FrancophonIA/ELRC3.0 huggingface dataset:
English: Question 1- The Applicant should provide the protocol of the in vitro comparisons of the particle size distributions in dry conditions, humid conditions and with spacer where all the relevant information should have been pre-specified, e.g. objective, sample size required to demonstrate equivalence in the predefined pools of stages within a pre-specified acceptance range, the pre-specified batches and the pre-specified statistical methods.
Maltese: Mistoqsija 1 - L-Applikant għandu jipprovdi l-protokoll tat-tqabbil in vitro tad-distribuzzjonijiet taddaqs tal-partiċelli f'kundizzjonijiet xotti, kundizzjonijiet umdi u bi spejser fejn l-informazzjoni relevanti kollha kellha tkun speċifikata minn qabel, ngħidu aħna, daqs ta' kampjun oġġettiv meħtieġ biex juri ekwivalenza fil-ġabriet ta' stadji definiti minn qabel fi ħdan medda ta' approvazzjoni speċifikat minn qabel, il-lottijiet speċifikati minn qabel u l-metodi statistiċi speċifikati minn qabel.
English: The full EPAR and risk management plan summary for Orbactiv can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It contains the active substance oritavancin.
Maltese: Fih is-sustanza attiva oritavancin.
English: This is a summary of the European public assessment report (EPAR) for Orbactiv.
Maltese: Dan huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Orbactiv.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Orbactiv on 19 March 2015.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Orbactiv fid-19 ta' Marzu 2015.
English: Orbactiv, given as a single infusion, was compared with a 7 to 10-day treatment with vancomycin (another glycopeptide) in two main studies involving a total of around 1,959 patients with acute bacterial infections of the skin and of skin structures, such as cellulitis, skin abscesses and wound infections.
Maltese: Orbactiv, li jingħata bħala infużjoni waħda, meta mqabbel ma' 7 sa 10 ijiem ta' kura b'vancomycin (glikopeptid ieħor) f'żewġ studji ewlenin li jinvolvu total ta' madwar 1,959 pazjent b'infezzjonijiet batteriċi akuti tal-ġilda u tal-istrutturi tal-ġilda, bħal ċellulite, axxessi tal-ġilda u infezzjonijiet fil-ġrieħi.
English: Orbactiv has been shown to work against bacteria (such as methicillin resistant Staphylococcus aureus (MRSA)) for which standard antibiotics do not work.
Maltese: Orbactiv intwera li jaħdem kontra batterji (bħal Staphylococcus aureus reżistenti għall-metiċillina (MRSA)) li kontriha ma jaħdmux antibijotiċi standard.
English: Other information about Orbactiv
Maltese: Informazzjoni oħra dwar Orbactiv
English: Why is Orbactiv approved?
Maltese: Għaliex ġie approvat Orbactiv?
English: The recommended dose is a single infusion of 1,200 mg over three hours.
Maltese: Id-doża rakkomandata hija ta' infużjoni waħda ta' 1,200 mg għal tliet sigħat.
English: Orbactiv was at least as effective as vancomycin at treating the infection: 80.1% of patients treated with Orbactiv in the first study and 82.3% in the second study responded to treatment, compared with 82.9% and 78.9% respectively of patients treated with vancomycin.
Maltese: 1% tal-pazjenti kkurati b'Orbactiv fl-ewwel studju u 82.3% fit-tieni studju rrispondew għall-kura, meta mqabbel ma' 82.9% u 78.9% rispettivament tal-pazjenti kkurati b'vancomycin.
English: The active substance in Orbactiv, oritavancin, is a type of antibiotic called a glycopeptide.
Maltese: Is-sustanza attiva f'Orbactiv, oritavancin, hija tip ta' antibijotiku msejjaħ glikopeptid.
English: A risk management plan has been developed to ensure that Orbactiv is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jassigura li Orbactiv jintuża bl-aktar mod sigur possibbli.
