FrancophonIA/ELRC3.0 huggingface dataset:
English: - inhibition of uterine contractions resulting in delayed or prolonged labour.
Slovenian: - zavrtju krčenja maternice in posledično odloženemu ali podaljšanemu porodu.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Teva Pharma B.V.
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Teva Pharma B.V.
English: The combination of clopidogrel/acetylsalicylic acid should be used with caution in patients who receive concomitant glycoprotein IIb/IIIa inhibitors (see section 4.4).
Slovenian: Kombinacijo klopidogrela/acetilsalicilne kisline morate uporabljati previdno pri bolnikih, ki se sočasno zdravijo z zaviralci glikoproteina IIb/IIIa (glejte poglavje 4.4).
English: Patients were randomised to clopidogrel (300 mg loading dose followed by 75 mg/day, N=6,259) plus ASA (75-325 mg once daily) or ASA alone (N=6,303), (75-325 mg once daily) and other standard therapies.
Slovenian: Bolniki so bili naključno razporejeni v skupino, ki je prejemala klopidogrel (začetni odmerek 300 mg, nato pa 75 mg/dan, N=6.259) in ASA (75 do 325 mg enkrat na dan) ali samo ASA (N=6.303), (75 do 325 mg enkrat na dan) in drugimi standardnimi terapijami.
English: • heparin or any other injectable medicine used to reduce blood clotting,
Slovenian: • heparin ali drugo zdravilo v obliki injekcij proti strjevanju krvi,
English: The number of patients experiencing the co-primary endpoint (CV death, MI, stroke or refractory ischaemia) was 1,035 (16.5%) in the clopidogrel plus ASA group and 1,187 (18.8%) in the ASA group, a 14% relative risk reduction (95% CI of 6%-21%, p=0.0005) for the clopidogrel plus ASA group.
Slovenian: Število bolnikov s primarnim opazovanim dogodkom (SŽ smrt, MI, kap ali refraktorno ishemijo) je bilo 1.035 (16,5 %) v skupini, zdravljeni s klopidogrelom in z ASA in 1.187 (18,8 %) v skupini, zdravljeni z ASA, kar je 14 % zmanjšanje relativnega tveganja (95 % IZ od 6 % do 21 %, p=0,0005) za skupino, zdravljeno s klopidogrelom in z ASA.
English: Since clopidogrel is metabolised to its active metabolite partly by CYP2C19, use of medicinal products that inhibit the activity of this enzyme would be expected to result in reduced drug levels of the active metabolite of clopidogrel.
Slovenian: Glede na to, da se klopidogrel v aktivni presnovek deloma presnovi s CYP2C19, je mogoče pričakovati, da uporaba zdravil, ki zavrejo delovanje tega encima, zmanjša koncentracijo aktivnega presnovka klopidogrela.
English: This effect lasts for the life of the platelet.
Slovenian: Učinek traja celotno življenjsko dobo trombocita.
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.
Slovenian: V opazovalnih in kliničnih študijah so poročali o razhajajočih se podatkih o kliničnih posledicah tega farmakokinetičnega/farmakodinamskega medsebojnega delovanja, z vidika večjih kardiovaskularnih dogodkov.
English: Clopidogrel/Acetylsalicylic acid Teva is used following initiation of therapy with clopidogrel and ASA given separately.
Slovenian: Zdravilo Klopidogrel/acetilsalicilna kislina Teva se uporablja po začetni terapiji s klopidogrelom in z ASA, ki ju bolnik prejema ločeno:
English: • probenecid, benzbromarone, or sulfinpyrazone, medicines used to treat gout,
Slovenian: • probenecid, benzbromaron ali sulfinpirazon, zdravila za zdravljenje protina,
English: Clopidogrel/Acetylsalicylic acid Teva contains lactose.
Slovenian: Zdravilo Klopidogrel/acetilsalicilna kislina Teva vsebuje laktozo.
English: Film-coated tablet 14 film-coated tablets 28 film-coated tablets 30 film-coated tablets
Slovenian: filmsko obložena tableta 14 filmsko obloženih tablet 28 filmsko obloženih tablet 30 filmsko obloženih tablet
English: Patients received clopidogrel (75 mg/day, n=22,961) plus ASA (162 mg/day), or ASA alone (162 mg/day) (n=22,891), for 28 days or until hospital discharge.
