natgillin/translations-raw huggingface dataset:
The result appeared early (absolute risk reduction [ARR] 0.6% and relative risk reduction [RRR] of 12% at 30 days), with a constant treatment effect over the entire 12-month period, yielding ARR 1.9% per year with RRR of 16%.
Rezultat se je pojavil zgodaj (absolutno zmanjšanje tveganja [ARR - absolute risk reduction] 0,6 % in relativno zmanjšanje tveganja [RRR - relative risk reduction] 12 % po 30 dneh), s stalnim terapevtskim učinkom med celotnim 12-mesečnim obdobjem, kar pomeni ARR 1,9 % na leto in RRR 16 %.
RRR a (%) (95% CI)
RRR a (%) (95 % IZ)
Adverse reactions are listed by MedDRA System Organ Class (SOC).
Neželeni učinki so našteti po MedDRA organskih sistemih (System Organ Class - SOC).
and not crude adverse event report frequency.
in ne groba poročana pogostnost neželenih dogodkov.
Frequencies derived from lab observations (Uric acid increases to >upper limit of normal from baseline below or within reference range.
Pogostnosti na podlagi laboratorijskih opažanj (Zvišanje sečne kisline na > zgornjo normalno mejo od izhodiščne vrednosti pod referenčnim območjem ali znotraj njega.
What Brilique is and what it is used for
Kaj je zdravilo Brilique in za kaj ga uporabljamo
• unstable angina (angina or chest pain that is not well controlled).
• nestabilno angino pektoris (angina pektoris ali bolečina v prsih, ki ni dobro urejena).
Bleeding findings in PEGASUS Overall outcome of bleeding events in the PEGASUS study are shown in Table 3.
Izsledki o krvavitvah v študiji PEGASUS Skupni izidi dogodkov, povezanih s krvavitvami, v študiji PEGASUS so prikazani v preglednici 3.
ACS patients with prior ischaemic stroke can be treated with ticagrelor for up to 12 months (PLATO study).
Bolniki z AKS in predhodno ishemično možgansko kapjo lahko prejemajo zdravljenje s ticagrelorjem do 12 mesecev (študija PLATO).
Some bleeding is common (like bruising and nosebleeds).
Nekatere krvavitve so pogoste (npr. podplutbe in krvavitev iz nosu).
• High level of uric acid in your blood (as seen in tests)
• visoka koncentracija sečne kisline v krvi (pokaže se na preiskavah)
The RRR for the composite endpoint from 1 to 360 days (17% RRR) and from 361 days and onwards (16% RRR) was similar.
RRR za sestavljeni opazovani dogodek od 1. do 360. dne (17 % RRR) in od 361. dne naprej (16 % RRR) je bilo podobno.
The mean t1/2 was approximately 7 hours for ticagrelor and 8.5 hours for the active metabolite.
Povprečni t1/2 je bil približno 7 ur za ticagrelor in 8,5 ure za aktivni presnovek.
The mean absolute bioavailability of ticagrelor was estimated to be 36%.
Ocenjena povprečna absolutna biološka uporabnost ticagrelorja je bila 36 %.
Ticagrelor is also a P-glycoprotein (P-gp) substrate and a weak P-gp inhibitor and may increase the exposure of P-gp substrates.
Ticagrelor je tudi substrat P-glikoproteina (P-gp) in šibek zaviralec P-gp in lahko poveča izpostavljenost substratom P-gp.
However, a link between the observed increases in adenosine and clinical outcomes (e.g. morbidity-mortality) has not been clearly elucidated.
Vendar pa povezava med opaženim dvigom koncentracije adenozina in kliničnimi izidi (npr.: obolevnost/umrljivost) ni povsem pojasnjena.
It can then be swallowed with or without water (see section 5.2).
Tableto je mogoče vzeti z vodo ali brez nje (glejte poglavje 5.2).
The exposure in patients self-identified as Hispanic or Latino was similar to that in Caucasians.
Pri bolnikih, ki so se sami opredelili za hispano- ali latinoameričane, je bila izpostavljenost podobna kot pri belcih.
When radiolabelled ticagrelor is administered, the mean recovery of radioactivity is approximately 84% (57.8% in faeces, 26.5% in urine).
Po uporabi radioaktivno označenega ticagrelorja je povprečni delež izločene radioaktivnosti 84 % (57,8 % v blatu, 26,5 % v urinu).
