FrancophonIA/ELRC3.0 huggingface dataset:
English: This authorisation was based on the authorisation granted to Renvela in 2009 (‘informed consent').
Maltese: Din l-awtorizzazzjoni kienet ibbażata fuq l-awtorizzazzjoni mogħtija lil Renvela fl2009 (‘kunsens infurmat').
English: Side effects reported with Sevelamer carbonate Winthrop are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Sevelamer carbonate Winthrop huma evalwati birreqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: As for all medicines, data on the use of Sevelamer carbonate Winthrop are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Sevelamer carbonate Winthrop hija ssorveljata kontinwament.
English: Sevelamer carbonate Winthrop has been shown in studies to be effective at lowering levels of blood phosphate in patients with hyperphosphataemia.
Maltese: Studji wrew li Sevelamer carbonate Winthrop huwa effettiv biex jitbaxxew il-livelli ta' fosfat fid-demm f'pazjenti b'iperfosfatemija.
English: Studies show that Sevelamer carbonate Winthrop is effective at reducing levels of blood phosphate in patients with hyperphosphataemia, and its side effects are considered manageable.
Maltese: Studji juru li Sevelamer carbonate Winthrop huwa effettiv biex inaqqas il-livelli ta' fosfat fid-demm f'pazjenti b'iperfosfatemija, u l-effetti sekondarji tiegħu huma kkunsidrati ġestibbli.
English: How is Sevelamer carbonate Winthrop used?
Maltese: Kif jaħdem Sevelamer carbonate Winthrop?
English: The most common side effects with Sevelamer carbonate Winthrop (which may affect more than 1 in 10 people) are nausea (feeling sick), vomiting, upper abdominal (belly) pain and constipation.
Maltese: L-effetti sekondarji l-aktar komuni b'Sevelamer carbonate Winthrop (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10) huma nawżja (tħossok ma tiflaħx), rimettar, uġigħ addominali fil-parti ta' fuq (fiż-żaqq) u stitikezza.
English: ATC code: J05AR17.
Maltese: J05AR17.
English: Triple nucleoside therapy
Maltese: Terapija nukleoside tripla
English: Table 3: Tabulated list of adverse reactions1
Maltese: Tabella 3: Lista tabulata ta' reazzjonijiet avversi1
English: < 50 years ≥ 50 years
Maltese: < 50 sena ≥ 50 sena
English: a n = 24 adolescents (GS-US-292-0106); n = 19 adults (GS-US-292-0102) b n = 23 adolescents (GS-US-292-0106, population PK analysis) c n = 539 (TAF) or 841 (TFV) adults (GS-US-292-0111 and GS-US-292-0104, population PK analysis)
Maltese: n = 19 adulti (GS-US-292-0102) b n = 23 adolexxenti (GS-US-292-0106, analiżi PK tal-popolazzjoni) c n = 539 (TAF) jew 841 (TFV) adulti (GS-US-292-0111 u GS-US-292-0104, analiżi PK tal-popolazzjoni)
English: Tablet core: Microcrystalline cellulose, croscarmellose sodium, magnesium stearate.
Maltese: Microcrystalline cellulose, croscarmellose sodium, magnesium stearate.
English: Table 2: Interactions between the individual components of Descovy and other medicinal products
Maltese: Tabella 2: Interazzjonijiet bejn il-komponenti individwali ta' Descovy u prodotti mediċinali oħra
English: rifabutin, rifampicin, and rifapentine
Maltese: rifabutin, rifampicin, u rifapentine
English: Film-coating: Polyvinyl alcohol, titanium dioxide, macrogol 3350, talc, iron oxide black (E172).
Maltese: Polyvinyl alcohol, titanium dioxide, macrogol 3350, talc, iron oxide black (E172).
English: EU/1/16/1099/001 EU/1/16/1099/002
Maltese: EU/1/16/1099/002
English: Film-coating: Polyvinyl alcohol, titanium dioxide, macrogol 3350, talc, indigo carmine aluminium lake (E132).