Slovenian: Bolniki so 28 dni oziroma do odpusta dobivali klopidogrel (75 mg/dan, n=22.961) in ASA (162 mg/dan) ali samo ASA (162 mg/dan, n=22.891).
English: Patients received clopidogrel (300 mg loading dose, followed by 75 mg/day, n=1,752) plus ASA or ASA alone (n=1,739), (150 to 325 mg as a loading dose, followed by 75 to 162 mg/day), a fibrinolytic agent and, when appropriate, heparin.
Slovenian: Bolniki so prejemali klopidogrel (300 mg začetni odmerek, nato pa 75 mg/dan, n=1.752) in ASA ali samo ASA (n=1.739), (150 mg do 325 mg kot začetni odmerek, nato 75 mg do 162 mg/dan), fibrinolitično sredstvo in po potrebi heparin.
English: Thrombotic thrombocytopenic purpura (TTP) (see section 4.4), aplastic anaemia, pancytopenia, agranulocytosis, severe thrombocytopenia, granulocytopenia, anaemia, acquired haemophilia A.
Slovenian: Trombotična trombocitopenična purpura (TTP) (glejte poglavje 4.4), aplastična anemija, pancitopenija, agranulocitoza, huda trombocitopenija, granulocitopenija, anemija, pridobljena hemofilija A
English: 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.
Slovenian: Po večkratnih odmerkih 75 mg klopidogrela na dan, je bilo pri osebah s hudo ledvično boleznijo (očistek kreatinina od 5 do 15 ml/min) zaviranje z ADP sprožene agregacije trombocitov manjše (25 %) od tiste, opažene pri zdravih osebah.
English: 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).
Slovenian: Pri sočasni uporabi omperazola 80 mg/dan in klopidogrela ali v presledku 12 ur, se je izpostavljenost aktivnemu presnovku klopidogrela zmanjšala za 45 % (začetni odmerek) oz. 40 % (vzdrževalni odmerek).
English: White HDPE multi-layer bottles and green polypropylene (PP) child-resistant closures with dessicant.
Slovenian: Bele večplastne plastenke iz polietilena visoke gostote (HDPE) z zelenimi za otroke varnimi zaporkami iz polipropilena (PP) s sušilnim sredstvom.
English: • fluoxetine, fluvoxamine, or moclobemide, medicines to treat depression,
Slovenian: • fluoksetin, fluvoksamin ali moklobemid, zdravila za zdravljenje depresije,
English: There are no fertility data with the combination of clopidogrel/acetylsalicylic acid.
Slovenian: Podatkov o plodnosti za kombinacijo klopidogrela/acetilsalicilna kisline ni.
English: Clopidogrel/Acetylsalicylic acid Teva is supplied in blisters in pack sizes of 14, 28 and 30 film-coated tablets or in bottles in a pack size of 30 film-coated tablets.
Slovenian: Zdravilo Klopidogrel/acetilsalicilna kislina Teva je na voljo v pretisnih omotih v pakiranjih po 14, 28 in 30 filmsko obloženih tablet ali v plastenkah v pakiranju po 30 filmsko obloženih tablet.
English: • ST segment elevation acute myocardial infarction in medically treated patients eligible for
Slovenian: • akutnem miokardnem infarktu z elevacijo ST spojnice pri bolnikih, ki se zdravijo z zdravili in so primerni za trombolitično zdravljenje.
English: White HDPE bottles and green polypropylene (PP) child-resistant closures with dessicant.
Slovenian: Bele plastenke iz polietilena visoke gostote (HDPE) z zelenimi za otroke varnimi zaporkami iz polipropilena (PP) s sušilnim sredstvom.
English: Clopidogrel/Acetylsalicylic acid Teva is supplied in blisters in pack sizes of 10, 14, 28, 30, 50, 90 and 100 film-coated tablets or in bottles in a pack size of 30 film-coated tablets.
Slovenian: Zdravilo Klopidogrel/acetilsalicilna kislina Teva je na voljo v pretisnih omotih v pakiranjih po 10, 14, 28, 30, 50, 90 in 100 filmsko obloženih tablet ali v plastenkah v pakiranju po 30 filmsko obloženih tablet.
