FrancophonIA/ELRC3.0 huggingface dataset:
English: A pharmacodynamic interaction between clopidogrel and acetylsalicylic acid is possible, leading to increased risk of bleeding.
Slovenian: Farmakodinamična interakcija med klopidogrelom in acetilsalicilno kislino je možna in lahko poveča tveganje za pojav krvavitev.
English: 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.
Slovenian: Acetilsalicilna kislina: 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 sproženo agregacijo trombocitov.
English: Clopidogrel significantly reduced the incidence of new ischaemic events (combined end point of myocardial infarction, ischaemic stroke and vascular death) when compared to ASA.
Slovenian: Klopidogrel je v primerjavi z acetilsalicilno kislino značilno zmanjšal incidenco novih ishemičnih dogodkov (sestavljen opazovani dogodek miokardni infarkt, ishemična kap in žilna smrt).
English: However, if you are in any doubt, bleeding becomes serious or you experience unexpected bleeding from unusual parts of your body you should contact your doctor straight away (see section 2 ‘Warnings and precautions').
Slovenian: Vendar pa se morate takoj posvetovati s svojim zdravnikom, če ste glede krvavitve v kakršnihkoli dvomih, če krvavitve postanejo resne ali se pojavijo krvavitve na neobičajnih mestih telesa (glejte poglavje 2 »Opozorila in previdnostni ukrepi«).
English: Then, the usual dose is one 75-mg tablet of Clopidogrel Teva Pharma B.V. per day
Slovenian: Nato je običajni odmerek ena 75-mg tableta zdravila Klopidogrel Teva Pharma B.V.
English: Risk Management Plan (RMP)
Slovenian: • Načrt za obvladovanje tveganja (RMP) Navedba smiselno ni potrebna.
English: This includes any possible side effects not listed in this leaflet.
Slovenian: Posvetujte se tudi, če opazite katere koli neželene učinke, ki niso navedni v tem navodilu.
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: Zlasti post-hoc analiza podatkov 2172 bolnikov (17 % celotne populacije CURE), ki so jim namestili žilno opornico (Stent-CURE), je ob klopidogrelu v primerjavi s placebom pokazala značilno 26,2 % zmanjšanje RT za sestavljen primarni opazovani dogodek (srčnožilna smrt, MI, možganska kap) in tudi značilno 23,9 % zmanjšanje RT za drug sestavljen primarni opazovani dogodek (srčnožilna smrt, MI, možganska kap ali neodzivna ishemija).
English: 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.
Slovenian: 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 (vključno z inzulinom), antiepileptičnimi sredstvi in antagonisti glikoproteina IIb/IIIa, brez dokazov o klinično pomembnih neželenih interakcijah.
English: For minor cuts and injuries (e.g. shaving cuts) you should not worry.
Slovenian: Pri manjših urezninah ali poškodbah (npr. če se urežete pri britju), to navadno ni zaskrbljujoče.
English: België/Belgique/Belgien Teva Pharma Belgium N.V./S.A.
Slovenian: België/Belgique/Belgien
English: 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).
Slovenian: Kot pri drugih antitrombotikih je potrebno klopidogrel uporabljati previdno pri bolnikih 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.
English: Clopidogrel should be given as a single daily dose of 75 mg.
Slovenian: • Odrasli in starostniki Klopidogrel je treba dajati kot enkratni dnevni odmerek 75 mg.
English: A serious condition called thrombotic thrombocytic purpura (rare disorder of the blood clotting system which causes multiple blood clots to form around the body).
Slovenian: • resno obolenje, ki se imenuje trombotična trombocitopenična purpura (redka motnja strjevanja krvi, ki povzroči pojav številnih krvnih strdkov po celem telesu).
English: Intracranial bleeding (some cases were reported with fatal outcome), headache, paraesthesia, dizziness
Slovenian: Bolezni živčevja intrakranialna krvavitev (opisani so primeri s smrtnim izidom), glavobol, parestezije, omotica motnje okušanja
English: Therefore, concomitant use should be undertaken with caution (see section 4.4).
Slovenian: Zato je pri sočasni uporabi potrebna previdnost (glejte poglavje 4.4).
English: The 2x2 factorial design COMMIT trial included 45,852 patients presenting within 24 hours of the onset of the symptoms of suspected MI with supporting ECG abnormalities (i.e. ST elevation, ST depression or left bundle-branch block).
Slovenian: V študijo COMMIT z 2x2 faktorsko raziskovalno zasnovo je bilo vključenih 45.852 bolnikov v 24 urah po nastopu simptomov, ki bi lahko kazali na miokardni infarkt in z neustreznimi vrednostmi EKG, ki so to potrjevale (elevacija ST spojnice, depresija ST spojnice ali levokračni blok).
English: Deutschland ratiopharm GmbH Tel: +49 731 402 02
Slovenian: Deutschland Teva GmbH Tel: +49 731 402 08
English: 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).
Slovenian: Možganska kap 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 tveganja 28,4 %, 95 % IZ: od 16,8 % do 38,3 %, p = 0,00001).
English: • 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')
Slovenian: • 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 poglavje 4 »Možni neželeni učinki«).
English: Within each system organ class, adverse drug reactions are presented in order of decreasing seriousness.
Slovenian: V razvrstitvah pogostnosti so neželeni učinki navedeni po organskih sistemih in po padajoči resnosti.
English: Therefore clopidogrel should be used with caution in these patients (see section 4.2).
Slovenian: Zato je potrebno pri teh bolnikih klopidogrel uporabljati previdno (glejte poglavje 4.2).
English: The concomitant administration of clopidogrel with oral anticoagulants is not recommended since it may increase the intensity of bleedings (see section 4.5).
Slovenian: Sočasno dajanje klopidogrela s peroralnimi antikoagulansi ni priporočljivo, ker lahko poveča jakost krvavitev (glejte poglavje 4.5).
English: • Fever, signs of infection (e.g. sore throat), pale skin or extreme tiredness.
Slovenian: • povišana telesna temperatura, znaki okužbe (npr. vnetje grla), bledost kože ali huda utrujenost.
English: Warnings and precautions Tell your doctor before you start to take this medicine if:
Slovenian: Opozorila in previdnostni ukrepi Pred uporabo tega zdravila se posvetujte z zdravnikom v naslednjih primerih:
English: This could indicate that you are suffering from a serious condition called thrombotic thrombocytic purpura (rare disorder of the blood clotting system which causes multiple blood clots to form around the body)
Slovenian: To lahko pomeni, da je pri vas prisotna trombotična trombocitopenična purpura (redka motnja strjevanja krvi, ki lahko povzroči pojav številnih krvnih strdkov po celem telesu).
English: Major bleeding was mostly of extracranial origin in both groups (5.3% in the clopidogrel + ASA group; 3.5% in the placebo +ASA group), mainly from the gastrointestinal tract (3.5% vs. 1.8%).
Slovenian: Hujše krvavitve so bile v obeh skupinah večinoma ekstrakranialne (5,3 % v skupini s klopidogrelom + acetilsalicilno kislino, 3,5 % v skupini s placebom + acetilsalicilno kislino), predvsem v prebavilih (3,5 % v prim.
English: The number of patients experiencing the primary endpoint [cardiovascular (CV) death, myocardial infarction (MI), or stroke] was 582 (9.3%) in the clopidogrel-treated group and 719 (11.4%) in the placebo-treated group, a 20% relative risk reduction (95% CI of 10%-28%; p=0.00009) for the clopidogrel-treated group (17% relative risk reduction when patients were treated conservatively, 29% when they underwent percutaneous transluminal coronary angioplasty (PTCA) with or without stent and 10% when they underwent coronary artery bypass graft (CABG)).
Slovenian: Delež bolnikov s primarnim opazovanim dogodkom [srčno-žilna (SŽ) smrt, miokardni infarkt (MI) ali kap] je bil 582 (9,3 %) v skupini, zdravljeni s klopidogrelom, in 719 (11,4 %) v skupini, ki je prejemala placebo, to je 20 % zmanjšanje relativnega tveganja (95 % IZ od 10 % - 28 %; p=0,00009) v skupini, zdravljeni s klopidogrelom (17 % zmanjšanje relativnega tveganja, če so bili bolniki zdravljeni konzervativno, 29 % kadar je bila izvedena perkutana transluminalna koronarna angioplastika (PTKA) z ali brez stenta in 10 %, če je bila izvedena premostitvena operacija koronarnih arterij (POKA)).
English: What you need to know before you take Clopidogrel Teva Pharma B.V.
Slovenian: Kaj morate vedeti preden boste vzeli zdravilo Klopidogrel Teva Pharma B.V.
English: If you suffer from hardening of the arteries (“atherosclerosis”) there is an increased risk of a blood clot forming in your blood vessels.
Slovenian: Če imate aterosklerozo (otrdele krvne žile), je pri vas prisotno povečano tveganje za nastanek krvnega strdka v krvnih žilah večje.
English: 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.
Slovenian: 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.
English: In patients suffering from acute coronary syndrome: - Non-ST segment elevation acute coronary syndrome (unstable angina or non-Qwave myocardial infarction): clopidogrel treatment should be initiated with a single 300-mg loading dose and then continued at 75 mg once a day (with acetylsalicylic acid (ASA) 75 mg-325 mg daily).
Slovenian: - Akutni koronarni sindrom brez elevacije ST spojnice (nestabilna angina ali miokardni infarkt brez Q zobca):zdravljenje moramo začeti z enkratnim udarnim odmerkom 300 mg klopidogrela in nadaljevati s 75 mg enkrat na dan (s 75 mg do 325 mg acetilsalicilne kisline (ASA) dnevno).
English: • Bruising, haematoma (unusual bleeding under the skin), nose bleeds, bleeding in the stomach or bowels, increased bleeding at the site of a puncture wound
Slovenian: • odrgnine, hematomi (neobičajne krvavitve pod kožo), krvavitve iz nosu, krvavitve iz želodca ali črevesja, povečane krvavitve na mestu vboda,
English: 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.
Slovenian: 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) in fibrinolitičnim sredstvom in po potrebi s heparinom.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 75 mg of clopidogrel (as hydrobromide).
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena filmsko obložena tableta vsebuje 75 mg klopidogrela (v obliki bromida).
English: Bullous dermatitis (toxic epidermal necrolysis, Stevens Johnson Syndrome, erythema multiforme), angioedema, drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms (DRESS), rash erythematous or exfoliative, urticaria, eczema, lichen planus
Slovenian: Hypersensitivity Syndrome), kožni izpuščaj z eozinofilijo in sistemskimi simptomi, kot posledica zdravljenja z zdravilom (sindrom DRESS, Drug Rash with Eosinophilia and Systemic Symptoms), izpuščaj, eritematozni izpuščaj, urtikarija, ekcem, lichen planus
English: 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.
Slovenian: Primarni opazovani dogodek je bil opažen pri 15,0 % bolnikov v skupini s klopidogrelom in 21,7 % bolnikov v skupini 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.
English: - Keep this leaflet.
Slovenian: Previdno odlepite zadnjo stran.
English: • 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).
Slovenian: • 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).
English: Please note that instructions on how to remove the tablet from the blister strip are given on the outer carton of the peelable blisters.
Slovenian: • Navodila za odstranjevanje tablet iz pretisnega omota se nahajajo na škatlici, v katerem so shranjeni pretisni omoti, ki se odlepijo.
English: 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.
Slovenian: Pri analizi po načelu začetnega namena zdravljenja so v skupini, ki je prejemala klopidogrel, opazili 939 dogodkov in v skupini, ki je prejemala acetilsalicilno kislino, 1.020 dogodkov (zmanjšanje relativnega tveganja (zmanjšanje RT) 8,7 %, [95 % IZ: 0,2 do 16,4]; p=0,045), kar ustreza preprečevanju pojava novega ishemičnega dogodka na vsakih 1.000 bolnikov, zdravljenih 2 leti, pri dodatnih 10 [IZ: 0 do 20] bolnikih.
English: - Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA) - ST segment elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy.
Slovenian: • odraslih bolnikih z akutnim koronarnim sindromom: akutni koronarni sindrom brez elevacije ST spojnice (nestabilna angina ali miokardni infarkt brez Q zobca), vključno z bolniki, katerim je bil vstavljen stent po perkutani koronarni intervenciji, v kombinaciji z acetilsalicilno kislino (ASA - acetylsalicylic acid).
English: Lactose monohydrate Hypromellose (E464) Titanium dioxide (E171) Macrogol 4000
Slovenian: Filmska obloga laktoza monohidrat hipromeloza (E464) titanov dioksid (E171) makrogol 4000 rdeči železov oksid (E172) rumeni železov oksid (E172)
English: Each film-coated tablet contains 75 mg of clopidogrel (as hydrobromide).
Slovenian: Ena filmsko obložena tableta vsebuje 75 mg klopidogrela (v obliki bromida).
English: Patients should be evaluated for history of hypersensitivity to thienopyridines (such as clopidogrel, ticlopidine, prasugrel) since cross-reactivity among thienopyridines has been reported (see section 4.8).
Slovenian: Pri bolnikih je treba preveriti anamnezo preobčutljivosti na druge tienopiridine (kot sta npr. tiklopidin in prasugrel), ker so poročali o navzkrižnih alergijah med tienopiridini (glejte poglavje 4.8).
English: 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.
Slovenian: 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).
English: 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.
Slovenian: Med skupinama ni bilo statistično značilne razlike v deležih krvavitev s smrtnim izidom (1,1 % klopidogrel + acetilsalicilna kislina, 0,7 % placebo + acetilsalicilna kislina) in hemoragičnih možganskih kapi (0,8 % v prim.
English: • Ticlopidine, other antiplatelet agent.
Slovenian: • tiklopidin, druga antiagregacijska zdravila.
English: No effect on hepatic metabolising enzymes was observed in humans receiving clopidogrel at the therapeutic dose.
Slovenian: Pri ljudeh, ki so prejemali terapevtski odmerek klopidogrela, niso opazili nobenega učinka na jetrne presnovne encime.
English: 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.
Slovenian: skupaj z acetilsalicilno kislino, če ne morete prejemati "peroralnih antikoagulantov", ali če nimate tveganja za večjo krvavitev.
English: If you become pregnant while taking Clopidogrel Teva Pharma B.V., consult your doctor immediately as it is recommended not to take clopidogrel while you are pregnant.
Slovenian: zanosite, se takoj posvetujte s svojim zdravnikom, saj jemanje klopidogrela med nosečnostjo ni priporočljivo.
English: At very high doses, a poor gastric tolerability (gastritis, gastric erosions and/or vomiting) of clopidogrel was also reported in rat and baboon.
Slovenian: Pri podganah in pavijanih so poročali tudi o slabem želodčnem prenašanju (gastritis, želodčne erozije in/ali bruhanje), pri uporabi zelo velikih odmerkov.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: jemljejo odrasali za preprečavanje nastanka krvnih strdkov (trombov) ter tako preprečuje pojav resnih dogodkov, kot je srčni napad in kap.
English: Push the tablet out
Slovenian: Potisnite tableto iz omota.
English: However, clopidogrel and ASA have been administered together for up to one year (see section
Slovenian: Vseeno so klopidogrel in acetilsalicilno kislino sočasno uporabljali do enega leta (glejte poglavje 5.1).
English: Although the administration of clopidogrel 75 mg/day did not modify the pharmacokinetics of S-warfarin or International Normalised Ratio (INR) in patients receiving long-term warfarin therapy, coadministration of clopidogrel with warfarin increases the risk of bleeding because of independent effects on hemostasis.
Slovenian: Uporaba 75 mg klopidogrela na dan ni spremenila farmakokinetike S-varfarina ali internacionalnega normaliziranega razmerja (INR) pri bolnikih, ki so dolgotrajno prejemali varfarin.
English: Clopidogrel Teva Pharma B.V. is supplied in peelable perforated blisters of aluminium/ aluminium containing 14x1, 28x1, 30x1, 50x1, 84x1, 90x1 or 100x1 tablet; perforated blisters of aluminium/ aluminium containing 14x1, 28x1, 30x1, 50x1, 84x1, 90x1 or 100x1 tablet or HDPE bottles with polypropylene closures or child resistant polypropylene closures and silica gel desiccant containing 30 or 100 tablets.
Slovenian: je na voljo v perforiranih pretisnih omotih iz aluminija, ki se odlepijo, in sicer po 14x1, 28x1, 30x1, 50x1, 84x1, 90x1 ali 100x1 tablet; ter perforiranih pretisnih omotih iz aluminija, in sicer po 14x1, 28x1, 30x1, 50x1, 84x1, 90x1 ali 100x1 tablet ali v HDPE stekleničkah z zaporkami iz polipropilena, varnimi pred otroci ter silikagel sušilnim sredstvom, ki vsebujejo 30 ali 100 tablet.
English: The number of patients who reached the primary endpoint (time to first occurrence of stroke, MI, non-CNS systemic embolism or vascular death) was 832 (22.1%) in the group treated with clopidogrel + ASA and 924 (24.4%) in the placebo + ASA group (relative risk reduction of 11.1%; 95% CI of 2.4% to 19.1%; p=0.013), primarily due to a large reduction in the incidence of strokes.
Slovenian: Primarni opazovani dogodek (čas do prvega pojava možganske kapi, MI, sistemske embolije (ne v osrednjem živčevju) ali žilne smrti) je doseglo v skupini s klopidogrelom + acetilsalicilno kislino 832 (22,1 %) bolnikov in v skupini s placebom + acetilsalicilno kislino 924 (24,4 %) bolnikov (relativno zmanjšanje tveganja 11,1 %, 95 % IZ: od 2,4 % do 19,1 %, p = 0,013), predvsem kot posledica velikega zmanjšanja incidence možganskih kapi.
English: Hepatic impairment
Slovenian: Ušesne bolezni vrtoglavica
English: 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.
Slovenian: in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Klopidogrel Teva Pharma B.V.
English: As a precautionary measure, breast-feeding should not be continued during treatment with Clopidogrel Teva Pharma B.V.
Slovenian: Iz previdnostnih razlogov naj se z dojenjem med zdravljenjem z zdravilom Klopidogrel Teva Pharma B.V.
English: Other medicines and Clopidogrel Teva Pharma B.V.
Slovenian: Druga zdravila in zdravilo Kopidogrel Teva Pharma B.V.
English: Clopidogrel should therefore be used with caution in this population (see section 4.2).
Slovenian: Zato je potrebno pri tej skupini bolnikov klopidogrel uporabljati previdno (glejte poglavje 4.2).