FrancophonIA/ELRC3.0 huggingface dataset:
English: Switching from a more potent P2Y12 receptor inhibitor to clopidogrel in association with aspirin after acute phase in ACS has been evaluated in two randomized investigator-sponsored studies (ISS)TOPIC and TROPICAL-ACS - with clinical outcome data.
Croatian: Prelazak s potentnijeg inhibitora P2Y12 receptora na klopidogrel u kombinaciji s acetilsalicilatnom kiselinom nakon akutne faze akutnog koronarnog sindroma ispitan je u dva randomizirana ispitivanja sponzorirana od strane ispitivača (engl. investigator-sponsored studies, ISS) TOPIC i TROPICALACS, s podacima o kliničkim ishodima.
English: In CURE, there was no excess in major bleeds with clopidogrel plus ASA within 7 days after coronary bypass graft surgery in patients who stopped therapy more than five days prior to surgery .
Croatian: U studiji CURE s klopidogrelom uz ASK nije bilo povećanja broja velikih krvarenja tijekom 7 dana nakon ugrađivanja srčane premosnice u bolesnika koji su lijekove prestali uzimati više od pet dana prije kirurškog zahvata.
English: Mean peak plasma levels of unchanged clopidogrel (approximately 2.2-2.5 ng/ml after a single 75 mg oral dose) occurred approximately 45 minutes after dosing.
Croatian: Srednje vršne razine nepromijenjenog klopidogrela u plazmi (oko 2,2 - 2,5 ng/ml nakon jednokratne oralne doze od 75 mg), postiže se otprilike 45 minuta nakon uzimanja lijeka.
English: No substantial differences in active metabolite exposure and mean inhibition of platelet aggregation (IPA) were observed between ultrarapid, extensive and intermediate metabolisers.
Croatian: Nisu opažene značajne razlike u izloženosti aktivnom metabolitu i prosječnoj vrijednosti inhibicije agregacije trombocita (IPA) među ultrabrzim, brzim i umjerenim metabolizatorima.
English: There was no statistically significant difference in the rates of fatal bleeding (1.1% in the clopidogrel + ASA group and 0.7% in the placebo +ASA group) and haemorrhagic stroke (0.8% and 0.6%, respectively) between groups.
Croatian: Nije bilo statistički značajne razlike u učestalosti fatalnih krvarenja (1,1% u skupini klopidogrel + ASK i 0,7% u skupini placebo + ASK) i hemoragijskog moždanog udara (0,8% naspram 0,6%) među skupinama.
English: In addition to clinical studies experience, adverse reactions have been spontaneously reported.
Croatian: Uz iskustvo iz kliničkih ispitivanja, nuspojave su se prijavljivale i spontano.
English: Consistent with the above results, in a meta-analysis including 6 studies of 335 clopidogrel-treated subjects at steady state, it was shown that active metabolite exposure was decreased by 28% for intermediate metabolisers, and 72% for poor metabolisers while platelet aggregation inhibition (5 μM ADP) was decreased with differences in IPA of 5.9% and 21.4%, respectively, when compared to extensive metabolisers.
Croatian: U skladu s gore navedenim rezultatima, u meta analizi koja je uključivala 6 studija sa 335 osoba liječenih klopidogrelom u stanju dinamičke ravnoteže, pokazano je da je izloženost aktivnom metabolitu smanjena za 28% za umjerene metabolizatore te 72% za slabe metabolizatore, dok je inhibicija agregacije trombocita (5 μM ADP) smanjena s razlikama za vrijednsoti IPA-e od 5,9%, odnosno 21,4%, u usporedbi s brzim metabolizatorima.
English: • Adult 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.
Croatian: - odraslih bolesnika koji su pretrpjeli infarkt miokarda (u rasponu od nekoliko do najviše 35 dana), ishemijski moždani udar (u rasponu od 7 dana do najviše 6 mjeseci) ili imaju utvrđenu bolest perifernih arterija.
English: Major bleeding was mostly of extracranial origin in both groups (5.3% in the clopidogrel + ASA group; 3.5% in the placebo +ASA group), mainly from the gastrointestinal tract (3.5% vs. 1.8%).
Croatian: Velika krvarenja su najčešće bila ekstrakranijalnog porijekla u obje skupine (5,3% u skupini klopidogrel + ASK; 3,5% u skupini placebo + ASK), uglavnom iz probavnog trakta (3,5% naspram 1,8%).
