FrancophonIA/ELRC3.0 huggingface dataset:
English: Marketing Authorisation Holder Teva Generics B.V., Computerweg 10, 3542 DR Utrecht, The Netherlands
Maltese: Teva Generics B.V., Computerweg 10, 3542 DR Utrecht, L-Olanda.
English: Poor metabolism: CYP2C19*2/*2, *2/*3 or *3/*3
Maltese: CYP2C19*2/*2, *2/*3 or *3/*3
English: Excipient:
Maltese: Manifattur:
English: The use of clopidogrel in CURE was associated with a decrease in the need of thrombolytic therapy (RRR=43.3%; CI: 24.3%, 57.5%) and GPIIb/IIIa inhibitors (RRR=18.2%; CI: 6.5%, 28.3%).
Maltese: L-użu ta' clopidogrel fi CURE kien assoċjat mat-tnaqqis fil-bżonn ta' kura trombolitika (RRR = 43.3%; CI: 24.3%, 57.5%) u inibituri ta' GPIIb/IIIa (RRR = 18.2%; CI: 6.5%, 28.
English: • Adults and elderly
Maltese: • Adulti u anzjani
English: INFORMATION IN BRAILLE Clopidogrel Teva Generics B.V. 75 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Clopidogrel Teva Generics B.V. 75 mg
English: The CLARITY trial included 3,491 patients presenting within 12 hours of the onset of a ST elevation MI and planned for thrombolytic therapy.
Maltese: Il-prova CLARITY inkludiet 3,491 pazjenti li daħlu fi żmien 12-il siegħa mill-bidu ta' infart mijokardijaku b'ST elevat, fejn kien ippjanat li tingħata t-terapija trombolitika.
English: Thrombotic thrombocytopenic purpura (TTP) (see section 4.4), aplastic anaemia, pancytopenia, agranulocytosis, severe thrombocytopenia, granulocytopenia, anaemia
Maltese: Purpura tromboċitopenika trombotika (TTP) (ara sezzjoni 4.4), anemija aplastika, panċitopenja, agranuloċitosi, tromboċitopenja severa, granuloċitopenja, anemija
English: The incidence of major bleeding was similar between groups (1.3% versus 1.1% for the clopidogrel + ASA and the placebo + ASA groups, respectively).
Maltese: L-inċidenza ta' fsada maġġuri kienet simili bejn il-gruppi (1.3% kontra 1.1% għal gruppi clopidogrel + ASA u l-plaċebo + ASA, rispettivament).
English: Taste disturbances
Maltese: Disturbi vaskulari
English: In CLARITY, there was an overall increase in bleeding in the clopidogrel + ASA group (17.4%) vs. the placebo + ASA group (12.9%).
Maltese: F'CLARITY, kien hemm żieda totali ta' fsada fil-grupp ta' clopidogrel + ASA (17.4%) kontra l-grupp ta' plaċebo + ASA (12.9%).
English: Hydrogenated castor oil
Maltese: Hydrogenated castor oil Kisi tar-rita:
English: Glomerulonephritis, blood creatinine increased
Maltese: Glomerulonefrite, żieda tal-kreatinina fiddemm
English: • Pharmacogenetics
Maltese: • Farmakoġenetika
English: 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
Maltese: Il-frekwenza tagħhom hija definita skont dawn il-konvenzjonijiet: komuni (≥1/100 sa <1/10); mhux komuni (≥/1,000 sa <1/100); rari (≥1/10,000 sa <1/1,000); rari ħafna
English: A total of 99.7% of patients received fibrinolytics (fibrin specific: 68.7%, non- fibrin specific: 31.1%), 89.5% heparin, 78.7% beta blockers, 54.7% ACE inhibitors and 63% statins.
Maltese: 31.1%), 89.5% heparin, 78.7% imblokkaturi tar-riċetturi beta, 54.7% l-inibituri ACE u 63% statins.
