FrancophonIA/ELRC3.0 huggingface dataset:
English: The combination of emtricitabine, rilpivirine and tenofovir disoproxil has been studied as the component products in treatment-naïve patients (Phase III studies C209 and C215).
Maltese: Il-kombinazzjoni ta' emtricitabine, rilpivirine u tenofovir disoproxil ġiet studjata bħala l-prodotti komponenti f'pazjenti li qatt ma rċivew kura fil-passat (studji C209 u 215 ta' Fażi
English: Emtricitabine is not significantly metabolised by liver enzymes, so the impact of liver impairment should be limited.
Maltese: Emtricitabine ma jiġix metabolizzat b'mod sinifikanti mill-enzimi epatiċi, u għalhekk l-impatt ta' indeboliment epatiku għandu jkun limitat.
English: After single dose oral administration of [14C]-rilpivirine, on average 85% and 6.1% of the radioactivity could be retrieved in faeces and urine, respectively.
Maltese: Wara l-għoti ta' doża waħda orali ta' [14C]-rilpivirine, bħala medja 85% u 6.1% tar-radjuattività setgħet tinkiseb lura fl-ippurgar u fl-awrina, rispettivament.
English: ORAL CONTRACEPTIVES Ethinylestradiol/Norethindrone/ Emtricitabine
Maltese: Ethinylestradiol/Norethindrone/
English: In a study of healthy subjects, supratherapeutic doses of rilpivirine (75 mg once daily and 300 mg once daily) have been shown to prolong the QTc interval of the ECG (see section 5.1).
Maltese: Fi studju fuq individwi b'saħħithom, intwera li dożi supraterapewtiċi ta' rilpivirine (75 mg darba kuljum u 300 mg darba kuljum) itawlu l-intervall tal-QTc tal-ECG (ara sezzjoni 5.1).
English: Table 6: Phenotypic resistance outcomes from studies C209 and C215 (pooled data for patients receiving rilpivirine hydrochloride or efavirenz in combination with emtricitabine/tenofovir disoproxil) at week 96 (based on resistance analysis)
Maltese: Tabella 6: Riżultati ta' reżistenza fenotipika minn studji C209 u C215 (dejta miġbura għal pazjenti li jirċievu rilpivirine hydrochloride jew efavirenz flimkien ma' emtricitabine/tenofovir disoproxil) f'ġimgħa 96 (ibbażat fuq analiżi tar-reżistenza)
English: ANTACIDS
Maltese: Anzjani
English: In some patients with advanced HIV infection (AIDS) and a history of opportunistic infections (infections that occur in people with a weak immune system), signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started.
Maltese: F'xi pazjenti b'infezzjoni avvanzata tal-HIV (AIDS) u bi storja medika ta' infezzjonijiet opportunistiċi (infezzjonijiet li jseħħu f'nies b'sistema immuni dgħajfa), sinjali u sintomi ta' infjammazzjoni minn infezzjonijiet fil-passat jistgħu jseħħu dritt wara li tinbeda l-kura kontra l-HIV.
English: ANTIDIABETICS Metformin/Emtricitabine
Maltese: Metformin/Emtricitabine
English: It is unlikely that a dose adjustment would be required for Eviplera in patients with mild or moderate hepatic impairment (see sections 4.2 and 5.2).
Maltese: Mhux probabbli li aġġustament fid-doża ser ikun meħtieġ għal Eviplera f'pazjenti b'indeboliment ħafif jew moderat epatiku (ara sezzjonijiet 4.2 u 5.2).
English: The efficacy of Eviplera is based on the analyses of 96 week data from two randomised, double-blind, controlled studies C209 and C215.
Maltese: Pazjenti infettati bl-HIV-1 li qatt ma rċivew kura fil-passat L-effikaċja ta' Eviplera hi bbażata fuq l-analiżijiet ta' dejta ta' 96 ġimgħa minn żewġ studji kkontrollati, randomised, double-blind, C209 u C215.
English: In the studies, the presence of the mutations V90I and V189I at baseline did not affect the response.
