natgillin/translations-raw huggingface dataset:
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 (glejte poglavja 4. 2, 4. 4 in 4. 8).
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.
9 Bolniki ≥ 75 let, pri katerih je bila korist zdravljenja s prasugrelom bolj očitna, so vključevali tiste z diabetesom, STEMI, večjim tveganjem za trombozo žilne opornice ali ponovljenimi dogodki.
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 v anamnezi ali ishemično kapjo v anamnezi več kot 3 mesece pred zdravljenjem s prasugrelom, niso imeli znižanja primarnega sestavljenega cilja.
Patients with Outcome Events in TRITON Primary Analysis
Bolniki z izidi v primarni analizi TRITON
Hazard Ratio (HR)
Razmerje tveganja
Outcome Events
+ ASA
+ASA
(RT)
(95% CI)
vrednos
value
Izidi
Primary Composite Outcome Events Cardiovascular (CV) death, non fatal MI, or non fatal stroke Primary Individual Outcome Events
Primarni sestavljeni izidi Srčnožilna (CV) smrt, ne- smrtni MI ali ne - smrtna kap Primarni posamezni izidi
CV death Nonfatal MI Nonfatal stroke
CV smrt Ne- smrtni MI Ne- smrtna kap
UA/ NSTEMI Primary Composite Outcome Events
UA/ NSTEMI Primarni sestavljeni izidi
CV death, nonfatal MI, or nonfatal stroke CV death Nonfatal MI Nonfatal stroke STEMI Primary Composite Outcome Events
CV smrt, ne- smrtni MI ali ne- smrtna kap CV smrt
9.3 1.8 7.1 0.8 (N= 1769)%
(N= 1769)%
CV death, nonfatal MI, or nonfatal stroke CV death Nonfatal MI Nonfatal stroke
CV smrt, ne- smrtni MI ali ne- smrtna kap CV smrt Ne- smrtni MI Ne- smrtna kap
9.8 2.4 6.7 1.2
9, 8 2, 4 6, 7 1, 2
12.2 3.3 8.8 1.1
12, 2 3, 3 8, 8 1, 1
0.793 (0.649, 0.968) 0.738 (0.497,1.094) 0.746 (0.588,0.948) 1.097 (0.590,2.040)
0, 793 (0, 649; 0, 968) 0, 738 (0, 497; 1, 094) 0, 746 (0, 588; 0, 948) 1, 097 (0, 590; 2, 040)
0.019 0.129 0.016 0.770
0, 019 0, 129 0, 016 0, 770
In the All ACS population, analysis of each of the secondary endpoints showed a significant benefit (p < 0.001) for prasugrel versus clopidogrel.
V celotni ACS populaciji je analiza vsakega od sekundarnih ciljev kazala signifikantno korist (p < 0, 001) za prasugrel v primerjavi s klopidogrelom.
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).
Te so vključevale določene ali možne tromboze žilne opornice ob koncu študije (0, 9% proti 1, 8%; RT 0, 498; IZ 0, 364; 0, 683); CV smrt, ne- smrtni MI ali urgentno ciljno žilno revaskulizacijo v 30 dneh (5, 9% proti 7, 4%; RT 0, 784; IZ 0, 688; 0, 894); vse vzroke smrti, ne- smrtni MI ali ne- smrtno kap do konca študije (10, 2% proti 12, 1%; RT 0, 831; IZ 0, 751; 0, 919); CV smrt, ne- smrtni MI, ne- smrtno kap ali ponovno hospitalizacijo zaradi srčnega ishemičnega dogodka do konca študije (11, 7% proti 13, 8%; RT 0, 838; IZ 0, 762; 0, 921).
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 ACS populaciji (2, 76% proti 2, 90%), UA/ NSTEMI populaciji (2, 58% proti 2, 41%), in STEMI populaciji (3, 28% proti 4, 31%) ni pokazala kakršnekoli značilne razlike med prasugrelom in klopidogrelom.
Prasugrel was associated with a 50% reduction in stent thrombosis through the 15 month follow-up period.
Prasugrel je bil povezan s 50% zmanjšanjem tromboze žilne opornice v 15 mesečnem obdobju spremljanja.
In an analysis of patients who survived an ischaemic event, prasugrel was associated with a reduction in the incidence of subsequent primary endpoint events (7.8% for prasugrel vs 11.9% for clopidogrel).
Pri analizi bolnikov, ki so preživeli ishemični dogodek, je bil prasugrel povezan z zmanjšanjem incidence nadaljnjih primarnih ciljnih dogodkov (7, 8% za prasugrel proti 11, 9% za klopidogrel).