A weakly significant treatment interaction was observed with region whereby the hazard ratio (HR) for the primary endpoint favours ticagrelor in the rest of world but favours clopidogrel in North America, which represented approximately 10% of the overall population studied (interaction p-value=0.045).
Šibko značilno terapevtsko interakcijo so ugotovili z regijo, pri čemer je razmerje ogroženosti (Rog) za primarni opazovani dogodek v korist ticagrelorja v preostalih delih sveta, v koristi klopidogrela pa v Severni Ameriki, ki je predstavljala približno 10 % celotne raziskovane populacije (vrednost p za interakcijo = 0,045).
ASA alone N=6996
Samo ASA N = 6996
The clinical relevance is unknown, but data indicate the potential for reduced ticagrelor efficacy in patients co-administered ticagrelor and morphine.
Klinični pomen tega ni znan, a podatki kažejo na možnost manjše učinkovitosti ticagrelorja pri bolnikih, ki sočasno prejemajo ticagrelor in morfin.
There are limited data on the efficacy and safety of ticagrelor beyond 3 years of extended treatment.
Podatkov o učinkovitosti in varnosti ticagrelorja po več kot 3 letih podaljšanega zdravljenja je malo.
The incidence of intracranial bleeding was low in both treatment groups given the significant comorbidity and CV risk factors of the population under study.
Incidenca intrakranialnih krvavitev je bila v obeh terapevtskih skupinah majhna upoštevaje pomembno komorbidnost in srčno-žilne dejavnike tveganja v raziskovani populaciji.
• Feeling dizzy or light-headed, or having blurred vision - these are signs of low blood pressure
• omotica ali vrtoglavica ali zamegljen vid - to so znaki nizkega krvnega tlaka
Orodispersible tablet.
orodisperzibilno tableto.
Table 5 - Analysis of primary and secondary efficacy endpoints (PEGASUS)
Preglednica 5 - Analiza primarnih in sekundarnih opazovanih dogodkov učinkovitosti (PEGASUS)
• the clot can partly block the blood vessels to the heart; this reduces the blood flow to the heart and can cause chest pain which comes and goes (called ‘unstable angina').
• strdek delno zamaši srčno žilo - to zmanjša pretok krvi v srčno mišico in lahko povzroči bolečine v prsih, ki pridejo in minejo (to imenujemo "nestabilna angina pektoris").
*p-value calculated from Cox proportional hazards model with treatment group as the only explanatory variable.
*Vrednost p je izračunana iz Coxovega modela sorazmernih tveganj s terapevtsko skupino kot edino eksplanatorno spremenljivko.
Clopidogrel N=9186 p-value*
Klopidogrel n = 9186 Vrednost p*
Patients received a 300 mg loading dose of clopidogrel (600 mg possible if having PCI) or 180 mg of ticagrelor.
Bolniki so dobili 300-mg polnilni odmerek klopidogrela (600-mg odmerek je bil možen v primeru PCI) ali 180 mg ticagrelorja.
Effect of ticagrelor on other P-gp substrates has not been studied.
Vpliv ticagrelorja na druge substrate P-gp ni raziskan.
Hypersensitivity including angioedema
Bolezni imunskega sistema preobčutljivost, vključno z angioedemom
If clinically indicated, ticagrelor should be used with caution in the following patient groups:
Če je ticagrelor klinično indiciran, ga je treba previdno uporabljati v naslednjih skupinah bolnikov:
The safety and efficacy of ticagrelor in children below the age of 18 years have not been established.
Varnost in učinkovitost ticagrelorja nista ugotovljeni pri otrocih, mlajših od 18 let.
The steady state volume of distribution of ticagrelor is 87.5 l. Ticagrelor and the active metabolite is extensively bound to human plasma protein (>99.0%).
Volumen porazdelitve ticagrelorja v stanju dinamičnega ravnovesja je 87,5 l. Ticagrelor in njegov aktivni presnovek sta v veliki meri vezana na človeške beljakovine v plazmi (> 99,0 %).
• ‘oral anticoagulants' often referred to as ‘blood thinners' which include warfarin.
• "peroralne antikoagulante" (pogosto jih imenujejo "zdravila za redčenje krvi"), med katere spada varfarin.
The glass should be rinsed with a further half glass of water and the contents drunk.
Kozarec morajo nato splakniti z dodatnega pol kozarca vode in to vodo popiti.
Severe bleeding is uncommon but can be life threatening.
Hude krvavitve so občasne, vendar so lahko smrtno nevarne.
