FrancophonIA/ELRC3.0 huggingface dataset:
English: Subsequent metabolism of the 2-oxo-clopidogrel intermediate metabolite results in formation of the active metabolite, a thiol derivative of clopidogrel.
Maltese: Metaboliżmu suċċessiv tal-metabolit intermedjarju 2-oxo-clopidogrel iwassal għallformazzjoni tal-metabolit attiv, derivattiv thiol ta' clopidogrel.
English: TAD Pharma GmbH
Maltese: AKTAR TAGĦRIF
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
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: Calendar Blister of OPA/Al/PVC-Al containing 7, 14, 28, 56, 84 film-coated tablets in the box.
Maltese: Folja tax-xahar magħmula minn OPA/Al/PVC-Al li fih 7, 14, 28 , 56 u 84 pillola miksija b'rita f'kaxxa.
English: Pharmacotherapeutic group: platelet aggregation inhibitors excl. heparin, ATC code: B01AC-04.
Maltese: Inibituri tal-aggregazzjoni tal-plejtlets li jeskludu heparin, Kodiċi ATC:
English: - fever, signs of infection or extreme tiredness.
Maltese: - Deni, sinjali ta' infezzjoni jew għeja estrema.
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 filmetabolizzaturi dgħajfa meta mqabbla ma' metabolizzaturi estensivi.
English: Although the administration of clopidogrel 75 mg/day did not modify the pharmacokinetics of S-warfarin or International Normalised Ratio (INR) in patients receiving long-term warfarin therapy, coadministration of clopidogrel with warfarin increases the risk of bleeding because of independent
Maltese: Għalkemm l-għoti ta' clopidogrel 75 mg/jum ma mmodifikax il-farmakokinetika ta' S-warfarin jew il-Proporzjon Normalizzat Internazzjonali (INR) f'pazjenti li rċevew terapija għat-tul ta' warfarin, l-għoti flimkien ta' clopidogrel ma' warfarin iżid ir-riskju ta' fsada minħabba effetti indipendenti fuq l-emostasi.
English: At steady state, the average inhibition level observed with a dose of 75 mg per day was between 40% and
Maltese: Fi stat fiss, illivell medju ta' inibizzjoni osservat b'doża ta' 75 mg kuljum kien bejn 40 % u 60 %.
English: • Adults 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
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: 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: 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 tal-fibrini u mhux fribrini u heparins ġiet eżaminata f'pazjenti li kellhom infart mijokardijaku akut.
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: NSAIDs: in a clinical study conducted in healthy volunteers, the concomitant administration of clopidogrel and naproxen increased occult gastrointestinal blood loss.
Maltese: NSAIDs: fi studju kliniku li sar fuq voluntiera f'saħħithom l-għoti ta' clopidogrel u naproxen flimkien żid lemorraġija moħbija gastrointestinali.
English: The other ingredients are:
Maltese: Effetti kollaterali rari:
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: Serious haemorrhage, haemorrhage of operative wound, vasculitis, hypotension Respiratory tract bleeding (haemoptysis, pulmonary haemorrhage), bronchospasm, interstitial pneumonitis
Maltese: Emorraġija fil-passaġġ respiratorju (emoptassi, emorraġija pulmonari), bronkospażmu, pnewmonite interstizjali gastrointestinali
English: The incidence of severe cases was similar for clopidogrel and ASA.
Maltese: L-inċidenza ta' każi severi kienet simili għal clopidogrel simili għal ASA.
English: What Clopidogrel Qualimed contains
Maltese: Clopidogrel Qualimed;
English: The prevalence of CYP2C19 alleles that result in intermediate and poor CYP2C19 metabolism differs according to race/ethnicity (see Pharmacogenetics).
Maltese: L-inċidenza tal-alleli ta' CYP2C19 li tirriżulta f'metaboliżmu intermedju u dgħajjef ta' CYP2C19 tvarja skont ir-razza/etniċità (ara l-Farmakoġenetika).
English: Very rare aplastic anaemia, pancytopenia, agranulocytosis, severe thrombocytopenia, granulocytopenia, anaemia
Maltese: Purpura tromboċitopenikatrombotika (thrombotic thrombocytopenic purpura (TTP)) (ara sezzjoni 4.4), anemija aplastika, panċitopenija, agranuloċitosi, tromboċitopenija severa granuloċitopenija, anemija
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 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, ittolleranza klinika kienet tajba fil-pazjenti kollha.
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, linibizzjoni tal-aggregazzjoni tal-plejtlits kawża tal-ADP kien simili għal dak osservat f'suġġetti b'saħħithom.
English: Boxes of 7, 14, 28, 56, 84 film-coated tablets in calendar blisters are available.
Maltese: Kaxxi disponibbli f'7 pilloli, 14-il pillola, 28, 56, 84 pillola miksija b'rita ġo folji kalendarji.