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 Efient 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 kapi in večje krvavitve po TIMI, povezane z non- CABG, dala prednost zdravilu Efient v primerjavi s klopidogrelom (razmerje tveganja 0, 87; 95% IZ; 0, 79 do 0, 95; p=0, 004).
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.
V študiji TRITON je bilo na vsakih 1000 bolnikov, zdravljenih z zdravilom Efient, 22 manj bolnikov z miokardnim infarktom in 5 več z večjo krvavitvijo po TIMI, povezano z non- CABG, v primerjavi z bolniki, zdravljenimi s klopidogrelom.
10 5.2 Pharmacokinetic properties
10 5. 2 Farmakokinetične lastnosti
The active metabolite’ s exposure (AUC) has moderate to low between-subject (27%) and within-subject (19%) variability.
Izpostavljenost (AUC) aktivnemu presnovku je zmerno do nizko variabilna med- osebami (27%) in pri- osebah (19%).
Prasugrel’ s pharmacokinetics are similar in healthy subjects, patients with stable atherosclerosis, and patients undergoing percutaneous coronary intervention.
Farmakokinetika prasugrela je podobna pri zdravih osebah, bolnikih s stabilno aterosklerozo in bolnikih, ki imajo perkutano koronarno intervencijo.
Absorption The absorption and metabolism of prasugrel are rapid, with peak plasma concentration (Cmax) of the active metabolite occurring in approximately 30 minutes.
Absorpcija Absorpcija in presnova prasugrela je hitra, vrh plazemske koncentracije (Cmax) aktivnega presnovka se pojavi v približno 30 minutah.
The active metabolite’ s exposure (AUC) increases proportionally over the therapeutic dose range.
Izpostavljenost (AUC) aktivnemu presnovku se povečuje sorazmerno z razponom terapevtskega odmerka.
In a study of healthy subjects, AUC of the active metabolite was unaffected by a high fat, high calorie meal, but Cmax was decreased by 49% and the time to reach Cmax (Tmax) was increased from 0.5 to 1.5 hours.
V študiji pri zdravih osebah je bila AUC aktivnega presnovka nespremenjena pri obroku z veliko maščob in kalorij, vendar se je Cmax znižal za 49% in čas do dosega Cmax (tmax) je bil podaljšan z 0, 5 na 1, 5 ure.
Therefore, Efient 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 zdravilo Efient dajemo neodvisno od hrane; vendar lahko dajanje polnilnega odmerka prasugrela v obdobju stradanja nudi najhitrejši začetek delovanja (glejte poglavje 4. 2).
Distribution Active metabolite binding to human serum albumin (4% buffered solution) was 98%.
Porazdelitev Vezava aktivnega presnovka na humani serumski albumin (v 4% pufrski raztopini) je bila 98%.
Metabolism Prasugrel is not detected in plasma following oral administration.
Presnova Po peroralnem dajanju prasugrela v plazmi ni zaznati.
The active metabolite is further metabolised to two inactive compounds by S- methylation or conjugation with cysteine.
Aktivni presnovek se nato nadalje presnovi v dve neaktivni spojini, z S- metilizacijo ali s konjugacijo s cisteinom.
Elimination Approximately 68% of the prasugrel dose is excreted in the urine and 27% in the faeces, as inactive metabolites.
Izločanje Približno 68% odmerka prasugrela se v obliki neaktivnih presnovkov izloči z urinom in 27% z blatom.
The active metabolite has an elimination half-life of about 7.4 hours (range 2 to 15 hours).
Aktivni presnovek ima razpolovni čas izločanja približno 7, 4 ure (razpon 2 do 15 ur).
In the large phase 3 clinical trial, the mean estimated exposure (AUC) of the active metabolite was 19% higher in very elderly patients (≥ 75 years of age) compared to subjects < 75 years of age.
V velikem kliničnem preskušanju faze 3, je bila srednja ocenjena izpostavljenost (AUC) aktivnemu presnovku 19% višja pri zelo starih bolnikih (≥ 75 let) v primerjavi z osebami < 75 let.
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).
No dose adjustment is necessary for patients with mild to moderate impaired hepatic function (Child Pugh Class A and B).
Prilagoditev odmerka ni potrebna pri bolnikih z blago do zmerno okvaro jeter (razreda A in B po Child Pugh- u).
3).
Prasugrela ne smemo uporabljati pri bolnikih s hudo okvaro jeter (glejte poglavje 4. 3).
