natgillin/translations-raw huggingface dataset:
Razen zgoraj navedenih podatkov o specifičnih interakcijah z zdravili, študij o interakcijah klopidogrela z nekaterimi drugimi zdravili, ki jih bolniki z aterotrombotično boleznijo pogosto uporabljajo, niso izvedli.
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.
Če vam je zdravnik povedal, da imate intoleranco za nekatere sladkorje, se pred uporabo tega zdravila posvetujte
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Jemanje teh zdravil v kombinaciji z zdravilom Klopidogrel Teva Pharma B.V. lahko poveča tveganje za pojav krvavitev.
Taking these medicines in combination with Clopidogrel Teva Pharma B.V. could result in an increased risk of bleeding.
če ste alergični na klopidogrel ali katerokoli sestavino tega zdravila (navedno v poglavju 6).
• If you are allergic (hypersensitive) to clopidogrel or any of the other ingredients of this medicine (listed in section 6).
Pri slabih metabolizatorjih je bila izpostavljenost aktivnemu presnovku za 63 do 71 % manjša kot pri dobrih metabolizatorjih.
In poor metabolisers, active metabolite exposure was decreased by 63-71% compared to extensive metabolisers.
V nekliničnih študijah pri podganah in pavijanih so bili najpogosteje opaženi neželeni učinki jetrne spremembe.
During non clinical studies in rat and baboon, the most frequently observed effects were liver changes.
s CYP2C19 so približno 2% pri Kavkazijcih, 4% pri črncih in 14% pri Kitajcih.
Published frequencies for the poor CYP2C19 metaboliser genotypes are approximately 2% for Caucasians, 4% for Blacks and 14% for Chinese.
NSAIDs: v klinični študiji, ki je bila izvedena pri zdravih prostovoljcih, je sočasna uporaba klopidogrela in naproksena povečala prikrito izgubo krvi iz prebavil.
NSAIDs: in a clinical study conducted in healthy volunteers, the concomitant administration of clopidogrel and naproxen increased occult gastrointestinal blood loss.
EU/1/10/649/001-016
MARKETING AUTHORISATION NUMBER(S) EU/1/10/649/001-016
• vnetje v ustih (stomatitis),
Sore mouth (stomatitis)
Preprečevanje aterotrombotičnih dogodkov: Klopidogrel je indiciran pri:
Prevention of atherothrombotic events Clopidogrel is indicated in:
Sestavljeni opazovani dogodki so bili smrt zaradi kateregakoli vzroka ali prvi pojav ponovnega infarkta, kapi ali smrt.
The co-primary endpoints were death from any cause and the first occurrence of re-infarction, stroke or death.
Če ste vzeli večji odmerek zdravila Klopidogrel Teva Pharma B.V., kot bi smeli Če vi (ali kdorkoli drug) meni, da ste pomotoma vzeli preveliko število tablet ali mislite, da jih je pogoltnil otrok, nemudoma obiščite najbližji oddelek nujne medicinske pomoči ali o tem nemudoma obvestite
If you take more Clopidogrel Teva Pharma B.V. than you should If you (or someone else) swallow a lot of the tablets all together, or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately.
Akutni koronarni sindrom
Acute coronary syndrome
Občasna uporaba acetilsalicilne kisline (ne več kot 1.000 mg v obdobju 24 ur) na splošno ne povzroča težav, vendar
An occasional use of acetylsalicylic acid (no more than 1,000 mg in any 24 hour period) should generally not cause a problem, but prolonged use in other circumstances should be discussed with your doctor.
spremembe ravni določenih snovi v krvi ali urinu. To je mogoče ugotoviti
Changes in levels of certain substances in your blood or urine.
Rezultati te podskupine se torej skladajo
Thus, the results from this subset are in line with the overall trial results.
Ugotovili so, da klopidogrel nima nobenega učinka na plodnost podganjih samcev in samic ter da ni teratogen pri podganah ali kuncih.
Clopidogrel was found to have no effect on the fertility of male and female rats and was not teratogenic in either rats or rabbits.