English: Overall, 645 of 646 patients with STEMI or NSTEMI or unstable angina were analyzed (de-escalated DAPT (n=322); unchanged DAPT (n=323)).
Croatian: Sveukupno je ispitano 645 od 646 bolesnika s infarktom miokarda sa ST elevacijom (STEMI), infarktom miokarda bez ST elevacije (NSTEMI) i nestabilnom anginom (smanjeni DAPT (n=322); nepromijenjen DAPT (n=323)).
English: film-coated tablet
Croatian: filmom obložena tableta
English: Although the administration of clopidogrel 75 mg/day did not modify the pharmacokinetics of S-warfarin or International Normalised Ratio (INR) in patients receiving long-term warfarin therapy, coadministration of clopidogrel with warfarin increases the risk of bleeding because of independent effects on hemostasis.
Croatian: Iako primjena klopidogrela u dozi od 75 mg dnevno nije utjecala na farmakokinetiku S-varfarina ili INR (International Normalised Ratio) u bolesnika koji primaju dugotrajnu terapiju varfarinom, istodobna primjena klopidogrela s varfarinom povećava rizik od krvarenja zbog nezavisnih učinaka na hemostazu.
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].
Croatian: Na taj učinak najviše je utjecalo statistički značajno smanjenje incidencije infarkta miokarda [287 (4,6%) u skupini koja je primala klopidogrel i 363 (5,8%) u skupini koja je primala placebo].
English: In a dose escalation study of 86 neonates or infants up to 24 months of age at risk for thrombosis (PICOLO), clopidogrel was evaluated at consecutive doses of 0.01, 0.1 and 0.2 mg/kg in neonates and infants and 0.15 mg/kg only in neonates.
Croatian: U studiji s postupnim povećanjem doze na 86 novorođenčadi ili dojenčadi u dobi do najviše 24 mjeseca te s rizikom od tromboze (PICOLO), procijenjen je učinak klopidogrela u konsekutivnim dozama od 0,01, 0,1 i 0,2 mg/kg u novorođenčadi i dojenčadi te u dozi od 0,15 mg/kg samo u novorođenčadi.
English: This statistically significant difference was mainly driven by fewer bleeding events, with no difference reported in ischaemic endpoints (p=0.36), while BARC ≥2 bleeding occurred less frequently in the de-escalated DAPT group (4.0%) versus 14.9% in the unchanged DAPT group (p<0.01).
Croatian: Ova statistički značajna razlika uglavnom je posljedica manjeg broja događaja krvarenja, bez prijavljene razlike u ishemijskim mjerama ishoda (p=0,36), dok se BARC stupanj krvarenja ≥ 2 javljao rjeđe u skupini s de-eskaliranim DAPT-om (4,0%) u odnosu na skupinu sa nepromijenjenim DAPT-om (p < 0,01).
English: Patients were treated for up to one year.
Croatian: Bolesnici su lijek primali do jedne godine.
English: There have been a number of retrospective analyses, however, to evaluate this effect in patients treated with clopidogrel for whom there are genotyping results: CURE (n=2721), CHARISMA (n=2428), CLARITY-TIMI 28 (n=227), TRITON-TIMI 38 (n=1477), and ACTIVE-A (n=601), as well as a number of published cohort studies.
Croatian: Međutim, postoji veći broj retrospektivnih analiza za procjenu ovog učinka u bolesnika liječenih klopidogrelom za koje postoje rezultati genotipizacije: CURE (n=2721), CHARISMA (n=2428), CLARITY-TIMI 28 (n=227),
English: The incidence of clinically significant bleeding was similar to that observed when thrombolytic agents and heparin are co-administered with ASA (see section 4.8).
Croatian: Incidencija klinički značajnog krvarenja bila je slična onoj zamijećenoj pri istodobnoj primjeni trombolitika i heparina s ASK (vidjeti dio 4.8).
English: Clopidogrel should be given as a single daily dose of 75 mg.
Croatian: Klopidogrel se daje u jednokratnoj dnevnoj dozi od 75 mg.
English: Therefore, the guided de-escalation arm had patients on either prasugrel (40%) or clopidogrel (60%).
Croatian: Dakle, u skupini sa deeskalacijom vođenoj na temelju vrijednosti HPR-a, bolesnici su primali ili prasugrel (40%) ili klopidogrel (60%).