English: What are the risks associated with Orbactiv?
Maltese: X'inhuma r-riskji assoċjati ma' Orbactiv?
English: Orbactiv is an antibiotic used in adults to treat acute (short-term) bacterial infections of the skin and of skin structures (tissue below the skin) such as cellulitis (inflammation of the deep skin tissue), skin abscesses and wound infections.
Maltese: Orbactiv huwa antibijotiku li jintuża fl-adulti biex jiġu kkurati infezzjonijiet batteriċi akuti (għal żmien qasir) tal-ġilda u tal-istrutturi tal-ġilda (tessut taħt il-ġilda) bħal ċellulite (infjammazzjoni tat-tessut filfond fil-ġilda), axxessi tal-ġilda u infezzjonijiet fil-ġrieħi.
English: The most common side effects with Orbactiv (which may affect 5 people or more in 100) are nausea (feeling sick), hypersensitivity (allergy) reactions or reactions at the site of infusion and headache.
Maltese: L-effetti sekondarji l-aktar komuni b'Orbactiv (li jistgħu jaffettwaw 5 persuni jew aktar f'kull 100) huma nawsja (tħossok ma tiflaħx), reazzjonijiet ta' sensittività eċċessiva (allerġija) jew reazzjonijiet fis-sit tal-infużjoni u uġigħ ta' ras.
English: In addition, 82.7% of patients treated with Orbactiv in the first study and 79.6% in the second study were cured, compared with 80.5% and 80.0% respectively of patients treated with vancomycin.
Maltese: Barra minn hekk, 82.7% tal-pazjenti kkurati b'Orbactiv fl-ewwel studju u 79.6% fit-tieni studju kienu kkurati, meta mqabbel ma' 80.
English: A list of bacteria against which Orbactiv is active can be found in the summary of product characteristics (also part of the EPAR).
Maltese: Lista ta' batterji li Orbactiv huwa attiv kontrihom tinstab fissommarju tal-karatteristiċi tal-prodott (parti wkoll mill-EPAR).
English: What measures are being taken to ensure the safe and effective use of Orbactiv?
Maltese: X'miżuri qed jitteħdu biex jassiguraw l-użu sigur u effikaċi ta' Orbactiv?
English: Although Orbactiv's safety profile overall is similar to that of other glycopeptides, the CHMP noted that some side effects occurred more frequently such as abscesses and bone infections.
Maltese: Għalkemm il-profil tas-sigurtà komplessivament huwa simili għal dak ta' glikopeptidi oħrajn, is-CHMP innota li xi effetti sekondarji bħal axxessi u infezzjonijiet fl-għadam seħħew b'mod aktar frekwenti.
English: These also included infections caused by MRSA.
Maltese: Dawn jinkludu wkoll infezzjonijiet ikkawżati minn MRSA.
English: It is not intended to provide practical advice on how to use Orbactiv.
Maltese: Dan mhux maħsub biex jipprovdi konsultazzjoni prattika dwar l-użu ta' Orbactiv.
English: The most common side effects that resulted in treatment being stopped were cellulitis and osteomyelitis (bone infection).
Maltese: L-effetti sekondarji l-aktar komuni li rriżultaw fil-waqfien tal-kura kienu ċellulite u osteomajlite (infezzjoni tal-għadam).
English: The CHMP considered that Orbactiv, which can be given as a single dose, could be a valuable alternative treatment option for acute bacterial infections of the skin and of skin structures.
Maltese: Is-CHMP ikkunsidra li Orbactiv, li jista' jingħata bħala doża waħda, jista' jkun għażla ta' kura alternattiva siewja għal infezzjonijiet batteriċi akuti tal-ġilda u tal-istrutturi tal-ġilda.
English: For the full list of all side effects and restrictions with Orbactiv, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u restrizzjonijiet kollha b'Orbactiv, ara l-fuljett ta' tagħrif.
