FrancophonIA/ELRC3.0 huggingface dataset:
English: Also, emtricitabine did not inhibit uridine-5'-diphosphoglucuronyl transferase (UGT), the enzyme responsible for glucuronidation.
Maltese: Barra minn hekk, emtricitabine ma inibixxiex uridine-5'-diphosphoglucuronyl transferase (UGT), l-enzima responsabbli għall-glukuronidazzjoni.
English: Overall response and a subgroup analysis of the virologic response (< 50 HIV-1 RNA copies/mL) at both 48 weeks and 96 weeks, and virologic failure by baseline viral load (pooled data from the two Phase 3 clinical studies, TMC278-C209 and TMC278-C215, for patients receiving the FTC/TDF BR) are presented in Table 4.
Maltese: HIV-1 RNA kopji/mL) kemm f'Ġimgħa 48 kif ukoll Ġimgħa 96, u falliment viroloġiku skont l-ammont virali fil-linja bażi (dejta miġbura miż-żewġ studji kliniċi ta' Fażi 3, TMC278-C209 u TMC278-C215, għal pazjenti li ngħataw il-BR FTC/TDF), huma ppreżentati fit-Tabella 4.
English: Date of first authorisation: 21 June 2016
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 21 Ġunju 2016
English: The pharmacokinetics of emtricitabine have not been studied in patients with varying degrees of hepatic insufficiency; however emtricitabine is not significantly metabolised by liver enzymes, so the impact of liver impairment should be limited.
Maltese: Il-farmakokinetika ta' emtricitabine ma ġietx studjata f'pazjenti b'livelli differenti ta' insuffiċjenza epatika; madankollu, emtricitabine ma jiġix metabolizzat b'mod sinifikanti mill-enzimi tal-fwied, u għalhekk l-impatt ta' indeboliment epatiku għandu jkun limitat.
English: How to store Odefsey
Maltese: Tiqafx tieħu Odefsey
English: These changes in adrenal safety parameters were not clinically relevant.
Maltese: Dan it-tibdil fil-parametri tas-sigurtà adrenali ma kellu l-ebda rilevanza klinika.
English: Table 4: Virologic outcomes of randomised treatment of Studies TMC278-C209 and TMC278-C215 (pooled data for patients receiving rilpivirine hydrochloride or efavirenz in combination with FTC/TDF) at Week 48 (primary) and Week 96
Maltese: Tabella 4: Ir-riżultati viroloġiċi tat-trattament li fih il-parteċipanti ntgħażlu b'mod każwali tal-Istudji TMC278-C209 u TMC278-C215 (dejta miġbura għal pazjenti li ngħataw rilpivirine hydrochloride jew efavirenz flimkien ma' FTC/TDF) f'Ġimgħa 48 (primarja) u Ġimgħa 96
English: Patients with chronic hepatitis B or C treated with antiretroviral therapy are at an increased risk for severe and potentially fatal hepatic adverse reactions.
Maltese: Pazjenti b'epatite kronika B jew Ċ u li huma kkurati b'terapija antiretrovirali huma f'riskju akbar għal reazzjonijiet avversi epatiċi severi u potenzjalment fatali.
English: Treatment-naïve HIV-1 infected adult patients The efficacy of rilpivirine is based on the analyses of 96 weeks data from two randomised, double-blind, controlled studies in treatment-naïve patients (TMC278-C209 and emtricitabine + tenofovir disoproxil fumarate subset of TMC278-C215).
Maltese: L-effikaċja ta' rilpivirine hija bbażata fuq l-analiżi tad-dejta ta' 96 ġimgħa minn żewġ studji kkontrollati, li fihom il-parteċipanti ntgħażlu b'mod każwali u double-blind f'pazjenti li qatt ma ngħataw trattament fil-passat (TMC278-C209 u s-subsett ta' emtricitabine + tenofovir disoproxil fumarate ta' TMC278-C215).
