natgillin/translations-raw huggingface dataset:
7 film-coated tablets - calendar blister: EU/1/09/559/012 14 film-coated tablets - calendar blister: EU/1/09/559/013 28 film-coated tablets - calendar blister: EU/1/09/559/014 56 film-coated tablets - calendar blister: EU/1/09/559/015 84 film-coated tablets - calendar blister: EU/1/09/559/016
7 filmom obloženih tableta - blister s kalendarom: EU/1/09/559/012 14 filmom obloženih tableta - blister s kalendarom: EU/1/09/559/013 28 filmom obloženih tableta - blister s kalendarom: EU/1/09/559/014 56 filmom obloženih tableta - blister s kalendarom: EU/1/09/559/015 84 filmom obloženih tableta - blister s kalendarom: EU/1/09/559/016
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Od zdravstvenih djelatnika se traži da prijave svaku sumnju na nuspojavu lijeka putem: nacionalnog sustava prijave nuspojava navedenog u Dodatku V.
Moreover, the safety profile of clopidogrel in this subgroup of patients did not raise any particular concern.
Sigurnosni profil klopidogrela u toj podskupini bolesnika nije dao konkretne razloge za zabrinutost.
In addition, a subgroup analysis by age suggested that the benefitof clopidogrel in patients over 75 years was less than that observed in patients ≤75 years.
Dodatno, analiza podskupina prema dobi ukazuje da je korist od liječenja klopidogrelom manja u bolesnika iznad 75 godina nego u onih ≤ 75 godina.
Clopidogrel Mylan contains clopidogrel and belongs to a group of medicines called antiplatelet medicinal products.
Clopidogrel Mylan sadrži klopidogrel i pripada skupini lijekova koji se nazivaju antitrombocitni lijekovi.
For patients over 75 years of age clopidogrel should be initiated without a loading dose.
Za bolesnike starije od 75 godina terapiju klopidogrelom valja započeti bez udarne doze.
Clinical trial data support use up to 12 months, and the maximum benefit was seen at 3 months (see section 5.1).
Prema podacima dobivenima kliničkim ispitivanjima preporučuje se korištenje u trajanju do 12 mjeseci, a najveći je učinak primijećen nakon 3 mjeseca (vidjeti dio 5.1).
As a precautionary measure, breast-feeding should not be continued during treatment with Clopidogrel Mylan.
Kao mjera opreza, treba prestati s dojenjem za vrijeme liječenja lijekom Clopidogrel Mylan.
In CURE, 823 (6.6%) patients received concomitant GPIIb/IIIa receptor antagonist therapy.
Tijekom ispitivanja CURE, 823 (6,6%) bolesnika primala su istodobnu terapiju antagonistima GPIIb/IIIa receptorima.
The active metabolite is formed mostly by CYP2C19 with contributions from several other CYP enzymes, including CYP1A2, CYP2B6 and CYP3A4.
Aktivni metabolit nastaje većinom putem CYP2C19 uz sudjelovanje nekoliko drugih CYP enzima, uključujući CYP1A2, CYP2B6 i CYP3A4.
Your doctor should have prescribed Clopidogrel Mylan plus acetylsalicylic acid if you cannot take ‘oral anticoagulants' and you do not have a risk of major bleeding.
Liječnik vam je Clopidogrel Mylan i acetilsalicilnu kiselinu smio propisati ako ne možete uzimati "oralne antikoagulanse" i u vas ne postoji rizik od jakog krvarenja.
You should have been told that ‘oral anticoagulants' are more effective than acetylsalicylic acid or the combined use of Clopidogrel Mylan and acetylsalicylic acid for this condition.
Morali ste biti upozoreni da su "oralni antikoagulansi" učinkovitiji za tu bolest od acetilsalicilne kiseline ili kombinacije lijeka Clopidogrel Mylan i acetilsalicilne kiseline.
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.
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), TRITON-TIMI 38 (n = 1477) te ACTIVE-A (n = 601), kao i određeni broj objavljenih kohortnih kliničkih studija.
