FrancophonIA/ELRC3.0 huggingface dataset:
English: If HPR≥46 units, the patients were escalated back to prasugrel 5 or 10 mg/d for 11.5 months; if HPR<46 units, the patients continued on clopidogrel 75 mg/d for 11.5 months.
Maltese: Jekk l-HPR≥46 unità, il-pazjenti reġgħu marru lura fuq it-trattament aktar qawwi ta' prasugrel 5 jew 10 mg/ġ għal 11.5 xhur; jekk l-HPR<46 unità, il-pazjenti komplew fuq clopidogrel 75 mg/ġ għal 11.5 xhur.
English: 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 clopidogrel 75 mg/day.
Maltese: 3% (5 µM ta' aggregazzjoni tal-plejtlits ikkaġunat mill-ADP) li huwa simili għal dak ta' adulti li jieħdu 75 mg/ġurnata ta' clopidogrel.
English: No substantial differences in active metabolite exposure and mean inhibition of platelet aggregation (IPA) were observed between ultrarapid, extensive and intermediate metabolisers.
Maltese: Ma ġew osservati l-ebda differenzi sostanzjali fl-espożizzjoni tal-metabolit attiv u linibizzjoni medja tal-aggregazzjoni tal-plejtlits (IPA) bejn metabolizzaturi estremament mgħaġġla, estensivi u intermedji.
English: ASA treatment group compared to the placebo + ASA group (1.4% versus 0.8%, respectively).
Maltese: Kien hemm iżjed fsada ġewwa l-kranju fil-grupp ta' kura clopidogrel + ASA meta mqabbel malgrupp plaċebo + ASA (1.4% kontra 0.8%, rispettivament).
English: Each film-coated tablet contains 75 mg of clopidogrel (as hydrochloride).
Maltese: Kull pillola miksija b'rita fiha 75 mg clopidogrel (bħala hydrochloride).
English: Patients were treated for up to 5 years.
Maltese: Il-pazjenti ġew ikkurati sa 5 snin.
English: The major exclusion criteria for patients were documented peptic ulcer disease within the previous 6 months; prior intracerebral hemorrhage; significant thrombocytopenia (platelet count < 50 x 10
Maltese: Il-kriterji prinċipali sabiex pazjent ikun eskluż kienu mard minn ulċera peptika ddokumentata f'dawn l-aħħar 6 xhur; emorraġija intraċerebrali preċedenti; tromboċitopinja sinifikanti (għadd tal-plejtlits < 50 x 10
English: In patients suffering from acute coronary syndrome: - 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) 75 mg-325 mg daily).
Maltese: - Sindromu koronarju akut bis-segment mhux ST elevat (anġina mhux stabbli jew infart mijokarijaku mhux mewġa Q): it-trattament b'clopidogrel għandu jiġi mibdi b'doża inizjali waħda ta' 300 mg (4 pilloli ta' 75 mg kollha flimkien) u mbagħad jitkompla b'75 mg darba kuljum (b'acetylsalicylic acid (ASA) 75 mg-325 mg kuljum).
English: The prasugrel-only patients were continued on prasugrel for 11.5 months.
Maltese: Il-pazjenti li kienu fuq prasugrel biss komplew fuq prasugrel għal 11.5 xhur.
English: In CURE, CLARITY, ACTIVE-A and one of the cohort studies (Trenk), no increased event rate was observed based on metaboliser status.
Maltese: Fi CURE, CLARITY, ACTIVE-A u wieħed mill-istudji ko-orti (Trenk), ma ġiet osservata l-ebda żieda firrata ta' avvenimenti bbażata fuq l-istatus tal-metaboliżżatur.
English: The ACTIVE-W and ACTIVE-A studies, separate trials in the ACTIVE program, included patients with atrial fibrillation (AF) who had at least one risk factor for vascular events.
Maltese: L-istudji ACTIVE-W u ACTIVE-A, studji separati fil-programm ACTIVE, kellhom fihom pazjenti b'fibrillazzjoni atrijali (AF) li kellhom għallinqas fattur wieħed ta' riskju għal avvenimenti vaskulari.
