FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on the evaluation of the currently available data, the CVMP concluded that no benefit could be demonstrated when using colistin combination products instead of monotherapy and no feasible risk mitigation measures could be identified to address the identified potential risk for human health, as even limited use of colistin combination products was considered unnecessary.
Maltese: Skont l-evalwazzjoni tad-data disponibbli bħalissa, is-CVMP ikkonkluda li ma jista' jintwera l-ebda benefiċċju meta jintużaw prodotti ta' kombinazzjoni ta' colistin minflok il-monoterapija u l-ebda miżura ta' mitigazzjoni tar-riskju possibbli ma setgħet tiġi identifikata biex tindirizza r-riskju potenzjali identifikat għas-saħħa tal-bniedem, peress li anki l-użu limitat ta' prodotti ta' kombinazzjoni ta' colistin kien meqjus bħala mhux neċessarju.
English: Use of colistin products in animals within the European Union: development of resistance and possible impact on human and animal health (EMA/755938/2012) http://www.ema.europa.eu/docs/en_GB/document_library/Report/2013/07/WC500146813.pdf
Maltese: L-użu ta' prodotti li fihom colistin fl-annimali fi ħdan l-Unjoni Ewropea: żvilupp ta' reżistenza u impatt possibbli fuq is-saħħa tal-bniedem u tal-annimali (EMA/755938/2012) http://www.ema.europa.eu/docs/en_GB/document_library/Report/2013/07/WC500146813.pdf
English: The procedure was concluded and on 16 March 2015 the European Commission adopted a Decision
Maltese: Il-proċedura ġiet konkluża u fis-16 ta' Marzu 2015, il-Kummissjoni Ewropea adottat Deċiżjoni
English: Proprietary data, scientific references and expert reports were provided in this Article 35 referral procedure in support of some indications of some of the products included in the scope of the procedure.
Maltese: F'din il-proċedura ta' riferiment skont l-Artikolu 35 ġiet ipprovduta data proprjetarja kif ukoll referenzi xjentifiċi u rapporti ta' esperti b'appoġġ għal xi indikazzjonijiet ta' xi wħud mill-prodotti inklużi fil-kamp ta' applikazzjoni ta' din il-proċedura.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the overall benefit-risk balance for the aforementioned products is negative, due to a lack of clinical relevance and in view of over-exposure of colistin that could pose a potential risk to animal and human health from an acceleration of the occurrence of colistin resistance.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) tal-Aġenzija kkonkluda li l-bilanċ ġenerali bejn il-benefiċċju u r-riskju għall-prodotti msemmija hawn fuq huwa wieħed negattiv, minħabba n-nuqqas ta' rilevanza klinika u fid-dawl tal-espożizzjoni żejda ta' colistin li jista' jkollha riskju potenzjali għas-saħħa talannimal u tal-bniedem minn aċċelerazzjoni ta' okkorrenza tar-reżistenza ta' colistin.
English: On 4 May 2015, the European Commission initiated a referral procedure under Article 35 of Directive 2001/82/EC for all veterinary medicinal products containing colistin in combination with other antimicrobial substances to be administered orally.
Maltese: Fl-4 ta' Mejju 2015, il-Kummissjoni Ewropea tat bidu għal proċedura ta' riferiment skont l-Artikolu 35 tad-Direttiva 2001/82/KE, fir-rigward tal-prodotti mediċinali veterinarji li fihom colistin flimkien ma' sustanzi antimikrobiċi oħrajn biex jingħataw b'mod orali.
English: The CVMP recommended that all marketing authorisations for veterinary medicinal products containing colistin in combination with other antimicrobial substances to be administered orally should be withdrawn throughout the European Union (EU).
Maltese: Is-CVMP irrakkomanda li l-awtorizzazzjonijiet kollha għat-tqegħid fis-suq għall-prodotti mediċinali veterinarji li fihom colistin flimkien ma' sustanzi antimikrobiċi oħra li għandhom jiġu amministrati b'mod orali għandhom jiġu rtirati fl-Unjoni Ewropea (UE).
