FrancophonIA/ELRC3.0 huggingface dataset:
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, illivell medju ta' inibizzjoni osservat b'doża ta' 75 mg kuljum kien bejn 40% u 60%.
English: Thrombotic thrombocytopenic purpura (TTP) (see section 4.4), aplastic anaemia, pancytopenia, agranulocytosis, severe thrombocytopenia, acquired haemophilia A, granulocytopenia, anaemia
Maltese: Purpura tromboċitopenikatrombotik a (thrombotic thrombocytopenic purpura (TTP)) (ara sezzjoni 4.4), anemija aplastika,
English: Thur
Maltese: Tli
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucosegalactose malabsorption should not take this medicinal product.
Maltese: Pazjenti li għandhom problemi ereditarji rari ta' intolleranza għall-galactose, nuqqas totali ta' lactase jew malassorbiment tal-glucose-galactose m'għandhomx jieħdu din il-mediċina.
English: Musculoskeletal, connective tissue and bone disorders
Maltese: Disturbi muskoluskeletriku, tessut konnettiv u fl għadam
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 ċirkolanti (mhux attiv) kien ta' 8 sigħat wara amministrazzjoni waħda u ripetuta.
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-mortalità totali bħala punt sekondarju ta' tmiem, m'urietx xi differenza sinifikanti bejn clopidogrel (5.8%) u ASA (6.0%).
English: The population included 27.8% women, 58.4% patients ≥60 years (26% ≥70 years) and
Maltese: Il-popolazzjoni kienet tinkludi 27.8% nisa, 58.4% pazjenti ≥ 60 sena
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: thienopyridines (bħal ticlopidine, prasugrel) (ara sezzjoni 4.4)*, sindromu awtoimmunitarju talinsulina, li jista' jwassal għal ipogliċemija severa speċjalment f'pazjenti bis sottotip HLA DRA4 (aktar frekwenti fil-popolazzjoni
English: Manufacturer:
Maltese: Il-Manifatturi:
English: Eye bleeding (conjunctival, ocular, retinal)
Maltese: (konġuntivali, okulari, retinali)
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: 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 incidence of severe cases was similar for clopidogrel and ASA.
Maltese: L-inċidenza ta' każi severi kienet simili għal clopidogrel u ASA.
English: Respiratory tract bleeding (haemoptysis, pulmonary haemorrhage), bronchospasm, interstitial pneumonitis, eosinophilic pneumonia
Maltese: bronkospażmu, pnewmonite interstizjali, pulmonte eosinofilika
English: − Calendar pack of perforated blisters of aluminium/aluminium containing 28x1 tablets
Maltese: - Pakketti kalendarjani ta' folji pperforati ta' aluminju/aluminju li fihom 28x1 pillola
English: Clopidogrel Teva 75 mg film-coated tablets clopidogrel oral use
Maltese: Clopidogrel Teva 75mg pilloli miksija b'rita clopidogrel użu orali
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 109/l); requirement for clopidogrel or oral anticoagulants (OAC); or intolerance to any of the two compounds.
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 109/l); ilbżonn ta' clopidogrel jew antikoagulanti orali (OAC); jew intolleranza għal xi wieħed miż-żewġ sustanzi.
English: In patients suffering from acute coronary syndrome:
Maltese: F'pazjenti li jbatu minn sindromu koronarju akut:
English: Thrombolytics: the safety of the concomitant administration of clopidogrel, fibrin or non-fibrin specific thrombolytic agents and heparins was assessed in patients with acute myocardial infarction.
Maltese: Thrombolitiċi: is-sigurtà tat-teħid flimkien ta' clopidogrel, sustanzi trombolitiċi speċifiċi tal-fibrini u mhux fribrini u heparins ġiet eżaminata f'pazjenti li kellhom infart mijokardijaku akut.
English: The active metabolite of clopidogrel selectively inhibits the binding of adenosine diphosphate (ADP) to its platelet P2Y12 receptor and the subsequent ADP-mediated activation of the glycoprotein GPIIb/IIIa complex, thereby inhibiting platelet aggregation.