English: Patients who have received Orbactiv must not be given an infusion of unfractionated heparin (a medicine used to prevent blood clots) for 120 hours after the infusion of Orbactiv.
Maltese: Orbactiv kien tal-anqas effikaċi daqs vancomycin fil-kura tal-infezzjoni: 80.
English: Cellulose, microcrystalline Colloidal anhydrous silica Crospovidone (type A) Macrogol 6000
Maltese: Cellulose, microcrystalline Colloidal anhydrous silica Crospovidone (tip A) Macrogol 6000
English: Sverige Mylan AB
Maltese: Mylan AB
English: 4.0%; CI: -22.5 to 11.7 [p=0.639]).
Maltese: (RRR = -4.0 %; CI: minn -22.5 sa 11.7 [p= 0.639]).
English: New cardiovascular events (primary endpoint) were prevented, with relative risk reductions of 22% (CI: 8.6, 33.4), 32% (CI: 12.8, 46.4), 4% (CI: -26.9, 26.7), 6% (CI: -33.5, 34.3) and 14% (CI: -31.6, 44.2), during the 0-1, 1-3, 3-6, 6-9 and 9-12 month study intervals, respectively.
Maltese: Avvenimenti kardjovaskulari ġodda (punt aħħari primarju) ġew evitati, bi tnaqqis fir-riskju relattiv ta' 22% (CI: 8.6, 33.4), 32% (CI: 12.8, 46.4), 4% (CI: -26.9, 26.7), 6% (CI: -33.5, 34.3) u 14% (CI:31.6, 44.2), matul l-intervalli tal-istudji ta' 0-1, 1-3, 3-6, 6-9 u 9-12-il xahar, rispettivament.
English: Date of latest renewal: 22 May 2014
Maltese: Data tal-aħħar tiġdid: 22 ta' Mejju 2014
English: INFORMATION IN BRAILLE Clopidogrel Mylan 75 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Clopidogrel Mylan 75 mg
English: Phone: + 351 21 412 72 56
Maltese: Tel: + 351 21 412 72 56
English: In CURE, 823 (6.6%) patients received concomitant GPIIb/IIIa receptor antagonist therapy.
Maltese: Fi CURE, 823 (6.6%) pazjent irċivew terapija fl-istess ħin b'antagonista ta' riċettur GPIIb/IIIa.
English: The other ingredients are: Tablet core: microcrystalline cellulose, colloidal anhydrous silica, crospovidone (type A), macrogol 6000, hydrogenated castor oil (see section 2 ‘Clopidogrel Mylan contains hydrogenated castor oil') Film-coating: polyvinyl alcohol, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), talc and macrogol 3000.
Maltese: Qalba tal-pillola: microcrystalline cellulose, colloidal anhydrous silica, crospovidone (tip A), macrogol 6000, żejt ir-riġnu idroġenat (ara sezzjoni 2 ‘Clopidogrel Mylan fih castor oil idroġenat') Rita tal-pillola: polyvinyl alcohol, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), talc and macrogol 3000.
English: The use of clopidogrel in CURE was associated with a decrease in the need of thrombolytic therapy (RRR = 43.3%; CI: 24.3%, 57.5%) and GPIIb/IIIa inhibitors (RRR = 18.2%; CI: 6.5%, 28.3%).
Maltese: L-użu ta' clopidogrel fi CURE ġie assoċjat ma' tnaqqis fil-ħtieġa ta' kura trombolitika (RRR= 43.3%; CI: 24.3%, 57.5%) u inibituri ta' GPIIb/IIIa (RRR= 18.2%; CI: 6.5%, 28.3%).
