FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients with events*
Maltese: Pazjenti li kellhom avvenimenti*
English: Pharmacokinetics of vorapaxar are similar between elderly, including those ≥75 years of age, and younger patients.
Maltese: Il-farmakokinetika ta' vorapaxar tixxiebah bejn anzjani, inkluż dawk li għandhom ≥75 sena, u pazjenti iżgħar.
English: TIMI Minor: Clinically apparent with 30-50 g/L decrease in haemoglobin.
Maltese: Tidher b'mod kliniku bi tnaqqis ta' 30-50 g/L fl-emoglobina.
English: Strong CYP3A inhibitors
Maltese: Impedituri qawwija ta' CYP3A
English: In the TRA 2ºP-TIMI 50 trial, although CABG-related TIMI major bleeding was observed in patients taking vorapaxar (see section 4.8), patients who continued therapy with vorapaxar while undergoing CABG did not show an increased risk of major bleeding compared to placebo.
Maltese: Fil-prova TRA 2ºP-TIMI 50, għalkemm fsada maġġuri TIMI marbuta ma' CABG ġiet osservata f'pazjenti li kienu qed jieħdu vorapaxar (ara sezzjoni 4.8), pazjenti li komplew it-terapija b'vorapaxar waqt li sarilhom CABG ma wrewx żieda fir-riskju ta' fsada maġġuri meta mqabbla ma' plaċebo.
English: Excipient(s) with known effect: Each film-coated tablet contains 66.12 mg of lactose (as monohydrate).
Maltese: Kull pillola miksija b'rita fiha 66.12 mg ta' lactose (bħala monohydrate).
English: Based upon in vitro data, chronic administration of vorapaxar is unlikely to induce the metabolism of drugs metabolized by major CYP isoforms.
Maltese: Abbażi ta' dejta in vitro, mhux probabbli li għoti kroniku ta' vorapaxar jinduċi l-metaboliżmu ta' mediċini metabolizzati permezz tal-iżoformi prinċipali ta' CYP.
English: The duration of these pharmacodynamic effects is consistent with the drug's elimination half-life.
Maltese: It-tul ta' żmien ta' dawn l-effetti farmakodinamiċi huwa konsistenti mal-half-life ta' eliminazzjoni talmediċina.
English: A delayed onset of action (at least 7 days) should be expected when starting therapy with Zontivity.
Maltese: Bidu ta' azzjoni ttardjata (mill-inqas 7 ijiem) għandu jiġi mistenni meta tinbeda terapija b'Zontivity.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għall-galactose, b'defiċjenza ta' Lapp lactase, jew assorbiment ħażin ta' glucose-galactose m'għandhomx jieħdu din il-mediċina.
English: Bleeding was the most common adverse reaction leading to study drug discontinuation for both treatments (3.0% for Zontivity and 1.8% for placebo).
Maltese: Il-fsada kienet l-aktar reazzjoni avversa komuni li wasslet għat-twaqqif tal-mediċina għaż-żewġ kuri (3.0% għal Zontivity u 1.8% għall-plaċebo).
English: Zontivity is indicated for the reduction of atherothrombotic events in adult patients with
Maltese: Zontivity huwa indikat għat-tnaqqis ta' avvenimenti aterotrombotiċi f'pazjenti adulti bi
English: Weight
Maltese: valur
English: No clinically relevant differences in vorapaxar pharmacokinetics were observed following daily co-administration of an aluminium hydroxide/magnesium carbonate antacid or pantoprazole (a proton pump inhibitor).
Maltese: Ma kienu osservati l-ebda differenzi rilevanti b'mod kliniku fil-farmakokinetika ta' vorapaxar wara għoti kuljum flimkien ma' antaċidu li fih aluminium hydroxide/magnesium carbonate jew pantoprazole (impeditur tal-pompa tal-proton).
English: Co-administration of rifampin (600 mg once-daily) with vorapaxar substantially decreased the vorapaxar mean Cmax and AUC by 39% and 55%, respectively.
