FrancophonIA/ELRC3.0 huggingface dataset:
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 intermedijarne metabolizatore te 72% za spore metabolizatore, dok je inhibicija agregacije trombocita (5 µM ADP) smanjena s razlikama za vrijednosti IPA-e od 5,9%, odnosno 21,4%, u usporedbi sa brzim metabolizatorima.
English: After repeated doses of 75 mg clopidogrel per day in subjects with severe renal disease (creatinine clearance from 5 to 15 ml/min), inhibition of ADP-induced platelet aggregation was lower (25%) than that observed in healthy subjects, however, the prolongation of bleeding time was similar to that seen in healthy subjects receiving 75 mg of clopidogrel per day.
Croatian: Nakon ponovljenih doza od 75 mg klopidogrela dnevno, inhibicija ADP-om inducirane agregacije trombocita bila je niža (25%) u ispitanika s teškim oštećenjem funkcije bubrega (klirens kreatinina od 5 do 15 ml/min), u usporedbi sa zdravim ispitanicima, iako je produljenje vremena krvarenja bilo slično onom zabilježenom u zdravih ispitanika koji su primali 75 mg klopidogrela dnevno.
English: Following absorption, the ASA in the combination of clopidogrel/acetylsalicylic acid is hydrolyzed to salicylic acid with peak plasma levels of salicylic acid occurring within 1 hour of dosing, such that plasma levels of ASA are essentially undetectable 1.5-3 hours after dosing.
Croatian: Nakon apsorpcije, ASK iz kombinacije klopidogrel/acetilsalicilatna kiselina se hidrolizira u salicilatnu kiselinu čija se vršna koncentracija u plazmi pojavljuje unutar jednog sata od primjene, tako da je koncentraciju ASK u plazmi gotovo nemoguće odrediti poslije 1,5-3 sata nakon doziranja.
English: This benefit was consistent across all prespecified subgroups including patients' age and gender, infarct location, and type of fibrinolytic or heparin used.
Croatian: Ova korist bila je dosljedno prisutna u svim unaprijed određenim podskupinama prema dobi i spolu bolesnika, lokaciji infarkta te tipu primijenjenog fibrinolitika ili heparina.
English: Other concomitant therapy with ASA
Croatian: Ostala istodobna terapija s ASK
English: What Clopidogrel/Acetylsalicylic acid Teva is and what it is used for
Croatian: Što je Klopidogrel/Acetilsalicilatna kiselina Teva i za što se koristi
English: It is unknown whether ASA alters fertility.
Croatian: Nije poznato utječe li ASK na plodnost.
English: Clopidogrel/Acetylsalicylic acid Teva is used following initiation of therapy with clopidogrel and ASA given separately.
Croatian: Klopidogrel/acetilsalicilatna kiselina Teva koristi se nakon početka liječenja u kojem se klopidogrel i ASK daju odvojeno.
English: If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Croatian: U slučaju bilo kakvih pitanja u vezi s primjenom ovoga lijeka obratite se svom liječniku ili ljekarniku.
English: • ST segment elevation acute myocardial infarction in medically treated patients eligible for
Croatian: • akutnog infarkta miokarda s elevacijom ST segmenta u medikamentozno liječenih bolesnika podobnih za liječenje tromboliticima
English: Clopidogrel/Acetylsalicylic acid Teva is a fixed-dose combination medicinal product for continuation of therapy in:
Croatian: Klopidogrel/acetilsalicilatna kiselina Teva je fiksna kombinacija lijeka za nastavak liječenja:
English: However, if you are concerned by your bleeding, you should contact your doctor straightaway (see section 4
Croatian: Ako ste ipak zabrinuti zbog krvarenja, odmah obavijestite svog liječnika (vidjeti dio 4. „Moguće nuspojave“).
English: The clinically relevant adverse reactions observed in four major studies, the CAPRIE study (a study comparing clopidogrel alone to ASA) and the CURE, CLARITY and COMMIT studies (studies comparing clopidogrel plus ASA to ASA alone) are discussed below.
Croatian: Klinički značajne nuspojave opažene u četiri velika ispitivanja, odnosno CAPRIE (usporedba klopidogrela u monoterapiji i ASK) te CURE, CLARITY i COMMIT (usporedba klopidogrela uz ASK s ASK u monoterapiji) koja su opisana u daljnjem tekstu.
