FrancophonIA/ELRC3.0 huggingface dataset:
English: You should specifically tell your doctor if you take medicines that may increase your risk of bleeding such as: o oral anticoagulants, medicines used to reduce blood clotting, o a non-steroidal anti-inflammatory medicine, usually used to treat painful and/or inflammatory conditions of muscle or joints, o heparin or any other injectable medicine used to reduce blood clotting, o ticlopidine, other antiplatelet agent, o a selective serotonin reuptake inhibitor (including but not restricted to fluoxetine or fluvoxamine), medicines usually used to treat depression, omeprazole or esomeprazole, medicines to treat upset stomach, fluconazole or voriconazole, medicines to treat fungal infections,
Maltese: Għandek speċifikament tgħid lit-tabib tiegħek jekk tieħu mediċini li jistgħu jżidu r-riskju li inti jkollok xi fsada bħal: o sustanzi kontra l-koagulazzjoni tad-demm li jittieħdu mill-ħalq, mediċini użati biex iraqqu d-demm, o mediċina anti-infjammatorja li mhijiex sterojde, normalment użata biex jiġi ittrattat luġigħ u/jew kundizzjonijiet infjammatorji tal- muskoli jew tal-ġogi,, o l-eparina jew xi mediċina oħra li tiġi injettata biex tnaqqas il-koagulazzjoni tad-demm, o ticlopidine, sustanza oħra kontra l-plejtlits, o inibitur selettiv tal-ġbir mill-ġdid ta' serotonin (li jinkludi iżda mhux limitat għal fluoxetine jew fluvoxamine), mediċini li ssoltu jintużaw fil-kura tad-dipressjoni, - omeprazole jew esomeprazole, mediċini għat-taqlib tal-istonku
English: 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: Mard minn serum, reazzjonijiet anafilattojdi, reazzjoni ta' sensittività eċċessiva li hija komuni għat-tipi differenti ta' thienopyridines (bħal ticlopidine, prasugrel) (ara sezzjoni 4.4)*, sindrome awtoimmuni tal-insulina, li jista' jwassal għal ipogliċemija severa partikolarment f'pazjenti bis-sottotip HLADRA4 (aktar ta' spiss fil-popolazzjoni Ġappuniża)*
English: United Kingdom Apotex Europe B.V.
Maltese: Deutschland Apotex Europe B.V.
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: Ħamsa u disgħin pazjent (7%) fil-grupp ta' deskalazzjoni gwidata u 118-il pazjent (9%) fil-grupp ta' kontroll (p mingħajr inferjorità=0.
English: A significantly lower exposure to clopidogrel active metabolite and reduced platelet inhibition have 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 talpjastrini mnaqqsa f'pazjenti infettati bl-HIV li ġew ikkurati b'terapiji antiretrovirali (ART) imsaħħa ta' ritonavir jew cobicistat.
English: If you have experienced severe chest pain (unstable angina or heart attack), your doctor may give you 300 mg of Clopidogrel Apotex (4 tablets of 75 mg) once at the start of treatment.
Maltese: Jekk kellek uġigħ sever f'sidrek (anġina instabbli jew attakk tal-qalb), it-tabib jista' jagħtik 300 mg ta' Clopidogrel - Apotex (4 pilloli ta' 75 mg) darba fil-bidu tal-kura.
English: Following an oral dose of 14C-labelled clopidogrel in man, approximately 50% was excreted in the urine and approximately 46% in the faeces in the 120-hour interval after dosing.
Maltese: Wara doża orali ta' clopidogrel 14C-tikkettat fil-bniedem, bejn wieħed u ieħor 50% kien mneħħi fl-urina u bejn wieħed u ieħor 46% ħareġ fl-ippurgar fl-intervall ta' 120 siegħa wara d-dożaġġ.
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) 75 mg-325 mg daily).