English: In studies in treatment-naïve adult patients, E/C/F/TAF was associated with lower impact on renal safety parameters (as measured after 144 weeks treatment by eGFRCG and urine protein to creatinine ratio [UPCR] and after 96 weeks treatment by urine albumin to creatinine ratio [UACR]) compared to E/C/F/TDF.
Maltese: Fi studji f'pazjenti li qatt ma ngħataw trattament fil-passat, E/C/F/TAF ġie assoċjat ma' impatt iżgħar fuq parametri tas-sigurtà renali (kif imkejla wara 144 ġimgħa ta' trattament mill-eGFRCG u l-proporzjon ta' proteina fl-awrina mal-kreatinina [UPCR, urine protein to creatinine ratio] u wara 96 ġimgħa ta' trattament mill-proporzjon ta' albumina fl-awrina mal-kreatinina [UACR, urine albumin to creatinine ratio]) meta mqabbel ma' E/C/F/TDF.
English: There was no impact of body weight on rilpivirine pharmacokinetics in paediatric patients in Study C213 (33 to 93 kg), similar to what was observed in adults.
Maltese: Ma kien hemm l-ebda impatt tal-piż tal-ġisem fuq il-farmakokinetika ta' rilpivirine f'pazjenti pedjatriċi fl-Istudju C213 (33 sa 93 kg), u dan kien simili għal dak osservat fl-adulti.
English: FTC = emtricitabine; TAF = tenofovir alafenamide; TFV = tenofovir, N/A = not applicable Data are presented as mean (%CV).
Maltese: TFV = tenofovir, N/A = mhux applikabbli Id-dejta hi ppreżentata bħala medja (%CV). a n = 24 adolexxenti (GS-US-292-0106);
English: In the pooled analysis for TMC278-C209 and TMC278-C215 of 1,096 patients who received a background regimen (BR) of FTC/TDF, demographic and baseline characteristics were balanced between the rilpivirine and efavirenz (EFV) arms.
Maltese: Fl-analiżi miġbura flimkien għal TMC278-C209 u TMC278-C215 ta' 1,096 pazjenti li ngħataw kors fl-isfond (BR, background regimen) ta' FTC/TDF, il-karatteristiċi demografiċi u fil-linja bażi kienu bbilanċjati bejn il-fergħat tal-istudju b'rilpivirine u efavirenz (EFV).
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, O), including subtypes A, B, C, D, E, F, and G (EC50 values ranged from 0.10 to 12.0 nM) and showed activity against HIV-2 (EC50 values ranged from 0.91 to 2.63 nM).
Maltese: Il-figuri tal-50% konċentrazzjoni effettiva (EC50) għal emtricitabine kienu fil-medda ta' 0.0013 sa 0.64 µM. Emtricitabine wera attività antivirali fil-koltura taċ-ċelluli kontra s-sottotipi 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 kontra HIV-2 (il-figuri ta' EC50 kienu jvarjaw minn 0.007 sa 1.5 µM).
English: At Week 48, 81.8% (45/55 patients) maintained HIV-1 RNA < 50 copies/mL after switching to E/C/F/TAF.
Maltese: 8% (45/55 pazjent) żammew l-RNA ta' HIV-1 < 50 kopja/mL wara li qalbu għal E/C/F/TAF.
English: Rilpivirine exposures were bioequivalent when comparing Odefsey 200/25/25 mg to one rilpivirine (as hydrochloride) 25 mg film-coated tablet following single dose administration to healthy subjects (n = 95) under fed conditions.
Maltese: L-esponimenti għal rilpivirine kienu bijoekwivalenti meta jiġu mqabbla Odefsey 200/25/25 mg ma' rilpivirine (bħala hydrochloride) 25 mg pillola miksija b'rita waħda wara għoti ta' doża waħda lil individwi b'saħħithom (n = 95) li jkunu kielu.
English: Co-administration of Odefsey with proton pump inhibitors has been observed to decrease the plasma concentrations of rilpivirine (due to an increase in gastric pH) which could potentially lead to loss of virologic response to Odefsey (see section 4.3) and possible resistance to rilpivirine and to the NNRTI class.
