natgillin/translations-raw huggingface dataset:
Since platelets participate in the initiation and/or evolution of thrombotic complications of atherosclerotic disease, inhibition of platelet function can result in the reduction of the rate of cardiovascular events such as death, myocardial infarction, or stroke.
Ker trombociti sodelujejo pri začetku in/ali razvoju trombotičnih komplikacij aterosklerotične bolezni, lahko zaviranje delovanja trombocitov vodi v zmanjšanje stopnje srčno-žilnih dogodkov, kot so smrt, miokardni infarkt ali možganska kap.
If you then take Prasugrel Mylan and experience allergic reactions that may be recognised as a rash, itching, a swollen face, swollen lips or shortness of breath you need to tell your doctor immediately.
Če ob jemanju zdravila Prasugrel Mylan opazite alergijske reakcije, ki se kažejo kot izpuščaj, srbenje, otekel obraz, otekle ustnice ali težko dihanje, morate o tem nemudoma obvestiti svojega zdravnika.
Prasugrel Mylan can be concomitantly administered with medicinal products metabolised by cytochrome P450 enzymes (including statins), or medicinal products that are inducers or inhibitors of cytochrome P450 enzymes.
Zdravilo Prasugrel Mylan lahko sočasno dajemo z zdravili, ki se presnavljajo z encimi citokroma P450 (vključno s statini) ali zdravili, ki so induktorji ali zaviralci encimov citokroma P450.
Driving and using machines Prasugrel Mylan is unlikely to affect your ability to drive or use machines.
Vpliv na sposobnost upravljanja vozil in strojev Za zdravilo Prasugrel Mylan je malo verjetno, da vpliva na vašo sposobnost upravljanja vozil in strojev.
Patients with acute coronary syndromes undergoing PCI treated with prasugrel and ASA showed an increased risk of major and minor bleeding according to the TIMI classification system.
Pri bolnikih z akutnim koronarnim sindromom, ki so imeli PCI, zdravljenih s prasugreloml in ASK, se je pokazalo povečano tveganje za velike in manjše krvavitve, glede na TIMI sistem klasifikacije.
The rodent-specific association of liver tumours and drug-induced enzyme induction is well documented in the literature.
Povezava jetrnih tumorjev in indukcije encima, značilna za glodavce, je dobro dokumentirana v literaturi.
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.
Pri bolnikih ≥ 60 kg in starih < 75 let so bile stopnje večjih in manjših krvavitev po TIMI, nepovezanih z aortokoronarrnim obvodom, 3,6 % za prasugrel in 2,8 % za klopidogrel; stopnje smrtnih krvavitev so bile 0,2 % za prasugrel in 0,1 % za klopidogrel.
Table 2: Haemorrhagic and non-haemorrhagic adverse reactions
Preglednica 2: Hemoragični in ne-hemoragični neželeni učinki
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.
Druga zdravila in zdravilo Prasugrel Mylan Obvestite zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo, tudi če ste ga dobili brez recepta, prehranska dopolnila ali zeliščna sredstva.
In a 30 month study (TRILOGY-ACS) in 9326 patients with UA/NSTEMI ACS medically managed without revascularisation (non-licensed indication), prasugrel did not significantly reduce the frequency of the composite endpoint of CV death, MI or stroke compared to clopidogrel.
V 30­mesečni študiji (TRILOGY-ACS) pri 9326 bolnikih z UA/NSTEMI ACS, ki je bila medicinsko obravnavana brez revaskularizacije (neregistrirana indikacija), prasugrel ni bistveno znižal pogostnosti sestavljenega opazovanega dogodka srčno-žilne smrti, miokardnega infarkta ali možganske kapi v primerjavi s klopidogrelom.
Analysis of the composite endpoint in the All ACS population (combined UA/NSTEMI and STEMI cohorts) was contingent on showing statistical superiority of prasugrel versus clopidogrel in the UA/NSTEMI cohort (p<0.05).
Analiza sestavljenega cilja študije v celotni ACS populaciji (kombinacija UA/NSTEMI in STEMI skupin) je kazala možno statistično superiornost prasugrela proti klopidogrelu v skupini UA/NSTEMI (p < 0,05).
Prasugrel has no clinically significant effect on the pharmacokinetics of digoxin.
Digoksin Prasugrel nima klinično značilnega učinka na farmakokinetiko digoksina.
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.
Bolniki z UA/NSTEMI v 72 urah simptomov ali s STEMI med 12 urami do 14 dnevi simptomov so bili randomizirani po ugotovljeni srčni anatomiji.
