natgillin/translations-raw huggingface dataset:
Monitoring for signs of hypersensitivity in patients with a known allergy to thienopyridines is advised.
Preporuča se nadzirati znakove preosjetljivosti u bolesnika s poznatom alergijom na tienopiridine
The most common side effect reported with Clopidogrel HCS is bleeding.
Najčešća nuspojava lijeka Klopidogrel HCS jest krvarenje.
There was no significant difference between groups in the primary composite endpoint of death, shunt thrombosis or cardiac-related intervention prior to 120 days of age following an event considered of thrombotic nature (89 [19.1%] for the clopidogrel group and 90 [20.5%] for the placebo group) (see section 4.2).
Nije bilo značajne razlike među skupinama u primarnom kompozitnom ishodu koji se odnosi na smrt, trombozu šanta ili kardiološku intervenciju prije 120-og dana starosti nakon događaja za koji se smatra da je trombološke prirode (89 [19,1%] za klopidogrel skupinu i 90 [20,5%]
When poor metabolisers received the 600 mg/150 mg regimen, active metabolite exposure was greater than with the 300 mg/75 mg regimen.
600 mg/150 mg, izloženost aktivnom metabolitu bila je veća nego kod režima doziranja od
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.
U skladu s gore navedenim rezultatima, metaanaliza koja je uključivala 6 studija sa 335 osoba liječenih klopidogrelom u stanju dinamičke ravnoteže, pokazala je da je izloženost aktivnom metabolitu smanjena za 28% u umjerenih metabolizatora te za 72% u slabih metabolizatora, dok je inhibicija agregacije trombocita (5 μM ADP) smanjena uz razlike u vrijednosti IAT-e od 5,9%, odnosno 21,4%, u usporedbi s brzim metabolizatorima.
If you are pregnant or suspect that you are pregnant, you should tell your doctor or your pharmacist before taking Plavix.
Ako ste trudni ili sumnjate na trudnoću, obavijestite svog liječnika ili ljekarnika prije nego što uzmete
The recommended dose, including for patients with a condition called ‘atrial fibrillation' (an irregular heartbeat), is one 75 mg tablet of Clopidogrel HCS per day to be taken orally with or without food, and at the same time each day.
Preporučena doza, uključujući za bolesnike sa stanjem zvanim "fibrilacija atrija" (nepravilni otkucaji srca), je jedna tableta Klopidogrela HCS od 75 mg dnevno koja se uzima kroz usta, s obrokom ili bez obroka, i u isto vrijeme svaki dan.
Patients randomized in the ACTIVE program were those presenting with documented AF, i.e., either permanent AF or at least 2 episodes of intermittent AF in the past 6 months, and had at least one of the following risk factors: age ≥75 years or age 55 to 74 years and either diabetes mellitus requiring drug therapy, or documented previous MI or documented coronary artery disease; treated for systemic hypertension; prior stroke, transient ischaemic attack (TIA), or non-CNS systemic embolus; left ventricular dysfunction with left ventricular ejection fraction <45%; or documented peripheral vascular disease.
Bolesnici randomizirani u programu ACTIVE imali su dokumentiranu fibrilaciju atrija (FA), tj. ili permanentnu FA ili najmanje 2 epizode intermitentne FA u zadnjih 6 mjeseci te su imali najmanje jedan od sljedećih faktora rizika: dob ≥75 godina ili 55 do 74 godine te ili dijabetes koji zahtijeva terapiju lijekovima ili dokumentirani prethodni infarkt miokarda ili dokumentiranu bolest koronarnih arterija; ako su primali terapiju za sistemsku hipertenziju; prethodni moždani udar, prolazni ishemijski napadaj (TIA) ili ne-CNS sistemska embolija; disfunkcija lijevog ventrikula s ejekcijskom frakcijom lijevog ventrikula <45% ili dokumentirana periferna vaskularna bolest.
Clopidogrel HCS is taken by adults to prevent blood clots (thrombi) forming in hardened blood vessels (arteries), a process known as atherothrombosis, which can lead to atherothrombotic events (such as stroke, heart attack, or death).
Klopidogrel HCS uzimaju odrasli za sprječavanje stvaranja krvnih ugrušaka (tromba) u otvrdnutim krvnim žilama (arterijama), a taj poremećaj zove se aterotromboza i može dovesti do aterotrombotičkih događaja (kao što su moždani udar, srčani udar ili smrt).