English: - The other ingredients are microcrystalline cellulose, colloidal anhydrous silica, crospovidone (type A), macrogol 6000, hydrogenated castor oil in the tablet core and hydroxypropylcellulose (E463), titanium dioxide (E171), red iron oxide (E172), talc and propylene glycol in the filmcoating.
Maltese: Is-sustanzi l-oħra huma microcrystalline cellulose, colloidal anhydrous silica, crospovidone (type A), macrogol 6000, żejt ir-riġnu idroġenat fil-qalba tal-pillola u hydroxypropylcellulose (E463), titanium dioxide (E171), red iron oxide (E172), talc u propylene glycol fil-kisja tar-rita..
English: Very rare
Maltese: Rari Ħafna
English: Pharmacotherapeutic group: platelet aggregation inhibitors excl. heparin, ATC code: B01AC-04.
Maltese: Kategorija farmakoterapewtika: inibituri tal-aggregazzjoni tal-plejtlets eskl. heparin, Kodiċi ATC:
English: White (n=1356) Black (n=966) Chinese (n=573)
Maltese: Suwed (n=966)
English: The population included 27.8% women, 58.4% patients ≥60 years (26% ≥70 years) and 54.5% patients who received fibrinolytics.
Maltese: Il-grupp studjat inkluda 27.8% nisa, 58.4% pazjenti ≥60 sena (26% ≥70 sena) u 54.5% tal-pazjenti li rċevew issustanzi fibrinolitiċi.
English: The patient population included 19.7% women and 29.2% patients ≥65 years.
Maltese: Il-grupp ta' pazjenti studjati kien jinkludi 19.7% nisa u 29.2% pazjenti ≥65 sena.
English: Teva Generics B.V. Computerweg 10
Maltese: Computerweg 10
English: Musculo-skeletal bleeding (haemarthrosis), arthritis, arthralgia, myalgia
Maltese: Fsada muskoluskeltrali (emartrożi), artrite, artralġja, majalġja
English: Clopidogrel is indicated in adults for the prevention of atherothrombotic events in:
Maltese: Clopidogrel huwa indikat fl-adulti għall-prevenzjoni ta' każijiet aterotrombotiċi f':
English: Respiratory tract bleeding (haemoptysis, pulmonary haemorrhage), bronchospasm, interstitial pneumonitis
Maltese: Fsada fil-passaġġ respiratorju (emoptisi, emorraġija fil-pulmun), bronkospażmu, pulmonite interstizjali
English: Gastrointestinal and retroperitoneal haemorrhage with fatal outcome, pancreatitis, colitis (including ulcerative or lymphocytic colitis), stomatitis
Maltese: Emorraġija gastrointestinali u tar-retroperitonew b'eżitu fatali, pankreatite, kolite (inklużi kolite ulċerattiva jew limfoċitika), stomatite
English: Rash, pruritus, skin bleeding (purpura)
Maltese: Raxx, ħakk, fsada fil-ġilda (purpura)
English: The CYP2C19*2 and CYP2C19*3 alleles account for 85% of reduced function alleles in whites and 99% in Asians.
Maltese: L-alleli CYP2C19*2 u CYP2C19*3 jgħoddu għal 85% tal-alleli b'funzjoni mnaqqsa fil-bojod u 99% fl-Asjatiċi.
English: In the fifth cohort study (n=2,208; Simon), the increased event rate was observed only in poor metabolisers.
Maltese: Fil-ħames studju tas-sett (n=2,208; Simon), iż-żieda fir-rata ta' avvenimenti ġie osservat biss fil-metabolizzaturi dgħajfa.
English: 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.
Maltese: F'pazjenti b'MI akut bl-ST segment elevat, is-sigurtà u l-effikaċja ta' clopidogrel kienu evalwati f'2 studji randomised, ikkontrollati bil-plaċebo, u double-blind, CLARITY u COMMIT.
English: The CYP2C19*1 allele corresponds to fully functional metabolism while the CYP2C19*2 and CYP2C19*3 alleles correspond to reduced metabolism.
