FrancophonIA/ELRC3.0 huggingface dataset:
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3) with the components of Eviplera.
Maltese: Studji f'annimali ma urewx effetti diretti jew indiretti tossiċi fuq is-sistema riproduttiva (ara sezzjoni 5.3) bil-komponenti ta' Eviplera.
English: In vitro binding of emtricitabine to human plasma proteins was < 4% and independent of concentration over the range of 0.02 to 200 µg/mL.
Maltese: It-twaħħil in vitro ta' emtricitabine ma' proteini tal-plażma umana kienet ta' <4% u indipendenti mill-konċentrazzjoni fil-medda ta' 0.
English: In another study, the Y188L substitution resulted in a reduced susceptibility to rilpivirine of 9-fold for clinical isolates and 6-fold for site-directed mutants.
Maltese: Fi studju ieħor, is-sostituzzjoni Y188L irriżultat fi tnaqqis tassuxxettibilità għal rilpivirine ta' 9 darbiet għal iżolati kliniċi u 6 darbiet għal mutants diretti għas-sit.
English: Rifabutin (300 mg once daily)/ Rilpivirine3
Maltese: Rifabutin (300 mg darba kuljum)/ Rilpivirine3
English: depression2, depressed mood2, sleep disorders2, abnormal dreams1, 2 Nervous system disorders
Maltese: dipressjoni2, burdata dipressa2, disturbi fl-irqad2, ħolm anormali1, 2
English: GLUCOCORTICOIDS Dexamethasone (systemic, except for single dose use)
Maltese: GLUKOKORTIKOJDI Dexamethasone (sistemiku, ħlief għal użu b'doża waħda)
English: Sofosbuvir/Velpatasvir/ Voxilaprevir (400 mg/100 mg/ 100 mg + 100 mg once daily)5/ Rilpivirine/Emtricitabine (25 mg/200 mg once daily)6
Maltese: Voxilaprevir (400 mg/100 mg/ 100 mg + 100 mg darba kuljum)5/ Rilpivirine/Emtricitabine (25 mg/ 200 mg darba kuljum)6
English: The mean (%CV) tenofovir drug exposure increased from 2,185 (12%) ng•h/mL in patients with normal renal function, to 3,064 (30%) ng•h/mL, 6,009 (42%) ng•h/mL and 15,985 (45%) ng•h/mL, in patients with mild, moderate and severe renal impairment, respectively.
Maltese: L-esponiment medju tal-mediċina ta' tenofovir (%CV) żdiedet minn 2,185 (12%) ng•h/mL f'pazjenti b'funzjoni renali normali, għal 3,064 (30%) ng•h/mL, 6,009 (42%) ng•h/mL u 15,985 (45%) ng•h/mL f'pazjenti b'indeboliment renali ħafif, moderat u sever, rispettivament.
English: Very common: increased pancreatic amylase2, vomiting1, 2, 3, diarrhoea1, 3, nausea1, 2, 3
Maltese: Komuni ħafna: żieda f'amylase pankreatika2, rimettar1, 2, 3, dijarea1, 3, dardir1, 2, 3 Komuni:
English: Other antiviral agents Ledipasvir/Sofosbuvir (90 mg/400 mg once daily)/ Emtricitabine/Rilpivirine/ Tenofovir disoproxil (200 mg/25 mg/245 mg once daily)
Maltese: Sustanzi antivirali oħrajn Ledipasvir/Sofosbuvir (90 mg/400 mg darba kuljum)/ Emtricitabine/Rilpivirine/Tenofovir disoproxil (200 mg/25 mg/245 mg darba kuljum)
English: The K103N substitution alone did not result in reduced susceptibility to rilpivirine, but the combination of K103N and L100I resulted in a 7-fold reduced susceptibility to rilpivirine.
Maltese: Is-sostituzzjoni K103N waħidha ma rriżultatx f'suxxettibilità mnaqqsa għal rilpivirine, iżda l-kombinazzjoni ta' K103N u L100I irriżultat f'suxxettibilità seba' darbiet aktar imnaqqsa għal rilpivirine.
English: Croscarmellose sodium Lactose monohydrate Magnesium stearate Microcrystalline cellulose Polysorbate 20
Maltese: Microcrystalline cellulose Polysorbate 20
English: Co-administration of tenofovir disoproxil and didanosine results in a 40-60% increase in systemic exposure to didanosine that may increase the risk of didanosinerelated adverse reactions.
