FrancophonIA/ELRC3.0 huggingface dataset:
English: Please, see also section 3.
Maltese: Jekk jogħġbok, ara wkoll sezzjoni 3.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
Maltese: Lista ta' reazzjonijiet avversi miġbura f'tabella
English: Results from clinical trials demonstrated that the incidence of confirmed hypoglycaemia (at any time of the day and nocturnal) was lower in patients treated with Toujeo compared to insulin glargine 100 units/ml-treated patients, in patients with type 2 diabetes treated in combination with either non-insulin anti-hyperglycaemic medicinal product or mealtime insulin.
Maltese: Ir-riżultati mill-provi kliniċi urew li l-inċidenza ta' ipogliċemija kkonfermata (fi kwalunkwe ħin tal ġurnata u mal-lejl) kienet aktar baxxa f'pazjenti trattati b'Toujeo meta mqabbla ma' pazjenti kkurati b'insulin glargine 100 unità/ml, f'pazjenti b'dijabete tat-tip 2 li flimkien miegħu kienu ttrattati wkoll bi prodott mediċinali kontra l-ipergliċemija li mhuwiex insulina jew inkella b'insulina waqt il-ħin tal ikel.
English: INFORMATION IN BRAILLE
Maltese: INFORMAZZJONI BIL-BRAILLE Toujeo 300
English: *GIR: Glucose infusion rate: determined as amount of glucose infused to maintain constant plasma glucose levels (hourly mean values).
Maltese: *GIR: Ir-rata ta' infużjoni tal-glukożju: ikkalkulata bħala l-ammont ta' glukożju infuż biex iżomm il-livelli tal-glukożju kostanti fil-plażma (valuri medji kull siegħa).
English: The exposure to M1 increases with the administered dose of insulin glargine.
Maltese: esponiment għal M1 jiżdied mad-doża ta' insulin glargine li tingħata.
English: Switch between insulin glargine 100 units/ml and Toujeo Since insulin glargine 100 units/ml and Toujeo are not bioequivalent and are not interchangeable, switching may result in the need for a change in dose and should only be done under strict medical supervision (see section 4.2).
Maltese: Peress li insulin glargine 100 unità/ml u Toujeo mhumiex bijoekwivalenti u ma jistgħux jinbidlu ma' xulxin, il-bidla tista' tirriżulta fil-ħtieġa li jkun hemm bidla fid-doża u għandha ssir biss taħt sorveljanza medika stretta (ara sezzjoni 4.2).
English: The cumulative review of cutaneous amyloidosis included 29 cases of which 15 were well documented cases in which the event was confirmed with histopathology.
Maltese: L-evalwazzjoni kumulattiva ta' amilojdosis tal-ġilda inkludiet 29 każ li minnhom 15 kienu każijiet ddokumentati sew fejn l-avveniment ġie kkonfermat bl-istopatoloġija.
English: Meal-time insulin analog Meal-time insulin analog+/-metformin
Maltese: Fil-plażma, is-sustanza ewlenija li tiċċirkola hija l-metabolit M1. L
English: The frequency, type and severity of adverse reactions in the paediatric population do not indicate differences to the experience in the general diabetes population (see section 5.1).
Maltese: Ma dehret ebda differenza fil-frekwenza, tip u severità tar-reazzjonijiet avversi fil-popolazzjoni pedjatrika minn dawk esperjenzati fil-popolazzjoni dijabetika in ġenerali (ara sezzjoni 5.1).
English: There were no differences between insulin glargine and standard care for the two co-primary outcomes; for any component endpoint comprising these outcomes; for all-cause mortality; or for the composite microvascular outcome.
Maltese: Ma kien hemm l-ebda differenza bejn insulin glargine u l-kura standard għaż-żewġ lottijiet ta' riżultati primarji; għal kwalunkwe komponent talgħan finali li jagħmel parti minn dawn ir-riżultati; għall-mewt minn kwalunkwe kawża; jew għar riżultat kompost mikrovaskulari.
English: Intercurrent illness requires intensified metabolic monitoring.
Maltese: jġib miegħu aggravament temporanju tar-retinopatija tad-dijabete.
English: Switch from Toujeo to other basal insulins
Maltese: Jekk ma tidher l-ebda insulina:
English: - Switching from twice-daily basal insulins to once-daily Toujeo, the recommended initial Toujeo dose is 80% of the total daily dose of basal insulin that is being discontinued.
Maltese: - Għall-bidla minn insulini tal-bażi li jingħataw darbtejn kuljum għal Toujeo li jingħata darba kuljum, id-doża rrakkomandata tal-bidu ta' Toujeo hija 80% tad-doża totali ta' kuljum tal-insulina tal-bażi li se titwaqqaf.
English: EU/1/16/1112/001 EU/1/16/1112/002
Maltese: EU/1/16/1112/002
English: Odefsey contains lactose monohydrate.
Maltese: Odefsey fih lactose monohydrate.
English: 11.5% (63/550)c
Maltese: 11.5% (63/550)ċ
English: The proportion of virologic failures was 22.2% (8/36).
Maltese: Il-proporzjon ta' fallimenti viroloġiċi kien 22.2% (8/36).
English: Macrolide antibiotics Clarithromycin Erythromycin
Maltese: Antibijotiċi makrolidi Clarithromycin Erythromycin
English: Each tablet contains 189.8 mg lactose monohydrate.
Maltese: Kull pillola fiha 189.8 mg ta' lactose monohydrate.
English: Film-coating: Macrogol, polyvinyl alcohol, talc, titanium dioxide (E171), iron oxide black (E172).
Maltese: Macrogol, polyvinyl alcohol, talc, titanium dioxide (E171), iron oxide black (E172).
English: Croscarmellose sodium Lactose (as monohydrate) Magnesium stearate Microcrystalline cellulose Polysorbate 20
Maltese: Croscarmellose sodium Lactose (bħala monohydrate) Magnesium stearate Microcrystalline cellulose Polysorbate 20
English: increased bilirubin1
Maltese: żieda fil-bilirubina1
English: Croscarmellose sodium, lactose (as monohydrate), magnesium stearate, microcrystalline cellulose, polysorbate 20, povidone.
Maltese: Croscarmellose sodium, lactose (bħala monohydrate), magnesium stearate, microcrystalline cellulose, polysorbate 20, povidone.
English: Rilpivirine inhibits P-glycoprotein (P-gp) in vitro (50% inhibitory concentration [IC50] is 9.2 µM).
Maltese: Rilpivirine jinibixxi P-glikoproteina (P-gp) in vitro (il-konċentrazzjoni inibitorja ta' 50% [IC50] hija 9.2 µM).
English: Antacids (e.g., aluminium or magnesium hydroxide, calcium carbonate)
Maltese: Antaċidi (eż., aluminium jew magnesium hydroxide, calcium carbonate)
English: Cortisol
Maltese: Kortisol
English: AUC: ↑ Cmax: ↑
Maltese: AUC: ↑
English: Alternatively, switching to another antiretroviral regimen could be considered (see sections 4.4, 4.6, 5.1 and 5.2).
Maltese: B'mod alternattiv, jista' jitqies il-qlib għal kors antiretrovirali ieħor (ara sezzjonijiet 4.4, 4.6, 5.1 u 5.2).
English: increased transaminases (AST and/or ALT)1
Maltese: żieda fit-transaminases (AST u/jew ALT)1
English: c n = 539 (TAF) or 841 (TFV) adults (GS-US-292-0111 and GS-US-292-0104, population PK analysis).
Maltese: c n = 539 (TAF) jew 841 (TFV) adulti (GS-US-292-0111 u GS-US-292-0104, analiżi PK tal-popolazzjoni).
English: Mitochondrial dysfunction following exposure in utero
Maltese: Disfunzjoni mitokondrija wara esponiment in utero
English: • Use effective contraception while taking Odefsey.
Maltese: • Uża kontraċezzjoni effettiva waqt li tkun qed tieħu Odefsey.
English: Induction of P-gp
Maltese: Induzzjoni ta' P-gp
English: b n = 23 adolescents (GS-US-292-0106, population PK analysis).
Maltese: b n = 23 adolexxenti (GS-US-292-0106, analiżi PK tal-popolazzjoni).
English: Tenofovir alafenamide is not an inhibitor of human uridine diphosphate glucuronosyltransferase (UGT) 1A1 in vitro.
