽENE TABLETE
Efient 5 mg: Each tablet contains 5 mg of prasugrel (as hydrochloride).
Efient 5 mg: Jedna tableta sadrži 5 mg prasugrela (u obliku prasugrelklorida).
10.1% (0% fatal)
10,1% (0% smrtonosna)
treatment is deemed necessary in the ≥ 75 years age group then following a loading dose of 60 mg, a reduced maintenance dose of 5mg should be prescribed.
≥ 75 godina, tada se nakon udarne doze od 60 mg mora propisati niža doza održavanja od 5 mg. o bolesnici tjelesne težine < 60 kg moraju primati nižu dozu održavanja od 5 mg.
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.
Stoga se ne predviđa da bi inhibitori CYP3A4 poput azolnih antimikotika, inhibitora HIV proteaze, klaritromicina, telitromicina, verapamila,
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Safety in patients with acute coronary syndrome undergoing PCI was evaluated in one clopidogrelcontrolled study (TRITON) in which 6741 patients were treated with prasugrel (60 mg loading dose and 10 mg once daily maintenance dose) for a median of 14.5 months (5802 patients were treated for over 6 months, 4136 patients were treated for more than 1 year).
Sigurnost prasugrela u bolesnika s akutnim koronarnim sindromom podvrgnutih PCI-u procijenjena je u jednom ispitivanju kontroliranom klopidogrelom (TRITON), u kojemu je 6741 bolesnik liječen prasugrelom (udarna doza od 60 mg i doza održavanja od 10 mg jedanput na dan).
Patients with UA/NSTEMI within 72 hours of symptoms or STEMI between 12 hours to 14 days of symptoms were randomised after knowledge of coronary anatomy.
Bolesnici koji su imali UA/NSTEMI randomizirani su unutar 72 sata od pojave simptoma, a oni koji su imali STEMI u razdoblju između 12 sati i 14 dana od pojave simptoma, s tim da je kod svih prethodno utvrđena anatomija koronarnog krvožilja.
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.
Efient nisu zabilježeni značajni učinci genetskih varijacija na CYP3A5, CYP2B6, CYP2C9 ili CYP2C19 na farmakokinetiku prasugrela odnosno na njegov učinak na inhibiciju agregacije trombocita.
Efient 10 mg: Each tablet contains 10 mg of prasugrel (as hydrochloride).
Efient 10 mg: Jedna tableta sadrži 10 mg prasugrela (u obliku prasugrelklorida).
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.
uključujući i one koje ste nabavili bez recepta te nadomjeske prehrani i biljne lijekove.
Efient is contraindicated in patients with severe hepatic impairment (Child Pugh class C).
Efient je kontraindiciran u bolesnika s teškim oštećenjem jetre
a 10 mg prasugrel; 5 mg prasugrel if <60 kg
a10 mg prasugrela; 5 mg prasugrela ako je tjelesna težina <60 kg
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).
U bolesnika koji su podvrgnuti operaciji ugradnje premosnica koronarnih arterija (engl. coronary artery bypass graft, CABG) može se povećati učestalost (trostruko) i težina krvarenja unutar 7 dana od prestanka primjene prasugrela (vidjeti dio 4.8).
Blood and Lymphatic System disorders
Poremećaji bubrega i mokraćnog sustava hematurija
Thrombocytopaenia Thrombotic thrombocytopaenic purpura (TTP) -see section 4.4
Poremećaji krvi i limfnog sustava anemija trombocitopenija trombotična trombocitopenična purpura (TTP)vidjeti dio 4.4
c Any intracranial haemorrhage or any clinically overt bleeding associated with a fall in haemoglobin ≥5 g/dL.
b Svako intrakranijalno krvarenje ili svako klinički zamjetno krvarenje udruženo s padom vrijednosti hemoglobina ≥ 5 g/dl.
Thrombotic Thrombocytopaenic Purpura (TTP) TTP has been reported with the use of prasugrel.
Trombotična trombocitopenična purpura (TTP)
3.0% (0.5% fatal)
3,0% (0,5% smrtonosna)
Efient 10 mg film-coated tablets Efient 5 mg film-coated tablets Prasugrel
Efient 10 mg filmom obložene tablete Efient 5 mg filmom obložene tablete
Adults
Doziranje Odrasli
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Reduced prasugrel efficacy has been seen in patients co-administered prasugrel and morphine (see section 4.5).
U bolesnika koji su istodobno primali prasugrel i morfin opažena je smanjena djelotvornost prasugrela (vidjeti dio 4.5).
Efient should be initiated with a single 60 mg loading dose and then continued at 10 mg once a day.
Liječenje lijekom Efient treba započeti jednokratnom udarnom dozom od 60 mg, a zatim nastaviti s
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.