Maltese: L-għoti flimkien ta' tenofovir disoproxil u didanosine jirriżulta f'żieda ta' 40-60% fl-espożizzjoni sistemika għal didanosine, li tista' żżid ir-riskju għal avvenimenti avversi assoċjati ma' didanosine.
English: PROTON PUMP INHIBITORS Omeprazole/Emtricitabine
Maltese: TAL-POMPA TAL-PROTON Omeprazole/Emtricitabine
English: In vitro binding of tenofovir to plasma or serum protein was less than 0.7% and 7.2%, respectively, over the tenofovir concentration range 0.01 to 25 µg/mL.
Maltese: Ir-rabta in vitro ta' tenofovir ma' proteini tal-plażma jew proteini fis-serum kienet anqas minn 0.7% u 7.2%, rispettivament, ogħla mill-medda tal-konċentrazzjoni ta' tenofovir 0.01 sa 25 μg/mL.
English: In virologically suppressed patients switching to Eviplera, the most frequently reported adverse reactions considered possibly or probably related to Eviplera were fatigue (3%), diarrhoea (3%), nausea (2%) and insomnia (2%) (48 week data from the Phase III study GS-US-264-0106).
Maltese: F'pazjenti viroloġikament soppressi li qalbu għal Eviplera, l-iktar reazzjonijiet avversi li kienu rrappurtati b'mod frekwenti u li kienu kkunsidrati bħala possibbilment jew probabbilment relatati ma' Eviplera kienu għeja (3%), d-dijarea (3%), t-tqalligħ (2%) u nuqqas ta' rqad (2%) (dejta ta' 48 ġimgħa miġbura mill-istudji kliniku ta' Fażi III GS-US-264-0106).
English: Atazanavir/Ritonavir/Rilpivirine Interaction not studied.
Maltese: Atazanavir/Ritonavir/Rilpivirine L-interazzjoni ma ġietx studjata.
English: When supratherapeutic doses of 75 mg once daily and 300 mg once daily of rilpivirine hydrochloride were studied in healthy adults, the maximum mean time-matched (95% upper confidence bound) differences in QTcF interval from placebo after baseline correction were 10.7 (15.3) and 23.3 (28.4) ms, respectively.
Maltese: Meta dożi supraterapewtiċi ta' 75 mg darba kuljum u 300 mg darba kuljum ta' rilpivirine hydrochloride ġew studjati f'individwi adulti b'saħħithom, il-medja tad-differenzi massimi timematched (95% upper confidence bound) fl-intervall tal-QTcF mill-plaċebo wara l-korrezzjoni tal-linja bażi kienu ta' 10.7 (15.3) u 23.3 (28.4) ms, rispettivament.
English: Date of first authorisation: 28 November 2011 Date of latest renewal: 22 July 2016
Maltese: Data tal-aħħar tiġdid: 22 ta' Lulju 2016
English: Rare side effects
Maltese: Rappurtar tal-effetti sekondarji
English: In the pooled efficacy analysis from the two Phase III clinical studies (C209 [ECHO] and C215 [THRIVE]) through 96 weeks, patients treated with emtricitabine/tenofovir disoproxil + rilpivirine with a baseline viral load > 100,000 HIV-1 RNA copies/mL had a greater risk of virologic failure (17.6% with rilpivirine versus 7.6% with efavirenz) compared to patients with a baseline viral load ≤ 100,000 HIV-1 RNA copies/mL (5.9% with rilpivirine versus 2.4% with efavirenz).
Maltese: [THRIVE]) sa 96 ġimgħa, pazjenti kkurati b'emtricitabine/tenofovir disoproxil + rilpivirine b'ammont virali fillinja bażi ta' >100,000 HIV-1 RNA kopji/mL kellhom riskju akbar ta' insuffiċjenza viroloġika (17.6% b'rilpivirine versus 7.6% b'efavirenz) meta mqabbel ma' pazjenti b'ammont virali fil-linja bażi ta' ≤100,000 HIV-1 RNA kopji/mL (5.9% b'rilpivirine versus 2.4% b'efavirenz).