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.
Farmakokinetika prasugrela in njegovo zaviranje agregacije trombocitov sta podobna pri bolnikih z zmerno okvaro ledvic (GFR 30 - < 50 ml/ min/ 1, 73 m2) in zdravih osebah.
11 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.
Zaviranje agregacije trombocitov, povzročeno s prasugrelom, je bilo tudi podobno pri bolnikih z ESRD, ki so potrebovali hemodializo, v primerjavi z zdravimi osebami, čeprav je bila pri ESRD bolnikih Cmax aktivnega presnovka zmanjšana za 51%, AUC pa za 42%.
Body weight:
11 Telesna masa:
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.
Srednja izpostavljenost (AUC) aktivnemu presnovku prasugrela je približno 30 do 40% višja pri zdravih osebah in bolnikih s telesno maso < 60 kg, v primerjavi s tistimi, ki tehtajo ≥ 60 kg.
Prasugrel 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).
Prasugrel moramo uporabljati previdno pri bolnikih s telesno maso < 60 kg, zaradi možnega tveganja za krvavitev v tej populaciji (glejte poglavje 4. 4).
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.
In healthy subjects and patients, the pharmacokinetics of prasugrel are similar in men and women.
Pri zdravih osebah in bolnikih je farmakokinetika prasugrela podobna pri moških in ženskah.
Pharmacokinetics and pharmacodynamics of prasugrel have not been evaluated in a paediatric population (see section 4.2).
Farmakokinetike in farmakodinamike prasugrela v pediatrični populaciji niso preučevali (glejte poglavje 4. 2).
Embryo-foetal developmental toxicology studies in rats and rabbits showed no evidence of malformations due to prasugrel.
Toksikološke študije razvoja ploda- zarodka pri podganah in zajcih niso podale dokazov o malformacijah zaradi prasugrela.
At a very high dose (> 240 times the recommended daily human maintenance dose on a mg/ m2 basis) that caused effects on maternal body weight and/ or food consumption, there was a slight decrease in offspring body weight (relative to controls).
Pri zelo visokem odmerku (> 240 krat priporočeni dnevni vzdrževalni odmerek za ljudi na osnovi mg/ m2), ki je povzročil učinke na telesno maso breje samice in/ ali uživanje hrane, je bil opazen rahel upad telesne mase mladičev (glede na kontrolo).
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 do izpostavitve 240- kratnemu priporočenemu dnevnemu vzdrževalnemu odmerku pri ljudeh (na osnovi mg/ m2).
No compound-related tumours were observed in a 2-year rat study with prasugrel exposures ranging to greater than 75 times the recommended therapeutic exposures in humans (based on plasma exposures to the active and major circulating human metabolites).
V 2- letnih študijah pri podganah, pri izpostavitvah prasugrelu v obsegu do večjih od 75- kratnih priporočenih terapevtskih izpostavitvev pri ljudeh (na osnovi plazemske izpostavitve aktivnemu in pomembnejšim krožečim humanim presnovkom), niso opazili tumorjev, povezanih z zdravilno učinkovino.
Microcrystalline cellulose Mannitol (E421) Croscarmellose sodium Hypromellose (E464) Magnesium stearate
Mikrokristalna celuloza Manitol (E421) Natrijev karmelozat, premreženi Hipromeloza (E464) Magnezijev stearat
Lactose monohydrate Hypromellose (E464) Titanium dioxide (E171) Triacetin (E1518) Iron oxide yellow (E172) Talc
12 Hipromeloza (E464) Titanov dioksid (E171) Triacetin (E1518) Rumeni železov oksid (E172) Smukec
Aluminium foil blisters in cartons of 14, 28, 30 (x1), 56, 84, 90 (x1) and 98 tablets.
Aluminijasti pretisni omot v škatlah po 14, 28, 30 (x1), 56, 84, 90 (x1) in 98 tablet.
< {DD month YYYY} >
< {DD mesec LLLL} >
Each tablet contains 2.1 mg lactose.
Ena tableta vsebuje 2, 1 mg laktoze.
Beige and double-arrow shaped tablets, debossed with “ 10 mg” on one side and “ 4759” on the other.
Bež tablete v obliki dvojne puščice, z vtisnjenim “ 10 mg ” na eni strani in “ 4759 ” na drugi strani.
Patients weighing < 60 kg Efient should be given as a single 60 mg loading dose and then continued at a 5 mg once daily dose.