English: Questions and answers on veterinary medicinal products containing colistin in combination with other antimicrobial substances to be administered orally
Maltese: Il-mistoqsijiet u t-tweġibiet dwar il-prodotti mediċinali veterinarji li fihom colistin flimkien ma' sustanzi antimikrobiċi oħra li għandhom jiġu amministrati b'mod orali
English: In addition, the marketing authorisation holders were asked to justify the benefits of using a colistin combination product over the use of monotherapy for the treatment of the respective conditions, particularly taking into account the CVMP guideline on pharmaceutical fixed combination products
Maltese: Barra minn hekk, id-detenturi tal-awtorizzazzjoni għat-tqegħid fissuq intalbu jiġġustifikaw il-benefiċċji tal-użu ta' prodott ta' kombinazzjoni colistin fuq l-użu ta' monoterapija għall-kura tal-kundizzjonijiet rispettivi, b'mod partikolari fid-dawl tal-linja gwida tasCVMP dwar prodotti farmaċewtiċi ta' kombinazzjoni fissa
English: The CVMP was requested to review the marketing authorisations and the available data in order to ensure responsible use of the substance in protecting animal health and limiting the possibility of future risk to public health.
Maltese: Is-CVMP intalab jirrevedi l-awtorizzazzjonijiet għat-tqegħid fis-suq u d-data disponibbli sabiex jiġi żgurat l-użu responsabbli tas-sustanza f'dak li għandu x'jaqsam mal-protezzjoni tas-saħħa tal-annimali u biex tiġi limitata l-possibbiltà ta' riskju futur għas-saħħa pubblika.
English: Request for scientific advice on the impact on public health and animal health of the use of antibiotics in animals, answer to the first request from the European Commission (EMA/363834/2013) http://www.ema.europa.eu/docs/en_GB/document_library/Other/2013/07/WC500146812.pdf
Maltese: Talba għal parir speċifiku dwar l-impatt fuq is-saħħa pubblika u s-saħħa tal-annimali tal-użu tal-antibijotiċi fl-annimali, tweġiba għall-ewwel talba mill-Kummissjoni Ewropea (EMA/363834/2013) http://www.ema.europa.eu/docs/en_GB/document_library/Other/2013/07/WC500146812.pdf
English: EU/2/09/105/001 EU/2/09/105/002
Maltese: EU/2/09/105/001
English: Date of last renewal: 07/11/2014
Maltese: Data tal-aħħar tiġdid.: 07/11/2014
English: - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports)
Maltese: kura waħda) - komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal) - mhux komuni (aktar minn wieħed iżda inqas minn10 annimali f'1,000 annimal) - rari (aktar minn wieħed iżda inqas minn10 annimali f'10,000 annimal) - rari ħafna (inqas minn annimal wieħed f'10,000 annimal, inklużi rapporti iżolati).
English: 100 ml (50 doses)
Maltese: 100 ml (50 doża)
English: ATC vet code: QI02AA08
Maltese: QI02AA08
English: ROUTE(S) OF ADMINISTRATION IM
Maltese: MOD(I) TA' AMMINISTRAZZJONI
English: Store and transport refrigerated (2 °C - 8 °C).
Maltese: Aħżen u ttrasporta fil- friġġ (2 °C - 8 °C).
English: 20 ml (10 doses) 100 ml (50 doses)
Maltese: 20ml (10 dożi) 100 ml (50 doża)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Carton box 1 x 20ml / Carton box 1 x 100 ml
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA Kaxxa tal-kartun 1 x 20 ml / Kaxxa tal-kartun 1 x 100 ml
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) One dose of 2 ml: Inactivated bluetongue virus, serotype 8, strain BTV-8/BEL2006/02
Maltese: TAS-SUSTANZA(I) ATTIVA(I) Doża waħda ta' 2 ml: Virus bluetongue inattivat, serotip 8, strejn BTV-8/BEL2006/02
English: NAME OF THE VETERINARY MEDICINAL PRODUCT ZULVAC 8 Bovis suspension for injection for cattle
Maltese: VETERINARJU ZULVAC 8 Bovis suspensjoni għall-injezzjoni għall-baqar
English: Inactivated bluetongue virus, serotype 8, strain BTV-8/BEL2006/02 RP* ≥ 1 *Relative Potency by a mice potency test compared to a reference vaccine that was shown efficacious in cattle.
Maltese: BTV-8/BEL2006/02 RP* ≥ 1 * Qawwa Relattiva skont test ta' qawwa fil-ġrieden imqabbel ma' tilqima ta' referenza li ntweriet li hija effikaċi fil-baqar.
