FrancophonIA/ELRC3.0 huggingface dataset:
English: PVC/PVDC-Al perforated unit dose blister pack containing 84 x 1 and 100 x 1 hard capsule
Maltese: Pakkett bil-folji perforati tal-PVC/PVDC-Al b'doża tal-unità li jkun fih jkun fih 84 x 1 and 100 x 1 kapsula iebsa.
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Mylan Pharma 200 mg hard capsules pregabalin
Maltese: Pregabalin Mylan Pharma 200 mg kapsuli iebsin Pregabalin
English: A meta-analysis of randomised placebo controlled studies of anti-epileptic drugs has also shown a small increased risk of suicidal ideation and behaviour.
Maltese: F'meta-analisi ta' studji magħmula b'għażla każwali, li kienu kkontrollati bi plaċebo ta' prodotti mediċinali kontra l-epilessija, ntwera ukoll li kien hemm żieda fir-riskju ta' ideat u atteġġamenti ta' suwiċidju.
English: Available in blister packs containing 14, 56, 100 capsules, in perforated unit dose blister packs containing 56 x 1, 100 x 1 capsules and in bottles containing 200 capsules.
Maltese: Disponibbli f'pakketti bil-folji li jkun fihom 14, 56, 100 kapsula, f'pakketti ta' folji perforati li jkun fihom 56 x 1, 100 x 1 kapsula u fi fliexken li jkun fihom 200 kapsula.
English: Pregabalin Mylan Pharma 150 mg hard capsules Each hard capsule contains 150 mg of pregabalin.
Maltese: Pregabalin Mylan Pharma 150 mg kapsuli iebsin Pregabalin
English: Pregabalin Mylan Pharma 300 mg hard capsules Each hard capsule contains 300 mg of pregabalin.
Maltese: Pregabalin Mylan Pharma 300 mg kapsuli iebsin Pregabalin
English: Pregabalin Mylan Pharma 300 mg hard capsules The 300 mg capsule are No. 0, light peach opaque cap and white opaque body, hard-shell gelatin capsules filled with white to off-white powder.
Maltese: Meta pregabalin u mediċini opjojdi ikunu ser jintużaw flimkien, miżuri jistgħu ikunu kkunsidrati biex l-istitikezza tiġi evitata (speċjalment f'pazjenti li huma nisa u l-anzjani).
English: 120 pre-filled syringes (in a plastic bucket)
Maltese: 120 siringa mimlija (f'barmil tal-plastik)
English: Target species Route of administration
Maltese: Mod ta' Amministrazzjoni
English: Packaging Content Package size Withdrawal Period
Maltese: Ippakkjar Kontenut Daqs talpakkett
English: MA Numbers Invented name Strength Pharmaceutical Form
Maltese: Numru ta' l-UE Isem kummerċjali
English: It is available as white tablets (round: 400 mg; oblong: 600 mg and 800 mg).
Maltese: Huwa disponibbli bħala pilloli bojod (tondi: 400 mg; oblongi: 600 mg u 800 mg).
English: Exalief is a medicine that contains the active substance eslicarbazepine acetate.
Maltese: Exalief huwa mediċina li fiha s-sustanza attiva eslicarbazepine acetate.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Exalief to Bial - Portela & Ca, SA on 21 April 2009.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Exalief lil Bial - Portela & Ca, SA fi 21 ta' April 2009.
English: All three studies compared Exalief given at different doses (400 mg, 800 mg or 1200 mg once a day) with placebo (a dummy treatment).
Maltese: It-tliet studji kollha qabblu Exalief mogħti f'dożijiet differenti ((400 mg, 800 mg jew 1200 mg darba kuljum) ma' plaċebo (trattament finta).
English: Three main studies were performed, involving a total of 1,050 adults with partial-onset seizures that were not controlled by other medicines.
Maltese: Twettqu tliet studji ewlenin, li involvew total ta' 1,050 adult bil-bidu parzjali ta' aċċessjoni li ma kinux ikkontrollati minn mediċini oħra.
English: Over the 12 weeks of treatment, this fell to 9.8 and 9 seizures per month in patients taking Exalief 800 mg and Exalief 1200 mg respectively, compared with 11.7 per month in those taking placebo.
