FrancophonIA/ELRC3.0 huggingface dataset:
English: Post procedural haemorrhage, Traumatic bleedings e.g. bleeding from bladder cancer, gastric cancer, colon cancer e.g. increased tendency to bruise, spontaneous haematoma, haemorrhagic diathesis Identified in post-marketing experience d
Maltese: Emorraġija wara operazzjoni, Fsada trawmatika eż. fsada mill-kanċer tal-bużżieqa tal-awrin, kanċer tal-istonku, kanċer tal-kolon eż. tendenza ikbar li titbenġel, ematoma spontanja, dijateżi emorraġika Identifikati f'esperjenza ta' wara t-tqegħid fis-suq d
English: 14 film-coated tablets 56 film-coated tablets 60 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 168 pillola miksija b'rita 180 pillola miksija b'rita
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 (jintużaw sabiex jikkuraw l-infezzjoni tal-HIV u AIDS), cisapride (għall-ħruq ta'
English: • Bleeding into the brain or inside the skull is an uncommon side effect, and may cause signs of a stroke such as: - sudden numbness or weakness of your arm, leg or face, especially if only on one side of the body - sudden confusion, difficulty speaking or understanding others - sudden difficulty in walking or loss of balance or co-ordination - suddenly feeling dizzy or sudden severe headache with no known cause
Maltese: • Sinjali ta' fsada bħal: - fsada li hija qawwija jew li ma tistax tiġi kkontrollata - fsada mhux mistennija jew fsada li ddum ħafna - awrina roża, ħamra jew kannella - tirremetti demm aħmar jew ir-rimettar tiegħek ikun qisu “ċiċri tal-kafè” - ippurgar aħmar jew iswed (ikun qisu qatran) - tisgħol jew tirremetti ċapep tad-d-demm
English: Hyperuricaemia may occur during treatment with ticagrelor (see section 4.8).
Maltese: Tista' sseħħ iperuriċemija waqt il-kura b'ticagrelor (ara sezzjoni 4.8).
English: • A 2-fold increase of ticagrelor exposure was observed after daily consumption of large quantities of grapefruit juice (3x200 ml).
Maltese: • Ġiet osservata żieda ta' darbtejn aktar l-espożizzjoni ta' ticagrelor wara l-konsum ta' kuljum ta' kwantitajiet kbar ta' meraq tal-grejpfrut (3 x 200 ml).
English: • Feeling sick (nausea)
Maltese: - Ħass ħażin (sinkope)
English: • Itching
Maltese: • Tinfaraġ
English: • Allergic reaction - a rash, itching or a swollen face or swollen lips/tongue may be signs of an allergic reaction
Maltese: • Reazzjoni allerġika - raxx, ħakk jew jintefħu x-xofftejn/ilsien jistgħu jkunu sinjali ta' reazzjoni allerġika
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini (EMA) http://www.ema.europa.eu/.
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: 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 b'ticagrelor hu akbar meta mqabbel ma clopidogrel meta jiġi mwaqqaf anqas minn 96 siegħa qabel il-proċedura.
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: Maġġuri Fatali/Fsada ta' theddida għall-ħajja: Klinikament viżibbli bi tnaqqis ta' >50 g/L tal-emoglobina jew ≥4 unitajiet ta' ċelloli ħomor trasfużi; jew fatali; jew ġol-kranju; jew ġol-perikardju b'tamponaġġ kardijaku; jew b'xokk ipovolimiku jew pressjoni baxxa severa li teħtieġ pressors jew operazzjoni.
English: Frequencies derived from lab observations (Uric acid increases to >upper limit of normal from baseline below or within reference range.
Maltese: Frekwenzi derivati minn osservazzjonijiet fil-laboratorju (Żidiet fl-uric acid sa >limitu ta' fuq tan-normal mil-linja bażi taħt jew fi ħdan il-medda ta' referenza.
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 joħorġu malħalib (ara sezzjoni 5.3).