English: Breast-feeding
Maltese: Il-Manifattur
English: The primary outcome, a composite of cardiovascular death, stroke, urgent revascularization, and BARC (Bleeding Academic Research Consortium) bleeding ≥2 at 1 year post ACS, occurred in 43 patients (13.4%) in the de-escalated DAPT group and in 85 patients (26.3%) in the unchanged DAPT group (p<0.01).
Maltese: Ir-riżultat primarju , taħlita ta' mewt kardjovaskulari, puplesija, vaskularazzjoni urġenti mill-ġdid u fsada BARC (Bleeding Academic Research Consortium) ≥2 f'sena wara ACS, seħħ f'43 pazjent (13.4%) fil-grupp DAPT ta' tnaqqis fil-qawwa u f'85 pazjent (26.
English: 75 mg film-coated tablets clopidogrel
Maltese: Clopidogrel Krka d.d. 75 mg pilloli miksija b'rita clopidogrel
English: Musculoskeletal, connective tissue and bone disorders
Maltese: Disturbi muskoluskeletrali, tat-tessut konnettiv u flgħadam
English: The CURE study included 12,562 patients with non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), and presenting within 24 hours of onset of the most recent episode of chest pain or symptoms consistent with ischaemia.
Maltese: L-istudju CURE kien jinkludi 12,562 pazjent bis-sindromu koronarju akut tas-segment mhux-ST elevat (anġina isntabbli jew infart mijokardijaku li mhux mewġa Q), u li seħħew fi żmien 24 siegħa mill-aktar episodju riċenti ta' uġigħ fis-sider jew sintomi konsistenti mal-iskemja.
English: In vitro studies have shown the increase in repaglinide exposure is due to inhibition of CYP2C8 by the glucuronide metabolite of clopidogrel.
Maltese: Studji in vitro wrew li ż-żieda fl-espożizzjoni ta' repaglinide ġiet minħabba linibizzjoni ta' CYP2C8 mill-metabolit glukuronidu ta' clopidogrel.
English: - ST segment elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy.
Maltese: - Infart mijokardijaku akut b'segment ST elevat, flimkien ma' ASA f'pazjenti ittrattati bilmediċini u eliġibbli għat-terapija trombolitika.
English: Although the administration of clopidogrel 75 mg/day did not modify the pharmacokinetics of S-warfarin or International Normalised Ratio (INR) in patients receiving long-term warfarin therapy, coadministration of clopidogrel with warfarin increases the risk of bleeding because of independent effects on hemostasis.
Maltese: Għalkemm l-għoti ta' clopidogrel 75 mg/jum ma mmodifikax il-farmakokinetika ta' S-warfarin jew il-Proporzjon Normalizzat Internazzjonali (INR) f'pazjenti li rċevew terapija għat-tul ta' warfarin, l-għoti flimkien ta' clopidogrel ma' warfarin iżid ir-riskju ta' fsada minħabba effetti indipendenti fuq l-emostasi.
English: Switching from a more potent P2Y12 receptor inhibitor to clopidogrel in association with aspirin after acute phase in ACS has been evaluated in two randomized investigator-sponsored studies (ISS)TOPIC and TROPICAL-ACS - with clinical outcome data.
Maltese: Il-bidla minn inibitur aktar qawwi tar-riċettur P2Y12 għal clopidogrel flimkien mal-aspirina wara l-fażi akuta f'ACS ġiet evalwata f'żewġ studji mħallsin mill-investigutur u magħmula b'mod arbitrarju (ISS investigatorsponsored studies -TOPIC u TROPICAL-ACS - b'tagħrif dwar ir-riżultat kliniku.
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 nkonsistenti dwar l-implikazzjonijiet kliniċi ta' din l-interazzjoni farmakokinetika (PK)/farmakodinamika (PD) f'termini ta' avvenimenti kardjovaskulari ewlenin ġew irrapportati sew millosservazzjoni kif ukoll mill-istudji kliniċi.
English: Detailed information is available on the European Medicines Agency website: http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini http://www.ema.europa.eu.
English: Prevention of atherothrombotic and thromboembolic events in atrial fibrillation In adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with Vitamin K antagonists (VKA) and who have a low bleeding risk, clopidogrel is indicated in combination with ASA for the prevention of atherothrombotic and thromboembolic events, including stroke.