Maltese: L-għoti ta' rifampin (600 mg darba kuljum) flimkien ma' vorapaxar naqqas b'mod sostanzjali l-medja tas-Cmax u l-AUC ta' vorapaxar b'39% u 55%, rispettivament.
English: Other medicines and Zontivity
Maltese: Mediċini oħra u Zontivity
English: Patients with events
Maltese: Pazjenti b'avvenimenti
English: Lactose monohydrate Cellulose, microcrystalline (E460) Croscarmellose sodium (E468) Povidone (E1201) Magnesium stearate (E572)
Maltese: Croscarmellose sodium (E468) Povidone (E1201) Magnesium stearate (E572)
English: Vorapaxar is a selective and reversible inhibitor of the PAR-1 receptors on platelets that are activated by thrombin.
Maltese: Vorapaxar huwa impeditur selettiv u riversibbli tar-riċetturi PAR-1 fuq il-plejtlits li huma attivati permezz ta' thrombin.
English: No vorapaxar-related tumours were observed in 2-year rat and mouse studies at oral doses up to 30 mg/kg/day in rats and 15 mg/kg/day in mice (8.9 and 30 times the recommended therapeutic exposures in humans based on plasma exposure to vorapaxar for rats and mice, respectively).
Maltese: Ma kienu osservati l-ebda tumuri marbuta ma' vorapaxar fi studji ta' sentejn fuq firien u ġrieden b'dożi mill-ħalq sa 30 mg/kg/jum fil-firien u 15-il mg/kg/jum fil-ġrieden (8.9 u 30 darba l-esponimenti terapewtiċi rrakkomandati fil-bnedmin abbażi ta' esponiment għal vorapaxar fil-plażma għall-firien u lġrieden, rispettivament).
English: Patients undergoing urgent CABG, PCI, non CABG surgery, or other invasive procedures while on Zontivity may remain on Zontivity.
Maltese: Pazjenti li jsirulhom CABG, PCI, kirurġija mhux CABG, jew proċeduri invażivi oħra urġenti waqt li jkunu qed jieħdu Zontivity jistgħu jibqgħu jieħdu Zontivity.
English: Table 5: Multiple Occurrences of Net Clinical Outcome (CV Death/MI/Stroke/GUSTO Severe*) in Post-MI or PAD Patients with No History of Stroke or TIA
Maltese: Okkorrenzi multipli ta' Riżultat Kliniku Nett (Mewt CV/MI/Puplesija/GUSTO Qawwi*) f'Pazjenti Wara
English: BE-2220 Heist-op-den-Berg Belgium
Maltese: Heist-op-den-Berg Il-Belġju
English: The primary route of elimination is through the faeces, with approximately 91.5% of radiolabeled dose predicted to be recovered in the faeces compared to 8.5% in the urine.
Maltese: Ir-rotta primarja ta' eliminazzjoni hija permezz tal-ippurgar, b'madwar 91.5% tad-doża radjutikkettata mbassra li tiġi rkuprata fl-ippurgar meta mqabbla ma' 8.5% fl-awrina.
English: Tabulated list of Adverse Reactions
Maltese: Lista ta' Reazzjonijiet Avversi miġbura f'Tabella
English: For post-MI or PAD patients with no history of stroke or TIA, the rate of study drug discontinuation because of adverse reactions was 6.8% for Zontivity and 6.9% for placebo.
Maltese: MI jew b'PAD mingħajr l-ebda storja ta' puplesija jew TIA, ir-rata ta' twaqqif talmediċina tal-istudju minħabba reazzjonijiet avversi kienet 6.8% għal Zontivity u 6.9% għall-plaċebo.
English: Patients with a history of PAD but without a history of stroke or TIA randomized to vorapaxar had fewer peripheral revascularization procedures (15.4% v 19.3%, 3-year KM rates; HR 0.82 [0.71-0.94, 95% CI]; P=0.005) and fewer hospitalizations for acute limb ischemia (2.0% v 3.3%; HR 0.59 [0.400.86]; P=0.007) than patients randomized to placebo.
