FrancophonIA/ELRC3.0 huggingface dataset:
English: Alternative endothelin receptor antagonists may be considered.
Maltese: Antagonisti alternattivi tar-riċetturi ta' endothelin jistgħu jiġu kkunsidrati.
English: Of the 10 patients who were not HBV suppressed at baseline (HBV DNA ≥ 29 IU/mL), 7 became suppressed, 2 remained detectable, and 1 had missing data.
Maltese: Mill-10 pazjenti li ma kellhomx soppressjoni ta' HBV fil-linja bażi (DNA ta' HBV ≥ 29 IU/mL), 7 saru soppressi, 2 kellhom DNA ta' HBV li baqgħet tiġi osservata, u 1 kellu data nieqsa.
English: The following pack sizes are available: outer cartons containing 1 bottle of 30 film-coated tablets and outer cartons containing 90 (3 bottles of 30) film-coated tablets.
Maltese: Id-daqsijiet tal-pakketti li ġejjin huma disponibbli: kartun ta' barra li fihom flixkun wieħed ta' 30 pillola miksija b'rita u kartun ta' barra li fihom 90 (3 fliexken ta' 30) pillola miksija b'rita.
English: Genvoya should be discontinued in patients with estimated CrCl that declines below 30 mL/min during treatment (see section 5.2).
Maltese: Genvoya għandu jitwaqqaf f'pazjenti b'CrCl stmata li tonqos taħt 30 mL/min waqt it-trattament (ara sezzjoni 5.2).
English: Emtricitabine-resistant viruses with the M184V/I substitution were cross-resistant to lamivudine, but retained sensitivity to didanosine, stavudine, tenofovir, and zidovudine.
Maltese: Virusijiet reżistenti għal emtricitabine bis-sostituzzjoni M184V/I kienu reżistenza inkroċjata għal lamivudine, iżda żammew is-sensittività għal didanosine, stavudine, tenofovir, u zidovudine.
English: 6 This study was conducted using emtricitabine/tenofovir alafenamide.
Maltese: Dan l-istudju twettaq bl-użu ta' emtricitabine/tenofovir alafenamide.
English: After switching to Genvoya, 100% (23/23) of patients in Cohort 2 remained suppressed (HIV-1 RNA < 50 copies/mL) at Week 48.
Maltese: Wara bidla għal Genvoya, 100% (23/23) tal-pazjenti f'Koorti 2 baqgħu soppressi (RNA ta' HIV-1 < 50 kopja/mL) f'Ġimgħa 48.
English: Emtricitabine triphosphate inhibits HIV replication through incorporation into viral DNA by the HIV reverse transcriptase (RT), which results in DNA chain-termination.
Maltese: Emtricitabine triphosphate jinibixxi r-replikazzjoni tal-HIV permezz ta' inkorporazzjoni fid-DNA virali mill-HIV reverse transcriptase (RT), li tirriżulta fit-terminazzjoni tal-katina tad-DNA.
English: The safety profile in paediatric patients who received treatment with Genvoya was similar to that in adults.
Maltese: Ilprofil tas-sigurtà f'pazjenti pedjatriċi li rċivew trattament b'Genvoya kien simili għal dak fl-adulti.
English: The difference in percentage was 4.2% (95% CI: 0.6% to 7.8%).
Maltese: Id-differenza fil-perċentwali kienet ta' 4.2% (95% CI: 0.6% sa 7.8%).
English: The mean baseline CD4+ cell count was 427 cells/mm3 (range 0-1,360) and 13% had a CD4+ cell count < 200 cells/mm3.
Maltese: Il-medja tal-għadd ta' ċelluli CD4+ fillinja bażi kienet ta' 427 ċellula/mm3 (medda 0-1,360) u 13% kellhom għadd ta' ċelluli CD4+ ta' < 200 ċellula/mm3.
English: Three patients had virologic failure at Week 48; there was no virologic resistance detected to Genvoya.
Maltese: Tliet pazjenti kellhom insuffiċjenza viroloġika f'Ġimgħa 48; ma kien hemm lebda reżistenza viroloġika osservata għal Genvoya.
