natgillin/translations-raw huggingface dataset:
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.
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.
Hallucinations, confusion Taste disturbances
Psihiatrične motnje halucinacije, zmedenost
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
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).
However, clopidogrel and ASA have been administered together for up to one year (see
Vendar pa so klopidogrel in ASA sočasno jemali do eno leto (glejte poglavje 5.1).
SPECIAL STORAGE CONDITIONS Store in the original package in order to protect from moisture and light.
POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte v originalni ovojnini za zagotovitev zaščite pred vlago in svetlobo.
The CLARINET and the PICOLO trials were conducted using a constituted solution of clopidogrel.
Preskušanji CLARINET in PICOLO so izvedli z uporabo pripravljene raztopine klopidogrela.
• Renal impairment Therapeutic experience is limited in patients with renal impairment (see section 4.4).
• Okvara ledvic Terapevtske izkušnje pri bolnikih z ledvično okvaro so omejene (glejte poglavje 4.4).
Clopidogrel active metabolite pharmacokinetics and antiplatelet effects, as measured by ex vivo platelet aggregation assays, differ according to CYP2C19 genotype.
Farmakokinetika aktivnega presnovka klopidogrela in njegovo antitrombocitno delovanje, merjeno s preskusi agregacije trombocitov ex vivo, se razlikuje glede na genotip CYP2C19.
Glycoprotein IIb/IIIa inhibitors: clopidogrel should be used with caution in patients receive concomitant glycoprotein IIb/IIIa inhibitors (see section 4.4).
Zaviralci glikoproteina IIb/IIIa: klopidogrel moramo uporabljati previdno pri bolnikih, ki prejemajo sočasno zaviralce glikoproteina IIb/IIIa (glejte poglavje 4.4).
Ask your doctor or pharmacist for advice before taking any medicine.
Posvetujete se z zdravnikom ali s farmacevtom, preden vzamete katerokoli zdravilo
Less pronounced reductions of metabolite exposure has been observed with pantoprazole or
Manj izrazita zmanjšana izpostavljenost presnovkov je bila opažena pri pantoprazolu ali lansoprazolu.
Important information about some of the ingredients of Clopidogrel Qualimed Clopidogrel Qualimed contains hydrogenated castor oil which may cause stomach upset and diarrhoea.
Pomembne informacije o nekaterih sestavinah zdravila Klopidogrel Qualimed Hidrogenirano ricinusovo olje lahko povzroči želodčne motnje ali drisko.
B. CONDITIONS OF THE MARKETING AUTHORISATION • CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON
• POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, PREDPISANI IMETNIKU
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 v nadaljevanju.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Qualimed, 117 allee des Parcs, 69 800 Saint Priest, France
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Qualimed, 117 allee des Parcs, 69 800 Saint Priest, Francija
Medicinal products that inhibit CYP2C19 include omeprazole and esomeprazole, fluvoxamine, fluoxetine, moclobemide, voriconazole, fluconazole, ticlopidine, ciprofloxacin, cimetidine, carbamazepine, oxcarbazepine and chloramphenicol.
Med zdravili, ki zavirajo CYP2C19, so omeprazol in esomeprazol, fluvoksamin, fluoksetin, moklobemid, vorikonazol, flukonazol, tiklopidin, ciprofloksacin, cimetidin, karbamazepin, okskarbazepin in kloramfenikol.
No effect on hepatic metabolising enzymes was observed in humans receiving clopidogrel at the therapeutic dose.
Nobenega učinka na presnovne encime pa niso opazili pri ljudeh ob jemanju terapevtskih odmerkov.
Mean peak plasma levels of unchanged clopidogrel (approximately 2.2-2.5 ng/ml after a single 75 mg oral dose) occurred approximately 45 minutes after dosing.
Povprečna največja koncentracija nespremenjenega klopidogrela v plazmi (približno 2,2-2,5 ng/ml po enem 75-mg peroralnem odmerku) se je pojavila približno 45 minut po odmerjanju.
In a small number of cases, bleeding in the eye, inside the head, the lung or the joints has also been reported.