Maltese: F'pazjenti adulti b'fibrillazzjoni atrijali li għallinqas għandhom fattur wieħed ta' riskju għal avvenimenti vaskulari u li ma jistgħux jieħdu t-terapija ta' kontra l-vitamina K (VKA) u li għandhom riskju baxx ta' fsada, clopidogrel flimkien ma' ASA huwa indikat għall-prevenzjoni ta' avvenimenti aterotrombotiċi u tromboemboliċi li jinkludu l-attakk ta' puplesija.
English: A significantly lower exposure to clopidogrel active metabolite and reduced platelet inhibition has been demonstrated in HIV-infected patients treated with ritonavir- or cobicistat-boosted anti-retroviral therapies (ART).
Maltese: Intwera kemm esponiment ferm aktar baxx għall-metabolit attiv clopidogrel kif ukoll inibizzjoni tal-pjastrini mnaqqsa f'pazjenti infettati bl-HIV li ġew ikkurati b'terapiji antiretrovirali (ART) imsaħħa ta' ritonavir jew cobicistat.
English: Haematoma
Maltese: Ematurja
English: Other medicines and Clopidogrel Krka d.d.
Maltese: Mediċini oħra u Clopidogrel Krka d.d.
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).
Maltese: Bħal fil-każ ta' sustanzi oħra kontra l-plejtlets, clopidogrel għandu jintuża b'kawtela f'pazjenti li jista' jkollhom riskju ta' iktar dmija minn trawma, operazzjoni jew kundizzjonijiet patoloġiċi oħra u pazjenti li jkunu qed jirċievu l-kura b'ASA, heparin, inibituri ta' glycoprotein IIb/IIIa jew mediċini kontra l-infjammazzjoni li m'humiex sterojdi (NSAIDs) li jinkludu l-inibituri ta' Cox-2, jew inibituri selettivi tal-ġbir mill-ġdid ta' serotonin (SSRIs), jew prodotti mediċinali marbuta ma' riskju ta'fsada bħal pentoxifylline (ara sezzjoni 4.5).
English: Gynaecomastia
Maltese: IL-PROVVISTA
English: Rare side effects (may affect up to 1 in 1000 people): Vertigo, enlarged breasts in males.
Maltese: Effetti sekondarji rari(jistgħu jaffettwaw sa 1 minn kull 1000 persuna):
English: • Adult patients suffering from acute coronary syndrome: - Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA).
Maltese: - Bis-segment mhux ST elevat (anġina instabbli jew infart mijokardijaku mhux-mewġa-Q), li jinkludu pazjenti fi proċess li titpoġġa stent wara intervent koronarju perkutaneju, flimkien ma' acetylsalicylic acid (ASA).
English: In ACTIVE-A, the rate of major bleeding was greater in the clopidogrel + ASA group than in the placebo + ASA group (6.7% versus 4.3%).
Maltese: F'ACTIVE-A, ir-rata ta' fsada qawwija kienet ikbar fil-grupp clopidogrel + ASA milli fil-grupp plaċebo + ASA (6.7 % kontra 4.3 %).
English: What Clopidogrel Krka d.d.
Maltese: Tiħux Clopidogrel Krka d.d.:
English: (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), not known (cannot be estimated from the available data).
Maltese: Il-frekwenza tagħhom hi definita skont dawn il-konvenzjonijiet: komuni (≥1/100 sa <1/10); mhux komuni (≥1/1,000 sa <1/100); rari (≥1/10,000 sa <1/1,000); rari ħafna (<1/10,000), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).F'kull sistema tal-klassifika ta' l-organi, l-effetti mhux mixtieqa huma mniżżla skond is-serjeta' tagħhom, bl-aktar serji jitniżżlu l-ewwel.
English: 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.
Maltese: Wara dożi ripetuti ta' 75 mg ta' clopidogrel kuljum, f'persuni b'mard sever tal-kliewi (tneħħija tal-kreatinina minn 5 sa 15 ml/min), l-inibizzjoni ta' l-agreggrazzjoni tal-plejtlets indotti minn ADP kien iktar baxx (25%) minn dak osservat f'persuni f'saħħithom, madankollu it-titwil fil-ħin tad-dmija kien simili għal dak osservat f'persuni f'saħħithom li kienu qed jingħataw 75 mg ta' clopidogrel kuljum.Barra minn hekk, it-tolleranza klinika kienet tajba fil-pazjenti kollha.
English: Kounis syndrome (vasospastic allergic angina / allergic myocardial infarction) in the context of a hypersensitivity reaction due to clopidogrel*
Maltese: Sindrome ta' Kounis (anġina allerġika vasospastika / infart mijokardijaku allerġiku) f'kuntest ta' reazzjoni ta' sensittività eċċessiva għal clopidogrel*
English: Serious haemorrhage, haemorrhage of operative wound, vasculitis, hypotension
Maltese: Emorraġija serja, Emorraġija ta' ferita minn operazzjoni, vaskulite, pressjoni baxxa
English: Patients should be evaluated for history of hypersensitivity to thienopyridines (such as clopidogrel, ticlopidine, prasugrel) since cross-reactivity among thienopyridines has been reported (see section 4.8).
Maltese: Il-pazjenti għandhom jiġu evalwati għal storja ta' sensittività eċċessiva għal thienopyridines (bħal clopidogrel, ticlopidine, prasugrel) minħabba li ġiet irrappurtata reattività inkroċjata fost thienopyridines (ara sezzjoni 4.8).
English: • Adults and elderly
Maltese: Pożoloġija - Adulti u anzjani
English: Platelet aggregation induced by agonists other than ADP is also inhibited by blocking the amplification of platelet activation by released ADP.
Maltese: L-aggregazzjoni talplejtlits stimulata minn agonisti oħra barra ADP tiġi impedita wkoll permezz ta' mblukkar tal-amplifikazzjoni tal-attivazzjoni ta' plejtlits minn ADP meħlus.
English: Serum sickness, anaphylactoid reactions cross-reactive drug hypersensitivity among thienopyridines (such as ticlopidine, prasugrel) (see section 4.4)*, insulin autoimmune syndrome, which can lead to severe hypoglycemia, particularly in patients with HLA DRA4 subtype (more frequent in the Japanese population)*
Maltese: *, sindromu awtoimmunitarju talinsulina, li jista' jwassal għal ipogliċemija severa speċjalment f'pazjenti bissottotip HLA DRA4 (aktar frekwenti fil-popolazzjoni Ġappuniża)*
English: Very rare side effects (may affect up to 1 in 10,000 people): jaundice; severe abdominal pain with or without back pain; fever, breathing difficulties sometimes associated with cough; generalised allergic reactions (for example, overall sensation of heat with sudden general discomfort until fainting); swelling in the mouth; blisters of the skin; skin allergy; sore mouth (stomatitis); decrease in blood pressure; confusion; hallucinations; joint pain; muscular pain; changes in taste or loss of taste of food.
Maltese: Suffejra, uġigħ addominali qawwi flimkien ma' jew mingħajr uġigħ fid-dahar; deni, diffikultajiet biex tieħu n-nifs assoċjati ma' tħarħir; reazzjonijiet allerġiċi ġeneralizzati (per eżempju, sensazzjoni ta' sħana ma' ġismek kollu b'skonfort ġenerali f'daqqa sakemm tħossok ħażin), nefħa fil-ħalq, nfafet fuq il-ġilda; allerġiji fuq il-ġilda; uġigħ fil-ħalq (stomatite) tnaqqis fil-pressjoni tad-demm; konfużjoni; alluċinazzjonijiet; uġigħ tal-għadam; uġigħ muskolari, tibdil fit-togħma ta' l-ikel jew ma tibqax ittiegħem l-ikel.
English: In contrast, post-hoc analyses demonstrated statistically significant increases in the bleeding risk with the more potent P2Y12 inhibitors, occurring predominantly during the maintenance phase, after the first month post-ACS.
Maltese: F'kuntrast, analiżi post-hoc wera żidiet statistikament sinifikanti fir-riskju ta' fsada blinibituri aktar potenti ta' P2Y12 , li seħħew l-aktar fil-fażi ta' manteniment, wara l-ewwel xahar wara ACS.