English: In patients co-infected with HIV and HBV
Maltese: Pazjenti ko-infettati bl-HIV u bl-HBV
English: Table 6: Pharmacokinetics of elvitegravir, cobicistat, emtricitabine, tenofovir, and tenofovir alafenamide in virologically suppressed children and adults
Maltese: Il-farmakokinetika ta' elvitegravir, cobicistat, emtricitabine, tenofovir, u tenofovir alafenamide fi tfal u adulti soppressi b'mod viroloġiku
English: Missing data during window but on study drug Proportion (%) of patients with HIV-1 RNA < 50 copies/mL by prior treatment regimen EFV/FTC/tenofovir disoproxil
Maltese: Dejta nieqsa matul lintervall ta' żmien iżda fuq il-mediċina tal-istudju Proporzjon (%) ta' pazjenti b'HIV-1 RNA ta' < 50 kopja/mL skont il-kors ta' trattament fil-passat EFV/FTC/tenofovir disoproxil
English: f n = 539 (TAF) or 841 (TFV) adults.
Maltese: a n = 24 adolexxenti b n = 23 adolexxenti c AUClast d n = 15-il adolexxent e n = 19-il adult f n = 539 (TAF) jew 841 (TFV) adult
English: Patients with pre-existing liver dysfunction, including chronic active hepatitis, have an increased frequency of liver function abnormalities during combination antiretroviral therapy (CART) and should be monitored according to standard practice.
Maltese: Pazjenti li diġà jbatu minn disfunzjoni tal-fwied li tinkludi epatite attiva kronika, għandhom żieda filfrekwenza ta' anormalitajiet tal-funzjoni tal-fwied waqt it-terapija antiretrovirali kombinata (CART) u jeħtieġ li jiġu monitorjati skond il-prattika normali.
English: For information on other acid reducing agents (e.g., H2-receptor antagonists and proton pump inhibitors), see “Studies conducted with other medicinal products”.
Maltese: Għal informazzjoni dwar mediċini oħrajn li jnaqqsu l-aċidu (eż. antagonisti ta' riċettur H2 u impedituri tal-pompa tal-proton), ara “Studji li saru bi prodotti mediċinali oħra”.
English: 4 This study was conducted using elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate.
Maltese: 4 Dan l-istudju twettaq bl-użu ta' elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate. 5
English: In clinical trials, the incidence of SAEs related to suicide for Genvoya was 0.6% (26/4137 subjects), therefore, the frequency proposed is “uncommon”.
Maltese: Fi provi kliniċi, l-inċidenza ta' SAEs relatati ma' suwiċidju għal Genvoya kienet ta' 0.6% (26/4,137 individwu), għalhekk, il-frekwenza pproposta hija “mhux komuni”.
English: No dose adjustment of Genvoya is required in patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment.
Maltese: L-ebda aġġustament fid-doża ta' Genvoya mhu meħtieġ f'pazjenti b'indeboliment epatiku ħafif (Child-Pugh Klassi A) jew moderat (Child-Pugh Klassi B).
English: In vitro studies have shown that tenofovir alafenamide is metabolised to tenofovir (major metabolite) by cathepsin A in PBMCs (including lymphocytes and other HIV target cells) and macrophages; and by carboxylesterase-1 in hepatocytes.
Maltese: Studji in vitro wrew li tenofovir alafenamide jiġi metabolizzat għal tenofovir (metabolit maġġuri) minn cathepsin A f'PBMCs (li jinkludu limfoċiti u ċelluli HIV oħrajn fil-mira) u makrofaġi; u minn carboxylesterase-1 fl-epatoċiti.
English: There were no new safety issues identified in patients with end stage renal disease on chronic haemodialysis receiving Genvoya (see section 4.8).
Maltese: Ma ġewx identifikati problemi ġodda ta' sigurtà f'pazjenti b'marda talkliewi fl-aħħar stadju fuq emodijalisi kronika li kienu qed jirċievu Genvoya (ara sezzjoni 4.8).
English: Comparison to paired postpartum data, n
Maltese: Paragun ma' dejta ta' wara t-twelid akkoppjata, n
English: Genvoya is a single tablet for the treatment of human immunodeficiency virus 1 (HIV-1) infection in adults, adolescents and children 6 years of age and older, who weigh at least 25 kg. Genvoya reduces the amount of HIV in your body.