English: Although rilpivirine demonstrated limited in vitro activity against HIV-2 with EC50 values ranging from 2,510 to 10,830 nM (920 to 3,970 ng/mL), treatment of HIV-2 infection with rilpivirine hydrochloride is not recommended in the absence of clinical data.
Maltese: HIV-2 b'valuri EC50 li jvarjaw minn 2,510 sa 10,830 nM (920 sa 3,970 ng/mL), il-kura ta' infezzjoni b'HIV-2 b'rilpivirine hydrochloride mhijiex rakkomandata flassenza ta' dejta klinika.
English: By baseline viral load (copies/mL)
Maltese: Skont l-ammont virali fil-linja bażi (kopji/mL)
English: Antiretroviral treatment-naïve HIV-1 infected patients were enrolled (n = 1,368) who had a plasma HIV-1 RNA ≥ 5,000 copies/mL and were screened for susceptibility to N(t)RTI and for absence of specific NNRTI resistance-associated mutations.
Maltese: Pazjenti infettati bl-HIV-1 li qatt ma rċivew kura b'antiretrovirali fil-passat, kienu rreġistrati (n = 1,368); dawn kellhom HIV-1 RNA fil-plażma ta' ≥5,000 kopja/mL u kienu skrinjati għal suxxettibilità għal N(t)RTI u għall-assenza ta' mutazzjonijiet assoċjati mar-reżistenza għal NNRTI speċifiċi.
English: Omeprazole (20 mg once daily)/ Rilpivirine1
Maltese: Omeprazole (20 mg darba kuljum)/ Rilpivirine1
English: The antiviral activity of emtricitabine against laboratory and clinical isolates of HIV-1 was assessed in lymphoblastoid cell lines, the MAGI-CCR5 cell line, and peripheral blood mononuclear cells.
Maltese: L-attività antivirali ta' emtricitabine kontra iżolati tal-laboratorju u kliniċi ta' HIV-1 ġiet evalwata f'razza ta' ċelluli limfoblastojde, ir-razza ta' ċelluli MAGI-CCR5, u ċelluli mononukleari fid-demm periferali.
English: In a panel of 67 HIV-1 recombinant laboratory strains with one resistance-associated mutation at RT positions associated with NNRTI resistance, including the most commonly found K103N and Y181C, rilpivirine showed antiviral activity against 64 (96%) of these strains.
Maltese: F'sensiela ta' 67 razza ta' HIV-1 rikombinanti fil-laboratorju b'mutazzjoni waħda assoċjata ma' reżistenza f'pożizzjonijiet RT assoċjati ma' reżistenza għal NNRTI, li kienu jinkludu K103N u Y181C li jinsabu b'mod l-iktar komuni, rilpivirine wera attività antivirali kontra 64 (96%) minn dawn ir-razez.
English: The antiviral activity of tenofovir against laboratory and clinical isolates of HIV-1 was assessed in lymphoblastoid cell lines, primary monocyte/macrophage cells and peripheral blood lymphocytes.
Maltese: L-attività antivirali ta' tenofovir kontra iżolati tal-laboratorju u kliniċi ta' HIV-1 ġiet evalwata f'razza ta' ċelluli limfoblastojdi, ċelluli monoċiti/makrofagi primarji u limfoċiti tad-demm periferali.
English: Lopinavir (400 mg twice daily)/ Ritonavir (100 mg twice daily)/ Rilpivirine1 (soft capsule)
Maltese: Lopinavir (400 mg darbtejn kuljum)/Ritonavir (100 mg darbtejn kuljum)/Rilpivirine1 (kapsula ratba)
English: The most commonly observed resistanceassociated mutations that emerged included L100I, K101E, V108I, E138K, V179F, Y181C, H221Y, F227C and M230I.
Maltese: L-iktar mutazzjonijiet assoċjati ma' reżistenza osservati b'mod komuni li rriżultaw kienu jinkludu L100I, K101E, V108I, E138K, V179F, Y181C, H221Y, F227C u M230I.
English: No clinically relevant drug-drug interaction is expected.
Maltese: L-ebda interazzjoni klinikament rilevanti bejn mediċina u oħra mhi mistennija.