English: Oral anticoagulants: the concomitant administration of clopidogrel with oral anticoagulants is not recommended since it may increase the intensity of bleedings (see section 4.4).
Croatian: Oralni antikoagulansi: istodobna primjena klopidogrela i oralnih antikoagulansa se ne preporučuje, jer se može povećati intenzitet krvarenja (vidjeti dio 4.4).
English: In patients who remained on therapy within five days of bypass graft surgery, the event rate was 9.6% for clopidogrel plus ASA, and 6.3% for placebo plus ASA.
Croatian: U bolesnika koji su terapiju nastavili primati i unutar 5 dana do ugrađivanja premosnice, stopa krvarenja bila je 9,6% za klopidogrel uz ASK, odnosno 6,3% za placebo uz ASK.
English: The active metabolite of clopidogrel selectively inhibits the binding of adenosine diphosphate (ADP) to its platelet P2Y12 receptor and the subsequent ADP-mediated activation of the glycoprotein GPIIb/IIIa complex, thereby inhibiting platelet aggregation.
Croatian: Aktivni metabolit klopidogrela selektivno inhibira vezanje adenozin difosfata (ADP) za njegov receptor P2Y12 na trombocitima te posljedično ADP-om posredovano aktiviranje kompleksa GPIIb/IIIa, inhibirajući tako agregaciju trombocita.
English: The decrease was associated with a 39% (loading dose) and 21% (maintenance dose) reduction of inhibition of platelet aggregation.
Croatian: Smanjenje je bilo povezano s oslabljenom inhibicijom agregacije trombocita od 39% (udarna doza) i 21% (doza održavanja).
English: The primary endpoint (the combined incidence of CV death, MI, stroke and BARC bleeding grade ≥2 at 12 months) was met showing non-inferiority.
Croatian: Primarna mjera ishoda (kombinirana incidencija kardiovaskularne smrti, infarkta miokarda, moždanog udara i BARC stupnja krvarenja ≥ 2 u 12 mjeseci) je ostvarena te je pokazala neinferiornost.
English: • You should tell your doctor if a surgery (including dental) is planned.
Croatian: Dok uzimate Clopidogrel Krka d.d.: - Obavijestite svog liječnika ako planirate kirurški zahvat (uključujući stomatološke zahvate).
English: No clinically significant pharmacodynamic interactions were observed when clopidogrel was coadministered with atenolol, nifedipine, or both atenolol and nifedipine.
Croatian: Nisu primijećene klinički značajne farmakodinamičke interakcije pri istodobnoj primjeni klopidogrela i atenolola, odnosno nifedipina, ili klopidogrela i ta dva lijeka zajedno.
English: Serum sickness, anaphylactoid reactions cross-reactive drug hypersensitivity among thienopyridines (such as ticlopidine, prasugrel) (see section 4.4)*, insulin autoimmune syndrome, which can lead to severe hypoglycemia, particularly in patients with HLA DRA4 subtype (more frequent in the Japanese population)*
Croatian: Poremećaji imunološkog sustava serumska bolest, anafilaktoidne reakcije, križno reaktivna preosjetljivost na lijekove iz skupine tienopiridina (kao što su tiklopidin, prasugrel) (vidjeti dio 4.4)*, autoimuni inzulinski sindrom koji može dovesti do teške hipoglikemije, osobito u bolesnika s podtipom HLA DRA4 (češći u japanskoj populaciji)*
English: • Adult patients suffering from acute coronary syndrome: - Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA).
Croatian: - odraslih bolesnika koji boluju od akutnog koronarnog sindroma: - Akutni koronarni sindrom bez elevacije ST-segmenta (nestabilna angina ili non-Q infarkt miokarda), uključujući bolesnike koji se podvrgavaju ugradnji stenta nakon perkutane koronarne intervencije, u kombinaciji s acetilsalicilatnom kiselinom (ASK).
English: In patients suffering from acute coronary syndrome: - Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), clopidogrel treatment should be initiated with a single 300 mg loading dose and then continued at 75 mg once a day (with acetylsalicylic acid (ASA) 75 mg-325 mg daily).