English: Although minor upper GI symptoms, such as dyspepsia, are common and can occur anytime during therapy, physicians should remain alert for signs of ulceration and bleeding, even in the absence of previous GI symptoms.
Slovenian: dispepsija, so pogosti in se lahko pojavijo kadarkoli med zdravljenjem, zato morajo zdravniki ostati pozorni na gastrointestinalne znake razjede in krvavitve, četudi bolnik pred tem ni imel takšnih simptomov.
English: • ticlopidine, other antiplatelet agent.
Slovenian: • tiklopidin, drugo antiagregacijsko zdravilo.
English: 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.
Slovenian: V študiji CURE pri bolnikih, ki so imeli narejeno koronarno premostitev in so pred tem jemali klopidogrel in ASA, v 7 dneh po operaciji niso ugotovili čezmernega števila hujših krvavitev, če so to zdravljenje prekinili vsaj pet dni pred operacijo.
English: Furthermore, the pharmacodynamic activity of clopidogrel was not significantly influenced by the co-administration of phenobarbital or oestrogen.
Slovenian: Poleg tega na farmakodinamično aktivnost klopidogrela sočasna uporaba fenobarbitala ali estrogena ni pomembno vplivala.
English: Acute liver failure, liver injury, mainly hepatocellular*, hepatitis, elevation of hepatic
Slovenian: Akutna odpoved jeter, poškodba jeter, predvsem hepatocelularna*, hepatitis, zvišane vrednosti jetrnih encimov*, nenormalni testi jetrne funkcije
English: The combination of clopidogrel/acetylsalicylic acid must not be used in patients with severe hepatic impairment (see section 4.3).
Slovenian: Kombinacija klopidogrela/acetilsalicilne kisline se ne sme uporabljati pri bolnikih s hudo okvarjenim delovanjem jeter (glejte poglavje 4.3).
English: Interactions with the following medicinal products with higher (anti-inflammatory) doses of ASA have also been reported: angiotensin converting enzyme (ACE) inhibitors, acetazolamide, anticonvulsants (phenytoin and valproic acid), beta blockers, diuretics, and oral hypoglycemic agents.
Slovenian: Med uporabo večjih (protivnetnih) odmerkov ASA so poročali o interakcijah z naslednjimi zdravili: zaviralci angiotenzin konvertaze (ACE), acetazolamidom, antiepileptiki (fenitoin in valprojska kislina), zaviralci adrenergičnih receptorjev beta, diuretiki in peroralnimi hipoglikemiki.
English: Clopidogrel was found to have no effect on the fertility of male and female rats and was not teratogenic in either rats or rabbits.
Slovenian: Ugotovili so, da klopidogrel nima vpliva na plodnost podganjih samcev in samic.
English: Clopidogrel has been evaluated for safety in more than 42,000 patients who have participated in clinical studies, including over 30,000 patients treated with clopidogrel plus ASA, and over 9,000 patients treated for 1 year or more.
Slovenian: Več kot 30.000 teh bolnikov je prejemalo kombinacijo klopidogrela in ASA, pri več kot 9.000 pa je zdravljenje trajalo 1 leto ali več.
English: The safety of the concomitant administration of the combination of clopidogrel/acetylsalicylic acid with other thrombolytic agents has not been formally established and should be undertaken with caution (see section 4.4).
Slovenian: Varnost sočasne uporabe kombinacije klopidogrela/acetilsalicilne kisline z drugimi trombolitiki ni bila formalno ugotovljena, zato je pri njihovi sočasni uporabi potrebna previdnost (glejte poglavje 4.4).
English: • The other ingredients are: Tablet core: lactose monohydrate, microcrystalline cellulose, hydroxypropylcellulose 100 cP, crospovidone (type A), stearic acid, croscarmellose sodium, hydrogenated vegetable oil and sodium lauril sulfate.
Slovenian: Jedro tablete: laktoza monohidrat, mikrokristalna celuloza, hidroksipropilceluloza 100 cP, krospovidon (tip A), stearinska kislina, premrežen natrijev karmelozat, hidrogenirano rastlinsko olje in natrijev lavrilsulfat.
English: 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.
Slovenian: Cmax aktivnega presnovka je po enem 300 mg začetnem odmerku klopidogrela dvakrat večja kot po štirih dneh uporabe vzdrževalnega odmerka 75 mg. Cmax je dosežena približno 30 do 60 minut po odmerjanju.
English: Serious haemorrhage, haemorrhage of operative wound, vasculitis, hypotension
Slovenian: Resne krvavitve, krvavitve operacijske rane, vaskulitis, hipotenzija
English: The concomitant administration of the combination of clopidogrel/acetylsalicylic acid with oral anticoagulants is not recommended since it may increase the intensity of bleeding (see section 4.4).
Slovenian: Sočasna uporaba kombinacije klopidogrela/acetilsalicilne kisline s peroralnimi antikoagulanti ni priporočljiva, ker lahko poveča intenzivnost krvavitev (glejte poglavje 4.4).
English: After first opening the bottle use within 30 days.
Slovenian: Porabiti v 30 dneh po prvem odprtju plastenke.
English: Clopidogrel is a prodrug, one of whose metabolites is an inhibitor of platelet aggregation.
Slovenian: Klopidogrel je predzdravilo, eden njegovih presnovkov pa zavira agregacijo trombocitov.
English: 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.
Slovenian: Če bolnik izpusti odmerek: - če je zamuda manj kot 12 ur po običajnem času za odmerek, naj bolnik odmerek vzame takoj,
English: 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).
Slovenian: Pri 2.172 bolnikih (17 % vseh bolnikov, vključenih v študijo CURE), katerim je bil vstavljen stent (Stent-CURE), so podatki post-hoc analize še posebej pokazali, da je klopidogrel v primerjavi s placebom pri sestavljenem primarnem opazovanem dogodku (SŽ smrt, MI, kap) pomembno zmanjšal relativno tveganje za 26,2 %.
English: • if you have a risk of bleeding such as: a medical condition that puts you at risk of internal bleeding (such as a stomach ulcer).
Slovenian: • če je pri vas prisotno tveganje za krvavitev, kot na primer: bolezen, zaradi katere ste v nevarnosti za notranjo krvavitev (npr. razjeda na želodcu), krvna motnja, zaradi katere ste bolj nagnjeni k notranji krvavitvi (krvavitev v katerakoli tkiva, organe ali sklepe v telesu),
English: Lactose monohydrate Microcrystalline cellulose Hydroxypropylcellulose 100 cP Crospovidone (type A) Stearic Acid
Slovenian: Jedro tablete: laktoza monohidrat mikrokristalna celuloza hidroksipropilceluloza 100 cP krospovidon (tip A) stearinska kislina premrežen natrijev karmelozat hidrogenirano rastlinsko olje natrijev lavrilsulfat
English: Polydextrose
Slovenian: Trombolitiki
English: Subsequent metabolism of the 2-oxo-clopidogrel intermediate metabolite results in formation of the active metabolite, a thiol derivative of clopidogrel.
Slovenian: 2-oksoklopidogrela povzroči nastanek aktivnega presnovka, ki je tiolski derivat klopidogrela.
English: The ASA in the combination of clopidogrel/acetylsalicylic acid is rapidly hydrolyzed in plasma to salicylic acid, with a half-life of 0.3 to 0.4 hours for ASA doses from 75 to 100 mg. Salicylic acid is primarily conjugated in the liver to form salicyluric acid, a phenolic glucuronide, an acyl glucuronide, and a number of minor metabolites.
Slovenian: ASA iz kombinacije klopidogrela/acetilsalicilne kisline v plazmi hitro hidrolizira v salicilno kislino, z razpolovnim časom od 0,3 do 0,4 ure za odmerke od 75 do 325 mg ASA.
English: • muscular pain
Slovenian: • bolečine v mišicah,
English: Non-cardiogenic pulmonary edema can occur with acute and chronic acetylsalicylic acid overdose (see section 4.8).
Slovenian: Zaradi akutnega ali kroničnega prevelikega odmerjanja acetilsalicilne kisline se lahko pojavi nekardiogeni pljučni edem (glejte poglavje 4.8).
English: Very rare, not known colitis (including ulcerative or lymphocytic colitis), upper gastro-intestinal symptoms* such as gastralgia (see section 4.4), stomatitis.
Slovenian: Zelo redki, neznana npr. gastralgija (glejte poglavje 4.4), stomatitis.
English: Therefore, concomitant use should be undertaken with caution (see section
Slovenian: Zato moramo biti pri sočasni uporabi previdni (glejte poglavje 4.4).
English: Acquired haemophilia has been reported following use of clopidogrel.
Slovenian: Poročali so o pojavu pridobljene hemofilije po uporabi klopidogrela.
English: ASA is known to be excreted in limited amounts in human milk.
Slovenian: Znano je, da se pri človeku ASA izloča v materino mleko.
English: No substantial differences in active metabolite exposure and mean inhibition of platelet aggregation (IPA) were observed between ultrarapid, extensive and intermediate metabolisers.
Slovenian: Med ultra hitrimi, obsežnimi in srednje dobrimi metabolizatorji niso ugotovili bistvenih razlik v izpostavljenosti aktivnemu presnovku in povprečnem zavrtju agregacije trombocitov (IPA).
English: Clopidogrel/Acetylsalicylic acid Teva should be given as a single daily 75 mg/75 mg dose.
Slovenian: Zdravilo Klopidogrel/acetilsalicilna kislina Teva se mora dajati kot enkratni dnevni odmerek 75 mg/75 mg.
English: • nausea (feeling sick)
Slovenian: • navzea (siljenje na bruhanje),
English: The concomitant administration of the combination of clopidogrel/acetylsalicylic acid with oral anticoagulants is not recommended since it may increase the intensity of bleeding (see section 4.5).
Slovenian: Sočasna uporaba kombinacije klopidogrela/acetilsalicilne kisline in peroralnih koagulantov ni priporočljiva, ker lahko poveča jakost krvavitev (glejte poglavje 4.5).
English: • If you suffer from severe liver disease.
Slovenian: • če imate hudo bolezen ledvic,
English: Clopidogrel/Acetylsalicylic acid Teva should be given as a single daily 75 mg/100 mg dose.
Slovenian: Zdravilo Klopidogrel/acetilsalicilna kislina Teva se mora dajati kot enkratni dnevni odmerek 75 mg/100 mg.
English: Clopidogrel is extensively metabolised by the liver.
Slovenian: Klopidogrel se obsežno presnovi v jetrih.
English: • kidney disease
Slovenian: Žilne bolezni
English: What Clopidogrel/Acetylsalicylic acid Teva looks like and contents of the pack Clopidogrel/Acetylsalicylic acid Teva 75 mg/100 mg film-coated tablets are light pink to pink, film-coated capsule shaped tablets.
Slovenian: Izgled zdravila Klopidogrel/acetilsalicilna kislina Teva in vsebina pakiranja Klopidogrel/acetilsalicilna kislina Teva 75 mg/100 mg filmsko obložene tablete so svetlo roza do roza, filmsko obložene tablete v obliki kapsule.
English: What Clopidogrel/Acetylsalicylic acid Teva looks like and contents of the pack Clopidogrel/Acetylsalicylic acid Teva 75 mg/75 mg film-coated tablets are yellow, film-coated capsule shaped tablets.
Slovenian: Izgled zdravila Klopidogrel/acetilsalicilna kislina Teva in vsebina pakiranja Klopidogrel/acetilsalicilna kislina Teva 75 mg/75 mg filmsko obložene tablete so rumene, filmsko obložene tablete v obliki kapsule.
English: Bullous dermatitis (toxic epidermal necrolysis, Stevens Johnson Syndrome, erythema multiforme), angioedema, drug induced hypersentsitivity syndrome, drug rash with eosinophilia and systemic symptoms (DRESS), rash erythematous or exfoliative, urticaria, eczema, lichen planus
Slovenian: Zelo redki, neznana povzročen sindrom preobčutljivosti, kožni izpuščaj z eozinofilijo in sistemskimi simptomi, kot posledica zdravljenja z zdravilom (sindrom DRESS), eritematozen ali eksfoliativni izpuščaj, urtikarija, ekcem, lihen planus
English: Clopidogrel/Acetylsalicylic acid Teva 75 mg/75 mg
Slovenian: Klopidogrel/acetilsalicilna kislina Teva 75 mg/75 mg
English: MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: IZDELOVALCI, ODGOVORNI ZA SPROŠČANJE SERIJ
English: Clopidogrel/Acetylsalicylic acid Teva 75 mg/100 mg
Slovenian: Klopidogrel/acetilsalicilna kislina Teva 75 mg/100 mg
English: Tablet coating: hypromellose, polydextrose, titanium dioxide (E171), talc, maltodextrin, medium chain triglycerides, iron oxide yellow (E172).
Slovenian: Obloga tablete: hipromeloza, polidekstroza, titanov dioksid (E171), smukec, maltodekstrin, srednjeverižni trigliceridi, rumeni železov oksid (E172), karmin (E120),
English: With moderate intoxication an attempt can be made to induce vomiting; if this fails, gastric lavage is indicated.
Slovenian: V primeru zmerne zastrupitve je mogoče poskusiti izzvati bruhanje.
English: Tablet coating: hypromellose, polydextrose, titanium dioxide (E171), quinoline yellow aluminium lake (E104), talc, maltodextrin, medium chain triglycerides and iron oxide yellow (E172).
Slovenian: Obloga tablete: hipromeloza, polidekstroza, titanov dioksid (E171), kinolinsko rumeno (E104), smukec, maltodekstrin, srednjeverižni trigliceridi in rumeni železov oksid
English: While you are taking Clopidogrel/Acetylsalicylic acid Teva:
Slovenian: Ko jemljete zdravilo Klopidogrel/acetilsalicilna kislina Teva:
English: These may be the signs of an allergic reaction.
Slovenian: To so lahko znaki
English: How to take Clopidogrel/Acetylsalicylic acid Teva
Slovenian: Kako jemati zdravilo Klopidogrel/acetilsalicilna kislina Teva
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.
Slovenian: Pri sočasni uporabi pantoprazola 80 mg/dan, so se zmanjšale plazemske koncentracije aktivnega presnovka za 20 % (začetni odmerek) in 14 % (vzdrževalni odmerek).
English: Repeated doses of clopidogrel 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.
Slovenian: Večkratni odmerki klopidogrela po 75 mg na dan so povzročili pomembno zaviranje z ADP sprožene agregacije trombocitov od prvega dne dalje.
English: Very rare, not known among thienopyridines (such as ticlopidine, prasugrel) (see section 4.4)*
Slovenian: Zelo redki, neznana alergijskih simptomov alergije na hrano*, navzkrižna preobčutljivost med tienopiridini (kot sta tiklopidin in prasugrel) (glejte poglavje 4.4) *
English: In CLARITY, there was an overall increase in bleeding in the clopidogrel plus ASA group vs. the group taking ASA alone.
Slovenian: V študiji CLARITY je v skupini s klopidogrelom in z ASA prišlo do splošnega povečanja krvavitev v primerjavi z ASA.
English: Gastrointestinal and retroperitoneal haemorrhage with fatal outcome, pancreatitis, gastro-duodenal ulcer/perforations*,
Slovenian: Krvavitev v prebavila in retroperitonealna krvavitev s smrtnim izidom, pankreatitis, razjede/perforacije na želodcu/dvanajstniku*, kolitis (vključno z ulceroznim in limfocitnim kolitisom), simptomi zgornjih prebavil*,
English: Do not take Clopidogrel/Acetylsalicylic acid Teva
Slovenian: Ne jemljite zdravila Klopidogrel/acetilsalicilna kislina Teva:
English: (psoriasis),
Slovenian: • driska,
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 75 mg of clopidogrel (as hydrogen sulphate) and 100 mg of acetylsalicylic acid (ASA).
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena filmsko obložena tableta vsebuje 75 mg klopidogrela (v obliki hidrogensulfata) in 100 mg acetilsalicilne kisline (ASA).
English: A crossover study in 40 healthy subjects, 10 each in the four CYP2C19 metaboliser groups (ultrarapid, extensive, intermediate and poor), evaluated pharmacokinetic and antiplatelet responses using 300 mg followed by 75 mg/day and 600 mg followed by 150 mg/day, each for a total of 5 days (steady state).
Slovenian: Študija je ocenjevala farmakokinetiko in antiagregacijski odziv po uporabi odmerka 300 mg in nato 75 mg/dan ter 600 mg in nato 150 mg/dan, vsakega skupaj 5 dni (stanje dinamičnega ravnovesja).