FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Slovenian: Primarni opazovani dogodki so bili navzočnost kompozita zaradi infarkta zamašene arterije na angiogramu pred odpustom ali smrt ali ponovni miokardni infarkt pred koronarno angiografijo.
English: The safety and efficacy of clopidogrel have been evaluated in 5 double-blind studies involving over 88,000 patients: the CAPRIE study, a comparison of clopidogrel to ASA, and the CURE, CLARITY, COMMIT and ACTIVE-A studies comparing clopidogrel to placebo, both medicinal products given in combination with ASA and other standard therapy.
Slovenian: Varnost in učinkovitost klopidogrela so ovrednotili v 5 dvojno slepih študijah, v katere je bilo vključenih več kot 88.000 bolnikov: študija CAPRIE je obsegala primerjavo klopidogrela in acetilsalicilne kisline, v študijah CURE, CLARITY, COMMIT in ACTIVE-A, pa so primerjali klopidogrel s placebom; oboje pa so bolniki dobivali v kombinaciji z acetilsalicilno kislino in drugim standardnim zdravljenjem.
English: This was consistent across subgroups of patients defined by baseline characteristics, and type of fibrinolytic or heparin therapy.
Slovenian: To je veljalo za vse podskupine bolnikov, opredeljene z določenimi izhodiščnimi značilnostmi in tipom fibrinolitičnega ali heparinskega zdravljenja.
English: • 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')
Slovenian: • znaki jetrnih težav, kot je porumenelost kože in očesnih beločnic (zlatenica), ki so lahko ali pa ne povezani s krvavitvijo, ki se pojavi pod kožo kot drobne rdeče pike, in/ali zmedenostjo (glejte poglavje 2 »Opozorila in previdnostni ukrepi«).
English: The efficacy of clopidogrel was observed independently of the dose of ASA (75-325 mg once daily).
Slovenian: Učinkovitost klopidogrela so opazili neodvisno od odmerka acetilsalicilnske kisline (75-325 mg enkrat na dan).
English: 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
Slovenian: • 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,
English: The ACTIVE-W study demonstrated that anticoagulant treatment with vitamin K antagonists was more effective than with clopidogrel and ASA.
Slovenian: Študija ACTIVE-W je pokazala, da je bilo zdravljenje z antagonisti vitamina K učinkovitejše kot zdravljenje s klopidogrelom in acetilsalicilno kislino.
English: • 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.
Slovenian: • 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.
English: This benefit was consistent across all prespecified subgroups including patients' age and gender, infarct location, and type of fibrinolytic or heparin used.
Slovenian: 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.
English: Finnland ratiopharm Oy Sími: +358 20 180 5900
Slovenian: Ísland ratiopharm Oy Sími: +358 20 180 5900
English: Patients should be told that it might take longer than usual to stop bleeding when they take clopidogrel (alone or in combination with ASA), and that they should report any unusual bleeding (site or duration) to their physician.
Slovenian: Bolnike je treba obvestiti, da je ob jemanju klopidogrela (samega ali v kombinaciji z acetilsalicilno kislino) čas, potreben za zaustavitev krvavitve, lahko daljši kot običajno, in da morajo svojemu zdravniku poročati o kakršnikoli neobičajni krvavitvi (mesto ali trajanje).
English: You should have been told that ‘oral anticoagulants' are more effective than acetylsalicylic acid or the combined use of Clopidogrel Teva Pharma B.V. and acetylsalicylic acid for this condition.
Slovenian: Povedati so vam morali, da so "peroralni antikoagulanti" pri tej motnji učinkovitejši kot acetilsalicilna kislina ali kombinirana uporaba zdravila Klopidogrel Teva Pharma B.V.
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 število velikih krvavitev s klopidogrelom 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.
English: • Adult patients suffering from acute coronary syndrome:
Slovenian: Pri bolnikih z akutnim koronarnim sindromom:
English: Patients randomized in the ACTIVE program were those presenting with documented AF, i.e., either permanent AF or at least 2 episodes of intermittent AF in the past 6 months, and had at least one of the following risk factors: age ≥75 years or age 55 to 74 years and either diabetes mellitus requiring drug therapy, or documented previous MI or documented coronary artery disease; treated for systemic hypertension; prior stroke, transient ischaemic attack (TIA), or non-CNS systemic embolus; left ventricular dysfunction with left ventricular ejection fraction <45%; or documented peripheral vascular disease.
Slovenian: V program ACTIVE so bili randomizirani bolniki, ki so imeli dokumentirano AF, tj. bodisi permanentno AF ali vsaj 2 epizodi intermitentne AF v zadnjih 6 mesecih ter vsaj enega od naslednjih dejavnikov tveganja: starost ≥ 75 let ali starost od 55 do 74 let in bodisi sladkorno bolezen, ki je zahtevala zdravljenje z zdravili, ali dokumentiran predhodni MI ali dokumentirano koronarno bolezen; zdravljenje zaradi sistemske hipertenzije; predhodno možgansko kap, tranzitorno ishemično atako (TIA) ali sistemski embolus (ne v osrednjem živčevju); disfunkcijo levega prekata z iztisnim deležem levega prekata (LVEF) < 45 %; ali dokumentirano bolezen perifernih žil.
English: • Glycoprotein IIb/IIIa inhibitors (medicines used to stop blood clotting).
Slovenian: • zaviralce glikoproteina IIb/IIIb (zdravila, ki se uporabljajo za preprečevanje strjevanja krvi).
English: 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.
Slovenian: Heparin so uporabljali pri več kot 90 % bolnikov in sočasna uporaba heparinske terapije ni pomembno vplivala na relativni delež krvavitev med klopidogrelom in placebom.
English: eptifibatide or tirofiban.
Slovenian: Na primer abciksimab, eptifibatid ali tirofiban.
English: An overdose is likely to cause an increased risk of bleeding.
Slovenian: Prevelik odmerek bo najverjetneje povečal tveganje za pojav krvavitev.
English: This medicinal product contains hydrogenated castor oil which may cause stomach upset and diarrhoea.
Slovenian: To zdravilo vsebuje hidrogenirano ricinusovo olje, ki lahko povzroči želodčne težave in drisko.
English: • Paediatric population Clopidogrel should not be used in children because of efficacy concerns (see section 5.1)
Slovenian: Klopidogrel naj se pri otrocih ne uporablja iz razlogov, ki zadevajo učinkovitost (glejte poglavje 5.1).
English: For minor cuts and injuries, e.g. cutting yourself shaving, this is usually of no concern.
Slovenian: Pri manjših urezninah ali poškodbah, npr. če se urežete ali pri britju, navadno ni razloga za skrb.
English: The pharmacokinetics of digoxin or theophylline were not modified by the co-administration of clopidogrel.
Slovenian: Farmakokinetika digoksina ali teofilina ob sočasni uporabi klopidogrela ni bila spremenjena.
English: Overall, clopidogrel 75 mg/day was comparable to ASA 325 mg/day in CAPRIE regardless of age, gender and race.
Slovenian: 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.
English: PHARMACEUTICAL FORM AND CONTENTS
Slovenian: FARMACEVTSKA OBLIKA IN VSEBIN
English: Severe reduction in certain blood cells leading to increased risk of bleeding or bruising, increased risk of infections, pale skin and extreme tiredness
Slovenian: • veliko zmanjšanje števila določenih krvnih celic, kar vodi do povečanega tveganja za pojav krvavitev ali odrgnin, okužb, bledosti kože in hudo utrujenost,
English: However, if you are concerned by your bleeding, you should contact your doctor straightaway (see section 4 ‘Possible Side Effects')
Slovenian: Če pa vas glede krvavitve skrbi, se nemudoma posvetujte z zdravnikom (glejte poglavje 4 »Možni neželeni učinki«).
English: 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).
Slovenian: 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).
English: 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).
Slovenian: 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).
English: • If you have severe liver disease.
Slovenian: • če imate hudo jetrno obolenje.
English: • Swelling in the mouth or skin disorders such as rashes, itching and blistering of the skin.
Slovenian: • otekanje ust ali bolezni kože, kot so izpuščaj, srbenje in mehurji na koži.
English: 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.
Slovenian: 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.
English: Clopidogrel has been tested in a range of in vitro and in vivo genotoxicity studies, and showed no genotoxic activity.
Slovenian: Klopidogrel so preučevali v številnih študijah genotoksičnosti in vitro in in vivo, ki niso pokazale nobenega genotoksičnega učinka.
English: If you have experienced severe chest pain (unstable angina or heart attack), your doctor may give you 300 mg of Clopidogrel Teva Pharma B.V. once at the start of treatment.
Slovenian: Če ste imeli hudo bolečino v prsih (nestabilna angina pektoris ali srčna kap), vam lahko zdravnik na začetku zdravljenja da enkrat 300 mg zdravila Klopidogrel Teva Pharma B.V.
English: • If you think any of these apply to you, or if you are in any doubt at all, consult your doctor before taking Clopidogrel Teva Pharma B.V.
Slovenian: Če menite, da se karkoli od navedenega nanaša na vas ali če ste kakorkoli v dvomih, se posvetujte s svojim zdravnikom, preden boste vzeli zdravilo Klopidogrel Teva Pharma B.V..
English: 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.
Slovenian: 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.
English: • You have liver or kidney disease.
Slovenian: • Če imate ledvično ali jetrno bolezen.
English: These occurred at doses representing at least 25 times the exposure seen in humans receiving the clinical dose of 75 mg/day and were a consequence of an effect on hepatic metabolising enzymes.
Slovenian: Pojavile so se pri odmerkih, ki so bili vsaj 25-krat večji od odmerkov pri človeku, pri prejemanju kliničnega odmerka 75 mg na dan, in so bile posledica učinka na jetrne presnovne encime.
English: The use of clopidogrel in CURE was associated with a decrease in the need of thrombolytic therapy (RRR=43.3%; CI: 24.3%, 57.5%) and GPIIb/IIIa inhibitors (RRR=18.2%; CI: 6.5%, 28.3%).
Slovenian: Uporaba klopidogrela v študiji CURE je bila povezana z zmanjšano potrebo po zdravljenju s trombolitiki (zmanjšanje RT= 43,3 %; IZ: 24,3 %, 57,5 %) in inhibitorji glikoproteinov IIb/IIIa (zmanjšanje RT =18,2 %; IZ: 6,5 %, 28,3 %).
English: Discard any remaining tablets 30 days after first opening of the bottle.
Slovenian: Preostale tablete zavrzite 30 dni po odprtju stekleničke.
English: • Hypersensitivity to the active substance or to any of the excipients listed in section 2 or section
Slovenian: • Preobčutljivost za zdravilno učinkovino ali katerokoli pomožno snov, nevedno v poglavju 2 ali v poglavju 6.1.
English: Discard any remaining tablets 100 days after first opening of the bottle.
Slovenian: Preostale tablete zavrzite 100 dni po odprtju stekleničke.
English: Glomerulonephritis, blood creatinine increased
Slovenian: Bolezni sečil hematurija glomerulonefritis, zvišanje ravni kreatinina v krvi
English: In patients who were enrolled in the trial on the sole basis of a recent myocardial infarction, clopidogrel was numerically inferior, but not statistically different from ASA (RRR=-4.0%; CI: -22.5 to 11.7 [p=0.639]).
Slovenian: Pri bolnikih, ki so bili vključeni v preskušanje samo na podlagi nedavnega miokardnega infarkta, je bil rezultat za klopidogrel numerično sicer slabši, vendar se statistično ni razlikoval od acetilsalicilne kisline (zmanjšanje RT=4,0 %; IZ: -22,5 do 11,7 [p=0,639]).
English: Glycoprotein IIb/IIIa inhibitors: clopidogrel should be used with caution in patients who receive concomitant glycoprotein IIb/IIIa inhibitors (see section 4.4).
Slovenian: Zaviralci glikoproteina IIb/IIIa: klopidogrel je potrebno uporabljati previdno pri bolnikih, ki se sočasno zdravijo z zaviralci glikoproteina IIb/IIIa (glejte poglavje 4.4).
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Slovenian: vsebuje laktozo Če vam je zdravnik povedal, da imate intoleranco za nekatere sladkorje, se pred uporabo tega zdravila posvetujte s svojim zdravnikom.
English: • Oral anticoagulants (oral medicines used to stop blood clotting) such as warfarin.
Slovenian: • peroralne koagulanse (zdravila, ki se uporabljajo za preprečevanje strjevanja krvi), kot je varfarin.
English: 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).
Slovenian: 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).
English: A pharmacodynamic interaction between clopidogrel and heparin is possible, leading to increased risk of bleeding.
Slovenian: Farmakodinamična interakcija med klopidogrelom in heparinom je možna in vodi do povečanega tveganja za pojav krvavitev.
English: In CAPRIE, in patients treated with either clopidogrel or ASA, the overall incidence of any bleeding was 9.3%.
Slovenian: V študiji CAPRIE je bila pri bolnikih, zdravljenih ali s klopidogrelom ali acetilsalicilno kislino, celokupna incidenca kakršnihkoli krvavitev 9,3 %.
English: • Renal impairment Therapeutic experience is limited in patients with renal impairment (see section 4.4).
Slovenian: • Okvarjeno delovanje ledvic Terapevtske izkušnje pri bolnikih z okvaro ledvic so omejene (glejte poglavje 4.4).
English: • Fluconazole, voriconazole, ciprofloxacin, or chloramphenicol, medicines to treat bacterial and fungal infections.
Slovenian: • flukonazol, vorikonazol, ciprofloksacin ali klorampfenikol, zdravila za zdravljenje bakterijskih in glivičnih okužb,
English: The incidence of clinically significant bleeding was similar to that observed when thrombolytic agents and heparin are co-administered with ASA (see section 4.8).
Slovenian: Incidenca klinično pomembnih krvavitev je bila podobna tisti, ki so jo opazili pri uporabi trombolitikov in heparina sočasno z acetilsalicilno kislino (glejte poglavje 4.8).
English: • You are at increased risk of bleeding.
Slovenian: • Če pri vas obstaja povečano tveganje za pojav krvavitev.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJ ZA PROMET
English: You should also be given acetylsalicylic acid (a substance used to relieve pain and lower fever as well as to prevent blood clotting) by your doctor.
Slovenian: Zdravnik vam bo moral predpisati tudi acetilsalicilno kislino (učinkovina proti bolečinam in za zniževanje zvišane telesne tempreature, kakor tudi za preprečevanje strjevanja krvi).
English: • Non-steroidal anti-inflammatory medicines (used to treat painful inflammatory conditions of the joints or muscles).
Slovenian: • nesteroidna protivnetna zdravila (za lajšanje bolečin zaradi vnetih sklepov ali mišic).
English: Appropriate therapy should be considered if bleedings are observed.
Slovenian: V primeru opaženih krvavitev je potrebno razmisliti o uvedbi ustreznega zdravljenja.
English: Bleeding may occur as bleeding in the stomach or bowels, bruising, haematoma (unusual bleeding or bruising under the skin), nose bleeds or blood in the urine.
Slovenian: Krvavitev se lahko pojavi kot krvavitev iz želodca ali črevesja, kot odrgnine, hematomi (neobičajne krvavitve ali odrgnine pod kožo), krvavitev iz nosu, kri v urinu.
English: Co-administration of heparin had no effect on the inhibition of platelet aggregation induced by clopidogrel.
Slovenian: Sočasna uporaba heparina ni imela nobenega vpliva na zaviranje agregacije trombocitov, sproženo s klopidogrelom.
English: LIST OF EXCIPIENTS It also contains lactose and hydrogenated castor oil.
Slovenian: Zdravilo vsebuje tudi laktozo in hidrogenirano ricinusovo olje.
English: 14x1 film-coated tablet 28x1 film-coated tablet 30x1 film-coated tablet 50x1 film-coated tablet 84x1 film-coated tablet 90x1 film-coated tablet 100x1 film-coated tablet
Slovenian: 14x1 filmsko obložena tableta 28x1 filmsko obložena tableta 30x1 filmsko obložena tableta 50x1 filmsko obložena tableta 84x1 filmsko obložena tableta 90x1 filmsko obložena tableta 100x1 filmsko obložena tableta
English: • Omeprazole, esomeprazole or cimetidine, medicines to treat upset stomach.
Slovenian: • omeprazol, esomeprazol ali cimetidin, zdravila za zdravljenje težav z želodcem,
English: The benefits observed with clopidogrel were independent of other acute and long-term cardiovascular therapies (such as heparin/LMWH, GPIIb/IIIa antagonists, lipid lowering medicinal products, beta blockers, and ACE-inhibitors).
Slovenian: Koristi, ki so jih opazili pri uporabi klopidogrela, so bile neodvisne od drugih akutnih in dolgotrajnih srčnožilnih terapij (kot je heparin /nizkomolekularni heparin, antagonisti glikoproteina IIb/IIIa, učinkovine za zniževanje lipidov, blokatorji beta in zaviralci angiotenzinske konvertaze).
English: It is characterised by thrombocytopenia and microangiopathic haemolytic anaemia associated with either neurological findings, renal dysfunction or fever.
Slovenian: Zanjo je značilna trombocitopenija in mikroangiopatična hemolitična anemija, povezana ali z nevrološkimi spremembami, motnjo v delovanju ledvic ali povišano telesno temperaturo.
English: In ACTIVE-A, the rate of major bleeding was greater in the clopidogrel + ASA group than in the placebo + ASA group (6.7% versus 4.3%).
Slovenian: V ACTIVE-A je bil delež hujših krvavitev v skupini s klopidogrelom + acetilsalicilno kislino večji kot v skupini s placebom + acetilsalicilno kislino (6,7 % v primerjavi s 4,3 %).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON of bottles (30 or 100 film-coated tablets)
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLICA za stekleničke (30 ali 100 filmsko obloženih tablet)
English: Patients were randomised to clopidogrel 75 mg/day or ASA 325 mg/day, and were followed for 1 to 3 years.
Slovenian: Bolniki so bili naključno razdeljeni v skupine, ki so prejemale klopidogrel 75 mg/dan ali acetilsalicilno kislino 325 mg/dan, spremljali so jih od 1 do 3 let.
English: In a subgroup analysis by qualifying condition (myocardial infarction, ischaemic stroke, and PAD) the benefit appeared to be strongest (achieving statistical significance at p=0.003) in patients enrolled due to PAD (especially those who also had a history of myocardial infarction) (RRR=23.7%; CI: 8.9 to 36.2) and weaker (not significantly different from ASA) in stroke patients (RRR=7.3%; CI: -5.7 to 18.7 [p=0.258]).
Slovenian: Pri analizi podskupin glede na vključitveni pogoj (miokardni infarkt, ishemična kap in periferna arterijska bolezen (PAD)) je videti najmočnejšo korist (doseganje statistične značilnosti pri p=0,003) pri bolnikih, vključenih zaradi PAD (zlasti pri tistih, ki so doživeli tudi miokardni infarkt) (zmanjšanje RT=23,7 %; IZ: 8,9 do 36,2), in šibkejšo (ni bila značilno različna od acetilsalicilne kisline) pri bolnikih s kapjo (zmanjšanje RT=7,3 %; IZ: -5,7 do 18,7 [p=0,258]).
English: In patients who remained on therapy within five days of bypass graft surgery, the event rate was 9.6% for clopidogrel plus ASA, and 6.3% for placebo plus ASA.
Slovenian: Pri bolnikih, ki so ostali na zdravljenju do pet dni pred koronarno premostitveno operacijo, je bil delež dogodkov 9,6 % za klopidogrel v kombinaciji z acetilsalicilno kislino in 6,3 % za placebo v kombinaciji z acetilsalicilno kislino.
English: Light pink to pink, capsule-shaped film-coated tablets debossed with “C75” on one side and plain on the other side.
Slovenian: Svetlo roza do roza filmsko obložene tablete v obliki kapsul, ki imajo na eni strani gladko površino, na drugi strani pa vtisnjeno oznako »C75«.
English: Consequently, NSAIDs including Cox-2 inhibitors and clopidogrel should be co-administered with caution (see section 4.4).
Slovenian: Zaradi tega je potrebno nesteroidna protivnetna zdravila, vključno s COX-2 inhibitorji, in klopidogrel sočasno uporabljati previdno (glejte poglavje 4.4).
English: The incidence of severe cases was similar for clopidogrel and ASA.
Slovenian: Incidenca hujših primerov je bila podobna za klopidogrel in za acetilsalicilno kislino.
English: Lactose monohydrate Cellulose, microcrystalline Hydroxypropylcellulose (E463) Crospovidone (type A) Hydrogenated castor oil Sodium laurilsulfate
Slovenian: Jedro tablete laktoza monohidrat mikrokristalna celuloza hidroksipropil celuloza (E463) krospovidon (tip A) hidrogenirano ricinusovo olje natrijev lavrilsulfat
English: • If you cut or injure yourself, it may take longer than usual for bleeding to stop.
Slovenian: • če se urežete ali poškodujete, se lahko krvavitev ustavi počasneje kot običajno.
English: In a small number of cases, bleeding in the eye, inside the head, the abdomen, the lung and the joints have also been reported.
Slovenian: V majhnem številu primerov so poročali tudi o očesnih krvavitvah, krvavitvah v glavi, pljučih ali sklepih.
English: Oral anticoagulants: the concomitant administration of clopidogrel with oral anticoagulants is not recommended since it may increase the intensity of bleedings (see section 4.4).
Slovenian: Peroralni antikoagulanti: sočasna uporaba klopidogrela in peroralnih antikoagulansov ni priporočljiva, ker lahko poveča intenzivnost krvavitev (glejte poglavje 4.4).