FrancophonIA/ELRC3.0 huggingface dataset:
English: A pharmacodynamic interaction between clopidogrel and heparin is possible, leading to increased risk of bleeding.
Maltese: Huwa possibbli li jkun hemm interazzjoni farmakodinamika bejn clopidogrel u heparin, li jista' jwassal għal riskju ikbar ta' dmija.
English: Elimination 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: Eliminazzjoni 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: 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' kondizzjoni qwalifikanti (infart mijokardijaku, puplesija iskemika, u PAD) il-benefiċċju jidher li kien l-ikbar (b'relevanza statistika ta' p = 0.003) f'pazjenti li ddaħħlu minħabba PAD (speċjalment dawk li kellhom ukoll storja medika ta' infart mijokardijaku) (RRR = 23.7%; CI: minn 8.9 sa 36.2) u inqas (mhux differenti b'mod sinifikanti minn ASA) f'pazjenti b'puplesija (RRR = 7.3%; CI: minn -5.7 sa 18.7 [p=0.258]).
English: • Severe liver impairment.
Maltese: • Indeboliment sever tal-fwied.
English: There is no evidence that other medicinal products that reduce stomach acid such as H2 blockers (except cimetidine which is a CYP2C19 inhibitor) or antacids interfere with antiplatelet activity of clopidogrel.
Maltese: M'hemm ebda evidenza li prodotti mediċinali oħra li jnaqqsu l-aċtu fl-istonku bħall-imblokkaturi ta' H2 (ħlief cimetidine li huwa inibitur ta' CYP2C19) jew l-antaċidi jaffettwaw l-attività kontra l-plejtlits ta' clopidogrel.
English: In a crossover clinical study, clopidogrel (300-mg loading dose followed by 75 mg/day) alone and with omeprazole (80 mg at the same time as clopidogrel) were administered for 5 days.
Maltese: Fi studju kliniku tat-tip inkroċjat, clopidogrel (300 mg bħala d-doża qawwija inizjali segwita minn 75 mg /kuljum) waħdu u ma' omeprazole (80mg fl-istess ħin bħal clopidogrel) ġew amministrati għal 5 ijiem.
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 fiha 75 mg ta' clopidogrel (bħala hydrochloride).
English: Mon Tue Wed Thu Fri Sat Sun
Maltese: KUNDIZZJONIJIET TA' L-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ
English: In CURE, the major bleeding event rate for clopidogrel + ASA was dose-dependent on ASA (<100 mg: 2.6%; 100-200 mg: 3.5%; >200 mg: 4.9%) as was the major bleeding event rate for placebo + ASA (<100 mg: 2.0%; 100-200 mg: 2.3%; >200 mg: 4.0%).The risk of bleeding (life-threatening, major, minor, other) decreased during the course of the trial: 0-1 months (clopidogrel: 9.6%; placebo: 6.6%), 1-3 months (clopidogrel: 4.5%; placebo: 2.3%), 3-6 months (clopidogrel: 3.8%; placebo: 1.6%), 6-9 months (clopidogrel: 3.2%; placebo: 1.5%), 9-12 months (clopidogrel: 1.9%; placebo: 1.0%).
Maltese: Ir-riskju ta' fsada (ta' theddida għall-ħajja, maġġuri, minuri, ta' tip ieħor) naqas matul l-istudju: 0-1 xahar (clopidogrel: 9.6%; plaċebo: 6.6%), 1-3 xhur (clopidogrel: 4.5%; plaċebo:
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 bis-sindromu koronarju akut tas-segment mhux-ST elevat (anġina instabbli jew infart mijokardijaku li mhux-mewġa-Q), u li ddaħħlu fl-istudju f'24 siegħa mill-iktar episodju reċenti ta' uġigħ fis-sider jew sintomi konsistenti ma' l-iskemija.
English: No antidote to the pharmacological activity of clopidogrel has been found.
Maltese: Ma nstabx antidotu għall-attivita` farmakoloġika ta' clopidogrel.
English: The elimination half-life of the main circulating (inactive) metabolite was 8 hours after single and repeated administration.
Maltese: Il-half-life tat-tneħħija tal-metabolit prinċipali (inattiv) ċirkolanti kien 8 sigħat wara amministrazzjoni waħda u ripetuta.