Maltese: Genvoya hu pillola waħda għat-trattament għal virus ta' l-immunodefiċjenza umana 1 (HIV-1) fladulti, adolexxenti u tfal li jkollhom 6 snin u aktar, li jiżnu mill-inqas 25 kg.
English: • If you are intolerant to lactose (see Genvoya contains lactose later in this section).
Maltese: • Jekk inti intolleranti għal lactose (ara Genvoya fih il-lactose aktar 'l isfel f'din is-sezzjoni).
English: Patients had a mean age of 41 years (range 21-77), 89% were male, 67% were White, and 19% were Black.
Maltese: Il-pazjenti kellhom età medja ta' 41 sena (medda 21-77), 89% kienu rġiel, 67% kienu Bojod u 19% kienu Suwed.
English: Thirteen percent of patients were identified as Hispanic/Latino.
Maltese: Dsatax fil-mija tal-pazjenti ġew identifikati bħala Ispaniċi/Latini.
English: A minimal infiltration of histiocytes was present in the eye in dogs at tenofovir alafenamide and tenofovir exposures of approximately 4 and 17 times greater, respectively, than those expected after administration of Genvoya.
Maltese: Infiltrazzjoni minimali ta' istjoċiti kienet preżenti flgħajnejn tal-klieb f'esponimenti ta' tenofovir alafenamide u tenofovir ta' madwar 4 u 17-il darba ikbar, rispettivament, minn dawn mistennija wara l-għoti ta' Genvoya.
English: AUC: ↑ 525% Cmin: ↑ 394% Cmax: ↑ 384%
Maltese: 25-O-desacetyl-rifabutin AUC: ↑ 525% Cmin: ↑ 394% Cmax: ↑ 384%
English: The mean age was 50 years (range 28-67), 92% of patients were male, 69% were White, 18% were Black, and 10% were Asian.
Maltese: Letà medja kienet ta' 50 sena (firxa ta' 28-67), 92% tal-pazjenti kienu rġiel, 69% kienu Bojod, 18% kienu Suwed, u 10% kienu Asjatiċi.
English: At baseline, median CD4+ cell count was 969 cells/mm3 (range: 603 to 1,421), and median CD4+% was 39% (range: 30 to 51%).
Maltese: Fil-linja bażi, l-għadd medjan ta' ċelluli CD4+ kien ta' 969 ċellula/mm3 (firxa: 603 sa 1421), u CD4+% medjan kien ta' 39% (medda: 30 sa 51%).
English: Genvoya should not be co-administered with other antiretroviral medicinal products.
Maltese: Genvoya m'għandux jingħata flimkien ma' prodotti mediċinali antiretrovirali oħrajn.
English: Co-administration of Genvoya and some medicinal products that are primarily metabolised by CYP3A may result in increased plasma concentrations of these products, which are associated with the potential for serious or life-threatening adverse reactions such as peripheral vasospasm or ischaemia (e.g., dihydroergotamine, ergotamine, ergometrine), or myopathy, including rhabdomyolysis (e.g., simvastatin, lovastatin), or prolonged or increased sedation or respiratory depression (e.g., orally administered midazolam or triazolam).
Maltese: L-għoti ta' Genvoya flimkien ma' xi prodotti mediċinali li huma primarjament metabolizzati minn CYP3A jista' jirriżulta f'żieda tal-konċentrazzjonijiet ta' dawn il-prodotti fil-plażma, li huma assoċjati mal-potenzjal għal reazzjonijiet avversi serji jew ta' periklu għall-ħajja bħal vażospażmu periferali jew iskemija (eż., dihydroergotamine, ergotamine, ergometrine), jew mijopatija, li tinkludi rabdomijolosi (eż., simvastatin, lovastatin), jew sedazzjoni fit-tul jew żieda fis-sedazzjoni jew tnaqqis respiratorju (eż., midazolam li jingħata mill-ħalq jew triazolam).
English: Magnesium/aluminium-containing antacid suspension (20 mL single dose)/ Elvitegravir (50 mg single dose)/ Ritonavir (100 mg single dose)
Maltese: Suspensjoni ta' antaċidu li jkun fiha magnesium/aluminium (doża waħda ta' 20 mL)/Elvitegravir (doża waħda ta' 50 mg)/Ritonavir (doża waħda ta' 100 mg)
English: At baseline, median CD4+ cell count was 742 cells/mm3 (range: 255 to 1,246) and median CD4+% was 34% (range: 21 to 53%).
