FrancophonIA/ELRC3.0 huggingface dataset:
English: An occasional use of acetylsalicylic acid (no more than 1,000 mg in any 24 hour period) should generally not cause a problem, but prolonged use in other circumstances should be discussed with your doctor.
Slovenian: Priložnostna uporaba acetilsalicilne kisline (ne več kot 1.000 mg v kateremkoli 24 urnem obdobju) na splošno ne bi smela povzročati težav, vendar pa se morate o daljši uporabi v drugih okoliščinah posvetovati s svojim zdravnikom.
English: Moreover, the safety profile of clopidogrel in this subgroup of patients did not raise any particular concern.
Slovenian: Poleg tega varnostne značilnosti klopidogrela v tej podskupini bolnikov niso bile skrb zbujajoče.
English: • You should tell your doctor if a surgery (including dental) is planned
Slovenian: • morate zdravniku povedati, če imate predvideno kakšno operacijo (tudi zobozdravstveni poseg);
English: Since the CAPRIE trial was not powered to evaluate efficacy of individual subgroups, it is not clear whether the differences in relative risk reduction across qualifying conditions are real, or a result of chance.
Slovenian: Ker CAPRIE nima moči za oceno učinkovitosti v posameznih podskupinah, ni jasno, ali so razlike pri zmanjšanju relativnega tveganja glede na vključitvene pogoje resnične ali naključne.
English: Clopidogrel has been evaluated for safety in more than 42,000 patients who have participated in clinical studies, including over 9,000 patients treated for 1 year or more.
Slovenian: Varnost klopidogrela so vrednotili pri več kot 42.000 bolnikih, ki so sodelovali v kliničnih študijah, vključno z več kot 9.000 bolniki, ki so se zdravili eno leto ali več.
English: The patient population included 19.7% women and 29.2% patients ≥65 years.
Slovenian: Populacijo bolnikov je sestavljalo 19,7 % žensk in 29,2 % bolnikov v starosti ≥ 65 let.
English: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).
Slovenian: Študije na živalih ne kažejo neposrednih ali posrednih škodljivih vplivov na nosečnost, razvoj zarodka/ploda, porod ali postnatalni razvoj (glejte poglavje 5.3).
English: Consequently, a direct effect (slight toxicity), or an indirect effect (low palatability) cannot be excluded.
Slovenian: Posledično ni mogoče izključiti neposrednega učinka (blaga toksičnost) ali posrednega učinka (neprijetnost).
English: Clinical trial data support use up to 12 months, and the maximum benefit was seen at 3 months (see section 5.1).
Slovenian: Podatki iz kliničnih preskušanj podpirajo uporabo do 12 mesecev, največjo korist pa so opazili po 3 mesecih (glejte poglavje 5.1).
English: However, clopidogrel and ASA have been administered together for up to one year (see section 5.1).
Slovenian: Vendar pa so klopidogrel in ASA sočasno jemali do eno leto (glejte poglavje 5.1).
English: In view of the lack of data, clopidogrel cannot be recommended during the first 7 days after acute ischaemic stroke.
Slovenian: Zaradi pomanjkanja podatkov se klopidogrel ne priporoča prvih sedem dni po akutni ishemični kapi.
English: Their frequency is defined using the following conventions: common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare
Slovenian: Njihova pogostnost je navedena po naslednjem dogovoru: pogosti (≥1/100 do <1/10), občasni (≥1/1.000 do <1/100), redki (≥1/10.000 do <1/1.000), zelo redki (<1/10.000).
English: KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia Pharmachemie B.V., Swensweg 5, 2031 GA Haarlem, The Netherlands
Slovenian: KRKA, d. d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenija Pharmachemie B.V., Swensweg 5, 2031 GA Haarlem, Nizozemska
English: Analysis of total mortality as a secondary endpoint did not show any significant difference between clopidogrel (5.8%) and ASA (6.0%).
Slovenian: Analiza skupne umrljivosti kot sekundarnega opazovanega dogodka ni pokazala pomembne razlike med klopidogrelom (5,8%%) in ASA (6%%).
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu/.
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMA) http://www.ema.europa.eu/.
English: PHARMACEUTICAL FORM Film-coated tablet.