English: • any other antiviral medicines that contain lamivudine or adefovir dipivoxil
Maltese: • kwalunkwe mediċina antivirali oħra li fiha lamivudine jew adefovir dipivoxil
English: HIV/HBV or HCV co-infected patients
Maltese: Perċentwali ta' pazjenti infettati wkoll bl-HBV/HCV
English: In treatment-naïve patients, the most frequently reported adverse reactions considered possibly or probably related to rilpivirine hydrochloride and emtricitabine/tenofovir disoproxil were nausea (9%), dizziness (8%), abnormal dreams (8%), headache (6%), diarrhoea (5%) and insomnia (5%) (pooled data from the Phase III clinical studies C209 and C215, see section 5.1).
Maltese: F'pazjenti li qatt ma rċivew kura fil-passat, l-iktar reazzjonijiet avversi li kienu rrappurtati b'mod frekwenti u li kienu kkunsidrati bħala possibbilment jew probabbilment relatati ma' rilpivirine hydrochloride u emtricitabine/tenofovir disoproxil, kienu t-tqalligħ (9%), sturdament (8%), ħolm anormali (8%), uġigħ ta' ras (6%), d-dijarea (5%) u nuqqas ta' rqad (5%) (dejta miġbura mill-istudji kliniċi ta' Fażi
English: Very common: headache1, 2, 3, dizziness1, 2, 3 Common:
Maltese: Komuni ħafna: uġigħ ta' ras1, 2, 3, sturdament1, 2, 3 Komuni:
English: Virologic failurec
Maltese: Insuffiċjenza viroloġikac
English: When emtricitabine (one of the components of Eviplera) was administered to paediatric patients, the following adverse reactions were observed more frequently in addition to the adverse reactions reported in adults: anaemia was common (9.5%) and skin discolouration (increased pigmentation) was very common (31.8%) in paediatric patients (see section 4.8, Tabulated summary of adverse reactions).
Maltese: Meta emtricitabine (wieħed mill-komponenti ta' Eviplera) ingħata lil pazjenti pedjatriċi, irreazzjonijiet avversi li ġejjin ġew osservati b'mod aktar frekwenti flimkien mar-reazzjonijiet avversi rrappurtati fl-adulti: anemija kienet komuni (9.5%) u tibdil tal-kulur tal-ġilda (żieda filpigmentazzjoni) kien komuni ħafna (31.8%) f'pazjenti pedjatriċi (ara sezzjoni 4.8, Sommarju tabulat tar-reazzjonijiet avversi).
English: Discontinued for non-AE reasone n = total number of patients per treatment group a ITT TLOVR = Intention to treat time to loss of virologic response b The difference of response rate is 1% (95% confidence interval -3% to 6%) using normal approximation.
Maltese: b Id-differenza fir-rata ta' rispons hi ta' 1% (95% intervall ta' kunfidenza −3% sa 6%) bl-użu ta' approssimazzjoni normali.
English: Considering all of the available in vitro data and data generated in previously untreated patients, the following resistance-associated mutations in HIV-1 RT, when present at baseline, may affect the activity of Eviplera: K65R, K70E, K101E, K101P, E138A, E138G, E138K, E138Q, E138R, V179L, Y181C, Y181I, Y181V, M184I, M184V, Y188L, H221Y, F227C, M230I, M230L and the combination of L100I and K103N.
Maltese: K65R, K70E, K101E, K101P, E138A, E138G, E138K, E138Q, E138R, V179L, Y181C, Y181I, Y181V, M184I, M184V, Y188L, H221Y, F227C, M230I, M230L u l-kombinazzjoni ta' L100I u K103N.
English: Rifampicin (600 mg once daily)/ Rilpivirine1
Maltese: Rifampicin (600 mg darba kuljum)/ Rilpivirine1
English: Paracetamol (500 mg single dose)/ Rilpivirine1
Maltese: Paracetamol (doża waħda ta' 500 mg)/Rilpivirine1
English: 2 Phenotypic resistance to rilpivirine (> 3.7-fold change compared to control).
Maltese: 1 Reżistenza fenotipika għal (bidla ta' > 3.7 meta mqabbel mal-kontroll).
English: AUC: ↑ 16%* Cmin: ↔* Cmax: ↑ 43%*
Maltese: AUC: ↑ 16%* Cmin: ↔*
English: Protease inhibitors (PIs) - boosted (with co-administration of low-dose ritonavir) Atazanavir/Ritonavir/Emtricitabine Interaction not studied.
