FrancophonIA/ELRC3.0 huggingface dataset:
English: Contributing towards stimulating the innovation and research of medicines in the EU, to allow faster access to new therapies and technologies;
Maltese: Kontribuzzjoni lejn l-istimulazzjoni ta' l-innovazzjoni u r-riċerka dwar il-mediċini fl-UE, sabiex ikun hemm aċċess aktar mgħaġġel għal terapiji u teknoloġiji ġodda;
English: Safety of medicines
Maltese: Sigurtà tal-mediċini
English: Cooperation between the EMEA and the US Food and Drug Administration will continue in the context of the EU-USA confidentiality arrangements, with primary focus on the parallel scientificadvice process and the exchange of safety-related information.
Maltese: Il-kooperazzjoni bejn l-EMEA u l-Food and Drug Administration ta' l-Istati Uniti ser tkompli filkuntest ta' l-arranġamenti ta' kunfidenzjalità bejn l-UE u l-Istati Uniti, b'emfażi ewlenija fuq ilproċess parallel ta' pariri xjentifiċi u l-bdil ta' informazzjoni relatata mas-sigurtà.
English: In the increasingly global pharmaceuticals sector, the Agency's contribution to international scientific forums on harmonisation of the regulatory environment is significant.
Maltese: Fis-settur farmaċewtiku li qed isir dejjem aktar globalizzat, il-kontribut ta' l-Aġenzija fi ħdan ilfora xjentifiċi internazzjonali dwar l-armonizzazzjoni ta' l-ambjent regolatorju huwa wieħed sinifikanti.
English: Pre-accession activities in view of the next wave of EU enlargement, in 2007, will include operation of the pre-accession linguistic review process (PALC II) and CADREAC procedures, as well as participation in the PHARE multi-beneficiary programme, to facilitate the integration of Bulgarian and Romanian regulatory authorities in the work of the Agency.
Maltese: L-attivitajiet ta' qabel l-adeżjoni fid-dawl tal-fażi ta' tkabbir ta' l-UE li jmiss, fl-2007, ser jinkludu t-tħaddim tal-proċess ta' reviżjoni lingwistika ta' qabel l-adeżjoni (PALC II) u l-proċeduri CADREAC, kif ukoll il-parteċipazzjoni fi ħdan il-programm PHARE għal diversi benefiċċjarji, sabiex tiġi ffaċilitata l-integrazzjoni ta' l-awtoritajiet regolatorji Bulgari u Rumeni fi ħdan ilħidma ta' l-Aġenzija.
English: 20-22 June
Maltese: 20-22 ta' Ġunju
English: Coordination groups for mutual-recognition and decentralised procedures (human and veterinary products)
Maltese: Gruppi ta' koordinazzjoni għar-rikonoxximent reċiproku u proċeduri deċentralizzati (prodotti għall-bniedem u veterinarji)
English: Work within the network to establish an EU communications strategy; Work to ensure availability for the Agency of the highest-quality expertise at EU level for evaluation of medicines and for monitoring and assessing their safety; Establish an inventory of available scientific expertise in the European medicines network; identify and complement insufficient expertise and plan for succession of established expertise; Develop an EU competence-development strategy and strengthen competence development at EU level.
Maltese: It-twaqqif ta' inventarju ta' ħila esperta xjentifika disponibbli fin-netwerk Ewropew talmediċini; l-identifikazzjoni u l-ikkumplimentar tan-nuqqas ta' ħila esperta u l-ippjanar għassuċċessjoni ta' ħila esperta stabbilita;
English: Two to three new upgrade versions of the main EudraVigilance application (7.1, 7.2, 7.3) will be released in the course of 2006.
Maltese: Matul l-2006 għandhom jinħarġu bejn tnejn u tlett verżjonijiet ġodda li jaġġornaw lapplikazzjoni ewlenija ta' l-EudraVigilance (7.1, 7.2, 7.3).