Croatian: Bolesnici s akutnim koronarnim sindromom: - Akutni koronarni sindrom bez elevacije ST-segmenta (nestabilna angina ili non-Q infarkt miokarda): liječenje klopidogrelom treba započeti s jednokratnom udarnom dozom od 300 mg, a zatim nastaviti sa 75 mg jedanput dnevno (uz acetilsalicilatnu kiselinu (ASK) 75 mg do 325 mg dnevno).
English: Co-administration of heparin had no effect on the inhibition of platelet aggregation induced by clopidogrel.
Croatian: Istodobna primijena heparina nije imala učinak na inhibiciju agregacije trombocita induciranu klopidogrelom.
English: You should specifically tell your doctor if you take - medicines that may increase your risk of bleeding such as: o oral anticoagulants, medicines used to reduce blood clotting, o a non-steroidal anti-inflammatory medicine, usually used to treat painful and/or inflammatory conditions of muscle or joints, o heparin or any other injectable medicine used to reduce blood clotting, o ticlopidine, other antiplatelet agent, o a selective serotonin reuptake inhibitor (including but not restricted to fluoxetine or fluvoxamine), medicines usually used to treat depression, - omeprazole or esomeprazole, medicines to treat upset stomach, - fluconazole or voriconazole, medicines to treat fungal infections, - efavirenz, a medicine to treat HIV (human immunodeficiency virus) infections,
Croatian: Posebno je važno obavijestiti liječnika ako uzimate - lijekove koji mogu povećati rizik od krvarenja, na primjer: - oralne antikoagulanse, lijekove koji smanjuju zgrušavanje krvi, - nesteroidne protuupalne lijekove, koji se obično primjenjuju za liječenje bolnih i/ili upalnih stanja mišića ili zglobova, - heparin ili bilo koji drugi lijek koji se daje putem injekcije za smanjivanje zgrušavanja krvi, - tiklopidin, drugi antitrombocitni lijek, - selektivne inhibitore ponovne pohrane serotonina (uključujući, ali ne ograničeno na fluoksetin ili fluvoksamin), lijekove koji se obično koriste za liječenje depresije, - omeprazol ili esomeprazol, lijekove za smanjenje želučanih tegoba, - flukonazol ili vorikonazol, lijekove koji se primjenjuju za liječenje gljivičnih infekcija, - efavirenz, lijek koji se primjenjuje za liječenje HIV (virus humane imunodeficijencije) infekcija, - karbamazepin, lijek koji se primjenjuje za liječenje nekih oblika epilepsije, - moklobemid, lijek za liječenje depresije, - repaglinid, lijek za liječenje dijabetesa,
English: TOPIC (Timing Of Platelet Inhibition after acute Coronary syndrome) This randomized, open-label trial included ACS patients requiring PCI.
Croatian: Timing of Platelet Inhibition after Acute Coronary Syndrome) Ovo randomizirano, otvoreno ispitivanje uključivalo je bolesnike s akutnim koronarnim sindromom u kojih je bila potrebna perkutana koronarna intervencija (PCI).
English: Pharmacogenetics: In patients who are poor CYP2C19 metabolisers, clopidogrel at recommended doses forms less of the active metabolite of clopidogrel and has a smaller effect on platelet function.
Croatian: Farmakogenetika: u bolesnika koji su slabi CYP2C19 metabolizatori, kod preporučenih doza klopidogrela stvara se manja količina aktivnog metabolita te ima manji učinak na funkciju trombocita.
English: The efficacy of clopidogrel was observed independently of the dose of ASA (75-325 mg once daily).
Croatian: Djelotvornost klopidogrela nije ovisila o dozi ASK (75 do 325 mg jedanput dnevno).
English: Manufacturer:
Croatian: Proizvođač
English: is taken by adults to prevent blood clots (thrombi) forming in hardened blood vessels (arteries), a process known as atherothrombosis, which can lead to atherothrombotic events (such as stroke, heart attack, or death).
Croatian: Clopidogrel Krka d.d. uzimaju odrasli za sprječavanje stvaranja krvnih ugrušaka (tromba) u otvrdnutim krvnim žilama (arterijama), a taj poremećaj zove se aterotromboza i može dovesti do aterotrombotičkih događaja (kao što su moždani udar, srčani udar ili smrt).
English: Fifteen percent (15.0%) of patients in the clopidogrel group and 21.7% in the placebo group reached the primary endpoint, representing an absolute reduction of 6.7% and a 36 % odds reduction in favor of clopidogrel (95% CI: 24, 47%; p < 0.001), mainly related to a reduction in occluded infarct-related arteries.
Croatian: Petnaest posto (15,0%) bolesnika u skupini s klopidogrelom i 21,7% u skupini s placebom dostigli su primarni ishod, što predstavlja apsolutno smanjenje od 6,7% i smanjenje izgleda (od engl. odds reduction) od 36% u korist klopidogrela (95% CI: 24, 47%; p<0,001), većinom povezano sa smanjenjem okluzije arterija povezanih s infarktom.
English: Titanium dioxide (E171)Red iron oxide (E172) Yellow iron oxide (E172) Talc
Croatian: Film ovojnica: poli(vinilni alkohol) titanijev dioksid (E171) željezov oksid, crveni (E172) željezov oksid, žuti (E172) talk makrogol 3000
English: You should not breast-feed while taking this medicine.
Croatian: Dok uzimate ovaj lijek, ne biste smjeli dojiti.
English: The dose of 0.2 mg/kg achieved the mean percent inhibition of 49.3% (5 µM ADP-induced platelet aggregation) which was comparable to that of adults taking clopidogrel 75 mg/day.
Croatian: S dozom od 0,2 mg/kg postignut je prosječni postotak inhibicije od 49,3% (5 µM ADP-om inducirane agregacije trombocita), što je usporedivo s postotkom u odraslih koji uzimaju klopidogrel u dozi od 75 mg/dnevno.
English: As with other antiplatelet agents, clopidogrel should be used with caution in patients who may be at risk of increased bleeding from trauma, surgery or other pathological conditions and in patients receiving treatment with ASA, heparin, glycoprotein IIb/IIIa inhibitors or non-steroidal anti-inflammatory drugs (NSAIDs) including Cox-2 inhibitors, or selective serotonin reuptake inhibitors (SSRIs), or other medicinal products associated with bleeding risk such as pentoxifylline (see section 4.5).
Croatian: Kao i u slučaju drugih antitrombocitnih lijekova, klopidogrel s oprezom treba davati bolesnicima koji su izloženi povećanom riziku od krvarenja zbog povrede, kirurških zahvata ili drugih patoloških stanja te bolesnicima koji se liječe s ASK, heparinom, inhibitorima glikoproteina IIb/IIIa ili nesteroidnim protuupalnim lijekovima (NSAIL), uključujući Cox-2 inhibitore ili selektivne inhibitore ponovne pohrane serotonina (SSRI) ili druge lijekove povezane s rizikom od krvarenja kao što je pentoksifilin (vidjeti dio 4.5).
English: Patients should be evaluated for history of hypersensitivity to thienopyridines (such as clopidogrel, ticlopidine, prasugrel) since cross-reactivity among thienopyridines has been reported (see section 4.8).
Croatian: Kod bolesnika treba procijeniti prethodnu preosjetljivost na tienopiridine u povijesti bolesti (kao što su klopidogrel, tiklopidin, prasugrel) budući da je zabilježena ukrižena reaktivnost među tienopiridinima (vidjeti dio 4.8).
English: Some other medicines may influence the use of Clopidogrel Krka d.d.
Croatian: Neki lijekovi mogu utjecati na djelovanje Clopidogrela Krka d.d. i obratno.
English: The mean age was 71 years, 41.6% of patients were ≥75 years.
Croatian: Prosječna dob iznosila je 71 godinu, uz 41,6%
English: • If you cut or injure yourself, it may take longer than usual for bleeding to stop.
Croatian: - Ako se porežete ili ozlijedite, možda će biti potrebno više vremena da se krvarenje zaustavi.
English: Clopidogrel significantly reduced the incidence of new ischaemic events (combined end point of myocardial infarction, ischaemic stroke and vascular death) when compared to ASA.
Croatian: Pri usporedbi s ASK, klopidogrel je značajno smanjio incidenciju novih ishemijskih događaja (kombinirani ishod infarkta miokarda, ishemijskog moždanog udara i vaskularne smrti).
English: Due to the risk of increased plasma concentrations, concomitant administration of clopidogrel and drugs primarily cleared by CYP2C8 metabolism (e.g., repaglinide, paclitaxel) should be undertaken with caution (see section 4.4).
Croatian: Zbog rizika od povećanja koncentracija u plazmi, potreban je oprez pri istodobnoj primjeni klopidogrela i lijekova koji se primarno metaboliziraju putem CYP2C8 (npr. repaglinid, paklitaksel) (vidjeti dio 4.4).
English: Rare side effects (may affect up to 1 in 1000 people): Vertigo, enlarged breasts in males.
Croatian: Rijetke nuspojave (mogu se javiti u manje od 1 na 1000 osoba): vrtoglavica, povećanje grudi u muškaraca.
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 Krka d.d..
Croatian: Ako se bilo što od navedenog odnosi na Vas, ili niste sigurni, obratite se svom liječniku prije uzimanja Clopidogrela Krka d.d.
English: De-escalation of P2Y12 Inhibitor Agents in ACS
Croatian: De-eskalacija P2Y12 inhibitora (prelazak sa potentnijeg na slabiji P2Y12 inhibitor) kod akutnog koronarnog sindroma
English: Strokes occurred in 296 (7.8%) patients receiving clopidogrel + ASA and 408 (10.8%) patients receiving placebo + ASA (relative risk reduction, 28.4%; 95% CI, 16.8% to 38.3%; p=0.00001).
Croatian: Moždani udar doživjelo je 296 (7,8%) bolesnika koji su primali klopidogrel + ASK te 408 (10,8%) bolesnika koji su primali placebo + ASK (relativno smanjenje rizika od 28,4%; 95% CI, 16,8% do 38,3%; p=0,00001).
English: The clinical benefit provided by the more potent P2Y12 inhibitors, ticagrelor and prasugrel, in their pivotal studies is related to a significant reduction in recurrent ischaemic events (including acute and subacute stent thrombosis (ST), myocardial infarction (MI), and urgent revascularization).
Croatian: Klinička korist koju su u pivotalnim ispitivanjima pokazali potentniji inhibitori P2Y12, tikagrelor i prasugrel, povezana je sa značajnim smanjenjem rekurentnih ishemijskih događaja (uključujući akutnu i subakutnu trombozu stenta, infarkt miokarda i hitnu revaskularizaciju).
English: A crossover study in 40 healthy subjects, 10 each in the four CYP2C19 metaboliser groups (ultrarapid, extensive, intermediate and poor), evaluated pharmacokinetic and antiplatelet responses using 300 mg followed by 75 mg/day and 600 mg followed by 150 mg/day, each for a total of 5 days (steady state).
Croatian: U križnoj studiji na 40 zdravih osoba, po 10 iz svake skupine CYP2C19 metabolizatora (ultrabrzi, brzi, umjereni i slabi), procijenjen je farmakokinetički i antitrombocitni odgovor upotrebom doze od 300 mg, nakon čega je slijedila doza od 75 mg/dan te doze od 600 mg, nakon čega je slijedila doza od 150 mg/dan, u trajanju od ukupno 5 dana (stanje dinamičke ravnoteže).
English: Patients received clopidogrel (75 mg/day, n=22,961) or placebo (n=22,891), in combination with ASA (162 mg/day), for 28 days or until hospital discharge.
Croatian: Bolesnici su primali klopidogrel (75 mg dnevno, n=22 961) ili placebo (n=22 891), u kombinaciji s ASK (162 mg dnevno), u trajanju do 28 dana ili do otpusta iz bolnice.
English: Caution is required in patients treated concomitantly with clopidogrel and CYP2C8 substrate medicinal products (see section 4.5).
Croatian: Potreban je oprez u bolesnika koji se istodobno liječe klopidogrelom i lijekovima koji su supstrati CYP2C8 (vidjeti dio 4.5).
English: Prevention of atherothrombotic and thromboembolic events in atrial fibrillation In adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with Vitamin K antagonists (VKA) and who have a low bleeding risk, clopidogrel is indicated in combination with ASA for the prevention of atherothrombotic and thromboembolic events, including stroke.
Croatian: U odraslih bolesnika s fibrilacijom atrija koji imaju najmanje jedan faktor rizika za krvožilne događaje, nisu podobni za terapiju antagonistima vitamina K (VKA) te imaju nizak rizik od krvarenja, klopidogrel je indiciran u kombinaciji s ASK za prevenciju aterotrombotičkih i tromboembolijskih događaja, uključujući moždani udar.
English: Therapeutic experience with clopidogrel is limited in patients with renal impairment.
Croatian: Terapijsko iskustvo s klopidogrelom u bolesnika s narušenom funkcijom bubrega je ograničeno.