Maltese: Il-metabolit attiv ta' clopidogrel silettivament jimpedixxi l-irbit ta' adenosine diphosphate(ADP) mar-riċettatur tal-plejtlet tiegħu P2Y12 u l-attivazzjoni sussegwenti li ssir permezz ta' ADP tal-kumpless ta' glycoprotein GPIIb/IIIa, li b'hekk jimpedixxi l-aggregazzjoni ta' plejtlets.
English: Light pink to pink, capsule-shaped film-coated tablets debossed with “93” on one side and “7314” on the other side.
Maltese: Pilloli miksija b'rita li huma ta' lewn roża ċar għal roża, f'għamla ta' kapsuli b' “93” imnaqqxa fuq naħa waħda u “7314” fuq in-naħa l-oħra.
English: 14x1 film-coated tablets 28x1 film-coated tablets 30x1 film-coated tablets 50x1 film-coated tablets 84x1 film-coated tablets 90x1 film-coated tablets 100x1 film-coated tablets
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 pillolamiksija b'rita 100x1 pillola miksija b'rita
English: Each film-coated tablet contains 75 mg clopidogrel (as hydrogen sulfate).
Maltese: Kull pillola miksija b'rita fiha 75 mg clopidogrel (bħala hydrogen sulfate).
English: Thrombocytopenia, leucopenia, eosinophilia
Maltese: Tromboċitopenija lewkopenija, esinofilja
English: In addition, IPA was 32% (24 hours) and 61% (Day 5), which were greater than in the poor metabolisers receiving the 300 mg/75 mg regimen, and were similar to the other CYP2C19 metaboliser groups receiving the 300 mg/75 mg regimen.
Maltese: Barra minn hekk, l-IPA kien ta' 32% (24 siegħa) u 61% (Jum 5), li kienu akbar minn dawk tal-metabolizzaturi batuti li rċevew il-programm ta' kura ta' 300 mg/75 mg u kien simili għall-gruppi l-oħra ta' metabolizzaturi ta' CYP2C19 li qed jirċievu l-programm ta' kura ta' 300 mg/75 mg.
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 flimkien ma' ASA f'pazjenti trattati bil-mediċini u eleġibbli għal terapija trombotika.
English: • Active pathological bleeding such as peptic ulcer or intracranial haemorrhage.
Maltese: Emorraġija patoloġika attiva bħal b'ulċera peptika jew emorraġija intrakranjali.
English: BARC (Bleeding Academic Research Consortium) bleeding ≥2 at 1 year post ACS, occurred in
Maltese: 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: − 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)
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)
English: Ninety five patients (7%) in the guided de-escalation group and 118 patients (9%) in the control group (p non-inferiority=0.0004) had an event.
Maltese: (7%) fil-grupp iggwidat ta' tnaqqis fil-qawwa u 118-il pazjent (9%) fil-grupp ta' kontroll (p mhux inferjuri=0.
English: 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: Effetti sekondarji rari ħafna (jistgħu jaffettwaw sa 1 minn kull 10,000 persuna) Suffejra; uġigħ addominali qawwi flimkien ma' jew mingħajr uġigħ fid-dahar; deni, diffikultajiet fin-nifs kultant assoċjati mas-sogħla; reazzjonijiet allerġiċi ġeneralizzati ( per eżempju, sensazzjoni ta' sħana ma' ġismek kollu b'skonfort ġenerali f'daqqa sakemm tħossok ħażin); nefħa fil-ħalq; infafet fil-ġilda; reazzjoni allerġika fil-ġilda; uġigħ fil-ħalq (stomatite); tnaqqis fil-pressjoni tad-demm; konfużjoni; alluċinazzjonijiet; uġigħ fil-ġogi; uġigħ muskolari; tibdil fit-togħma ta' l-ikel jew ma tibqax ittiegħem l-ikel.
English: Bullous dermatitis (toxic epidermal necrolysis, Stevens Johnson Syndrome, erythema multiforme), acute generalised exanthematous pustulosis (AGEP)), angioedema, drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms (DRESS), rash erythematous or exfoliative, urticaria, eczema, lichen planus
Maltese: (AGEP), anġjoedema, sindromu ta' sensittività eċċessiva kkawżat millmediċina, raxx kkawżat mill-mediċina b'eosinofilja u sintomi sistemiċi
English: In a dose escalation study of 86 neonates or infants up to 24 months of age at risk for thrombosis (PICOLO), clopidogrel was evaluated at consecutive doses of 0.01, 0.1 and 0.2 mg/kg in neonates and infants and 0.15 mg/kg only in neonates.