U kliničkom ispitivanju u bolesnika s NSTEMI (ispitivanje ACCOAST), u kojem su bolesnici bili podvrgnuti koronarnoj angiografiji unutar 2 do 48 sati nakon randomizacije, udarna doza prasugrela primijenjena prosječno 4 sata prije koronarne angiografije povećala je rizik od značajnog i manjeg krvarenja tijekom postupka u usporedbi s primjenom udarne doze prasugrela u vrijeme perkutane koronarne intervencije.
The incidence of Non-CABG-related TIMI major bleeding, including life-threatening and fatal, as well as TIMI minor bleeding, was statistically significantly higher in subjects treated with prasugrel compared to clopidogrel in the UA/NSTEMI and All ACS populations.
CABG, uključujući po život opasna i smrtonosna krvarenja, kao i manjih krvarenja (prema TIMI kriterijima) bila je statistički značajno viša u bolesnika liječenih prasugrelom u odnosu na one liječene klopidogrelom u populaciji bolesnika koji su imali UA/NSTEMI kao i u populaciji svih bolesnika s akutnim koronarnim sindromom.
For patients who received their thienopyridine within 3 days prior to CABG, the frequencies of TIMI major or minor bleeding were 26.7% (12 of 45 patients) in the prasugrel group, compared with 5.0% (3 of 60 patients) in the clopidogrel group.
Među bolesnicima koji su primili tienopiridin unutar 3 dana prije CABG-a, učestalost značajnih ili manjih krvarenja prema TIMI kriterijima iznosila je 26,7% (12 od 45
Efient 5 mg film-coated tablets.
Efient 5 mg filmom obložene tablete prasugrel
Prasugrel must not be used in patients with severe hepatic impairment (see section 4.
Prasugrel se ne smije primjenjivati u bolesnika s teškim oštećenjem jetre (vidjeti dio 4.3).
In the phase 3 clinical trial these patients were at greater risk of bleeding, including fatal bleeding, compared to patients <75 years of age.
U faze III kliničkog ispitivanja ti su bolesnici bili izloženi većem riziku od krvarenja,
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Daiichi Sankyo Europe GmbH
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Eye haemorrhage
Poremećaji oka očno krvarenje
There is limited therapeutic experience in patients with mild and moderate hepatic dysfunction (see section 4.4).
Terapijsko iskustvo u bolesnika s blagim do umjerenim oštećenjem jetre je ograničeno (vidjeti dio 4.4).
f Clinically overt bleeding associated with a fall in haemoglobin of ≥3 g/dL but <5 g/dL.
e IKK=intrakranijalno krvarenje f Klinički zamjetno krvarenje udruženo s padom hemoglobina od ≥ 3 g/dl, ali < 5 g/dl.
1.6% (0.2% fatal)
1,6% (0,2% smrtonosna)
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).
NSAIL-ima (uključujući COX-2 inhibitore) (vidjeti dio 4.4).
Requiring inotropes Requiring surgical intervention Requiring transfusion (≥ 4
Značajno krvarenje prema TIMI c životno ugrožavajućed smrtonosno simptomatsko IKKe potrebna primjena inotropnih lijekova potrebna kirurška intervencija potrebna transfuzija (≥ 4 jedinice)
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).
Prosječna izloženost (AUC) aktivnom metabolitu prasugrela je približno 30 do 40% veća u zdravih ispitanika i bolesnika tjelesne težine manje od 60 kg u usporedbi s onima čija je težina ≥ 60 kg.
Bleeding risk
• iskašljavanje krvi
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.
Maksimalna inhibicija ADP-om potaknute agregacije trombocita prasugrelom iznosi 83% uz 5 µm ADP-a, odnosno 79% uz 20 µm ADP-a.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF 5mg FILM-COATED TABLETS
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA ZA 5 mg FILMOM OBLOŽENE TABLETE
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.
Konkretno, u ispitanika koji su primili prasugrel prije koronarne angiografije, prasugrel tijekom 7 dana nakon randomizacije nije značajno smanjio učestalost objedinjene mjere ishoda, koja je uključivala kardiovaskularnu smrt, infarkt miokarda, moždani udar, hitnu revaskularizaciju ili hitno liječenje inhibitorom glikoproteina IIb/IIIa, u usporedbi s bolesnicima koji su primili cijelu udarnu dozu prasugrela u vrijeme perkutane koronarne intervencije.
Patients ≥ 75 years old Non-CABG-related TIMI major or minor bleeding rates:
Bolesnici u dobi od ≥ 75 godina ili oni čija je tjelesna težina manja od
Efient 5 mg: The tablets are yellow and double-arrow-shaped, with “5 MG” debossed on one side and “4760” on the other.
Efient 5 mg: Tablete su žute boje u obliku dvostruke strelice, s utisnutom oznakom "5 mg" na jednoj i "4760" na drugoj strani.