In CURE, there was no excess in major bleeds with clopidogrel plus ASA within 7 days after coronary bypass graft surgery in patients who stopped therapy more than five days prior to surgery.
U studiji CURE, u kojoj je klopidogrel primjenjivan istodobno s ASK nije bilo povećanja broja velikih krvarenja tijekom 7 dana nakon ugrađivanja srčane premosnice u bolesnika koji su lijekove prestali uzimati više od pet dana prije kirurškog zahvata.
• If you have a medical condition that is currently causing bleeding such as a stomach ulcer or bleeding within the brain.
• ako imate poremećaj koji izaziva krvarenje, kao što je, primjerice, čir želuca ili krvarenje u mozgu.
If you stop taking Clopidogrel HCS
Ako prestanete uzimati Klopidogrel HCS
As a precautionary measure, breast-feeding should not be continued during treatment with Plavix.
Kao mjera opreza, treba prestati s dojenjem za vrijeme liječenja lijekom
During non-clinical studies in rat and baboon, the most frequently observed effects were liver changes.
5.3 Neklinički podaci o sigurnosti primjene Tijekom nekliničkih ispitivanja na štakorima i babunima, najčešće zabilježeni učinci bile su promjene na jetri.
Common side effects (may affect up to 1 in 10 people): 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.
Kounis syndrome (vasospastic allergic angina / allergic myocardial infarction) in the context of a hypersensitivity reaction due to clopidogrel*
alergijski infarkt miokarda) u kontekstu reakcije preosjetljivosti na klopidogrel*
The active substance is clopidogrel.
- Djelatna tvar je klopidogrel.
Intracranial bleeding (some cases were reported with fatal outcome), headache, paraesthesia, dizziness
Poremećaji živčanog sustava intrakranijalno krvarenje (prijavljeni su neki slučajevi s fatalnim ishodom), glavobolja, parestezija, omaglica poremećaj okusa,
This was consistent across subgroups of patients defined by baseline characteristics, and type of fibrinolytic or heparin therapy.
Kozistentni podaci dobiveni su i u podskupinama bolesnika koje su definirane prema početnim karakteristikama i tipu terapije fibrinoliticima ili heparinom.
Therapeutic experience with clopidogrel is limited in patients with renal impairment.
Terapijsko je iskustvo s klopidogrelom u bolesnika s narušenom funkcijom bubrega je ograničeno.
What you need to know before you take Plavix Do not take Plavix:
Što morate znati prije nego počnete uzimati Klopidogrel HCS Nemojte uzimati Klopidogrel HCS:
The safety of the concomitant administration of clopidogrel, fibrin or non-fibrin specific thrombolytic agents and heparins was assessed in patients with acute myocardial infarction.
Trombolitici Sigurnost istodobne primjene klopidogrela, fibrinskih ili afibrinskih specifičnih trombolitika i heparina procjenjivana je u bolesnika s akutnim infarktom miokarda.
Fifteen percent (15.0%) of patients in the clopidogrel group and 21.7% in the placebo group reached the primary endpoint, representing an absolute reduction of 6.7% and a 36 % odds reduction in favor of clopidogrel (95% CI: 24, 47%; p < 0.001), mainly related to a reduction in occluded infarct-related arteries.
Petnaest posto (15,0%) bolesnika u skupini s klopidogrelom i 21,7% u skupini s placebom dostigli su primarni ishod, što predstavlja apsolutno smanjenje od 6,7% i smanjenje izgleda (engl. odds reduction) od 36% u korist klopidogrela (95% CI: 24, 47%; p<0,001), većinom povezano sa smanjenjem okluzije arterija povezanih s infarktom.
If you forget to take Clopidogrel HCS
Ako ste zaboravili uzeti Klopidogrel HCS
• Tablet coating: Polyvinyl alcohol, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), talc and macrogol 3000.
