natgillin/translations-raw huggingface dataset:
EU/1/08/464/001 - Cartons of 14 film-coated tablets in PVC/PVDC/Alu blisters EU/1/08/464/002 - Cartons of 14 film-coated tablets in all aluminium blisters EU/1/08/464/003 - Cartons of 28 film-coated tablets in PVC/PVDC/Alu blisters EU/1/08/464/004 - Cartons of 28 film-coated tablets in all aluminium blisters EU/1/08/464/005 - Cartons of 30 film-coated tablets in PVC/PVDC/Alu blisters EU/1/08/464/006 - Cartons of 30 film-coated tablets in all aluminium blisters EU/1/08/464/007 - Cartons of 50x1 film-coated tablets in PVC/PVDC/Alu blisters EU/1/08/464/008 - Cartons of 50x1 film-coated tablets in all aluminium blisters EU/1/08/464/009 - Cartons of 84 film-coated tablets in PVC/PVDC/Alu blisters EU/1/08/464/010 - Cartons of 84 film-coated tablets in all aluminium blisters EU/1/08/464/011 - Cartons of 90 film-coated tablets in PVC/PVDC/Alu blisters EU/1/08/464/012 - Cartons of 90 film-coated tablets in all aluminium blisters EU/1/08/464/013 - Cartons of 100 film-coated tablets in PVC/PVDC/Alu blisters EU/1/08/464/014 - Cartons of 100 film-coated tablets in all aluminium blisters EU/1/08/464/018 - Cartons of 7 film-coated tablets in PVC/PVDC/Alu blisters EU/1/08/464/019 - Cartons of 7 film-coated tablets in all aluminium blisters
EU/1/08/464/001 - škatle s 14 filmsko obloženimi tabletami v PVC/PVDC/alu pretisnih omotih EU/1/08/464/002- škatle s 14 filmsko obloženimi tabletami v aluminijastih pretisnih omotih EU/1/08/464/003 - škatle z 28 filmsko obloženimi tabletami v PVC/PVDC/alu pretisnih omotih EU/1/08/464/004 - škatle z 28 filmsko obloženimi tabletami v aluminijastih pretisnih omotih EU/1/08/464/005 - škatle s 30 filmsko obloženimi tabletami v PVC/PVDC/alu pretisnih omotih EU/1/08/464/006 - škatle s 30 filmsko obloženimi tabletami v aluminijastih pretisnih omotih EU/1/08/464/007 - škatle s 50x1 filmsko obloženimi tabletami v PVC/PVDC/alu pretisnih omotih EU/1/08/464/008 - škatle s 50x1 filmsko obloženimi tabletami v aluminijastih pretisnih omotih EU/1/08/464/009 - škatle z 84 filmsko obloženimi tabletami v PVC/PVDC/alu pretisnih omotih EU/1/08/464/010 - škatle z 84 filmsko obloženimi tabletami v aluminijastih pretisnih omotih EU/1/08/464/011 - škatle z 90 filmsko obloženimi tabletami v PVC/PVDC/alu pretisnih omotih EU/1/08/464/012 - škatle z 90 filmsko obloženimi tabletami v aluminijastih pretisnih omotih EU/1/08/464/013 - škatle s 100 filmsko obloženimi tabletami v PVC/PVDC/alu pretisnih omotih EU/1/08/464/014 - škatle s 100 filmsko obloženimi tabletam v aluminijastih pretisnih omotih EU/1/08/464/018 - škatle s 7 filmsko obloženimi tabletami v PVC/PVDC/alu pretisnih omotih EU/1/08/464/019 - škatle s 7 filmsko obloženimi tabletami v aluminijastih pretisnih omotih
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 16 July 2008
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve pridobitve dovoljenja za promet: 16. julij 2008
Detailed information on this product is available on the website of the European Medicines Agency
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila
Therefore, concomitant use of Proton Pump Inhibitors should be avoided unless absolutely necessary.
Zato naj bi se sočasni uporabi zaviralcev protonske črpalke izognili, razen če ni nujno potrebna.
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6, Boulevard de l'Europe, F-21800 Quétigny, Francija
Combined therapy should be started as early as possible after symptoms start and continued for at least four weeks.
kombiniranim zdravljenjem je potrebno začeti čim prej po nastopu simptomov in z njim nadaljevati vsaj štiri tedne.
