FrancophonIA/ELRC3.0 huggingface dataset:
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.
Bulgarian: 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: The ACTIVE-W study demonstrated that anticoagulant treatment with vitamin K antagonists was more effective than with clopidogrel and ASA.
Bulgarian: Študija ACTIVE-W je pokazala, da je bilo zdravljenje z antagonisti vitamina K učinkovitejše kot zdravljenje
English: Bleeding and haematological disorders
Bulgarian: Krvavitve in hematološke motnje
English: • Glycoprotein IIb/IIIa inhibitors (medicines used to stop blood clotting).
Bulgarian: • zaviralce glikoproteina IIb/IIIb (zdravila, ki se uporabljajo za preprečevanje strjevanja krvi).
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.
Bulgarian: Heparin so uporabljali pri več kot 90 % bolnikov in sočasna uporaba heparinske terapije ni pomembno vplivala na relativni delež krvavitev med klopidogrelom in placebom.
English: What Clopidogrel Teva Pharma B.V. is and what it is used for What you need to know before you take Clopidogrel Teva Pharma B.V. How to take Clopidogrel Teva Pharma B.V.
Bulgarian: Kaj je zdravilo Klopidogrel Teva Pharma B.V. in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Klopidogrel Teva Pharma B.V. Kako jemati zdravilo Klopidogrel Teva Pharma B.V.
English: The incidence of major bleeding was similar between groups.
Bulgarian: Incidenca večjih krvavitev je bila v obeh skupinah podobna.
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.
Bulgarian: in acetilsalicilno kislino ni bilo prekoračeno v 7 dneh po koronarni premostitveni operaciji pri bolnikih, ki so prenehali z zdravljenjem več kot pet dni pred kirurškim posegom.
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.
Bulgarian: s klopidogrelom, za katere so na voljo rezultati genotipizacije: CURE (n = 2721), CHARISMA (n = 2428), CLARITY-TIMI 28 (n = 227), TRITON-TIMI 38 (n = 1477) in ACTIVE-A (n = 601), poleg tega pa tudi številne objavljene kohortne študije.
English: The efficacy of clopidogrel was observed independently of the dose of ASA (75-325 mg once daily).
Bulgarian: Učinkovitost klopidogrela so opazili neodvisno od odmerka acetilsalicilnske kisline (75-325 mg enkrat na dan).
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 used to relieve pain and lower fever.
Bulgarian: Če ste doživeli hudo bolečino v prsih (nestabilna angina ali sršni napad), vam bo morda predpisan klopidogrel v kombinaciji z acetilsalicilno kislino, učinkovino proti bolečinam in za zniževanje zvišane telesne tempreature.
English: Furthermore, the pharmacodynamic activity of clopidogrel was not significantly influenced by the coadministration of phenobarbital or oestrogen.
Bulgarian: Poleg tega na farmakodinamično aktivnost klopidogrela ni pomembno vplivala sočasna uporaba fenobarbitala ali estrogena.
English: An overdose is likely to cause an increased risk of bleeding.
Bulgarian: Prevelik odmerek bo najverjetneje povečal tveganje za pojav krvavitev.
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).
Bulgarian: Tako se pri zdravljenju več kot 3 mesece opažena korist v skupini, ki je prejemala klopidogrel in acetilsalicilnsko kislino, ni nadalje povečevala, medtem ko je tveganje za krvavitev ostalo (glejte poglavje 4.4).
English: For minor cuts and injuries, e.g. cutting yourself shaving, this is usually of no concern.
Bulgarian: Pri manjših urezninah ali poškodbah, npr. če se urežete ali pri britju, navadno ni razloga za skrb.
English: Do not store above 25°C.
Bulgarian: ZA SHRANJEVANJE Shranjujte pri temperaturi do 25 ºC.
English: A pharmacodynamic interaction between clopidogrel and heparin is possible, leading to increased risk of bleeding.
Bulgarian: Farmakodinamična interakcija med klopidogrelom in heparinom je možna in vodi do povečanega tveganja za pojav krvavitev.
English: Pharmacotherapeutic group: platelet aggregation inhibitors excl. heparin, ATC Code: B01AC-04.
Bulgarian: Zaviralci agregacije trombocitov brez heparina Oznaka ATC: B01AC04
English: • moclobemide, medicine to treat depression.
Bulgarian: moklobemid, zdravila za zdravljenje depresije.
English: eptifibatide or tirofiban.
Bulgarian: Na primer abciksimab, eptifibatid ali tirofiban.
English: 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.
