FrancophonIA/ELRC3.0 huggingface dataset:
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 ma' tnaqqis fil-bżonn ta' terapija trombolitika (RRR=43.3; CI: 24.3 %, 57.5 %) u impedituri ta' GPIIb/IIIa (RRR=18.2 %; CI: 6.5 %, 28.3 %).
English: * Information related to clopidogrel with frequency “not known”.
Maltese: * Informazzjoni li għandha x'taqsam ma' clopidogrel b'frekwenza “mhux magħrufa”.
English: In vitro, this metabolic pathway is mediated by CYP3A4, CYP2C19, CYP1A2 and CYP2B6.
Maltese: Il-passaġġ metaboliku in vitro jsir permezz ta' CYP3A4, CYP2C19, CYP1A2 u CYP2B6.
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: B'kollox total ta' 99.7 % pazjenti rċevew fibrinolitiċi (speċifiċi għal fibrin: 68.7 %, mhux speċifiċi għal fibrin: 31.1 %), 89.5 % heparin, 78.7 % imblokkaturi beta, 54.7 % impedituri ACE u 63 % statins.
English: Musculo-skeletal bleeding (haemarthrosis), arthritis, arthralgia, myalgia
Maltese: Emorraġija muskoluskeletrika (emartrosi), artrite, artralġja, majalġjia
English: The patient population included 19.7% women and 29.2% patients ≥65 years.
Maltese: Il-popolazzjoni ta' pazjenti kienu jinkludu 19.7 % nisa u 29.2 % pazjenti ≥ 65 years.
English: The other ingredients in the tablet core are (see section 2 ‘Clopidogrel Teva Pharma B.V. contains lactose' and ‘Clopidogrel Teva Pharma B.V. contains hydrogenated castor oil') lactose monohydrate, microcrystalline cellulose, hydroxypropylcellulose (E463), crospovidone (type A), hydrogenated castor oil and sodium laurilsulfate, and in the film-coating are lactose monohydrate, hypromellose (E464), titanium dioxide (E171), macrogol 4000, iron oxide red (E172), iron oxide yellow (E172), indigo carmine aluminium lake (E132).
Maltese: • Is-sustanzi l-oħra fil-qalba tal-pillola huma (ara sezzjoni 2 ‘Clopidogrel Teva Pharma B.V. fih illactose' u Clopidogrel Teva Pharma B.V. fih il-castor oil idroġenat') lactose monohydrate, microcrystalline cellulose, hydroxypropylcellulose (E463), crospovidone (tip A), żejt ir-riġnu idroġenat u sodiumlauril sulfate u s-sustanzi l-oħra fil-kisi huma lactose monohydrate, hypromellose (E464), titanium dioxide (E171), macrogol 4000, iron oxide red (E172), iron oxide yellow (E172), indigo carmine aluminium lake (E132).
English: • Fluconazole, voriconazole, ciprofloxacin, or chloramphenicol, medicines to treat bacterial and fungal infections.
Maltese: • Fluconazole, voriconazole, ciprofloxacin jew chloramphenicol, mediċini użati għal kura ta'
English: INFORMATION IN BRAILLE Clopidogrel Teva Pharma B.V. 75 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Clopidogrel Teva Pharma B.V. 75 mg
English: • 30 tablets bottle: 30 days
Maltese: • flixkun ta' 30 pillola: 30 jum
English: Bullous dermatitis (toxic epidermal necrolysis, Stevens Johnson Syndrome, erythema multiforme), angioedema, drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms (DRESS), rash erythematous or exfoliative, urticaria, eczema, lichen planus
Maltese: Dermatite bl-infafet (nekrolisi tossika talepidermide, Sindromu ta' Stevens Johnson, eritema multiforme), anġjoedema, sindromu ta' sensittività eċċessiva kkawżat millmediċina, raxx kkawżat mill-mediċina b'eosinofilja u sintomi sistemiċi (DRESS), raxx eritematsi jew bil-qoxra, urtikarja, ekżema, lichen planus
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 (<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).
English: Clopidogrel Teva Pharma B.V. contains hydrogenated castor oil.
Maltese: Clopidogrel Teva Pharma B.V. fih il-castor oil idroġenat.
English: The population included 27.8% women, 58.4% patients ≥60 years (26% ≥70 years) and 54.5% patients who received fibrinolytics.
Maltese: Il-popolazzjoni kienet tinkludi 27.8 % nisa, 58.4 % pazjenti ≥ 60 sena (26 %≥70 sena) u 54.5 % pazjenti li rċevew fibrinolitiċi.
