FrancophonIA/ELRC3.0 huggingface dataset:
English: The company that markets Perjeta will carry out a study to assess the effects of using Perjeta and trastuzumab together with a type of cancer medicines called taxanes, in previously untreated patients with HER2-positive metastatic or locally advanced breast cancer.
Maltese: Il-kumpanija li tqiegħed Perjeta fis-suq se twettaq studju sabiex tivvaluta l-effetti tal-użu ta' Perjeta u trastuzumab flimkien ma' tip ta' mediċini kontra l-kanċer li jissejħu tassani, f'pazjenti b'kanċer tassider metastatiku pożittiv għall-HER2 jew avvanzat li ma kinux irċevew kura preċedenti.
English: This is followed by a dose of 420 mg every three weeks, with each dose given over half an hour to one hour.
Maltese: Din tiġi segwita minn doża ta' 420 mg kull tliet ġimgħat, kull doża tingħata fuq perjodu ta' nofs siegħa sa siegħa.
English: For the full list of all side effects and restrictions with Perjeta, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet b'Perjeta, ara l-fuljett ta' tagħrif.
English: The Agency considered that, despite the side effects of Perjeta, the overall safety profile was acceptable.
Maltese: L-Aġenzija kkunsidrat li, minkejja l-effetti sekondarji ta' Perjeta, il-profil ġenerali tas-sigurtà kien aċċettabbli.
English: Side effects reported with Perjeta are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Perjeta huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: Blister (PVC/aluminium) 70x1 tablets
Maltese: Daqs tal-pakkett folji (PVC/aluminju) 70x1 pillola
English: EU number administration
Maltese: Numru ta' l-EU
English: The full EPAR for Reagila can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Reagila contains the active substance cariprazine.
Maltese: Reagila fih is-sustanza attiva cariprazine.
English: Reagila is available as capsules (1.5, 3, 4.5 and 6 mg) to be taken by mouth.
Maltese: Reagila jiġi bħala kapsuli (1.5, 3, 4.5 u 6 mg) li għandhom jittieħdu mill-ħalq.
English: Other information about Reagila
Maltese: Informazzjoni oħra dwar Reagila
English: In three main studies in a total of 1,795 adults, Reagila was more effective than placebo (a dummy treatment) at reducing symptoms on a standard rating scale called PANSS (positive and negative syndrome scale).
Maltese: Fi tliet studji ewlenin f'total ta' 1,795 adult, Reagila kien aktar effettiv mill-plaċebo (kura finta) biex inaqqas is-sintomi fuq skala ta' klassifikazzjoni standard imsejħa PANSS (skala ta' sindrome pożittiv u negattiv, positive and negative syndrome scale).
English: This is a summary of the European public assessment report (EPAR) for Reagila.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta᾽ valutazzjoni (EPAR) għal Reagila.
English: The dose can be increased by 1.5 mg at a time up to a maximum of 6 mg per day.
Maltese: Id-doża tista' tiżdied b'1.5 mg kull darba sa massimu ta' 6 mg kuljum.
English: Why is Reagila approved?
Maltese: Għaliex ġie approvat Reagila?
English: A fourth main study in 461 patients who mostly had ‘negative' symptoms (such as lack of drive, social withdrawal, and problems with attention and memory) and only few ‘positive' symptoms (such as delusions and hallucinations) showed that Reagila was effective at treating negative symptoms: after 26 weeks of treatment Reagila lowered the PANSS score for negative symptoms by around 9 points compared with around 7 points with another medicine, risperidone.
Maltese: Ir-raba' studju ewlieni f'461 pazjent li l-aktar kellhom sintomi “negattivi” (bħal nuqqas ta' motivazzjoni, nuqqas ta' interazzjoni soċjali, u problemi bl-attenzjoni u l-memorja) u ftit sintomi “pożittivi” biss (bħal delużjonijiet u alluċinazzjonijiet) wera li Reagila kien effettiv biex jikkura s-sintomi negattivi: wara 26 ġimgħa ta' kura
English: The most common side effects with Reagila are akathisia (a constant urge to move) and parkinsonism (effects similar to Parkinson's disease such as shaking, muscle stiffness and slow movement).
Maltese: L-effetti sekondarji l-aktar komuni b'Reagila huma akatiżja (urġenza kostanti biex tiċċaqlaq) u parkinsoniżmu (effetti simili għall-marda ta' Parkinson bħal tertir, ebusija fil-muskoli u moviment bilmod).
English: Reagila is an antipsychotic medicine used to treat schizophrenia in adults.
Maltese: Reagila huwa mediċina antipsikotika li tintuża biex tikkura l-iskizofrenja fl-adulti.
English: The PANSS score, which ranges from a minimum of 30 (no symptoms) to a maximum of 210 (severest symptoms), was around 96 at the start of treatment.
Maltese: Il-punteġġ PANSS, li jvarja minn minimu ta' 30 (lebda sintomu) għal massimu ta' 210 (l-aktar sintomi severi), kien madwar 96 fil-bidu tal-kura.
English: The recommended starting dose is 1.5 mg once a day.
Maltese: Id-doża tal-bidu rakkomandata hija ta' 1.5 mg darba kuljum.
English: The active substance in Reagila, cariprazine, attaches to receptors (targets) in the brain for two neurotransmitters called dopamine and serotonin, which nerve cells use to communicate with neighbouring cells.
Maltese: Is-sustanza attiva f'Reagila, cariprazine, teħel mar-riċetturi (miri) fil-moħħ għal żewġ newrotrażmettituri li jissejħu dopamine u serotonin, li ċ-ċelloli tan-nervituri jużawhom biex jikkomunikaw maċ-ċelloli ta' ħdejhom.
English: After 6 weeks, depending on the study, the PANSS score fell by 17 to 23 points with Reagila compared with 9 to 14 points with placebo.
Maltese: Wara 6 ġimgħat, skont l-istudju, il-punteġġ PANSS niżel bi 17 għal 23 punt b'Reagila meta mqabbel ma' 9 għal 14-il punt bil-plaċebo.
English: What are the risks associated with Reagila?
Maltese: X' inhuma r-riskji assoċjati ma' Reagila?
English: Finally, a fifth main study in 200 patients showed that Reagila was more effective than placebo at preventing symptoms from coming back after initial treatment.
Maltese: Finalment, il-ħames studju ewlieni f'200 pazjent wera li Reagila kien aktar effettiv mill-plaċebo biex jipprevjeni milli jirritornaw is-sintomi wara kura inizjali.
English: Side effects are mostly mild or moderate.
Maltese: L-effetti sekondarji huma l-aktar ħfief jew moderati.
English: Most of the side effects are as expected with antipsychotic medicines and many can be treated.
Maltese: Ħafna mill-effetti sekondarji huma kif mistennija b'mediċini antipsikotiċi u bosta jistgħu jiġu kkurati.
English: For the full list of all side effects and restrictions with Reagila, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet kollha rrappurtati b'Reagila, ara l-fuljett ta' tagħrif.
English: Since dopamine and serotonin play a role in schizophrenia, by attaching to their receptors, cariprazine helps normalise the activity of the brain.
Maltese: Peress li dopamine u serotonin għandhom rwol fl-iskizofrenja, meta jeħel mar-riċetturi tagħhom, cariprazine jgħin biex jinnormalizza l-attività tal-moħħ.
English: Schizophrenia is a mental illness with symptoms such as delusions, disorganised thinking and speech, suspiciousness and hallucinations (hearing or seeing things that are not there).
Maltese: L-iskizofrenja hija marda mentali b'sintomi bħal delużjonijiet, diżorganizzazzjoni fil-ħsibijiet u l-kliem, suspetti u alluċinazzjonijiet (smigħ jew viżjoni ta' oġġetti li mhumiex hemm).
English: Studies showed that Reagila improves symptoms of schizophrenia and prevents symptoms from returning.
Maltese: L-istudji wrew li Reagila jtejjeb is-sintomi tal-iskizofrenja u jipprevjeni milli s-sintomi jirritornaw.
English: Over a 72 week period, symptoms returned in a quarter of patients taking Reagila compared with around half of those taking placebo.
Maltese: Fuq perjodu ta' 72 ġimgħa, is-sintomi rritornaw fi kwart tal-pazjenti li kienu qed jieħdu Reagila meta mqabbla ma' madwar nofs ta' dawk li kienu qed jieħdu l-plaċebo.
English: Hypersensitivity including angioedema
Maltese: Sensittività eċċessiva inkluż anġjoedema
English: • Active pathological bleeding.
Maltese: • Fsada patoloġika attiva.
English: KM% p-value
Maltese: KM% valur-p
English: PLATO study (Acute Coronary Syndromes)
Maltese: Studju PLATO (Sindromi Koronarji Akuti)
English: Gastrointestinal haemorrhage g,
Maltese: Emorriġija gastrointestinali g,
English: A negative RRR indicates a relative risk increase.
Maltese: RRR negattiv jindika żieda tar-riskju relattiv.
English: AstraZeneca UK Limited Silk Road Business Park Macclesfield, Cheshire, SK10 2NA United Kingdom
Maltese: AstraZeneca UK Limited Silk Road Business Park Macclesfield Cheshire, SK10 2NA Ir-Renju Unit
English: • Severe hepatic impairment (see sections 4.2, 4.4 and 5.2).
Maltese: • Indeboliment epatiku sever (ara sezzjonijiet 4.2, 4.4 u 5.2).
English: Other medicines and Brilique
Maltese: Mediċini oħra u Brilique
English: Excluding silent MI.
Maltese: MI (eskluż MI silenzjuż)
English: ASA alone N = 7067
Maltese: ASA waħdu N = 7067
English: ASA alone N=6996
Maltese: ASA waħdu N=6996
English: Adverse reactions are listed by MedDRA System Organ Class (SOC).
Maltese: Ir-reazzjonijiet avversi elenkati mis-Sistema tal-Klassifika tal-Organi (SOC) ta' MedDRA.
English: Effects of medicinal and other products on ticagrelor
Maltese: Effetti ta' prodotti mediċinali u prodotti oħra fuq ticagrelor
English: Exposure of the active metabolite increased to a lesser extent (AUC 13-14% and Cmax 17-36%).
Maltese: L-esponiment tal-metabolit attiv żdied sa limitu inqas (AUC 13-14% and Cmax 17-36%).
English: p-value*
Maltese: valur-p*
English: АстраЗенека България ЕООД Teл.
Maltese: АстраЗенека България ЕООД
English: PEGASUS study (History of Myocardial Infarction)
Maltese: Studju PEGASUS (Storja ta' Infart Mijokardijaku)
English: Table 1 - Adverse reactions by frequency and system organ class (SOC)
Maltese: Tabella 1 - Reazzjonijiet avversi skont il-frekwenza u s-sistema tal-klassifika tal-organi (SOC)
English: Tabulated list of adverse reactions
Maltese: Lista tabulata reazzjonijiet avversi
English: Premature discontinuation
Maltese: Twaqqif prematur
English: Cyclosporine (P-gp and CYP3A inhibitor)
Maltese: Cyclosporine (inibitur ta' P-gp u CYP3A)
English: Clinical safety
Maltese: Sigurtà Klinika
English: Clopidogrel 75 mg once daily (% patients with event) N=9291
Maltese: Clopidogrel 75 mg darba kuljum (% tal-pazjenti b'każ) N=9291
English: PLATO-defined bleeding categories
Maltese: Kategoriji ta' PLATO-definiti
English: Nominal significance value; all others are formally statistically significant by pre-defined hierarchical testing.
Maltese: Valur ta' sinifikat nominali; l-oħrajn kollha huma statistikament sinifikanti b'testijiet ta' ġerarkija pre-definita.
English: Acute coronary syndromes
Maltese: Sindromi koronarji akuti
English: Therefore, premature discontinuation of treatment should be avoided.
Maltese: Ittwaqqif prematur tal-kura għandu jiġi evitat.
English: Clopidogrel N=9186 p-value*
Maltese: Clopidogrel N=9186
English: KM percentage calculated at 36 months.
Maltese: Perċentwal KM ikkalkolat wara 36 xahar.
English: • The PLATO [PLATelet Inhibition and Patient Outcomes] study, a comparison of ticagrelor to clopidogrel, both given in combination with ASA and other standard therapy.
Maltese: • L-istudju PLATO [PLATelet Inhibition and Patient Outcomes], paragun ta' ticagrelor ma' clopidogrel, li t-tnejn ingħataw flimkien ma' ASA u terapija standard oħra.
English: Ticagrelor does not affect tests of pulmonary function.
Maltese: Ticagrelor ma jaffettwax testijiet tal-funzjoni pulmonari
English: The primary variable of interest was the occurrence of ventricular pauses ≥3 seconds.
Maltese: Ilvarjant ewlieni ta' interess kien li seħħew pawżi ventrikolari ta' ≥3 sekondi.
English: Al/Al perforated unit dose blister of 8 or 10 tablets; cartons of 10 x 1 tablets (1 blister), cartons of 56 x 1 tablets (7 blisters) and cartons of 60 x 1 tablets (6 blisters).
Maltese: Folja b'unità ta' doża mtaqqba Al/Al ta' 8 jew 10 pilloli; kartun ta'10 x 1 pilloli (folja 1), kartun ta' 56 x 1 pilloli (7 folji) u kartun ta' 60 x 1 pilloli (6 folji).
English: Each of the components contributed to the reduction in the primary composite endpoint (CV death 17% RRR, MI 16% RRR and stroke 25% RRR).
Maltese: Kull wieħed mill-komponenti kkontribwixxa għat-tnaqqis fil-punt ta' tmiem primarju (mewt CV 17% RRR, MI 16% RRR u puplesija 25% RRR).
English: The corresponding numbers in PEGASUS were 9.1%, 8.8% and 5.5% for ticagrelor 90 mg, 60 mg and placebo, respectively.
Maltese: In-numri korrispondenti f'PEGASUS kienu ta' 9.1%, 8.8% u 5.5% għal ticagrelor 90 mg, 60 mg u plaċebo, rispettivament.
English: Medicinal products metabolised by CYP3A4
Maltese: Prodotti mediċinali metabolizzati b'CYP3A4
English: Ticagrelor 60 mg twice daily + ASA N=6958
Maltese: Ticagrelor 60 mg darbtejn kuljum + ASA N=6958
English: Uric acid increase
Maltese: Żieda fil-uric acid
English: The steady state volume of distribution of ticagrelor is 87.5 l. Ticagrelor and the active metabolite is extensively bound to human plasma protein (>99.0%).
Maltese: Il-volum ta' distribuzzjoni fi stat fiss ta' ticagrelor huwa 87.5 l. Ticagrelor ul-metabolit attiv jeħlu b'mod estensiv mal-proteina fil-plażma tal-bniedem (>99.0%).
English: • phenytoin, carbamazepine and phenobarbital (used to control seizures)
Maltese: • phenytoin, carbamazepine u phenobarbital (jintużaw sabiex jikkontrollaw l-aċessjonijiet)
English: Table 5 - Analysis of primary and secondary efficacy endpoints (PEGASUS)
Maltese: Tabella 5 - Analiżi tal-punti ta' tmiem primarji u sekondarji tal-effikaċja (PEGASUS)
English: • Selective Serotonin Reuptake Inhibitors (abbreviated as SSRIs) taken as antidepressants such as paroxetine, sertraline and citalopram.
Maltese: • Inibituri Selettivi ta' Reuptake tas-Serotonin (fil-qasir SSRIs - selective serotonin reuptake inhibitors) jittieħdu bħala anti-depressanti bħal paroxetine, sertraline u citalopram.
English: Ticagrelor 60 mg twice daily +ASA N = 7045
Maltese: Ticagrelor 60 mg darbtejn kuljum +ASA N = 7045
English: Ticagrelor may have similar effect on lovastatin.
Maltese: Ticagrelor jista' jkollu effett simili fuq lovastatin.
English: TIMI-defined bleeding categories
Maltese: TIMI-definit Maġġuri
English: • beta blockers and verapamil (used to treat high blood pressure)
Maltese: • beta-blockers u verapamil (jintużaw għall-kura ta' pressjoni għolja)
English: The PEGASUS TIMI-54 study was a 21,162 patient, event-driven, randomised, double-blind, placebo-controlled, parallel group, international multicentre study to assess the prevention of atherothrombotic events with ticagrelor given at 2 doses (either 90 mg twice daily or 60 mg twice daily) combined with low dose ASA (75-150 mg), compared to ASA therapy alone in patients with history of MI and additional risk factors for atherothrombosis.
Maltese: L-istudju PEGASUS TIMI-54 kien studju multiċentriku internazzjonali, ta' grupp parallel, ikkontrollat bi plaċebo, double-blind, randomizzat, immexxi mill-avvenimenti ta' 21,162 pazjent biex tiġi vvalutata l-prevenzjoni ta' avvenimenti ateretrombotiċi b'ticagrelor mogħti f'2 dożi (jew 90 mg darbtejn kuljum jew 60 mg darbtejn kuljum) flimkien ma' ASA f'doża baxxa (75-150 mg), meta mqabbel ma' terapija ASA waħedha f'pazjenti bi storja ta' MI u fatturi ta' riskju addizzjonali għal aterotrombożi.
English: • The PEGASUS TIMI-54 [PrEvention with TicaGrelor of SecondAry Thrombotic Events in High-RiSk AcUte Coronary Syndrome Patients] study, a comparison of ticagrelor combined with ASA to ASA therapy alone.
Maltese: [PrEvention with TicaGrelor of SecondAry Thrombotic Events in High-RiSk AcUte Coronary Syndrome Patients], paragun ta' ticagrelor flimkien ma' terapija ASA ma' ASA waħedha.
English: • The other ingredients are: mannitol (E421), microcrystalline cellulose (E460), crospovidone (E1202), xylitol (E967), anhydrous calcium hydrogen phosphate (E341), sodium stearyl fumarate, hydroxypropylcellulose (E463), colloidal anhydrous silica.
Maltese: • L-eċċipjenti l-oħra huma: mannitol (E421), microcrystalline cellulose (E460), crospovidone (E1202), xylitol (E967), anhydrous calcium hydrogen phosphate (E341), sodium stearyl fumarate, hydroxypropylcellulose (E463), colloidal anhydrous silica.
English: Table 3 - Analysis of overall bleeding events, Kaplan-Meier estimates at 36 months (PEGASUS)
Maltese: Tabella 3 - Analiżi tal-avvenimenti globali ta' fsada, stimi ta' Kaplan-Meier wara 36 xahar (PEGASUS)
English: Date of first authorisation: 03 December 2010 Date of latest renewal: 17 July 2015
Maltese: Data tal-aħħar tiġdid: 17 Lulju 2015
English: Ticagrelor also increases local endogenous adenosine levels by inhibiting the equilibrative nucleoside transporter-1 (ENT-1).
Maltese: Ticagrelor iżid ukoll il-livelli ta' adenosine endoġenużi lokali billi jinibixxi t-trasportatur nukleoside ekwilibrattiv -1 (ENT-1).
English: • more than 40 mg daily of either simvastatin or lovastatin (medicines used to treat high cholesterol)
Maltese: • Aktar minn 40 mg kuljum ta' simvastatin jew lovastatin (mediċini li jintużaw sabiex ibaxxu l kolesterol)
English: Ticagrelor 90 mg twice daily N=9235
Maltese: Ticagrelor 90 mg darbtejn kujum N=9235
English: Treating 54 ACS patients with ticagrelor instead of clopidogrel will prevent 1 atherothrombotic event; treating 91 will prevent 1 CV death (see Figure 1 and Table 4).
Maltese: Meta 54 pazjent ACS jiġu ikkurati b'ticagrelor minflok bi clopidogrel jiġi evitat każ aterotrombotiku 1; meta jiġu ikkurati 91 tiġi evitata mewta 1 b'CV (ara Figura 1 u Tabella 4).
English: Brilique, co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with - acute coronary syndromes (ACS) or - a history of myocardial infarction (MI) and a high risk of developing an atherothrombotic event (see sections 4.2 and 5.1).
Maltese: Brilique, mogħti ma' acetylsalicylic acid (ASA), huwa indikat għall-prevenzjoni ta' każijiet aterotrombotiċi f'pazjenti adulti - b'sindromi akuti koronarji (ACS) jew - storja ta' infart mijokardijaku (MI) u riskju għoli ta' żvilupp ta' avveniment aterotrombotiku (ara sezzjonijiet 4.2 u 5.1).
English: Co-administration of cyclosporine (600 mg) with ticagrelor increased ticagrelor Cmax and AUC equal to 2.3-fold and 2.8-fold, respectively.
Maltese: L-għoti flimkien ta' cyclosporine (600 mg) ma' ticagrelor żied ticagrelor Cmax u AUC daqs 2.3 drabi u 2.8 drabi, rispettivament.
English: Frequency categories are defined according to the following conventions: Very common (≥1/10), common (≥1/100 to 1/10), uncommon (≥1/1,000 to 1/100), rare (≥1/10,000 to 1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Maltese: Il-kategoriji tal-frekwenza huma definiti skont il-konvenzjonijiet li ġejjin: Komuni ħafna (≥1/10), komuni (≥1/100 sa 1/10), mhux komuni (≥1/1,000 sa 1/100), rari (≥1/10,000 sa 1/1,000), rari ħafna (<1/10,000), mhux magħruf (ma jistax jiġi stmat mid-dejta disponibbli).
English: There were few fatal bleeding events in the study, 11 (0.3%) for ticagrelor 60 mg and 12 (0.3%) for ASA therapy alone.
Maltese: Kien hemm ftit avvenimenti ta' fsada fatali fl-istudju, 11 (0.3%) għal ticagrelor 60 mg u 12 (0.3%) għal terapija b'ASA waħdu.
English: Calcium hydrogen phosphate dihydrate Magnesium stearate (E470b) Sodium starch glycolate type A Hydroxypropylcellulose (E463)
Maltese: Calcium hydrogen phosphate dihydrate Magnesium stearate (E470b) Sodium starch glycolate tip A Hydroxypropyl-cellulose (E463)
English: The RRR for the composite endpoint from 1 to 360 days (17% RRR) and from 361 days and onwards (16% RRR) was similar.
Maltese: L-RRR għall-punt ta' tmiem kompost minn 1 sa 360 jum (17% RRR) u minn 361 jum 'il quddiem (16% RRR) kien simili.
English: Dizziness, Syncope, Headache
Maltese: Sturdament, Sinkope, Uġigħ ta' ras
English: • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 (see section 4.8).
Maltese: • Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis-sezzjoni 6.1 (ara sezzjoni 4.8).
English: Figure 1 - Analysis of primary clinical composite endpoint of CV death, MI and stroke (PLATO)
Maltese: Figura 1 - Analiżi tal-punt ta' tmiem kompost primarju ta' mewt CV, MI u puplesija (PLATO)
English: The pharmacokinetics of ticagrelor and AR-C124910XX in patients with a history of MI were generally similar to that in the ACS population.
Maltese: Il-farmakokinetika ta' ticagrelor u AR-C124910XX f'pazjenti bi storja ta' MI kienu ġeneralment simili għal dawk talpopolazzjoni ACS.
English: Chronic daily ASA doses to accompany ticagrelor should be 75-150 mg (see sections 4.2 and 4.4).
Maltese: Dożi kroniċi ta' ASA kuljum li jmorru ma' ticagrelor għandhom ikunu 75-150 mg (ara sezzjoni 4.2 u 4.4)
English: Table 2 - Analysis of overall bleeding events, Kaplan-Meier estimates at 12 months (PLATO)
Maltese: Tabella 2 - Analiżi tal-avvenimenti ta' fsada globali, stimi ta' Kaplan-Meier wara 12-il xahar (PLATO)
English: • PVC-PVDC/Al perforated unit dose transparent blister of 10 tablets; cartons of 100x1 tablets (10 blisters).
Maltese: • Folja trasparenti tal-PVC-PVDC/Al imtaqqba għal doża individwali ta' 10 pilloli; kartuna ta' 100 pillola (10 folji).
English: The systemic exposure to the active metabolite is approximately 30-40% of that obtained for ticagrelor.
Maltese: L-esponiment sistematiku għall-metabolit attiv huwa madwar 30-40% ta' dak miksub għal ticagrelor.
English: PLATO Total Major PLATO Major Fatal/Life-Threatening Non-CABG PLATO Major Non-Procedural PLATO Major PLATO Total Major + Minor Non-Procedural PLATO Major + Minor TIMI-defined Major TIMI-defined Major + Minor
Maltese: PLATO Maġġuri Fatali/Ta' theddida għall-ħajja 5.8 Mhux-CABG PLATO Maġġuri Mhux-Proċedurali PLATO Maġġuri PLATO Totali Maġġuri + Minuri Mhux-Proċedurali PLATO Maġġuri + Minuri TIMI-definit Maġġuri
English: The corresponding numbers for gout/gouty arthritis in PEGASUS were 1.6%, 1.5% and 1.1% for ticagrelor 90 mg, 60 mg and placebo, respectively.
Maltese: In-numri korrispondenti għal gotta/artrite bil-gotta f'PEGASUS kienu ta' 1.6%, 1.5% u 1.1% għal ticagrelor 90 mg, 60 mg u plaċebo, rispettivament.
English: 90% of patients had final extent IPA>70% by 2 hours post dose.
Maltese: 90% tal-pazjenti kellhom estent IPA finali ta' >70% wara sagħtejn mid-doża.
English: Brilique contains an active substance called ticagrelor.
Maltese: Brilique fih sustanza attiva li tissejjaħ ticagrelor.
English: Figure 2 - Analysis of primary clinical composite endpoint of CV death, MI and stroke (PEGASUS)
Maltese: 2 - Analiżi tal-punt ta' tmiem kompost kliniku primarju ta' mewt CV, MI u puplesija (PEGASUS)
English: clarithromycin, nefazodone, ritonavir and atazanavir), as co-administration may lead to a substantial increase in exposure to ticagrelor (see section 4.5).
Maltese: clarithromycin, nefozodone, ritonavir u atazanavir), dan jista' jwassal għal żieda sostanzjali fl esponiment għal ticagrelor (ara sezzjoni 4.5).
English: In absolute terms, this risk was higher than in the overall PLATO population.
Maltese: F'termini assoluti, dan ir-riskju kien ogħla milli filpopolazzjoni ġenerali ta' PLATO.
English: Both 60 mg twice daily and 90 mg twice daily regimens of ticagrelor in combination with ASA were superior to ASA alone in the prevention of atherothrombotic events (composite endpoint: CV death, MI and stroke), with a consistent treatment effect over the entire study period, yielding a 16% RRR and 1.27% ARR for ticagrelor 60 mg and a 15% RRR and 1.19% ARR for ticagrelor 90 mg.
Maltese: Kemm ir-reġim ta' 60 mg darbtejn kuljum kif ukoll dak ta' 90 mg darbtejn kuljum ta' ticagrelor flimkien ma' ASA kienu superjuri għal ASA waħdu fil-prevenzjoni ta' avvenimenti aterotrombotiċi (punt ta' tmiem kompost: mewt CV, MI u puplesija), b'effett ta' kura konsistenti matul il-perjodu ta' studju kollu, li jirriżulta f'16% RRR u 1.27% ARR għal ticagrelor 60 mg u 15% RRR u 1.19% ARR għal ticagrelor 90 mg.