FrancophonIA/ELRC3.0 huggingface dataset:
English: Store in a refrigerator (+2 °C to +8 °C) at all times, ensuring the tube is in the box inside the childresistant, transparent, sealable, plastic bag.
Maltese: Aħżen fi friġġ (+2 °C sa +8 °C) il-ħin kollu, filwaqt li tiżgura li l-istoċċ huwa fil-kaxxa ġewwa l-borża tal-plastik li tista' tiġi ssiġillata, trasparenti u reżistenti għat-tfal.
English: No dedicated animal studies on the effects of chlormethine on female fertility have been reported in the literature.
Maltese: Fil-letteratura ma ġie rrappurtat l-ebda studju dedikat fuq l-annimali dwar l-effetti ta' chlormethine fuq il-fertilità femminili.
English: Skin-directed therapies for MF-type CTCL have been associated with secondary skin cancers, although the specific contribution of chlormethine has not been established.
Maltese: Terapiji diretti lejn il-ġilda għal MF-type CTCL ġew assoċjati ma' kanċer tal-ġilda sekondarju, minkejja li l-kontribut speċifiku ta' chlormethine ma ġiex stabbilit.
English: Ledaga is indicated for the topical treatment of mycosis fungoides-type cutaneous T-cell lymphoma (MF-type CTCL) in adult patients (see section 5.1).
Maltese: Fl-annimali, ġew iddokumentati effetti avversi ta' chlormethine fuq il-fertilità maskili wara għoti sistemiku (ara sezzjoni 5.3). Ir-rilevanza għall-bnedmin li jirċievu chlormethine topiku mhix magħrufa.
English: • warfarin (an anti-coagulant),
Maltese: • warfarin (antikoagulant),
English: Mylan utca 1, Komárom, 2900, Hungary
Maltese: Mylan utca 1, Komárom, 2900, l-Ungerija
English: McDermott Laboratories Limited t/a Gerard Laboratories 35/36 Baldoyle Industrial Estate, Grange State, Dublin 13, Ireland
Maltese: McDermott Laboratories Limited t/a Gerard Laboratories 35/36 Baldoyle Industrial Estate, Grange State, Dublin 13, l-Irlanda
English: Patients ≥60 kg and age <75 years
Maltese: Pazjenti ≥60 kg u età <75 sena
English: Inhibitors of CYP3A
Maltese: Inibituri ta' CYP3A
English: Prasugrel prior to coronary angiographya (N=2037) %
Maltese: Prasugrel qabel anġjografija koronarja (N=2037) %
English: (see sections 4.2, 4.8 and 5.1).
Maltese: (ara sezzjonijiet 4.2, 4.8 u 5.1).
English: The patient population was 92% Caucasian, 26% female, and 39% ≥65 years of age.
Maltese: Il-poplazzjoni tal-pazjenti kienet ta' 92% Kawkasi, 26% femminili, u 39% ≥ 65 sena.
English: Mylan Hungary Kft./Mylan Hungary Ltd. Mylan utca 1
Maltese: Mylan Hungary Kft./Mylan Hungary Ltd.
English: Non-steroidal anti-inflammatory drugs (NSAIDs)
Maltese: Mediċini anti-infjammatorji mhux sterojdi (NSAIDs)
English: Hypersensitivity including angioedema
Maltese: Sensittività eċċessiva inkluża l­anġjoedima
English: Primary Individual Outcome Events
Maltese: Avvenimenti Primarji
English: Thrombotic thrombocytopaenic purpura (TTP)
Maltese: Purpura trombotika tromboċitopenika (TTP)
English: Non fatal MI
Maltese: MI mhux fatali
English: Medicinal products metabolised by CYP2B6
Maltese: Prodotti mediċinali mmetabolizzati minn CYP2B6
English: Medicinal products metabolised by CYP2C9
Maltese: Prodotti mediċinali mmetabolizzati minn CYP2C9
English: Table 3: Patients with outcome events in TRITON primary analysis
Maltese: Tabella 3: Pazjenti b'avvenimenti li seħħew fl-analiżi primarja TRITON
English: (See sections 4.2, 4.4, and 4.8)
Maltese: (Ara sezzjonijiet 4.2, 4.4 u 4.8).