Slovenian: FARMACEVTSKA OBLIKA filmsko obložena tableta
English: Platelets are very small structures in the blood, which clump together during blood clotting.
Slovenian: Trombociti so zelo majhne strukture v krvi, in se zlepljajo pri strjevanju krvi.
English: In the fifth cohort study (n=2,208; Simon), the increased event rate was observed only in poor metabolisers.
Slovenian: V peti kohortni študiji (n = 2.208; Simon) so večji delež dogodkov ugotovili samo pri slabih presnavljalcih.
English: The elimination half-life of the main circulating (inactive) metabolite was 8 hours after single and repeated administration.
Slovenian: Razpolovni čas izločanja glavnega krožečega presnovka (neaktivnega) je bil 8 ur po enkratnem in večkratnem dajanju.
English: There was no observed effect on the rate of rehospitalisation for unstable angina.
Slovenian: Učinka na delež ponovnih hospitalizacij zaradi nestabilne angine niso opazili.
English: The binding is non-saturable in vitro over a wide concentration range.
Slovenian: Pri vezavi in vitro ni nasičenja v širokem koncentracijskem razponu.
English: Clopidogrel and the main circulating (inactive) metabolite bind reversibly in vitro to human plasma proteins (98% and 94% respectively).
Slovenian: Klopidogrel in glavni krožeči (neaktivni) metabolit se in vitro reverzibilno vežeta na humane plazemske proteine (98% oziroma 94%).
English: In CLARITY and one of the cohort studies (n=765; Trenk), cardiovascular event rates did not differ significantly by genotype.
Slovenian: V CLARITY in eni od kohortnih študij (n = 765; Trenk) se deleži kardiovaskularnih dogodkov po genotipu niso bistveno razlikovali.
English: If you cut or injure yourself, it may take slightly longer than usual for bleeding to stop.
Slovenian: Če se urežete ali poškodujete, lahko traja dlje kot običajno, da se krvavitev ustavi.
English: The population included 27.8% women, 58.4% patients ≥60 years (26% ≥70 years) and 54.5% patients who received fibrinolytics.
Slovenian: Populacijo bolnikov je sestavljalo 27,8% žensk, 58,4% bolnikov starost ≥ 60 let (26% ≥ 70 let ) in 54,5% bolnikov, ki so dobivali fibrinolitike.
English: Antacids did not modify the extent of clopidogrel absorption.
Slovenian: Antacidi niso spremenili obsega absorpcije klopidogrela.
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu.
English: Cytochrome P450 2C19 (CYP2C19)
Slovenian: Citokrom P450 2C19 (CYP2C19)
English: To date, diminished antiplatelet responses to clopidogrel have been described for intermediate and poor metabolisers in 21 reported studies involving 4,520 subjects.
Slovenian: Doslej so zmanjšane antitrombocitne odzive na klopidogrel opisali pri srednjih in slabih presnavljalcih v 21 opisanih študijah, ki so zajele 4.520 bolnikov.
English: The optimal dose regimen for poor metabolisers has yet to be determined (see section 5.2).
Slovenian: Optimalna shema odmerjanja za slabe presnavljalce še ni določena (glejte poglavje 5.2).
English: Other alleles associated with reduced metabolism include CYP2C19*4, *5, *6, *7, and *8, but these are less frequent in the general population.
Slovenian: Med drugimi aleli, povezanimi z zmanjšano presnovo, so CYP2C19*4, *5, *6, *7 in *8, ki pa so v splošni populaciji redkejši.
English: For patients over 75 years of age clopidogrel should be initiated without a loading dose.
Slovenian: Pri bolnikih, ki so starejši od 75 let, je treba zdravljenje s klopidogrelom začeti brez udarnega odmerka.
English: For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder
Slovenian: Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom:
English: Marketing Authorisation Holder Teva Generics B.V., Computerweg 10, 3542 DR Utrecht, The Netherlands
Slovenian: Imetnik dovoljenja za promet z zdravilom Teva Generics B.V., Computerweg 10, 3542 DR Utrecht, Nizozemska
English: This benefit was consistent across age, gender and with or without fibrinolytics, and was observed as early as 24 hours.