Maltese: Fil-linja bażi l-għadd medjan ta' ċelluli CD4+ kien ta' 742 ċellula/mm3 (firxa: 255 sa 1246) u l-għadd medjan ta' CD4+% kien ta' 34% (firxa: 21 sa 53%).
English: • bronchodilators, used to treat asthma and other lung-related problems: salmeterol
Maltese: • bronkodilaturi, li jintużaw għal trattament tal-ażżma u problemi oħra relatati mal-pulmun: salmeterol
English: Atorvastatin: AUC: ↑ 160% Cmin: NC Cmax: ↑ 132%
Maltese: ↑160% Cmin: NC Cmax: ↑132%
English: The use of Genvoya should be accompanied by the use of effective contraception (see sections 4.4 and 4.5).
Maltese: L-użu ta' Genvoya għandu jiġi akkompanjat mill-użu ta' kontraċettiv effettiv (ara sezzjonijiet 4.4 u 4.5).
English: In vivo, tenofovir alafenamide is hydrolysed within cells to form tenofovir (major metabolite), which is phosphorylated to the active metabolite tenofovir diphosphate.
Maltese: In vivo, tenofovir alafenamide jiġi idrolizzat fiċ-ċelluli biex jifforma tenofovir (metabolit maġġuri), li jiġi fosforilat għall-metabolit attiv tenofovir diphosphate.
English: Norgestimate (0.180/0.215 mg once daily)/ Ethinyloestradiol (0.025 mg once daily)/ Elvitegravir (150 mg once daily)/ Cobicistat (150 mg once daily)4
Maltese: 215 mg darba kuljum)/Ethinyloestradiol (0.025 mg darba kuljum)/ Elvitegravir (150 mg darba kuljum)/Cobicistat (150 mg darba kuljum)4
English: The safety of Genvoya was evaluated in 72 HIV/HBV co-infected patients receiving treatment for HIV in an open-label clinical study (GS-US-292-1249), through Week 48, in which patients were switched from another antiretroviral regimen (which included tenofovir disoproxil in 69 of 72 patients) to Genvoya.
Maltese: Is-sigurtà ta' Genvoya ġiet evalwata fi 72 pazjent ko-infettati bl-HIV/HBV li kienu qed jirċievu trattament għall-HIV fi studju kliniku open-label (GS-US-292-1249), sa tul Ġimgħa 48, fejn ilpazjenti nqalbu minn kors antiretrovirali ieħor (li kien jinkludi tenofovir disoproxil f'69 minn 72 pazjent) għal Genvoya.
English: Of the patients who were HBsAg positive at baseline, 3/70 (4.3%) achieved seroconversion to anti-HBs at Week 48.
Maltese: Mill-pazjenti li kienu pożittivi għal HBsAg fil-linja bażi, 3/70 (4.3%) kisbu serokonverżjoni għal anti-HBs f'Ġimgħa 48.
English: Mean exposures of elvitegravir, cobicistat, emtricitabine, tenofovir, and tenofovir alafenamide achieved in children aged 8 to < 12 years (> 25 kg; n = 23) who received Genvoya in study GS-US-292-0106 were higher (20 to 80%) than the mean exposures achieved in adults (Table 6).
Maltese: Esponimenti medji għal elvitegravir, cobicistat, emtricitabine, tenofovir, u tenofovir alafenamide li ntlaħqu fi tfal ta' età minn 8 snin sa < 12-il sena (> 25 kg; n = 23) li rċevew Genvoya fl-istudju GS-US-292-0106 kienu ogħla (20 sa 80%) mill-esponimenti medji miksuba fl-adulti (Tabella 6).
English: Ketoconazole (200 mg twice daily)/ Elvitegravir (150 mg once daily)2
Maltese: Ketoconazole (200 mg darbtejn kuljum)/Elvitegravir (150 mg darba kuljum)2
English: Cobicistat is also a weak CYP2D6 inhibitor and is metabolised, to a minor extent, by CYP2D6.