Although the efficacy profile of 90 mg and 60 mg were similar, there is evidence that the lower dose has a better tolerability and safety profile in relation to risk of the bleeding and dyspnoea.
Profila učinkovitosti 90 mg in 60 mg sta bila sicer podobna, vendar obstajajo dokazi, da ima manjši odmerek boljše prenašanje in varnostne značilnosti, kar zadeva tveganje za krvavitve in dispnejo.
Brilique affects blood clotting, so most side effects are related to bleeding.
Zdravilo Brilique vpliva na strjevanje krvi, zato je večina neželenih učinkov povezanih s krvavitvami.
What Brilique is and what it is used for What you need to know before you take Brilique How to take Brilique
Kaj je zdravilo Brilique in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Brilique Kako jemati zdravilo Brilique Možni neželeni učinki
• Crush the tablet to a fine powder.
• Zdrobite tableto v droben prašek.
Table 4 - Analysis of primary and secondary efficacy endpoints (PLATO)
- Analiza primarnih in sekundarnih opazovanih dogodkov učinkovitosti (PLATO)
Within each SOC the adverse reactions are ranked by frequency category.
Pri vsakem posameznem organskem sistemu so neželeni učinki razvrščeni po kategoriji pogostnosti.
It might be due to your heart disease or another cause, or it might be a side effect of Brilique.
Lahko je posledica bolezni srca ali kakšnega drugega vzroka, lahko pa je tudi neželeni učinek zdravila Brilique.
For patients who are unable to swallow the tablet(s) whole, the tablets can be crushed to a fine powder and mixed in half a glass of water and drunk immediately.
Bolniki, ki tablete/tablet ne morejo pogoltniti cele/celih, lahko tablete zdrobijo v droben prašek, ki ga zmešajo s pol kozarca vode in takoj popijejo.
Similar to the overall PLATO study, total PLATO Major bleeding did not differ between ticagrelor and clopidogrel, regardless of CYP2C19 or ABCB1 genotype.
Podobno kot v študij PLATO v celoti se vse hude krvavitve po PLATO med ticagrelorjem in klopidogrelom niso razlikovale, ne glede na genotip CYP2C19 ali ABCB1.
CI = Confidence interval; CV = Cardiovascular; HR = Hazard ratio; KM = Kaplan-Meier; MI = Myocardial infarction; N = Number of patients.
IZ = interval zaupanja, KV = kardiovaskularen, ROg = razmerje ogroženosti, KM = Kaplan-Meier, MI = miokardni infarkt, N = število bolnikov.
During treatment with ticagrelor, dizziness and confusion have been reported.
Med zdravljenjem s ticagrelorjem so poročali o omotici in zmedenosti.
Absorption of ticagrelor is rapid with a median tmax of approximately 1.5 hours.
Absorpcija ticagrelorja je hitra in mediani tmax je približno 1,5 ure.
Ticagrelor does not prevent ADP binding but when bound to the P2Y12 receptor prevents ADP-induced signal transduction.
Ticagrelor ne prepreči vezave ADP, temveč z vezavo na receptor P2Y12 prepreči prevajanje signalov, sproženih z ADP.
The majority of these bleedings were of less severity (classified as TIMI Requiring medical attention), e.g. epistaxis, bruising and haematomas.
Večina teh krvavitev je bila manj izrazita (opredeljene kot potreba po medicinski oskrbi po TIMI), npr. epistaksa, podplutbe in hematomi.
If you forget to take Brilique
Če ste pozabili vzeti zdravilo Brilique
If you have trouble swallowing the tablet If you have trouble swallowing the tablet you can crush it and mix with water as follows:
Če tableto težko pogoltnete, jo lahko zdrobite in zmešate z vodo na naslednji način:
Most reported symptoms of dyspnoea were mild to moderate in intensity, and most were reported as a single episode early after starting treatment.
Večina opisanih simptomov z dispnejo je bila blagih do zmernih in večina jih je bila zabeleženih kot enkraten pojav zgodaj po začetku zdravljenja.
A 60 mg orodispersible tablet is not available.
60 mg orodisperzibilne tablete ni na voljo.
This suggests it is appropriate to treat patients with ticagrelor 90 mg twice daily for 12 months (see section 4.2).
To kaže, da je bolnike ustrezno z 90 mg ticagrelorja dvakrat na dan zdraviti 12 mesecev (glejte poglavje 4.2).
If a patient is to undergo elective surgery and antiplatelet effect is not desired, ticagrelor should be discontinued 5 days prior to surgery (see section 5.1).