Since the CAPRIE trial was not powered to evaluate efficacy of individual subgroups, it is not clear whether the differences in relative risk reduction across qualifying conditions are real, or a result of
Ker CAPRIE nima moči za oceno učinkovitosti v posameznih podskupinah, ni jasno, ali so razlike pri zmanjšanju relativnega tveganja glede na vključitvene pogoje resnične ali slučajne.
Clopidogrel has been evaluated for safety in more than 42,000 patients who have participated in clinical studies, including over 9,000 patients treated for 1 year or more.
Varnost klopidogrela so vrednotili pri več kot 42.000 bolnikih, ki so sodelovali v kliničnih študijah, vključno z več kot 9.000 bolniki, ki so se zdravili 1 leto ali več.
Platelets are very small structures in the blood, smaller than red or white blood cells, which clump together during blood clotting.
Trombociti so zelo majhne strukture v krvi, manjše kot rdeče ali bele krvne celice, ki se zlepljajo pri strjevanju krvi.
- a recent serious injury - a recent surgery (including dental) - a planned surgery (including dental) in the next seven days
- nedavna huda poškodba - nedaven kirurški poseg (vključno na zobeh) - načrtovan kirurški poseg (vključno na zobeh) v naslednjih 7 dneh
The relative difference in antiplatelet response between genotype groups varies across studies depending on the method used to evaluate response, but is typically greater than 30%.
Relativna razlika antitrombocitnega odziva med genotipskima skupinama se med študijami razlikuje glede na metodo, uporabljeno za oceno odziva, a je praviloma večja od 30 %.
It is preferable not to use this product during pregnancy and breast-feeding.
Priporočljivo je, da se tega zdravila v nosečnosti in med dojenjem ne uporablja.
Some other medicines may influence the use of Clopidogrel BMS or vice versa.
Nekatera druga zdravila lahko vplivajo na uporabo klopidogrela in obratno.
The MAH must ensure that the system of pharmacovigilance, as described in version 2.0 dated 25 September 2007 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Imetnik dovoljenja za promet mora zagotoviti, da je sistem farmakovigilance, kot je opisan v različici 2.0 z datumom 25. september 2007, predstavljeni v Modulu 1.8.1. vloge za pridobitev dovoljenja za promet z zdravilom, vzpostavljen in da deluje, preden da zdravilo v promet in toliko časa, kolikor bo zdravilo v uporabi.
The incidence of severe cases was 1.4% for clopidogrel and 1.6% for ASA.
Incidenca hujših primerov je bila 1,4 % za klopidogrel in 1,6 % za ASA.
The elimination half-life of the main circulating (inactive) metabolite was 8 hours after single and repeated administration.
Razpolovni čas izločanja glavnega krožečega (neaktivnega) metabolita je bil 8 ur po enkratnem in večkratnem dajanju.
Taking Clopidogrel BMS with food and drink Clopidogrel BMS may be taken with or without food.
Jemanje zdravila Clopidogrel BMS skupaj s hrano in pijačo Klopidogrel lahko jemljete s hrano ali brez nje.
The binding is non-saturable in vitro over a wide concentration
Pri vezavi in vitro ni nasičenja v širokem koncentracijskem
Contact your doctor immediately if you experience: - fever, signs of infection or extreme tiredness.
Nemudoma se posvetujte s svojim zdravnikom, če se pri vas pojavijo: - zvišana telesna temperatura, znaki okužbe ali huda utrujenost.
Their frequency is defined using the following conventions: common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000).
Njihova pogostnost je navedena upoštevaje naslednji dogovor: pogosti (≥ 1/100, < 1/10), občasni (≥ 1/1.000, < 1/100), redki (≥ 1/10.000, < 1/1.000), zelo redki (< 1/10.000).
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)
Bolniki morajo biti obveščeni, da je lahko čas, potreben za zaustavitev krvavitve, daljši kot ponavadi, ko jemljejo klopidogrel (sam ali v kombinaciji z ASA) in da morajo poročati svojemu zdravniku o kakršnikoli neobičajni krvavitvi (mesto ali trajanje).
If you experience prolonged bleeding when taking Clopidogrel BMS If you cut or injure yourself, it may take longer than usual for bleeding to stop.