Maltese: Polyvinyl alcohol, titanium dioxide, macrogol 3350, talc, indigo carmine aluminium lake (E132).
English: Date of first authorisation: 21 April 2016
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 21 April 2016
English: Tenofovir alafenamide is a substrate of OATP1B1 and OATP1B3 in vitro.
Maltese: Tenofovir alafenamide hu substrat ta' OATP1B1 u OATP1B3 in vitro.
English: Tenofovir alafenamide is not an inhibitor of human uridine diphosphate glucuronosyltransferase (UGT) 1A1 in vitro.
Maltese: Tenofovir alafenamide mhuwix impeditur ta' uridine diphosphate glucuronosyltransferase (UGT) 1A1 uman in vitro.
English: Emtricitabine/tenofov ir disoproxil fumarate containing regimen (n = 330)
Maltese: Kors li fih emtricitabine/ tenofovir disoproxil fumarate (n = 330)
English: It is not an inhibitor or inducer of CYP3A in vivo.
Maltese: Mhuwiex impeditur jew induttur ta' CYP3A in vivo.
English: EU/1/16/1099/003 EU/1/16/1099/004
Maltese: EU/1/16/1099/004
English: emtricitabine and tipranavir
Maltese: emtricitabine u tipranavir
English: {MM/YYYY}
Maltese: {numru} NN: {numru}
English: Tenofovir alafenamide is not an inhibitor of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, or CYP2D6 in vitro.
Maltese: Tenofovir alafenamide mhuwiex impeditur ta' CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, jew CYP2D6 in vitro.
English: E/C/F/TAF = elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide fumarate FTC = emtricitabine; TAF = tenofovir alafenamide fumarate; TFV = tenofovir N/A = not applicable
Maltese: E/C/F/TAF = elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide fumarate FTC = emtricitabine; TAF = tenofovir alafenamide fumarate;
English: Baseline viral load ≤ 100,000 copies/mL > 100,000 copies/mL
Maltese: Ammont virali fil-linja bażi ≤ 100,000 kopja/mL
English: The active substances are emtricitabine and tenofovir alafenamide.
Maltese: Is-sustanzi attivi huma emtricitabine u tenofovir alafenamide.
English: • Use effective contraception while taking Descovy.
Maltese: • Uża kontraċezzjoni effettiva waqt li tkun qed tieħu Descovy.
English: The 50% effective concentration (EC50) values for emtricitabine were in the range of 0.0013 to 0.64 μM.
Maltese: Il-figuri tal-50% konċentrazzjoni effettiva (EC50) għal emtricitabine kienu fil-medda ta' 0.0013 sa 0.64 µM.
English: Tenofovir alafenamide is transported by P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP).
Maltese: Tenofovir alafenamide jiġi ttrasportat minn P-glikoproteina (P-gp) u proteina ta' reżistenza għallkanċer tas-sider (Breast Cancer Resistance Protein, BCRP).
English: ANTICONVULSANTS Oxcarbazepine Phenobarbital Phenytoin
Maltese: carbamazepine, oxcarbazepine, phenobarbital u phenytoin
English: In vitro 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: Tipranavir/ritonavir results in P-gp induction.
Maltese: Tipranavir/ritonavir jirriżulta f'induzzjoni ta' P-gp.
English: At baseline, median eGFR was 56 mL/min, and 33% of patients had an eGFR from 30 to 49 mL/min.
Maltese: Fil-linja bażi, l-eGFR medjan kien ta' 56 mL/min, u 33% tal-pazjenti kellhom eGFR minn 30 sa 49 mL/min.
English: No emergent resistance to E/C/F/TAF was detected through Week 48.
Maltese: Ma ġiet osservata l-ebda reżistenza emerġenti għal E/C/F/TAF sa Ġimgħa 48.