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 ta' linċidenza ta' MI [287 (4.6 %) fil-grupp ittrattat bi clopidogrel u 363 (5.8 %) fil-grupp ittrattat bi plaċebo].
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 bis-segment elevat, is-sigurtà u l-effikaċja ta' clopidrogel ġew evalwati f'2 studji każwali, ikkontrollati bi plaċebo u double-blind, CLARITY u COMMIT.
English: • Ticlopidine, other antiplatelet agent.
Maltese: • Ticlopidine, sustanza oħra li taġixxi kontra l-plejtlets
English: 4042 Debrecen,
Maltese: Pallagi út 13, 4042 Debrecen, L-Ungerija
English: • Fever, signs of infection (e.g. sore throat), pale skin or extreme tiredness.
Maltese: • Deni, sinjali ta' infezzjoni (e.g. ġriżmejn jweġgħuk), ġilda pallida jew għeja estrema.
English: • You are at increased risk of bleeding.
Maltese: • Tinsab f'riskju ogħla ta' emorraġija.
English: Pharmacotherapeutic group: platelet aggregation inhibitors excl. heparin, ATC Code: B01AC-04.
Maltese: Kategorija farmakoterapewtika: inibituri tal-aggregazzjoni tal-plejtlets li jeskludu heparin, Kodiċi ATC:
English: 30 tablets HDPE bottles:
Maltese: Flixkun HDPE ta' 30 pillola:
English: Clopidogrel Teva Pharma B.V. is supplied in peelable perforated blisters of aluminium/ aluminium containing 14x1, 28x1, 30x1, 50x1, 84x1, 90x1 or 100x1 tablet; perforated blisters of aluminium/ aluminium containing 14x1, 28x1, 30x1, 50x1, 84x1, 90x1 or 100x1 tablet or HDPE bottles with polypropylene closures or child resistant polypropylene closures and silica gel desiccant containing 30 or 100 tablets.
Maltese: • Clopidogrel Teva Pharma B.V. jiġi f'folji li jitqaxxru /aluminju/aluminju li fihom 14x1, 28x1, 30x1, 50x1, 84x1, 90x1 jew 100x1 pillola; folji ipperforati ta' aluminju/alumiju li fihom 14x1, 28x1, 30x1, 50x1, 84x1, 90x1 or 100x1 pillola jew fi fliexken tal-HDPE li fihom għotjien tal-polypropylene jew għotjien tal-polypropylene reżistenti għat-tfal b'dessikant tas-silika ġel li fihom 30 jew 100 pillola.
English: • Medicines used to break down blood clots (e.g. alteplase and streptokinase).
Maltese: • Mediċini użati biex iħollu l-emboli tad-demm (eż. alteplase u streptokinase).
English: One side of the tablet is debossed with “C75”.
Maltese: Naħa waħda mill-pillola tkun intaljata b'“C75”.
English: The elimination half-life of the main circulating (inactive) metabolite was 8 hours after single and repeated administration.
Maltese: Il-half-life ta' eliminazzjoni tal-metabolit (mhux attiv) ċirkolanti kien ta' 8 sigħat wara amministrazzjoni waħda u ripetuta.
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-risku relattiv tal-kombinazzjoni tal-infart mill-ġdid, puplesija jew mewt b'9 % (p=0.002), li jirrappreżenta tnaqqis assolut ta' 0.5 % u 0.9 %, rispettivament.
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 ngħataw clopidogrel (300 mg bħala doża inizjali, segwita b'75 mg/day, n=1,752) jew plaċebo (n=1,739), ittnejn flimkien ma' ASA (150 sa 325 mg bħala doża inizjali, segwiti b'75 sa 162 mg/jum), sustanza fibrinolitika u, meta kien meħtieġ, heparin.
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 osservat bi clopidogrel kienu indipendenti minn terapiji kardjovaskulari ohra akuti u fuq perijodu ta' żmien twil (bħal heparin/LMWH, antagonisti GPIIb/IIIa, prodotti mediċinali li jbaxxu llipidi, imblokkaturi beta, u impedituri ACE).
English: The number of patients experiencing the co-primary endpoint (CV death, MI, stroke or refractory ischaemia) was 1,035 (16.5%) in the clopidogrel-treated group and 1,187 (18.8%) in the placebo-treated group, a 14% relative risk reduction (95% CI of 6%-21%, p=0.0005) for the clopidogrel-treated group.
Maltese: L-għadd ta' pazjenti li kellhom punt ta' riferiment aħħari ko-primarju (mewt CV, MI, puplesija jew iskemija refrattorja) kien 1,035 (16.5 %) fil-grupp ittrattat bi clopidogrel u 1,187 (18.8 %) fil-grupp ittrattat bi plaċebo, tnaqqis ta' 14 % fir-riskju relattiv (95% CI of 6 %-2 %, p=0.0005) għall-grupp ittrattat bi clopidogrel.
