FrancophonIA/ELRC3.0 huggingface dataset:
English: 2007, Sidney et al., 2013).
Maltese: Intwera li r-riskju ta' VTE huwa l-ogħla fl-ewwel sena li mara tibda kontraċettivi ormonali jew meta terġa' tibda wara perjodu ta' mill-inqas xahar li ma tkunx użathom (Dinger et al,. 2007, Sidney et al., 2013).
English: The CHMP, having considered the PRAC recommendation dated 10 October 2013 pursuant to Article 107k(3) of Directive 2001/83/EC, is of the opinion that the marketing authorisations for Evra, Ioa and Zoely should be varied.
Maltese: Is-CHMP, wara li kkunsidra r-rakkomandazzjoni tal-PRAC datata l-10 ta' Ottubru 2013 skont lArtikolu 107k(3) tad-Direttiva 2001/83/KE, huwa tal-opinjoni li l-awtorizzazzjonijiet għat-tqegħid fissuq għal Evra, Ioa u Zoely għandhom jiġu varjati.
English: The revised Summary of Product Characteristics (SmPC) and Package Leaflet (PL) are set out in the respective annexes I and IIIB for Evra, Ioa and Zoely.
Maltese: Is-Sommarju tal-Karatteristiċi tal-Prodott (SmPC) u l-Fuljett ta' Tagħrif (PL) riveduti huma stabbiliti fl-annessi I u IIIB rispettivi għal Evra, Ioa u Zoely.
English: The CHMP considered the below PRAC recommendation dated 10 October 2013 with regards to combined hormonal contraceptives containing chlormadinone, desogestrel, dienogest, drospirenone, etonogestrel, gestodene, norelgestromin, norgestimate or nomegestrol.
Maltese: Is-CHMP ikkunsidra r-rakkomandazzjoni tal-PRAC ta' hawn taħt datata l-10 ta' Ottubru 2013 firrigward ta' kontraċettivi ormonali kkombinati li fihom chlormadinone, desogestrel, dienogest, drospirenone, etonogestrel, gestodene, norelgestromin, norgestimate jew nomegestrol.
English: Known risk factors for VTE include history of VTE, pregnancy, trauma, surgery, immobilisation (e.g. after surgery or long flights), obesity and smoking (i.e. all situations of a pro-thrombotic state).
Maltese: Fatturi magħrufa ta' riskju għal VTE jinkludu storja ta' VTE, tqala, trawma, kirurġija, immobilizzazzjoni (eż. wara kirurġija jew titjiriet fit-tul), obeżità u tipjip (jiġifieri s-sitwazzjonijiet kollha ta' stat pro-trombotiku).
English: Many studies have evaluated the risk of VTE and its complications (deep vein thrombosis, pulmonary embolism) among users of different CHCs.
Maltese: Bosta studji vvalutaw ir-riskju ta' VTE u l-komplikazzjonijiet tiegħu (trombożi tal-vini fil-fond, emboliżmu pulmonari) fost l-utenti ta' CHCs differenti.
English: “The increased risk of VTE during the postpartum period should be considered when re-starting [invented name] (see section 4.2 and 4.4).”
Maltese: “Iż-żieda fir-riskju ta' VTE matul il-perjodu ta' wara t-twelid għandha tiġi kkunsidrata meta jerġa' jinbeda [isem ivvintat] (ara sezzjoni 4.2 u 4.4).”
English: In February 2013, the French medicines agency (ANSM) initiated a referral procedure under Article 31 of Directive 2001/83/EC on the basis that the benefit-risk balance of these combined hormonal contraceptives had become unfavourable in the currently authorised indication of contraception due to the increased risk of thromboembolism (TE) and therefore it was in the interest of the Union to refer the matter to the PRAC.
Maltese: Fi Frar 2013, l-aġenzija tal-mediċini Franċiża (ANSM) tat bidu għal proċedura ta' riferiment skont lArtikolu 31 tad-Direttiva 2001/83/KE abbażi tal-fatt li l-bilanċ tal-benefiċċju-riskju ta' dawn ilkontraċettivi ormonali kkombinati kien sar sfavorevoli fl-indikazzjoni attwalment awtorizzata ta' kontraċezzjoni minħabba ż-żieda fir-riskju ta' tromboemboliżmu (TE) u għalhekk kien fl-interess talUnjoni li tirreferi l-kwistjoni lill-PRAC.
