FrancophonIA/ELRC3.0 huggingface dataset:
English: 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).
Croatian: 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).
English: Appropriate therapy should be considered if bleedings are observed.
Croatian: Ako se primijeti krvarenje, treba razmotriti primjerenu terapiju.
English: 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]).
Croatian: 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]).
English: Patients were randomized to clopidogrel 75 mg/day or ASA 325 mg/day, and were followed for 1 to 3 years.
Croatian: 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.
English: Lietuva UAB “Sicor Biotech” Tel: +370 5 266 02 03 This leaflet was last approved in {MM/YYYY}.
Croatian: UAB “Sicor Biotech” Tel: +370 5 266 02 03
English: − 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.
Croatian: 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.
English: 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]).
Croatian: 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]).
English: Therefore clopidogrel should be used with caution in these patients (see section 4.2).
Croatian: Stoga se tim bolesnicima klopidogrel mora davati s oprezom (vidjeti dio 4.2).
English: The pharmacokinetics of the active metabolite of clopidogrel is not known in these special populations.
Croatian: Farmakokinetika aktivnog metabolita klopidogrela nije poznata za sljedeće posebne skupine bolesnika.
English: Bullous dermatitis (toxic epidermal necrolysis, Stevens Johnson Syndrome, erythema multiforme), angioedema, rash erythematous, urticaria, eczema, lichen planus
Croatian: bulozni dermatitis (toksična epidermalna nekroliza, Stevens Johnsonov sindrom, erythema multiforme), angioedem, sindrom preosjetljivosti izazvane lijekom, osip uzrokovan lijekom s eozinofilijom i sistemskim simptomima (engl.
English: Propylene glycol
Croatian: <DD mjesec GGGG>
English: • CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
Croatian: UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I PRIMJENU
English: 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)).
Croatian: 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.
English: 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.
Croatian: 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.
English: INFORMATION IN BRAILLE Clopidogrel Teva Generics B.V. 75 mg
Croatian: Klopidogrel Teva Generics B.V 75 mg
English: Consequently, a direct effect (slight toxicity), or an indirect effect (low palatability) cannot be excluded.
Croatian: Stoga se ne može isključiti izravni (slaba toksičnost) ili neizravni (loš okus) učinak.
English: The PSUR submission schedule for Clopidogrel Teva Generics B.V. should follow the PSURs submission schedule for the reference medicinal product.
Croatian: Raspored predaje periodičkih izvješća o neškodljivosti lijeka za Klopidogrel Teva Generics B.V. treba slijediti onaj za referentni lijek.
English: Experience is limited in patients with moderate hepatic disease who may have bleeding diatheses.
Croatian: Ograničeno je iskustvo u bolesnika s umjereno narušenom funkcijom jetre koji bi mogli imati hemoragičnu dijatezu.
English: 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.
Croatian: 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.
English: 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)
Croatian: 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)
English: Recent ischaemic stroke
Croatian: Nedavni ishemijski moždani udar
English: Name and address of the manufacturer(s) responsible for batch release
Croatian: Naziv i adresa proizvođača odgovornih za puštanje serije lijeka u promet
English: While you are taking Clopidogrel Teva Generics B.V.:
Croatian: Dok uzimate Klopidogrel Teva Generics B.V.:
English: Data from the CAPRIE study indicate that phenytoin and tolbutamide can be safely co-administered with clopidogrel.
Croatian: Podaci iz studije CAPRIE pokazuju da se fenitoin i tolbutamid, koji se metaboliziraju pomoću CYP2C9, mogu sigurno primjenjivati istodobno s klopidogrelom.
English: Glomerulonephritis, blood creatinine increased
Croatian: Poremećaji bubrega i mokraćnog sustava hematurija glomerulonefritis, povećanje kreatinina u krvi
English: Danmark Teva Denmark A.S. Tlf: +45 44 98 55 11
Croatian: Tlf: +45 44 98 55 11
English: Platelet aggregation induced by agonists other than ADP is also inhibited by blocking the amplification of platelet activation by released ADP.
Croatian: Također, klopidogrel inhibira i agregaciju trombocita induciranu drugim agonistima, pored ADP-a, i to tako što blokira pojačanu aktivaciju trombocita oslobođenim ADP-om.
English: Tel: +(39) 0289179805
Croatian: Teva Italia S.r.l. Tel: +(39) 0289179805
English: If you forget to take Clopidogrel Teva Generics B.V.
Croatian: Ako ste zaboravili uzeti Klopidogrel Teva Generics B.V.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use.
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA Prije uporabe pročitajte Uputu o lijeku.
English: Consequently, NSAIDs including Cox-2 inhibitors and clopidogrel should be co-administered with caution (see section 4.4).
Croatian: Stoga je potreban oprez pri istodobnoj primjeni NSAIL, uključujući Cox-2 inhibitore, i klopidogrela (vidjeti dio 4.4.).
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 umjereno narušenom funkcijom jetre koji mogu imati hemoragijsku dijatezu je ograničeno (vidjeti dio 4.4.).
English: 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.
Croatian: 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.
English: Common side effects (affects 1 to 10 patients in 100): Diarrhoea, abdominal pain, indigestion or heartburn.
Croatian: Česte nuspojave (mogu se javiti u manje od 1 na 10 osoba): Proljev, bol u trbuhu, loša probava ili žgaravica.
English: Clopidogrel is first metabolised to a 2-oxo-clopidogrel intermediate metabolite.
Croatian: Klopidogrel se prvo metabolizira u intermedijarni metabolit 2-okso-klopidogrel.
English: If you think any of these apply to you, or if you are in any doubt at all, consult your doctor before taking Clopidogrel Teva Generics B.V..
Croatian: 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.
English: Ear and labyrinth disorders
Croatian: Poremećaji uha i labirinta vrtoglavica
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-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.
Croatian: 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.
English: Hydroxypropylcellulose (E463) Titanium dioxide (E171) Red iron oxide (E172) Talc
Croatian: poli(vinilni alkohol) titanijev dioksid (E171) željezov oksid, crveni (E172) željezov oksid, žuti (E172) talk makrogol 3000
English: Teva Nederland B.V. Tel: +31 (0) 800 0228400
Croatian: Tel: +31 (0) 800 0228400
English: Therefore, concomitant use should be undertaken with caution (see section 4.4).
Croatian: Zbog toga je kod istodobne primjene potreban oprez (vidjeti dio 4.4.).
English: • Renal impairment Therapeutic experience is limited in patients with renal impairment (see section 4.4).
Croatian: Oštećenje funkcije bubrega Terapijsko iskustvo u bolesnika s narušenom funkcijom bubrega je ograničeno (vidjeti dio 4.4.).
English: Boxes of 28, 30, 50, 56, 84, 90 or 100 film-coated tablets in blisters or boxes of 28x1, 28x1 (calendar pack), 30x1, 50x1, 56x1, 84x1, 90x1 and 100x1 film-coated tablets in perforated unit dose blisters are available.
Croatian: Dostupne su kutije sa 28, 30, 50, 56, 84, 90 ili 100 filmom obloženih tableta u blisterima ili kutije sa 28x1, 28x1 (kalendarsko pakiranje), 30x1, 50x1, 56x1, 84x1, 90x1 i 100x1 filmom obloženih tableta u blisterima djeljivima na jedinične doze.
English: Musculo-skeletal bleeding (haemarthrosis), arthritis, arthralgia, myalgia
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva mišićnokoštano krvarenje (hemartroza), artritis, artralgija, mijalgija
English: Respiratory tract bleeding (haemoptysis, pulmonary haemorrhage), bronchospasm, interstitial pneumonitis
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja epistaksa krvarenje u dišnome sustavu (hemoptiza, plućno krvarenje), bronhospazam, intersticijski pneumonitis, eozinofilna pneumonija
English: POSSIBLE SIDE EFFECTS
Croatian: Moguće nuspojave
English: • Severe liver impairment.
Croatian: Teško oštećenje funkcije jetre.
English: As a precaution, concomitant use of omeprazole or esomeprozole should be discouraged (see section 4.4).
Croatian: Stoga se zbog opreza ne preporučuje istodobna primjena s omeprazolom ili esomeprazolom (vidjeti dio 4.4).
English: Rash, pruritus, skin bleeding (purpura)
Croatian: Poremećaji kože i potkožnog tkiva modrice osip, svrbež, krvarenja na koži (purpura)
English: Rare side effect (affects 1 to 10 patients in 10,000): Vertigo.
Croatian: Rijetke nuspojave (mogu se javiti u manje od 1 na 1000 osoba): Vrtoglavica.
English: Cellulose, microcrystalline Colloidal anhydrous silica Crospovidone (type A) Macrogol 6000
Croatian: Jezgra tablete: celuloza, mikrokristalična silicijev dioksid, koloidni, bezvodni krospovidon (tip A) makrogol 6000 ricinusovo ulje, hidrogenirano
English: Do not use Clopidogrel Teva Generics B.V. after the expiry date which is stated on the carton and blister after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru nakon oznake "Rok valjanosti".
English: As a precaution concomitant use of medicinal products that inhibit CYP2C19 should be discouraged (see sections 4.4 and 5.2).
Croatian: Zbog opreza ne preporučuje se istodobna primjena klopidogrela i lijekova koji su jaki ili umjereni inhibitori CYP2C19 (vidjeti dio 4.4. i 5.2.).
English: Clopidogrel is extensively metabolised by the liver.
Croatian: Klopidogrel se najvećim dijelom metabolizira u jetri.
English: Patients were required to have either ECG changes compatible with new ischaemia or elevated cardiac enzymes or troponin I or T to at least twice the upper limit of normal.
Croatian: Kriteriji za uključivanje u studiju bili su promjene u EKG-u povezane s novom ishemijom ili povećane vrijednosti srčanih enzima, ili troponin
English: In the intention to treat analysis, 939 events were observed in the clopidogrel group and 1,020 events with ASA (relative risk reduction (RRR) 8.7%, [95% CI: 0.2 to 16.4]; p = 0.045), which corresponds, for every 1,000 patients treated for 2 years, to 10 [CI: 0 to 20] additional patients being prevented from experiencing a new ischaemic event.
Croatian: U analizi ITT (engl. „intention to treat“) zabilježeno je 939 slučajeva u skupini koja je primala klopidogrel, a 1020 u skupini koja je primala ASK (realtivno smanjenje rizika, RRR - engl. relative risk reduction = 8,7% [95% CI: 0,2 do 16,4]; p=0,045), što odgovara broju od dodatnih 10 bolesnika kojima je spriječen novi ishemijski događaj na svakih 1000 bolesnika liječenih 2 godine [CI: 0 do 20]. Analiza ukupne smrtnosti, sekundarnog ishoda studije, nije pokazala značajnu razliku između klopidogrela (5,8%) i ASK (6,0%).
English: Excipient:
Croatian: Serija:
English: Clopidogrel should be given as a single daily dose of 75 mg with or without food.
Croatian: Klopidogrel se daje u jednokratnoj dnevnoj dozi od 75 mg.
English: Do not take Clopidogrel Teva Generics B.V.
Croatian: Nemojte uzimati Klopidogrel Teva Generics B.V.:
English: You should specifically tell your doctor if you take - oral anticoagulants, medicines used to reduce blood clotting, - a non-steroidal anti-inflammatory medicine, usually used to treat painful and/or inflammatory conditions of muscle or joints, - heparin, or any other medicine used to reduce blood clotting.
Croatian: Posebno je važno obavijestiti liječnika ako uzimate - oralne antikoagulanse, odnosno lijekove koji smanjuju zgrušavanje krvi, - nesteroidne protuupalne lijekove, koji se obično primjenjuju za liječenje bolnih i/ili upalnih stanja mišića ili zglobova, - heparin ili bilo koji drugi lijek koji se daje putem injekcije za smanjivanje zgrušavanja krvi, - omeprazol, esomeprazol ili cimetidin, odnosno lijekove za smanjenje želučanih tegoba, - flukonazol, vorikonazol, ciprofloksacin ili kloramfenikol, odnosno lijekove koji se primjenjuju za liječenje bakterijskih i gljivičnih infekcija, - fluoksetin, fluvoksamin ili moklobemid, odnosno lijekove koji se primjenjuju za liječenje depresije,
English: Acute liver failure, hepatitis, abnormal liver function test
Croatian: Poremećaji jetre i žuči akutno zatajenje jetre, hepatitis, poremećene vrijednosti jetrenih enzima
English: In the fifth cohort study (n=2,208; Simon), the increased event rate was observed only in poor metabolisers.
Croatian: U studiji CHARISMA i jednoj kohortnoj studiji (Simon), povećana stopa događaja bila je zapažena samo u slabih metabolizatora, u usporedbi s brzim metabolizatorima.
English: Hepatic impairment
Croatian: Stečena hemofilija
English: Thrombotic thrombocytopenic purpura (TTP) (see section 4.4), aplastic anaemia, pancytopenia, agranulocytosis, severe thrombocytopenia, granulocytopenia, anaemia
Croatian: Poremećaji krvi i limfnog sustava trombocitopenija, leukopenija, eozinofilija neutropenija, uključujući tešku neutropeniju trombotična trombocitopenična purpura (TTP) (vidjeti dio 4.4.), aplastična anemija, pancitopenija, agranulocitoza, teška trombocitopenija, stečena hemofilija A, granulocitopenija, anemija
English: Deutschland Teva Generics GmbH Tel: (49) 351 834 0
Croatian: Deutschland Teva GmbH Tel: (+49) 731 402 08
English: However, if you are concerned by your bleeding, you should contact your doctor straightaway (see section 2 ‘Take special care with Clopidogrel Teva Generics B.V.').
Croatian: Ako ste ipak zabrinuti zbog krvarenja, odmah obavijestite svog liječnika (vidjeti dio 2. "Upozorenja i mjere opreza").
English: Serious haemorrhage, haemorrhage of operative wound, vasculitis, hypotension
Croatian: Krvožilni poremećaji hematomi ozbiljno krvarenje, krvarenje kirurške rane, vaskulitis, hipotenzija
English: CONDITIONS OF THE MARKETING AUTHORISATION
Croatian: ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
English: Bruising
Croatian: Dojenje
English: Clopidogrel Teva Generics B.V. 75 mg film-coated tablets Clopidogrel
Croatian: Klopidogrel Teva Generics B.V. 75 mg filmom obložene tablete klopidogrel
English: MARKETING AUTHORISATION NUMBER(S)
Croatian: Plan upravljanja rizikom (RMP)
English: Clopidogrel must be metabolised by CYP450 enzymes to produce the active metabolite that inhibits platelet aggregation.
Croatian: Da bi nastao taj aktivni metabolit koji inhibira agregaciju trombocita, klopidogrel se mora metabolizirati pomoću enzima CYP450.
English: PSURs
Croatian: Hrvatska
English: HOW TO TAKE CLOPIDOGREL TEVA GENERICS B.V.
Croatian: Kako uzimati Klopidogrel Teva Generics B.V.
English: Taking other medicines
Croatian: UPUTA O LIJEKU
English: Metabolism
Croatian: Biotransformacija
English: ACEI, calcium antagonists, cholesterol lowering agents, coronary vasodilators, antidiabetic agents (including insulin), antiepileptic agents, and GPIIb/IIIa antagonists without evidence of clinically significant adverse interactions.
Croatian: Međutim, bolesnici koji su sudjelovali u kliničkim ispitivanjima s klopidogrelom istodobno su primali niz lijekova, među kojima su bili diuretici, beta blokatori, ACE inhibitori, antagonisti kalcija, lijekovi za snižavanje kolesterola, koronarni vazodilatatori, antidijabetici (uključujući inzulin), antiepileptici te antagonisti glikoproteina IIb/IIIa i nisu primijećene klinički značajne štetne interakcije.
English: The association between CYP2C19 genotype and clopidogrel treatment outcome was evaluated in 2 post hoc clinical trial analyses (substudies of CLARITY [n=465] and TRITON-TIMI 38 [n=1,477]) and 5 cohort studies (total n=6,489).
Croatian: Međutim, postoji veći broj retrospektivnih analiza za procjenu ovog učinka u bolesnika liječenih klopidogrelom, a 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.
English: Uncommon side effects (affects 1 to 10 patients in 1,000): Headache, stomach ulcer, vomiting, nausea, constipation, excessive gas in stomach or intestines, rashes, itching, dizziness, sensation of tingling and numbness.
Croatian: Glavobolja, čir želuca, povraćanje, mučnina, zatvor, povećano stvaranje plinova u želucu ili crijevima, osip, svrbež, omaglica, osjećaj peckanja i utrnulosti.
English: Mean inhibition of platelet aggregation (IPA) with 5 μM ADP was diminished by 39% (24 hours) and 21% (Day 5) when clopidogrel and omeprazole were administered together.
Croatian: Smanjenje je bilo povezano s oslabljenom inhibicijom agregacije trombocita od 39% (udarna doza) i 21% (doza održavanja).
English: To date, the impact of CYP2C19 genotype on the pharmacokinetics of the active metabolite of clopidogrel has been evaluated in 227 subjects from 7 reported studies.
Croatian: Utjecaj CYP2C19 genotipa na kliničke ishode u bolesnika liječenih klopidogrelom nije procijenjen u prospektivnim, randomiziranim, kontroliranim ispitivanjima.
English: For minor cuts and injuries e.g., cutting yourself, shaving, this is of no concern.
Croatian: Ne trebate biti zabrinuti zbog manjih posjekotina ili ozljeda, primjerice porezotina nastalih tijekom brijanja.
English: - The other ingredients are microcrystalline cellulose, colloidal anhydrous silica, crospovidone (type A), macrogol 6000, hydrogenated castor oil in the tablet core and hydroxypropylcellulose (E463), titanium dioxide (E171), red iron oxide (E172), talc and propylene glycol in the filmcoating.
Croatian: Jezgra tablete: mikrokristalična celuloza, koloidni bezvodni silicijev dioksid, krospovidon (tip A), makrogol 6000 i hidrogenirano ricinusovo ulje.
English: Always take Clopidogrel Teva Generics B.V. exactly as your doctor has told you.
Croatian: Uvijek uzmite ovaj lijek točno onako kako su Vam rekli Vaš liječnik ili ljekarnik.
English: In CLARITY, there was an overall increase in bleeding in the clopidogrel + ASA group (17.4%) vs. the placebo + ASA group (12.9%).
Croatian: U studiji ACTIVE-A stopa velikih krvarenja bila je veća u skupini klopidogrel + ASK, nego u skupini placebo + ASK (6,7% naspram 4,3%).
English: In CLARITY and one of the cohort studies (n=765; Trenk), cardiovascular event rates did not differ significantly by genotype.
Croatian: U studijama CURE, CLARITY, ACTIVE-A i jednoj od kohortnih studija (Trenk), nije uočena povećana stopa događaja temeljena na metabolizatorskom statusu.
English: - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
Croatian: Ovo uključuje i svaku moguću nuspojavu koja nije navedena u ovoj uputi.
English: If you experience prolonged bleeding when taking Clopidogrel Teva Generics B.V.
Croatian: Ako pri uzimanju lijeka Klopidogrel Teva Generics B.V. imate produljeno krvarenje