Ne vzemite dvojnega odmerka, da bi nadomestili posamezne izpuščene odmerke.
Do not take a double dose to make up for a forgotten tablet.
Običajni odmerek je ena 75 mg tableta na dan, ki jo zaužijete z vodo ali drugo tekočino.
The recommended dose is one 75 mg tablet per day which should be swallowed with water or another liquid.
Če je potrebno takojšnje korigiranje podaljšanega časa krvavitve, lahko s transfuzijo trombocitov dosežemo nasprotni učinek klopidogrela.
If prompt correction of prolonged bleeding time is required, platelet transfusion may reverse the effects of clopidogrel.
s spojem in prvo uporabo raziskovanega zdravila je bil 20 dni.
The mean time between shunt palliation and first administration of study medicinal product was 20 days.
Redki
Rare
V študijah CURE, CLARITY, ACTIVE-A in eni od kohortnih študij (Trenk) niso odkrili večjega deleža dogodkov glede na metabolizatorsko stanje.
In CURE, CLARITY, ACTIVE-A and one of the cohort studies (Trenk), no increased event rate was observed based on metaboliser status.
Heparin: v klinični študiji, ki je bila izvedena pri zdravih osebah, uporaba klopidogrela ni pomenila spremembe odmerka heparina ali spremembe učinka heparina na koagulacijo.
Heparin: in a clinical study conducted in healthy subjects, clopidogrel did not necessitate modification of the heparin dose or alter the effect of heparin on coagulation.
Bolniki z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze/galaktoze ne smejo jemati tega zdravila.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
DATUM ZADNJE REVIZIJE BESEDILA <{DD.
DATE OF REVISION OF THE TEXT <DD month YYYY>
Populacijo bolnikov je sestavljalo 27,8 % žensk, 58,4 % bolnikov starih ≥ 60 let (2 % ≥ 70 let ) in 54,5 % bolnikov, ki so prejemali fibrinolitike.
The population included 27.8% women, 58.4% patients ≥60 years (26% ≥70 years) and 54.5% patients who received fibrinolytics.
Pri bolnikih z akutnim miokardnim infarktom z elevacijo ST spojnice sta bili varnost in učinkovitost klopidogrela vrednoteni v dveh randomiziranih, s placebom kontroliranih, dvojno slepih študijah, CLARITY in COMMIT.
In patients with acute ST-segment elevation MI, safety and efficacy of clopidogrel have been evaluated in 2 randomised, placebo-controlled, double-blind studies, CLARITY and COMMIT.
karbamazepin ali oksakarbazepin, zdravila za zdravljenje nekaterih oblik epilepsije,
• Carbamazepine, or oxcarbazepine, medicines to treat some forms of epilepsy.
Posebne farmakokinetične študije, ki so jih opravili z radioaktivno označenim klopidogrelom, so pokazale, da se izvorna spojina ali njeni presnovki izločajo v mleko.
Specific pharmacokinetic studies performed with radiolabelled clopidogrel have shown that the parent compound or its metabolites are excreted in the milk.
Triinsedemdeset odstotkov (73 %) bolnikov, vključenih v študijo ACTIVE-A, je bilo neprimernih za prejemanje VKA po zdravnikovi oceni, nezmožnosti upoštevanja kontrol INR (internacionalnega normaliziranega razmerja), nagnjenosti k padcem ali poškodbe glave, ali specifičnega tveganja krvavitev; pri 26 % bolnikov je zdravnikova odločitev temeljila na tem, da bolnik ni želel jemati VKA.
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.
Ni bilo dokazov o kancerogenem učinku pri dajanju klopidogrela 78 tednov mišim in 104 tedne podganam v odmerkih do 77 mg/kg na dan (kar predstavlja najmanj 25-krat večjo izpostavljenost kot pri človeku pri prejemanju kliničnega odmerka 75 mg/dan).
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).