English: The CLARINET and the PICOLO trials were conducted using a constituted solution of clopidogrel.
Maltese: L-istudji CLARINET u PICOLO saru bl-użu ta' soluzzjoni kostitwita ta' clopidogrel.
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-istudju 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: Consequently, NSAIDs including Cox-2 inhibitors and clopidogrel should be co-administered with caution (see section 4.4).
Maltese: Konsegwentement, NSAIDs li jinkludu l-impedituri ta' Cox-2 u clopidogrel għandhom jingħataw b'kawtela (ara sezzjoni 4.4).
English: Patients were randomised to clopidogrel 75 mg/day or ASA 325 mg/day, and were followed for 1 to 3 years.
Maltese: Il-pazjenti kienu magħżula b'mod każwali għal clopidogrel 75 mg/jum jew ASA 325 mg/jum, u ġew osservati għal bejn sena u 3 snin.
English: A pharmacodynamic interaction between clopidogrel and acetylsalicylic acid is possible, leading to increased risk of bleeding.
Maltese: Huwa possibbli li jkun hemm interazzjoni farmakodinamika bejn clopidogrel u acetylsalicylic acid li jista' jwassal għal riskju akbar ta' emorraġija.
English: Bruising
Maltese: Pożoloġija
English: Very rare erythema multiforme), angioedema, rash erythematous, urticaria, eczema, lichen planus
Maltese: Dermatite bl-infafet (nekrolisi tossika talepidermide, Sindromu ta' Stevens Johnson, eritema multiforme), anġjoedema, raxx eritematsi, urtikarja, ekżema, lichen planus
English: Breastfeeding
Maltese: Tbenġil
English: Other concomitant therapy:
Maltese: Kategorija farmakoterapewtika:
English: The pharmacokinetics of digoxin or theophylline were not modified by the co-administration of clopidogrel.
Maltese: Il-farmakokinetiċi ta' digoxin jew theophylline ma ġewx modifikati bl-amministrazzjoni flimkien ma' clopidogrel.
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 għoljin ħafna, ġiet irrapurtata tollerabilità baxxa fl-istonku (gastrite, erożijonijiet gastriċi u/jew rimettar) ta' clopidogrel fil-firien u l-babwini.
English: 50x1 film-coated tablets EU/1/09/559/011
Maltese: EU/1/09/559/011
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 bis-sistema ta' dożaġġ ta' 300 mg/75 mg.
English: 7 film-coated tablets - calendar blister: EU/1/09/559/012 14 film-coated tablets - calendar blister: EU/1/09/559/013 28 film-coated tablets - calendar blister: EU/1/09/559/014 56 film-coated tablets - calendar blister: EU/1/09/559/015 84 film-coated tablets - calendar blister: EU/1/09/559/016
Maltese: 7 pilloli miksija b'rita 7 pilloli miksija b'rita - folja kalendarja 14-il pillola miksija b'rita 14-il pillola miksija b'rita - folja kalendarja 28 pillola miksija b'rita 28 pillola miksija b'rita - folja kalendarja 30 pillola miksija b'rita 30x1 pillola miksija b'rita 50 pillola miksija b'rita 50x1 pillola miksija b'rita 56 pillola miksija b'rita 56 pillola miksija b'rita - folja kalendarja 84 pillola miksija b'rita 84 pillola miksija b'rita - folja kalendarja 90 pillola miksija b'rita 100 pillola miksija b'rita
English: Uncommon side effects: Headache, stomach ulcer, vomiting, nausea, constipation, excessive gas in stomach or intestines, rashes, itching, dizziness, sensation of tingling and numbness.
Maltese: Effetti kollaterali mhux komuni: Uġigħ ta' ras, ulċeri fl-istonku, remettar, tqalligħ, stitikezza, ħafna gass flistonku jew l-imsaren, raxxijiet, ħakk, sturdament, sensazzjoni ta' tnemnim u tirżiħ.
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
English: A. THE MANUFACTURING AUTHORISATION HOLDER(S)
Maltese: <MANIFATTUR(I)
English: Excipient:
Maltese: Lot:
English: The incidence of major bleeding was similar between groups.
Maltese: L-inċidenza ta' emorraġija maġġuri kienet simili bejn il-gruppi.
English: Take special care with Clopidogrel Qualimed
Maltese: X'INHU CLOPIDOGREL QUALIMED
English: Slovenia
Maltese: Lietuva
English: QUALITATIVE AND QUANTITATIVE COMPOSITION 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: Recent myocardial infarction (MI), recent stroke or established peripheral arterial disease
Maltese: Infart mijokardjali riċenti (MI), puplesija riċenti jew mard periferali stabbilit tal-arterji
English: In patients who remained on therapy within five days of bypass graft surgery, the event rate was 9.6% for clopidogrel plus ASA, and 6.3% for placebo plus ASA.