Patients should be advised to inform physicians and dentists that they are taking prasugrel before any surgery is scheduled and before any new medicinal product is taken.
Bolnikom je treba svetovati, naj pred kakršnim koli načrtovanim kirurškim posegom in preden začnejo jemati kakršno koli novo zdravilo povedo zdravnikom in zobozdravnikom, da jemljejo prasugrel.
In patients with or without a history of TIA or stroke, the incidence of stroke in the phase 3 clinical trial was as follows (see section 4.4):
Pri bolnikih, ki so ali niso doživeli tranzitorno ishemično atako (TIA) ali možgansko kap, je bila pogostnost možganske kapi v kliničnem preskušanju faze 3 naslednja (glejte poglavje 4.4):
PHARMACEUTICAL FORM Film-coated tablet (tablet).
Filmsko obložena tableta (tableta).
In pre- and post-natal rat studies, maternal treatment had no effect on the behavioural or reproductive development of the offspring at doses up to an exposure 240 times the recommended daily human maintenance dose (based on mg/m²).
V pre- in post-natalnih študijah pri podganah zdravljenje breje samice ni imelo učinka na vedenjski ali razmnoževalni razvoj mladičev pri odmerkih izpostavitve do 240-kratnemu priporočenemu dnevnemu vzdrževalnemu odmerku pri ljudeh (na osnovi mg/m²).
- have severe liver disease.
- če imate hudo bolezen jeter.
If you weigh less than 60 kg or are more than 75 years of age, the dose is 5 mg Prasugrel Mylan per day.
Če tehtate manj kot 60 kg ali ste starejši od 75 let, boste jemali odmerek 5 mg zdravila Prasugrel Mylan na dan.
Overdose of Prasugrel Mylan may lead to prolonged bleeding time and subsequent bleeding complications.
Preveliko odmerjanje zdravila Prasugrel Mylan lahko vodi v podaljšan čas krvavitve in nadaljnje zaplete zaradi krvavitve.
Although not studied in specific interaction studies, prasugrel 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.
Čeprav ga niso preučevali v posebnih študijah medsebojnega delovanja, so v kliničnem preskušanju faze 3 prasugrel sočasno dajali z nizko molekularnim heparinom, bivalirudinom in zaviralci GP IIb/IIIa (na voljo ni podatkov o uporabljenih zaviralcih GP IIb/IIIa) brez dokazov o klinično pomembnem neželenem medsebojnem delovanju.
In TRITON, for every 1000 patients treated with prasugrel, there were 22 fewer patients with myocardial infarction, and 5 more with non-CABG-related TIMI major haemorrhages, compared with patients treated with clopidogrel.
V študiji TRITON je bilo na vsakih 1000 bolnikov, zdravljenih s prasugrelom, 22 manj bolnikov z miokardnim infarktom in 5 več z večjo krvavitvijo po TIMI, nepovezano z aortokoronarnim obvodom, v primerjavi z bolniki, zdravljenimi s klopidogrelom.
• Haematoma (bleeding under the skin at the site of an injection, or into a muscle, causing swelling)
• Hematom (podkožna krvavitev na mestu injiciranja ali v mišico, ki povzroča oteklino)
STEMI Primary Composite Outcome Events
STEMI Primarni sestavljeni izidi
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.
Pri bolnikih, ki so prejeli zadnji odmerek tienopiridina v 4 do 7 dneh pred aortokoronarnim obvodom, je pogostnost padla na 11,3 % (9 od 80 bolnikov) v skupini, ki je jemala prasugrel in 3,4 % (3 od 89 bolnikov) v skupini, ki je jemala klopidogrel.
Analysis of all cause death did not show any significant difference between prasugrel and clopidogrel in the All ACS population (2.76% vs 2.90%), in the UA/NSTEMI population (2.58% vs 2.41%), and in the STEMI population (3.28% vs 4.31%).
Analiza vseh vzrokov smrti v celotni populaciji ACS (2,76 % proti 2,90 %), populaciji UA/NSTEMI (2,58 % proti 2,41 %), in populaciji STEMI (3,28 % proti 4,31 %) ni pokazala kakršne koli značilne razlike med prasugrelom in klopidogrelom.
White opaque HDPE bottle closed with white opaque polypropylene screw cap and aluminium induction sealing liner wad.
Bela neprozorna HDPE plastenka z belim neprozornim polipropilenskim navojnim pokrovčkom in aluminijastim indukcijskim tesnilom.