English: It is known that the risk of arterial thromboembolism (ATE) (myocardial infarction, cerebrovascular accident) is also increased with use of CHCs, however there was no evidence for differences between CHCs in their relative risk of ATE.
Maltese: Huwa magħruf li r-riskju ta' tromboemboliżmu arterjali (ATE) (infart mijokardijaku, inċident ċerebrovaskulari) jiżdied ukoll bl-użu ta' CHCs, iżda ma kien hemm l-ebda evidenza ta' differenzi bejn is-CHCs fir-riskju relattiv tagħhom ta' ATE.
English: Medicinal products containing chlormadinone, desogestrel, dienogest, drospirenone, etonogestrel, gestodene, norelgestromin, norgestimate or nomegestrol are authorised in the European Union as combined hormonal contraceptives (CHCs).
Maltese: Prodotti mediċinali li fihom chlormadinone, desogestrel, dienogest, drospirenone, etonogestrel, gestodene, norelgestromin, norgestimate jew nomegestrol huma awtorizzati fl-Unjoni Ewropea bħala kontraċettivi ormonali kkombinati (CHCs).
English: • The estimated incidence of risk is higher with the progestogens etonogestrel and norelgestromin, with between 6 and 12 cases yearly per 10,000 women.
Maltese: • L-inċidenza stmata tar-riskju hija ogħla bil-proġestoġeni etonogestrel u norelgestromin, b'bejn 6 u 12-il każ fis-sena għal kull 10,000 mara.
English: Based on the totality of the available data the PRAC concluded that the risk of VTE differs between products - with the lower risk products being those containing the progestogens levonorgestrel, norethisterone and norgestimate.
Maltese: Abbażi tat-totalità tad-dejta disponibbli, il-PRAC ikkonkluda li r-riskju ta' VTE jvarja bejn il-prodotti - bil-prodotti b'riskju aktar baxx ikunu dawk li fihom ilproġestoġeni levonorgestrel, norethisterone u norgestimate.
English: The current review confirmed the previous understanding that the level of VTE risk with CHCs containing low dose of ethinylestradiol (ethinylestradiol <50µg) is small, but differences in the VTE risk were observed between most products depending on the type of progestogen they contain.
Maltese: Ir-reviżjoni attwali kkonfermat il-fehim preċedenti li l-livell tar-riskju ta' VTE b'CHCs li fihom doża baxxa ta' ethinylestradiol (ethinylestradiol <50µg) huwa baxx, iżda kienu osservati differenzi fir-riskju ta' VTE bejn ħafna millprodotti skont it-tip ta' proġestoġen li fihom.
English: • The estimated incidence of risk is also higher with the progestogens gestodene, desogestrel, drospirenone, with between 9 and 12 cases yearly per 10,000 women.
Maltese: • L-inċidenza stmata tar-riskju hija wkoll ogħla bil-proġestoġeni gestodene, desogestrel, drospirenone, b'bejn 9 u 12-il każ fil-sena għal kull 10,000 mara.
English: The PRAC confirmed the known risk of thromboembolism of combined hormonal contraceptive containing medicinal products, and recommended clear labelling of symptoms of thromboembolic events, as well as the risk factors for thromboembolic events.
Maltese: Il-PRAC ikkonferma r-riskju magħruf ta' tromboemboliżmu ta' prodotti mediċinali li fihom kontraċettivi ormonali kkombinati, u rrakkomanda tikkettar ċar tas-sintomi ta' avvenimenti tromboemboliċi, kif ukoll il-fatturi ta' riskju għal avvenimenti tromboemboliċi.
English: Furthermore, proactive information to communicate the outcome of the present review and to highlight the risk of the thromboembolic events through a direct healthcare professional communication (DHPC) was recommended.
Maltese: Barra minn hekk, kien irrakkomandat li jkun hemm informazzjoni proattiva li tikkomunika r-riżultat tar-reviżjoni attwali u li tenfasizza r-riskju talavvenimenti tromboemboliċi permezz ta' komunikazzjoni diretta lill-professjonisti tal-kura tas-saħħa (DHPC).
English: 1 - Overall summary of the scientific evaluation
Maltese: 1 - Sommarju ġenerali tal-valutazzjoni xjentifika
English: When diagnosis is not made and no treatment is started, or when clear symptoms of thrombosis are not identifiable, the clot can move upwards to the lung (pulmonary embolism, PE) or the brain (cerebral embolism, CE).
