FrancophonIA/ELRC3.0 huggingface dataset:
English: • PVC-PVDC/Al transparent calendar blister (with sun/moon symbols) of 14 tablets; cartons of 14 tablets (1 blister), 56 tablets (4 blisters) and 168 tablets (12 blisters).
Maltese: • Folji trasparenti bil-ġranet (b'simboli tax-xemx/qamar) ta' 14-il pillola tal-PVC-PVDC/Al f'kartun ta' 14-il pillola (folja 1), 56 pillola (4 folji) u 168 pillola (12-il folja).
English: Spontaneous ICHs were reported in similar rates for ticagrelor 60 mg and ASA therapy alone (n=13, 0.2% in both treatment groups).
Maltese: Kienu rrapportati ICHs spontanji b'rati simili għal ticagrelor 60 mg u terapija ASA waħedha (n=13, 0.2% fiż-żewġ gruppi ta' kura).
English: CYP3A4 is the major enzyme responsible for ticagrelor metabolism and the formation of the active metabolite and their interactions with other CYP3A substrates ranges from activation through to inhibition.
Maltese: CYP3A4 huwa l-enzima maġġuri responsabbli għal metaboliżmu ta' ticagrelor u l-formazzjoni talmetabolit attiv u l-interazzjonijiet tagħhom ma' sottostrati oħra ta' CYP3A ivarjaw minn attivazzjoni għal inibizzjoni.
English: In PEGASUS, a reversible increase in mean serum uric acid levels of 6.3% and 5.6% was found for ticagrelor 90 mg and 60 mg, respectively, compared to a 1.5% decrease in the placebo group.
Maltese: F'PEGASUS, kienet instabet żieda riversibbli fil-livelli medji ta' uric acid ta' 6.3% u 5.6% għal ticagrelor 90 mg u 60 mg, rispettivment, meta mqabbel ma' tnaqqis ta' 1.5% fil-grupp ta' plaċebo.
English: EU/1/10/655/001 60 film-coated tablets EU/1/10/655/002 180 film-coated tablets EU/1/10/655/003 14 film-coated tablets EU/1/10/655/004 56 film-coated tablets EU/1/10/655/005 168 film-coated tablets EU/1/10/655/006 100x1 film-coated tablets
Maltese: EU/1/10/655/001 60 pillola miksija b'rita EU/1/10/655/002 180 pillola miksija b'rita EU/1/10/655/003 14-il pillola miksija b'rita EU/1/10/655/004 56 pillola miksija b'rita EU/1/10/655/005 168 pillola miksija b'rita EU/1/10/655/006 100x1 pillola miksija b'rita
English: EU/1/10/655/007 14 film-coated tablets EU/1/10/655/008 56 film-coated tablets EU/1/10/655/009 60 film-coated tablets EU/1/10/655/010 168 film-coated tablets EU/1/10/655/011 180 film-coated tablets
Maltese: EU/1/10/655/007 14-il pillola miksija b'rita EU/1/10/655/008 56 pillola miksija b'rita EU/1/10/655/009 60 pillola miksija b'rita EU/1/10/655/010 168 pillola miksija b'rita EU/1/10/655/011 180 pillola miksija b'rita
English: • History of intracranial haemorrhage (see section 4.8).
Maltese: • Storja ta' emorraġija fil-kranju (ara sezzjoni 4.8).
English: For further details see section 4.8.
Maltese: Għal iktar dettalji ara sezzjoni 4.8.
English: The AUC of the active metabolite was increased by 32% and Cmax was decreased by 15% in the presence of cyclosporine.
Maltese: L-AUC tal-metabolit attiv żdiedet bi 32% u s-Cmax naqas bi 15% fil-preżenza ta' cyclosporine.
English: Composite of CV Death/MI/Stroke
Maltese: Kompost ta' Mewt CV/MI/Puplesija
English: Tablet core: mannitol (E421), calcium hydrogen phosphate dihydrate, sodium starch glycolate type A, hydroxypropylcellulose (E463), magnesium stearate (E470b).
Maltese: Qalba tal-pillola: mannitol (E421), calcium hydrogen phosphate dihydrate, sodium starch glycolate tip A, hydroxypropyl cellulose (E463), magnesium stearate (E470b)
English: • Simvastatin - Co-administration of ticagrelor with simvastatin increased simvastatin Cmax by 81% and AUC by 56% and increased simvastatin acid Cmax by 64% and AUC by 52% with some individual increases equal to 2- to 3-fold.