English: Name and address of the manufacturer of the biological active substance(s): Zoetis Manufacturing & Research Spain, S.L.
Maltese: Isem u indirizz tal-manufattur(i) tas-sustanza(i) bioloġika(ċi) attiva(i) Zoetis Manufacturing & Research Spain, S.L.
English: Local reactions of more than 2 cm are common after 2 fold overdose while reactions of up to 5 cm may occasionally occur after overdose administration, these resolve within a maximum of 57 days.
Maltese: Reazzjonijiet lokali ta' aktar minn 2 cm huma komuni wara doża eċċessiva 'il fuq minn darbtejn dik rakkomandata filwaqt li reazzjonijiet sa 5 cm jistgħu iseħħu wara amministrazzjoni ta' doża eċċessiva, dawn jitilqu wara massimu ta' 57 jum.
English: To stimulate active immunity against bluetongue virus, serotype 8 in cattle.
Maltese: Biex jistimula immunità attiva kontra l-virus bluetongue, serotip 8, fil-baqar.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali veterinarju tinsab fuq il-websajt tal-Aġenzija Ewropea dwar il-Mediċini (http://www.ema.europa.eu/.
English: The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Maltese: L-addittivi (inkluż l-aġġuvanti) elenkati f'sezzjoni 6.1 tas-Sommarju tal-karatteristiċi tal-prodott huma jew sustanzi ammissibbli li għalihom m'hemmx bżonn ta' limiti massimi ta' residwi kif indikat fittabella numru 1 tal-anness tar-Regolament tal-Kummissjoni (UE) Nru 37/2010 jew huma kkunsidrati li ma jaqgħux fi ħdan l-iskop tar-Regolament (KE) Nru 470/2009 meta wżati bħal f'dan il-prodott mediċinali veterinarju
English: This clinical sign has been reported very rarely from the field.
Maltese: Dan is-sinjal kliniku rari ħafna ġie rrappurtat .
English: On day 2 after vaccination, rectal temperatures had returned to normal values.
Maltese: Fit-2 ġurnata wara t-tilqima, it-temperaturi tar-rektum kienu lura għall-valuri normali.
English: Intramuscular use:
Maltese: Grupp farmako-terapewtiku:
English: Any revaccination scheme should be agreed by the Competent Authority or by the responsible veterinarian, taking into account the local epidemiological situation.
Maltese: Kull skema tilqim mill-ġdid għandhom jiġu miftehma mill-Awtorità Kompetenti jew mill-veterinarju responsabbli, filwaqt li titqies is-sitwazzjoni epidemjoloġika lokali.
English: PACKAGE LEAFLET FOR: ZULVAC 8 Bovis suspension for injection for cattle
Maltese: ZULVAC 8 Bovis suspensjoni għall-injezzjoni għall-baqar
English: Type I glass bottle (10 doses) or type II glass bottle (50 doses) with butyl elastomer closure
Maltese: In-natura u l-għamla tal-ippakkjar li jmiss mall-prodott Flixkun tal-ħġieġ tat-tip I (10 dożi) jew flixkun tal-ħġieġ tat-tip II (50 doża) b'għeluq ta' butyl elastomere
English: In this category of animals the vaccine should be used only according to the benefit/risk assessment by the responsible veterinarian and/or national Competent Authorities on the current vaccination policies against BTV.
Maltese: Kull skema ta' tilqim mill-ġdid għandha tiġi miftehma mill-Awtorità Kompetenti jew mill-veterinarju responsabbli, filwaqt li titqies is-sitwazzjoni epidemjoloġika lokali.
English: After the second injection of a single dose, a slight and transient but significant increase in the mean rectal temperature of 0.4ºC was very commonly recorded in the vaccinated calves during the first 24 hours.
Maltese: Wara t-tieni injezzjoni ta' doża waħda, waqt l-ewwel 24 siegħa kienet komuni ħafna żjieda ħafifa u temporanja iżda sinjifikanti ta' 0.4ºC fit-temperatura medja tar-rektum fl-għoġiela mlaqqma.
English: METHOD AND ROUTE(S) OF ADMINISTRATION For intramuscular use.
Maltese: METODU U MOD(I) TA' AMMINISTRAZZJONI Użu għal ġol-muskoli
English: In one laboratory safety study, no adverse reactions were observed after the first injection of a single dose of vaccine to calves.