English: Recent myocardial infarction (MI), recent stroke or established peripheral arterial disease
Maltese: Infart mijokardijaku reċenti (MI), puplesija reċenti jew mard periferali stabbilit tal-arterji
English: The incidence of clinically significant bleeding was similar to that observed when thrombolytic agents and heparin are co-administered with ASA (see section 4.8).
Maltese: L-inċidenza tad-dmija klinikament sinifikanti kienet simili għal dik osservata meta sustanzi trombolitiċi u heparin jingħataw flimkien ma' ASA (ara sezzjoni 4.8).
English: Boxes of 28, 30, 50, 56, 84, 90 or 100 film-coated tablets in blisters or boxes of 28x1, 28x1 (calendar pack), 30x1, 50x1, 56x1, 84x1, 90x1 and 100x1 film-coated tablets in perforated unit dose blisters are available.
Maltese: Kaxxi jiġu f'daqsijiet ta' 28, 30, 50, 56, 84, 90 jew100 pillola miksija b'rita ġo folji jew kaxxi f'daqsijiet ta' 28x1, 28x1(kaxxi ta' xahar), 30x1, 50x1, 56x1, 84x1, 90x1 u 100x1 pilloli miksija b'rita ġo folji pperforati ta' doża unika
English: Recent ischaemic stroke
Maltese: Puplesija iskemika reċenti
English: Retroperitoneal haemorrhage
Maltese: Emorraġija tarretroperitonew
English: The MAH must ensure that the system of pharmacovigilance, as described in version version 8 dated November 2009 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq għandu jiżgura li s-sistema ta' farmakoviġilanza, kif deskritta fil-verżjoni 8 datat Novembru 2009 inkluża f'Modulu 1.8.1 tal-applikazzjoni għall-awtorizzazzjoni għat-tqegħid fis-suq, tkun fis-seħħ u tiffunzjona qabel u waqt li l-prodott ikun fuq is-suq.
English: Repeated doses of 75 mg per day produced substantial inhibition of ADP-induced platelet aggregation from the first day; this increased progressively and reached steady state between Day 3 and Day 7.
Maltese: Dożi repetuti ta' 75 mg kuljum ipproduċew inibizzjoni sostanzjali tal-aggregazzjoni tal-plejtlets indotti minn ADP mill-ewwel ġurnata; dan żied progressivament u laħaq livell fiss bejn Jum 3 u Jum 7.
English: Other side effects reported with Clopidogrel Teva Generics B.V. are:
Maltese: Effetti oħra li ġew irrappurtati b'Clopidogrel Teva Generics B.V. huma:
English: Bruising
Maltese: Vertiġni
English: Detailed information on this medicine 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 dwar il-mediċini: http://www.ema.europa.eu/
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 tal-clopidogrel u 21.7% tal-grupp bil-plaċebo laħqu lpunt primarju u aħħari, li jirrappreżentaw tnaqqis assolut ta' 6.7% u 36% ta' tnaqqis probabbli favur clopidogrel (95% CI: 24, 47%; p <0.
English: Each film-coated tablet contains 75 mg of clopidogrel (as hydrochloride).
Maltese: Kull pillola fiha 75 mg ta' clopidogrel (bħala hydrochloride).
English: Very rare side effects (affects less than 1 patient in 10,000): Jaundice; severe abdominal pain with or without back pain; fever, breathing difficulties sometimes associated with cough; generalised allergic reactions; swelling in the mouth; blisters of the skin; skin allergy; inflammation of the mouth (stomatitis); decrease in blood pressure; confusion; hallucinations; joint pain; muscular pain; changes in the way things taste.
Maltese: Effetti sekondarji rari ħafna (jaffettwaw anqas minn pazjent 1 minn kull 10,000): Suffejra; uġigħ addominali qawwi flimkien ma' jew mingħajr uġigħ fid-dahar; deni, diffikultajiet fin-nifs kultant assoċjati mas-sogħla; reazzjonijiet allerġiċi ġeneralizzati; nefħa fil-ħalq; infafet fil-ġilda; reazzjoni allerġika fil-ġilda; infjammazzjoni tal-ħalq (stomatite); tnaqqis fil-pressjoni tad-demm; konfużjoni; alluċinazzjonijiet; uġigħ fil-ġogi; uġigħ muskolari; tibdiliet fil-mod ta' kif jintegħmu l-affarijiet.