English: In a subgroup analysis by qualifying condition (myocardial infarction, ischaemic stroke, and PAD) the benefit appeared to be strongest (achieving statistical significance at p=0.003) in patients enrolled due to PAD (especially those who also had a history of myocardial infarction) (RRR=23.7%; CI: 8.9 to 36.2) and weaker (not significantly different from ASA) in stroke patients (RRR=7.3%; CI: -5.7 to 18.7 [p=0.258]).
Maltese: F'analiżi tas-sottogrupp permezz ta' kundizzjoni kwalifikanti (infart mijokardijaku, puplesija iskemika, u PAD) il-benefiċċju jidher li kien l-akbar (fejn intlaħqet rilevanza statistika b'p=0.003) f'pazjenti li ddaħħlu minħabba PAD (speċjalment dawk li kellhom ukoll storja medika ta' infart mijokardijaku) (RRR=23.7%; CI: 8.9 sa 36.2) u aktar dgħajjef (mhux differenti b'mod sinifikanti minn ASA) f'pazjenti b'puplesija (RRR = 7.3%; CI: -5.7 sa 18.7 [p=0.258]).
English: • Oral anticoagulants (oral medicines used to stop blood clotting) such as warfarin.
Maltese: • Antikoagulanti orali (mediċini li jaġixxu kontra l-koagulazzjoni tad-demm li jittieħdu mill-ħalq) bħal warfarina.
English: There is no evidence that other medicinal products that reduce stomach acid such as H2 blockers (except cimetidine which is a CYP2C19 inhibitor) or antacids interfere with antiplatelet activity of clopidogrel.
Maltese: Mhemmx evidenza li prodotti mediċinali oħra li jnaqqsu l-aċidu mill-istonku bħal imblokkaturi ta' H2 (ħlief cimetidine li hu impeditur ta' CYP2C19) jew antaċidi jinterferixxu mal-attività kontra l-plejtlets ta' clopidogrel.
English: Nervous system disorders
Maltese: Disturbi fis-sistema nervuża sturdament
English: Fifteen percent (15.0%) of patients in the clopidogrel group and 21.7% in the placebo group reached the primary endpoint, representing an absolute reduction of 6.7% and a 36% odds reduction in favor of clopidogrel (95% CI: 24, 47%; p<0.001), mainly related to a reduction in occluded infarct-related arteries.
Maltese: Ħmistax fil-mija (15.0 %) tal-pazjenti fil-grupp clopidogrel u 21.7 % fil-grupp tal-plaċebo laħqu l-punt prinċipali aħħari, li jirrapreżenta tnaqqis assolut ta' 6.7 % u 36 % ta' tnaqqis probabbli favur clopidogrel (95 % CI: 24, 47 %; p < 0.001), relatat prinċipalment għal tnaqqis fis-sadd tal-arterji assoċjati mal-infart.
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: (11.4 %) fil-grupp trattat bi plaċebo, tnaqqis ta' 20% fir-risku relattiv (95 % CI ta' 10%-28%; p=0.00009) għall-grupp ittrattat b'clopidogrel (tnaqqis fir-riskju relattiv ta' 17% f'pazjenti li kienu trattati b'mod konservattiv, 29 % meta kellhom angoplastija koronarja transluminali perkutanja (PTCA) bi stent jew mingħajru u 10 % meta kellhom trapjant ta' bajpass f'arterja koronarja (CABG)).
English: • moclobemide, medicine to treat depression.
Maltese: • moclobemide, mediċini li jittrattaw d-dipressjoni
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 fl-istess waqt l-inibituri ta' glycoprotein IIb/IIIa (ara sezzjoni 4.4).
English: Posology: • Adults and older people
Maltese: Pożoloġija • Adulti u nies akbar fl-età
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 fattorjali 2x2 tal-prova COMMIT inkludiet 45,852 pazjent li daħlu di żmien 24 siegħa millħin li bdew is-sintomi suspettużi ta' MI b'abnormalitajiet fl-ECG suġestivi t'hekk (i.e. ST elevat, ST imniżżel jew bundle-branch block tax-xellug).