Maltese: Flistudji, il-preżenza tal-mutazzjonijiet V90I u V189I fil-linja bażi ma affettwatx ir-rispons.
English: Rilpivirine is primarily metabolised by CYP3A Medicinal products that induce or inhibit CYP3A may thus affect the clearance of rilpivirine (see section 5.2).
Maltese: Prodotti mediċinali li jinduċu jew jinibixxu CYP3A jistgħu għaldaqstant jaffettwaw it-tneħħija ta' rilpivirine (ara sezzjoni 5.2).
English: In patients receiving tenofovir disoproxil, rare events of renal impairment, renal failure and uncommon events of proximal renal tubulopathy (including Fanconi syndrome) sometimes leading to bone abnormalities (infrequently contributing to fractures) have been reported.
Maltese: F'pazjenti li jkunu qed jirċievu tenofovir disoproxil, avvenimenti rari ta' indeboliment renali, kollass renali u avvenimenti mhux komuni ta' tubulopatija renali prossimali (inkluż is-sindromu ta' Fanconi), li xi kultant wasslu għal anormalitajiet fl-għadam (li b'mod mhux frekwenti jikkontribwixxu għal ksur) kienu rrappurtati.
English: The efficacy data from study GS-US-264-0111 (see section 5.1) indicates that the brief period of lower rilpivirine exposure does not impact antiviral efficacy of Eviplera.
Maltese: Id-dejta dwar l-effikaċja mill-istudju GS-US-264-0111 (ara sezzjoni 5.1) tindika li l-perjodu qasir ta' esponiment aktar baxx għal rilpivirine m'għandux impatt fuq l-effikaċja antivirali ta' Eviplera.
English: • Lactic acidosis (see Possible side effects: tell a doctor immediately)
Maltese: • Aċidożi lattika (ara Effetti sekondarji possibbli: għid lil tabib immedjatament)
English: If Eviplera is discontinued in patients co-infected with HIV and hepatitis B virus (HBV), these patients should be closely monitored for evidence of exacerbation of hepatitis (see section 4.4).
Maltese: Jekk Eviplera jitwaqqaf f'pazjenti infettati kemm bl-HIV u bil-virus tal-epatite B (HBV), dawn ilpazjenti għandhom ikunu immonitorjati mill-qrib għal evidenza jekk l-epatite tmur għall-agħar (ara sezzjoni 4.4).
English: The oral bioavailability of tenofovir from tenofovir disoproxil tablets in fasted patients was approximately 25%.
Maltese: Il-bijodisponibilità orali ta' tenofovir minn pilloli ta' tenofovir disoproxil f'pazjenti fl-istat sajjem kienet ta' madwar 25%.
English: The efficacy and safety of switching from a ritonavir-boosted PI in combination with two NRTIs to Eviplera STR was evaluated in a randomised, open-label study in virologically suppressed HIV-1 infected adults.
Maltese: L-effikaċja u s-sigurtà tal-qlib minn PI msaħħaħ b'ritonavir f'kombinazzjoni ma' żewġ NRTIs għal Eviplera STR ġew evalwati fi studju randomised, open-label f'adulti soppressi viroloġikament infettati bl-HIV-1.
English: • Other medicines used for HIV infection: Non-nucleoside reverse transcriptase inhibitors (NNRTIs).
Maltese: Non-inibituri ta' nucleoside reverse transcriptase (NNRTIs).
English: Ελλάδα
Maltese: TA' EĊĊIPJENTI
English: Co-administration of Eviplera and medicinal products that induce CYP3A has been observed to decrease the plasma concentrations of rilpivirine which could potentially lead to loss of therapeutic effect of Eviplera (see section 4.3).
Maltese: L-għoti flimkien ta' Eviplera u prodotti mediċinali li jinduċu CYP3A ġie osservat li jnaqqas ilkonċentrazzjonijiet fil-plażma ta' rilpivirine li jista' potenzjalment iwassal għat-telf tal-effett terapewtiku ta' Eviplera (ara sezzjoni 4.3).
English: Since rilpivirine is highly protein bound, dialysis is unlikely to result in significant removal of the active substance.
Maltese: Billi rilpivirine jeħel ħafna mal-proteina, id-dijalisi mhux mistennija li tirriżulta fi tneħħija sinifikanti tas-sustanza attiva.
English: A negative impact by NNRTI mutations other than those listed above (e.g. mutations K103N or L100I as single mutations) cannot be excluded, since this was not studied in vivo in a sufficient number of patients.
Maltese: Impatt negattiv minn mutazzjonijiet NNRTI ħlief dawk elenkati hawn fuq (eż. mutazzjonijiet K103N jew L100I bħala mutazzjonijiet waħidhom) ma jistgħux jiġu esklużi, għax dan ma ġiex studjat in vivo f'numru suffiċjenti ta' pazjenti.
English: Animal studies do not indicate harmful effects of emtricitabine, rilpivirine hydrochloride or tenofovir disoproxil on fertility.
Maltese: Studji f'annimali ma jurux effetti ħżiena fuq il-fertilità minn emtricitabine, rilpivirine hydrochloride jew tenofovir disoproxil.
English: Ketoconazole/Tenofovir disoproxil Interaction not studied.
Maltese: Ketoconazole/Tenofovir disoproxil L-interazzjoni ma ġietx studjata.
English: Film-coated tablet.
Maltese: Eviplera fil-linja bażi.
English: Overall response (HIV-1 RNA < 50 copies/mL (TLOVRa))b
Maltese: <50 kopji/mL (TLOVRa))b
English: However, it may not be completely excluded that rilpivirine can increase the exposure to other medicinal products transported by P-gp that are more sensitive to intestinal P-gp inhibition (e.g. dabigatran etexilate).
Maltese: Madankollu, ma jistax jiġi eskluż kompletament li rilpivirine jista' jżid l-esponiment għal prodotti mediċinali oħrajn li jiġu ttrasportati minn P-gp li huma iktar sensittivi għal inibizzjoni ta' P-gp intestinali (eż. dabigatran etexilate).
English: In the cumulative week 96 pooled resistance analysis for patients receiving rilpivirine in combination with emtricitabine/tenofovir disoproxil, a greater risk of virologic failure for patients in the rilpivirine arm was observed within the first 48 weeks of these studies (11.5% in the rilpivirine arm and 4.2% in the efavirenz arm) while low rates of virologic failure, similar between the treatment arms, were observed from the week 48 to week 96 analysis (15 patients or 2.7% in the rilpivirine arm and 14 patients or 2.6% in the efavirenz arm).
Maltese: Fl-analiżi kumulattiva miġbura tar-reżistenza f'ġimgħa 96 għal pazjenti li kienu qed jirċievu rilpivirine flimkien ma' emtricitabine/tenofovir disoproxil, ġie osservat riskju akbar ta' insuffiċjenza viroloġika għal pazjenti fil-parti tal-istudju dwar rilpivirine matul l-ewwel 48 ġimgħa ta' dawn l-istudji (11.5% fil-parti tal-istudju dwar rilpivirine u 4.2% fil-parti tal-istudju dwar efavirenz) filwaqt li kienu osservati rati baxxi ta' insuffiċjenza viroloġika, li kienu simili bejn ilpartijiet tal-istudju, mill-analiżi ta' ġimgħa 48 sa ġimgħa 96 (15-il pazjent jew 2.7% fil-parti tal-istudju dwar rilpivirine u 14-il pazjent jew 2.6% fil-parti tal-istudju dwar efavirenz).
English: In this analysis, the NNRTI resistance-associated mutations that developed most commonly in these patients were: V90I, K101E, E138K/Q, V179I, Y181C, V189I, H221Y and F227C.
Maltese: F'din l-analiżi, il-mutazzjonijiet assoċjati ma' reżistenza għal NNRTIs li żviluppaw bl-iktar mod komuni f'dawn pazjenti kienu: V90I, K101E, E138K/Q, V179I, Y181C, V189I, H221Y u F227C.
English: As rilpivirine is highly bound to plasma proteins, it is unlikely that it will be significantly removed by haemodialysis or peritoneal dialysis (see section 4.9).
Maltese: Billi rilpivirine jeħel ħafna mal-proteini tal-plażma, x'aktarx li mhuwiex ser jitneħħa b'mod sinifikanti permezz ta' emodijalisi jew dijalisi peritoneali (ara sezzjoni 4.9).
English: Signs of osteonecrosis are:
Maltese: Is-sinjali ta' osteonekrosi huma:
English: Eviplera should not be co-administered with the following medicinal products as significant decreases in rilpivirine plasma concentrations may occur (due to cytochrome P450 [CYP]3A enzyme induction or gastric pH increase), which may result in loss of therapeutic effect of Eviplera:
Maltese: Eviplera m'għandux jingħata flimkien mal-prodotti mediċinali li ġejjin għax tnaqqis sinifikanti talkonċentrazzjonijiet ta' rilpivirine fil-plażma jistgħu jseħħu (minħabba l-induzzjoni talenzima ċitokrom P450 [CYP]3A jew żieda fil-pH gastriku), li jista' jirriżulta fit-telf tal-effett terapewtiku ta' Eviplera:
English: • Tiredness, feeling sleepy (somnolence)
Maltese: • Għeja, tħossok bi ngħas (sonnolenza)
English: The most common emergent resistance mutations in Eviplera-treated patients were M184V/I and E138K in RT. All patients remained susceptible to tenofovir.
Maltese: L-aktar mutazzjonijiet komuni ta' reżistenza emerġenti f'pazjenti li rċivew kura b'Eviplera kienu M184V/I u E138K f'RT. Il-pazjenti kollha baqgħu suxxettibbli għal tenofovir.
English: Tenofovir is primarily excreted by the kidney by both filtration and an active tubular transport system (human organic anion transporter 1 [hOAT1]) with approximately 70-80% of the dose excreted unchanged in urine following intravenous administration.
Maltese: Tenofovir jitneħħa mill-ġisem prinċipalment mill-kliewi kemm permezz tal-filtrazzjoni kif ukoll permezz ta' sistema attiva ta' trasport tubulari (trasportatur enajoniku organiku uman 1 [hOAT1]) b'madwar 70-80% tad-doża titneħħa mingħajr tibdil fl-awrina wara l-għoti minn ġol-vina.
English: After week 24, the HIV-1 from 2 additional patients in the Eviplera arm developed resistance by week 48 (total of 4 of 469 patients, 0.9%).
Maltese: Wara l-ġimgħa 24, l-HIV-1 minn 2 pazjenti addizzjonali fil-parti tal-istudju ta' Eviplera żviluppaw reżistenza sal-ġimgħa 48 (total ta' 4 minn 469 pazjent, 0.9%).
English: Since Eviplera is a combination product and the dosing interval of the individual components cannot be altered, treatment with Eviplera must be interrupted in patients with confirmed CrCl decreased to < 50 mL/min or decreases in serum phosphate to < 1.0 mg/dL (0.32 mmol/L).
Maltese: Billi Eviplera hu prodott kombinat u l-intervall tad-dożaġġ tal-komponenti individwali ma jistax jinbidel, it-trattament b'Eviplera irid jiġi interrott f'pazjenti b'konferma ta' CrCl imnaqqsa għal <50 mL/min jew tnaqqis tal-phosphate fisserum għal <1.0 mg/dL (0.32 mmol/L).
English: Of the 24 patients treated with Eviplera who had the NNRTI-associated K103N substitution pre-existing at baseline in their HIV-1, 17 of 18 patients in the Eviplera arm and 5 of 6 patients in the SBR arm maintained virologic suppression after switching to Eviplera through 48 weeks and 24 weeks of treatment, respectively.
Maltese: Mill-24 pazjent li rċivew kura b'Eviplera li kellhom is-sostituzzjoni K103N assoċjata ma' NNRTI pre-eżistenti fil-linja bażi fl-HIV-1 tagħhom, 17 minn 18-il pazjent fil-parti tal-istudju ta' Eviplera u 5 minn 6 pazjenti filparti tal-istudju ta' SBR żammew soppressjoni viroloġika wara li qalbu għal Eviplera sat-48 ġimgħa u l-24 ġimgħa ta' kura, rispettivament.
English: Sofosbuvir/Velpatasvir (400 mg/100 mg once daily)/ Emtricitabine/Rilpivirine/Tenofovir disoproxil (200 mg/25 mg/245 mg once daily)
Maltese: (400 mg/100 mg darba kuljum)/ Emtricitabine/Rilpivirine/Tenofovir disoproxil (200 mg/25 mg/245 mg darba kuljum)
English: Sex Male Female Ethnicity White Black/African American Asian Other Not allowed to ask per local regulations Baseline disease characteristics Median baseline plasma HIV-1 RNA (range), log10 copies/mL Median baseline CD4+ cell count (range), x 106 cells/L Percentage of patients with HBV/HCV co-infection
Maltese: Il-pazjenti kellhom ikunu jew fuq l-ewwel jew fuq it-tieni kors antiretrovirali bl-ebda storja ta' insuffiċjenza viroloġika, ma jkollhom l-ebda storja attwali jew passata ta' reżistenza għal xi wieħed mit-tliet komponenti ta' Eviplera, u kellhom ikunu soppressi b'mod stabbli (HIV-1 RNA <50 kopja/mL) għal mill-inqas 6 xhur qabel l-iskrinjar.
English: • Tell your doctor if you have an allergy to sunset yellow aluminium lake (E110).
Maltese: • Għid lit-tabib tiegħek jekk għandek allerġija għal sunset yellow aluminium lake (E110).
English: pancreatitis3
Maltese: proteinurija3
English: Co-administration of Eviplera with medicinal products that inhibit CYP3A enzyme activity has been observed to increase rilpivirine plasma concentrations.
Maltese: L-għoti flimkien ta' Eviplera ma' prodotti mediċinali li jinibixxu l-attività tal-enzima CYP3A ġie osservat li jżid il-konċentrazzjonijiet ta' rilpivirine fil-plażma.
English: A decreased dosage of 250 mg didanosine co-administered with tenofovir disoproxil therapy has been associated with reports of high rates of virological failure within several tested combinations for the treatment of HIV-1 infection.
Maltese: Dożaġġ imnaqqas ta' 250 mg ta' didanosine mogħti flimkien ma' terapija b'tenofovir disoproxil ġie assoċjat ma' rapporti ta' rati għoljin ta' insuffiċjenza viroloġika f'diversi kombinazzjonijiet li kienu ttestjati għall-kura ta' infezzjoni bl-HIV-1.
English: The frequency category was estimated from a statistical calculation based on the total number of patients exposed to Eviplera or all of its components in randomised controlled clinical studies (n = 1,261).
Maltese: Il-kategorija ta' frekwenza ġiet stmata minn kalkolazzjoni statistika bbażata fuq in-numru totali ta' pazjenti esposti għal Eviplera jew il-komponenti kollha tiegħu, fi studji kliniċi kkontrollati li fihom il-parteċipanti ntgħażlu b'mod każwali (n = 1,261).
English: The safety and efficacy of Eviplera in children under the age of 18 years have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Eviplera fit-tfal taħt l-età ta' 18-il sena għadhom ma ġewx determinati s'issa.
English: HIV-1 RNA copies/mL (see sections 4.2, 4.4 and 5.1).
Maltese: HIV-2 (il-valuri EC50 varjaw minn 1.6 sa 5.5 µM).
English: There were no new safety findings compared with the known safety profile of rilpivirine in HIV-1 infected adults (see sections 4.2, 4.4 and 5.2).
Maltese: Ma kienx hemm sejbiet ġodda dwar is-sigurtà meta mqabbla mal-profil tas-sigurtà magħruf ta' rilpivirine f'adulti infettati bl-HIV-1 (ara sezzjonijiet 4.2, 4.4 u 5.2).
English: In the Phase III studies (C209 and C215), lower rilpivirine exposure, similar to that seen during pregnancy, has been associated with an increased risk of virological failure, therefore viral load should be monitored closely (see sections 4.6, 5.1 and 5.2).
Maltese: III (C209 u C215), esponiment iktar baxx għal rilpivirine, simili għal dak li deher matul it-tqala, kien ġie assoċjat ma' żieda fir-riskju ta' insuffiċjenza viroloġika, għalhekk l-ammont virali għandu jiġi mmonitorjat mill-qrib (ara sezzjonijiet 4.6, 5.1 u 5.2).
English: • Diarrhoea, being sick (vomiting), feeling sick (nausea)
Maltese: • Dijarea, tkun imdardar (tirremetti), tħossok imdardar (nawseja)
English: Patients were randomised in a 2:1 ratio to either switch to Eviplera at baseline (Eviplera arm, n = 317), or stay on their baseline antiretroviral regimen for 24 weeks (SBR arm, n = 159) before switching to Eviplera for an additional 24 weeks (Delayed Switch arm, n = 152).
Maltese: Il-pazjenti kienu randomised fi proporzjon ta' 2:1 għal jew qlib għal Eviplera fil-linja bażi (parti tal-istudju ta' Eviplera, n = 317), jew jibqgħu fuq il-kors antiretrovirali tagħhom fil-linja bażi għal 24 ġimgħa (parti tal-istudju ta' SBR, n = 159) qabel ma qalbu għal Eviplera għal 24 ġimgħa addizzjonali (parti tal-istudju tal-Qlib Ittardjat, n = 152).
English: Population pharmacokinetic analysis indicated that hepatitis B and/or C virus co-infection had no clinically relevant effect on the exposure to rilpivirine.
Maltese: Analiżi farmakokinetika tal-popolazzjoni indikat li koinfezzjoni bil-virus tal-epatite B u/jew Ċ ma kellha l-ebda effett klinikament rilevanti fuq l-espożizzjoni għal rilpivirine.
English: No clinically relevant differences in pharmacokinetics of rilpivirine have been observed between men and women.
Maltese: L-ebda differenzi klinikament rilevanti fil-farmakokinetika ta' rilpivirine ma ġew osservati bejn l-irġiel u n-nisa.
English: 4 Anaemia was common and skin discolouration (increased pigmentation) was very common when emtricitabine was administered to paediatric patients (see section 4.8, Paediatric population).
Maltese: L-anemija kienet komuni u t-tibdil fil-kulur tal-ġilda (żieda fil-pigmentazzjoni) kien komuni ħafna meta emtricitabine ingħata lil pazjenti pedjatriċi (ara sezzjoni 4.8, Popolazzjoni pedjatrika).
English: AUC: ↔ Cmin: ↔ Cmax: ↑ 17%
Maltese: AUC: ↔ Cmax: ↔ Cmin: ↑ 25%
English: Through week 24, two patients who switched to Eviplera at baseline (2 of 317 patients, 0.6%) and one patient who maintained their ritonavir-boosted PI-based regimen [Stayed on Baseline Regimen (SBR) arm] (1 of 159 patients, 0.6%) developed genotypic and/or phenotypic resistance to study drugs.
Maltese: Sal-ġimgħa 24, żewġ pazjenti li qalbu għal Eviplera fil-linja bażi (2 minn 317-il pazjent, 0.6%) u pazjent wieħed li żammew il-kors tagħhom abbażi ta' PI msaħħaħ b'ritonavir [parti tal-istudju li Baqgħu fuq il-Kors fil-Linja Bażi (SBR)] (pazjent 1 minn 159, 0.6%) żviluppaw reżistenza ġenotipika u/jew fenotipika għall-mediċini tal-istudju.
English: Emtricitabine and tenofovir disoproxil are excreted in human milk.
Maltese: Emtricitabine u tenofovir disoproxil huma eliminati fil-ћalib tas-sider tal-bniedem.
English: Eviplera should not be administered concomitantly with adefovir dipivoxil (see section 4.5).
Maltese: Dan jista' jirriżulta fittelf tal-effett terapewtiku ta' Eviplera (ara sezzjoni 4.3).
English: Table 5: Virologic outcomes of randomised treatment of studies C209 and C215 (pooled data for patients receiving rilpivirine hydrochloride or efavirenz in combination with emtricitabine/tenofovir disoproxil) at week 48 (primary) and week 96
Maltese: Riżultati viroloġiċi ta' kura ta' parteċipanti li ġew randomised ta' studji C209 u C215 (dejta miġbura għal pazjenti li kienu qed jirċievu rilpivirine hydrochloride jew efavirenz flimkien ma' emtricitabine/tenofovir disoproxil) f'gimgħa 48 (primarja) u ġimgħa 96
English: The administration of Eviplera to healthy adult subjects with either a light meal (390 kcal) or a standard meal (540 kcal) resulted in increased exposures of rilpivirine and tenofovir relative to fasting conditions.
Maltese: L-għoti ta' Eviplera lil individwi adulti b'saħħithom jew ma' ikla ħafifa (390 kcal) jew ikla standard (540 kcal) irriżultat f'żieda fl-espożizzjonijiet ta' rilpivirine u tenofovir meta mqabbla mal-kundizzjonijiet tal-istat sajjem.
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 RNA kopji/mL li kellhom insuffiċjenza viroloġika, urew rata ogħla ta' reżistenza għall-klassi ta' NNRTI li tirriżulta mill-kura.
English: Rilpivirine hydrochloride at the recommended dose of 25 mg once daily is not associated with a clinically relevant effect on QTc.
Maltese: Rilpivirine hydrochloride fid-doża rakkomandata ta' 25 mg darba kuljum, mhuwiex assoċjat ma' effett klinikament rilevanti fuq il-QTc.
English: Famotidine (40 mg single dose taken 4 hours after rilpivirine)/ Rilpivirine1
Maltese: Famotidine (doża waħda ta' 40 mg meħuda 4 sigħat wara rilpivirine)/ Rilpivirine1
English: HERBAL PRODUCTS St. John's wort (Hypericum perforatum)
Maltese: John's wort (Hypericum perforatum) (rimedju li ġej mill-ħxejjex li jintuża għad-dipressjoni u l-ansjetà)
English: Rilpivirine does not inhibit the human cellular DNA polymerases α, β and mitochondrial DNA polymerase γ.
Maltese: Madankollu, ma jistax jiġi eskluż li espożizzjoni farmakoloġikament attiva għal rilpivirine mhux imwaħħal, tiżdied b'mod sinifikanti f'indeboliment moderat.
English: The response rate (confirmed undetectable viral load < 50 HIV-1 RNA copies/mL) at week 96 was comparable between the rilpivirine arm and the efavirenz arm.
Maltese: Ir-rata ta' rispons (ammont virali kkonfermat li ma jistax jiġi osservat ta' <50 HIV-1 RNA kopji/mL) f'ġimgħa 96 kienet komparabbli bejn il-parti tal-istudju dwar rilpivirine u l-parti tal-istudju dwar efavirenz.
English: pain1, fatigue2
Maltese: uġigħ1, għeja2
English: • If you are taking an antacid (such as medicines containing magnesium or potassium), take it at least 2 hours before or at least 4 hours after Eviplera (see section 3, How to take Eviplera).
Maltese: • Jekk qed tieħu antaċidu (bħal mediċini li jkun fihom magnesium jew potassium), ħudu millinqas sagħtejn qabel jew mill-inqas 4 sigħat wara Eviplera (ara sezzjoni 3 Kif għandek tieħu Eviplera).
English: Cases of severe skin reactions with systemic symptoms have been reported during post-marketing experience with Eviplera, including but not limited to rashes accompanied by fever, blisters, conjunctivitis, angioedema, elevated liver function tests, and/or eosinophilia.
Maltese: Każijiet ta' reazzjonijiet severi tal-ġilda b'sintomi sistemiċi ġew irrappurtati matul l-esperjenza ta' wara t-tqegħid fis-suq b'Eviplera, li jinkludu, iżda mhumiex limatati għal, raxxijiet akkumpanjati minn deni, infafet, konġuntivite, anġjoedema, testijiet tal-funzjoni tal-fwied b'riżultati għoljin, u/jew eosinofilija.