Maltese: Meta ma ssirx dijanjosi u ma tinbeda l-ebda kura, jew meta s-sintomi ċari tattrombożi ma jkunux identifikabbli, l-embolu jista' jimxi 'l fuq lejn il-pulmun (emboliżmu pulmonari, PE) jew lejn il-moħħ (emboliżmu ċerebrali, CE).
English: Harald Enzmann (DE)
Maltese: Anness IV
English: However, the CHMP considered that the section on Fertility, pregnancy and lactation of the SmPC should be amended to reflect the increased risk of VTE in the post-partum period, to ensure consistency with the warning section of the SmPC.
Maltese: Madankollu, is-CHMP ikkunsidra li s-sezzjoni dwar il-Fertilità, tqala u treddigħ tal-SmPC għandha tiġi emendata biex tirrifletti r-riskju akbar ta' VTE fil-perjodu ta' wara ttwelid, biex tiġi żgurata konsistenza mas-sezzjoni tat-twissija tal-SmPC.
English: • The PRAC reviewed all available data from clinical studies, pharmacoepidemiological studies, published literature, post-marketing experience, including responses submitted by the marketing authorisation holders (MAHs) in writing and at oral explanations, on the efficacy and safety of the combined hormonal contraceptive containing medicinal products, in particular with regards to the risk of thromboembolism.
Maltese: • Il-PRAC irreveda d-dejta kollha disponibbli minn studji kliniċi, studji farmakoepidemjoloġiċi, letteratura ppubblikata, esperjenza wara t-tqegħid fis-suq, inkluż it-tweġibiet ippreżentati middetenturi tal-awtorizzazzjoni għat-tqegħid fis-suq (MAHs) bil-miktub u waqt spjegazzjonijiet orali, dwar l-effikaċja u s-sigurtà tal-prodotti mediċinali li fihom kontraċettivi ormonali kkombinati, b'mod partikolari fir-rigward tar-riskju ta' tromboemboliżmu.
English: The risk of VTE is also higher in the presence of intrinsic risk factors.
Maltese: Ir-riskju ta' VTE huwa wkoll ogħla fil-preżenza ta' fatturi intrinsiċi ta' riskju.
English: For chlormadinone this will be investigated through a post-authorisation safety study, which is further discussed below.
Maltese: Għal chlormadinone dan se jiġi investigat permezz ta' studju tassigurtà wara l-awtorizzazzjoni, li ġie diskuss aktar 'l isfel.
English: In addition the PRAC imposed a post-authorisation safety study in order to better characterise the relative risk of thromboembolic events due to chlormadinone compared to the levonorgestrelcontaining medicinal products.
Maltese: Barra minn hekk il-PRAC impona studju dwar is-sigurtà wara l-awtorizzazzjoni sabiex jiġi kkaratterizzat aħjar ir-riskju relattiv ta' avvenimenti tromboembolitiċi minħabba chlormadinone meta mqabbla malprodotti mediċinali li fihom levonorgestrel.
English: The PRAC was requested to give a recommendation on whether the indication of medicinal products containing chlormadinone, desogestrel, dienogest, drospirenone, etonogestrel, gestodene, norelgestromin, norgestimate or nomegestrol combined with an oestrogen (ethinylestradiol or estradiol) should be restricted and/or any other regulatory measure(s) taken.
Maltese: Il-PRAC intalab jagħti rakkomandazzjoni dwar jekk l-indikazzjoni ta' prodotti mediċinali li fihom chlormadinone, desogestrel, dienogest, drospirenone, etonogestrel, gestodene, norelgestromin, norgestimate jew nomegestrol ikkombinati ma' estroġenu (ethinylestradiol jew estradiol) għandhiex tiġi ristretta u/jew għandhiex tittieħed xi miżura/miżuri regolatorji oħra.
English: The PRAC, as a consequence, concluded that the benefit-risk balance of the medicinal products Evra, Ioa and Zoely in the indication of contraception remains favourable, subject to the agreed conditions, restrictions, warnings, other changes to the product information and additional risk minimisation measures.
Maltese: Il-PRAC, bħala konsegwenza, ikkonkluda li l-bilanċ tal-benefiċċju-riskju tal-prodotti mediċinali Evra, Ioa u Zoely fl-indikazzjoni ta' kontraċezzjoni jibqa' favorevoli, soġġett għall-kundizzjonijiet, restrizzjonijiet, twissijiet, tibdil ieħor lill-informazzjoni dwar il-prodott u miżuri addizzjonali għall-minimizzazzjoni tarriskju miftiehma.