Maltese: Inibituri tal-protease (PIs) - imsaħħa (bl-għoti flimkien ma' doża baxxa ta' ritonavir) Atazanavir/Ritonavir/Emtricitabine L-interazzjoni ma ġietx studjata.
English: In a study comparing 8 patients with mild hepatic impairment (CPT Score A) to 8 matched controls and 8 patients with moderate hepatic impairment (CPT Score B) to 8 matched controls, the multiple dose exposure of rilpivirine was 47% higher in patients with mild hepatic impairment and 5% higher in patients with moderate hepatic impairment.
Maltese: Fi studju li qabbel 8 pazjenti b'indeboliment ħafif epatiku (Punteġġ CPT A) ma' 8 kontrolli mqabbla u 8 pazjenti b'indeboliment moderat epatiku (Punteġġ CPT B) ma' 8 kontrolli mqabbla, l-espożizzjoni ta' doża multipla ta' rilpivirine kienet 47% ogħla f'pazjenti b'indeboliment ħafif epatiku u 5% ogħla f'pazjenti b'indeboliment moderat epatiku.
English: Switching to Eviplera was non-inferior in maintaining HIV-1 RNA < 50 copies/mL when compared to patients who stayed on a ritonavir-boosted PI in combination with two NRTIs [treatment difference (95% CI): + 3.8% (-1.6% to 9.1%)].
Maltese: Il-qlib għal Eviplera ma kienx inferjuri fiż-żamma tal-HIV-1 RNA <50 kopja/mL meta mqabbel ma' pazjenti li baqgħu fuq PI msaħħaħ b'ritonavir f'kombinazzjoni ma' żewġ NRTIs [differenza fil-kura (95% CI): + 3.8% (−1.6% sa 9.
English: Exacerbations of hepatitis after discontinuation of treatment In HIV infected patients co-infected with HBV, clinical and laboratory evidence of hepatitis have occurred after discontinuation of treatment (see section 4.4).
Maltese: Epatite li tmur għall-agħar wara t-twaqqif tat-trattament F'pazjenti infettati bl-HIV li kienu infettati wkoll bl-HBV, seħħet evidenza klinika u tal-laboratorju ta' epatite wara t-twaqqif tal-trattament (ara sezzjoni 4.4).
English: HIV-1 containing the K103N, Y181C, or rilpivirine-associated substitutions with resistance to NNRTIs were susceptible to tenofovir.
Maltese: HIV-1 li kien fih il-mutazzjoni K103N jew Y181C, jew sostituzzjonijiet assoċjati ma' rilpivirine b'reżistenza għal NNRTIs, kien suxxettibbli għal tenofovir.
English: Alternatively, switching to another antiretroviral regimen could be considered.
Maltese: B'mod alternattiv, jista' jitqies il-qlib għal kors antiretrovirali ieħor.
English: Didanosine The co-administration of Eviplera and didanosine is not recommended (see section 4.4 and Table 1).
Maltese: Didanosine L-għoti ta' Eviplera flimkien ma' didanosine mhuwiex rakkomandat (ara sezzjoni 4.4 u Tabella 1).
English: Virologic response to tenofovir disoproxil was not reduced in patients with HIV-1 that expressed the abacavir/emtricitabine/lamivudine resistance-associated M184V substitution.
Maltese: Rispons viroloġiku għal tenofovir disoproxil ma tnaqqasx f'pazjenti bl-HIV-1 li kien jesprimi s-sostituzzjoni M184V assoċjata mar-reżistenza għal abacavir/emtricitabine/lamivudine.
English: In women receiving rilpivirine 25 mg once daily during the 2nd trimester of pregnancy, mean intraindividual values for total rilpivirine Cmax, AUC24h and Cmin values were 21%, 29% and 35% lower, respectively, as compared to postpartum; during the 3rd trimester of pregnancy, Cmax, AUC24h and Cmin values were 20%, 31% and 42% lower, respectively, as compared to postpartum.