Maltese: F'studju b'dożi li jibqgħu jogħlew u li sar f'86 tarbija tat-twelid jew tfal ċkejknin sa 24 xahar ta' età f'riskju ta' trombożi (PICOLO), clopidogrel ġie evalwat f'dożi konsekuttivi ta' 0.01, 0.1 u 0.2 mg/kg fit-trabi tat twelid u fit-tfal ċkejknin u 0.15 mg/kg fit-trabi tat-twelid biss.
English: Film-coated tablet.
Maltese: metabolizzaturi batuti.
English: Major bleeding was mostly of extracranial origin in both groups (5.3% in the clopidogrel + ASA group; 3.5% in the placebo +ASA group), mainly from the gastrointestinal tract (3.5% vs. 1.8%).
Maltese: Fiż-zewġ gruppi, l-aktar fsada qawwija nstabet barra mill-kranju (5.3 % fil-grupp clopidogrel + ASA; 3.5% fil-grupp plaċebo +ASA ), l-aktar mill-passaġġ gastrointestinali (3.5% kontra
English: Calendar days Mon
Maltese: Jiem tal-kalendarju Tne
English: Clopidogrel is first metabolised to a 2-oxo-clopidogrel intermediate metabolite.
Maltese: Clopidogrel huwa l-ewwel metabolizzat għal metabolit intermedjarju ta' 2
English: Bleeding events defined as all BARC occurred in 30 patients (9.3%) in the de-escalated DAPT group and in 76 patients (23.5%) in the unchanged DAPT group (p<0.01).
Maltese: seħħew f'30 pazjent (9.3%) fil-grupp ta' DAPT ta' tnaqqis fil-qawwa u f'76 pazjenti (23.5%) fil-grupp ta' DAPT mingħajr tibdil (p<0.01)
English: There was no significant difference between groups in the primary composite endpoint of death, shunt thrombosis or cardiac-related intervention prior to 120 days of age following an event considered of thrombotic nature (89 [19.1%] for the clopidogrel group and 90 [20.5%] for the placebo group) (see section 4.2).
Maltese: Ma kien hemm ebda differenza sinifikanti bejn il-gruppi fil-varjetà ta' riżultati finali primarji ta' mewt, trombożi tad-devjazzjoni kirurġika jew intervent tat-tip kardijaku sa qabel l-età ta' 120 ġurnata wara avveniment li kien ikkunsidrat ta' natura trombotika (89 [19.1%] għall-grupp ta' clopidogrel u 90
English: This statistically significant difference was mainly driven by fewer bleeding events, with no difference reported in ischaemic endpoints (p=0.36), while BARC ≥2 bleeding occurred less frequently in the de-escalated DAPT group (4.0%) versus 14.9% in the unchanged DAPT group (p<0.01).
Maltese: Din id differenza statistikament sinifikanti kienet ikkawżata l-iżjed minħabba li kien hemm inqas avvenimenti ta' fsada, mingħajr ma ġiet irrapportata ebda differenza fil-punti finali iskemiċi (p=0.36), waqt li BARC ≥2
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;
English: Therefore, the guided de-escalation arm had patients on either prasugrel (40%) or clopidogrel (60%).
Maltese: (40%) jew clopidogrel (60%).
English: − Tablet core: lactose monohydrate, microcrystalline cellulose, hydroxypropylcellulose (E463), crospovidone (type A), hydrogenated vegetable oil and sodium laurilsulfate.
Maltese: - Il-qalba tal-pillola: lactose monohydrate, microcrystalline cellulose, hydroxypropylcellulose
English: In CURE, there was no excess in major bleeds with clopidogrel plus ASA within 7 days after coronary bypass graft surgery in patients who stopped therapy more than five days prior to surgery.
