FrancophonIA/ELRC3.0 huggingface dataset:
English: Eli Lilly Sweden AB Tel: + 46 (0) 8 7378800
Maltese: Tel: + 46 (0) 8 7378800
English: Requiring inotropes Requiring surgical intervention Requiring transfusion (≥ 4
Maltese: Ħtieġa ta' inotropes Ħtieġa ta' intervent kirurġiku Ħtieġu ta' trasfużjoni (≥4
English: The efficacy of prasugrel was independent of the ASA dose (75 mg to 325 mg once daily).
Maltese: L-effikaċja ta' prasugrel kienet indipendenti mid-doża ta' ASA (75 mg sa 325 mg darba kujum).
English: • with a propensity to bleed (e.g. due to recent trauma, recent surgery, recent or recurrent gastrointestinal bleeding, or active peptic ulcer disease)
Maltese: • b'tendenza li jkollhom xi fsada (eż. minħabba trawma reċenti, kirurġija reċenti, fsada gastrointestinali reċenti jew rikorrenti, jew mard attiv ta' ulċera peptika)
English: Approximately 68% of the prasugrel dose is excreted in the urine and 27% in the faeces, as inactive metabolites.
Maltese: Madwar 68% tad-doża ta' prasugrel titneħħa fl-awrina u 27% fl-ippurgar, bħala metaboliti inattivi.
English: Rare side effects (may affect up to 1 in 1,000 people)
Maltese: Effetti sekondarji rari (jistgħu jaffettwaw sa persuna waħda minn kull 1,000)
English: TIMI minor bleeding f
Maltese: Fsada minuri skont TIMI f
English: Prasugrel-mediated inhibition of platelet aggregation was also similar in patients with ESRD who required haemodialysis compared to healthy subjects, although Cmax and AUC of the active metabolite decreased 51% and 42%, respectively, in ESRD patients.
Maltese: suġġetti b'saħħithom, għalkemm Cmax u AUC tal-metabolit attiv naqsu 51% u 42%, rispettivament, f'pazjenti b'ESRD.
English: The active metabolite's exposure (AUC) has moderate to low between-subject (27%) and within-subject (19%) variability.
Maltese: espożizzjoni (AUC) tal-metabolit attiv għandha varjabbilità bejn is-suġġetti (27%) u fis-suġġetti (19%) minn moderata għal baxxa.
English: In patients ≥60 kg and age <75 years, non-CABG-related TIMI major or minor bleeding rates were 3.6% for prasugrel and 2.8% for clopidogrel; rates for fatal bleeding were 0.2% for prasugrel and 0.1% for clopidogrel.
Maltese: F'pazjenti ≥60 kg u età <75 sena, ir-rati ta' fsada maġġuri jew minuri skont TIMI relatata ma' nonCABG kienu ta' 3.6% għal prasugrel u 2.8% għal clopidogrel; ir-rati ta' fsada fatali kienu ta' 0.2% għal prasugrel u 0.1% għal clopidogrel.
English: Therefore, known CYP3A inducers such as rifampicin, carbamazepine, and other inducers of cytochromes P450 are not anticipated to have significant effect on the pharmacokinetics of the active metabolite.
Maltese: Għaldaqstant, stimulanti magħrufa ta' CYP3A bħal rifampicin, carbamazepine, u stimulanti oħra ta' ċitokromi P450 mhumiex mistennija li jkollhom effett sinifikanti fuq il-farmakokinetika tal-metabolit attiv.
English: For patients who received their last dose of thienopyridine within 4 to 7 days prior to CABG, the frequencies decreased to 11.3% (9 of 80 patients) in the prasugrel group and 3.4% (3 of 89 patients) in the clopidogrel group.
Maltese: 7 ijiem qabel CABG, il-frekwenzi naqsu għal 11.3% (9 minn 80 pazjent) fil-grupp ta' prasugrel u 3.4% (3 minn 89 pazjent) fil-grupp ta' clopidogrel.
English: Analysis of all cause death did not show any significant difference between prasugrel and clopidogrel in the All ACS population (2.76% vs 2.90%), in the UA/NSTEMI population (2.58% vs 2.41%), and in the STEMI population (3.28% vs 4.31%).