Maltese: Fi studju wieħed tas-sigurtà fil-laboratorju, ma kienux osservati reazzjonijiet mhux mixtieqa wara lewwel injezzjoni ta' doża waħda tal-vaċċin lill-għoġiela.
English: ADVICE ON CORRECT ADMINISTRATION In order to avoid accidental contamination of the vaccine during use, it is recommended to use a multiinjection type vaccination system when larger dose presentations are used.
Maltese: Sabiex tiġi evitata kontaminazzjoni aċċidentali tal-vaċċin waqt l-użu, huwa rrakkomandat li tintuża sistema ta' tilqim tat-tip ta' aktar minn injezzjoni waħda meta jintużaw preżentazzjonijiet ta' dożi kbar.
English: Any person intending to manufacture, import, possess, sell, supply and use ZULVAC 8 BOVIS must consult the relevant Member State's competent authority on the current vaccination policies prior to the manufacture, import, possession, sale, supply and/or use.
Maltese: Kull persuna li għandha l-ħsieb li timmanifattura, timporta, tieħu pussess, tbiegħ, tipprovdi u/jew tuża ZULVAC 8 BOVIS għandha tikkonsulta mal-Awtorità Kompetenti talIstat Membru dwar il-programmi ta' tilqim fis-seħħ qabel ma timmanifattura, timporta, tieħu pussess, tbiegħ, tipprovdi u/jew tuża.
English: The manufacture, import, possession, sale, supply and/or use of ZULVAC 8 BOVIS may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.
Maltese: L-importazzjoni, il-pussess, il-bejgħ, il-provvista u/jew l-użu tal-prodott mediċinali veterinarju jista' jiġi pprojibit f'ċerti Stati Membri fit-territorju Kollu tagħhom jew f'parti minnu.
English: *(Cycling value (Ct) ≥ 36 by a validated RT- PCR method, indicating no presence of viral genome).
Maltese: Tilqim attiv ta' baqar minn 3 xhur 'il fuq għall-prevenzjoni* ta' viremija kkawżata mill-virus bluetongue, serotip 8. *(Valur cycling (Ct) ≥ 36 minn metodu RT_PCR validat, jindika li m'hemmx preżenza tal-ġenom virali)
English: EU Number
Maltese: Numru tal-EU Isem Ivvintat
English: • Symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in elderly (excluding Alzheimer's disease and other dementia)
Maltese: [Indikazzjonijiet taħt approvati bħalissa għandhom jitneħħew (formulazzjoni tal-indikazzjoni tista 'tvarja minn prodott wieħed għall-ieħor)] Trattament għas-sintomi ta' indeboliment konjittiv kroniku u mard neurosensorjali fl-anzjani (minbarra marda ta 'Alzheimer u dimenzji oħrajn) Trattament addizzjonali ta 'sindromu ta' Raynaud Referenzi kollha għall-informazzjoni t'hawn fuq għandha titneħħa fit-taqsimiet rilevanti tal-bqija tassommarji tal-karatteristiċi tal-prodott.
English: B. Package Leaflet
Maltese: B.
English: All references to the above mentioned indications should be deleted from the remaining relevant sections of the summaries of product characteristics.
Maltese: Referenzi kollha għall-informazzjoni t'hawn fuq għandha titneħħa fit-taqsimiet rilevanti tar-rekords.
English: Annex III Amendments to relevant sections of the summaries of product characteristics and package leaflets
Maltese: Anness III Bidliet Sommarju tal-Karatteristiċi tal-Prodott u Fuljett ta 'Tagħrif
English: The full EPAR for Kadcyla can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Kadcyla
Maltese: Informazzjoni oħra dwar Kadcyla
English: This is a summary of the European public assessment report (EPAR) for Kadcyla.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Kadcyla.
English: The most common serious side effects are haemorrhage (bleeding), pyrexia (fever), dyspnoea (difficulty breathing), musculoskeletal pain (pain in muscles and bones), thrombocytopenia (low blood platelet counts), abdominal pain (stomach ache), and vomiting.
Maltese: L-effetti sekondarji l-aktar komuni huma emorraġiji (fsada), piressija (deni), dispnea (diffikultà fin-nifs), uġigħ muskoluskeletali (uġigħ fil-muskoli u flgħadam), tromboċitopenija (għadd baxx ta' pjastrini fid-demm), uġigħ addominali (uġigħ fl-istonku), u remettar.