Maltese: L-allel CYP2C19*1 jikkorrispondi ma' metaboliżmu kompletament funzjonali filwaqt li l-alleli CYP2C19*2 u CYP2C19*3 jikkorrispondu ma' metaboliżmu mnaqqas.
English: Overall, clopidogrel 75 mg/day was comparable to ASA 325 mg/day in CAPRIE regardless of age, gender and race.
Maltese: In ġenerali, clopidogrel 75 mg/jum kien jikkompara ma' ASA 325 mg/jum f'CAPRIE irrispettivament mill-età, sess u razza.
English: 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).
Maltese: L-assoċjazzjoni bejn il-ġenotip CYP2C19 u r-riżultat tal-kura b'clopidogrel ġie evalwat f'2 post hoc analiżi ta' studji kliniċi (sottostudji ta' CLARITY [n=465] u TRITON-TIMI 38 [n=1,477] u f'sett ta' 5 studji (total n=6,489).
English: The number of patients experiencing the primary endpoint [cardiovascular (CV) death, myocardial infarction (MI), or stroke] was 582 (9.3%) in the clopidogrel-treated group and 719 (11.4%) in the placebo-treated group, a 20% relative risk reduction (95% CI of 10%-28%; p=0.00009) for the clopidogrel-treated group (17% relative risk reduction when patients were treated conservatively, 29% when they underwent percutaneous transluminal coronary angioplasty (PTCA) with or without stent and 10% when they underwent coronary artery bypass graft (CABG)).
Maltese: In-numru ta' pazjenti li għaddew mill-punt primarju ta' tmiem [mewt kardjovaskulari (CV), infart mijokardijaku (MI) jew puplesija] kien 582 (9.3%) fil-grupp ikkurat bi clopidogrel u 719 (11.4%) fil-grupp ikkurat bil-plaċebo, li jissarraf fi tnaqqis fir-riskju relattiv ta' 20% (95% CI ta' 10%-28%; p=0.00009) għall-grupp ikkurat bi clopidogrel (tnaqqis fir-riskju relattiv ta' 17% f'pazjenti li kienu kkurati b'mod konservattiv, 29% meta kellhom anġoplastija koronarja transluminali perkutanja (PTCA) bi stent jew mingħajru u 10% meta kellhom trapjant ta' bajpass f'arterja koronarja (CABG)).
English: Lietuva UAB “Sicor Biotech” Tel: +370 5 266 02 03 This leaflet was last approved in {MM/YYYY}.
Maltese: UAB “Sicor Biotech” Tel: +370 5 266 02 03
English: Gastrointestinal haemorrhage, diarrhoea, abdominal pain, dyspepsia
Maltese: Emorraġija gastrointestinali, dijarea, uġigħ addominali, dispepsja
English: Absorption is at least 50%, based on urinary excretion of clopidogrel metabolites.
Maltese: L-assorbiment huwa millinqas ta' 50%, skont l-eskrezzjoni fl-urina ta' metaboliti ta' clopidogrel.
English: CYP2C19 is involved in the formation of both the active metabolite and the 2-oxo-clopidogrel intermediate metabolite.
Maltese: CYP2C19 huwa involut fil-formazzjoni kemm tal-metabolit attiv kif ukoll tal-metabolit intermedjarju 2-oxo-clopidogrel.
English: In TRITON-TIMI 38 and 3 of the cohort studies (n= 3,516; Collet, Sibbing, Giusti), patients with an impaired metaboliser status (intermediate and poor combined) had a higher rate of cardiovascular events (death, myocardial infarction, and stroke) or stent thrombosis compared to extensive metabolisers.
Maltese: F'TRITON-TIMI 38 u f'3 mis-sett ta' studji (n=3,516;Collet,Sibbing,Giusti), pazjenti b'indeboliment fil-mod ta' kif jimmetabolizzaw (intermedji u dgħajfa flimkien) kellhom rata ogħla ta' avvenimenti kardjovaskulari (mewt, infart mijokardiku u attakk ta' puplesija) jew trombożi fl-istent meta mqabbla ma' metabolizzaturi estensivi.
English: Reduced CYP2C19 metabolism in intermediate and poor metabolisers decreased the Cmax and AUC of the active metabolite by 30-50% following 300- or 600-mg loading doses and 75-mg maintenance doses.
Maltese: Tnaqqis fil-metaboliżmu ta' CYP2C19 f'metabolizzaturi intermedji u dgħajfa naqqas is-Cmax u l-AUC tal-metabolit attiv b'30 - 50% wara dożi ta' kkargar ta' 300- jew 600-mg u dożi ta' manteniment ta' 75 mg.
English: Esomeprazole is expected to give a similar interaction with clopidogrel.
Maltese: Esomeprazole huwa mistenni li jagħti interazzjoni simili ma' clopidogrel.
English: Pharmacogenetics: Based on literature data, patients with genetically reduced CYP2C19 function have lower systemic exposure to the active metabolite of clopidogrel and diminished antiplatelet responses, and generally exhibit higher cardiovascular event rates following myocardial infarction than do patients with normal CYP2C19 function (see section 5.2).
Maltese: Ibbażat fuq tagħrif minn dokumentazzjoni, pazjenti b'funzjoni ġenetikament imnaqqsa ta' CYP2C19 għandhom espożizzjoni sistemika aktar baxxa għall-metabolit attiv ta' clopidogrel u risponsi mnaqqsa kontra l-plejtlits, u ġeneralment juru rati ogħla ta' ġrajjiet kardjovaskulari wara infart mijokardijaku milli juru pazjenti b'funzjoni normali ta' CYP2C19 (ara sezzjoni 5.2).
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.
Maltese: In vitro u in vivo, clopidogrel jiġi mmetabolizzat permezz ta' żewġ sensiliet ta' reazzjonijiet metaboliċi: waħda bl-intervent ta' esterases u li twassal għall-idroliżi fid-derivattiv inattiv tiegħu carboxylic acid (85% tal-metaboliti fiċċirkulazzjoni), u waħda bl-intervent ta' ċitokromi P450 multipli. Clopidogrel jiġi mmetabolizzat lewwel f'metabolit intermedjarju 2-oxo-clopidogrel.
English: 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.
Maltese: Potenzjalment dan jista' jwassal għal livelli ogħla fil-plażma ta' prodotti mediċinali bħal phenytoin u tolbutamide u NSAIDs, li huma metabolizzati minn Cytochrome P450 2C9.
English: Teva Sweden AB Tlf: (46) 42 12 11 00
Maltese: Tlf: (46) 42 12 11 00
English: This benefit was mostly driven by the statistically significant reduction in the incidence of MI [287 (4.6%) in the clopidogrel treated group and 363 (5.8%) in the placebo treated group].
Maltese: Dan il-benefiċċju ġie l-iktar mit-tnaqqis li kien statistikament sinifikanti tal-inċidenza ta' MI [287 (4.6%) fil-grupp ikkurat bi clopidogrel u 363 (5.8%) fil-grupp ikkurat bil-plaċebo].
English: The incidence of severe cases was 1.4% for clopidogrel and 1.6% for ASA.
Maltese: L-inċidenza ta' każi severi kienet ta' 1.4% għal clopidogrel u ta' 1.6% għal ASA.
English: 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.
Maltese: Clopidogrel naqqas b'mod sinifikanti r-riskju relattiv tal-mewt minn kwalunkwe kawża b'7% (p=0.029), u r-riskju relattiv ta' infart ġdid, puplesija jew il-mewt b'9% (p=0.002), li jirrappreżentaw tnaqqis assolut ta' 0.5% u 0.9%, rispettivament.
English: In COMMIT, the overall rate of noncerebral major bleeding or cerebral bleeding was low and similar in both groups (0.6% versus 0.5% in the clopidogrel + ASA and the placebo + ASA groups, respectively).
Maltese: F'COMMIT, ir-rata totali ta' fsada maġġuri mhux ċerebrali jew ta' fsada ċerebrali kienet baxxa u simili fiż-zewġ gruppi (0.6% kontra 0.5% fil-gruppi clopidogrel + ASA u l-plaċebo + ASA, rispettivament).
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER (28, 28x1, 30, 30x1, 50, 50x1, 56, 56x1, 84, 84x1, 90, 90x1, 100, 100x1 film-coated tablets)
Maltese: FOLJA (28, 28x1, 30, 30x1, 50, 50x1, 56, 56x1, 84, 84x1, 90, 90x1, 100, 100x1 pillola miksija b'rita)
English: 28 film-coated tablets 28x1 film-coated tablets 30 film-coated tablets 30x1 film-coated tablets 50 film-coated tablets 50x1 film-coated tablets 56 film-coated tablets 56x1 film-coated tablets 84 film-coated tablets 84x1 film-coated tablets 90 film-coated tablets 90x1 film-coated tablets 100 film-coated tablets 100x1 film-coated tablets
Maltese: 28 pillola miksija b'rita 28x1 pillola miksija b'rita 30 pillola miksija b'rita 30x1 pillola miksija b'rita 50x1 pilloli miksijin b'rita 50x1 pillola miksija b'rita 56 pillola miksija b'rita 56x1 pillola miksija b'rita 84 pillola miksija b'rita 84x1 pillola miksija b'rita 90 pillola miksija b'rita 90x1 pillola miksija b'rita 100 pillola miksija b'rita 100x1 pillola miksija b'rita
English: 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).
Maltese: Ma kienx hemm eċċessi fi fsada maġġuri b'clopidogrel+ASA fis-7 ijiem ta' wara operazzjoni ta' trapjant ta' bajpass koronarju f'pazjenti li waqqfu l-kura iktar minn ħamest ijiem qabel l-operazzjoni (4.4% clopidogrel+ASA kontra 5.3% plaċebo + ASA).
English: Pharmacogenetic testing can identify genotypes associated with variability in CYP2C19 activity.
Maltese: Testijiet farmakoġenetiċi jistgħu jidentifikaw il-ġenotipi assoċjati mal-varjabilità fl-attività ta' CYP2C19.
English: Glycoprotein IIb/IIIa inhibitors: clopidogrel should be used with caution in patients who receive concomitant glycoprotein IIb/IIIa inhibitors (see section 4.4).
Maltese: Inibituri ta' Glycoprotein IIb/IIIa: clopidogrel għandu jintuża b'kawtela f'pazjenti li jirċievu l-inibituri ta' glycoprotein IIb/IIIa flimkien mal-prodott mediċinali (ara sezzjoni 4.4).
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 placebotreated group, a 14% relative risk reduction (95% CI of 6%-21%, p=0.0005) for the clopidogreltreated group.
Maltese: In-numri ta' pazjenti li kellhom punt ko-primarju ta' tmiem (mewt b'CV, MI, puplesija jew iskemija li mhux qed tirrisondi għall-kura) kien 1 035 (16.5%) fil-grupp ikkurat bi clopidogrel u 1 187 (18.7%) fil-grupp ikkurat bil-plaċebo, tnaqqis ta' 14% fir-riskju relattiv) (95% CI ta' 6%-21%, p= 0.0005) għall-grupp ikkurat bi clopidogrel.
English: 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.
Maltese: Informazzjoni inkonsistenti dwar l-implikazzjonijiet kliniċi ta' din l-interazzjoni farmakokinetika (PK)/farmakodinamika (PD) f'termini ta' avvenimenti kardjovaskulari ewlenin ġew irrapportati sew mill-osservazzjoni kif ukoll mill-istudji kliniċi.
English: Analysis of total mortality as a secondary endpoint did not show any significant difference between clopidogrel (5.8%) and ASA (6.0%).
Maltese: L-analiżi tal-mortalita` totali bħala punt sekondarju ta' tmiem m'urietx xi differenza sinifikanti bejn clopidogrel (5.8%) u ASA (6.0%).
English: Mean inhibition of platelet aggregation (IPA) with 5 μM ADP was diminished by 39% (24 hours) and 21% (Day 5) when clopidogrel and omeprazole were administered together.
