FrancophonIA/ELRC3.0 huggingface dataset:
English: Ticagrelor has not been studied in patients with severe hepatic impairment and there is no pharmacokinetic information in patients with moderate hepatic impairment.
Maltese: Ticagrelor ma ġiex studjat f'pazjenti b'indeboliment tal-fwied sever u m'hemm ebda informazzjoni farmakokinetika f'pazjenti b'indeboliment tal-fwied moderat.
English: The treatment effect of ticagrelor over clopidogrel appears consistent across many subgroups, including weight; sex; medical history of diabetes mellitus, transient ischaemic attack or non-haemorrhagic stroke, or revascularisation; concomitant therapies including heparins, GpIIb/IIIa inhibitors and proton pump inhibitors (see section 4.5); final index event diagnosis (STEMI, NSTEMI or UA); and treatment pathway intended at randomisation (invasive or medical).
Maltese: L-effett tal-kura ta' ticagrelor fuq clopidogrel jidher konsistenti fuq ħafna sottogruppi, inkluż piż; sess; passat mediku ta' dijabete mellitus, attakk iskemiku temporanju jew attakk ta' puplesija mhux emorraġiku, jew rivaskularizzazzjoni; terapiji oħrajn li jinkludu l-eparini, inibituri ta' GpIIb/IIIa u inibituri tal-pompi tal-protoni (ara sezzjoni 4.5); dijanjosi tal-aħħar każ fl-indiċi (STEMI, NSTEMI jew UA); u l-mezz ta' kura li kien intiż meta saret ir-randomisation (invażiva jew medika).
English: Mean serum uric acid increased approximately 15% with ticagrelor compared to approximately 7.5% with clopidogrel and after treatment was stopped, decreased to approximately 7% on ticagrelor but with no decrease observed for clopidogrel.
Maltese: Il-medja ta' uric acid fis-serum żdied b'madwar 15% b'ticagrelor meta mqabbla ma' madwar 7.5% bi clopidogrel u wara li l-kura twaqqfet, naqset għal madwar 7% fuq ticagrelor iżda ma deherx tnaqqis għal clopidogrel.
English: Ticagrelor and clopidogrel did not differ in rates of PLATO Major Fatal/Life-threatening bleeding, PLATO total Major bleeding, TIMI Major bleeding, or TIMI Minor bleeding (Table 2).
Maltese: Ticagrelor u clopidogrel fl-istudju PLATO ma kellhomx rati differenti ta' fsada Fatali Maġġuri/Ta' theddida għall-ħajja, Fsada PLATO Maġġuri totali, fsada TIMI Maġġuri, jew fsada TIMI Minuri (Tabella 3).
English: Initial exposure (0.5 and 1 hour post-dose) from crushed ticagrelor tablets mixed in water was higher compared to whole tablets, with a generally identical concentration profile thereafter (2 to 48 hours).
Maltese: Espożizzjoni inizjali (0.5 u 1 siegħa wara d-doża) minn pilloli ticagrelor imfarrka imħallta fl-ilma, kienet ogħla meta mqabbla ma' pilloli sħaħ, bi profil ta' konċentrazzjoni ġeneralment identiku minn hemm 'il quddiem (2 sa 48 siegħa).
English: Characteristic
Maltese: Karatteristika
English: A combined efficacy and safety composite (CV death, MI, stroke, or PLATO-defined ‘Total Major' bleeding) indicates that the benefit in efficacy of ticagrelor compared to clopidogrel is not offset by the major bleeding events (ARR 1.4%, RRR 8%, HR 0.92; p=0.0257) over 12 months after ACS.
Maltese: Kompost kombinat tal-effikaċja u s-sigurtà (Mewt CV, MI, attakk ta' puplesija, jew fsada ‘Totali Maġġuri' hekk kif definita fi PLATO) jindika li l-benefiċċju tal-effikaċja ta' ticagrelor meta mqabbel ma' clopidogrel mhuwiex imxekkel mil-każijiet ta' fsada maġġuri (ARR 1.4%, RRR 8%, HR 0.92; p=0.0257) fit-12-il xahar wara l-ACS.
