FrancophonIA/ELRC3.0 huggingface dataset:
English: Taking into account the PRAC Assessment Report on the PSUR(s) for cobicistat / elvitegravir / emtricitabine / tenofovir alafenamide, the scientific conclusions of CHMP are as follows:
Maltese: Meta jiġi kkunsidrat ir-Rapport ta' Valutazzjoni tal-PRAC dwar il-PSUR(s) għal cobicistat / elvitegravir / emtricitabine / tenofovir alafenamide, il-konklużjonijiet xjentifiċi tas-CHMP huma kif ġej:
English: Orally administered midazolam (2.5 mg single dose)/ Tenofovir alafenamide (25 mg once daily)
Maltese: Midazolam li jingħata mill-ħalq (doża waħda ta' 2.5 mg)/Tenofovir alafenamide (25 mg darba kuljum)
English: The antiviral activity of elvitegravir against laboratory and clinical isolates of HIV-1 was assessed in lymphoblastoid cells, monocyte/macrophage cells, and peripheral blood lymphocytes and the 50% effective concentration (EC50) values were in the range of 0.02 to 1.7 nM. Elvitegravir displayed antiviral activity in cell culture against HIV-1 clades A, B, C, D, E, F, G, and O (EC50 values ranged from 0.1 to 1.3 nM) and activity against HIV-2 (EC50 of 0.53 nM).
Maltese: L-attività antivirali ta' elvitegravir kontra iżolati tal-laboratorju u kliniċi ta' HIV-1 ġiet evalwata f'ċelluli limfoblastojdi, ċelluli monoċiti/makrofagi u limfoċiti tad-demm periferali u l-valuri talkonċentrazzjoni effettiva ta' 50% (EC50) kienu fil-medda ta' 0.02 sa 1.7 nM.
English: The results reported from a prospective study (IMPAACT P1026s) showed that treatment with cobicistat and elvitegravir-containing regimens during pregnancy results in lower elvitegravir and cobicistat exposures (Table 7).
Maltese: Ir-riżultati rrappurtati minn studju prospettiv (IMPAACT P1026s) urew li t-trattament b'korsijiet li jkun fihom cobicistat u elvitegravir matul it-tqala jirriżulta f'esponimenti aktar baxxi għal cobicistat u elvitegravir (Tabella 7).
English: Emtricitabine displayed antiviral activity in cell culture against HIV-1 clades A, B, C, D, E, F, and G (EC50 values ranged from 0.007 to 0.075 µM) and showed strain specific activity against HIV-2 (EC50 values ranged from 0.007 to 1.5 µM).
Maltese: Elvitegravir wera attività antivirali fil-koltura taċ-ċelluli kontra HIV-1 clades A, B, Ċ, D, E, F, G, u O (il-figuri EC50 kienu jvarjaw minn 0.1 sa 1.3 nM) u attività kontra
English: Missing data during window but on study drug Proportion (%) of patients with HIV-1 RNA < 50 copies/mL by subgroup
Maltese: Proporzjon (%) ta' pazjenti b'HIV-1 RNA ta' < 50 kopja/mL skont issottogrupp
English: In an in vitro chromosomal aberration test, elvitegravir was negative with metabolic activation; however, an equivocal response was observed without activation.
Maltese: F'test in vitro dwar aberrazzjonijiet kromosomali, elvitegravir kien negattiv b'attivazzjoni metabolika; madankollu, ġie osservat rispons ekwivoku mingħajr attivazzjoni.
English: At Week 48, 92% of patients (66/72) maintained HIV-1 RNA < 50 copies/mL after switching to Genvoya.
Maltese: F'Ġimgħa 48, 92% tal-pazjenti (66/72) żammew RNA ta' HIV-1 < 50 kopja/mL wara li qalbu għal Genvoya.
English: In open-label Study GS-US-292-1249, the efficacy and safety of Genvoya were evaluated in adult patients co-infected with HIV-1 and chronic hepatitis B. Sixty-nine of the 72 patients were on prior tenofovir disoproxil-containing antiretroviral therapy.