Maltese: Fuq perjodu ta' 12-il ġimgħa ta' trattament, dan niżel għal bejn 9.8 u 9 aċċessjonijet fix-xahar għal pazjenti li kienu taħt Exalief 800 mg u Exalief 1200 mg rispettivament, meta mqabbel ma' 11.7 fix-xahar għal dawk li kienu qed jieħdu plaċebo.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) EXALIEF EPAR summary for the public
Maltese: RAPPORT PUBBLIKU EWROPEW TA' VALUTAZZJONI (EPAR) EXALIEF
English: Exalief should not be used in people who may be hypersensitive (allergic) to eslicarbazepine acetate, any of the other ingredients or other carboxamide derivatives (medicines with a similar structure to eslicarbazepine acetate, such as carbamazepine or oxcarbazepine).
Maltese: Exalief ma għandux jintuża f'nies li jistgħu jkunu ipersensittivi (allerġiċi) għal eslicarbazepine acetate, jew kull ingredjent ieħor jew derivattivi oħra tal-carboxamide (mediċini bi struttura simili għal eslicarbazepine acetate, bħalma huma carbamazepine jew oxcarbazepine).
English: The active substance in Exalief, eslicarbazepine acetate, is converted into the anti-epileptic medicine eslicarbazepine in the body.
Maltese: Is-sustanza attiva f'Exalief, eslicarbazepine acetate, tiġi konvertita fil-mediċina antiepilettika eslicarbazepine fil-ġisem.
English: This summary was last updated in 02-2009.
Maltese: Dan is-sommarju ġie aġġornat fi: 02-2009.
English: What is the risk associated with Exalief?
Maltese: X'inhu r-riskju assoċjat ma' Exalief?
English: Why has Exalief been approved?
Maltese: Għaliex ġie approvat Exlief?
English: Other information about Exalief:
Maltese: Tagħrif ieħor dwar Exalief:
English: How has Exalief been studied?
Maltese: Kif ġie studjat Exalief?
English: Eslicarbazepine is thought to work by blocking ‘voltage-gated sodium channels', which stops sodium entering the nerve cells.
Maltese: Eslicarbazepine huwa maħsub li jaħdem billi jimblokka l-‘kanali tas-sodju mimlija vultaġġs', li jwaqqaf is-sodju milli jidħol fiċ-ċelloli tan-nervituri.
English: This is a type of epilepsy where too much electrical activity in one side of the brain causes symptoms such as sudden, jerky movements of one part of the body, distorted hearing, sense of smell, or vision, numbness or a sudden sense of fear.
Maltese: Din hija tip ta' epilessija fejn ħafna attività elettrika f'naħa waħda tal-moħħ tikkawża sintomi bħalma huma movimenti għall-għarrieda, mimlija skossi ta' naħa minnhom tal-ġisem, smiegħ mhux ċar, sens ta' xamm, jew viżjoni, tgħarix jew sens ta' biża' f'daqqa.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Exalief's benefits are greater than its risks for the treatment of partial-onset seizures with or without secondary generalisation in adults who are also taking other anti-epilepsy medicines.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) iddeċieda li l-benefiċċji ta' Exalief huma akbar mir-riskji għat-trattament tal-bidu parzjali ta' aċċessjoni bi jew mingħajr ġeneralizzazzjoni sekondarja fl-adulti li qegħdin jieħdu wkoll mediċina oħra antiepilettika.
English: The medicine is not recommended in patients with severe problems with their kidneys or liver.
Maltese: Il-mediċina mhix rakkomandata għal pazjenti bi problemi serji fil-kliewi u filfwied.
English: The effects of Exalief were first tested in experimental models before being studied in humans.
Maltese: L-effetti ta' Exalief għall-ewwel ġew ittestjati fuq mudelli sperimentali qabel ma ġew studjati filbniedem.
English: What is Exalief?
Maltese: X'inhu Exalief?
English: Looking at the results of the three studies taken together, Exalief 800 mg and 1200 mg were more effective than placebo at reducing the number of seizures, when used as add-ons to other anti-epileptic medicines.
Maltese: Meta wieħed iħares lejn ir-riżultati tat-tliet studji meħuda flimkien, Exalief 800 mg u 1200 mg kienu iktar effikaċi mill-plaċebo fit-tnaqqis tan-numru ta' aċċessjonijiet, meta użati flimkien ma' mediċini oħra antiepilettiċi.
