FrancophonIA/ELRC3.0 huggingface dataset:
English: The usual dose is one 75 mg tablet of Clopidogrel Qualimed per day to be taken orally with or without food, and at the same time each day.
Slovenian: Običajni odmerek je ena 75 mg tableta zdravila Klopidogrel Qualimed na dan, ki jo lahko vzamete s hrano ali brez nje; odmerek morate jemati vsak dan ob istem času.
English: Clopidogrel prolongs bleeding time and should be used with caution in patients who have lesions with a propensity to bleed (particularly gastrointestinal and intraocular).
Slovenian: Klopidogrel podaljša čas krvavitve, zato ga previdno dajemo bolnikom z lezijami, ki so nagnjene h krvavitvam (zlasti gastrointestinalnim in intraokularnim).
English: An occasional use of acetylsalicylic acid (no more than 1000 mg in any 24 hour period), a substance present in many medicines used to relieve pain and lower fever, should generally not cause a problem, but prolonged use in other circumstances should be discussed with your doctor.
Slovenian: Občasno jemanje acetilsalicilne kisline, učinkovine, ki je v številnih zdravilih za lajšanje bolečine in zniževanje zvišane telesne temperature (ne več kot 1000 mg v kateremkoli 24-urnem obdobju), ne bi smelo povzročati težav, o daljšem jemanju v drugih okoliščinah pa se morate posvetovati s svojim zdravnikom.
English: Pink, round and slightly convex film-coated tablets.
Slovenian: Rožnate, okrogle in rahlo izbočene filmsko obložene tablete.
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), ishemično kapjo (med 7 dni in 6 meseci) ali razvito periferno arterijsko boleznijo (PAD).
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 pa so, da klopidogrel ne vpliva na plodnost podganjih samcev in samic in da ni teratogen niti za podgane ali kunce.
English: Data from the CAPRIE study indicate that phenytoin and tolbutamide which are metabolised by CYP2C9 can be safely co-administered with clopidogrel.
Slovenian: Podatki študije CAPRIE kažejo, da je sočasno jemanje fenitoina in tolbutamid, ki se presnavljata s CYP2C9, sočasno s klopidogrelom varno uporabljata.
English: After single and repeated oral doses of 75 mg per day, clopidogrel is rapidly absorbed.
Slovenian: Po enkratnem in večkratnih peroralnih odmerkih 75 mg na dan se klopidogrel hitro absorbira.
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 stevilo velikih krvavitev s klopidogrelom in ASA ni bilo prekoračeno v sedmih dneh po koronarni premostitveni operaciji pri bolnikih, ki so zdravljenje prekinili več kot pet dni pred kirurškim posegom.
English: The other ingredients are:
Slovenian: Navodilo vsebuje:
English: In addition, clinical tolerance was good in
Slovenian: Dodatno je bilo klinično prenašanje dobro pri vseh bolnikih.
English: If any of the situations mentioned below apply to you, you should tell your doctor before taking Clopidogrel Qualimed:
Slovenian: Če katerokoli od spodaj navedenih stanj velja za vas, morate o tem obvestiti svojega zdravnika, preden boste vzeli zdravilo Klopidogrel Qualimed:
English: • if you have a medical condition that is currently causing bleeding such as a stomach ulcer or
Slovenian: • če imate zdravstveno stanje, ki trenutno povzroča krvavitev, npr. rana na želodcu ali možganska krvavitev;
English: The binding is non-saturable in vitro over a wide concentration
Slovenian: Pri vezavi in vitro ni nasičenja v širokem koncentracijskem razponu.
English: Each film-coated tablet contains 13 mg hydrogenated castor oil.
Slovenian: Ena filmsko obložena tableta vsebuje 13 mg hidrogeniranega ricinusovega olja.
English: In CHARISMA and one cohort study (Simon), an increased event rate was observed only in poor metabolisers when compared to extensive metabolisers.
Slovenian: V študiji CHARISMA in eni kohortni študiji (Simon) so večji delež dogodkov ugotovili samo pri slabih metabolizatorjih v primerjavi z dobrimi.
English: Specific pharmacokinetic studies performed with radiolabelled clopidogrel have shown that the parent compound or its metabolites are excreted in the milk.
Slovenian: Specifične farmakokinetične študije, izvedene z radioaktivno označenim klopidogrelom, so pokazale, da se izhodna spojina ali njeni presnovki izločajo v mleko.
English: Due to the irreversible binding, platelets exposed are affected for the remainder of their lifespan (approximately 7-10 days) and recovery of normal platelet function occurs at a rate consistent with platelet turnover.