Maltese: Fl-Istudju open-label GS-US-292-1249, l-effikaċja u s-sigurtà ta' Genvoya kienu evalwati f'pazjenti adulti koinfettati b'HIV-1 u epatite B kronika.
English: Co-administration of Genvoya and some medicinal products that induce CYP3A such as St. John's wort (Hypericum perforatum), rifampicin, carbamazepine, phenobarbital, and phenytoin may result in significantly decreased cobicistat and elvitegravir plasma concentrations, which may result in loss of therapeutic effect and development of resistance (see section 4.3).
Maltese: John's wort (Hypericum perforatum), rifampicin, carbamazepine, phenobarbital u phenytoin, jista' jirriżulta fi tnaqqis sinifikanti tal-konċentrazzjonijiet ta' cobicistat u elvitegravir fil-plażma, li jista' jirriżulta f'telf tal-effett terapewtiku u l-iżvilupp ta' reżistenza (ara sezzjoni 4.3).
English: However, upon co-administration with cobicistat in Genvoya, near maximal inhibition of P-gp by cobicistat is achieved leading to increased availability of tenofovir alafenamide with resulting exposures comparable to tenofovir alafenamide 25 mg administered alone.
Maltese: Madankollu, meta jingħata flimkien ma' cobicistat fi Genvoya, tinkiseb inibizzjoni ta' P-gp minn cobicistat qrib il-massimu, u twassal għal żieda fid-disponibilità ta' tenofovir alafenamide, bl-esponimenti li jirriżultaw li jkunu komparabbli għal tenofovir alafenamide 25 mg mogħti waħdu.
English: In vitro binding of tenofovir to human plasma proteins is < 0.7% and is independent of concentration over the range of 0.01-25 µg/mL.
Maltese: It-twaħħil in vitro ta' tenofovir ma' proteini tal-plażma umana hu ta' < 0.7% u hu indipendenti millkonċentrazzjoni fuq il-medda ta' 0.
English: There were no clinically significant changes in fasting lipid laboratory tests in patients who switched to Genvoya.
Maltese: Ma kien hemm l-ebda bidla klinikament sinifikanti fit-testijiet tal-laboratorju tal-lipidi waqt is-sawm f'pazjenti li qalbu għal Genvoya.
English: The interactions described are based on studies conducted with Genvoya, or the components of Genvoya (elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide), as individual agents and/or in combination, or are potential drug-drug interactions that may occur with Genvoya.
Maltese: L-interazzjonijiet deskritti huma bbażati fuq studji li saru bi Genvoya jew bil-komponenti ta' Genvoya (elvitegravir, cobicistat, emtricitabine, u tenofovir alafenamide), bħala mediċini individwali u/jew flimkien, jew huma interazzjonijiet potenzjali bejn mediċina u oħra li jistgħu jseħħu ma' Genvoya.
English: HIV-1 RNA < 50 copies/mL Treatment difference
Maltese: HIV-1 RNA < 50 kopja/mL
English: At Week 48, 81.8% (45/55 patients) maintained HIV-1 RNA < 50 copies/mL after switching to Genvoya.
Maltese: 8% (45/55 pazjent) żammew l-RNA ta' HIV-1 < 50 kopja/mL wara li qalbu għal Genvoya.
English: If you are taking an antacid such as aluminium/magnesium hydroxide or a multivitamin supplement, take it at least 4 hours before or at least 4 hours after Genvoya.
Maltese: Jekk qed tieħu antaċidu bħal aluminium/magnesium hydroxide, jew suppliment ta' multivitamini, ħudu mill-inqas 4 sigħat qabel jew mill-inqas 4 sigħat wara Genvoya.
English: Aromatic and aliphatic hydroxylation or glucuronidation metabolites are present in very low levels, displaying considerably lower antiviral activity against HIV-1 and do not contribute to the overall antiviral activity of elvitegravir.
Maltese: Hydroxylation aromatika u alifatika jew metaboliti tal-glukoronidazzjoni kienu preżenti f'livelli baxxi ħafna, u juru attività antivirali kontra l-HIV li kienet iktar baxxa b'mod konsiderevoli, u ma jikkontribwixxux għall-attività antivirali globali ta' elvitegravir.