Maltese: Cobicistat hu wkoll impeditur dgħajjef ta' CYP2D6 u jiġi metabolizzat, sa ċertu punt, minn CYP2D6.
English: The mean increase from baseline in CD4+ cell count was 230 cells/mm3 in Genvoya-treated patients and 211 cells/mm3 in E/C/F/TDF-treated patients (p = 0.024) at Week 48, and 326 cells/mm3 in Genvoya-treated patients and 305 cells/mm3 in E/C/F/TDF-treated patients (p = 0.06) at Week 144.
Maltese: Il-medja taż-żieda mil-linja bażi fl-għadd ta' ċelluli CD4+ kienet ta' 230 ċellula/mm3 f'pazjenti ttrattati bi Genvoya u ta' 211-il ċellula/mm3 f'pazjenti ttrattati b'E/C/F/TDF- (p = 0.024) f'Ġimgħa 48, u 326 ċellula/mm3 f'pazjenti ttrattati b'Genvoya u 305 ċelluli/mm3 f'pazjenti ttrattati b'E/C/F/TDF (p = 0.06) f'Ġimgħa 144.
English: How to store Genvoya
Maltese: Tiqafx tieħu Genvoya
English: There are limited clinical data on the use of Genvoya in HIV/HBV co-infected patients who are treatment-naïve.
Maltese: Hemm data klinika limitata dwar l-użu ta' Genvoya f'pazjenti koinfettati b'HIV/HBV li qatt ma ħadu trattament qabel.
English: HIV-1 isolates with reduced susceptibility to tenofovir alafenamide express a K65R mutation in HIV-1 RT; in addition, a K70E mutation in HIV-1 RT has been transiently observed.
Maltese: Iżolati ta' HIV-1 b'suxxettibilità mnaqqsa għal tenofovir alafenamide jesprimu mutazzjoni K65R f'HIV-1 RT; barra minn hekk, mutazzjoni K70E f'HIV-1 RT ġiet osservata b'mod temporanju.
English: In studies in treatment-naïve patients, Genvoya was associated with smaller reductions in bone mineral density (BMD) compared to E/C/F/TDF as measured by DXA analysis of hip (mean change: -0.8% versus -3.4%, p < 0.001) and lumbar spine (mean change: -0.9% versus -3.0%, p < 0.001) after 144 weeks of treatment.
Maltese: Fi studji f'pazjenti li qatt ma ngħataw trattament fil-passat, Genvoya ġie assoċjat ma' tnaqqis iżgħar fid-densità minerali tal-għadam (BMD - bone mineral density) meta mqabbel ma' E/C/F/TDF kif imkejla permezz ta' analiżi DXA tal-ġenbejn (bidla medja: −0.8% vs −3.4%, p < 0.001) u tas-sinsla lumbari (bidla medja:
English: Cmax: ↑ 41%
Maltese: AUC: ↔ Cmax: ↑ 41%
English: Antimycobacterials Rifabutin (150 mg every other day)/ Elvitegravir (150 mg once daily)/ Cobicistat (150 mg once daily)
Maltese: Antimikobatteriċi Rifabutin (150 mg kull jumejn)/ Elvitegravir (150 mg darba kuljum)/Cobicistat (150 mg darba kuljum)
English: Elvitegravir undergoes primarily oxidative metabolism via CYP3A, and is secondarily glucuronidated via UGT1A1/3 enzymes.
Maltese: Elvitegravir jgħaddi minn metaboliżmu primarju ossidattiv permezz ta' CYP3A, u jiġi glukuronidat b'mod sekondarju permezz tal-enzimi ta' UGT1A1/3.
English: Tenofovir alafenamide is permeable into cells and due to increased plasma stability and intracellular activation through hydrolysis by cathepsin A, tenofovir alafenamide is more efficient than tenofovir disoproxil in concentrating tenofovir in peripheral blood mononuclear cells (PBMCs) (including lymphocytes and other HIV target cells) and macrophages.
Maltese: Tenofovir alafenamide hu permeabbli fiċ-ċelluli u minħabba ż-żieda tal-istabbiltà fil-plażma u l-attivazzjoni intraċellulari permezz ta' idrolisi minn cathepsin A, tenofovir alafenamide hu aktar effiċjenti minn tenofovir disoproxil fil-konċentrazzjoni ta' tenofovir fiċ-ċelluli mononukleari fid-demm periferali (PBMCs) (li jinkludu limfoċiti u ċelluli HIV oħrajn fil-mira) u makrofaġi.