Maltese: F'CURE ma kienx hemm eċċessi ta' emorraġiji maġġuri b'clopidogrel flimkien ma' ASA fis-7 ijiem wara operazzjoni ta' trapjant ta' bajpass koronarju f'pazjenti li waqqfu t-terapija aktar minn 5 ijiem qabel l-intervent kirurġiku.
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 u COMMIT u
English: The benefit of the combination of clopidogrel with ASA beyond four weeks has not been studied in this setting (see section 5.1).
Maltese: Madankollu, clopidogrel u ASA ngħataw flimkien sa perijodu ta' sena (ara sezzjoni 5.1).
English: As a precaution concomitant use of strong or moderate CYP2C19 inhibitors should be discouraged (see sections 4.4 and 5.2).
Maltese: CYP2C19 għandu jiġi skorraġit (ara sezzjonijiet 4.4 u 5.2).
English: The guided de-escalation did not result in an increased combined risk of ischemic events (2.5% in the deescalation group vs 3.2% in the control group; p non-inferiority=0.0115), nor in the key secondary endpoint of BARC bleeding ≥2 ((5%) in the de-escalation group versus 6% in the control group (p=0.23)).
Maltese: 0115), u l-anqas fil-punt finali sekondarju prinċipali ta' fsada BARC ≥2 ((5%) fil-grupp ta' tnaqqis fil-qawwa kontra 6% fil-grupp ta' kontroll (p=0.23)).
English: Cross-reactions among thienopyridines
Maltese: Żejt veġetali idroġenat
English: For the 28x1 tablets pack size, you can check the day on which you last took a tablet of Clopidogrel Teva by referring to the calendar printed on the blister
Maltese: Għad-daqs tal-pakkett ta' 28x1 pilloli, tista' tiċċekkja il-jum meta l-aħħar li ħadt il-pillola ta' Clopidogrel Teva billi tirreferi għal kalendarju stampat fuq il-folja.
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: 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%;
English: Recent ischaemic stroke
Maltese: paraestesija, sturdament
English: Contains lactose.
Maltese: Popolazzjoni pedjatrika.
English: Calendar pack of aluminium-aluminium perforated blisters containing 28x1film coated tablets
Maltese: Pakketti kalendarji ta' folji pperforati ta' aluminju/aluminju li fihom 28x1 pilloli miksija b'rita.
English: Clopidogrel Teva 75 mg film-coated tablets clopidogrel
Maltese: Clopidogrel Teva 75 mg pilloli miksija b'rita clopidogrel
English: The pharmacokinetics of digoxin or theophylline were not modified by the co-administration of clopidogrel.
Maltese: Il-farmakokinetiċi ta' digoxin jew theophylline ma ġewx modifikati bl-amministrazzjoni flimkien ma'
English: If you become pregnant while taking Clopidogrel Teva, consult your doctor immediately as it is recommended not to take clopidogrel while you are pregnant.
Maltese: Jekk tinqabad tqila waqt li qed tieħu Clopidogrel Teva, ikkonsulta minnufih mat-tabib tiegħek peress li hu rakkomandat li ma tieħux clopidogrel meta tkun tqila.
English: Clopidogrel Teva 75 mg film-coated tablets
Maltese: Clopidogrel Teva 75 mg pilloli miksija b'rita
English: Perforated blisters contain 14x1, 28x1, 30x1, 50x1, 84x1, 90x1 or 100x1 film-coated tablets.
Maltese: FOLJA (14x1, 28x1, 30x1, 50x1, 84x1, 90x1 jew 100x1 pilloli miksija b'rita)
English: Aluminium-aluminium peelable perforated unit-dose blisters, aluminium-aluminium perforated unit dose blisters and HDPE bottles with polypropylene closures or child resistant polypropylene closures and silica gel desiccant.
Maltese: Clopidogrel ntwera li ma kellu l-ebda effett fuq il-fertilità tal-firien irġiel u nisa u ma kellux effett tossiku fuq is-sistema riproduttiva la fil-firien u lanqas fil-fniek.
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.