English: Misdiagnosis is possible, since TE presents with diffuse symptoms and is a rare event in a population of healthy young women.
Maltese: Dijanjosi ħażina hija possibbli, peress li TE jippreżenta b'diversi sintomi u huwa avveniment rari f'popolazzjoni ta' nisa żgħażagħ b'saħħithom.
English: Checking personal and family history of VTE before prescribing combined CHC medicinal products is, therefore, recommended in the product information of the products.
Maltese: Għalhekk, fl-informazzjoni dwar il-prodott talprodotti, ġie rrakkomandat li qabel ma jiġu preskritti prodotti mediċinali CHC, għandha tiġi ċċekkjata listorja personali u familjari ta' VTE.
English: The PRAC reviewed all available data from clinical studies, pharmacoepidemiological studies, published literature, post-marketing experience, including responses submitted by the marketing authorisation holders (MAHs) in writing and at oral explanations, as well as the views of an ad hoc expert meeting on the efficacy and safety of the CHCs, in particular in relation to the risk of thromboembolism.
Maltese: Il-PRAC irreveda d-dejta kollha disponibbli minn studji kliniċi, studji farmakoepidemjoloġiċi, letteratura ppubblikata, esperjenza wara t-tqegħid fis-suq, inkluż it-tweġibiet ippreżentati mid-detenturi talawtorizzazzjoni għat-tqegħid fis-suq (MAHs) bil-miktub u waqt spjegazzjonijiet orali, kif ukoll il-fehmiet ta' laqgħa ta' esperti ad hoc dwar l-effikaċja u s-sigurtà tas-CHCs, b'mod partikolari fir-rigward tarriskju ta' tromboemboliżmu.
English: • For CHCs containing chlormadinone, dienogest and nomegestrol, the available data are insufficient to know how the risk compares with the other CHCs.
Maltese: • Għal CHCs li fihom chlormadinone, dienogest u nomegestrol, id-dejta disponibbli mhijiex biżżejjed biex wieħed ikun jaf kif ir-riskju jikkompara mas-CHCs l-oħra.
English: • The PRAC considered that further data are required for the combined hormonal contraceptives containing chlormadinone and imposed the conduct of a post authorisation safety study (PASS) to evaluate the relative risk of thromboembolic events due to these products compared to the ones containing levonorgestrel.
Maltese: • Il-PRAC huwa tal-fehma li l-benefiċċji ta' prodotti mediċinali li fihom kontraċettivi ormonali kkombinati jkomplu jegħlbu r-riskji fl-indikazzjoni ta' kontraċezzjoni.
English: For these women, these members were in favour of implementing in the “Indication” section of chlormadinone, desogestrel, dienogest, drospirenone, gestodene, nomegestrol, (those with a higher or a yet not sufficiently evaluated VTE risk) a recommendation to prescribe a CHC with a documented low VTE risk (levonorgestrel or noresthisterone or norgestimate containing product) with the aim of reducing the number of VTE events among CHC users, in particular in first ever users or women with an increased baseline risk of VTE.
Maltese: B'mod partikolari, dawn il-prodotti mediċinali għandhom ikunu kontraindikati f'pazjenti b'bosta fatturi ta' riskju (piż żejjed, tipjip, pressjoni għolja, età akbar, eċċ), f'pazjenti wara kirurġija maġġuri b'immobilizzazzjoni fit-tul u pazjenti bi storja jew bi predispożizzjoni ereditarja ta' trombożi filvini.
English: For dienogest and nomegestrol studies are on going and results will be submitted when available.
Maltese: Għal dienogest u nomegestrol hemm studji għaddejjin u r-riżultati se jiġu ppreżentati meta jkunu disponibbli.
English: EMA/87390/2014 EMEA/V/C/002740
Maltese: EMEA/V/C/002740
English: It contains a strain called GM 199.
Maltese: Fih razza msejħa GM 199.
English: Parvoduk is a vaccine.
Maltese: Parvoduk huwa vaċċin.
English: Growth after exposure to Muscovy duck parvovirus or goose parvovirus was improved in vaccinated ducklings by 70% and 110%, respectively.
Maltese: It-tkabbir wara esponiment għal parvovirus tal-papra Muscovy jew parvovirus tal-gniedes tjieb b'70% u 110% rispettivament f'papri mlaqqmin.