14 Bolniki, ki tehtajo < 60 kg Zdravilo Efient moramo dati kot enkratni 60 mg polnilni odmerek in nato nadaljevati s 5 mg odmerkom enkrat na dan.
The use of Efient in patients ≥ 75 years of age is generally not recommended and should only be undertaken with caution after a careful individual benefit/ risk evaluation by the prescribing physician indicates that benefits in terms of prevention of ischaemic events outweigh the risk of serious bleedings.
Uporaba zdravila Efient pri bolnikih ≥ 75 let starosti na splošno ni priporočena in mora biti opravljena 15 previdno, samo po skrbni oceni lečečega zdravnika glede posameznikove koristi/ tveganja, ki meni, da koristi v smislu preprečevanja ishemičnih dogodkov pretehtajo tveganje za resne krvavitve.
In the phase 3 clinical trial these patients were at greater risk of bleeding, including fatal 15 bleeding, compared to patients < 75 years of age.
V kliničnem preskušanju faze 3 so imeli ti bolniki večje tveganje za krvavitev, vključno s krvavitvijo s smrtnim izidom, v primerjavi z bolniki < 75 let starosti.
16 Heparin:
16 možna farmakodinamična interakcija z ASK, ki vodi v povečano tveganje za krvavitev, so dokazi o učinkovitosti in varnosti prasugrela pridobljeni pri bolnikih, ki so bili sočasno zdravljeni z ASK.
17 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).
17 Prasugrel nima učinka na plodnost samcev in samic podgan pri peroralnih odmerkih, ki so do 240- krat večji od izpostavljenosti, pri priporočenem dnevnem vzdrževalnem odmerku pri ljudeh (glede na mg/ m2).
0.3 0.3
0, 1 0, 3
a Centrally adjudicated events defined by the Thrombolysis in Myocardial Infarction (TIMI) Study Group criteria. b Other standard therapies were used as appropriate. c Any intracranial haemorrhage or any clinically overt bleeding associated with a fall in haemoglobin ≥ 5 g/ dL.
a Centralno določeni dogodki, definirani po kriterijih preiskovane skupine za trombolizo pri miokardnem infarktu (Thrombolysis in Myocardial Infarction, TIMI). b Ostala standardna zdravljenja so bila ustrezno uporabljena.
18 d Life-threatening bleeding is a subset of TIMI major bleeding and includes the types indented below.
18 c Vsaka intrakranialna krvavitev ali klinično očitna krvavitev, povezana s padcem hemoglobina ≥ 5 g/ dl. d Smrtno nevarna krvavitev je podskupina večje krvavitve po TIMI in vključuje tipe, navedene spodaj.
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.
20 ali močnejše zaviranje agregacije trombocitov so opazili pri prasugrelu.
21 The observed benefit of prasugrel in patients ≥ 75 years was less than that observed in patients < 75 years.
Opazovane koristi prasugrela pri bolnikih ≥ 75 let so bile manjše, kot pri bolnikih < 75 let.
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.
21 Bolniki ≥ 75 let, pri katerih je bila korist zdravljenja s prasugrelom bolj očitna, so vključevali tiste z diabetesom, STEMI, večjim tveganjem za trombozo žilne opornice ali ponovljenimi dogodki.
22 5.2 Pharmacokinetic properties
22 5. 2 Farmakokinetične lastnosti
23 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.
Zaviranje agregacije trombocitov, povzročeno s prasugrelom, je bilo tudi podobno pri bolnikih z ESRD, ki so potrebovali hemodializo, v primerjavi z zdravimi osebami, čeprav je bila pri ESRD bolnikih Cmax aktivnega presnovka zmanjšana za 51%, AUC pa za 42%.
Body weight:
23 Telesna masa:
Lactose monohydrate Hypromellose (E464) Titanium dioxide (E171) Triacetin (E1518) Iron oxide red (E172) Iron oxide yellow (E172) Talc
24 Hipromeloza (E464) Titanov dioksid (E171) Triacetin (E1518) Rdeči železov oksid (E172) Rumeni železov oksid (E172) Smukec
Avda de la Industria 30 E-28108 Alcobendas (Madrid) Spain
Avda de la Industria 30 E- 28108 Alcobendas (Madrid) Španija
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version v2.1 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Sistem farmakovigilance Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance, kot je opisan v različici 2. 1, predstavljeni v modulu 1. 8. 1 vloge za pridobitev dovoljenja za promet z zdravilom, vzpostavljen in da deluje, preden da zdravilo v promet in toliko časa, kolikor bo zdravilo v uporabi.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in Revision 1.4 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Načrt za obvladovanje tveganja Imetnik dovoljenja za promet z zdravilom se obvezuje, da bo izvedel študije in dodatne farmakovigilančne aktivnosti, podrobno opisane v načrtu farmakovigilance, sprejetem v različici 1. 4 načrta za obvadovanje tveganja (RMP), predstavljenega v modulu 1. 8. 2 vloge za pridobitev dovoljenja za promet z zdravilom in vseh nadaljnih posodobitvah RMP, s katerimi soglaša Odbor za zdravila za uporabo v humani medicini (CHMP).