English: Clopidogrel/Acetylsalicylic acid Teva is supplied in blisters in pack sizes of 14, 28 and 30 film-coated tablets or in bottles in a pack size of 30 film-coated tablets.
Croatian: Klopidogrel/acetilsalicilatna kiselina Teva dostupan je u blisterima, u pakiranjima sa 14, 28 i 30 filmom obloženih tableta ili u bocama sa 30 filmom obloženih tableta.
English: • Hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs) and syndrome of asthma, rhinitis, and nasal polyps.
Croatian: • Kod preosjetljivosti na nesteroidne protuupalne lijekove i sindroma astme, rinitisa i nosnih polipa.
English: - renal dysfunction, which may progress to renal failure with oligo-hydroamniosis;
Croatian: - disfunkciji bubrega, koja može progredirati u zatajenje bubrega s oligohidroamnionom
English: White HDPE bottles and green polypropylene (PP) child-resistant closures with dessicant.
Croatian: Bijele HDPE boce i zeleni polipropilenski (PP) sigurnosni zatvarač za djecu sa sredstvom za sušenje.
English: The number of patients experiencing the primary endpoint [cardiovascular (CV) death, myocardial infarction (MI), or stroke] was 582 (9.3%) in the clopidogrel plus ASA group and 719 (11.4%) in the ASA group, a 20% relative risk reduction (RRR) (95% CI of 10%-28%; p=0.00009) for the clopidogrel plus ASA group [17% relative risk reduction when patients were treated conservatively, 29% when they underwent percutaneous transluminal coronary angioplasty (PTCA) with or without stent and 10% when they underwent coronary artery bypass graft (CABG)].
Croatian: Broj bolesnika s primarnim ishodom [smrt zbog kardiovaskularnih uzroka, infarkt miokarda ili moždani udar] bio je 582 (9,3%) u skupini koja je primala klopidogrel uz ASK, a 719 (11,4%) u skupini koja je primala ASK, što je 20%-tno smanjenje relativnog rizika (95% CI od 10% do 28%; p=0,00009) u skupini koja se liječila klopidogrelom uz ASK (17% smanjenje relativnoga rizika u bolesnika koji su liječeni konzervativno, 29% u bolesnika podvrgnutih perkutanoj transluminalnoj koronarnoj angioplastici (PTCA) s ili bez ugradnje stenta i 10% za bolesnike kojima je obavljeno aortokoronarno premoštenje (CABG, engl.
English: ASA:
Croatian: ASK:
English: Monitoring for signs of hypersensitivity in patients with a known allergy to thienopyridines is advised.
Croatian: Savjetuje se pratiti bolesnike s poznatom alergijom na tienopiridine radi mogućih znakova preosjetljivosti.
English: The safety of the concomitant administration of the combination of clopidogrel/acetylsalicylic acid with other thrombolytic agents has not been formally established and should be undertaken with caution (see section 4.4).
Croatian: Sigurnost istovremene primjene kombinacije klopidogrela/acetilsalicilatne kiseline s drugim tromboliticima nije formalno utvrđena i pri toj je primjeni potreban oprez (vidjeti dio 4.4).
English: Adverse reactions that occurred with clopidogrel alone, with ASA alone* or with clopidogrel in combination with ASA either during clinical studies or that were spontaneously reported are presented in the table below.
Croatian: Nuspojave koje su se pojavile pri primjeni klopidogrela u monoterapiji, ASK u monoterpiji* ili klopidogrela u kombinaciji s ASK prijavljene ili tijekom kliničkih ispitivanja ili spontano navedene su u tablici.
English: ASA is known to be excreted in limited amounts in human milk.
Croatian: Poznato je da se ograničene količine ASK izlučuju u majčino mlijeko u ljudi.
English: Driving and using machines Clopidogrel/Acetylsalicylic acid Teva should not affect your ability to drive or to use machines.
Croatian: Klopidogrel/acetilsalicilatna kiselinaTeva ne bi trebao utjecati na Vašu sposobnost upravljanja vozilima ili strojevima.