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 irrapurtata tollerabilita` baxxa fiż-żaqq (gastrite, erożjonijiet gastriċi u/jew rimettar) ta' clopidogrel fil-firien u l-babwini.
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 m'humiex u heparins ġiet eżaminata f'pazjenti li kellhom infart mijokardijaku akut.
English: Gastric ulcer and duodenal ulcer, gastritis, vomiting, nausea, constipation, flatulence
Maltese: Ulċera gastrika u ulċera dwodenali, gastrite, rimettar, tqalligħ, stitikezza, gas fl-istonku
English: Other alleles associated with reduced metabolism include CYP2C19*4, *5, *6, *7, and *8, but these are less frequent in the general population.
Maltese: Alleli oħra assoċjati ma' tnaqqis filmetaboliżmu jinkludu CYP2C19*4, *5, *6, *7, u *8, iżda dawn huma anqas frekwenti fil-popolazzjoni ġenerali. Frekwenzi ppubblikati għall-fenotipi u l-ġenotipi CYP2C19 komuni huma elenkati fit-tabella ta' hawn taħt.
English: - a proton pump inhibitor (e.g, omeprazole) for upset stomach, - fluconazole, voriconazole, ciprofloxacin, or chloramphenicol, medicines to treat bacterial and fungal infections, - cimetidine, medicine to treat upset stomach, - fluoxetine, fluvoxamine, or moclobemide, medicines to treat depression, - carbamazepine, or oxcarbazepine, medicines to treat some forms of epilepsy, - ticlopidine, other antiplatelet agent.
Maltese: Għandek speċifikament tgħid lit-tabib tiegħek jekk qiegħed tieħu - sustanzi kontra l-koagulazzjoni tad-demm li jittieħdu mill-ħalq, mediċini li jraqqu d-demm, - mediċina li hija anti-infjammatorju li mhux sterojde, normalment użat biex jiġi ittrattat l-uġigħ u/jew kundizzjonijiet infjammatorji tal- muskoli jew tal-ġogi, - heparin jew xi mediċina oħra użata biex traqqaq id-demm, - inibitur tal-pompa protonika (eż. omeprazole) għat-taqlib tal-istonku - fluconazole, voriconazole, ciprofloxacin, jew chloramphenicol, mediċini li jittrattaw infezzjonijiet tal-batterja u tal-fungu, - cimetidine, mediċina li tittratta taqlib tal-istonku, - fluoxetine, fluvoxamine, jew moclobemide, mediċinii li jittrattaw d-dipressjoni, - carbamazepine, jew oxcarbazepine, mediċini li jittrattaw xi tip ta' epilessija, - ticlopidine, sustanzi oħra kontra l-plejtlets.
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 clopidogrel kuljum għal 10 ijiem f'pazjenti b'indeboliment epatiku sever, l-inibizzjoni tal-aggregazzjoni tal-plejtlits kawża tal-ADP kien simili għal dak osservat f'suġġetti b'saħħithom.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER (28x1 film-coated tablets-calendar pack)
Maltese: TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL-FOLJI JEW L-ISTRIXXI FOLJI (28x1 pillola miksija b'rita - ġo pakkett kalendarjan
English: Clopidogrel is a prodrug, one of whose metabolites is an inhibitor of platelet aggregation.
Maltese: Clopidogrel huwa prodrug, b'metabolit minnhom ikun inibitur tal-aggregazzjoni tal-plejtlits.
English: As a precaution concomitant use of medicinal products that inhibit CYP2C19 should be discouraged (see sections 4.4 and 5.2).
Maltese: Bħala prekawzjoni, l-użu konkomitanti ta'prodotti mediċinali li jinibixxu CYP2C19 għandu jiġi skoraġġut (ara sezzjonijiet 4.4 u 5.2).
English: Teva Eesti esindus UAB Sicor Biotech Eesti filiaal
Maltese: Teva Eesti esindus UAB Sicor Biotech Eesti filiaal Tel: +372 611 2409
English: Patients were randomized to clopidogrel 75 mg/day or ASA 325 mg/day, and were followed for 1 to 3 years.