V redkih primerih so poročali tudi o očesnih krvavitvah, krvavitvah v glavi, pljučih ali sklepih.
- Tablet core: microcrystalline cellulose, colloidal anhydrous silica, crospovidone (type A), macrogol 6000, hydrogenated castor oil - Film-coating: hydroxypropylcellulose (E463), titanium dioxide (E171), red iron oxide (E172), talc and propylene glycol.
Pomožne snovi so: - Jedro tablete: mikrokristalna celuloza, brezvodni koloidni silicijev dioksid, krospovidon (vrsta A), makrogol 6000 in hidrogenirano ricinusovo olje - Obloga tablete: hidroksipropilceluloza (E463), titanov dioksid (E171), rdeči železov oksid (E172), smukec ter propilenglikol.
After a single oral dose of 75 mg, clopidogrel has a half-life of approximately 6 hours.
Po enem peroralnem odmerku 75 mg je razpolovni čas klopidogrela približno 6 ur.
The active thiol metabolite which has been isolated in vitro, binds rapidly and irreversibly to platelet receptors, thus inhibiting platelet aggregation.
In vitro izolirani aktivni tiolski presnovek se hitro in ireverzibilno veže na trombocitne receptorje in tako zavre agregacijo trombocitov.
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.
Tako kot druge antitrombotike tudi klopidogrel previdno uporabljamo pri bolnikih, pri katerih zaradi poškodbe, kirurškega posega ali drugih patoloških stanj obstaja tveganje za povečano krvavitev, in pri bolnikih, ki so na zdravljenju z ASA, s heparinom, z zaviralci glikoproteina IIb/IIIa ali z nesteroidnimi protivnetnimi zdravili, vključno z zaviralci ciklooksigenaze-2 (COX-2).
CYP2C19 is involved in the formation of both the active metabolite and the 2-oxo-clopidogrel intermediate metabolite.
CYP2C19 je vključen tako v nastajanje aktivnega presnovka kot vmesnega presnovka, 2oksoklopidogrela.
What Clopidogrel Qualimed is and what it is used for 2.
KAJ JE ZDRAVILO KLOPIDOGREL QUALIMED IN ZA KAJ GA UPORABLJAMO
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]).
Pri analizi podskupin glede na vključitveni pogoj (MI, ishemična kap in PAD) je bila korist (doseganje statistične značilnosti pri p = 0,003) največja pri bolnikih, vključenih zaradi PAD (zlasti pri tistih, ki so doživeli tudi MI) (zmanjšanje RT: =23,7 %; IZ: 8,9 do 36,2), in manjša (ni bila pomembno drugačna kot pri ASA) pri bolnikih s kapjo (zmanjšanje RT: 7,3 %; IZ: -5,7 do 18,7 /p = 0,258/).
In the intention to treat analysis, 939 events were observed in the clopidogrel group and 1,020 events with ASA (relative risk reduction (RRR) 8.7%, [95% CI: 0.2 to 16.4]; p = 0.045), which corresponds, for every 1000 patients treated for 2 years, to 10 [CI: 0 to 20] additional patients being prevented from experiencing a new ischaemic event.
Pri analizi vključenih bolnikov (intention to treat analysis) so v skupini, ki je jemala klopidogrel, opazili 939 dogodkov, v skupini, ki je jemala ASA, pa 1.020 dogodkov (zmanjšanje relativnega tveganja /RT/: 8,7 %, 95-odstotni interval zaupanja /IZ/: 0,2 do 16,4; p = 0,045), kar ustreza preprečevanju pojava novega ishemičnega dogodka na vsakih 1.000 bolnikov, zdravljenih 2 leti, dodatnim 10 (IZ: 0 do 20) bolnikom.
Perforated unit dose blister of OPA/Al/PVC-Al containing 30x1 and 50x1 film-coated tablets in the box.
Perforiran pretisni omot za posamicno odmerjanje iz OPA/Al/PVC-Al , ki vsebuje 30 x 1 in 50 x 1 filmsko obloženo tableto in je pakiran v škatli.
Clopidogrel must be metabolised by CYP450 enzymes to produce the active metabolite that inhibits platelet aggregation.