English: Muscovy duck parvovirus (live attenuated)
Maltese: Parvovirus tal-papra Muscovy (ħaj attenwat)
English: Parvoduk is used to protect Muscovy ducks against Muscovy duck parvovirosis and Derzsy's disease.
Maltese: Parvoduk jintuża biex jipproteġi papri Muscovy kontra parvovirożi tal-papri Muscovy u l-marda ta' Derzsy.
English: The effectiveness of Parvoduk was investigated in laboratory studies.
Maltese: L-effikaċja ta' Parvoduk ġiet investigata fl-istudji tal-laboratorji.
English: Derzsy's disease is a similar infection caused by the closely related virus, goose parvovirus.
Maltese: Il-marda ta' Derzsy hija infezzjoni simili kkawżata mill-virus relatat mill-qrib, il-parvovirus tal-gniedes.
English: What is the withdrawal period?
Maltese: Liema benefiċċju wera Parvoduk waqt l-istudji li twettqu?
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Parvoduk on 11/04/2014.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida madwar l-Unjoni Ewropea kollha għal Parvoduk fil-11/04/2014.
English: What is the risk associated with Parvoduk?
Maltese: X'riskji huma assoċjati ma' Parvoduk?
English: The vaccine is given to day-old ducklings as an injection under the skin, repeated after 16 days.
Maltese: It-tilqima tingħata lil papri żgħar ta' ġurnata bħala injezzjoni taħt il-ġilda, u jiġi ripetut wara 16-il jum.
English: The measure of effectiveness was reduction in death rates, stunting of growth, feather abnormalities and damage to organs seen at post-mortem.
Maltese: Il-miżura tal-effikaċja kienet tnaqqis fir-rati ta' mwiet, tkabbir imħarbat, annormalitajiet fir-rix u ħsara fl-organi li dehru post-mortem.
English: Two further studies were carried out to investigate the effects of Parvoduk in ducklings who had inherited protective antibodies against Muscovy duck parvovirus or goose parvovirus from their mother.
Maltese: Twettqu żewġ studji oħrajn sabiex jinvestigaw l-effetti ta' Parvoduk f'papri żgħar li wirtu antikorpi protettivi kontra l-parvovirus talpapra Muscovy jew il-parvovirus tal-gniedes minn ommhom.
English: What is Parvoduk?
Maltese: X'inhu Parvoduk?
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Parvoduk exceed the risks for the approved indication and recommended that Parvoduk be given a marketing authorisation.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għal Użu Veterinarju (CVMP) ikkonkluda li l-benefiċċji ta' Parvoduk jisbqu r-riskji għall-indikazzjoni approvata u rrakkomanda li Parvoduk jingħata awtorizzazzjoni għattqegħid fis-suq.
English: The laboratory studies showed that, two weeks after vaccination, Parvoduk prevented deaths in the ducklings and reduced damage to organs.
Maltese: L-istudji tal-laboratorju wrew li, ġimagħtejn wara t-tilqima, Parvoduk impedixxa mwiet fil-papri żgħar u naqqas il-ħsara fl-organi.
English: Parvoduk is available as a suspension and diluent for injection.
Maltese: Parvoduk huwa disponibbli bħala sospensjoni u dilwent għal injezzjoni.
English: This was considered acceptable, given the laboratory data and taking into account that the Muscovy duck is a minor species.
Maltese: Dan tqies bħala aċċettabbli, minħabba d-dejta tal-laboratorju u filwaqt li jitqies li l-papra Muscovy hija speċi minuri.
English: Muscovy duck parvovirosis is an infectious disease caused by Muscovy duck parvovirus.
Maltese: Il-parvovirożi tal-papra Muscovy hija marda li tittieħed ikkawżata mill-parvovirus tal-papra Muscovy.
English: Because goose parvovirus is very similar to Muscovy duck parvovirus, the immune response also provides protection if the animal is exposed to goose parvovirus.
Maltese: Minħabba li l-parvovirus tal-gniedes huwa simili ħafna għall-parvovirus tal-papra Muscovy, irreazzjoni immuni tipprovdi wkoll protezzjoni jekk l-annimal jiġi espost għal parvovirus tal-gniedes.
English: Other information about Parvoduk:
Maltese: Tagħrif ieħor dwar Parvoduk:
English: Parvoduk is a veterinary vaccine that contains live attenuated (weakened) Muscovy duck parvovirus.
Maltese: Parvoduk huwa mediċina veterinarja li fiha l-parvovirus tal-papra Muskovy ħaj attenwat (imdgħajjef).