English: The EMEA receives safety reports from within the EU and outside concerning centrally authorised medicinal products and coordinates action relating to the safety and quality of medicinal products.
Maltese: L-EMEA tirċievi rapporti ta' sigurtà minn ġewwa l-UE u minn barra dwar prodotti mediċinali awtorizzati ċentralment u tikkoordina l-azzjoni li tittieħed fir-rigward tas-sigurtà u l-kwalità tal-prodotti mediċinali.
English: In addition, reviews of RMPs (including risk-minimisation measures and other pharmacovigilance activities) to identify known and potential risks with the medicinal product will be required for some variations and line extensions which result in a significant change in a marketing authorisation.
Maltese: Barra minn hekk, ser ikunu meħtieġa reviżjonijiet ta' l-RMPs (inklużi miżuri għall-imminimizzar tar-riskju u attivitajiet oħra ta' farmakoviġilanza) sabiex jiġu identifikati rriskji magħrufa u potenzjali marbuta mal-prodott mediċinali għal xi varjazzjonijiet u estensjonijiet tal-linja li jwasslu għal bidla sinifikanti f'awtorizzazzjoni għal tqegħid fis-suq.
English: Executive support
Maltese: Sostenn ezekuttiv
English: The Agency will implement procedures for the organisation of emergency meetings.
Maltese: L-Aġenzija ser timplimenta proċeduri għall-organizzazzjoni ta' laqgħat ta' emerġenza.
English: General EU contribution
Maltese: Kontribuzzjoni miż-ŻEE
English: Meetings at the EMEA Document management and publishing
Maltese: Gestjoni tad-dokumenti u lpubblikazzjoni Gestjoni ta' laqghat u konferenzi
English: Silvia DOMINGO ROIGÉ Direct telephone: (44-20) 74 18 85 52 Fax: (44-20) 74 18 85 45
Maltese: (44-20) 74 18 85 52 Fax:
English: • by email request to info@emea.eu.int
Maltese: E-mail: europeanexperts@emea.eu.int
English: Type-II (clinical) variations
Maltese: Kwalità tal-medicini
English: Greater openness and provision of information relating to medicinal products submitted to the Agency for evaluation, both before and after the granting of a marketing authorisation;
Maltese: European Medicines Agency©EMEA 2006 Reproduction and/or distribution of this document is authorised for non-commercial purposes only provided the EMEA is acknowledged
English: 300 Meetings
Maltese: Infiq operazzjonali 300 Laqgħat
English: Cooperation will also continue with the European Pharmacopoeia and with the European Directorate for the Quality of Medicines, in the context of the sampling and testing programme being operated to supervise the quality of centrally authorised medicinal products placed on the market.
Maltese: Il-kooperazzjoni ser tkompli wkoll mal-Farmakopea Ewropea u mad-Direttorat Ewropew għallKwalità tal-Mediċini, fil-kuntest tal-programm ta' teħid ta' kampjuni u ttestjar li qed jiġi mħaddem biex tiġi sorveljata l-kwalità ta' prodotti mediċinali awtorizzati ċentralment li jitpoġġew fis-suq.
English: The Agency expects that all national competent authorities will be reporting electronically to the EudraVigilance system by the end of 2006, which is reflected in the forecast increase of electronic reports in the chart below.
Maltese: L-Aġenzija tistenna li l-awtoritajiet kompetenti nazzjonali kollha ser jibdew jirrapportaw elettronikament lis-sistema EudraVigilance sat-tmiem ta' l-2006, li hija riflessa fiż-żjieda ta' rapporti elettroniċi mbassra fil-grafika li tinsab hawn taħt.
English: Direct telephone: (44-20) 75 23 71 08 E-mail: panos.tsintis@emea.eu.int
Maltese: Martin HARVEY ALLCHURCH Telefon dirett (44-20) 74 18 84 27 E-mail: press@emea.eu.int
English: Assuring the quality of assessments, including strengthened regulatory and scientific consistency.
Maltese: Tiġi żgurata l-kwalità tal-valutazzjonijiet, inkluża konsistenza regolatorja u xjentifika msaħħa.
English: As part of this approach, the EMEA and national competent authorities have implemented the EU Benchmarking System, with its regular cycle of self-assessment activities and peer-review visits.
Maltese: Bħala parti minn din l-istrateġija, l-EMEA u l-awtoritajiet kompetenti nazzjonali implimentaw is-Sistema ta' Benchmarking ta' l-UE, biċ-ċiklu regolari tagħha ta' attivitajiet ta' valutazzjoni fi ħdanhom u żjarat għar-reviżjoni minn pari.
English: Monitoring the safety of medicines for human and veterinary use is a priority area for the EMEA.
Maltese: Is-sorveljanza tas-sigurtà tal-mediċini għall-użu tal-bniedem u veterinarju hija qasam ta' prijorità għall-EMEA.
English: Development of corporate applications will concentrate on the completion of phase III of the Meetings Management System (end of March), the continuing update of the corporate product database and tracking system SIAMED to include provisions of the new medicines legislation, and its migration to a different technical platform, and further work on a number of smaller systems such as the contracts database.
Maltese: III tas-Sistema ta' Ġestjoni tal-Laqgħat (tmiem ta' Marzu), l-aġġornament kontinwu tal-bażi tad-data tal-prodotti u sistema ta' intraċċar korporattiv SIAMED sabiex jinkludu dispożizzjonijiet tal-leġiżlazzjoni lġdida dwar il-mediċini, u l-migrazzjoni tagħha għal pjattaforma teknika differenti, u aktar xogħol fuq għadd ta' sistemi iżgħar bħal-bażi tad-data tal-kuntratti.
English: This document provides a summary of the Agency's work programme 2006, adopted by the Management Board on 15 December 2005.
Maltese: Dan id-dokument jipprovdi ġabra fil-qosor tal-programm ta' ħidma ta' l-Aġenzija għall-2006, adottat mill-Bord ta' Tmexxija fil-15 ta' Diċembru 2005.
English: Out of hours telephone: (44-7880) 55 06 97
Maltese: (44-20) 74 18 85 90 Telefon wara l-ħin: (44-7880) 55 06 97
English: The Agency expects an increase in the number of extension or modification applications for maximum residue limits (MRLs) in 2006.
Maltese: L-Aġenzija qed tistenna żjieda fl-għadd ta' applikazzjonijiet għal estensjoni jew modifika għalllimiti ta' residwi massimi (MRLs - Maximum Residue Limits) fl-2006.
English: MRL ext./mod.
Maltese: Parir xjentifiku lill-intrapriżi
English: Arbitration and Community referrals to EMEA (Human medicines)
Maltese: Arbitragg u riferenzi Komunitarji lillEMEA (Medicini ghall-bniedem)
English: EMEA structure
Maltese: Organigramma ta' l-EMEA
English: New regulatory procedures aimed at increasing access to medicines, including acceleratedassessment, conditional-marketing-authorisation and compassionate-use procedures, will also be applied.
Maltese: It-tħaddim ta' proċeduri regolatorji ġodda, inklużi proċeduri ta' valutazzjoni mgħaġġla, awtorizzazzjoni kondizzjonali għal tqegħid fis-suq u l-użu kompassjonali;
English: EU reports Non-EU reports
Maltese: rapporti minn barra l-UE rapporti mill-UE
English: Annex 5 EMEA contact points
Maltese: Punti ta' kuntatt fl-EMEA
English: Panos TSINTIS
Maltese: Bini/tagħmir
English: Establishment of maximum residue limits for veterinary medicines Post-authorisation activities
Maltese: L-ifissar ta' limiti massimi ta' residwi għal mediċini veterinarji Attivitajiet ta' wara l-awtorizzazzjoni
English: The Agency's inspection-related working parties will: harmonise inspection procedures and processes, in particular those relating to inspections of active substances and to pharmacovigilance; develop guidelines in light of the requirements of Community legislation on clinical trials and blood; and continue to work on GMP guidelines on products used as gene and cell therapies.
