FrancophonIA/ELRC3.0 huggingface dataset:
English: The adverse reaction profile of emtricitabine, rilpivirine hydrochloride and tenofovir disoproxil in patients co-infected with HIV/HBV or HIV/HCV was similar to that observed in patients infected with HIV without co-infection.
Maltese: Il-profil tar-reazzjoni avversa ta' emtricitabine, rilpivirine hydrochloride u tenofovir disoproxil f'pazjenti infettati kemm bl-HIV/HBV jew bl-HIV/HCV kien jixbah lil dak osservat f'pazjenti infettati bl-HIV biss.
English: Eviplera is a treatment for Human Immunodeficiency Virus (HIV) infection in adults aged
Maltese: Eviplera hu trattament għal Virus ta' l-Immunodefiċjenza Umana (HIV) fl-adulti minn età ta' 18-il sena u aktar.
English: • omeprazole, lansoprazole, rabeprazole, pantoprazole and esomeprazole (proton pump inhibitors that are medicines used to prevent and treat stomach ulcers, heartburn, acid reflux disease)
Maltese: • omeprazole, lansoprazole, rabeprazole, pantoprazole u esomeprazole (inibituri talpompa tal-proton li huma mediċini li jintuża biex jiġu evitati u għal kura ta' ulċeri flistonku ulċeri, qrusa fl-istonku, u mard tar-rifluss tal-aċidu)
English: Liver toxicity associated with liver enzyme induction was observed in rodents.
Maltese: Tossiċità epatiku assoċjata mal-induzzjoni tal-enzima epatiku ġiet osservata f'annimali gerriema.
English: Atorvastatin (40 mg once daily)/ Rilpivirine1
Maltese: Atorvastatin (40 mg darba kuljum)/ Rilpivirine1
English: The following pack sizes are available: outer cartons containing 1 bottle of 30 film-coated tablets and outer cartons containing 90 (3 bottles of 30) film-coated tablets.
Maltese: Id-daqsijiet tal-pakketti li ġejjin huma disponibbli: kartun ta' barra li fihom 1 flixkun ta' 30 pillola miksija b'rita u kartun ta' barra li fihom 90 (3 fliexken ta' 30) pillola miksija b'rita.
English: One patient with pre-existing K103N at baseline had virologic failure with additional emergent resistance by week 48.
Maltese: Pazjent wieħed b'K103N pre-eżistenti fil-linja bażi kellu insuffiċjenza viroloġika b'reżistenza emerġenti addizzjonali sal-ġimgħa 48.
English: (rilpivirine) and 5/14 (efavirenz) were in patients with a baseline viral load of ≤ 100,000 copies/mL.
Maltese: Minn dawn l-insuffiċjenzi viroloġiċi, 5/15 (rilpivirine) u 5/14 (efavirenz) kienu f'pazjenti b'ammont virali fil-linja bażi ta' ≤100,000 kopja/mL.
English: Maraviroc (300 mg twice daily)/ Tenofovir disoproxil (245 mg once daily)
Maltese: Maraviroc (300 mg darbtejn kuljum)/Tenofovir disoproxil (245 mg darba kuljum)
English: immune reactivation syndrome
Maltese: Sindromu tar-Riattivazzjoni Immuni
English: Hepatitis B and/or hepatitis C virus co-infection
Maltese: Koinfezzjoni bil-virus tal-epatite B u/jew epatite Ċ
English: Contains lactose monohydrate and sunset yellow aluminium lake (E110), see leaflet for further information.
Maltese: Fih lactose monohydrate u sunset yellow aluminium lake (E110), ara l-fuljett ta' tagħrif għal iktar informazzjoni.
English: In virologically suppressed HIV-1 infected patients In study GS-US-264-0106, 4 of the 469 patients who switched from a ritonavir-PI-based regimen to Eviplera had HIV-1 with reduced susceptibility to at least one component of Eviplera through week 48.