Bulgarian: Skupno je 99,7 % bolnikov prejemalo fibrinolitike (fibrinsko specifične: 68,7 %, nefebrinsko specifične: 31,1 %), 89,5 % heparin, 78,7 % blokatorji beta, 54,7 % zaviralce angiotenzinske konvertaze in 63 % statine.
English: • Paediatric population Clopidogrel should not be used in children because of efficacy concerns (see section 5.1)
Bulgarian: Pediatrična populacija Klopidogrel naj se pri otrocih ne uporablja iz razlogov, ki zadevajo učinkovitost (glejte
English: 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).
Bulgarian: Študija CAPRIE je vključevala 19.185 bolnikov z aterotrombozo, ki se je odrazila z nedavnim miokardnim infarktom (<35 dni), nedavno ishemično kapjo (med 7 dni in 6 meseci) ali razvito periferno arterijsko boleznijo (PAD).
English: Not all pack sizes may be marketed.
Bulgarian: Na trgu ni vseh navedenih pakiranj.
English: Data from the CAPRIE study indicate that phenytoin and tolbutamide which are metabolised by CYP2C9 can be safely co-administered with clopidogrel.
Bulgarian: Podatki študije CAPRIE kažejo, da se lahko fenitoin in tolbutamid, ki se presnavljata s CYP2C9, sočasno
English: However, if you are concerned by your bleeding, you should contact your doctor straightaway (see section 4 ‘Possible Side Effects')
Bulgarian: Če pa vas glede krvavitve skrbi, se nemudoma posvetujte z zdravnikom (glejte poglavje 4 »Možni neželeni učinki«).
English: • 30 tablets bottle: 30 days
Bulgarian: s 30 tabletami: 30 dni
English: The pharmacokinetics of digoxin or theophylline were not modified by the co-administration of clopidogrel.
Bulgarian: Farmakokinetika digoksina ali teofilina ob sočasni uporabi klopidogrela ni bila spremenjena.
English: In TRITON-TIMI 38 and 3 of the cohort studies (Collet, Sibbing, Giusti) the combined group of patients with either intermediate or poor metaboliser status had a higher rate of cardiovascular events (death, myocardial infarction, and stroke) or stent thrombosis compared to extensive metabolisers.
Bulgarian: V TRITON-TIMI 38 in 3 kohortnih študijah (Collet, Sibbing, Giusti) je imela kombinirana skupina bolnikov, ki so bili ali srednji ali slabi metabolizatorji, večji delež kardiovaskularnih dogodkov (smrt, miokardni infarkt, možganska kap) ali trombozo na žilni opornici kot dobri metabolizatorji.
English: Patients should be followed carefully for any signs of bleeding including occult bleeding, especially during the first weeks of treatment and/or after invasive cardiac procedures or surgery.
Bulgarian: s prikrito krvavitvijo, zlasti prve tedne zdravljenja in/ali po invazivnih kardioloških postopkih ali kirurških posegih.
English: Overall, clopidogrel 75 mg/day was comparable to ASA 325 mg/day in CAPRIE regardless of age, gender and race.
Bulgarian: V celoti je bil klopidogrel v odmerku 75 mg/dan v študiji CAPRIE, primerljiv z acetilsalicilno kislino v odmerku 325 mg/dan, ne glede na starost, spol ali raso.
English: After single and repeated oral doses of 75 mg per day, clopidogrel is rapidly absorbed.
Bulgarian: in večkratnih peroralnih odmerkih 75 mg na dan se klopidogrel hitro absorbira.
English: België/Belgique/Belgien Teva Pharma Belgium N.V./S.A.
Bulgarian: België/Belgique/Belgien
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.
Bulgarian: V študiji povečevanja odmerka, ki je zajela 86 novorojenčkov ali dojenčkov, starih do 24 mesecev, s tveganjem tromboze (PICOLO), so klopidogrel ocenili v zaporednih odmerkih 0,01, 0,1 in 0,2 mg/kg pri novorojenčkih
English: Patients with a confirmed diagnosis of acquired haemophilia should be managed and treated by specialists, and clopidogrel should be discontinued.
Bulgarian: s potrjeno diagnozo pridobljene hemofilije morajo obravnavati in zdraviti zdravniki specialisti, zdravljenje
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.
Bulgarian: odraslih bolnikih z 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: If you cut or injure yourself, it may take slightly longer than usual for bleeding to stop.
Bulgarian: če se urežete ali poškodujete, se lahko krvavitev ustavi počasneje kot običajno.
English: • You have liver or kidney disease.
Bulgarian: Če imate ledvično ali jetrno bolezen.
English: Repeated doses of 75 mg per day produced substantial inhibition of ADP-induced platelet aggregation from the first day; this increased progressively and reached steady state between Day 3 and Day 7.