English: Why is Kadcyla approved?
Maltese: Għaliex ġie approvat Kadcyla?
English: Kadcyla is a cancer medicine that contains the active substance trastuzumab emtansine.
Maltese: Kadcyla huwa mediċina kontra l-kanċer li fiha s-sustanza attiva trastuzumab emtansine.
English: Patients who tolerate the first 90-minute infusion can receive subsequent infusions over 30 minutes.
Maltese: Il-pazjenti li jittolleraw l-ewwel infużjoni ta' 90 minuta jistgħu jirċievu l-infużjonijiet sussegwenti fuq perjodu ta' 30 minuta.
English: The active substance in Kadcyla, trastuzumab emtansine, is made up of two active components which are linked together:
Maltese: Is-sustanza attiva f'Kadcyla, trastuzumab emtansine, hija magħmula minn żewġ komponenti attivi li huma marbutin flimkien:
English: What are the risks associated with Kadcyla?
Maltese: X'inhuma r-riskji assoċjati ma' Kadcyla?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Kadcyla on 15.11.2013.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Kadcyla fil-15.11.2013
English: In one main study, which involved 991 such patients, those treated with Kadcyla lived on average for 9.6 months without their disease getting worse compared with 6.4 months for patients who were treated with two other anti-cancer medicines, capecitabine and lapatanib.
Maltese: Fi studju ewlieni, li fih ħadu sehem 991 pazjent minn dawn, dawk li ngħataw Kadcyla għexu bħala medja għal 9.6 xhur mingħajr ma l-marda tagħhom marret għall-agħar meta mqabbel ma' 6.4 xhur fil-każ tal-pazjenti kkurati b'żewġ mediċini oħra kontra l-kanċer, capecitabine u lapatinib.
English: Kadcyla is available as a powder that is made up into a solution for infusion (drip) into a vein.
Maltese: Kadcyla huwa disponibbli bħala trab li jsir soluzzjoni għall-infużjoni (dripp) fil-vina.
English: • DM1, a toxic substance that kills cells when they attempt to divide and grow.
Maltese: • DM1, sustanza tossika li toqtol iċ-ċelloli meta dawn jippruvaw jinqasmu u jikbru.
English: About a quarter of breast cancers overexpress HER2.
Maltese: Madwar kwart tal-kanċers tas-sider jipproduċu wisq HER2.
English: • Trastuzumab, a monoclonal antibody (a type of protein) that has been designed to recognise and attach to the protein HER2, which is found in large quantities on the surface of some cancer cells.
Maltese: • Trastuzumab, antikorp monoklonali (tip ta' proteina) li ġiet iddisinjata biex tagħraf u teħel malproteina HER2, li tinstab fi kwantitajiet kbar fuq il-wiċċ ta' xi ċelloli tal-kanċer.
English: The most common side effects with Kadcyla (which may affect more than 25% of patients) are nausea (feeling sick), fatigue (tiredness) and headache.
Maltese: L-effetti sekondarji l-aktar komuni bi Kadcyla (li jistgħu jaffettwaw aktar minn 25% tal-persuni) huma dardir (tħossok imqalla), rimettar u wġigħ ta' ras.
English: DM1 becomes active once Kadcyla enters the cancer cell.
Maltese: DM1 issir attiva ladarba Kadcyla jidħol fiċ-ċellola tal-kanċer.
English: The CHMP considered that in patients treated with Kadcyla, there was a significant improvement in survival compared with standard therapy.
Maltese: Is-CHMP ħass li fil-pazjenti kkurati b'Kadcyla, kien hemm titjib sinifikanti fis-sopravivenza meta mqabbel mat-terapija standard.
English: Kadcyla has been shown to significantly delay disease getting worse and to prolong survival in patients with advanced and metastatic breast cancer that expressed HER2 and who were previously treated with trastuzumab and a taxane.
Maltese: Kadcyla ntwera li jittardja b'mod sinifikanti l-marda milli tmur imur għall-agħar u li jtawwal issopravivenza f'pazjenti li jkollhom kanċer tas-sider avvanzat u metastatiku li esprima HER2 u li jkunu ngħataw kura qabel bi trastuzumab u taxane.
English: Because of a potential risk of confusion between Kadcyla and Herceptin due to their similar sounding active substances (trastuzumab emtansine and trastuzumab) the company will provide educational material to all healthcare professionals expected to use Kadcyla or Herceptin to alert them not to use these medicines interchangeably and to inform them of measures they should take to avoid medication errors.
Maltese: Kadcyla jista' jinkiseb biss b'riċetta ta' tabib u l-kura għandha tiġi preskritta minn tabib u tingħata taħt is-superviżjoni ta' professjonist tal-kura tas-saħħa li jkollu esperjenza fil-kura ta' pazjenti morda bilkanċer.
English: Kadcyla can only be used when the cancer has been shown to ‘overexpress HER2': this means that the cancer cell produces on its surface large quantities of a protein which stimulates the growth of the cancer cell and is called HER2 (human epidermal growth factor).
Maltese: Kadcyla jista' jintuża biss meta l-kanċer wera li kien ‘overexpress HER2': dan ifisser li fuq il-wiċċ tagħha ċ-ċellola tal-kanċer tipproduċi kwantitajiet kbar ta' proteina li tistimula t-tkabbir taċ-ċellola talkanċer u tissejjaħ HER2 (fattur tat-tkabbir epidermali uman).
English: A risk management plan has been developed to ensure that Kadcyla is used as safely as possible.
Maltese: Pjan ta' ġestjoni tar-riskju ġie żviluppat biex jiżgura li Kadcyla jintuża bl-aktar mod sigur possibbli.
English: Patients treated with Kadcyla also survived for 31 months compared with 25 months for patients treated with capecitabine and lapatinib.
Maltese: Il-pazjenti kkurati b'Kadcyla baqgħu ħajjin ukoll għal 31 xahar meta mqabbel ma' 25 xahar fil-każ tal-pazjenti kkurati b'capecitabine u lapatinib.
English: How is Kadcyla used?
Maltese: Kif jintuża Kadcyla?
English: Further information on Viekirax can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Viekirax is available as tablets containing 12.5 mg ombitasvir, 75 mg paritaprevir and 50 mg ritonavir.
Maltese: Viekirax jiġi bħala pilloli li fihom 12.5 mg ta' ombitasvir, 75 mg ta' paritaprevir u 50 mg ta' ritonavir.
English: It contains 3 active substances: ombitasvir, paritaprevir and ritonavir.
Maltese: Fiha 3 sustanzi attivi: ombitasvir, paritaprevir u ritonavir.
English: Viekirax received a marketing authorisation valid throughout the EU on 15 January 2015.
Maltese: Viekirax ingħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-EU kollha fil-15 ta' Jannar 2015.
English: Other information about Viekirax
Maltese: Informazzjoni oħra dwar Viekirax
English: What are the risks associated with Viekirax?
Maltese: X'inhuma r-riskji assoċjati ma' Viekirax?
English: The third active substance, ritonavir, does not act directly against hepatitis C virus but it blocks the action of an enzyme called CYP3A that breaks down paritaprevir.
Maltese: It-tielet sustanza attiva, ritonavir, ma taġixxix direttament kontra l-virus tal-epatite Ċ iżda timblokka lazzjoni ta' enzima msejħa CYP3A li tkisser paritaprevir.
English: The 3 active substances in Viekirax work in different ways: ombitasvir blocks the action of a protein in the hepatitis C virus called ‘NS5A' and paritaprevir blocks the action of another protein called ‘NS3/4A', both of which the virus needs to multiply.
Maltese: It-tliet sustanzi attivi f'Viekirax jaħdmu b'modi differenti: ombitasvir timblokka l-azzjoni ta' proteina filvirus tal-epatite Ċ imsejħa ‘NS5A' u l-paritaprevir timblokka l-azzjoni ta' proteina oħra msejħa ‘NS3/4A', li t-tnejn li huma għandu bżonnhom il-virus biex jimmultiplika.
English: Between 96% and 100% of patients without liver scarring had their blood cleared of the virus after 12 weeks of treatment (with or without ribivarin).
Maltese: Bejn 96% u 100% tal-pazjenti mingħajr ċikatriċi tal-fwied tneħħielhom il-virus mid-demm wara 12-il ġimgħa ta' kura (bi u mingħajr ribivarin).