Maltese: F'pazjenti li baqgħu jieħdu l-kura fil-ħamest ijiem ta' qabel l-operazzjoni ta' trapjant ta' bajpass, ir-rata ta' avvenimenti kienet ta' 9.6% għal clopidogrel miżjud ma' ASA, u 6.3% għal placebo miżjud ma' ASA.
English: Each film-coated tablet contains 75 mg of clopidogrel (as hydrochloride).
Maltese: Kull pillola miksija b'rita fiha 75 mg ta' clopidogrel (bħala hydrochloride).
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 oħrajn: saru 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: 30x1 film-coated tablets EU/1/09/559/010
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/09/559/001-016
English: NAME OF THE MEDICINAL PRODUCT Clopidogrel Qualimed 75 mg film-coated tablets
Maltese: TAL-PRODOTT MEDIĊINALI Clopidogrel Qualimed 75 mg pilloli miksija b'rita
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 waħda 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: Clopidogrel Qualimed 75 mg film-coated tablets Clopidogrel
Maltese: Clopidogrel Qualimed 75 mg pilloli miksija b'rita Clopidogrel
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 jagħżel li jkollu operazzjoni u l-effett kontra l-plejtlets huwa temporanjament mhux mixtieq, clopidogrel għandu jitwaqqaf 7 ijiem qabel il-kirurġija.
English: Clopidogrel is a prodrug, one of whose metabolites is an inhibitor of platelet aggregation.
Maltese: Clopidogrel huwa pro-mediċina, b'metabolit minnhom ikun inibitur tal-aggregazzjoni tal-plejtlits.
English: • not known (frequency cannot be estimated from the available data)
Maltese: • Mhux magħruf (il-frekwenza ma tistax tiġi stmata mit-tagħrif disponibbli)
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 Qualimed').
Maltese: - Sinjali ta' problemi fil-fwied bħal sfurija tal-ġilda u l-abjad tal-għajnejn (suffejra), li jista' jkun jew ma jkunx assoċjat ma' emorraġija li tidher taħt il-ġilda bħala marki rqaq ħomor u/jew konfużjoni (ara sezzjoni 2 ‘Oqgħod attent ħafna meta tieħu Clopidogrel Qualimed').
English: After a single oral dose of 75 mg, clopidogrel has a half-life of approximately 6 hours.
Maltese: Wara doża orali waħda ta' 75mg, clopidogrel għandu l-half-life bejn wieħed u ieħor ta' 6 sigħat.
English: If you forget to take Clopidogrel Qualimed:
Maltese: Tieħux Clopidogrel Qualimed:
English: Clopidogrel has been evaluated for safety in more than 42,000 patients, who have participated in clinical studies, including over 9,000 patients treated for 1 year or more.
Maltese: Clopidogrel ġie evalwat għas-sigurtà f'aktar minn 42,000 pazjent li pparteċipaw fi studji kliniċi, li kienu jinkludu aktar minn 9,000 pazjent trattati għal sena jew aktar.
English: Thrombotic Thrombocytopenic Purpura (TTP) has been reported very rarely following the use of clopidogrel, sometimes after a short exposure.
Maltese: Ġiet rapportata Purpura Trombotika Tromboċitopenika (TTP) b'mod rari ħafna wara l-użu ta' clopidogrel, xi kultant wara espożizzjoni qasira.
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 parti mill-metaboliżmu ta' clopidogrel għall-metabolit attiv tiegħu jsir minn CYP2C19, huwa mistenni li l-użu tal-prodotti mediċinali li jinibixxu l-attività ta' din l-enzima jwasslu għal tnaqqis fil-livell tal-metabolit attiv 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 konkomitanti inibituri qawwijin jew moderati ta' CYP2C19għandu jiġu skoraġġut (ara sezzjoni 4. 5 għal lista ta' inibituri ta' CYP2C19, ara wkoll sezzjoni 5.2).
English: Absorption is at least 50%, based on urinary
Maltese: L-assorbiment huwa mill-inqas ta' 50%, skond l-eskrezzjoni fl-urina ta' metaboliti ta' clopidogrel.
English: Due to the risk of bleeding and haematologicaladverse reactions, blood cell count determination and/or other appropriate testing should be promptly considered whenever clinical symptoms suggestive of bleeding arise during the course of treatment (see section 4.8).
Maltese: Minħabba r-riskju ta' emorraġiji u effetti ematoloġiċi mhux mixtieqa, l-għadd ta' ċelluli tad-demm u/jew kull ittestjar ieħor xieraq għandhom jiġu kkonsidrati kull meta waqt it-trattament ikun hemm sintomi kliniċi li jindikaw emorraġiji (ara sezzjoni 4.8).
