FrancophonIA/ELRC3.0 huggingface dataset:
English: Because of the potential for increased risk of bleeding, warfarin and Efient should be co-administered with caution (see section 4.4).
Estonian: Verejooksu suurenenud riski tõttu, tuleb varfariini ja Efient'i samaaegsel kasutamisel olla ettevaatlik (vt lõik 4.4).
English: Patients ≥ 75 years were at increased risk of bleeding, including fatal (see sections 4.2, 4.4,
Estonian: Selles vanusegrupis patsientidel esines suurem veritsuse, sh ka surmava veristuse oht (vt lõik 4.2, 4.4 ja 4.8).
English: eClinically overt bleeding associated with a fall in haemoglobin of ≥3 g/dL but <5 g/dL.
Estonian: e kliiniliselt ilmne verejooks, mis on seotud hemoglobiinisisalduse langusega ≥3 g/dl, kuid <5 g/dl.
English: Uncommon side effects (may affect up to 1 in 100 people)
Estonian: Aeg-ajalt ilmnevad kõrvaltoimed (võivad esineda kuni 1 inimesel 100st):
English: Nonfatal MI
Estonian: Mitte fataalne MI
English: 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.
Estonian: 3 kuu jooksul enne prasugreel ravi anamneesis TIA-ga või isheemilise insuldiga patsientidel ei olnud esmastes liit-tulemusnäidatajates langust.
English: Effects of Efient on other medicinal products Digoxin:
Estonian: Efient'i toime teistele ravimitele:
English: Because of the potential for increased risk of bleeding, chronic NSAIDs (including COX-2 inhibitors) and Efient should be coadministered with caution (see section 4.4).
Estonian: Võimaliku verejooksude riski tõusu tõttu tuleb krooniliselt kasutatavate MSPVA-te (k.a COX-2 inhibiitorid) ja prasugreeli kooskasutamisel olla ettevaatlik (vt lõik 4.4).
English: including oral anticoagulants, clopidogrel, non-steroidal anti-inflammatory drugs (NSAIDs), and fibrinolytics.
Estonian: samaaegne verejooksu riski suurendavate ravimite kasutamine, k.a suukaudsed antikoagulandid, klopidogreel, mitte-steroidsed põletikuvastased ained (MSPVA) ja fibrinolüütikumid.
English: Switching directly to prasugrel 60 mg loading dose resulted in the most rapid onset of higher platelet inhibition.
Estonian: Üle viimine kohe 60 mg löökannusele tagab kiirema toime trombotsüütide ulatuslikumaks inhibeerimiseks.
English: This leaflet was last revised in {MM/YYYY}.
Estonian: Infoleht on viimati uuendatud:
English: Other therapies, such as heparin and GPIIb/IIIa inhibitors, were administered at the discretion of the physician.
Estonian: Teisi ravimeid, nt hepariini ja glükoproteiin IIb/IIIa inhibiitoreid manustati raviarsti äranägemisel.
English: Gender: In healthy subjects and patients, the pharmacokinetics of prasugrel are similar in men and women.
Estonian: Nii tervetel vabatahtlikel kui haigetel nais- ja meessoost isikutel on prasugreeli farmakokineetika sarnane.
English: Patients with STEMI within 12 hours of symptoms and planned for primary PCI could be randomised without knowledge of coronary anatomy.
Estonian: STEMI-ga patsiente, kellele planeeritakse esmane perkutaanne koronaarinterventsioon võib randomiseerida 12 tunni jooksul pärast sümptomite ilmnemist ka ilma eelneva koronarograafiata.
English: No dose adjustment is necessary for patients with mild to moderate impaired hepatic function (Child Pugh Class A and B).
Estonian: Kerge kuni mõõduka maksafunktsioonihäirega (Child Pugh klass A ja B) patsientidel ei ole annust vaja muuta.
English: OTHER <MON, TUE, WED, THU, FRI, SAT, SUN>
Estonian: MUU E, T, K, N, R, L, P
English: 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.
Estonian: Uuringus osalenud stabiilse ateroskleroosiga 5 mg prasugreeli saanud ≥75 aastaste patsientide aktiivse metaboliidi AUC, oli võrreldes 10 mg prasugreeli saanud < 65 aasta vanuste patsientide aktiivse metaboliidi AUC-st ligikaudu pool.
