natgillin/translations-raw huggingface dataset:
In TRITON-TIMI 38 and 3 of the cohort studies (n= 3,516; Collet, Sibbing, Giusti), patients with an impaired metaboliser status (intermediate and poor combined) had a higher rate of cardiovascular events (death, myocardial infarction, and stroke) or stent thrombosis compared to extensive metabolisers. 
U studiji TRITON-TIMI 38 i 3 kohortne studije (Collet, Sibbing, Giusti), stopa kardiovaskularnih događaja (smrt, infarkt miokarda i moždani udar) ili tromboze stenta bila je veća u kombiniranoj skupini bolesnika sa statusom umjerenih ili slabih metabolizatora nego u brzih metabolizatora.
The active thiol metabolite which has been isolated in vitro, binds rapidly and irreversibly to platelet receptors, thus inhibiting platelet aggregation. 
Aktivni tiolni metabolit, koji je izoliran in vitro, brzo se i ireverzibilno veže na receptore na trombocitima i time inhibira agregaciju trombocita.
The efficacy of clopidogrel was observed independently of the dose of ASA (75-325 mg once daily). 
Djelotvornost klopidogrela nije ovisila o dozi ASK (75 do 325 mg jedanput na dan).
CYP2C19 is involved in the formation of both the active metabolite and the 2-oxo-clopidogrel intermediate metabolite. 
CYP2C19 je uključen u formiranje aktivnog metabolita i 2-okso-klopidogrel intermedijarnog metabolita.
• 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 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).
28 film-coated tablets 28x1 film-coated tablets 30 film-coated tablets 30x1 film-coated tablets 50 film-coated tablets 50x1 film-coated tablets 56 film-coated tablets 56x1 film-coated tablets 84 film-coated tablets 84x1 film-coated tablets 90 film-coated tablets 90x1 film-coated tablets 100 film-coated tablets 100x1 film-coated tablets 
28 filmom obloženih tableta 28x1 filmom obloženih tableta 30 filmom obloženih tableta 30x1 filmom obloženih tableta 50 filmom obloženih tableta 50x1 filmom obloženih tableta 56 filmom obloženih tableta 56x1 filmom obloženih tableta 84 filmom obložene tablete 84x1 filmom obloženih tableta 90 filmom obloženih tableta 90x1 filmom obloženih tableta 100 filmom obloženih tableta 100x1 filmom obloženih tableta
If you have any further questions on the use of this product, ask your doctor or pharmacist. 
U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka obratite se svom liječniku ili ljekarniku.
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). 
Oralni antikoagulansi: ne preporučuje se istodobna primjena klopidogrela i oralnih antikoagulansa jer se može povećati intenzitet krvarenja (vidjeti dio 4.4.).
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. 
Bolesnici su primali klopidogrel (75 mg na dan, n=22 961) ili placebo (n=22 891), u kombinaciji s ASK (162 mg na dan), u trajanju do 28 dana ili do otpusta iz bolnice.
Driving and using machines Clopidogrel Teva Generics B.V. is unlikely to affect your ability to drive or to use machines. 
Klopidogrel Teva Generics B.V. ne bi trebao utjecati na Vašu sposobnost upravljanja vozilima ili strojevima.
Like all medicines, Clopidogrel Teva Generics B.V. can cause side effects, although not everybody gets them. 
Kao i svi drugi lijekovi, ovaj lijek može uzrokovati nuspojave iako se one neće javiti kod svakoga.
Clopidogrel is a prodrug, one of whose metabolites is an inhibitor of platelet aggregation. 
Klopidogrel je predlijek, čiji je jedan metabolit inhibitor agregacije trombocita.
In patients who remained on therapy within five days of bypass graft surgery, the event rate was 9.6% for clopidogrel+ASA, and 6.3% for placebo + ASA. 
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.
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. 
Kao i u slučaju drugih antitrombocitnih lijekova, klopidogrel s oprezom treba davati bolesnicima koji su izloženi povećanom riziku od krvarenja zbog povreda, 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.