Maltese: Analiżi tal-mewt mill-kawżi kollha ma wriet ebda differenza sinifikanti bejn prasugrel u clopidogrel fil-poplazzjoni tal-Pazjenti Kollha b'ACS (2.7 % vs 2.9 %), fil-popolazzjoni UA/NSTEMI (2.58 % vs 2.41 %) u fil-popolazzjoni STEMI (3.28 % vs
English: The most common site of spontaneous bleeding was the gastrointestinal tract (1.7% rate with prasugrel and 1.3% rate with clopidogrel); the most frequent site of provoked bleeding was the arterial puncture site (1.3% rate with prasugrel and 1.2% with clopidogrel).
Maltese: Is-sit l-aktar komuni ta' fsada spontanja kien l-apparat gastro-intestinali (rata ta' 1.7% b'prasugrel u rata ta' 1.3% b'clopidogrel); l-aktar sit frekwenti ta' fsada pprovokata kien is-sit tattitqib arterjali (rata ta' 1.3% b'prasugrel u rata ta' 1.2% b'clopidogrel).
English: f Clinically overt bleeding associated with a fall in haemoglobin of ≥3 g/dL but <5 g/dL.
Maltese: f Fsada li tidher klinikament u assoċċjata ma' waqa' ta' emoglobina ta' ≥3 g/dL iżda <5 g/dL.
English: Symptomatic ICHe
Maltese: ICH sintomatikae
English: Daiichi Sankyo Portugal, Unip.
Maltese: Daiichi Sankyo Italia S.p.A.
English: Clopidogrelb +ASA (N = 1736)
Maltese: Prasugrelb +ASA (N=1740)
English: Thrombocytopaenia Thrombotic thrombocytopaenic purpura (TTP) -see section 4.4
Maltese: Purpura Trombotika Tromboċitopenika (TTP)
English: 3.8% (0.2% fatal)
Maltese: 3.8% (0.2% fatali)
English: Reduced prasugrel efficacy has been seen in patients co-administered prasugrel and morphine (see section 4.5).
Maltese: Deher tnaqqis fl-effikaċja ta' prasugrel meta pazjenti ngħataw fl-istess ħin prasugrel u morfina ( ara sezzjoni 4.5)
English: Daily co-administration of ranitidine (an H2 blocker) or lansoprazole (a proton pump inhibitor) did not change the prasugrel active metabolite's AUC and Tmax, but decreased the Cmax by 14% and 29%, respectively.
Maltese: It-teħid kuljum flimkien ma' ranitidine (imblokkatur ta' H2) jew lansoprazole (inibitur tal-pompa tal proton) ma bidilx l-AUC u Tmax tal-metabolit attiv ta' prasugrel, iżda naqqas is-Cmax b'14% u 29%, rispettivament.
English: Clopidogrelb +ASA (N = 6716)
Maltese: Prasugrelb +ASA (N=6741)
English: Your doctor will also give you acetylsalicylic acid (e.g. aspirin), another antiplatelet agent.
Maltese: It-tabib tiegħek se jagħtik ukoll acetylsalicylic acid (eż. aspirina), sustanza oħra kontra l-plejtlits.
English: The active metabolite has an elimination half-life of about 7.4 hours (range 2 to 15 hours).
Maltese: Ilmetabolit attiv għandu half-life ta' l-eliminazzjoni ta madwar 7.4 sigħat (f'skala minn 2 sa 15-il siegħa).
English: As in the < 75 years old and ≥60 kg patients treated with 10 mg prasugrel, there was no difference between 5 mg prasugrel and 75 mg clopidogrel in CV outcomes.
Maltese: Bħall-pazjenti < 75 sena u ≥60 kg ikkurati b'10 mg prasugrel, ma kien hemm ebda differenza bejn 5 mg prasugrel u 75 mg clopidogrel f'avvenimenti kardjovaskulari.