English: It must not be used in people with second or third degree atrioventricular block (a problem with electrical transmission in the heart).
Maltese: Lanqas ma għandu jintuża f'nies li għandhom blokk atrijoventrikulari tat-tieni jew tat-tielet grad (problema bit-trażmissjoni elettrika fil-qalb).
English: For electrical impulses to travel along nerves there needs to be a rapid movement of sodium into the nerve cells.
Maltese: L-epilessija tiġi kkawżata mill-attività elettrika eċċessiva fil-moħħ. Sabiex limpulsi elettriċi jivvjaġġaw fin-nervituri jeħtieġ li jkun hemm movement rapidu tas-sodju fiċ-ċelloli tan-nervturi.
English: Exalief is used to treat adults with partial-onset seizures (epileptic fits) with or without secondary generalisation.
Maltese: Exalief jintuża fit-trattament ta' adulti li jbatu bil-bidu parzjali ta' aċċessjoni (epilessija severa) bi jew mingħajr ġeneralizzazzjoni sekondarja.
English: How does Exalief work?
Maltese: X'benefiċċju wera Exalief waqt l-istudji mwettqa?
English: 85276 Pfaffenhofen Germany
Maltese: 85276 Pfaffenhofen
English: Hazard Ratio (HR) (95% CI)
Maltese: Proporzjon ta' Periklu (HR) (95% CI)
English: Ethnicity:
Maltese: Etniċità:
English: Avda de la Industria 30 E-28108 Alcobendas (Madrid) Spain
Maltese: Avda de la Industria 30 E-28108 Alcobendas (Madrid) Spanja
English: Active pathological bleeding.
Maltese: Fsada patoloġika attiva.
English: ТП "Ели Лили Недерланд" Б.В.
Maltese: ТП "Ели Лили Недерланд" Б.В. - България тел.
English: units)
Maltese: unitajiet)
English: Non-steroidal anti-inflammatory drugs (NSAIDs):
Maltese: Mediċini anti-infjammatorji mhux sterojdi (NSAIDs):
English: No (N=13090)
Maltese: Le (N=13090)
English: TRITON was a 13,608 patient, multicentre international, randomised, double blind, parallel group study.
Maltese: TRITON b'13,608 pazjenti kien studju tat-tip internazzjonali b'ħafna ċentri, randomised, double blind, b'grupp parallel.
English: Efient is available in packs of 14, 28, 30, 56, 84, 90 and 98 tablets.
Maltese: Efient issibu f'pakketti ta' 14, 28, 30, 56, 84, 90 u 98 pillola.
English: Hypersensitivity including angioedema
Maltese: Sensittività eċċessiva inkluża l-anġjoedima
English: Aluminium foil blisters in cartons of 14, 28, 30, 30 (x1), 56, 84, 90 (x1) and 98 tablets.
Maltese: Folji tal-fojl tal-aluminju f'pakketti ta' 14, 28, 30, 30 (x1), 56, 84, 90 (x1) u 98 pillola.
English: 4.6 Fertility, pregnancy and lactation
Maltese: 4.6 Fertilità, tqala u treddigħ
English: Medicinal products metabolised by CYP2C9:
Maltese: Prodotti mediċinali mmetabolizzati minn CYP2C9:
English: Eli Lilly Polska Sp. z o.o.
Maltese: Eli Lilly Polska Sp. z o.o. Tel.
English: Inducers of cytochromes P450:
Maltese: Stimulanti ta' ċitokromi P450:
English: EU/1/08/503/001 - 007, 015 Efient 10 mg: EU/1/08/503/008 - 014, 016
Maltese: Efient 10 mg: EU/1/08/503/008 - 014, 016
English: What Efient contains - The active substance is prasugrel.
Maltese: X'fih Efient - Is-sustanza attiva hi prasugrel.
English: Prasugrel is a prodrug and is rapidly metabolised in vivo to an active metabolite and inactive metabolites.
Maltese: Prasugrel huwa prodrug u jiġi metabolizzat malajr in vivo f'metabolit attiv u metaboliti inattivi.