English: Elvitegravir: AUC: ↔
Maltese: Elvitegravir (għoti fl-istess ħin): AUC: ↓ 45%
English: For the treatment of erectile dysfunction, it is recommended that a single dose of sildenafil no more than 25 mg in 48 hours, vardenafil no more than 2.5 mg in 72 hours, or tadalafil no more than 10 mg in 72 hours be co-administered with Genvoya.
Maltese: Għat-trattament ta' disfunzjoni erettili, hu rakkomandat li doża waħda ta' sildenafil ta' mhux aktar minn 25 mg fi 48 siegħa, vardenafil mhux aktar minn 2.5 mg fi 72 siegħa, jew tadalafil mhux aktar minn 10 mg fi 72 siegħa, jingħataw flimkien ma' Genvoya.
English: A potential risk of nephrotoxicity resulting from chronic exposure to low levels of tenofovir due to dosing with tenofovir alafenamide cannot be excluded (see section 5.3).
Maltese: Riskju potenzjali ta' nefrotossiċità li jirriżulta minn esponiment kroniku għal livelli baxxi ta' tenofovir minħabba d-dożaġġ b'tenofovir alafenamide ma jistax jiġi eskluż (ara sezzjoni 5.3).
English: Antiviral synergy was maintained for elvitegravir, emtricitabine, and tenofovir alafenamide when tested in the presence of cobicistat.
Maltese: Is-sinerġija antivirali nżammet għal elvitegravir, emtricitabine, u tenofovir alafenamide meta ġew ittestjati fil-preżenza ta' cobicistat.
English: • If you are allergic to elvitegravir, cobicistat, emtricitabine, tenofovir alafenamide or any of the other ingredients of this medicine (listed in section 6 of this leaflet).
Maltese: • Jekk inti allerġiku għal elvitegravir, cobicistat, emtricitabine, tenofovir alafenamide, jew għal xi sustanza oħra ta' din il-mediċina (imniżżla fis-sezzjoni 6 ta' dan il-fuljett).
English: Sofosbuvir (400 mg once daily)/ Velpatasvir (100 mg once daily)/ Elvitegravir (150 mg once daily)/ Cobicistat (150 mg once daily)/ Emtricitabine (200 mg once daily)/ Tenofovir alafenamide (10 mg once daily)5
Maltese: Sofosbuvir (400 mg darba kuljum)/ Velpatasvir (100 mg darba kuljum)/ Elvitegravir (150 mg darba kuljum)/ Cobicistat (150 mg darba kuljum)/ Emtricitabine (200 mg darba kuljum)/ Tenofovir alafenamide (10 mg darba kuljum)5
English: However, based on the information retrieved in literature and in the product information of integrase inhibitors containing medicinal products, it could be concluded that the following psychiatric disorders: depression, suicidal ideation and suicidal behaviour (particularly in patients with pre-existing history of psychiatric illness) are class-effect of integrase inhibitors and these are listed in the SmPC of other medicinal products containing integrase inhibitors in monotherapy and in fixed-dose combination (FDC).
Maltese: Madankollu, abbażi tal-informazzjoni miġbura fil-letteratura u fl-informazzjoni talprodott ta' prodotti mediċinali li fihom inibituri ta' integrase, jista' jiġi konkluż li d-disturbi psikjatriċi li ġejjin: depressjoni, formazzjoni ta' ħsieb biex jitwettaq suwiċidju u aġir suwiċidali (b'mod partikolari f'pazjenti bi storja medika li kienet teżisti minn qabel ta' mard psikjatriku) huma effetti talklassi ta' inibituri ta' integrase u dawn huma elenkati fl-SmPC ta' prodotti mediċinali oħra li fihom inibituri ta' integrase f'monoterapija jew kombinazzjoni ta' doża fissa (FDC - fixed-dose combination).
English: Buprenorphine: AUC: ↑ 35% Cmin: ↑ 66% Cmax: ↑ 12%
Maltese: ↑ 35% Cmin: ↑ 66% Cmax: ↑ 12%
English: Ninety-two percent (66/72 patients) had HBV DNA < 29 IU/mL using missing = failure analysis at Week 48.