English: 3.0% (0.5% fatal)
Maltese: 3.0% (0.5% fatali)
English: • Bleeding after surgery
Maltese: • Fsada wara operazzjoni
English: Specifically, prasugrel did not significantly reduce the frequency of the composite endpoint of cardiovascular (CV) death, myocardial infarction (MI), stroke, urgent revascularization (UR), or glycoprotein (GP) IIb/IIIa inhibitor bailout through 7 days from randomization in subjects receiving prasugrel prior to coronary angiography compared to patients receiving the full loading dose of prasugrel at the time of PCI, and the rate of the key safety objective for all TIMI major bleeding (CABG and non-CABG events) through 7 days from randomization in all treated subjects was significantly higher in subjects receiving prasugrel prior to coronary angiography versus patients receiving the full loading dose of prasugrel at the time of PCI.
Maltese: B'mod speċifiku, prasugrel ma naqqasx b'mod sinifikanti numru ta' għanijiet finali bħal mewt kardjovaskulari (CV), infart mijokardijaku (MI), attakk ta' puplesija, vaskularizzazzjoni urġenti mill-ġdid (UR) jew il-bżonn ta' inibitur ta' glycoprotein (GP) IIb/IIIa matul is-7 ijiem minn meta ntagħżlu b'mod arbitrarju f'suġġetti li rċevew prasugrel qabel l-anġjografija koronarja meta mqabbla ma' pazjenti li rċevew id-doża sħiħa ta' kkargar ta' prasugrel fil-ħin tal-PCI u r-rata tal-aktar objettiv importanti ta' sigurtà għal kull fsada maġġuri TIMI (avvenimenti CABG u non-CABG) matul is-7 ijiem minn meta ntagħżlu b'mod arbitrarju fil-pazjenti kkurati kollha kien ogħla b'mod sinifikanti fissuġġetti li rċevew prasugrel qabel l-anġjografija koronarja kontra s-suġġetti li rċevew id-doża sħiħa ta' kkargar ta' prasugrel fil-ħin tal-PCI.
English: Efient is contraindicated in patients with severe hepatic impairment (Child Pugh class C).
Maltese: Efient huwa kontraindikat f'pazjenti b'indeboliment qawwi tal-fwied (Child Pugh klassi Ċ).
English: (see sections 4.2, 4.8 and 5.1).
Maltese: (ara sezzjonijiet 4.2 u 4.8).
English: In healthy subjects, patients with stable atherosclerosis, and patients with ACS receiving Efient, there was no relevant effect of genetic variation in CYP3A5, CYP2B6, CYP2C9, or CYP2C19 on the pharmacokinetics of prasugrel or its inhibition of platelet aggregation.
Maltese: F'suġġetti b'saħħithom, pazjenti b'aterosklerosi stabbli, u pazjenti b'ACS li jirċievu Efient, ma kienx hemm effett rilevanti ta' varjazzjoni ġenetika f'CYP3A5, CYP2B6, CYP2C9, jew CYP2C19 fuq il farmakokinetika jew l-inibizzjoni ta' l-aggregazzjoni ta' plejtlits ta' prasugrel.
English: Following a 60 mg loading dose of prasugrel, inhibition of ADP-induced platelet aggregation occurs at 15 minutes with 5 µM ADP and 30 minutes with 20 µM ADP.
Maltese: Wara doża ta' kkargar ta' 60 mg prasugrel, inibizzjoni ta' aggregazzjoni ta' plejtlits stimulata minn ADP seħħet wara 15-il minuta b'5 µM ADP u 30 minuta b'20 µM ADP.
English: In an analysis of patients who survived an ischaemic event, prasugrel was associated with a reduction in the incidence of subsequent primary endpoint events (7.8% for prasugrel vs 11.9% for clopidogrel).
Maltese: F'analiżi ta' pazjenti li baqgħu ħajjin wara avveniment iskemiku, prasugrel ġie assoċjat ma' tnaqqis flinċidenza ta' avvenimenti ta' riżultati finali primarji sussegwenti (7.8% għal prasugrel kontra 11.9%
English: 1.6% (0.2% fatal)
Maltese: 1.6% (0.2% fatali)
English: A treatment of up to 12 months is recommended unless the discontinuation of Efient is clinically indicated (see sections 4.4 and 5.1).
Maltese: Huwa rrakkomandat li l-kura ddum sa 12-il xahar, għajr meta t-twaqqif ta' Efient huwa klinikament indikat (ara sezzjonijiet 4.4 u 5.1).
English: Although bleeding was increased with prasugrel, an analysis of the composite endpoint of death from any cause, nonfatal myocardial infarction, nonfatal stroke, and non-CABG-related TIMI major haemorrhage favoured Efient compared to clopidogrel (Hazard ratio, 0.87; 95% CI, 0.79 to 0.95; p = 0.004).
Maltese: non-CABG iffavorixxit Efient meta mqabbel ma' clopidogrel (Proporzjon ta' periklu, 0.87; 95% CI, 0.79 sa 0.95; p=0.004).
English: 6.5% (0.3% fatal)
Maltese: 6.5% (0.3% fatali)
English: Patients ≥ 75 years were at increased risk of bleeding, including fatal (see sections 4.2, 4.4,
Maltese: Pazjenti ≥ 75 sena kellhom riskju ogħla ta' fsada inkluża dik fatali (ara sezzjonijiet 4.2,4.4 u 4.8).
English: Following administration of a 900 mg loading dose of clopidogrel (with ASA), 56 subjects with ACS were treated for 14 days with either prasugrel 10 mg once daily or clopidogrel 150 mg once daily, and then switched to either clopidogrel 150 mg or prasugrel 10 mg for another 14 days.
Maltese: Wara li ngħatat doża ta' kkargar ta' 900 mg clopidogrel (ma' ASA), 56 suġġett b'ACS ġew ikkurati għal 14-il ġurnata jew b'prasugrel 10 mg darba kuljum jew b'clopidogrel 150 mg darba kuljum, u mbagħad inqalbu jew għal clopidogrel 150 mg jew prasugrel 10 mg għal 14-il ġurnata oħra.
English: (see section 2 ‘What you need to know before you take Efient').
Maltese: (ara sezzjoni 2 ‘X'għandek tkun taf qabel ma tieħu Efient).
English: Event
Maltese: Avveniment
English: 6.9% (0.1% fatal)
Maltese: 6.9% (0.1% fatali)
English: Other therapies, such as heparin and GPIIb/IIIa inhibitors, were administered at the discretion of the physician.
Maltese: Terapiji oħra, bħal eparina u inibituri ta' GPIIb/IIIa, ingħataw skont id-deċiżjoni ta' l-ispeċjalista.
English: Prasugrelb
Maltese: Clopidogrelb
English: Efient showed superior efficacy compared to clopidogrel in reducing the primary composite outcome events as well as the pre-specified secondary outcome events, including stent thrombosis (see Table 3).
Maltese: Efient wera effikaċja superjuri meta mqabbel ma' clopidogrel fit-tnaqqis tal-avvenimenti primarji komposti riżultanti kif ukoll tal-avvenimenti sekondarji riżultanti speċifikati minn qabel, fosthom it trombożi minn stent (ara Tabella 3).
English: CV death, nonfatal MI, or nonfatal stroke CV death Nonfatal MI Nonfatal stroke STEMI Primary Composite Outcome Events
Maltese: Avvenimenti Primarji Komposti li Seħħew Mewt kardjovaskulari (CV), MI mhux fatali, jew puplesija mhux fatali Avvenimenti Primarji Individwali li Seħħew
English: The active metabolite is further metabolised to two inactive compounds by S-methylation or conjugation with cysteine.
Maltese: Il-metabolit attiv jerġa' jiġi metabolizzat f'żewġ kompożizzjonijiet inattivi b'S-metilazzjoni jew konjugazzjoni ma' cysteine.
English: A delayed and decreased exposure to oral P2Y12 inhibitors, including prasugrel and its active metabolite, has been observed in patients with acute coronary syndrome treated with morphine.
Maltese: Ġie osservat dewmien u tnaqqis fl-espożizzjoni għall-inibituri orali P2Y12 , inkluż prasugrel u lmetabolit attiv tiegħu, f'pazjenti b'sindromu koronarju akut ittrattati b'morfina.
English: Safety in patients with acute coronary syndrome undergoing PCI was evaluated in one clopidogrelcontrolled study (TRITON) in which 6741 patients were treated with prasugrel (60 mg loading dose and 10 mg once daily maintenance dose) for a median of 14.5 months (5802 patients were treated for over 6 months, 4136 patients were treated for more than 1 year).