Če doživite podaljšanje krvavitve v času jemanja zdravila Clopidogrel BMS Če se urežete ali poškodujete, lahko traja dlje kot običajno, da se vam krvavitev ustavi.
Due to the risk of bleeding and haematological undesirable effects, blood cell count determination and/or other appropriate testing should be promptly considered whenever clinical symptoms suggestive of bleeding arise during the course of treatment (see section 4.8).
Zaradi tveganja krvavitve in hematoloških neželenih učinkov moramo takoj pretehtati potrebo po določanju števila krvnih celic in/ali drugih ustreznih preiskav, kadarkoli se v času zdravljenja pojavijo klinični simptomi, ki nakazujejo krvavitev (glejte poglavje 4.8).
The efficacy of clopidogrel was observed independently of the dose of
Učinkovitost klopidogrela so opazili neodvisno od odmerka ASA
Do not use Clopidogrel BMS if you notice any visible sign of deterioration.
Ne uporabljajte klopidogrela, če ste opazili vidne znake kvarjenja.
Absorption is at least 50%, based on urinary excretion
Absorpcija je najmanj 50 %, na podlagi metabolitov klopidrogela, izločenih z urinom.
Data from the CAPRIE study indicate that phenytoin and tolbutamide can be safely co-administered with clopidogrel.
Podatki študije CAPRIE kažejo, da se lahko fenitoin in tolbutamid sočasno s klopidogrelom varno
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Uxbridge UB8 1DH Velika Britanija
This could potentially lead to increased plasma levels of medicinal products such as phenytoin and tolbutamide and the NSAIDs, which are metabolised by Cytochrome P450 2C9.
To lahko potencialno vodi do povečanja plazemskih ravni zdravil, kot so fenitoin in tolbutamid ter NSAIDs, ki se presnavljajo s citokromom P450 2C9.
You should take Clopidogrel BMS for as long as your doctor continues to prescribe it.
Klopidogrel morate jemati, vse dokler vam ga vaš zdravnik predpisuje.
Do not use Clopidogrel BMS after the expiry date which is stated on the carton and on the blister.
Ne uporabljajte klopidogrela po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu.
• You should tell your doctor if a surgery (including dental) is planned.
• morate povedati zdravniku, če imate predvideno kakšno operacijo (vključno z
- You have experienced a severe type of chest pain known as ‘unstable angina' or ‘myocardial infarction' (heart attack).
- ste doživeli hudo obliko bolečine v prsih, znano kot “nestabilna angina” ali “miokardni infarkt” (srčni napad).
The association between CYP2C19 genotype and clopidogrel treatment outcome was evaluated in 2 post hoc clinical trial analyses (substudies of CLARITY [n=465] and TRITON-TIMI 38 [n=1,477]) and 5 cohort studies (total n=6,489).
Povezavo med genotipom CYP2C19 in izidom zdravljenja s klopidogrelom so ocenili v 2 post hoc analizah kliničnih preskušanj (podštudiji CLARITY [n = 465] in TRITON-TIMI 38 [n = 1.477]) ter 5 kohortnih študijah (celotni n = 6.489).
If you are pregnant or suspect that you are pregnant, you should tell your doctor or your pharmacist before taking Clopidogrel BMS.
Če ste noseči ali mislite, da ste noseči, morate o tem obvestiti svojega zdravnika ali farmacevta, preden vzamete klopidogrel.
Therapeutic experience is limited in patients with renal impairment (see section 4.4).
Terapevtske izkušnje pri bolnikih z okvaro ledvic so omejene (glejte poglavje 4.4).
Clopidogrel BMS is not intended for use in children or adolescents.
Klopidogrel ni namenjeno za uporabo pri otrocih ali mladostnikih.
In view of the lack of data, clopidogrel cannot be recommended during the first 7 days after acute ischaemic stroke.
Zaradi pomanjkanja podatkov klopidogrela ne moremo priporočiti prvih 7 dni po akutni ishemični kapi .
If you forget to take a dose of Clopidogrel BMS, but remember within 12 hours of your usual time, take your tablet straightaway and then take your next tablet at the usual time.
Če pozabite vzeti odmerek zdravila Clopidogrel BMS in se nanj spomnite do 12 ur po ustaljenem času, takoj vzemite tableto in nato vzemite naslednjo tableto spet ob ustaljenem času jemanja.