27 As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
27 V skladu s smernicami CHMP za sisteme za obvladovanje tveganja za zdravila za uporabo v humani medicini mora biti posodobljen RMP predložen hkrati z naslednjim rednim posodobljenim poročilom o varnosti zdravila (PSUR).
In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
Poleg tega je treba posodobljen RMP predložiti: • kadar imetnik dovoljenja za promet z zdravilom prejme nove informacije, ki lahko vplivajo na trenutne specifikacije varnosti zdravila, načrt farmakovigilance ali na dejavnosti za zmanjševanje tveganja • v 60 dneh po dosegu pomembnega mejnika (farmakovigilančnega ali povezanega z zmanjševanjem tveganja) • na zahtevo Evropske agencije za zdravila (EMEA)
14 film-coated tablets 28 film-coated tablets 30x1 film-coated tablet 56 film-coated tablets 84 film-coated tablets 90x1 film-coated tablet 98 film-coated tablets
14 filmsko obloženih tablet 28 filmsko obloženih tablet 30x1 filmsko obložena tableta 56 filmsko obloženih tablet 84 filmsko obloženih tablet 90x1 filmsko obložena tableta 98 filmsko obloženih tablet
EU/ X/ XX/ XXX/ XXX 14 film-coated tablets EU/ X/ XX/ XXX/ XXX 28 film-coated tablets EU/ X/ XX/ XXX/ XXX 30x1 film-coated tablet EU/ X/ XX/ XXX/ XXX 56 film-coated tablets EU/ X/ XX/ XXX/ XXX 84 film-coated tablets EU/ X/ XX/ XXX/ XXX 90x1 film-coated tablet EU/ X/ XX/ XXX/ XXX 98 film-coated tablets
EU/ X/ XX/ XXX/ XXX 14 filmsko obloženih tablet EU/ X/ XX/ XXX/ XXX 28 filmsko obloženih tablet EU/ X/ XX/ XXX/ XXX 30x1 filmsko obložena tableta EU/ X/ XX/ XXX/ XXX 56 filmsko obloženih tablet EU/ X/ XX/ XXX/ XXX 84 filmsko obloženih tablet EU/ X/ XX/ XXX/ XXX 90x1 filmsko obložena tableta EU/ X/ XX/ XXX/ XXX 98 filmsko obloženih tablet
32 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
32 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
< MON, TUE, WED, THU, FRI, SAT, SUN, >
< PON, TOR, SRE, ČET, PET, SOB, NED, >
35 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
35 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
< MON, TUE, WED, THU, FRI, SAT, SUN, >
< PON, TOR, SRE, ČET, PET, SOB, NED,
What Efient is and what it is used for 2.
Kaj je zdravilo Efient in za kaj ga uporabljamo 2.
Before you take Efient 3.
Kaj morate vedeti, preden boste vzeli zdravilo Efient 3.
How to take Efient 4.
Kako jemati zdravilo Efient 4.
How to store Efient 6.
Shranjevanje zdravila Efient 6.
WHAT EFIENT IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO EFIENT IN ZA KAJ GA UPORABLJAMO
Efient, belongs to a group of medicines called anti-platelet agents.
Efient spada v skupino zdravil, imenovanih zdravila proti trombocitom.
When a blood vessel is damaged, for example if it is cut, platelets clump together to help form a blood clot (thrombus).
Ko je krvna žila poškodovana, na primer, če je vrezana, se trombociti združijo skupaj, da pomagajo tvoriti krvni strdek (tromb).
If clots form within a hardened blood vessel such as an artery they can be very dangerous as they can cut off the blood supply, causing a heart attack (myocardial infarction), stroke or death.
Če se strdki tvorijo v trdi žili, kot je arterija, so lahko zelo nevarni, ker lahko prekinijo dotok krvi, s čimer povzročijo srčni infarkt (miokardni infarkt), kap ali smrt.