Encimi CYP450 morajo presnoviti klopidogrel, da nastane aktivni presnovek, ki zavira agregacijo trombocitov.
The pharmacokinetics of the active metabolite of clopidogrel is not known in these special
Posebne skupine bolnikov Farmakokinetika aktivnega presnovka klopidogrela v teh posebnih skupinah bolnikov ni znana.
NSAIDs: in a clinical study conducted in healthy volunteers, the concomitant administration of clopidogrel and naproxen increased occult gastrointestinal blood loss.
V klinični študiji, na zdravih prostovoljcih je sočasno jemanje klopidogrela in naproksena povečalo prikrito krvavitev iz prebavil.
Boxes of 30x1 and 50x1 film-coated tablets in perforated unit dose blisters are available.
Na voljo so škatle s 30 x 1 ali 50 x 1 filmsko obloženo tableto v perforiranem pretisnem omotu za posamicno odmerjanje.
If you forget for more than 12 hours, simply take the next single dose at the usual time.
Če na odmerek pozabite za več kot 12 ur, izpustite pozabljeni odmerek in vzemite naslednji odmerek kot običajno.
4.7 Effects on ability to drive and use machines Clopidogrel has no or negligible influence on the ability to drive and use machines.
Klopidogrel nima ali ima zanemarljiv vpliv na sposobnost za vožnjo in upravljanje strojev.
Glomerulonephritis, blood creatinine increased
Bolezni sečil hematurija glomerulonefritis, povečana vrednost kreatinina v krvi
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 niso ugotovili nobenega genotoksičnega učinka.
As a precaution concomitant use of strong or moderate CYP2C19 inhibitors should be discouraged (see section 4.5 for a list of CYP2C19 inhibitors, see also section 5.2).
Iz previdnosti naj sočasno ne bi uporabljali močnih ali srednje močnih zaviralcev CYP2C19 (za seznam zaviralcev CYP2C19 glejte poglavje 4.5; glejte tudi poglavje 5.2).
Co-administration of heparin had no effect on the inhibition of platelet aggregation induced by clopidogrel.
Sočasno jemanje heparina ni vplivalo na zaviranje agregacije trombocitov, ki jo je sprožil klopidogrel.
No antidote to the pharmacological activity of clopidogrel has been found.
Antidot farmakološkemu delovanju klopidogrela ni znan.
Store in the original package in order to protect from moisture and light.
Shranjujte v originalni ovojnini za zagotovitev zaščite pred vlago in svetlobo.
In CURE, CLARITY and one of the cohort studies (Trenk), no increased event rate was observed
V študijah CURE, CLARITY in eni od kohortnih študij (Trenk) niso odkrili večjega deleža dogodkov glede na metabolizatorsko stanje.
Very rare side effects: Jaundice; severe abdominal pain with or without back pain; fever, breathing difficulties sometimes associated with cough; generalised allergic reactions; swelling in the mouth; blisters of the skin; skin allergy; inflammation of the mouth (stomatitis); decrease in blood pressure; confusion; hallucinations; joint pain; muscular pain; changes in the way things taste..
Zelo redki neželeni učinki: zlatenica, huda bolečina v trebuhu z bolečino v hrbtu ali brez nje, zvišana telesna temperatura, težave pri dihanju, ki so včasih povezane s kašljem, splošne alergijske reakcije, oteklina v ustih, mehurji na koži, kožna alergija, vnetje v ustih (stomatitis), znižanje krvnega tlaka, zmedenost, halucinacije, bolečine v sklepih, bolečine v mišicah, motnje okusa.
Tests are available to determine a patient's CYP2C19 genotype.
Na voljo so testi za določitev bolnikovega CYP2C19-genotipa.
In addition to clinical studies experience, adverse reactions have been spontaneously reported.
Poleg neželenih učinkov, ki so jih bolniki navajali v kliničnih študijah, so neželene učinke prijavljali tudi spontano.