Maltese: 71-0.94, CI ta' 95%]; P=0.005) u inqas rikoverar l-isptar għal iskemija akuta fir-riġlejn (2.0% v 3.3%; HR 0.59 [0.40 - 0.86]; P=0.007) minn pazjenti li ntagħżlu b'mod każwali biex jirċievu plaċebo.
English: Patients who experience a stroke, TIA, or ICH while on Zontivity should have therapy discontinued permanently (see sections 4.8 and 5.1).
Maltese: Il-pazjenti li jkollhom puplesija, TIA, jew ICH waqt li jkunu qed jieħdu Zontivity għandha titwaqqfilhom it-terapija b'mod permanenti (ara sezzjonijiet 4.8 u 5.1).
English: The post-MI patient population with no history of stroke or TIA was 88% Caucasian, 20% female, and 29% ≥65 years of age, with a median age of 58 years, and included patients with diabetes (21%) and patients with hypertension (62%).
Maltese: MI mingħajr riskju ta' puplesija jew TIA kienet 88% Kawkasiċi, 20% nisa, u 29% b'età ≥65 sena, b'medjan ta' età ta' 58 sena, u kienet tinkludi pazjenti bid-dijabete (21%) u pazjenti bi pressjoni għolja (62%).
English: There is limited experience with the concomitant use of vorapaxar with warfarin or other oral anticoagulants.
Maltese: Hemm esperjenza limitata bl-użu flimkien ta' vorapaxar ma' warfarin jew antikoagulanti orali oħra.
English: The safety and efficacy of Zontivity in children aged less than 18 years have not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' Zontivity fit-tfal taħt l-età ta' 18-il sena ma ġewx determinati s'issa.
English: Concomitant use of Zontivity with strong (potent) inducers of CYP3A (e.g., rifampin, carbamazepine and phenytoin) should be avoided.
Maltese: L-użu ta' Zontivity flimkien ma' indutturi qawwija (potenti) ta' CYP3A (eż., rifampin, carbamazepine u phenytoin) għandhom jiġu evitati.
English: In the cohort of post-MI or PAD patients with no history of stroke or TIA, the findings for the primary and key secondary composite endpoints are consistent with the overall population (see Figure 1 and Table 4).
Maltese: MI jew b'PAD mingħajr storja ta' puplesija jew TIA, is-sejbiet għall-punti finali amalgamati primarji u sekondarji importanti huma konsistenti mal-popolazzjoni totali (ara Figura 1 u Tabella 4).
English: • boceprevir, telaprevir (used to treat hepatitis C virus infections)
Maltese: • boceprevir, telaprevir (jintużaw biex jikkuraw infezzjonijiet bil-virus tal-epatite Ċ)
English: The findings for the primary efficacy composite endpoint show a 3-year Kaplan-Meier (K-M) event rate of 11.2% in the Zontivity group compared with that of 12.4% in the placebo group (Hazard Ratio [HR]: 0.88; 95% Confidence Interval [CI], 0.82 to 0.95; p=0.001) and demonstrated superiority of Zontivity over placebo in preventing CV death, MI, stroke, or UCR.
Maltese: Is-sejbiet għall-punt finali primarju amalgamat ta' effikaċja wrew rata ta' 11.2% ta' avvenimenti Kaplan-Meier (K-M) fuq 3 snin fil-grupp ta' Zontivity mqabbla ma' dik ta' 12.4% fil-grupp ta' plaċebo (Proporzjon ta' Periklu [HR - Hazard Ratio]: 0.88; 95% Confidence Interval [CI], 0.
English: Placebo n=10,049
Maltese: Plaċebo n=10,049
English: In the TRACER (Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome) trial, comprising patients with a NSTEACS (non-ST segment elevation acute coronary syndrome) who were largely antiplatelet naive, vorapaxar, with a loading dose of 40 mg and then maintained at 2.5 mg/day in addition to standard of care, initiated within 24 hours of NSTEACS, did not achieve its primary efficacy endpoint (cardiovascular death, MI, stroke, urgent coronary revascularization, and recurrent ischemia with rehospitalisation) and there was an increased risk of GUSTO moderate or severe bleeding.
Maltese: Fil-prova TRACER (Antagonist tar-Riċettur ta' Thrombin għal Tnaqqis ta' Avvenimenti Kliniċi fisSindrome Koronarju Akut -Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome), magħmula minn pazjenti b'NSTEACS (sindrome koronarju akut b'elevazzjoni tas-segment mhux ST - non-ST segment elevation acute coronary syndrome) li l-biċċa l-kbira tagħhom qatt ma kienu ħadu kura kontra l-plejtlits qabel, vorapaxar, bl-ewwel doża ogħla ta' 40 mg u mbagħad b'doża miżmuma ta' 2.5 mg/kuljum flimkien mal-istandard ta' kura, li nbdiet fi żmien 24 siegħa minn NSTEACS, ma kisibx il-punt finali primarju ta' effikaċja tiegħu (mewt kardjovaskulari, MI, puplesija, vaskularizzazzjoni korornarja urġenti mill-ġdid, u iskemija rikurrenti bi dħul l-isptar mill-ġdid) u kien hemm żieda fir-riskju ta' fsada moderata jew qawwija GUSTO.
English: There are limited data on the efficacy and safety of Zontivity beyond 24 months.
Maltese: Hemm dejta limitata dwar l-effikaċja u s-sigurtà ta' Zontivity wara aktar minn 24 xahar.
English: Based on population pharmacokinetic analysis using data from healthy subjects and patients with atherosclerotic disease, vorapaxar mean AUC is estimated to be higher in patients with mild (17%) and moderate (34%) renal impairment compared to those with normal renal function; these differences are not considered to be clinically relevant.
Maltese: Abbażi ta' analiżi farmakokinetika ta' popolazzjoni bl-użu ta' dejta minn individwi f'saħħithom u pazjenti b'mard aterosklerotiku, il-medja tal-AUC ta' vorapaxar hija stmata li hija ogħla f'pazjenti b'indeboliment ħafif (17%) u moderat (34%) tal-kliewi meta mqabbla ma' dawk b'funzjoni normali tal-kliewi; dawn id-differenzi mhumiex meqjusa li huma rilevanti b'mod kliniku.
English: The mean estimated vorapaxar Cmax and AUC were 35% and 33% higher, respectively, in patients with a body weight of <60 kg compared to those weighing 60-100 kg. By comparison, vorapaxar exposure (AUC and Cmax) is estimated to be 19-21% lower in patients with a body weight of >100 kg compared to those weighing 60-100 kg.
Maltese: Il-medji stmati tas-Cmax u tal-AUC ta' vorapaxar kienu 35% u 33% ogħla, rispettivament, f'pazjenti b'piż tal-ġisem ta' <60 kg meta mqabbla ma' dawk li kienu jiżnu minn 60-100 kg.
English: The median duration of treatment with vorapaxar was 823 days (interquartile range: 645-1016 days).
Maltese: Il-medjan tat-tul ta' żmien ta' kura b'vorapaxar kien 823 jum (firxa interquartile: 645-1016-il jum).
English: • warfarin, other oral anticoagulants, heparin, or low molecular weight heparin (blood thinner medicines)
Maltese: • warfarin, antikoagulanti oħra mill-ħalq, heparin, jew heparin b'piż molekulari baxx (mediċini li jintużaw biex iraqqu d-demm)
English: Pack sizes
Maltese: FEJN MA
English: Zontivity contains an active substance called vorapaxar, and it belongs to a group of medicines called ‘anti-platelet medicines.'
Maltese: Zontivity fih sustanza attiva msejħa vorapaxar, u jagħmel parti minn grupp ta' mediċini msejħa ‘mediċini kontra l-plejtlits.'
English: Co-administration of ketoconazole (400 mg once-daily) with vorapaxar significantly increased the vorapaxar mean Cmax and AUC by 93% and 96%, respectively.