If you forget for more than 12 hours, simply take the next single dose at the usual time. 
Ako se ne sjetite propuštene doze u roku od 12 sati, sljedeću uzmite u uobičajeno vrijeme.
This was consistent across subgroups of patients defined by baseline characteristics, and type of fibrinolytic or heparin therapy. 
Konzistentni podaci dobiveni su i u podskupinama bolesnika koje su definirane prema početnim karakteristikama i tipu terapije fibrinoliticima ili heparinom.
Then, the usual dose is one 75 mg tablet of Clopidogrel Teva Generics B.V. per day to be taken orally with or without food, and at the same time each day. 
Nakon toga, preporučena doza lijeka Klopidogrel Teva Generics B.V. je jedna tableta od 75 mg na dan koja se uzima kroz usta s obrokom ili između obroka, u isto vrijeme svaki dan.
Since clopidogrel is metabolised to its active metabolite partly by CYP2C19, use of medicinal products that inhibit the activity of this enzyme would be expected to result in reduced drug levels of the active metabolite of clopidogrel. 
S obzirom da se klopidogrel djelomično metabolizira do svog aktivnog metabolita pomoću enzima CYP2C19, očekuje se da će primjena lijekova koji inhibiraju aktivnost ovog enzima rezultirati smanjenom koncentracijom aktivnog metabolita klopidogrela.
Bleeding is the most common reaction reported both in clinical studies as well as in post-marketing experience where it was mostly reported during the first month of treatment. 
Najčešće prijavljena nuspojava u kliničkim ispitivanjima i praćenju nakon stavljanja lijeka u promet je krvarenje, a zabilježeno je najčešće tijekom prvog mjeseca liječenja.
Subsequent metabolism of the 2-oxo-clopidogrel intermediate metabolite results in formation of the active metabolite, a thiol derivative of clopidogrel. 
Naknadni metabolizam 2-okso-klopidogrela rezultira nastajanjem aktivnog metabolita, tiolnog derivata klopidogrela.
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. 
Nakon ponovljenih doza od 75 mg klopidogrela na dan, inhibicija ADP-om inducirane agregacije trombocita bila je niža (25%) u ispitanika s teško narušenom funkcijom bubrega (klirens kreatinina od 5 do 15 ml/min) nego u zdravih ispitanika, iako je produljenje vremena krvarenja bilo slično onom zabilježenom u zdravih bolesnika koji su primali 75 mg klopidogrela na dan.
Co-administration of heparin had no effect on the inhibition of platelet aggregation induced by clopidogrel. 
Istodobna primijena heparina nije utjecala na inhibiciju agregacije trombocita induciranu klopidogrelom.
Therapeutic experience with clopidogrel is limited in patients with renal impairment. 
Terapijsko je iskustvo s klopidogrelom u bolesnika s narušenom funkcijom bubrega ograničeno.
The CURE study included 12,562 patients with non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), and presenting within 24 hours of onset of the most recent episode of chest pain or symptoms consistent with ischaemia. 
Studija CURE uključivala je 12 562 bolesnika s akutnim koronarnim sindromom bez elevacije STsegmenta (nestabilna angina ili non-Q infarkt miokarda), koji su u zadnja 24 sata imali epizodu boli u prsištu ili simptome ishemije.
Each film-coated tablet contains 75 mg of clopidogrel (as hydrochloride). 
Jedna filmom obložena tableta sadrži 75 mg klopidogrela (u obliku klopidogrelklorida).
If any of the situations mentioned below apply to you, you should tell your doctor before taking Clopidogrel Teva Generics B.V.: 
Ako se na Vas odnosi bilo koje od stanja navedenih u daljnjem tekstu, morate obavijestiti liječnika prije nego što uzmete Klopidogrel Teva Generics B.V.:
• 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.
Very rare side effects (affects less than 1 patient in 10,000): Jaundice; severe abdominal pain with or without back pain; fever, breathing difficulties sometimes associated with cough; generalised allergic reactions; swelling in the mouth; blisters of the skin; skin allergy; inflammation of the mouth (stomatitis); decrease in blood pressure; confusion; hallucinations; joint pain; muscular pain; changes in the way things taste. 
Žutica; jaka bol u trbuhu s bolovima u leđima ili bez njih; vrućica, teškoće pri disanju, ponekad povezane s kašljem; generalizirane alergijske reakcije (primjerice, sveukupni osjećaj vrućine s iznenadnom općom nelagodom do nesvjestice); oticanje u ustima; mjehurići na koži; kožne alergijske reakcije; upala u usnoj šupljini (stomatitis); pad krvnoga tlaka; zbunjenost; halucinacije; bol u zglobovima, bol u mišićima, poremećaj okusa hrane.
In particular, in a post-hoc analysis in 2,172 patients (17% of the total CURE population) who underwent stent placement (Stent-CURE), the data showed that clopidogrel compared to placebo, demonstrated a significant RRR of 26.2% favouring clopidogrel for the co-primary endpoint (CV death, MI, stroke) and also a significant RRR of 23.9% for the second co-primary endpoint (CV death, MI, stroke or refractory ischaemia). 
U tzv. post-hoc analizi 2.172 bolesnika (17% ukupne CURE populacije) koji su se podvrgli ugradnji stenta (Stent-CURE), podaci su pokazali da je klopidogrel u usporedbi s placebom, pokazao značajno smanjenje relativnog rizika od 26,2% za koprimarni ishod (kardiovaskularna smrt, infarkt miokarda, moždani udar) kao i značajno smanjenje relativnog rizika od 23,9% za drugi koprimarni ishod (kardiovaskularna smrt, infarkt miokarda, moždani udar ili refraktorna ishemija).
It is unknown whether clopidogrel is excreted in human breast milk. 
Nije poznato izlučuje li se klopidogrel u majčino mlijeko.
4.6 Pregnancy and lactation 
4.6 Plodnost, trudnoća i dojenje
Antacids did not modify the extent of clopidogrel absorption. 
Antacidi nisu utjecali na opseg apsorpcije klopidogrela.
Clopidogrel is indicated in adults for the prevention of atherothrombotic events in: 
Prevencija aterotrombotičkih događaja Klopidogrel je indiciran u:
Patients should be told that it might take longer than usual to stop bleeding when they take clopidogrel (alone or in combination with ASA), and that they should report any unusual bleeding (site or duration) to their physician. 
Bolesnicima koji uzimaju klopidogrel (kao monoterapiju ili u kombinaciji s ASK) potrebno je objasniti da će krvarenje možda trajati dulje nego obično i da moraju obavijestiti liječnika o svakom neočekivanom krvarenju (odnosno o mjestu i trajanju krvarenja).
The concomitant administration of clopidogrel with oral anticoagulants is not recommended since it may increase the intensity of bleedings (see section 4.5). 
Ne preporučuje se istodobna primjena klopidogrela i drugih oralnih antikoagulansa, jer to može pojačati intenzitet krvarenja (vidjeti dio 4.5.).
− 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). 
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 na dan (uz acetilsalicilnu kiselinu (ASK)
As a precaution concomitant use of medicinal products that inhibit CYP2C19 should be discouraged (see section 4.5 for a list of CYP2C19 inhibitors, see also section 5.2). 
Kao mjera opreza, ne preporučuje se istodobna primjena lijekova koji su jaki ili umjereni inhibitori CYP2C19 (za popis inhibitora CYP2C19 vidjeti dio 4.5, također vidjeti dio 5.2).
Appropriate therapy should be considered if bleedings are observed. 
Ako se primijeti krvarenje, treba razmotriti primjerenu terapiju.
In patients who were enrolled in the trial on the sole basis of a recent myocardial infarction, clopidogrel was numerically inferior, but not statistically different from ASA (RRR =4.0%; CI: -22.5 to 11.7 [p=0.639]). 
U bolesnika koji su u studiju uključeni samo zbog nedavnog infarkta miokarda, klopidogrel je bio brojčano slabiji, ali se statistički nije razlikovao od ASK (RRR = -4,0%; CI: -22,5 do 11,7 [p=0,639]).
Patients were randomized to clopidogrel 75 mg/day or ASA 325 mg/day, and were followed for 1 to 3 years. 
Bolesnici su randomizirani u skupine koje su primale 75 mg klopidogrela ili 325 mg acetilsalicilatne kiseline na dan te su praćeni od 1 do 3 godine.
− ST segment elevation acute myocardial infarction: clopidogrel should be given as a single daily dose of 75 mg initiated with a 300 mg loading dose in combination with ASA and with or without thrombolytics. 
Akutni infarkt miokarda s elevacijom ST-segmenta: liječenje klopidogrelom provodi se jednom dnevnom dozom od 75 mg, a započinje udarnom dozom od 300 mg u kombinaciji s ASK te s tromboliticima ili bez njih.
In a subgroup analysis by qualifying condition (myocardial infarction, ischaemic stroke, and PAD) the benefit appeared to be strongest (achieving statistical significance at p = 0.003) in patients enrolled due to PAD (especially those who also had a history of myocardial infarction) (RRR = 23.7%; CI: 8.9 to 36.2) and weaker (not significantly different from ASA) in stroke patients (RRR = 7.3%; CI: -5.7 to 18.7 [p=0.258]). 
U analizi podskupina sačinjenih prema stanju (infarkt miokarda, ishemijski moždani udar, BPA) najveću su korist od liječenja (postignuta statistička značajnost pri p = 0,003) imali bolesnici s bolešću perifernih arterija (BPA), posebno oni koji su u anamnezi imali infarkt miokarda (RRR = 23,7%; CI: 8,9 do 36,2), a manja korist (ne značajno različita od učinka ASK) uočena je u bolesnika s moždanim udarom (RRR = 7,3%; CI: -5,7 do 18,7 [p=0,258]).
Therefore clopidogrel should be used with caution in these patients (see section 4.2). 
Stoga se tim bolesnicima klopidogrel mora davati s oprezom (vidjeti dio 4.2).
The pharmacokinetics of the active metabolite of clopidogrel is not known in these special populations. 
Farmakokinetika aktivnog metabolita klopidogrela nije poznata za sljedeće posebne skupine bolesnika.
Bullous dermatitis (toxic epidermal necrolysis, Stevens Johnson Syndrome, erythema multiforme), angioedema, rash erythematous, urticaria, eczema, lichen planus 
bulozni dermatitis (toksična epidermalna nekroliza, Stevens Johnsonov sindrom, erythema multiforme), angioedem, sindrom preosjetljivosti izazvane lijekom, osip uzrokovan lijekom s eozinofilijom i sistemskim simptomima (engl.
Propylene glycol 
<DD mjesec GGGG>
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER 
UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I PRIMJENU
The number of patients experiencing the primary endpoint [cardiovascular (CV) death, myocardial infarction (MI), or stroke] was 582 (9.3%) in the clopidogrel-treated group and 719 (11.4%) in the placebo-treated group, a 20% relative risk reduction (95% CI of 10%-28%; p=0.00009) for the clopidogrel-treated 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)). 
Broj bolesnika koji su doživjeli primarni ishod [kardiovaskularna smrt, infarkt miokarda ili moždani udar] bio je 582 (9,3%) u skupini koja je primala klopidogrel i 719 (11,4%) u skupini koja je primala placebo, uz 20%-tno smanjenje relativnog rizika (95% CI od 10% do 28%; p=0,00009) u skupini koja se liječila klopidogrelom (17% smanjenje relativnoga rizika u bolesnika koji su liječeni konzervativno, 29% u bolesnika podvrgnutih perkutanoj transluminalnoj koronarnoj angioplastici (PTCA) s ugradnjom stenta ili bez ugradnje stenta i 10% za bolesnike kojima je obavljeno aortokoronarno premoštenje (CABG, engl.
Patients were randomised to clopidogrel (300 mg loading dose followed by 75 mg/day, N=6,259) or placebo (N=6,303), both given in combination with ASA (75-325 mg once daily) and other standard therapies. 
Bolesnici su randomizirani u skupine koje su primale klopidogrel (udarna doza od 300 mg, a nakon toga 75 mg/dan, N=6259) ili placebo (N=6303), oboje u kombinaciji s ASK (75 do 325 mg jedanput na dan) i drugom standardnom terapijom.
INFORMATION IN BRAILLE Clopidogrel Teva Generics B.V. 75 mg 
Klopidogrel Teva Generics B.V 75 mg
Consequently, a direct effect (slight toxicity), or an indirect effect (low palatability) cannot be excluded. 
Stoga se ne može isključiti izravni (slaba toksičnost) ili neizravni (loš okus) učinak.
The PSUR submission schedule for Clopidogrel Teva Generics B.V. should follow the PSURs submission schedule for the reference medicinal product. 
Raspored predaje periodičkih izvješća o neškodljivosti lijeka za Klopidogrel Teva Generics B.V. treba slijediti onaj za referentni lijek.
Experience is limited in patients with moderate hepatic disease who may have bleeding diatheses. 
Ograničeno je iskustvo u bolesnika s umjereno narušenom funkcijom jetre koji bi mogli imati hemoragičnu dijatezu.
Patients received clopidogrel (300 mg loading dose, followed by 75 mg/day, n=1,752) or placebo (n=1,739), both in combination with ASA (150 to 325 mg as a loading dose, followed by 75 to 162 mg/day), a fibrinolytic agent and, when appropriate, heparin. 
Bolesnici su primali klopidogrel (najprije udarnu dozu od 300 mg, a nakon toga dozu od 75 mg na dan, n=1752) ili placebo (n=1739), oboje u kombinaciji s ASK (150 do 325 mg kao udarna doza nakon čega je slijedila doza od 75 do 162 mg na dan), fibrinolitik i, po potrebi, heparin.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER (28, 28x1, 30, 30x1, 50, 50x1, 56, 56x1, 84, 84x1, 90, 90x1, 100, 100x1 film-coated tablets) 
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER(28, 28x1,/30, 30x1, 50, 50x1, 56, 56x1, 84, 84x1, 90 90x1, 100 100x1 filmom obloženih tableta)
Recent ischaemic stroke 
Nedavni ishemijski moždani udar
Name and address of the manufacturer(s) responsible for batch release 
Naziv i adresa proizvođača odgovornih za puštanje serije lijeka u promet
While you are taking Clopidogrel Teva Generics B.V.: 
Dok uzimate Klopidogrel Teva Generics B.V.:
Data from the CAPRIE study indicate that phenytoin and tolbutamide can be safely co-administered with clopidogrel. 
Podaci iz studije CAPRIE pokazuju da se fenitoin i tolbutamid, koji se metaboliziraju pomoću CYP2C9, mogu sigurno primjenjivati istodobno s klopidogrelom.
Glomerulonephritis, blood creatinine increased 
Poremećaji bubrega i mokraćnog sustava hematurija glomerulonefritis, povećanje kreatinina u krvi
Platelet aggregation induced by agonists other than ADP is also inhibited by blocking the amplification of platelet activation by released ADP. 
Također, klopidogrel inhibira i agregaciju trombocita induciranu drugim agonistima, pored ADP-a, i to tako što blokira pojačanu aktivaciju trombocita oslobođenim ADP-om.
Tel: +(39) 0289179805 
Teva Italia S.r.l. Tel: +(39) 0289179805
If you forget to take Clopidogrel Teva Generics B.V. 
Ako ste zaboravili uzeti Klopidogrel Teva Generics B.V.
METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use. 
NAČIN I PUT(EVI) PRIMJENE LIJEKA Prije uporabe pročitajte Uputu o lijeku.
Consequently, NSAIDs including Cox-2 inhibitors and clopidogrel should be co-administered with caution (see section 4.4). 
Stoga je potreban oprez pri istodobnoj primjeni NSAIL, uključujući Cox-2 inhibitore, i klopidogrela (vidjeti dio 4.4.).
Therapeutic experience is limited in patients with moderate hepatic disease who may have bleeding diatheses (see section 4.4). 
Terapijsko iskustvo u bolesnika s umjereno narušenom funkcijom jetre koji mogu imati hemoragijsku dijatezu je ograničeno (vidjeti dio 4.4.).
OPA/Al/PVC-Al blisters containing 28, 30, 50, 56, 84, 90 and 100 film-coated tablets or perforated unit dose blister containing 28x1, 28x1 (calendar pack), 30x1, 50x1, 56x1, 84x1, 90x1 and 100x1 film-coated tablets in a carton. 
OPA/Al/PVC-Al blisteri koji sadrže 28, 30, 50, 56, 84, 90 ili 100 filmom obloženih tableta ili perforirani blisteri djeljivi na jedinične doze koji sadrže 28x1, 28x1 (kalendarsko pakiranje), 30x1, 50x1, 56x1, 84x1, 90x1 i 100x1 filmom obloženih tableta, u kutiji.
Common side effects (affects 1 to 10 patients in 100): Diarrhoea, abdominal pain, indigestion or heartburn. 
Česte nuspojave (mogu se javiti u manje od 1 na 10 osoba): Proljev, bol u trbuhu, loša probava ili žgaravica.
Clopidogrel is first metabolised to a 2-oxo-clopidogrel intermediate metabolite. 
Klopidogrel se prvo metabolizira u intermedijarni metabolit 2-okso-klopidogrel.
If you think any of these apply to you, or if you are in any doubt at all, consult your doctor before taking Clopidogrel Teva Generics B.V.. 
Ako se bilo što od navedenog odnosi na Vas ili ako niste sigurni, obratite se svom liječniku prije uzimanja lijeka Klopidogrel Teva Generics B.V.
Ear and labyrinth disorders 
Poremećaji uha i labirinta vrtoglavica
The number of patients experiencing the co-primary endpoint (CV death, MI, stroke or refractory ischaemia) was 1,035 (16.5%) in the clopidogrel-treated group and 1,187 (18.8%) in the placebotreated group, a 14% relative risk reduction (95% CI of 6%-21%, p=0.0005) for the clopidogreltreated group. 
Broj bolesnika koji je doživio koprimarni ishod (kardiovaskularna smrt, infarkt miokarda, moždani udar ili refraktorna ishemija) bio je 1035 (16,5%) u skupini koja je primala klopidogrel, a 1187 (18,8%) u skupini koja je primala placebo, što znači smanjenje relativnoga rizika od 14% (95% CI: 6% do 21%, p=0,0005) u skupini koja je primala klopidogrel.
Hydroxypropylcellulose (E463) Titanium dioxide (E171) Red iron oxide (E172) Talc 
poli(vinilni alkohol) titanijev dioksid (E171) željezov oksid, crveni (E172) željezov oksid, žuti (E172) talk makrogol 3000
Therefore, concomitant use should be undertaken with caution (see section 4.4). 
Zbog toga je kod istodobne primjene potreban oprez (vidjeti dio 4.4.).
• Renal impairment Therapeutic experience is limited in patients with renal impairment (see section 4.4). 
Oštećenje funkcije bubrega Terapijsko iskustvo u bolesnika s narušenom funkcijom bubrega je ograničeno (vidjeti dio 4.4.).