Maltese: L-inibizzjoni medja tal-aggregazzjoni tal-plejtlets (IPA) flimkien ma' 5 μM ta' ADP naqas bi 39% (24 siegħa) u 21% (Jum 5) meta clopidogrel u omeprazole ngħataw flimkien.
English: Data from studies with human liver microsomes indicated that the carboxylic acid metabolite of clopidogrel could inhibit the activity of Cytochrome P450 2C9.
Maltese: Tagħrif minn studji b'mikrosomi tal-fwied uman indikaw li l-metabolit ta' carboxylic acid ta' clopidogrel jista' jinibixxi l-attivita` ta' Cytochrome P450 2C9.
English: At steady state, the average inhibition level observed with a dose of 75 mg per day was between 40% and 60%.
Maltese: Fi stat fiss, il-livell medju ta' inibizzjoni osservat b'doża ta' 75 mg kuljum kien bejn 40% u 60%.
English: Patients received clopidogrel (75 mg/day, n=22,961) or placebo (n=22,891), in combination with ASA (162 mg/day), for 28 days or until hospital discharge.
Maltese: Il-pazjenti ngħataw clopidogrel (75 mg/kuljum, n=22,961) jew il-plaċebo (n=22,891), flimkien ma' ASA (162 mg/kuljum), għal 28 jum jew sakemm ġew illiċenzjati mill-isptar.
English: Tablet core:
Maltese: Metaboliżmu intermedju:
English: The 2x2 factorial design COMMIT trial included 45,852 patients presenting within 24 hours of the onset of the symptoms of suspected MI with supporting ECG abnormalities (i.e. ST elevation, ST depression or left bundle-branch block).
Maltese: L-għamla ta' 2x2 factorial tal-prova COMMIT inkludiet 45,852 pazjent li daħlu fi żmien 24 siegħa mill-ħin li bdew is-sintomi suspettużi ta' MI b'abnormalitajiet fl-ECG suġġestivi t'hekk (iġifieri ST elevat, ST imniżżel jew bundle branch block tax-xellug).
English: The efficacy of clopidogrel was observed independently of the dose of ASA (75-325 mg once daily).
Maltese: L-effikaċja ta' clopidogrel kienet osservata b'mod indipendenti mid-doża ta' ASA (75-325 mg darba kuljum).
English: In CURE, 823 (6.6%) patients received concomitant GPIIb/IIIa receptor antagonist therapy.
Maltese: F'CURE, 823 pazjent ingħataw terapija ta' antagonista għar-riċetturi GPIIb/IIIa fl-istess ħin.
English: Rare side effect (affects 1 to 10 patients in 10,000): Vertigo.
Maltese: Effetti sekondarji rari (jaffettwaw minn 1 sa 10 pazjenti minn kull 10,000):
English: The exposure to the active metabolite of clopidogrel was decreased by 45% (Day 1) and 40% (Day 5) when clopidogrel and omeprazole were administered together.
Maltese: L-espożizzjoni għall-metabolit attiv ta' clopidogrel kien naqas bi 45% (Jum 1) u 40% (Jum 5) meta clopidogrel u omeprazole ngħataw flimkien.
English: The benefits observed with clopidogrel were independent of other acute and long-term cardiovascular therapies (such as heparin/LMWH, GPIIb/IIIa antagonists, lipid lowering medicinal products, beta blockers, and ACE-inhibitors).
Maltese: Il-benefiċċji osservati bi clopidogrel kienu indipendenti minn terapiji kardjovaskulari oħra akuti u fittul (bħall- heparin/LMWH, antagonisti ta' GPIIb/IIIa, prodotti mediċinali li jbaxxu l-lipidi, imblokkaturi tar-riċetturi beta , u inibituri ta' ACE).
English: While you are taking Clopidogrel Teva Generics B.V.:
Maltese: Tiħux Clopidogrel Teva Generics B.V.:
English: Patients were randomised to clopidogrel (300 mg loading dose followed by 75 mg/day, N=6,259) or placebo (N=6,303), both given in combination with ASA (75-325 mg once daily) and other standard therapies.