English: In patients with stable coronary artery disease (CAD) 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 (CAD - Coronary Artery Disease) fuq ASA, ticagrelor wera li jibda jkollu effett farmakoloġiku malajr hekk kif indikat mill-medja tal-aggregazzjoni tal-inibizzjoni talplejtlets (IPA - inhibition of platelet aggregation) għal ticagrelor wara 0.5 sigħat wara doża tal-bidu 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: Tablet core
Maltese: Intent invażiv
English: There was no effect of simvastatin on ticagrelor plasma levels.
Maltese: Ma kienx hemm effett ta' simvastatin fuq il-livelli fil-plażma ta' ticagrelor.
English: Ticagrelor is also a P-glycoprotein (P-gp) substrate and a weak P-gp inhibitor and may increase the exposure of P-gp substrates.
Maltese: Ticagrelor huwa wkoll sottostrat ta' P-glycoprotein (P-gp) u inibitur dgħajjef ta' P-gP u jista' jżid l-esponiment ghassottostrati ta' P-gP.
English: ICH: Intracranial haemorrhage.
Maltese: Emorraġija ġol-kranju.
English: Platelet transfusion is unlikely to be of clinical benefit in patients with bleeding (see section 4.4).
Maltese: It-trasfużjoni tal-plejtlets hija improbabbli li tkun ta' benefiċċju kliniku f'pazjenti bi fsada (ara sezzjoni 4.4).
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 possibilità ta' assoċjazzjoni ma' doża ta' ASA tant li tnaqqis fl-effikaċja kien osservat b'ticagrelor ma' żidiet fid-dożi ta' ASA.
English: Patients taking Brilique should also take a daily low maintenance dose of ASA 75-150 mg, unless specifically contraindicated.
Maltese: Pazjenti li qed jieħdu Brilique għandhom jieħdu wkoll doża ta' manteniment baxxa ta' kuljum ta' ASA ta' 75 sa 150 mg, sakemm mhux speċifikament kontraindikata.
English: Patients with prior ischaemic stroke
Maltese: Pazjenti b'puplesija iskemika preċedenti
English: Round, flat, bevelled edged, white to pale pink, orodispersible tablets marked with ‘90' above ‘TI' on one side and plain on the other.
Maltese: Il-pilloli huma tondi, bikunvessi, sofor, miksija b'rita mmarkati b'“90” fuq ”T” fuq naħa waħda.
English: Brilique in combination with acetylsalicylic acid (another antiplatelet agent) is to be used in adults only.
Maltese: Brilique flimkien ma' acetylsalicylic acid (sustanza oħra kontra l-plejtlits) għandu jintuża biss fladulti.
English: In PLATO patients undergoing coronary artery bypass grafting (CABG), ticagrelor 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 grafting ta' bypass tal-arterja koronarja (CABG), ticagrelor 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: Co-administration of ticagrelor and CYP3A4 substrates with narrow therapeutic indices (i.e. cisapride or ergot alkaloids) is not recommended, as ticagrelor may increase the exposure to these medicinal products.
Maltese: L-għoti f'daqqa ta' ticagrelor ma' sottostrati ta' CYP3A4 b'indiċi terapewtiċi dojoq (i.e. cisapride jew alkalojdi ergot) mhux rakkomandat, minħabba li ticagrelor jista' jżid l-esponiment ta' dawn il-mediċini.
English: Stroke
Maltese: Maġġuri
English: • Co-administration of ticagrelor with strong CYP3A4 inhibitors (e.g. ketoconazole,
Maltese: • digoxin (jintuża sabiex jikkura l-insuffiċjenza tal-qalb)
English: Ticagrelor 90 mg twice daily (% patients with event) N=9333
Maltese: Tabella 4 - Analiżi tal-punti ta' tmiem primarji u sekondarji PLATO Ticagrelor 90 mg darbtejn kuljum (% talpazjenti b'każ) N=9333
English: Brilique 60 mg twice daily is the recommended dose when an extended treatment is required for patients with a history of MI of at least one year and a high risk of an atherothrombotic event (see section 5.1).
Maltese: Brilique 60 mg darbtejn kuljum hija d-doża rrakkomandata meta tkun meħtieġa kura estiża għal pazjenti bi storja ta' MI ta' mill-inqas sena u b'riskju għoli ta' avveniment aterotrombotiku (ara sezzjoni 5.1).
English: Ticagrelor has been documented to augment the following adenosine-induced effects in healthy subjects and in patients with ACS: vasodilation (measured by coronary blood flow increases in healthy volunteers and ACS patients; headache), inhibition of platelet function (in human whole blood in vitro) and dyspnoea.
Maltese: Ticagrelor ġie ddokumentat li jżid l-effetti li ġejjin, indotti minn adenosine f'individwi b'saħħithom u f'pazjenti b'ACS: vażodilazzjoni (imkejla b'żidiet fil-flussi tad-demm koronarji f'voluntiera b'saħħithom u f'pazjenti b'ACS; uġigħ ta' ras), inibizzjoni tal-funzjoni tal-plejtlits (f'demm sħiħ uman in vitro) u dispnea.
English: In patients with ACS, in whom morphine cannot be withheld and fast P2Y12 inhibition is deemed crucial, the use of a parenteral P2Y12 inhibitor may be considered.
Maltese: F'pazjenti b'ACS, li fihom ma tistax ma tingħatax il-morfina u li fuqhom l-inibizzjoni mgħaġġla ta' P2Y12 titqies bħala kruċjali, jista' jiġi kkunsidrat l-użu ta' inibitur ta' P2Y12 parenterali.
English: Ticagrelor reduced the occurrence of the primary composite endpoint compared to clopidogrel in both the UA/NSTEMI and STEMI population (Table 4).
Maltese: Ticagrelor naqqas l-okkorrenza tal-punt ta' tmiem kompost primarju meta mqabbel ma' clopidogrel kemm fil-popolazzjoni UA/NSTEMI kif ukoll STEMI (Tabella 4).
English: Other strong inhibitors of CYP3A4 (clarithromycin, nefazodone, ritonavir and atazanavir) would be expected to have similar effects and therefore concomitant use of strong CYP3A4 inhibitors with ticagrelor is contraindicated (see section 4.3).
Maltese: (clarithromycin, nefazadone, ritonavir u azatanavir) huma mistennija li jkollhom effetti simili u għalhekk l-użu ta' inibituri qawwija ta ' CYP3A4 flimkien ma' ticagrelor huwa kontra-indikat (ara sezzjoni 4.3).
English: Each film-coated tablet contains 90 mg of ticagrelor.
Maltese: Kull pillola miksija b'rita fiha 90 mg ta' ticagrelor.
English: Clopidogrel
Maltese: Iperuriċemija
English: In PEGASUS, TIMI Major bleeding for ticagrelor 60 mg twice daily was higher than for ASA alone.
Maltese: F'PEGASUS, fsada TIMI Maġġuri għal ticagrelor 60 mg darbtejn kuljum kienet ogħla għal ASA waħdu.
English: Patients in PLATO receiving ticagrelor took a variety of statins, with no concern of an association with statin safety among the 93% of the PLATO cohort taking these medicinal products.
Maltese: Pazjenti fi PLATO li kienu qed jirċievu ticagrelor ħadu varjetà ta' statins, mingħajr tħassib dwar assoċjazzjoni mas-sigurtà tal-istatin fost 93% tal-grupp PLATO li kienu qed jieħdu dawn ilprodotti mediċinali.
English: 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 iktar 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 ta' fsada, 0.2%), li minnhom 11-il każ ta' fsada b'ticagrelor u każ wieħed bi clopidogrel kienu fatali.
English: In PEGASUS, patients with history of MI with prior ischaemic stroke were not included.
Maltese: F'PEGASUS, il-pazjenti bi storja ta' MI b'puplesija iskemika preċedenti ma kinux inklużi.
English: PLATO Major Fatal/life-threatening: Fatal bleeding, OR any intracranial bleeding, OR intrapericardial with cardiac tamponade, OR with hypovolaemic shock or severe hypotension requiring pressors/inotropes or surgery OR clinically apparent with >50 g/L decrease in haemoglobin or ≥4 red cell units transfused.
Maltese: Fsada fatali, JEW kwalunkwe fsada ġol-moħħ, ġol-perikardju b'tamponaġġ kardijaku, JEW b'xokk ipovolemiku jew pressjoni baxxa severa li teħtieġ pressors/inotropi jew kirurġija JEW klinikament evidenti b'tnaqqis ta' >50 g/L fl-emoglobina jew ≥4 unitajiet ta' ċelloli ħomor trasfużi.
English: MI (excl. silent MI) Stroke
Maltese: (mestrwali) tiegħek
English: Hypotension
Maltese: Puplesija
English: Ingestion of a high-fat meal resulted in a 21% increase in ticagrelor AUC and 22% decrease in the active metabolite Cmax but had no effect on ticagrelor Cmax or the AUC of the active metabolite.
Maltese: Il-bijodisponibilità medja assoluta ta' ticagrelor kienet stmata 36%. Meta ittieħdet ikla b'kontenut għoli ta' xaħam kien hemm żieda ta' 21% fl-AUC ta' ticagrelor u tnaqqis ta' 22% tas-Cmax talmetabolit attiv iżda ma kellu l-ebda effett fuq is-Cmax ta' ticagrelor jew l-AUC tal-metabolit attiv.
English: The most commonly reported adverse reactions in patients treated with ticagrelor were bleeding and dyspnoea (see section 4.4).
Maltese: Liktar reazzjonijiet avversi rrapportati b'mod komuni f'pazjenti kkurati b'ticagrelor kienu fsada u dispnea (ara sezzjoni 4.4).
English: Each film-coated tablet contains 60 mg ticagrelor
Maltese: Kull pillola miksija b'rita fiha 60 mg ticagrelor
English: Based on a relationship observed in PLATO between maintenance ASA dose and relative efficacy of ticagrelor compared to clopidogrel, co-administration of ticagrelor and high maintenance dose ASA (>300 mg) is not recommended (see section 5.1).
Maltese: Mir-relazzjoni li dehret fi PLATO bejn id-doża ta' manteniment ASA u l-effikaċja relattiva ta' ticagrelor meta mqabbel ma' clopidogrel, l-għoti ta' ticagrelor fl-istess ħin ma' doża ta' manteniment għolja ta' ASA (>300 mg) mhuwiex rakkomandat (ara sezzjoni 5.1).
English: Your doctor will usually also tell you to take acetylsalicylic acid.
Maltese: Din id-doża normalment tingħata lilek l-isptar.
English: Brilique is available in:
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq:
English: • Bleeding after surgery or from cuts (for example while shaving) and wounds more than is normal
Maltese: • Fsada wara kirurġija jew minn qtugħ (pereżempju waqt li tkun qed tqaxxar il-leħja) u feriti aktar min-normal
English: Bleeding findings in PLATO
Maltese: Sejbiet ta' fsada fi PLATO
English: There were 6 fatal ICHs with ticagrelor 60 mg and 5 fatal ICHs with ASA therapy alone.
Maltese: Kien hemm 6 ICHs fatali b'ticagrelor 60 mg u 5
English: Gastrointestinal irritation was observed in several animal species at clinical relevant exposure levels (see section 4.8).
Maltese: Irritazzjoni gastro-intestinali kienet osservata fi speċi varji t' annimali b'livelli t'esponiment klinikament relevanti
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 CABG.
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' CABG.
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).
Maltese: Minħabba osservazzjonijiet ta' pawżi ventrikulari u bradikardija l-aktar asintomatiċi, għandha tingħata kawtela meta ticagrelor jingħata flimkien ma' mediċini magħrufa li jikkawżaw bradikardija (ara sezzjoni 4.4). Madankollu, m'hemmx evidenza ta' interazzjonijiet avversi klinikament sinifikanti fi provi PLATO wara li ingħata flimkien ma mediċina waħda jew aktar magħrufa li jikkawżaw bradikardija (eż. 96% imblukkaturi beta, 33% imblukkaturi tal-kanal tal-calcium diltiazem u verapamil u 4% digoxin).
English: In addition, caution should be exercised when administering ticagrelor 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: There was no evidence of benefit (no reduction in the primary composite endpoint of CV death, MI and stroke, but an increase in major bleeding) when ticagrelor 60 mg twice daily was introduced in clinically stable patients >2 years from the MI, or more than one year after stopping previous ADP receptor inhibitor treatment (see also section 4.2).
Maltese: Ma kien hemm ebda evidenza ta' benefiċċju (ebda tnaqqis fil-punt ta' tmiem kompost primarju ta' mewta kardjovaskulari, infart mijokardijaku u puplesija, iżda żieda fi fsada maġġuri) meta ticagrelor 60 mg darbtejn kuljum ġie introdott f'pazjenti stabbli klinikament > sentejn mill-infart mijakardijaku, jew aktar minn sena wara t-twaqqif ra' kura b'inibitur riċettur ta' ADP preċedenti (ara sezzjoni 4.2).
English: Discontinuation of treatment due to bleeding was more common with ticagrelor 60 mg compared to ASA therapy alone (6.2% and 1.5%, respectively).
Maltese: It-twaqqif ta' kura minħabba fsada kien iktar komuni b'ticagrelor 60 mg meta mqabbel ma' terapija ASA waħedha (6.2% u 1.5%, rispettivament).
English: It is important that you inform your doctor that you are taking both Brilique and heparin, as Brilique may affect the diagnostic test.
Maltese: Huwa importanti li tinforma lit-tabib tiegħek li qed tieħu kemm Brilique kif ukoll l-eparina, peress li Brilique jista' jaffettwa t-test dijanjostiku.
English: Dyspnoea, a sensation of breathlessness, is reported by patients treated with ticagrelor.
Maltese: Dispnea, sensazzjoni ta' qtugħ ta' nifs, hija rrapportata minn pazjenti kkurati bi ticagrelor.
English: ACS patients with prior ischaemic stroke can be treated with ticagrelor for up to 12 months (PLATO study).
Maltese: Pazjenti b'ACS b'puplesija iskemika jistgħu jiġu kkurati bi ticagrelor għal sa 12-il xahar (studju PLATO).
English: There is currently no known antidote to reverse the effects of ticagrelor, and ticagrelor is not dialysable (see section 5.2).
Maltese: S'issa m'hemmx antidotu li hu magħruf li jreġġa' lura l-effetti ta' ticagrelor, u ticagrelor ma jistax jitneħħa bid-dijaliżi (ara sezzjoni 5.2).
English: Tumour bleedings
Maltese: X'inhu Brilique
English: Only limited information is available in patients with moderate hepatic impairment.
Maltese: Hemm disponibbli biss informazzjoni limitata f'pazjenti b'indoboliment tal-fwied moderat.
English: • Your heart rate is abnormally low (usually lower than 60 beats per minute) and you do not already have in place a device that paces your heart (pacemaker).
Maltese: • Jekk qalbek tħabbat bil-mod (normalment inqas minn 60 darba fil-minuta) u għad ma għandekx f'postu strument li jgħin lil qalbek tħabbat regolari (pacemaker)
English: Bleeding findings in PEGASUS Overall outcome of bleeding events in the PEGASUS study are shown in Table 3.
Maltese: Sejbiet ta' fsada f'PEGASUS L-eżiti globali ta' avvenimenti ta' fsada fl-istudju PEGASUS huma murija fit-Tabella 5.
English: Subcutaneous or dermal bleeding h, Rash,
Maltese: Fsada minn taħt ilġilda jew millġilda h, Raxx, Ħakk
English: • You are taking any of the following medicines: - 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) Do not take Brilique if any of the above applies to you.
Maltese: • ritonavir u atazanavir (jintuża sabiex jikkura l-infezzjoni tal-HIV u AIDS) Tiħux Brilique jekk xi waħda minn dawn tapplika għalik.