Bulgarian: Večkratni odmerki po 75 mg na dan tvorijo pomembno zaviranje z ADP sprožene agregacije trombocitov od prvega dne. To se progresivno povečuje in doseže stanje dinamičnega ravnovesja (“steady state”) med 3.
English: The ACTIVE-A study (N=7,554) was a multicenter, randomized, double-blind, placebo-controlled study which compared clopidogrel 75 mg/day + ASA (N=3,772) to placebo + ASA (N=3,782).
Bulgarian: Študija ACTIVE-A (n = 7.554) je bila multicentrična, randomizirana, dvojno slepa, s placebom kontrolirana študija, ki je primerjala klopidogrel 75 mg/dan + acetilsalicilno kislino (n = 3.772) in placebo + acetilsalicilno kislino (n = 3.782).
English: Thrombotic Thrombocytopenic Purpura (TTP)
Bulgarian: Trombotična trombocitopenična purpura (TTP)
English: 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.
Bulgarian: Glavna merila za nevključitev bolnikov so bila potrjena peptična ulkusna bolezen v preteklih 6 mesecih, predhodna intracerebralna krvavitev, pomembna trombocitopenija (število trombocitov < 50 x 109/l), potreba po klopidogrelu ali peroralnih antikoagulantih ali intoleranca za katero od obeh snovi.
English: These occurred at doses representing at least 25 times the exposure seen in humans receiving the clinical dose of 75 mg/day and were a consequence of an effect on hepatic metabolising enzymes.
Bulgarian: Pojavile so se pri odmerkih, ki so bili vsaj 25-krat večji od odmerkov pri človeku, pri prejemanju kliničnega odmerka 75 mg na dan, in so bile posledica učinka na jetrne presnovne encime.
English: Method of administration For oral use
Bulgarian: Način uporabe za peroralno uporabo
English: For patients who did not undergo angiography, the primary endpoint was death or recurrent myocardial infarction by Day 8 or by hospital discharge.
Bulgarian: 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: If a patient is to undergo elective surgery and antiplatelet effect is temporarily not desirable, clopidogrel should be discontinued 7 days prior to surgery.
Bulgarian: Če ima bolnik predviden kirurški poseg in antitrombotični učinek začasno ni zaželen, je potrebno zdravljenje
English: Österreich ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1 97007-0
Bulgarian: ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1 97007-0
English: Discard any remaining tablets 30 days after first opening of the bottle.
Bulgarian: Preostale tablete zavrzite 30 dni po odprtju stekleničke.
English: Glomerulonephritis, blood creatinine increased
Bulgarian: Bolezni sečil glomerulonefritis, zvišanje ravni kreatinina v krvi
English: The CLARINET and the PICOLO trials were conducted using a constituted solution of clopidogrel.
Bulgarian: Preskušanji CLARINET in PICOLO so izvedli z uporabo pripravljene raztopine klopidogrela.
English: Glycoprotein IIb/IIIa inhibitors: clopidogrel should be used with caution in patients who receive concomitant glycoprotein IIb/IIIa inhibitors (see section 4.4).
Bulgarian: Zaviralci glikoproteina IIb/IIIa: klopidogrel je potrebno uporabljati previdno pri bolnikih, ki se sočasno zdravijo z zaviralci glikoproteina IIb/IIIa (glejte poglavje 4.4).
English: The Cmax of the active metabolite is twice as high following a single 300-mg clopidogrel loading dose as it is after four days of 75-mg maintenance dose.
Bulgarian: Cmax aktivnega presnovka je po enem 300-mg polnilnem odmerku klopidogrela dvakrat večja kot po štirih dneh uporabe vzdrževalnega odmerka 75 mg.
English: Discard any remaining tablets 100 days after first opening of the bottle.
Bulgarian: Preostale tablete zavrzite 100 dni po odprtju stekleničke.
English: Film-coated tablet.
Bulgarian: filmsko obložena tableta
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.
Bulgarian: Farmakogenetika: Pri bolnikih, ki so slabi metabolizatorji CYP2C19, med uporabo priporočenih odmerkov klopidogrela nastane manj aktivnega presnovka klopidogrela in ima manjši učinek na delovanje trombocitov.
English: This may be detectable via blood or urine tests.
Bulgarian: s preiskavami krvi ali urina.
English: For the treatment of this condition your doctor may have placed a stent in the blocked or narrowed artery to restore effective blood flow.
Bulgarian: Pri zdravljenju tega stanja vam je zdravnik v zamašeno ali zoženo arterijo morda moral vstaviti stent (žično opornico), da bi žilo tako razširil in obnovil pretok krvi.