English: Secondary prevention of atherothrombotic events
Maltese: Il-prevenzjoni sekondarja ta' avvenimenti aterotrombotiċi
English: Musculoskeletal bleeding (haemarthrosis), arthritis, arthralgia, myalgia
Maltese: Emorraġija muskoluskeletriku (emartrosi), artrite, artralġja, majalġjia
English: 7 film-coated tablets 14 film-coated tablets 28 film-coated tablets 30 film-coated tablets 30x1 film-coated tablets 50 film-coated tablets 50x1 film-coated tablets 56 film-coated tablets 84 film-coated tablets 90 film-coated tablets 100 film-coated tablets
Maltese: 7 pilloli miksija b'rita 14-il pillola miksija b'rita 28 pillola miksija b'rita 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 84 pillola miksija b'rita 90 pillola miksija b'rita 100 pillola miksija b'rita
English: A total of 99.7% of patients received fibrinolytics (fibrin specific: 68.7%, non-fibrin specific: 31.1%), 89.5% heparin, 78.7% beta blockers, 54.7% ACE inhibitors and 63% statins.
Maltese: Total ta' 99.7% tal-pazjenti rċivew sustanzi fibrinolitiċi (speċifiċi għal fibrin: 68.7%, mhux speċifiċi għal fibrin: 31.1%), 89.5% heparin, 78.7% imblokkaturi beta, 54.7% inibituri ta' ACE u 63% statins.
English: Mylan bvba/sprl /Tel: + 32 (0)2 658 61 00 (Belgique/Belgien)
Maltese: Luxembourg/Luxemburg Mylan bvba/sprl Tel: + 32 (0)2 658 61 00 (Belgique/Belgien)
English: The mean CHADS2 score was 2.0 (range 0-6).
Maltese: Il-medja tal-punteġġ CHADS2 kienet ta' 2.0 (medda 0-6).
English: There have been a number of retrospective analyses, however, to evaluate this effect in patients treated with clopidogrel for whom there are genotyping results: CURE (n=2721), CHARISMA (n=2428), CLARITY-TIMI 28 (n=227), TRITON-TIMI 38 (n=1477), and ACTIVE-A (n=601), as well as a number of published cohort studies.
Maltese: CURE (n= 2721), CHARISMA (n= 2428), CLARITY-TIMI 28 (n= 227), TRITON-TIMI 38 (n= 1477), u ACTIVE-A (n= 601), kif ukoll numru ta' studji ko-orti ppubblikati.
English: Medicinal products that are strong or moderate CYP2C19 inhibitors include, for example, omeprazole and esomeprazole, fluvoxamine, fluoxetine, moclobemide, voriconazole, fluconazole, ticlopidine, carbamazepine, and efavirenz.
Maltese: Prodotti mediċinali li huma inibituri qawwijin ta' CYP2C19 jinkludu, pereżempju, omeprazole u esomeprazole, fluvoxamine, fluoxetine, moclobemide, voriconazole, fluconazole, ticlopidine, carbamazepine, u efavirenz.
English: The ACTIVE-A study (N=7,554) was a multicenter, randomized, double-blind, placebo-controlled study which compared clopidogrel 75 mg/day + ASA (N=3,772) to placebo + ASA (N=3,782).
Maltese: L-istudju ACTIVE-A (N= 7,554) kien studju multiċentriku, li fih il-parteċipanti ntgħażlu b'mod każwali, double-blind, ikkontrollat bi plaċebo, li pparaguna clopidogrel 75 mg/jum + ASA (N= 3,772) ma' plaċebo + ASA (N= 3,782).
English: A total of 23.0% of patients received anti-arrhythmics, 52.1% beta-blockers, 54.6% ACE inhibitors, and 25.4% statins.
Maltese: Total ta' 23.0% tal-pazjenti rċivew sustanzi antiarritmiċi, 52.1% imblokkaturi beta, 54.6% inibituri ta' ACE, u 25.
English: The active metabolite is formed mostly by CYP2C19 with contributions from several other CYP enzymes, including CYP1A2, CYP2B6 and CYP3A4.
Maltese: Il-metabolit attiv isir primarjament minn CYP2C19 b'kontribuzzjonijiet minn bosta enzimi CYP oħra li jinkludu, CYP1A2, CYP2B6 u CYP3A4.