The safety and efficacy of clopidogrel have been evaluated in 4 double-blind studies involving over 80,000 patients: the CAPRIE study, a comparison of clopidogrel to ASA, and the CURE, CLARITY and COMMIT studies comparing clopidogrel to placebo, both medicinal products given in combination with ASA and other standard therapy.
Varnost in učinkovitost klopidogrela so vrednotili v 4 dvojno slepih študijah, v katere je bilo vključenih več kot 80.000 bolnikov: študija CAPRIE je obsegala primerjavo klopidogrela in ASA, v študijah CURE, CLARITY in COMMIT pa so primerjali klopidogrel s placebom; oboje pa so bolniki dobivali v kombinaciji z ASA in drugo standardno terapijo.
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Sanofi Winthrop Industrie 1, route de la vierge, Ambarès & Lagrave F-33565 Carbon Blanc Cedex
For this dose, tablets containing 75 mg are available.
Za ta odmerek so na voljo tablete, ki vsebujejo 75 mg klopidogrela.
Data from studies with human liver microsomes indicated that the carboxylic acid metabolite of clopidogrel could inhibit the activity of Cytochrome P450 2C9.
Podatki iz študij s humanimi jetrnimi mikrosomi kažejo, da lahko karboksilni kislinski metabolit klopidogrela zavira aktivnost citokroma P450 2C9.
If you think any of these apply to you, or if you are in any doubt at all, consult your doctor before taking Clopidogrel BMS.
Če menite, da se karkoli od navedenega nanaša na vas, ali če ste kakorkoli v dvomih, se posvetujte s svojim zdravnikom, preden boste vzeli klopidogrel.
Clopidogrel has been tested in a range of in vitro and in vivo genotoxicity studies, and showed no
Klopidogrel so preizkušali v številnih in vitro ter in vivo študijah genotoksičnosti in ni pokazal
The CYP2C19*2 and CYP2C19*3 alleles account for 85% of reduced function alleles in whites and 99% in Asians.
Na račun alelov CYP2C19*2 in CYP2C19*3 gre 85 % alelov z zmanjšanim delovanjem pri belcih in 99 % pri Azijcih.
The most common side effect (affects 1 to 10 patients in 100) reported with Clopidogrel BMS is bleeding.
Najpogostejši neželeni učinek (pojavi se pri 1 do 10 od 100 bolnikov), o katerem so poročali s klopidogrelom je krvavitev.
The clinically relevant adverse reactions observed in the CAPRIE, CURE, CLARITY and COMMIT studies are discussed below.
Klinično pomembni neželeni učinki, zabeleženi v študijah CAPRIE, CURE, CLARITY in COMMIT, so predstavljeni spodaj.
• 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) - a blood disorder that makes you prone to internal bleeding (bleeding inside any tissues, organs or joints of your body).
• če imate tveganje za krvavitev, kot je: - zdravstveno stanje s tveganjem za notranjo krvavitev (kot je rana na želodcu) - krvna motnja, zaradi katere ste bolj nagnjeni k notranji krvavitvi (krvavitev v tkivih, organih ali sklepih vašega telesa).
If you have experienced severe chest pain (unstable angina or heart attack), you may be prescribed Clopidogrel BMS in combination with acetylsalicylic acid, a substance present in many medicines used to relieve pain and lower fever.
Če ste doživeli hudo bolečino v prsih (nestabilna angina pektoris ali srčni napad), so vam morda predpisali zdravilo Clopidogrel BMS v kombinaciji z acetilsalicilno kislino, učinkovino, ki je prisotna v številnih zdravilih, ki se uporabljajo za lajšanje bolečine in zniževanje zvišane telesne temperature.
Clopidogrel BMS is taken to prevent blood clots (thrombi) forming in hardened blood vessels (arteries), a process known as atherothrombosis, which can lead to atherothrombotic events (such as
Clopidogrel BMS se jemlje za preprečevanje nastanka krvnih strdkov (trombov) v otrdelih krvnih žilah (arterijah), proces je znan kot aterotromboza in lahko vodi do aterotrombotičnih dogodkov (kot
Clopidogrel significantly reduced the relative risk of death from any cause by 7% (p = 0.029), and the relative risk of the combination of re-infarction, stroke or death by 9% (p = 0.002), representing an absolute reduction of 0.5% and 0.9%, respectively.
