FrancophonIA/ELRC3.0 huggingface dataset:
English: The 2012 sampling and testing programme completed in cooperation with the EDQM Q1-Q4 The 2013 sampling and testing programme prepared
Maltese: Matul l-2012, sejra tingħata attenzjoni fuq il-kisba tal-effiċjenza u fuq ir-reviżjoni u t-tfassil mill-ġdid tal-proċessi.
English: As reflected in the road map and its implementation plan, the Agency and its Committee for Medicinal Products for Veterinary Use will continue to contribute on a wide range of topics related to veterinary medicines at European Union and international level, such as antimicrobial resistance, maximum residue limits, risk assessment, benefit-risk analysis methodology and harmonisation of standards and requirements.
Maltese: Kif rifless fil-pjan direzzjonali u l-pjan ta' implimentazzjoni tiegħu, l-Aġenzija u l-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju tagħha sejrin ikomplu jikkontribwixxu f'firxa wiesgħa ta' suġġetti marbuta mal-mediċini veterinarji fil-livell tal-Unjoni Ewropea u dak internazzjonali, bħar-reżistenza antimikrobali, il-limiti massimi ta' residwi, il-valutazzjoni tar-riskju, il-metodoloġija u l-armonizzazzjoni tal-istandards u r-rekwiżiti tal-analiżi riskju/benefiċċju.
English: There is a need for the Co-ordination Group for Mutual Recognition and Decentralised Procedures Veterinary (CMDv) to have an active role in effecting the maintenance of harmonisation achieved via Commission decisions following CVMP referrals, and in 2012, the CMDv will most likely start pilot procedures for the transfer of purely national MAs to MRP status following positive Commission decisions for Article 34 referrals.
Maltese: Is-suġġett għall-2012 fil-qasam veterinarju ser ikun dak tal-kontinwazzjoni tal-ġestjoni tal-attivitajiet prinċipali fuq sfond ta' limitazzjonijiet ta' riżorsi.
English: CHMP Pharmacogenomics Working Party CHMP Pharmacokinetics Working Party CHMP Rheumatology/Immunology Working Party CHMP Vaccine Working Party
Maltese: Il-parti l-kbira tal-ħidma ta' farmakoviġilanza li l-Aġenzija qiegħda twettaq bħalissa hija relatata ma' madwar 600 prodott għall-użu mill-bniedem awtorizzati ċentralment.
English: Type-IA variations Type-IB variations Type-II variations Line extensions
Maltese: Il-ħtiġijiet tas-saħħa pubblika u d-disponibbiltà tal-mediċini
English: GMP (including PMF) GCP Pharmacovigilance GLP
Maltese: • il-leġiżlazzjoni l-ġdida dwar il-farmakoviġilanza;
English: Prepare for the implementation of the anti-falsification legislation.
Maltese: Il-leġiżlazzjoni kontra l-falsifikazzjoni
English: • the climate of austerity, both for the Agency and the national competent authorities (NCAs).
Maltese: • il-klima ta' awsterità, kemm għall-Aġenzija kif ukoll għall-awtoritajiet kompetenti nazzjonali (AKN).
English: CVMP Scientific Advisory Group on Antimicrobials CVMP Efficacy Working Party CVMP Environmental Risk Assessment Working Party CVMP Immunologicals Working Party CVMP Pharmacovigilance Working Party (PhVWP-V) CVMP Safety Working Party CVMP Scientific Advice Working Party
Maltese: Rigward il-mediċini veterinarji, il-Kummissjoni Ewropea hija mistennija li tiffinalizza l-proposti leġiżlattivi li rriżultaw mill-konsultazzjoni tagħha dwar regolamentazzjoni aħjar fis-settur veterinarju u l-valutazzjoni tal-impatt fuq il-leġiżlazzjoni veterinarja li saret fl-2010.
English: Transparency of clinical-trial information remains a key issue with the anticipated inclusion of summaries of clinical-trial results in EudraCT and in EudraPharm's EU Clinical Trials Register.
Maltese: EMA), li, fost objettivi oħrajn, sejjer janalizza gradwalment proċessi ta' negozju ewlenin u jiżgura li dawn ikunu sostnuti minn sistemi effiċjenti u effettivi tal-informatika.
English: One of the pillars of the implementation will be the strengthening of the Agency's collaboration with the national competent authorities in the area of communication and provision of information.
Maltese: Wieħed mill-pilastri tal-implimentazzjoni ser ikun it-tisħiħ talkollaborazzjoni tal-Aġenzija mal-awtoritajiet kompetenti nazzjonali fil-qasam tal-komunikazzjoni u lgħoti ta' informazzjoni.
English: Planned activities include identifying areas where additional medicines are needed, reflecting on the difficulties faced by SMEs in addressing unmet medical needs, and considering the merits and mechanics of an optional approach to the early authorisation of medicines in a restricted population.
Maltese: L-attivitajiet ippjanati jinkludu l-identifikazzjoni ta' oqsma fejn huma meħtieġq aktar mediċini, ir-riflessjoni dwar id-diffikultajiet li jiltaqgħu magħhom lSMEs fl-indirizzar ta' ħtiġijiet mediċi mhux issodisfati, u l-ikkunsidrar tal-merti u l-mekkaniżmi ta' approċċ fakultattiv għall-awtorizzazzjoni bikrija ta' mediċini f'popolazzjoni ristretta.
English: New work includes involvement in the following fields: adverse drug reaction (ADR) reporting and data provision (estimated 80,000 ADR reports per year), data analysis for centrally authorised products to detect new or changing safety issues ('signal detection' - estimated 3,000 analyses in 2012), approval of post-authorisation safety-study protocols and results (624 new assessments per annum), and establishment and maintenance of a listing of product information for all EU medicines.
Maltese: Sadanittant, l-aktar riżultati notevoli fil-qasam tat-trasparenza fl-2012 sejrin ikunu l-għoti tal-aċċess għad-dejta tal-EudraVigilance għallmediċini veterinarji u għall-bniedem, l-għoti ta' aktar informazzjoni dwar il-provi kliniċi u l-bidu talpubblikazzjoni tal-aġendi u l-minuti tal-kumitat xjentifiku.
English: CHMP Gastroenterology Drafting Group CHMP Radiopharmaceuticals Drafting Group CHMP Respiratory Drafting Group CHMP Urology Drafting Group
Maltese: Sejrin jibdew diskussjonijiet dwar kif jiġi żgurat li l-valuri tal-pazjenti jiġu kkunsidrati fil-valutazzjonijiet tar-rapport benefiċċju/riskju.
English: Strengthen monitoring, quality assurance and consistency of CHMP initial evaluation (day 120 list of questions).
Maltese: It-twettiq ta' responsabbiltajiet xjentifiċi kontinwi bi standards tal-ogħla kwalità jibqa' l-prijorità ewlenija tal-Aġenzija.
English: Ask EMA: Deliver in Q4 a system to support the Agency policy on access to documents in line with Regulation 1049/2001 Requests for information Ask EMA: Deliver in Q4 a system to support the Agency policy on requests for information Core business performance indicators for the area Performance indicator
Maltese: Sabiex tagħmel aktar progress fil-qasam tal-komunikazzjoni u l-għoti ta' informazzjoni, l-Aġenzija sejra tħejji strateġija ta' komunikazzjoni.
English: The work programme takes into account the above factors, the broader context of the Agency's legislative, economic, social and technological environment, and relevant measures outlined in the implementation plan for the Agency's 'Road map to 2015'.
Maltese: Il-programm ta' ħidma jikkunsidra dawn il-fatturi, il-kuntest usa' tal-ambjent leġiżlattiv, ekonomiku, soċjali u teknoloġiku tal-Aġenzija, u l-miżuri rilevanti deskritti fil-pjan ta' implimentazzjoni għall-‘Pjan Direzzjonali għall-2015' tal-Aġenzija.
English: Business case submitted to senior management on vaccine health outcome data link Q2 Objective
Maltese: L-Aġenzija sejra tiffinalizza wkoll il-politika tagħha dwar it-trasparenza, wara l-eżitu tal-konsultazzjoni pubblika.
English: There will be continued need for manual quality control and recoding of the available product data until the time of full availability of a fully functional central EU veterinary medicinal product database linked to the revised EVVet, which is under development.
Maltese: L-Aġenzija sejra taħdem mal-partijiet interessati u mannetwerk regolatorju sabiex tassigura li jkun hemm stabbilita gwida adegwata u xierqa li tiffaċilita laċċess ta' teknoloġiji ġodda għas-suq kemm qabel, jew bħala parti mir-reviżjoni tal-leġiżlazzjoni veterinarja.
English: New ISO standards for the electronic submission of individual case safety reports (ICSRs) and for the identification of medicinal products (IDMP) should be finalised in 2012; see also Section 6.2 - EU telematics.
Maltese: Il-programm ta' ħidma tal-Aġenzija Ewropea għall-Mediċini għall-2012 huwa influwenzat minn għadd ta' fatturi, fosthom:
English: Guzmán el Bueno 133, Edificio Britania 4ºIzq.
Maltese: TEVA GENERICOS ESPAÑOLA, S.L. Guzmán el Bueno 133, Edificio Britania 4ºIzq.
English: - Quality issues
Maltese: - Kwestjonijiet ta' kwalità
English: Applicant company name, address
Maltese: L-Applikant isem tal-kumpanija, indirizz
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR POSITIVE OPINION PRESENTED BY THE EUROPEAN MEDICINES AGENCY
Maltese: ANNESS II KONKLUŻJONIJIET U RAĠUNIJIET XJENTIFIĊI GĦAL OPINJONI POŻITTIVA IPPREŻENTATA
English: Out of 19 adverse events observed, 14 were for the reference product and 5 were for the test product.
Maltese: Mid-dsatax-il episodju avvers, 14 kienu għall-prodott ta' referenza u 5 għall-prodott taħt studju.
English: Whereas - the Applicant's choice of the clopidogrel base and consequently the use of BHA has been sufficiently explained - the overall control strategy to ensure suitable and reproducible quality of the product has been justified with regard to the handling of the viscous mass of the clopidogrel base - the Applicant's Clopidogrel Base Tablets 75 mg has adequate quality and benefit/risk ratio and is comparable to the reference product the CHMP has recommended the granting of the Marketing Authorisation for which the Summary of Product Characteristics, labelling and package leaflet remain as per the final versions achieved during the Coordination group procedure as mentioned in Annex III of this Opinion.
Maltese: - il-Pilloli bil-Bażi ta' Clopidogrel ta' 75 mg tal-Applikant għandhom kwalità u proporzjon ta' benefiċċju/riskju adegwati u huma kumparabbli mal-prodott ta' referenza is-CHMP irrakkomanda illi tingħata l-Awtorizzazzjoni għat-Tqegħid fis-Suq li għaliha, is-Sommarju talKaratteristiċi tal-Prodott, it-tikketta u l-fuljett ta' tagħrif jibqgħu skont il-verżjonijiet finali milħuqa waqt ilproċedura tal-grupp ta' Kordinament kif imsemmi fl-Anness
English: Teva Pharma BV.
Maltese: Teva Pharma
English: Severe hypotension (<90/50 mm Hg).
Maltese: Ipotensjoni severa (< 90/50 mm Hg).
English: INFORMATION IN BRAILLE ADCIRCA 20 mg
Maltese: INFORMAZZJONI BIL-BRAILLE ADCIRCA 20 mg
English: ADCIRCA contains lactose monohydrate.
Maltese: ADCIRCA fih l-lactose monohydrate.
English: Date of latest renewal: 1 October 2013
Maltese: Data tal-aħħar tiġdid: 1 Ottubru 2013
English: Avda de la Industria 30 28108 Alcobendas (Madrid) Spain
Maltese: de la Industria 30 28108 Alcobendas (Madrid) Spanja
English: Stevens-Johnson Syndrome, Exfoliative dermatitis
Maltese: Sindromu ta' Stevens-Johnson, Dermatite esfoljattiva
English: ADCIRCA with alcohol
Maltese: ADCIRCA mal-alkoħol
English: The overall frequency of discontinuation due to adverse events was low (ADCIRCA 11 %, placebo 16 %).
Maltese: Il-frekwenza totali ta' twaqqif mill-kura minħabba avvenimenti avversi kien baxx (ADCIRCA 11 %, plaċebo 16 %).
English: Azole Antifungals (e.g. ketoconazole)
Maltese: Azole (eż. ketoconazole)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/476/005-006
Maltese: EU/1/08/476/005-006
English: Vision
Maltese: Vista
English: de la Industria 30, 28108 Alcobendas, Madrid, Spain
Maltese: Lilly S.A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spanja
English: Syncope, Migraine5
Maltese: Sinkope, Emigranja5
English: CYP2C9 substrates (e.g.R-warfarin)
Maltese: Sustrati ta' CYP2C9 (eż. R-warfarin)
English: CYP1A2 substrates (e.g. theophylline)
Maltese: Sustrati ta' CYP1A2 (eż. theophylline)
English: PDE5 is the predominant phosphodiesterase in the pulmonary vasculature.
Maltese: PDE5 huwa laktar phosphodiesterase importanti fil-vaskulatura pulmonarja.
English: ADCIRCA contains the active substance tadalafil.
Maltese: ADCIRCA fih is-sustanza attiva tadalafil.
English: Immune system disorders Hypersensitivity reactions5
Maltese: Disturbi fis-sistema immuni Reazzjonijiet ta' sensittività eċċessiva5
English: Unstable angina pectoris, Ventricular arrhythmia, Myocardial Infarction2
Maltese: Angina pectoris instabbli, Arritmja ventrikulari, Infart mijokardijaku2
English: Film-coated tablet core lactose monohydrate croscarmellose sodium hydroxypropylcellulose microcrystalline cellulose sodium laurilsulfate magnesium stearate
Maltese: Qalba tal-pillola miksija b'rita lactose monohydrate croscarmellose sodium hydroxypropylcellulose microcrystalline cellulose sodium laurilsulfate magnesium stearate
English: Protease inhibitors (e.g. ritonavir)
Maltese: Inibituri ta' protease (eż.ritonavir)
English: Each film-coated tablet contains 233 mg lactose (as monohydrate).
Maltese: Kull pillola miksija b'rita fiha 233 mg lactose (bħala monohydrate).
English: The active substance is tadalafil.
Maltese: Is-sustanza attiva hi tadalafil.
English: Palpitations2, 5
Maltese: Palpitazzjonijiet2,5
English: Tadalafil is a potent and selective inhibitor of phosphodiesterase type 5 (PDE5), the enzyme responsible for the degradation of cyclic guanosine monophosphate (cGMP).
Maltese: Tadalafil huwa inibitur qawwi u selettiv ta' phosphodiesterase tip 5 (PDE5), l-enzima risponsabbli għad-degradazzjoni ta' cyclic guanosine monophosphate (cGMP).
English: Pharmacokinetic studies have included subjects and patients from different ethnic groups, and no differences in the typical exposure to tadalafil have been identified.
Maltese: Studji farmakokinetiċi inkludew suġġetti u pazjenti minn gruppi etniċi differenti u ma ġew identifikati ebda differenzi fl-espożizzjoni tipika ta' tadalafil.
English: Stroke2 (including haemorrhagic events)
Maltese: puplesija2 (inklużi avvenimenti emorraġiċi)
English: Seizures5, Transient amnesia5
Maltese: Amnesija temporanja5
English: - rifampicin (to treat bacterial infections) - ketoconazole tablets (to treat fungal infections) - ritonavir (for HIV treatment) - tablets for erectile dysfunction (PDE5 inhibitors).
Maltese: - rifampicin (għall-kura ta' infezzjonijiet tal-batteri) - pilloli ta' ketoconazole (għall-kura ta' infezzjonjiet tal-fungi) - ritonavir (għall-kura tal-HIV) - pilloli għad-disfunzjoni erettili (inibituri ta' PDE5).
English: Frequency estimate: 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) and not known (cannot be estimated from the available data).
Maltese: Komuni ħafna (≥ 1/10), Komuni (≥ 1/100 sa < 1/10), Mhux komuni (≥ 1/1000 sa < 1/100), Rari (≥ 1/10,000 sa < 1/1000), Rari
English: Tadalafil is predominantly metabolised by the cytochrome P450 (CYP) 3A4 isoform.
Maltese: Tadalafil huwa prinċipalment metabolizzat permezz tal-iżoforma ċitokromju P450 (CYP) 3A4 .
English: Marketing Authorisation Holder: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u l-Manifattur Detentur tal-Awtorizzazzjoni għat-tqegħid fis-Suq : Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, L-Olanda
English: Film-coat lactose monohydrate hypromellose triacetin titanium dioxide (E171) iron oxide yellow (E172) iron oxide red (E172) talc
Maltese: Kisja b'rita lactose monohydrate hypromellose triacetin titanium dioxide (E171) iron oxide isfar (E172)
English: Excipient with known effect:
Maltese: Ġew irrappurtati effetti sekondarji oħra:
English: Efficacy in patients with pulmonary arterial hypertension (PAH) A randomised, double-blind, placebo-controlled study was conducted in 405 patients with pulmonary arterial hypertension.
Maltese: L-effikaċja f'pazjenti b'ipertensjoni arterjali pulmonarja (PAH) Studju kkontrollat bil-plaċebo, double-blind u randomised ġie magħmul fuq 405 pazjent b'ipertensjoni arterjali pulmonarja.
English: Allowed background therapy included bosentan (stable maintenance dose up to 125 mg twice daily) and chronic anticoagulation, digoxin, diuretics and oxygen.
Maltese: Terapiji li tħallew jintużaw fl-istess ħin inkludew bosentan (doża stabbli ta' manteniment sa 125 mg darbtejn kuljum) u antikoagulazzjoni kronika, digoxin, dijuretiċi u ossiġenu.
English: Treatments for erectile dysfunction
Maltese: Trattamenti għad-disfunzjoni erettili
English: ADCIRCA 20 mg is available in blister packs containing 28 or 56 tablets.
Maltese: ADCIRCA 20 mg issibu f'pakketti b'folji ta' 28 jew 56 pillola.
English: Tadalafil did not show efficacy in slowing the decline in ambulation as measured by the primary 6 minute walk distance (6MWD) endpoint: least squares (LS) mean change in 6MWD at 48 weeks was -51.0 meters (m) in the placebo group, compared with -64.7 m in the tadalafil 0.3 mg/kg group (p = 0.307) and -59.1 m in the tadalafil 0.6 mg/kg group (p = 0.538).
Maltese: Tadalafil ma weriex effikaċja biex inaqqas ittnaqqis fl-ippassiġġar kif imkejjel permezz tal-punt finali primarju tad-distanza li wieħed jimxi f'6 minuti (6MWD - 6 minute walk distance): il-bidla medja fl-inqas numru ta' kwadrati (LS -least squares ) f'6MWD fit-48 ġimgħa kien -51.0 metri (m) fil-grupp tal-plaċebo, meta mqabbel ma' -64.7 m fil-grupp ta' tadalafil 0.3 mg/kg (p = 0.307) u -59.1 m fil-grupp ta' tadalafil 0.6 mg/kg (p = 0.538).
English: Priapism5, Penile haemorrhage,
Maltese: Prijapiżmu5, Emorraġija fil pene, Ematospermja
English: Orange and almond shaped film-coated tablets, marked "4467" on one side.
Maltese: Pilloli oranġjo u għandhom forma ta' lewża, immarkati "4467" fuq naħa waħda.
English: Aluminium/PVC/PE/PCTFE blisters in cartons of 28 and 56 film-coated tablets.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Folji tal-aluminju /PVC/PE/PCTFE f'kartuniet ta' 28 u 56 pillola miksija b'rita.
English: Film-coat: lactose monohydrate, hypromellose, triacetin, titanium dioxide (E171), iron oxide yellow (E172), iron oxide red (E172), talc.
Maltese: Kisja b'rita: lactose monohydrate, hypromellose, triacetin, titanium dioxide (E171), iron oxide isfar
English: Other medicines and ADCIRCA
Maltese: Mediċini oħra u ADCIRCA
English: Between 20 mg to 40 mg, a less than proportional increase in exposure is observed.
Maltese: Bejn 20 mg sa 40 mg, ġiet osservata żieda li kienet inqas minn dik proporzjonali.
English: Cytochrome P450 Inducers
Maltese: Inibituri taċ-Ċitokromu P450
English: ADCIRCA 20 mg film-coated tablets Tadalafil
Maltese: ADCIRCA 20 mg pilloli tadalafil
English: Tadalafil is also > 10,000-fold more potent for PDE5 than for PDE7 through PDE10.
Maltese: Tadalafil huwa wkoll > 10,000 darba aktar potenti għal PDE5 milli għal PDE7 permezz ta' PDE10.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Pazjenti bi problemi ereditarji rari ta' intoleranza għall galactose, ta' nuqqas ta' Lapp lactase jew ta' malassorbiment ta'glucose-galactose m'għandhomx jieħdu dan il-prodott mediċinali.
English: MARKETING AUTHORISATION HOLDER Eli Lilly Nederland B.V.
Maltese: Eli Lilly Nederland B.V.
English: Results were generally consistent in subgroups according to age, gender, PAH aetiology and baseline WHO functional class and 6MWD.
Maltese: B'mod ġenerali, ir-riżultati kienu konsistenti fis-sottogruppi skont l-età, sess, etjoloġija tal-PAH u linja bażi ta' klassi ta' funzjonament WHO u ta' 6MWD.
English: - In clinical studies, tadalafil was shown to augment the hypotensive effects of nitrates.
Maltese: - Fi studji kliniċi, tadalafil intwera li jkabbar l-effetti ipotensivi tan-nitrati.
English: Vomiting, Gastroesophageal reflux
Maltese: Rimettar Rifluss gastroesofagali
English: Ketoconazole (400 mg daily) increased tadalafil (20 mg) single dose exposure (AUC) 4-fold and Cmax by 22 %.
Maltese: Ketoconazole (400 mg kuljum) żied l-espożizzjoni (AUC) ta' doża waħda ta'tadalafil (20 mg) b'erba darbiet u Cmax bi 22%.
English: Tadalafil (20 mg) did not augment the mean blood pressure decrease produced by alcohol (0.7 g/kg or approximately 180 ml of 40 % alcohol [vodka] in an 80 kg male), but in some subjects, postural dizziness and orthostatic hypotension were observed.
Maltese: Tadalafil (20 mg) ma żiedx il-medja tat-tnaqqis tal- pressjoni tad-demm ikkawżata mill alkoħol (0.7 g/kg jew madwar 180 ml ta' 40% alkoħol [vodka] f'raġel ta' 80 kg) iżda f'xi individwi, kienu osservati sturdament dovut għat-tibdil fil-pożizzjoni tal-persuna u ipotensjoni ortostatika..
English: There were no clinically relevant differences in Cmax compared to healthy volunteers.
Maltese: Ma kien hemm ebda differenza klinikament sinifikanti fis-Cmax meta mqabbel ma' volontiera b'saħħithom.
English: Ritonavir (200 mg twice daily), which is an inhibitor of CYP3A4, CYP2C9, CYP2C19, and CYP2D6, increased tadalafil (20 mg) single dose exposure (AUC) 2-fold with no change in Cmax.
Maltese: Ritonavir (200 mg darbtejn kuljum), li huwa inibitur ta' CYP3A4, CYP2C9, CYP2C19, u CYP2D6, żied l-esponiment (AUC) ta' doża waħda ta' tadalafil (20 mg) b'darbtejn, bl-ebda tibdil f'Cmax.
English: The mean baseline 6-minute-walk-distance (6MWD) was 343.6 meters.
Maltese: Il-medja tal-linja bażi tad-distanza li wieħed jista' jimxi f'6 minuti (6MWD) kienet ta' 343.6 metri.
English: Concomitant use of riociguat with PDE5 inhibitors, including tadalafil, is contraindicated (see section 4.3).
Maltese: L-użu fl-istess ħin ta' riociguat ma' inibituri ta' PDE5, inkluż tadalafil, huwa kontraindikat (ara sezzjoni 4.3).
English: Patients were at least 12 years of age and had a diagnosis of PAH that was idiopathic, related to collagen disease, related to anorexigen use, related to human immunodeficiency virus (HIV) infection, associated with an atrial-septal defect, or associated with surgical repair of at least 1 year in duration of a congenital systemic-to-pulmonary shunt (for example, ventricular septal defect, patent ductus arteriosus).
Maltese: PAH li kienet idjopatika u relatata ma' mard tal-kollaġini, relatata mal-użu anoreksiġenu, relatata malinfezzjoni tal-virus ta' immunodefiċjenza umana (HIV), assoċjata ma' difett atriju-settali jew assoċjata ma' intervent kirurġiku ta' tiswija li ilu li sar għall-inqas sena ta' ‘shunt' sistemiku għal pulmonarju konġenitali, (per eżempju difett settali ventrikulari, patent ductus arteriosus).
English: At therapeutic concentrations, 94 % of tadalafil in plasma is bound to proteins.
Maltese: F'konċentrazzjonijiet terapewtiċi, 94 % ta' tadalafil fil-plażma jkun marbut mal-proteini.
English: Tadalafil is
Maltese: tadalafil.
English: Bosentan (125 mg twice daily), a substrate of CYP2C9 and CYP3A4 and a moderate inducer of CYP3A4, CYP2C9 and possibly CYP2C19, reduced tadalafil (40 mg once per day) systemic exposure by 42 % and Cmax by 27 % following multiple dose co-administration.
Maltese: Antagonisti tar-riċettur endothelin-1 (eż. bosentan) Bosentan (125 mg darbtejn kuljum), sustrat ta' CYP2C9 u CYP3A4 u stimulatur moderat ta' CYP3A4, CYP2C9 u wisq probabbli ta' CYP2C19, naqqas l-espożizzjoni sistemika ta' tadalafil
English: The majority of patients had a World Health Organization (WHO) Functional Class III (65.2 %) or II (32.1 %).
Maltese: III (65.2%) jew II (32.1%) ta' Funzjonament skont l-Organizzazzjoni Dinija tas-Saħħa (WHO).
English: In clinical pharmacology studies using single-dose tadalafil (5 to 20 mg), tadalafil exposure (AUC) approximately doubled in subjects with mild (creatinine clearance 51 to 80 ml/min) or moderate (creatinine clearance 31 to 50 ml/min) renal impairment and in subjects with end-stage renal disease on dialysis.
Maltese: Fl-istudji tal-farmakoloġija klinika fejn intużat doża waħda ta' tadalafil (5 mg-20 mg), l-esponiment għal tadalafil (AUC) kien madwar id-doppju f'individwi b'indeboliment ħafif fil-kliewi (tneħħija tal krejatinina 51 sa 80 ml/min) jew moderat (tneħħija tal-krejatinina 31 sa 50 ml/min) u f'individwi fuq id-dijaliżi bi stat terminali tal-funzjoni tal-kliewi.
English: When tadalafil 10 mg was administered with theophylline (a non-selective phosphodiesterase inhibitor) there was no pharmacokinetic interaction.
Maltese: Meta tadalafil 10 mg ingħata ma' theophylline (inibitur mhux selettiv tal-phosphodiesterase) ma kien hemm ebda interazzjoni farmakokinetika.
English: They are in the shape of almonds and have "4467" marked on one side.
Maltese: Dawn għandhom forma ta' lewża, u huma mmarkati "4467" fuq naħa waħda.