English: L-Irlanda
Maltese: L-Ungerija
English: Patients randomized in the ACTIVE program were those presenting with documented AF, i.e., either permanent AF or at least 2 episodes of intermittent AF in the past 6 months, and had at least one of the following risk factors: age ≥75 years or age 55 to 74 years and either diabetes mellitus requiring drug therapy, or documented previous MI or documented coronary artery disease; treated for systemic hypertension; prior stroke, transient ischaemic attack (TIA), or non-CNS systemic embolus; left ventricular dysfunction with left ventricular ejection fraction <45%; or documented peripheral vascular disease.
Maltese: Il-pazjenti li b'mod arbitrarju ġew magħżula fil-programm ACTIVE kienu dawk li ppreżentaw b'fibrillazzjoni atrijali (AF) ddokumentata, jiġifieri jew AF permanenti jew li fl-aħħar 6 xhur kellhom għallinqas żewġ episodji ta' AF li tiġi u tmur u li għallinqas kellhom wieħed minn dawn il-fatturi ta' riskju li ġejjin: età ≥ 75 sena jew età bejn 55 sa 74 sena u jew id-dijabete mellitus fejn ikun hemm il-bżonn tat-terapija bil-mediċini jew passat mediku ta' MI ddokumentat jew mard tal-arterji koronarji ddokumentat; ikkurat/a għall-ipertensjoni sistemika; passat mediku ta' puplesija, attakk iskemiku mhux permanenti (TIA) jew embolu sistemiku li ma jkunx fis-CNS; tnaqqis fil-funzjoni tal-ventriklu tax-xellug bil-porzjon tal-ħruġ mill-ventriklu tax-xellug < 45 %; jew mard vaskulari periferiku ddokumentat.
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: Il-pazjenti kienu każwalment magħżula għal clopidogrel (b'doża tal-bidu ta' 300 mg segwita b'75 mg/jum, N=6,259) jew plaċebo (N=6,303), li t-tnejn ingħataw flimkien ma' ASA (75-325 mg darba kuljum) u terapiji standard oħra.
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 mal-grupp plaċebo + ASA (1.4% kontra 0.8%, rispettivament).
English: 14x1 film-coated tablet 28x1 film-coated tablet 30x1 film-coated tablet 50x1 film-coated tablet 84x1 film-coated tablet 90x1 film-coated tablet 100x1 film-coated tablet
Maltese: 14x1 pillola miksija b'rita 28x1 pillola miksija b'rita 30x1 pillola miksija b'rita 50x1 pillola miksija b'rita 84x1 pillola miksija b'rita 90x1 pillola miksija b'rita 100x1 pillola miksija b'rita
English: In particular, in a post-hoc analysis in 2,172 patients (17% of the total CURE population) who underwent stent placement (Stent-CURE), the data showed that clopidogrel compared to placebo, demonstrated a significant RRR of 26.2% favouring clopidogrel for the co-primary endpoint (CV death, MI, stroke) and also a significant RRR of 23.9% for the second co-primary endpoint (CV death, MI, stroke or refractory ischaemia).
Maltese: B'mod partikulari, f'analiżi post-hoc f'2,172 pazjent (17 % tal-popolazzjoni totali ta' CURE) li kellhom stent impoġġija (Stent-CURE), id-dejta wriet li clopidogrel imqabbel ma' plaċebo, wera RRR sinifikanti ta' 26.2 % favur clopidogrel għal punt ko-primarju aħħari ta' riferiment ta' tmiem (mewt CV, MI, puplesija) u wkoll RRR sinifikanti ta' 23.9 % għat-tieni punt ko-primarju aħħari ta' riferiment (mewt CV, MI, puplesija jew iskemija rifrattorja).
English: Clopidogrel Teva Pharma B.V. contains lactose.
Maltese: Clopidrogel Teva Pharma B.V. fih lactose.
English: Teva Pharma B.V.,
Maltese: Teva Pharma, S.
English: In patients suffering from acute coronary syndrome: - Non-ST segment elevation acute coronary syndrome (unstable angina or non-Qwave 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 u mbagħad jitkompla b'75 mg darba kuljum (b'acetylsalicylic acid (ASA) 75 mg-325 mg kuljum).
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 (including insulin), antiepileptic agents, and GPIIb/IIIa antagonists without evidence of clinically significant adverse interactions.
Maltese: Madankollu, pazjenti li daħlu fi studji kliniċi bi clopidogel ngħataw diversi prodotti mediċinali fl-istess ħin u dawn kienu jinkludu dijuretiċi, beta blockers ACEI, antagonisti tal-kalċju, sustanzi li jbaxxu l-kolesterol, vażodilaturi koronarji, sustanzi kontra d-dijabete (li jinkludu l-insulina), sustanzi antiepilettiċi, u antagonisti GPIIb/IIIa mingħajr ma kien hemm evidenza ta' interazzjonijiet avversi klinikament sinifikanti.
