FrancophonIA/ELRC3.0 huggingface dataset:
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) ) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines webportal.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq għandu jippreżenta rapporti perjodiċi aġġornati dwar issigurtà għal dan il-prodott f'konformità mar-rekwiżiti mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.>
English: Other medicines and Clopidogrel Mylan
Maltese: Mediċini oħra u Clopidogrel Mylan
English: Week 2 (for boxes of 14, 28, 56, 84) Week 3 (for boxes of 28, 56, 84) Week 4 (for boxes of 28, 56, 84)
Maltese: Ġimgħa 2 (għal kaxex ta' 14, 28, 56, 84) Ġimgħa 3 (għal kaxex ta' 28, 56, 84) Ġimgħa 4 (għal kaxex ta' 28,56, 84)
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 ntgħażlu b'mod każwali għal clopidogrel (doża qawwija tal-bidu ta' 300 mg segwita minn 75 mg/jum, N= 6,259) jew plaċebo (N= 6,303), it-tnejn ingħataw flimkien ma' ASA (75-325 mg darba kuljum) u terapiji oħrajn standard.
English: Τηλ: + 357 99403969
Maltese: Pharmaceutical Trading Co Ltd Τηλ: + 357 99403969
English: The benefits observed with clopidogrel were independent of other acute and long-term cardiovascular therapies (such as heparin/LMWH, GPIIb/IIIa antagonists, lipid lowering medicinal products, beta blockers, and ACE-inhibitors).
Maltese: Il-benefiċċji osservati bi clopidogrel kienu indipendenti minn terapiji oħrajn kardjovaskulari akuti u fit-tul (bħal heparin/LMWH, antagonisti ta' GPIIb/IIIa, prodotti mediċinali li jbaxxu l-lipidi, imblokkaturi beta, u inibituri ta' ACE).
English: What Clopidogrel Mylan contains The active substance is clopidogrel.
Maltese: Is-sustanza attiva hi clopidogrel.
English: There was an excess of intracranial bleeding in the clopidogrel + ASA treatment group compared to the placebo + ASA group (1.4% versus 0.8%, respectively).
Maltese: Kien hemm eċċess ta' ħruġ ta' demm intrakranjali fil-grupp ta' kura ta' clopidogrel + ASA meta mqabbel mal-grupp ta' plaċebo + ASA (1.4% kontra 0.8%, rispettivament).
English: Overall, clopidogrel 75 mg/day was comparable to ASA 325 mg/day in CAPRIE regardless of age, gender and race.
Maltese: In ġenerali, clopidogrel 75 mg/jum kien paragunabbli ma' ASA 325 mg/jum f'CAPRIE minkejja l-età, ġeneru sesswali u razza.
English: In a randomised, double-blind, parallel-group study (CLARINET), 906 paediatric patients (neonates and infants) with cyanotic congenital heart disease palliated with a systemic-to-pulmonary arterial shunt were randomised to receive clopidogrel 0.2 mg/kg (n=467) or placebo (n=439) along with concomitant background therapy up to the time of second stage surgery.
Maltese: F'studju magħmul b'mod arbitrarju, b'grupp parallel u double-blind (CLARINET), 906 pazjenti pedjatriċi (trabi tat-twelid u tfal ċkejknin) b'mard tal-qalb konġenitali ċjanotiku u megħjuna b'devjazzjoni kirurġika ta' arterja sistemika għal dik pulmonarja, ġew mogħtija b'mod arbitrarju clopidogrel 0.2 mg/kg (n= 467) jew plaċebo (n= 439) flimkien ma' terapija konkomitanti ta' rutina sakemm kien hemm il-bżonn ta' kirurġija tattieni fażi.
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: Żieda f'sindrome koronarju akut b'segment mhux ST (anġina instabbli jew infart mijokardijaku nonQ-wave): kura bi clopidogrel għandha tinbeda b'doża waħda għolja tal-bidu ta' 300 mg u mbagħad titkompla b'75 mg darba kuljum (ma' acetylsalicylic acid (ASA) 75 mg-325 mg kuljum).
English: The ACTIVE-W study demonstrated that anticoagulant treatment with vitamin K antagonists was more effective than with clopidogrel and ASA.
Maltese: L-istudju ACTIVE-W wera li kura antikoagulanti b'antagonisti ta' vitamina K kienet aktar effettiva milli kura bi clopidogrel u ASA.
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 b'żieda akuta tas-segment ST, is-sigurtà u effikaċja ta' clopidogrel ġew evalwati f'2 studji, li fihom il-parteċipanti ntgħażlu b'mod każwali, ikkontrollati bi plaċebo, double-blind, CLARITY u COMMIT.
English: The patients were followed for 30 days.
Maltese: Il-pazjenti ġew segwiti għal 30 jum.
English: PC: SN: NN:
Maltese: Jekk tintesa doża:
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: Żieda f'sindrome koronarju akut b'segment mhux ST (anġina instabbli jew infart mijokardijaku non-Q-wave), inklużi pazjenti li jkunu fi proċess li titpoġġielhom stent wara intervent koronarju perkutaneju, flimkien ma' acetylsalicylic acid (ASA).
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 il-website ta' l-Aġenzija Ewropea dwar il-Mediċini http://www.ema.europa.eu.
English: In patients suffering from acute coronary syndrome:
Maltese: F'pazjenti li jbatu minn sindrome koronarju akut:
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 maġġuri ta' esklużjoni għall-pazjenti kienu mard dokumentat ta' ulċera peptika fis-6 xhur ta' qabel; emorraġija intraċerebrali fil-passat; tromboċitopenija sinifikanti (għadd tal-plejtlits ta' < 50 x 109/l); ħtieġa għal clopidogrel jew antikoagulanti orali (OAC); jew intolleranza għal kwalunkwe wieħed miż-żewġ komposti.
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 rċivew clopidogrel (300 mg doża qawwija tal-bidu, segwita minn 75 mg/jum, n= 1,752) jew plaċebo (n= 1,739), it-tnejn flimkien ma' ASA (150325 mg bħala doża qawwija tal-bidu segwita minn 75-162 mg/jum), sustanza fibrinolitika u, fejn kien xieraq, heparin.
English: For the 7, 14, 28, 56, 84 tablets (calendar blister) pack sizes, you can check the day on which you last took a tablet of Clopidogrel Mylan by referring to the calendar printed on the blister
Maltese: Għad-daqsijiet tal-pakketti ta' 7 pilloli, 14-il pillola, 28, 56 u 84 pillola, inti tista' tiċċekkja d-data li fiha laħħar li ħadt il-pillola ta' Clopidrogel Mylan billi tirreferi għal kalendarju stampat fuq il-folja.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 75 mg of clopidogrel (as hydrochloride).
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pillola miksija b'rita fiha 75 mg clopidogrel (bħala hydrochloride).
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 ta' clopidogrel u 21.7% fil-grupp tal-plaċebo laħqu l-punt aħħari primarju, li jirrappreżenta tnaqqis assolut ta' 6.7% u 36% ta' tnaqqis fil-probabbiltà favur clopidogrel (95% CI: 24, 47%; p < 0.001), il-biċċa l-kbira relatat ma' tnaqqis f'arterji imblukkati relatata ma' infart.
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: Il-prova 2x2 factorial design COMMIT kienet tinkludi 45,852 pazjent li ppreżentaw ruħhom fi żmien 24 siegħa mill-bidu tas-sintomi ta' MI ssuspettat b'anormalitajiet fl-ECG li jappoġġjaw dan il-fatt (i.e. żieda f'ST, tnaqqis f'ST, jew imblokk fil-bundle branch tax-xellug).
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, provi separati fil-programm ACTIVE, kienu jinkludu pazjenti b'fibrillazzjoni atrijali (AF) li kellhom mill-inqas fattur ta' riskju wieħed għal avvenimenti vaskulari.
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 clopidogrel mal-plaċebo, fejn iż-żewġ prodotti mediċinali ngħataw flimkien ma' ASA u terapija oħra li soltu tingħata.
English: • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: • Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis sezzjoni 2 jew fis-sezzjoni 6.1.
English: While you are taking Clopidogrel Mylan:
Maltese: Waqt li qed tieħu Clopidogrel Mylan:
English: Do not take Clopidogrel Mylan
Maltese: Tieħux Clopidogrel Mylan:
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 periferali.
English: You should have been told that ‘oral anticoagulants' are more effective than acetylsalicylic acid or the combined use of Clopidogrel Mylan and acetylsalicylic acid for this condition.
Maltese: Suppost li t-tabib qallek li ‘antikoagulanti orali' huma aktar effettivi minn acetylsalicylic acid jew l-użu kombinat ta' Mylan Clopidogrel u acetylsalicylic acid għal din il-kundizzjoni.
English: Based on enrollment criteria, physicians enrolled patients in ACTIVE-W if they were candidates for vitamin K antagonist (VKA) therapy (such as warfarin).
Maltese: Ibbażat fuq kriterji tar-reġistrazzjoni, it-tobba rreġistraw pazjenti f'ACTIVE-W jekk kienu kandidati għal terapija b'antagonista ta' vitamina K (VKA) (bħal warfarin).
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: Mard minn seru barrani, reazzjonijiet anafilattojdi, reazzjoni ta' sensittività eċċessiva li hija komuni għat-tipi differenti ta' thienopyridines (bħal ticlopidine, prasugrel) (ara sezzjoni 4.4), sindromu awtoimmunitarju talinsulina, li jista' jwassal għal ipogliċemija severa speċjalment f'pazjenti bissottotip HLA DRA4 (aktar frekwenti fil-popolazzjoni Ġappuniża)
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
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 tal-pjastrini mnaqqsa f'pazjenti infettati bl-HIV li ġew ikkurati b'terapiji antiretrovirali (ART) imsaħħa ta' ritonavir jew cobicistat.
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 b'sindrome koronarju akut b'żieda tas-segment mhux ST (anġina instabbli jew infart mijokardijaku non-Q-wave), u li ppreżentaw ruħhom fi żmien 24 siegħa millbidu tal-iktar episodju riċenti ta' wġigħ fis-sider jew sintomi konsistenti ma' iskemija.
English: If you have experienced severe chest pain (unstable angina or heart attack), your doctor may give you 300 mg of Clopidogrel Mylan (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 Mylan (4 pilloli ta' 75 mg) darba fil-bidu tal-kura.
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, tibdiliet fil-mod fit-togħma tal-ikel jew ma tibqax ittiegħem l-ikel.
English: Clopidogrel Mylan 75 mg film-coated tablets clopidogrel
Maltese: Clopidogrel Mylan 75 mg pilloli miksija b'rita clopidogrel
English: The results obtained in populations with different characteristics (e.g. unstable angina or non-Q-wave MI, low to high risk levels, diabetes, need for revascularisation, age, gender, etc.) were consistent with the results of the primary analysis.
Maltese: Ir-riżultati miksuba f'popolazzjonijiet b'karatteristiċi differenti (eż. anġina instabbli jew non-Q-wave MI, livelli minn baxxi sa għoljin ta' riskju, dijabete, il-ħtieġa ta' vaskularizzazzjoni mill-ġdid, età, sess eċċ.) kienu konsistenti mar-riżultati tal-analiżi primarja.
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 tgħarraf 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 bħala dbabar żgħar ħomor, b'għeja sfinita spjegabbli jew mhix spjegabbli, konfużjoni, sfurija tal-ġilda jew l-għajnejn (suffejra) (ara sezzjoni 4 ‘Effetti sekondarji possibbli')
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: 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' ħruġ ta' demm maġġuri kienet ikbar fil-grupp ta' clopidogrel + ASA milli fil-grupp ta' plaċebo + ASA (6.7% kontra 4.3%).
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 1000 persuna): Vertiġini, tkabbir tas-sider fl-irġiel.
English: 90 film-coated tablets: EU/1/09/559/008
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/09/559/001-016
English: The CLARITY trial included 3,491 patients presenting within 12 hours of the onset of a ST elevation MI and planned for thrombolytic therapy.
Maltese: Il-prova CLARITY kienet tinkludi 3,491 pazjent li ppreżentaw ruħhom fi żmien 12-il siegħa mill-bidu ta' MI b'żieda f'ST u li ppjanaw għal terapija trombolitika.
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 jkollhom mill-inqas fattur wieħed ta' riskju għal avvenimenti vaskulari, mhumiex adattati għal kura b'antagonisti ta' Vitamina K (VKA), u li għandhom riskju baxx ta' ħruġ ta' demm, clopidogrel hu indikat flimkien ma' ASA għall-prevenzjoni ta' avvenimenti aterotrombotiċi u tromboemboliċi, li jinkludu puplesija.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/559/001-016
Maltese: EU/1/09/559/016
English: After a single oral dose of 75 mg, clopidogrel has a half-life of approximately 6 hours.
Maltese: Wara doża orali waħda ta' 75 mg, clopidogrel għandu l-half-life bejn wieħed u ieħor ta' 6 sigħat.
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 rreġistrati fl-istudju ACTIVE-A ma kinux kapaċi jieħdu VKA minħabba evalwazzjoni minn tabib, inabbiltà li jkunu konformi ma' monitoraġġ INR (international normalised ratio - Proporzjon Normalizzat Internazzjonali), predispożizzjoni li jaqgħu jew trawma fir-ras, jew riskju speċifiku ta' ħruġ ta' demm; għal 26% tal-pazjenti, id-deċiżjoni tat-tabib kienet ibbażata fuq nuqqas ta' rieda tal-pazjent biex jieħu VKA.
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: - ST segment elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy.
Maltese: Żieda f'infart mijokardijaku akut b'segment ST, flimkien ma' ASA f'pazjenti kkurati medikament eliġibbli għal terapija trombolitika.
English: You have been prescribed Clopidogrel Mylan to help prevent blood clots and reduce the risk of these severe events because:
Maltese: Inti ngħatatlek riċetta għal Clopidogrel Mylan sabiex jiġi evitat li jiffurmaw emboli tad-demm u jitnaqqas ir-riskju ta' dawn il-każijiet minħabba:
English: NAME OF THE MEDICINAL PRODUCT Clopidogrel Mylan 75 mg film-coated tablets
Maltese: TAL-PRODOTT MEDIĊINALI Clopidogrel Mylan 75 mg pilloli miksija b'rita
English: Clopidogrel Mylan is taken by adults to prevent blood clots (thrombi) forming in hardened blood vessels (arteries), a process known as atherothrombosis, which can lead to atherothrombotic events (such as stroke, heart attack, or death).
Maltese: Clopidogrel Mylan jittieħed mill-adulti sabiex jevita li jiġu ffurmati emboli tad-demm (trombi) b'vażi taddemm li qed jibbiesu (arterji), proċess magħruf bħala aterosklerosi, li jista' jwassal għal każijiet arterotrombotiċi (bħal puplesija, attakk tal-qalb, jew mewt).
English: NAME OF THE MEDICINAL PRODUCT Clopidogrel Mylan 75 mg film-coated tablets clopidogrel
Maltese: TAL-PRODOTT MEDIĊINALI Clopidogrel Mylan 75 mg pilloli miksija b'rita clopidogrel
English: Tel: + 34 900 102 712
Maltese: Mylan Pharmaceuticals, S.L Tel: + 34 900 102 712
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 mal-plaċebo, wera RRR sinifikanti ta' 26.
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,
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 użat biex jiġi ittrattat l-uġigħ 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,