English: Date of first authorisation: 16 May 2018
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 16 Mejju, 2018
English: Microcrystalline cellulose Mannitol
Maltese: Il-qalba tal-pillola Microcrystalline cellulose Mannitol
English: • ‘non-steroidal anti-inflammatory drugs' for pain and fever (such as ibuprofen, naproxen, etoricoxib).
Maltese: • mediċini anti-nfjammatorji li mhumiex sterojdi għall-uġigħ u d­deni (bħal ibuprofen, naproxen, etoricoxib).
English: System Organ Class
Maltese: Sistema ta' klassifika ta' l-organi
English: Inducers of cytochromes P450
Maltese: Stimulanti ta' ċitokromi P450
English: Distribution Active metabolite binding to human serum albumin (4% buffered solution) was 98%.
Maltese: Distribuzzjoni L-irbit tal-metabolit attiv ma' l­albumina fis-serum uman (soluzzjoni bafferjata ta' 4%) kien ta' 98%.
English: • with body weight <60 kg (see sections 4.2 and 4.8).
Maltese: • b'piż tal-ġisem <60 kg (ara sezzjonijiet 4.2 u 4.8).
English: Latvija Mylan Healthcare SIATel: +371 676 055 80
Maltese: Mylan Healthcare SIA Tel: +371 676 055 80
English: Patients ≥75 years old
Maltese: Pazjenti ≥75 sena
English: • clopidogrel (an anti-platelet agent),
Maltese: • clopidogrel (sustanza kontra l-plejtlets),
English: Contains sunset yellow FCF aluminium lake (E110).
Maltese: Fih sunset yellow FCF aluminium lake (E110).
English: Pharmacokinetics of prasugrel and its inhibition of platelet aggregation are similar in patients with moderate renal impairment (GFR 30<50 ml/min/1.73 m²) and healthy subjects.
Maltese: Il-farmakokinetika u l­inibizzjoni ta' l­aggregazzjoni ta' plejtlets ta' prasugrel kienu simili f'suġġetti b'indeboliment tal-kliewi moderat (GFR 30<50 ml/min/1.73 m²) u f'suġġetti b'saħħithom.
English: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1000 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: Komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10); mhux komuni (≥1/1000 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: Patients weighing <60 kg
Maltese: Pazjenti li jiżnu <60 kg
English: Prasugrel Mylan 10 mg: microcrystalline cellulose, mannitol, crospovidone, silica colloidal anhydrous, magnesium stearate, polyvinyl alcohol, talc, titanium dioxide (E171), glyceryl monocaprylocaprate, sodium lauryl sulfate, iron oxide yellow (E172), sunset yellow FCF aluminium lake (E110) (see section 2, ‘Prasugrel Mylan 10 mg contains sunset yellow FCF aluminium lake'), iron oxide red (E172).
Maltese: Prasugrel Mylan 10 mg: microcrystalline cellulose, mannitol, crospovidone, silica colloidal anhydrous, magnesium stearate, polyvinyl alcohol, talc, titanium dioxide (E171), glyceryl monocaprylocaprate, sodium lauryl sulfate, iron oxide yellow (E172), sunset yellow FCF aluminium lake (E110) (ara sezzjoni 2, ‘Prasugrel Mylan 10 mg fih sunset yellow FCF aluminium lake'), iron oxide red (E172).
English: In healthy subjects, prasugrel decreased exposure to hydroxybupropion, a CYP2B6-mediated metabolite of bupropion, by 23%.
Maltese: F'suġġetti b'saħħithom, prasugrel naqqas l­espożizzjoni għal hydroxybupropion, metabolit ta' bupropion permezz ta' CYP2B6, b'23%.
English: The rate of study drug discontinuation due to adverse events was 7.2% for prasugrel and 6.3% for clopidogrel.
Maltese: Ir-rata tat-twaqqif talmediċina taħt studju minħabba avvenimenti avversi kienet ta' 7.2% għal prasugrel u 6.3% għal clopidogrel.
English: Effects of other medicinal products on Prasugrel Mylan
Maltese: Effetti ta' prodotti mediċinali oħra fuq Prasugrel Mylan
English: Ketoconazole (400 mg daily), a selective and potent inhibitor of CYP3A4 and CYP3A5, did not affect prasugrel-mediated inhibition of platelet aggregation or the prasugrel active metabolite's AUC and Tmax, but decreased the Cmax by 34% to 46%.