Maltese: Tenofovir alafenamide mhuwiex impeditur ta' uridine diphosphate glucuronosyltransferase (UGT) 1A1 uman in vitro.
English: b Week 96 window was between Day 631 and 714 (inclusive).
Maltese: b L-intervall ta' żmien ta' Ġimgħa 96 kien bejn Jum 631 u 714 (inklużivi).
English: Antimycobacterials Rifampicin/ Rilpivirine
Maltese: Antimikobatterjali Rifampicin/Rilpivirine
English: EU/1/16/1112/001 30 film-coated tablets EU/1/16/1112/002 90 (3 bottles of 30) film-coated tablets
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/16/1112/001 30 pillola miksija b'rita EU/1/16/1112/002 90 (3 fliexken ta' 30 pillola miksija b'rita
English: Week 96
Maltese: jew 96
English: Rilpivirine is an in vitro inhibitor of the transporter MATE-2K with an IC50 of < 2.7 nM.
Maltese: Rilpivirine huwa impeditur in vitro tat-trasportatur MATE-2K b'IC50 ta' < 2.7 nM.
English: Alanine aminotransferase (ALT) normalisation was achieved in 40% (4/10) of subjects with ALT greater than upper limit of normal (ULN) at baseline.
Maltese: Normalizzazzjoni ta' alanine aminotransferase (ALT) inkisbet f'40% (4/10) tal-individwi b'ALT ogħla mil-limitu ta' fuq tan-normal (ULN - upper limit of normal) fil-linja bażi.
English: Tenofovir alafenamide is a nucleotide reverse transcriptase inhibitor (NtRTI) and prodrug of tenofovir (2'-deoxyadenosine monophosphate analogue).
Maltese: Tenofovir alafenamide hu impeditur ta' nucleotide reverse transcriptase inhibitor (NtRTI) u prodrug ta' tenofovir (2'-deoxyadenosine monophosphate analogue).
English: Overall response (HIV-1 RNA < 50 copies/mL (TLOVRa))b
Maltese: Rispons globali (HIV-1 RNA < 50 kopja/mL (TLOVRa))b
English: Tenofovir alafenamide is not an inhibitor of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 or CYP2D6 in vitro.
Maltese: Tenofovir alafenamide mhuwiex impeditur ta' CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, jew CYP2D6 in vitro.
English: EFV = efavirenz; RPV = rilpivirine a ITT TLOVR = Intention to treat time to loss of virologic response.
Maltese: RPV = rilpivirine a ITT TLOVR = Intention to treat time to loss of virologic response (Ħin ta' nuqqas ta' rispons viroloġiku tal-popolazzjoni b'intenzjoni li jiġu kkurati).
English: Tenofovir alafenamide is a substrate of organic anion transporting polypeptide (OATP) 1B1 and OATP1B3 in vitro.
Maltese: Tenofovir alafenamide hu substrat ta' anjoniċi organiċi li jittrasportaw polypeptide (OATP, organic anion transporting polypeptide) 1B1 u OATP1B3 in vitro.
English: Baseline regimen (n = 477)
Maltese: Kors tal-linja bażi (n = 477)
English: arthralgia3
Maltese: artralġja3
English: The combination of NRTIs most frequently used together with rilpivirine was FTC/TDF (24 subjects [66.7%]).
Maltese: Il-kombinazzjoni ta' NRTIs użati l-aktar frekwentament flimkien ma' rilpivirine kienet FTC/TDF (24 individwu [66.7%]).
English: Odefsey comes in bottles of 30 tablets and in packs made up of 3 bottles, each containing 30 tablets.
Maltese: Odefsey jiġi fi fliexken ta' 30 pillola u f'pakketti magħmulin minn 3 fliexken, kull wieħed fih 30 pillola.
English: The virologic failure rate in patients treated with emtricitabine/tenofovir disoproxil fumarate + rilpivirine at Week 48 and Week 96 was 9.5% and 11.5% respectively, and 4.2% and 5.1% in the emtricitabine/tenofovir disoproxil fumarate + efavirenz arm.
Maltese: Ir-rata ta' falliment viroloġiku f'pazjenti kkurati b'emtricitabine/tenofovir disoproxil fumarate + rilpivirine f'Ġimgħa 48 u Ġimgħa 96 kienet ta' 9.5% u 11.5% rispettivament, u 4.2% u 5.1% fil-fergħa tal-istudju b'emtricitabine/tenofovir disoproxil fumarate + efavirenz.