Maltese: Fin-nisa li kienu qed jirċievu rilpivirine 25 mg darba kuljum matul it-tieni trimestru tat-tqala, il-valuri intraindividwali medji għall-valuri Cmax, AUC24h u Cmin ta' rilpivirine totali kienu 21%, 29% u 35% iktar baxxi, rispettivament, meta mqabbla ma' wara l-ħlas; matul it-tielet trimestru ta' tqala, il-valuri Cmax, AUC24h u Cmin kienu 20%, 31% u 42% iktar baxxi, rispettivament, meta mqabbla ma' wara l-ħlas.
English: Both emtricitabine triphosphate and tenofovir diphosphate are weak inhibitors of mammalian DNA polymerases and there was no evidence of toxicity to mitochondria in vitro and in vivo.
Maltese: Kemm emtricitabine triphosphate u tenofovir diphosphate huma inibituri dgħajfa tal-polimerases tadDNA mammifera u ma kienx hemm evidenza ta' tossiċità lill-mitokondrija in vitro jew in vivo.
English: In addition, a K70E substitution in HIV-1 RT has been selected by tenofovir and results in low-level reduced susceptibility to abacavir, emtricitabine, tenofovir and lamivudine.
Maltese: Flimkien ma' dan, sostituzzjoni K70E f'HIV-1 RT intgħażlet minn tenofovir u tirriżulta f'tnaqqis ta' livell baxx fis-suxxettibilità għal abacavir, emtricitabine, tenofovir u lamivudine.
English: Simeprevir (150 mg once daily)/ Rilpivirine (25 mg once daily)
Maltese: Simeprevir (150 mg darba kuljum)/ Rilpivirine (25 mg darba kuljum)
English: N/A = not applicable
Maltese: N/A = mhux applikabbli
English: Severe skin reactions with systemic symptoms have been reported during post-marketing experience with Eviplera, including rashes accompanied by fever, blisters, conjunctivitis, angioedema, elevated liver function tests, and/or eosinophilia (see section 4.4).
Maltese: Reazzjonijiet severi tal-ġilda b'sintomi sistematiċi, ġew irrappurtati matul l-esperjenza ta' wara t-tqegħid fis-suq b'Eviplera, li jinkludu raxxijiet akkumpanjati minn deni, infafet, konġuntivite, anġjoedema, testijiet tal-funzjoni tal-fwied b'riżultati għoljin, u/jew eosinofilija (ara sezzjoni 4.4).
English: proximal renal tubulopathy including Fanconi syndrome3, increased creatinine3, proteinuria3
Maltese: Mhux komuni: tubulopatija renali prossimali li tinkludi s-sindromu ta' Fanconi3, żieda fil-kreatinina3,
English: Sofosbuvir (400 mg once daily)/ Rilpivirine (25 mg once daily)
Maltese: Sofosbuvir (400 mg darba kuljum)/ Rilpivirine (25 mg darba kuljum)
English: At 96 weeks in the pooled Phase III C209 and C215 studies of treatment-naïve patients, in the rilpivirine arm the mean change from baseline in total cholesterol (fasted) was 5 mg/dL, in high-density lipoprotein (HDL)-cholesterol (fasted) 4 mg/dL, in low density lipoprotein (LDL)-cholesterol (fasted) 1 mg/dL, and in triglycerides (fasted) -7 mg/dL. At 48 weeks in Phase III study GS-US-264-0106 of virologically suppressed patients switching to Eviplera from a regimen containing a ritonavir-boosted PI, the mean change from baseline in total cholesterol (fasted) was -24 mg/dL, in HDL-cholesterol (fasted) -2 mg/dL, in LDL-cholesterol (fasted) -16 mg/dL, and in triglycerides (fasted) -64 mg/dL.
Maltese: III miġbura C209 u C215 ta' pazjenti li qatt ma rċivew kura filpassat, fil-parti tal-istudju dwar rilpivirine, il-medja tal-bidla mil-linja bażi fil-kolesterol totali (fl-istat sajjem) kienet ta' 5 mg/dL, fil-kolesterol ta' lipoproteina ta' densità għolja (HDL, high-density lipoprotein) (fl-istat sajjem) 4 mg/dL, fil-kolesterol ta' lipoproteina ta' densità baxxa (LDL, low density lipoprotein) (fl-istat sajjem) 1 mg/dL, u fit-triglycerides (fl-istat sajjem) −7 mg/dL.