Detailed information is available on the European Medicines Agency website:
<Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http:// www.ema.europa.eu/
• Adults 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
• odraslihbolnikih z miokardnim infarktom (od nekaj dni do manj kot 35 dni), ishemično kapjo
Overdose following clopidogrel administration may lead to prolonged bleeding time and subsequent bleeding complications.
Preveliki odmerki klopidogrela lahko podaljšajo čas krvavitve in posledično povzročijo zaplete s krvavitvijo.
Tests are available to identify a patient's CYP2C19 genotype.
Na voljo so testi za ugotavljanje bolnikovega CYP2C19-genotipa.
After repeated doses of 75 mg clopidogrel per day for 10 days in patients with severe hepatic impairment, inhibition of ADP-induced platelet aggregation was similar to that observed in healthy subjects.
Po večkratnem odmerjanju 75 mg klopidogrela na dan 10 dni pri bolnikih s hudo okvaro jeter je bilo zavrtje z ADP izzvane agregacije trombocitov podobno kot pri zdravih preiskovancih.
Take special care with Clopidogrel Qualimed
Bodite posebno pozorni pri jemanju zdravila Klopidogrel Qualimed
Subsequent metabolism of the 2-oxo-clopidogrel intermediate metabolite results in formation of the active metabolite, a thiol derivative of clopidogrel.
Nadaljnja presnova vmesnega presnovka 2-oksoklopidogrela povzroči nastanek aktivnega presnovka, ki je tiolski derivat klopidogrela.
Pregnancy and breast-feeding It is preferable not to take this product during pregnancy..
Nosečnost in dojenje Priporočljivo je, da tega zdravila ne jemljejo nosečnice in matere, ki dojijo.
Therapeutic experience is limited in patients with moderate hepatic disease who may have bleeding diatheses (see section 4.4).
Terapevtske izkušnje pri bolnikih z zmerno jetrno boleznijo, ki imajo lahko hemoragično diatezo, so omejene (glejte poglavje 4.4).
Uncommon side effects: Headache, stomach ulcer, vomiting, nausea, constipation, excessive gas in stomach or intestines, rashes, itching, dizziness, sensation of tingling and numbness.
Občasni neželeni učinki: glavobol, razjeda na želodcu, bruhanje, slabost, zaprtost, preveč plinov v želodcu ali črevesju, izpuščaji, srbenje, omotica, občutek mravljinčenja in omrtvelosti.
Furthermore, the pharmacodynamic activity of clopidogrel was not significantly influenced by the coadministration of phenobarbital, or oestrogen.
Na farmakodinamiko klopidogrela tudi ni pomembno vplivalo sočasno jemanje fenobarbitala, ali estrogena.
Contact your doctor immediately if you experience:
Še posebej pomembno je, da obvestite svojega zdravnika, če jemljete
Esomeprazole is expected to give a similar interaction with clopidogrel.
Pričakovati je mogoče, da ima podobno medsebojno delovanje s klopidogrelom tudi esomeprazol.
At steady state, the average inhibition level observed with a dose of 75 mg per day was between 40% and
V stanju dinamičnega ravnovesja je bila povprečna raven zaviranja z odmerkom 75 mg na dan 40- do 60-odstotna.
This medicinal product contains hydrogenated castor oil which may cause stomach upset and
Pomožne snovi Zdravilo vsebuje hidrogenirano ricinusovo olje, ki lahko razdraži želodec in povzroči drisko.
Acetylsalicylic acid (ASA): ASA did not modify the clopidogrel-mediated inhibition of ADP-induced platelet aggregation, but clopidogrel potentiated the effect of ASA on collagen-induced platelet aggregation.
ASA ni spremenila s klopidogrelom dosežene inhibicije z ADP-jem sprožene agregacije trombocitov, vendar klopidogrel ojača učinek ASA na s kolagenom sproženo agregacijo trombocitov.
- fluconazole, voriconazole, ciprofloxacin, or chloramphenicol, medicines to treat bacterial and
• flukonazol, vorikonazol, ciprofloksacin ali klorampfenikol, zdravila za zdravljenje bakterijskih in glivičnih okužb,
Heparin: in a clinical study conducted in healthy subjects, clopidogrel did not necessitate modification of the heparin dose or alter the effect of heparin on coagulation.