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 talepidermide, Sindromu ta' Stevens Johnson, eritema multiforme), pustulożi exanthematous ġeneralizzata akuta (AGEP), anġjoedema, sindromu ta' sensittività eċċessiva kkawżat millmediċina, raxx kkawżat mill-mediċina b'eosinofilja u sintomi sistemiċi (DRESS), raxx eritematsi jew bil-qxur, urtikarja, ekżema, lichen planus
English: The mean age was 71 years, 41.6% of patients were ≥75 years.
Maltese: L-età medja kienet ta' 71 sena, 41.6% tal-pazjenti kellhom ≥ 75 sena.
English: The clinically relevant adverse reactions observed in the CAPRIE, CURE, CLARITY, COMMIT and ACTIVE-A studies are discussed below.
Maltese: Irreazzjonijiet avversi klinikament rilevanti li ntwerew fl-istudji CAPRIE, CURE, CLARITY, COMMIT u ACTIVE-A huma diskussi hawn taħt.
English: The number of patients experiencing the primary endpoint [cardiovascular (CV) death, myocardial infarction (MI), or stroke] was 582 (9.3%) in the clopidogrel-treated group and 719 (11.4%) in the placebo-treated group, a 20% relative risk reduction (95% CI of 10%-28%; p=0.00009) for the clopidogrel-treated group (17% relative risk reduction when patients were treated conservatively, 29% when they underwent percutaneous transluminal coronary angioplasty (PTCA) with or without stent and 10% when they underwent coronary artery bypass graft (CABG)).
Maltese: In-numru ta' pazjenti li kellhom il-punt aħħari primarju [mewt kardjovaskulari (CV), infart mijokardijaku (MI) jew puplesija] kien ta' 582 (9.3%) fil-grupp ikkurat bi clopidogrel, u 719 (11.4%) fil-grupp ikkurat bilplaċebo, tnaqqis fir-riskju relattiv ta' 20% (95% CI ta' 10%-28%; p= 0.00009) għall-grupp ikkurat bi clopidogrel (tnaqqis fir-riskju relattiv ta' 17% f'pazjenti li ġew ikkurati b'mod konservattiv, 29% meta kellhom angioplasty koronarja perkutanja transluminali (percutaneous transluminal coronary angioplastyPTCA) bi jew mingħajr stent, u 10% meta kellhom bypass graft tal-arterja koronarja (coronary artery bypass graft - CABG)).
English: The CAPRIE study included 19,185 patients with atherothrombosis as manifested by recent myocardial infarction (<35 days), recent ischaemic stroke (between 7 days and 6 months) or established peripheral arterial disease (PAD).
Maltese: L-istudju CAPRIE kien jinkludi 19,185 pazjent b'aterotrombosi li ntweriet permezz ta' infart mijokardjali riċenti (< 35 jum), puplesija iskemika riċenti (bejn 7 ijiem u 6 xhur) jew mard stabbilit tal-arterji periferali (peripheral arterial disease (PAD)).
English: The patient population included 41.8 % women.
Maltese: Il-popolazzjoni ta' pazjenti kienet tinkludi 41.8% nisa.
English: Their frequency is defined using the following conventions: common (1/100 to <1/10); uncommon (1/1,000 to < 1/100); rare (1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Maltese: Il-frekwenza tagħhom hi definita skont dawn il-konvenzjonijiet: komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1,000 sa < 1/100); rari (≥ 1/10,000 sa < 1/1,000); rari ħafna (< 1/10,000), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: The patient population included 19.7% women and 29.2% patients ≥ 65 years.
Maltese: Il-popolazzjoni ta' pazjenti kienet tinkludi 19.7% nisa u 29.2% tal-pazjenti li kellhom ≥ 65 sena.
English: The recommended dose for ASA was 75 to 100 mg/day.
Maltese: Id-doża rakkomandata għal ASA kienet minn 75 sa 100 mg/jum.