English: Medicinal products metabolised by CYP2B6:
Maltese: Prodotti mediċinali mmetabolizzati minn CYP2B6:
English: Morphine and other opioids:
Maltese: Morfina u opiojdi oħra:
English: Table 3: Patients with Outcome Events in TRITON Primary Analysis
Maltese: Tabella 3: Pazjenti b'Avvenimenti li Seħħew fl-Analiżi Primarja TRITON
English: Date of latest renewal: 13 November 2013
Maltese: Data tal-ewwel awtorizzazzjoni: 25 ta' Frar 2009 Data tal-aħħar tiġdid: 13 ta' Novembru 2013
English: Microcrystalline cellulose, mannitol (E421), croscarmellose sodium, hypromellose (E464) magnesium stearate, lactose monohydrate, titanium dioxide (E171), triacetin (E1518), iron oxide red (10 mg tablets only) (E172), iron oxide yellow (E172) and talc.
Maltese: Microcrystalline cellulose, mannitol (E421), croscarmellose sodium, hypromellose (E464) magnesium stearate, lactose monohydrate, titanium dioxide (E171), triacetin (E1518), iron oxide aħmar (pilloli ta' 10 mg biss) (E172), iron oxide isfar (E172) u talc.
English: Patients ≥ 75 years old
Maltese: Pazjenti ≥ 75 sena
English: a 10 mg prasugrel; 5 mg prasugrel if <60 kg
Maltese: a 10 mg prasugrel; 5 mg prasugrel jekk <60 kg
English: Each tablet contains 2.7 mg lactose.
Maltese: Kull pillola fiha 2.7 mg lactose.
English: Effects of other medicinal products on Efient
Maltese: Effetti ta' prodotti mediċinali oħra fuq Efient
English: INFORMATION IN BRAILLE Efient 10 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Efient 10 mg
English: • A copy of the SPC
Maltese: • Kopja tal-SPC
English: Each tablet contains 2.1 mg lactose.
Maltese: Kull pillola fiha 2.1 mg lactose.
English: The patient population was 92% Caucasian, 26% female, and 39% ≥ 65 years of age.
Maltese: Il-poplazzjoni tal-pazjenti kienet ta' 92% Kawkasi, 26% femminili, u 39%
English: NAME OF THE MARKETING AUTHORISATION HOLDER Daiichi-Sankyo (Logo)
Maltese: Daiichi-Sankyo (Logo)
English: Rifampicin (600 mg daily), a potent inducer of CYP3A and CYP2B6, and an inducer of CYP2C9, CYP2C19, and CYP2C8, did not significantly change the pharmacokinetics of prasugrel.
Maltese: Rifampicin (600 mg kuljum), stimulant qawwi ta' CYP3A u CYP2B6, u stimulant ta' CYP2C9, CYP2C19, u CYP2C8, ma bidilx il-farmokokinetika ta' prasugrel b'mod sinifikanti.
English: Efient 10 mg: 3 years.
Maltese: Efient 10 mg: 3 snin.
English: INFORMATION IN BRAILLE Efient 5 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Efient 5 mg
English: CV death
Maltese: Mewt CV
English: Morphine and other opioids
Maltese: Morfina u opiojdi oħra
English: <75 years (N=11672)*
Maltese: <75 sena (N=11672)*
English: EU/1/08/503/008 14 film-coated tablets EU/1/08/503/009 28 film-coated tablets EU/1/08/503/010 30x1 film-coated tablet EU/1/08/503/011 56 film-coated tablets EU/1/08/503/012 84 film-coated tablets EU/1/08/503/013 90x1 film-coated tablet EU/1/08/503/014 98 film-coated tablets EU/1/08/503/016 30 film-coated tablets
Maltese: EU/1/08/503/008 14-il pillola miksija b'rita EU/1/08/503/009 28 pillola miksija b'rita EU/1/08/503/010 30 x 1 pillola miksija b'rita EU/1/08/503/011 56 pillola miksija b'rita EU/1/08/503/012 84 pillola miksija b'rita EU/1/08/503/013 90 x 1 pillola miksija b'rita EU/1/08/503/014 98 pillola miksija b'rita EU/1/08/503/016 30 pillola miksija b'rita
English: EU/1/08/503/001 14 film-coated tablets EU/1/08/503/002 28 film-coated tablets EU/1/08/503/003 30x1 film-coated tablet EU/1/08/503/004 56 film-coated tablets EU/1/08/503/005 84 film-coated tablets EU/1/08/503/006 90x1 film-coated tablet EU/1/08/503/007 98 film-coated tablets EU/1/08/503/015 30 film-coated tablets
Maltese: EU/1/08/503/001 14-il pillola miksija b'rita EU/1/08/503/002 28 pillola miksija b'rita EU/1/08/503/003 30 x 1 pillola miksija b'rita EU/1/08/503/004 56 pillola miksija b'rita EU/1/08/503/005 84 pillola miksija b'rita EU/1/08/503/006 90 x 1 pillola miksija b'rita EU/1/08/503/007 98 pillola miksija b'rita EU/1/08/503/015 30 pillola miksija b'rita
English: Distribution Active metabolite binding to human serum albumin (4% buffered solution) was 98%.
Maltese: L-irbit tal-metabolit attiv ma' l-albumina fis-serum uman (soluzzjoni bafferjata ta' 4%) kien ta' 98%.
English: • with body weight < 60 kg (see sections 4.2 and 4.8).
Maltese: • b'piż tal-ġisem <60 kg (ara sezzjonijiet 4.2 u 4.8).
English: *TRITON study in ACS patients undergoing PCI **TRILOGY-ACS study in patients not undergoing PCI (see 5.1):
Maltese: *Studju TRITON f'pazjenti ACS li qed jagħmlu PCI **Studju TRILOGY-ACS f'pazjenti li mhumiex jagħmlu PCI (ara 5.1):
English: Efient 5 mg: 2 years.
Maltese: Efient 5 mg: 2 snin.
English: The rate of study drug discontinuation due to adverse events was 7.2% for prasugrel and 6.3% for clopidogrel.
Maltese: Ir-rata tat-twaqqif tal mediċina taħt studju minħabba avvenimenti avversi kienet ta' 7.2% għal prasugrel u 6.3% għal clopidogrel.
English: Epistaxis
Maltese: Epistassi
English: a Centrally adjudicated events defined by the Thrombolysis in Myocardial Infarction (TIMI) Study Group criteria.
Maltese: a Avvenimenti ġġudikati ċentrali mfissra mill-kriterji tal-Grupp ta' Studju ta' Trombolisi f'Infart Mijokardijaku (TIMI) .
English: (See sections 4.2, 4.4, and 4.8)
Maltese: (Ara sezzjonijiet 4.2,4.4 u 4.8).
English: Yes (N=518)
Maltese: Iva (N=518)
English: In healthy subjects, prasugrel decreased exposure to hydroxybupropion, a CYP2B6-mediated metabolite of bupropion, by 23%.
Maltese: F'suġġetti b'saħħithom, prasugrel naqqas l-espożizzjoni għal hydroxybupropion, metabolit ta' bupropion permezz ta' CYP2B6, b'23%.
English: Table 1: Incidence of Non-CABG related bleedinga (% Patients)
Maltese: Tabella 1: Inċidenza ta' fsada relatata ma' Non-CABG a (% ta' Pazjenti)
English: Iron oxide red (E172) {only Efient 10 mg} Iron oxide yellow (E172) Talc
Maltese: Iron oxide isfar (E172) Talc
English: Mean steady-state inhibition of platelet aggregation was 74% and 69% respectively for 5 µM ADP and 20 µM ADP, and was achieved following 3 to 5 days of administration of the 10 mg prasugrel maintenance dose preceded by a 60 mg loading dose.
Maltese: Steady state medju tal-inibizzjoni ta' aggregazzjoni ta' plejtlits kien ta' 74% u 69% rispettivament għal 5 µM ADP u 20 µM ADP, u ntlaħaq wara li ngħatat id-doża ta' manteniment ta' 10 mg prasugrel għal 3 sa 5 ijiem wara d-doża ta' kkargar ta' 60 mg.
English: Analysis of the composite endpoint in the All ACS population (combined UA/NSTEMI and STEMI cohorts) was contingent on showing statistical superiority of prasugrel versus clopidogrel in the UA/NSTEMI cohort (p < 0.05).