English: The elimination halflife of the main circulating (inactive) metabolite was 8 hours after single and repeated administration.
Maltese: Il-half-life tat-tneħħija talmetabolit prinċipali (inattiv) ċirkolanti kien 8 sigħat wara amministrazzjoni waħda u ripetuta.
English: Furthermore, the pharmacodynamic activity of clopidogrel was not significantly influenced by the coadministration of phenobarbital, or oestrogen.
Maltese: Barra minn hekk, l-attività farmakodinamika ta' clopidogrel ma ġietx influwenzata b'mod sinifikanti mit-teħid konġunt ma' phenobarbital, jew oestrogen.
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
Maltese: B'doża ta' 0.2 mg/kg kien hemm medja perċentwali ta' inibizzjoni ta' 49.
English: Acetylsalicylic acid (ASA): ASA did not modify the clopidogrel-mediated inhibition of ADP-induced platelet aggregation, but clopidogrel potentiated the effect of ASA on collagen-induced platelet aggregation.
Maltese: 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: Clopidogrel active metabolite pharmacokinetics and antiplatelet effects, as measured by ex vivo platelet aggregation assays, differ according to CYP2C19 genotype.
Maltese: Sabiex jipproduċi l-metabolit attiv li jimpedixxi l-aggregazzjoni tal-plejtlits, clopidogrel irid jiġi mmetabolizzat mill-enzimi CYP450.
English: After single and repeated oral doses of 75 mg per day, clopidogrel is rapidly absorbed.
Maltese: Wara doża orali waħda u ripetuta ta' 75 mg kuljum, clopidogrel kien assorbit b'rata mgħaġġla.
English: There was no evidence of carcinogenic effect when clopidogrel was administered for 78 weeks to mice and 104 weeks to rats when given at doses up to 77 mg/kg per day (representing at least 25 times the exposure seen in humans receiving the clinical dose of 75 mg/day).
Maltese: Ma kienx hemm evidenza ta' riskju ta' kanċer meta clopidogrel ingħata għal 78 ġimgħa lil ġrieden u 104 ġimgħa lil firien meta ngħataw dożi sa 77 mg/kg kuljum (li jirrapreżenta tal-anqas 25 darba l-espożizzjoni osservata fil-bniedem li kienu qed jingħataw doża klinika ta' 75 mg/kuljum).
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: Il-livell medju fil-plażma ta' clopidogrel mhux mibdul (bejn wieħed u ieħor 2.2-2.5ng/ml wara doża orali waħda ta' 75 mg) seħħew bejn wieħed u ieħor 45 minuta wara d-dożaġġ.
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.
Maltese: Bħal fil-każ ta' sustanzi oħra kontra l-plejtlets, 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 li jinkludu l-inibituri ta' Cox-2.
English: In CAPRIE, in patients treated with either clopidogrel or ASA, the overall incidence of any bleeding was 9.3%.
Maltese: F'CAPRIE, f'pazjenti li ngħataw jew clopidogrel jew ASA, l-inċidenza globali ta' kull tip ta' emorraġija kienet ta' 9.3 %.
English: Neutropenia, including severe neutropenia
Maltese: Disturbi fis-sistema nervuża
English: These results indicate that clopidogrel can be administered with pantoprazole.
Maltese: Dawn ir-riżultati jindikaw li clopidogrel jista' jingħata flimkien ma' pantoprazole.
English: The mean time between shunt palliation and first administration of study medicinal product was 20 days.
Maltese: Iż-żmien medju bejn id-devjazzjoni kirurġika ta' għajnuna u l-ewwel għotja tal-prodott mediċinali taħt studju kien ta' 20 ġurnata.
English: • rare (affects 1 to 10 users in 10,000)
Maltese: • Rari (taffettwa minn 1 sa 10 f'kull 10,000 li jeħduh)
English: Clopidogrel significantly reduced the incidence of new ischaemic events (combined end point of myocardial infarction, ischaemic stroke and vascular death) when compared to ASA.
Maltese: Clopidogrel naqqas b'mod sinifikanti l-inċidenza ta' każijiet iskemiċi ġodda (punt ta' riferiment ikkombinat għal infart mijokardijaku, puplesija iskemika u mewt vaskulari) meta mqabbel ma' ASA.
English: Clopidogrel should be given as a single daily dose of 75 mg.
Maltese: Clopidogrel ghandu jinghata darba kuljum bhala doza ta' 75 mg.
English: 56 film-coated tablets - calendar blister 84 film-coated tablets - calendar blister
Maltese: 7 pilloli miksija b'rita - folja kalendarja:
English: Antacids did not modify the extent of clopidogrel absorption.
Maltese: Antaċidi ma mmodifikawx kemm ġie assorbit clopidogrel.
English: Pregnancy
Maltese: Ematoma