English: Package leaflet: Information for the user Clopidogrel Teva 75 mg film-coated tablets clopidogrel
Maltese: Informazzjoni għall-utent Clopidogrel Teva 75 mg pilloli miksija b'rita clopidogrel
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-sigurtà f'aktar minn 44,000 pazjent li pparteċipaw fi studji kliniċi, li kienu jinkludu aktar minn 12,000 pazjent trattati għal sena jew aktar.
English: 54.5% patients who received fibrinolytics.
Maltese: (26%≥70 sena) u 54.5% pazjenti li rċevew fibrinolitiċi.
English: Peelable perforated blisters contain 14x1, 28x1, 30x1, 50x1, 84x1, 90x1 or 100x1 film-coated tablets.
Maltese: Folji pperforati li jitqaxxru li fihom 14x1, 28x1, 30x1, 50x1, 84x1, 90x1 jew 100x1 pilloli miksija b'rita.
English: Clopidogrel is extensively metabolised by the liver.
Maltese: Bijotrasformazzjoni Clopidogrel huwa metabolizzat b'mod estensiv fil-fwied.
English: Other alleles associated with absent or reduced metabolism are less frequent and include CYP2C19*4, *5, *6, *7, and *8.
Maltese: Alleli oħra assoċjati ma' metaboliżmu nieqes jew imnaqqas jinkludu huma inqas frekwenti u jinkludu CYP2C19*4, *5,
English: The number of patients who reached the primary endpoint (time to first occurrence of stroke, MI, non-CNS systemic embolism or vascular death) was 832 (22.1%) in the group treated with clopidogrel + ASA and 924 (24.4%) in the placebo + ASA group (relative risk reduction of 11.1%; 95% CI of 2.4% to 19.1%; p=0.013), primarily due to a large reduction in the incidence of strokes.
Maltese: In-numru ta' pazjenti li laħqu l-indikatur ewlieni (iż- żmien sakemm isseħħ l-ewwel puplesija, MI, emboliżmu sistemiku mhux fis-CNS jew mewt minn kawża vaskulari) kien ta' 832 (22.1%) fil-grupp ikkurat b'clopidogrel + ASA u 924 (24.4%) fil-grupp plaċebo + ASA (tnaqqis relattiv fir-riskju ta' 11.1%; 95% CI
English: Teva Pharmaceuticals Polska Sp. z o.o.
Maltese: Teva Pharma Belgium N.V./S.A.
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 clopidrogrel u acetylsalicylic acid li jista' jwassal għal riskju akbar ta' emorraġija.
English: Published frequencies for the poor CYP2C19 metaboliser genotypes are approximately 2% for Caucasians, 4% for Blacks and 14% for Chinese.
Maltese: Kawkasi, 4% għas-Suwed u 14% għaċ-Ċiniżi.
English: Due to the risk of bleeding and haematological adverse reactions, blood cell count determination and/or other appropriate testing should be promptly considered whenever clinical symptoms suggestive of bleeding arise during the course of treatment (see section 4.8).
Maltese: Minħabba r-riskju ta' reazzjonijiet emorraġiji avversi u effetti ematoloġiċi, l-għadd ta' ċelluli tad-demm u/jew kull ittestjar ieħor xieraq għandhom jiġu kkonsidrati kull meta waqt it-trattament ikun hemm sintomi kliniċi li jindikaw emorraġiji (ara sezzjoni 4.8).
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER (14x1, 28x1, 30x1, 50x1, 84x1, 90x1 or 100x1 film-coated tablets)
Maltese: FOLJA (14x1, 28x1, 30x1, 50x1, 84x1, 90x1 jew 100x1pillola miksija b'rita)
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: (ara sezzjoni 4.5 għal lista ta' impedituri ta' CYP2C19, ara wkoll sezzjoni 5.2).
English: Lactose
Maltese: Fertilità
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 uriet żidiet statistikament sinifikanti fir-riskju ta' fsada bl inibituri aktar potenti ta' P2Y12, li seħħew l-aktar fil-fażi ta' manteniment, wara l-ewwel xahar wara ACS.
English: How to store Clopidogrel Teva
Maltese: X'fih Clopidogrel Teva
English: 100x1 film-coated tablets 28x1 film-coated tablets
Maltese: Kartun ta' 84x1 film- pillola miksija b'rita ġo folji tal-aluminju li jitqaxxru