English: HIV-1 RNA ≥ 50 copies/mLc
Maltese: HIV-1 RNA ≥ 50 kopja/mLc
English: None of the changes was considered clinically relevant.
Maltese: L-ebda bidla ma kienet meqjusa klinikament rilevanti.
English: • emtricitabine, an antiretroviral medicine of a type known as a nucleoside reverse transcriptase inhibitor (NRTI)
Maltese: • emtricitabine, mediċina antiretrovirali of a type magħrufa bħala impeditur tan-nucleoside reverse transcriptase (NRTI - nucleoside reverse transcriptase inhibitor)
English: ORAL CONTRACEPTIVES Norgestimate (0.180/0.215/0.250 mg once daily), ethinylestradiol (0.025 mg once daily), emtricitabine/tenofovir alafenamide (200/25 mg once daily)5
Maltese: Norgestimate (0.180/0.215/0.250 mg darba kuljum), ethinylestradiol (0.025 mg darba kuljum), emtricitabine/tenofovir alafenamide (200/25 mg darba kuljum)5
English: In the E/C/F/TAF group, the mutations that emerged were M184V/I (n = 11) and K65R/N (n = 2) in RT and T66T/A/I/V (n = 2), E92Q (n = 4), Q148Q/R (n = 1), and N155H (n = 2) in integrase.
Maltese: Fil-grupp ta' E/C/F/TAF, il-mutazzjonijiet li ħarġu kienu M184V/I (n = 11) u K65R/N (n = 2) f'RT u T66T/A/I/V (n = 2), E92Q (n = 4), Q148Q/R (n = 1) u N155H (n = 2) f'integrase.
English: Pharmacotherapeutic group: Antiviral for systemic use; antivirals for treatment of HIV infections, combinations.
Maltese: Antiviral għal użu sistemiku; antivirali għat-trattament ta' infezzjonijiet tal-HIV, kombinazzjonijiet.
English: Descovy containing regimen (n = 333)
Maltese: (n = 333)
English: < 20 copies/mL
Maltese: > 100,000 kopja/mL
English: Descovy should not be administered concomitantly with medicinal products containing tenofovir alafenamide, tenofovir disoproxil, emtricitabine, lamivudine or adefovir dipivoxil.
Maltese: Descovy m'għandux jingħata fl-istess ħin ma' prodotti mediċinali li jkun fihom tenofovir alafenamide, tenofovir disoproxil, emtricitabine, lamivudine jew adefovir dipivoxil.
English: Baseline CD4+ cell count < 200 cells/mm3
Maltese: Għadd ta' ċelluli CD4+ fillinja bażi < 200 ċellula/mm3 ≥ 200 ċellula/mm3
English: Table 5: Virological outcomes of Study GS-US-299-0102 at Week 24 and 48a
Maltese: Riżultati viroloġiċi ta' Studju GS-US-299-0102 f'Ġimgħa 24 u 48a
English: N/A 10.6
Maltese: Ġimgħa 96
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: The adverse reactions in Table 3 are listed by system organ class and frequency.
Maltese: Ir-reazzjonijiet avversi f'Tabella 3 huma elenkati skont is-sistema tal-klassifika tal-organi u lfrekwenza.
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: Table 6: Virological outcomes of Study GS-US-311-1089 at Weeks 48a and 96b
Maltese: Riżultati viroloġiċi ta' Studju GS-US-311-1089 f'Ġimgħat 48a u 96b
English: -0.5% (95% CI: -5.3% to 4.4%)
Maltese: -0.5% (95% CI: -5.3% sa 4.4%)
English: 1.3% (95% CI: -2.5% to 5.1%)
Maltese: 1.3% (95% CI: -2.5% sa 5.1%)
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 E/C/F/TAF 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' E/C/F/TAF u ta' 0.1 (-0.4, 0.6) fil-grupp ta' E/C/F/TDF (p = 0.006 għad-differenza bejn il-gruppi tat-trattament).
English: b In both studies, patients were stratified by baseline HIV-1 RNA (≤ 100,000 copies/mL, > 100,000 copies/mL to ≤ 400,000 copies/mL, or > 400,000 copies/mL), by CD4+ cell count (< 50 cells/μL, 50-199 cells/μL, or ≥ 200 cells/μL), and by region (US or ex-US).
Maltese: b Fiż-żewġ studji, il-pazjenti ġew stratifikati skont HIV-1 RNA fil-linja bażi (≤ 100,000 kopja/mL, > 100,000 kopja/mL sa ≤ 400,000 kopja/mL, jew > 400,000 kopja/mL), skont l-għadd ta' ċelluli CD4+ (< 50 ċellula/μL, 50-199 ċellula/μL, jew ≥ 200 ċellula/μL), u skont ir-reġjun (Stati Uniti jew barra mill-Istati Uniti).
English: • tenofovir alafenamide, an antiretroviral medicine of a type known as a nucleotide reverse transcriptase inhibitor (NtRTI)
Maltese: • tenofovir alafenamide, mediċina antiretrovirali ta' tip magħrufa bħala impeditur tan-nucleotide reverse transcriptase (NtRTI)
English: Table 4: Pooled virological 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: Of the HIV-1 isolates from 12 patients with resistance development in the E/C/F/TDF group, the mutations that emerged were M184V/I (n = 9), K65R/N (n = 4), and L210W (n = 1) in RT and E92Q/V (n = 4) and Q148R (n = 2), and N155H/S (n=3) in integrase.
Maltese: Mill-iżolati tal-HIV-1 minn 12-il pazjent li żviluppaw reżistenza fil-grupp ta' E/C/F/TDF, il-mutazzjonijiet li ħarġu kienu M184V/I (n = 9), K65R/N (n = 4), u L210W (n = 1) f'RT u E92Q/V (n = 4) u Q148R (n = 2), u N155H/S (n = 3) f'integrase.
English: Relative to fasting conditions, the administration of tenofovir alafenamide with a high fat meal (~800 kcal, 50% fat) resulted in a decrease in tenofovir alafenamide Cmax (15-37%) and an increase in AUClast (17-77%).
Maltese: Meta mqabbel ma' kundizzjonijiet fl-istat sajjem, l-għoti ta' tenofovir alafenamide ma' ikla b'ħafna xaħam (~800 kcal, 50% xaħam) irriżulta fi tnaqqis fis-Cmax (15-37%) ta' tenofovir alafenamide u żieda fl-AUClast (17-77%).
English: EU/1/16/1099/003 30 film-coated tablets EU/1/16/1099/004 90 (3 bottles of 30) film-coated tablets
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/16/1099/003 30 pillola miksija b'rita EU/1/16/1099/004 90 (3 fliexken ta' 30) pillola miksija b'rita
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: 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: At 48 weeks, 92% (46/50) achieved HIV-1 RNA < 50 copies/mL, similar to response rates in studies of treatment-naïve HIV-1 infected adults.
Maltese: Wara 48 ġimgħa, 92% (46/50) kisbu HIV-1 RNA < 50 kopja/mL, simili għal rati ta' rispons fl-istudji ta' adulti infettati bl-HIV-1 li qatt ma ngħataw trattament fil-passat.
English: Descovy 200 mg/10 mg [Outer packaging only]
Maltese: Descovy 200 mg/10 mg [Pakkett ta' barra biss]
English: In clinical studies of 866 treatment-naïve adult patients receiving emtricitabine and tenofovir alafenamide with elvitegravir and cobicistat as the fixeddose combination tablet elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide (as fumarate) 10 mg (E/C/F/TAF) through 144 weeks, the most frequently reported adverse reactions were diarrhoea (7%), nausea (11%), and headache (6%).
Maltese: Fi studji kliniċi ta' 866 pazjent adult li qatt ma ngħataw trattament fil-passat, li kienu qed jirċievu emtricitabine u tenofovir alafenamide ma' elvitegravir u cobicistat bħala l-pillola kombinata ta' doża fissa ta' elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide (bħala fumarate) 10 mg (E/C/F/TAF) matul 144 ġimgħa, l-iktar reazzjonijiet avversi li kienu rrappurtati b'mod frekwenti kienu dijarea (7%), dardir (11%) u wġigħ ta' ras (6%).
English: ANTIRETROVIRALS HIV protease inhibitors Atazanavir/cobicistat (300 mg/150 mg once daily), tenofovir alafenamide (10 mg)
Maltese: Inibituri tal-protease tal-HIV Atazanavir/cobicistat (300 mg/150 mg darba kuljum), tenofovir alafenamide (10 mg)
English: The frequencies were derived from Phase 3 E/C/F/TAF clinical studies in 866 treatment-naïve adult patients through 144 weeks of treatment (GS-US-292-0104 and GS-US-292-0111).
Maltese: Il-frekwenzi nkisbu minn studji kliniċi ta' Fażi 3 ta' E/C/F/TAF li saru fuq 866 pazjent adult li qatt ma ngħataw trattament fil-passat sa 144 ġimgħa ta' kura (GS-US-292-0104 u GS-US-292-0111).
English: Descovy 200 mg/10 mg film-coated tablets emtricitabine/tenofovir alafenamide
Maltese: Descovy 200 mg/10 mg pilloli miksija b'rita emtricitabine/tenofovir alafenamide
English: Emtricitabine triphosphate inhibits HIV replication through incorporation into viral deoxyribonucleic acid (DNA) by the HIV reverse transcriptase (RT), which results in DNA chaintermination.
Maltese: Emtricitabine triphosphate jinibixxi r-replikazzjoni tal-HIV permezz ta' inkorporazzjoni fid-deoxyribonucleic acid (DNA) virali mill-HIV reverse transcriptase (RT), li tirriżulta fitterminazzjoni tal-katina tad-DNA.
English: Descovy 200 mg/25 mg film-coated tablets emtricitabine/tenofovir alafenamide
Maltese: Descovy 200 mg/25 mg pilloli miksija b'rita emtricitabine/tenofovir alafenamide
English: E/C/F/TAF demonstrated statistical superiority in achieving HIV-1 RNA < 50 copies/mL when compared to E/C/F/TDF at Week 144.
Maltese: Il-grupp ta' E/C/F/TAF 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 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 f'pazjenti b'indeboliment renali minn ħafif sa moderat kien simili għal dak f'pazjenti b'funzjoni normali renali (ara sezzjoni 5.1).
English: EU/1/16/1099/001 30 film-coated tablets EU/1/16/1099/002 90 (3 bottles of 30) film-coated tablets
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/16/1099/001 30 pillola miksija b'rita EU/1/16/1099/002 90 (3 fliexken ta' 30) pillola miksija b'rita
English: 7 Study conducted with additional voxilaprevir 100 mg to achieve voxilaprevir exposurers expected in HCV-infected patients.
Maltese: 7 Studju mwettaq b'voxilaprevir 100 mg addizzjonali biex jinkisbu l-esponimenti għal voxilaprevir mistennija f'pazjenti infettati bl-HCV.
English: D/C/F/TAF = darunavir/cobicistat/emtricitabine/tenofovir alafenamide a Week 48 window was between Day 294 and 377 (inclusive).
Maltese: D/C/F/TAF = darunavir/cobicistat/emtricitabine/tenofovir alafenamide a L-intervall ta' żmien ta' Ġimgħa 48 kien bejn Jum 294
English: At Week 48, the median percentage change in urine retinol binding protein to creatinine ratio was 4% in the Descovy group and 16% in those remaining on an abacavir/lamivudine containing regimen; and in urine beta-2 microglobulin to creatinine ratio it was 4% vs. 5%.
Maltese: F'Ġimgħa 48, il-bidla perċentwali medjana fil-proporzjon ta' proteina li teħel ma' retinol għal kreatinina fl-awrina kienet ta' 4% fil-grupp ta' Descovy u 16% f'dawk li baqgħu fuq kors li kien fih abacavir/lamivudine; u fil-proporzjon ta' beta-2 mikroglobulina għal kreatinina fl-awrina kienet ta' 4% vs 5%.
English: to 1.5 μM).
Maltese: 01-25 μg/mL.
English: The safety profile of emtricitabine and tenofovir alafenamide given with elvitegravir and cobicistat in 50 adolescent patients was similar to that in adults (see section 5.1).
Maltese: Il-profil tas-sigurtà ta' emtricitabine u tenofovir alafenamide mogħtija ma' elvitegravir u cobicistat f'50 pazjent adolexxenti li kien simili għal dak fl-adulti (ara sezzjoni 5.1).
English: The mean age was 36 years (range: 18-76), 85% were male, 57% were White, 25% were Black, and 10% were Asian.
Maltese: Letà medja kienet ta' 36 sena (medda: 18-76), 85% kienu rġiel, 57% kienu Bojod, 25% kienu Suwed, u 10% kienu Asjatiċi.
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: L-età 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: Efavirenz (600 mg once daily), tenofovir alafenamide (40 mg once daily)4
Maltese: Efavirenz (600 mg darba kuljum), tenofovir alafenamide (40 mg darba kuljum)4
English: The safety of emtricitabine and tenofovir alafenamide has not been established in patients with severe renal impairment (estimated CrCl ≥ 15 mL/min and < 30 mL/min).
Maltese: Is-sigurtà ta' emtricitabine u tenofovir alafenamide ma ġietx stabbilita f'pazjenti b'indeboliment renali sever (CrCl stmata ta' ≥ 15-il mL/min u < 30 mL/min).
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+ fil-linja bażi kienet ta' 427 ċellula/mm3 (medda: 0-1,360) u 13% kellhom għadd ta' ċelluli CD4+ ta' < 200 ċellula/mm3.
English: HIV-1 RNA < 50 copies/mL 92% Treatment difference
Maltese: HIV-1 RNA < 50 kopja/mL 92%
English: Descovy 200 mg/25 mg [Outer packaging only]
Maltese: Descovy 200 mg/25 mg [Pakkett ta' barra biss]
English: Carbamazepine (titrated from 100 mg to 300 mg twice a day), emtricitabine/tenofovir alafenamide (200 mg/25 mg once daily)5,6
Maltese: Carbamazepine (ittitrat minn 100 mg għal 300 mg darbtejn kuljum), emtricitabine/tenofovir alafenamide (200 mg/25 mg darba kuljum)5,6
English: Frequencies are defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10) and uncommon (≥ 1/1,000 to
Maltese: Il-frekwenzi huma deskritti kif ġej bħala: komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10) u mhux komuni (≥ 1/1,000 sa < 1/100).
English: Atazanavir/ritonavir (300/100 mg once daily), tenofovir alafenamide (10 mg)
Maltese: Atazanavir/ritonavir (300/100 mg darba kuljum), tenofovir alafenamide (10 mg)
English: Descovy should be discontinued in patients with estimated CrCl that declines below 30 mL/min during treatment (see section 5.2).
Maltese: Descovy għandu jitwaqqaf f'pazjenti b'CrCl stmata li tonqos taħt 30 mL/min waqt it-trattament (ara sezzjoni 5.2).
English: The mean baseline CD4+ cell count was 636 cells/mm3 (range 263-1498).
Maltese: L-għadd medju ta' ċelluli CD4+ fil-linja bażi kien ta' 636 ċellula/mm3 (firxa ta' 263-1498).
English: There are limited clinical data on the use of E/C/F/TAF in HIV/HBV co-infected patients who are treatment-naïve.
Maltese: Hemm data klinika limitata dwar l-użu ta' E/C/F/TAF f'pazjenti koinfettati b'HIV/HBV li qatt ma ħadu trattament qabel.
English: In studies in treatment-naïve patients, emtricitabine and tenofovir alafenamide given with elvitegravir and cobicistat as a fixed-dose combination tablet was associated with smaller reductions in bone mineral density (BMD) compared to E/C/F/TDF through 144 weeks of treatment as measured by dual energy X ray absorptiometry (DXA) analysis of hip (mean change: −0.8% vs −3.4%, p < 0.001) and lumbar spine (mean change: −0.9% vs −3.0%, p < 0.001).
Maltese: Fi studji f'pazjenti li qatt ma ngħataw trattament fil-passat, emtricitabine u tenofovir alafenamide mogħtija ma' elvitegravir u cobicistat bħala pillola kombinata ta' doża fissa ġew assoċjati ma' tnaqqis iżgħar fid-densità minerali tal-għadam (BMD - bone mineral density) meta mqabbla ma' E/C/F/TDF matul 144 ġimgħa ta' trattament kif imkejla permezz ta' analiżi dual energy X ray absorptiometry (DXA) tal-ġenbejn (bidla medja: −0.8% vs −3.4%, p < 0.001) u tas-sinsla lumbari (bidla medja:
English: In Study GS-US-299-0102, patients were randomised in a 2:1 ratio to receive either fixed-dose combination D/C/F/TAF once daily (n = 103) or darunavir and cobicistat and emtricitabine/tenofovir disoproxil fumarate once daily (n = 50).
Maltese: Fi Studju GS-US-299-0102, il-pazjenti ntgħażlu b'mod randomised fi proporzjon ta' 2:1 biex jirċievu jew kombinazzjoni ta' doża fissa D/C/F/TAF darba kuljum (n = 103) jew darunavir u cobicistat u emtricitabine/tenofovir disoproxil fumarate darba kuljum (n = 50).
English: The mean baseline plasma HIV-1 RNA was 4.5 log10 copies/mL (range: 1.3-7.0) and 23% had baseline viral loads > 100,000 copies/mL.
Maltese: Il-medja talHIV-1 RNA fil-plażma fil-linja bażi kienet ta' 4.5 log10 kopji/mL (medda: 1.3-7.0) u 23% kellhom ammont virali fil-linja bażi ta' > 100,000 kopja/mL.
English: Blue, rectangular-shaped, film-coated tablet of dimensions 12.5 mm x 6.4 mm debossed with “GSI” on one side and “225” on the other side of the tablet.
Maltese: Pillola miksija b'rita, blu, b'forma rettangolari, b'daqs ta' 12.5 mm x 6.4 mm imnaqqxa b'“GSI” fuq naħa waħda u “225” fuq in-naħa l-oħra tal-pillola.
English: Following multiple dose oral administration of emtricitabine to 20 HIV-1 infected subjects, the (mean ± SD) steady state plasma emtricitabine peak concentrations (Cmax) were 1.8 ± 0.7 μg/mL and the area-under the plasma concentration-time curve over a 24-hour dosing interval (AUC) was 10.0 ± 3.1 μg•h/mL.
Maltese: Wara l-għoti orali ta' dożi multipli ta' emtricitabine lil 20 individwu infettati bl-HIV-1, il-(medja ± SD) ta' konċentrazzjonijiet massimi ta' emtricitabine fil-plażma fl-istat fiss (Cmax) kienu ta' 1.8 ± 0.7 μg/mL u l-erja taħt il-kurva konċentrazzjoni-żmien tal-plażma fuq intervall ta' dożaġġ ta' 24 siegħa (AUC) kienet ta' 10.0 ± 3.1 μg•h/mL.