Klopidogrel je pomembno zmanjšal relativno tveganje za smrt zaradi kateregakoli vzroka za 7 % (p=0,029) in relativno tveganje za ponovni infarkt, kap ali smrt za 9 % (p=0,002), kar je predstavljalo absolutno zmanjšanje za 0,5 % oziroma 0,9 %.
• If you are allergic (hypersensitive) to clopidogrel or any of the other ingredients of Clopidogrel
- če ste alergični na (preobčutljivi za) klopidogrel ali katerokoli sestavino zdravila Clopidogrel
Marketing Authorisation Holder and Manufacturer:
Imetnik dovoljenja za promet z zdravilom in izdelovalec:
For patients over 75 years of age clopidogrel, should be initiated without a loading dose.
Pri bolnikih, ki so starejši od 75 let, je treba zdravljenje s klopidogrelom začeti brez udarnega odmerka.
Take special care with Clopidogrel BMS: If any of the situations mentioned below apply to you, you should tell your doctor before taking Clopidogrel BMS:
Bodite posebno pozorni pri jemanju zdravila Clopidogrel BMS: Če katerokoli od spodaj navedenih stanj velja za vas, morate o tem obvestiti svojega zdravnika, preden boste vzeli klopidogrel:
Like all medicines, Clopidogrel BMS can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Clopidogrel BMS neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Clopidogrel BMS contains lactose.
Zdravilo Clopidogrel BMS vsebuje laktozo.
CYP2C19 poor metaboliser status is associated with diminished response to clopidogrel.
Status slabega presnavljalca s CYP2C19 je povezan z manjšim odzivom na klopidogrel.
Clopidogrel BMS is unlikely to affect your ability to drive or to use machines.
Ni verjetno, da bi klopidogrel vplival na vašo sposobnost za vožnjo ali upravljanje strojev.
There was no excess in major bleeds with clopidogrel + ASA within 7 days after coronary bypass graft surgery in patients who stopped therapy more than five days prior to surgery (4.4% clopidogrel+ASA vs. 5.3% placebo+ASA).
Število velikih krvavitev s klopidogrelom in ASA ni bilo prekoračeno v 7 dneh po koronarni premostitveni operaciji pri bolnikih, ki so prenehali z zdravljenjem več kot 5 dni pred kirurškim posegom (4,4 % klopidogrel in ASA proti 5,3 % placebo in ASA).
In patients who remained on therapy within five days of bypass graft surgery, the event rate was 9.6% for clopidogrel+ASA, and 6.3% for placebo+ASA.
Pri bolnikih, ki so ostali na zdravljenju do 5 dni pred koronarno premostitveno operacijo, je bil delež dogodkov 9,6 % za klopidogrel in ASA in 6,3 % za placebo in ASA.
In patients with acute ST-segment elevation MI, safety and efficacy of clopidogrel have been evaluated in 2 randomised, placebo-controlled, double-blind studies, CLARITY and COMMIT.
Pri bolnikih z akutnim miokardnim infarktom z elevacijo ST spojnice sta bili varnost in učinkovitost klopidogrela vrednoteni v dveh randomiziranih, s placebom kontroliranih, dvojno slepih študijah,
See leaflet for further information.
Za dodatne informacije glejte navodilo za
PARTICULARS TO APPEAR ON BLISTERS (boxes of 7, 14, 28 or 84 tablets)
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU (Škatle po 7, 14, 28 ali 84 tablet)
There may be genetic variants of other CYP450 enzymes with effects on the ability to form the active
Mogoče je, da obstajajo tudi genetske različice drugih encimov CYP450, ki vplivajo na zmožnost tvorbe aktivnega presnovka klopidogrela.
• You should also tell your doctor immediately if you develop a medical condition 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
• morate takoj povedati zdravniku, če razvijete bolezensko stanje z vročino 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
Clopidogrel BMS is supplied in cardboard cartons containing 7, 14, 28, 30, 84, 90 and 100 tablets in PVC/PVDC/Aluminium blisters or in all aluminium blisters, or 50x1 tablets in PVC/PVDC/Aluminium blisters or in all aluminium perforated unit-dose blisters.
