FrancophonIA/ELRC3.0 huggingface dataset:
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.
Croatian: Bolesnike treba pomno nadzirati radi bilo kakvih znakova krvarenja, uključujući okultno krvarenje, poglavito tijekom prvih tjedana liječenja i/ili nakon invazivnih kardioloških postupaka ili kirurških zahvata.
English: In poor metabolisers, active metabolite exposure was decreased by 63-71% compared to extensive metabolisers.
Croatian: U slabih metabolizatora, izloženost aktivnom metabolitu bila je smanjena za 63-71% u usporedbi s brzim metabolizatorima.
English: (1/100 to <1/10); uncommon (1/1,000 to <1/100); rare (1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Croatian: Njihova je učestalost definirana na sljedeći način: česte (≥1/100, <1/10); manje česte (≥1/1000, <1/100); rijetke (≥1/10 000, <1/1000); vrlo rijetke (<1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Patients should inform physicians and dentists that they are taking clopidogrel before any surgery is scheduled and before any new medicinal product is taken.
Croatian: Bolesnici moraju obavijestiti liječnika i stomatologa o uzimanju klopidogrela prije nego se planira bilo kakav kirurški zahvat i prije nego se započne uzimati bilo koji novi lijek.
English: In COMMIT, the overall rate of noncerebral major bleeding or cerebral bleeding was low and similar in both groups.
Croatian: U studiji COMMIT, ukupna stopa necerebralnog velikog krvarenja ili cerebralnog krvarenja bila je niska i slična u obje skupine.
English: The patient population included 19.7% women and 29.2% patients ≥ 65 years.
Croatian: Populacija bolesnika uključivala je 19,7% žena i 29,2% bolesnika ≥65 godina.
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.
Croatian: Bolesnici koji su prethodno razvili alergijsku reakciju i/ili hematološku reakciju na jedan od tienopiridina mogu imati povišeni rizik od razvoja iste ili druge reakcije na drugi tienopiridin.
English: However, clopidogrel and ASA have been administered together for up to one year (see section 5.1).
Croatian: Međutim, klopidogrel i ASK su se istodobno primjenjivali u trajanju do jedne godine (vidjeti dio 5.1).
English: Do not use this medicine 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 "EXP".
English: Since higher doses of ASA were associated with higher bleeding risk it is recommended that the dose of ASA should not be higher than 100 mg.
Croatian: Budući da se više doze acetilsalicilatne kiseline povezuju s visokim rizikom od krvarenja, preporučuje se da doza ASK ne bude veća od 100 mg.
English: The incidence of severe cases was similar for clopidogrel and ASA.
Croatian: Incidencija teških slučajeva bila je slična za klopidogrel i ASK.
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.
Croatian: Ako se bolesnik planira podvrgnuti elektivnom kirurškom zahvatu, pa antitrombocitni učinak trenutno nije poželjan, davanje klopidogrela treba prekinuti 7 dana prije zahvata.
English: Clopidogrel has been evaluated for safety in more than 44,000 patients who have participated in clinical studies, including over 12,000 patients treated for 1 year or more.
Croatian: Sigurnost primjene klopidogrela ispitana je na više od 44 000 bolesnika koji su sudjelovali u kliničkim ispitivanjima, uključujući više od 12 000 bolesnika koji su lijek primali godinu ili više dana.
English: The characteristics of the studied cohort were similar in the 2 groups.
Croatian: Značajke ispitivane kohorte bile su slične u obje skupine.
English: In the long-term safety follow-up of this study, 26 patients with the shunt still in place at one year of age received clopidogrel up to 18 months of age.
Croatian: U dugotrajnoj nastavnoj studiji o sigurnosti primjene, 26 bolesnika koji su još uvijek imali šant nakon godinu dana starosti, primali su klopidogrel do 18 mjeseci starosti.
English: CYP2C8 substrates
Croatian: Supstrati CYP2C8
English: Approximately 88% of patients received concomitant ASA (range of 1 to 23 mg/kg/day).