Če ima bolnik predvideno elektivno operacijo in antiagregacijski učinek ni zaželen, je treba uporabo ticagrelorja prekiniti 5 dni pred operacijo (glejte poglavje 5.1).
The European Medicines Agency has waived the obligation to submit the results of studies with Brilique in all subsets of the paediatric population in acute coronary syndromes (ACS) and history of myocardial infarction (MI) (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je odstopila od obveze za predložitev rezultatov študij z zdravilom Brilique za vse skupine pediatrične populacije pri akutnih koronarnih sindromih (AKS) in anamnezi miokardnega infarkta (MI) (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
• To make sure there is no medicine left, rinse the empty glass with another half a glass of water and drink it.
• Da boste zagotovo zaužili celoten odmerek zdravila, prazni kozarec splaknite z dodatnega pol kozarca vode in to vodo popijte.
Treating 54 ACS patients with ticagrelor instead of clopidogrel will prevent 1 atherothrombotic event; treating 91 will prevent 1 CV death (see Figure 1 and Table 4).
Zdravljenje 54 bolnikov z akutnimi koronarnimi sindromi s ticagrelorjem namesto s klopidogrelom bo preprečilo 1 aterotrombotičen dogodek, zdravljenje 91 bolnikov bo preprečilo 1 kardiovaskularno smrt (glejte sliko 1 in preglednico 4).
• cyclosporine (used to lessen your body's defenses)
• ciklosporin (uporablja se za zmanjševanje telesne obrambe)
PEGASUS study (History of Myocardial Infarction)
Študija PEGASUS (anamneza miokardnega infarkta)
• phenytoin, carbamazepine and phenobarbital (used to control seizures)
• fenitoin, karbamazepin in fenobarbital (uporabljajo se za obvladovanje napadov krčev)
In patients with ACS, in whom morphine cannot be withheld and fast P2Y12 inhibition is deemed crucial, the use of a parenteral P2Y12 inhibitor may be considered.
Pri tistih bolnikih z AKS, pri katerih se uporabi morfina ni mogoče izogniti, hitro zavrtje P2Y12 pa je ključnega pomena, pride v poštev parenteralna uporaba zaviralca P2Y12.
Age, sex, weight, race, geographic region, concurrent conditions, concomitant therapy and medical history, including a previous stroke or transient ischaemic attack, all did not predict either overall or non-procedural PLATO Major bleeding.
Starost, spol, telesna masa, rasa, geografska regija, sočasne bolezni, sočasna zdravljenja in zdravstvena anamneza, vključno s predhodno možgansko kapjo ali tranzitorno ishemično atako, niso bili napovedniki ne vseh in ne s postopki nepovezanih krvavitev po PLATO.
• You can check when you last took a tablet of Brilique by looking on the blister.
• Kdaj ste vzeli zadnjo tableto zdravila Brilique, lahko preverite tako, da pogledate na pretisni omot.
• You have severe liver disease.
• če imate hudo bolezen jeter.
Initial exposure (0.5 and 1 hour post-dose) from crushed ticagrelor tablets mixed in water was higher compared to whole tablets, with a generally identical concentration profile thereafter (2 to 48 hours).
Začetna izpostavljenost (0,5 in 1 uro po odmerku) pri zdrobljenih tabletah ticagrelorja, zmešanih z vodo, je bila v primerjavi z uporabo celih tablet večja, pozneje (od 2 do 48 ur) pa je bil profil koncentracij na splošno enak.
A negative RRR indicates a relative risk increase.
Negativno RRR pomeni povečanje relativnega tveganja izključujoč nemi MI
If you are in the hospital you may be given this tablet mixed with some water and given through a tube via the nose (nasogastric tube).
Če ste v bolnišnici, boste tableto morda dobili zmešano z nekaj vode in po cevki, speljani skozi nos v želodec (po nazogastrični sondi).
The metabolite parent ratios are 0.28 for Cmax and 0.42 for AUC.
Razmerje presnovek matična snov je za Cmax 0,28 in za AUC 0,42.
In patients who have developed HIT, the benefit-risk of continued treatment with ticagrelor should be assessed, taking both the prothrombotic state of HIT and the increased risk of bleeding with concomitant anticoagulant and ticagrelor treatment into consideration.