English: • Crush the tablet to a fine powder.
Maltese: • attakk tal-qalb, iktar minn sena ilu.
English: Similar increases in AUC and Cmax were observed for all atorvastatin acid metabolites.
Maltese: Żidiet simili fl-AUC u s-Cmax dehru għal metaboli kollha tal-aċidu ta' atorvastatin.
English: Hrvatska AstraZeneca d.o.o.
Maltese: AstraZeneca UK Ltd.
English: Patients were eligible to participate if they were aged 50 years or over, with a history of MI (1 to 3 years prior to randomisation), and had at least one of the following risk factors for atherothrombosis: age ≥65 years, diabetes mellitus requiring medication, a second prior MI, evidence of multivessel CAD or chronic non-end-stage renal dysfunction.
Maltese: Il-pazjenti kienu eliġibbli biex jieħdu sehem jekk kellhom 50 sena jew iktar, bi storja ta' MI (sena sa 3 sena qabel ir-randomizzazzjoni), u kellhom tal-inqas wieħed mill-fatturi ta' riskju li ġejjin għal aterotrombożi: li għandhom ≥65 sena, dijabete mellitus li teħtieġ medikazzjoni, MI preċedenti ieħor, evidenza ta' CAD f'ħafna vini, jew disfunzjoni tal-kliewi kronika mhux fi stadju finali.
English: • Strong CYP3A4 inhibitors - Co-administration of ketoconazole with ticagrelor increased the ticagrelor Cmax and AUC equal to 2.4-fold and 7.3-fold, respectively.
Maltese: L-użu ta' ticagrelor huwa kontraindikat f'pazjenti b'indeboliment tal-fwied sever (ara sezzjonijiet 4.2 u 4.3).
English: Fatal: A bleeding event that directly led to death within 7 days.
Maltese: Fatali: Avveniment ta' fsada li jwassal direttament għal mewt fi żmien 7 ijiem.
English: Manufacturer:
Maltese: Tel:
English: Round, biconvex, pink tablets marked with ‘60' above ‘T' on one side and plain on the other.
Maltese: Il-pilloli huma tondi, bikunvessi, roża, miksija b'rita mmarkati b'”60” fuq ”T” fuq naħa waħda.
English: • Signs of a blood clotting problem called Thrombotic Thrombocytopenic Purpura (TTP) such as: - fever and purplish spots (called purpura) on the skin or in the mouth, with or without yellowing of the skin or eyes (jaundice), unexplained extreme tiredness or confusion
Maltese: • Sinjali ta' problema ta' embolu tad-demm imsejħa Purpura Tromboċitopenika Trombotika (TTP) bħal: - deni u tikek jagħtu fil-vjola (imsejħa purpura) fuq il-ġilda jew fil-ħalq, bi jew mingħajr sfurija tal-ġilda jew l-għajnejn (suffejra), għeja estrema bla spjegazzjoni jew konfużjoni
English: Total MI includes silent MI, with date of event set to date when discovered.
Maltese: MI totali jinkludi MI silenzjuż, bid-data tal-każ imniżżla bħala d-data meta kien skopert.
English: Possible side effects of MicardisPlus:
Maltese: Effetti sekondarji possibbli ta' MicardisPlus:
English: Rottendorf Pharma GmbH Ostenfelder Straße 51 - 61 D-59320 Ennigerloh
Maltese: Rottendorf Pharma GmbH Ostenfelder Straße 51 - 61 D-59320 Ennigerloh Il-Ġermanja
English: MicardisPlus 40 mg/12.5 mg tablets EU/1/02/213/001-005, 011, 013-014
Maltese: MicardisPlus 40 mg/12.5 mg pilloli EU/1/02/213/001-005, 011, 013-014
English: MicardisPlus 80 mg/12.5 mg tablets EU/1/02/213/006-010, 012, 015-016
Maltese: MicardisPlus 80 mg/12.5 mg pilloli EU/1/02/213/006-010, 012, 015-016