English: ANTIARRHYTHMICS Digoxin/ Rilpivirine
Maltese: MEDIĊINI ANTIARRITIMIĊI Digoxin/Rilpivirine
English: abdominal pain1, 3, vomiting1, 3, increased lipase1, abdominal discomfort1, dry mouth1, flatulence3, diarrhoea3
Maltese: uġigħ addominali1,3, rimettar1,3, żieda fil-lipase1, skumdità addominali1, ħalq niexef1, gass fl-istonku3, dijarea3
English: Rilpivirine is a diarylpyrimidine NNRTI of HIV-1.
Maltese: Rilpivirine huwa NNRTI tad-diarylpyrimidine tal-HIV-1.
English: Reduced absorption, increase in gastric pH
Maltese: Tnaqqis fl-assorbiment, żieda fil-pH gastriku
English: Odefsey is an antiviral medicine used to treat infection by the Human Immunodeficiency Virus (HIV).
Maltese: Odefsey hija mediċina antivirali użata għat-trattament tal-infezzjoni mill-Virus tal-Immunodefiċjenza Umana (HIV).
English: Rilpivirine is primarily metabolised by CYP3A.
Maltese: Rilpivirine hu primarjament metabolizzat minn CYP3A.
English: nausea1, 3, increased pancreatic amylase1
Maltese: tqalligħ1,3, żieda fl-amylase pankreatiċi1
English: Table 1: Interactions between Odefsey or its individual component(s) and other medicinal products
Maltese: Tabella 1: Interazzjonijiet bejn Odefsey u l-komponent(i) individwali tiegħu u prodotti mediċinali oħra
English: Pharmacotherapeutic group: Antiviral for systemic use; antivirals for treatment of HIV infections, combinations, ATC code: J05AR19
Maltese: Antivirali għal użu sistemiku; antivirali għat-trattament ta' infezzjonijiet tal-HIV, kombinazzjonijiet, kodiċi ATC:
English: insomnia1
Maltese: insomnja1
English: 1 Adverse reactions identified from rilpivirine clinical studies.
Maltese: 1 Reazzjonijiet avversi identifikati minn studji kliniċi b'rilpivirine.
English: In vitro binding of rilpivirine to human plasma proteins is approximately 99.7%, primarily to albumin.
Maltese: It-twaħħil in vitro ta' rilpivirine mal-proteini tal-plażma umana huwa madwar 99.7%, primarjament mal-albumina.
English: GLUCOCORTICOIDS Dexamethasone (systemic, except for single dose use)
Maltese: GLUKOKORTIKOJDI Dexamethasone (sistematiku, ħlief għall-użu b'doża waħda)
English: Over 96 weeks of treatment with rilpivirine mean changes of 0.1 mg/dL (range: -0.3 mg/dL to 0.6 mg/dL) for creatinine and -13.3 mL/min/1.73 m2 (range: -63.7 mL/min/1.73 m2 to 40.1 mL/min/1.73 m2) for eGFR were observed.
Maltese: Matul 96 ġimgħa ta' trattament b'rilpivirine kienu osservati bidliet medji ta' 0.1 mg/dL (firxa: -0.3 mg/dL sa 0.6 mg/dL) għall-kreatinina u -13.3 mL/min/1.73 m2 (firxa: -63.7 mL/min/ 1.73 m2 sa 40.1 mL/min/1.73 m2) għall-eGFR.
English: Among these 12 HIV-1 isolates, the mutations that emerged were M184V/I (n = 11) and K65R/N (n = 2) in RT and T66T/A/I/V (n = 2), E92Q (n = 4), Q148Q/R (n = 1), and N155H (n = 2) in integrase.
Maltese: Fost dawn it-12-il iżolat tal-HIV-1, il-mutazzjonijiet li ħarġu kienu M184V/I (n = 11) u K65R/N (n = 2) f'RT u T66T/A/I/V (n = 2), E92Q (n = 4), Q148Q/R (n = 1) u N155H (n = 2) f'integrase.
English: The active substances are emtricitabine, rilpivirine and tenofovir alafenamide.
Maltese: Is-sustanzi attivi huma emtricitabine, rilpivirine u tenofovir alafenamide.
