FrancophonIA/ELRC3.0 huggingface dataset:
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' plejtlets stimulata minn ADP seħħet wara 15­il minuta b'5 µM ADP u 30 minuta b'20 µM ADP.
English: The absorption and metabolism of prasugrel are rapid, with peak plasma concentration (Cmax) of the active metabolite occurring in approximately 30 minutes.
Maltese: L­assorbiment u l­metaboliżmu ta' prasugrel huma mgħaġġlin, bl-ogħla konċentrazzjoni fil-plażma (Cmax) tal-metabolit attiv iseħħ f'madwar 30 minuta.
English: - have ever had a stroke or a transient ischaemic attack (TIA).
Maltese: Passat ta' puplesija jew attakk iskemiku temporanju (TIA).
English: A treatment of up to 12 months is recommended unless the discontinuation of Prasugrel Mylan is clinically indicated (see sections 4.4 and 5.1).
Maltese: Huwa rrakkomandat li l-kura ddum sa 12-il xahar, għajr meta t­twaqqif ta' Prasugrel Mylan huwa klinikament indikat (ara sezzjonijiet 4.4 u 5.1).
English: OPA/Aluminium/PE/Desiccant/PE- Aluminium blister packs containing 28, 30, 84 or 98 film-coated tablets.
Maltese: Pakketti bil-folji tal-OPA/Aluminju/PE/Dessikant/PE-Aluminju li fihom 28, 30, 84 jew 98 pillola miksija b'rita.
English: Blister packs:
Maltese: Pakketti bil-folji biss:
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: L­inibizzjoni ta' aggregazzjoni ta' plejtlets permezz ta' prasugrel kienet simili wkoll f'pazjenti b'ESRD li kellhom bżonn dijaliżi tad-demm meta mqabbel ma' suġġetti b'saħħithom, għalkemm Cmax u AUC tal-metabolit attiv naqsu b'51% u 42%, rispettivament, f'pazjenti b'ESRD.
English: In healthy subjects, patients with stable atherosclerosis, and patients with ACS receiving prasugrel, 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 prasugrel, ma kienx hemm effett rilevanti ta' varjazzjoni ġenetika f'CYP3A5, CYP2B6, CYP2C9, jew CYP2C19 fuq il-farmakokinetika jew l­inibizzjoni tal­aggregazzjoni ta' plejtlets ta' prasugrel.
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 riċenti, kirurġija riċenti, fsada gastro intestinali riċenti jew rikorrenti, jew mard attiv ta' ulċera peptika)
English: e Clinically overt bleeding associated with a fall in haemoglobin of ≥3 g/dL but <5 g/dL.
Maltese: e Fsada evidenti b'mod kliniku assoċjata ma' tnaqqis fl-emoglobina ta' ≥3 g/dL iżda <5 g/dL.
English: Non-Coronary Artery Bypass Graft (CABG) related bleeding
Maltese: Fsada relatata ma' trapjant ta' bypass ta' arterja li mhijiex koronarja (non-CABG)
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' l­attivazzjoni u l­aggregazzjoni tal-plejtlets permezz ta' rbit irriversibbli tal-metabolit attiv tiegħu mal-klassi P2Y12 tar-riċetturi ADP fuq il-plejtlets.
English: 28 film-coated tablets 30 film-coated tablets 84 film-coated tablets 98 film-coated tablets
Maltese: 28 pillola miksija b'rita 30 pillola miksija b'rita 84 pillola miksija b'rita 98 pillola miksija b'rita
English: The maximum inhibition by prasugrel of ADP-induced platelet aggregation is 83% with 5 µM ADP and 79% with 20 µM ADP, in both cases with 89% of healthy subjects and patients with stable atherosclerosis achieving at least 50% inhibition of platelet aggregation by 1 hour.
Maltese: L-inibizzjoni massima permezz ta' prasugrel ta' aggregazzjoni ta' plejtlets stimulata minn ADP hija ta' 83% b'5 µM ADP u ta' 79% b'20 µM ADP, fiż-żewġ każijiet b'89% tas-suġġetti b'saħħithom u pazjenti b'aterosklerosi li kellhom mill-anqas 50% inibizzjoni ta' aggregazzjoni ta' plejtlets f'siegħa.
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 talproton) ma bidilx l-AUC u Tmax tal-metabolit attiv ta' prasugrel, iżda naqqas is-Cmax b'14% u 29%, rispettivament.
English: EU/1/18/1273/009 EU/1/18/1273/010 EU/1/18/1273/011 EU/1/18/1273/012 EU/1/18/1273/013 EU/1/18/1273/014 EU/1/18/1273/015
Maltese: EU/1/18/1273/009 EU/1/18/1273/010 EU/1/18/1273/011 EU/1/18/1273/012 EU/1/18/1273/013 EU/1/18/1273/014
English: In a 30-day study (ACCOAST) in 4033 patients with NSTEMI with elevated troponin who were scheduled for coronary angiography followed by PCI within 2 to 48 hours after randomization, subjects who received prasugrel 30 mg loading dose on average 4 hours prior to coronary angiography followed by a 30 mg loading dose at the time of PCI (n=2037) had an increased risk of non-CABG peri-procedural bleeding and no additional benefit compared to patients receiving a 60 mg loading dose at the time of PCI (n=1996).
Maltese: Fi studju li dam 30 ġurnata (ACCOAST), f'4033 pazjent b'NSTEMI u b'livell għoli ta' troponin li kellhom ippjanata anġjografija koronarja segwita minn PCI fi żmien sagħtejn sa 48 siegħa minn meta ntagħżlu b'mod arbitrarju, il-pazjenti li ngħataw doża ta' kkargar ta' 30 mg prasugrel, b'medja ta' 4 sigħat qabel l­anġjografija koronarja segwita minn doża ta' kkargar ta' 30 mg fil-ħin tal-PCI (n=2037) kellhom żieda fir-riskju ta' fsada non-CABG peri-proċedurali u ebda benefiċċju addizzjonali meta mqabbla ma' pazjenti li ngħataw doża ta' kkargar ta' 60 mg fil-ħin tal-PCI (n=1996).
English: Prasugrel Mylan, 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: Prasugrel Mylan, 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) primarju jew ittardjat.
English: Prasugrelb + ASA (N=6741)
Maltese: ASA (N=6741)
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: 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 l­inibizzjoni ta' l­aggregazzjoni ta' plejtlets ta' prasugrel.
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: Fi 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: Prasugrel 5 mg Mylan contains sodium
Maltese: Prasugrel 5 mg Mylan fih is-sodium
English: There is limited therapeutic experience in patients with renal impairment (see section 4.4).
Maltese: L­esperjenza terapewtika f'pazjenti b'indeboliment talkliewi hija limitata (ara sezzjoni 4.4).
English: Results of a pharmacodynamic/pharmacogenomic study in 720 Asian ACS PCI patients demonstrated that higher levels of platelet inhibition are achieved with prasugrel compared to clopidogrel, and that prasugrel 60 mg loading dose/10 mg maintenance dose is an appropriate dose regimen in Asian subjects who weigh at least 60 kg and are less than 75 years of age (see section 4.2).
Maltese: Ir-riżultati ta' studju farmakodinamiku/farmakoġenomiku li sar f'720 pazjent Ażjatiku b'ACS PCI urew li prasugrel, meta mqabbel ma' clopidogrel, kiseb livelli ogħla ta' inibizzjoni tal-plejtlets u li doża ta' kkargar ta' 60 mg/ doża ta' manteniment ta'10 mg ta' prasugrel hija skeda ta' dożaġġ tajba għal suġġetti Ażjatiċi li għandhom piż ta' mill-anqas 60 kg u li għandhom inqas minn 75 sena (ara sezzjoni 4.2).
English: Safety in patients with acute coronary syndrome undergoing PCI was evaluated in one clopidogrel controlled 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: Fi studju wieħed ikkontrollat bi clopidogrel (TRITON) ġiet ivvalutata s­sigurtà f'pazjenti b'sindromu koronarju akut ittrattati b'PCI fejn 6741 pazjent ġew ikkurati 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 ġew ikkurati għal aktar minn sena).
English: Retroperitoneal haemorrhage Rectal haemorrhage Haematochezia Gingival bleeding
Maltese: Emorraġija retroperitonali Emorraġija firrektum
English: Table 2: Haemorrhagic and non-haemorrhagic adverse reactions
Maltese: Tabella 1: Inċidenza ta' fsada relatata ma' Non-CABG
English: Patients taking Prasugrel Mylan should also take ASA daily (75 mg to 325 mg).
Maltese: Il-pazjenti rċevew ukoll ASA (75 mg sa 325 mg darba kuljum).
English: Prasugrel 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: Prasugrel wera effikaċja superjuri meta mqabbel ma' clopidogrel fit-tnaqqis tal-avvenimenti primarji komposti li seħħew kif ukoll tal-avvenimenti sekondarji li seħħew speċifikati minn qabel, inkluża t­trombożi minn stent (ara Tabella 3).
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'S­metilazzjoni jew konjugazzjoni ma' cysteine.
English: Following administration of 75 mg clopidogrel once daily for 10 days, 40 healthy subjects were switched to prasugrel 10 mg once daily with or without a loading dose of 60 mg.
Maltese: Wara li ngħatat 75 mg clopidogrel darba kuljum għal 10 ijiem, 40 suġġett b'saħħtu nqalbu għal prasugrel 10 mg darba kuljum bid-doża ta' kkargar ta' 60 mg jew mingħajrha.
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 PCI.
English: The mean exposure (AUC) of the active metabolite of prasugrel is approximately 30 to 40% higher in healthy subjects and patients with a body weight of <60 kg compared to those weighing ≥60 kg.
Maltese: L­espożizzjoni medja (AUC) tal-metabolit attiv ta' prasugrel hija madwar 30 sa 40% ogħla f'suġġetti b'saħħithom u pazjenti b'piż tal-ġisem ta' <60 kg ikkomparaw ma' dawk li jiżnu ≥60 kg.
English: Bleeding risk associated with timing of loading dose in NSTEMI In a clinical study of NSTEMI patients (the ACCOAST study), where patients were scheduled to undergo coronary angiography within 2 to 48 hours after randomization, patients given a 30 mg loading dose on average 4 hours prior to coronary angiography followed by a 30 mg loading dose at the time of PCI had an increased risk of non-CABG peri-procedural bleeding and no additional benefit compared to patients receiving a 60 mg loading dose at the time of PCI (see sections 4.2 and 4.4).
Maltese: Fi studju kliniku ta' pazjenti b'NSTEMI (l­istudju ACCOAST), fejn il-pazjenti kellhom ippjanat li ssirilhom anġjografija koronarja fi żmien sagħtejn sa 48 siegħa minn meta ntagħżlu b'mod arbitrarju, il-pazjenti li ngħataw doża ta' kkargar ta' 30 mg, b'medja ta' 4 sigħat qabel l­anġjografija koronarja segwita minn doża ta' kkargar ta' 30 mg fil-ħin tal-PCI kellhom żieda fir-riskju ta' fsada non-CABG peri-proċedurali u ebda benefiċċju addizzjonali meta mqabbla ma' pazjenti li ngħataw doża ta' kkargar ta' 60 mg fil-ħin tal-PCI (ara sezzjonijiet 4.2 u 4.4).
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: Fi 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-plejtlets tal-5 mg kien simili għal dak tal10 mg.
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: Fi studju ta' 276 pazjent ACS ittrattati b'PCI, ilbidla minn doża inizjali ta' kkargar ta' 600 mg clopidogrel jew plaċebo mogħti mal-wasla tagħhom l­isptar qabel l­anġjografija 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-plejtlets għattul ta' żmien tal-istudju ta' 72 siegħa.
English: If prescribed, a lower maintenance dose of 5 mg should be used; the 10 mg maintenance dose is not recommended (see sections 4.2 and 4.8).
Maltese: Jekk jiġi preskritt, għandha tintuża doża ta' manteniment aktar baxxa ta' 5 mg; id-doża ta' manteniment ta' 10 mg mhix irrakkomandata (ara sezzjonijiet 4.2 u 4.8).
English: This effect is likely to be of clinical concern only when prasugrel is co administered with medicinal products for which CYP2B6 is the only metabolic pathway and have a narrow therapeutic window (e.g. cyclophosphamide, efavirenz).
Maltese: Dan l­effett jista' jkun ta' interess kliniku biss meta prasugrel jingħata flimkien ma' prodotti mediċinali għal liema CYP2B6 hija l­unika katalista għas-sensiela ta' reazzjonijiet metaboliċi u għandhom skala terapewtika dejqa (eż. cyclophosphamide, efavirenz).
English: For patients who received their thienopyridine within 3 days prior to CABG, the frequencies of TIMI major or minor bleeding were 26.7% (12 of 45 patients) in the prasugrel group, compared with 5.0% (3 of 60 patients) in the clopidogrel group.
Maltese: Għall-pazjenti li rċevew thienopyridine fi żmien 3 ijiem qabel CABG, il-frekwenzi ta' fsada maġġuri jew minuri skont TIMI kienu ta' 26.7% (12 minn 45 pazjent) fil-grupp ta' prasugrel, meta mqabbel ma' 5.0% (3 minn 60 pazjent) fil-grupp ta' clopidogrel.
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: Għall-pazjenti li rċevew l­aħħar doża ta' thienopyridine fi żmien 4 sa 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: Prasugrel Mylan 10 mg: Each tablet contains prasugrel besilate equivalent to 10 mg prasugrel.
Maltese: Prasugrel Mylan 10 mg: Kull pillola fiha prasugrel besilate ekwivalenti għal 10 mg prasugrel.
English: Prasugrel Mylan 5 mg film-coated tablets Prasugrel Mylan 10 mg film-coated tablets prasugrel
Maltese: Prasugrel Mylan 5 mg pilloli miksija b'rita Prasugrel Mylan 10 mg pilloli miksija b'rita
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: Fi studju kliniku kbir ta' fażi 3, l­espożizzjoni medja stmata (AUC) tal-metabolit attiv kienet 19% ogħla f'pazjenti anzjani ħafna (≥75 sena) meta mqabbel ma' suġġetti <75 sena.
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: f Clinically overt bleeding associated with a fall in haemoglobin of ≥3 g/dL but <5 g/dL.
Maltese: f Fsada evidenti b'mod kliniku assoċjata ma' tnaqqis fl-emoglobina ta' ≥3 g/dL iżda <5 g/dL.
English: Effects of Prasugrel Mylan on other medicinal products
Maltese: Effetti ta' Prasugrel Mylan fuq prodotti mediċinali oħra
English: OPA/Aluminium/PE/Desiccant/PE- Aluminium perforated unit dose blister pack containing 30 x 1 or 90 x 1 film-coated tablets.
Maltese: Pakkett bil-folji perforati b'doża waħda tal-OPA/Aluminju/PE/Dessikant/PE-Aluminju li fih 30 × 1 jew 90 × 1 pillola miksija b'rita.
English: Prasugrel Mylan 5 mg: Do not store above 30°C.
Maltese: Prasugrel Mylan 5 mg: Taħżinx f'temperatura 'l fuq minn 30°C.
English: Patients ≥75 years were at increased risk of bleeding, including fatal (see sections 4.2, 4.4, and 4.8).
Maltese: Pazjenti ≥75 sena kellhom riskju ogħla ta' fsada inkluża dik fatali (ara sezzjonijiet 4.2, 4.4
English: Non fatal stroke
Maltese: Puplesija mhux fatali
English: 2D barcode carrying the unique identifier included.
Maltese: fuq il-kartuna biss: barcode 2D li jkollu l-identifikatur uniku inkluż.
English: Although not studied in specific interaction studies, prasugrel 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 prasugrel 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: • Emphasis that: ◦ Severe haemorrhagic events are more frequent in patients ≥75 years of age (including fatal events) or those weighing <60 kg ◦ Treatment with prasugrel is generally not recommended for patients of ≥75 years of age.
Maltese: ◦ Avvenimenti emorraġiċi serji huma iżjed frekwenti f'pazjenti ≥75 sena (inklużi avvenimenti fatali) jew dawk li għandhom piż <60 kg ◦ Normalment kura b'prasugrel mhux rakkomandata f'pazjenti ≥75 sena.
English: Prasugrel Mylan 5 mg film-coated tablets are yellow film-coated, capsule shaped, biconvex tablets, of dimensions 8.15 mm × 4.15 mm, debossed with ‘PH3' on one side of the tablet and ‘M' on the other side.
Maltese: Prasugrel Mylan 5 mg pilloli miksija b'rita huma ta' lewn isfar, miksija b'rita, b'forma ta' kapsula, konvessa fuq iż-żewġ naħat, b'daqs ta' 8.15 mm × 4.15 mm, imnaqqxa b'‘PH3' fuq naħa waħda talpillola u ‘M' fuq in-naħa l­oħra.
English: Yellow film-coated, capsule shaped, biconvex tablet, of dimensions 8.15 mm × 4.15 mm, debossed with ‘PH3' on one side and ‘M' on the other side.
Maltese: Pillola miksija b'rita, ta' lewn isfar, b'forma ta' kapsula, konvessa fuq iż-żewġ naħat, b'daqs ta' 8.15 mm × 4.15 mm, imnaqqxa b'‘PH3' fuq naħa waħda u ‘M' fuq in-naħa l­oħra.
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 14­il ġurnata oħra.
English: This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodiumfree'.
Maltese: Dan il-prodott mediċinali fih anqas minn 1 mmol sodium (23 mg) f'kull pillola, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: Prasugrelb + ASA (N=5001)
Maltese: ASA (N=5001)
English: Prasugrel Mylan 10 mg film-coated tablets are beige film-coated, capsule shaped, biconvex tablets, of dimensions 11.15 mm × 5.15 mm, debossed with ‘PH4' on one side of the tablet and ‘M' on the other side.
Maltese: Prasugrel Mylan 10 mg pilloli miksija b'rita huma ta' lewn beige, miksija b'rita, b'forma ta' kapsula, konvessa fuq iż-żewġ naħat, b'daqs ta' 11.15 mm × 5.15 mm, imnaqqxa b'‘PH4' fuq naħa waħda talpillola u ‘M' fuq in-naħa l­oħra.
English: Beige film-coated, capsule shaped, biconvex tablet, of dimensions 11.15 mm × 5.15 mm, debossed with ‘PH4' on one side and ‘M' on the other side.
Maltese: Pillola miksija b'rita, ta' lewn beige, b'forma ta' kapsula, konvessa fuq iż-żewġ naħat, b'daqs ta' madwar 11.15 mm × 5.15 mm, imnaqqxa b'‘PH4' fuq naħa waħda u ‘M' fuq in-naħa l­oħra.
English: The educational material should include:
Maltese: • Jiġi enfasizzat li:
English: Your doctor should prescribe a daily dose of 5 mg of Prasugrel Mylan if you weigh less than 60 kg - renal (kidney) disease or moderate liver problems - taking certain types of medicines (see ‘Taking other medicines' below) - planned surgery (including some dental procedures) in the next seven days.
Maltese: 5 mg ta' Prasugrel Mylan kuljum jekk inti tiżen inqas minn 60 kg - mard renali (tal-kliewi) jew problemi moderati fil-fwied - tieħu xi ċerti tipi ta' mediċini (ara ‘Meta tieħu mediċini oħra' aktar 'l isfel) - operazzjoni li ser issirlek (inklużi xi proċeduri li għandhom x'jaqsmu mas-snien) fis-sebat ijiem li ġejjin.
English: Platelet aggregation gradually returned to baseline values after treatment in 7 to 9 days after administration of a single 60 mg loading dose of prasugrel and in 5 days following discontinuation of maintenance dosing at steady-state.
Maltese: L­aggregazzjoni ta' plejtlets reġgħet lura bil-mod għall-valuri fil-linja bażi wara l­kura f'7 sa 9 ijiem wara li ngħatat doża waħda ta' kkargar ta' 60 mg prasugrel u f'5 ijiem wara t-twaqqif tad-dożaġġ ta' manteniment fi steady state.
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 (tliet darbiet aktar) (ara sezzjoni 4.8).
English: Prasugrel Mylan 10 mg: Do not store above 25°C.
Maltese: Prasugrel Mylan 10 mg: Taħżinx f'temperatura 'l fuq minn 25°C.
English: Each tablet contains prasugrel besilate equivalent to 10 mg prasugrel.
Maltese: Kull pillola fiha prasugrel besilate ekwivalenti għal 10 mg prasugrel.