Maltese: Il-pazjenti kienu randomised għal clopidogrel 75 mg/jum jew ASA 325 mg/jum, u ġew osservati għal bejn sena u 3 snin.
English: In patients suffering from acute coronary syndrome:
Maltese: F'pazjenti bis-sindromu koronarju akut:
English: Pharmacogenetics
Maltese: Farmakoġenetika
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: As a precaution concomitant use of medicinal products that inhibit CYP2C19 should be discouraged (see section 4.5 for a list of CYP2C19 inhibitors, see also section 5.2).
Maltese: Bħala prekawzjoni, l-użu konkomitanti ta'prodotti mediċinali li jinibixxu CYP2C19għandu jiġu skoraġġut (ara sezzjoni 4. 5 għal lista ta' inibituri ta' CYP2C19, ara wkoll sezzjoni 5.2).
English: • 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 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: If you have experienced severe chest pain (unstable angina or heart attack), your doctor may give you 300 mg of Clopidogrel Teva Generics B.V. (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 Generics B.V. (4 pilloli ta' 75 mg) darba fil-bidu tal-kura.
English: Clopidogrel Teva Generics B.V. 75 mg film-coated tablets Clopidogrel
Maltese: Clopidogrel Teva Generics B.V. 75 mg pilloli miksija b'rita Clopidogrel
English: Musculoskeletal, connective tissue and bone disorders
Maltese: Disturbi muskoluskeltrali, tat-tessut konnettiv u flgħadam
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu/.
Maltese: L-KITBA Informazzjoni dettaljata dwar dan il-prodott mediċinali tinstab fuq is-sit elettroniku tal-Agenzija Ewropea dwar il-Mediċini (EMA) : http://www.ema.europa.eu/
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' 2172 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 CLARITY and one of the cohort studies (n=765; Trenk), cardiovascular event rates did not differ significantly by genotype.
Maltese: F'CLARITY u f'wieħed mis-sett ta' studji (n=765; Trenk), ir-rati ta' avvenimenti kardjovaskulari ma varjawx b'mod sinifikanti minħabba l-ġenotip.
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 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: MARKETING AUTHORISATION NUMBER(S)
Maltese: Frekwenza(%)
English: The safety and efficacy of clopidogrel have been evaluated in 4 double-blind studies involving over 80,000 patients: the CAPRIE study, a comparison of clopidogrel to ASA, and the CURE, CLARITY and COMMIT 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'4 studji double blind li involvew 'il fuq minn 80,000 pazjent: fl-istudju CAPRIE, paragun ta' clopidogrel ma' ASA, u fl-istudji CURE, CLARITY u COMMIT kienu mqabblin clopidogrel mal-plaċebo, fejn iż-żewġ prodotti mediċinali ngħataw flimkien ma' ASA u terapija oħra li soltu tingħata.
English: If a patient is to undergo elective surgery and antiplatelet effect is temporarily not desirable, clopidogrel should be discontinued 7 days prior to surgery.
Maltese: Jekk pazjent jkollu operazzjoni u l-effett kontra l-plejtlits huwa temporanjament mhux mixtieq, clopidogrel m'għandux jibqa' jingħata 7 ijiem qabel l-operazzjoni.
English: Clopidogrel Teva Generics B.V. is taken 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 Teva Generics B.V. jittieħed biex inaqqas ir-riskju li emboli tad-demm (trombi) jifformaw fl-arterji mwebbsin (arterji), proċess imsejjaħ aterotrombosi, li jista' jwassal għal konsegwenzi aterotrombotiċi (bħal puplesija, attakk tal-qalb, jew mewt).
English: Neutropenia, including severe neutropenia
Maltese: Newtropenja, inkluża newtropenja severa
English: - signs of liver problems such as yellowing of the skin and/or the eyes (jaundice), whether or not associated with bleeding which appears under the skin as red pinpoint dots and/or confusion (see section 2 ‘Take special care with Clopidogrel Teva Generics B.V.').
Maltese: Madanakollu, jekk id-demm li ħiereġ jinkwetak, għandek tkellem lit-tabib tiegħek minnufih (ara sezzjoni 2 'Oqgħod attent ħafna b'Clopidogrel Teva Generics B.V.').