English: The bleeding profile of ticagrelor 60 mg was consistent across multiple pre-defined subgroups (e.g. by age, gender, weight, race, geographic region, concurrent conditions, concomitant therapy and medical history) for TIMI Major, TIMI Major or Minor and PLATO Major bleeding events.
Maltese: Il-profil ta' fsada ta' ticagrelor 60 mg kien konsistenti f'diversi sottogruppi ddefiniti minn qabel (eż. skont l-età, is-sess, il-piż, ir-razza, ir-reġjun ġeografiku, il-kundizzjonijiet konkomitanti, it-terapija konkomitanti u l-passat mediku) għal avvenimenti ta' fsada TIMI Maġġuri, TIMI Maġġuri jew Minuri u PLATO Maġġuri.
English: The observed increased risk of TIMI Major bleeding with ticagrelor 60 mg was primarily due to a higher frequency of Other TIMI Major bleedings driven by events in the gastrointestinal SOC.
Maltese: Irriskju ikbar osservat ta' fsada TIMI Maġġuri b'ticagrelor 60 mg kien prinċipalment minħabba frekwenza ogħla ta' episodji ta' fsada TIMI Oħrajn Maġġuri mmexxija minn avvenimenti fl-SOC gastrointestinali.
English: Since co-administration of ticagrelor with desmopressin did not decrease template-bleeding time, desmopressin is unlikely to be effective in managing clinical bleeding events (see section 4.5).
Maltese: Minħabba li l-għoti ta' ticagrelor ma' desmopressin ma żiedx it-“template bleeding time”, mhux probabbli li desmopressin ikun effettiv biex jimmaniġġa każijiet ta' fsada klinika (ara sezzjoni 4.5).
English: When radiolabelled ticagrelor is administered, the mean recovery of radioactivity is approximately 84% (57.8% in faeces, 26.5% in urine).
Maltese: Meta jingħata ticagrelor radjutikkettat, il-medja tar-radjuattività rkuprata hija madwar 84% (57.8% flippurgar, 26.
English: What Brilique contains • The active substance is ticagrelor.
Maltese: X'fih Brilique - Is-sustanza attiva hija ticagrelor.
English: Clinical efficacy and safety The clinical evidence for the efficacy and safety of ticagrelor is derived from two phase 3 trials:
Maltese: Effikaċja klinika u sigurtà L-evidenza klinika għall-effikaċja u s-sigurtà ta' ticagrelor hija derivata minn żewġ provi ta' fażi 3:
English: P-gp substrates (including digoxin, cyclosporine) Concomitant administration of ticagrelor increased the digoxin Cmax by 75% and AUC by 28%.
Maltese: L-għoti flimkien ma' ticagrelor żied is-Cmax ta' digoxin b'75% u l-AUC b'28%.
English: PLATO Major Other: Significantly disabling, OR clinically apparent with 30-50 g/L decrease in haemoglobin, OR 2-3 red cell units transfused.
Maltese: B'diżattivazzjoni sinifikanti, JEW klinikament evidenti b'tnaqqis ta' 30-50 g/L fl-emoglobina, JEW 2-3 unitajiet ta' ċelloli ħomor trasfużi.
English: History of myocardial infarction
Maltese: Storja ta' infart mijokardijaku
English: The metabolite parent ratios are 0.28 for Cmax and 0.42 for AUC.
Maltese: Il-proporzjon talmetaboliti minn fejn ikunu ġejjin huma 0.28 għal Cmax u 0.
English: The mixture can also be administered via a nasogastric tube (CH8 or greater).
Maltese: It-taħlita tista' tingħata permezz ta' tubu nasogastriku (CH8 jew akbar).
English: Ear haemorrhage
Maltese: PLATO Maġġuri
English: Switching data
Maltese: Ma hemmx dejta disponibbli
English: Following an oral ticagrelor 90 mg single dose under fasted conditions in healthy subjects, Cmax is 529 ng/ml and AUC is 3451 ng*h/ml.
Maltese: Wara doża orali waħda ta' ticagrelor 90 mg f'kundizzjoni ta' sawm f'individwi b'saħħithom, Cmax tkun 529 ng/ml u l-AUC tkun 3451 ng*h/ml.
English: The formation of the major circulating metabolite AR-C124910XX (also active) from ticagrelor is rapid with a median tmax of approximately 2.5 hours.
Maltese: Il-formazzjoni talmetabolit ewlieni fiċ-ċirkolazzjoni AR-C124910XX (attiv ukoll) minn ticagrelor huwa mgħaġġel b'tmax medjan ta' madwar 2.5 sigħat.
English: CV death, MI (excl. silent MI) or stroke Invasive intent Medical intent CV death
Maltese: Mewt CV, MI (eskluż MI silenzjuż) jew attakk ta' puplesija
English: România AstraZeneca Pharma SRL
Maltese: United Kingdom AstraZeneca UK Ltd
English: Treatment may be started without interruption as continuation therapy after the initial one-year treatment with Brilique 90 mg or other adenosine diphosphate (ADP) receptor inhibitor therapy in ACS patients with a high risk of an atherothrombotic event.
Maltese: Il-kura tista' tinbeda mingħajr interruzzjoni bħala terapija ta' kontinwazzjoni wara l-kura inizjali ta' sena bi Brilique 90 mg jew terapija oħra b'inibitur tar-riċettur ta' adenosine diphosphate (Adenosine Diphosphate, ADP) f'pazjenti b'ACS b'riskju għoli ta' episodju aterotrombotiku.
English: The inhibition of platelet aggregation (IPA) effect of ticagrelor was independent of dialysis in patients with end stage renal disease and similar to subjects with normal renal function (see section 4.2).
Maltese: L-inbizzjoni tal-effett tal-aggregazzjoni tal-pjastrini (IPA) ta' ticagrelor kienet indipendenti mid-dijaliżi f'pazjenti b'marda tal-kliewi tal-aħħar stadju u simili għal individwi b'funzjoni renali normali (ara sezzjoni 4.2).
English: e.g. conjunctival, retinal, intraocular bleeding e.g. epistaxis, haemoptysis e.g. gingival bleeding, rectal haemorrhage, gastric ulcer haemorrhage e.g. ecchymosis, skin haemorrhage, petechiae e.g. haemarthrosis, muscle haemorrhage e.g. haematuria, cystitis haemorrhagic e.g. vaginal haemorrhage, haematospermia, postmenopausal haemorrhage e.g. contusion, traumatic haematoma, traumatic haemorrhage
Maltese: Fi studji kliniċi, ticagrelor ingħata ta' spiss ma' ASA, inibituri tal-pompi tal-protoni, statins, imblukkaturi tal-beta, inibituri tal-angiotensin converting enzyme (ACE) u inblukkaturi tar-riċetturi tal-angiotensin hekk kif kien meħtieġ għall-kundizzjonijiet l-oħra li kienu jsofru minnhom għal żmien twil kif ukoll heparin, heparin ta' piż molekulari baxx u inibituri GpIIb/IIIa minn ġol vina għal perijodi qosra (ara sezzjoni 5.1).
English: Hyperuricaemia d Gout/Gouty Arthritis
Maltese: X'inhu Brilique u għalxiex jintuża
English: Bleeding risk The use of ticagrelor in patients at known increased risk for bleeding should be balanced against the benefit in terms of prevention of atherothrombotic events (see sections 4.8 and 5.1).
Maltese: Riskju ta' fsada L-użu ta' ticagrelor f'pazjenti li jkun magħruf li jkollhom riskju akbar ta' fsada għandu jitqies kontra lbenefiċċju li jkollu biex jiġu evitati każijiet aterotrombotiċi (ara sezzjonijiet 4.8 u 5.1).
English: Age, sex, weight, race, geographic region, concurrent conditions, concomitant therapy and medical history, including a previous stroke or transient ischaemic attack, all did not predict either overall or non-procedural PLATO Major bleeding.
Maltese: L-età, is-sess, il-piż, ir-razza, ir-reġjun ġeografiku, il-kundizzjonijiet konkomitanti, it-terapiji konkomitanti u l-passat mediku, inkluż attakk ta' puplesija jew attakk iskemiku temporanju, kollha kemm huma ma setgħux ibassru la fsada globali u lanqas fsada Maġġuri PLATO mhux relatata malproċedura.
English: Increased bleeding patterns similar to TIMI Major were seen for TIMI Major or Minor and PLATO Major and PLATO Major or Minor bleeding categories (see Table 3).
Maltese: Mudelli ta' fsada ikbar simili għal TIMI Maġġuri kienu osservati għall-kategoriji ta' fsada TIMI Maġġuri jew Minuri u PLATO Maġġuri u PLATO Maġġuri jew Minuri (ara Tabella 3).
English: The Cmax and AUC of the active metabolite were reduced by 89% and 56%, respectively.
Maltese: Is-Cmax u l-AUC tal-metabolit attiv tnaqqsu b'89% u b'56% rsipettivament.
English: • Nosebleed
Maltese: • Tbenġil
English: In PLATO, 42% of the 1584 patients (12% of cohort) who underwent coronary artery bypass graft (CABG) surgery had a PLATO Major Fatal/Life-threatening bleeding with no difference between treatment groups.
Maltese: Fi PLATO, 42% tal-1584 pazjent (12% tal-koorti) li għamlu operazzjoni CABG kellhom Fsada PLATO Fatali
English: Holter substudy:
Maltese: Fsada TIMI Maġġuri:
English: Reproductive system and breast disorders
Maltese: Fsada mis-sistema riproduttiva
English: However, more PLATO combined Major + Minor bleeding occurred with ticagrelor compared with clopidogrel.
Maltese: Madankollu, kien hemm iktar fsada PLATO Maġġuri + Minuri kkombinata ma' ticagrelor meta mqabbel ma' clopidogrel.
English: Pruritus
Maltese: Sodertalje
English: CALENDAR BLISTER
Maltese: FOLJA BIL-KALENDARJU
English: Intracranial haemorrhage
Maltese: Tromboċitopenika Trombotika
English: This is because of the increased risk of bleeding.
Maltese: Tista' tkun f'riskju ta' żieda ta' fsada.
English: The safety profile of ticagrelor has been evaluated in two large phase 3 outcome trials (PLATO and PEGASUS) including more than 39,000 patients (see section 5.1).
Maltese: Il-profil tas-sigurtà ta' ticagrelor ġie evalwat f'żewġ provi kliniċi kbar ta' fażi 3 (PLATO u PEGASUS) li kienu jinkludu iktar minn 39,000 pazjent (ara sezzjoni 5.1).
English: Premature discontinuation with any antiplatelet therapy, including Brilique, could result in an increased risk of cardiovascular (CV) death, MI or stroke due to the patient's underlying disease.
Maltese: It-twaqqif prematur ta' kwalunkwe terapija kontra l-plejtlets, inkluż Brilique, jista' jwassal f'żieda ta' riskju ta' mewt kardjovaskulari (CV), MI jew attakk ta' puplesija minħabba l-marda tal-pazjent.
English: Information on concomitant treatment with ticagrelor is required for interpretation of HIT platelet function tests.
Maltese: Hija meħtieġa informazzjoni dwar trattament konkomitanti b'ticagrelor għallinterpretazzjoni tat-testijiet tal-funzjoni tal-pjastrini HIT.
English: Note: the number of first events for the components CV death, MI and stroke are the actual number of first events for each component and do not add up to the number of events in the composite endpoint (s) Indicates statistical significance.
Maltese: Nota: in-numru tal-ewwel avvenimenti għall-komponenti mewt CV, MI u puplesija huma n-numru attwali tal-ewwel avvenimenti għal kull komponent u ma jagħmlux parti min-numru ta' avvenimenti fil-punt ta' tmiem kompost (s) Tindika sinifikat statistiku.
English: Uric acid elevations: In PLATO, serum uric acid increased to more than upper limit of normal in 22% of patients receiving ticagrelor compared to 13% of patients receiving clopidogrel.
Maltese: Fi PLATO, l-uric acid fis-serum żdiedet għal aktar mil-limitu ta' fuq tannormal fi 22% tal-pazjenti li kienu qed jirċievu ticagrelor imqabbla ma' 13% tal-pazjenti li kienu qed jirċievu clopidogrel.
English: Safety Endpoints
Maltese: Punti ta' Tmiem tas-Sigurtà
English: • Moderate CYP3A4 inhibitors - Co-administration of diltiazem with ticagrelor increased the ticagrelor Cmax by 69% and AUC to 2.7-fold and decreased the active metabolite Cmax by 38% and AUC was unchanged.
Maltese: - L-għoti f'daqqa ta' diltiazem ma' ticagrelor żied is-Cmax ta' ticagrelor b'69% u l-AUC b'2.7 drabi u naqsu s-Cmax tal-metabolit attiv bi 38% u l-AUC ma nbidilx.
English: CABG-related bleeding:
Maltese: Fsada relatata mas-CABG:
English: • The usual dose is one tablet of 60 mg twice a day.
Maltese: • Id-doża normali hija pillola waħda ta' 60 mg darbtejn kuljum.
English: Muscular bleedings
Maltese: Fsada mill-muskoli
English: There was no difference in overall fatal bleeds.
Maltese: Ma kienx hemm differenza fin-numru globali ta' każijiet fatali ta' fsada.
English: • Patients with a propensity to bleed (e.g. due to recent trauma, recent surgery, coagulation disorders, active or recent gastrointestinal bleeding).
Maltese: • Pazjenti b'tendenza li jkollhom fsada (eż. minħabba trawma riċenti, operazzjoni riċenti, disturbi ta' koagulazzjoni, fsada gastro-intestinali attiva jew riċenti).
English: 14 film-coated tablets 56 film-coated tablets 60 film-coated tablets 100x1 film-coated tablets 168 film-coated tablets 180 film-coated tablets
Maltese: 14-il pillola miksija b'rita 56 pillola miksija b'rita 60 pillola miksija b'rita 100x1 pillola miksija b'rita 168 pillola miksija b'rita 180 pillola miksija b'rita
English: Co-administration of ticagrelor with doses of simvastatin exceeding 40 mg daily could cause adverse reactions of simvastatin and should be weighed against potential benefits.
Maltese: simvastatin ogħla minn 40 mg kuljum jista' jikkawża reazzjonijiet avversi ta' simvastatin u għandha titqies mal-benefiċċji li jista' jkollu.
English: This is related to inhibition of the P2Y12-receptor on the healthy donor platelets in the test by ticagrelor in the patient's sera/plasma.
Maltese: Dan huwa relatat mal-inibizzjoni tar-riċettur P2Y12 fuq il-pjastrini tad-donaturi b'saħħithom fit-test minn ticagrelor fisseri/plażma tal-pazjent.
English: Ticagrelor orodispersible tablets, dispersed in saliva and swallowed without water or suspended in water and administered through a nasogastric tube into the stomach, were bioequivalent to film-coated whole tablets (AUC and Cmax within 80-125% for ticagrelor and the active metabolite).
Maltese: Ticagrelor bħala pilloli li jinħallu fil-ħalq, li jinħallu fil-bżieq u jinbelgħu mingħajr ilma jew jiġu sospiżi fl-ilma u li jingħataw permezz ta' tubu nażogastriku għal ġewwa l-istonku, kienu bijoekwivalenti għal pilloli sħaħ miksijin b'rita (AUC u Cmax f'80-125 % għal ticagrelor u l-metabolit attiv).
English: In PEGASUS, dyspnoea was reported in 14.2% of patients taking ticagrelor 60 mg twice daily and in 5.5% of patients taking ASA alone.
Maltese: F'PEGASUS, kienet irrapportata dispnea f'14.2% tal-pazjenti li kienu qegħdin jieħdu ticagrelor 60 mg darbtejn kuljum u f'5.5% tal-pazjenti li kienu qegħdin jieħdu ASA waħdu.
English: Ticagrelor as crushed tablets mixed in water, given orally or administered through a nasogastric tube into the stomach, has a comparable bioavailability to whole tablets with regards to AUC and Cmax for ticagrelor and the active metabolite.
Maltese: Ticagrelor bħala pilloli mfarrka mħallta mal-ilma, mogħti oralment permezz ta' tubu nasogastriku għal ġewwa l-istonku, għandu bijodisponibilità komparabbli għal pilloli sħaħ fir-rigward ta' AUC u Cmax għal ticagrelor u l-metabolit attiv.
English: • ‘oral anticoagulants' often referred to as ‘blood thinners' which include warfarin.
Maltese: • Anti-koagulanti orali magħrufin ukoll bħala dawk li ‘jraqqu d-demm' li jinkludu warfarina.
English: Sun/Moon symbol
Maltese: Tél/Tel:
English: • Non-Steroidal Anti-Inflammatory Drugs (abbreviated as NSAIDs) often taken as painkillers such as ibuprofen and naproxen.
Maltese: • Mediċini Anti-Infjammatorji u Mhux Sterojdi (fil-qasir NSAIDs - non-steroidal anti-inflammatory drugs) li jittieħdu għal kontra l-uġigħ bħal ibuprofen u naproxen.
English: This imbalance did not occur at one month: 2.0% versus 2.1% for ticagrelor patients with and without CHF history, respectively; and 3.8% versus 1.4% with clopidogrel.
Maltese: 2.0% kontra 2.1% għallpazjenti fuq ticagrelor għal dawk li fil-passat kellhom u għal dawk li ma kellhomx CHF, rispettivament; u 3.8% kontra 1.4% bi clopidogrel.
English: Interference with platelet function tests to diagnose heparin induced thrombocytopenia (HIT) In the heparin induced platelet activation (HIPA) test used to diagnose HIT, anti-platelet factor 4/heparin antibodies in patient serum activate platelets of healthy donors in the presence of heparin.
Maltese: Fit-test tal-attivazzjoni tal-pjastrini indotta mill-eparina (HIPA) użat biex tiġi dijanjostikata HIT, lantikorpi tal-fattur 4 kontra l-pjastrini/eparina fis-seru tal-pazjent jattivaw il-pjastrini ta' donaturi b'saħħithom fil-preżenza tal-eparina.
English: Thus, Brilique 90 mg twice daily together with low-dose ASA can be used in patients with ACS (unstable angina, non-ST elevation Myocardial Infarction [NSTEMI] or ST elevation Myocardial Infarction [STEMI]); including patients managed medically, and those who are managed with percutaneous coronary intervention (PCI) or coronary artery by-pass grafting (CABG).
Maltese: Għalhekk, Brilique 90 mg darbtejn kuljum flimkien ma' ASA f'doża baxxa jista' jintuża f'pazjenti b'ACS (anġina mhux stabbli, infart mijokardijaku b'elevazzjoni mhux tal-ST [NSTEMI] jew Infart Mijokardijaku b'elevazzjoni tal-ST [STEMI]); inklużi pazjenti li jkunu mmaniġġjati b'mod mediku, u dawk li huma mmaniġġjati b'intervent koronarju perkutaneju (PCI - Percutaneous Coronary Intervention) jew bi grafting ta' bypass b'trapjant tal-arterja koronarja (CABG - Coronary artery by-pass grafting).
English: Each film-coated tablet contains 60 mg of ticagrelor.
Maltese: Kull pillola miksija b'rita fiha 60 mg ta' ticagrelor.
English: In patients with end stage renal disease on haemodialysis AUC and Cmax of ticagrelor 90 mg administered on a day without dialysis were 38% and 51% higher compared to subjects with normal renal function.
Maltese: F'pazjenti b'marda tal-kliewi tal-aħħar stadju fuq emodijaliżi, l-AUC u s-Cmax ta' ticagrelor 90 mg mogħti f'jum mingħajr dijaliżi kienu 38% u 51% ogħla meta mqabbla ma' individwi b'funzjoni renali noromali.
English: Hazard ratio and p-values are calculated separately for ticagrelor vs. ASA therapy alone from Cox proportional hazards model with treatment group as the only explanatory variable.
Maltese: Il-proporzjon tar-riskju u l-valuri-p huma kkalkolati b'mod separat għal ticagrelor vs. terapija ASA waħedha minn mudell ta' periklu proporzjonali ta' Cox bil-grupp ta' kura bħala l-unika varjabbli ta' spjegazzjoni.
English: Patients self-identified as black had an 18% lower bioavailability of ticagrelor compared to Caucasian patients, in clinical pharmacology studies, the exposure (Cmax and AUC) to ticagrelor in Japanese subjects was approximately 40% (20% after adjusting for body weight) higher compared to that in Caucasians.
Maltese: Pazjenti li jidentifikaw irwieħhom bħala suwed kellhom bijodisponibilità 18% aktar baxxa għal ticagrelor meta mqabbla mal-pazjenti Kawkażi, fi studji ta' farmakoloġija klinika, l-esponiment (Cmax u AUC) għal ticagrelor f'individwi Ġappuniżi kienet madwar 40% (20% wara li taġġusta għallpiż tal-ġisem) ogħla meta mqabbel ma' dak fil-Kawkażi.
English: Patients were ineligible if there was planned use of a P2Y12 receptor antagonist, dipyridamole, cilostazol, or anticoagulant therapy during the study period; if they had a bleeding disorder or a history of an ischaemic stroke or intracranial bleeding, a central nervous system tumour or an intracranial vascular abnormality; if they had had gastrointestinal bleeding within the previous 6 months or major surgery within the previous 30 days.
Maltese: Il-pazjenti kienu ineliġibbli jekk kien ippjanat li jintuża antagonist tar-riċettur ta' P2Y12, dipyridamole, cilostazol, jew terapija b'antikoagulanti matul il-perjodu ta' studju; jekk kellhom disturb ta' fsada jew li fil-passat kellhom puplesija iskemika jew fsada ġol-kranju, tumur fis-sistema nervuża ċentrali jew anormalità vaskulari ġol-kranju; jekk kellhom fsada gastrointestinali matul is-6 xhur preċedenti jew operazzjoni maġġuri matul it-30 jum preċedenti.
English: The increase in ventricular pauses in the acute phase of ACS was more pronounced in ticagrelor patients with history of CHF (9.2% versus 5.4% in patients without CHF history; for clopidogrel patients, 4.0% in those with versus 3.6% in those without CHF history).
Maltese: Iż-żieda fil-pawżi ventrikulari fil-fażi akuta ta' ACS kienu iktar qawwija f'pazjenti fuq ticagrelor li fil-passat kellhom CHF (9.2% kontra 5.4% talpazjenti li ma kellhomx CHF fil-passat; għall-pazjenti fuq clopidogrel, 4.0% f'dawk bil-kontra 3.6% f'dawk mingħajr passat ta' CHF).
English: The Cmax of the active metabolite was unchanged and the AUC was decreased by 46%, respectively.
Maltese: Is-Cmax tal-metabolit attiv ma nbidilx u l-AUC naqas b'46% rispettivament.
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say it is essentially ‘sodium-free'.
Maltese: Din il-mediċina fiha inqas minn 1 mmol sodium (23 mg) f'kull doża, jiġifieri hija essenzjalment “mingħajr sodium”.
English: Major Other: Clinically apparent with 30-50 g/L decrease in haemoglobin or 2-3 red cell units transfused; or significantly disabling.
Maltese: Oħrajn: Klinikament viżibbli bi tnaqqis ta' 30-50 g/L tal-emoglobina jew trasfużjoni ta' 2-3 unitajiet ta' ċelloli ħomor; jew li jikkawża diżabbiltà sinifikanti.
English: Exposure to ticagrelor was approximately 20% lower and exposure to the active metabolite was approximately 17% higher in patients with severe renal impairment (creatinine clearance <30 ml/min) compared to subjects with normal renal function.
Maltese: L-esponiment għal ticagrelor kien madwar 20% aktar baxx u l-esponiment għall-metabolit attiv kien madwar 17% ogħla f'pazjenti b'indeboliment renali sever (tneħħija tal-krejatinina < 30 mL/min) imqabbel ma' individwi b'funzjoni renali normali.
English: PLATO genetic substudy
Maltese: PLATO Totali Maġġuri