Zdravilo Clopidogrel BMS je na voljo v škatlah, ki vsebujejo 7, 14, 28, 30, 84, 90 in 100 tablet v PVC/PVDC/alu pretisnih omotih ali v pretisnih omotih iz aluminija, ali 50x1 tableta v PVC/PVDC aluminijastih pretisnih omotih ali v aluminijastih perforiranih pretisnih omotih za enkratni odmerek.
A. MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
A. IMETNIKI DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVORNI ZA SPROŠČANJE SERIJE
(primary endpoint) were prevented, with relative risk reductions of 22% (CI: 8.6, 33.4), 32% (CI: 12.8, 46.4), 4% (CI: -26.9, 26.7), 6% (CI: -33.5, 34.3) and 14% (CI: -31.6, 44.2), during the 0-1, 1-3, 3-6, 6-9 and 9-12 month study intervals, respectively.
Nove srčnožilne dogodke (primarni opazovani dogodek) so preprečeli z zmanjšanjem relativnega tveganja: 22 % (IZ: 8,6, 33,4), 32 % (IZ: 12,8, 46,4), 4 % (IZ: -26,9, 26,7), 6 % (IZ: -33,5, 34,3) in 14 % (IZ: -31,6, 44,2) tekom 0-1, 1-3, 3-6, 6-9 oziroma 9-12 mesečnimi intrevali študije.
In addition to clinical studies experience, adverse reactions have been
Poleg neželenih učinkov v kliničnih študijah so bili neželeni učinki
Adverse reactions that occurred either during clinical studies or that were spontaneously reported are presented in the table below.
Neželeni učinki, zabeleženi v kliničnih študijah ali opisani spontano, so našteti v spodnji tabeli.
However, if you are concerned by your bleeding, you should contact your doctor straightaway (see section 2 ‘Take special care with Clopidogrel BMS').
Vendar pa se morate takoj posvetovati s svojim zdravnikom, če ste glede krvavitve v kakršnihkoli dvomih (glejte poglavje 2 »Bodite posebno pozorni pri jemanju zdravila Clopidogrel BMS«).
As a precautionary measure, breast-feeding should not be continued during treatment with Clopidogrel BMS.
Iz varnostnih razlogov naj se z dojenjem med zdravljenjem z zdravilom Clopidogrel BMS ne nadaljuje.
The risk of bleeding (life-threatening, major, minor, other) decreased during the course of the trial: 0-1 months (clopidogrel: 9.6%; placebo: 6.6%), 1-3 months (clopidogrel: 4.5%; placebo: 2.3%), 3-6 months (clopidogrel: 3.8%; placebo: 1.6%), 6-9 months (clopidogrel: 3.2%; placebo: 1.5%), 9-12 months (clopidogrel: 1.9%; placebo: 1.0%).
Tveganje za krvavitev (življenje ogrožajoče, velike, manjše, druge) se je zmanjševalo tekom preskušanja: 0-1 mesec (klopidogrel: 9,6 %; placebo: 6,6 %), 1-3 meseci (klopidogrel: 4,5 %; placebo: 2,3 %), 3-6 mesecev (klopidogrel: 3,8 %; placebo: 1,6 %), 6-9 mesecev (klopidogrel: 3,2 %; placebo: 1,5 %), 9-12 mesecev (klopidogrel: 1,9 %; placebo: 1,0 %).
WHAT CLOPIDOGREL BMS IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO CLOPIDOGREL BMS IN ZA KAJ GA UPORABLJAMO
Uncommon side effects (affects 1 to 10 patients in 1,000): Headache, stomach ulcer, vomiting, nausea, constipation, excessive gas in stomach or intestines, rashes, itching, dizziness, sensation of
Občasni neželeni učinki (pojavijo se pri 1 do 10 od 1.000 bolnikov): Glavobol, razjeda na želodcu, bruhanje, slabost, zaprtost, preveč plinov v želodcu ali črevesju, izpuščaji, srbenje, omotica, občutek
Concomitant use of drugs that inhibit CYP2C19 should be discouraged (see sections 4.4 and 5.2).
Sočasno naj ne bi uporabljali zdravil, ki zavirajo CYP2C19 (glejte poglavji 4.4 in 5.2).
• You should tell your doctor or pharmacist if you notice any side effect not listed in section 4 ‘POSSIBLE SIDE EFFECTS' or if you notice that a side effect gets serious.
• obvestite svojega zdravnika ali farmacevta, če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v poglavju 4 »MOŽNI NEŽELENI UČINKI«.