Maltese: Il-gruppi ta' ħidma ta' l-Aġenzija relatati ma' l-ispezzjonijiet ser: jarmonizzaw il-proċeduri u lproċessi ta' l-ispezzjonijiet, b'mod partikolari dawk relatati ma' spezzjonijiet ta' sustanzi attivi u mal-farmakoviġilanza; jiżviluppaw linji ta' gwida fid-dawl tar-rekwiżiti tal-leġiżlazzjoni talKomunità dwar provi kliniċi u d-demm; u jkomplu jaħdmu fuq linji ta' gwida tal-GMP dwar prodotti użati għal terapija ġenetika u dik ċellulari.
English: Taking into account the level of the orphanmedicinal-products fund (requested amount of EUR 5,900,000) and recommendations of the Committee for Orphan Medicinal Products (COMP), the Agency proposes fee reductions that will provide maximum possible incentives during the development and marketing-authorisation phases of orphan medicines.
Maltese: Meta wieħed iqis il-livell tal-fond għall-prodotti mediċinali ltiema (l-ammont mitlub huwa ta' EUR 5,900,000) u rrakkomandazzjonijiet tal-Kumitat għall-Prodotti Mediċinali Ltiema (COMP), l-Aġenzija tipproponi roħs fil-ħlasijiet li ser jipprovdi inċentivi kemm jista' jkun massimi matul il-fażijiet ta' żvilupp u ta' awtorizzazzjoni għal tqegħid fis-suq tal-mediċini ltiema.
English: The Agency's continuing cooperation at the European level will include work with the EU institutions on the handling of pandemic threats, a project on innovative human and veterinary medicines for Europe (technology platforms), and activities relating to the forthcoming regulations on medicinal products for paediatric use and on advanced therapies.
Maltese: Il-kooperazzjoni kontinwa ta' l-Aġenzija fuq livell Ewropew ser tinkludi ħidma ma' listituzzjonijiet ta' l-UE fir-rigward ta' l-indirizzar ta' theddid pandemiku, proġett dwar mediċini innovattivi għall-bnedmin u veterinarji għall-Ewropa (pjattaformi teknoloġiċi), u attivitajiet relatati mar-regolamenti li ser jiddaħħlu dwar prodotti mediċinali għal użu pedjatriku u dwar terapiji avvanzati.
English: Annex 4 Management Board and scientific committee meeting dates in 2006 Annex 5 EMEA contact points
Maltese: Anness 4 Dati ta' laqgħat tal-Bord ta' Tmexxija u l-kumitati xjentifiċi fl-2006 Anness 5
English: With regard to the area of personnel-management, the Agency will work to implement the staff regulations and a new competence-development policy, and will direct professional-training management towards a continuous system of competence development, taking account of the greater scientific orientation of the Agency.
Maltese: Fir-rigward tal-qasam tal-ġestjoni tal-personal, l-Aġenzija ser taħdem biex timplimenta rregolamenti tal-personal u politika ġdida għall-iżvilupp tal-kompetenza, u twassal il-ġestjoni tattaħriġ professjonali lejn sistema kontinwa ta' żvilupp tal-kompetenza, waqt li tiġi kkunsidrata lorjentazzjoni xjentifika akbar ta' l-Aġenzija.
English: Fully apply tools provided by the new legislation, including risk-management plans and specialised studies on safety profiles of medicinal products post authorisation; Work to establish a network for intensive monitoring of targeted medicines; Full integration of the pharmacovigilance network between EU regulatory bodies.
Maltese: L-applikazzjoni sħiħa ta' l-għodda provduti mill-leġiżlazzjoni l-ġdida, inklużi l-pjanijiet ta' ġestjoni tar-riskju u l-istudji speċjalizzati dwar profili ta' sigurtà ta' prodotti mediċinali wara lawtorizzazzjoni;
English: 18-21 September
Maltese: 18-21 ta' Settembru
English: The database of authorised medicinal products in the EU will make authoritative, up-to-date information on all these products available to regulators, health professionals and the general public; while the current version of the application is already available to EU regulators, public access will be provided by September 2006.
Maltese: Il-bażi tad-data ta' prodotti mediċinali awtorizzati fl-UE ser ipoġġi għad-dispożizzjoni tarregolaturi, tal-professjonisti tal-kura tas-saħħa u tal-pubbliku ġenerali informazzjoni awtorevoli u aġġornata dwar dawn il-prodotti kollha; fil-waqt li l-verżjoni preżenti hija diġà disponibbli għar-regolaturi ta' l-UE, ser jingħata aċċess pubbliku sa Settembru 2006.
English: For product defect and other quality-related matters E-mail: qualitydefects@emea.eu.int Fax: (44-20) 74 18 85 90
Maltese: Għal prodotti difettużi u kwistjonijiet oħra relatati E-mail: qualitydefects@emea.eu.int mal-kwalità
English: The second goal is to effectively manage arbitrations and referrals.
Maltese: It-tieni għan huwa li jitmexxew b'mod effettiv l-arbitraġġi u r-riferenzi.
English: The quality-assurance system will be strengthened by implementing recommendations resulting from the audit of the Committee for Medicinal Products for Veterinary Use (CVMP) conducted in October 2005.
Maltese: Is-sistema ta' assigurazzjoni tal-kwalità ser tiġi msaħħa permezz ta' l-implimentazzjoni ta' rakkomandazzjonijiet li jirriżultaw mill-verifika tal-Kumitat għal Prodotti Mediċinali għal Użu Veterinarju (CVMP) li saret f'Ottubru 2005.
English: Veterinary marketing authorisation procedures Safety of veterinary medicines
Maltese: Sigurtà ta' medicini veterinariji
English: A coordinated approach to continuous quality improvement across the European medicines network of more than 40 members is essential if we are to have strong quality-assurance systems in place.
Maltese: Strateġija kkoordinata għat-titjib kontinwu tal-kwalità fi ħdan in-netwerk Ewropew tal-mediċini li għandu aktar minn 40 membru hija essenzjali jekk irridu li jkollna fis-seħħ sistemi b'saħħithom ta' l-assigurazzjoni tal-kwalità.
English: Information technology
Maltese: Teknologija ta' l-informatika
English: Openness, communication and provision of information
Maltese: It-trasparenza, il-komunikazzjoni u l-għoti ta' informazzjoni
English: Innovation and continual improvement in the context of manufacturing and control methods will be facilitated through the work of the Process Analytical Technology (PAT) team.
Maltese: L-innovazzjoni u t-titjib kontinwu fil-kuntest tal-metodi ta' manifattura u kontroll ser jiġu ffaċilitati permezz tal-ħidma tat-tîm tat-Teknoloġija Analitika tal-Proċess (Process Analytical Technology - PAT).
English: Highlights in 2006 for initial evaluation of medicines for human use are expected in four main areas:
Maltese: Il-miri ewlenin fl-2006 għall-valutazzjoni inizzjali tal-mediċini għall-użu tal-bniedem jaqgħu taħt erba' oqsma prinċipali:
English: Information on nationally authorised products may be included for those Member States who have provided their product data and signed a memorandum of understanding on data exchange and maintenance.
Maltese: Informazzjoni dwar prodotti awtorizzati nazzjonalment tista' tiġi inkluża għal dawk l-Istati Membri li pprovdew id-data dwar prodotti tagħhom u li ffirmaw memorandum ta' ftehim dwar il-bdil u l-manutenzjoni tad-data.