Maltese: L-għoti ta' ketoconazole (400 mg darba kuljum) flimkien ma' vorapaxar żied b'mod sinifikanti lmedja tas-Cmax u l-AUC ta' vorapaxar b'93% u 96%, rispettivament.
English: Strong CYP3A inducers
Maltese: Indutturi qawwija ta' CYP3A
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Ir-rekwiżiti għas-sottomissjoni tar-rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont lArtikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunke aġġornament sussegwenti ppubblikati fuq ilportal elettroniku Ewropew tal-mediċini.
English: The PAD patient population with no history of stroke or TIA was 90% Caucasian, 29% female, and 57% ≥65 years of age, with a median age of 66 years, and included patients with diabetes (35%) and patients with hypertension (82%).
Maltese: Il-popolazzjoni ta' pazjenti b'PAD mingħajr l-ebda storja ta' puplesija jew TIA kienet 90% Kawkasa, 29% nisa, u 57% b'età ≥65 sena, b'medjan ta' età ta' 66 sena, u kienet tinkludi pazjenti bid-dijabete (35%) u pazjenti bi pressjoni għolja (82%).
English: Placebo (n=10,090)
Maltese: Plaċebo (n=10,090)
English: The mean estimated vorapaxar Cmax and AUC were 24% and 22% higher in Asian patients compared to that of Caucasians.
Maltese: Il-medji stmati tas-Cmax u tal-AUC ta' vorapaxar kienu 24% u 22% ogħla f'pazjenti Ażjatiċi meta mqabbla ma' dawk tal-Kawkasiċi.
English: TIMI Bleeding Category
Maltese: Kategorija ta' Fsada TIMI Maġġuri
English: • clarithromycin, telithromycin (used to treat infections)
Maltese: • clarithromycin, telithromycin (jintużaw biex jikkuraw infezzjonijiet)
English: Randomization to 12 months Total Events
Maltese: Għażla b'mod każwali għal 12-il xahar Avvenimenti Totali
English: Tel.: +48 22 549 51 00 msdpolska@merck.com
Maltese: MSD Polska Sp. z o.o. Tel.: +48 22 549 51 00 msdpolska@merck.com
English: Adverse reactions were evaluated in 19,632 patients treated with Zontivity [13,186 patients, including 2,187 patients treated for more than 3 years, in the TRA 2°P TIMI 50 (Thrombin Receptor Antagonist in Secondary Prevention of Atherothrombotic Ischemic Events) study and 6,446 patients in the TRACER (Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome) study].
Maltese: Reazzjonijiet avversi ġew evalwati f'19,632 pazjent ikkurati b'Zontivity [13,186 pazjent inkluż 2,187 pazjent ikkurati għal aktar minn 3 snin, fl-istudju TRA 2°P TIMI 50
English: Packs of 10 and 50 tablets in aluminium unit-dose blister cards.
Maltese: Pakketti ta' 10 u 50 pillola f'folji tal-aluminju rettangolari b'dożi waħdiet.
English: Overall Population
Maltese: Popolazzjoni Totali
English: Suomi/Finland MSD Finland Oy Puh/Tel: +358 (0) 9 804650 info@msd.fi
Maltese: +358 (0) 9 804650 info@msd.fi
English: At a dose of 2.5 mg of vorapaxar sulfate (equivalent to 2.08 mg vorapaxar) daily, vorapaxar consistently achieves ≥80% inhibition of TRAP-induced platelet aggregation within one week of initiation of treatment.
Maltese: B'doża ta' 2.5 mg ta' vorapaxar sulfate (ekwivalenti għal 2.08 mg vorapaxar) kuljum, vorapaxar jikseb b'mod konsistenti inibizzjoni ta' ≥80% ta' tagħqid tal-plejtlits ikkaġunata minn TRAP fi żmien ġimgħa minn meta tinbeda l-kura.
English: Primary Efficacy Endpoint (CV death/MI/stroke/UCR) CV Death
Maltese: CV/MI/puplesija/UCR)
English: Placebo (n= 10,049)
Maltese: Plaċebo (n=10,049)
English: In repeat dose oral toxicity studies in rodents and monkeys, the principal treatment-related findings were urinary bladder and ureter hyperplasia in mice, hepatic vascular thrombi, lymphoid necrosis and retinal vacuolation in rats and phospholipidosis in all species.
