FrancophonIA/ELRC3.0 huggingface dataset:
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: In Study GS-US-236-0103 HIV-1 infected antiretroviral treatment-naïve adult patients received once daily treatment of Stribild or ritonavir-boosted atazanavir (ATV/r) plus fixed-dose combination of emtricitabine (FTC)/tenofovir disoproxil.
Maltese: Fl-Istudju GS-US-236-0103, pazjenti adulti infettati bl-HIV-1, li qatt ma ngħataw trattament b'mediċini antiretrovirali fil-passat, irċivew trattament bi Stribild darba kuljum jew atazanavir imsaħħaħ b'ritonavir (ATV/r) flimkien ma' kombinazzjoni ta' doża fissa ta' emtricitabine (FTC)/tenofovir disoproxil.
English: to < 1/1,000).
Maltese: 4.4 u 5.1).
English: At week 48, six adolescents in the tenofovir disoproxil group and one adolescent in the placebo group had significant lumbar spine BMD loss (defined as > 4% loss).
Maltese: F'ġimgħa 48, sitt adolexxenti fil-grupp ta' tenofovir disoproxil u adolexxent wieħed fil-grupp ta' plaċebo kellhom telf sinifikanti fil-BMD tas-sinsla tad-dahar lumbari (iddefinita bħala telf ta' > 4%).
English: Stribild film-coated tablets are green, capsule-shaped tablets, debossed on one side with “GSI” and the number “1” surrounded by a square box on the other side of the tablet.
Maltese: Il-pilloli miksija b'rita ta' Stribild huma ħodor, f'forma ta' kapsula, b'“GSI” imnaqqxa fuq naħa waħda u n-numru “1” imdawwar b'kaxxa kwadra fuq in-naħa l-oħra tal-pillola.
English: No clinically relevant pharmacokinetic differences due to ethnicity have been identified for cobicistat-boosted elvitegravir, emtricitabine and tenofovir disoproxil.
Maltese: L-ebda differenza farmakokinetika klinikament rilevanti minħabba l-etniċità ma ġiet identifikata għal elvitegravir imsaħħaħ b'cobicistat, emtricitabine u tenofovir disoproxil.
English: In Study GS-US-236-0102 HIV-1 infected antiretroviral treatment-naïve adult patients received oncedaily treatment of Stribild or once-daily treatment of fixed-dose combination of EFV/FTC/tenofovir disoproxil.
Maltese: Pazjenti adulti infettati b'HIV-1 li qatt ma ngħataw trattament fil-passat Fl-Istudju GS-US-236-0102, pazjenti adulti infettati bl-HIV-1, li qatt ma ngħataw trattament b'mediċini antiretrovirali fil-passat, irċivew trattament bi Stribild darba kuljum jew trattament darba kuljum b'kombinazzjoni ta' doża fissa ta' EFV/FTC/tenofovir disoproxil.
English: Cobicistat is a strong mechanism-based CYP3A inhibitor and a CYP3A substrate.
Maltese: Cobicistat hu impeditur qawwi ta' CYP3A ibbażat fuq il-mekkaniżmu u substrat ta' CYP3A.
English: increased transaminases1, hyperbilirubinaemia1
Maltese: żieda fit-transaminases1, iperbilirubinimja1
English: Concomitant use of Stribild and corticosteroids that are metabolised by CYP3A (e.g. fluticasone propionate or other inhaled or nasal corticosteroids) may increase the risk of development of systemic corticosteroid effects, including Cushing's syndrome and adrenal suppression.
Maltese: fluticasone propionate jew kortikosterojdi oħra li jinġibdu mannifs jew nażali) jista' jżid ir-riskju tal-iżvilupp ta' effetti sistemiċi talkortikosterojdi, inkluż s-sindrome ta' Cushing u s-suppressjoni adrenali.
English: In patients who received treatment with tenofovir disoproxil or placebo, mean lumbar spine BMD Z-score was -1.004 and -0.809, and mean total body BMD Z-score was -0.866 and -0.584, respectively, at baseline.
Maltese: tas-sinsla tad-dahar lumbari kienet ta' -1.004 u -0.809, u l-medja tal-punteġġ Z tal-BMD tal-ġisem sħiħ kienet ta' -0.866 u -0.584, rispettivament, fil-linja bażi.
English: In phenotypic analyses of isolates from patients in the resistance analysis population, 13 patients (31%) had HIV-1 isolates with reduced susceptibility to elvitegravir, 17 patients (40%) had reduced susceptibility to emtricitabine, and 2 patients (5%) had reduced susceptibility to tenofovir.
Maltese: F'analiżi fenotipika ta' iżolati minn pazjenti fil-popolazzjoni ta' analiżi tar-reżistenza, 13-il pazjent (31%) kellhom iżolati ta' HIV-1 b'suxxettibbilità mnaqqsa għal elvitegravir, 17-il pazjent (40%) kellhom suxxettibbilità mnaqqsa għal emtricitabine, u 2 pazjenti (5%) kellhom suxxettibbilità mnaqqsa għal tenofovir.
English: The median terminal plasma half-life of cobicistat following administration of Stribild 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' Stribild 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: Stribild has not been studied in patients over 65 years of age.
Maltese: Stribild ma ġiex studjat f'pazjenti li għandhom iktar minn 65 sena.
English: Comparison to paired postpartum data, n
Maltese: wara t-twelid akkoppjata, n
English: In addition to the adverse reactions reported in adults, anaemia (9.5%) and skin discolouration (31.8%) occurred more frequently in clinical trials in paediatric patients than in adults (see section 4.8, Tabulated summary of adverse reactions).
Maltese: Minbarra r-reazzjonijiet avversi rrappurtati fl-adulti, anemija (9.5%) u telf tal-kulur tal-ġilda (31.8%) seħħew b'mod aktar frekwenti fi provi kliniċi f'pazjenti pedjatriċi milli fl-adulti (ara sezzjoni 4.8, Tabella ta' reazzjonijiet avversi fil-qosor).
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Pazjenti li għandhom problemi ereditarji rari ta' intolleranza għallgalactose, nuqqas totali ta' lactase jew malassorbiment tal-glucose-galactose m'għandhomx jieħdu dan il-prodott mediċinali.
English: In HIV-1 infected adolescents (aged 12 to < 18 years), the BMD Z-scores observed in subjects who received tenofovir disoproxil were lower than those observed in subjects who received placebo.
Maltese: Fl-adolexxenti infettati bl-HIV-1 (b'età ta' 12 sa < 18-il sena), il-punteġġi Z tal-BMD osservati f'individwi li rċevew tenofovir disoproxil kienu aktar baxxi minn dawk osservati f'individwi li rċevew plaċebo.
English: ANTIDEPRESSANTS Escitalopram Trazodone
Maltese: mediċini li fihom trazodone jew escitalopram
English: Mean age, years (range)
Maltese: Medja ta' età, snin (medda) Sess
English: • If you are over 65.
Maltese: • Jekk għandek iktar minn 65 sena.
English: Recommended dose for adults and adolescents aged 12 to less than 18 years who weigh at least 35 kg:
Maltese: Doża rakkomandata għall-adulti u l-adolexxenti b'età ta' 12 sa inqas minn 18-il sena li jiżnu mill-inqas 35 kg:
English: Tenofovir displayed antiviral activity in cell culture against HIV-1 clades A, B, C, D, E, F, G, and O (EC50 values ranged from 0.5 to 2.2 µM) and strain specific activity against HIV-2 (EC50 values ranged from 1.6 to 5.5 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: The mean increase from baseline in CD4+ cell count at Week 48 was 40 cells/mm3 in the Stribild-treated patients and 32 cells/mm3 in the PI+RTV+FTC/tenofovir disoproxil-treated patients.
