natgillin/translations-raw huggingface dataset:
Odrasli in starostniki Klopidogrel je treba dajati kot enkratni dnevni odmerek 75 mg.
Clopidogrel should be given as a single daily dose of 75 mg.
Pokazala je, da se je v primerjavi z dobrimi metabolizatorji izpostavljenost aktivnemu presnovku pri srednjih metabolizatorjih za 28 % zmanjšala, pri slabih metabolizatorjih se je zmanjšala za 72 %, zavrtje agregacije trombocitov (5 µM ADP) pa se je zmanjšalo tako, da je bila razlika IPA v primerjavi z dobrimi metabolizatorji pri prvih 5,9 % in pri drugih 21,4 %.
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.
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena filmsko obložena tableta vsebuje 75 mg klopidogrela (v obliki bromida).
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 75 mg of clopidogrel (as hydrobromide).
s COX-2 inhibitorji, in klopidogrel sočasno uporabljati previdno (glejte poglavje 4.4).
Consequently, NSAIDs including Cox-2 inhibitors and clopidogrel should be co-administered with caution (see section 4.4).
Če bolnik izpusti odmerek: - če je zamuda manj kot 12 ur po pravem času: bolnik naj odmerek vzame takoj, potem pa
If a dose is missed: - 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.
Bolezni jeter, žolčnika in žolčevodov akutna odpoved jeter, hepatitis, nenormalni testi jetrne funkcije
Acute liver failure, hepatitis, abnormal liver function test
Če opazite kateri koli neželeni učinek, se posvetujete z zdravnikom ali farmacevtom.
If you get any side effects, talk to your doctor or pharmacist.
Bolezni mišičnoskeletnega sistema in vezivnega tkiva mišično-skeletne krvavitve (hemartroza), artritis, artralgija, mialgija
Musculo-skeletal bleeding (haemarthrosis), arthritis, arthralgia, myalgia
Na voljo so testi za določitev bolnikovega CYP2C19-genotipa.
Tests are available to determine a patient's CYP2C19 genotype.
Bolnike so spremljali 30 dni. Primarni opazovani dogodki so bili navzočnost kompozita zaradi infarkta zamašene arterije na angiogramu pred odpustom ali smrt ali ponovni miokardni infarkt pred koronarno angiografijo.
The primary endpoint was the occurrence of the composite of an occluded infarct-related artery on the predischarge angiogram, or death or recurrent MI before coronary angiography.
Bolniki so bili naključno razporejeni v skupino, ki je prejemala klopidogrel (udarni odmerek 300 mg, nato 75 mg/dan, n=6.259) ali skupino, ki je prejemala placebo (n=6.303), oboje prejeto v kombinaciji z acetilsalicilnsko kislino (75-325 mg enkrat na dan) in drugimi standardnimi terapijami.
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.
ime in naslov izdelovalca, odgovornega za sproščanje zadevne serije.
The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Če imate aterosklerozo (otrdele krvne žile), je pri vas prisotno povečano tveganje za nastanek krvnega strdka v krvnih žilah večje.
If you suffer from hardening of the arteries (“atherosclerosis”) there is an increased risk of a blood clot forming in your blood vessels.
Po odmerni shemi 300 mg/75 mg se je antiagregacijski odziv pri slabih metabolizatorjih zmanjšal: povprečno IPA (5 µM ADP) je bilo 24 % (24 ur) in 37 % (5.
After the 300 mg/75 mg dose regimen, antiplatelet responses were decreased in the poor metabolisers with mean IPA (5 μM ADP) of 24% (24 hours) and 37% (Day 5) as compared to IPA of 39% (24 hours) and 58% (Day 5) in the extensive metabolisers and 37% (24 hours) and 60% (Day 5) in the intermediate metabolisers.
Na voljo so testi za ugotavljanje bolnikovega CYP2C19-genotipa.
Tests are available to identify a patient's CYP2C19 genotype.
s krvavitvijo, ki se pojavi pod kožo kot drobne rdeče pike, in/ali zmedenostjo (glejte poglavje 2 »Opozorila in previdnostni ukrepi«).
• Signs of liver problems such as yellowing of the skin and whites of the eyes (jaundice), whether or not associated with bleeding which appears under the skin as red pinpoint dots and/or confusion (see section 2 ‘Warnings and precautions')
Zdravilo Klopidogrel Teva Pharma B.V. jemljejo odrasali za preprečavanje nastanka krvnih strdkov (trombov) ter tako preprečuje pojav resnih dogodkov, kot je srčni napad in kap.
In adults Clopidogrel Teva Pharma B.V. reduces the risk of blood clots forming which in turn reduces the risk of serious conditions such as heart attack and stroke from occurring.
tablete in ovojnino, da bodo vedeli katere tablete ste zaužili.
Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so that they know which tablets were consumed.
Bolnike z znano alergijo na tienopiridine je priporočljivo kontrolirati glede znakov preobčutljivosti.
Monitoring for signs of hypersensitivity in patients with a known allergy to thienopyridines is advised.
Bolezni dihal, prsnega koša in mediastinalnega prostora krvavitve v dihalih (hemoptiza, pljučna krvavitev), bronhospazem, intersticijski pnevmonitis, eozinofilna pljučnica
Respiratory tract bleeding (haemoptysis, pulmonary haemorrhage), bronchospasm, interstitial pneumonitis, eosinophilic pneumonia
Klopidogrel je pomembno zmanjšal relativno tveganje za smrt zaradi kateregakoli vzroka za 7 % (p=0,029) in relativno tveganje za ponovni infarkt, kap ali smrt za 9 % (p=0,002), kar je predstavljalo absolutno zmanjšanje za 0,5 % oziroma 0,9 %. Ta koristni učinek se je pojavil pri vseh starostih, obeh spolih in ob jemanju fibrinolitikov ali brez njega, opažen pa je bil že po 24 urah.
Clopidogrel significantly reduced the relative risk of death from any cause by 7% (p=0.029), and the relative risk of the combination of re-infarction, stroke or death by 9% (p=0.002), representing an absolute reduction of 0.5% and 0.9%, respectively.
acetilsalicilna kislina ni spremenila s klopidogrelom doseženega zaviranja agregacije trombocitov, ki je bila sprožena z ADP-jem, vendar je klopidogrel okrepil učinek acetilsalicilne kisline na s kolagenom
Acetylsalicylic acid (ASA): ASA did not modify the clopidogrel-mediated inhibition of ADP-induced platelet aggregation, but clopidogrel potentiated the effect of ASA on collagen-induced platelet aggregation.
povišana telesna temperatura, znaki okužbe (npr. vnetje grla), bledost kože ali huda utrujenost.
• Fever, signs of infection (e.g. sore throat), pale skin or extreme tiredness.
Posebne skupine bolnikov Farmakokinetika aktivnega presnovka klopidogrela v teh posebnih
The pharmacokinetics of the active metabolite of clopidogrel is not known in these special populations.
s hudo ledvično boleznijo (očistek kreatinina 5 do 15 ml/min) inhibicija z ADP sprožene agregacije trombocitov manjša (25 %) od tiste, opažene pri zdravih osebah.
After repeated doses of 75 mg clopidogrel per day in subjects with severe renal disease (creatinine clearance from 5 to 15 ml/min), inhibition of ADP-induced platelet aggregation was lower (25%) than that observed in healthy subjects, however, the prolongation of bleeding time was similar to that seen in healthy subjects receiving 75 mg of clopidogrel per day.
Če pri vas obstaja povečano tveganje za pojav krvavitev.
• You are at increased risk of bleeding.
s 14C-označenega klopidogrela pri človeku, se ga je približno 50 % izločilo z urinom
Following an oral dose of 14C-labelled clopidogrel in man, approximately 50% was excreted in the urine and approximately 46% in the faeces in the 120-hour interval after dosing.
Pri ljudeh, ki so prejemali terapevtski odmerek klopidogrela, niso opazili nobenega učinka na jetrne presnovne encime.
No effect on hepatic metabolising enzymes was observed in humans receiving clopidogrel at the therapeutic dose.
s farmacevtom, preden vzamete katerokoli zdravilo.
Ask your doctor or pharmacist for advice before taking any medicine.
morate zdravniku takoj povedati, če se pri vas pojavi bolezensko stanje (znano kot tombotična trombocitopenična purpura), ki vključuje spremembe vedenja, glavobol, komo, motnje vida, napade (krče), odpovedovanje ledvic, povišano telesno temperaturo, šibkost in krvavitev v trebuhu, črevesju ali na koži (vključno z drobnimi rdečimi pikami in večjimi odrgninami) (glejte
• You should also tell your doctor immediately if you develop a medical condition (known as Thrombotic Thrombocytopenic Purpura) that includes altered behaviour, headaches, coma, visual disturbances, seizures (fitting), kidney failure, fever, extreme tiredness, weakness or bleeding into the stomach, bowels or skin (including small red spots or large bruised areas) (see section 4 ‘Possible Side Effects')
Pomožne snovi v jedru tablete so (glejte poglavje 2 »Zdravilo Klopidogrel Teva Pharma B.V. vsebuje laktozo« in »Zdravilo Klopidogrel Teva Pharma B.V. vsebuje hidrogenirano ricinusovo olje«: laktoza monohidrat, mikrokristalna celuloza, hidroksipropil celuloza (E463), krospovidon (tip A), hidrogenirano ricinusovo olje in natrijev lavrilsulfat.
The other ingredients in the tablet core are (see section 2 ‘Clopidogrel Teva Pharma B.V. contains lactose' and ‘Clopidogrel Teva Pharma B.V. contains hydrogenated castor oil') lactose monohydrate, microcrystalline cellulose, hydroxypropylcellulose (E463), crospovidone (type A), hydrogenated castor oil and sodium laurilsulfate, and in the film-coating are lactose monohydrate, hypromellose (E464), titanium dioxide (E171), macrogol 4000, iron oxide red (E172), iron oxide yellow (E172), indigo carmine aluminium lake (E132).
Bolniki so 28 dni oziroma do odpusta dobivali klopidogrel (75 mg na dan, n=22.961) ali placebo (n=22.891) v kombinaciji z acetilsalicilnsko kislino (162 mg na dan).
Patients received clopidogrel (75 mg/day, n=22,961) or placebo (n=22,891), in combination with ASA (162 mg/day), for 28 days or until hospital discharge.
Vpliv CYP2C19-genotipa na klinične izide pri bolnikih, zdravljenih
The influence of CYP2C19 genotype on clinical outcomes in patients treated with clopidogrel has not been evaluated in prospective, randomised, controlled trials.
Previdno odlepite zadnjo stran.
- Keep this leaflet.
in esomeprazol, fluvoksamin, fluoksetin, moklobemid, vorikonazol, flukonazol, tiklopidin, ciprofloksacin, cimetidin, karbamazepin, okskarbazepin in kloramfenikol.
Medicinal products that inhibit CYP2C19 include omeprazole and esomeprazole, fluvoxamine, fluoxetine, moclobemide, voriconazole, fluconazole, ticlopidine, ciprofloxacin, cimetidine, carbamazepine, oxcarbazepine and chloramphenicol.
Simptomi lahko vključujejo spremembe vedenja, glavobole, komo, motnje vida, napade (krče), odpovedovanje ledvic, povišano telesno temperaturo, hudo utrujenost, šibkost ali krvavitve iz želodca, črevesja ali kože (vključno z manjšimi rdečimi madeži ali večjimi odrgninami).
Symptoms may include altered behaviour, headaches, coma, visual disturbances, seizures (fitting), kidney failure, fever, extreme tiredness, weakness, or bleeding into the stomach, bowels or skin (including small red spots or large bruised areas)
Perforirani pretisni omoti iz aluminija za enkratno odmerjanje, ki se odlepijo in perforirani pretisni omoti za enkratno odmerjanje iz aluminija ter HDPE stekleničke z zaporkami iz polipropilena ter silikagel sušilno sredstvo.
Aluminium-aluminium peelable perforated unit-dose blisters, aluminium-aluminium perforated unit dose blisters and HDPE bottles with polypropylene closures or child resistant polypropylene closures and silica gel desiccant.
Krvavitve so bile najpogosteje opisan učinek tako v kliničnih študijah kot v obdobju
Bleeding is the most common reaction reported both in clinical studies as well as in post-marketing experience where it was mostly reported during the first month of treatment.
s tveganjem za povečano krvavitev zaradi poškodbe, kirurškega posega ali drugih patoloških stanj in pri bolnikih, ki se zdravijo z acetilsalicilno kislino, heparinom ali zaviralci glikoproteina IIb/IIIa ali nesteroidnimi protivnetnimi zdravili (NSAID) vključno z zaviralci COX-2 ali
As with other antiplatelet agents, clopidogrel should be used with caution in patients who may be at risk of increased bleeding from trauma, surgery or other pathological conditions and in patients receiving treatment with ASA, heparin, glycoprotein IIb/IIIa inhibitors or non-steroidal anti-inflammatory drugs (NSAIDs) including Cox-2 inhibitors, or selective serotonin reuptake inhibitors (SSRIs).
tablete v obliki kapsul, ki imajo na eni strani gladko površino, na drugi strani pa vtisnjeno oznako »C75«.
Light pink to pink, capsule-shaped film-coated tablets debossed with “C75” on one side and plain on the other side.
Zavrta je tudi agregacija trombocitov, ki jo izzovejo drugi agonisti kot ADP, ker pride do blokade ojačenja trombocitne aktivacije
Platelet aggregation induced by agonists other than ADP is also inhibited by blocking the amplification of platelet activation by released ADP.
PODATKI V BRAILLOVI PISAVI Klopidogrel Teva Pharma B.V. 75 mg
INFORMATION IN BRAILLE Clopidogrel Teva Pharma B.V. 75 mg
Pri podganah in pavijanih so poročali tudi o slabem želodčnem prenašanju (gastritis, želodčne erozije in/ali bruhanje), pri uporabi zelo velikih odmerkov.
At very high doses, a poor gastric tolerability (gastritis, gastric erosions and/or vomiting) of clopidogrel was also reported in rat and baboon.
Filmska obloga laktoza monohidrat hipromeloza (E464) titanov dioksid (E171) makrogol 4000 rdeči železov oksid (E172) rumeni železov oksid (E172) indigotin (E132)
Lactose monohydrate Hypromellose (E464) Titanium dioxide (E171) Macrogol 4000
podaljšan čas krvavitve, krvavitve v dihalih, krvavitve v očesu, kri v urinu in/ali purpura (rdeče pike na koži, ki nastajajo zaradi krvavitev pod kožo),
Prolonged bleeding, bleeding inside the head, bleeding in the eye, blood in the urine and/or purpura (red spots on the skin caused by bleeding underneath the skin) Rashes, itching, abnormal touch sensation
tveganja za žilne dogodke in ki niso primerni za zdravljenje z antagonisti vitamina K (VKA) ter imajo majhno tveganje za krvavitev, je klopidogrel v kombinaciji z ASA indiciran za preprečevanje aterotrombotičnih in trombemboličnih dogodkov, vključno z možgansko kapjo.
Prevention of atherothrombotic and thromboembolic events in atrial fibrillation In adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with Vitamin K antagonists (VKA) and who have a low bleeding risk, clopidogrel is indicated in combination with ASA for the prevention of atherothrombotic and thromboembolic events, including stroke.
V primeru potrjenega izoliranega podaljšanja aktiviranega parcialnega tromboplastičnega časa (aPTČ)
In cases of confirmed isolated activated Partial Thromboplastin Time (aPTT) prolongation with or without bleeding, acquired haemophilia should be considered.
Vendar pa so bolniki, ki so bili vključeni v klinična preskušanja klopidogrela, sočasno prejemali različna zdravila, vključno z diuretiki, blokatorji beta, zaviralci angiotenzinske konvertaze, kalcijevimi antagonisti, sredstvi za zmanjševanje ravni holesterola, koronarnimi vazodilatatorji, antidiabetiki
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.
skupaj z acetilsalicilno kislino, če ne morete prejemati "peroralnih antikoagulantov", ali če nimate tveganja za večjo krvavitev.
Your doctor should have prescribed Clopidogrel Teva Pharma B.V. plus acetylsalicylic acid if you cannot take ‘oral anticoagulants' and you do not have a risk of major bleeding.
Med ultrahitrimi, dobrimi in srednjimi metabolizatorji niso ugotovili bistvenih razlik v izpostavljenosti aktivnemu presnovku in povprečnem zavrtju agregacije trombocitov (IPA).
No substantial differences in active metabolite exposure and mean inhibition of platelet aggregation (IPA) were observed between ultrarapid, extensive and intermediate metabolisers.
odrgnine, hematomi (neobičajne krvavitve pod kožo), krvavitve iz nosu, krvavitve iz želodca ali črevesja, povečane krvavitve na mestu vboda,
• Bruising, haematoma (unusual bleeding under the skin), nose bleeds, bleeding in the stomach or bowels, increased bleeding at the site of a puncture wound
ustreza polno funkcionalni presnovi, medtem ko alela CYP2C19*2
The CYP2C19*1 allele corresponds to fully functional metabolism while the CYP2C19*2 and CYP2C19*3 alleles are nonfunctional.
s placebom je bila krvavitev, vendar se pojavljanje krvavitev med skupinama ni značilno razlikovalo.
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.
Če ste pozabili vzeti zdravilo Klopidogrel Teva Pharma B.V.
If you forget to take Clopidogrel Teva Pharma B.V.
Bolniki so dobivali klopidogrel (300 mg udarni odmerek, nato pa 75 mg na dan, n=1.752) ali placebo (n=1.739), oboje v kombinaciji z acetilsalicilno kislino (150 do 325 mg kot udarni odmerek, nato 75 do 162 mg na dan)
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.
Ne jemljite zdravila Klopidogrel Teva Pharma B.V.
Do not take Clopidogrel Teva Pharma B.V.
Tel: +44 (0) 1977 628500
United Kingdom Teva UK Limited Tel: +44 (0) 1977 628500
Ušesne bolezni vrtoglavica
Hepatic impairment
Druga zdravila in zdravilo Kopidogrel Teva Pharma B.V.
Other medicines and Clopidogrel Teva Pharma B.V.
Nedavna ishemična kap
Recent ischaemic stroke
Povprečna največja koncentracija nespremenjenega klopidogrela v plazmi (približno 2,2-2,5 ng/ml po enem 75-mg peroralnem odmerku)
Mean peak plasma levels of unchanged clopidogrel (approximately 2.2-2.5 ng/ml after a single 75 mg oral dose) occurred approximately 45 minutes after dosing.
Krvavitev
Bleeding
skupni delež večjih necerebralnih krvavitev ali cerebralne krvavitve nizek
In COMMIT, the overall rate of noncerebral major bleeding or cerebral bleeding was low and similar in both groups.
Odmerek 0,2 mg/kg je dosegel povprečno 49,3 % zavrtje (agregacija trombocitov povzročena
The dose of 0.2 mg/kg achieved the mean percent inhibition of 49.3% (5 µM ADP-induced platelet aggregation) which was comparable to that of adults taking clopidogrel 75 mg/day.
imate neredno bitje srca, motnjo, imenovano "atrijska fibrilacija", in ne morete prejemati zdravil, imenovanih "peroralni antikoagulanti" (antagonisti vitamina K), ki preprečujejo nastajanje novih krvnih strdkov in preprečujejo rast obstoječih krvnih strdkov. Povedati so vam morali, da so "peroralni antikoagulanti" pri tej motnji učinkovitejši kot acetilsalicilna kislina ali kombinirana uporaba zdravila Klopidogrel Teva Pharma B.V.
• 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.