Slovenian: Zaradi ireverzibilne vezave se učinek na izpostavljene trombocite ohrani vso njihovo preostalo življenjsko dobo (približno 7-10 dni) in normalno delovanje trombocitov se obnovi s hitrostjo, ki je v skladu s premeno trombocitov.
English: In addition, IPA was 32% (24 hours) and 61% (Day 5), which were greater than in the poor metabolisers receiving the 300 mg/75 mg regimen, and were similar to the other CYP2C19 metaboliser groups receiving the 300 mg/75 mg regimen.
Slovenian: Poleg tega je bilo IPA 32 % (24 ur) in 61 % (5. dan), kar je več kot pri slabih metabolizatorjih, ki so prejemali shemo 300 mg/75 mg, in podobno kot pri drugih metabolizatorskih skupinah s CYP2C19, ki so prejemale shemo 300 mg/75 mg.
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 jemale 75 mg klopidogrela na dan ali 325 mg ASA na dan, spremljali so jih od 1 leto do 3 leta.
English: The CYP2C19*2 and CYP2C19*3 alleles account for the majority of reduced function alleles in Caucasian (85%) and Asian (99%) poor metabolisers.
Slovenian: Na račun alelov CYP2C19*2 in CYP2C19*3 gre večina alelov z zmanjšanim delovanjem pri Kavkazijcih(85%) in pri Azijcih (99 %), ki so slabi metabolizatorji.
English: Pharmacotherapeutic group: platelet aggregation inhibitors excl. heparin, ATC code: B01AC-04.
Slovenian: Farmakoterapevtska skupina: zaviralci agregacije trombocitov brez heparina, oznaka ATC: B01AC
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 se zdravili do pet dni pred koronarno premostitveno operacijo, je bil delež dogodkov 9,6 % za klopidogrel in ASA in 6,3 % za placebo in ASA.
English: Because the active metabolite is formed by CYP450 enzymes, some of which are polymorphic or subject to inhibition by medicinal products, not all patients will have adequate platelet inhibition.
Slovenian: Ker aktivni presnovek nastane z delovanjem encimov CYP450, od katerih so nekateri polimorfni ali podvrženi zavrtju z drugimi zdravili, se ustrezno zavrtje trombocitov ne pojavi pri vseh bolnikih.
English: Thrombotic Thrombocytopenic Purpura (TTP) has been reported very rarely following the use of clopidogrel, sometimes after a short exposure.
Slovenian: O trombotični trombocitopenični purpuri (TTP) pri bolnikih, ki so jemali klopidogrel, so poročali zelo redko, včasih po kratkotrajnem jemanju.
English: • Hypersensitivity to the active substance or to any of the excipients.
Slovenian: • Preobčutljivost za zdravilno učinkovino ali katerokoli pomožno snov.
English: Animal studies have shown excretion of clopidogrel in breast milk.
Slovenian: Študije na živalih so pokazale, da se klopidogrel izloča v materinem mleku.
English: • You should also tell your doctor immediately if you develop a medical condition (also known as Thrombotic Thrombocytopenic Purpura or TTP) that includes fever and bruising under the skin that may appear as red pinpoint dots, with or without unexplained extreme tiredness, confusion, yellowing of the skin or eyes (jaundice) (see section 4 ‘Possible side effects').
Slovenian: • morate takoj povedati zdravniku, če razvijete bolezensko stanje (znano tudi kot trombotična trombocitopenična purpura ali TTP) z zvišano telesno temperaturo in modricami pod kožo, ki se lahko pojavijo kot drobne rdeče pike, z ali brez nerazložljive hude utrujenosti, zmedenosti, porumenele kože ali oči (zlatenica) (glejte poglavje 4 »MOŽNI NEŽELENI UČINKI«).
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 sočasnem jemanju trombolitikov in heparina ter ASA (glejte poglavje 4.8).
English: For the 7, 14, 28, 56, 84 tablets (calendar blister) pack sizes, you can check the day on which you last took a tablet of Clopidogrel Qualimed by referring to the calendar printed on the blister.
Slovenian: Pri velikosti pakiranja po 7, 14, 28, 56 ali 84 tablet (v koledarskem pretisnem omotu) lahko po koledarju, ki je natisnjen na pretisnem omotu, preverite, na kateri dan v tednu ste nazadnje vzeli tableto zdravila Klopidogrel Qualimed.
English: 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.
Slovenian: Najpogosteje opisani neželeni učinek tako v skupini s klopidogrelom kot v skupin s placebom je bila krvavitev, vendar se pojavljanje krvavitev med skupinama ni značilno razlikovalo.
English: 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.
Slovenian: Eliminacija Po peroralnem odmerku s 14C-označenega klopidogrela pri človeku, se ga je približno 50 % izločilo z urinom in približno 46 % z blatom v 120 urnem intervalu po odmerjanju.
English: Mylan Kft Tel: 36 1 8026993
Slovenian: Hungary Mylan Kft Tel: 36 1 8026993
English: The CYP2C19*1 allele corresponds to fully functional metabolism while the CYP2C19*2 and CYP2C19*3 alleles are nonfunctional.
Slovenian: Alel CYP2C19*1 ustreza polno funkcionalni presnovi, medtem ko alela CYP2C19*2 in CYP2C19*3 nista funkcionalna.
English: The incidence of major bleeding was similar between groups.
Slovenian: Incidenca večjih krvavitev je bila v obeh skupinah podobna.
English: Bleeding may occur as bleeding in the stomach or bowels, bruising, haematoma (unusual bleeding or bruising under the skin), nose bleed, blood in the urine.
Slovenian: Krvavitve se lahko pojavijo kot krvavitev iz želodca ali črevesja, modrice, hematomi (neobičajne krvavitve ali modrice pod kožo), krvavitev iz nosu, kri v seču.
English: The active metabolite of clopidogrel selectively inhibits the binding of adenosine diphosphate (ADP) to its platelet P2Y12 receptor and the subsequent ADP-mediated activation of the glycoprotein GPIIb/IIIa complex, thereby inhibiting platelet aggregation.
Slovenian: Aktivni presnovek klopidogrela selektivno zavira vezavo adenozin-difosfata (ADP) na njegov trombocitni receptor P2Y12 in nadaljnjo aktivacijo glikoproteinskega kompleksa GP IIb/IIIa z ADP, s čimer zavre agregacijo trombocitov.
English: During non clinical studies in rat and baboon, the most frequently observed effects were liver changes.
Slovenian: V predkliničnih študijah na podganah in pavijanih so bile najpogosteje opaženi učinek jetrne spremembe.
English: In COMMIT, the overall rate of noncerebral major bleeding or cerebral bleeding was low and similar
Slovenian: V študiji COMMIT je bil skupni delež večjih necerebralnih krvavitev ali cerebralne krvavitve majhen in podoben v obeh skupinah.
English: KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany For any information about this medicine, please contact the local representative of the Marketing
Slovenian: KRKA, d. d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenija TAD Pharma GmbH, Heinz-Lohmann-Strasse 5, 27472 Cuxhaven, Nemčija
English: There is no evidence that other medicinal products that reduce stomach acid such as H2 blockers (except cimetidine which is a CYP2C19 inhibitor) or antacids interfere with antiplatelet activity of
Slovenian: Ni dokazov, da druga zdravila za zmanjševanje želodčne kisline, npr. antagonisti histaminskih receptorjev H2 (razen cimetidina, ki je CYP2C19 inhibitor) ali antacidi, ovirajo antitrombocitno delovanje klopidogrela.
English: In the myocardial infarction subgroup, most of the patients received ASA for the first few days following the acute myocardial infarction.
Slovenian: V podskupini z MI je večina bolnikov jemala ASA prvih nekaj dni po akutnem MI.
English: Adverse reactions that occurred either during clinical studies or that were spontaneously reported are presented in the table below.
Slovenian: Neželeni učinki, zabeleženi v kliničnih študijah ali poročani spontano, so našteti v spodnji tabeli.
English: Thrombotic Thrombocytopenic Purpura (TTP)
Slovenian: Trombotična trombocitopenična purpura (TTP)
English: In view of the lack of data, clopidogrel cannot be recommended during the first 7 days after acute
Slovenian: Nedavna ishemična kap Zaradi pomanjkanja podatkov se klopidogrel ne priporoča prvih sedem dni po akutni ishemični kapi.
English: If you become pregnant while taking Clopidogrel Qualimed, consult your doctor immediately as it is recommended not to take clopidogrel while you are pregnant.
Slovenian: Če med zdravljenjem z zdravilom Klopidogrel Qualimed zanosite, se takoj posvetujte s svojim zdravnikom, saj jemanje klopidogrela med nosečnostjo ni priporočljivo.
English: Appropriate therapy should be considered if bleedings are observed.
Slovenian: Pri krvavitvi je treba zagotoviti ustrezno zdravljenje.
English: 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.
Slovenian: 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. dan) v primerjavi z 39 % (24 ur) in 58 % (5. dni) pri dobrih metabolizatorjih ter 37 % (24 ur) in 60 % (5. dan) pri srednjih metabolizatorjih.
English: Overall, clopidogrel 75 mg/day was comparable to ASA 325 mg/day in CAPRIE regardless of age, gender and race.
Slovenian: V študiji CAPRIE je bil dnevni odmerek po 75 mg klopidogrela primerljiv z dnevnim odmerkom po 325 mg ASA, ne glede na starost, spol ali raso.
English: If you are pregnant or suspect that you are pregnant, you should tell your doctor or your pharmacist before taking Clopidogrel Qualimed.
Slovenian: Če ste noseči ali mislite, da ste noseči, morate o tem obvestiti svojega zdravnika ali farmacevta, preden vzamete zdravilo Klopidogrel Qualimed.
English: Thrombolytics: the safety of the concomitant administration of clopidogrel, fibrin or non-fibrin specific thrombolytic agents and heparins was assessed in patients with acute myocardial infarction.
Slovenian: Varnost sočasnega jemanja klopidogrela, fibrinsko specifičnih ali fibrinsko nespecifičnih trombolitikov in heparinov je bila ovrednotena pri bolnikih z akutnim miokardnim infarktom.
English: There was no significant difference between groups in the primary composite endpoint of death, shunt thrombosis or cardiac-related intervention prior to 120 days of age following an event considered of thrombotic nature (89 [19.1%] for the clopidogrel group and 90 [20.5%] for the placebo group) (see section 4.2).
Slovenian: Med skupinama ni bilo značilnih razlik v primarnem sestavljenem opazovanem dogodku, ki je obsegal smrt, trombozo spoja ali srčno intervencijo pred starostjo 120 dni po dogodku, za katerega je bilo ocenjeno, da je trombotične narave: v skupini s klopidogrelom je bilo takšnih 89 (19,1 %) in v skupini s placebom 90 (20,5 %) (glejte poglavje 4.2).
English: If you have any further questions on the use of this product, ask your doctor or pharmacist.
Slovenian: Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom ali s farmacevtom.
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, ki so se zdravili s klopidogrelom ali z ASA, skupna incidenca vseh krvavitev 9,3-odstotna.
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 Qualimed.
Slovenian: Če menite, da se karkoli od navedenega nanaša na vas, ali če ste kakorkoli v dvomih, se posvetujte s svojim zdravnikom, preden vzamete Klopidogrel Qualimed.
English: In vitro and in vivo, clopidogrel is metabolised according to two main metabolic pathways: one mediated by esterases and leading to hydrolysis into its inactive carboxylic acid derivative (85% of circulating metabolites), and one mediated by multiple cytochromes P450.
Slovenian: Klopidogrel se in vitro in in vivo presnovi po dveh glavnih presnovnih poteh: ena poteka z esterazami in povzroči hidrolizo v neaktiven karboksilnokislinski derivat (85 % presnovkov v obtoku), druga pa z več encimi citokroma P450.
English: The prevalence of CYP2C19 alleles that result in intermediate and poor CYP2C19 metabolism differs according to race/ethnicity (see Pharmacogenetics).
Slovenian: Prevalenca alelov CYP2C19, ki povzročijo srednjo ali slabo presnovo s CYP2C19, se razlikuje glede na raso/etnično pripadnost (glejte Farmakogenetika).
English: In TRITON-TIMI 38 and 3 of the cohort studies (Collet, Sibbing, Giusti) the combined group of patients with either intermediate or poor metaboliser status had a higher rate of cardiovascular events (death, myocardial infarction, and stroke) or stent thrombosis compared to extensive metabolisers.
Slovenian: V TRITON-TIMI 38 in 3 kohortnih študijah (Collet, Sibbing, Giusti) je imela kombinirana skupina bolnikov, ki so bili ali srednji ali slabi metabolizatorji, večji delež kardiovaskularnih dogodkov (smrt, miokardni infarkt, možganska kap) ali trombozo na žilni opornici kot dobri metabolizatorji.
English: Clopidogrel should be given as a single daily dose of 75 mg.
Slovenian: Klopidogrel dajemo kot enkratni dnevni odmerek po 75 mg.
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 v preizkušanje vključeni samo na podlagi nedavnega MI, je bil klopidogrel numerično inferioren, vendar se statistično ni razlikoval od ASA (zmanjšanje RT: -4 %; IZ: -22,5 do 11,7 /p = 0,639/).
English: It is characterised by thrombocytopenia and microangiopathic haemolytic anaemia associated with either neurological findings, renal dysfunction or fever.
Slovenian: Zanjo sta značilni trombocitopenija in mikroangiopatična hemolitična anemija, ki sta lahko povezani bodisi z nevrološkimi spremembami, motnjo v ledvičnem delovanju ali vročino.
English: INFORMATION IN BRAILLE Clopidogrel Qualimed 75 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Klopidogrel Qualimed 75 mg
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 pomembno zmanjšal incidenco novih ishemičnih dogodkov (sestavljen opazovani dogodek MI, ishemična kap in žilna smrt) v primerjavi z ASA.
English: Pharmacogenetics: In patients who are poor CYP2C19 metabolisers, clopidogrel at recommended doses forms less of the active metabolite of clopidogrel and has a smaller effect on platelet function.
Slovenian: Farmakogenetika: Pri bolnikih, ki so slabi metabolizatorji CYP2C19, med uporabo priporočenih odmerkov klopidogrela nastane manj aktivnega presnovka klopidogrela in ima manjši učinek na delovanje trombocitov.
English: Proton Pump Inhibitors (PPI):
Slovenian: Zaviralci protonske črpalke (PPI):
English: Qualimed, 117 allee des Parcs, 69 800 Saint Priest, France
Slovenian: IMETNIK DOVOLJENJA ZA PROMET Qualimed, 117 allee des Parcs, 69 800 Saint Priest, Francija
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 predstavljajo najmanj 25-krat večjo izpostavljenost kot pri človeku ob jemanju kliničnega odmerka 75 mg na dan, in so bile posledica učinka na jetrne presnovne encime.
English: Hallucinations, confusion Taste disturbances
Slovenian: Psihiatrične motnje halucinacije, zmedenost
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
Slovenian: Bolnike, ki jemljejo klopidogrel (samega ali v kombinaciji z ASA), je treba opozoriti, da je lahko čas, ki je potreben za zaustavitev krvavitve, daljši kot ponavadi, in da morajo svojemu zdravniku poročati o kakršnikoli neobičajni krvavitvi (o mestu ali trajanju).
English: However, clopidogrel and ASA have been administered together for up to one year (see
Slovenian: Vendar pa so klopidogrel in ASA sočasno jemali do eno leto (glejte poglavje 5.1).
English: SPECIAL STORAGE CONDITIONS Store in the original package in order to protect from moisture and light.
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte v originalni ovojnini za zagotovitev zaščite pred vlago in svetlobo.
English: The CLARINET and the PICOLO trials were conducted using a constituted solution of clopidogrel.
Slovenian: Preskušanji CLARINET in PICOLO so izvedli z uporabo pripravljene raztopine klopidogrela.
English: • Renal impairment Therapeutic experience is limited in patients with renal impairment (see section 4.4).
Slovenian: • Okvara ledvic Terapevtske izkušnje pri bolnikih z ledvično okvaro so omejene (glejte poglavje 4.4).
English: Clopidogrel active metabolite pharmacokinetics and antiplatelet effects, as measured by ex vivo platelet aggregation assays, differ according to CYP2C19 genotype.
Slovenian: Farmakokinetika aktivnega presnovka klopidogrela in njegovo antitrombocitno delovanje, merjeno s preskusi agregacije trombocitov ex vivo, se razlikuje glede na genotip CYP2C19.
English: Glycoprotein IIb/IIIa inhibitors: clopidogrel should be used with caution in patients receive concomitant glycoprotein IIb/IIIa inhibitors (see section 4.4).
Slovenian: Zaviralci glikoproteina IIb/IIIa: klopidogrel moramo uporabljati previdno pri bolnikih, ki prejemajo sočasno zaviralce glikoproteina IIb/IIIa (glejte poglavje 4.4).
English: Ask your doctor or pharmacist for advice before taking any medicine.
Slovenian: Posvetujete se z zdravnikom ali s farmacevtom, preden vzamete katerokoli zdravilo
English: Less pronounced reductions of metabolite exposure has been observed with pantoprazole or
Slovenian: Manj izrazita zmanjšana izpostavljenost presnovkov je bila opažena pri pantoprazolu ali lansoprazolu.
English: Important information about some of the ingredients of Clopidogrel Qualimed Clopidogrel Qualimed contains hydrogenated castor oil which may cause stomach upset and diarrhoea.
Slovenian: Pomembne informacije o nekaterih sestavinah zdravila Klopidogrel Qualimed Hidrogenirano ricinusovo olje lahko povzroči želodčne motnje ali drisko.
English: B. CONDITIONS OF THE MARKETING AUTHORISATION • CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON
Slovenian: • POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, PREDPISANI IMETNIKU
English: The clinically relevant adverse reactions observed in the CAPRIE, CURE, CLARITY and COMMIT studies are discussed below.
Slovenian: Klinično pomembni neželeni učinki, zabeleženi v študijah CAPRIE, CURE, CLARITY in COMMIT, so predstavljeni v nadaljevanju.