FrancophonIA/ELRC3.0 huggingface dataset:
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 klopidogrel numerično inferioren, vendar se statistično ni razlikoval od ASA (zmanjšanje RT= -4,0 %; IZ: -22,5 do 11,7 [p=0,639]).
English: In a small number of cases, bleeding in the eye, inside the head, the lung or the joints has also been reported.
Slovenian: V majhnem številu primerov poročajo tudi o očesnih krvavitvah, krvavitvah v glavi, pljučih ali sklepih.
English: However, due to the lack of interaction studies with other NSAIDs it is presently unclear whether there is an increased risk of gastrointestinal bleeding with all NSAIDs.
Slovenian: NSAIDs danes nejasno, ali je povečano tveganje za gastrointestinalne krvavitve pri vseh NSAIDs.
English: Iron oxide red (E172) Iron oxide yellow (E172) Indigo carmine aluminium lake (E132)
Slovenian: rumeni železov oksid (E172) indigo karmin barvilo (E132)
English: It is preferable not to take this medicine during pregnancy.
Slovenian: Nosečnost in dojenje Priporočljivo je, da se tega zdravila v nosečnosti ne uporablja.
English: • If you cut or injure yourself, it may take longer than usual for bleeding to stop.
Slovenian: • Če se boste poškodovali ali urezali, bo potrebnega več časa za zaustavitev krvavitve.
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 ASA, ni nadalje povečevala, medtem ko je tveganje za krvavitev ostala (glejte poglavje
English: The population included 27.8% women, 58.4% patients ≥60 years (26% ≥70 years) and
Slovenian: Populacijo bolnikov je sestavljalo 27,8 % žensk, 58,4 % bolnikov starost ≥60 let (26 % ≥70 let ) in 54,5 % bolnikov, ki so dobivali fibrinolitike.
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 krvavitev skrbi, nemudoma pokličite zdravnika (glejte poglavje 4 »Možni neželeni učinki«).
English: Contents of the pack and other information What Clopidogrel Teva contains
Slovenian: Vsebina pakiranja in dodatne inforamcije Kaj vsebuje zdravilo Klopidogrel Teva
English: If you become pregnant while taking Clopidogrel Teva, consult your doctor immediately as it is recommended not to take clopidogrel while you are pregnant.
Slovenian: Če med uporabo zdravila Klopidogrel Teva zanosite, se nemudoma posvetujte z zdravnikom, saj se uporabo klopidogrela med nosečnostjo odsvetuje.
English: As a precautionary measure, breast-feeding should not be continued during treatment with Clopidogrel Teva.
Slovenian: Iz varnostnih razlogov naj se z dojenjem med zdravljenjem z zdravilom Klopidogrel Teva ne nadaljuje.
English: Glomerulonephritis, blood creatinine increased
Slovenian: Bolezni sečil hematurija glomerulonefritis, zvišanje kreatinina v krvi
English: • The active substance is clopidogrel.
Slovenian: • Zdravilna učinkovina je klopidogrel.
English: If you are pregnant or suspect that you are pregnant, you should tell your doctor or your pharmacist before taking Clopidogrel Teva.
Slovenian: Če ste noseči ali mislite, da ste noseči, morate o tem obvestiti svojega zdravnika, preden vzamete zdravilo Klopidogrel Teva.
English: Calendar days Mon
Slovenian: Dnevi v tednu Pon
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 antikoagulansi: sočasna uporaba klopidogrela s peroralnimi antikoagulansi ni priporočljiva, ker lahko poveča intenzivnost krvavitev (glejte poglavje 4.4).
English: This includes any possible side effects not listed in this leaflet.
Slovenian: če opazite neželene učinke, ki niso navedni v tem navodilu.
English: • Adult patients suffering from acute coronary syndrome:
Slovenian: • odraslih bolnikih z akutnim koronarnim sindromom;
English: If any of the situations mentioned below apply to you, you should tell your doctor before taking Clopidogrel Teva:
Slovenian: Če katerokoli od spodaj navedenih stanj velja za vas, morate o tem obvestite svojega zdravnika,
English: If you have experienced severe chest pain (unstable angina or heart attack), your doctor may give you 300 mg of Clopidogrel Teva (1 tablet of 300 mg or 4 tablets of 75 mg) 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 (eno 300-mg tableto ali štiri 75-mg tablete).
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), or other medicinal products associated with bleeding risk such as pentoxifylline (see section 4.5).
Slovenian: Kot pri drugih antitrombotikih, moramo klopidogrel uporabljati previdno pri bolnikih s tveganjem za povečano krvavitev zaradi poškodbe, kirurškega posega ali drugih patoloških stanj in pri bolnikih, ki so na zdravljenju z ASA, heparinom, zaviralci glikoproteina IIb/IIIa ali nesteroidnimi protivnetnimi zdravili (NSAIDs) vključno z zaviralci COX-2 ali s selektivnimi zaviralci privzema serotonina (SSRI) ali z drugimi zdravili, ki so povezana s tveganjem za krvavitve, kot je pentoksifilin (glejte poglavje 4.5).
English: Respiratory tract bleeding (haemoptysis, pulmonary haemorrhage), bronchospasm, interstitial pneumonitis, eosinophilic pneumonia
Slovenian: pljučna krvavitev), bronhospazem, intersticijski pnevmonitis, eozinofilna pljučnica
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 se lahko fenitoin in tolbutamid, ki se presnavljata s CYP2C9
English: EU/1/09/540/008 30 film-coated tablets EU/1/09/540/009 100 film-coated tablets
Slovenian: EU/1/09/540/008 30 filmsko obloženih tablet EU/1/09/540/009 100 filmsko obloženih tablet
English: 14x1 film-coated tablets 28x1 film-coated tablets 30x1 film-coated tablets 50x1 film-coated tablets 84x1 film-coated tablets 90x1 film-coated tablets 100x1 film-coated tablets
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: How to take Clopidogrel Teva
Slovenian: Kako jemati zdravilo Klopidogrel Teva
English: Lactose monohydrate Cellulose, microcrystalline Hydroxypropylcellulose (E463) Crospovidone (type A) Hydrogenated vegetable oil Sodium laurilsulfate
Slovenian: Jedro tablete: laktoza monohidrat mikrokristalna celuloza hidroksipropilceluloza (E463) krospovidon (vrsta A) hidrogenirano rastlinsko olje natrijev lavril sulfat
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 se ne priporoča, ker lahko poveča jakost krvavitev (glejte poglavje 4.5).
English: Do not use this medicine after the expiry date which is stated on the outer carton, bottle or blister, after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli,
English: However, if you are concerned by your bleeding, you should contact your doctor straightaway (see section 2 ‘Warnings and precautions').
Slovenian: Vendar pa se se morate takoj posvetovati s svojim zdravnikom, če ste glede krvavitve v kakršnihkoli dvomih (glejte poglavje 2 »Opozorila in previdnostni ukrepi«).
English: Clopidogrel Teva contains clopidogrel and belongs to a group of medicines called antiplatelet medicinal products.
Slovenian: Zdravilo Klopidogrel Teva vsebuje klopidogrel in spada v skupino zdravil, imenovanih zaviralci agregacije trombocitov.
English: − 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 je zamuda manj kot 12 ur po pravem času: bolnik naj odmerek vzame takoj, potem pa naslednji odmerek ob pravem času.
English: • If you suffer from severe liver disease.
Slovenian: • Če imate hudo jetrno obolenje.
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.
Slovenian: Če menite, da kaj od zgornjega velja za vas, ali če se pri vas porajajo kakršnikoli dvomi, se pred uporabo zdravila Klopidogrel Teva posvetujte z zdravnikom.
English: Luxembourg/Luxemburg ratiopharm GmbH Allemagne/Deutschland Tél/Tel: +49 731 402 02
Slovenian: GmbH Allemagne/Deutschland Tél/Tel: +49 731 402 02
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: 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
English: • Clopidogrel Teva is supplied in:
Slovenian: Klopidogrel je indiciran pri:
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 2.172 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 (srčno žilna smrt, miokardni infarkt, možganska kap) in tudi značilno, 23,9 % zmanjšanje RT za drugsestavljen primarni opazovani dogodek (srčno-žilna smrt, miokardni infarkt, možganska kap ali neodzivna ishemija).
English: • Paediatric population Clopidogrel should not be used in children because of efficacy concerns (see section 5.1).
Slovenian: Klopidrogel naj se pri otrocih ne uporablja iz razlogov, ki zadevajo učinkovitost (glejte poglavje
English: In CURE, 823 (6.6%) patients received concomitant GPIIb/IIIa receptor antagonist therapy.
Slovenian: (6,6 %) bolnikov sočasno prejemalo terapijo z antagonisti receptorjev glikoproteinov IIb/IIIa.