English: 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
Maltese: Madankollu, pazjenti li daħlu fi studji kliniċi bi clopidogrel ngħataw varjeta` ta' prodotti mediċinali fl-istess ħin u dawn kienu jinkludu dijuretiċi, beta blockers ACEI, antagonisti tal-kalċju, sustanzi li jbaxxu l-kolesterol, vasodilataturi koronarji, sustanzi kontra d-dijabete (inkluża linsulina), sustanzi antiepilettiċi u antagonisti GPIIb/IIIa mingħajr ma kien hemm evidenza ta' interazzjonijiet avversi klinikament sinifikanti.
English: 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).
Maltese: Bħala prekawzjoni, lużu konkomitanti ta' inibituri qawwijin jew moderati ta' CYP2C19 għandu jiġu skoraġġut (ara sezzjoni 4. 5 għal lista ta' inibituri ta' CYP2C19, ara wkoll sezzjoni 5.2).
English: Secondary prevention of atherothrombotic events Clopidogrel is indicated in:
Maltese: Il-prevenzjoni sekondarja ta' avvenimenti aterotrombotiċi Clopidogrel huwa indikat f':
English: • Severe hepatic impairment.
Maltese: - Indeboliment epatiku
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/
English: The safety and efficacy of clopidogrel have been evaluated in 5 double-blind studies involving over 88,000 patients: the CAPRIE study, a comparison of clopidogrel to ASA, and the CURE, CLARITY, COMMIT and ACTIVE-A studies comparing clopidogrel to placebo, both medicinal products given in combination with ASA and other standard therapy.
Maltese: Is-sigurtà u l-effikaċja ta' clopidogrel kienu evalwati f'4 studji double-blind li involvew 'il fuq minn 80,000 pazjent: fl-istudju CAPRIE, paragun ta' clopidogrel ma' ASA, u fl-istudju CURE, CLARITY u COMMIT kienu mqabblin clopidogrel mal-plaċebo, fejn iż-żewġ prodotti mediċinali ngħataw flimkien ma' ASA u terapija oħra li soltu tingħata.
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.
Maltese: - Pazjenti adulti li għandhom infart mijokardijaku (minn ftit jiem sa inqas minn 35 jum), puplesija iskemika (minn 7 ijiem sa inqas minn 6 xhur) jew mard stabbilit ta' l-arterji periferali.
English: Pharmacogenetics
Maltese: FARMAĊEWTIKU
English: Other concomitant therapy: Since clopidogrel is metabolised to its active metabolite partly by CYP2C19, use of medicinal products that inhibit the activity of this enzyme would be expected to result in reduced drug levels of the active metabolite of clopidogrel.
Maltese: Peress li parti mill-metaboliżmu ta' clopidogrel għall-metabolit attiv tiegħu jsir minn CYP2C19, huwa mistenni li l-użu tal-prodotti mediċinali li jinibixxu l-attività ta' din l-enzima jwasslu għal tnaqqis fil-livell tal-metabolit attiv ta' clopidogrel.
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).
Maltese: Għalhekk, wara 3 xhur ta' trattament, is-siwi osservat fil-grupp ta' clopidogrel + ASA ma kibirx iżjed, filwaqt li r-riskju ta' emorraġija ppersista (ara sezzjoni 4.4).
English: 75 mg film-coated tablets
Maltese: Clopidogrel Krka d.d. 75 mg pilloli miksija b'rita
English: Data from the CAPRIE study indicate that phenytoin and tolbutamide which are metabolised by CYP2C9 can be safely co-administered with clopidogrel.
Maltese: Tagħrif mill-istudju CAPRIE jindika li phenytoin u tolbutamide li jiġu mmetaboliżżati minn CYP2C9 jistgħu jiġu amministrat b'sigurta` flimkien ma' clopidogrel.
English: KRKA Pharma Dublin, Ltd. Tel: + 353 1 293 91 80
Maltese: KRKA Farmacéutica S.L. Tel: + 34 911 61 03 81
English: This was consistent across subgroups of patients defined by baseline characteristics, and type of fibrinolytic or heparin therapy.
Maltese: Dan kien konsistenti fil-firxa ta' sottogruppi ta' pazjenti miġbura skond linja bażi ta' karatteristiċi u t-tip ta' terapija fibrinolitika jew bil-heparin.