In the phase 3 clinical trial, prasugrel was administered without regard to co administration of a proton pump inhibitor or H2 blocker.
V kliničnem preskušanju faze 3 so dajali prasugrel brez ozira na sočasno dajanje zaviralca protonske črpalke ali blokatorja H2.
Patients ≥75 years were at increased risk of bleeding, including fatal (see sections 4.2, 4.4, and 4.8).
Bolniki ≥ 75 let so imeli večje tveganje za krvavitev, vključno s smrtno krvavitvijo (glejte poglavja 4.2, 4.4 in 4.8).
Prasugrel Mylan reduces the chances of you having a further heart attack or stroke or of dying from one of these atherothrombotic events.
Zdravilo Prasugrel Mylan zmanjša možnost, da bi prišlo do naslednjega srčnega infarkta ali možganske kapi ali da bi umrli zaradi enega izmed teh aterotrombotičnih dogodkov.
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 azolni antimikotiki, zaviralci HIV proteaze, klaritromicin, telitromicin, verapamil, diltiazem, indinavir, ciprofloksacin in sok grenivke, ne predvideva, da imajo značilen učinek na farmakokinetiko aktivnega presnovka.
Prasugrel Mylan can also be concomitantly administered with ASA, heparin, digoxin, and medicinal products that elevate gastric pH, including proton pump inhibitors and H2 blockers.
Zdravilo Prasugrel Mylan lahko dajemo sočasno tudi z ASK, heparinom, digoksinom in zdravili, ki višajo želodčni pH, vključno z zaviralci protonske črpalke ter H2 blokatorji.
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 CYP2C8, ni značilno spremenil farmakokinetike prasugrela.
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.
Po dajanju 75 mg klopidogrela enkrat na dan 10 dni so 40 zdravim preiskovancem pričeli dajati prasugrel v odmerku 10 mg enkrat na dan z ali brez 60 mg polnilnega odmerka.
• If you have had allergic reactions (hypersensitivity) to clopidogrel or any other anti-platelet agent please tell your doctor before starting treatment with Prasugrel Mylan.
• Če ste pri jemanju klopidogrela ali drugih zdravil proti trombocitom dobili alergijsko (preobčutljivostno) reakcijo, to pred začetkom jemanja zdravila Prasugrel Mylan povejte svojemu zdravniku.
Beyond 7 days after drug discontinuation, the observed rates of CABG-related bleeding were similar between treatment groups (see section 4.4).
Po 7 dneh po prekinitvi jemanja zdravila, so bile opazovane stopnje krvavitve, povezane z aortokoronarnim obvodom, podobne pri obeh skupinah zdravljenja (glejte poglavje 4.4).
Mylan Healthcare Sp. zo.o.
Mylan Healthcare Sp. z.o.o.
Prasugrel Mylan is contraindicated in patients with severe hepatic impairment (Child Pugh class C).
Zdravilo Prasugrel Mylan je kontraindicirano pri bolnikih s hudo okvaro jeter (razred C po Child-Pughu).
In the phase 3 clinical trial, 437 patients underwent CABG during the course of the study.
Krvavitev, povezana z aortokoronarnim obvodom (CABG) V kliničnem preskušanju faze 3, je 437 bolnikov prestalo aortokoronarni obvod v času trajanja študije.
Therefore, prasugrel can be administered without regard to food; however, the administration of prasugrel loading dose in the fasted state may provide most rapid onset of action (see section 4.2).
Zato lahko prasugrel dajemo neodvisno od hrane, vendar lahko dajanje polnilnega odmerka prasugrela na tešče nudi najhitrejši začetek delovanja (glejte poglavje 4.2).
Ketoconazole (400 mg daily), a selective and potent inhibitor of CYP3A4 and CYP3A5, did not affect prasugrel-mediated inhibition of platelet aggregation or the prasugrel active metabolite's AUC and Tmax, but decreased the Cmax by 34% to 46%.
Ketokonazol (400 mg na dan), selektiven in močan zaviralec CYP3A4 in CYP3A5, ni vplival na zaviranje agregacije trombocitov, povzročeno s prasugrelom ali AUC in Tmax aktivnega presnovka prasugrela, je pa zmanjšal Cmax za 34 % do 46 %.
• Allergic reaction (rash, itching, swollen lips/tongue, or shortness of breath)
• Alergijske reakcije (izpuščaj, srbenje, otekle ustnice/jezik ali težko dihanje)
Prasugrel did not inhibit CYP2C9, as it did not affect the pharmacokinetics of S-warfarin.
Prasugrel ne zavira CYP2C9 in ne vpliva na farmakokinetiko S-varfarina.
Effects of Prasugrel Mylan on other medicinal products
Učinki zdravila Prasugrel Mylan na druga zdravila
Non-CABG- related TIMI bleeding rates through 7 days for patients were as follows:
Stopnje krvavitve po TIMI, ki niso bile povezane z aortokoronarnim obvodom, so bile v obdobju 7 dni za bolnike:
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.
Primarno merilo izida preskušanja je bil čas do pojava srčno-žilne (CV) smrti, ne-smrtnega miokardnega infarkta (MI) ali ne-smrtne možganske kapi.
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.
Izmed teh bolnikov, je bila stopnja večjih in manjših krvavitev po TIMI, povezanih z aortokoronarnim obvodom, 14,1 % za skupino, ki je jemala prasugrel, in 4,5 % za skupino, ki je jemala klopidogrel.
If you are breast-feeding, ask your doctor or pharmacist for advice before taking any medicine.
Če dojite, se posvetujte z zdravnikom ali farmacevtom, preden vzamete katero koli zdravilo.
Stroke is an uncommon side effect of Prasugrel Mylan in patients who have never had a stroke or transient ischaemic attack (TIA).
Možganska kap je občasen neželen učinek zdravila Prasugrel Mylan pri bolnikih, ki niso nikoli imeli možganske kapi ali tranzitorne ishemične atake (TIA).
In healthy subjects, patients with stable atherosclerosis, and patients with ACS receiving prasugrel, 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.
Pri zdravih osebah, bolnikih s stabilno aterosklerozo in bolnikih z ACS, ki so prejeli prasugrel, zaradi genetske variacije CYP3A5, CYP2B6, CYP2C9 ali CYP2C19 ni bilo pomembnega učinka na farmakokinetiko prasugrela ali njegovo zaviranje agregacije trombocitov.
Safety in patients with acute coronary syndrome undergoing PCI was evaluated in one clopidogrel controlled 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).
Varnost pri bolnikih z akutnim koronarnim sindromom, ki so imeli PCI, so ocenjevali v eni, s klopidogrelom nadzorovani študiji (TRITON), v kateri je bilo 6741 bolnikov, zdravljenih s prasugrelom (60 mg polnilni odmerek in 10 mg vzdrževalni odmerek enkrat na dan), z mediano 14,5 meseca (5802 bolnika sta bila zdravljena več kot 6 mesecev, 4136 bolnikov je bilo zdravljenih več kot 1 leto).
It is rapidly hydrolysed in theintestine 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
V črevesju se hitro hidrolizira v tiolakton, ki se nato v eni stopnji s citokromom P450, zlasti s CYP3A4 in CYP2B6 ter v manjši meri s CYP2C9 in CYP2C19, presnovi do aktivnega presnovka.
c Life-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.
Patients ≥75 years old or those below 60 kg (N=3022) were randomized to 5 mg prasugrel.
Bolniki ≥ 75 let in bolniki s telesno maso pod 60 kg (N = 3022) so bili randomizirani v skupino s 5 mg prasugrela.
A single intravenous bolus dose of unfractionated heparin (100 U/kg) did not significantly alter the prasugrel-mediated inhibition of platelet aggregation.
Enkratni intravenski bolusni odmerek nefrakcioniranega heparina (100 enot/kg) ni značilno spremenil zaviranja agregacije trombocitov, povzročenega s prasugrelom.
Non-Coronary Artery Bypass Graft (CABG) related bleeding
Krvavitev, ki ni v povezavi z operacijo aortokoronarnega obvoda (Coronary Artery Bypass Graft, CABG)
Prasugrel should be used with caution in patients ≥75 years of age due to the potential risk of bleeding in this population (see sections 4.2 and 4.4).
Prasugrel moramo uporabljati previdno pri bolnikih ≥ 75 let zaradi možnega tveganja za krvavitev v tej populaciji (glejte poglavji 4.2 in 4.4).
In TRITON, the frequency of patients experiencing a non-CABG related bleeding event is shown in Table 1.
V študiji TRITON je pogostnost bolnikov, ki so imeli krvavitev, nepovezano z aortokoronarnim obvodom, prikazana v Preglednici 1.
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.
V študiji s 276 bolniki z ACS, ki so imeli PCI, je zamenjava začetnega polnilnega odmerka 600 mg klopidogrela ali placeba, danega ob vstopu v bolnišnico pred koronarno angiografijo, s 60-miligramskim polnilnim odmerkom prasugrela, danega v času perkutane koronarne intervencije, povzročila podobno povečano zaviranje agregacije trombocitov v 72­urnem obdobju študije.
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.
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 29 %.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodiumfree'.
To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na tableto, kar v bistvu pomeni ''brez natrija''.
28 film-coated tablets 30 film-coated tablets 30 x 1 film-coated tablets 84 film-coated tablets 90 film-coated tablets 90 x 1 film-coated tablets 98 film-coated tablets
28 filmsko obloženih tablet 30 filmsko obloženih tablet 30 x 1 filmsko obložena tableta 84 filmsko obloženih tablet 90 filmsko obloženih tablet 90 x 1 filmsko obložena tableta 98 filmsko obloženih tablet
The efficacy of prasugrel was independent of the ASA dose (75 mg to 325 mg once daily).
Učinkovitost prasugrela je bila neodvisna od odmerka ASK (75 mg do 325 mg enkrat na dan).
Prasugrel Mylan inhibits the clumping of platelets and so reduces the chance of a blood clot forming.
Zdravilo Prasugrel Mylan zavira združevanje trombocitov in tako zmanjša možnost za tvorbo krvnega strdka.
Although bleeding was increased with prasugrel, an analysis of the composite endpoint of death from any cause, nonfatal myocardial infarction, nonfatal stroke, and non-CABG-related TIMI major haemorrhage favoured prasugrel compared to clopidogrel (Hazard ratio, 0.87; 95% CI, 0.79 to 0.95; p=0.004).
Čeprav je pri zdravljenju s prasugrelom prišlo do povečanega pojava krvavitve, je analiza sestavljenega cilja študije, smrti iz kateregakoli vzroka, ne-smrtnega miokardnega infarkta, ne-smrtne možganske kapi in večje krvavitve po TIMI, nepovezane s CABG, dala prednost prasugrelu v primerjavi s klopidogrelom (razmerje tveganja 0,87; 95 % IZ; 0,79 do 0,95; p=0,004).
Crospovidone Colloidal anhydrous silica Magnesium stearate
Brezvodni koloidni silicijev dioksid Magnezijev stearat
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.
V študijah klinične farmakologije je bil AUC aktivnega presnovka po prilagoditvi glede telesne mase 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.
An increased risk of bleeding is possible when Prasugrel Mylan is co-administered with heparin.
Povečano tveganje za krvavitev je možno, kadar sočasno dajemo zdravilo Prasugrel Mylan s heparinom.
In patients with acute coronary syndrome (ACS) who are managed with PCI, premature discontinuation of any antiplatelet agent, including Prasugrel Mylan, could result in an increased risk of thrombosis, myocardial infarction or death due to the patient's underlying disease.
Pri bolnikih z akutnim koronarnim sindromom (AKS), ki so zdravljeni s PCI, lahko predhodna prekinitev kakršnegakoli zdravila proti trombocitom, vključno z zdravilom Prasugrel Mylan, vodi v povečano tveganje za trombozo, miokardni infarkt ali smrt zaradi osnovne bolnikove bolezni.
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 je zaviralec aktivacije in agregacije trombocitov preko nepovratne vezave njegovih aktivnih presnovkov na razred P2Y12 receptorjev ADP na trombocitih.
Prasugrel Mylan should be initiated with a single 60 mg loading dose and then continued at 10 mg once a day.
Odmerjanje zdravila Prasugrel Mylan je treba začeti z enkratnim 60 mg polnilnim odmerkom in nato nadaljevati z 10 mg enkrat na dan.
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.
Bolniki s TIA ali ishemično možgansko kapjo v anamnezi več kot 3 mesece pred zdravljenjem s prasugrelom niso imeli znižanja primarnega sestavljenega opazovanega dogodka.
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.
Pri bolnikih, ki so prejemali tienopiridin v 3 dneh pred aortokoronarnim obvodom, sta bili pogostnosti večjih in manjših krvavitev po TIMI, povezanih z aortokoronarnim obvodom, 26,7 % (12 od 45 bolnikov) v skupini, ki je jemala prasugrel, v primerjavi s 5,0 % (3 od 60 bolnikov) v skupini, ki je jemala klopidogrel.
Concomitant administration with chronic NSAIDs has not been studied.
Študij sočasnega dajanja s kroničnim zdravljenjem z NSAID niso opravili.