English: In addition to the maintenance and operational support of corporate and EU telematics applications - and the development of new EU telematics projects - the Agency's efforts and resources in the IT area will be applied to the operation, support, maintenance and development of a number of corporate and business-continuity projects.
Maltese: Minbarra l-manutenzjoni u l-appoġġ għat-tħaddim ta' l-applikazzjonijiet telematiċi korporattivi u ta' l-UE - u l-iżvilupp ta' proġetti telematiċi ġodda ta' l-UE - l-isforzi u r-riżorsi ta' l-Aġenzija filqasam ta' l-IT ser jiġu applikati għat-tħaddim, l-apoġġ, il-manutenzjoni u l-iżvilupp ta' għadd ta' proġetti korporattivi u ta' kontinwità tan-negozju.
English: 25-26 October
Maltese: 25-26 ta' Ottubru
English: Further development of the EudraVigilance system (comprising an electronic database and dataprocessing network for adverse drug reactions) is paramount to the successful implementation of the strategy and will, therefore, remain at the top of the Agency's agenda in the field of safety of medicines.
Maltese: L-iżvilupp ulterjuri tas-sistema EudraVigilance (li tinkludi bażi tad-data elettroniku u netwerk ta' l-ipproċessar tad-data għar-reazzjonijiet mhux mixtieqa għall-mediċini) huwa essenzjali għallimplimentazzjoni ta' l-istrateġija b'suċċess.
English: Further development of the European risk-management strategy will target the implementation of the new legislation, complementary implementation initiatives (in the fields of risk detection, risk assessment, risk minimisation and risk communication, and in insufficiently developed fields of pharmacovigilance such as paediatrics and vaccines) and further strengthening of the EU pharmacovigilance system.
Maltese: L-iżvilupp ulterjuri ta' l-istrateġija Ewropea ta' ġestjoni tar-riskju ser jimmira lejn limplimentazzjoni tal-leġiżlazzjoni l-ġdida, inizzjattivi kumplimentari ta' implimentazzjoni (floqsma tas-sejba tar-riskju, valutazzjoni tar-riskju u komunikazzjoni tar-riskju, u f'oqsma li m'humiex żviluppati biżżejjed tal-farmakoviġilanza bħall-pedjatrija u t-tilqim) u t-tisħiħ ulterjuri tas-sistema ta' farmakoviġilanza ta' l-UE.
English: Legal sector
Maltese: Settur legali
English: Riprazo HCT contains lactose.
Maltese: Riprazo HCT fih lactose.
English: BLISTERS (PVC/PCTFE OR PA/ALU/PVC) BLISTER (CALENDAR) (PVC/PCTFE OR PA/ALU/PVC)
Maltese: FOLJI (PVC/PCTFE JEW PA/ALU/PVC) FOLJI (KALENDARJU)(PVC/PCTFE JEW PA/ALU/PVC)
English: Riprazo HCT contains wheat starch.
Maltese: Riprazo HCT fih wheat starch.
English: Packs containing 90 (3x30), 98 (2x49) or 280 (20x14) tablets are multi-packs.
Maltese: Pakketti li fihom 90 (3x30), 98 (2x49) jew 280 (20x14) pillola huma pakketti b'ħafna.
English: No clinically relevant interactions have been identified.
Maltese: L-ebda interazzjonijiet ta' rilevanza klinika ma ġew identifikati.
English: Acute renal failure, renal impairment General disorders and administration site conditions Uncommon: Investigations Common: Rare:
Maltese: Insuffiċjenza akuta tal-kliewi, indeboliment tal-kliewi Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata Mhux komuni: Investigazzjonijiet Komuni: Rari:
English: Pharmacotherapeutic group: Renin inhibitor (aliskiren) combinations with diuretics (hydrochlorothiazide), ATC code: C09XA52
Maltese: Inibitur tar-renin (aliskiren) f'taħlita ma' dijuretiċi (hydrochlorothiazide), Kodiċi ATC: C09XA52
English: 56 film-coated tablets (56x1; perforated unit dose blister)
Maltese: 56 pillola miksija b'rita (56x1; folja mtaqqba b'doża waħda)
English: Compounds that have been investigated in aliskiren clinical pharmacokinetic studies include acenocoumarol, atenolol, celecoxib, fenofibrate, pioglitazone, allopurinol, isosorbide-5-mononitrate, digoxin, metformin, amlodipine, atorvastatin, cimetidine and hydrochlorothiazide.
Maltese: Sustanzi kimiċi li kienu investigati b'aliskiren fi studji ta' farmakokinetika klinika kienu jinkludu acenocoumarol, atenolol, celecoxib, fenofibrate, pioglitazone, allopurinol, isosorbide-5-mononitrate, digoxin, metformin, amlodipine, atorvastatin, cimetidine u hydrochlorothiazide.
English: Severe renal impairment (GFR < 30 ml/min/1.73 m Refractory hypokalaemia, hyponatraemia, hypercalcaemia and symptomatic hyperuricaemia.
Maltese: Indeboliment renali sever (GFR < 30 ml/min/1.73 m Ipokalimja refrattorja, iponatrimija, iperkalċimja u iperuriċemija sintomatika.
English: Moderate P-gp inhibitors: Co-administration of ketoconazole (200 mg) or verapamil (240 mg) with aliskiren (300 mg) resulted in a 76% or 97% increase in aliskiren AUC, respectively.
Maltese: Inibituri moderati ta' P-gp: L-għoti ta' ketoconazole (200 mg) jew verapamil (240 mg) ma' aliskiren (300 mg) irriżulta f'żieda ta' 76% jew 97% fl-AUC ta' aliskiren, rispettivament.
English: Excipients: Each tablet contains 50 mg lactose monohydrate and 49 mg wheat starch.
Maltese: Kull pillola fiha 50 mg lactose monohydrate u 49 mg wheat starch.
English: Excipients: Each tablet contains 25 mg lactose monohydrate and 24.5 mg wheat starch.
Maltese: Kull pillola fiha 25 mg lactose monohydrate u 24.5 mg wheat starch.
English: Multi-packs containing 280 tablets.
Maltese: Pakketti b'ħafna li fihom 280 pillola.
English: Contains lactose and wheat starch.
Maltese: Fih lactose u wheat starch.
English: Aliskiren/hydrochlorothiazide Over 3,900 hypertensive patients received Riprazo HCT once daily in clinical trials.
Maltese: Aliskiren/hydrochlorothiazide 'L fuq minn 3,900 pazjent bil-pressjoni għolja irċievew Riprazo HCT darba kuljum fi provi kliniċi.
English: 98 film-coated tablets (2x49; perforated unit dose blister)
Maltese: 98 pillola miksija b'rita (2x49; folja mtaqqba b'doża waħda)
English: Riprazo HCT is contraindicated in patients with severe hepatic impairment (see sections 4.3 and 4.4).
Maltese: Riprazo HCT huwa kontra-indikat f'pazjenti b'indeboliment epatiku sever (ara sezzjonijiet 4.3 u 4.4).
English: Aliskiren was devoid of any mutagenic potential, embryo-foetal toxicity or teratogenicity.
Maltese: Aliskiren ma kellux potenzjal mutaġeniku, tossiċità fuq l-embrijufetu jew teratoġeniċità.
English: In controlled clinical trials, the incidence of diarrhoea in Riprazo HCT-treated patients was 1.3% compared to 1.4% for aliskirenor 1.9% for hydrochlorothiazide-treated patients.
Maltese: Fi provi kliniċi kontrollati, il-frekwenza ta' dijarea f'pazjenti kkurati b'Riprazo HCT kienet 1.3% meta mqabbla ma' 1.4% f'pazjenti kkurati b'aliskiren jew 1.9% f'pazjenti kkurati b'hydrochlorothiazide.