English: Cytochrome P450 enzyme inhibitors
Maltese: Inibituri tal-enzima ta' ċitokrom P450
English: • rilpivirine
Maltese: • emtricitabine • rilpivirine
English: By baseline CD4+ cell count (x 106 cells/L)
Maltese: Żieda medjana fis-CD4+ mil-linja bażi (x 106 ċelluli/L)
English: In patients with BL VL1 > 100,000 copies/mL (n = 44)
Maltese: F'pazjenti b'ammont virali fil-linja bażi ta' >100,000 kopja/mL (n = 44)
English: Eviplera has not been evaluated in patients with previous virologic failure to any other antiretroviral therapy.
Maltese: Eviplera ma ġiex evalwat f'pazjenti b'insuffiċjenza viroloġika fil-passat għal kwalunkwe terapija antiretrovirali oħra.
English: Rifampicin (600 mg once daily)/ Tenofovir disoproxil (245 mg once daily)
Maltese: Rifampicin (600 mg darba kuljum)/ Tenofovir disoproxil (245 mg darba kuljum)
English: Ketoconazole (400 mg once daily)/ Rilpivirine1
Maltese: Ketoconazole (400 mg darba kuljum)/Rilpivirine1
English: Pharmacokinetic parameters were mainly determined following administration of single doses of emtricitabine 200 mg or tenofovir disoproxil 245 mg to non-HIV infected patients with varying degrees of renal impairment.
Maltese: Il-parametri farmakokinetiċi kienu deċiżi primarjament wara l-għoti ta' dożi waħedhom ta' 200 mg emtricitabine jew 245 mg tenofovir disoproxil lil pazjenti mhux infettati b'HIV b'livelli differenti ta' indeboliment renali.
English: Darunavir (300 mg once daily)/ Ritonavir (100 mg once daily)/ Tenofovir disoproxil (245 mg once daily)
Maltese: Darunavir (300 mg darba kuljum)/ Ritonavir (100 mg darba kuljum)/ Tenofovir disoproxil (245 mg darba kuljum)
English: Limited data from clinical studies support once daily dosing of Eviplera in patients with mild renal impairment (CrCl 50-80 mL/min).
Maltese: Informazzjoni limitata minn studji kliniċi tappoġġja d-dożaġġ ta' Eviplera darba kuljum f'pazjenti b'indeboliment ħafif renali (CrCl ta' 50-80 mL/min).
English: It is important not to stop taking Eviplera without talking to your doctor: see section 3, Do not stop taking Eviplera.
Maltese: Hu importanti li ma tiqafx tieħu Eviplera mingħajr ma tkellem lit-tabib tiegħek: ara sezzjoni 3, Tiqafx tieħu Eviplera.
English: In vitro experiments indicate that rilpivirine hydrochloride primarily undergoes oxidative metabolism mediated by the CYP3A system.
Maltese: Esperimenti in vitro jindikaw li rilpivirine hydrochloride primarjament jgħaddi minn metaboliżmu ossidattiv medjat mis-sistema ta' CYP3A.
English: Rilpivirine (taken as Eviplera in 16 of 19 patients and another background regimen in 3 of 19 patients) was evaluated in study TMC114HIV3015 in pregnant women during the 2nd and 3rd trimesters, and postpartum.
Maltese: Rilpivirine (meħud bħala Eviplera f'16 minn 19-il pazjent u kors fl-isfond ieħor fi 3 minn 19-il pazjent) ġie evalwat fl-istudju TMC114HIV3015 f'nisa tqal matul it-tieni u t-tielet trimestri, u wara l-ħlas.
English: Tenofovir displayed antiviral activity in cell culture against HIV-1 subtype 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: Tenofovir wera attività antivirali fil-koltura taċ-ċelluli kontra sottotip ta' HIV-1 A, B, Ċ, D, E, F, G u O (il-valuri EC50 varjaw minn 0.5 sa 2.2 µM) u wera attività speċifika tar-razza kontra
English: The combination of Eviplera with these macrolide antibiotics may cause an increase in the plasma concentrations of rilpivirine (inhibition of CYP3A enzymes).
Maltese: Il-kombinazzjoni ta' Eviplera ma' dawn l-antibijotiċi macrolide tista' tikkawża żieda talkonċentrazzjonijiet fil-plażma ta' rilpivirine (inibizzjoni tal-enzimi ta' CYP3A).