Navzkrižne reakcije med tienopiridini
Cross reactions among thienopyridines
6.6 Posebni varnostni ukrepi za odstranjevanje
6.6 Special precautions for disposal
Trombolitiki: varnost sočasne uporabe klopidogrela, fibrinsko specifičnih ali fibrinsko nespecifičnih trombolitikov in heparinov je bila ovrednotena pri bolnikih z akutnim miokardnim infarktom.
Thrombolytics: 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.
Študije pri živalih so pokazale, da se klopidogrel izloča v mleko.
Animal studies have shown excretion of clopidogrel in breast milk.
ste doživeli hudo obliko bolečine v prsih, znano kot “nestabilna angina” ali “miokardni infarkt” (srčni napad).
• You have experienced a severe type of chest pain known as ‘unstable angina' or ‘myocardial infarction' (heart attack).
Na podlagi meril za vključitev so zdravniki bolnike vključili v ACTIVE-W, če so bili kandidati za zdravljenje z antagonistom vitamina K (VKA), npr. z varfarinom.
Based on enrollment criteria, physicians enrolled patients in ACTIVE-W if they were candidates for vitamin K antagonist (VKA) therapy (such as warfarin).
Poročali so o naslednjih neželenih učinkih.
The following side effects have been reported.
splošne alergijske reakcije (na primer, splošni občutek toplote z nenadnim nelagodjem do nezavesti); težave pri dihanju, otekanje ali vnetje v ustih, kožne alergije, mehurji na koži,
Generalised allergic reactions (for example, overall sensation of heat with sudden general discomfort until fainting); breathing difficulties, swelling or inflammation of the mouth, skin allergy, blisters on the skin
Farmakogenetika
Pharmacogenetics
Ime in naslov izdelovalca (izdelovalcev), odgovornega (odgovornih) za sproščanje serije
Name and address of the manufacturer(s) responsible for batch release
če imate zdravstveno stanje, ki trenutno povzroča krvavitev, kot je želodčna razjeda ali krvavitev v možganih.
• If you are suffering from another condition which is currently causing bleeding such as a stomach ulcer or bleeding within the brain.
To je veljalo za vse podskupine bolnikov, opredeljene z določenimi izhodiščnimi značilnostmi in tipom fibrinolitičnega ali heparinskega zdravljenja.
This was consistent across subgroups of patients defined by baseline characteristics, and type of fibrinolytic or heparin therapy.
Izkušnje so omejene pri bolnikih z zmerno jetrno boleznijo, ki imajo lahko hemoragično diatezo.
Experience is limited in patients with moderate hepatic disease who may have bleeding diatheses.
To zdravilo vsebuje hidrogenirano ricinusovo olje, ki lahko povzroči želodčne težave in drisko.
This medicinal product contains hydrogenated castor oil which may cause stomach upset and diarrhoea.
Povprečna starost je bila 71 let, 41,6 % bolnikov je bilo
The mean age was 71 years, 41.6% of patients were ≥75 years.
V celoti je 23,0 % bolnikov prejemalo antiaritmike, 52,1 % blokatorje beta, 54,6 % zaviralce ACE in 25,4 % statine.
A total of 23.0% of patients received anti-arrhythmics, 52.1% beta-blockers, 54.6% ACE inhibitors, and 25.4% statins.
Ta koristni učinek se je pojavljal v vseh podskupinah, ki so bile predhodno opredeljene glede na bolnikovo starost ali spol, mesto infarkta in tip uporabljenega fibrinolitika ali heparina.
This benefit was consistent across all prespecified subgroups including patients' age and gender, infarct location, and type of fibrinolytic or heparin used.
V stanju dinamičnega ravnovesja je bila povprečno opažena raven zaviranja z odmerkom 75 mg na dan med 40 % in 60 %.
At steady state, the average inhibition level observed with a dose of 75 mg per day was between 40% and 60%.
Klinično pomembni neželeni učinki, zabeleženi v študijah CAPRIE, CURE, CLARITY, COMMIT in ACTIVE-A, so predstavljeni spodaj.
The clinically relevant adverse reactions observed in the CAPRIE, CURE, CLARITY, COMMIT and ACTIVE-A studies are discussed below.
tveganjem za krvavitve, se priporoča, da odmerek ASA ni večji od 100 mg.
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.
9AG East Sussex
BN22 9AG East Sussex United Kingdom
veliko zmanjšanje števila določenih krvnih celic, kar vodi do povečanega tveganja za pojav krvavitev ali odrgnin, okužb, bledosti kože in hudo utrujenost,
Severe reduction in certain blood cells leading to increased risk of bleeding or bruising, increased risk of infections, pale skin and extreme tiredness
Tienopiridini lahko povzročijo blage do hude alergijske reakcije, na primer izpuščaj, angioedem ali hematološke navzkrižne reakcije, naprimer trombocitopenijo in nevtropenijo.
Thienopyridines may cause mild to severe allergic reactions such as rash, angioedema, or haematological cross-reactions such as thrombocytopaenia and neutropaenia.
V študijo CLARITY je bilo vključenih 3.491 bolnikov v 12 urah po nastopu akutnega miokardnega infarkta z elevacijo ST spojnice, ki so bili predvideni za trombolitično terapijo.
The CLARITY trial included 3,491 patients presenting within 12 hours of the onset of a ST elevation MI and planned for thrombolytic therapy.
Študija ACTIVE-W je pokazala, da je bilo zdravljenje z antagonisti vitamina K učinkovitejše kot zdravljenje
The ACTIVE-W study demonstrated that anticoagulant treatment with vitamin K antagonists was more effective than with clopidogrel and ASA.
Krvavitve in hematološke motnje
Bleeding and haematological disorders
• zaviralce glikoproteina IIb/IIIb (zdravila, ki se uporabljajo za preprečevanje strjevanja krvi).
• Glycoprotein IIb/IIIa inhibitors (medicines used to stop blood clotting).
Heparin so uporabljali pri več kot 90 % bolnikov in sočasna uporaba heparinske terapije ni pomembno vplivala na relativni delež krvavitev med klopidogrelom in placebom.
Heparins were administered in more than 90% of the patients and the relative rate of bleeding between clopidogrel and placebo was not significantly affected by the concomitant heparin therapy.
Kaj je zdravilo Klopidogrel Teva Pharma B.V. in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Klopidogrel Teva Pharma B.V. Kako jemati zdravilo Klopidogrel Teva Pharma B.V.
What Clopidogrel Teva Pharma B.V. is and what it is used for What you need to know before you take Clopidogrel Teva Pharma B.V. How to take Clopidogrel Teva Pharma B.V.
Incidenca večjih krvavitev je bila v obeh skupinah podobna.
The incidence of major bleeding was similar between groups.
in acetilsalicilno kislino ni bilo prekoračeno v 7 dneh po koronarni premostitveni operaciji pri bolnikih, ki so prenehali z zdravljenjem več kot pet dni pred kirurškim posegom.
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.
s klopidogrelom, za katere so na voljo rezultati genotipizacije: CURE (n = 2721), CHARISMA (n = 2428), CLARITY-TIMI 28 (n = 227), TRITON-TIMI 38 (n = 1477) in ACTIVE-A (n = 601), poleg tega pa tudi številne objavljene kohortne študije.
There have been a number of retrospective analyses, however, to evaluate this effect in patients treated with clopidogrel for whom there are genotyping results: CURE (n=2721), CHARISMA (n=2428), CLARITY-TIMI 28 (n=227), TRITON-TIMI 38 (n=1477), and ACTIVE-A (n=601), as well as a number of published cohort studies.
Učinkovitost klopidogrela so opazili neodvisno od odmerka acetilsalicilnske kisline (75-325 mg enkrat na dan).
The efficacy of clopidogrel was observed independently of the dose of ASA (75-325 mg once daily).
Če ste doživeli hudo bolečino v prsih (nestabilna angina ali sršni napad), vam bo morda predpisan klopidogrel v kombinaciji z acetilsalicilno kislino, učinkovino proti bolečinam in za zniževanje zvišane telesne tempreature.
If you have experienced severe chest pain (unstable angina or heart attack), you may be prescribed clopidogrel in combination with acetylsalicylic acid, a substance used to relieve pain and lower fever.