English: Odefsey 200 mg/25 mg/25 mg film-coated tablets emtricitabine/rilpivirine/tenofovir alafenamide
Maltese: Odefsey 200 mg/25 mg/25 mg pilloli miksija b'rita emtricitabine/rilpivirine/tenofovir alafenamide
English: NARCOTIC ANALGESICS Methadone (60-100 mg once daily, individualised dose)/ Rilpivirine
Maltese: ANALĠESIĊI NARKOTIĊI Methadone (60-100 mg darba kuljum, doża individwalizzata)/Rilpivirine
English: Discontinued due to adverse event (AE)
Maltese: Imwaqqaf minħabba avveniment avvers (AE)
English: dyspepsia3
Maltese: dispepsja3
English: PHOSPHODIESTERASE TYPE 5 (PDE-5) INHIBITORS Sildenafil (50 mg single dose)/ Rilpivirine1
Maltese: TA' PHOSPHODIESTERASE TA' TIP 5 (PDE-5) Sildenafil (50 mg doża waħda)/
English: a Week 48 window was between Day 294 and 377 (inclusive); Week 144 window was between Day 966 and 1,049 (inclusive).
Maltese: u 377 (inklużiv); l-intervall ta' żmien tal-Ġimgħa 144 kien bejn Jum 966 u 1,049 (inklużiv).
English: Rilpivirine has not been studied in patients with severe hepatic impairment (Child Pugh Class C) (see section 4.2).
Maltese: Rilpivirine ma ġiex studjat f'pazjenti b'indeboliment epatiku sever (Child-Pugh Klassi Ċ) (ara sezzjoni 4.2).
English: At baseline, median eGFRCG was 56 mL/min, and 33% of patients had an eGFRCG from 30 to 49 mL/min.
Maltese: L-eGFRCG medjan fil-linja bażi kien ta' 56 mL/min, u 33% tal-pazjenti kellhom eGFRCG minn 30 sa 49 mL/min.
English: The safety of emtricitabine + tenofovir alafenamide has not been established in patients with severe renal impairment (estimated CrCl ≥ 15 mL/min and < 30 mL/min).
Maltese: Is-sigurtà ta' emtricitabine + tenofovir alafenamide ma ġietx stabbilita f'pazjenti b'indeboliment renali sever (CrCl stmata ta' ≥ 15-il mL/min u < 30 mL/min).
English: Tenofovir alafenamide is transported by P-gp and breast cancer resistance protein (BCRP).
Maltese: Tenofovir alafenamide jiġi ttrasportat minn P-gp u proteina ta' reżistenza għall-kanċer tas-sider (BCRP, Breast Cancer Resistance Protein).
English: Laboratory abnormalities
Maltese: Anormalitajiet fil-laboratorju
English: At supratherapeutic doses (75 mg once daily and 300 mg once daily), rilpivirine has been associated with prolongation of the QTc interval of the electrocardiogram (ECG) (see sections 4.5 and 4.9).
Maltese: B'dożi supraterapewtiċi (75 mg darba kuljum u 300 mg darba kuljum), rilpivirine kien assoċjat ma' titwil tal-intervall QTc tal-elettrokardjogramma (ECG, electrocardiogram) (ara sezzjonijiet 4.5 u 4.9).
English: The proportion of patients with HIV-1 RNA < 50 copies/mL at Week 48 (TLOVR) was 72.2% (26/36).
Maltese: Il-proporzjon (%) ta' pazjenti b'HIV-1 RNA ta' < 50 kopja/mL f'Ġimgħa 48 (TLOVR) kien 72.2% (26/36).
English: Odefsey 200 mg/25 mg/25 mg film-coated tablets
Maltese: Odefsey 200 mg/25 mg/25 mg pilloli miksija b'rita
English: The combinations of emtricitabine, rilpivirine, and tenofovir alafenamide were not antagonistic and showed synergistic effects with each other in cell culture combination antiviral activity assays.
Maltese: Il-kombinazzjonijiet ta' emtricitabine, rilpivirine, u tenofovir alafenamide ma kinux antagonistiċi u wrew effetti sinerġistiċi ma' xulxin f'assaġġi tal-attività antivirali kombinati ta' kolturi ta' ċelluli.
English: ORAL CONTRACEPTIVES Ethinylestradiol (0.035 mg once daily)/ Rilpivirine
Maltese: Ethinylestradiol (0.035 mg darba kuljum)/Rilpivirine
English: increased total cholesterol (fasted)1, increased LDL-cholesterol (fasted)1
Maltese: żieda fil-kolesterol totali (fi stat sajjem)1, żieda fil-kolesterol LDL (fi stat sajjem)1
English: Intracellular tenofovir is subsequently phosphorylated to the active metabolite tenofovir diphosphate.
Maltese: Tenofovir intraċellulari jiġi fosforilat sussegwentement għall-metabolit attiv tenofovir diphosphate.
English: Treatment outcomes of Studies GS-US-366-1216 and GS-US-366-1160 are presented in Table 5.
Maltese: Ir-riżultati tat-trattament tal-Istudji GS-US-366-1216 u GS-US-366-1160 huma ppreżentati f'Tabella 5.
English: b The difference of response rate at Week 48 is 1% (95% confidence interval -3% to 6%) using normal approximation.
Maltese: b Id-differenza tar-rata ta' rispons f'Ġimgħa 48 hija 1% (95% intervall ta' kunfidenza-3% sa 6%) bl-użu ta' approssimazzjoni normali.
English: depression1, abnormal dreams1, 3, sleep disorders1, depressed mood1
Maltese: depressjoni1, ħolm anormali1,3, disturbi fl-irqad1, burdata depressa1
English: Co-administration of Odefsey with other medicinal products that inhibit P-gp and BCRP activity (e.g., ketoconazole, fluconazole, itraconazole, posaconazole, voriconazole, ciclosporin) is expected to increase the absorption and plasma concentration of tenofovir alafenamide.
Maltese: L-għoti flimkien ta' Odefsey ma' prodotti mediċinali oħrajn li jinibixxu l-attività ta' P-gp u BCRP (eż., ketoconazole, fluconazole, itraconazole, posaconazole, voriconazole, ciclosporin) huwa mistenni li jżid l-assorbiment u l-konċentrazzjoni ta' tenofovir alafenamide fil-plażma.
English: There are a limited amount of data (less than 300 pregnancy outcomes) from the use of rilpivirine and tenofovir alafenamide in pregnant women (see sections 4.4, 5.1 and 5.2).
Maltese: Hemm dejta limitata (inqas minn 300 riżultat ta' tqala) dwar l-użu ta' rilpivirine u tenofovir alafenamide fin-nisa tqal (ara sezzjonijiet 4.4, 5.1 u 5.2).
English: HYPNOTICS/SEDATIVES Midazolam (2.5 mg, orally, single dose)/ Tenofovir alafenamide
Maltese: MEDIĊINI IPNOTIĊI/SEDATTIVI Midazolam (2.5 mg, il jingħata mill-ħalq, doża waħda)/Tenofovir alafenamide
English: Sofosbuvir/Velpatasvir (400 mg/100 mg once daily)/ Rilpivirine2
Maltese: Sofosbuvir/Velpatasvir (400 mg/100 mg darba kuljum)/ Rilpivirine2
English: Odefsey should be discontinued in patients with estimated CrCl that declines below 30 mL/min during treatment (see section 5.2).
Maltese: Odefsey għandu jitwaqqaf f'pazjenti b'CrCl stmata li tonqos taħt 30 mL/min waqt it-trattament (ara sezzjoni 5.2)
English: In Odefsey studies in virologically suppressed adult patients, increases in BMD were noted at 96 weeks after switching to Odefsey compared to minimal changes with maintaining FTC/RPV/TDF or EFV/FTC/TDF at the hip (mean change 1.6% for Odefsey versus -0.6% for FTC/RPV/TDF, p < 0.001; 1.8% for Odefsey versus -0.6% for EFV/FTC/TDF, p < 0.001) and the spine (mean change 2.0% for Odefsey versus -0.3% for FTC/RPV/TDF, p < 0.001; 1.7% for Odefsey versus 0.1% for EFV/FTC/TDF, p < 0.001).
Maltese: Fi studji b'Odefsey f'pazjenti adulti b'soppressjoni virali, żidiet fil-BMD ġew osservati 96 ġimgħa wara li l-pazjenti qalbu għal Odefsey meta mqabbla mat-tibdil żgħir f'dawk li żammew FTC/RPV/TDF jew EFV/FTC/TDF fil-ġenbejn (bidla medja ta' 1.6% għal Odefsey kontra -0.6% għal FTC/RPV/TDF, p<0.001; 1.8% għal Odefsey kontra -0.6% għal EFV/FTC/TDF, p<0.001) u s-sinsla (bidla medja ta' 2.0% għal Odefsey kontra -0.3% għal FTC/RPV/TDF, p<0.001; 1.7% għal Odefsey kontra 0.1% għal EFV/FTC/TDF, p<0.001).
English: Emtricitabine is a nucleoside reverse transcriptase inhibitor (NRTI) and analogue of 2'-deoxycytidine.
Maltese: Emtricitabine huwa impeditur ta' nucleoside reverse transcriptase (NRTI, nucleoside reverse transcriptase inhibitor) u analogu ta' 2'-deoxycytidine.
English: Norgestimate (0.180/0.215/0.250 mg once daily)/ Ethinylestradiol (0.025 mg once daily)/ Emtricitabine/Tenofovir alafenamide (200/25 mg once daily)
Maltese: 215/0.250 mg darba kuljum)/Ethinylestradiol (0.025 mg darba kuljum)/Emtricitabine/tenofovir alafenamide (200/25 mg darba kuljum)
English: Non-response Virologic failure (all patients)
Maltese: Falliment viroloġiku (il-pazjenti kollha)
English: Grey, capsule-shaped, film-coated tablets, of dimensions 15 mm x 7 mm, debossed with “GSI” on one side of the tablet and “255” on the other side of the tablet.
Maltese: Pilloli miksija b'rita, griża, forma ta' kapsula, b'daqs ta' 15 mm x 7 mm, imnaqqxa b'“GSI” fuq naħa waħda tal-pillola u “255” fuq in-naħa l-oħra tal-pillola.
English: The absolute bioavailability of emtricitabine from 200 mg hard capsules was estimated to be 93%.
Maltese: Il-bijodisponibbiltà assoluta ta' emtricitabine minn 200 mg pilloli ibsin kienet stmata li hija 93%.
English: In studies in treatment-naïve patients receiving emtricitabine + tenofovir alafenamide (FTC + TAF) or emtricitabine + tenofovir disoproxil fumarate (FTC + TDF), both given with elvitegravir + cobicistat as a fixed-dose combination tablet, increases from baseline were observed in both treatment groups for the fasting lipid parameters total cholesterol, direct low-density lipoprotein (LDL)- and high-density lipoprotein (HDL)-cholesterol, and triglycerides at Week 144.
Maltese: Fi studji f'pazjenti li qatt ma ngħataw trattament fil-passat li rċivew emtricitabine + tenofovir alafenamide (FTC + TAF) jew emtricitabine + tenofovir disoproxil fumarate (FTC + TDF), fejn it-tnejn ingħataw ma' elvitegravir + cobicistat bħala pillola kombinata ta' doża fissa, żidiet mil-linja bażi ġew osservati fiż-żewġ gruppi ta' trattament għall-parametri tal-lipidi fl-istat sajjem tal-kolesterol totali, kolesterol ta' lipoproteina diretta ta' densità baxxa (LDL) u lipoproteina ta' densità għolja (HDL), u trigliċeridi f'Ġimgħa 144.
English: AUC: ↑ 32% Cmax: ↑ 3%
Maltese: ↑ 32% Cmax: ↑ 3%
English: CYP enzyme inhibitors
Maltese: Impedituri tal-enzimi CYP
English: Ledipasvir/Sofosbuvir (90 mg/400 mg once daily)/ Tenofovir alafenamide
Maltese: Ledipasvir/Sofosbuvir (90 mg/400 mg darba kuljum)/ Tenofovir alafenamide
English: -2.0% (95% CI: -5.9% to 1.8%)
Maltese: -2.0% (CI ta' 95%: -5.9% sa 1.8%)
English: Table 5: Virologic outcomes of Studies GS-US-366-1216 and GS-US-366-1160 at Weeks 48a and
Maltese: Riżultati viroloġiċi ta' Studji GS-US-366-1216 u GS-US-366-1160 f'Ġimgħat 48a u 96b