Maltese: Bis-segment mhux ST elevat (anġina instabbli jew infart mijokardijaku mhux-mewġa-Q): ilkura bi clopidogrel għandha tinbeda b'doża qawwija tal-bidu ta' 300 mg u titkompla b'75 mg darba kuljum (b'acetylsalicylic acid (ASA) 75 mg-325 mg kuljum).
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 tal-arterji periferiċi.
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 jimpedixxi b'mod selettiv l-irbit ta' adenosine diphosphate (ADP) mar-riċettur tal-plejtlits P2Y12 u l-attivazzjoni suċċessiva tal- kumpless ta' glikoproteina GPIIb/IIIa bl-intervent ta' ADP, u b'hekk jimpedixxi l-aggregazzjoni tal- plejtlits.
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, IPA kienet ta' 32% (24 siegħa) u 61% (Jum 5), u dawn kienu akbar milli fil-metabolizzaturi dgħajfa li rċevew is-sistema ta' dożaġġ ta' 300 mg/75 mg, u simili għall-gruppi ta' metabolizzaturi l-oħra ta' CYP2C19 li rċevew is-sistema ta' dożaġġ ta' 300 mg/75 mg.
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: suffejra, uġigħ addominali severi bi jew mingħajr uġigħ fid-dahar; deni, diffikultajiet biex tieħu n-nifs assoċjati ma' tħarħir; reazzjonijiet allerġiċi ġeneralizzati (pereżempju, sensazzjoni ta' sħana ma' ġismek kollu b'skonfort ġenerali f'daqqa sakemm tħossok ħażin), nefħa fil-ħalq, nfafet fuq il-ġilda; allerġiji fuq ilġilda; uġigħ fil-ħalq (stomatite) tnaqqis fil-pressjoni tad-demm; konfużjoni; alluċinazzjonijiet; uġigħ talgħadam; uġigħ muskolari, tibdil fit-togħma ta' l-ikel jew ma tibqax ittiegħem l-ikel.
English: EU/1/09/568/001 Cartons of 7 film-coated tablets in PVC/PE/PVDC/Alu blisters EU/1/09/568/002 Cartons of 14 film-coated tablets in PVC/PE/PVDC/Alu blisters EU/1/09/568/003 Cartons of 28 film-coated tablets in PVC/PE/PVDC/Alu blisters EU/1/09/568/004 Cartons of 30 film-coated tablets in PVC/PE/PVDC/Alu blisters EU/1/09/568/005 Cartons of 50 film-coated tablets in PVC/PE/PVDC/Alu blisters EU/1/09/568/006 Cartons of 56 film-coated tablets in PVC/PE/PVDC/Alu blisters EU/1/09/568/007 Cartons of 84 film-coated tablets in PVC/PE/PVDC/Alu blisters EU/1/09/568/008 Cartons of 90 film-coated tablets in PVC/PE/PVDC/Alu blisters EU/1/09/568/009 Cartons of 100 film-coated tablets in PVC/PE/PVDC/Alu blisters EU/1/09/568/010 Cartons of 7 film-coated tablets in PA/ALL/PVDC/Alu blisters EU/1/09/568/011 Cartons of 14 film-coated tablets in PA/ALL/PVDC /Alu blisters EU/1/09/568/012 Cartons of 28 film-coated tablets in PA/ALL/PVDC /Alu blisters EU/1/09/568/013 Cartons of 30 film-coated tablets in PA/ALL/PVDC /Alu blisters EU/1/09/568/014 Cartons of 50 film-coated tablets in PA/ALL/PVDC /Alu blisters EU/1/09/568/015 Cartons of 56 film-coated tablets in PA/ALL/PVDC /Alu blisters EU/1/09/568/016 Cartons of 84 film-coated tablets in PA/ALL/PVDC /Alu blisters
Maltese: Kaxex ta' 56 pillola miksija b'rita fil-folji tal-PVC/PVDC/Alu EU/1/09/568/001-007 Kaxex ta' 84 pillola miksija b'rita fil-folji tal-PVC/PVDC/Alu EU/1/09/568/001-008 Kaxex ta' 90 pillola miksija b'rita fil-folji tal-PVC/PVDC/Alu EU/1/09/568/001-009 Kaxex ta' 100 pillola miksija b'rita fil-folji tal-PVC/PVDC/Alu EU/1/09/568/001-010
English: What Clopidogrel Apotex contains The active substance is clopidogrel.
Maltese: Is-sustanza attiva hija clopidogrel.
English: • You should also tell your doctor immediately if you develop a medical condition (also known as Thrombotic Thrombocytopenic Purpura or TTP) that includes fever and bruising under the skin that may appear as red pinpoint dots, with or without unexplained extreme tiredness, confusion, yellowing of the skin or eyes (jaundice) (see section 4 ‘Possible side effects').
Maltese: • Għandek ukoll tgħid lit-tabib tiegħek minnufih jekk tiżviluppa kundizzjoni medika (magħrufa wkoll bħala Purpura Trombotika Tromboċitopenika jew TTP) li tinkludi deni u tbenġil taħt il-ġilda li jidher bħal tikek ħomor irqaq, flimkien ma' jew mingħajr għeja kbira mhux spjegata, konfużjoni, sfurija tal-ġilda jew ta' l-għajnejn (suffejra) (ara sezzjoni 4 'Effetti sekondarji possibbli').
English: At very high doses, a poor gastric tolerability (gastritis, gastric erosions and/or vomiting) of clopidogrel was also reported in rat and baboon.
Maltese: F'dożi għolja ħafna, ġiet irrappurtata tollerabilità baxxa fiż-żaqq (gastrite, erożjonijiet gastriċi u/jew rimettar) ta' clopidogrel fil-firien u l-babwini.
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: Id-differenza statistikament sinjifikanti kienet prinċipalment dovuta għal inqas każijiet emorraġiċi, bl-ebda differenza rapportata f'punti ta' tmiem iskemiċi (p=0.36), filwaqt li emorraġija BARC ≥2 seħħet inqas frekwenti fil-grupp b'DAPT deskalat (4.0%) versu 14.9% fil-grupp DAPT mhux mibdul (p<0.01). Każijiet ta' emorraġija imfissra bħala BARC kollu seħħew fi 30 pazjent (9.3%) fil-grupp DAPT deskalat u f'76 pazjent (23.5%) fil-grupp DAPT mhux mibdul (P<0.01).
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 Apotex.
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: L-eżitu prinċipali, li jinkludi fih mewt kardjovaskulari, puplesija, rivaskularizzazzjoni urġenti u emorraġija BARC (Bleeding Academic Research Consortium (Konsorzju dwar ir-Riċerka Akademika fuq Emorraġiji)) ≥2 f'sena wara ACS, seħħ fi 43 pazjent (13.4%) fil-grupp DAPT deskalat u f'85 pazjent (26.
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: Partikularment, f'analiżi post-hoc f' 2,172 pazjenti (17% tal-popolazzjoni kollha CURE) li kellhom stent impoġġija (Stent-CURE), id-data wriet li clopidogrel, imqabbel ma' plaċebo, wera RRR sinifikanti ta' 26.
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 fittrabi tat-twelid u fit-tfal ċkejknin u 0.15 mg/kg fit-trabi tat-twelid biss.
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: 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: Madankollu, pazjenti li daħlu fi studji kliniċi bi clopidogrel ngħataw varjetà 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 l-insulina), sustanzi antiepilettiċi, u antagonisti GPIIb/IIIa mingħajr ma kien hemm evidenza ta' interazzjonijiet avversi klinikament sinifikanti.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Il-pazjenti li għandhom problemi ereditarji rari ta' intolleranza għallgalattożju, b'defiċit ta' Lapp-lattażi jew malassorbiment ta' glukożju-galattożju m'għandhomx jieħdu dan il-prodott mediċinali.
English: In CHARISMA and one cohort study (Simon), an increased event rate was observed only in poor metabolisers when compared to extensive metabolisers.
Maltese: F'CHARISMA u studju ko-ort wieħed (Simon), rata ogħla ta' avvenimenti ġiet osservata biss fil-metabolizzaturi dgħajfa meta mqabbla ma' metabolizzaturi estensivi.
English: Therefore, the guided de-escalation arm had patients on either prasugrel (40%) or clopidogrel (60%).
Maltese: Għalhekk, il-grupp ta' deskalazzjoni gwidata kellu pazjenti jew fuq prasugrel (40%) jew clopidogrel (60%).
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 l inibizzjoni ta' CYP2C8 mill-metabolit glukuronidu ta' clopidogrel.
English: Clopidogrel Apotex 75 mg film-coated tablets clopidogrel
Maltese: Clopidogrel Apotex 75 mg pillola miksija b'rita clopidogrel
English: Approximately 88% of patients received concomitant ASA (range of 1 to 23 mg/kg/day).
Maltese: Madwar 88% tal- pazjenti rċevew fl-istess ħin ASA (b'varjazzjoni minn 1 sa 23 mg/kg/jum).
English: NAME OF THE MEDICINAL PRODUCT Clopidogrel Apotex 75 mg film-coated tablets
Maltese: IL-PRODOTT MEDIĊINALI Clopidogrel Apotex 75 mg pilloli miksija b'rita
English: When poor metabolisers received the 600 mg/150 mg regimen, active metabolite exposure was greater than with the 300 mg/75 mg regimen.
Maltese: Meta l-metabolizzaturi dgħajfa rċevew is-sistema ta' dożaġġ ta' 600 mg/150 mg, l-espożizzjoni tal-metabolit attiv kienet akbar milli bissistema ta' dożaġġ ta' 300 mg/75 mg.
English: Film:
Maltese: PC:
English: 6.3 Shelf-life
Maltese: 4. GĦAMLA
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: B'kuntrast, analiżi post-hoc wriet żidiet statistikament sinjifikanti fir-riskju ta' emorraġija blaktar impedituri qawwija ta' P2Y12, li prinċipalment seħħ fil-fażi ta' manteniment, wara l-ewwel xahar post-ACS.
English: Johnson Syndrome, erythema multiforme, acute generalised exanthematous pustulosis (AGEP)), angioedema,
Maltese: Dermatite bulloża (nekroliżi tossika talepidermide, sindromu ta' Stevens Johnson, eritema multiformi, Pustulosi eksantematosi ġenalizzata akuta (acute generalized exanthematous pustulosis, AGEP)), anġjoedema, sindromu ta' sensittività eċċessiva kkawżat millmediċina, raxx kkawżat millmediċina b'eosinofilja u sintomi sistemiċi (DRESS), raxx eritematika jew bilqoxra, urtikarja, ekzema, lichen planus
English: myalgia
Maltese: Ematurja
English: Rare side effect (may affect up to 1 in 1000 people): Vertigo, enlarged breasts in males.
Maltese: Effetti sekondarji rari (jistgħu jaffettwaw sa 1 minn kull 1,000 persuna): Vertigo, sdieri akbar fl-irġiel.
English: Oral anticoagulants: the concomitant administration of clopidogrel with oral anticoagulants is not recommended since it may increase the intensity of bleedings (see section 4.4).
Maltese: Antikoagulanti orali: mhix rakkomandata l-amministrazzjoni ta' clopidogrel flimkien ma' antikoagulanti orali billi dan jista' jkattar l-intensità tal-fsada (ara sezzjoni 4.4).
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 talkreatinina minn 5 sa 15 ml/min) l-inibizzjoni tal-agreggrazzjoni tal-plejtlets indotti minn ADP kien iktar baxx (25%) minn dak osservat f'persuni f'saħħithom, madankollu it-titwil tal-fsada kien simili għal dak osservat f'persuni f'saħħithom li kienu qed jingħataw 75 mg ta' clopidogrel kuljum.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON for blisters of 7, 14, 28, 30, 50, 56, 84, 90 or 100 film-coated tablets
Maltese: Kartuna għal folji ta' 7, 14, 28, 30, 50, 56, 84, 90 jew 100 pillola miksija b'rita
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: 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: Trombolitiċi: is-sigurtà tat-teħid flimkien ta' clopidogrel, sustanzi trombolitiċi speċifiċi għall-fibrina jew li mhumiex u eparini ġiet eżaminata f'pazjenti li kellhom infart mijokardijaku akut.
English: The primary endpoint (the combined incidence of CV death, MI, stroke and BARC bleeding grade ≥2 at 12 months) was met showing non-inferiority.
Maltese: Il-punt ta' tmiem primarju (l-inċidenza kombinata ta' mewt kardjovaskulari, MI, puplesija u grad ta' emorraġija BARC ≥2 wara 12-il xahar) intlaħaq mingħajr ma wera inferjorità.
English: - 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: 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'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: NAME OF THE MEDICINAL PRODUCT Clopidogrel Apotex 75 mg film-coated tablets clopidogrel
Maltese: TAL-PRODOTT MEDIĊINALI Clopidogrel Apotex 75 mg pilloli miksija b'rita clopidogrel
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTERS containing 7, 14, 28, 30, 50, 56, 84, 90 or 100 film-coated tablets 1.
Maltese: TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL-FOLJI JEW STRIXXI (FOLJI li fihom 7, 14, 28, 30, 50, 56, 84, 90 jew 100 pillola miksija b'rita) 1.
English: The Cmax of the active metabolite is twice as high following a single 300-mg clopidogrel loading dose as it is after four days of 75-mg maintenance dose.
Maltese: Cmax tal-metabolit attiv huwa d-doppju wara doża qawwija inizjali ta' 300 mg clopidogrel kif ukoll wara erbat ijiem ta' doża ta' manteniment ta' 75 mg. Cmax iseħħ madwar 30 sa 60 minuta wara doża.
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, ulċera fl-istonku, rimettar, nawżea, stitikezza, gass eċċessiv fl-istonku jew fl-imsaren, raxxijiet, ħakk, sturdament, sensazzjoni ta' tnemnim u tirżiħ.
English: How to take Clopidogrel Apotex
Maltese: X'fih Clopidogrel Apotex
English: The median follow-up for both groups was 359 days.
Maltese: Issussegwirsi medjan għaż-żewġ gruppi kien ta' 359 jum.
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 talINR (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.
English: This leaflet was last revised in {MM/YYYY} .
Maltese: Reazzjonijet inkroċjati fost thienopyridines
English: Each film-coated tablet contains 75 mg of clopidogrel (as besilate).
Maltese: Kull pillola miksija b'rita fiha75 mg ta' clopidogrel (bħala besilat [besilate]).
English: Patients on aspirin and a more potent P2Y12 blocker and without adverse event at one month were assigned to switch to fixed-dose aspirin plus clopidogrel (de-escalated dual antiplatelet therapy (DAPT)) or continuation of their drug regimen (unchanged DAPT).
Maltese: Pazjenti fuq l-aspirina u l-imblokkatur aktar qawwi P2Y12 u mingħajr każ avvers wara xahar kienu assenjati biex jinqalbu fuq doża fissa ta' aspirina flimkien ma' clopidogrel (terapija ta' deskalazzjoni antiplejtlet doppja (DAPT, de-escalated dual antiplatlet therapy) jew jibqgħu għadejjin bil-kors ta-mediċina tagħhom (DAPT mhux mibdul).
English: Blood and the lymphatic system disorders
Maltese: Disturbi tad-demm u tas-sistema linfatika
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 ttrattati bilmediċini u eliġibbli għat-terapija trombolitika