English: Patients with chronic hepatitis B or C treated with antiretroviral therapy are at an increased risk for severe and potentially fatal hepatic adverse reactions.
Maltese: Pazjenti b'epatite kronika B jew Ċ u li huma ttrattati b'terapija antiretrovirali huma f'riskju akbar għal reazzjonijiet avversi epatiċi severi u potenzjalment fatali.
English: 2 This adverse reaction was not observed in the Phase 3 clinical studies for Genvoya but identified from clinical studies for elvitegravir when used with other antiretrovirals.
Maltese: 2 Din ir-reazzjoni avversa ma ġietx osservata fl-istudji kliniċi ta' Fażi 3 għal Genvoya iżda ġiet identifikata minn studji kliniċi għal elvitegravir meta użat ma' mediċini antiretrovirali oħrajn.
English: Additional integrase mutations observed in cell culture selection included H51Y, F121Y, S147G, S153Y, E157Q, and R263K.
Maltese: Mutazzjonijiet addizzjonali ta' integrase osservati filkoltura taċ-ċelluli kienu jinkludu H51Y, F121Y, S147G, S153Y, E157Q, u R263K. HIV-1 massostituzzjonijiet magħżula ta' raltegravir T66A/K, Q148H/K, u N155H wera reżistenza inkroċjata għal elvitegravir.
English: No clinically relevant differences in elvitegravir or cobicistat pharmacokinetics were observed between patients with moderate hepatic impairment and subjects with normal hepatic function.
Maltese: L-ebda differenzi klinikament rilevanti fil-farmakokinetika ta' elvitegravir jew cobicistat ma ġew osservati bejn pazjenti b'indeboliment epatiku moderat u individwi b'funzjoni tal-fwied normali.
English: The median terminal plasma half-life of cobicistat following administration of E/C/F/TDF is approximately 3.5 hours and the associated cobicistat exposures provide elvitegravir Ctrough approximately 10-fold above the protein-binding adjusted IC95 for wild-type HIV-1 virus.
Maltese: Il-medjan tal-half-life terminali fil-plażma ta' cobicistat wara l-għoti ta' E/C/F/TDF hu ta' madwar 3.5 sigħat u l-esponimenti assoċjati ta' cobicistat jipprovdu lil elvitegravir b'Ctrough ta' madwar 10 darbiet ogħla minn IC95 aġġustat għat-twaħħil tal-proteina għal virus HIV-1 wild-type.
English: In Study GS-US-292-1515, the efficacy and safety of Genvoya were evaluated in an open-label study in HIV-1 infected, virologically suppressed adolescents between the ages of 12 and 18 years, weighing ≥ 35 kg (n = 50).
Maltese: Fl-Istudju GS-US-292-1515, l-effikaċja u s-sigurtà ta' Genvoya kienu evalwati fi studju open-label f'adolexxenti infettati b'HIV-1, soppressi b'mod viroloġiku bejn l-etajiet ta' 12 u 18-il sena li jiżnu ≥ 35 kg (n = 50).
English: • In adults and adolescents aged from 12 years and with body weight at least 35 kg
Maltese: • F'adulti u adolexxenti ta' età minn 12-il sena u b'piż tal-ġisem ta' mill-inqas 35 kg
English: Based on drug-drug interaction studies conducted with Genvoya or the components of Genvoya, no clinically significant drug-drug interactions have been either observed or are expected between the components of Genvoya and the following medicinal products: entecavir, famciclovir, ribavirin, famotidine, and omeprazole.
Maltese: Ibbażat fuq studji dwar l-interazzjonijiet ta' bejn mediċina u oħra li saru bi Genvoya jew ilkomponenti ta' Genvoya, l-ebda interazzjonijiet klinikament sinifikanti bejn mediċina u oħra ma kienu osservati jew huma mistennija bejn il-komponenti ta' Genvoya u l-prodotti mediċinali li ġejjin: entecavir, famciclovir, ribavirin, famotidine, u omeprazole.