Maltese: Ketoconazole (400 mg kuljum), inibitur selettiv u qawwi ta' CYP3A4 u CYP3A5, ma affettwax l­inibizzjoni tal­aggregazzjoni ta' plejtlets permezz ta' prasugrel jew l­AUC u Tmax tal-metabolit attiv ta' prasugrel, iżda naqqas is-Cmax b'34% sa 46%.
English: Thrombocytopaenia
Maltese: Tromboċitopinja
English: 2.0% (0.1% fatal)a
Maltese: 2.0% (0.1% fatali)a
English: UA/NSTEMI Primary Composite Outcome Events
Maltese: UA/NSTEMI Avvenimenti Primarji Komposti li Seħħew
English: Pharmacokinetics and pharmacodynamics of prasugrel have not been evaluated in a paediatric population (see section 4.2).
Maltese: Il-farmakokinetika u l­farmakodinamika ta' prasugrel ma ġewx stmati fil-popolazzjoni pedjatrika (ara sezzjoni 4.2).
English: * TRITON study in ACS patients undergoing PCI ** TRILOGY-ACS study in patients not undergoing PCI (see 5.1): a 10 mg prasugrel; 5 mg prasugrel if <60 kg
Maltese: * Studju TRITON f'pazjenti ACS ittrattati b'PCI ** Studju TRILOGY-ACS f'pazjenti li mhumiex ittrattati b'PCI (ara 5.1): a 10 mg prasugrel; 5 mg prasugrel jekk <60 kg
English: ≥75 years (N=2060)**
Maltese: ≥75 sena(N=2060)**
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% għal clopidogrel).
English: These included definite or probable stent thrombosis at study end (0.9% vs 1.8%; HR 0.498; CI 0.364, 0.683); CV death, nonfatal MI, or urgent target vessel revascularisation through 30 days (5.9% vs 7.4%; HR 0.784; CI 0.688,0.894); all cause death, nonfatal MI, or nonfatal stroke through study end (10.2% vs 12.1%; HR 0.831; CI 0.751, 0.919); CV death, non-fatal MI, nonfatal stroke or rehospitalisation for cardiac ischaemic event through study end (11.7% vs 13.8%; HR 0.838; CI 0.762, 0.921).
Maltese: Dawn inkludew trombożi ċerta jew probabbli fl-istent fl-aħħar tal-istudju (0.9% kontra 1.8%; HR 0.498; CI 0.364, 0.683); mewt CV, MI mhux fatali, jew rivaskularizzazzjoni tal-vina/arterja mira urġenti tul 30 ġurnata (5.9% kontra 7.4%; HR 0.784; CI 0.688,0.
English: Mean steady-state inhibition of platelet aggregation was 74% and 69% respectively for 5 µM ADP and 20 µM ADP, and was achieved following 3 to 5 days of administration of the 10 mg prasugrel maintenance dose preceded by a 60 mg loading dose.
Maltese: Steady state medju tal-inibizzjoni ta' aggregazzjoni ta' plejtlets kien ta' 74% u 69% rispettivament għal 5 µM ADP u 20 µM ADP, u ntlaħaq wara li ngħatat id-doża ta' manteniment ta' 10 mg prasugrel għal 3 sa 5 ijiem wara d­doża ta' kkargar ta' 60 mg.
English: The active metabolite's exposure (AUC) increases proportionally over the therapeutic dose range.
Maltese: L­espożizzjoni (AUC) tal-metabolit attiv tiżdied proporzjonalment fuq l-iskala tad-doża terapewtika.
English: Sunset yellow FCF aluminium lake (E110) [only Prasugrel Mylan 10 mg]
Maltese: Sunset yellow FCF aluminium lake (E110) [Prasugrel Mylan 10 mg biss] Iron oxide aħmar (E172) [Prasugrel Mylan 10 mg biss]
English: Table 2 summarises haemorrhagic and non-haemorrhagic adverse reactions in TRITON, or that were spontaneously reported, classified by frequency and system organ class.
Maltese: Tabella 2 tiġbor fil-qosor ir-reazzjonijiet avversi emorraġiċi u mhux emorraġiċi fi TRITON jew li ġew irrapportati b'mod spontanju, ikklassifikati skont il-frekwenza u s­sistema ta' klassifika ta' l­organi.
English: 28 film-coated tablets 30 film-coated tablets 30 x 1 film-coated tablets 84 film-coated tablets 90 film-coated tablets 90 x 1 film-coated tablets 98 film-coated tablets
Maltese: 28 pillola miksija b'rita 30 pillola miksija b'rita 30 × 1 pillola miksija b'rita 84 pillola miksija b'rita 90 pillola miksija b'rita 90 × 1 pillola miksija b'rita 98 pillola miksija b'rita
English: Analysis of the composite endpoint in the All ACS population (combined UA/NSTEMI and STEMI cohorts) was contingent on showing statistical superiority of prasugrel versus clopidogrel in the UA/NSTEMI cohort (p<0.05).
Maltese: L­analiżi tar-riżultat finali kompost fil-popolazzjoni tal-Pazjenti Kollha b'ACS (gruppi ta' UA/NSTEMI kkombinati u STEMI) kienet kontinġenti fit-turija ta' superjorità statistika ta' prasugrel kontra clopidogrel fil-grupp ta' UA/NSTEMI (p<0.05).
English: Each tablet contains 0.016 mg of sunset yellow FCF aluminium lake (E110).
Maltese: Eċċipjent b'effett magħruf Kull pillola fiha 0.016 mg ta' sunset yellow FCF aluminium lake (E110).
English: Prasugrel-mediated inhibition of platelet aggregation exhibits low between-subject (9%) and within-subject (12%) variability with both 5 µM and 20 µM ADP.
Maltese: L­inibizzjoni ta' aggregazzjoni ta' plejtlets permezz ta' prasugrel turi varjabbilità baxxa bejn is-suġġetti (9%) u fissuġġetti (12%) kemm b'5 µM u b'20 µM ADP.
English: Prasugrel Mylan is contraindicated in patients with severe hepatic impairment (Child Pugh class C).
Maltese: Prasugrel Mylan huwa kontraindikat f'pazjenti b'indeboliment qawwi tal-fwied (Child Pugh klassi Ċ).
English: Patients ≥75 years of age have greater sensitivity to bleeding and higher exposure to the active metabolite of prasugrel (see sections 4.4, 4.8, 5.1 and 5.2).
Maltese: Pazjenti ≥75 sena għandhom tendenza ogħla ta' fsada u espożizzjoni akbar għal metabolit attiv ta' prasugrel (ara sezzjonijiet 4.4, 4.8, 5.1 u 5.2).
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 (2.76% vs 2.90%), fil-popolazzjoni UA/NSTEMI (2.58% vs 2.41%) u fil-popolazzjoni STEMI (3.28% vs
English: What Prasugrel Mylan contains - The active substance is prasugrel.
Maltese: X'fih Prasugrel Mylan - Is-sustanza attiva hi prasugrel.
English: Prasugrel Mylan 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: Prasugrel Mylan jista' jingħata flimkien ma' prodotti mediċinali li jiġu mmetabolizzati minn enzimi ta' ċitokromu P450 (inklużi statins), jew prodotti mediċinali li huma stimulanti jew inibituri tal­enzimi ta' ċitokromu P450.
English: * TRITON study in ACS patients undergoing PCI ** TRILOGY-ACS study in patients not undergoing PCI (see 5.1): a 10 mg prasugrel; 5 mg prasugrel if ≥75 years of age
Maltese: * Studju TRITON f'pazjenti ACS ittrattati b'PCI ** Studju TRILOGY-ACS f'pazjenti li mhumiex ittrattati b'PCI (ara 5.1): a 10 mg prasugrel; 5 mg prasugrel jekk ≥75 sena
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 prasugrel compared to clopidogrel (Hazard ratio, 0.87; 95% CI, 0.79 to 0.95; p=0.004).
Maltese: Għalkemm bi prasugrel żdiedet il-fsada, analiżi tar-riżultat finali kompost ta' mewt minn kull kawża, infart mijokardijaku mhux fatali, puplesija mhux fatali, emorraġija maġġuri skont TIMI relatata ma' non-CABG ffavorixxit prasugrel meta mqabbel ma' clopidogrel (Proporzjon ta' periklu, 0.87; 95% CI, 0.79 sa 0.95; p=0.004).
English: Prasugrel did not inhibit CYP2C9, as it did not affect the pharmacokinetics of S-warfarin.
Maltese: Prasugrel ma inibixxiex CYP2C9, u ma affettwax il-farmakokinetika ta' S­warfarin.
English: In the phase 3 clinical trial (TRITON) key exclusion criteria included an increased risk of bleeding; anaemia; thrombocytopaenia; a history of pathological intracranial findings.
Maltese: Fil-prova klinika ta' fażi 3 (TRITON), il-kriterji ta' esklużjoni l­aktar importanti kienu jinkludu riskju akbar ta' fsada; anemija; tromboċitopenija; passat ta' sejbiet patoloġiċi fil-kranju.
English: Prasugrel
Maltese: Pożoloġija
English: (see section 2 ‘What you need to know before you take Prasugrel Mylan')
Maltese: (ara sezzjoni 2 ‘X'għandek tkun taf qabel ma tieħu Prasugrel Mylan')
English: No dose adjustment is necessary in subjects with mild to moderate hepatic impairment (Child Pugh class A and B) (see section 5.2).
Maltese: Mhux meħtieġ aġġustament fid-doża għal pazjenti b'indeboliment tal-fwied ħafif jew moderat (Child Pugh klassi A u B) (ara sezzjoni 5.2).
English: The efficacy of prasugrel was independent of the ASA dose (75 mg to 325 mg once daily).
Maltese: L­effikaċja ta' prasugrel kienet indipendenti middoża ta' ASA (75 mg sa 325 mg darba kujum).
English: This medicine is available in plastic bottles containing a desiccant and 28 or 30 film-coated tablets and in blister packs containing 28, 30, 84, 90, 98 and in perforated blister packs containing 30 x 1 and 90 x 1 film-coated tablets.
Maltese: Din il-mediċina hija disponibbli fi fliexken tal-plastik li jkun fihom dessikant u 28 jew 30 pillola miksija b'rita u f'pakketti bil-folji li jkun fihom 28, 30, 84, 90, 98 pilloli miksija b'rita u f'pakketti bilfolji perforati li jkun fihom 30 × 1 u 90 × 1 pillola miksija b'rita.
English: The benefits associated with prasugrel were independent of the use of other acute and long-term cardiovascular therapies, including heparin/low molecular weight heparin, bivalirudin, intravenous GP IIb/IIIa inhibitors, lipid-lowering medicinal products, beta-blockers, and angiotensin converting enzyme inhibitors.
Maltese: Il-benefiċċji assoċjati ma' prasugrel kienu indipendenti mill-użu ta' terapiji oħra kardjovaskulari akuti u għat-tul, inklużi eparina/ eparina b'piż molekulari baxx, bivalirudin, inibituri ta' GP IIb/IIIa li jingħataw ġol-vini, prodotti mediċinali li jbaxxu l­lipidi, imblokkaturi tar-riċetturi beta, u inibituri tal­enzim li jikkonverti angiotensin.
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: 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 l­aktar komuni ta' fsada spontanja kien l­apparat gastro-intestinali (rata ta' 1.7% b'prasugrel u rata ta' 1.3% b'clopidogrel); l­aktar sit frekwenti ta' fsada pprovokata kien is-sit tat-titqib arterjali (rata ta' 1.3% b'prasugrel u rata ta' 1.2% b'clopidogrel).
English: • Before you take Prasugrel Mylan:
Maltese: • Qabel tieħu Prasugrel Mylan:
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: Other therapies, such as heparin and GP IIb/IIIa inhibitors, were administered at the discretion of the physician.
Maltese: Terapiji oħra, bħal eparina u inibituri ta' GP IIb/IIIa, ingħataw skont id-deċiżjoni ta' l­ispeċjalista.
English: OPA/Aluminium/PE/Desiccant/PE- Aluminium blister packs containing 28, 30, 84, 90 or 98 filmcoated tablets.
Maltese: Pakketti bil-folji tal-OPA/Aluminju/PE/Dessikant/PE-Aluminju li fihom 28, 30, 84, 90 jew 98 pillola miksija b'rita.
English: In the All ACS population, analysis of each of the secondary endpoints showed a significant benefit (p<0.001) for prasugrel versus clopidogrel.
Maltese: Fil-poplazzjoni tal-Pazjenti Kollha b'ACS, l­analiżi ta' kull riżultat finali sekondarju wera benefiċċju sinifikanti (p<0.001) għal prasugrel kontra clopidogrel.
English: Therefore, CYP3A inhibitors such as azol antifungals, HIV protease inhibitors, clarithromycin, telithromycin, verapamil, diltiazem, indinavir, ciprofloxacin, and grapefruit juice are not anticipated to have a significant effect on the pharmacokinetics of the active metabolite.
Maltese: Għaldaqstant, inibituri ta' CYP3A bħal sustanzi azol kontra l­fungi, inibituri ta' HIV protease, clarithromycin, telithromycin, verapamil, diltiazem, indinavir, ciprofloxacin, u meraq tal-grejpfrut mhumiex mistennija li jkollhom effett sinifikanti fuq ilfarmakokinetika tal-metabolit attiv.
English: The active metabolite's exposure (AUC) has moderate to low between-subject (27%) and within-subject (19%) variability.
Maltese: L-espożizzjoni (AUC) tal-metabolit attiv għandha varjabbilità bejn is-suġġetti (27%) u fis-suġġetti (19%) minn moderata għal baxxa.
English: BLISTER CARTON OF 10 MG FILM-COATED TABLETS
Maltese: KARTUNA BIL-FOLJI TA' 10 MG PILLOLI MIKSIJA
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' plejtlets waqt id-dożaġġ ta' manteniment.
English: and CYP2C19.
Maltese: B01AC22.
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 ilbżonn ta' inibitur ta' glycoprotein (GP) IIb/IIIa matul is­7 ijiem minn meta ntagħżlu b'mod arbitrarju f'suġġetti li rċevew prasugrel qabel l­anġjografija koronarja meta mqabbla ma' pazjenti li rċevew iddoża 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 fis-suġġetti li rċevew prasugrel qabel l­anġjografija koronarja kontra s­suġġetti li rċevew id-doża sħiħa ta' kkargar ta' prasugrel fil-ħin tal-PCI.
English: It is rapidly hydrolysed in theintestine to a thiolactone, which is then converted to the active metabolite by a single step of cytochrome P450 metabolism, primarily by CYP3A4 and CYP2B6 and to a lesser extent by CYP2C9
Maltese: Huwa jiġi idrolizzat b'mod rapidu filmusrana f'thiolactone li b'pass wieħed tal-metaboliżmu ta' ċitokromu P450 jinbidel fil-metabolit attiv, prinċipalment minn CYP3A4 u CYP2B6 u anqas minn CYP2C9 u CYP2C19.
English: Rash Ecchymosis
Maltese: Raxx Ekkimożi
English: Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Maltese: Huwa importanti li jiġu rrappurtati reazzjonijiet avversi suspettati wara l­awtorizzazzjoni tal-prodott mediċinali.
English: Prasugrel Mylan 10 mg contains sunset yellow FCF aluminium lake (E110) and sodium Sunset yellow FCF aluminium lake is an azo colouring agent, which may cause allergic reactions.
Maltese: Prasugrel Mylan 10 mg fih sunset yellow FCF aluminium lake (E110) u s-sodium Sunset yellow FCF aluminium lake huwa aġent koloranti, li jista' jikkawża reazzjonijiet allerġiċi.
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' l­eliminazzjoni ta madwar 7.4 sigħat (f'skala minn 2 sa 15­il siegħa).
English: Primary Composite Outcome Events Cardiovascular (CV) death, non fatal MI, or non fatal stroke
Maltese: Mewt kardjovaskulari (CV), MI mhux fatali, jew puplesija mhux fatali
English: White opaque HDPE bottle closed with white opaque polypropylene screw cap and aluminium induction sealing liner wad.
Maltese: Flixkun tal-HDPE opak u ta' lewn abjad b'għatu bil-kamin tal-polypropylene opak u ta' lewn abjad u b'aluminium induction sealing liner wad.
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 l­plejtlets.