Maltese: • Simvastatin - L-għoti ta' ticagrelor flimkien ma' simvastatin żied is-Cmax ta' simvastatin b'81% u l-AUC b'56% u żied is-Cmax tal-aċidu ta' simvastatin b'64% u l-AUC b'52% b'xi wħud miżżidiet individwali jiżdiedu bid-doppju jew bi 3 darbiet.
English: Discontinuation of treatment due to non-procedural bleeding was more common for ticagrelor (2.9%) than for clopidogrel (1.2%; p<0.001).
Maltese: Ittwaqqif tal-kura minħabba fsada mhux relatata mal-proċedura kienet aktar komuni għal ticagrelor (2.9%) milli għal clopidogrel (1.2%; p<0.001).
English: Thrombotic Thrombocytopenic Purpura
Maltese: Purpura Tromboċitop enika
English: • standard blisters (with sun/moon symbols) in cartons of 60 and 180 tablets
Maltese: • Folji standard (xemx/qamar) f'kartun ta' 60 u 180 pillola
English: Diarrhoea, Nausea, Dyspepsia, Constipation
Maltese: Dijarea, Dardir, Dispnea, Stitikezza
English: Similar to the overall PLATO study, total PLATO Major bleeding did not differ between ticagrelor and clopidogrel, regardless of CYP2C19 or ABCB1 genotype.
Maltese: PLATO, Fsada Maġġuri tal-PLATO totali ma kienetx differenti bejn ticagrelor u clopidogrel, irrispettivament jekk il-ġenotip kienx CYP2C19 jew ABCB1.
English: CI = Confidence interval; CV = Cardiovascular; HR = Hazard ratio; KM = Kaplan-Meier; MI = Myocardial infarction; N = Number of patients.
Maltese: CI (Confidence Interval) = Intervall ta' kunfidenza; CV = Kardjovaskulari;
English: Ticagrelor demonstrates linear pharmacokinetics and exposure to ticagrelor and the active metabolite (AR-C124910XX) are approximately dose proportional up to 1260 mg.
Maltese: Ticagrelor għandu farmakokinetika linejari u l-esponiment għal ticagrelor u l-metabolit attiv tiegħu (AR-C124910XX) huma bejn wieħed u ieħor proporzjonali mad-doża sa 1260 mg.
English: No clinically relevant effect on oral contraceptive efficacy is expected when levonorgestrel and ethinyl estradiol are co-administered with ticagrelor.
Maltese: Mhux mistenni xi effett ta' rilevanza klinika fuq l-effikaċja tal-kontraċettiv orali meta levonorgestrel u ethinyl estradiol jingħataw flimkien ma' ticagrelor.
English: Few patients in PLATO had fatal bleeds: 20 (0.2%) for ticagrelor and 23 (0.3%) for clopidogrel (see section 4.4).
Maltese: Numru żgħir ta' pazjenti fl-istudju PLATO kellhom fsadiet fatali: 20 (0.2%) għal ticagrelor u 23 (0.3%) għal clopidogrel (ara sezzjoni 4.4).
English: In PLATO, the frequency of gouty arthritis was 0.2% for ticagrelor vs. 0.1% for clopidogrel.
Maltese: F'PLATO, il-frekwenza ta' artrite bil-gotta, kienet ta' 0.2% għal ticagrelor vs. 0.1% għal clopidogrel.
English: Compared with clopidogrel, patients with asthma/COPD treated with ticagrelor may have an increased risk of experiencing non-serious dyspnoea (3.29% ticagrelor versus 0.53% clopidogrel) and serious dyspnoea (0.38% ticagrelor versus 0.00% clopidogrel).
Maltese: Meta mqabbla ma' clopidogrel, pazjenti b'ażżma/COPD ikkurati b'ticagrelor jista' jkollhom riskju miżjud ta' li jesperjenzaw dispnea mhux serja (3.29% ticagrelor kontra 0.53% clopidogrel) u dispnea serja (0.38% ticagrelor kontra 0.00% clopidogrel).
English: Musculoskeletal connective tissue and bone
Maltese: Disturbi muskoluskeletriċi u tat-tessuti konnettivi
English: • PVC-PVDC/Al transparent blister (with sun/moon symbols) of 10 tablets; cartons of 60 tablets (6 blisters) and 180 tablets (18 blisters).