English: The decrease was associated with a 39% (loading dose) and 21% (maintenance dose) reduction of inhibition of platelet aggregation.
Maltese: 21 % (id-doża ta' manteniment) fl-inibizzjoni tal-aggregazzjoni tal-plejtlits.
English: film-coated tablet
Maltese: Disturbi fil-qalb
English: Clopidogrel active metabolite pharmacokinetics and antiplatelet effects, as measured by ex vivo platelet aggregation assays, differ according to CYP2C19 genotype.
Maltese: L-effetti kemm farmakokinetiċi kif ukoll dawk kontra l-plejtlits tal-metabolit attiv ta' clopidogrel, kif imkejla b'analiżi ex vivo tal-aggregazzjoni tal-plejtlis, jinbidlu skont il-ġenotip ta' CYP2C19.
English: contains clopidogrel and belongs to a group of medicines called antiplatelet medicinal products.
Maltese: Clopidogrel Krka d.d. fih clopidogrel u jappartjeni għal grupp ta' mediċini li jissejħu prodotti mediċinali li jaġixxu kontra l-plejtlets.
English: Clopidogrel has been tested in a range of in vitro and in vivo genotoxicity studies, and showed no genotoxic activity.
Maltese: Clopidogrel ġie ttestjat fuq firxa ta' studji in vitro u in vivo dwar l-effett tossiku fuq il-ġeni, u ma wriex attività tossika fuq il-ġeni.
English: Headache, stomach ulcer, vomiting, nausea, constipation, excessive gas in stomach or intestines, rashes, itching, dizziness, sensation of tingling and numbness.
Maltese: Uġigħ ta' ras, ulċeri fl-istonku, remettar, tqalligħ, stitikezza, ħafna gass fl-istonku jew l-imsaren, raxxijiet, ħakk, sturdament, sensazzjoni ta' tnemnim u tirżiħ.
English: Clopidogrel has been evaluated for safety in more than 44,000 patients who have participated in clinical studies, including over 12,000 patients treated for 1 year or more.
Maltese: Clopidogrel ġie evalwat għas-sigurta` f'iktar minn 44,000 pazjent li pparteċipaw fi studji kliniċi, inklużi iktar minn 12,000 pazjent li kienu kkurati bih għal sena jew iktar.
English: The patients were followed for 30 days.
Maltese: Il-pazjenti ġew osservati għal 30 jum.
English: Clopidogrel is extensively metabolised by the liver.
Maltese: Clopidogrel jiġi mmetabolizzat b'mod estensiv mil-fwied.
English: The patient population included 41.8 % women.
Maltese: Mill-pazjenti kollha, 41.8 % kienu nisa.
English: 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.
Maltese: Fl-analiżi tal-intenzjoni tal-kura, ġew osservati 939 każ fil-grupp ta' clopidogrel u 1,020 każ ma' ASA (tnaqqis tar-riskju relattiv, relative risk reduction (RRR) 8.7 %, [95 % CI: 0.2 sa 16.4]; p = 0.
English: Some other medicines may influence the use of Clopidogrel Krka d.d.
Maltese: Effetti sekondarji li possibbli Kif taħżen Clopidogrel Krka d.d.
English: Seventy-three percent (73%) of patients enrolled into the ACTIVE-A study were unable to take VKA due to physician assessment, inability to comply with INR (international normalised ratio) monitoring, predisposition to falling or head trauma, or specific risk of bleeding; for 26% of the patients, the physician's decision was based on the patient's unwillingness to take VKA.
Maltese: Tlieta u sebgħin fil-mija (73 %) tal-pazjenti li ġew irreġistrati fl-istudju ACTIVE-A ma kinux kapaċi jieħdu l-VKA minħabba l-evalwazzjoni tat-tobba, in-nuqqas ta' kapaċità li joqgħodu għall-monitorġġ tal-INR (Proporzjon Normalizzat Internazzjonali), kellhom tendenza li jaqgħu jew li jweġġgħu rashom jew xi riskju speċifiku ta' fsada; għal 26 % tal-pazjenti, id-deċiżjoni tat-tobba kienet bbażata fuq il-fatt li l-pazjent ma riedx jieħu l-VKA.