Maltese: Fi studju GS-US-264-0106, 4 mill-469 pazjent li qalbu minn kors ibbażat fuq PI msaħħaħ b'ritonavir għal Eviplera kellhom HIV-1 b'suxxettibilità mnaqqsa għal mill-inqas komponent wieħed ta' Eviplera sa ġimgħa 48.
English: Through week 96, fewer patients in the rilpivirine arm with baseline viral load ≤ 100,000 copies/mL had emerging resistance-associated substitutions and/or phenotypic resistance to rilpivirine (7/288) than patients with baseline viral load > 100,000 copies/mL (30/262).
Maltese: Sa ġimgħa 96, inqas pazjenti fil-parti tal-istudju dwar rilpivirine b'ammont virali fil-linja bażi ta' ≤100,000 kopja/mL kellhom sostituzzjonijiet ġodda assoċjati mar-reżistenza u/jew reżistenza fenotipika għal rilpivirine (7/288) minn pazjenti b'ammont virali fil-linja bażi ta' >100,000 kopja/mL (30/262).
English: 5 Study conducted with additional voxilaprevir 100 mg to achieve voxilaprevir exposures expected in hepatitis C virus
Maltese: Studju mwettaq b'voxilaprevir 100 mg addizzjonali sabiex jinkisbu l-esponimenti għal voxilaprevir mistennija f'pazjenti infettati bil-virus tal-epatite Ċ (HCV, hepatitis C virus).
English: Emtricitabine-resistant viruses with the M184V/I substitution were cross-resistant to lamivudine, but retained sensitivity to didanosine, stavudine, tenofovir, and zidovudine.
Maltese: Il-viruses reżistenti għal emtricitabine mal-sostituzzjoni M184V/I kienu cross-resistant għal lamivudine, iżda żammew is-sensittività għal didanosine, stavudine, tenofovir, u zidovudine.
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-ġenbejn u tas-sinsla tad-dahar kienu osservati fiż-żewġ gruppi tattrattament.
English: Rilpivirine hydrochloride has not been studied in patients with severe hepatic impairment (CPT Score C).
Maltese: Rilpivirine hydrochloride ma ġiex studjat f'pazjenti b'indeboliment sever epatiku (Punteġġ CPT Ċ).
English: lactic acidosis3
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: At week 96 the mean changes in CD4+ cell count from baseline were +226 x 106 cells/L and +222 x 106 cells/L for the rilpivirine and efavirenz treatment arms, respectively, of patients receiving the emtricitabine/tenofovir disoproxil background regimen.
Maltese: F'ġimgħa 96 it-tibdil medju fl-għadd ta' ċelluli CD4+ mil-linja bażi kien +226 x 106 ċelluli/L u +222 x 106 ċelluli/L għall-parti tal-istudju dwar rilpivirine u efavirenz, rispettivament, tal-pazjenti li rċevew il-kors fl-isfond ta' emtricitabine/tenofovir disoproxil.
English: Emtricitabine-resistant viruses with the M184V/I mutation were cross-resistant to lamivudine, but retained sensitivity to didanosine, stavudine, tenofovir, zalcitabine and zidovudine.
Maltese: Il-viri reżistenti għal emtricitabine bil-mutazzjoni M184V/I kienu cross-resistant għal lamivudine, iżda żammew is-sensittività għal didanosine, stavudine, tenofovir, zalcitabine u zidovudine.
English: • Lactic acidosis (excess lactic acid in the blood) is a rare but potentially life-threatening side effect of some HIV medicines.
Maltese: • Aċidożi lattika (ammont żejjed ta' lactic acid fid-demm) hi effett sekondarju rari ta' xi mediċini kontra l-HIV, iżda li potenzjalment jista' jkun ta' periklu għall-ħajja.
English: Elderly patients are more likely to have decreased renal function, therefore caution should be exercised when treating elderly patients with Eviplera (see sections 4.2 and 5.2).
Maltese: Pazjenti anzjani huma aktar probabbli li jkollhom tnaqqis tal-funzjoni renali, għalhekk għandha tingħata attenzjoni partikulari meta pazjenti anzjani jkunu qed jingħataw it-trattament b'Eviplera (ara sezzjonijiet 4.2 u 5.2).
English: Didanosine (400 mg once daily)/ Rilpivirine1
Maltese: Didanosine (400 mg darba kuljum)/ Rilpivirine1
English: The frequency category was estimated from a statistical calculation based on the total number of patients exposed to tenofovir disoproxil in randomised controlled clinical studies and the expanded access program (n = 7,319).
Maltese: Il-kategorija ta' frekwenza ġiet stmata mill-kalkolazzjoni statistika bbażata fuq innumru totali ta' pazjenti esposti għal tenofovir disoproxil fi studji kliniċi kkontrollati li fihom il-parteċipanti ntgħażlu b'mod każwali u l-programm ta' aċċess imkabbar (n = 7,319).
English: Patients were randomised in a 1:1 ratio to receive either rilpivirine hydrochloride 25 mg (n = 686) once daily or efavirenz 600 mg (n = 682) once daily in addition to a BR.
Maltese: Il-pazjenti ġew randomised fi proporzjon ta' 1:1 biex jirċievu jew rilpivirine hydrochloride 25 mg (n = 686) darba kuljum jew efavirenz 600 mg (n = 682) darba kuljum flimkien ma' mal-kors fl-isfond.
English: d There were 10 new virologic failures between the week 48 primary analysis and week 96 (3 patients with baseline viral load ≤ 100,000 copies/mL and 7 patients with baseline viral load > 100,000 copies/mL).
Maltese: d Kien hemm 10 insuffiċjenzi viroloġiċi ġodda bejn l-analiżi primarja ta' ġimgħa 48 u ġimgħa 96 (3 pazjenti b'ammont virali fil-linja bażi ta' ≤100,000 kopja/mL u 7 pazjenti b'ammont virali fil-linja bażi ta' >100,000 kopja/mL).
English: The effect of rilpivirine hydrochloride at the recommended dose of 25 mg once daily on the QTcF interval was evaluated in a randomised, placebo and active (moxifloxacin 400 mg once daily) controlled crossover study in 60 healthy adults, with 13 measurements over 24 hours at steady-state.
Maltese: L-effett ta' rilpivirine hydrochloride fid-doża rakkomandata ta' 25 mg darba kuljum fuq l-intervall talQTcF ġie evalwata fi studju crossover, randomised, ikkontrollat bi plaċebo u b'mod attiv (moxifloxacin 400 mg darba kuljum) f'60 individwu adult b'saħħithom, bi 13-il kejl fuq perjodu ta' 24 sigħat fl-istat fiss.
English: vesiculobullous rash1, pustular rash1, urticaria1, skin discolouration (increased pigmentation)1, 4, maculopapular rash1, pruritus1
Maltese: raxx bl-imsiemer1, raxx bil-ponot1, urtikarja1, telf tal-kulur tal-ġilda (żieda fil pigmentazzjoni)1, 4, raxx makulopapulari1, ħakk1 Mhux komuni: anġjoedema1, 3, 6, reazzjonijiet severi tal-ġilda b'sintomi sistemiċi7
English: Rifabutin (300 mg once daily)/ Rilpivirine (50 mg once daily)
Maltese: Rifabutin (300 mg darba kuljum)/ Rilpivirine (50 mg darba kuljum)
English: If serum phosphate is < 1.5 mg/dL (0.48 mmol/L) or CrCl is decreased to < 50 mL/min in any patient receiving Eviplera, renal function should be re-evaluated within one week, including measurements of blood glucose, blood potassium and urine glucose concentrations (see section 4.8, proximal tubulopathy).
Maltese: Jekk il-phosphate fis-serum huwa <1.5 mg/dL (0.48 mmol/L) jew CrCl tonqos għal <50 mL/min, fi kwalunkwe pazjent li qed jirċievi Eviplera, il-funzjoni renali għandha tkun evalwata mill-ġdid fi żmien ġimgħa, inkluż il-kejl tal-konċentrazzjonijiet tal-glucose fid-demm, tal-potassium fid-demm u talglucose fl-awrina (ara sezzjoni 4.8, tubulopatija prossimali).
English: Eviplera contains sunset yellow aluminium lake also called “E110” which may cause allergic reactions.
Maltese: Eviplera fih sunset yellow aluminium lake, imsejjaħ ukoll “E110”, li jista' jikkawża reazzjonijiet allerġiċi.
English: Simeprevir (150 mg once daily)/ Tenofovir disoproxil (245 mg once daily)
Maltese: Simeprevir (150 mg darba kuljum)/ Tenofovir disoproxil (245 mg darba kuljum)
English: Emtricitabine displayed antiviral activity in cell culture against HIV-1 subtype 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-valuri EC50 varjaw minn 0.007 sa 0.075 µM) u wera attività speċifika tar-razza kontra
English: Limited data from clinical studies support once daily dosing of Eviplera in patients with mild renal impairment (creatinine clearance (CrCl) 50-80 mL/min).
Maltese: Informazzjoni limitata minn studji kliniċi tappoġġja d-dożaġġ ta' Eviplera darba kuljum f'pazjenti b'indeboliment ħafif renali (tneħħija tal-krejatinina (CrCl, creatinine clearance) ta' 50-80 mL/min).
English: Elderly patients are more likely to have decreased renal function, therefore caution should be exercised when treating elderly patients with Eviplera (see section 4.4).
Maltese: Pazjenti anzjani huma aktar probabbli li jkollhom tnaqqis tal-funzjoni renali, għalhekk għandha tingħata attenzjoni partikulari meta pazjenti anzjani jkunu qed jingħataw it-trattament b'Eviplera (ara sezzjoni 4.4).
English: The mutations associated with NRTI resistance that developed in 3 or more patients were: K65R, K70E, M184V/I and K219E during the treatment period.
Maltese: Il-mutazzjonijiet assoċjati ma' reżistenza għal NRTIs li żviluppaw fi 3 jew iktar pazjenti kienu: K65R, K70E, M184V/I u K219E matul il-perjodu ta' kura.
English: Table 3: Phenotypic resistance and cross-resistance outcomes from studies C209 and C215 (pooled data) for patients receiving rilpivirine hydrochloride in combination with emtricitabine/tenofovir disoproxil at week 96 (based on resistance analysis)
Maltese: Tabella 3: Riżultati ta' reżistenza fenotipika u cross-resistance minn studji C209 u C215 (dejta miġbura) għal pazjenti li rċivew rilpivirine hydrochloride flimkien ma' emtricitabine/tenofovir disoproxil f'ġimgħa 96 (ibbażat fuq analiżi tar-reżistenza)
English: • Emtricitabine, a nucleoside reverse transcriptase inhibitor (NRTI).
Maltese: • Emtricitabine, li hu inibitur ta' nucleoside reverse transcriptase (NRTI).
English: Sildenafil (50 mg single dose)/ Rilpivirine1
Maltese: Sildenafil (doża waħda ta' 50 mg)/ Rilpivirine1
English: Through week 48, no emergent resistance developed in the 2 patients who failed virologically among patients who switched to Eviplera from efavirenz/emtricitabine/tenofovir disoproxil (0 of 49 patients).
Maltese: Sal-ġimgħa 48, ma żviluppat l-ebda reżistenza emerġenti fiż-2 pazjenti b'insuffiċjenza viroloġika fost il-pazjenti li qalbu għal Eviplera minn efavirenz/emtricitabine/tenofovir disoproxil (0 minn 49 pazjent).
English: There is limited information regarding the use of Eviplera in patients with mild or moderate hepatic impairment (Child-Pugh-Turcotte (CPT) Score A or B).
Maltese: Hemm informazzjoni limitata dwar l-użu ta' Eviplera f'pazjenti b'indeboliment epatiku ħafif jew moderat (Punteġġ ta' Child-Pugh-Turcotte (CPT) ta' A jew B).
English: Lopinavir (400 mg twice daily)/ Ritonavir (100 mg twice daily)/ Tenofovir disoproxil (245 mg once daily)
Maltese: Lopinavir (400 mg darbtejn kuljum)/Ritonavir (100 mg darbtejn kuljum)/Tenofovir disoproxil (245 mg darba kuljum)
English: The pharmacokinetic data demonstrate that total exposure (AUC) to rilpivirine as a part of an antiretroviral regimen was approximately 30% lower during pregnancy compared with postpartum (6-12 weeks).
Maltese: Id-dejta farmakokinetika turi li l-esponiment totali (AUC) għal rilpivirine bħala parti minn kors antiretrovirali kien madwar 30% inqas matul it-tqala meta mqabbel ma' wara l-ħlas (6-12-il ġimgħa).
English: Co-administration of Eviplera and didanosine is not recommended as it results in a 40-60% increase in systemic exposure to didanosine that may increase the risk of didanosine-related adverse reactions (see section 4.5).
Maltese: L-għoti ta' Eviplera flimkien ma' didanosine mhuwiex rakkomandat għax jista' jirriżulta f'żieda ta' 40-60% fl-esponiment sistemiku għal didanosine li jista' jżid ir-riskju għal reazzjonijiet avversi relatati ma' didanosine (ara sezzjoni 4.5).
English: 6 Study conducted with emtricitabine/rilpivirine/tenofovir alafenamide fixed-dose combination tablet.
Maltese: Studju mwettaq b'pillola kombinata b'doża fissa ta' emtricitabine/rilpivirine/tenofovir alafenamide.
English: 5 This adverse reaction may occur as a consequence of proximal renal tubulopathy.
Maltese: Din ir-reazzjoni avversa tista' sseħħ bħala konsegwenza ta' tubulopatija renali prossimali.
English: Resistance to emtricitabine or tenofovir has been seen in vitro and in some HIV-1 infected patients due to the development of the M184V or M184I substitution in RT with emtricitabine, or the K65R substitution in RT with tenofovir.
Maltese: Ir-reżistenza għal emtricitabine jew tenofovir intweriet in vitro u f'xi pazjenti infettati bl-HIV-1 minħabba l-iżvilupp tas-sostituzzjoni M184V jew M184I f'RT b'emtricitabine jew is-sostituzzjoni K65R f'RT b'tenofovir.
English: In patients with end-stage renal disease (ESRD) requiring haemodialysis, between dialysis drug exposures substantially increased over 72 hours to 53 µg•h/mL (19%) of emtricitabine, and over 48 hours to 42,857 ng•h/mL (29%) of tenofovir.
Maltese: F'pazjenti b'mard renali tal-aħħar stadju (ESRD) li jeħtieġ emodijalisi, l-esponimenti tal-mediċina bejn id-dijalisi żdiedu b'mod sostanzjali fuq 72 siegħa għal 53 µg•h/mL (19%) ta' emtricitabine, u fuq 48 siegħa għal 42,857 ng•h/mL (29%) ta' tenofovir.
English: Population pharmacokinetic analysis in HIV infected patients showed that rilpivirine pharmacokinetics is not different across the age range (18 to 78 years) evaluated, with only 2 patients aged 65 years of age or older.
Maltese: Analiżi farmakokinetika tal-popolazzjoni f'pazjenti infettati bl-HIV uriet li l-farmakokinetika ta' rilpivirine mhijiex differenti fuq il-medda ta' età (18 sa 78 sena) li ġiet evalwata, b'2 pazjenti biss li kellhom 65 sena jew aktar.
English: c There were 17 new virologic failures between the week 48 primary analysis and week 96 (6 patients with baseline viral load ≤ 100,000 copies/mL and 11 patients with baseline viral load > 100,000 copies/mL).
Maltese: ċ Kien hemm 17-il insuffiċjenza viroloġika ġdida bejn l-analiżi primarja ta' ġimgħa 48 u ġimgħa 96 (6 pazjenti b'ammont virali fil-linja bażi ta' ≤100,000 kopja/mL u 11-il pazjent b'ammont virali fil-linja bażi ta' >100,000 kopja/mL).
English: Rifabutin (300 mg once daily)/ Rilpivirine (25 mg once daily)
Maltese: Rifabutin (300 mg darba kuljum)/ Rilpivirine (25 mg darba kuljum)
English: Eviplera has not been studied in patients over the age of 65 years.
Maltese: Eviplera ma ġiex studjat f'pazjenti ta' ‘l fuq minn 65 sena.
English: Eviplera is not recommended for patients with moderate or severe renal impairment (CrCl < 50 mL/min).
Maltese: Eviplera mhuwiex rakkomandat għal pazjenti b'indeboliment moderat jew sever renali (CrCl ta' <50 mL/min).
English: Interaction not studied with Eviplera.
Maltese: Mediċini oħra u Eviplera
English: Table 2: Tabulated summary of adverse reactions to Eviplera based on clinical study and post-marketing experience with Eviplera and its individual components
Maltese: Tabella 2: Sommarju tabulat ta' reazzjonijiet avversi għal Eviplera bbażat fuq studju kliniku u esperjenza ta' wara t-tqegħid fis-suq b'Eviplera u l-komponenti individwali tiegħu
English: Among those patients who developed resistance to rilpivirine, 4/7 patients with baseline viral load ≤ 100,000 copies/mL and 28/30 patients with baseline viral load > 100,000 copies/mL had cross-resistance to other NNRTIs.
Maltese: Fost dawk il-pazjenti li żviluppaw reżistenza għal rilpivirine, 4/7 pazjenti b'ammont virali fil-linja bażi ta' ≤100,000 kopja/mL u 28/30 pazjent b'ammont virali fil-linja bażi ta' >100,000 kopja/mL kellhom cross-resistance għal NNRTIs oħrajn.
English: In the pooled analysis for C209 and C215 of patients who received a background regimen of emtricitabine/tenofovir disoproxil, demographic and baseline characteristics were balanced between the rilpivirine and efavirenz arm. Table 4 displays selected demographic and baseline disease characteristics.
Maltese: F'analiżi miġbura għal C209 u C215 ta' pazjenti li rċivew kors fl-isfond ta' emtricitabine/ tenofovir disoproxil, il-karatteristiċi demografiċi u fil-linja bażi kienu bbilanċjati bejn il-parti talistudju dwar rilpivirine u efavirenz.
English: Rilpivirine-resistant strains were selected in cell culture starting from wild-type HIV-1 of different origins and subtypes as well as NNRTI-resistant HIV-1.
Maltese: Razez reżistenti għal rilpivirine intgħażlu fil-koltura taċ-ċelluli li tibda minn wild-type HIV-1 ta' oriġini u sottotipi differenti kif ukoll HIV-1 reżistenti għal NNRTI.
English: Table 7: Outcomes of randomised treatment in study GS-US-264-0106 at week 24a
Maltese: Wara 48 ġimgħa fl-istudju GS-US-264-0106 ta' Fażi
English: Eviplera is indicated for the treatment of adults infected with human immunodeficiency virus type 1 (HIV-1) without known mutations associated with resistance to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class, tenofovir or emtricitabine, and with a viral load ≤ 100,000
Maltese: Eviplera huwa indikat għall-kura ta' adulti infettati bil-virus tal-immunodefiċjenza umana ta' tip 1 (HIV-1) mingħajr mutazzjonijiet magħrufa assoċjati ma' reżistenza għall-klassi ta' non-inibitur ta' nucleoside reverse transcriptase (NNRTI), tenofovir jew emtricitabine, u b'ammont virali ta' ≤100,000 HIV-1 RNA kopji/mL (ara sezzjonijiet 4.2, 4.4 u 5.1).
English: Eviplera contains a colourant called sunset yellow aluminium lake (E110), which may cause allergic reactions.
Maltese: Eviplera fih kolorant imsejjaħ sunset yellow aluminium lake (E110), li jista' jikkawża reazzjonijiet allerġiċi.
English: • non-steroidal anti-inflammatory drugs (NSAIDs, to relieve bone or muscle pains)
Maltese: • mediċini anti-infjammatorji mhux sterojdi (NSAIDs, għas-serħan mill-uġigħ fl-għadam jew fil-muskoli)
English: There were 7/317 patients (2%) in the Eviplera arm and 6/152 patients (4%) in the Delayed Switch arm who permanently discontinued study drug due to a treatment-emergent adverse event (TEAE).
Maltese: Kien hemm 7/317-il pazjent (2%) fil-parti tal-istudju ta' Eviplera u 6/152 pazjent (4%) fil-parti tal-istudju tal-Qlib Ittardjat li waqqfu l-mediċina tal-istudju b'mod permanenti minħabba avveniment avvers b'riżultat tal-kura (TEAE).
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Ir-rekwiżiti biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq ilportal web Ewropew tal-mediċini.
English: DXA substudies showed that small but statistically significant decreases from baseline in whole body BMD and BMC were similar for rilpivirine and control at week 48 and week 96.
Maltese: Sottostudji DXA wrew li tnaqqis żgħir iżda statistikament sinifikanti mil-linja bażi fil-BMD tal-ġisem sħiħ u l-BMC kienu simili għal rilpivirine u għall-kontroll f'ġimgħa 48 u ġimgħa 96.
English: The safety and efficacy of Eviplera have not been established for the treatment of chronic HBV infection.
Maltese: Is-sigurtà u l-effikaċja ta' Eviplera ma ġewx stabbiliti għat-trattament ta' infezzjoni kronika bl-HBV.
English: Table 4: Demographic and baseline characteristics of antiretroviral treatment-naïve HIV-1 infected adult patients in studies C209 and C215 (pooled data for patients receiving rilpivirine hydrochloride or efavirenz in combination with emtricitabine/tenofovir disoproxil) at week 96
Maltese: Tabella 4: Il-karatteristiċi demografiċi u fil-linja bażi tal-pazjenti adulti infettati bl-HIV-1 li qatt ma rċivew kura b'antiretrovirali fil-passat, fi Studji C209 u C215 (dejta miġbura għal pazjenti li kienu qed jirċievu rilpivirine hydrochloride jew efavirenz flimkien ma' emtricitabine/tenofovir disoproxil) f'ġimgħa 96
English: After taking rilpivirine 25 mg once daily as part of an antiretroviral regimen, the total exposure of rilpivirine was lower during pregnancy (similar for the 2nd and 3rd trimester) compared with postpartum.
Maltese: Wara t-teħid ta' rilpivirine 25 mg darba kuljum bħala parti minn kors antiretrovirali, l-esponiment totali ta' rilpivirine kien iktar baxx matul it-tqala (simili għat-tieni u t-tielet trimestru) meta mqabbel ma' wara l-ħlas.
English: Among 49 patients who received at least one dose of Eviplera, 100% of patients remained suppressed (HIV-1 RNA < 50 copies/mL) at week 12 and week 24.
Maltese: Fost id-49 pazjent li rċivew mill-inqas doża waħda ta' Eviplera, 100% tal-pazjenti baqgħu soppressi (HIV-1 RNA <50 kopja/mL) fil-ġimgħa 12 u l-ġimgħa 24.