Maltese: F'studju wieħed ikkontrollat bi clopidogrel (TRITON) ġiet ivvalutata s-sigurtà f'pazjenti b'sindromu koronarju akut ittrattati b'PCI fejn 6741 pazjent ġie kkurat b'prasugrel (doża ta' kkargar ta' 60 mg u doża ta' manteniment ta' 10 mg darba kuljum) għal medjan ta' 14.5 xhur (5802 pazjenti ġew ikkurati għal aktar minn 6 xhur, 4136 pazjent ġie kkurati għal aktar minn sena).
English: Efient can be concomitantly administered with medicinal products metabolised by cytochrome P450 enzymes (including statins), or medicinal products that are inducers or inhibitors of cytochrome P450 enzymes.
Maltese: Efient jista' jingħata flimkien ma' prodotti mediċinali li jiġu mmetabolizzati minn enzimi ta' ċitokromu P450 (fosthom statins), jew prodotti mediċinali li huma stimulanti jew inibituri ta' l-enzimi ta' ċitokromu P450.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Daiichi Sankyo Europe GmbH
Maltese: Isem u indirizz tal-manifattur(i) responsabbli għall-ħruġ tal-lott Daiichi Sankyo Europe GmbH
English: Efient 10 mg: Beige and double-arrow shaped tablets, debossed with “10 MG” on one side and “4759” on the other.
Maltese: Efient 10 mg : Il-pilloli huma ta' kulur kanella jagħti fl-isfar b'forma ta' vleġġa doppja, imnaqqxa b' “10 MG” fuq naħa waħda u b' “4759” fuq in-naħa l-oħra.
English: Although not studied in specific interaction studies, Efient has been co-administered in the phase 3 clinical trial with low molecular weight heparin, bivalirudin, and GP IIb/IIIa inhibitors (no information available regarding the type of GP IIb/IIIa inhibitor used) without evidence of clinically significant adverse interactions.
Maltese: Għalkemm ma ġiex studjat fi studji speċifiċi ta' interazzjonijiet, fl-istudju kliniku ta' fażi 3 Efient ġie mogħti flimkien ma' eparina b'piż molekulari baxx, bivalirudin, u inibituri ta' GP IIb/IIIa (m'hemmx tagħrif dwar liema tip ta' inibitur ta' GP IIb/IIIa ġie użat) mingħajr evidenza ta' interazzjonijiet avversi klinikament sinifikanti.
English: 2.9% (0.1% fatal)
Maltese: 2.9% (0.1% fatali)
English: - If you have ever had a stroke or a transient ischaemic attack (TIA).
Maltese: Passat ta' puplesija jew attakk iskemiku temporanju (TIA).
English: More than 98% of subjects had ≥ 20% inhibition of platelet aggregation during maintenance dosing.
Maltese: Aktar minn 98% tas-suġġetti kellhom ≥20% inibizzjoni ta' aggregazzjoni ta' plejtlits waqt id-dożaġġ ta'
English: • Emphasis that:
Maltese: • Jiġi enfasizzat:
English: No dose adjustment is necessary for patients with mild to moderate impaired hepatic function (Child Pugh Class A and B).
Maltese: Mhux meħtieġ li jsir aġġustament fid-doża għal pazjenti b'indeboliment ħafif jew moderat tal-funzjoni tal-fwied (Child Pugh Klassi A u B).
English: Efient, co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with acute coronary syndrome (i.e. unstable angina, non-ST segment elevation myocardial infarction [UA/NSTEMI] or ST segment elevation myocardial infarction [STEMI]) undergoing primary or delayed percutaneous coronary intervention (PCI).
Maltese: Efient, mogħti ma' acetylsalicylic acid (ASA), huwa indikat għall-prevenzjoni ta' avvenimenti aterotrombotiċi f'pazjenti adulti b'sindromu koronarju akut (jiġifieri anġina mhux stabbli, infart mijokardijaku mingħajr elevazzjoni tas-segment ST [UA/NSTEMI] jew infart mijokardijaku b'elevazzjoni tas-segment ST [STEMI]) li għaddejjin minn intervent koronarju minn ġol-ġilda (PCI)
English: 4.2% (0.3% fatal)
Maltese: 4.2% (0.3% fatali)
English: This interaction may be related to reduced gastrointestinal motility and apply to other opioids.
Maltese: Din l-interazzjoni tista' tkun minħabba tnaqqis fil-motilità gastrointestinali u tapplika għal opiojdi oħra.
English: Efient 5 mg film-coated tablets.
Maltese: Efient 5 mg pilloli miksija b'rita.
English: Atorvastatin (80 mg daily) did not alter the pharmacokinetics of prasugrel and its inhibition of platelet aggregation.
Maltese: Atorvastatin (80 mg kuljum) ma bidilx il-farmakokinetika u l-inibizzjoni ta' l-aggregazzjoni ta' plejtlets ta' prasugrel.
English: Approximately 98% of patients (in each of the treatment groups) received antithrombins (heparin, low molecular weight heparin, bivalirudin, or other agent) directly in support of PCI.
Maltese: Madwar 98% tal-pazjenti (f'kull grupp ta' kura) irċevew sustanzi kontra thrombin (eparina, eparina b'piż molekulari baxx, bivalirudin, jew sustanza oħra) direttament bħala sostenn għal
English: 1.4% (0.1% fatal)
Maltese: 1.4% (0.1% fatali)
English: Efient 10 mg: Each tablet contains 10 mg of prasugrel (as hydrochloride).
Maltese: Efient 10 mg: Kull pillola fiha 10 mg prasugrel (bħala hydrochloride).
English: The superior efficacy was accompanied by an increase in major bleeding (see sections 4.4 and 4.8).
Maltese: L-effikaċja superjuri kienet akkumpanjata ma' żieda fi fsada maġġuri (ara sezzjonijiet 4.4 u 4.8).
English: 3.3% (0.1% fatal)
Maltese: 3.3% (0.1% fatali)
English: Patients ≥75 years old or those below 60 kg (N=3022) were randomized to 5 mg prasugrel.
Maltese: B'mod arbitrarju, pazjenti ≥75 sena jew dawk inqas minn 60 kg (N=3022) ġew mogħtija 5 mg prasugrel.
English: In a study in subjects with stable atherosclerosis, the mean AUC of the active metabolite in patients <60 kg taking 5 mg prasugrel was 38% lower than in patients ≥60 kg taking 10 mg prasugrel, and the antiplatelet effect of 5 mg was similar to 10 mg.
Maltese: F'studju f'pazjenti b'aterosklerożi stabbli, il-medja tal-AUC talmetabolit attiv f'pazjenti < 60 kg li kienu qed jieħdu 5 mg prasugrel kienet 38 % inqas milli f'pazjenti ≥ 60 kg li kienu qed jieħdu 10 mg prasugrel u l-effett kontra l-plejtlits tal-5 mg kien simili għal dak tal-10 mg.
English: Prasugrel 5 mg provided greater antiplatelet effect than clopidogrel 75 mg. Prasugrel should be used with caution in patients ≥ 75 years old and in patients weighing <60 kg (see sections 4.2, 4.4 and 4.8).
Maltese: Prasugrel għandu jintuża b'kawtela f'pazjenti ≥ 75 sena u f'pazjenti li għandhom piż <60 kg (ara sezzjonijiet 4.2, 4.4 u 4.8).
English: 2.2% (0.3% fatal)
Maltese: 2.2% (0.3% fatali)
English: Efient 5 mg: Each tablet contains 5 mg of prasugrel (as hydrochloride).
Maltese: Efient 5 mg: Kull pillola fiha 5 mg ta' prasugrel (bħala hydrochloride).
English: 2.6% (0.3% fatal)
Maltese: 2.6% (0.3% fatali)
English: In a study of 276 ACS patients managed with PCI, switching from an initial loading dose of 600 mg clopidogrel or placebo administered upon presentation to the hospital prior to coronary angiography to a 60 mg loading dose of prasugrel administered at the time of percutaneous coronary intervention, resulted in a similar increased inhibition of platelet aggregation for the 72 hour duration of the study.
Maltese: F'studju ta' 276 pazjent ACS li għamlu PCI, il-bidla minn doża inizjali ta' kkargar ta' 600 mg clopidogrel jew plaċebo mogħti malwasla tagħhom l-isptar qabel l-anġjografija koronarja għal doża ta' kkargar ta' 60 mg prasugrel mogħti fil-ħin tal-intervent koronarju perkutanju, irriżulta f'żieda simili fl-inibizzjoni tal aggregazzjoni tal-plejtlits għat-tul ta' żmien tal-istudju ta' 72 siegħa.
English: Gastrointestinal haemorrhage
Maltese: Emorraġija gastro intestinali
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu
English: In a 30 month study (TRILOGY-ACS) in 9326 patients with UA/NSTEMI ACS medically managed without revascularisation (non-licensed indication), prasugrel did not significantly reduce the frequency of the composite endpoint of CV death, MI or stroke compared to clopidogrel.
Maltese: F'studju li dam 30 xahar (TRILOGY-ACS) f'9326 pazjent b'UA/NSTEMI ACS ikkurati bil-mediċini mingħajr rivaskularizzazzjoni (indikazzjoni li mhijiex liċenzjata), prasugrel ma naqqasx b'mod sinifikanti l-frekwenza tar-riżultat finali kompost ta' mewt kardjovaskulari, MI jew puplesija meta mqabbel ma' clopidogrel.
English: For the 14, 28, 56 84 and 98 tablet pack sizes, you can check the day on which you last took a tablet of Efient by referring to the calendar printed on the blister.
Maltese: Għall pakketti ta' 14, 28 56,84 u 96 pillola, tista' tiċċekkja l-ġurnata li fiha ħadt l-aħħar il-pillola ta' Efient billi tirreferi għall-kalendarju stampat fuq il-folja.
English: Prasugrel is an inhibitor of platelet activation and aggregation through the irreversible binding of its active metabolite to the P2Y12 class of ADP receptors on platelets.
Maltese: Prasugrel huwa inibitur ta' l-attivazzjoni u l-aggregazzjoni tal-plejtlits permezz ta' rbit irriversibbli tal metabolit attiv tiegħu mal-klassi P2Y12 tar-riċetturi ADP fuq il-plejtlits.
English: Each tablet contains 5 mg prasugrel (as hydrochloride).
Maltese: Kull pillola fiha 5 mg prasugrel (bħala hydrochloride).
English: The absorption and metabolism of prasugrel are rapid, with peak plasma concentration (Cmax) of the active metabolite occurring in approximately 30 minutes.
Maltese: L-assorbiment u l-metaboliżmu ta' prasugrel huma mgħaġġlin, bl-ogħla konċentrazzjoni fil-plażma (Cmax) tal-metabolit attiv iseħħ f'madwar 30 minuta.
English: Renal impairment
Maltese: Disturbi vaskulari
English: Of those patients, the rate of CABG-related TIMI major or minor bleeding was 14.1% for the prasugrel group and 4.5% in the clopidogrel group.
Maltese: 1% għall-grupp ta' prasugrel u 4.5% fil-grupp ta' clopidogrel.
English: The observed benefit of prasugrel in patients ≥ 75 years was less than that observed in patients < 75 years.
Maltese: Il-benefiċċju ta' prasugrel li ġie osservat f'pazjenti ≥ 75 sena kien anqas minn dak osservat f'pazjenti <75 sena.
English: 1.3% (0.1% fatal)
Maltese: 1.3% (0.1% fatali)
English: Patients < 60 kg Non-CABG-related TIMI major or minor bleeding rates:
Maltese: Pazjenti < 60 kg Rati ta' fsada maġġuri jew minuri skont TIMI relatata ma' non-CABG :
English: Increased frequency (3-fold) and severity of bleeding may occur in patients undergoing CABG surgery within 7 days of discontinuation of prasugrel (see section 4.8).
Maltese: F'pazjenti li ssirilhom kirurġija ta' CABG fi żmien 7 ijiem li jitwaqqaf prasugrel tista' sseħħ fsada b'severità u frekwenza akbar (ara sezzjoni 4.8).
English: In the large phase 3 clinical trial, the mean estimated exposure (AUC) of the active metabolite was 19% higher in very elderly patients (≥ 75 years of age) compared to subjects < 75 years of age.
Maltese: fażi 3, l-espożizzjoni medja stmata (AUC) tal-metabolit attiv kienet 19% ogħla f'pazjenti anzjani ħafna (≥75 sena) meta mqabbel ma' suġġetti <75 sena.