FrancophonIA/ELRC3.0 huggingface dataset:
English: Tabulated summary of adverse reactions The following adverse reactions have been identified following studies with Possia (Table 1).
Maltese: Ir-reazzjonijiet avversi li ġejjin kienu identifikati wara studji bi Possia (Tabella 1).
English: Adverse reactions are classified according to frequency and System Organ Class.
Maltese: Ir-reazzjonijiet avversi huma klassifikati skont il-frekwenza u l-Klassi tas-Sistema tal-Organi.
English: Pharmacotherapeutic group: Platelet aggregation inhibitors excluding heparin, ATC code: B01AC24
Maltese: Kategorija farmakoterapewtika: inibituri tat- tagħqid tal-plejtlits jeskludi heparin, Kodiċi ATC:
English: Ticagrelor is a mild CYP3A4 inhibitor.
Maltese: Ticagrelor huwa inibitur ħafif ta' CYP3A4.
English: Co-administration of Possia with tolbutamide resulted in no change in the plasma levels of either medicinal product, which suggest that ticagrelor is not a CYP2C9 inhibitor and unlikely to alter the CYP2C9 mediated metabolism of medicinal products like warfarin and tolbutamide.
Maltese: L-għotja ta' Possia ma' tolbutamide ma kkawżat 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: These differences are not considered clinically significant (see section 4.2).
Maltese: Dawn id-differenzi mhumiex meqjusa klinikament sinifikanti (ara sezzjoni 4.2).
English: No data are available on concomitant use of Possia with potent P-glycoprotein (P-gp) inhibitors (e.g. verapamil, quinidine, cyclosporin) that may increase ticagrelor exposure.
Maltese: M'hemmx dejta dwar l-użu ta' Possia f'daqqa ma' inibituri qawwija ta' glikoproteina-P (P-gp) (eż verapamil, quinidine, cyclosporin) li jistgħu jżidu l-esponiment ta' ticagrelor.
English: Sweden
Maltese: Spanja
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 Possia.
Maltese: Inibituri moderati oħra ta' CYP3A4 (eż amprenavir, aprepitant, erythromycin u fluconazole) ikunu mistennija li jkollhom effett simili u jistgħu jingħataw ukoll ma' Possia.
English: NAME OF THE MEDICINAL PRODUCT
Maltese: Sistema Farmakoviġilanti
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'
English: Patients with hepatic impairment
Maltese: Indeboliment epatiku
English: When radiolabeled 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: The metabolite parent ratios are 0.28 for Cmax and 0.42
Maltese: Il-proporzjon tal-metaboli minn fejn ikunu ġejjin huma 0.28 għal Cmax u 0.42 għall-AUC.
English: • rifampicin (an antibiotic), phenytoin, carbamazepine and phenobarbital (used to control seizures), dexamethasone (used to treat inflammatory and auto immune conditions), digoxin (used to treat heart failure), cyclosporin (used to lessen your body's defenses), quinidine and diltiazem (used to treat abnormal heart rhythms), beta blockers and verapamil (used to treat high
Maltese: • Rifampicin (antibijotiku), phenytoin, carbamazepine u phenobarbital (jintużaw sabiex jikkontrollaw l-epilessija), dexamethasone (jintużaw sabiex jikkuraw kundizzjonijiet infjammatorji u awtoimmunitarji), digoxin (jintuża sabiex jikkura l-insuffiċjenza tal-qalb), cyclosporin (jintuża sabiex inaqqas id-difiża tal-ġisem), quinidine u diltiazem (jintużaw sabiex jikkuraw ir-ritmi abnormali tal-qalb), beta-blockers u verapamil (jintużaw għall-kura ta' pressjoni għolja)
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 nonhaemorrhagic 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, il-mezz ta' kura li kien intiż meta saret ir-randomisation (invażiva jew medika).
English: Higher exposures to ticagrelor (approximately 25% for both Cmax and AUC) and the active metabolite were observed in elderly (≥ 75years) 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-metabolu attiv dehru fl-anzjani (≥ 75 sena) pazjenti ACS meta mqabbla ma' pazjenti iżgħar permezz ta' analiżi farmakokinetika tal-popolazzjoni.
English: Ticagrelor has not been evaluated in a paediatric population (see section 4.2 and 5.1).
Maltese: Pedjatriċi Ticagrelor ma kienx evalwat fil-popolazzjoni pedjatrika (ara sezzjoni 4.2 u 5.1).
English: Dyspnoea was reported by 13.8% of patients treated with Possia and by 7.8% of patients treated with clopidogrel.
Maltese: Dispneja kienet irrapurtata minn 13.8% tal-pazjenti ikkurati bi Possia u minn 7.8% tal- pazjenti ikkurati bi clopidogrel.
English: 5.3 Preclinical safety data
Maltese: 4.3 Kontra-indikazzjonijiet
English: You have been given Possia because you have had:
Maltese: Sewqan u tħaddim ta' magni:
English: However, more PLATO combined Major + Minor bleeding occurred with ticagrelor compared with clopidogrel.
Maltese: Iżda, kien hemm aktar fsada PLATO Maġġuri + Minuri kombinati bi ticagrelor imqabbla ma' clopidogrel.
English: The PLATO study included 18,624 patients who presented within 24 hours of onset of symptoms of unstable angina (UA), non ST elevation myocardial infarction (NSTEMI) or ST elevation myocardial infarction (STEMI), and were initially managed medically, or with percutaneous coronary intervention (PCI), or with coronary artery bypass grafting (CABG) (see section 4.1).
Maltese: L-istudju PLATO kien jinkludi 18,624 pazjent li ppreżentaw rwieħhom fi żmien 24 siegħa minn meta kellhom l-ewwel sintomi tal-anġina mhux stabbli (UA), infart mijokardijaku mingħajr żieda fl-ST (NSTEMI) jew infart mijokardijaku b'żieda fl-ST (STEMI), u l-ewwel ingħataw kura medika, jew permezz ta' intervent perkutanju fil-koronarji (PCI), jew permezz ta' graft by-pass tal-arterja koronarja (CABG) (ara sezzjoni 4.1).
English: Non-CABG related bleeding and non-procedural related bleeding: Possia and clopidogrel did not differ in non-CABG PLATO-defined Major Fatal/Life-threatening bleeding, but PLATO-defined Total Major, TIMI Major, and TIMI Major + Minor bleeding were more common with ticagrelor.
Maltese: Fsada mhux relatata mas-CABG u fsada mhux relatata mal-proċedura: Possia u clopidogrel ma kienux differenti fil-fsada mhux relatata mas-CABG PLATO - definita Fsada Maġġuri Fatali/ Ta' tgħeddida għal-ħajja, iżda dik definita-PLATO Maġġuri Totali, TIMI Maġġuri, u TIMI Minuri + Minuri kienu aktar komuni b'ticagrelor.
English: • History of intracranial haemorrhage (see section 4.8).
Maltese: • Emorraġija fil-kranju fil-passat (ara sezzjoni 4.8).
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 mqabbel ma' clopidogrel, pazjenti b'ażma/COPD ikkurati b'ticagrelor jista' jkollhom riskju akbar li jkollhom dispneja mhux serja (3.29% ticagrelor kontra 0.53% clopidogrel) u dispneja serja (0.38% ticagrelor kontra 0.00% clopidogrel).
English: Portugal
Maltese: Il-Portugal
English: • ‘oral anticoagulants' often referred to as 'blood thinners' which include warfarin.
Maltese: • Anti-koagulanti orali magħrufa wkoll bħala dawk li ‘jraqqu d-demm' li jinkludu warfarina.
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 talmetabolu ewlieni fiċ-ċirkolazzjoni AR-C124910XX (attiv ukoll) minn ticagrelor huwa mgħaġġel b'tmax medjan ta' madwar 2.5 sigħat.
English: About 30% of episodes resolved within 7 days.
Maltese: Madwar 30% tal-episodji għaddew waħidhom fi żmien 7 ijiem.
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 metabolu attiv.
English: Mean serum uric acid concentration 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 tal-konċentrazzjoni ta' uric acid fis-serum żdiedet 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: The primary route of ticagrelor elimination is via hepatic metabolism.
Maltese: Il-mezz ewlieni tal-eliminazzjoni ta' ticagrelor huwa permezz ta' metaboliżmu mill-fwied.
English: Medicinal products known to induce bradycardia
Maltese: Mediċini magħrufa li jikkawżaw bradikardija
English: Rare (affects 1 to 10 users in 10,000)
Maltese: Rari (jaffettwaw minn 1 sa 10 minn kull 10,000 li jużawh)
English: Norge
Maltese: Franza
English: Since co-administration of Possia 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-għotja ta' Possia ma' desmopressin ma żiedetx it-“template bleeding time”, mhux probabbli li desmopressin ikun effettiv biex jimmaniġġa każijiet ta' fsada klinika (ara sezzjoni 4.5).
English: Each film-coated tablet contains 90 mg of ticagrelor.
Maltese: Kull pillola miksija b' rita fiha 90 mg ta' ticagrelor.
English: 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: Avvenimenti avversi (AEs) ta' dispneja (dispneja, dispneja waqt li tkun irpużat, dispneja waqt l-eżerċizzju, dispneja paroksiż mali ta' bil-lejl u dispneja ta' bil-lejl), meta jiġu kombinati, kienu rappurtati minn 13.8% tal-pazjenti kkurati b' ticagrelor u minn 7.8% tal-pazjenti kkurati b' clopidogrel.
English: Patients self-identified as Black had an 18% lower bioavailability of ticagrelor compared to Caucasian patients.
Maltese: Pazjenti li jidentifikaw rwieħhom bħala Suwed kellhom bijodisponibilità 18% aktar baxxa għal ticagrelor meta mqabbla mal-pazjenti Kawkażi.
English: Definite stent thrombosis d
Maltese: Trombożi ta' stent definit
English: • non-steroidal anti-inflammatory drugs (abbreviated as NSAIDs) often taken as pain killers such as ibuprofen and naproxen.
Maltese: • Mediċini anti-infjammatorji u mhux sterojdi (fil-qasir NSAIDs) li jittieħdu għal kontra l-uġigħ bħal ibuprofen u naproxen.
English: Common (affects 1 to 10 users in 100) • Bruising
Maltese: Komuni (jaffettwaw minn 1 sa 10 minn kull 100 li jużawh) • Tbenġil
English: Possia, co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with Acute Coronary Syndromes (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: Possia, mogħti ma' acetylsalicylic acid (ASA), huwa indikat għall-prevenzjoni ta' każijiet aterotrombotiċi f'pazjenti adulti b'Sindromi Akuti Koronarji (anġina mhux stabbli, Infart Mijokardijaku b'elevazzjoni mhux tal-ST [NSTEMI] jew Infart Mijokardijaku b'elevazzjoni tal-ST [STEMI]); inklużi pazjenti li jkunu maniġġati b'mod mediku, u dawk li huma maniġġati b'intervent koronarju perkutaneju (PCI) jew by-pass b'trapjant tal-arterja koronarja (CABG).
English: If you stop taking Possia
Maltese: Riskju ta' fsada
English: Uric acid elevations: In PLATO, serum uric acid concentration increased to more than upper limit of normal in 22% of patients receiving ticagrelor compared to 13% of patients receiving clopidogrel.
Maltese: Fi PLATO, il-konċentrazzjoni ta' uric acid fis-serum żdiedet għal aktar mil-limitu ta' fuq tan-normal fi 22% tal-pazjenti li kienu qed jirċievu ticagrelor imqabbla ma' 13% tal-pazjenti li kienu qed jirċievu clopidogrel.
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, sess, piż, razza, reġjun ġeografiku, kundizzjonijiet oħra mal-marda, terapiji oħrajn li jkunu qed jingħataw u passat mediku, inkluż attakk ta' puplesija jew attakk iskemiku tal-qalb, kollha kemm huma ma setgħux ibassru la fsada globali u lanqas fsada Maġġuri PLATO mhux relatata malproċedura.
English: Wound haemorrhage, Traumatic haemorrhage
Maltese: Emorraġija tal-ferita, Emorraġija Trawmatika
English: Hyperuricaemia a
Maltese: AstraZeneca A.E.
English: Switching from clopidogrel to ticagrelor 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 għal ticagrelor 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: This is because of the increased risk of bleeding.
Maltese: Tista' tkun f' riskju ta' żieda ta' fsada.
English: There was no effect of simvastatin on ticagrelor plasma levels.
Maltese: Ma kienx hemm effett ta' simvastatin fuq il-livelli filplażma ta' ticagrelor.
English: • Co-administration of ticagrelor with strong CYP3A4 inhibitors (e.g., ketoconazole,
Maltese: • Huwa kontraindikat li ticagrelor jingħata flimkien ma' inibituri qawwija CYP3A4 (e.ż,
English: • CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Maltese: • KONDIZZJONIJIET JEW RESTRIZZJONIJIET RIGWARD L-UŻU SIGUR U EFFETTIV TAL-PRODOTT MEDIĊINALI
English: Blood creatinine increased
Maltese: Elevazzjonijiet tal-krejatinina
English: Possia 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: Possia u clopidogrel fl-istudju PLATO ma kellhomx rati differenti ta' fsada Fatali Maġġuri/ Tgħeddid għal-ħajja, Fsada Maġġuri PLATO Totali, Fsada TIMI Maġġuri, jew Fsada Timi Minuri (Tabella 2).
English: In patients with stable coronary artery disease on ASA, ticagrelor demonstrates a rapid onset of pharmacological effect as demonstrated by a mean Inhibition of Platelet Aggregation (IPA) for ticagrelor at 0.5 hours after 180 mg loading dose of about 41%, with the maximum IPA effect of 89% by 2-4 hours post dose, and maintained between 2-8 hours.
Maltese: F'pazjenti fuq mard tal-qalb stabbli fuq ASA, ticagrelor wera li jibda jkollu effett farmakoloġiku malajr hekk kif indikat mill-Medja tal-Inibizzjoni tal-Plejtlets (IPA) għal ticagrelor wara 0.5 sigħat wara doża ta' tagħbija ta' 180 mg ta' madwar 41%, bl-ogħla effett IPA ta' 89% minn 2-4 sigħat wara d-doża u miżmuma bejn 2-8 sigħat.
English: ARR
Maltese: Maġġuri
English: Possia reduced the occurrence of the primary composite endpoint compared to clopidogrel in both the UA/NSTEMI and STEMI population (Table 3).
Maltese: Possia naqqas il-fini ewlenija komposita meta mqabbel ma' clopidogrel kemm fil-popolazzjoni UA/NSTEMI kif ukoll STEMI (Tabella 3).
English: In addition, caution should be exercised when administering Possia concomitantly with medicinal products known to induce bradycardia.
Maltese: Ma deherx li kien hemm evidenza ta' interazzjonijiet avversi klinikament sinifikanti b'dawn il-prodotti mediċinali.
English: The Cmax of the active metabolite was unchanged and the AUC was decreased by 46%, respectively.
Maltese: Is-Cmax tal-metabolu attiv ma nbidilx u l-AUC naqas b'46% rispettivament.
English: RRR
Maltese: Oħrajn
English: If a CABG procedure is planned, ticagrelor bleeding risk is increased compared to clopidogrel when discontinued within less than 96 hours prior to procedure.
Maltese: Jekk proċedura CABG hija ppjanata, riskju ta' fsada bi ticagrelor hu akbar meta mqabbel ma clopidogrel meta jiġi mwaqqaf anqas minn 96 siegħa qabel il-proċedura.
English: Exploratory analyses suggest a possible association with ASA dose such that reduced efficacy was observed with ticagrelor with increasing ASA doses.
Maltese: Analiżi esploratorja ssuġġeriet possibilita ta' assoċċjazzjoni ma doża ta' ASA tant li tnaqqis fleffikaċja kienet osservata b' ticagrelor ma żidiet fid-dożi ta' ASA.
English: Ticagrelor is orally active, and reversibly interacts with the platelet P2Y12 ADP-receptor.
Maltese: Ticagrelor huwa attiv meta jittieħed b'mod orali, u jinteraġixxi b'mod riversibbli mar-riċettur P2Y12 ADP.
English: On a background of daily ASA, ticagrelor 90 mg twice daily showed superiority to 75 mg daily clopidogrel in preventing the composite endpoint of cardiovascular [CV] death, myocardial infarction [MI], or stroke, with the difference driven by CV death and MI.
Maltese: Flimkien ma' ASA meħud kuljum, ticagrelor 90 mg darbtejn kuljum wera superjorità għal 75mg clopidogrel kuljum biex jevita l-fini kompositu ta' mewt kardjovaskulari [CV], infart mijokardijaku [MI], jew attakk ta' puplesija , bl-ogħla differenza fil-mewt b'CV u MI.
English: CABG-related bleeding: 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-grupp) li għamlu operazzjoni ta' trapjant bypass tal-arterja koronarja (CABG) kellhom Fsada PLATO Fatali Maġġuri/ta' Tgħeddida għal Ħajja bl-ebda differenza bejn iż-żewġ gruppi ta' kura.
English: Skin and subcutaneous tissue disorders
Maltese: Ear and labyrinth disorders
English: TIMI Major Bleed: Clinically apparent with >50 g/l decrease in haemoglobin or intracranial haemorrhage.
Maltese: Klinikament viżibbli bi tnaqqis ta' >50 g/l tal-emoglobina jew fsada ġol kranju.
English: Do not take Possia if:
Maltese: Tieħux Possia jekk:
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
English: Major Fatal/Life-threatening Bleed: Clinically apparent with >50 g/l decrease in haemoglobin or ≥4 red cell units transfused; or fatal; or intracranial; or intrapericardial with cardiac tamponade; or with hypovolaemic shock or severe hypotension requiring pressors or surgery.
Maltese: Klinikament viżibbli bi tnaqqis ta' >50 g/l tal-emoglobina jew ≥4 units ta' ċelluli ħomor trasfużi; jew fatali; jew ġol kranju; jew ġol perikardju b'taponaġġ kardijaku; jew b'xokk ipovolimiku jew ipotensjoni severa li teħtieġ pressors jew operazzjoni.
English: The superiority of ticagrelor over clopidogrel in reducing major CV events was not significantly affected by patient CYP2C19 or ABCB1 genotype.
Maltese: Is-superjorità ta' ticagrelor fuq clopidogrel biex inaqqas każijiet ta' CV maġġuri ma kienetx effettwata b'mod sinifikanti bis-CYP2C19 tal-pazjenti jew ġenotip ABCB1.
English: • Itching
Maltese: • Stitikezza
English: 6.5 Nature and contents of container
Maltese: 6.1 Lista ta' sustanzi mhux attivi
English: • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached
Maltese: • Fi żmien 60 ġurnata minn meta jintlaħaq punt importanti (farmakoviġilanza jew tnaqqis tar-riskju)
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-Għotja f'daqqa ta' diltiazem ma' ticagrelor żiedet is-Cmax ta' ticagrelor b'69% u l-AUC b'2.7-il darba u naqset is-Cmax tal-metabolu attiv b'38% u l-AUC ma nbidilx.
English: In PLATO patients undergoing coronary artery bypass grafting (CABG), Possia had more bleeding than clopidogrel when stopped within 1 day prior to surgery but a similar rate of major bleeds compared to clopidogrel after stopping therapy 2 or more days before surgery (see section 4.8).
Maltese: Fi PLATO il-pazjenti li kienu ser jagħmlu trapjant bypass tal-arterja koronarja (CABG), Possia ikkawża aktar fsada minn clopidogrel meta twaqqaf fi żmien jum 1 qabel l-operazzjoni iżda kellu rata simili ta' fsadiet maġġuri meta mqabbel ma' clopidogrel wara li twaqqfet it-terapija jumejn jew aktar qabel l-operazzjoni (ara sezzjoni 4.8).
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: Available pharmacodynamic/toxicological data in animals have shown excretion of ticagrelor and its active metabolites in milk (see section 5.3).
Maltese: Dejta farmakodinamika/tossikoloġika fl-annimali urew li ticagrelor u l-metaboliti tiegħu joħroġ malħalib (ara sezzjoni 5.3).
English: P-glycoprotein (P-gp) substrates (including digoxin, cyclosporin) Concomitant administration of Possia increased the digoxin Cmax by 75% and AUC by 28%.
Maltese: Sottostrati ta' glikoproteina-P (P-gP) (inkluż digoxin, cyclosporin)
English: • other medicines such as ketoconazole (used to treat fungal infections), clarithromycin (used to treat bacterial infections), nefazodone, (an antidepressant), ritonavir and atazanavir (used to treat HIV infection and AIDS), cisapride (used to treat heartburn), ergot alkaloids (used to treat migraines and headaches).
Maltese: (jintuża sabiex jikkura infezzjonijiet tal-batteri), nefozodone (anti-dipressant), ritonavir u atazanavir (jintuża sabiex jikkura l-infezzjoni tal-HIV u AIDS), cisapride (għal ħruq ta' stonku),
English: Intracranial bleeding: There were more intracranial non-procedural bleeds with ticagrelor (n=27 bleeds in 26 patients, 0.3%) than with clopidogrel (n=14 bleeds, 0.2%), of which 11 bleeds with ticagrelor and 1 with clopidogrel were fatal.
Maltese: Kien hemm aktar każijiet ta' fsada ġol-kranju mhux minħabba l-proċedura b'ticagrelor (n=27 każ f'26 pazjent, 0.3%) milli b'clopidogrel (n=14-il każ, 0.2%), li minnhom 11-il każ ta' fsada b'ticagrelor u każ 1 b'clopidogrel kienu fatali.
English: Haemarthrosis h
Maltese: Fergħa tal-istudju Holter