English: • Omeprazole, esomeprazole or cimetidine, medicines to treat upset stomach.
Maltese: • Omeprazole, esomeprazole jew cimetidine, mediċini għal stonku mqalla'.
English: The prevalence of CYP2C19 alleles that result in intermediate and poor CYP2C19 metabolism differs according to race/ethnicity (see Pharmacogenetics).
Maltese: Il-prevalenza ta' alleli ta' CYP2C19 li jirriżultaw f'metaboliżmu intermedjarju u dgħajjef ta' CYP2C19 ivarja skont ir-razza/etniċità (ara Farmakoġenetika).
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'5 studji double-blind li involvew 'il fuq minn 88,000 pazjent: fl-istudju CAPRIE, paragun ta' clopidogrel ma' ASA, u fl-istudju CURE, CLARITY, COMMIT u ACTIVE-A kienu mqabblin clopidrogel mal-plaċebo, fejn iż-żewġ prodotti mediċinali ngħataw flimkien ma' ASA u terapija oħra li soltu tingħata.
English: Musculoskeletal, connective tissue and bone disorders
Maltese: Disturbi muskoluskeletriċi, tessut konnettiv u fl-għadam
English: Prevention of atherothrombotic events Clopidogrel is indicated in:
Maltese: Il-prevenzjoni ta' avvenimenti aterotrombotiċi Clopidogrel hu indikat f':
English: In adults Clopidogrel Teva Pharma B.V. reduces the risk of blood clots forming which in turn reduces the risk of serious conditions such as heart attack and stroke from occurring.
Maltese: Fl-adulti Clopidogrel Teva Pharma B.V. innaqqas r-riskju li jiffurmaw emboli tad-demm li min-naħa l-oħra tnaqqas ir-riskju ta' kundizzjonijiet serji milli jseħħu bħal attakk tal-qalb u puplesija.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Pazjenti li għandhom problemi ereditarji rari ta' intolleranza għal galactose, id-defiċjenza ta' Lapp lactase jew problemi fl-assorbiment ta' glucosegalactose m'għandhomx jieħdu dan il-prodott mediċinali.
English: Clopidogrel Teva Pharma B.V. contains lactose
Maltese: Clopidogrel Teva Pharma B.V. fih il-lactose
English: Do not take Clopidogrel Teva Pharma B.V.
Maltese: Tiħux Clopidogrel Teva Pharma B.V.
English: • Carbamazepine, or oxcarbazepine, medicines to treat some forms of epilepsy.
Maltese: • Carbamazepine, jew oxcarbazepine, mediċini użati għall-kura ta' xi forom ta' epilessija
English: Other medicinal products: A number of other clinical studies have been conducted with clopidogrel and other concomitant medicinal products to investigate the potential for pharmacodynamic and pharmacokinetic interactions.
Maltese: Prodotti mediċinali oħrajn: Għadd ta' studji kliniċi oħra bi clopidogrel u prodotti mediċinali oħra li ngħataw flimkien sabiex tiġi mistħarrġa l-possibilità ta' interazzjonijiet farmakodinamiċi u farmakokinetiċi.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 75 mg clopidogrel (as hydrobromide)
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pillola miksija b'rita fiha 75 mg clopidogrel (bħala hydrobromide)
English: The most common side effect (affects 1 to 10 users in 100) reported for medicines containing clopidogrel is bleeding.
Maltese: L-aktar effett kollaterali komuni rapportat (li jaffettwa utent 1 sa 10 f'kull 100) f'mediċini li fihom clopidogrel hu l-emorraġija.
English: - Perforated blisters contain 14x1, 28x1, 30x1, 50x1, 84x1, 90x1 or 100x1 film-coated tablet.
Maltese: - Folji pperforati li jitqaxxru li fihom 14x1, 28x1, 30x1, 50x1, 84x1, 90x1 jew 100x1 pillola miksija b'rita.
English: - 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) - ST segment elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy.
Maltese: - Sindromu koronarju akut bis-segment mhux ST elevat (angina mhux stabbli jew infart mijokardijaku mhux-mewga-Q), li jinkludi pazjenti fi proċess li titpoġġa stent wara intervent koronarju perkutaneju flimkien ma' acetylsalicylic acid (ASA).
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: Recent ischaemic stroke
Maltese: Puplesija Iskemika Riċenti
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, l-użu fl-istess waqt ta' inibituri qawwijin jew moderati ta' CYP2C19 għandu jiġi skorraġit (ara sezzjoni 4.5 għal lista ta' impedituri ta' CYP2C19, ara wkoll sezzjoni 5.2).