Croatian: Približno 88% bolesnika istodobno je primalo ASK (u rasponu od 1 do 23 mg/kg/dnevno).
English: The mean time between shunt palliation and first administration of study medicinal product was 20 days.
Croatian: Prosječno vrijeme između ugradnje šanta te prve primjene lijeka iz studije bilo je 20 dana.
English: All patients were continued on aspirin and were followed for one year.
Croatian: Svi bolesnici su nastavili primati acetilsalicilatnu kiselinu i bili su praćeni godinu dana.
English: TROPICAL-ACS (Testing Responsiveness to Platelet Inhibition on Chronic Antiplatelet Treatment for Acute Coronary Syndromes)
Croatian: Testing Responsiveness to Platelet Inhibition on Chronic Antiplatelet Treatment for Acute Coronary Syndromes)
English: The binding is non-saturable in vitro over a wide concentration range.
Croatian: Vezanje nije zasićeno in vitro u širokom rasponu koncentracije.
English: The influence of CYP2C19 genotype on clinical outcomes in patients treated with clopidogrel has not been evaluated in prospective, randomised, controlled trials.
Croatian: Utjecaj CYP2C19 genotipa na kliničke ishode u bolesnika liječenih klopidogrelom nije procijenjen u prospektivnim, randomiziranim, kontroliranim ispitivanjima.
English: In addition, a subgroup analysis by age suggested that the benefitof clopidogrel in patients over 75 years was less than that observed in patients ≤75 years.
Croatian: Dodatno, analiza podskupina prema dobi ukazuje da je korist od liječenja klopidogrelom manja u bolesnika iznad 75 godina nego u onih ≤75 godina.
English: If you cut or injure yourself, it may take slightly longer than usual for bleeding to stop.
Croatian: Ako se porežete ili ozlijedite, može trajati nešto dulje nego obično da krvarenje prestane.
English: When poor metabolisers received the 600 mg/150 mg regimen, active metabolite exposure was greater than with the 300 mg/75 mg regimen.
Croatian: Kad su slabi metabolizatori primili dozu od 600 mg/150 mg, izloženost aktivnom metabolitu bila je veća nego kod režima doziranja od 300 mg/75 mg.
English: In cases of confirmed isolated activated Partial Thromboplastin Time (aPTT) prolongation with or without bleeding, acquired haemophilia should be considered.
Croatian: U slučajevima kada je potvrđeno izolirano produljenje aktiviranog parcijalnog tromboplastinskog vremena (aPTV), uz krvarenje ili bez njega, u obzir treba uzeti mogućnost stečene hemofilije.
English: A patient with poor metaboliser status will possess two loss-of-function alleles as defined above.
Croatian: Bolesnici sa statusom slabih metabolizatora imaju 2 nefunkcionalna alela kako je definirano gore.
English: You should have been told that ‘oral anticoagulants' are more effective than acetylsalicylic acid or the combined use of Clopidogrel Krka d.d.
Croatian: Trebalo Vam je biti rečeno da su za ovo stanje 'oralni antikoagulansi' učinkovitiji od acetilsalicilatne kiseline ili kombinirane primjene Clopidogrela Krka d.d. i acetilsalicilatne kiseline.
English: After single and repeated oral doses of 75 mg per day, clopidogrel is rapidly absorbed.
Croatian: Nakon jednokratne i ponovljene oralne doze od 75 mg dnevno, klopidogrel se brzo apsorbira.
English: Based on enrollment criteria, physicians enrolled patients in ACTIVE-W if they were candidates for vitamin K antagonist (VKA) therapy (such as warfarin).
Croatian: Na temelju uključujućih kriterija, liječnici su bolesnike uključivali u studiju ACTIVE-W ako su bili kandidati za terapiju antagonistima vitamina K (kao što je varfarin).
English: This was associated with a reduction of the mean inhibition of platelet aggregation by 15% and 11%, respectively.