Ovojnica tablete: poli(vinilni alkohol), titanijev dioksid (E171), crveni željezov oksid (E172), žuti željezov oksid (E172), talk i makrogol 3000
EU/1/10/651/001 28 film-coated tablets EU/1/10/651/002 30 film-coated tablets EU/1/10/651/003 50 film-coated tablets EU/1/10/651/004 56 film-coated tablets EU/1/10/651/005 84 film-coated tablets EU/1/10/651/006 90 film-coated tablets EU/1/10/651/007 100 film-coated tablets EU/1/10/651/008 28x1 film-coated tablets EU/1/10/651/009 28x1 film-coated tablets (calendar pack) EU/1/10/651/010 30x1 film-coated tablets EU/1/10/651/011 50x1 film-coated tablets EU/1/10/651/012 56x1 film-coated tablets EU/1/10/651/013 84x1 film-coated tablets EU/1/10/651/014 90x1 film-coated tablets EU/1/10/651/015 100x1 film-coated tablets
EU/1/10/651/001 28 filmom obloženih tableta EU/1/10/651/002 30 filmom obloženih tableta EU/1/10/651/003 50 filmom obloženih tableta EU/1/10/651/004 56 filmom obloženih tableta EU/1/10/651/005 84 filmom obloženih tableta EU/1/10/651/006 90 filmom obloženih tableta EU/1/10/651/007 100 filmom obloženih tableta EU/1/10/651/008 28x1 filmom obloženih tableta EU/1/10/651/009 28x1 filmom obloženih tableta (kalendarsko pakovanje) EU/1/10/651/010 30x1 filmom obloženih tableta EU/1/10/651/011 50x1 filmom obloženih tableta EU/1/10/651/012 56x1 filmom obloženih tableta EU/1/10/651/013 84x1 filmom obloženih tableta EU/1/10/651/014 90x1 filmom obloženih tableta EU/1/10/651/015 100x1 filmom obloženih tableta
Respiratory tract bleeding (haemoptysis, pulmonary haemorrhage), bronchospasm, interstitial pneumonitis, eosinophilic pneumonia
bronhospazam, intersticijski pneumonitis, eozinofilna pneumonija
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)
Polyvinyl alcohol Titanium dioxide (E171) Red iron oxide (E172) Yellow iron oxide (E172) Talc
Poli(vinilni alkohol) titanijev dioksid (E171) željezov oksid, crveni (E172) željezov oksid, žuti (E172) talk makrogol 3000
Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/
Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranicama Europske agencije za lijekove http://www.ema.europa.eu
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
Clopidogrel should be used with caution in patients who receive concomitant glycoprotein IIb/IIIa inhibitors (see section 4.4).
Klopidogrel se s oprezom mora davati bolesnicima koji istodobno primaju inhibitore glikoproteina IIb/IIIa (vidjeti dio 4.4.).
Then, the recommended dose is one 75 mg tablet of Plavix per day as described above.
HCS je jedna tableta od 75 mg dnevno, kao što je opisano iznad.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).
embrionalni/fetalni razvoj, porođaj ili postnatalni razvoj (vidjeti dio 5.3.).
If you think any of these apply to you, or if you are in any doubt at all, consult your doctor before taking Clopidogrel HCS.
Ako se bilo što od navedenog odnosi na Vas ili ako niste sigurni, obratite se svom liječniku prije uzimanja lijeka Klopidogrel HCS.
New cardiovascular events (primary endpoint) were prevented, with relative risk reductions of 22% (CI: 8.6, 33.4), 32% (CI: 12.8, 46.4), 4% (CI: -26.9, 26.7), 6% (CI: -33.5, 34.3) and 14% (CI: -31.6, 44.2), during the 0-1, 1-3, 3-6, 6-9 and 9-12 month study intervals, respectively.
46,4), 4% (CI: -26,9, 26,7), 6% (CI: -33,5, 34,3) i 14% (CI: -31,6, 44,2) tijekom studijskih razdoblja od 0 do 1 mjesec, 1 do 3 mjeseca, 3 do 6 mjeseci, 6 do 9 mjeseci, odnosno 9 do 12 mjeseci.
You have been prescribed Plavix to help prevent blood clots and reduce the risk of these severe events because: - You have a condition of hardening of arteries (also known as atherosclerosis), and - You have previously experienced a heart attack, stroke or have a condition known as peripheral arterial disease, or - You have experienced a severe type of chest pain known as ‘unstable angina' or ‘myocardial infarction' (heart attack).
- imate otvrdnuće arterija (koje se još zove ateroskleroza) - ste već imali srčani udar, moždani udar ili imate stanje koje se zove bolest perifernih arterija, ili - ste imali teški oblik boli u prsištu, poznat pod nazivom “nestabilna angina” ili “infarkt miokarda” (srčani udar).
Serum sickness, anaphylactoid reactions, cross-reactive drug hypersensitivity among thienopyridines (such as ticlopidine, prasugrel) (see section
Poremećaji imunološkog sustava serumska bolest, anafilaktoidne reakcije, križno reaktivna preosjetljivost na lijekove iz skupine tienopiridinima (kao što su tiklopidin, prasugrel) (vidjeti dio
A total of 99.7% of patients received fibrinolytics (fibrin specific: 68.7%, non-fibrin specific: 31.1%), 89.5% heparin, 78.7% beta blockers, 54.7% ACE inhibitors and 63% statins.
fibrin-nespecifični: 31,1%), 89,5% heparin, 78,7% beta blokatore, 54,7% ACE inhibitore i 63% statine.
Bullous dermatitis (toxic epidermal necrolysis, Stevens Johnson Syndrome, erythema multiforme, acute generalised exanthematous pustulosis (AGEP)), angioedema, drug-induced hypersensitivity syndrome, drug rash with
(toksična epidermalna nekroliza, Stevens Johnsonov sindrom, erythema multiforme, akutna generalizirana egzantematozna pustuloza (AGEP)), angioedem, sindrom preosjetljivosti izazvane lijekom, osip uzrokovan lijekom s eozinofilijom i sistemskim simptomima (engl.
- a blood disorder that makes you prone to internal bleeding (bleeding inside any tissues, organs or joints of your body).
- poremećaja krvi zbog čega ste skloni unutrašnjim krvarenjima (krvarenje u tkivima, organima ili zglobovima), - nedavne teške ozljede,
Driving and using machines Clopidogrel HCS is unlikely to affect your ability to drive or to use machines.
Klopidogrel HCS ne bi trebao utjecati na Vašu sposobnost upravljanja vozilima ili strojevima.
Patients were randomised 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 dnevno primale 75 mg klopidogrela ili 325 mg acetilsalicilatne kiseline na dan te su praćeni od 1 do 3 godine.
eosinophilia and systemic symptoms (DRESS), rash erythematous or exfoliative, urticaria, eczema, lichen planus
DRESS), eritematozni ili eksfolijativni osip, urtikarija, ekcem, lichen planus
− Within less than 12 hours after regular scheduled time: patients should take the dose immediately and then take the next dose at the regular scheduled time.
Ako je prošlo manje od 12 sati od uobičajenog termina uzimanja lijeka: bolesnik treba odmah uzeti dozu, a sljedeću dozu treba uzeti prema uobičajenom rasporedu.
Package leaflet: Information for the user Clopidogrel HCS 75 mg film-coated tablets
Uputa o lijeku: Informacije a za korisnika Klopidogrel HCS 75 mg filmom obložene tablete klopidogrel
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.
− 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 i s tromboliticima ili bez njih.
6 Contents of the pack and other information What Plavix contains
Sadržaj pakiranja i druge informacije Što Klopidogrel
OPA/Al/PVC-Al blisters containing 28, 30, 50, 56, 84, 90 and 100 film-coated tablets or perforated unit dose blister (OPA/Al/PVC-Al) 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 i 100 filmom obloženih tableta ili perforirani blisteri djeljivi na jedinične doze (OPA/Al/PVC-Al) koji sadrže 28x1, 28x1 (kalendarsko pakovanje), 30x1, 50x1, 56x1, 84x1, 90x1 i 100x1 filmom obloženih tableta u kutiji.
Bleeding may occur as bleeding in the stomach or bowels, bruising, haematoma (unusual bleeding or bruising under the skin), nose bleed, blood in the urine.
(neuobičajeno krvarenje ili modrica ispod kože), krvarenja iz nosa, krvi u mokraći.
However, patients entered into clinical trials with clopidogrel received a variety of concomitant medicinal products including diuretics, beta blockers, 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.
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 primjećene klinički značajne štetne interakcije.
EU/1/10/651/001 Cartons of 28 film-coated tablets in OPA/Al/PVC - Al blisters EU/1/10/651/002 Cartons of 30 film-coated tablets in OPA/Al/PVC - Al blisters EU/1/10/651/003 Cartons of 50 film-coated tablets in OPA/Al/PVC - Al blisters EU/1/10/651/004 Cartons of 56 film-coated tablets in OPA/Al/PVC - Al blisters EU/1/10/651/005 Cartons of 84 film-coated tablets in OPA/Al/PVC - Al blisters EU/1/10/651/006 Cartons of 90 film-coated tablets in OPA/Al/PVC - Al blisters EU/1/10/651/007 Cartons of 100 film-coated tablets in OPA/Al/PVC - Al blisters EU/1/10/651/008 Cartons of 28x1 film-coated tablets in OPA/Al/PVC - Al perforated unit-dose blisters
EU/1/10/651/003 Kutija sa 50 filmom obloženih tableta u OPA/Al/PVC - Al blisteru EU/1/10/651/004 Kutija sa 56 filmom obloženih tableta u OPA/Al/PVC - Al blisteru EU/1/10/651/005 Kutija sa 84 filmom obloženih tablete u OPA/Al/PVC - Al blisteru EU/1/10/651/006 Kutija sa 90 filmom obloženih tableta u OPA/Al/PVC - Al blisteru EU/1/10/651/007 Kutija sa 100 filmom obloženih tableta u OPA/Al/PVC - Al blisteru EU/1/10/651/008 Kutije sa 28x1 filmom obloženih tableta u OPA/Al/PVC - Al perforiranim blisterima djeljivim na jedinične doze
Vistor hf.
Klopidogrel HCS.
Cellulose, microcrystalline Colloidal anhydrous silica Crospovidone (type A) Macrogol 6000
celuloza, mikrokristalična silicijev dioksid, koloidni, bezvodni krospovidon (tip A) makrogol 6000 ricinusovo ulje, hidrogenirano
The concomitant administration of clopidogrel with oral anticoagulants is not recommended since it may increase the intensity of bleedings (see section 4.4).
Ne preporučuje se istodobna primjena klopidogrela i oralnih antikoagulansa, jer se može povećati intenzitet krvarenja (vidjeti dio 4.4.).
Clopidogrel HCS:
Klopidogrel HCS
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.
Dostupne su kutije sa 28, 30, 50, 56, 84, 90 ili 100 filmom obloženih tableta u blisteru ili kutije sa 28x1, 28x1 (kalendarsko pakovanje), 30x1, 50x1, 56x1, 84x1, 90x1 i 100x1 filmom obloženih tableta u perforiranim blisterima djeljivim na jedinične doze.
• Renal impairment Therapeutic experience is limited in patients with renal impairment (see section 4.4).
Terapijsko iskustvo u bolesnika s narušenom funkcijom bubrega je ograničeno (vidjeti dio 4.4.).
Thrombotic thrombocytopenic purpura (TTP) (see section 4.4), aplastic anaemia, pancytopenia, agranulocytosis, severe thrombocytopenia, acquired haemophilia A, granulocytopenia, anaemia
uključujući tešku neutropeniju trombotična trombocitopenična purpura (TTP) (vidjeti dio 4.4.), aplastična anemija, pancitopenija, agranulocitoza, teška trombocitopenija,
Data from the CAPRIE study indicate that phenytoin and tolbutamide which are metabolised by CYP2C9 can be safely co-administered with clopidogrel.
Podaci iz studije CAPRIE pokazuju da se fenitoin i tolbutamid, koji se metaboliziraju pomoću
- fluconazole or voriconazole medicines to treat fungal infections, - efavirenz, a medicine to treat HIV (human immunodeficiency virus) infections, - carbamazepine, a medicine to treat some forms of epilepsy, - moclobemide, medicine to treat depression, - repaglinide, medicine to treat diabetes, - paclitaxel, medicine to treat cancer.
- flukonazol ili vorikonazol, odnosno lijekove koji se primjenjuju za liječenje gljivičnih infekcija, - efavirenz, lijek koji se primjenjuje za liječenje HIV (virus humane imunodeficijencije) infekcija, - karbamazepin, lijek koji se primjenjuje za liječenje nekih oblika epilepsije,
Absorption is at least 50%, based on urinary excretion of clopidogrel metabolites.
50%, na temelju izlučivanja metabolita klopidogrela putem mokraće.
DATE OF REVISION OF THE TEXT <DD month YYYY>
<DD mjesec GGGG>
Approximately 88% of patients received concomitant ASA (range of 1 to 23 mg/kg/day).
Približno 88% bolesnika istodobno je primalo ASK (u rasponu od 1 do
The Cmax of the active metabolite is twice as high following a single 300-mg clopidogrel loading dose as it is after four days of 75-mg maintenance dose.
Cmax aktivnog metabolita je dvostruko veći nakon jednokratne udarne doze od 300 mg klopidogrela,
How to take Clopidogrel HCS
Kako uzimati Klopidogrel HCS
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.
(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
In patients with atrial fibrillation, clopidogrel should be given as a single daily dose of 75 mg. ASA (75-100 mg daily) should be initiated and continued in combination with clopidogrel (see section 5.1).
Primjenu ASK (75-100 mg na dan) treba započeti i nastaviti je davati u kombinaciji s klopidogrelom (vidjeti dio 5.1).