Maltese: L-għoti flimkien ta' Odefsey u impedituri tal-pompi tal-protoni kien osservat li jnaqqas il-konċentrazzjonijiet fil-plażma ta' rilpivirine (minħabba żieda fil-pH gastriku) li jista' jwassal potenzjalment għal telf ta' rispons viroloġiku għal Odefsey (ara sezzjoni 4.3) u possibilment reżistenza għal rilpivirine u għall-klassi NNRTI.
English: Exposures of emtricitabine and tenofovir in 12 patients with end stage renal disease (estimated CrCl < 15 mL/min) on chronic haemodialysis who received emtricitabine + tenofovir alafenamide in combination with elvitegravir + cobicistat as a fixed-dose combination tablet (E/C/F/TAF) in Study GS-US-292-1825 were significantly higher than in patients with normal renal function.
Maltese: Esponimenti għal emtricitabine u tenofovir fi 12-il pazjent b'marda tal-kliewi fl-aħħar stadju (CrCl stmata ta' < 15-il mL/min) fuq emodijalisi kronika li rċivew emtricitabine + tenofovir alafenamide flimkien ma' elvitegravir + cobicistat bħala pillola kkombinata ta' doża fissa (E/C/F/TAF) fl-Istudju GS-US-292-1825 kienu sinifikament ogħla milli f'pazjenti b'funzjoni renali normali.
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 (US jew ex US). ċ Il-valur p għat-test tas-superjorità li jqabbel il-perċentwali tas-suċċess viroloġiku kien mit-test CMH (Cochran-Mantel-Haenszel) stratifikat skont il-kors ta' trattament minn qabel (EFV/FTC/TDF, FTC/TDF flimkien ma' atazanavir imsaħħaħ, jew E/C/F/TDF).
English: In Study GS-US-366-1216, the mean change from baseline in CD4+ cell count at Week 96 was 12 cells/mm3 in patients who switched to Odefsey and 16 cells/mm3 in those who remained on FTC/RPV/TDF.
Maltese: Fl-Istudju GS-US-366-1216, il-bidla medja mil-linja bażi fl-għadd ta' ċelluli CD4+ f'Ġimgħa 96 kienet ta' 12-il ċellula/mm3 f'pazjenti li qalbu għal Odefsey u ta' 16-il ċellula/mm3 f'dawk li baqgħu fuq FTC/RPV/TDF.
English: If overdose occurs the patient must be monitored for evidence of toxicity (see section 4.8), and standard supportive treatment applied as necessary including observation of the clinical status of the patient and monitoring of vital signs and ECG (QT interval).
Maltese: Jekk iseħħ każ ta' doża eċċessiva, il-pazjent għandu jiġi mmonitorjat għal sinjali ta' tossiċità (ara sezzjoni 4.8), u jingħata trattament ta' appoġġ normali kif meħtieġ, inkluż osservazzjoni tal-istat kliniku tal-pazjent u monitoraġġ tas-sinjali vitali u ECG (intervall QT).
English: In Study GS-US-292-0109, the efficacy and safety of switching from either EFV/FTC/TDF, FTC/TDF plus atazanavir (boosted by either cobicistat or ritonavir), or E/C/F/TDF to E/C/F/TAF FDC tablet were evaluated in a randomised, open-label study of virologically suppressed (HIV-1 RNA < 50 copies/mL) HIV-1 infected adults (n = 959 switching to E/C/F/TAF, n = 477 Stayed on Baseline Regimen [SBR]).
Maltese: FDC ġew evalwati fi studju li fih il-parteċipanti ntgħażlu b'mod każwali, open-label, ta' adulti b'soppressjoni virali infettati bl-HIV-1 (HIV-1 RNA < 50 kopja/mL) (n = 959 li qalbu għal E/C/F/TAF, n = 477 li baqgħu fil-kors tal-linja bażi
English: Rilpivirine (one of the components of Odefsey) in combination with a background regimen was evaluated in Study TMC114HIV3015 in 19 pregnant women during the 2nd and 3rd trimesters, and postpartum.