V klinični študiji na zdravih osebah zaradi jemanja klopidogrela ni bilo treba spremeniti odmerka heparina, pa tudi učinek heparina na koagulacijo se ni spremenil.
By preventing this clumping, antiplatelet medicinal products reduce the chances of blood clots forming (a process called
Zaviralci agregacije trombocitov preprečujejo to zlepljanje in s tem zmanjšajo možnost za nastanek krvnih strdkov (proces se imenuje tromboza).
The concomitant administration of clopidogrel with oral anticoagulants is not recommended since it may increase the intensity of bleedings (see section 4.5).
Sočasno jemanje klopidogrela in peroralnih antikoagulantov ni priporočljivo, ker lahko poveča intenzivnost krvavitev (glejte poglavje 4.4).
Inconsistent data on the clinical implications of this pharmacokinetic (PK)/pharmacodynamic (PD) interaction in terms of major cardiovascular events have been reported from both observational and clinical studies.
Opazovalne in klinične študije so dale razhajajoče se podatke o kliničnih posledicah tega farmakokinetičnega/farmakodinamskega medsebojnega delovanja, kar zadeva večje kardiovaskularne dogodke.
At very high doses, a poor gastric tolerability (gastritis, gastric erosions and/or vomiting) of clopidogrel was also reported in rat and baboon.
Pri zelo velikih odmerkih so pri podganah in pavijanih poročali tudi o slabem želodčnem prenašanju (gastritis, želodčne erozije in/ali bruhanje).
As no clinical data on exposure to clopidogrel during pregnancy are available, it is preferable not to use clopidogrel during pregnancy as a precautionary measure.
Kliničnih podatkov o zdravljenju nosečnic s klopidogrelom ni, zato je iz varnostnih razlogov priporočeno, da nosečnice klopidogrela ne jemljejo.
The dose of 0.2 mg/kg achieved the mean percent inhibition of 49.3% (5 µM ADP-induced platelet aggregation) which was comparable to that of adults taking
Odmerek 0,2 mg/kg je dosegel povprečno 49,3 % zavrtje (agregacija trombocitov povzročena s 5 µM ADP), primerljivo kot pri odraslih ob uporabi zdravila Plavix v odmerku 75 mg/dan.
Serious haemorrhage, haemorrhage of operative wound, vasculitis, hypotension Respiratory tract bleeding (haemoptysis, pulmonary haemorrhage), bronchospasm, interstitial pneumonitis
Bolezni dihal, prsnega koša in mediastinalnega prostora epistaksa krvavitve v dihalih (hemoptiza, pljučna krvavitev), bronhospazem, intersticijski pnevmonitis
- For more than 12 hours: patients should take the next dose at the regular scheduled time
- če je zamuda več kot 12 ur: bolnik naj naslednji odmerek vzame ob pravem času; odmerka ne sme podvojiti.
• very rare (affects less than 1 user in 10,000)
• zelo redki (pojavijo se pri manj kot 1 od 10.000 uporabnikov)
NAME OF THE MARKETING AUTHORISATION HOLDER
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Qualimed
Clopidogrel Qualimed is unlikely to affect your ability to drive or to use machines.
Vpliv na sposobnost upravljanja vozil in strojev Ni verjetno, da bi zdravilo Klopidogrel Qualimed vplivalo na vašo sposobnost za vožnjo ali upravljanje strojev.
However, patients entered into clinical trials with clopidogrel received a variety of concomitant medicinal products including diuretics, beta blockers, ACEI, calcium antagonists, cholesterol lowering agents, coronary vasodilators, antidiabetic agents (including insulin), antiepileptic agents, and GPIIb/IIIa antagonists without evidence of clinically significant adverse interactions.
Vendar pa so bolniki, ki so bili vključeni v klinično preizkušanje klopidogrela, brez dokazov o klinično pomembnih neželenih interakcijah sočasno jemali različna zdravila, tudi diuretike, zaviralce adrenergičnih receptorjev beta, zaviralce angiotenzinske konvertaze (ACE), kalcijeve antagoniste, učinkovine za zniževanje holesterola, koronarne vazodilatatorje, antidiabetike (tudi insulin), antiepileptične učinkovine in antagoniste glikoproteinov IIb/IIIa.