Maltese: Tnejn u disgħin fil-mija (66/72 pazjent) kellhom DNA ta' HBV < 29 IU/mL bl-użu ta' analiżi ta' nieqsa = falliment f'Ġimgħa 48.
English: Female patients of childbearing potential should use either a hormonal contraceptive containing at least 30 µg ethinyloestradiol and containing drospirenone or norgestimate as the progestogen or should use an alternative reliable method of contraception (see sections 4.5 and 4.6).
Maltese: Il-kontraċettiv ormonali għandu jkun fih mill-inqas 30 µg ta' ethinyloestradiol u fih drospirenone jew norgestimate bħala l-progestogen jew il-pazjenti għandhom jużaw metodu affidabbli alternattiv ta' kontraċezzjoni (ara sezzjonijiet 4.4 u 4.6).
English: The mean baseline CD4+ cell count was 636 cells/mm3 (range 263-1,498).
Maltese: L-għadd medju ta' ċelluli CD4+ fil-linja bażi kien ta' 636 ċellula/mm3 (firxa ta' 263-1498).
English: Tablet core:
Maltese: Tabella 6:
English: HIV-1 infected, treatment-naïve patients
Maltese: Pazjenti infettati b'HIV-1 li qatt ma ngħataw trattament fil-passat Fi studji
English: Genvoya should be avoided in patients with estimated CrCl ≥ 15 mL/min and < 30 mL/min, or < 15 mL/min who are not on chronic haemodialysis, as the safety of Genvoya has not been established in these populations.
Maltese: Genvoya għandu jiġi evitat f'pazjenti b'CrCl stmata ta' ≥ 15-il mL/min u < 30 mL/min, jew < 15-il mL/min li mhumiex fuq emodijalisi kronika, peress li s-sigurtà ta' Genvoya ma ġietx stabbilita f'dawn il-popolazzjonijiet.
English: There are no or limited data (less than 300 pregnancy outcomes) from the use of Genvoya in pregnant women.
Maltese: M'hemmx dejta klinika jew hemm dejta limitata (inqas min 300 riżultat ta' tqala) dwar l-użu ta' Genvoya f'nisa tqal.
English: After switching to Genvoya, 90% (45/50) of patients remained suppressed (HIV-1 RNA < 50 copies/mL) at Week 48.
Maltese: Wara li qalbu għal Genvoya, 90% (45/50) tal-pazjenti baqgħu soppressi (RNA ta' HIV-1 < 50 kopja/mL) f'Ġimgħa 48.
English: Relative to fasting conditions, the administration of Genvoya with a light meal (~400 kcal, 20% fat) or high-fat meal (~800 kcal, 50% fat) did not affect overall exposures of tenofovir alafenamide to a clinically meaningful extent (approximately 15% and 18% higher AUC with a light or high-fat meal, respectively, versus fasted).
Maltese: Fir-rigward ta' kundizzjonijiet fl-istat sajjem, l-għoti ta' Genvoya ma' ikla ħafifa (~400 kcal, 20% xaħam) jew ikla b'ħafna xaħam (~800 kcal, 50% xaħam) ma affettwax l-esponimenti globali ta' tenofovir alafenamide għal grad klinikament sinifikanti (AUC li kien bejn wieħed u ieħor 15% u 18% ogħla ma' ikla ħafifa jew ikla b'ħafna xaħam, rispettivament, meta mqabbla mal-istat sajjem).
English: Cobicistat has no detectable antiviral activity against HIV-1 and does not antagonise the antiviral effects of elvitegravir, emtricitabine, or tenofovir.
Maltese: Cobicistat m'għandu l-ebda attività antivirali li tista' tiġi ntraċċata kontra l-HIV-1 u ma jantagonizzax l-effetti antivirali ta' elvitegravir, emtricitabine, jew tenofovir.
English: Genvoya should generally be avoided but may be used in adults with end stage renal disease (estimated CrCl < 15 mL/min) on chronic haemodialysis if the potential benefits outweigh the potential risks (see section 4.2).
Maltese: Genvoya ġeneralment għandu jiġi evitat iżda jista' jintuża f'adulti b'marda tal-kliewi fl-aħħar stadju (CrCl stmata ta' < 15-il mL/min) fuq emodijalisi kronika jekk il-benefiċċji potenzjali jkunu akbar mirriskji potenzjali (ara sezzjoni 4.2).
English: Genvoya can cause dizziness.
Maltese: Genvoya jista' tikkawża sturdament.
English: When corrected for protein binding, unbound (free) plasma concentrations of tenofovir alafenamide in severe hepatic impairment and normal hepatic function are similar.
Maltese: Meta kkoreġuti għall-irbit mal-proteini, il-konċentrazzjonijiet ta' tenofovir alafenamide mhux marbut (ħieles) fil-plażma f'indeboliment epatiku sever u funzjoni tal-fwied normali huma simili.
English: Caution should be exercised when co-administering Genvoya and a hormonal contraceptive.
Maltese: Għandu jkun hemm kawtela meta Genvoya u kontraċettiv ormonali jingħataw flimkien.
English: Based on this, section 4.8 of the SmPC of medicinal products containing elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide FDC has been updated to add suicidal ideation and suicide attempt (in patients with a pre-existing history of depression or psychiatric illness) as new adverse drug reactions.
Maltese: Abbażi ta' dan, is-sezzjoni 4.8 tal-SmPC tal-prodotti mediċinali li fihom FDC ta' elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide ġiet aġġornata sabiex jiżdiedu formazzjoni ta' ħsieb biex jitwettaq suwiċidju u tentattiv ta' suwiċidju (f'pazjenti bi storja medika li kienet teżisti minn qabel ta' depressjoni jew mard psikjatriku) bħala reazzjonijiet avversi ġodda għall-mediċina.
English: Of the patients who were HBeAg positive at baseline, 1/30 (3.3%) achieved seroconversion to anti-HBe at Week 48.
Maltese: Mill-pazjenti li kienu pożittivi għal HBeAg fil-linja bażi, 1/30 (3.3%) kisbu serokonverżjoni għal antiHBe f'Ġimgħa 48.
English: Based on these limited data, the safety profile of Genvoya in patients with HIV/HBV co-infection was similar to that in patients with HIV-1 monoinfection.
Maltese: Ibbażat fuq din id-data limitata, il-profil tas-sigurtà ta' Genvoya, f'pazjenti b'ko-infezzjoni bl-HIV/HBV, kien simili għal dak f'pazjenti b'monoinfezzjoni bl-HIV-1.
English: Each tablet contains 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine and tenofovir alafenamide fumarate equivalent to 10 mg of tenofovir alafenamide.
Maltese: Kull pillola fiha 150 mg ta' elvitegravir, 150 mg ta' cobicistat, 200 mg ta' emtricitabine u tenofovir alafenamide fumarate, ekwivalenti għal 10 mg ta' tenofovir alafenamide.
English: Co-administration of Genvoya with medicinal products that induce CYP3A may result in decreased plasma concentrations of elvitegravir and reduced therapeutic effect of Genvoya (see “Concomitant use contraindicated” and section 4.3).
Maltese: L-għoti flimkien ta' Genvoya ma' prodotti mediċinali li jinduċu CYP3A, jista' jirriżulta fi tnaqqis fil-konċentrazzjonijiet ta' elvitegravir fil-plażma u effett terapewtiku mnaqqas ta' Genvoya (ara “L-użu fl-istess ħin hu kontraindikat” u sezzjoni 4.3).
English: What you need to know before you take Genvoya Do not take Genvoya:
Maltese: X'għandek tkun taf qabel ma tieħu Genvoya Tiħux Genvoya:
English: At Week 48, the virologic response rate to Genvoya in treatment-naïve HIV-1 infected adolescents was similar to response rates in studies of treatment-naïve HIV-1 infected adults.
Maltese: Wara 48 ġimgħa, ir-rata ta' rispons viroloġiku għal Genvoya f'adolexxenti infettati bl-HIV-1 li qatt ma ngħataw trattament fil-passat, kienet simili għal rati ta' rispons fl-istudji ta' adulti infettati blHIV-1 li qatt ma ngħataw trattament fil-passat.