Maltese: Rilpivirine (wieħed mill-komponenti ta' Odefsey) flimkien ma' kors fl-isfond ġie evalwat fl-Istudju TMC114HIV3015 f'19-il mara tqila matul it-tieni u t-tielet trimestri, u wara l-ħlas.
English: Sofosbuvir/Velpatasvir/Voxilaprevir (400 mg/100 mg/100 mg + 100 mg once daily)3/
Maltese: Sofosbuvir/Velpatasvir/Voxilaprevir (400 mg/100 mg/100 mg + 100 mg darba kuljum)3/ Emtricitabine/Rilpivirine/Tenofovir alafenamide (200 mg/25 mg/25 mg darba kuljum)
English: Odefsey has not been studied in patients with severe hepatic impairment (Child Pugh Class C); therefore, Odefsey is not recommended for use in patients with severe hepatic impairment (see sections 4.4 and 5.2).
Maltese: Odefsey ma ġiex studjat f'pazjenti b'indeboliment epatiku sever (Child-Pugh Klassi Ċ): għalhekk, Odefsey mhuwiex rakkomandat għall-użu f'pazjenti b'indeboliment epatiku sever (ara sezzjonijiet 4.4 u 5.2).
English: The safety of emtricitabine + tenofovir alafenamide was evaluated through 144 weeks in an open-label clinical study (GS-US-292-0112), in which 248 HIV-1 infected patients who were either treatment-naïve (n = 6) or virologically suppressed (n = 242) with mild to moderate renal impairment (estimated glomerular filtration rate by Cockcroft-Gault method [eGFRCG]: 30-69 mL/min) received emtricitabine + tenofovir alafenamide in combination with elvitegravir + cobicistat as a fixed-dose combination tablet.
Maltese: Is-sigurtà ta' emtricitabine + tenofovir alafenamide ġiet evalwata sa 144 ġimgħa fi studju kliniku open-label (GS-US-292-0112) li fih 248 pazjent infettati bl-HIV-1 li jew qatt ma ngħataw trattament fil-passat (n = 6) jew li kienu b'soppressjoni virali (n = 242), b'indeboliment renali minn ħafif sa moderat (rata tal-filtrazzjoni glomerulari stmata bil-metodu Cockcroft-Gault [eGFRCG]:
English: In a clinical study, rilpivirine did not significantly affect the pharmacokinetics of digoxin.
Maltese: Fi studju kliniku, rilpivirine ma kellux effett sinifikanti fuq il-farmakokinetika ta' digoxin.
English: The median increase from baseline for these parameters was greater in patients receiving FTC + TAF compared with patients receiving FTC + TDF (p < 0.001 for the difference between treatment groups for fasting total cholesterol, direct LDL- and HDL-cholesterol, and triglycerides).
Maltese: FTC + TDF (p < 0.001 għad-differenza bejn il-gruppi tat-trattament għall-kolesterol totali fl-istat sajjem, kolesterol ta' LDL dirett u HDL, u trigliċeridi).
English: Interaction not studied with any of the components of Odefsey.
Maltese: L-interazzjoni ma ġietx studjata ma' kwalunkwe wieħed mill-komponenti ta' Odefsey.
English: In a panel of 67 HIV-1 recombinant laboratory strains with one resistance-associated mutation at RT positions associated with NNRTI resistance, the only single resistance-associated mutations associated with a loss of susceptibility to rilpivirine were K101P and Y181V/I.
Maltese: Fi grupp ta' 67 razza fil-laboratorju rikombinati ta' HIV-1 b'mutazzjoni waħda assoċjata mar-reżistenza f'pożizzjonijiet RT assoċjati mar-reżistenza NNRTI, l-uniċi mutazzjonijiet assoċjati mar-reżistenza uniċi assoċjati ma' telf għas-suxxettibbiltà għal rilpivirine kienu K101P u Y181V/I.