Maltese: • Folji trasparenti (b'simboli tax-xemx/qamar) ta' 10 pilloli tal-PVC-PVDC/Al; kartun ta' 60 pillola (6 folji) u 180 pillola (18-il folja).
English: TIMI Major or Minor
Maltese: TIMI Maġġuri jew Minuri
English: Brilique contains ticagrelor, a member of the chemical class cyclopentyltriazolopyrimidines (CPTP), which is an oral, direct acting, selective and reversibly binding P2Y12 receptor antagonist that prevents ADP-mediated P2Y12 dependent platelet activation and aggregation.
Maltese: Brilique fih ticagrelor, li hu membru ta' klassi kimika cyclopentyltriazolopyrimidines (CPTP), li hu antagonist tar-riċettur P2Y12 orali, li jaġixxi direttament, selettiv u li jeħel b'mod riversibbli li jipprevjeni l-attivazzjoni u l-aggregazzjoni ta' plejtlits dipendenti fuq P2Y12 medjati b'ADP.
English: Respiratory system bleedings
Maltese: Fsada mis-sistema respiratorja
English: Ticagrelor as well as the active metabolite are P-gp substrates.
Maltese: Ticagrelor kif ukoll il-metabolit attiv huma sottostrati ta' P-gP.
English: The exposure in patients self-identified as Hispanic or Latino was similar to that in Caucasians.
Maltese: L-esponiment f'pazjenti awtoidentifikati bħala Ispaniċi jew Latini kien simili ta' dik fil-Kawkażi.
English: • Atorvastatin - Co-administration of atorvastatin and ticagrelor increased atorvastatin acid Cmax by 23% and AUC by 36%.
Maltese: • Atorvastatin - L-għoti ta' atorvastatin u ticagrelor żied is-Cmax tal-aċidu ta' atorvastatin bi 23% u l-AUC b'36%.
English: Creatinine elevations
Maltese: Elevazzjonijiet tal-krejatinina
English: Tablet film-coating: hypromellose (E464), titanium dioxide (E171), macrogol 400, iron oxide black (E172), iron oxide red (E172).
Maltese: Il-kisja tar-rita tal-pillola: hypromellose (E464), titanium dioxide (E171), macrogol 400, iron oxide black (E172), iron oxide red (E172).
English: Thrombotic Thrombocytopenic Purpura (TTP) has been reported very rarely with the use of ticagrelor.
Maltese: Ġiet irrappurtata Purpura Tromboċitopenika Trombotika (TTP) f'każijiet rari ħafna bl-użu ta' ticagrelor.
English: However, no evidence of clinically significant adverse reactions was observed in the PLATO trial after concomitant administration with one or more medicinal products known to induce bradycardia (e.g. 96% beta blockers, 33% calcium channel blockers diltiazem and verapamil and 4% digoxin) (see section 4.5).
Maltese: Madankollu l-ebda evidenza ta' reazzjonijiet avversi klinikament sinifikanti ma kienet osservata fil-prova PLATO wara l-għoti flimkien ma' prodott mediċinali wieħed jew aktar magħrufin li jinduċu bradikardija (eż, 96% imblokkaturi beta, 33% imblokkaturi tal-kanal tal-kalċju diltiazem u verapamil u 4% digoxin) (ara sezzjoni 4.5).
English: A delayed and decreased exposure to oral P2Y12 inhibitors, including ticagrelor and its active metabolite, has been observed in patients with ACS treated with morphine (35% reduction in ticagrelor exposure).
Maltese: Ġiet osservata espożizzjoni mdewma u mnaqqsa għal inibituri ta' P2Y12 orali, inkluż ticagrelor u lmetabolit attiv tiegħu, f'pazjenti b'ACS ikkurati bil-morfina (tnaqqis ta' 35 % fl-espożizzjoni ta' ticagrelor).
English: Patients received a 300 mg loading dose of clopidogrel (600 mg possible if having PCI) or 180 mg of ticagrelor.
Maltese: Il-pazjenti irċievew doża tal-bidu ta' 300 mg clopidogrel (600 mg setgħu jingħataw jekk kellhom PCI) jew 180 mg ticagrelor.
English: Traumatic and procedural ICHs showed a minor increase with ticagrelor 60 mg treatment, (n=15, 0.2%) compared with ASA therapy alone (n=10, 0.1%).
Maltese: ICHs trawmatiċi u proċedurali wrew żieda minuri b'kura ta' ticagrelor 60 mg, (n=15, 0.2%) meta mqabbel ma' terapija ASA waħedha (n=10, 0.1%).
English: EU/1/10/655/012 10 x 1 orodispersible tablets EU/1/10/655/013 56 x 1 orodispersible tablets EU/1/10/655/014 60 x 1 orodispersible tablets
Maltese: EU/1/10/655/012 10 x 1 pilloli li jinħallu fil-ħalq EU/1/10/655/013 56 x 1 pilloli li jinħallu fil-ħalq EU/1/10/655/014 60 x 1 pilloli li jinħallu fil-ħalq
English: The clinical relevance is unknown, but data indicate the potential for reduced ticagrelor efficacy in patients co-administered ticagrelor and morphine.
Maltese: Ir-rilevanza klinika mhijiex magħrufa, iżda d-dejta tindika l-potenzjal għal effikaċja mnaqqsa ta' ticagrelor f'pazjenti li jingħataw ticagrelor u l-morfina flimkien.
English: In PLATO, dyspnoea adverse events (AEs) (dyspnoea, dyspnoea at rest, dyspnoea exertional, dyspnoea paroxysmal nocturnal and nocturnal dyspnoea), when combined, was reported by 13.8% of patients treated with ticagrelor and by 7.8% of patients treated with clopidogrel.
Maltese: Fi PLATO, episodji avversi (adverse events, AE) ta' dispnea (dispnea, dispnea f'serħan, dispnea waqt eżerċizzju, dispnea parossimali notturna u dispnea notturna), meta kkombinati, ġew irrapportati minn 13.8% talpazjenti kkurati b'ticagrelor u minn 7.8% tal-pazjenti kkurati bi clopidogrel.
English: Tablet coating Titanium dioxide (E171) Iron oxide black (E172) Iron oxide red (E172) Macrogol 400
Maltese: Iron oxide black (E172) Iron oxide red (E172) Macrogol 400
English: Treatment with Brilique 90 mg twice daily is recommended for 12 months in ACS patients unless discontinuation is clinically indicated (see section 5.1).
Maltese: Il-kura bi Brilique 90 mg darbtejn kuljum hija rrakkomandata għal 12-il xahar f'pazjenti ACS sakemm it-twaqqif ikun indikat klinikament (ara sezzjoni 5.1).
English: More patients had ventricular pauses with ticagrelor (6.0%) than with clopidogrel (3.5%) in the acute phase; and 2.2% and 1.6%, respectively, after 1 month (see section 4.4).
Maltese: Kien hemm iktar pazjenti li kellhom pawżi ventrikolari b'ticagrelor (6.0%) milli bi clopidogrel (3.5%) fil-fażi akuta; u 2.2% u 1.6%, rispettivament, wara xahar (ara sezzjoni 4.4).
English: Co-administration of ticagrelor and levonorgestrel and ethinyl estradiol increased ethinyl estradiol exposure approximately 20% but did not alter the pharmacokinetics of levonorgestrel.
Maltese: L-għoti flimkien ta' ticagrelor u levonorgestrel u ethinyl estradiol żied l-esponiment għal ethinyl estradiol b'madwar 20% iżda ma bidilx il-farmakokinetika ta' levonorgestrel.
English: Brilique 60 mg tablets ticagrelor
Maltese: Brilique 60 mg pilloli ticagrelor
English: AstraZeneca AB SE-151 85
Maltese: Manifattur AstraZeneca AB Gartunavagen SE-151 85
English: Effects of ticagrelor on other medicinal products
Maltese: Effetti ta' ticagrelor fuq prodotti mediċinali oħra
English: PLATO Major or Minor
Maltese: PLATO Maġġuri jew Minuri
English: In PEGASUS, patients on ticagrelor had a higher incidence of discontinuation due to adverse events compared to ASA therapy alone (16.1% for ticagrelor 60 mg with ASA vs. 8.5% for ASA therapy alone).
Maltese: F'PEGASUS, il-pazjenti fuq ticagrelor kellhom inċidenza ta' twaqqif ogħla minħabba avvenimenti avversi meta mqabbel ma' terapija ASA waħedha (16.1% għal ticagrelor 60 mg b'ASA vs. 8.5% għal terapija ASA waħedha).
English: Based on a population pharmacokinetic analysis of the PEGASUS study the median ticagrelor Cmax was 391 ng/ml and AUC was 3801 ng*h/ml at steady state for ticagrelor 60 mg. For ticagrelor 90 mg Cmax was 627 ng/ml and AUC was 6255 ng*h/ml at steady state.
Maltese: Abbażi ta' analiżi farmakokinetika tal-popolazzjoni tal-istudju PEGASUS, is-Cmax medjan ta' ticagrelor kien 391 ng/ml u l-AUC medjan kien 3801 ng*h/ml fi stat fiss għal ticagrelor 60 mg.
English: Södertälje Sweden
Maltese: Södertälje L-Isvezja
English: For ticagrelor, 0.9% of patients discontinued study drug because of dyspnoea compared with 0.1% taking clopidogrel.
Maltese: Għal ticagrelor, 0.9% tal-pazjenti waqfu l-mediċina ta' studju minħabba dispnea meta mqabbel ma' 0.1% li kienu qed jieħdu clopidogrel.
English: Other moderate CYP3A4 inhibitors (e.g. amprenavir, aprepitant, erythromycin and fluconazole) would be expected to have a similar effect and can as well be co-administered with ticagrelor.
Maltese: Inibituri moderati oħrajn ta' CYP3A4 (eż amprenavir, aprepitant, erythromycin u fluconazole) ikunu mistennija li jkollhom effett simili u jistgħu jingħataw ukoll ma' ticagrelor.
English: Co-administration of ticagrelor with tolbutamide resulted in no change in the plasma levels of either medicinal product, which suggests that ticagrelor is not a CYP2C9 inhibitor and unlikely to alter the CYP2C9 mediated metabolism of medicinal products like warfarin and tolbutamide.
Maltese: L-għoti ta' ticagrelor ma' tolbutamide ma kkawża l-ebda bidla tal-livelli fil-plażma tal-ebda wieħed mill-prodotti mediċinali, li jissuġġerixxi li ticagrelor mhuwiex inibitur ta' CYP2C9 u mhux probabbli li jibdel il-metaboliżmu medjat mis-CYP2C9 ta' prodotti mediċinali bħal warfarina u tolbutamide.
English: A similar increase in exposure was observed when ticagrelor was administered immediately prior to dialysis (49% and 61%, respectively) showing that ticagrelor is not dialysable.
Maltese: Żieda simili ġiet osservata meta ticagrelor ingħata immedjatament qabel id-dijaliżi (49% u 61%, rispettivament) billi wera li ticagrelor ma jistax jitneħħa b'dijaliżi.
English: TIMI Minor: Clinically apparent with 30-50 g/L decrease in haemoglobin.
Maltese: Klinikament Evidenti b'tnaqqis ta' 30-50 g/L fl-emoglobina.
English: Tablet film-coating: hypromellose (E464), titanium dioxide (E171), talc, macrogol 400, iron oxide yellow (E172).
Maltese: Il-kisja tar-rita tal-pillola: hypromellose (E464), titanium dioxide (E171), talc, macrogol 400, iron oxide black (E172), iron oxide yellow (E172).
English: Paediatric population Ticagrelor has not been evaluated in a paediatric population (see sections 4.2 and 5.1).
Maltese: Popolazzjoni pedjatrika Ticagrelor ma kienx evalwat fil-popolazzjoni pedjatrika (ara sezzjoni 4.2 u 5.1).
English: TIMI Major
Maltese: TIMI Maġġuri
English: • quinidine and diltiazem (used to treat abnormal heart rhythms)
Maltese: • quinidine u diltiazem (jintużaw sabiex jikkuraw ir-ritmi abnormali tal-qalb)
English: In 2.2% of patients taking ticagrelor and by 0.6% taking clopidogrel investigators considered the dyspnoea causally related to treatment in the PLATO study and few were serious (0.14% ticagrelor; 0.02% clopidogrel), (see section 4.4).
Maltese: Fi 2.2% tal-pazjenti likienu qed jieħdu ticagrelor u minn 0.6% li kienu qed jieħdu clopidogrel l-investigaturi qiesu li dispnea kawżalment relatata mal-kura fl-istudju PLATO u xi ftit kienu serji (0.14% ticagrelor; 0.02% clopidogrel), (ara sezzjoni 4.4).
English: TIMI Major: Fatal bleeding, OR any intracranial bleeding, OR clinically overt signs of haemorrhage associated with a drop in haemoglobin (Hgb) of ≥50 g/L, or when Hgb is not available, a fall in haematocrit (Hct) of 15%.
Maltese: Fsada fatali, JEW kwalunkwe fsada ġol-kranju, JEW sinjali klinikament evidenti ta' emorraġija assoċjata ma' tnaqqis fl-emoglobina (Hgb) ta' ≥50 g/L, jew meta l-Hgb mhijiex disponibbli, tnaqqis fl-ematokrit (Hct) ta' 15%.
English: • calendar blisters (with sun/moon symbols) in cartons of 14, 56 and 168 tablets Not all pack sizes may be marketed.
Maltese: • Folji bil-kalendarju (xemx/qamar) f'kartun ta' 14, 56 u 168 pillola Jista' jkun li mhux il-pakketti tad-daqsijiet kollha jkunu fis-suq.
English: Although the efficacy profile of 90 mg and 60 mg were similar, there is evidence that the lower dose has a better tolerability and safety profile in relation to risk of the bleeding and dyspnoea.
Maltese: Għalkemm il-profili ta' effikaċja ta' 90 mg u 60 mg kienu simili, hemm evidenza li d-doża iktar baxxa kellha tollerabbiltà u profil tas-sigurtà aħjar fir-rigward tar-riskju ta' fsada u dispnea.
English: Switching from clopidogrel 75 mg to ticagrelor 90 mg twice daily results in an absolute IPA increase of 26.4% and switching from ticagrelor to clopidogrel results in an absolute IPA decrease of 24.5%.
Maltese: Meta jsir qlib minn clopidogrel 75 mg għal ticagrelor 90 mg darbtejn kuljum ikun hemm żieda fl-IPA assolut ta' 26.4% u meta jsir qlib minn ticagrelor għal clopidogrel ikun hemm tnaqqis fl-IPA assolut ta' 24.5%.
English: • unstable angina (angina or chest pain that is not well controlled).
Maltese: • anġina stabbli (anġina jew uġigħ tas-sider li mhuwiex ikkontrollat sew).
English: The following adverse reactions have been identified following studies or have been reported in post-marketing experience with ticagrelor (Table 1).
Maltese: Ir-reazzjonijiet avversi li ġejjin kienu identifikati wara studji jew ġew irrapportati wara l-esperjenza ta' wara t-tqegħid fis-suq b'ticagrelor (Tabella 1).
English: In PLATO, patients on ticagrelor had a higher incidence of discontinuation due to adverse events than clopidogrel (7.4% vs. 5.4%).
Maltese: Fi PLATO, il-pazjenti fuq ticagrelor kellhom inċidenza ogħla ta' twaqqif meta mqabbel ma dawk fuq clopidogrel minħabba avvenimenti avversi (7.4% vs. 5.4%).
English: Co-administration of rifampicin with ticagrelor decreased ticagrelor Cmax and AUC by 73% and 86%, respectively.
Maltese: L-għoti ta' rifampicin ma' ticagrelor naqqas is-Cmax u l-AUC bi 73% u b'86% rispettivament.
English: The rate of discontinuations with ticagrelor 60 mg due to bleeding and dyspnoea was higher in patients >75 years (42%) than in younger patients (range: 23-31%), with a difference versus placebo higher than 10% (42% vs. 29%) in patients >75 years.
Maltese: Ir-rata ta' waqfien bi ticagrelor 60 mg minħabba fsada u dispnea kienet ogħla f'pazjenti >75 sena (42%) milli f'pazjenti iżgħar (medda: 23-31%), b'differenza meta mqabbla ma' plaċebo ikbar minn 10% (42% vs. 29%) f'pazjenti >75 sena.
English: About 30% of episodes resolved within 7 days.
Maltese: Madwar 30% tal-episodji għaddew wara 7 ijiem.
English: Antifibrinolytic therapy (aminocaproic acid or tranexamic acid) and/or recombinant factor VIIa therapy may increase haemostasis.
Maltese: Terapija anti-fibrinolitika (aminocaproic acid jew tranexamic acid) u/jew terapija b'fattur VIIa rikombinanti jista' jżid l-emostażi.
English: If you are taking both Brilique and heparin:
Maltese: Tiħux Brilique jekk:
English: Patients with asthma/chronic obstructive pulmonary disease (COPD) may have an increased absolute risk of experiencing dyspnoea with ticagrelor.
Maltese: Il-pazjenti b'ażma/mard pulmonari ostruttiv kroniku (Chronic Obstructive Pulmonary Disease, COPD) jista' jkollhom żieda fir-riskju assolut li jaqbadhom dispnea b'ticagrelor.
English: 10 x 1 orodispersible tablets 56 x 1 orodispersible tablets 60 x 1 orodispersible tablets
Maltese: 10 x 1 pilloli li jinħallu fil-ħalq 56 x 1 pilloli li jinħallu fil-ħalq 60 x 1 pilloli li jinħallu fil-ħalq
English: The mean t1/2 was approximately 7 hours for ticagrelor and 8.5 hours for the active metabolite.
Maltese: Il-medja tat-t1/2 kienet madwar 7 sigħat għal ticagrelor u 8.5 sigħat għal metabolit attiv.
English: TIMI Major or Minor or Requiring medical attention
Maltese: TIMI Maġġuri jew Minuri jew li jeħtieġ attenzjoni medika
English: Cmax and AUC for ticagrelor were 12% and 23% higher in patients with mild hepatic impairment compared to matched healthy subjects, respectively, however, the IPA effect of ticagrelor was similar between the two groups.
Maltese: Cmax u AUC għal ticagrelor kienu 12% u 23% ogħla f'pazjenti b'indeboliment epatiku ħafif meta mqabbla ma' pazjenti b'saħħithom, rispettivament, madankollu, l-effett tal-IPA ta' ticagrelor kien simili bejn iż-żewġ gruppi.
English: • perforated unit dose blisters in cartons of 10 x 1, 56 x 1 and 60 x 1 orodispersible tablets.
Maltese: Brilique huwa disponibbli f' - folji mtaqqba b'doża waħda f'kartun ta' 10 x 1, 56 x 1 u 60 x 1 pilloli li jinħallu fil-ħalq.
English: The result appeared early (absolute risk reduction [ARR] 0.6% and relative risk reduction [RRR] of 12% at 30 days), with a constant treatment effect over the entire 12-month period, yielding ARR 1.9% per year with RRR of 16%.
Maltese: Ir-riżultat deher kmieni (tnaqqis assolut tar-riskju [ARR] 0.6% u tnaqqis tar-riskju relattiv [RRR] ta' 12% mat-30 jum), b'effett ta' kura kontinwu tul il-perijodu kollu ta' 12-il xahar, li wassal għal ARR ta' 1.9% kull sena u RRR ta' 16%.
English: Higher exposures to ticagrelor (approximately 25% for both Cmax and AUC) and the active metabolite were observed in elderly (≥75 years) ACS patients compared to younger patients by the population pharmacokinetic analysis.
Maltese: Esponimenti ogħla għal ticagrelor (madwar 25% għal Cmax kif ukoll għall-AUC) u l-metabolit attiv dehru fl-anzjani (≥ 75 sena) pazjenti ACS meta mqabbla ma' pazjenti iżgħar permezz ta' analiżi farmakokinetika tal-popolazzjoni.
English: Brilique contains less than 1 mmol sodium (23 mg) per dose, i.e. is essentially ‘sodium-free'.
Maltese: Brilique fih inqas minn 1 mmol sodium (23 mg) f'kull doża, jiġifieri huwa essenzjalment “mingħajr sodium”.
English: Brilique 90 mg tablets ticagrelor
Maltese: Brilique 90 mg pilloli ticagrelor
English: Ticagrelor and clopidogrel did not differ in non-CABG PLATO-defined Major Fatal/Lifethreatening bleeding, but PLATO-defined Total Major, TIMI Major, and TIMI Major + Minor bleeding were more common with ticagrelor.
Maltese: Ticagrelor u clopidogrel ma kienux differenti fil-fsada mhux relatata mas-CABG PLATO - definita Fsada Maġġuri Fatali/Ta' theddida għall-ħajja, iżda dik definita-PLATO Maġġuri Totali, TIMI Maġġuri, u TIMI Minuri + Minuri kienu iktar komuni b'ticagrelor.