Other concomitant therapy:
Drugo sočasno zdravljenje.
As a precaution concomitant use of strong or moderateCYP2C19 inhibitors should be discouraged (see sections 4.4 and 5.2).
Iz previdnosti naj sočasno ne bi uporabljali močnih ali srednje močnih zaviralcev CYP2C19 (glejte poglavji 4.4 in 5.2).
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER (Boxes of 7, 14, 28, 30, 30x1, 50, 50x1, 56, 84, 90 and 100)
PRETISNI OMOT ŠKATLE Z DNE 7, 14, 28, 30, 30X1, 50, 50X1, 56, 84, 90 IN 100
Acute liver failure, hepatitis, abnormal liver function test
Bolezni jeter, žolčnika in žolčevodov akutna jetrna odpoved, hepatitis, nenormalni testi jetrne funkcije
Consistent with the above results, in a meta-analysis including 6 studies of 335 clopidogrel-treated subjects at steady state, it was shown that active metabolite exposure was decreased by 28% for intermediate metabolisers, and 72% for poor metabolisers while platelet aggregation inhibition (5 μM ADP) was decreased with differences in IPA of 5.9% and 21.4%, respectively, when compared to
Pokazala je, da se je v primerjavi z dobrimi metabolizatorji izpostavljenost aktivnemu presnovku pri srednjih metabolizatorjih za 28 % zmanjšala, pri slabih metabolizatorjih se je zmanjšala za 72 %, zavrtje agregacije trombocitov (5 µM ADP) pa se je zmanjšalo tako, da je bila razlika IPA v primerjavi z dobrimi metabolizatorji pri prvih 5,9 % in pri drugih 21,4 %.
After repeated doses of 75 mg clopidogrel per day in subjects with severe renal disease (creatinine clearance from 5 to 15 ml/min) inhibition of ADP-induced platelet aggregation was lower (25%) than that observed in healthy subjects, however, the prolongation of bleeding time was similar to that seen in healthy subjects receiving 75 mg of clopidogrel per day.
Po večkratnih odmerkih 75 mg klopidogrela na dan, je bila pri osebah s hudo ledvično boleznijo (očistek kreatinina 5 do 15 ml/min) inhibicija z ADP sprožene agregacije trombocitov manjša (25 %) od tiste, opažene pri zdravih osebah.
There was no evidence of carcinogenic effect when clopidogrel was administered for 78 weeks to mice and 104 weeks to rats when given at doses up to 77 mg/kg per day (representing at least 25 times the exposure seen in humans receiving the clinical dose of 75 mg/day).
O kancerogenem učinku klopidogrela v odmerkih do 77 mg/kg na dan (kar predstavlja najmanj 25krat večjo izpostavljenost kot pri človeku ob jemanju kliničnega odmerka 75 mg na dan), ki so ga mišim dajali 78 tednov, podganam pa 104 tedne, ni bilo dokazov.
Clopidogrel Qualimed 75 mg film-coated tablets Clopidogrel
Klopidogrel Qualimed 75 mg filmsko obložene tablete klopidogrel
• if you suffer from severe liver disease;
• če imate hudo jetrno obolenje.
- 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.
Če bolnik izpusti odmerek: - če je zamuda manj kot 12 ur po pravem času: bolnik naj odmerek vzame takoj, potem pa naslednji odmerek ob pravem času.
Calendar Blister of OPA/Al/PVC-Al containing 7, 14, 28, 56, 84 film-coated tablets in the box.
Koledarski pretisni omot iz OPA/Al/PVC-Al , ki vsebuje 7, 14, 28, 56 ali 84 filmsko obloženih tablet in je pakiran v škatli.
NAME OF THE MEDICINAL PRODUCT Clopidogrel Qualimed 75 mg film-coated tablets
IME ZDRAVILA Klopidogrel Qualimed 75 mg filmsko obložene tablete