English: Nephrotoxicity
Maltese: Oxcarbazepine
English: The safety and efficacy of Odefsey in patients co-infected with HIV-1 and hepatitis C virus (HCV) have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Odefsey f'pazjenti koinfettati bl-HIV-1 u l-virus tal-epatite Ċ (HCVhepatitis C virus) ma ġewx stabbiliti.
English: somnolence1
Maltese: ngħas1
English: Odefsey should not be co-administered with medicinal products that can result in significant decreases in rilpivirine plasma concentrations (due to cytochrome P450 [CYP]3A enzyme induction or gastric pH increase), which may result in loss of therapeutic effect of Odefsey (see section 4.5), including:
Maltese: Odefesy ma għandux jingħata ma' prodotti mediċinali li jistgħu jirriżultaw fi tnaqqis sinifikanti fil-konċentrazzjonijiet fil-plażma ta' rilpivirine (minħabba induzzjoni tal-enzimataċ-ċitokrom P450 [CYP]3A jew żieda fil-pH gastriku), li jista' jwassal għal telf tal-effett terapewtiku ta' Odefsey (ara sezzjoni 4.5), li jinkludu:
English: In Study GS-US-292-1825, the efficacy and safety of E/C/F/TAF were evaluated in a single arm, open-label clinical study in which 55 HIV-1 infected adults with end stage renal disease (eGFRCG < 15 mL/min) on chronic haemodialysis for at least 6 months before switching to E/C/F/TAF FDC tablet.
Maltese: Fi Studju GS-US-292-1825, l-effikaċja u s-sigurtà ta' E/C/F/TAF kienu evalwati fi studju kliniku, open-label, bi grupp wieħed li fih 55 adult infettati bl-HIV-1 b'marda tal-kliewi fl-aħħar stadju (eGFRCG < 15-il mL/min) fuq emodijalisi kronika għal mill-inqas 6 xhur qabel ma qalbu għall-pillola E/C/F/TAF
English: 0.4% (95% CI: -3.0% to 3.8%) 5.4% (95% CI: 1.5% to 9.2%)
Maltese: 5.4% (95% CI: 1.5% sa 9.2%)
English: Odefsey may interact with other medicines.
Maltese: Odefsey jista' jinteraġixxi ma' mediċini oħrajn.
English: In patients receiving rilpivirine hydrochloride in combination with FTC/TDF in Phase 3 studies (TMC278-C209 and TMC278-C215 pooled data), most HIV-1 isolates with emergent phenotypic resistance to rilpivirine had cross-resistance to at least one other NNRTI (28/31).
Maltese: F'pazjenti li ngħataw rilpivirine hydrochloride flimkien ma' FTC/TDF fi studji ta' Fażi 3 (dejta miġbura flimkien ta' TMC278-C209 u TMC278-C215), il-maġġoranza tal-iżolati tal-HIV-1 b'reżistenza fenotipika emerġenti għal rilpivirine kellhom reżistenza inkroċjata għal mill-inqas NNRTI wieħed ieħor (28/31).
English: Virologically suppressed HIV-1 infected adult patients In Study GS-US-366-1216, the efficacy and safety of switching from FTC/RPV/TDF to Odefsey were evaluated in a randomised, double-blind study of virologically suppressed HIV-1 infected adults.
Maltese: Fl-Istudju GS-US-366-1216, l-effikaċja u s-sigurtà tal-qlib minn FTC/RPV/TDF għal Odefsey kienu evalwati fi studju li fih il-parteċipanti ntgħażlu b'mod każwali, double-blind ta' adulti infettati bl-HIV-1 b'soppressjoni virali.
English: Nucleos(t)ide analogues may impact mitochondrial function to a variable degree, which is most pronounced with stavudine, didanosine and zidovudine.
Maltese: L-analogi tan-nukleos(t)idi jista' jkollhom impatt fuq il-funzjoni tal-mitokondrija sa livell varjabbli, li huwa l-aktar qawwi b'stavudine, didanosine u zidovudine.
English: Medicinal products that affect P-gp and BCRP activity may lead to changes in tenofovir alafenamide absorption (see Table 1).
Maltese: Prodotti mediċinali li jaffettwaw l-attività ta' P-gp u BCRP, jistgħu jwasslu għal tibdil fl-assorbiment ta' tenofovir alafenamide (ara Tabella 1).
English: Patients with a baseline viral load > 100,000 HIV-1 RNA copies/mL who experienced virologic failure exhibited a higher rate of treatment-emergent resistance to the NNRTI class.
Maltese: HIV-1 kopja ta' RNA/mL li kellhom falliment viroloġiku kellhom rata ogħla ta' reżistenza għall-kura għall-klassi NNRTI.
English: The safety assessment of rilpivirine is based on Week 48 data from one single-arm open-label study (TMC278-C213) in 36 paediatric patients 12 to < 18 years and weighing at least 32 kg. No patients discontinued rilpivirine due to adverse reactions.
Maltese: L-evalwazzjoni tas-sigurtà ta' rilpivirine hija bbażata fuq id-dejta minn Ġimgħa 48 minn studju wieħed b'fergħa waħda open-label (TMC278-C213) f'36 pazjent pedjatriku li kellhom minn 12 sa < 18-il sena u jiżnu mill-inqas 32 kg.
English: QT prolonging medicinal products
Maltese: TAL-PRODOTT MEDIĊINALI
English: In Study GS-US-292-0109, switching from a tenofovir disoproxil fumarate-based regimen to E/C/F/TAF was superior in maintaining HIV-1 RNA < 50 copies/mL compared to staying on the baseline regimen.
Maltese: Fl-Istudju GS-US-292-0109, il-qlib minn kors ibbażat fuq tenofovir disoproxil fumarate għal E/C/F/TAF kien superjuri fiż-żamma ta' HIV-1 RNA ta' < 50 kopja/mL meta mqabbel ma' li wieħed baqa' fuq il-kors tal-linja bażi.
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 għall-galactose, nuqqas totali ta' lactase jew għandhom problemi biex jassorbu l-glucose-galactose m'għandhomx jieħdu dan il-prodott mediċinali.
English: At Week 96, switching to Odefsey was non-inferior in maintaining HIV-1 RNA < 50 copies/mL when compared to patients who stayed on FTC/RPV/TDF or on EFV/FTC/TDF in respective studies.
Maltese: F'Ġimgħa 96, il-qlib għal Odefsey ma kienx inferjuri fiż-żamma ta' HIV-1 RNA < 50 kopja/mL meta mqabbel ma' pazjenti li baqgħu fuq FTC/RPV/TDF jew fuq EFV/FTC/TDF fl-istudji rispettivi.
English: Relative to fasting conditions, the administration of Odefsey to healthy adult subjects with food resulted in increased rilpivirine exposure (AUC) by 13-72%.
Maltese: Fir-rigward tal-kundizzjonijiet fi stat sajjem, l-għoti ta' Odefsey lil individwi adulti b'saħħithom mal-ikel irriżulta f'żieda fl-esponiment ta' rilpivirine (AUC) b'13-72%.
English: (78.6%, 22/28) as compared to those with a baseline viral load > 100,000 copies/mL (50.0%, 4/8).
Maltese: (7/288) minn pazjenti b'ammont virali fil-linja bażi > 100,000 kopja/mL
English: 2 This adverse reaction was not observed in the Phase 3 studies of emtricitabine + tenofovir alafenamide in combination with elvitegravir + cobicistat or in the Phase 3 studies with Odefsey but identified from clinical studies or post-marketing experience of emtricitabine when used with other antiretrovirals.
Maltese: 2 Din ir-reazzjoni avversa ma ġietx osservata fl-istudji kliniċi ta' Fażi 3 għal emtricitabine + tenofovir alafenamide flimkien ma' elvitegravir + cobicistat jew fl-istudji kliniċi ta' Fażi 3 b'Odefsey, iżda ġiet identifikata minn studji kliniċi jew esperjenza ta' wara t-tqegħid fis-suq għal emtricitabine meta użat ma' mediċini antiretrovirali oħrajn.
English: • dexamethasone (oral and parenteral doses), except as a single dose treatment
Maltese: • dexamethasone (dożi orali u parenterali), minbarra bħala kura b'doża waħda
English: There were no new safety issues identified in patients with end stage renal disease on chronic haemodialysis receiving emtricitabine + tenofovir alafenamide, given with elvitegravir + cobicistat as a fixed-dose combination tablet (see section 4.8).
Maltese: Ma ġewx identifikati problemi ġodda ta' sigurtà f'pazjenti b'marda tal-kliewi fl-aħħar stadju fuq emodijalisi kronika li kienu qed jirċievu emtricitabine + tenofovir alafenamide, mogħtija flimkien ma' elvitegravir + cobicistat bħala pillola kkombinata ta' doża fissa (ara sezzjoni 4.8).
English: Additionally, in a clinical drug-drug interaction study with tenofovir alafenamide, which is more sensitive to intestinal P-gp inhibition, rilpivirine did not affect tenofovir alafenamide exposures when administered concurrently, indicating that rilpivirine is not a P-gp inhibitor in vivo.
Maltese: Barra minn hekk, fi studju kliniku tal-interazzjoni bejn mediċina u oħra b'tenofovir alafenamide, li huwa aktar sensittiv għall-inibizzjoni ta' P-gp intestinali, rilpivirine ma kellux effett fuq l-esponiment ta' tenofovir alafenamide meta ngħataw flimkien, li jindika li rilpivirine mhuwiex impeditur ta' P-gp in vivo.
English: Based on these limited data, the safety profile of emtricitabine + tenofovir alafenamide in combination with elvitegravir and cobicistat as a fixed-dose combination tablet, in patients with HIV/HBV co-infection, was similar to that in patients with HIV-1 monoinfection.
Maltese: Ibbażat fuq din iddata limitata, il-profil tas-sigurtà ta' emtricitabine + tenofovir alafenamide flimkien ma' elvitegravir u cobicistat bħala pillola kombinata ta' doża fissa, f'pazjenti b'koinfezzjoni bl-HIV/HBV, kien simili għal dak f'pazjenti b'monoinfezzjoni bl-HIV-1.
English: (may affect up to 1 in 10 people)
Maltese: (jistgħu jaffettwaw sa 1 minn kull 10 persuni)
English: There were no new safety issues identified in patients with end stage renal disease on chronic haemodialysis receiving emtricitabine + tenofovir alafenamide, given with elvitegravir + cobicistat as a fixed-dose combination tablet (see section 5.2).
Maltese: Ma ġewx identifikati problemi ġodda ta' sigurtà f'pazjenti b'marda talkliewi fl-aħħar stadju fuq emodijalisi kronika li kienu qed jirċievu emtricitabine + tenofovir alafenamide, mogħtija ma' elvitegravir + cobicistat bħala pillola kkombinata ta' doża fissa (ara sezzjoni 5.2).
English: In Study GS-US-366-1160, the efficacy and safety of switching from EFV/FTC/TDF to Odefsey were evaluated in a randomised, double-blind study of virologically suppressed HIV-1 infected adults.
Maltese: Fl-Istudju GS-US-366-1160, l-effikaċja u s-sigurtà tal-qlib minn EFV/FTC/TDF għal Odefsey kienu evalwati fi studju li fih il-parteċipanti ntgħażlu b'mod każwali, double-blind ta' adulti infettati bl-HIV-1 b'soppressjoni virali.
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 ġiex osservat f'pazjenti b'indeboliment epatiku ħafif jew moderat.
English: Famotidine (40 mg single dose taken 4 hours after rilpivirine)/ Rilpivirine1
Maltese: Famotidine (40 mg doża waħda meħuda 4 sigħat wara rilpivirine)/Rilpivirine1