Patients with a confirmed diagnosis of acquired haemophilia should be managed and treated by specialists, and clopidogrel should be discontinued
Bolesnike s potvrđenom dijagnozom stečene hemofilije trebaju liječiti i tretirati specijalisti, a primjenu klopidogrela treba prekinuti.
If you forget to take a dose of Clopidogrel Mylan, but remember within 12 hours of your usual time, take your tablet straightaway and then take your next tablet at the usual time.
Ako zaboravite uzeti jednu dozu lijeka Clopidogrel Mylan, ali se toga sjetite u roku od 12 sati, odmah uzmite tabletu, a sljedeću tabletu uzmite u uobičajeno vrijeme.
Pharmacotherapeutic group: Antithrombotic agents, platelet aggregation inhibitors excl. heparin, ATC code: B01AC04.
Farmakoterapijska skupina: Antitrombocitni agensi, inhibitori agregacije trombocita izuzev heparina, ATK oznaka: B01AC-04.
What Clopidogrel Mylan is and what it is used for
Što je Clopidogrel Mylan i za što se koristi
Based on enrollment criteria, physicians enrolled patients in ACTIVE-W if they were candidates for vitamin K antagonist (VKA) therapy (such as warfarin).
Liječnici su na temelju kriterija uključivanja prijavljivali bolesnike za ispitivanje ACTIVEW ako su bili kandidati za terapiju antagonistima vitamina K (kao što je varfarin).
The population included 27.8% women, 58.4% patients ≥ 60 years (26% ≥ 70 years) and 54.5% patients who received fibrinolytics.
Populacija je obuhvaćala 27,8% žena, 58,4% bolesnika ≥ 60 godina (26% ≥ 70 godina) te 54,5% bolesnika koji su primali fibrinolitike.
If you become pregnant while taking Clopidogrel Mylan, consult your doctor immediately as it is recommended not to take clopidogrel while you are pregnant.
Ako zatrudnite za vrijeme uzimanja lijeka Clopidogrel Mylan, odmah se posavjetujte s liječnikom, jer nije preporučeno uzimati klopidogrel za vrijeme trudnoće.
The ACTIVE-W and ACTIVE-A studies, separate trials in the ACTIVE program, included patients with atrial fibrillation (AF) who had at least one risk factor for vascular events.
Ispitivanja ACTIVE-W i ACTIVE-A, dva zasebna ispitivanja u sklopu programa ACTIVE, obuhvaćala su bolesnike s atrijskom fibrilacijom s najmanje jednim faktorom rizika za vaskularne incidente.
Patients were treated for up to 5 years.
Bolesnici su lijek primali u razdoblju do pet godina.
Other side effects include:
Ostali sastojci su:
There was no observed effect on the rate of rehospitalisation for unstable angina.
Nije primijećen učinak na stopu ponovne hospitalizacije zbog nestabilne angine.
Pink, round and biconvex film-coated tablets.
Ružičaste, okrugle i bikonveksne filmom obložene tablete.
Since higher doses of ASA were associated with higher bleeding risk it is recommended that the dose of ASA should not be higher than 100 mg.
Budući da su veće doze acetilsalicilne kiseline povezane s većim rizikom od krvarenja, ne preporučuju se doze acetilsalicilne kiseline veće od 100 mg.
The results obtained in populations with different characteristics (e.g. unstable angina or non-Q-wave MI, low to high risk levels, diabetes, need for revascularisation, age, gender, etc.) were consistent with the results of the primary analysis.
Rezultati dobiveni u populacijama različitih karakteristika (npr. nestabilna angina ili infarkt miokarda bez Q-valova, niska ili visoka razina rizika, dijabetes, potreba za revaskularizacijom, dob, spol i dr.) sukladni su rezultatima primarne analize.
The clinically relevant adverse reactions observed in the CAPRIE, CURE, CLARITY, COMMIT and ACTIVE-A studies are discussed below.
Klinički značajne nuspojave opažene u studijama CAPRIE, CURE, CLARITY,COMMIT i ACTIVE-A opisane su u daljnjem tekstu.
For the treatment of this condition your doctor may have placed a stent in the blocked or narrowed artery to restore effective blood flow.
Liječnik vam je zbog toga možda ugradio stent u blokiranu ili suženu arteriju zbog ponovne uspostave djelotvornog protoka krvi.