English: • fluoxetine, fluvoxamine, or moclobemide, medicines to treat depression,
Croatian: • fluoksetin, fluvoksamin ili moklobemid, lijekove koji se koriste u liječenju depresije
English: • If you suffer from severe kidney disease.
Croatian: • ako patite od teške bolesti bubrega
English: • if you have had a clot in an artery of your brain (ischaemic stroke) which occurred in the last
Croatian: • ako ste imali krvni ugrušak u arteriji u mozgu (ishemijski moždani udar) koji se pojavio unutar posljednjih sedam dana.
English: Patients should also be told that it might take longer than usual to stop bleeding when they take the combination of clopidogrel/acetylsalicylic acid, and that they should report any unusual bleeding (site or duration) to their physician.
Croatian: Bolesnicima koji uzimaju kombinaciju klopidogrela i acetilsalicilatne kiseline potrebno je objasniti da će krvarenje možda trajati dulje nego obično i da moraju obavijestiti liječnika o bilo kakvom neočekivanom krvarenju (s obzirom na mjesto i trajanje krvarenja).
English: Oral use SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT Keep out of the sight and reach of children.
Croatian: POSEBNO UPOZORENJE O ČUVANJU LIJEKA IZVAN POGLEDA
English: Clopidogrel/Acetylsalicylic acid Teva is supplied in blisters in pack sizes of 10, 14, 28, 30, 50, 90 and 100 film-coated tablets or in bottles in a pack size of 30 film-coated tablets.
Croatian: Klopidogrel/acetilsalicilatna kiselina Teva dostupan je u blisterima, u pakiranjima sa 10, 14, 28, 30, 50, 90 i 100 filmom obloženih tableta ili u bocama sa 30 filmom obloženih tableta.
English: White HDPE multi-layer bottles and green polypropylene (PP) child-resistant closures with dessicant.
Croatian: Bijele HDPE višeslojne boce i zeleni polipropilenski (PP) sigurnosni zatvarač za djecu sa sredstvom za sušenje.
English: As a precaution, concomitant use of omeprazole or esomeprazole should be discouraged (see section 4.4).
Croatian: Kao mjera opreza, ne preporučuje se istovremena primjena omeprazola ili esomeprazola (vidjeti dio 4.4).
English: The most common side effect which has been seen with Clopidogrel/Acetylsalicylic acid Teva is bleeding.
Croatian: Najčešća nuspojava pri primjeni lijeka Klopidogrel/acetilsalicilatna kiselinaTeva je krvarenje.
English: • blisters of the skin
Croatian: • mjehurići na koži
English: Patients were randomised to clopidogrel (300 mg loading dose followed by 75 mg/day, N=6,259) plus ASA (75-325 mg once daily) or ASA alone (N=6,303), (75-325 mg once daily) and other standard therapies.
Croatian: Bolesnici su randomizirani u skupine koje su primale klopidogrel (udarna doza od 300 mg, a nakon toga 75 mg/dan, N=6259) u kombinaciji s ASK (75 mg do 325 mg jedanput dnevno) ili samu ASK (N=6303, 75 mg do 325 mg jedanput dnevno), uz drugu standardnu terapiju.
English: Musculo-skeletal bleeding (haemarthrosis), arthritis, arthralgia, myalgia
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva mišićno-koštano krvarenje (hemartroza), artritis, artralgija, mijalgija
English: Do not take Clopidogrel/Acetylsalicylic acid Teva
Croatian: Nemojte uzimati Klopidogrel/acetilsalicilatna kiselina Teva
English: This leaflet was last revised in <MM/YYYY> Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Croatian: Detaljni podaci o ovome lijeku dostupni su na stranicama Europske agencije za lijekove: http://www.ema.europa.eu.
English: If you take more Clopidogrel/Acetylsalicylic acid Teva than you should Contact your doctor or the nearest hospital emergency department immediately because of the increased risk of bleeding.
Croatian: Odmah se morate obratiti svom liječniku ili otići u najbližu stanicu hitne medicinske pomoći zbog povećanog rizika od krvarenja.
English: Acute liver failure, liver injury, mainly hepatocellular*, hepatitis, elevation of hepatic
Croatian: Poremećaji jetre i akutno zatajenje žuči jetre, ozljeda jetre, uglavnom hepatocelularna*, hepatitis, povišenje jetrenih enzima*, poremećene vrijednosti testova jetrene funkcije
English: Respiratory tract bleeding (haemoptysis, pulmonary haemorrhage), bronchospasm, interstitial pneumonitis, non-cardiogenic pulmonary edema with chronic use and in the context of a hypersensitivity reaction due to acetylsalicylic acid*, eosinophilic pneumonia.
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja krvarenje u dišnome sustavu (hemoptiza, plućno krvarenje), bronhospazam, intersticijski pneumonitis, nekardiogeni plućni edem kod kronične primjene i u sklopu reakcije preosjetljivosti na acetilsalicilatnu kiselinu*, eozinofilna pneumonija
English: Bullous dermatitis (toxic epidermal necrolysis, Stevens Johnson Syndrome, erythema multiforme), angioedema, drug induced hypersentsitivity syndrome, drug rash with eosinophilia and systemic symptoms (DRESS), rash erythematous or exfoliative, urticaria, eczema, lichen planus
Croatian: bulozni dermatitis (toksična epidermalna nekroliza, Stevens Johnsonov sindrom, erythema multiforme), angioedem, sindrom preosjetljivosti izazvan lijekom, osip uzrokovan lijekom s eozinofilijom i sistemskim simptomima (engl.
English: The concomitant administration of the combination of clopidogrel/acetylsalicylic acid with oral anticoagulants is not recommended since it may increase the intensity of bleeding (see section 4.5).
Croatian: Ne preporučuje se istodobna primjena kombinacije klopidogrela i acetilsalicilatne kiseline s oralnim antikoagulansima jer to može pojačati intenzitet krvarenja (vidjeti dio 4.5).
English: Very rare side effects (may affect up to 1 in 10,000 people):
Croatian: Vrlo rijetke nuspojave (mogu se javiti u do 1 od na 10 000 osoba):
English: Heparins were administered in more than 90% of the patients and the relative rate of bleeding between clopidogrel plus ASA and ASA alone was not significantly affected by the concomitant heparin therapy.
Croatian: Heparine je primalo više od 90% bolesnika, a na relativnu stopu krvarenja nije značajno utjecalo istodobno liječenje heparinom niti u skupini koja je primala klopidogrel uz ASK niti u onoj koja je primala ASK u monoterapiji.
English: Thus, beyond 3 months of treatment, the benefit observed in the clopidogrel plus ASA group was not further increased, whereas the risk of haemorrhage persisted (see section 4.4).
Croatian: Tako se, nakon 3 mjeseca liječenja, opažena korist u skupini koja je liječena kombinacijom klopidogrela i ASK nije dalje povećavala, dok je opasnost od krvarenja i nadalje postojala (vidjeti dio
English: Upper gastrointestinal disorders (oesophagitis, oesophageal ulceration, perforation, erosive gastritis, erosive duodenitis; gastro-duodenal ulcer/perforations)*; lower gastrointestinal disorders (small [jejunum and ileum] and large [colon and rectum] intestinal ulcers, colitis and intestinal perforation)*; upper gastro-intestinal symptoms* such as gastralgia (see section 4.4); these ASA-related GI reactions may or may not be associated with haemorrhage, and may occur at any dose of acetylsalicylic acid and in patients with or without warning symptoms or a previous history of serious GI events*.
Croatian: [jejunum i ileum] i debelog [kolon i rektum] crijeva, kolitis i perforacija crijeva)*, simptomi u gornjem probavnog sustavu* kao što je gastralgija (vidjeti dio 4.4); ove gastrointestinalne nuspojave povezane s ASK mogu i ne moraju biti popraćene hemoragijom i mogu se javiti pri primjeni bilo koje doze acetilsalicilatne kiseline te u bolesnika sa simptomima upozorenja ili bez njih ili anamnezom prethodnih ozbiljnih gastrointestinalnih događaja*.
English: Patients received clopidogrel (300 mg loading dose, followed by 75 mg/day, n=1,752) plus ASA or ASA alone (n=1,739), (150 to 325 mg as a loading dose, followed by 75 to 162 mg/day), a fibrinolytic agent and, when appropriate, heparin.