Slovenian: Ta koristni učinek se je pojavil pri vseh starostih, obeh spolih in ob jemanju fibrinolitikov ali brez njega, opažen pa je bil že po 24 urah.
English: For the 28x1 tablets pack size, you can check the day on which you last took the tablet by referring to the calendar printed on the blister.
Slovenian: Če uporabljate pakiranje 28 x 1 tableta, lahko dan, ko ste nazadnje vzeli tableto, preverite na koledarju odtisnjenem na pretisnem omotu.
English: This benefit was mostly driven by the statistically significant reduction in the incidence of MI [287 (4.6%) in the clopidogrel treated group and 363 (5.8%) in the placebo treated group].
Slovenian: Ta korist je bila v glavnem zaradi statistično pomembnega zmanjšanja incidence MI [287 (4,6%) v skupini, zdravljeni s klopidogrelom, in 363 (5,8%) v skupini s placebom].
English: Clopidogrel is indicated in adults for the prevention of atherothrombotic events in:
Slovenian: Klopidogrel je indiciran pri odraslih za preprečevanje aterotrombotičnih dogodkov pri bolnikih z:
English: Pharmacotherapeutic group: platelet aggregation inhibitors excl. heparin, ATC code: B01AC-04.
Slovenian: Farmakoterapevtska skupina: zaviralci agregacije trombocitov brez heparina, oznaka ATC: B01AC04.
English: In another study it was shown that administering clopidogrel and omeprazole 12 hours apart did not prevent their interaction that is likely to be driven by the inhibitory effect of omeprazole on CYP2C19.
Slovenian: Druga študija je pokazala, da uporaba klopidogrela in omeprazola v presledku 12 ur ne prepreči njunega medsebojnega delovanja, ki je verjetno posledica zavrtja CYP2C19 z omeprazolom.
English: NSAIDs: in a clinical study conducted in healthy volunteers, the concomitant administration of clopidogrel and naproxen increased occult gastrointestinal blood loss.
Slovenian: NSAID: v klinični študiji, na zdravih prostovoljcih je sočasno jemanje klopidogrela in naproksena povečalo prikrito krvavitev iz prebavil.
English: The co-primary endpoints were death from any cause and the first occurrence of re-infarction, stroke or death.
Slovenian: Sestavljeni opazovani dogodki so bili smrt zaradi kateregakoli vzroka ali prvi pojav ponovnega infarkta, kapi ali smrt.
English: Hallucinations, confusion
Slovenian: Psihiatrične motnje halucinacije, zmedenost
English: • if you have a medical condition that is currently causing bleeding such as a stomach ulcer or bleeding within the brain
Slovenian: • če imate zdravstveno stanje, ki trenutno povzroča krvavitev, npr. rana na želodcu ali možganska krvavitev;
English: If you have experienced severe chest pain (unstable angina or heart attack), you may be prescribed clopidogrel in combination with acetylsalicylic acid, a substance present in many medicines used to relieve pain and lower fever.
Slovenian: Če ste doživeli hudo bolečino v prsih (nestabilna angina pektoris ali srčni napad), so vam morda predpisali zdravilo klopidogrel v kombinaciji z acetilsalicilno kislino, učinkovino, ki je prisotna v številnih zdravilih, ki se uporabljajo za lajšanje bolečine in zniževanje zvišane telesne temperature.
English: Because the active metabolite is formed by CYP450 enzymes, some of which are polymorphic or subject to inhibition by other drugs, not all patients will have adequate platelet inhibition.
Slovenian: Ker aktivni presnovek nastane z delovanjem encimov CYP450, od katerih so nekateri polimorfni ali podvrženi zavrtju z drugimi zdravili, se ustrezno zavrtje trombocitov ne pojavi pri vseh bolnikih.
English: In patients with acute ST-segment elevation MI, safety and efficacy of clopidogrel have been evaluated in 2 randomised, placebo-controlled, double-blind studies, CLARITY and COMMIT.
Slovenian: Pri bolnikih z akutnim miokardnim infarktom z elevacijo ST spojnice sta bili varnost in učinkovitost klopidogrela vrednoteni v dveh randomiziranih, s placebom kontroliranih, dvojno slepih študijah, CLARITY in COMMIT.
English: 4.5 Interaction with other medicinal products and other forms of interaction
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Peroralni antikoagulanti.
English: Pharmacogenetic testing can identify genotypes associated with variability in CYP2C19 activity.
Slovenian: Farmakogenetsko testiranje lahko odkrije genotipe, povezane z variabilnostjo aktivnosti CYP2C19.
English: Data from studies with human liver microsomes indicated that the carboxylic acid metabolite of clopidogrel could inhibit the activity of Cytochrome P450 2C9.
Slovenian: Podatki iz študij s humanimi jetrnimi mikrosomi kažejo, da lahko karboksilni kislinski presnovek klopidogrela zaustavi aktivnost citokroma P450 2C9.
English: To date, the impact of CYP2C19 genotype on the pharmacokinetics of the active metabolite of clopidogrel has been evaluated in 227 subjects from 7 reported studies.
Slovenian: Doslej so vpliv genotipa CYP2C19 na farmakokinetiko aktivnega presnovka klopidogrela ocenili pri 227 preiskovancih v 7 opisanih študijah.
English: If you think any of these apply to you, or if you are in any doubt at all, consult your doctor before taking Clopidogrel Teva Generics B.V..
Slovenian: Če menite, da se karkoli od navedenega nanaša na vas, ali če ste kakorkoli v dvomih, se posvetujte s svojim zdravnikom, preden vzamete zdravilo Klopidogrel Teva Generics B.V..
English: • Patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease.
Slovenian: • Miokardnim infarktom (od nekaj dni do manj kot 35 dni), ishemično kapjo (od 7 dni do manj kot 6 mesecev) ali dokazano periferno arterijsko boleznijo.
English: The CYP2C19*2 and CYP2C19*3 alleles account for 85% of reduced function alleles in whites and 99% in Asians.
Slovenian: Na račun alelov CYP2C19*2 in CYP2C19*3 gre 85% alelov z zmanjšanim delovanjem pri belcih in 99% pri Azijcih.
English: Film coating:
Slovenian: Filmska obloga:
English: Heparins were administered in more than 90% of the patients and the relative rate of bleeding between clopidogrel and placebo was not significantly affected by the concomitant heparin therapy.
Slovenian: Heparine so uporabljali pri več kot 90% bolnikov, sočasna uporaba heparinske terapije ni pomembno vplivala na relativni delež krvavitev med klopidogrelom in placebom.
English: This was consistent across subgroups of patients defined by baseline characteristics, and type of fibrinolytic or heparin therapy.
Slovenian: To je veljalo tudi za podskupine bolnikov, opredeljene z določenimi izhodiščnimi značilnostmi in tipom fibrinolitičnega ali heparinskega zdravljenja.
English: The association between CYP2C19 genotype and clopidogrel treatment outcome was evaluated in 2 post hoc clinical trial analyses (substudies of CLARITY [n=465] and TRITON-TIMI 38 [n=1,477]) and 5 cohort studies (total n=6,489).
Slovenian: Povezavo med genotipom CYP2C19 in izidom zdravljenja s klopidogrelom so ocenili v 2 post hoc analizah kliničnih preskušanj (podštudiji CLARITY [n = 465] in TRITON-TIMI 38 [n = 1.477]) ter 5
English: Data from the CAPRIE study indicate that phenytoin and tolbutamide can be safely co-administered with clopidogrel.
Slovenian: Podatki študije CAPRIE kažejo, da je sočasno jemanje fenitoina in tolbutamida s klopidogrelom varno.
English: Thus, beyond 3 months of treatment, the benefit observed in the clopidogrel + ASA group was not further increased, whereas the risk of haemorrhage persisted (see section 4.4).
Slovenian: Tako se pri zdravljenju več kot 3 mesece opažena korist v skupini, ki je prejemala klopidogrel in ASA, ni nadalje povečevala, medtem ko je tveganje za krvavitev ostala (glejte poglavje 4.4).
English: Clopidogrel significantly reduced the relative risk of death from any cause by 7% (p=0.029), and the relative risk of the combination of re-infarction, stroke or death by 9% (p=0.002), representing an absolute reduction of 0.5% and 0.9%, respectively.
Slovenian: Klopidogrel je pomembno zmanjšal relativno tveganje za smrt zaradi kateregakoli vzroka za 7% (p=0,029) in relativno tveganje za ponovni infarkt, kap ali smrt za 9% (p=0,002), kar je predstavljalo absolutno zmanjšanje za 0,5% oziroma 0,9%.
English: In TRITON-TIMI 38 and 3 of the cohort studies (n= 3,516; Collet, Sibbing, Giusti), patients with an impaired metaboliser status (intermediate and poor combined) had a higher rate of cardiovascular events (death, myocardial infarction, and stroke) or stent thrombosis compared to extensive metabolisers.
Slovenian: V TRITON-TIMI 38 in 3 kohortnih študijah (n = 3.516; Collet, Sibbing, Giusti) so imeli bolniki s statusom nezadostnega presnavljalca (srednji in slabi presnavljalci skupaj) večji delež kardiovaskularnih dogodkov (smrt, miokardni infarkt, možganska kap) ali tromboze na opornici kot močni metabolizatorji.
English: The pharmacokinetics of the active metabolite of clopidogrel is not known in these special populations.
Slovenian: Farmakokinetika aktivnega presnovka klopidogrela v teh posebnih skupinah bolnikov ni znana.
English: Within each system organ class, adverse drug reactions are presented in order of decreasing seriousness.
Slovenian: Pri vsakem organskem sistemu so neželeni učinki navedeni po padajoči resnosti.
English: You should also be given acetylsalicylic acid (a substance present in many medicines used to relieve pain and lower fever as well as to prevent blood clotting) by your doctor.
Slovenian: Zdravnik vam bo moral predpisati tudi acetilsalicilno kislino (učinkovina, ki je prisotna v številnih zdravilih proti bolečinam in za zniževanje zvišane telesne tempreature, kakor tudi za preprečevanje strjevanja krvi).
English: Hydroxypropylcellulose (E463) Titanium dioxide (E171) Red iron oxide (E172) Talc
Slovenian: hipromeloza (E464) titanov dioksid (E171)
English: There may be genetic variants of other CYP450 enzymes with effects on the ability to form the active metabolite of clopidogrel.
Slovenian: Mogoče je, da obstajajo tudi genetske različice drugih encimov CYP450, ki vplivajo na zmožnost tvorbe aktivnega presnovka klopidogrela.
English: After single and repeated oral doses of 75 mg per day, clopidogrel is rapidly absorbed.
Slovenian: Absorpcija Po enkratnem in večkratnih peroralnih odmerkih po 75 mg na dan se klopidogrel hitro absorbira
English: This benefit was consistent across all prespecified subgroups including patients' age and gender, infarct location, and type of fibrinolytic or heparin used.
Slovenian: Ta koristni učinek se je pojavljal v vseh prehodno opredeljenih podskupinah glede na bolnikovo starost ali spol, mesto infarkta in tip uporabljenega fibrinolitika ali heparina.
English: Lower active metabolite exposure results in less platelet inhibition or higher residual platelet reactivity.
Slovenian: Manjša izpostavljenost aktivnemu presnovku povzroči manjše zavrtje trombocitov ali večjo rezidualno reaktivnost trombocitov.
English: Further information
Slovenian: DODATNE INFORMACIJE
English: Pregnancy and breast-feeding It is preferable not to use this product during pregnancy and breast-feeding.
Slovenian: Nosečnost in dojenje Priporočljivo je, da tega zdravila ne jemljejo nosečnice in matere, ki dojijo.
English: 3542 DR Utrecht The Netherlands
Slovenian: Computerweg 10 3542 DR Utrecht Nizozemska
English: The CLARITY trial included 3,491 patients presenting within 12 hours of the onset of a ST elevation MI and planned for thrombolytic therapy.
Slovenian: V študijo CLARITY je bilo vključenih 3.491 bolnikov v 12 urah po nastopu akutnega miokardnega infarkta z elevacijo ST spojnice, ki so bili predvideni za trombolitično terapijo.
English: Clopidogrel has been tested in a range of in vitro and in vivo genotoxicity studies, and showed no genotoxic activity.
Slovenian: Klopidogrel so preizkušali v številnih in vitro ter in vivo študijah genotoksičnosti in niso ugotovili nobenega genotoksičnega učinka.
English: For patients who did not undergo angiography, the primary endpoint was death or recurrent myocardial infarction by Day 8 or by hospital discharge.
Slovenian: Pri bolnikih, pri katerih ni bila opravljena angiografija, sta bila primarna opazovana dogodka smrt ali ponovni miokardni infarkt do 8. dneva oziroma do odpusta.
English: Patients should be told that it might take longer than usual to stop bleeding when they take clopidogrel (alone or in combination with ASA), and that they should report any unusual bleeding (site or duration) to their physician.
Slovenian: Bolnike, ki jemljejo klopidogrel (samega ali v kombinaciji z ASA), je treba opozoriti, da je lahko čas, ki je potreben za zaustavitev krvavitve, daljši kot ponavadi, in da morajo svojemu zdravniku poročati o kakršnikoli neobičajni krvavitvi (o mestu ali trajanju).
English: Pharmacogenetics
Slovenian: Farmakogenetika
English: TEVA PHARMA, S.L.U.
Slovenian: España TEVA PHARMA, S.L.U.
English: Elimination Following an oral dose of 14C-labelled clopidogrel in man, approximately 50% was excreted in the urine and approximately 46% in the faeces in the 120-hour interval after dosing.
Slovenian: Po peroralnem odmerku s 14C označenega klopidogrela pri človeku se ga je v 120-urnem intervalu po odmerjanju približno 50%% izločilo s sečem in približno 46% z blatom.
English: Reduced CYP2C19 metabolism in intermediate and poor metabolisers decreased the Cmax and AUC of the active metabolite by 30-50% following 300- or 600-mg loading doses and 75-mg maintenance doses.
Slovenian: Zmanjšana presnova s CYP2C19 pri srednjih in slabih presnavljalcih je po 300- ali 600-mg polnilnem odmerku in 75-mg vzdrževalnem odmerku zmanjšala Cmax in AUC aktivnega presnovka za 30 do 50%.
English: The use of clopidogrel in CURE was associated with a decrease in the need of thrombolytic therapy (RRR=43.3%; CI: 24.3%, 57.5%) and GPIIb/IIIa inhibitors (RRR=18.2%; CI: 6.5%, 28.3%).
Slovenian: Uporaba klopidogrela v CURE je bila povezana z zmanjšano potrebo po zdravljenju s trombolitiki (zmanjšanje RT= 43,3%; IZ: 24,3%, 57,5%) in inhibitorji glikoproteinov IIb/IIIa (zmanjšanje RT =18,2%; IZ: 6,5%, 28,3%).
English: The primary endpoint was the occurrence of the composite of an occluded infarct-related artery on the predischarge angiogram, or death or recurrent MI before coronary angiography.
Slovenian: Primarni opazovani dogodki so bili navzočnost kompozita (zaradi infarkta zamašene arterije) na angiogramu pred odpustom ali smrt ali ponovni miokardni infarkt pred koronarno angiografijo.
English: Pharmacogenetics: Based on literature data, patients with genetically reduced CYP2C19 function have lower systemic exposure to the active metabolite of clopidogrel and diminished antiplatelet responses, and generally exhibit higher cardiovascular event rates following myocardial infarction than do patients with normal CYP2C19 function (see section 5.2).
Slovenian: Farmakogenetika: Podatki iz literature kažejo, da imajo bolniki z genetsko zmanjšano funkcijo CYP2C19 manjšo sistemsko izpostavljenost aktivnemu presnovku klopidogrela in manjše antitrombocitne odzive; delež kardiovaskularnih dogodkov po miokardnem infarktu je pri teh bolnikih na splošno večji kot pri bolnikih z normalnim delovanjem CYP2C19 (glejte poglavje 5.2).
English: There was no excess in major bleeds with clopidogrel + ASA within 7 days after coronary bypass graft surgery in patients who stopped therapy more than five days prior to surgery (4.4% clopidogrel + ASA vs. 5.3% placebo + ASA).
Slovenian: Število velikih krvavitev s klopidogrelom in ASA ni bilo prekoračeno v sedmih dneh po koronarni premostitveni operaciji pri bolnikih, ki so zdravljenje prekinili več kot pet dni pred kirurškim posegom (klopidogrel in ASA: 4,4%%; placebo in ASA 5,3%%).