FrancophonIA/ELRC3.0 huggingface dataset:
English: - The Committee considered that bicalutamide 150 mg is effective in the treatment of locally advanced prostate cancer; however the CHMP considered that the therapeutic indication should be restricted to treatment of patients at high risk of disease progression.
Maltese: - Il-Kumitat ikkunsidra li bicalutamide 150 mg hu effettiv fit-trattament tal-kanċer tal-prostata lokalment avvanzat; madankollu s-CHMP ikkonsidra li l-indikazzjoni terapewtika m'għandhiex tkun ristretta għat-trattament ta' pazjenti b'riskju għoli ta' progressjoni tal-marda.
English: Germany
Maltese: Polonja
English: Events (%) in placebo patients
Maltese: Mwiet (%) f'pazjenti fuq plaċebo
English: The median PSA levels on initiation of active therapy for each subgroup are above the thresholds in current European Association of Urology (EAU) guidance.
Maltese: Il-livelli medjani tal-PSA fil-bidu tat-terapija attiva għal kull wieħed mis-sottogruppi huma 'l fuq mil-livelli msemmija fil-gwidi attwali ta' l-Assoċjazzjoni Ewropea ta' l-Uroloġija (EAU).
English: How does the company justify the absence of adjustment for tests of multiplicity in the analysis of the EPC results?
Maltese: Il-kumpanija kif tiġġustifika n-nuqqas ta' aġġustament għat-testijiet tal-multipliċità fl-analiżi tarriżultati ta' l-EPC?
English: The SPC has been amended accordingly and notes in section 5.1 that, for patients with locally advanced disease “A reduction in risk of objective disease progression… was most evident in those at highest risk of disease progression.
Maltese: L-SPC ġie emendat kif xieraq u f'Taqsima 5.1 jinnota li, għal pazjenti b'marda lokalment avvanzata “tnaqqis fir-riskju tal-progressjoni oġġettiva tal-marda…kien l-iktar evidenti f'dawk il-pazjenti bl-ogħla riskju ta' progressjoni tal-marda.
English: - The CHMP concluded that the benefit/risk balance of bicalutamide 150 mg containing medicinal products in the agreed restricted indication is favourable.
Maltese: - Is-CHMP ikkonkluda li l-bilanċ bejn il-benefiċċji u r-riskji ta' prodotti mediċinali li fihom bicalutamide 150 mg lifl-indikazzjonijiet ristretti li dwarhom hemm qbil, hu favorevoli.
English: There was no evidence of an overall excess mortality.
Maltese: Ma kienx hemm evidenza ta' żieda fil-mortalità globali.
English: Further, the referral concerned only the locally advanced prostate cancer indication based on the Early Prostate Cancer study programme, and the directly related wording in sections 4.1 and 5.1 of the SPC.
Maltese: Ir-referenza kienet tikkonċerna biss l-indikazzjoni tal-kanċer tal-prostata lokalment avvanzat ibbażata fuq il-programm ta' studju Early Prostate Cancer (EPC) u l-kliem direttament relatat li hemm fit-taqsima 4.1 u 5.1 tal- SPC.
English: SK - Slovakia AstraZeneca UK Limited Silk Road Business Park Macclesfield
Maltese: CY- Ċipru AstraZeneca UK Limited Silk Road Business Park Macclesfield
English: The requested additional analyses of the EPC trial data confirm an increased risk for deaths coded as heart failures (however, with no overall excess risk in the cardiovascular system), an increased risk of urogenital symptoms (including gynaecomastia and breast pain) mainly during the first year of intake, and further indicate the absence of an adverse effect on thromboembolic events during the follow-up (supported by a pattern of events inconsistent with hormonal effects).
Maltese: L-analiżi addizzjonali mitluba għat-tagħrif dwar l-istudju ta' l-EPC tikkonferma żieda ikbar fir-riskju għallmewt ikkodifikata bħala kollass tal-qalb (madankollu, bl-ebda riskju globali żejjed fis-sistema kardjovaskulari), żieda fir-riskju ta' sintomi uroġenitali (inkluż il-kobor tas-sider u l-uġigħ fis-sider) prinċipalment matul l-ewwel sena tad-dħul ta' pazjenti fl-istudju, u jindikaw ukoll in-nuqqas ta' effetti mhux mixtieqa fl-avvenimenti tromboembolitiċi matul is-sorveljanza tal-pazjent (appoġġjata minn sensiela ta' avveniment mhux konsistenti ma' l-effetti ormonali).