English: There were no new safety issues identified in patients with end stage renal disease on chronic haemodialysis receiving Genvoya (see section 5.2).
Maltese: Ma ġewx identifikati problemi ġodda ta' sigurtà f'pazjenti b'marda tal-kliewi fl-aħħar stadju fuq emodijalisi kronika li kienu qed jirċievu Genvoya (ara sezzjoni 5.2).
English: Mean percent change in AUC,
Maltese: Bidla medja f'perċentwali fl-AUC,
English: Co-administration of Genvoya with carbamazepine is contraindicated (see section 4.3).
Maltese: L-għoti flimkien ta' Genvoya ma' carbamazepine hu kontraindikat (ara sezzjoni 4.3).
English: Based on data from an in vitro study, co-administration of tenofovir alafenamide and xanthine oxidase inhibitors (e.g., febuxostat) is not expected to increase systemic exposure to tenofovir in vivo.
Maltese: Abbażi ta' tagħrif minn studju in vitro, l-għoti fl-istess waqt ta' tenofovir alafenamide u impedituri ta' xanthine oxidase (eż. febuxostat) mhux mistenni li jżid l-esponiment sistemiku għal tenofovir in vivo.
English: Patients were randomised in a 2:1 ratio to either switch to Genvoya at baseline (n = 959), or stay on their baseline antiretroviral regimen (n = 477).
Maltese: Il-pazjenti ntgħażlu b'mod każwali fi proporzjon ta' 2:1 biex jew jaqilbu għal Genvoya fil-linja bażi (n = 959), jew jibqgħu fuq il-kors antiretrovirali tagħhom fil-linja bażi (n = 477).
English: Fifteen percent of patients identified as Hispanic/Latino.
Maltese: Ħmistax fil-mija tal-pazjenti identifikaw bħala Ispaniċi/Latino.
English: Genvoya has not been studied in patients with severe hepatic impairment (Child-Pugh Class C); therefore, Genvoya is not recommended for use in patients with severe hepatic impairment (see sections 4.4 and 5.2).
Maltese: Genvoya ma ġiex studjat f'pazjenti b'indeboliment epatiku sever (Child-Pugh Klassi Ċ): għalhekk, Genvoya mhuwiex rakkomandat għallużu f'pazjenti b'indeboliment epatiku sever (ara sezzjonijiet 4.4 u 5.2).
English: The mean change from baseline in CD4+ cell count and percentage at Week 48 was -90 cells/mm3 and -1.3%, respectively.
Maltese: Il-bidla medja mil-linja bażi fl-għadd u l-persentaġġ ta' ċelluli CD4+ f'Ġimgħa 48 kienet ta' -90 ċellula/mm3 u -1.3%, rispettivament.
English: In Study GS-US-292-0106, the efficacy, safety, and pharmacokinetics of Genvoya were evaluated in an open-label study in HIV-1 infected, treatment-naïve adolescents between the ages of 12 to < 18 years, weighing ≥ 35 kg (n = 50) in Cohort 1, and in virologically suppressed children between the ages of 8 to < 12 years, weighing > 25 kg (n = 23) in Cohort 2.
Maltese: Fi Studju GS-US-292-0106, l-effikaċja, is-sigurtà u l-farmakokinetika ta' Genvoya ġew evalwati fi studju open-label f'adolexxenti infettati bl-HIV-1, li qatt ma ngħataw trattament fil-passat bejn letajiet ta' 12 sa < 18-il sena li jiżnu ≥ 35 kg (n = 50) f'Koorti 1, u fi tfal soppressi b'mod viroloġiku bejn l-etajiet ta' 8 sa < 12-il sena li jiżnu > 25 kg (n = 23) f'Koorti 2.
English: Genvoya is indicated for the treatment of human immunodeficiency virus-1 (HIV-1) infection without any known mutations associated with resistance to the integrase inhibitor class, emtricitabine or tenofovir as follows:
Maltese: Genvoya hu indikat għat-trattament ta' infezzjoni bil-virus tat-tip 1 tal-immunodefiċjenza umana (HIV-1) mingħajr xi mutazzjonijiet magħrufa assoċjati ma' reżistenza għall-klassi ta' impedituri ta' integrase, emtricitabine jew tenofovir kif ġej: