FrancophonIA/ELRC3.0 huggingface dataset:
English: See sections 4.2, 4.4 and 5.1.
Maltese: Ara sezzjonijiet 4.2, 4.4 u 5
English: Genvoya contains lactose monohydrate.
Maltese: Genvoya fih lactose monohydrate.
English: anaemia1
Maltese: anemija1
English: Elvitegravir is an HIV-1 integrase strand transfer inhibitor (INSTI).
Maltese: Elvitegravir hu HIV-1 integrase strand transfer inhibitor (INSTI).
English: • gastrointestinal motility agents: cisapride
Maltese: • mediċini tal-motilità gastrointestinali: cisapride
English: Genvoya (n = 959)
Maltese: (n = 959)
English: PHOSPHODIESTERASE TYPE 5 (PDE-5) INHIBITORS Sildenafil
Maltese: TA' PHOSPHODIESTERASE TA' TIP 5 (PDE-5) Sildenafil
English: For more information see section 4, Possible side effects.
Maltese: Għal aktar informazzjoni ara sezzjoni 4, Effetti sekondarji possibbli.
English: Since the previous review, 6 new cases were identified (5 valid and 1 invalid).
Maltese: Sa mir-rieżami preċedenti, ġew identifikati 6 każijiet ġodda (5 validi u 1 invalidu).
English: Study GS-US-292-1515
Maltese: L-Istudju GS-US-292-1515
English: Sofosbuvir metabolite GS-566500:
Maltese: Metabolit ta' sofosbuvir GS-566500:
English: Table 2: Tabulated list of adverse reactions
Maltese: Tabella 2: Lista tabulata ta' reazzjonijiet avversi
English: Disopyramide Flecainide Systemic lidocaine Mexiletine Propafenone
Maltese: Disopyramide Flecainide Lidocaine sistemiku
English: sildenafil, tadalafil and vardenafil
Maltese: sildenafil, tadalafil u vardenafil
English: FTCa TAFa TFVa EVGe COBIe FTCe TAFf
Maltese: TAFa TFVa EVGe COBIe FTCe TAFf
English: angioedema3,4, pruritus, urticaria4
Maltese: anġjoedema3,4, ħakk, urtikarja4
English: Genvoya (n = 866)
Maltese: (n = 866)
English: Tricyclic antidepressants (TCAs) Trazodone
Maltese: Antidepressanti triċiklikċi (TCAs)
English: Each tablet contains 61 mg lactose (as monohydrate).
Maltese: Kull pillola fiha 61 mg ta' lactose (bħala monohydrate).
English: Selective serotonin reuptake inhibitors (SSRIs) Escitalopram
Maltese: Impedituri selettivi talassorbiment mill-ġdid ta' serotonin (selective serotonin reuptake inhibitors (SSRIs)) Escitalopram
English: Sofosbuvir/Velpatasvir/ Voxilaprevir (400 mg/100 mg/100 mg+100 mg once daily)7/
Maltese: Sofosbuvir/Velpatasvir/ Voxilaprevir (400 mg/100 mg/100 mg+100 mg darba kuljum)7/
English: Study GS-US-292-0106
Maltese: L-Istudju GS-US-292-0106
English: (18.9)b d
Maltese: (18.9)b
English: Tenofovir alafenamide is minimally metabolised by CYP3A4.
Maltese: Tenofovir alafenamide jiġi metabolizzat minimament minn CYP3A4.
English: Elvitegravir (antacid suspension after ± 2 hours):
Maltese: Elvitegravir (suspensjoni ta' antaċidu wara ± sagħtejn):
English: Genvoya [Outer packaging only]
Maltese: Genvoya [Pakkett ta' barra biss]
English: Patients with CrCl between 30 mL/min and 60 mL/min:
Maltese: Pazjenti b'CrCl bejn 30 mL/min u 60 mL/min:
English: Lactose (as monohydrate) Microcrystalline cellulose Croscarmellose sodium Hydroxypropyl cellulose Silicon dioxide Sodium lauryl sulfate Magnesium stearate
Maltese: Lactose (bħala monohydrate) Microcrystalline cellulose Croscarmellose sodium Hydroxypropyl cellulose Silicon dioxide Sodium lauryl sulphate Magnesium stearate
English: Adolescents aged 12 to < 18 years, ≥ 35 kg
Maltese: Adolexxenti ta' età minn 12 sa< 18-il sena, ≥ 35 kg
English: Sofosbuvir metabolite GS-331007:
Maltese: Metabolit ta' sofosbuvir GS-331007:
English: Cobicistat is an inhibitor of the following transporters: P-gp, breast cancer resistance protein (BCRP), organic anion transporting polypeptide (OATP) 1B1 and OATP1B3.
Maltese: P-gp, proteina ta' reżistenza għall-kanċer tas-sider (breast cancer resistance protein, (BCRP)), organic anion transporting polypeptide (OATP) 1B1 u OATP1B3.
English: (36.1)b c
Maltese: (36.1)b
English: digoxin, disopyramide, flecainide, lidocaine, mexiletine, propafenone, metoprolol, timolol, amlodipine, diltiazem, felodipine, nicardipine, nifedipine and verapamil
Maltese: • mediċini tal-qalb, bħal: digoxin, disopyramide, flecainide, lidocaine, mexiletine, propafenone, metoprolol, timolol, amlodipine, diltiazem, felodipine, nicardipine, nifedipine u verapamil
English: Lactose (as monohydrate), microcrystalline cellulose, croscarmellose sodium, hydroxypropyl cellulose, silicon dioxide, sodium lauryl sulfate, magnesium stearate.
Maltese: Lactose (bħala monohydrate), microcrystalline cellulose, croscarmellose sodium, hydroxypropyl cellulose, silicon dioxide, sodium lauryl sulphate, magnesium stearate.
English: Children aged 8 to < 12 years, > 25 kg
Maltese: Tfal ta' età minn 8 sa < 12-il sena, > 25 kg
English: Tenofovir alafenamide is a substrate of OATP in vitro.
Maltese: Tenofovir alafenamide hu substrat ta' OATP in vitro.
English: 90 (3 bottles of 30) film-coated tablets 90 (3 bottles of 30) tablets
Maltese: 90 (3 fliexken ta' 30) pillola miksija b'rita 90 (3 fliexken ta' 30) pillola
English: TAFb TFVb EVGe COBIe FTCe TAFf
Maltese: TAFb TFVb EVGe COBIe
English: Mitochondrial dysfunction following exposure in utero
Maltese: Disfunzjoni tal-mitokondrija wara esponiment in utero
English: Cobicistat and tenofovir alafenamide are not inhibitors of human UGT1A1 in vitro.
Maltese: Cobicistat u tenofovir alafenamide mhumiex impedituri ta' UGT1A1 uman in vitro.
English: 2T = second trimester; 3T = third trimester; PP =postpartum a paired comparisons b P<0.10 compared with postpartum
Maltese: 2T = it-tieni trimestru; 3T = it-tielet trimestru; PP = wara t-twelid a paraguni akkoppjati b P<0.10 imqabbla ma' wara t-twelid
English: 5.4% (95% CI: 1.5% to 9.2%)
Maltese: 5.4% (95% CI: 1.5% sa 9.2%)
English: Tenofovir alafenamide is active against hepatitis B virus (HBV).
Maltese: Tenofovir alafenamide huwa attiv kontra l-virus tal-epatite B (HBV - hepatitis B virus).
English: Tenofovir alafenamide and tenofovir have a median plasma half-life of 0.51 and 32.37 hours, respectively.
Maltese: Tenofovir alafenamide u tenofovir għandhom half-life medjana fil-plażma ta' 0.51 u 32.37 sigħat, rispettivament.
English: Reduced susceptibility to emtricitabine is associated with M184V/I mutations in HIV-1 RT.
Maltese: Suxxettibilità mnaqqsa għal emtricitabine hi assoċjata ma' mutazzjonijiet M184V/I fl-HIV-1 RT.
English: Table 1: Interactions between the individual components of Genvoya and other medicinal products
Maltese: Tabella 1: Interazzjonijiet bejn il-komponenti individwali ta' Genvoya u prodotti mediċinali oħra
English: Date of first authorisation: 19 November 2015
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 19 Novembru 2015
English: 4.1% (95% CI: 1.6% to 6.7%, p < 0.001c)
Maltese: 4.1% (95% CI: 1.6% sa 6.7%, p < 0.001c)
English: Table 4: Virologic outcomes of Study GS-US-292-0109 at Weeks 48a and 96b
Maltese: Tabella 4: Riżultati viroloġiċi ta' Studju GS-US-292-0109 f'Ġimgħat 48a u 96b
English: The active substances are elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide.
Maltese: Is-sustanzi attivi huma elvitegravir, cobicistat, emtricitabine u tenofovir alafenamide.
English: 3.7% (95% CI: 0.4% to 7.0%, p < 0.017c)
Maltese: 3.7% (95% CI: 0.4% sa 7.0%, p < 0.017c)
English: Overall, 22% had baseline plasma HIV-1 RNA > 100,000 copies/mL.
Maltese: Globalment, 22% kellhom HIV-1 RNA fil-plażma fil-linja bażi ta' > 100,000 kopja/mL.
English: Data are presented as mean (%CV).
Maltese: Id-dejta hi ppreżentata bħala medja (%CV).
English: Tenofovir alafenamide is a nucleotide reverse transcriptase inhibitor (NtRTI) and phosphonamidate prodrug of tenofovir (2'-deoxyadenosine monophosphate analogue).
Maltese: Tenofovir alafenamide hu impeditur ta' nucleotide reverse transcriptase (NtRTI) u phosphonamidate prodrug ta' tenofovir (2'-deoxyadenosine monophosphate analogue).
English: b Week 96 window was between Day 630 and 713 (inclusive).
Maltese: b L-intervall ta' żmien tal-Ġimgħa 96 kien bejn Jum 630 u 713 (inklużiv).
English: Emtricitabine is phosphorylated by cellular enzymes to form emtricitabine triphosphate.
Maltese: Emtricitabine jiġi fosforilat permezz ta' enzimi ċellulari biex jifforma emtricitabine triphosphate.
English: Baseline regimen (n = 477)
Maltese: (n = 477)
English: Tenofovir alafenamide is not an inhibitor of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, or CYP2D6.
Maltese: Tenofovir alafenamide mhuwiex impeditur ta' CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, jew CYP2D6.
English: Elvitegravir was negative in an in vitro bacterial mutagenicity test (Ames test) and negative in an in vivo rat micronucleus assay at doses up to 2,000 mg/kg.
Maltese: Elvitegravir kien negattiv f'test in vitro għal mutaġeniċità batterjali (it-test ta' Ames) u negattiv f'assaġġ in vivo tal-mikronukleu tal-firien f'dożi sa 2,000 mg/kg.
English: One patient in the Genvoya group (1 of 22 [4.5%]) and 2 patients in the E/C/F/TDF group (2 of 20 [10%]) had reduced susceptibility to tenofovir.
Maltese: Pazjent wieħed fil-grupp ta' Genvoya (1 minn 22 [4.5%]) u 2 pazjenti fil-grupp ta' E/C/F/TDF (2 minn 20 [10%]) kellhom suxxettibilità mnaqqsa għal tenofovir.
English: All corticosteroids excluding cutaneous products Corticosteroids primarily metabolised by CYP3A (including betamethasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone).
Maltese: Il-kortikosterojdi kollha minbarra prodotti għall-ġilda Kortikosterojdi primarjament metabolizzati minn CYP3A (inklużi betamethasone, budesonide, fluticasone. mometasone, prednisone, triamcinolone).
English: Emtricitabine is a nucleoside reverse transcriptase inhibitor (NRTI) and nucleoside analogue of 2'-deoxycytidine.
Maltese: Emtricitabine huwa impeditur ta' nucleoside reverse transcriptase (NRTI) u analogu tan-nukleosidi ta' 2'-deoxycytidine.
English: A cumulative review of all cases related to suicide-related events showed a total of 42 valid cases reporting 48 suicide-related events for Genvoya (13 from spontaneous, 29 from clinical trials).
Maltese: Rieżami kumulattiv tal-każijiet kollha relatati ma' avvenimenti relatati ma' suwiċidju wera total ta' 42 każ validu li rrappurtaw 48 avveniment relatat ma' suwiċidju għal Genvoya (13 spontanji, 29 minn provi kliniċi).
English: Similar patterns of psychiatric disorders were observed in comparative studies of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) versus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF), which lists these events in its product information (studies GS-US-292-0104 or GS-US-292-0111).
Maltese: Xejriet simili ta' disturbi psikjatriċi kienu osservati fi studji komparattivi ta' elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) kontra elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF), li jelenka dawn lavvenimenti fl-informazzjoni tal-prodott tiegħu (l-istudji GS-US-292-0104 jew GS-US-292-0111).
English: Emtricitabine has activity against HIV-1, HIV-2, and HBV.
Maltese: Emtricitabine għandu attività kontra HIV-1, HIV-2, u HBV.
English: At baseline, 80 patients (33%) had eGFRCG < 50 mL/min and 162 patients had eGFRCG ≥ 50 mL/min.
Maltese: Fil-linja bażi, 80 pazjent (33%) kellhom eGFRCG ta' < 50 mL/min u 162 pazjent kellhom eGFRCG ta' ≥ 50 mL/min.
English: Pharmacotherapeutic group: Antivirals for systemic use; antivirals for treatment of HIV infections, combinations.
Maltese: Antivirali għal użu sistemiku; antivirali ghat-trattament ta' infezzjonijiet tal-HIV, kombinazzjonijiet.
English: Tenofovir has activity against HIV-1, HIV-2, and HBV.
Maltese: Tenofovir għandu attività kontra HIV-1, HIV-2, u HBV.
English: In patients treated with Genvoya, 92% (46/50) achieved HIV-1 RNA < 50 copies/mL.
Maltese: F'pazjenti ttrattati bi Genvoya, 92% (46/50) kisbu HIV-1 RNA < 50 kopja/mL.
English: • antifungals, used to treat fungal infections, such as: ketoconazole, itraconazole, voriconazole, posaconazole and fluconazole
Maltese: • antifungali, li jintużaw għal trattament ta' infezzjonijiet fungali, bħal: ketoconazole, itraconazole, voriconazole, posaconazole u flucanazole
English: 0.4% (95% CI: -3.0% to 3.8%)
Maltese: 0.4% (95% CI: -3.0% sa 3.8%)
English: The mean age was 48 years (range 23-64).
Maltese: L-età medja kienet ta' 48 sena (medda 23-64).
English: Inhibitors of OATP and BCRP include ciclosporin.
Maltese: Impedituri ta' OATP u BCRP jinkludu ciclosporin.
English: 2.0% (95% CI: -0.7% to 4.7%)
Maltese: 2.0% (95% CI: -0.7% sa 4.7%)
English: In vitro, tenofovir alafenamide is not metabolised by CYP1A2, CYP2C8, CYP2C9, CYP2C19, or CYP2D6.
Maltese: In vitro, tenofovir alafenamide ma jiġix metabolizzat minn CYP1A2, CYP2C8, CYP2C9, CYP2C19, jew CYP2D6.
English: • elvitegravir, an antiretroviral medicine known as an integrase inhibitor
Maltese: • elvitegravir, mediċina antiretrovirali magħrufa bħala impeditur ta' integrase
English: Table 3: Pooled virologic outcomes of studies GS-US-292-0104 and GS-US-292-0111 at Weeks 48 and 144a,b
Maltese: GS-US-292-0104 u GS-US-292-0111 f'Ġimgħat 48 u 144a,b
English: In studies GS-US-292-0104 and GS-US-292-0111, patients were randomised in a 1:1 ratio to receive either Genvoya (n = 866) once daily or elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil (as fumarate) 245 mg (E/C/F/TDF) (n = 867) once daily.
Maltese: GS-US-292-0104 u GS-US-292-0111, il-pazjenti ntgħażlu b'mod każwali fi proporzjon ta' 1:1 biex jirċievu jew Genvoya (n = 866) darba kuljum jew elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil (bħala fumarate) 245 mg (E/C/F/TDF) (n = 867) darba kuljum.
English: EU/1/15/1061/001 30 film-coated tablets EU/1/15/1061/002 90 (3 bottles of 30) film-coated tablets
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/15/1061/001 30 pillola miksija b'rita EU/1/15/1061/002 90 (3 fliexken ta' 30) pillola miksija b'rita
English: The antiviral activity of tenofovir alafenamide against laboratory and clinical isolates of HIV-1 subtype B was assessed in lymphoblastoid cell lines, PBMCs, primary monocyte/macrophage cells and CD4+-T lymphocytes.
Maltese: L-attività antivirali ta' tenofovir alafenamide kontra iżolati tal-laboratorju u kliniċi ta' HIV-1 sottotip B ġiet evalwata f'razza ta' ċelluli limfoblastojdi, PBMCs, ċelluli monoċiti/makrofagi primarji u CD4+-T limfoċiti.
English: The safety of Genvoya has not been established in patients with severe renal impairment (estimated CrCl ≥ 15 mL/min and < 30 mL/min).
Maltese: Is-sigurtà ta' Genvoya ma ġietx stabbilita f'pazjenti b'indeboliment renali sever (CrCl stmata ta' ≥ 15-il mL/min u < 30 mL/min).
English: Reduced susceptibility to elvitegravir is most commonly associated with the primary integrase mutations T66I, E92Q, and Q148R.
Maltese: Suxxettibbilita mnaqqsa għal elvitegravir hi b'mod l-aktar komuni assoċjata mal-mutazzjonijiet primarji ta' integrase T66I, E92Q, u Q148R.
English: Tenofovir alafenamide is transported by P-gp and BCRP.
Maltese: Tenofovir alafenamide jiġi ttrasportat minn P-gp u BCRP.
English: HIV-1 RNA ≥ 50 copies/mLd
Maltese: HIV-1 RNA ≥ 50 kopja/mLd
English: Other types of medicine:
Maltese: Kategorija farmakoterapewtika:
English: {MM/YYYY}
Maltese: {numru} SN:
English: Intracellular tenofovir is subsequently phosphorylated to the pharmacologically active metabolite tenofovir diphosphate.
Maltese: Tenofovir intraċellulari jiġi fosforilat sussegwentement għall-metabolit farmakoloġikament attiv tenofovir diphosphate.
English: • sedatives and hypnotics, used to treat anxiety: buspirone, clorazepate, diazepam, estazolam, flurazepam, zolpidem and lorazepam
Maltese: • sedattivi u mediċini ipnotiċi, li jintużaw għal trattament tal-ansjetà: buspirone, clorazepate, diazepam, estazolam, flurazepam, zolpidem u lorazapem
English: • tenofovir alafenamide, an antiretroviral medicine known as a nucleotide reverse transcriptase inhibitor (NtRTI)
Maltese: • tenofovir alafenamide, mediċina antiretrovirali magħrufa bħala impeditur tan-nucleotide reverse transcriptase (NtRTI)
English: • cobicistat, a booster (pharmacokinetic enhancer) of the effects of elvitegravir
Maltese: • cobicistat, mediċina li ssaħħaħ (enhancer farmakinetiku) l-effetti ta' elvitegravir
English: The adverse reactions in Table 2 are listed by system organ class and frequency.
Maltese: Ir-reazzjonijiet avversi f'Tabella 2 huma elenkati skont is-sistema tal-klassifika tal-organi u lfrekwenza.
English: Genvoya demonstrated statistical superiority in achieving HIV-1 RNA < 50 copies/mL when compared to E/C/F/TDF at Week 144.
Maltese: Genvoya wera superjorità statistika meta kiseb HIV-1 RNA < 50 kopja/mL meta mqabbel ma' E/C/F/TDF f'Ġimgħa 144.
English: The safety profile of Genvoya in patients with mild to moderate renal impairment was similar to that in patients with normal renal function (see section 5.1).
Maltese: Il-profil tas-sigurtà ta' Genvoya f'pazjenti b'indeboliment renali minn ħafif sa moderat kien simili għal dak f'pazjenti b'funzjoni normali renali (ara sezzjoni 5.1).
English: At baseline, median eGFR was 56 mL/min.
Maltese: Fil-linja bażi, l-eGFR medjan kien ta' 56 mL/min.
English: Cobicistat is metabolised via CYP3A (major)- and CYP2D6 (minor)-mediated oxidation and does not undergo glucuronidation.
Maltese: Cobicistat hu metabolizzat permezz ta' CYP3A (maġġuri)- u ossidazzjoni medjata minn CYP2D6 (minuri)- u ma jgħaddix minn glukoronidazzjoni.
English: d n = 15 adolescents.
Maltese: N/A 15.
English: Mean % change of cobicistat pharmacokinetic parametersa
Maltese: Bidla % medja fil-parametri talfarmakokinetika ta' cobicistata
English: HIV-1 isolates with the K65R mutation have low-level reduced susceptibility to abacavir, emtricitabine, tenofovir, and lamivudine.
Maltese: Iżolati ta' HIV-1 bil-mutazzjoni K65R, għandhom suxxettibilità mnaqqsa ta' livell baxx għal abacavir, emtricitabine, tenofovir, u lamivudine.
English: Three patients with emergent HIV-1 resistance to Genvoya were identified (M184M/I; M184I+E92G; M184V+E92Q) up to Week 96 in a clinical study of virologically suppressed patients who switched from a regimen containing emtricitabine/tenofovir disoproxil and a third agent (GS-US-292-0109, n = 959).
Maltese: Tliet pazjenti b'reżistenza emerġenti ta' HIV-1 għal Genvoya ġew identifikati (M184M/I; M184I+E92G; M184V+E92Q) sa Ġimgħa 96 fi studju kliniku dwar pazjenti b'soppressjoni virali li qalbu minn kors li kien fih emtricitabine/tenofovir disoproxil u t-tielet mediċina (GS-US-292-0109, n = 959).
English: Genvoya 150 mg/150 mg/200 mg/10 mg film-coated tablets Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide
Maltese: Genvoya 150 mg/150 mg/200 mg/10 mg pilloli miksija b'rita Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide
English: 4.2% (95% CI: 0.6% to 7.8%)
Maltese: 4.2% (95% CI: 0.6% sa 7.8%)
English: The mean age was 58 years (range 24-82), with 63 patients (26%) who were ≥ 65 years of age.
Maltese: L-età medja kienet ta' 58 sena (medda 24-82), bi 63 pazjent (26%) li kellhom ≥ 65 sena.
English: Buprenorphine/Naloxone (16/4 to 24/6 mg)/ Elvitegravir (150 mg once daily)/ Cobicistat (150 mg once daily)
Maltese: Buprenorphine/Naloxone (16/4 sa 24/6 mg)/Elvitegravir (150 mg darba kuljum)/Cobicistat (150 mg darba kuljum)
English: The median (Q1, Q3) change from baseline in total cholesterol to HDL-cholesterol ratio at Week 144 was 0.2 (-0.3, 0.7) in the Genvoya group and 0.1 (-0.4, 0.6) in the E/C/F/TDF group (p = 0.006 for the difference between treatment groups).
Maltese: Il-medjan tal-bidla (Q1, Q3) mil-linja bażi fil-kolesterol totali mal-proporzjon ta' kolesterol ta' HDL f'Ġimgħa 144 kien ta' 0.2 (-0.3, 0.7) fil-grupp ta' Genvoya u ta' 0.1 (-0.4, 0.6) filgrupp ta' E/C/F/TDF (p = 0.006 għad-differenza bejn il-gruppi tat-trattament).
English: Green, capsule-shaped, film-coated tablet of dimensions 19 mm x 8.5 mm, debossed with “GSI” on one side of the tablet and “510” on the other side of the tablet.
Maltese: Pillola miksija b'rita, ħadra, forma ta' kapsula, b'daqs ta' 19 mm x 8.5 mm, imnaqqxa b'“GSI” fuq naħa waħda tal-pillola u “510” fuq in-naħa l-oħra tal-pillola.
English: Mean increases from baseline in the Genvoya group were smaller than in the elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil (as fumarate) 245 mg (E/C/F/TDF) group at Week 144 (difference -0.04, p < 0.001).
Maltese: Żidiet medji mil-linja bażi fil-grupp ta' Genvoya kienu iżgħar milli fil-grupp ta' elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil (bħala fumarate) 245 mg (E/C/F/TDF) f'Ġimgħa 144 (differenza -0.04, p < 0.001).
English: Inhibition of integrase prevents the integration of HIV-1 deoxyribonucleic acid (DNA) into host genomic DNA, blocking the formation of the HIV-1 provirus and propagation of the viral infection.
Maltese: L-inibizzjoni ta' integrase timpedixxi l-integrazzjoni ta' HIV-1 deoxyribonucleic acid (DNA) ġo host genomic DNA, u timblokka l-formazzjoni tal-HIV-1 provirus u l-propagazzjoni tal-infezzjoni virali.
English: The mean baseline CD4+ cell count was 545 cells/mm3 (range 205-1473).
Maltese: L-għadd medju ta' ċelluli CD4+ fil-linja bażi kien ta' 545 ċellula/mm3 (medda 205-1473).
English: The most frequently reported adverse reactions in clinical studies through 144 weeks were nausea (11%), diarrhoea (7%), and headache (6%) (pooled data from Phase 3 clinical studies GS-US-292-0104 and GS-US-292-0111 in 866 treatment-naïve adult patients receiving Genvoya).
Maltese: L-iktar reazzjonijiet avversi li kienu rrappurtati b'mod frekwenti fi studji kliniċi wara 144 ġimgħa kienu ttqalligħ (11%), dijarea (7%) u uġigħ ta' ras (6%) (dejta miġbura minn studji kliniċi ta' Fażi 3 GS-US-292-0104 u GS-US-292-0111 fi 866 pazjent adult li qatt ma ngħataw trattament fil-passat li kienu qed jirċievu Genvoya).
English: Genvoya 150 mg/150 mg/200 mg/10 mg film-coated tablets.
Maltese: Genvoya 150 mg/150 mg/200 mg/10 mg pilloli miksija b'rita.
English: Co-administration with dabigatran etexilate, a P-glycoprotein (P-gp) substrate, is contraindicated (see section 4.5).
Maltese: L-għoti flimkien ma' dabigatran etexilate, substrat tal-glikoproteina P (P-gp - P-glycoprotein), huwa kontraindikat (ara sezzjoni 4.5).
English: The systemic clearance of emtricitabine averaged 307 mL/min.
Maltese: It-tneħħija sistemika ta' emtricitabine kienet fil-medja ta' 307 mL/min.
English: Inhibition of CYP3A-mediated metabolism by cobicistat enhances the systemic exposure of CYP3A substrates, such as elvitegravir, where bioavailability is limited and half-life is shortened by CYP3A-dependent metabolism.
Maltese: L-inibizzjoni tal-metaboliżmu medjat minn CYP3A minn cobicistat ittejjeb lesponiment sistemiku ta' substrati ta' CYP3A, bħal elvitegravir, fejn il-bijodisponibilità hi limitata u lhalf-life titqassar mill-metaboliżmu dipendenti fuq CYP3A.
English: Cobicistat is a selective, mechanism-based inhibitor of cytochrome P450 (CYP) enzymes of the CYP3A subfamily.
Maltese: Cobicistat hu impeditur selettiv, ibbażat fuq il-mekkaniżmu, ta' enzimi ta' ċitokrom P450 (CYP) tassottofamilja ta' CYP3A.
English: The mean baseline CD4+ cell count was 664 cells/mm3 (range 126-1,813).
Maltese: L-għadd medju ta' ċelluli CD4+ fil-linja bażi kien ta' 664 ċelluli/mm3 (medda 126-1,813).
English: • erectile dysfunction medicines, used to treat impotence, such as:
Maltese: • mediċini għal trattament ta' disfunzjoni erettili, li jintużaw għat-trattament ta' impotenza,
English: The mean baseline CD4+ cell count was 697 cells/mm3 (range 79-1,951).
Maltese: L-għadd medju ta' ċelluli CD4+ fil-linja bażi kien ta' 697 ċelluli/mm3 (medda 79-1,951).
English: The K65R and K70E mutations result in reduced susceptibility to abacavir, didanosine, lamivudine, emtricitabine, and tenofovir, but retain sensitivity to zidovudine.
Maltese: Il-mutazzjonijiet K65R u K70E jirriżultaw f'suxxettibilità mnaqqsa għal abacavir, didanosine, lamivudine, emtricitabine, u tenofovir, iżda jżommu s-sensittività għal zidovudine.
English: ANTI-INFECTIVES Antifungals
Maltese: MEDIĊINI KONTRA L-INFEZZJONIJIET Antifungali
English: Mean % change of elvitegravir pharmacokinetic parametersa
Maltese: Bidla % medja fil-parametri talfarmakokinetika ta' elvitegravira