FrancophonIA/ELRC3.0 huggingface dataset:
English: Poliovirus (Inactivated)3 Type 1 (Mahoney)
Maltese: Poljovirus (Inattivat)3 Tip 1 (Mahoney)
English: 10 vials
Maltese: 10 fjali
English: Content (concentration)
Maltese: Kontenut (konċentrazzjoni)
English: 1 Adsorbed on aluminium hydroxide, hydrated (0.6 mg Al3+) 2 As lower confidence limit (p= 0.95)
Maltese: 1 Assorbit fuq aluminium hydroxide, idrat (0.6 mg Al3+) 2 Blala l-limitu ta' kunfidenza 'l baxx (p= 0.95) 3 Prodott fuq ċelluli ta' Vero
English: Bordetella pertussis antigens Pertussis Toxoid
Maltese: Antiġen ta' Bordetella pertussis
English: --1 One dose1 (0.5 ml) contains: Diphtheria Toxoid
Maltese: --1 Doza waħda 1 (0.5 ml) fiha: Tossojdi tad-Difterite
English: Hepatitis B surface antigen5
Maltese: Antiġen superfiċjali ta' Epatite B 5
English: Filamentous Haemagglutinin
Maltese: Emaglutinin Filamentuż
English: 4 Or equivalent antigenic quantity determined by a suitable immunochemical method 5 Produced in yeast Hansenula polymorpha cells by recombinant DNA technology
Maltese: Jew kwantità antiġenika ekwivalenti stabbilita b'metodu immunokimiku adattat/1
English: Tetanus Toxoid
Maltese: Tossojdi tat-Tetnu
English: 10 pre-filled syringes + 10 needle
Maltese: 10 siringi mimlijien lesti għal-uzu
English: 1 pre-filled syringe + 2 needles
Maltese: Siringa mimlija lesta għal-uzu+2 labar
English: Pack size vial (glass)
Maltese: Użu ġol muskolu Fjala (ħġieġ)
English: • New neoplasm
Maltese: • Neoplasma ġdida
English: • Intracranial aneurysm and intracranial haemorrhage
Maltese: • Anewriżmu intrakranjali u emorraġija intrakranjali
English: The MAHs should submit/update the Risk Management Plans for all somatropin medicinal products to reflect the following potential risks:
Maltese: Il-MAHs għandhom jissottomettu/jaġġornaw il-Pjani ta' Ġestjoni tar-Riskji għall-prodotti mediċinali kollha li fihom somatropin sabiex jirriflettu r-riskji potenzjali li ġejjin:
English: Annex IV
Maltese: Anness IV Kondizzjonijiet tal-awtorizzazzjonijiet għat-tqegħid fis-suq
English: National Competent Authorities, coordinated by the Reference Member State as applicable, should ensure the following:
Maltese: L-Awtoritajiet Nazzjonali Kompetenti, ikkoordinati mill-Istat Membru ta' Referenza kif applikabbli, għandhom jiżguraw dan li ġej:
English: • Second neoplasm in childhood cancer survivors
Maltese: • Tieni neoplasma f'sovravissuti tal-kanċer fit-tfulija
English: The MAHs within 2 months of the Commission Decision should liaise with the National Competent Authorities to agree on the timelines for submission of the Risk Management Plans.
Maltese: Fi żmien xahrejn mid-Deċiżjoni tal-Kummissjoni, il-MAHs għandhom jiftiehmu mal-Awtoritajiet Nazzjonali Kompetenti sabiex jaqblu dwar l-iskadenzi għas-sottomissjoni tal-Pjani ta' Ġestjoni tarRiskji.
English: (%/yr)
Maltese: ARRa (%/yr)
English: Possia (%/year) N=9235
Maltese: Possia (%/sena) N=9235
English: Biotransformation
Maltese: Biotrasformazzjoni
English: BLISTER (10 TABLETS)
Maltese: Folja (10 pilloli)
English: Clopidogrel (%/year) N=9186
Maltese: Clopidogrel (%/sena) N=9186
English: Hypersensitivity including angioedema
Maltese: Sensittività eċċessiva inkluża anġjoedema
English: Medicinal products metabolised by CYP2C9
Maltese: Prodotti mediċinali metabolizzati min CYP2C9
English: • Moderate to severe hepatic impairment (see section 4.2, 4.4 and 5.2).
Maltese: • Indeboliment epatiku moderat sa sever (ara sezzjoni 4.2, 4.4 u 5.2).