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) - a recent serious injury - a recent surgery (including dental) - a planned surgery (including dental) in the next seven days
Maltese: • jekk tinsab f'riskju ta' fsada bħal: kundizzjoni medika li tpoġġik f'riskju ta' fsada interna (bħal ulċera fl-istonku) mard fid-demm li jwassal għal fsada interna (dmija f'xi tessuti, organi jew ġogi ta' ġismek); ferita serja riċenti; operazzjoni riċenti (anki tas-snien); operazzjoni li ser issirlek (anki tas-snien) fis-sebat ijiem li ġejjin.
English: What Clopidogrel Teva Generics B.V. is and what it is used for Before you take Clopidogrel Teva Generics B.V. How to take Clopidogrel Teva Generics B.V.
Maltese: Tagħrif importanti dwar xi wħud mis-sustanzi ta' Clopidogrel Teva Generics B.V. Clopidogrel Teva Generics B.V. fih iż-żejt ir-riġnu idroġenat li jista' jikkawża taqlib tal-istonku jew dijarrea.
English: ACEI, calcium antagonists, cholesterol lowering agents, coronary vasodilators, antidiabetic agents (including insulin), antiepileptic agents, and GPIIb/IIIa antagonists without evidence of clinically significant adverse interactions.
Maltese: Madankollu, pazjenti li daħlu fi studji kliniċi bi clopidogrel ngħataw varjeta` 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: A. MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
Maltese: DETENTUR (I) TA' L-AWTORIZZAZZJONI TAL-MANIFATTURA RESPONSABBLI
English: The pharmacokinetics of digoxin or theophylline were not modified by the co-administration of clopidogrel.
Maltese: Il-karatteristiċi farmakokinetiċi ta' digoxin jew theophylline ma ġewx modifikati bl-amministrazjoni flimkien ma' clopidogrel.
English: To date, the impact of CYP2C19 genotype on the pharmacokinetics of the active metabolite of clopidogrel has been evaluated in 227 subjects from 7 reported studies.
Maltese: S'issa, l-impatt tal-ġenotip CYP2C19 fuq il-farmakokinetika tal-metabolit attiv ta' clopidogrel ġie evalwat f'227 suġġett minn 7 studji li ġew irrapportati.
English: Platelet aggregation induced by agonists other than ADP is also inhibited by blocking the amplification of platelet activation by released ADP.
Maltese: L-aggregazzjoni tal-plejtlits stimulata minn agonisti oħra barra ADP tiġi impedita wkoll permezz ta' mblukkar tal-amplifikazzjoni tal-attivazzjoni ta' plejtlits minn ADP meħlus.
English: Serious haemorrhage, haemorrhage of operative wound, vasculitis, hypotension
Maltese: Emorraġija serja, emorraġija ta' ferita minn operazzjoni, vaskulite, pressjoni baxxa
English: A number of other clinical studies have been conducted with clopidogrel and other concomitant medicinal products to investigate the potential for pharmacodynamic and pharmacokinetic interactions.
Maltese: Prodotti mediċinali oħrajn: Saru numru ta' studji kliniċi oħra bi clopidogrel u prodotti mediċinali oħra li ngħataw flimkien biex tiġi investigata l-possibilita` ta' interazzjonijiet farmakodinamiċi u farmakokinetiċi.
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 Tromboċitopenika Trombotika jew TTP) li tinkludi deni u tbenġil taħt ilġilda li jidher bħal tikek ħomor irqaq, flimkien ma' jew mingħajr għeja kbira mhux spjegata, konfużjoni, sfurija tal-ġilda jew tal-għajnejn (suffejra) (ara sezzjoni 4 'EFFETTI SEKONDARJI LI JISTA' JKOLLU').
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 ittrattati bil-mediċini u eliġibbli għat-terapija trombolitika
English: Therapeutic experience is limited in patients with moderate hepatic disease who may have bleeding diatheses (see section 4.4).
Maltese: L-esperjenza terapewtika hija limitata f'pazjenti b'mard epatiku moderat li jista' jkollhom dijateżi emorraġika (ara sezzjoni 4.4).