English: Clinically relevant changes in the pharmacokinetics of tenofovir alafenamide or its metabolite tenofovir were not observed in patients with mild or moderate hepatic impairment.
Maltese: Tibdil klinikament rilevanti fil-farmakokinetika ta' tenofovir alafenamide jew tal-metabolit tiegħu tenofovir ma kienx osservat f'pazjenti b'indeboliment epatiku ħafif jew moderat.
English: c P-value for the superiority test comparing the percentages of virologic success was from the CMH test stratified by the prior treatment regimen (EFV/FTC/tenofovir disoproxil, FTC/tenofovir disoproxil plus boosted atazanavir, or
Maltese: c Il-valur p għat-test tas-superjorità li jqabbel il-perċentwali tas-suċċess viroloġiku kien mit-test CMH stratifikat skont ilkors ta' trattament minn qabel (EFV/FTC/tenofovir disoproxil, FTC/tenofovir disoproxil flimkien ma' atazanavir imsaħħaħ, jew E/C/F/TDF).
English: Following oral administration with food in HIV-1 infected patients, peak plasma concentrations were observed approximately 4 hours post-dose for elvitegravir, 3 hours post-dose for cobicistat, 3 hours post-dose for emtricitabine, and 1 hour post-dose for tenofovir alafenamide.
Maltese: Wara l-għoti mill-ħalq mal-ikel f'pazjenti infettati bl-HIV-1, il-konċentrazzjonijiet massimi fil-plażma ġew osservati madwar 4 sigħat wara d-doża għal elvitegravir, 3 sigħat wara d-doża għal cobicistat, 3 sigħat wara d-doża għal emtricitabine, u siegħa wara d-doża għal tenofovir alafenamide.
English: Cobicistat exposures were unaffected by a light meal and although there was a modest decrease of 24% and 18% in Cmax and AUC respectively with a high-fat meal, no difference was observed in its pharmacoenhancing effect on elvitegravir.
Maltese: L-esponimenti għal cobicistat ma kinux affettwati minn ikla ħafifa u għalkemm kien hemm tnaqqis modest ta' 24% u 18% fis-Cmax u fl-AUC rispettivament b'ikla b'ammont għoli ta' xaħam, l-ebda differenza ma ġiet osservata fl-effett tiegħu li jtejjeb il-farmakokinetika fuq elvitegravir.
English: The mean increase from baseline in CD4+ cell count at Week 48 was 224 cells/mm3.
Maltese: Iż-żieda medja mil-linja bażi fl-għadd ta' ċelluli CD4+ f'Ġimgħa 48 kien ta' 224 ċellula/mm3.
English: Co-administration of Genvoya and triazolam is contraindicated (see section 4.3).
Maltese: L-għoti flimkien ta' Genvoya u triazolam hu kontraindikat (ara sezzjoni 4.3).
English: Cmax: ↑ 28%
Maltese: Cmin: ↑ 58%
English: The EC50 values for tenofovir alafenamide were in the range of 2.0 to 14.7 nM. Tenofovir alafenamide displayed antiviral activity in cell culture against all HIV-1 groups (M, N, and O), including subtypes A, B, C, D, E, F, and G (EC50 values ranged from 0.10 to 12.0 nM) and showed strain specific activity against HIV-2 (EC50 values ranged from 0.91 to 2.63 nM).
Maltese: Il-figuri EC50 għal emtricitabine kienu fil-medda ta' 0.0013 sa 0.64 µM. Emtricitabine wera attività antivirali fil-koltura taċ-ċelluli kontra sottotip ta' HIV-1 A, B, Ċ, D, E, F, u G (il-figuri ta' EC50 kienu jvarjaw minn 0.007 sa 0.075 µM) u ntweriet attività speċifika tar-razza kontra
English: In a study of Genvoya in HIV-1 infected adults with end stage renal disease (estimated CrCl < 15 mL/min) on chronic haemodialysis, efficacy was maintained through 48 weeks but emtricitabine exposure was significantly higher than in patients with normal renal function.
Maltese: Fi studju ta' Genvoya f'adulti infettati b'HIV-1 b'marda tal-kliewi fl-aħħar stadju (CrCl stmata ta' < 15-il mL/min) fuq emodijalisi kronika, l-effikaċja nżammet sa ġimgħa 48 iżda l-esponiment għal emtricitabine kien ogħla b'mod sinifikanti milli f'pazjenti b'funzjoni tal-kliewi normali.
English: The pharmacokinetics of emtricitabine have not been studied in patients with hepatic impairment; however, emtricitabine is not significantly metabolised by liver enzymes, so the impact of liver impairment should be limited.
Maltese: Il-farmakokinetiċi ta' emtricitabine ma ġewx studjati f'pazjenti b'indeboliment epatiku; madankollu, emtricitabine ma jiġix metabolizzat b'mod sinifikanti mill-enzimi tal-fwied, u għalhekk l-impatt ta' indeboliment epatiku għandu jkun limitat.
English: ANTICONVULSANTS Carbamazepine (200 mg twice daily)/ Elvitegravir (150 mg once daily)/ Cobicistat (150 mg once daily)
Maltese: MEDIĊINI KONTRA L-KONVULŻJONIJIET Carbamazepine (200 mg darbtejn kuljum)/Elvitegravir (150 mg darba kuljum)/Cobicistat (150 mg darba kuljum)
English: Each film-coated tablet contains 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine and tenofovir alafenamide fumarate equivalent to 10 mg of tenofovir alafenamide.
Maltese: Kull pillola miksija b'rita fiha 150 mg ta' elvitegravir, 150 mg ta' cobicistat, 200 mg ta' emtricitabine u tenofovir alafenamide fumarate, ekwivalenti għal 10 mg ta' tenofovir alafenamide.
English: Baseline viral load ≤ 100,000 copies/mL > 100,000 copies/mL Baseline CD4+ cell count < 200 cells/mm3 ≥ 200 cells/mm3
Maltese: > 100,000 kopja/mL 171/196 (87%) Għadd ta' ċelluli CD4+ fillinja bażi < 200 ċellula/mm3 ≥ 200 ċellula/mm3 HIV-1 RNA < 20 kopja/mL 84.
English: HIV-1 infected patients with mild to moderate renal impairment In Study GS-US-292-0112, the efficacy and safety of Genvoya were evaluated in an open-label clinical study of 242 HIV-1 infected patients with mild to moderate renal impairment (eGFRCG: 30-69 mL/min).
Maltese: Pazjenti infettati bl-HIV-1 b'indeboliment renali ħafif sa moderat Fi Studju GS-US-292-0112, l-effikaċja u s-sigurtà ta' Genvoya ġew evalwati fi studju kliniku openlabel ta' 242 pazjent infettati bl-HIV-1 b'indeboliment renali ħafif sa moderat (eGFRCG:
English: cisapride (used to relieve certain stomach problems) St. John's wort (Hypericum perforatum, a herbal remedy used for depression and anxiety) or products that contain it lovastatin, simvastatin (used to lower blood cholesterol) pimozide, lurasidone (used to treat abnormal thoughts or feelings) sildenafil (when used to treat pulmonary arterial hypertension - a lung disease that makes breathing difficult) orally administered midazolam, triazolam (used to help you sleep and/or relieve anxiety)
Maltese: John's wort (Hypericum perforatum), rimedju li ġej mill-ħxejjex li jintuża għad-dipressjoni u l-ansjetà), jew prodotti li jinkluduh - lovastatin, simvastatin (jintużaw biex ibaxxu l-kolesterol fid-demm) - pimozide, lurasidone (jintużaw għal trattament ta' ħsibijiet jew sensazzjonijiet mhux normali) - sildenafil (meta jintuża għal trattament ta' pressjoni għolja arterjali pulmonari - marda tal-pulmun li tagħmilha diffiċli biex tieħu n-nifs) - midazolam li jingħata mill-ħalq, triazolam (jintużaw biex jgħinuk torqod u/jew biex itaffu l-ansjetà)  Jekk qed tieħu kwalunkwe minn dawn il-mediċini, tiħux Genvoya u għid lit-tabib tiegħek immedjatament.