English: c Any intracranial haemorrhage or any clinically overt bleeding associated with a fall in haemoglobin ≥5 g/dL.
Estonian: b mistahes intrakraniaalne verejooks või mistahes kliiniliselt ilmne verejooks, mis on seotud hemoglobiinisisalduse langusega ≥5 g/dl.
English: 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).
Estonian: ST-segmendi elevatsioonita kulgeva müokardiinfarktiga (UA/NSTEMI) patsientidele, kellel koronaarangiograafia viiakse läbi 48 tunni jooksul pärast hospitaliseerimist, tohib löökannuse manustada ainult PCI ajal (vt lõigud 4.4, 4.8 ja 5.1).
English: 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.
Estonian: Uuringus osalenud stabiilse ateroskleroosiga patsientidel kehakaaluga < 60 kg, kes said 5 mg prasugreeli, oli aktiivse metaboliidi AUC keskmine väärtus 62% ≥ 60 kg kehakaaluga patsientide AUC-st, kes said 10 mg prasugreeli ning 5 mg annuse trombotsüütide effekt oli sarnane 10 mg annusele.
English: Primary Composite Outcome Events
Estonian: UA/NSTEMI Esmased liit-tulemusnäitajad
English: cLife-threatening is a subset of TIMI Major bleeding and includes the types indented below.
Estonian: c eluohtlik verejooks TIMI suurte verejooksude alagrupist ning sisaldab allpool viidatud verejooksu tüüpe.
English: Efient 10 mg film-coated tablets Efient 5 mg film-coated tablets Prasugrel
Estonian: Efient 10 mg õhukese polümeerikattega tabletid Efient 5 mg õhukese polümeerikattega tabletid
English: Nonfatal stroke
Estonian: Mitte-fataalne insult
English: Your doctor should prescribe a daily dose of 5 mg as there is a greater risk of bleeding in patients older than 75 years - a recent serious injury - recent surgery (including some dental procedures) - recent or recurrent bleeding from the stomach or intestines (e.g. a stomach ulcer or colon polyps) - body weight of less than 60 kg.
Estonian: - hiljutine raske vigastus - hiljutine operatsioon (s.h mõningad hambaravi protseduurid) - hiljutine või korduv veritsus kõhuõõnest või soolestikust (nt maohaavand, käärsoole polüübid) - kehakaal vähem kui 60 kg.
English: Efient is contraindicated in patients with severe hepatic impairment (Child Pugh class C).
Estonian: Raske maksapuudulikkusega (Child Pugh klass C) patsientidele on Efient vastunäidustatud.
English: <75 years (N=7180)**
Estonian: < 75-aastased (N7180)**
English: Retroperitoneal haemorrhage Rectal haemorrhage Haematochezia Gingival bleeding
Estonian: Retroperitoneaal ne verejooks Rektaalne verejooks Pärasoole verejooks Igemete veritsus
English: 2.0% (0.1% fatal) a
Estonian: 20% (0,1% fataalsed) a
English: Tablet Core:
Estonian: Maksafunktsiooni häire:
English: CV death, nonfatal MI, or nonfatal stroke CV death
Estonian: KV surm, mitte-fataalne MI või mittefataalne insult
English: 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
Estonian: EU/1/08/503/008 14 õhukese polümeerikattega tabletti EU/1/08/503/009 28 polümeerikattega tabletti
English: In a 30-day study (ACCOAST) in 4033 patients with NSTEMI with elevated troponin who were scheduled for coronary angiography followed by PCI within 2 to 48 hours after randomization, subjects who received prasugrel 30 mg loading dose on average 4 hours prior to coronary angiography followed by a 30 mg loading dose at the time of PCI (n=2037) had an increased risk of non-CABG peri-procedural bleeding and no additional benefit compared to patients receiving a 60 mg loading dose at the time of PCI (n=1996).
Estonian: 30-päevases uuringus (ACCOAST) 4033-st patsiendist, kellel esines tõusnud troponiinitasemega NSTEMI ning kellele oli plaanitud koronaarangiograafia ja sellele järgnevalt PCI 2...48 tundi pärast randomiseerimist, täheldati mitte-CABG periprotseduurilise verejooksu riski tõusu ja täiendava kasu puudumist nendel patsientidel, kes said 30 mg prasugreeli löökannuse keskmiselt 4 tundi enne koronaarangiograafiat ja sellele järgnevalt 30 mg löökannuse PCI ajal (n=2037), võrreldes patsientidega, kes said 60 mg löökannuse PCI ajal (n=1996).
English: Mean steady-state inhibition of platelet aggregation was 74% and 69% respectively for 5 µM ADP and 20 µM ADP, and was achieved following 3 to 5 days of administration of the 10 mg prasugrel maintenance dose preceded by a 60 mg loading dose.
Estonian: Prasugreeli poolt vahendatud trombotsüütide agregatsiooni pärssimisel on madal inter- ja individuaalne varieeruvus (vastavalt 9 % ja 12 %) nii 5 µM kui 20 µM ADP-ga. Trombotsüütide agregatsiooni keskmine tasakaalu inhibeerimine oli 5 µM ADP puhul 74 % ja 20 µM ADP puhul 69 %, ning see saavutati prasugreeli 10 mg annuse 3…5-päevase manustamise järel, sellele eelnes 60 mg löökannuse manustamine.
English: Bleeding Risk Associated with Timing of Loading Dose in NSTEMI In a clinical trial of NSTEMI patients (the ACCOAST study), where patients were scheduled to undergo coronary angiography within 2 to 48 hours after randomization, a prasugrel loading dose given on average 4 hours prior to coronary angiography increased the risk of major and minor peri-procedural bleeding compared with a prasugrel loading dose at the time of PCI.
Estonian: NSTEMI löökannuse ajastamisega seotud verejooksu risk NSTEMI patsientidega läbi viidud kliinilises uuringus (ACCOAST-uuring), kus patsiendid, kes suunati 2…48 tundi pärast randomiseerimist koronaarangiograafiale, said prasugreeli löökannuse keskmiselt 4 tundi enne koronaarangiograafiat, olid suurema riskiga nii suuremate kui väiksemate protseduuriaegsete verejooksude osas võrreldes prasugreeli löökannuse manustamisega PCI ajal.
English: Epistaxis
Estonian: Epistaksis
English: Lactose monohydrate Hypromellose (E464) Titanium dioxide (E171) Triacetin (E1518)
Estonian: Titaandioksiid (E171)
English: You should tell your doctor immediately if you develop a medical condition called Thrombotic Thrombocytopaenic Purpura (or TTP) that includes fever and bruising under the skin that may appear as red pinpoint dots, with or without unexplained extreme tiredness, confusion, yellowing of the skin or eyes (jaundice) (see section 4 ‘Possible side effects').
Estonian: TTP-ga kaasneb palavik, nahaalused nõelapea suurused punased sinikad koos või ilma seletamatu tohutu väsimusega, segasus, naha või silmade kollasus (kollatõbi) (vt lõik 4 ”Võimalikud kõrvaltoimed”).
English: Requiring transfusion (≥4 units) TIMI Minor bleedinge aOther standard therapies were used as appropriate.
Estonian: Surmaga lõppevad Sümptomaatiline ICHd Nõuab inotroope Nõuab kirurgilist sekkumist Nõuab vereülekannet (≥4 ühikut) TIMI väiksed verejooksude a teised vajadusel kasutatud standardsed ravid.
English: The MAH should provide educational material to all physicians who may be involved in treating patients with prasugrel.
Estonian: Kõiki arste, kes võivad olla seotud patsientide ravimisega prasugreeliga, peab MLH varustama õppematerjaliga.
English: Thrombocytopaenia Thrombotic thrombocytopaenic purpura (TTP) -see section 4.4
Estonian: Trombootiline trombotsütopeeniline purpur (TTP) -vt lõik
English: Requiring inotropes Requiring surgical intervention Requiring transfusion (≥ 4
Estonian: Nõuab kirurgilist sekkumist Nõuab vereülekannet
English: If, after a careful individual benefit/risk evaluation by the prescribing physician (see section 4.4), treatment is deemed necessary in the patients age group ≥ 75 years, then following a 60 mg loading dose a reduced maintenance dose of 5 mg should be prescribed.
Estonian: o Juhul, kui raviarsti poolt pärast hoolikalt läbi viidud kasu/riski suhte analüüsi määratakse ≥75-aastastele patsientidele prasugreeli-ravi, tuleb peale 60 mg-st löökannust kasutada väikseimat, 5 mg ,säilitusannust.
English: Primary Composite Outcome Events Cardiovascular (CV) death, non fatal MI, or non fatal stroke
Estonian: Esmased liit-tulemusnäitajad Kardiovaskulaarne (KV) surm, mitte fataalne MI, või mitte-fataalne insult Esmased individuaalsed tulemusnäitajad
English: 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.
Estonian: Farmakoloogilise ohutuse, kroonilise toksilisuse, genotoksilisuse, kartsinogeensuse ja reproduktsioonitoksilisuse mittekliinilised uuringud ei ole näidanud kahjulikku toimet inimesele.
English: See leaflet for further information.
Estonian: Lisainformatsiooni vaata pakendi infolehest.
English: 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
Estonian: EU/1/08/503/001 14 õhukese polümeerikattega tabletti EU/1/08/503/002 28 polümeerikattega tabletti
English: 2.2% (0.3% fatal)
Estonian: 2,2% (0,3% fataalsed)
English: Pharmacokinetics of prasugrel and its inhibition of platelet aggregation are similar in patients with moderate renal impairment (GFR 30<50 ml/min/1.73m2) and healthy subjects.
Estonian: Mõõduka neerufunktsioonihäirega patsientidel (GFR 30…< 50 ml/min/1,73m2) oli prasugreeli farmakokineetika ja trombotsüütide agregatsiooni inhibeerimise võime sarnane tervete vabatahtlike omaga.
English: There is limited therapeutic experience in patients with mild and moderate hepatic dysfunction (see section 4.4).
Estonian: Kerge kuni mõõduka maksapuudulikkusega patsientidega on terapeutilise kasutuse kogemused piiratud (vt lõik 4.4).
English: 1.6% (0.2% fatal)
Estonian: 1,6% (0,2% fataalsed)
English: Efient 10 mg: Each tablet contains 10 mg of prasugrel (as hydrochloride).
Estonian: Efient 10 mg: Üks tablett sisaldab 10 mg prasugreeli (vesinikkloriidina).
English: Efient 5 mg: Each tablet contains 5 mg of prasugrel (as hydrochloride).
Estonian: Efient 5 mg: Üks tablett sisaldab 5 mg prasugreeli (vesinikkloriidina).
English: (see sections 4.2 and 4.4).
Estonian: (≥4 ühikut)
English: TIMI major bleedingc Life-threateningd Fatal
Estonian: TIMI suured verejooksudb Eluohtlikudc
English: Bleeding Risk Associated with Timing of Loading Dose in NSTEMI In a clinical study of NSTEMI patients (the ACCOAST study), where patients were scheduled to undergo coronary angiography within 2 to 48 hours after randomization, patients given a 30 mg loading dose on average 4 hours prior to coronary angiography followed by a 30 mg loading dose at the time of PCI 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 (see sections 4.2 and 4.4).
Estonian: NSTEMI löökannuse ajastamisega seotud verejooksu risk NSTEMI patsientidega läbi viidud kliinilises uuringus (ACCOAST-uuring), kus patsiendid, kes suunati 2…48 tundi pärast randomiseerimist koronaarangiograafiale, said prasugreeli löökannuse 30 mg keskmiselt 4 tundi enne koronaarangiograafiat, millele järgnes 30 mg-ne löökannus PCI ajal, olid suurema verejooksude tekke riskiga mitte-CABG-ga seotud protseduuriaegsetele verejooksudele ning puudusid täiendavad eelised võrreldes nende patsientidega, kes said PCI ajal 60 mg-se löökannuse (vt lõigud 4.2 ja 4.4).
English: Pharmacotherapeutic group: Platelet aggregation inhibitors excluding heparin, ATC code: B01AC22.
Estonian: Farmakoterapeutiline grupp: Trombotsüütide agregatsiooni inhibiitorid, välja arvatud hepariin.
English: 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.
Estonian: Patsientidel, kes said kogu löökannuse PCI ajal, ei vähendanud prasugreel olulisel määral liit-tulemusnäitajate, nagu kardiovaskulaarse (CV) surma, müokardiinfarkti, ägeda revaskularisatsiooni (UR) ega glükoproteiin (GP) IIb/IIIa inhibiitori vabanemise esinemissagedust 7-päevase perioodi jooksul randomiseerimisest, võrreldes patsientidega, kes said prasugreeli enne koronaarangiograafiat.
English: • Blood in urine
Estonian: • Veri uriinis
English: NAME OF THE MEDICINAL PRODUCT Efient 10 mg film-coated tablets prasugrel
Estonian: RAVIMPREPARAADI NIMETUS Efient 10 mg õhukese polümeerikattega tabletid prasugreel
English: 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).
Estonian: Prasugreeli tuleb kasutada ettevaatusega ≥ 75-aastastel ning kehakaaluga <60 kg patsientidel (vt lõigud 4.2, 4.4 ja 4.8).
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Daiichi Sankyo Europe GmbH
Estonian: MÜÜGILOA HOIDJA NIMI JA AADRESS Daiichi Sankyo Europe GmbH 81366 München
English: 1.4% (0.1% fatal)
Estonian: 1,4% (0,1% fataalsed)
English: Manufacturer:
Estonian: Tootja
English: NAME OF THE MEDICINAL PRODUCT Efient 5 mg film-coated tablets prasugrel
Estonian: RAVIMPREPARAADI NIMETUS Efient 5 mg õhukese polümeerikattega tabletid prasugreel
English: • Bleeding in the stomach or bowels
Estonian: • Veritsus kõhuõõnes või sooltes
English: Warfarin:
Estonian: Varfariin:
English: Post-procedural haemorrhage
Estonian: Kontusioon Protseduurijärgn e hemorraagia
English: Subcutaneous haematoma
Estonian: Subkutaanne hematoom
English: Efient 10 mg: The tablets are beige and double-arrow-shaped, with “10 MG” debossed on one side and “4759” on the other.
Estonian: Efient 10 mg: tabletid on beežid ja topeltnoole-kujulised, ühele küljele on sissepressitud „10 MG” ja teisele „4759”.
English: • Blood in stools
Estonian: • Veritsus nõelatorke kohas
English: Effects of other medicinal products on Efient
Estonian: Teiste ravimite toime Efient'ile:
English: Efient 5 mg: Yellow and double-arrow shaped tablets, debossed with “5 MG” on one side and “4760” on the other.
Estonian: Efient 5 mg: Kollane ja topeltnoole-kujuline tablett, ühel poolel on pimetrükk “5 MG” ja teisel poolel “4760”.
English: Prasugrel
Estonian: Hemoptüüs
English: Efient 5 mg: The tablets are yellow and double-arrow-shaped, with “5 MG” debossed on one side and “4760” on the other.
Estonian: Efient 5 mg: tabletid on kollased ja topeltnoole-kujulised, ühele küljele on sissepressitud „5 MG” ja teisele „4760”.
English: Prasugrel must not be used in patients with severe hepatic impairment (see section 4.
Estonian: Raske maksapuudulikkusega patsientidel ei tohi prasugreeli kasutada (vt lõik
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF 10 mg FILM-COATED TABLETS
Estonian: VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED 10 mg õhukese polümeerikattega tablettide karp
English: No dosage adjustment is necessary for patients with renal impairment, including patients with end stage renal disease (ESRD).
Estonian: Neerufunktsiooni häire: Neerufunktsiooni häirega, k.a lõpp-staadiumis neerupuudulikkusega (ESRD) haigetel ei ole vaja annust muuta.
English: Efient 5 mg film-coated tablets.
Estonian: 5 mg õhukese polümeerikattega tablettide blister
English: Symptomatic ICHe
Estonian: Sümptomaatiline
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 5 mg prasugrel (as hydrochloride)
Estonian: TOIMEAINE(TE) SISALDUS Üks tablett sisaldab 5 mg prasugreeli (vesinikkloriidina)
English: 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).
Estonian: Kehakaal: Prasugreeli aktiivse metaboliidi keskmine ekspositsioon (AUC) on tervetel isikutel ja patsientidel kehakaaluga < 60 kg ligikaudu 30…40 % kõrgem võrreldes ≥ 60 kg kehakaaluga patsientidega.
English: Prasugrel is not detected in plasma following oral administration.
Estonian: Pärast suukaudset manustamist ei ole prasugreel plasmas määratav.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 10 mg prasugrel (as hydrochloride)
Estonian: TOIMEAINE(TE) SISALDUS Üks tablett sisaldab 10 mg prasugreeli (vesinikkloriidina)
English: 1.3% (0.1% fatal)
Estonian: 1,3% (0,1% fataalsed)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF 5mg FILM-COATED TABLETS
Estonian: VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED 5 mg õhukese polümeerikattega tablettide karp
English: 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).
Estonian: Prasugreel manustatuna suukaudsete tilkadena (lähtudes mg/m2) annuses, mis ületab 240-kordselt inimese ööpäevase säilitusannuse, ei avalda isaste ja emaste rottide fertiilsusele toimet.
English: Weight
Estonian: pväärtus
English: Vessel puncture site haematoma Puncture site haemorrhage
Estonian: Hematoom veresoone punkteerimise kohas
English: units)
Estonian: Operatsioonid
English: 4.7 Effects on ability to drive and use machines
Estonian: 4.2 Annustamine ja manustamisviis
English: In a study of healthy subjects between the ages of 20 and 80 years, age had no significant effect on pharmacokinetics of prasugrel or its inhibition of platelet aggregation.
Estonian: Trombotsüütide agregatsiooni inhibeerimises ega prasugreeli farmakokineetikas 20…80-aastaste tervete vabatahtlikega läbi viidud uuringus märkimisväärseid erinevusi ei olnud.
English: Gastrointestinal haemorrhage
Estonian: Nahalööve Ekhümoos
English: A delayed and decreased exposure to oral P2Y12 inhibitors, including prasugrel and its active metabolite, has been observed in patients with acute coronary syndrome treated with morphine.
Estonian: Morfiiniga ravitud ägeda koronaarsündroomiga patsientidel on täheldatud suukaudsete P2Y12 inhibiitorite (sealhulgas prasugreeli ja selle aktiivse metaboliidi) ekspositsiooni vähenemist ja hilisemat saabumist.
English: +ASA (N = 5001)
Estonian: Prasugreelb +ASH (N=5001)
English: f Clinically overt bleeding associated with a fall in haemoglobin of ≥3 g/dL but <5 g/dL.
Estonian: f kliiniliselt silmnähtav verejooks, mis on seotud hemoglobiini sisalduse langusega ≥3 g/dl, kuid
English: 3.8% (0.2% fatal)
Estonian: 3,8 % (0,2 % fataalsed) 2,9 % (0,1 % fataalsed)
English: Haemoptysis
Estonian: Hematuuria
English: TIMI minor bleeding f
Estonian: TIMI väiksed verejooksud
English: +ASA (N = 6741)
Estonian: Prasugreelb +ASH (N=6741)
English: Therapeutic experience with prasugrel is limited in patients with renal impairment (including ESRD) and in patients with moderate hepatic impairment.
Estonian: Neerufunktsioonihäirega (k.a lõpp-staadiumi neerupuudulikkus, ESRD) ja mõõduka maksafunktsiooni häirega patsientidel on prasugreeli kasutamise kogemus piiratud.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Efient 10 mg:
Estonian: KVALITATIIVNE JA KVANTITATIIVNE KOOSTIS
English: Rash Ecchymosis
Estonian: Ülitundlikkus, sh angioödeem
English: 9.0% (1.0% fatal)
Estonian: 9,0 % (1,0 % fataalsed) 6,9 % (0,1 % fataalsed)
English: Heparin:
Estonian: Sugu:
English: An increased risk of bleeding is possible when Efient is co-administered with heparin.
Estonian: Efient'i manustamisel koos hepariiniga on võimalik suurenenud verejooksu riski teke.