Maltese: Ilpazjenti kienu randomised għal clopidogrel (doża qawwija tal-bidu ta' 300 mg u wara 75 mg/jum, N = 6,259) jew il-plaċebo (N = 6,303), u t-tnejn ingħataw flimkien ma' ASA (75-325 mg darba kuljum) u terapiji oħrastandard.
English: To date, diminished antiplatelet responses to clopidogrel have been described for intermediate and poor metabolisers in 21 reported studies involving 4,520 subjects.
Maltese: S'issa, it-tnaqqis fl-effetti inibitorji ta' clopidogrel fuq il-plejtlits ġie deskritt għal metabolizzaturi intermedji u dgħajfa f'21 studju li ġie rrapportat u li fihom ħadu sehem 4,520 suġġett.
English: No conclusive data on the pharmacodynamic interaction of clopidogrel and other PPIs are available.
Maltese: Ebda data konklużiva dwar l-interazzjoni farmakodinamika ta' clopidogrel u PPIs oħra huma disponibbli.
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).
Maltese: L-istudju CAPRIE kien jinkludi 19,185 pazjent bi trombożi fil-vini li ntweriet permezz ta' infart mijokardijaku reċenti (<35 jum), puplesija iskemika reċenti (bejn 7 ijiem u 6 xhur) jew mard stabbilit tal-arterji periferali (PAD).
English: Patients received clopidogrel (300 mg loading dose, followed by 75 mg/day, n=1,752) or placebo (n=1,739), both in combination with ASA (150 to 325 mg as a loading dose, followed by 75 to 162 mg/day), a fibrinolytic agent and, when appropriate, heparin.
Maltese: Il-pazjenti rċevew clopidogrel (300 mg bħala d-doża qawwija inizjali segwita minn 75 mg /kuljum, n=1752) jew ilplaċebo (n=1739), it-tnejn ma' ASA (150 sa 325 mg bħala doża qawwija inizjali segwita minn 75 sa 162 mg/kuljum), sustanza fibrinolitika u, fejn kien xieraq, heparin.
English: A pharmacodynamic interaction between clopidogrel and acetylsalicylic acid is possible, leading to increased risk of bleeding.
Maltese: Huwa possibbli li jkun hemm interazzjoni farmakodinamika bejn clopidogrel u acetylsalicylic acid, li jista' jwassal għal riskju ikbar ta' dmija.
English: Subsequent metabolism of the 2-oxo-clopidogrel intermediate metabolite results in formation of the active metabolite, a thiol derivative of clopidogrel.
Maltese: Metaboliżmu suċċessiv tal-metabolit intermedjarju 2-oxo-clopidogrel iwassal għall-formazzjoni tal-metabolit attiv, derivattiv thiol ta' clopidogrel.
English: OPA/Al/PVC-Al blisters containing 28, 30, 50, 56, 84, 90 and 100 film-coated tablets or perforated unit dose blister containing 28x1, 28x1 (calendar pack), 30x1, 50x1, 56x1, 84x1, 90x1 and 100x1 film-coated tablets in a carton.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Folji tal- OPA/Al/PVC-Aluminju li fihom 28, 30, 50, 56, 84, 90 u 100 pillola miksija b'rita jew folji pperforati ta' doża waħda li fihom 28x1, 28x1 (pakkett ta' xahar), 30x1, 50x1, 56x1, 84x1, 90x1 u 100x1 pillola miksija b'rita ġo kaxxa.
English: Intermediate metabolism: CYP2C19*1/*2 or *1/*3
Maltese: CYP2C19*1/*2 or
English: 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.
Maltese: F'pazjenti li baqgħu jieħdu l-kura fil-ħamest ijiem ta' qabel l-operazzjoni ta' trapjant ta' bajpass, ir-rata ta' avvenimenti kienet ta' 9.6% għal clopidogrel+ASA, u 6.3% għal placebo+ASA.