English: Week-old ducklings show a range of signs including death and muscle weakness whilst older ducklings display stunted growth, nervous symptoms and feather abnormalities.
Maltese: Papri żgħar ta' ġimgħa juru firxa ta' sinjali li jinkludu mewt u dgħjufija tal-muskoli filwaqt li papri żgħar imma ikbar juru tkabbir imħarbat, sintomi ta' nervożiżmu u annormalitajiet fir-rix.
English: In addition it was shown that Parvoduk remains effective until the ducklings are aged six weeks, which means that the ducklings are protected during the period when they are at risk of Muscovy duck parvovirosis and Derzsy's disease.
Maltese: Barra minn hekk intwera li Parvoduk jibqa' effettiv sakemm il-papri żgħar ikollhom sitt ġimgħat, li jfisser li lpapri żgħar huma protetti matul il-perjodu meta jkunu f'riskju ta' parvovirożi tal-papra Muscovy u talmarda Derzsy.
English: How has Parvoduk been studied?
Maltese: Kif ġie studjat Parvoduk?
English: How does Parvoduk work?
Maltese: Għal xiex jintuża Parvoduk?
English: This will help protect them against Muscovy duck parvovirosis.
Maltese: Dan jgħin jipproteġihom kontra l-parvovirożi tal-papra Muscovy.
English: The further study showed that Parvoduk vaccination of ducklings was not counteracted by protective antibodies from their mother.
Maltese: L-istudju ulterjuri wera li t-tilqima b'Parvoduk tal-papri żgħar ma ġietx ribattuta minn antikorpi protettivi minn ommhom.
English: One-day-old ducklings were given a single injection of Parvoduk and then exposed two weeks later to either Muscovy duck parvovirus or goose parvovirus.
Maltese: Papri żgħar ta' jum ingħataw injezzjoni waħda ta' Parvoduk u mbagħad ġimagħtejn wara dawn ġew esposti għal parvovirus tal-papra Muscovy jew għal parvovirus tal-gniedes.
English: MA (EU) number (Invented) name Strength Pharmaceutical Form
Maltese: Numru ta' l-EU Isem (ivvintat) Qawwa Għamla farmaċewtika
English: This summary was last updated in 01/2018.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'01/2018.
English: The full EPAR for Genvoya 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: Genvoya is available as tablets, each containing 150 mg elvitegravir, 150 mg cobicistat, 200 mg emtricitabine and 10 mg tenofovir alafenamide.
Maltese: Genvoya jiġi bħala pilloli, li kull waħda minnhom fiha 150 mg elvitegravir, 150 mg cobicistat, 200 mg emtricitabine u 10 mg tenofovir alafenamide.
English: After 48 weeks a viral load of less than 50 copies/ml was seen in 97% (932 of 959) of patients switched to Genvoya and 93% (444 of 477) of patients who continued with their usual treatment.
Maltese: Wara 48 ġimgħa, ġiet osservata tagħbija virali ta' inqas minn 50 kopja/ml f'97% (932 minn 959) tal-pazjenti li nqalbu għal Genvoya u 93% (444 minn 477) talpazjenti li baqgħu jieħdu l-kura tas-soltu tagħhom.
English: Other information about Genvoya
Maltese: Informazzjoni oħra dwar Genvoya
English: Genvoya elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide
Maltese: Sommarju tal-EPAR għall-pubbliku elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide
English: Genvoya was investigated in two main studies involving 1,733 adults infected with HIV-1 who had not been treated previously.
Maltese: Genvoya ġie investigat f'żewġ studji ewlenin li involvew 1,733 adult infettat bl-HIV-1 li ma ġewx ikkurati qabel.
English: This is a summary of the European public assessment report (EPAR) for Genvoya.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Genvoya.
English: Genvoya is an antiviral medicine used to treat individuals infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Maltese: Genvoya huwa mediċina antivirali li tintuża biex tikkura individwi infettati bil-virus talimmunodefiċjenza umana tat-tip 1 (HIV-1), virus li jikkawża s-sindromu mill-immunodefiċjenza akkwiżita (AIDS).
English: Genvoya's side effects were similar to those of the individual medicines.
Maltese: L-effetti sekondarji ta' Genvoya kienu simili għal dawk ta' mediċini individwali.
English: Genvoya contains the active substances elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide.
Maltese: Genvoya fih is-sustanzi attivi elvitegravir, cobicistat, emtricitabine u tenofovir alafenamide.