Maltese: Iż-żieda medja mil-linja bażi flgħadd ta' ċelluli CD4+ f'Ġimgħa 48 kienet ta' 40 ċellula/mm3 f'pazjenti ttrattati b'Stribild u ta' 32 ċellula/mm3 f'pazjenti ttrattati b'PI+RTV+FTC/tenofovir disoproxil.
English: Co-administration of Stribild 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 and/or life-threatening 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' Stribild 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 serji u/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: Pharmacokinetics of elvitegravir, cobicistat, emtricitabine and tenofovir have not been evaluated in the elderly (over 65 years).
Maltese: Il-farmakokinetika ta' elvitegravir, cobicistat, emtricitabine u tenofovir ma ġietx evalwata fl-anzjani (li kellhom iktar minn 65 sena).
English: The importance of regular monitoring of creatinine clearance, serum phosphate, urine glucose and urine protein during Stribild therapy.
Maltese: L-importanza ta' monitoraġġ regolari tat-tneħħija tal-krejatinina, fosfat fis-serum, glucose fl awrina u l-proteina fl-awrina matul it-terapija bi Stribild.
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: Gilead Sciences Ireland UC IDA Business & Technology Park Carrigtohill
Maltese: IDA Business & Technology Park
English: Baseline characteristics and treatment outcomes for both Studies GS-US-236-0102 and GS-US-236-0103 are presented in Tables 3 and 4, respectively.
Maltese: Il-karatteristiċi fil-linja bażi u r-riżultati tat-trattament għaż-żewġ Studji GS-US-236-0102 u GS-US-236-0103 huma ppreżentati f'Tabelli 3 u 4, rispettivament.
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 Stribild.
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
English: In Study GS-US-236-0102, the mean increase from baseline in CD4+ cell count at Week 48 was 239 cells/mm3 in the Stribild-treated patients and 206 cells/mm3 in the EFV/FTC/tenofovir disoproxiltreated patients.
Maltese: Fl-Istudju GS-US-236-0102, il-medja taż-żieda mil-linja bażi fl-għadd ta' ċelluli CD4+ f'Ġimgħa 48 kienet ta' 239 ċellula/mm3 f'pazjenti ttrattati b'Stribild u ta' 206 ċellula/mm3 f'pazjenti ttrattati b'EFV/FTC/tenofovir disoproxil.
English: The most frequently reported adverse reactions considered possibly or probably related to Stribild in clinical studies through 144 weeks in treatment-naïve adult patients were nausea (16%) and diarrhoea
Maltese: L-iktar reazzjonijiet avversi li kienu rrappurtati b'mod frekwenti u li kienu kkunsidrati bħala possibbilment jew probabbilment relatati ma' Stribild fi studji kliniċi sa 144 ġimgħa f'pazjenti adulti li qatt ma ngħataw trattament fil-passat kienu t-tqalligħ (16%) u d-dijarea (12%).
English: Pharmacokinetics of emtricitabine and tenofovir disoproxil have not been fully evaluated in hepatitis B and/or C virus co-infected patients.
Maltese: Il-farmakokinetika ta' emtricitabine u tenofovir disoproxil ma ġewx evalwati b'mod sħiħ f'pazjenti infettati wkoll b'virus tal-epatite B u/jew Ċ.
English: That there is an increased risk of renal disease in HIV infected patients associated with tenofovir disoproxil fumarate-containing products such as Stribild.
Maltese: Li hemm żieda fir-riskju ta' mard renali f'pazjenti infettati bl-HIV assoċjata ma' prodotti li jkun fihom tenofovir disoproxil fumarate bħal Stribild.
English: adverse reactions related to tenofovir disoproxil, including renal disorders.
Maltese: tenofovir disoproxil, li jinkludu disturbi renali.
English: Mean changes at week 48 (end of randomised phase) were 0.032 and 0.087 in lumbar spine BMD Z-score, and -0.184 and -0.027 in total body BMD Z-score for the tenofovir disoproxil and stavudine or zidovudine groups, respectively.
Maltese: 0.032 u 0.087 fil-punteġġ Z tal-BMD tas-sinsla tad-dahar lumbari, u -0.184 and -0.027 fil-punteġġ Z
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 tal konċentrazzjoni effettiva ta' 50% (EC50) kienu fil-medda ta' 0.02 sa 1.7 nM.
English: Eight of the 89 patients (9.0%) discontinued study drug due to renal adverse events.
Maltese: Tmienja mid89 pazjent (9.0%) waqqfu l-mediċina tal-istudju minħabba avvenimenti avversi renali.
English: In a 144-week controlled clinical study that compared tenofovir disoproxil with stavudine in combination with lamivudine and efavirenz in antiretroviral-naïve patients, small decreases in BMD of the hip and spine were observed in both treatment groups.
Maltese: Fi studju kliniku kkontrollat ta' 144 ġimgħa fejn tqabblu tenofovir disoproxil ma' stavudine mogħti flimkien ma' lamivudine u efavirenz f'pazjenti li qatt ma' kienu ngħataw mediċini antiretrovirali qabel, tnaqqis żgħir fil-BMD tal-għadam tal-ġenbejn u tas-sinsla tad-dahar kienu osservati fiż-żewġ gruppi tat-trattament.
English: ANTI-HYPERTENSIVES Metoprolol
Maltese: MEDIĊINI ANTIARRITIMIĊI
English: Co-administration of Stribild and lovastatin and simvastatin is contraindicated (see section 4.3).
Maltese: lovastatin u simvastatin hu kontraindikat (ara sezzjoni 4.3).
English: The use of Stribild is not recommended in paediatric patients with renal impairment (see sections 4.2 and 4.4).
Maltese: L-użu ta' Stribild mhuwiex rakkomandat f'pazjenti pedjatriċi b'indeboliment renali (ara sezzjonijiet 4.2 u 4.4).
English: Antimycobacterials Rifabutin (150 mg every other day)/Elvitegravir (150 mg once daily)/Cobicistat (150 mg once daily)
Maltese: Rifabutin (150 mg kull jumejn)/Elvitegravir (150 mg darba kuljum)/Cobicistat (150 mg darba kuljum)
English: The efficacy of Stribild in HIV-1 infected treatment-naïve adult patients is based on the analyses of 144-week data from 2 randomised, double-blinded, active-controlled, Phase 3 studies, GS-US-236-0102 and GS-US-236-0103 (n = 1,408).
Maltese: L-effikaċja ta' Stribild f'pazjenti adulti infettati b'HIV-1 li qatt ma ngħataw trattament fil-passat hi bbażata fuq l-analiżi ta' dejta fuq perjodu ta' 144 ġimgħa minn 2 studji ta' Fażi 3 li fihom il parteċipanti ntgħażlu b'mod każwali, double-blinded, ikkontrollati b'mod attiv, GS-US-236-0102 u
English: In the Phase 3 Study GS-US-236-0103, bone mineral density (BMD) was assessed in a non-random subset of 120 subjects (Stribild group n = 54; ritonavir-boosted atazanavir (ATV/r) plus emtricitabine (FTC)/tenofovir disoproxil group n = 66).
Maltese: Fl-Istudju ta' Fażi 3 GS-US-236-0103, id-densità minerali tal-għadam (BMD) ġiet evalwata f'sottosett li fih il-parteċipanti ma ntgħażluxb'mod każwali ta' 120 individwu (grupp ta' Stribild n = 54;
English: Total body bone gain was less in the tenofovir disoproxil treatment group compared to the stavudine or zidovudine treatment group.
Maltese: tal-BMD tal-ġisem sħiħ għall-gruppi ta' tenofovir disoproxil u ta' stavudine jew zidovudine, rispettivament.
English: In addition, a K70E substitution in HIV-1 reverse transcriptase has been selected clinically by tenofovir disoproxil and results in low-level reduced susceptibility to abacavir, emtricitabine, tenofovir, and lamivudine.
Maltese: Barra minn hekk, sostituzzjoni ta' K70E f'reverse transcriptase tal-HIV-1 kienet klinikament magħżula minn tenofovir disoproxil u wasslet għal tnaqqis fis-sensittività f'livell baxx għal abacavir, emtricitabine, tenofovir, u lamivudine.
English: Concomitant use contraindicated
Maltese: dabigatran huwa kontraindikat.
English: In this study, the safety profile of Stribild was similar to that in adults (see section 4.8, Tabulated summary of adverse reactions).
Maltese: F'dan l-istudju, il-profil tas-sigurtà ta' Stribild kien simili għal dak fl-adulti (ara sezzjoni 4.8, Tabella ta' reazzjonijiet avversi fil-qosor).
English: Co-administration of Stribild 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: The pharmacokinetics of emtricitabine have not been studied in subjects 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: The active substances elvitegravir, cobicistat and tenofovir disoproxil are persistent in the environment.
Maltese: Is-sustanzi attivi elvitegravir, cobicistat u tenofovir disoproxil huma persistenti fl-ambjent.
English: Twenty patients from these studies who switched to Stribild had the NNRTI-associated K103N substitution in their historical genotype prior to starting initial antiretroviral therapy.
Maltese: Għoxrin pazjent minn dawn l-istudji li qalbu għal Stribild kellhom is-sostituzzjoni K103N assoċjata ma' NNRTI fil-ġenotip storiku tagħhom qabel ma bdew it-terapija antiretrovirali inizjali.
English: All corticosteroids excluding cutaneous products Corticosteroids primarily metabolised by CYP3A (including betamethasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone).
Maltese: Kortikosterojdi primarjament metabolizzati minn CYP3A (inklużi betamethasone,
English: A study of pharmacokinetics of cobicistat-boosted elvitegravir was performed in non-HIV-1 infected subjects with moderate hepatic impairment.
Maltese: Studju dwar il-farmakokinetika ta' elvitegravir imsaħħaħ b'cobicistat twettaq f'individwi li ma kinux infettati b'HIV-1 b'indeboliment epatiku moderat.
English: Hepatitis Cvirus (HCV) antiviral agents Ledipasvir/Sofosbuvir
Maltese: Sustanzi antivirali tal-virus kontra l-Epatite Ċ (HCV)
English: In study GS-US-104-0321, 87 HIV-1-infected treatment experienced patients 12 to < 18 years of age were treated with tenofovir disoproxil (n = 45) or placebo (n = 42) in combination with an optimised background regimen (OBR) for 48 weeks.
Maltese: sa < 18-il sena kienu ttrattati b'tenofovir disoproxil (n = 45) jew plaċebo (n = 42) flimkien ma' kors ottimizzat fl-isfond (OBR, optimised background regimen) għal 48 ġimgħa.
English: No data are available on which to make a dose recommendation for patients over the age of 65 years (see sections 4.4 and 5.1).
Maltese: M'hemmx informazzjoni fuqhiex wieħed jista' jagħti rakkomandazzjoni għall-pazjenti ta' 'l fuq minn 65 sena (ara sezzjonijiet 4.4 u 5.1).
English: All 48 patients who received at least one dose of Stribild remained suppressed (HIV-1 RNA < 50 copies/mL) through Week 48.
Maltese: It-48 pazjent kollha li rċivew mill-inqas doża waħda ta' Stribild baqgħu soppressi (HIV-1 RNA ta' < 50 kopja/mL) sa Ġimgħa 48.
English: Antiviral synergy was maintained for elvitegravir, emtricitabine, and tenofovir when tested in the presence of cobicistat.
Maltese: Is-sinerġija antivirali nżammet għal elvitegravir, emtricitabine, u tenofovir meta ġew ittestjati fil-preżenza ta' cobicistat.
English: In a human clinical study of 35 healthy subjects, echocardiograms performed at baseline and after receiving 150 mg cobicistat once daily for at least 15 days indicated no clinically significant change in left ventricular function.
Maltese: Fi studju kliniku dwar il-bniedem li sar fuq 35 individwu b'saħħtu, ekokardjogrammi li twettqu fil-linja bażi u wara li l-individwi rċivew 150 mg ta' cobicistat darba kuljum għal mill-inqas 15-il jum, ma indikaw l-ebda tibdil klinikament sinifikanti fil-funzjoni ventrikulari fuq in-naħa tax-xellug.
English: INHALED BETA AGONIST Salmeterol
Maltese: AGONIST TAR-RIĊETTUR BETA LI JINĠIBED MAN-NIFS
English: There are uncertainties associated with the long-term effects of tenofovir disoproxil bone and renal toxicity.
Maltese: Hemm inċertezzi assoċjati mal-effetti fit-tul tat-tossiċità tal-għadam u renali b'tenofovir disoproxil.
English: The dual-drug combinations and the triple combination of elvitegravir, emtricitabine and tenofovir demonstrated synergistic activity in cell culture.
Maltese: Il-kombinazzjonijiet tal-mediċina doppja u l-kombinazzjoni tripla ta' elvitegravir, emtricitabine u tenofovir urew attività sinerġistika fil-koltura taċ-ċelluli.
English: The mean increase from baseline in CD4+ cell count at Week 48 was 56 cells/mm3 in the Stribild-treated patients and 58 cells/mm3 in the NNRTI+FTC/tenofovir disoproxil-treated patients.
Maltese: Iż-żieda medja mil-linja bażi fl-għadd ta' ċelluli CD4+ f'Ġimgħa 48 kienet ta' 56 ċellula/mm3 f'pazjenti ttrattati b'Stribild u ta' 58 ċellula/mm3 f'pazjenti ttrattati b'NNRTI+FTC/tenofovir disoproxil.
English: In patients, HIV-1 expressing three or more thymidine analogue associated mutations (TAMs) that included either the M41L or L210W reverse transcriptase mutation showed reduced susceptibility to tenofovir disoproxil.
Maltese: Fil-pazjenti, li l-marda tal-HIV-1 tagħhom kellha 3 mutazzjonijiet assoċjati mal-analogi ta' thymidine (TAMs) jew aktar li kienu jinkludu l-mutazzjoni M41L jew L210W reverse transcriptase wrew tnaqqis fis-sensittività għal tenofovir disoproxil.
English: Co-administration of Stribild with medicinal products that are primarily metabolised by CYP3A or CYP2D6, or are substrates of P-gp, BCRP, OATP1B1 or OATP1B3 may result in increased plasma concentrations of those products, which could increase or prolong their therapeutic effect and adverse reactions (see Concomitant use contraindicated and section 4.3).
Maltese: L-għoti ta' Stribild flimkien ma' prodotti mediċinali li huma primarjament metabolizzati minn CYP3A jew CYP2D6, jew li huma substrati ta' P-gp, BCRP, OATP1B1 jew OATP1B3, jista' jirriżulta f'żieda tal-konċentrazzjonijiet ta' dawk il-prodotti fil-plażma, li tista' żżid jew ittawwal l-effett terapewtiku tagħhom u r-reazzjonijiet avversi (ara L-użu fl-istess ħin hu kontraindikat u sezzjoni 4.3).
English: A study of pharmacokinetics of cobicistat-boosted elvitegravir was performed in non-HIV-1 infected subjects with severe renal impairment (creatinine clearance below 30 mL/min).
Maltese: Studju dwar il-farmakokinetika ta' elvitegravir imsaħħaħ b'cobicistat twettaq f'individwi li ma kinux infettati bl-HIV-1 b'indeboliment renali sever (tneħħija tal-krejatinina taħt 30 mL/min).