Maltese: L-analiżi tar-riżultat finali kompost fil-popolazzjoni tal-Pazjenti Kollha b'ACS (gruppi ta' UA/NSTEMI kkombinati u STEMI) kienet kontinġenti fit-turija ta' superjorità statistika ta' prasugrel kontra clopidogrel fil-grupp ta' UA/NSTEMI (p<0.05).
English: Prasugrel did not inhibit CYP2C9, as it did not affect the pharmacokinetics of S-warfarin.
Maltese: Prasugrel ma inibixxiex CYP2C9, u ma affettwax il-farmakokinetika ta' S-warfarin.
English: 14 film-coated tablets 28 film-coated tablets 30x1 film-coated tablet 56 film-coated tablets 84 film-coated tablets 90x1 film-coated tablet 98 film-coated tablets 30 film-coated tablets
Maltese: 14-il pillola miksija b'rita 28 pillola miksija b'rita 30 x 1 pillola miksija b'rita 56 pillola miksija b'rita 84 pillola miksija b'rita 90 x 1 pillola miksija b'rita 98 pillola miksija b'rita 30 pillola miksija b'rita
English: ≥75 years (N=1785)*
Maltese: ≥75 sena (N=1785)*
English: <75 years (N=7180)**
Maltese: <75 sena (N=7180)**
English: ≥75 years (N=2060)**
Maltese: ≥75 sena(N=2060) **
English: • Allergic reaction (rash, itching, swollen lips/tongue, or shortness of breath)
Maltese: • Reazzjoni allerġika (raxx, ħakk, nefħa fix-xufftejn/ilsien jew qtugħ ta' nifs)
English: These included definite or probable stent thrombosis at study end (0.9% vs 1.8%; HR 0.498; CI 0.364, 0.683); CV death, nonfatal MI, or urgent target vessel revascularisation through 30 days (5.9% vs 7.4%; HR 0.784; CI 0.688,0.894); all cause death, nonfatal MI, or nonfatal stroke through study end (10.2% vs 12.1%; HR 0.831; CI 0.751, 0.919); CV death, nonfatal MI, nonfatal stroke or rehospitalisation for cardiac ischaemic event through study end (11.7% vs 13.8%; HR 0.838; CI 0.762, 0.921).
Maltese: Dawn inkludew trombożi ċerta jew probabbli fl-istent fl-aħħar tal-istudju (0.9% kontra 1.8%; HR 0.498; CI 0.364, 0.683); mewt CV, MI mhux fatali, jew rivaskularizzazzjoni tal-vina/arterja mira tul 30 ġurnata (5.9% kontra 7.4%; HR 0.784; CI 0.688,0.
English: The active metabolite's exposure (AUC) increases proportionally over the therapeutic dose range.
Maltese: L-espożizzjoni (AUC) tal-metabolit attiv tiżdied proporzjonalment fuq l-iskala tad-doża terapewtika.
English: • warfarin (an anti-coagulant),
Maltese: • clopidogrel (sustanza kontra l-plejtlits), • warfarin (antikoagulant),
English: Mechanism of action / Pharmacodynamic effects
Maltese: Mekkaniżmu ta' azzjoni / Effetti farmakodinamiċi
English: Therefore, CYP3A inhibitors such as azol antifungals, HIV protease inhibitors, clarithromycin, telithromycin, verapamil, diltiazem, indinavir, ciprofloxacin, and grapefruit juice are not anticipated to have a significant effect on the pharmacokinetics of the active metabolite.
Maltese: Għaldaqstant, inibituri ta' CYP3A bħal sustanzi azol kontra l-fungi , inibituri ta' HIV protease, clarithromycin, telithromycin, verapamil, diltiazem, indinavir, ciprofloxacin, u meraq tal-grejpfrut mhumiex mistennija li jkollhom effett sinifikanti fuq ilfarmakokinetika tal-metabolit attiv.
English: Table 2 summarises haemorrhagic and non-haemorrhagic adverse reactions in TRITON, or that were spontaneously reported, classified by frequency and system organ class.
Maltese: Tabella 2 tiġbor fil-qosor ir-reazzjonijiet avversi emorraġiċi u mhux emorraġiċi fi TRITON jew li ġew irrapportati b'mod spontanju, ikklassifikati skont il-frekwenza u s-sistema ta' klassifika ta' l-organi.
English: In the phase 3 clinical trial, 437 patients underwent CABG during the course of the study.
Maltese: Fl-istudju kliniku ta' fażi 3, 437 pazjent saritilhom CABG matul l-istudju.
English: 2.2% (0.2% fatal) a
Maltese: 2.2% (0.2% fatali) a
English: Nonfatal MI
Maltese: MI mhux fatali
English: 9.0% (1.0% fatal)
Maltese: 9.0% (1.0% fatali)
English: 2.0% (0.1% fatal) a
Maltese: 2.0% (0.1% fatali) a
English: • If you have an increased risk of bleeding such as: - age of 75 years or older.
Maltese: • Jekk għandek riskju ogħla ta' fsada bħal: - età ta' 75 sena jew iżjed.
English: Prasugrel-mediated inhibition of platelet aggregation exhibits low between-subject (9%) and within-subject (12%) variability with both 5 µM and 20 µM ADP.
Maltese: L-inibizzjoni ta' aggregazzjoni ta' plejtlits permezz ta' prasugrel turi varjabbilità baxxa bejn is-suġġetti (9%) u fissuġġetti (12%) kemm b'5 µM u b'20 µM ADP.
English: Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 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: rari (≥ 1/10,000 sa < 1/1,000); rari ħafna (< 1/10,000); mhux magħruf (ma tistax tittieħed stima middata disponibbli).
English: a 10 mg prasugrel; 5 mg prasugrel if ≥75 years of age
Maltese: a 10 mg prasugrel; 5 mg prasugrel jekk ≥75 years of age Pazjenti ≥60 kg u età <75 sena
English: MARKETING AUTHORISATION HOLDER Daiichi Sankyo Europe GmbH Zielstattstrasse 48
Maltese: Daiichi Sankyo Europe GmbH Zielstattstrasse 48
English: Pharmacokinetics and pharmacodynamics of prasugrel have not been evaluated in a paediatric population (see section 4.2).
Maltese: Il-farmakokinetika u l-farmakodinamika ta' prasugrel ma ġewx stmati fil-popolazzjoni pedjatrika (ara sezzjoni 4.2).
English: Severe hepatic impairment (Child Pugh class C).
Maltese: Indeboliment qawwi tal-fwied (Child Pugh klassi Ċ).
English: The benefits associated with prasugrel were independent of the use of other acute and long-term cardiovascular therapies, including heparin/low molecular weight heparin, bivalirudin, intravenous GPIIb/IIIa inhibitors, lipid-lowering medicinal products, beta-blockers, and angiotensin converting enzyme inhibitors.
Maltese: Il-benefiċċji assoċjati ma' prasugrel kienu indipendenti mill-użu ta' terapiji oħra kardjovaskulari akuti u għat-tul, fosthom eparina/ eparina b'piż molekulari baxx, bivalirudin, inibituri ta' GPIIb/IIIa li jingħataw ġol-vini, prodotti mediċinali li jbaxxu l-lipidi, imblokkaturi tar-riċetturi beta, u inibituri ta' l-enzim li jikkonverti angiotensin.
English: Ketoconazole (400 mg daily), a selective and potent inhibitor of CYP3A4 and CYP3A5, did not affect prasugrel-mediated inhibition of platelet aggregation or the prasugrel active metabolite's AUC and Tmax, but decreased the Cmax by 34% to 46%.
Maltese: Inibituri ta' CYP3A: Ketoconazole (400 mg kuljum), inibitur selettiv u qawwi ta' CYP3A4 u CYP3A5, ma affettwax linibizzjoni ta' l-aggregazzjoni ta' plejtlits permezz ta' prasugrel jew l-AUC u Tmax tal-metabolit attiv ta' prasugrel, iżda naqqas is-Cmax b'34% sa 46%.
English: In the phase 3 clinical trial (TRITON) key exclusion criteria included an increased risk of bleeding; anaemia; thrombocytopaenia; a history of pathological intracranial findings.
Maltese: Fil-prova klinika ta' fażi 3 (TRITON), il-kriterji ta' esklużjoni l-aktar importanti kienu jinkludu riskju akbar ta' fsada; anemija; tromboċitopenija; passat ta' sejbiet patoloġiċi fil-kranju.
English: 10.1% (0% fatal)
Maltese: 10.1% (0% fatali)