Croatian: To je bilo povezano sa smanjenjem prosječne vrijednosti inhibicije agregacije trombocita od 15% odnosno 11%.
English: Detailed information is available on the European Medicines Agency website: http://www.ema.europa.eu
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove: http://www.ema.europa.eu/.
English: 7 film-coated tablets 14 film-coated tablets 28 film-coated tablets 30 film-coated tablets 50 film-coated tablets 56 film-coated tablets 84 film-coated tablets 90 film-coated tablets 100 film-coated tablets
Croatian: 7 filmom obloženih tableta 14 filmom obloženih tableta 28 filmom obloženih tableta 30 filmom obloženih tableta 50 filmom obloženih tableta 56 filmom obloženih tableta 84 filmom obložene tablete 90 filmom obloženih tableta 100 filmom obloženih tableta
English: If you forget to take a dose of Clopidogrel Krka d.d., but remember within 12 hours of your usual time, take your tablet straightaway and then take your next tablet at the usual time.
Croatian: Ako zaboravite uzeti jednu dozu Clopidogrela Krka d.d., ali se toga sjetite u roku od 12 sati, odmah uzmite tabletu, a sljedeću tabletu uzmite u uobičajeno vrijeme.
English: At steady state, the average inhibition level observed with a dose of 75 mg per day was between 40% and 60%.
Croatian: U stanju dinamičke ravnoteže prosječna opažena razina inhibicije, uz dozu od 75 mg dnevno, iznosi između 40% i 60%.
English: The most common side effect is bleeding.
Croatian: Najčešća nuspojava jest krvarenje.
English: Cross-reactions among thienopyridines
Croatian: Križne reakcije među tienopiridinima
English: The ACTIVE-W and ACTIVE-A studies, separate trials in the ACTIVE program, included patients with atrial fibrillation (AF) who had at least one risk factor for vascular events.
Croatian: Studije ACTIVE-W i ACTIVE-A, zasebna ispitivanja u programu ACTIVE, uključivale su bolesnike s fibrilacijom atrija (AF) koji su imali najmanje jedan faktor rizika za krvožilne događaje.
English: Platelet aggregation and bleeding time gradually returned to baseline values, generally within 5 days after treatment was discontinued.
Croatian: Agregacija trombocita i vrijeme krvarenja postupno se vraćaju na početne vrijednosti, obično unutar 5 dana nakon prekida uzimanja lijeka.
English: There is no evidence that other medicinal products that reduce stomach acid such as H2 blockers or antacids interfere with antiplatelet activity of clopidogrel.
Croatian: Nema dokaza da drugi lijekovi koji smanjuju lučenje želučane kiseline, poput H2 blokatora ili antacida, utječu na antitrombocitnu aktivnost klopidogrela.
English: As a precautionary measure, breast-feeding should not be continued during treatment with Clopidogrel Krka d.d.
Croatian: Kao mjera opreza, treba prestati s dojenjem za vrijeme liječenja Clopidogrelom Krka d.d.
English: Although the ischaemic benefit was consistent throughout the first year, greater reduction in ischaemic recurrence after ACS was observed during the initial days following the treatment initiation.
Croatian: Iako je korist s obzirom na ishemiju bila konzistentna tijekom prve godine liječenja, veće smanjenje u pogledu ponovne pojave ishemije nakon akutnog koronarnog sindroma uočeno je tijekom prvih dana nakon započinjanja liječenja.
English: These results indicate that clopidogrel can be administered with pantoprazole.
Croatian: Ovi rezultati upućuju na to da se klopidogrel može primjenjvati istodobno s pantoprazolom.
English: - You have an irregular heartbeat, a condition called ‘atrial fibrillation', and you cannot take medicines known as ‘oral anticoagulants' (vitamin K antagonists) which prevent new clots from forming and prevent existing clots from growing.
Croatian: - imate nepravilne otkucaje srca, stanje koje se zove "fibrilacija atrija", a ne možete uzimati lijekove poznate kao 'oralni antikoagulansi' (antagonisti vitamina K), koji sprječavaju stvaranje novih ugrušaka te rast postojećih ugrušaka.
English: Kounis syndrome (vasospastic allergic angina / allergic myocardial infarction) in the context of a hypersensitivity reaction due to clopidogrel*
Croatian: Kounisov sindrom (alergijska vazospastična angina / alergijski infarkt miokarda) u kontekstu reakcije preosjetljivosti na klopidogrel*
English: • Active pathological bleeding such as peptic ulcer or intracranial haemorrhage.
Croatian: - Aktivno patološko krvarenje, poput peptičkog ulkusa ili intrakranijalnog krvarenja.
English: Pharmacotherapeutic group: Antithrombotic agents, platelet aggregation inhibitors excl. heparin, ATC code: B01AC-04.
Croatian: Farmakoterapijska skupina: Antitrombotici, inhibitori agregacije trombocita izuzev heparina, ATK oznaka: B01AC04.
English: Within each system organ class, adverse reactions are presented in order of decreasing seriousness.
Croatian: Unutar svakog organskog sustava nuspojave su prikazane u padajućem nizu prema ozbiljnosti.
English: In CURE, CLARITY, ACTIVE-A and one of the cohort studies (Trenk), no increased event rate was observed based on metaboliser status.
Croatian: U studijama CURE, CLARITY, ACTIVE-A i jednoj od kohortnih studija (Trenk), nije uočena povećana stopa događaja temeljena na metabolizatorskom statusu.
English: What you need to know before you take Clopidogrel Krka d.d.
Croatian: Što morate znati prije nego počnete uzimati Clopidogrel Krka d.d.
English: The plasma concentrations of the active metabolite was 20% reduced (loading dose) and 14% reduced (maintenance dose) during concomitant treatment with pantoprazole 80 mg once daily.
Croatian: Koncentracija aktivnog metabolita u plazmi bila je smanjena za 20% (udarna doza) i 14% (doza održavanja) tijekom istodobne terapije pantoprazolom u dozi od 80 mg jednom dnevno.
English: In a small number of cases, bleeding in the eye, inside the head, the lung or the joints has also been reported.
Croatian: U malom broju slučajeva, također su zabilježena krvarenja u oku, glavi, plućima ili zglobovima.
English: In CAPRIE, in patients treated with either clopidogrel or ASA, the overall incidence of any bleeding was 9.3%.
Croatian: U studiji CAPRIE, u bolesnika koji su se liječili klopidogrelom ili ASK, ukupna incidencija bilo kakvog krvarenja iznosila je 9,3%.
English: In CHARISMA and one cohort study (Simon), an increased event rate was observed only in poor metabolisers when compared to extensive 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: This leaflet was last revised in MM/YYYY.
Croatian: Uputa je zadnji puta odobrena u MM/GGGG.
English: Exposure of clopidogrel and average platelet inhibition can be decreased with concomitant use of ritonavir.
Croatian: Izloženost klopidogrelu i prosječna inhibicija trombocita mogu se smanjiti istodobnom primjenom ritonavira.
English: The CYP2C19*1 allele corresponds to fully functional metabolism while the CYP2C19*2 and CYP2C19*3 alleles are nonfunctional.
Croatian: CYP2C19*1 alel odgovara potpuno funkcionalnom metabolizmu, dok su CYP2C19*2 i CYP2C19*3 aleli nefunkcionalni.
English: CYP2C8 substrate medicinal products: Clopidogrel has been shown to increase repaglinide exposure in healthy volunteers.
Croatian: Lijekovi koji su supstrati CYP2C8: Pokazalo se da klopidogel povećava izloženost repaglinidu u zdravih dobrovoljaca.
English: In contrast, post-hoc analyses demonstrated statistically significant increases in the bleeding risk with the more potent P2Y12 inhibitors, occurring predominantly during the maintenance phase, after the first month post-ACS.
Croatian: Međutim, post-hoc analize pokazale su statistički značajno povećanje rizika od krvarenja kod potentnijih inhibitora P2Y12, koji se javlja pretežno tijekom faze održavanja, nakon prvog mjeseca od pojave akutnog koronarnog sindroma.
English: If you are breast-feeding or planning to breast-feed, talk to your doctor before taking this medicine.
Croatian: Ako dojite ili planirate dojiti, razgovarajte sa svojim liječnikom prije uzimanja ovog lijeka.
English: • Your doctor may order blood tests.
Croatian: - Vaš liječnik će možda odrediti da Vam se naprave pretrage krvi.
English: The CYP2C19*2 and CYP2C19*3 alleles account for the majority of reduced function alleles in Caucasian (85%) and Asian (99%) poor metabolisers.
Croatian: CYP2C19*2 i CYP2C19*3 aleli čine većinu alela sa smanjenom funkcijom u slabih metabolizatora u bijelaca (85%) i Azijata (99%).
English: Published frequencies for the poor CYP2C19 metaboliser genotypes are approximately 2% for Caucasians, 4% for Blacks and 14% for Chinese.
Croatian: Učestalost genotipova slabih CYP2C19 metabolizatora prema objavljenim podacima iznosi otprilike 2% za bijelce, 4% za crnce i 14% za Kineze.
English: Apart from the specific medicinal product interaction information described above, interaction studies with clopidogrel and some medicinal products commonly administered in patients with atherothrombotic disease have not been performed.
Croatian: Osim gore opisanih interakcija specifičnih lijekova, nisu provedena ispitivanja interakcija klopidogrela s nekim lijekovima koji se obično propisuju bolesnicima s aterotrombotskom bolesti.
English: For minor cuts and injuries e.g., cutting yourself, shaving, this is of no concern.
Croatian: Za male posjekotine ili ozljede, kao što su, primjerice, porezotine nastale tijekom brijanja, ne treba se zabrinjavati.
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.
Croatian: Ponovljene doze klopidogrela od 75 mg dnevno uzrokuju snažnu inhibiciju ADP-om posredovane agregacije trombocita od prvoga dana; to se progresivno pojačava i dostiže stanje dinamičke ravnoteže između dana 3 i dana 7.
English: Patients with a confirmed diagnosis of acquired haemophilia should be managed and treated by specialists, and clopidogrel should be discontinued.
Croatian: Bolesnike s potvrđenom dijagnozom stečene hemofilije moraju liječiti specijalisti, a primjenu klopidogrela treba prekinuti.
English: There was no evidence of carcinogenic effect when clopidogrel was administered for 78 weeks to mice and 104 weeks to rats when given at doses up to 77 mg/kg per day (representing at least 25 times the exposure seen in humans receiving the clinical dose of 75 mg/day).
Croatian: Nije bilo dokaza o kancerogenim učincima kad se klopidogrel davao miševima 78 tjedana i štakorima 104 tjedna u dozama do 77 mg/kg dnevno (što predstavlja barem 25 puta veću izloženost nego u ljudi koji primaju kliničku dozu od 75 mg/dan).
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).
Croatian: Zbog opasnosti od krvarenja i hematoloških nuspojava, potrebno je odmah provjeriti krvnu sliku i/ili druge relevantne nalaze kad god se tijekom liječenja pojave klinički znakovi koji ukazuju na krvarenje (vidjeti dio 4.8).
English: Bleeding was the most frequently reported adverse reaction in both clopidogrel and placebo groups; however, there was no significant difference in the bleeding rate between groups.
Croatian: Krvarenje je bilo najčešće prijavljena nuspojava u klopidogrel i placebo skupini, međutim, nije bilo značajne razlike u učestalosti krvarenja među skupinama.
English: Inconsistent data on the clinical implications of this pharmacokinetic (PK)/pharmacodynamic (PD) interaction in terms of major cardiovascular events have been reported from both observational and clinical studies.
Croatian: Prijavljeni podaci iz opservacijskih i kliničkih studija o kliničkim implikacijama ove farmakokinetičke (PK)/farmakodinamičke (PD) interakcije u smislu značajnih kardiovaskularnih događaja su nekonzistentni.