English: • Inflamed stomach (gastritis)
Maltese: • Stonku infjammat (gastrite)
English: ARR = absolute risk reduction; RRR = relative risk reduction = (1-Hazard ratio) x 100%.
Maltese: RRR = tnaqqis relattiv tar-riskju = (1-Proporzjon tal-periklu) x 100%.
English: EU/1/10/656/002 180 film-coated tablets
Maltese: EU/1/10/656/001-006
English: Ear haemorrhage, Vertigo
Maltese: Fsada fil-widna, Vertigo
English: EU/1/10/656/005 168 film-coated tablets EU/1/10/656/006 100x1 film-coated tablets
Maltese: EU/1/10/656/001 60 pilloli miksija b' rita EU/1/10/656/002 180 pilloli miksija b' rita EU/1/10/656/003 14 pilloli miksija b' rita EU/1/10/656/004 56 pilloli miksija b' rita EU/1/10/656/005 168 pilloli miksija b' rita EU/1/10/656/006 100x1 pilloli miksija b' rita
English: Medinfar Produtos Farmacêuticos, S.A. Tel: + 351 21 499 74 00
Maltese: Medinfar Produtos Farmaceuticos, S.A. Tel: + 351 21 4997400
English: Tablet core: mannitol (E421), dibasic calcium phosphate, sodium starch glycolate, hydroxypropyl-cellulose (E463), magnesium stearate (E470b)
Maltese: Qalba tal-pillola: mannitol (E421), dibasic calcium phosphate, sodium starch glycolate, hydroxypropyl cellulose (E463), magnesium stearate (E470b)
English: • Rash
Maltese: • Raxx
English: Table 2 -Kaplan-Meier estimate of bleeding rates by treatment
Maltese: Tabella 2 - Kaplan-Meier estimu tar-rata ta' fsada skond it-trattament
English: Reproductive system and breast disorders Vaginal bleeding (including metrorrhagia)
Maltese: Disturbi fis-sistema riproduttiva u fis-sider Fsada mill-vaġina (inkluż metrorraġija)
English: Manufacturer: AstraZeneca AB Gärtunavägen SE-151 85
Maltese: AstraZeneca AB Gärtunavägen SE-151 85
English: Frequency categories are defined according to the following conventions: Very common (≥1/10), Common (≥1/100 to 1/10), Uncommon (≥1/1,000 to 1/100), Rare (≥1/10,000 to 1/1,000), Very rare (<1/10,000), Not known (cannot be estimated from the available data).
Maltese: Ilkategoriji tal-frekwenza huma definiti skont il-konvenzjonijiet li ġejjin: Komuni ħafna (≥1/10), Komuni (≥1/100 sa <1/10), Mhux komuni (≥1/1,000 sa <1/100), Rari (≥1/10,000 sa <1/1,000), Rari ħafna (<1/10,000), Mhux magħruf (ma jistax jiġi stmat mid-dejta disponibbli).
English: CALENDAR BLISTER (14 TABLETS)
Maltese: Folja bil-kalendarju (14- il pillola)
English: Musculoskeletal and connective tissue disorders
Maltese: Disturbi muskolu-skeltrali u tal-connective tissue
English: (95% CI)
Maltese: RRRa (%) (95% CI)
English: Following oral administration of ticagrelor 90 mg under fasted conditions, Cmax is 529 ng/ml and AUC is 3451 ng*h/ml.
Maltese: Wara li jingħata b'mod orali ticagrelor 90 mg f'kundizzjoni ta' sawm, Cmax tkun 529 ng/ml u l-AUC tkun 3451 ng.h/ml.
English: Slovenija
Maltese: Is-Slovenja
English: For oral use.
Maltese: Użu orali.
English: No data are available (see section 5.1 and 5.2).
Maltese: Ma hemmx dejta disponibbli (ara szzjoni 5.1 u 5.2)
English: There was no difference in overall fatal bleeds.
Maltese: Ma kienx hemm differenza finnumru globali ta' każijiet fatali ta' fsada.
English: Table 1 - Adverse reactions by frequency and System Organ Class (SOC)
Maltese: Tabella 1 - Reazzjonijiet avversi skont il-frekwenza u l-Klassi tas-Sistema tal-Organi (SOC)
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 (ara sezzjoni 4.8).
English: Possia may have similar effect on lovastatin.
Maltese: Possia jista' jkollu effett simili fuq lovastatin.
English: PERFORATED UNIT DOSE BLISTER (100X1 TABLETS)
Maltese: Folja b' unita ta' doża mtaqqba, folja (100x1 pilloli)
English: Nederland AstraZeneca BV Tel: +31 79 363 2222
Maltese: AstraZeneca BV Tel: +31 79 363 2222
English: Magyarország AstraZeneca kft Tel.: + 36 1 883 6500
Maltese: L-Ungerija AstraZeneca kft Tel.: + 36 1 883 6500
English: Effects of other medicinal products on Possia
Maltese: Effetti ta' prodotti mediċinali oħra fuq Possia
English: Tablet film coating: hypromellose (E464), titanium dioxide (E171), talc, polyethylene-glycol 400, and ferric oxide yellow (E172).
Maltese: Il-kisja tar-rita tal-pillola: hypromellose (E464), titanium dioxide (E171), terra, polyethyleneglycol 400, u ferric oxide yellow (E172)
English: Ísland
Maltese: L-Islanda
English: The steady state volume of distribution of ticagrelor is 87.5 l. Ticagrelor and the active metabolite is extensively bound to human plasma protein (>99.0%).
Maltese: Il-volum ta' distribuzzjoni fi stat fiss ta' ticagrelor huwa 87.5 l. Ticagrelor ul-metabolu attiv jeħlu b'mod estensiv mal-proteina fil-plażma tal-bniedem (>99.0%).
English: AstraZeneca AS Tlf: + 47 21 00 64 00
Maltese: In-Norveġja AstraZeneca AS Tlf: + 47 21 00 64 00
English: Medicinal products metabolised by CYP3A4
Maltese: Prodotti mediċinali metabolizzati minn CYP3A4
English: AstraZeneca UK Limited Silk Road Business Park
Maltese: AstraZeneca UK Limited Silk Road Business Park Macclesfield Cheshire, SK10 2NA Ir-Renju Unit
English: Patients with renal impairment
Maltese: Indeboliment renali
English: AstraZeneca Pharma SRL Tel: + 40 21 317 60 41
Maltese: Ir-Rumanija AstraZeneca Pharma SRL Tel: + 40 21 317 60 41
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: If you forget to take Possia
Maltese: X'inhu Possia
English: United Kingdom AstraZeneca UK Ltd Tel: + 44 1582 836 836
Maltese: Ir-Renju Unit AstraZeneca UK Ltd Tel: + 44 1582 836 836
English: Uric acid increase
Maltese: Żieda fil- uric acid
English: Creatinine elevations by >50% were more pronounced in patients > 75 years (ticagrelor 13.6% versus clopidogrel 8.8%), in patients with severe renal impairment at baseline (ticagrelor 17.8% versus clopidogrel 12.5%) and in patients receiving concomitant treatment with ARBs (ticagrelor 11.2% versus clopidogrel 7.1%).
Maltese: Żiediet tal-krejatinina b'>50% kienu aktar qawwija f'pazjenti >75 sena (ticagrelor 13.6% kontra clopidogrel 8.8%), f'pazjenti b'indeboliment renali sever mal-linja bażi (ticagrelor 17.8% kontra clopidogrel 12.5%) u f'pazjenti li kienu qed jirċievu kura f'daqqa ma' ARBs (ticagrelor 11.2% kontra clopidogrel 7.1%).
English: In the phase 3 pivotal trial (PLATO [PLATelet Inhibition and Patient Outcomes], 18,624 patients) key exclusion criteria included an increased risk for bleeding, clinically important thrombocytopenia or anaemia, previous intracranial bleed, gastrointestinal bleed within the past 6 months or major surgery within the past 30 days.
Maltese: Fi provi ta' fażi 3 PLATO ([PLATelet Inhibition and Patient Outcomes], 18,624 pazjent) kriterji importanti ta' esklużjoni nkludew riskju akbar ta' fsada, tromboċitopenija klinikament importanti jew anemija, fsada fil-kranju fil-passat, fsada gastrointestinali fis-6 xhur ta' qabel jew kirurġija maġġuri f' dawn l-aħħar 30 ġurnata.
English: Chronic daily ASA doses to accompany Possia should be 75-150 mg (see section 4.2 and 4.4).
Maltese: Dożi kroniċi ta' ASA kuljum li jmorru ma Possia għandhom ikunu 75-150 mg (ara sezzjoni 4.2 u 4.4)
English: Respiratory, thoracic and mediastinal disorders e, Haemorrhoidal
Maltese: Disturbi respiratorji, toraċiċi u medjastinali Dispneja c, Epistassi
English: The primary variable of interest was the occurrence of ventricular pauses ≥3 seconds.
Maltese: Il-varjant ewlieni ta' interess kienet li seħħew pawżi ventrikolari ta' ≥3 sekondi.
English: • Abdominal pain
Maltese: • Uġigħ addominali
English: Possible side effects
Maltese: Effetti sekondarji oħra
English: • selective serotonin reuptake inhibitors (abbreviated as SSRIs) taken as antidepressants such as paroxetine, sertraline and citalopram
Maltese: • Inibituri selettivi reuptake tas-serotonin (fil-qasir SSRIs) jittieħdu bħala anti-depressanti bħal paroxetine, sertraline u citalopram.
English: Södertälje
Maltese: Södertälje Svezzja
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 ta' tagħbija ta' 300 mg clopidogrel (600 mg setgħu jingħataw jekk kellhom PCI) jew 180 mg ticagrelor.
English: The systemic exposure to the active metabolite is approximately 30-40% of that obtained for ticagrelor.
Maltese: L-esponiment sistematiku għall-metabolu attiv huwa madwar 30-40% ta' dak miksub għal ticagrelor.
English: • A similar effect on other statins metabolised by CYP3A4 cannot be excluded.
Maltese: • Effett simili fuq statins oħrajn metabolizzati permezz ta' CYP3A4 ma jistax jiġi eskluż.
English: Manufacturer:
Maltese: Sími:
English: These differences are not considered clinically significant.
Maltese: Id-differenzi mhumiex meqjusa klinikament sinifikanti.
English: This can be
Maltese: Tista'
English: Treating 54 ACS patients with ticagrelor instead of clopidogrel will prevent 1 atherothrombotic event; treating 91 will prevent 1 CV death (see Figure 1 and Table 3).
Maltese: Meta 54 pazjenti ACS jiġu ikkurati b'ticagrelor minflok clopidogrel jevita każ aterotrombotiku 1; meta jiġu ikkurati 91 jevita mewta 1 b'CV (ara Figura 1 u Tabella 3).
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-metabolu attiv tiegħu (AR-C124910XX) huma bejn wieħed u ieħor proporzjonali mad-doża sa 1260 mg.
English: AstraZeneca AB S-151 85
Maltese: Manifattur AstraZeneca AB Gartunavagen S-151 85
English: Antifibrinolytic therapy (aminocaproic acid or tranexamic acid) and/or recombinant factor VIIa may increase haemostasis.
Maltese: Terapija anti-fibrinolitika (aminocaproic acid jew tranexamic acid) u/jew fattur VIIa rikombinanti jista' jżid l-emostażi.
English: Cmax and AUC for ticagrelor were 12% and 23% higher in patients with mild hepatic impairment compared to matched healthy subjects, respectively (see section 4.2).
Maltese: Cmax u AUC għal ticagrelor kienu 12% u 23% ogħla minn f'pazjenti b'indeboliment epatiku ħafif meta mqabbla ma' pazjenti b'saħħithom, rispettivament (ara sezzjoni 4.2).
English: The totality of renal AEs reported were 4.9% for ticagrelor vs. 3.8% for clopidogrel, however a similar percent of patients reported events considered by the investigators as causally related to treatment; 54 (0.6%) for ticagrelor and 43 (0.5%) for clopidogrel.
Maltese: It-totalita ta' AEs rappurtati dwar ilkliewi kienu 4.9% għall-ticagrelor vs 3.8% għall- clopidogrel, madankollu persentaġġ simili ta' avvenimenti rappurtati minn pazjenti kienu kkunsidrati mill-investigaturi bħala każwalment relatati mal-kura; 54 (0.6%) għal ticagrelor u 43 (0.5%) għal clopidogrel
English: Possia contains ticagrelor a member of the chemical class cyclopentyltriazolopyrimidines (CPTP), which is a selective adenosine diphosphate (ADP) receptor antagonist acting on the P2Y12
Maltese: Possia fih ticagrelor li hu membru ta' klassi kimika cyclopentyltriazolopyrimidines (CPTP), li hu antagonist tar-riċettur selettiv għal adenosine diphosphate (ADP) li jaħdem fuq ir-riċettur P2Y12 ADP li jista' jimpedixxi attivazzjoni u aggregazzjoni tal-plejtlets medjata mill-ADP.
English: Possia contains the active substance called ticagrelor.
Maltese: Possia fiħ is-sustanza attiva tissejjaħ ticagrelor.
English: Of these AEs 0.05% for ticagrelor vs. 0.02% for clopidogrel were considered causally related by investigators.
Maltese: Minn dawn lAEs 0.05% għall- ticagrelor vs. 0.02% għall- clopidogrel kienu kkonsidrati każwalment relatati millinvestigaturi.
English: • Atorvastatin - Co-administration of atorvastatin and ticagrelor increased atorvastatin acid Cmax by 23% and AUC by 36%.
Maltese: • Atorvastatin - L-għotja ta' atorvastatin u ticagrelor żiedet is-Cmax tal-aċidu ta' atorvastatin b'23% u l-AUC b'36%.
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 talmetabolu attiv u l-interazzjonijiet tagħhom ma' sottostrati oħra ta' CYP3A ivarjaw minn attivazzjoni għal inibizzjoni.
English: A combined efficacy and safety composite (CV death, MI, stroke, or PLATO-defined ‘Total Major' bleeding) indicates that the benefit in efficacy of Possia 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: Kompositu ta' l-Effikaċja u s- Sigurtà Kombinati Kompositu 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' Possia imqabbel 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: 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: For Possia, 0.9% of patients discontinued study drug because of dyspnoea compared with 0.1% taking clopidogrel.
Maltese: Għal Possia, 0.9% tal-pazjenti waqqfu l-prodott mediċinali minħabba d-dispneja imqabbla ma' 0,1% li kienu qed jieħdu clopidogrel.
English: TIMI Minor Bleed: Clinically apparent with 30-50 g/l decrease in haemoglobin.
Maltese: Klinikament viżibbli bu tnaqqis ta' 30-50 g/l tal-emoglobina.
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH
Maltese: MANIFATTUR(I) RESPONSABBLI
English: The hyperuricaemia AEs reported were 0.5% for ticagrelor vs. 0.2% for clopidogrel.
Maltese: L-AEs irrappurtati dwar iperuriċemija kienu 0.5% għall-ticagrelor vs. 0.2% għall- clopidogrel.
English: Other CYP3A inducers (e.g. dexamethasone, phenytoin, carbamazepine and phenobarbital) would be expected to decrease the exposure to Possia as well.
Maltese: Indutturi oħra ta' CYP3A (eż dexamethasone, phenytoin, carbamazepine u phenobarbital) ikunu mistennija li jnaqqsu l-esponiment għal Possia ukoll.
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-għotja ta' ticagrelor flimkien ma' simvastatin żiedet is-Cmax ta' simvastatin b'81% u l-AUC b'56% u żiedet is-Cmax tal-aċidu simvastatin b'64% u l-AUC b'52% b'xi wħud miż-żiediet individwali jiżdiedu bid-doppju jew 3 darbiet.
English: No clinically relevant effect on oral contraceptive efficacy is expected when levonorgestrel and ethinyl estradiol are
Maltese: Mhux mistenni xi effett ta' rilevanza klinika fuq l-effikaċja tal-kontraċettiv orali meta levonorgestrel u ethinyl estradiol jingħataw flimkien ma' Possia.
English: Date of first authorisation: 3 December 2010
Maltese: DATA TA' L-EWWEL AWTORIZZAZZJONI/TIĠDID TA' L-AWTORIZZAZZJONI Data ta' l-ewwel awtorizzazzjoni: 3 ta' Diċembru 2010
English: CYP2C19 and ABCB1 genotyping of 10,285 patients in PLATO provided associations of genotype groups with PLATO outcomes.
Maltese: L-għarfien tas-sekwenzi tal-ġeni ta' CYP2C19 u ABCB1 ta' 10,285 pazjent fi PLATO wera li hemm rabta bejn il-gruppi ta' ġenotipi mar-riżultati PLATO.
English: The Cmax and AUC of the active metabolite were reduced by 89% and 56%, respectively.
Maltese: Is-Cmax u l-AUC tal-metabolu attiv tnaqqsu bi 89% u 56% rsipettivament.
English: Co-administration of Possia and levonorgestrel and ethinyl estradiol increased ethinyl estradiol exposure approximately 20% but did not alter the pharmacokinetics of levonorgestrel.
Maltese: L-għotja flimkien ta' Possia u levonorgestrel u ethinyl estradiol żiedet l-esponiment għal ethinyl estradiol b'madwar 20% iżda ma bidlitx il-farmakokinetika ta' levonorgestrel.
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 units ta' ċelluli ħomor; jew li jikkawża diżabilità sinifikanti.
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% talpazjenti li kienu qed jieħdu ticagrelor u f'0.6% li kienu qed jieħdu clopidogrel l-investigaturi ikkunsidraw id-dispneja każwalment relatati mal-kura fl-istudju PLATO ., ftit kienu serji (0.14% ta' ticagrelor; 0.02% clopidogrel), (ara sezzjoni 4.4).
English: Ticagrelor as well as the active metabolite are P-gp substrates.
Maltese: Ticagrelor kif ukoll il-metabolu attiv huma sottostrati ta' P-gP.
English: Studies in animals have shown reproductive toxicity (see section 5.3).
Maltese: Studji flannimali kellhom tossiċità fis-sistema riproduttiva (ara sezzjoni 5.3).
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 aktar pazjenti li kellhom pawżi ventrikolari bi ticagrelor (6.0%) milli b'clopidogrel (3.5%) fil-fażi akuta; u 2.2% u 1.6% rispettivament wara xahar (ara sezzjoni 4.4).
English: Polska
Maltese: Il-Polonja
English: Ticagrelor is primarily a CYP3A4 substrate and a mild inhibitor of CYP3A4.
Maltese: Ticagrelor huwa primarjament sottostrat ta' CYP3A4 u inibitur ħafif ta' CYP3A4.
English: Co-administration of rifampicin with ticagrelor decreased ticagrelor Cmax and AUC by 73% and 86%, respectively.
Maltese: L-għotja ta' rifampicin ma' ticagrelor naqqset is-Cmax u l-AUC b'73% u 86% rispettivament.
English: Co-administration of Possia with strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, nefazodone, ritonavir, and atazanavir) is contraindicated (see section 4.3 and 4.5).
Maltese: (eż ketoconazole, clarithromycin, nefazodone, ritonavir u atazanavir) hija kontraindikata (ara sezzjoni 4.3 u 4.5).
English: The safety of Possia in patients with acute coronary syndromes (UA, NSTEMI and STEMI) was evaluated in the pivotal large phase 3 PLATO ([PLATelet Inhibition and Patient Outcomes] study, 18,624 patients), which compared patients treated with Possia (loading dose of 180 mg of Possia and a maintenance dose of 90 mg twice daily) to patients treated with clopidogrel (300-600 mg loading dose followed by 75 mg once daily maintenance dose) both given in combination with acetylsalicylic acid (ASA) and other standard therapies.
Maltese: Is-sigirtà ta' Possia f'pazjenti b'sindrome koronarji akuti (UA, NSTEMI u STEMI) kienet evalwata fi studju pivitali kbir ta' fażi 3 studju PLATO (studju [PLATelet Inibizzjoni u Outcomes tal-pazjenti], 18,624 pazjent), li qabbel pazjenti ikkurati bi Possia (doża ta' tagħbija ta' 180 mg ta' Possia u doża ta' manteniment ta' 90 mg darbtejn kuljum) ma' pazjenti ikkurati bi clopidogrel (300-600 mg doża ta'
English: Possia 90 mg tablets ticagrelor
Maltese: U MNEJN GĦANDU JINGĦATA Possia 90 mg pilloli ticagrelor
English: Bleeding of many different kinds can be increased, for example:
Maltese: Fsada ta' ħafna tipi differenti tista' tiżdied, per eżempju:
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: AstraZeneca S.p.A. Tel: + 39 02 98011
Maltese: Tel: + 39 02 98011
English: Slovenská republika AstraZeneca AB o.z.
Maltese: Ir-Republika Ċeka AstraZeneca Czech Republic s.r.o.
English: Figure 1 - Time to first occurrence of CV death, MI and Stroke (PLATO)
Maltese: Figura 1 - Ħin sakemm seħħet l-ewwel mewt b'CV, MI jew Stroke (PLATO)
English: Luxembourg/Luxemburg NV AstraZeneca SA Tél/Tel: + 32 2 370 48 11
Maltese: NV AstraZeneca SA Tel: +32 2 370 48 11
English: This is calculated as 3/9235 which equates to a frequency category of ‘rare'
Maltese: Dan huwa kalkulat bhala 3/9235 li jissarraf bħala kategorija ta' frekwenza “rari”