Maltese: Fi studji dwar effett tossiku minn għoti ta' dożi ripetuti mill-ħalq fl-annimali gerriema u fix-xadini, issejbiet prinċipali marbuta mal-kura kienu iperplasja fil-bużżieqa tal-awrina u fil-ureter fil-ġrieden, trombi vaskulari fil-fwied, nekrożi tat-tessut tal-limfa u vakwolazzjoni tar-retina fil-firien u fosfolipidożi fl-ispeċi kollha.
English: Packs of 10 and 50 film-coated tablets in aluminium/aluminium unit-dose blister cards.
Maltese: Pakketti ta' 10 u 50 pillola miksija b'rita f'folji rettangolari tal-aluminju/aluminju b'dożi waħdiet.
English: Age, gender, weight and race were included as factors assessed in the population pharmacokinetic model to evaluate vorapaxar pharmacokinetics in healthy subjects and patients:
Maltese: Età, sess, piż u razza ġew inklużi bħala fatturi stmati fil-mudell farmakokinetiku ta' popolazzjoni biex jistma l-farmakokinetika ta' vorapaxar f'individwi f'saħħithom u pazjenti:
English: Hazard Ratio is vorapaxar group versus placebo group.
Maltese: Il-Proporzjon ta' periklu huwa l-grupp ta' vorapaxar versus il-grupp ta' plaċebo.
English: TRA 2°P - TIMI 50 was a multicenter, randomized, double-blind, placebo-controlled study conducted in patients who had evidence or a history of atherosclerosis involving the coronary, cerebral, or peripheral vascular systems.
Maltese: TRA 2°P - TIMI 50 kien studju b'ħafna ċentri, double-blind, ikkontrollat bi plaċebo, f'pazjenti li ntgħażlu b'mod każwali li kellhom xhieda jew storja ta' aterosklerożi li tinvolvi s-sistemi vaskulari korornarji, ċerebrali jew periferali.
English: When administered in addition to standard care, generally acetylsalicylic acid and a thienopyridine, compared with standard care alone, Zontivity increased the risk of GUSTO (Global utilization of streptokinase and tpa for occluded arteries) moderate or severe bleeding (see section 4.8).
Maltese: Zontivity żied ir-riskju ta' fsada moderata jew qawwija GUSTO (Global utilisation of streptokinase and tpa for occluded arteries - Użu globali ta' streptokinase u tpa għal arterji miżdudin) (ara sezzjoni.
English: In TRA 2°P - TIMI 50, in vorapaxartreated patients, including those with history of stroke, a higher rate of ICH was observed in patients weighing <60 kg compared to patients weighing ≥60 kg. Zontivity should be used with caution in patients with a body weight <60 kg.
Maltese: Fi TRA 2°PTIMI 50, f'pazjenti kkurati b'vorapaxar, inkluż dawk bi storja ta' puplesija, kienet osservata rata ogħla ta' ICH f'pazjenti li kienu jiżnu <60 kg meta mqabbla ma' pazjenti li jiżnu ≥60 kg.
English: The adverse reactions in the vorapaxar-treated (n=10,059) and placebo-treated (n=10,049) post-MI or PAD patients with no history of stroke or TIA are shown below.
Maltese: Ir-reazzjonijiet avversi f'pazjenti kkurati b'vorapaxar (n=10,059) u bi plaċebo (n=10,049) wara
English: Film-coating: lactose monohydrate; hypromellose (E464); titanium dioxide (E171); triacetin (E1518); iron oxide yellow (E172).
Maltese: Kisja tar-rita: lactose monohydrate; hypromellose (E464); titanium dioxide (E171); triacetin
English: In patients treated with vorapaxar the concomitant use of heparin (including low molecular weight heparin (LMWH)) might be associated with an increased risk of bleeding and caution is advised.