English: Monitoring for signs of hypersensitivity in patients with a known allergy to thienopyridines is advised.
Croatian: Preporuča se nadzirati znakove preosjetljivosti u bolesnika s poznatom alergijom na tienopiridine.
English: Because the active metabolite is formed by CYP450 enzymes, some of which are polymorphic or subject to inhibition by other medicinal products, not all patients will have adequate platelet inhibition.
Croatian: Budući da se aktivni metabolit klopidogrela stvara pomoću enzima CYP450, od kojih su neki polimorfni ili podložni inhibiciji od strane drugih lijekova, svi bolesnici neće imati adekvatnu inhibiciju trombocita.
English: At Day 14, platelet function testing (PFT) was performed.
Croatian: Na dan 14 provedeno je ispitivanje funkcije trombocita.
English: Ninety five patients (7%) in the guided de-escalation group and 118 patients (9%) in the control group (p non-inferiority=0.0004) had an event.
Croatian: 95 bolesnika (7%) u skupini s vođenom de-eskalacijom i 118 bolesnika (9%) u kontrolnoj skupini (p neinferiornosti=0,0004) imalo je događaj.
English: Seventy-three percent (73%) of patients enrolled into the ACTIVE-A study were unable to take VKA due to physician assessment, inability to comply with INR (international normalised ratio) monitoring, predisposition to falling or head trauma, or specific risk of bleeding; for 26% of the patients, the physician's decision was based on the patient's unwillingness to take VKA.
Croatian: 73% bolesnika uključenih u studiju ACTIVE-A nisu bili sposobni za uzimanje VKA terapije prema procjeni liječnika, zbog nemogućnosti praćenja INR (International Normalised Ratio), sklonosti padanju ili traumatskim ozljedama glave ili zbog specifičnog rizika od krvarenja; za 26% bolesnika odluka liječnika bila je temeljena na nevoljnosti bolesnika za uzimanje VKA terapije.
English: Boxes of 7, 14, 28, 30, 50, 56, 84, 90 and 100 film-coated tablets in blisters are available.
Croatian: Kutije sadrže 7, 14, 28, 30, 50, 56, 84, 90 i 100 filmom obloženih tableta u blister pakiranjima.
English: If prompt correction of prolonged bleeding time is required, platelet transfusion may reverse the effects of clopidogrel.
Croatian: Ako je hitno potrebno korigirati produljeno vrijeme krvarenja, transfuzija trombocita može smanjiti učinak klopidogrela.
English: Thienopyridines may cause mild to severe allergic reactions such as rash, angioedema, or haematological cross-reactions such as thrombocytopaenia and neutropaenia.
Croatian: Tienopiridini mogu uzrokovati blage do teške alergijske reakcije poput osipa, angioedema ili hematoloških križnih reakcija kao što su trombocitopenija i neutropenija.
English: contains clopidogrel and belongs to a group of medicines called antiplatelet medicinal products.
Croatian: Clopidogrel Krka d.d. sadrži klopidogrel i pripada skupini lijekova koji se nazivaju antitrombocitni lijekovi.
English: 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.
Croatian: Ostali lijekovi: Određeni broj ostalih kliničkih studija provodio se s klopidogrelom i nekim drugim istodobno primjenjivanim lijekovima kako bi se ispitala mogućnost farmakodinamičkih i farmakokinetičkih interakcija.
English: As no clinical data on exposure to clopidogrel during pregnancy are available, it is preferable not to use clopidogrel during pregnancy as a precautionary measure.
Croatian: S obzirom na to da nema dovoljno podataka o primjeni klopidogrela u trudnica, preporučuje se, kao mjera opreza, ne koristiti klopidogrel za vrijeme trudnoće.
English: - If you have any further questions, ask your doctor or your pharmacist.
Croatian: - Ako imate dodatnih pitanja, obratite se liječniku ili ljekarniku.