CYP2C8 substrate medicinal products: Clopidogrel has been shown to increase repaglinide exposure in healthy volunteers.
Lijekovi koji su supstrati CYP2C8: pokazalo se da klopidogel povećava izloženost repaglinidu u zdravih dobrovoljaca.
For the 7, 14, 28, 56, 84 tablets (calendar blister) pack sizes, you can check the day on which you last took a tablet of Clopidogrel Mylan by referring to the calendar printed on the blister
Kod pakiranja od 7, 14, 28, 56 i 84 tablete (blister s kalendarom) možete provjeriti dan kad ste zadnji put uzeli tabletu lijeka Chlopidogrel Mylan tako da provjerite kalendar otisnut na blisteru.
The efficacy of clopidogrel was observed independently of the dose of ASA (75-325 mg once daily).
Djelotvornost klopidogrela zabilježena je neovisno o dozi ASA-a (75 - 325 mg jednom dnevno).
The co-primary endpoints were death from any cause and the first occurrence of re-infarction, stroke or death.
Primarne krajnje točke bile su smrt zbog bilo kojeg uzroka te prva pojava ponovnog infarkta, moždanog udara ili smrti.
For minor cuts and injuries e.g., cutting yourself, shaving, this is usually of no concern.
Za manje posjekotine i ozljede, primjerice nastale prilikom brijanja ili kad se sami porežete, to obično nije bitno.
• if you have kidney or liver disease.
• Ako imate bolest bubrega ili jetre
Titanium dioxide (E171) Red iron oxide (E172) Yellow iron oxide (E172) Talc
Ovojnica: polivinilni alkohol titanijev dioksid (E171) željezov oksid, crveni (E172) žuti željezov oksid (E172) talk
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.
Klopidogrel je znatno smanjio relativni rizik od smrt zbog bilo kojeg uzroka za 7% (p = 0,029) te relativni rizik kombinacije ponovnog infarkta, moždanog udara ili smrti za 9% (p = 0,002), uz apsolutno smanjenje od 0,5% odnosno 0,9%.
Driving and using machines Clopidogrel Mylan is unlikely to affect your ability to drive or to use machines.
Upravljanje vozilima i strojevima Clopidogrel Mylan ne bi trebao utjecati na Vašu sposobnost upravljanja vozilima ili strojevima.
Because the active metabolite is formed by CYP450 enzymes, some of which are polymorphic or subject to inhibition by other medicinal products, not all patients will have adequate platelet inhibition.
Budući da se aktivni metabolit klopidogrela stvara pomoću enzima CYP450, od kojih su neki polimorfni ili podložni inhibiciji od strane lijekova, svi bolesnici neće imati adekvatnu inhibiciju trombocita.
If you have experienced severe chest pain (unstable angina or heart attack), your doctor may give you 300 mg of Clopidogrel Mylan (4 tablets of 75 mg) once at the start of treatment.
Ako ste imali jake bolove u prsištu (nestabilna angina ili srčani udar), liječnik Vam u početku liječenja može jednokratno dati 300 mg Clopidogrel Mylan (4 tablete od po 75 mg).
The safety and efficacy of clopidogrel have been evaluated in 5 double-blind studies involving over 88,000 patients: the CAPRIE study, a comparison of clopidogrel to ASA, and the CURE, CLARITY, COMMIT and ACTIVE-A studies comparing clopidogrel to placebo, both medicinal products given in combination with ASA and other standard therapy.
Sigurnost i djelotvornost klopidogrela procijenjene su tijekom pet dvostruko slijepih ispitivanja u kojima je sudjelovalo više od 88.000 bolesnika: u ispitivanju CAPRIE, usporedbi klopidogrela s ASAom, te u ispitivanjima CURE, CLARITY, COMMIT i ACTIVE-A u kojima je klopidogrel uspoređivan s placebom, a oba su lijeka davana u kombinaciji s ASA-om i drugom standardnom terapijom.
The recommended dose for ASA was 75 to 100 mg/day.
Preporučena je doza ASA-e bila 75 do 100 mg na dan.
If a dose is missed:
Propuštena doza:
What you need to know before you take Clopidogrel Mylan
Što morate znati prije nego počnete uzimati Clopidogrel Mylan
For more than 12 hours: patients should take the next dose at the regular scheduled time and should not double the dose.
Ako je prošlo više od 12 sati: bolesnik treba sljedeću dozu uzeti prema uobičajenom rasporedu i ne smije uzeti dvostruku dozu.
If you are pregnant or suspect that you are pregnant, you should tell your doctor or your pharmacist before taking Clopidogrel Mylan.
Ako ste trudni ili sumnjate na trudnoću, obavjestite svog liječnika ili ljekarnika prije nego što uzmete Clopidogrel Mylan.
A total of 23.0% of patients received anti-arrhythmics, 52.1% beta-blockers, 54.6% ACE inhibitors, and 25.4% statins.
Ukupno je 23,0% bolesnika primalo antiaritmike, 52,1% beta blokere, 54,6% inhibitore ACE te 25,4% statine.
The CAPRIE study included 19,185 patients with atherothrombosis as manifested by recent myocardial infarction (<35 days), recent ischaemic stroke (between 7 days and 6 months) or established peripheral arterial disease (PAD).
Studija CAPRIE uključivala je 19 185 bolesnika s aterotrombozom koja se manifestirala kao nedavni infarkt miokarda (< 35 dana), nedavni ishemijski moždani udar (između 7 dana i 6 mjeseci) ili utvrđena bolest perifernih arterija (BPA).
In a randomised, double-blind, parallel-group study (CLARINET), 906 paediatric patients (neonates and infants) with cyanotic congenital heart disease palliated with a systemic-to-pulmonary arterial shunt were randomised to receive clopidogrel 0.2 mg/kg (n=467) or placebo (n=439) along with concomitant background therapy up to the time of second stage surgery.
U randomiziranoj, dvostrukoslijepoj studiji s paralelnim skupinama (CLARINET), 906 pedijatrijskih bolesnika (novorođenčad i dojenčad) s cijanotičnom kongenitalnom bolešću srca ublaženom sistemsko-plućnim arterijskim šantom, bilo je randomizirano da primaju klopidogrel u dozi od 0,2 mg/kg (n = 467) ili placebo (n = 439) zajedno s istodobnom popratnom terapijom sve do drugog operativnog zahvata.
For patients who did not undergo angiography, the primary endpoint was death or recurrent myocardial infarction by Day 8 or by hospital discharge.
Krajnja točka za bolesnike koji nisu podvrgnuti angiografiju bila je smrt ili ponovna pojava infarkta miokarda do osmog dana ili do otpuštanja iz bolnice.
Perforated unit dose blister of OPA/Al/PVC-Al containing 30x1 and 50x1 film-coated tablets in the box.
Perforirani blister s jediničnom dozom od OPA/Al/PVC-Al koji sadrži 30x1 i 50x1 filmom obloženih tableta u kutiji.
Boxes of 30x1 and 50x1 film-coated tablets in perforated unit dose blisters are available.
Dostupne su kutije s 30x1 i 50x1 filmom obloženih tableta u perforiranim blisterima s jediničnom dozom.
A total of 99.7% of patients received fibrinolytics (fibrin specific: 68.7%, non-fibrin specific: 31.1%), 89.5% heparin, 78.7% beta blockers, 54.7% ACE inhibitors and 63% statins.
Ukupno je 99,7% bolesnika primalo fibrinolitike (fibrin-specifične: 68,7%, fibrin-nespecifične: 31,1%), 89,5% primalo je heparin, 78,7% beta blokere, 54,7% inhibitore ACE te 63% statine.
The most common side effect reported with Clopidogrel Mylan is bleeding.
Najčešća prijavljena nuspojava lijeka Clopidogrel Mylan jest krvarenje.
Other medicines and Clopidogrel Mylan
Drugi lijekovi i Clopidogrel Mylan
The recommended dose, including for patients with a condition called ‘atrial fibrillation' (an irregular heartbeat), is one 75 mg tablet of Clopidogrel Mylan per day to be taken orally with or without food, and at the same time each day.
Preporučena je doza, uključujući za bolesnike s atrijskom fibrilacijom (nepravilni otkucaji srca), jedna tableta od 75 mg lijeka Clopidogrel Mylan na dan oralno uz hranu ili bez nje, i to svakog dana u isto vrijeme.
New cardiovascular events (primary endpoint) were prevented, with relative risk reductions of 22% (CI: 8.6, 33.4), 32% (CI: 12.8, 46.4), 4% (CI: -26.9, 26.7), 6% (CI: -33.5, 34.3) and 14% (CI: -31.6, 44.2), during the 0-1, 1-3, 3-6, 6-9 and 9-12 month study intervals, respectively.
Spriječeni su novi kardiovaskularni događaji (primarne krajnje točke) uz smanjenja relativnog rizika od 22% (interval pouzdanosti: 8,6, 33,4), 32% (interval pouzdanosti: 12,8, 46,4), 4% (interval pouzdanosti: -26,9, 26,7), 6% (interval pouzdanosti: -33,5, 34,3) i 14% (interval pouzdanosti: -31,6, 44,2) tijekom ispitivanja u intervalima od 0 - 1, 1 - 3, 3 - 6, 6 - 9 odnosno 9 - 12 mjeseci.
A significantly lower exposure to clopidogrel active metabolite and reduced platelet inhibition have been demonstrated in HIV-infected patients treated with ritonavir- or cobicistat-boosted anti-retroviral therapies (ART).
Značajno niža izloženost aktivnom metabolitu klopidogrela i smanjena inhibicija trombocita opaženi su u bolesnika zaraženih HIV-om koji su liječeni antiretrovirusnim terapijama (ART) pojačanim ritonavirom ili kobicistatom.
However, if you are concerned by your bleeding, you should contact your doctor straightaway (see section 4 ‘Possible side effects').
Ukoliko ste ipak zabrinuti zbog krvarenja, odmah obavijestite svog liječnika (vidjeti dio 4. "Moguće nuspojave").
INFORMATION IN BRAILLE Clopidogrel Mylan 75 mg
16. PODACI NA BRAILLOVOM PISMU Clopidogrel Mylan 75 mg
Keep out of the sight and reach of children.
Čuvati izvan dohvata pogleda i dohvata djece.
C-labelled clopidogrel in man, approximately 50% was excreted in the urine and approximately 46% in the faeces in the 120-hour interval after dosing.
Nakon oralne doze klopidogrela obilježenog s 14C u ljudi, približno 50% doze izlučilo se u mokraću, a približno 46% u stolicu u intervalu od 120 sati nakon doziranja.
Furthermore, the pharmacodynamic activity of clopidogrel was not significantly influenced by the co-administration of phenobarbital, or oestrogen.
Nadalje, na farmakodinamičku aktivnost klopidogrela nije značajno utjecala primjena fenobarbitala ili estrogena.
Clopidogrel Mylan 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).
Clopidogrel Mylan 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).
LIST OF EXCIPIENTS It also contains hydrogenated castor oil.
POPIS POMOĆNIH TVARI Sadrži i hidrogenizirano ricinusovo ulje.
• if you have had a clot in an artery of your brain (ischaemic stroke) which occurred within the last seven days.
• Ako ste imali krvni ugrušak u arteriji u mozgu (ishemijski moždani udar) koji se pojavio unutar posljednjih sedam dana.
• Paediatric population Clopidogrel should not be used in children because of efficacy concerns (see section 5.1).
Klopidogrel se ne primjenjuje u djece zbog nedovoljnih podataka o djelotvornosti (vidjeti dio 5.1).
This benefit was consistent across age, gender and with or without fibrinolytics, and was observed as early as 24 hours.
Djelotvornost je bila konzistentna bez obzira na dob, spol i primjenu fibrinolitika te je zabilježena već za 24 sata.
The 2x2 factorial design COMMIT trial included 45,852 patients presenting within 24 hours of the onset of the symptoms of suspected MI with supporting ECG abnormalities (i.e. ST elevation, ST depression or left bundle-branch block).
Ispitivanje COMMIT faktorskog dizajna 2x2 obuhvaćalo je 45.852 bolesnika primljenih u roku od 24 sata od pojave simptoma suspektnog infarkta miokarda uz popratne abnormalnosti EKG-a (tj. elevaciju ST segmenta, depresiju ST segmenta ili blok lijevog ogranka).
• 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).
• Odraslih bolesnika s akutnim koronarnim sindromom: Akutnim koronarnim sindromom bez elevacije ST segmenta (nestabilna angina ili infarkt miokarda bez Q-valova), uključujući bolesnike podvrgnute postavljanju stenta nakon perkutane koronarne intervencije, u kombinaciji s acetilsalicilnom kiselinom (ASA).
In CURE, CLARITY, ACTIVE-A and one of the cohort studies (Trenk), no increased event rate was observed based on metaboliser status.
U studijama CURE, CLARITY, ACTIVE-A i jednoj kohortnih studija s (Trenk) nije uočena povećana stopa događaja temeljena na metabolizatorskom statusu..
• 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.
• 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.
Follow-up at one year was performed for 316 patients (98.1%) in the de-escalated DAPT group and 318 patients (98.5%) in the unchanged DAPT group.
Nakon godine dana provedeno je praćenje 316 bolesnika (98,1%) u skupini sa de-eskaliranim DAPT-om i 318 bolesnika (98,5%) u skupini sa nepromijenjenim DAPT-om.
This benefit was consistent across all prespecified subgroups including patients' age and gender, infarct location, and type of fibrinolytic or heparin used.
Korist je bila konzistentna u svim unaprijed određenim podskupinama, uključujući one određene prema dobi i spolu bolesnika, mjestu infarkta te vrsti primjenjivanih fibrinolitika ili heparina.
Patients randomized in the ACTIVE program were those presenting with documented AF, i.e., either permanent AF or at least 2 episodes of intermittent AF in the past 6 months, and had at least one of the following risk factors: age 75 years or age 55 to 74 years and either diabetes mellitus requiring drug therapy, or documented previous MI or documented coronary artery disease; treated for systemic hypertension; prior stroke, transient ischaemic attack (TIA), or non-CNS systemic embolus; left ventricular dysfunction with left ventricular ejection fraction <45%; or documented peripheral vascular disease.
Bolesnici randomizirani u programu ACTIVE primljeni su uz dokumentiranu atrijsku fibrilaciju, tj. trajnu atrijsku fibrilaciju ili uz najmanje dvije epizode povremene atrijske fibrilacije tijekom zadnjih 6 mjeseci, te uz najmanje jedan od sljedećih faktora rizika: dob ≥ 75 godina ili dob od 55 do 74 godine uz dijabetes mellitus koji je potrebno tretirati lijekovima ili dokumentirani prethodni infarkt miokarda ili dokumentiranu bolest koronarnih arterija; liječeni zbog sistemske hipertenzija; prethodni moždani udar; tranzitorna ishemijska ataka ili sistemska embolija koja nije vezana uz središnji živčani sustav, disfunkcija lijeve klijetke uz izlaznu frakciju lijeve klijetke < 45%; dokumentirana periferna vaskularna bolest.
The major exclusion criteria for patients were documented peptic ulcer disease within the previous 6 months; prior intracerebral hemorrhage; significant thrombocytopenia (platelet count < 50 x 109/l); requirement for clopidogrel or oral anticoagulants (OAC); or intolerance to any of the two compounds.
Glavni kriteriji za isključivanje bolesnika bili su dokumentirani peptični ulkus tijekom prethodnih 6 mjeseci, prethodno intracerebralno krvarenje, ozbiljna trombocitopenija (broj trombocita < 50 x 109/l), potreba za klopidogrelom ili oralnim antikoagulansima ili preosjetljivost na neku od dvije tvari.
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).
Incidencija klinički značajnog krvarenja bila je slična onoj zamijećenoj pri istodobnoj uporabi trombolitika i heparina s ASK (vidjeti dio 4.8).
The benefit of the combination of clopidogrel with ASA beyond four weeks has not been studied in this setting (see section 5.1).
Koristi kombinacije klopidogrela i acetilsalicilne kiseline nakon četiri tjedna u tim okolnostima nisu ispitane (vidjeti dio 5.1).