Poleg tega na farmakodinamično aktivnost klopidogrela ni pomembno vplivala sočasna uporaba fenobarbitala ali estrogena.
Furthermore, the pharmacodynamic activity of clopidogrel was not significantly influenced by the coadministration of phenobarbital or oestrogen.
Prevelik odmerek bo najverjetneje povečal tveganje za pojav krvavitev.
An overdose is likely to cause an increased risk of bleeding.
Tako se pri zdravljenju več kot 3 mesece opažena korist v skupini, ki je prejemala klopidogrel in acetilsalicilnsko kislino, ni nadalje povečevala, medtem ko je tveganje za krvavitev ostalo (glejte poglavje 4.4).
Thus, beyond 3 months of treatment, the benefit observed in the clopidogrel + ASA group was not further increased, whereas the risk of haemorrhage persisted (see section 4.4).
Pri manjših urezninah ali poškodbah, npr. če se urežete ali pri britju, navadno ni razloga za skrb.
For minor cuts and injuries, e.g. cutting yourself shaving, this is usually of no concern.
ZA SHRANJEVANJE Shranjujte pri temperaturi do 25 ºC.
Do not store above 25°C.
Farmakodinamična interakcija med klopidogrelom in heparinom je možna in vodi do povečanega tveganja za pojav krvavitev.
A pharmacodynamic interaction between clopidogrel and heparin is possible, leading to increased risk of bleeding.
Zaviralci agregacije trombocitov brez heparina Oznaka ATC: B01AC04
Pharmacotherapeutic group: platelet aggregation inhibitors excl. heparin, ATC Code: B01AC-04.
moklobemid, zdravila za zdravljenje depresije.
• moclobemide, medicine to treat depression.
Na primer abciksimab, eptifibatid ali tirofiban.
eptifibatide or tirofiban.
Skupno je 99,7 % bolnikov prejemalo fibrinolitike (fibrinsko specifične: 68,7 %, nefebrinsko specifične: 31,1 %), 89,5 % heparin, 78,7 % blokatorji beta, 54,7 % zaviralce angiotenzinske konvertaze in 63 % statine.
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.
Pediatrična populacija Klopidogrel naj se pri otrocih ne uporablja iz razlogov, ki zadevajo učinkovitost (glejte
• Paediatric population Clopidogrel should not be used in children because of efficacy concerns (see section 5.1)
Študija CAPRIE je vključevala 19.185 bolnikov z aterotrombozo, ki se je odrazila z nedavnim miokardnim infarktom (<35 dni), nedavno ishemično kapjo (med 7 dni in 6 meseci) ali razvito periferno arterijsko boleznijo (PAD).
The CAPRIE study included 19,185 patients with atherothrombosis as manifested by recent myocardial infarction (<35 days), recent ischaemic stroke (between 7 days and 6 months) or established peripheral arterial disease (PAD).
Na trgu ni vseh navedenih pakiranj.
Not all pack sizes may be marketed.
Podatki študije CAPRIE kažejo, da se lahko fenitoin in tolbutamid, ki se presnavljata s CYP2C9, sočasno
Data from the CAPRIE study indicate that phenytoin and tolbutamide which are metabolised by CYP2C9 can be safely co-administered with clopidogrel.
Če pa vas glede krvavitve skrbi, se nemudoma posvetujte z zdravnikom (glejte poglavje 4 »Možni neželeni učinki«).
However, if you are concerned by your bleeding, you should contact your doctor straightaway (see section 4 ‘Possible Side Effects')
s 30 tabletami: 30 dni
• 30 tablets bottle: 30 days
Farmakokinetika digoksina ali teofilina ob sočasni uporabi klopidogrela ni bila spremenjena.
The pharmacokinetics of digoxin or theophylline were not modified by the co-administration of clopidogrel.
V TRITON-TIMI 38 in 3 kohortnih študijah (Collet, Sibbing, Giusti) je imela kombinirana skupina bolnikov, ki so bili ali srednji ali slabi metabolizatorji, večji delež kardiovaskularnih dogodkov (smrt, miokardni infarkt, možganska kap) ali trombozo na žilni opornici kot dobri metabolizatorji.