English: Note: This Annex III (Amendments to the Summary of Product Characteristics) is the one that was Annexed to the Commission Decision on this Article 31 referral for bicalutamide 150 mg containing medicinal products.
Maltese: III (Emendi fis-Sommarju tal-Karatteristiċi tal-Prodott) huwa dak li kien Anness mad-Deċiżjoni tal-Kummissjoni dwar din ir-referenza għall-Artikolu 31 dwar bicalutamide 150mg li jikkonsisti fi prodotti mediċinali.
English: Following their own review of these data carried out in 2004 and due to their resulting concerns over the benefit/risk balance of bicalutamide 150 mg in locally advanced prostate cancer, the Belgian Regulatory Authority suspended their national Marketing Authorisation for Casodex (bicalutamide) 150 mg in August
Maltese: Wara l-analiżi tagħhom ta' dan it-tagħrif li wettqu fl-2004 u minħabba l-preokkupazzjonijiet li konsegwentement irriżultaw minn naħa tagħhom dwar il-bilanċ bejn il-benefiċċju u r-riskju ta' bicalutamide 150 mg fil-kanċer tal-prostata lokalment avvanzat, l-Awtorità Regolatorja Belġjana ssospendiet lAwtorizzazzjoni għat-Tqegħid fis-Suq għal Casodex (bicalutamide) 150 mg f'Awwissu 2005.
English: It is acknowledged that overall there is no statistically significant survival benefit in locally advanced prostate cancer.
Maltese: Hu magħruf li m'hemmx benefiċċju fis-sopravivenza statistikament sinjifikanti fil-kanċer tal-prostata lokalment avvanzat.
English: RO-Romania AstraZeneca UK Ltd, 600 Capability Green Luton, Bedfordshire,
Maltese: Capability Green Luton, Bedfordshire,
English: Analysis population
Maltese: Analiżi tal popolazzjoni
English: How can the company rule out any role of bicalutamide 150 mg in the increased mortality due to heart failure in the Casodex arm of the EPC trial?
Maltese: Il-kumpanija kif tista' teskludi li bicalutamide 150 mg seta' kellu x'jaqsam maż-żieda fil-mortalità minħabba kollass tal-qalb fil-grupp li kien qed jingħata Casodex fl-istudju EPC?
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF BICALUTAMIDE 150 mg CONTAINING MEDICINAL PRODUCTS (see Annex I)
Maltese: XJENTIFIKA TA' PRODOTTI MEDIĊINA LI FIHOM BICALUTAMIDE 150 mg (ara Anness I)
English: None of the EPC trials mandated that treatment be withheld from patients in the placebo group until clinical progression.
Maltese: L-ebda studju EPC ma rrakkomanda li t-trattament jitwaqqaf lil pazjenti fil-grupp tal-plaċebo sakemm ikun hemm progress kliniku.
English: Further, the study will include prostate cancer subgroups to include those on Casodex (bicalutamide), and those treated with luteinizing hormone-releasing hormone (LHRH) analogues, orchidectomy, and other hormonal therapies.
Maltese: Barra minn hekk, l-istudju sa jinkludi sotto gruppi ta' pazjenti bilkanċer biex jinkludi dawk li qed jieħdu Casodex (bicalutamide), u dawk ittrattati b'analogi ta' l-LHRH, bittneħħija tat-testikoli, u b'terapiji ormonali oħra.
English: Locally advanced prostate cancer refers to larger tumours or tumours with spread to lymph nodes, but not involving spread to other organs.
Maltese: Kanċer tal-prostata lokalment avvanzat jirreferi għal tumuri ikbar jew tumuri mifruxa fin-nodi limfatiċi, iżda li ma jinkludux firxa lejn organi oħra.
English: The aim of the study is to estimate the incidence of heart failure, cardiovascular morbidity and mortality in patients with prostate cancer, compared to the general population.
Maltese: mortalità u morbidità kardjovaskulari f'pazjenti bil-kanċer tal-prostata, meta mqabbla ma' dawk tal popolazzjoni ġenerali.
English: At that time, the RMS concluded that Casodex (bicalutamide) 150 mg should not be used in the treatment of ‘localised' prostate cancer, however, it was concluded that the benefit/risk balance remained positive for selected patients in ‘locally advanced' prostate cancer, as immediate therapy either alone or as adjuvant to treatment by radical prostatectomy or radiotherapy.
Maltese: Għalhekk, il-professjonisti kliniċi jistgħu jiddeċiedu li l-aqwa strateġija medika għal pazjent b'riskju baxx ta' progressjoni tal-marda, partikolarment fil-kuntest tas-sorveljanza tat-tneħħija radikali tal-prostata, jista' jwassal għal posponiment tat-terapija ormonali sakemm ikun hemm sinjali li l-marda tkun qed tagħmel progress.
English: Based on the concerns raised, the following questions were posed to the Applicants/ MAHs as part of the consolidated CHMP List of Questions, the responses to which were the basis of the CHMP reassessment of the benefit/risk balance:
Maltese: Minħabba t-tħassib li tqajjem, tressqu dawn il-mistoqsijiet lill-Applikanti/Deteneturi ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq bħala parti mil-Lista konsolidata ta' Mistoqsijiet mis-CHMP, li t-tweġibiet għalihom kienu l-bażi tal-valutazzjoni mill-ġdid tal-bilanċ bejn il-benefiċċju u r-riskju mis-CHMP:
English: Interstitial lung disease
Maltese: Għamla farmaċewtika
English: Section 5.1 of the SPC was amended to note that the optimum medical strategy for a patient at low risk of disease progression, particularly in the adjuvant setting following radical prostatectomy, might be to defer hormonal therapy until signs that the disease is progressing.
Maltese: It-Taqsima 5.1 ta' l-SPC ġiet emendata biex tinnota li l-istrateġija medika ottima għal pazjent b'riskju baxx ta' progressjoni tal-marda, partikolarment bħala żieda mat-trattament wara t-tneħħija radikali talprostata, tista' tkun dik li tipposponi it-terapija ormonali sakemm ikun hemm sinjali li l-marda tkun qed tipprogressa.
English: Therefore, Belgium referred the issue on 27 July 2006 for consideration by CHMP under Article 31 of Directive 2001/83/EC, as amended.
Maltese: Għalhekk, fis-27 ta' Lulju il-Belġju rrefera l-kwistjoni għall-konsiderazzjoni mis-CHMP skond lArtiklu 31 tad-Direttiva 2001/83/KE, kif emendata.
English: FI - Finland AstraZeneca Oy Luomanportti 3
Maltese: AstraZeneca Oy Luomanportti 3 02200 Espoo
English: Macclesfield
Maltese: LU - IlLussemburgu
English: Further, the study should include prostate cancer subgroups to include those on bicalutamide, and those treated with LHRH analogues, orchidectomy, and other hormonal therapies.
Maltese: Barra minn hekk, l-istudju għandu jinkludi l-gruppi bil-kanċer tal-prostata biex ikunu inklużi dawk ittrattati bl-analogi ta' LHRH, bit-tneħħija tat-testikoli, u b'terapiji ormonali oħra.
English: As regards the multiplicity issue raised, it is considered appropriate to look at subgroups from a statistical viewpoint, as they have helped to narrow the indication to patients with a more favourable benefit/risk balance for bicalutamide 150 mg.
Maltese: Dwar il-kwistjoni tal-multipliċità li tqajmet, hu meqjus xieraq li wieħed iħares lejn is-sottogruppi minn perspettiva statistika, għax dawn għenu fit-tnaqqis ta' l-indikazzjoni għal pazjenti b'bilanċ favorevoli filbenefiċċju/riskju għal bicalutamide 150 mg.
English: Therefore, clinicians may decide that the optimum medical strategy for a patient at low risk of disease progression, particularly in the adjuvant setting following radical prostatectomy, may be to defer hormonal therapy until signs that the disease is progressing.
Maltese: Għalhekk, dawk li jmexxu l-klinika jistgħu jiddeċiedu li l-aħjar strateġija medika għal pazjent b'riskju baxx ta' progessjoni tal-marda, l-aktar f'xenarju ta' terapija aġġuntiva wara t-tneħħija radikali tal-prostata, hija li tiġi differita t-terapija ormonali sakemm ikun hemm sinjali ta' progressjoni tal-marda.
English: A new pharmacoepidemiological study will be undertaken as part of an agreed Risk Management Plan (RMP), a post-opinion commitment to get a better understanding of cardiovascular risk.
Maltese: Sa jsir studju farmakoepidemoloġiku ġdid bħala parti minn Pjan għall-Ġestjoni tar-Riskju (RMP) li sar qbil dwaru, bilgħan li jkun hemm għarfien aħjar dwar ir-riskju kardjovaskulari.
English: Astrazeneca S.P.A. Palazzo Volta Via F. Sforza 20080 - Basiglio (MI)
Maltese: Dan l-istess tagħrif ġie ikkunsidrata mir-Renju Unit, l-Istat Membru ta' Referenza (RMS) għall-Proċedura tarRikonoxximent Reċiproku (MRP), fl-2003.
English: With reference to the adequacy of treatment in the placebo group in the EPC studies, given that at the time of initiation of these studies there was no widely agreed standard of care in locally advanced prostate cancer (something which remains the case), the empirical design of the studies, which compared Casodex (bicalutamide) 150mg or placebo when given as an adjunct to “standard care” is considered reasonable.
Maltese: B'referenza għall-adegwatezza tat-trattament fil-grupp tal-plaċebo fl-istudji EPC, billi fi żmien il-bidu ta' dawn l-istudji, ma kienx hemm qbil dwar l-istandard tal-kura fil-kanċer tal-prostata lokalment avvanzat (kif għadu sal-lum), id-disinn empiriku ta' dawn l-istudji, li qabblu Casodex (bicalutamide) 150mg jew il-plaċebo meta mogħti bħala żieda mal-“kura standard” hu meqjus raġonevoli.
English: 112 (4 x 28) tablets (multipack)
Maltese: 112 (4 x 28) pillola (pakketti b'ħafna)
English: Invented name Strength Pharmaceutical Form
Maltese: Numru tal-EU Isem ivvintat Qawwa Għamla farmaċewtika
English: 0.6 ml (10 mg/ml) 1 pre-filled syringe + on body injector (Onpro kit)
Maltese: Siringa waħda mimlija għal-lest + injettur li jeħel mal-ġisem (Onpro kit)
English: 0.6 ml (10 mg/ml) 1 pre-filled syringe with needle guard
Maltese: Użu għal taħt il-ġilda siringa mimlija għal-lest (ħġieġ)
English: 1 bottle + 1 dosing syringe + 1 adapter
Maltese: 1 flixkun + 1 siringa tad-dożaġġ + 1 adapter
English: 20mg/mL Oral solution Oral use
Maltese: 20mg/mL Soluzzjoni orali
English: Blister (PVC/alu foil)
Maltese: Folja (Fojl tal-PVC/alu)
English: EXP: {MM/YYYY}
Maltese: EXP: {XX/SSSS}
English: Metabolism and Elimination
Maltese: Metaboliżmu u Eliminazzjoni
English: EU/1/06/353/001 EU/1/06/353/002 EU/1/06/353/003 EU/1/06/353/004 EU/1/06/353/005
Maltese: EU/1/06/353/001 EU/1/06/353/002 EU/1/06/353/003 EU/1/06/353/004
English: GEO. PAVLIDES & ARAOUZOS LTD,
Maltese: PAVLIDES & ARAOUZOS LTD,
English: The terminal elimination half-life (t½) is 10 hours.
Maltese: Il-half-life ta' l-eliminazzjoni terminali (t½) hi ta' 10 sigħat.
English: Store below 25°C.
Maltese: Aħżen f'temperatura taħt il-25°C.
English: The absolute bioavailability of Thelin is between 70 and 100%.
Maltese: Il-biodisponibilità assoluta ta' Thelin hi ta' bejn 70% u 100%.
English: • The active substance is sitaxentan sodium.
Maltese: • Is-sustanza attiva hi sitaxenan-sodium.
English: Symptomatic hepatitis
Maltese: Epatite sintomatika
English: Frequencies are reported as very common ( 1/10), common (> 1/100, < 1/10), uncommon (> 1/1,000,  1/100), rare (> 1/10,000,  1/1,000), and very rare ( 1/10,000).
Maltese: Il-frekwenzi huma rrappurtati bħala komuni ħafna (1/10), komuni (>1/100, <1/10), mhux komuni (>1/1,000, 1/100), rari (>1/10,000, 1/1,000), u rari ħafna (1/10,000).
English: Pfizer Limited Sandwich, Kent, CT13 9NJ, United Kingdom
Maltese: Pfizer Limited Sandwich Kent CT13 9NJ Ir-Renju Unit
English: Salomone Pharma Ltd.
Maltese: V.J. Salomone Pharma Ltd.
English: Conatains lactose monohydrate
Maltese: Fih lactose monohydrate
English: Refer to section 4.3.
Maltese: ara taqsima 4.3).
English: Systemic vascular resistance (-276 dynes*sec/cm
Maltese: Kien hemm ameljorament fir-reżistenza vaskulari sistematika (-276 dynes*sek/cm
English: Excipients: Also contains 166.3mg of lactose monohydrate.
Maltese: Fiha wkoll 166.3 mg ta' lactose monohydrate.
English: System Organ Class / Adverse reaction
Maltese: Sistema tal-klassifika tal-organi / Reazzjoni avversa
English: Pharmacotherapeutic group: Other antihypertensives, ATC code: C02KX03
Maltese: Prodotti oħrajn għal pressjoni għolja, Kodiċi ATC: C02KX03
English: Elevated aminotransferases prior to initiation of treatment (aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 3 x ULN).
Maltese: Aminotransferases għoljin qabel il-bidu tal-kura (aspartate aminotransferase (AST) u/jew alanine aminotransferase (ALT) >3 x ULN).
English: Elevations in ALT values > 5 ULN were 4% (36/887) for sitaxentan 100 mg QD and 0.6% in the placebo group (1/155).
Maltese: ULN kienu 4% (36/887) għal sitaxentan 100 mg QD u 0.6% fil-grupp plaċebo (1/155).
English: The reduction in mean pulmonary artery pressure of 3 mmHg (6%) was not statistically significant.
Maltese: It-tnaqqis ta' 3mmHg (6%) fil-medja tal-pressjoni arterjali pulmonari ma kenitx statistikament sinifikanti.
English: (See Annex I: Summary of Product Characteristics, section 4.2)
Maltese: (Ara Anness I: Sommarju tal-Karatteristiċi talProdott sezzjoni 4.2)
English: Concomitant administration with ciclosporin A (see section 4.5).
Maltese: Teħid konkomitanti ma' ciclosporin A (ara taqsima 4.5).
English: EU/1/06/353/001 (14 film-coated tablets in blisters) EU/1/06/353/002 (28 film-coated tablets in blisters) EU/1/06/353/003 (56 film-coated tablets in blisters) EU/1/06/353/004 (84 film-coated tablets in blisters)
Maltese: EU/1/06/353/001 (14-il pillola miksija b'rita f'folji) EU/1/06/353/002 (28 pillola miksija b'rita f'folji) EU/1/06/353/003 (56 pillola miksija b'rita f'folji) EU/1/06/353/004 (84 pillola miksija b'rita f'folji)
English: It is expected that a similar increase in anticoagulant effect will be seen with warfarin analogues, including acenocoumarol, fenprocoumon and fluindione.
Maltese: Huwa mistenni li żieda simili fl-effett antikoagulanti tidher meta jittieħdu analogi ta' warfarin, inklużi acenocoumarol, fenprocoumon u fluindione.
English: Oral contraceptives (substrate of CYP3A4/5): Concomitant administration of Thelin and OrthoNovum 1/35 (1 mg norethindrone/ 0.035 mg ethinyl estradiol) resulted in increases in exposure to ethinyl estradiol (substrate of CYP3A4/5) and norethindrone (CYP3A4/5) of 59 % and 47%, respectively.
Maltese: Kontraċettivi orali (sottostrat ta' CYP3A4/5): Meta Thelin ingħata flimkien ma' Ortho-Novum 1/35 (1 mg norethindrone/ 0.035 mg ethinyl estradiol) irriżulta f'żidiet fl-espożizzjoni għal ethinyl estradiol (sottostrat ta' CYP3A4/5) u għal norethindrone (CYP3A4/5) ta' 59% u 47% , rispettivament.
English: High-density polyethylene (HDPE) bottles containing 28 tablets.
Maltese: Fliexken tal-polyethylene ta' densità għolja (HDPE) li fihom 28 pillola.
English: Do not take Thelin:
Maltese: Tieħux Thelin:
English: Lactation (see section 4.6).
Maltese: Treddigħ (ara taqsima 4.6)
English: •That Thelin is teratogenic
Maltese: • Li Thelin hu teratoġinku
English: Functional Class
Maltese: Klassi funzjonali:
English: Improvements in functional class were observed across all studies (STRIDE-1, STRIDE-2 & STRIDE-4).
Maltese: Ameljorament fil-klassi funzjonali ġie osservat fl-istudji kollha (STRIDE-1, STRIDE-2 u STRIDE-4).
English: Cartons contain 14, 28, 56, or 84 tablets.
Maltese: Il-pakketti fihom 14, 28, 56, jew 84 pillola.
English: Among patients with PAH associated with CTD in STRIDE-1 and STRIDE-2, a statistically significant difference versus placebo was observed (37.73 metres, p < 0.05).
Maltese: Fost il-pazjenti li għandhom PAH assoċjat ma' CTD fi STRIDE-1 u STRIDE-2,, kienet osservata differenza statistikament sinifikanti meta mqabbla mal-plaċebo (37.73 metri, p<0.05).
English: Thelin comes in blister packs of 14, 28, 56, and 84 tablets and bottles of 28 tablets.
Maltese: Thelin jiġi f'folji ta' 14, 28, 56, u 84 pillola u fliexken ta' 28 pillola.
English: Cases of concurrent elevations of transaminases (ALT and/or AST) > 8 x ULN and total bilirubin > 2 x ULN have been reported following administration of sitaxentan sodium.
Maltese: Każijiet konkurrenti ta' elevazzjonijiet ta' transaminases (ALT u/jew AST) > 8 x ULN u bilirubin totali > 2 x ULN kienu rrapurtati wara amministrazzjoni ta' sitaxentan sodium.
English: Oral contraceptive agents
Maltese: Sustanzi kontraċettivi orali
English: Treatment Comparison of Change from Baseline in PVR, and CI at Week 12 by Functional Class - STRIDE 1: Sitaxentan 100 mg Versus Placebo
Maltese: Trattament komparattiv ta' bidla mill-linja bazi f'PVR, u CI f'ġimgħa 12 skont ilklassi funzjonali - STRIDE 1: Sitaxentan 100 meta mqabbla mal-Plaċebo
English: However, sitaxentan sodium did not affect the anti-ovulatory activity of the oral contraceptive as assessed by the plasma concentrations of follicle stimulating hormone (FSH), luteinising hormone (LH), and progesterone (see section 4.4).
Maltese: Madanakollu, sitaxentan sodium ma affettwax l-attività anti-ovulatorja tal-kontraċettiv orali kif assessjat mill-konċentrazzjonijiet tal-follicle stimulating hormone (FSH), lutenising hormone (LH), u progesterone fil-plażma (ara sezzjoni 4.4).
English: Mild to severe hepatic impairment (Child-Pugh Class A-C).
Maltese: Indeboliment tal-fwied minn ħafif sa serju (Child-Pugh Klassi
English: 14 film-coated tablets in blisters 28 film-coated tablets in blisters 56 film-coated tablets in blisters 84 film-coated tablets in blisters
Maltese: 14-il pillola miksija b'rita fil-folji 28 pillola miksija b'rita fil-folji 56 pillola miksija b'rita fil-folji 84 pillola miksija b'rita fil-folji
English: In vitro and in vivo tests on genetic toxicology did not provide any evidence for a clinically relevant genotoxic potential.
Maltese: Testijiet in vitro u in vivo fuq it-tossikoloġija ġenetika ma pprovdew ebda evidenza għal potenzjal ġenotossiku klinikament rilevanti.
English: PVC/ACLAR/paper-backed aluminium blisters
Maltese: PVC/ACLAR/ Folji ta' l-aluminju b'dahar tal-karti
English: Pulmonary veno-occlusive disease (PVOD)
Maltese: Mard okklużiv tal-vini pulmonari (PVOD)
English: Stearic acid (E570b) Hypromellose (E464) Cellulose, microcrystalline (E460) Titanium dioxide (E171) Yellow iron oxide dehydrate (E172) Red iron oxide dehydrate (E172) Talc (E553b)
Maltese: Stearic acid (E570b) Hypromellose (E464) Cellulose, microcrystalline (E460) Titanium dioxide (E171) Yellow iron oxide dihydrate (E172) Red iron oxide dihydrate (E172) Talc (E553b)
English: Pharmacovigilance system
Maltese: Sistema tal-Farmakoviġilanza
English: These survival estimates were similar in the subgroup of patients with PAH associated with CTD for the Thelin treated group (98%, 78% and 67% respectively).
Maltese: Dawn l-istimi ta' sopravivenza kienu simili fis-sottogrupp ta' pazjenti b'PAH assoċjat ma' CTD għallgrupp ikkurat b'Thelin (98%, 78% u 67% rispettivament).
English: Cellulose, microcrystalline (E460) Lactose monohydrate Hypromellose (E464) Sodium starch glycolate Magnesium stearate (E470b) Disodium phosphate, anhydrous (E339) Ascorbyl palmitate (E304) Disodium edetate
Maltese: Cellulose, microcrystalline (E460) Lactose monohydrate Hypromellose (E464) Sodium starch glycolate Magnesium stearate (E470b) Disodium phosphate, anhydrous (E339) Ascorbyl palmitate (E304)
English: Additionally, PAH also is characterized by reduced nitric oxide activity.
Maltese: Barra minn hekk, PAH hi ukoll ikkaratterizzata minn tnaqqis fl-attività tan-nitric oxide.
English: The 18 week STRIDE-2 trial, conducted in 246 patients, included 4 treatment arms: placebo once daily, Thelin 50 mg once daily, Thelin 100 mg once daily, and open-label bosentan twice daily (efficacy-rater blinded, administered according to the approved package insert).
Maltese: Il-prova STRIDE-2 li damet 18-il ġimgħa, saret fuq 246 pazjent, inkludiet 4 oqsma ta' kura: plaċebo darba kuljum, Thelin 50 mg darba kuljum, Thelin 100 mg darba kuljum, u open-label bosentan darbtejn kuljum (efficacy-rater blinded, mogħti skond il-fuljett ta' tagħrif approvat).
English: Sitaxentan sodium does not affect the p-glycoprotein transporter, but it is postulated to be a substrate of OATP transporter proteins.
Maltese: Sitaxentan sodium ma jaffettwax it-trasportatur pglycoprotein, imma kien issoponut li huwa sottostrat tal-proteini tat-trasportaturi ta' OATP.
English: Endothelin-1 (ET-1) is a potent vascular paracrine and autocrine peptide in the lung, and can also promote fibrosis, cell proliferation, cardiac hypertrophy, and remodelling and is pro-inflammatory.
Maltese: Endothelin-1 (ET-1) huwa paracrine vaskulari u autocrine peptide qawwi fil-pulmun, u jista' jikkaġuna l-fibrożi, il-proliferazzjoni taċ-ċelluli, tkabbir fid-daqs u tibdil fil-forma u fil-funzjoni talqalb u jiffavorixxi l-infjammazzjoni.