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: Aluminij-aluminij perforirani enoodmerni pretisni omoti z odstranljivo folijo, aluminij-aluminij perforirani pretisni omoti in HDPE plastenke z zaporkami iz polipropilena ali pred otroki varnimi zaporkami in sušilnim sredstvom, silikagelom.
English: What Clopidogrel Teva looks like and contents of the pack
Slovenian: Izgled zdravila Klopidogrel Teva in vsebina pakiranja
English: − ST segment elevation acute myocardial infarction: clopidogrel should be given as a single daily dose of 75 mg initiated with a 300 mg loading dose in combination with ASA and with or without thrombolytics.
Slovenian: − Akutni miokardni infarkt z elevacijo ST spojnice: klopidogrel je potrebno dajati v enkratnem dnevnem odmerku 75 mg, zdravljenje pa je potrebno začeti s 300 mg udarnim odmerkom v kombinaciji z ASA ter z ali brez uporabe trombolitikov.
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: • Zdravnika morate nemudoma obvestiti, če se pri vas pojavi 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,
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, agevzija
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 pomembno različna od ASA) pri bolnikih s kapjo
English: Acute liver failure, hepatitis, abnormal liver function test
Slovenian: žolčnika in žolčevodov akutna odpoved jeter, hepatitis, nenormalni testi jetrne funkcije
English: • Adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease.
Slovenian: • odraslih bolnikih z miokardnim infarktom (od nekaj dni do manj kot 35 dni), ishemično kapjo (od
English: Contact your doctor or the nearest hospital emergency department because of the increased risk of bleeding.
Slovenian: Zaradi povečanega tveganja krvavitve se posvetujte s svojim zdravnikom ali oddelkom najbližje bolnišnične nujne zdravniške pomoči.
English: Calendar pack of aluminium-aluminium perforated blisters containing 28x1film coated tablets
Slovenian: Koledarsko pakiranje: aluminij-aluminij perforirani pretisni omoti vsebuje 28x1 filmsko obloženo tableto.
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 o jemanju tablet iz pretisnega omota so na zunanji strani škatle s pretisnimi omoti z odstranljivo folijo.
English: Musculo-skeletal bleeding (haemarthrosis), arthritis, arthralgia, myalgia
Slovenian: Bolezni mišično skeletnega sistema in vezivnega tkiva mišično-skeletne krvavitve (hemartroza), artritis, artralgija, mialgija
English: − Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave 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)
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: 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 zaradi infarkta zamašenih arterij.
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-treated group and 1,187 (18.8%) in the placebo-treated group, a 14% relative risk reduction (95% CI of 6%-21%, p=0.0005) for the clopidogrel-treated group.
Slovenian: Število bolnikov s primarnim opazovanim dogodkom (srčno-žilna smrt, MI, kap ali neodzivna ishemija) je bilo 1.035 (16,5 %) v skupini zdravljeni s klopidogrelom in 1.187 (18,8 %) v skupini s placebom, to je 14 % zmanjšanje relativnega tveganja (95 % IZ od 6 %-21 %, p=0,0005) za skupino, zdravljeno s klopidogrelom.
English: The clinically relevant adverse reactions observed in the CAPRIE, CURE, CLARITY, COMMIT and ACTIVE-A studies are discussed below.
Slovenian: Klinično pomembni neželeni odzivi, zabeleženi v študijah CAPRIE, CURE, CLARITY in
English: Each film-coated tablet contains 75 mg clopidogrel (as hydrogen sulfate).
Slovenian: Ena filmsko obložena tableta vsebuje 75 mg klopidogrela v obliki klopidogrelijevega sulfata.
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: Na primer: o zdravstveno stanje s tveganjem za notranjo krvavitev (kot je rana na želodcu).
English: o a selective serotonin reuptake inhibitor (including but not restricted to fluoxetine or fluvoxamine), medicines usually used to treat depression, - omeprazole or esomeprazole, medicines to treat upset stomach, - fluconazole or voriconazole, medicines to treat fungal infections, - efavirenz, a medicine to treat HIV (human immunodeficiency virus) infections, - anti-retroviral medicines (medicines to treat HIV infections), - carbamazepine, a medicine to treat some forms of epilepsy, - moclobemide, medicine to treat depression, - repaglinide, medicine to treat diabetes, - paclitaxel, medicine to treat cancer.