English: The efficacy of clopidogrel was observed independently of the dose of ASA (75-325 mg once daily).
Maltese: L-effikaċja ta' clopidogrel ġiet osservata b'mod indipendenti mid-doża ta' ASA (75325 mg darba kuljum).
English: There was no statistically significant difference in the rates of fatal bleeding (1.1% in the clopidogrel + ASA group and 0.7% in the placebo +ASA group) and haemorrhagic stroke (0.8% and 0.6%, respectively) between groups.
Maltese: Ma kien hemm l-ebda differenza statistikament sinifikanti fir-rati ta' ħruġ ta' demm fatali (1.1% fil-grupp ta' clopidogrel + ASA u ta' 0.7% fil-grupp ta' plaċebo + ASA) u puplesija emorraġika (0.8% u 0.6%, rispettivament) bejn il-gruppi.
English: This benefit was mostly driven by the statistically significant reduction in the incidence of MI [287 (4.6%) in the clopidogrel treated group and 363 (5.8%) in the placebo treated group].
Maltese: Dan il-benefiċċju kien xprunat l-aktar mit-tnaqqis statistikament sinifikanti fl-inċidenza ta' MI [287 (4.6%) fil-grupp ikkurat bi clopidogrel u 363 (5.8%) filgrupp ikkurat bil-plaċebo].
English: The population included 27.8% women, 58.4% patients ≥ 60 years (26% ≥ 70 years) and 54.5% patients who received fibrinolytics.
Maltese: Il-popolazzjoni kienet tinkludi 27.8% nisa, 58.4% tal-pazjenti kellhom ≥ 60 sena (26% kellhom ≥ 70 sena) u 54.5% tal-pazjenti li rċivew sustanzi fibrinolitiċi.
English: Marketing Authorisation Holder Mylan S.A.S, 117 allée des Parcs, 69 800 Saint Priest, France
Maltese: ID-DETENTUR TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ Mylan S.A.S, 117 allée des Parcs, 69 800 Saint Priest, Franza
English: Patients randomized in the ACTIVE program were those presenting with documented AF, i.e., either permanent AF or at least 2 episodes of intermittent AF in the past 6 months, and had at least one of the following risk factors: age 75 years or age 55 to 74 years and either diabetes mellitus requiring drug therapy, or documented previous MI or documented coronary artery disease; treated for systemic hypertension; prior stroke, transient ischaemic attack (TIA), or non-CNS systemic embolus; left ventricular dysfunction with left ventricular ejection fraction <45%; or documented peripheral vascular disease.
Maltese: Il-pazjenti li ntgħażlu b'mod każwali fil-programm ACTIVE kienu dawk li kellhom AF dokumentata, i.e., jew AF permanenti jew mill-inqas 2 episodji ta' AF intermittenti fl-aħħar 6 xhur, u li kellhom mill-inqas wieħed mill-fatturi ta' riskju li ġejjin: età ta' ≥ 75 sena jew età minn 55 sa 74 sena ,u jew dijabete mellitus li kienet teħtieġ terapija bil-mediċina, jew MI dokumentata fil-passat, jew mard dokumentat tal-arterji koronarji; ikkurati għal pressjoni għolja sistemika; puplesija fil-passat, attakk iskemiku temporanju (TIA), jew embolu sistemiku mhux CNS; disfunzjoni ventrikulari tax-xellug flimkien ma' frazzjoni tal-ħruġ ventrikulari tax-xellug ta' < 45%; jew mard vaskulari periferali dokumentat.
English: The number of patients who reached the primary endpoint (time to first occurrence of stroke, MI, non-CNS systemic embolism or vascular death) was 832 (22.1%) in the group treated with clopidogrel + ASA and 924 (24.4%) in the placebo + ASA group (relative risk reduction of 11.1%; 95% CI of 2.4% to 19.1%; p=0.013), primarily due to a large reduction in the incidence of strokes.
Maltese: In-numru ta' pazjenti li laħqu l-punt aħħari primarju (żmien għall-ewwel okkorrenza ta' puplesija, MI, emboliżmu sistemiku mhux CNS jew mewt vaskulari) kien ta' 832 (22.1%) fil-grupp ikkurat bi clopidogrel + ASA u 924 (24.4%) fil-grupp ta' plaċebo + ASA (tnaqqis relattiv tar-riskju ta' 11.1%; 95% CI ta' 2.4% sa 19.1%; p= 0.013), l-aktar minħabba tnaqqis kbir fl-inċidenza ta' puplesiji.
English: The number of patients experiencing the co-primary endpoint (CV death, MI, stroke or refractory ischaemia) was 1,035 (16.5%) in the clopidogrel-treated group and 1,187 (18.8%) in the placebo-treated group, a 14% relative risk reduction (95% CI of 6%-21%, p=0.0005) for the clopidogrel-treated group.
Maltese: In-numru ta' pazjenti li kellhom punt aħħari koprimarju (mewt CV, MI, puplesija jew iskemija refrattarja) kien ta' 1,035 (16.5%) fil-grupp ikkurat bi clopidogrel, u 1,187 (18.8%) fil-grupp ikkurat bil-plaċebo, tnaqqis ta' 14% fir-riskju (95% CI ta' 6%-21%, p= 0.0005) għall-grupp ikkurat bi clopidogrel.
English: Clopidogrel significantly reduced the relative risk of death from any cause by 7% (p=0.029), and the relative risk of the combination of re-infarction, stroke or death by 9% (p=0.002), representing an absolute reduction of 0.5% and 0.9%, respectively.
Maltese: Clopidogrel naqqas b'mod sinifikanti r-riskju relattiv ta' mewt minn kwalunkwe kawża b'7% (p= 0.029), u rriskju relattiv tal-kombinazzjoni ta' infart mill-ġdid, puplesija jew mewt b'9% (p= 0.002), li jirrappreżenta tnaqqis assolut ta' 0.5 % u 0.9%, rispettivament.
English: Major bleeding was mostly of extracranial origin in both groups (5.3% in the clopidogrel + ASA group; 3.5% in the placebo +ASA group), mainly from the gastrointestinal tract (3.5% vs. 1.8%).
Maltese: Ħruġ ta' demm maġġuri kien il-biċċa l-kbira ta' oriġini extrakranjali fiż-żewġ gruppi (5.3% fil-grupp ta' clopidogrel + ASA; 3.5% fil-grupp ta' plaċebo + ASA), l-aktar millpassaġġ gastrointestinali (3.5% kontra 1.8%).
English: Strokes occurred in 296 (7.8%) patients receiving clopidogrel + ASA and 408 (10.8%) patients receiving placebo + ASA (relative risk reduction, 28.4%; 95% CI, 16.8% to 38.3%; p=0.00001).
Maltese: 8%) pazjent li ħadu plaċebo + ASA (tnaqqis relattiv tarriskju, 28.4%; 95% CI, 16.8% sa 38.3%; p= 0.00001).
English: Patients received clopidogrel (75 mg/day, n=22,961) or placebo (n=22,891), in combination with ASA (162 mg/day), for 28 days or until hospital discharge.
Maltese: Il-pazjenti rċivew clopidogrel (75 mg/jum, n= 22,961) jew plaċebo (n= 22,891), flimkien ma' ASA (162 mg/jum), għal 28 jum jew sakemm ħarġu millisptar.
English: C-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-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.
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Maltese: M'għandekx tgħaddiha lil persuni oħra.
English: Pharmacotherapeutic group: Antithrombotic agents, platelet aggregation inhibitors excl. heparin, ATC code: B01AC04.
Maltese: Aġenti trombotiċi, inibituri tal-aggregazzjoni tal-plejtlets li jeskludu heparin, Kodiċi ATC: