FrancophonIA/ELRC3.0 huggingface dataset:
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 rċevew clopidogrel (300 mg bħala d-doża qawwija inizjali segwita minn 75 mg /kuljum, n=1,752) jew ilplaċebo (n=1,739), it-tnejn ma' ASA (150 sa 325 mg bħala doża qawwija inizjali segwita minn 75 sa 162 mg/kuljum), sustanza fibrinolitika u, fejn kien xieraq, heparin.
English: Inconsistent data on the clinical implications of this pharmacokinetic (PK)/pharmacodynamic (PD) interaction in terms of major cardiovascular events have been reported from both observational and clinical studies.
Maltese: Tagħrif inkonsistenti dwar l-implikazzjonijiet kliniċi ta' din l-interazzjoni farmakokinetika (pharmacokinetic, PK)/farmakodinamika (pharmacodynamic, PD) f'termini ta' każijiet kardjovaskulari maġġuri ġew rapportati kemm mil-lat ta' studji ta' osservazzjoni u kemm kliniċi.
English: The plasma concentrations of the active metabolite was 20% reduced (loading dose) and 14% reduced (maintenance dose) during concomitant treatment with pantoprazole 80 mg once daily.
Maltese: Il-konċentrazzjonijiet tal-metabolit attiv fil-plażma kien imnaqqas b'20% (doża inizjali) u 14% imnaqqas (doża ta' manteniment) waqt terapija fl-istess waqt b'pantoprazole 80 mg darba kuljum.
English: Subsequent metabolism of the 2-oxo-clopidogrel intermediate metabolite results in formation of the active metabolite, a thiol derivative of clopidogrel.
Maltese: Metaboliżmu sussegwenti tal-metabolit intermedjarju 2-oxoclopidogrel jirriżulta fil-formazzjoni tal-metabolit attiv, derivat ta' thiol ta' 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: The clinical relevance of this interaction is uncertain.
Maltese: Ir-rilevanza klinika ta' din linterazzjoni għadu mhux stabbilit.
English: Serum sickness, anaphylactoid reactions, cross-reactive drug hypersensitivity among thienopyridines (such as ticlopidine, prasugrel) (see section 4.4)*
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)*
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: Ilpazjenti kienu randomised għal clopidogrel (doża qawwija tal-bidu ta' 300 mg u wara 75 mg/jum, N=6,259) jew il-plaċebo (N=6,303), u t-tnejn ingħataw flimkien ma' ASA (75-325 mg darba kuljum) u terapiji oħrastandard.
English: Published frequencies for the poor CYP2C19 metaboliser genotypes are approximately 2% for Caucasians, 4% for Blacks and 14% for Chinese.
Maltese: Frekwenzi ppubblikati għall-ġenotipi tal-metabolizzatur batut CTP2C19 huma madwar 2% għal Kawkasi, 4% għas-Suwed u 14% għaċ-Ċiniżi.
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 flimkien mal-prodott mediċinali (ara sezzjoni 4.4).
English: Clopidogrel is first metabolised to a 2-oxo-clopidogrel intermediate metabolite.
Maltese: Clopidogrel huwa l-ewwel metabolizzat għal metabolit intermedjarju ta' 2-oxo-clopidogrel.
English: The other ingredients are (see section 2 ‘Clopidogrel Teva Pharma contains hydrogenated castor oil'):
Maltese: Is-sustanzi l-oħra huma (ara sezzjoni 2 ‘Clopidogrel Teva Pharma fih il-castor oil idroġenat')
English: In TRITON-TIMI 38 and 3 of the cohort studies (Collet, Sibbing, Giusti) the combined group of patients with either intermediate or poor metaboliser status had a higher rate of cardiovascular events (death, myocardial infarction, and stroke) or stent thrombosis compared to extensive metabolisers.
Maltese: Fi TRITON-TIMI 38 u 3 tal-istudji ta' koorti (Collet, Sibbing, Giusti), il-grupp ikkombinat ta' pazjenti bi stat intermedjarju jew batut kellhom rata ogħla ta' każijiet kardjovaskulari (mewt, infart mijokardjali u puplesija) jew trombożi bi stent meta mqabbel ma' metabolizzaturi estensivi.
English: This leaflet was last revised in.
Maltese: Reazzjonijet inkroċjati fost thienopyridines
English: Less pronounced reductions of metabolite exposure has been observed with pantoprazole or lansoprazole.
Maltese: Tnaqqis notevoli iżgħar fl-espożizzjoni tal-metabolit ġie osservat għal pantoprazole jew lansoprazole.
English: EU/1/09/561/011 Cartons of 50x1 film-coated tablets in OPA/Al/PVC - Al perforated unit-dose blisters
Maltese: EU/1/09/561/011 Kartun ta' 50x1 pillola miksija b'rita f'folji perforati ta' doża waħda
English: Consistent with the above results, in a meta-analysis including 6 studies of 335 clopidogrel-treated subjects at steady state, it was shown that active metabolite exposure was decreased by 28% for intermediate metabolisers, and 72% for poor metabolisers while platelet aggregation inhibition (5 μM ADP) was decreased with differences in IPA of 5.9% and 21.4%, respectively, when compared to extensive metabolisers.
Maltese: B'mod konsistenti mar-riżultati t'hawn fuq, f'meta-analiżi li kien jinkludi 6 studji ta' 335 individwu ttrattat b'clopidogrel fi stadju fiss, intwera li l-espożizzjoni għall-metabolit attiv tnaqqset bi 28% għall-metabolizzaturi intermedjarji, u 72% għall-metabolizzaturi batuti filwaqt li l-impediment ta' aggregazzjoni ta' plejtlits (5 μM ADP) tnaqqset b'differenzi fl-IPA ta' 5.9% u 21.4% rispettivament meta mqabbel ma metabolizzaturi estensivi.
English: Esomeprazole is expected to give a similar interaction with clopidogrel.
Maltese: Esomeprazole hu mistenni li jagħti interazzjoni simili b'clopidogrel.
English: Caution is required in patients treated concomitantly with clopidogrel and CYP2C8 substrate medicinal products (see section 4.5).
Maltese: Hija meħtieġa l-kawtela f'pazjenti kkurati fl-istess ħin bi clopidogrel u bi prodotti mediċinali sustrati ta' CYP2C8 (ara sezzjoni 4.5).
English: Detailed information is available on the European Medicines Agency website: http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini (EMA) http://www.ema.europa.eu.
English: Do not take Clopidogrel Teva Pharma
Maltese: Tiħux Clopidogrel Teva Pharma
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 oħra: 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: Tel: +353 51 321740
Maltese: Teva Pharmaceuticals Ireland Tel: +353 51 321740
English: Clopidogrel must be metabolised by CYP450 enzymes to produce the active metabolite that inhibits platelet aggregation.
Maltese: Clopidogrel irid jiġi metabolizzat b'enzimi ta' CYP450 biex jipproduċi l-metabolit attiv li jimpedixxi l-aggregazzjoni ta' plejtlets.
English: The dose of 0.2 mg/kg achieved the mean percent inhibition of 49.3% (5 µM ADP-induced platelet aggregation) which was comparable to that of adults taking Clopidogrel 75 mg/day.
Maltese: 3% (5 µM ta' aggregazzjoni tal-plejtlits ikkaġunat mill-ADP) li huwa simili għal dak ta' adulti li jieħdu 75 mg/ġurnata ta' clopidogrel.
English: As with other antiplatelet agents, clopidogrel should be used with caution in patients who may be at risk of increased bleeding from trauma, surgery or other pathological conditions and in patients receiving treatment with ASA, heparin, glycoprotein IIb/IIIa inhibitors or non-steroidal anti-inflammatory drugs (NSAIDs) including Cox-2 inhibitors, or selective serotonin reuptake inhibitors (SSRIs), or other medicinal products associated with bleeding risk such as pentoxifylline (see section 4.5).
Maltese: Bħal fil-każ ta' sustanzi oħra kontra lplejtlets, clopidogrel għandu jintuża b'kawtela f'pazjenti li jista' jkollhom riskju ta' iktar dmija minn trawma, operazzjoni jew kundizzjonijiet patoloġiċi oħra u pazjenti li jkunu qed jirċievu l-kura b'ASA, heparin, inibituri ta' glycoprotein IIb/IIIa jew mediċini kontra l-infjammazzjoni li m'humiex sterojdi (NSAIDs) li jinkludu l-inibituri ta' Cox-2, jew inibituri selettivi tal-ġbir mill-ġdid ta' serotonin (SSRIs), jew prodotti mediċinali marbuta ma' riskju ta' fsada bħal pentoxifylline (ara sezzjoni 4.5).
English: 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 lirbit 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 laggregazzjoni ta' plejtlets.
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' CUP2C19 li jirriżultaw f'metaboliżmu intermedjarju u dgħajjef ta' CYP2C19 ivarja skont ir-razza/etniċità (ara Farmakoġenetika).
English: Clopidogrel Teva Pharma contains clopidogrel and belongs to a group of medicines called antiplatelet medicinal products.
Maltese: Clopidogrel Teva Pharma fih clopidrogel u jappartjeni għal grupp ta' mediċini li jissejħu prodotti mediċinali li jaġixxu kontra l-plejtlets.
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-mewġaQ): il-kura bi clopidogrel għandha tinbeda b'doża waħda qawwija tal-bidu ta' 300 mg u titkompla b'75 mg darba kuljum (b'acetylsalicylic acid (ASA) 75 mg-325 mg kuljum).
English: In the intention to treat analysis, 939 events were observed in the clopidogrel group and 1,020 events with ASA (relative risk reduction (RRR) 8.7%, [95% CI: 0.2 to 16.4]; p=0.045), which corresponds, for every 1000 patients treated for 2 years, to 10 [CI: 0 to 20] additional patients being prevented from experiencing a new ischaemic event.
Maltese: Fl-analiżi tal-intenzjoni tal-kura, ġew osservati 939 każ fil-grupp ta' clopidogrel u 1,020 każ ma' ASA (tnaqqis tar-riskju relattiv, relative risk reduction (RRR)) 8.7 %, [95 % CI: 0.2 sa 16.4]; p=0.045), li jikkorispondi, għal kull 1,000 pazjent trattat għal sentejn, ma' 10 [CI: 0 sa 20] pazjenti oħra li evitaw każ iskemiku ġdid.
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 of food.
Maltese: Effetti kollaterali rari ħafna (jistgħu jaffettwaw sa 1 minn kull 10,000 persuna) 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 il-ġilda; uġigħ fil-ħalq (stomatite) tnaqqis fil-pressjoni tad-demm; konfużjoni; alluċinazzjonijiet; uġigħ tal-għadam; uġigħ muskolari; tibdil fit-togħma tal-ikel.
English: If you have experienced severe chest pain (unstable angina or heart attack), your doctor may give you 300 mg of Clopidogrel Teva Pharma (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 Teva Pharma (4 pilloli ta' 75 mg) darba fil-bidu tal-kura.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 75 mg of clopidogrel (as hydrochloride).
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA Kull pillola miksija b'rita fiha 75 mg clopidogrel (bħala hydrochloride).
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: C fil-bniedem, madwar 50 % kien eliminat fl-awrina u madwar 46 % fl-ippurgar fl-intervall ta' 120 siegħa wara d-dożaġġ.
English: Mean peak plasma levels of unchanged clopidogrel (approximately 2.2-2.5 ng/ml after a single 75 mg oral dose) occurred approximately 45 minutes after dosing.
Maltese: L-ogħla livelli medji ta' clopidogrel mhux mibdul fil-plażma (madwar 2.2-2.5 ng/ml wara doża orali waħda ta' 75 mg) seħħew madwar 45 minuti wara d-doża.
English: • Severe hepatic impairment.
Maltese: • Indeboliment sever tal-fwied.
English: Prevention of atherothrombotic events
Maltese: Prevenzjoni ta' każijiet aterotrombotiċi
English: Renal impairment
Maltese: • Indeboliment renali.
English: Acquired haemophilia
Maltese: Emofilja akkwiżita
English: Clopidogrel is extensively metabolised by the liver.
Maltese: Clopidogrel huwa metabolizzat b'mod estensiv fil-fwied.
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: Dermatite bl-infafet (nekrolisi tossika tal-epidermide, Sindromu ta' Stevens Johnson, eritema multiforme), exanthematous pustulosis akuta u ġeneralizzata (AGEP),
English: Clopidogrel Teva Pharma 75 mg film-coated tablets Clopidogrel
Maltese: Clopidogrel Teva Pharma 75 mg pilloli miksija b'rita Clopidogrel
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: Data from the CAPRIE study indicate that phenytoin and tolbutamide which are metabolised by CYP2C9 can be safely co-administered with clopidogrel.
Maltese: Tagħrif mill-istudju CAPRIE jindika li phenytoin u tolbutamide li jiġu metabolizzati minn CYP2C9 jistgħu jiġu amminsitrati flimkien ma' clopidogrel b'mod sikur.
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: Other concomitant therapy: Since clopidogrel is metabolised to its active metabolite partly by CYP2C19, use of medicinal products that inhibit the activity of this enzyme would be expected to result in reduced drug levels of the active metabolite of clopidogrel.
Maltese: Terapija oħra meħuda fl-istess ħin: Peress li clopidogrel jiġi parzjalment metabolizzat għal metabolit attiv minn CYP2C19, l-użu ta' prodotti mediċinali li jimpedixxu l-attività ta' din l-enzima mistennija li jirriżultaw f'livelli mnaqqsa tal-metabolit attiv ta' clopidogrel.
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 clopidogrel kuljum, (tneħħija tal-kreatinina minn 5 sa 15 ml/min) meta mqabbla ma' individwi b'mard moderat tal-kliewi (tneħħija ta' kreatinina minn 30 sa 60 ml/min), linibizzjoni għall-aggregazzjoni tal-plejtlets indotti minn ADP kien aktar baxx (25 %) minn dak osservat f'individwi b'saħħithom, madankollu, it-titwil fiż-żmien ta' emorraġiji kien simili għal dak osservat f'individwi b'saħħithom li kienu qed jingħataw 75 mg ta' clopidogrel kuljum.
English: Batch
Maltese: Sib
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 metabolizzaturi batuti rċevew il-programm ta' kura ta' 600 mg/150 mg, l-espożizzjoni attiva għall-metabolit kien ikbar minn dak tal-programm ta' kura ta' 300 mg/75 mg.
English: After repeated doses of 75 mg clopidogrel per day for 10 days in patients with severe hepatic impairment, inhibition of ADP-induced platelet aggregation was similar to that observed in healthy subjects.
Maltese: Wara dożi ripetuti ta' 75 mg ta' clopidogrel kuljum għal 10 ijiem f'pazjenti b'indeboliment tal-fwied sever, l-impediment ta' aggregazzjoni ta' plejtlets mnebbħa mill-ADP kienet simili għal dik osservata f'individwi b'saħħithom.
English: In patients with atrial fibrillation, clopidogrel should be given as a single daily dose of 75 mg. ASA (75-100 mg daily) should be initiated and continued in combination with clopidogrel (see section 5.1).
Maltese: F'pazjenti b'fibrillazzjoni atrijali, clopidogrel għandu jingħata bħala doża waħda kuljum ta' 75 mg. ASA (75-100 mg) għandu jinbeda u jibqa' jittieħed flimkien ma' clopidogrel (ara sezzjoni 5.1)
English: The influence of CYP2C19 genotype on clinical outcomes in patients treated with clopidogrel has not been evaluated in prospective, randomised, controlled trials.
Maltese: L-influwenza tal-ġenotip CYP2C19 minn aspett kliniku f'pazjenti trattati bi clopidogrel ma ġietx ivvalorizzata fi provi prospettivi, każwali jew b'kontrolli.
English: • if you have a risk of bleeding such as - a medical condition that puts you at risk of internal bleeding (such as a stomach ulcer) - a blood disorder that makes you prone to internal bleeding (bleeding inside any tissues, organs or joints of your body).
Maltese: • tinsab f'riskju ogħla ta' emorraġija bħal - kundizzjoni medika li tpoġġik f'riskju ta' emorraġija interna (bħalma hi ulċera fl-istonku) - disturb fid-demm li jpoġġik f'riskju ta' emorraġija interna (emorraġija ġo kull tessut, organi
English: Since clopidogrel is metabolised to its active metabolite partly by CYP2C19, use of medicinal products that inhibit the activity of this enzyme would be expected to result in reduced drug levels of the active metabolite of clopidogrel.
Maltese: Peress li clopidogrel jiġi parzjalment metabolizzat għall-metabolit attiv tiegħu minn CYP2C19, l-użu ta' prodotti mediċinali li jimpedixxu l-attività ta' din l-enzima mistennija li jirriżultaw f'livelli mnaqqsa tal-metabolit attiv ta' clopidogrel Ir-rilevanza klinika ta' din l-interazzjoni għadu mhux stabbilit.
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 seħħet minħabba l-inibizzjoni ta' CYP2C8 mill-metabolit glukuronidu ta' clopidogrel.
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' impedituri qawwija jew moderati ta' CYP2C19 għandu jiġi skorraġit (ara sezzjoni 4.5 għal lista ta' impedituri ta' CYP2C19, ara wkoll sezzjoni 5.2).
English: Teva Pharmaceuticals Ireland L-Irlanda
Maltese: Teva Pharma - Produtos Farmacêuticos Lda Tel:
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 Tromboċitopenika Trombotika, jew TTP) li tinkludi deni u tbenġil taħt ilġilda 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
English: Thu
Maltese: Teva
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: 300 mg/75 mg u kien simili għall-gruppi l-oħra ta' metabolizzaturi ta' CYP2C19 li qed jirċievu lprogramm ta' kura ta' 300 mg/75 mg.
English: Sun
Maltese: Deni
English: Recent ischaemic stroke
Maltese: Effetti sekondarji oħra jinkludu
English: In CLARITY, there was an overall increase in bleeding in the clopidogrel plus ASA group vs. the placebo plus ASA group.
Maltese: F'CLARITY, kien hemm żieda globali ta' emorraġija fil-grupp ta' clopidogrel + ASA (17.4 %) vs.
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 dwar il-Mediċini http://www.ema.europa.eu/
English: Film coating:
Maltese: Sími:
English: After single and repeated oral doses of 75 mg per day, clopidogrel is rapidly absorbed.
Maltese: Wara dożi orali waħda u ripetuti ta' 75 mg kuljum, clopidogrel kien assorbit malajr b'rata mgħaġġla.
English: NAME OF THE MEDICINAL PRODUCT Clopidogrel Teva Pharma 75 mg film-coated tablets Clopidogrel
Maltese: TAL-PRODOTT MEDIĊINALI Clopidogrel Teva Pharma 75 mg pilloli miksija b'rita clopidogrel
English: Omeprazole 80 mg once daily administered either at the same time as clopidogrel or with 12 hours between the administrations of the two drugs decreased the exposure of the active metabolite by 45% (loading dose) and 40% (maintenance dose).
Maltese: Meta omeprazole 80 mg jingħata waħdu fl-istess ħin ma' clopidogrel jew bi 12-il siegħa differenza bejn l-għoti taż-żewġ mediċini l-espożizzjoni għall-metabolit effettiv żdiedet b'45% (doża inizjali) u 40% (doża ta' manteniment).