In TRITON-TIMI 38 and 3 of the cohort studies (Collet, Sibbing, Giusti) the combined group of patients with either intermediate or poor metaboliser status had a higher rate of cardiovascular events (death, myocardial infarction, and stroke) or stent thrombosis compared to extensive metabolisers.
s prikrito krvavitvijo, zlasti prve tedne zdravljenja in/ali po invazivnih kardioloških postopkih ali kirurških posegih.
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.
V celoti je bil klopidogrel v odmerku 75 mg/dan v študiji CAPRIE, primerljiv z acetilsalicilno kislino v odmerku 325 mg/dan, ne glede na starost, spol ali raso.
Overall, clopidogrel 75 mg/day was comparable to ASA 325 mg/day in CAPRIE regardless of age, gender and race.
in večkratnih peroralnih odmerkih 75 mg na dan se klopidogrel hitro absorbira.
After single and repeated oral doses of 75 mg per day, clopidogrel is rapidly absorbed.
België/Belgique/Belgien
België/Belgique/Belgien Teva Pharma Belgium N.V./S.A.
V študiji povečevanja odmerka, ki je zajela 86 novorojenčkov ali dojenčkov, starih do 24 mesecev, s tveganjem tromboze (PICOLO), so klopidogrel ocenili v zaporednih odmerkih 0,01, 0,1 in 0,2 mg/kg pri novorojenčkih
In a dose escalation study of 86 neonates or infants up to 24 months of age at risk for thrombosis (PICOLO), clopidogrel was evaluated at consecutive doses of 0.01, 0.1 and 0.2 mg/kg in neonates and infants and 0.15 mg/kg only in neonates.
s potrjeno diagnozo pridobljene hemofilije morajo obravnavati in zdraviti zdravniki specialisti, zdravljenje
Patients with a confirmed diagnosis of acquired haemophilia should be managed and treated by specialists, and clopidogrel should be discontinued.
odraslih bolnikih z miokardnim infarktom (od nekaj dni do manj kot 35 dni), ishemično kapjo (od 7 dni do manj kot 6 mesecev) ali dokazano periferno arterijsko boleznijo.
• Adult 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.
če se urežete ali poškodujete, se lahko krvavitev ustavi počasneje kot običajno.
If you cut or injure yourself, it may take slightly longer than usual for bleeding to stop.
Če imate ledvično ali jetrno bolezen.
• You have liver or kidney disease.
Večkratni odmerki po 75 mg na dan tvorijo pomembno zaviranje z ADP sprožene agregacije trombocitov od prvega dne. To se progresivno povečuje in doseže stanje dinamičnega ravnovesja (“steady state”) med 3.
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.
Študija ACTIVE-A (n = 7.554) je bila multicentrična, randomizirana, dvojno slepa, s placebom kontrolirana študija, ki je primerjala klopidogrel 75 mg/dan + acetilsalicilno kislino (n = 3.772) in placebo + acetilsalicilno kislino (n = 3.782).
The ACTIVE-A study (N=7,554) was a multicenter, randomized, double-blind, placebo-controlled study which compared clopidogrel 75 mg/day + ASA (N=3,772) to placebo + ASA (N=3,782).
Trombotična trombocitopenična purpura (TTP)
Thrombotic Thrombocytopenic Purpura (TTP)
Glavna merila za nevključitev bolnikov so bila potrjena peptična ulkusna bolezen v preteklih 6 mesecih, predhodna intracerebralna krvavitev, pomembna trombocitopenija (število trombocitov < 50 x 109/l), potreba po klopidogrelu ali peroralnih antikoagulantih ali intoleranca za katero od obeh snovi.
The major exclusion criteria for patients were documented peptic ulcer disease within the previous 6 months; prior intracerebral hemorrhage; significant thrombocytopenia (platelet count < 50 x 109/l); requirement for clopidogrel or oral anticoagulants (OAC); or intolerance to any of the two compounds.