Slovenian: - efavirenz, zdravilo za zdravljenje infekcij z virusom HIV (virus humane imunske pomanjkljivosti), - protiretrovirusna zdravila (zdravila za zdravljenje okužbe z virusom HIV), - karbamazepin, zdravilo za zdravljenje nekaterih oblik epilepsije, - moklobemid, zdravilo za zdravljenje depresije, - repaglinid, zdravilo za zdravljenje sladkorne bolezni, - paklitaksel, zdravilo za zdravljenje raka.
English: You have been prescribed Clopidogrel Teva to help prevent blood clots and reduce the risk of these severe events because:
Slovenian: Zdravilo Klopidogrel Teva vam je bilo predpisano za pomoč pri preprečevanju nastajanja krvnih strdkov in za zmanjšanje tveganja teh hudih dogodkov, ker: - imate stanje otrdelih arterij (znano tudi kot ateroskleroza), in
English: If you forget to take a dose of Clopidogrel Teva, but remember within 12 hours of usual time,take your tablet straightaway and then take your next tablet at the usual time.
Slovenian: Če pozabite vzeti odmerek zdravila Klopidogrel Teva, vendar se spomnite v naslednjih 12 urah,
English: Clopidogrel Teva contains sodium
Slovenian: Zdravilo Klopidogrel Teva vsebuje natrij
English: Light pink to pink, capsule-shaped film-coated tablets debossed with “93” on one side and “7314” on the other side.
Slovenian: Ena stran tablete ima vtisnjeno številko »93«, druga stran tablete pa številko »7314«.
English: Subsequent metabolism of the 2-oxo-clopidogrel intermediate metabolite results in formation of the active metabolite, a thiol derivative of clopidogrel.
Slovenian: oksoklopidogrela povzroči nastanek aktivnega presnovka, ki je tiolski derivat klopidogrela.
English: While you are taking Clopidogrel Teva:
Slovenian: Med jemanjem zdravila Klopidogrel Teva:
English: − Tablet coating: lactose monohydrate, hypromellose (E464), titanium dioxide (E171), macrogol 4000, iron oxide red (E172), iron oxide yellow (E172) and indigo carmine aluminium lake (E132).
Slovenian: • Pomožne snovi so glejte poglavje 2: »Zdravilo Klopidogrel Teva vsebuje laktozo«: - Jedro tablete: laktoza monohidrat, mikrokristalna celuloza, hidroksipropilceluloza (E463), krospovidon (vrsta A), hidrogenirano rastlinsko olje in natrijev lavril sulfat - Obloga tablete: laktoza monohidrat, hipromeloza (E464), titanov dioksid (E171), makrogol 4000, rdeč železov oksid (E172), rumen železov oksid (E172), indigo karmin barvilo (E132)
English: The expiry date refers to the last day of that month.
Slovenian: plastenki ali pretisnem omotu za EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: Clopidogrel Teva contains lactose
Slovenian: Zdravilo Klopidogrel Teva vsebuje laktozo
English: Kounis syndrome (vasospastic allergic angina / allergic myocardial infarction) in the context of a
Slovenian: (vazospastična alergijska angina / alergijski miokardni infarkt) v okviru preobčutljivostne reakcije zaradi klopidogrela*
English: In CLARITY, there was an overall increase in bleeding in the clopidogrel plus ASA group vs. the placebo plus ASA group.
Slovenian: V študiji CLARITY je v skupini s klopidogrelom in ASA prišlo do splošnega povečanja krvavitev v primerjavi s skupino s placebom in ASA.
English: Bullous dermatitis (toxic epidermal necrolysis, Stevens Johnson Syndrome, erythema multiforme), acute generalised exanthematous pustulosis (AGEP)), angioedema, drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms (DRESS), rash erythematous or exfoliative, urticaria, eczema, lichen planus
Slovenian: (sindrom DIHS, Drug-Induced Hypersensitivity Syndrome), kožni izpuščaj z eozinofilijo in sistemskimi simptomi, kot posledica zdravljenja z zdravilom (sindrom DRESS, Drug Rash with Eosinophilia and Systemic Symptoms), eritematozen ali eksfoliativen izpuščaj,
English: − Calendar pack of perforated blisters of aluminium/aluminium containing 28x1 tablets
Slovenian: - Koladarsko pakiranje: aluminij-aluminij perforirani pretisni omoti vsebuje 28x1 filmsko obloženo tableto.
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
English: If you cut or injure yourself, it may take longer than usual for bleeding to stop.
Slovenian: Če doživite podaljšanje krvavitve v času jemanja zdravila Klopidogrel Teva Če se urežete ali poškodujete, lahko traja malo dlje kot običajno, da se vam krvavitev ustavi.