Croatian: Bolesnici su primali klopidogrel (prvo udarnu dozu od 300 mg, a nakon toga dozu od 75 mg na dan, N=1725) uz ASK ili samo ASK (N=1739, 150 mg do 325 mg kao udarnu dozu nakon čega je slijedila doza od 75 mg do 162 mg na dan) uz fibrinolitik i, po potrebi, heparin.
English: • hearing loss
Croatian: • gubitak sluha
English: The concomitant administration of the combination of clopidogrel/acetylsalicylic acid with oral anticoagulants is not recommended since it may increase the intensity of bleeding (see section 4.4).
Croatian: Ne preporučuje se istodobna primjena kombinacije klopidogrela i acetilsalicilatne kiseline s oralnim antikoagulansima jer se može povećati intenzitet krvarenja (vidjeti dio 4.4.).
English: Since SSRIs affect platelet activation and increase the risk of bleeding, the concomitant administration of SSRIs with clopidogrel should be undertaken with caution.
Croatian: Budući da inhibitori ponovne pohrane serotonina utječu na aktivaciju trombocita i povećavaju rizik od krvarenja, nužan je oprez tijekom njihove istovremene primjene s klopidogrelom.
English: GI undesirable effects including stomach pain, heartburn, nausea, vomiting, and GI bleeding may occur.
Croatian: Mogu se javiti gastrointestinalne nuspojave, uključujući bol u želucu, žgaravicu, mučninu, povraćanje i gastrointestinalno krvarenje.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU
English: Film-coated tablet 14 film-coated tablets 28 film-coated tablets 30 film-coated tablets
Croatian: 14 filmom obloženih tableta 28 filmom obloženih tableta 30 filmom obloženih tableta
English: Therapeutic experience is limited in patients with moderate hepatic disease who may have bleeding diatheses (see section 4.4).
Croatian: Terapijsko iskustvo u bolesnika s umjerenim oštećenjem funkcije jetre, koji mogu imati hemoragijsku dijatezu, je ograničeno (vidjeti dio 4.4).
English: In CLARITY, there was an overall increase in bleeding in the clopidogrel plus ASA group vs. the group taking ASA alone.
Croatian: U studiji CLARITY uočeno je ukupno povećanje krvarenja u skupini koja je primala klopidogrel uz ASK u odnosu na skupinu koja je uzimala samo ASK.
English: While you are taking Clopidogrel/Acetylsalicylic acid Teva:
Croatian: Dok uzimate lijek Klopidogrel/acetilsalicilatna kiselina Teva:
English: The ASA in the combination of clopidogrel/acetylsalicylic acid is rapidly hydrolyzed in plasma to salicylic acid, with a half-life of 0.3 to 0.4 hours for ASA doses from 75 to 100 mg. Salicylic acid is primarily conjugated in the liver to form salicyluric acid, a phenolic glucuronide, an acyl glucuronide, and a number of minor metabolites.
Croatian: ASK iz kombinacije klopidogrel/acetilsalicilatna kiselina brzo se u plazmi hidrolizira u salicilatnu kiselinu koja ima poluvrijeme izlučivanja od 0,3-0,4 sata za doze ASK od 75 do 100 mg.
English: Each film-coated tablet contains 102.6 mg of lactose (as lactose monohydrate).
Croatian: Pomoćna tvar s poznatim učinkom: Jedna filmom obložena tableta sadrži 102,6 mg laktoze (u obliku laktoze hidrata).
English: What Clopidogrel/Acetylsalicylic acid Teva looks like and contents of the pack Clopidogrel/Acetylsalicylic acid Teva 75 mg/100 mg film-coated tablets are light pink to pink, film-coated capsule shaped tablets.
Croatian: Kako Klopidogrel/acetilsalicilatna kiselinaTeva izgleda i sadržaj pakiranja Klopidogrel/acetilsalicilatna kiselina Teva 75 mg/100 mg filmom obložene tablete su svijetloružičaste do ružičaste filmom obložene tablete u obliku kapsula.
English: Each film-coated tablet contains 117.8 mg of lactose (as lactose monohydrate).
Croatian: Pomoćna tvar s poznatim učinkom: Jedna filmom obložena tableta sadrži 117,8 mg laktoze (u obliku laktoze hidrata.
English: Anaphylactic shock*, serum sickness, anaphylactoid reactions, aggravation of allergic symptoms of food allergy*, cross-reactive drug hypersensitivity
Croatian: Anafilaktički šok*, serumska bolest, anafilaktoidne reakcije, pogoršanje simptoma alergije na hranu*, križno reaktivna preosjetljivost na lijekove iz skupine tienopiridina (kao što su tiklopidin, prasugrel) (vidjeti dio 4.4)*
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Croatian: Nuspojave možete prijaviti i izravno putem nacionalnog sustava za prijavu nuspojava navedenog u Dodatku V.
English: • burning in stomach and/or oesophagus
Croatian: • žarenje u želucu i/ili jednjaku
English: NAME OF THE MARKETING AUTHORISATION HOLDER Teva Pharma B.V.
Croatian: NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Teva Pharma B.V.
English: Marketing Authorisation Holder: Teva Pharma B.V.
Croatian: ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Teva Pharma B.V.
English: Patients who have 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.
Croatian: Rizik od razvoja iste ili druge reakcije na drugi tienopiridin može biti povišen u bolesnika koji su već imali alergijsku reakciju i/ili hematološku reakciju na jedan od tienopiridina.
English: There are no fertility data with the combination of clopidogrel/acetylsalicylic acid.
Croatian: Ne postoje podaci o plodnosti nakon primjene kombinacije klopidogrel/acetilsalicilatna kiselina.
English: What Clopidogrel/Acetylsalicylic acid Teva contains
Croatian: Što Klopidogrel/acetilsalicilatna kiselina Teva sadrži
English: There is no information concerning overdose with the combination of clopidogrel/acetylsalicylic acid.
Croatian: Nema podataka vezanih za predoziranje kombinacijom klopidogrela/acetilsalicilatne kiseline.
English: This benefit was mostly driven by the statistically significant reduction in the incidence of MI [287 (4.6%) in the clopidogrel plus ASA group and 363 (5.8%) in the ASA group].
Croatian: Na tu korist najviše je utjecalo statistički značajno smanjenje incidencije infarkta miokarda [287 (4,6%) u skupini koja je primala klopidogrel uz ASK te 363 (5,8%) u skupini koja je primala samo ASK]. Nije primijećen učinak na stopu ponovljene hospitalizacije zbog nestabilne angine.
English: How to take Clopidogrel/Acetylsalicylic acid Teva
Croatian: Kako uzimati Klopidogrel/acetilsalicilatna kiselina Teva
English: Polydextrose
Croatian: Trombolitici
English: Eye disorders Ear and labyrinth disorders
Croatian: Poremećaji oka Poremećaji uha i labirinta vrtoglavica gubitak sluha* ili tinitus*
English: The number of patients experiencing the co-primary endpoint (CV death, MI, stroke or refractory ischaemia) was 1,035 (16.5%) in the clopidogrel plus ASA group and 1,187 (18.8%) in the ASA group, a 14% relative risk reduction (95% CI of 6%-21%, p=0.0005) for the clopidogrel plus ASA group.
Croatian: U skupini koja je primala klopidogrel uz ASK bilo je 1035 (16,5%) bolesnika sa koprimarnim ishodom (smrt zbog kardiovaskularnih uzroka, infarkt miokarda, moždani udar ili refraktorna ishemija), odnosno 1187 (18,8%) bolesnika u skupini koja je primala samo ASK, što znači smanjenje relativnoga rizika od 14% (95% CI: 6%-21%, p=0,0005) u skupini koja je primala klopidogrel uz ASK.
English: Clopidogrel/Acetylsalicylic acid Teva 75 mg/75 mg
Croatian: Klopidogrel/acetilsalicilatna kiselina Teva 75 mg/75 mg
English: • swelling in the mouth or skin disorders such as rashes and itching, blisters of the skin.
Croatian: • oticanje u ustima ili kožne poremećaje kao što su osip i svrbež te mjehurići na koži; ti simptomi mogu biti znakovi alergijske reakcije.
English: Hypoglycaemia*, gout* (see section
Croatian: Poremećaji metabolizma i prehrane hipoglikemija*, giht* (vidjeti dio