Maltese: F'pazjenti kkurati b'vorapaxar, l-użu flimkien ma' heparin (inkluż heparin b'piż molekulari baxx (LMWH - low molecular weight heparin)) jista' jkun assoċjat ma' żieda fir-riskju ta' fsada u hija rrakkomandata kawtela.
English: When Zontivity was co-administered with warfarin, there were no alterations in the pharmacokinetics or pharmacodynamics of warfarin.
Maltese: Meta Zontivity ingħata ma' warfarin, ma kien hemm l-ebda tibdil fil-farmakokinetika jew filfarmakodinamika ta' warfarin.
English: In post-MI or PAD patients with no history of stroke or TIA, an analysis of multiple occurrences of adjudicated endpoints indicates that Zontivity was associated with a reduction in the incidence of recurrent events.
Maltese: MI jew b'PAD mingħajr l-ebda storja ta' puplesija jew TIA, analiżi ta' okkorrenzi multipli ta' punti finali iġġudikati tindika li Zontivity kien assoċjat ma' tnaqqis fl-inċidenza ta' avvenimenti rikurrenti.
English: Each tablet contains 2.08 mg of vorapaxar (as vorapaxar sulfate).
Maltese: Kull pillola fiha 2.08 mg ta' vorapaxar (bħala vorapaxar sulfate).
English: Co-administration with vorapaxar did not alter the single-dose pharmacokinetics of rosiglitazone (8 mg), a CYP2C8 substrate not marketed in the EU.
Maltese: L-għoti flimkien ma' vorapaxar ma bidilx il-farmakokinetika ta'doża waħda ta' rosiglitazone (8 mg), li huwa sustrat ta' CYP2C8 li mhuwiex qiegħed fis-suq fl-UE.
English: A history of bleeding disorders and use of certain concomitant medicinal products (e.g., anticoagulant and fibrinolytic therapy, and chronic nonsteroidal anti-inflammatory drugs (NSAIDS), selective serotonin reuptake inhibitors, serotonin norepinephrine reuptake inhibitors) may also increase the risk of bleeding in patients taking Zontivity.
Maltese: Storja ta' disturbi tal-fsada u użu ta' ċerti prodotti mediċinali flimkien miegħu (eż., terapija kontra l-koagulazzjoni jew fibrinolitika, u użu kroniku ta' mediċini antiinfjammatorji mhux sterojdi (NSAIDS - nonsteroidal anti-inflammatory drugs), inibituri tarriassorbiment selettiv ta' serotonin, inibituri tar-riassorbiment ta' serotonin u norepinephrine) jistgħu wkoll iżidu r-riskju ta' fsada f'pazjenti li jkunu qed jieħdu Zontivity.
English: Vorapaxar exposure increases in an approximately dose-proportional manner following single doses of 1 to 40 mg and multiple doses of 0.5 to 2.5 mg of vorapaxar sulfate.
Maltese: L-esponiment għal vorapaxar jiżdied, bejn wieħed u ieħor, b'mod fi proporzjon mad-doża wara dożi waħdiet ta' milligramma waħda sa 40 mg u ħafna dożi ta' 0.5 sa 2.5 mg ta' vorapaxar sulfate.
English: When Zontivity was co-administered with prasugrel, no clinically significant pharmacokinetic interaction was demonstrated.
Maltese: Meta Zontivity ingħata flimkien ma' prasugrel, ma ntweriet l-ebda interazzjoni farmakokinetika sinifikanti b'mod kliniku.
English: Among post-MI or PAD patients without a history of stroke or TIA, Zontivity appeared to reduce the rate of definite stent thrombosis (HR 0.71 (0.51-0.99 for adjudicated “definite”) vs. placebo in subjects receiving any stent before or during the study.
Maltese: MI jew b'PAD mingħajr l-ebda storja ta' puplesija jew TIA, Zontivity deher li jnaqqas ir-rata ta' trombożi żgura tal-istent (HR 0.71 (0.51-0.99 għal “żgura” iġġudikata) vs. plaċebo f'individwi jirċievu kwalunkwe stent qabel jew waqt l-istudju.