English: * Information related to clopidogrel with frequency “not known”.
Bulgarian: s pogostnostjo “neznani”.
English: Lactose monohydrate Cellulose, microcrystalline Hydroxypropylcellulose (E463) Crospovidone (type A) Hydrogenated castor oil Sodium laurilsulfate
Bulgarian: Jedro tablete laktoza monohidrat mikrokristalna celuloza hidroksipropil celuloza (E463) krospovidon (tip A) hidrogenirano ricinusovo olje natrijev lavrilsulfat
English: Tabulated list of adverse reactions
Bulgarian: Tabelarični seznam neželenih učinkov
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).
Bulgarian: Incidenca klinično pomembnih krvavitev je bila podobna tisti, ki so jo opazili pri uporabi trombolitikov in heparina sočasno z acetilsalicilno kislino (glejte poglavje 4.8).
English: If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Bulgarian: Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom ali
English: Thrombotic Thrombocytopenic Purpura (TTP) has been reported very rarely following the use of clopidogrel, sometimes after a short exposure.
Bulgarian: so po uporabi klopidogrela poročali zelo redko, včasih po kratki izpostavljenosti.
English: You should also be given acetylsalicylic acid (a substance used to relieve pain and lower fever as well as to prevent blood clotting) by your doctor.
Bulgarian: Zdravnik vam bo moral predpisati tudi acetilsalicilno kislino (učinkovina proti bolečinam in za zniževanje zvišane telesne tempreature, kakor tudi za preprečevanje strjevanja krvi).
English: Computerweg 10, 3542 DR Utrecht, The Netherlands
Bulgarian: Teva Pharma B.V., Computerweg 10, 3542 DR Utrecht, Nizozemska
English: You should continue taking Clopidogrel Teva Pharma B.V. for as long as your doctor has told you to take it.
Bulgarian: Zdravilo Klopidogrel Teva Pharma B.V. morate jemati vse dokler vam ga vaš zdravnik predpisuje.
English: Other medicinal products: A number of other clinical studies have been conducted with clopidogrel and other concomitant medicinal products to investigate the potential for pharmacodynamic and pharmacokinetic interactions.
Bulgarian: s klopidogrelom in drugimi sočasno danimi zdravili, da bi proučili potencial za farmakodinamične in farmakokinetične interakcije.
English: 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.
Bulgarian: Q zobca, nizka do visoka raven tveganja, diabetes, potreba po revaskularizaciji, starost, spol, itd), so skladni z rezultati primarne analize.
English: What Clopidogrel Teva Pharma B.V. is and what it is used for
Bulgarian: Kaj je zdravilo Klopidogrel Teva Pharma B.V. in za kaj ga uporabljamo
English: For example: o If you have recently suffered from a serious injury o If you have recently undergone surgery or are due to have surgery (including dental surgery) o If you have any blood disorder which makes internal bleeding (bleeding inside your body) more likely o If you suffer from any other illness which makes internal bleeding more likely (e.g. stomach ulcers or wounds inside the eye)
Bulgarian: o če ste imeli pred kratkim kirurški poseg ali načrtujete kirurški poseg (vključno z o če imate kakršnokoli krvno motnjo, zaradi katere ste bolj nagnjeni k notranji krvavitvi o če imate kakršnokoli bolezen, zaradi katere ste bolj nagnjeni k notranji krvavitvi (npr.
English: A serious condition called thrombotic thrombocytic purpura (rare disorder of the blood clotting system which causes multiple blood clots to form around the body).
Bulgarian: resno obolenje, ki se imenuje trombotična trombocitopenična purpura (redka motnja strjevanja krvi, ki povzroči pojav številnih krvnih strdkov po celem telesu).
English: CYP2C19 is involved in the formation of both the active metabolite and the 2-oxo-clopidogrel intermediate metabolite.
Bulgarian: CYP2C19 je vključen tako v nastajanje aktivnega presnovka kot vmesnega presnovka, 2oksoklopidogrela.
English: Patients who had developed a previous allergic reaction and/or haematological reaction to one thienopyridine may have an increased risk of developing the same or another reaction to another thienopyridine.
Bulgarian: in/ali hematološko reakcijo na enega od tienopiridinov, imajo lahko večje tveganje za pojav enake ali druge reakcije na drug tienopiridin.
English: • Omeprazole, esomeprazole or cimetidine, medicines to treat upset stomach.
Bulgarian: omeprazol, esomeprazol ali cimetidin, zdravila za zdravljenje težav z želodcem,
English: Overdose following clopidogrel administration may lead to prolonged bleeding time and subsequent bleeding complications.
Bulgarian: Preveliki odmerki klopidogrela lahko podaljšajo čas krvavitve in posledično povzročijo zaplete
English: The benefits observed with clopidogrel were independent of other acute and long-term cardiovascular therapies (such as heparin/LMWH, GPIIb/IIIa antagonists, lipid lowering medicinal products, beta blockers, and ACE-inhibitors).
Bulgarian: Koristi, ki so jih opazili pri uporabi klopidogrela, so bile neodvisne od drugih akutnih in dolgotrajnih srčnožilnih terapij (kot je heparin /nizkomolekularni heparin, antagonisti glikoproteina IIb/IIIa, učinkovine za zniževanje lipidov, blokatorji beta in zaviralci angiotenzinske konvertaze).
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.
Bulgarian: Pri bolnikih, ki so ostali na zdravljenju do pet dni pred koronarno premostitveno operacijo, je bil delež dogodkov 9,6 % za klopidogrel v kombinaciji z acetilsalicilno kislino in 6,3 % za placebo v kombinaciji z acetilsalicilno kislino.
English: • Fluconazole, voriconazole, ciprofloxacin, or chloramphenicol, medicines to treat bacterial and fungal infections.
Bulgarian: flukonazol, vorikonazol, ciprofloksacin ali klorampfenikol, zdravila za zdravljenje bakterijskih in glivičnih okužb,
English: Any remaining tablets should be discarded at the end of this period.
Bulgarian: Preostale tablete je potrebno odstraniti po preteku
English: Risk Management Plan (RMP)
Bulgarian: Načrt za obvladovanje tveganja (RMP) Navedba smiselno ni potrebna.
English: Their use with Clopidogrel Teva Pharma B.V. is not recommended.
Bulgarian: Sočasna uporaba z zdravilom Klopidogrel Teva Pharma B.V. ni priporočena.
English: • Adult patients suffering from acute coronary syndrome:
Bulgarian: Pri bolnikih z akutnim koronarnim sindromom:
English: Marketing Authorisation Holder and Manufacturer
Bulgarian: Imetnik dovoljenja za promet z zdravilom in izdelovalci
English: • Oral anticoagulants (oral medicines used to stop blood clotting) such as warfarin.
Bulgarian: peroralne koagulanse (zdravila, ki se uporabljajo za preprečevanje strjevanja krvi), kot je varfarin.
English: LIST OF EXCIPIENTS It also contains lactose and hydrogenated castor oil.
Bulgarian: Zdravilo vsebuje tudi laktozo in hidrogenirano ricinusovo olje.
English: Bleeding may occur as bleeding in the stomach or bowels, bruising, haematoma (unusual bleeding or bruising under the skin), nose bleeds or blood in the urine.
Bulgarian: Krvavitev se lahko pojavi kot krvavitev iz želodca ali črevesja, kot odrgnine, hematomi (neobičajne krvavitve ali odrgnine pod kožo), krvavitev iz nosu, kri v urinu.
English: Hallucinations, confusion
Bulgarian: Psihiatrične motnje halucinacije, zmedenost
English: It is characterised by thrombocytopenia and microangiopathic haemolytic anaemia associated with either neurological findings, renal dysfunction or fever.
Bulgarian: Zanjo je značilna trombocitopenija in mikroangiopatična hemolitična anemija, povezana ali z nevrološkimi spremembami, motnjo v delovanju ledvic ali povišano telesno temperaturo.
English: Appropriate therapy should be considered if bleedings are observed.
Bulgarian: V primeru opaženih krvavitev je potrebno razmisliti o uvedbi ustreznega zdravljenja.
English: Patients were randomised to clopidogrel 75 mg/day or ASA 325 mg/day, and were followed for 1 to 3 years.
Bulgarian: Bolniki so bili naključno razdeljeni v skupine, ki so prejemale klopidogrel 75 mg/dan ali acetilsalicilno kislino 325 mg/dan, spremljali so jih od 1 do 3 let.
English: Due to the risk of bleeding and haematological adverse reactions, blood cell count determination and/or other appropriate testing should be promptly considered whenever clinical symptoms suggestive of bleeding arise during the course of treatment (see section 4.8).
Bulgarian: takoj preučiti potrebo po določanju števila krvnih celic in/ali drugih ustreznih preiskav, kadar se v obdobju zdravljenja pojavijo klinični simptomi, ki nakazujejo krvavitev (glejte poglavje 4.8).
English: The incidence of severe cases was similar for clopidogrel and ASA.
Bulgarian: Incidenca hujših primerov je bila podobna za klopidogrel in za acetilsalicilno kislino.