Žilne bolezni hematom resne krvavitve, krvavitev operacijske rane, vaskulitis, hipotenzija
Serious haemorrhage, haemorrhage of operative wound, vasculitis, hypotension
Kaj vsebuje navodilo
What is in this leaflet
spremembe vedenja, glavoboli, koma, motnje vida, napadi (krči), odpovedovanje ledvic, povišana telesna temperatura, huda utrujenost, šibkost ali krvavitve iz želodca, črevesja ali kože (vključno z manjšimi rdečimi madeži ali večjimi odrgninami).
• Altered behaviour, headaches, coma, visual disturbances, seizures (fitting), kidney failure, fever, extreme tiredness, weakness or bleeding into the stomach, bowels or skin (including small red spots or large bruised areas).
Bolezni krvi in limfatičnega sistema nevtropenija, vključno
Blood and the lymphatic system disorders
so nekateri polimorfni ali podvrženi zavrtju z drugimi zdravili, se ustrezno zavrtje trombocitov ne pojavi pri vseh bolnikih.
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.
so pri bolnikih z ledvično okvaro omejene.
Therapeutic experience with clopidogrel is limited in patients with renal impairment.
Neželene reakcije, ki so se pojavile v kliničnih študijah ali o katerih
Adverse reactions that occurred either during clinical studies or that were spontaneously reported are presented in the table below.
Pri sočasni uporabi 80 mg pantoprazola enkrat dnevno, so se zmanjšale plazemske koncentracije aktivnega presnovka za 20 % (začetni odmerek) in 14 % (vzdrževalni odmerek), z zmanjšanjem zavrtja agregacije trombocitov za 15 % in 11 %. Ti rezultati kažejo, da se klopidogrel lahko uporablja skupaj s pantoprazolom.
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.
statistično značilne razlike v deležih krvavitev s smrtnim izidom (1,1 % klopidogrel + acetilsalicilna kislina, 0,7 % placebo + acetilsalicilna kislina)
There was no statistically significant difference in the rates of fatal bleeding (1.1% in the clopidogrel + ASA group and 0.7% in the placebo +ASA group) and haemorrhagic stroke (0.8% and 0.6%, respectively) between groups.
Zato je potrebno pri tej skupini bolnikov klopidogrel uporabljati previdno (glejte poglavje 4.2).
Clopidogrel should therefore be used with caution in this population (see section 4.2).
POGOJI ALI OMEJITVE V ZVEZI
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND
ŠTEVILOM ENOT
BATCH NUMBER
se je pojavila pri 296 (7,8 %) bolnikih, ki so prejemali klopidogrel + acetilsalicilno kislino, in pri 408 (10,8 %) bolnikih, ki so prejemali placebo + acetilsalicilno kislino (relativno zmanjšanje
Strokes occurred in 296 (7.8%) patients receiving clopidogrel + ASA and 408 (10.8%) patients receiving placebo + ASA (relative risk reduction, 28.4%; 95% CI, 16.8% to 38.3%; p=0.00001).
Zdravilna učinkovina je klopidogrel.
The active substance is clopidogrel.
in omeprazol uporabljena skupaj istočasno ali v presledku 12 ur, se je izpostavljenost aktivnemu presnovku klopidogrela zmanjšala za 45 % (začetni odmerek) oz.
Omeprazole 80 mg once daily administered either at the same time as clopidogrel or with 12 hours between the administrations of the two drugs decreased the exposure of the active metabolite by 45% (loading dose) and 40% (maintenance dose).
s placebom, kar predstavlja absolutno zmanjšanje za 6,7 % in 36 % zmanjšanje verjetnosti v prid klopidogrela (95 % IZ od 24 % do 47 %; p<0,001) v glavnem zaradi zmanjšanja pojavnosti zaradi infarkta zamašenih arterij.
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.
motnje okušanja,
Taste disturbances
s preskusi agregacije trombocitov ex vivo, se razlikuje glede na genotip CYP2C19.
Clopidogrel active metabolite pharmacokinetics and antiplatelet effects, as measured by ex vivo platelet aggregation assays, differ according to CYP2C19 genotype.
- če je zamuda več kot 12 ur: bolnik naj naslednji odmerek vzame ob pravem času;
- For more than 12 hours: patients should take the next dose at the regular scheduled time and should not double the dose.