Pri bolnikih, ki se jim pojavi HIT, je treba oceniti korist in tveganje nadaljnjega zdravljenja s ticagrelorjem, pri tem je treba upoštevati tako protrombotično stanje HIT kot večje tveganje za krvavitve med sočasnim antikoagulantnim zdravljenjem in zdravljenjem s ticagrelorjem.
Co-administration of ticagrelor and levonorgestrel and ethinyl estradiol increased ethinyl estradiol exposure approximately 20% but did not alter the pharmacokinetics of levonorgestrel.
Sočasna uporaba ticagrelorja ter levonorgestrela in etinilestradiola je povečala izpostavljenost etinilestradiolu za približno 20 %, farmakokinetike levonorgestrela pa ni spremenila.
Chronic daily ASA doses to accompany ticagrelor should be 75-150 mg (see sections 4.2 and 4.4).
Kronični dnevni odmerki ASA ob uporabi ticagrelorja morajo biti od 75 do 150 mg (glejte poglavji 4.2 in 4.4).
• Patients with concomitant administration of medicinal products that may increase the risk of bleeding (e.g. non-steroidal anti-inflammatory drugs (NSAIDs), oral anticoagulants and/or fibrinolytics) within 24 hours of ticagrelor dosing.
• Bolniki, sočasno zdravljeni z zdravili, ki lahko povečajo tveganje krvavitev (npr. nesteroidna protivnetna zdravila (NSAID), peroralni antikoagulanti in/ali fibrinolitiki) v 24 urah od uporabe ticagrelorja.
The concomitant use of ticagrelor with doses of simvastatin or lovastatin greater than 40 mg is not recommended.
Sočasna uporaba ticagrelorja z odmerki simvastatina ali lovastatina, večjimi od 40 mg, ni priporočljiva.
• To take out the tablet, tear open the blister foil - do not push it through the foil because the tablet may break.
• Da boste tableto vzeli ven, odtrgajte folijo pretisnega omota - ne potisnite tablete skozi folijo,
If a CABG procedure is planned, ticagrelor bleeding risk is increased compared to clopidogrel when discontinued within less than 96 hours prior to procedure.
Če je načrtovana koronarna obvodna operacija (CABG), je tveganje krvavitev s ticagrelorjem večje kot s klopidogrelom, če se uporaba preneha v manj kot 96 urah pred posegom.
When the orodispersible tablet was dispersed in saliva and swallowed with water, ticagrelor AUC was similar, while Cmax was about 15% lower than for the film-coated tablet.
Če je bila orodisperzibilna tableta raztopljena v slini in zaužita z vodo, je bila AUC ticagrelorja podobna, njegova Cmax pa približno 15 % nižja kot pri filmsko obloženih tabletah.
Brilique in combination with acetylsalicylic acid (another antiplatelet agent) is to be used in adults only.
Zdravilo Brilique v kombinaciji z acetilsalicilno kislino (to je drugo antiagregacijsko zdravilo) se lahko uporablja le pri odraslih.
• Bleeding after surgery or from cuts (for example while shaving) and wounds more than is normal
• krvavitev po operaciji ali krvavitev iz ureznin (npr. med britjem) in ran, ki je močnejša kot po navadi
This is related to inhibition of the P2Y12-receptor on the healthy donor platelets in the test by ticagrelor in the patient's sera/plasma.
To je povezano z zavrtjem receptorja P2Y12 na trombocitih zdravega darovalca v tej preiskavi zaradi prisotnosti ticagrelorja v bolnikovem serumu/plazmi.
This is because of the increased risk of bleeding.
Obstaja namreč večje tveganje za krvavitev.
• Signs of bleeding such as: - bleeding that is severe or that you cannot control - unexpected bleeding or bleeding that lasts a long time - pink, red or brown urine - vomiting red blood or your vomit looks like ‘coffee grounds' - red or black stools (look like tar) - coughing up or vomiting blood clots
• Znaki krvavitve, na primer: - krvavitev, ki je huda ali je ne morete nadzorovati - nepričakovana krvavitev ali krvavitev, ki traja dolgo časa - rožnat, rdeč ali rjav urin - bruhanje rdeče krvi ali izbruhana vsebina, ki je na pogled kot "kavna usedlina" - rdeče ali črno blato (kot katran) - izkašljevanje ali bruhanje krvnih strdkov
• The PEGASUS TIMI-54 [PrEvention with TicaGrelor of SecondAry Thrombotic Events in High-RiSk AcUte Coronary Syndrome Patients] study, a comparison of ticagrelor combined with ASA to ASA therapy alone.
• Študije PEGASUS TIMI-54 [PrEvention with TicaGrelor of SecondAry Thrombotic Events in High-RiSk AcUte Coronary Syndrome Patients], ki je primerjala ticagrelor v kombinaciji z ASA z uporabo ASA same.
Switching from clopidogrel 75 mg to ticagrelor 90 mg twice daily results in an absolute IPA increase of 26.4% and switching from ticagrelor to clopidogrel results in an absolute IPA decrease of 24.5%.
Prehod s 75 mg klopidogrela na 90 mg ticagrelorja dvakrat na dan povzroči absolutno povečanje IPA za 26,4 %, prehod s ticagrelorja na klopidogrel pa absolutno zmanjšanje IPA za 24,5 %.
PLATO genetic substudy
Genetska podštudija PLATO
Antifibrinolytic therapy (aminocaproic acid or tranexamic acid) and/or recombinant factor VIIa therapy may increase haemostasis.
Antifibrinolitično zdravljenje (aminokaprojska kislina ali traneksaminska kislina) in/ali zdravljenje z rekombinantnim faktorjem VIIa lahko povečajo hemostazo.
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking this medicine.
Če kaj od naštetega velja za vas (ali če niste prepričani), se posvetujte z zdravnikom ali farmacevtom, preden vzamete to zdravilo.
Ticagrelor does not affect tests of pulmonary function.
Ticagrelor ne vpliva na teste delovanja pljuč.
Table 3 - Analysis of overall bleeding events, Kaplan-Meier estimates at 36 months (PEGASUS)
Preglednica 3 - Analiza vseh dogodkov, povezanih s krvavitvami, Kaplan-Meierjeve ocene po 36 mesecih (PEGASUS)
Similarly, when removing all procedure related bleeds, more bleeding occurred with ticagrelor than with clopidogrel (Table 2).
Tudi po izločitvi vseh s postopki povezanih krvavitev je bilo, podobno, več krvavitev s ticagrelorjem kot s klopidogrelom (preglednica 2).
• Bleeding into your joints and muscles causing painful swelling
• krvavitev v sklepe in mišice, ki povzroči boleče otekanje
Fertility Ticagrelor had no effect on male or female fertility in animals (see section 5.3).
Plodnost Ticagrelor pri živalih ni vplival na moško ali žensko plodnost (glejte poglavje 5.3).
Few patients in PLATO had fatal bleeds: 20 (0.2%) for ticagrelor and 23 (0.3%) for clopidogrel (see section 4.4).
Malo bolnikov v PLATO je imelo krvavitve s smrtnim izidom: 20 (0,2 %) pri ticagrelorju in 23 (0,3 %) pri klopidogrelu (glejte poglavje 4.4).
Ticagrelor demonstrates linear pharmacokinetics and exposure to ticagrelor and the active metabolite (AR-C124910XX) are approximately dose proportional up to 1260 mg.
Ticagrelor ima linearno farmakokinetiko in izpostavljenost ticagrelorju in njegovemu aktivnemu presnovku (AR-C124910XX) sta približno sorazmerni odmerku do 1260 mg.
• Severe hepatic impairment (see sections 4.2, 4.4 and 5.2).
• Huda okvara jeter (glejte poglavja 4.2, 4.4 in 5.2).
• Bleeding caused by blood disorders
• krvavitve zaradi krvnih bolezni
Patients were ineligible if there was planned use of a P2Y12 receptor antagonist, dipyridamole, cilostazol, or anticoagulant therapy during the study period; if they had a bleeding disorder or a history of an ischaemic stroke or intracranial bleeding, a central nervous system tumour or an intracranial vascular abnormality; if they had had gastrointestinal bleeding within the previous 6 months or major surgery within the previous 30 days.
Bolniki niso bili primerni, če so imeli načrtovano uporabo antagonista receptorjev P2Y12, dipiridamola, cilostazola ali antikoagulantov med obdobjem študije; če so imeli motnjo strjevanja krvi ali anamnezo ishemične možganske kapi ali intrakranialne krvavitve, tumor osrednjega živčevja ali intrakranialno žilno nepravilnost; če so imeli gastrointestinalno krvavitev v zadnjih 6 mesecih ali večjo operacijo v zadnjih 30 dneh.
• You are bleeding now.
• če krvavite.
Clopidogrel 75 mg once daily (% patients with event) N=9291
Klopidogrel 75 mg enkrat na dan (% bolnikov z dogodkom) n = 9291