FrancophonIA/ELRC3.0 huggingface dataset:
English: Immune reactivation syndrome
Maltese: Sindrome ta' riattivazzjoni immuni
English: • telotristat ethyl (a medicine to treat diarrhea in people with carcinoid syndrome)
Maltese: • telotristat ethyl (mediċina biex tittratta dijarea f'persuni b'sindrome karċinojd)
English: After multiple-dose oral administration of lamivudine 300 mg once daily for 7 days to 60 healthy subjects, steady-state Cmax (Cmax,ss) was 2.04 ± 0.54 mcg per mL (mean ± SD) and the 24-hour steady-state AUC (AUC24,ss) was 8.87 ± 1.83 mcg•hour per mL.
Maltese: Wara għoti ta' ħafna dożi ta' lamivudine 300 mg mill-ħalq darba kuljum għal 7 ijiem lill-60 individwu f'saħħithom, is-Cmax fl-istat fiss (Cmax,ss) kien 2.04 ± 0.54 mcg f'kull mL (medja ± SD) u l-AUC ta' 24 siegħa fl-istat fiss (AUC24,ss) kienet 8.87 ± 1.83 mcg•siegħa kull mL.
English: Observed emergent amino acid substitutions in RT included: V106A, V106M, V106I, V108I, F227L, F227C, F227V, H221Y, M230I, L234I, P236L, and Y318F.
Maltese: V106A, V106M, V106I, V108I, F227L, F227C, F227V, H221Y, M230I, L234I, P236L, u Y318F.
English: Biotransformation Based on in vitro data, doravirine is primarily metabolised by CYP3A.
Maltese: Bijotrasformazzjoni Abbażi ta' data in vitro, doravirine jiġi metabolizzat primarjament minn CYP3A.
English: Single dose lamivudine oral solution 300 mg lamivudine
Maltese: Doża waħda ta' soluzzjoni ta' lamivudine 300 mg mill-ħalq lamivudine
English: • dabrafenib (a medicine to treat skin cancer)
Maltese: • dabrafenib (mediċina biex tittratta kanċer tal-ġilda)
English: Virologically suppressed adult subjects
Maltese: Individwi adulti soppressi b'mod viroloġiku
English: • Lamivudine - a nucleoside analogue reverse transcriptase inhibitor (NRTI)
Maltese: • Lamivudine - inibitur ta' reverse transcriptase analogu ta' nucleoside (NRTI, nucleoside analogue reverse transcriptase inhibitor)
English: Rare aggression, hallucination, adjustment disorder, mood altered, somnambulism
Maltese: Rari aggressjoni, alluċinazzjoni, disturb flaġġustament, burdata mibdula, sonnambuliżmu
English: Doravirine is primarily metabolised by CYP3A, and medicinal products that induce or inhibit CYP3A are expected to affect the clearance of doravirine (see section 5.2).
Maltese: Doravirine jiġi metabolizzat primarjament minn CYP3A, u prodotti mediċinali li jinduċu jew jinibixxu CYP3A huma mistennija li jaffettwaw it-tneħħija ta' doravirine (ara sezzjoni 5.2).
English:  doravirine AUC 0.50 (0.45, 0.55) Cmax 0.99 (0.85, 1.15) C24 0.32 (0.28, 0.35) (Induction of CYP3A)
Maltese: ↓ doravirine AUC 0.50 (0.45, 0.55) Cmax 0.99 (0.85, 1.15) C24 0.32 (0.28, 0.35) (Induzzjoni ta' CYP3A)
English: Pharmacotherapeutic group: Antivirals for systemic use, ATC code: J05AR24
Maltese: Antivirali għal użu sistemiku, Kodiċi ATC:
English: • decreased levels phosphate
Maltese: • tnaqqis fil-livelli tal-phosphate
English: Rare acute kidney injury, renal disorder, calculus urinary, nephrolithiasis, acute renal failure*, renal failure*, acute tubular necrosis*, nephritis (including acute interstitial)*, nephrogenic diabetes insipidus*
Maltese: Rari ħsara akuta fil-kliewi, disturb fil-kliewi, ġebla flawrina, nefrolitjasi, insuffiċjenza akuta talkliewi*, insuffiċjenza tal-kliewi*, nekrożi akuta tat-tubuli*, nefrite (inkluża akuta talinterstizju)*, dijabete insipidus nefroġenika* Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata Komuni għeja, deni*
English: Danmark MSD Danmark ApS Tlf: + 45 4482 4000 dkmail@merck.com
Maltese: Tlf: + 45 4482 4000 dkmail@merck.com
English: The tablets are film-coated with a coating material containing the following ingredients: carnauba wax E903, hypromellose E464; iron oxide yellow E172; lactose monohydrate; titanium dioxide E171; and triacetin E1518.
Maltese: Il-pilloli huma miksija b'rita b'materjal tal-kisi li fih is-sustanzi li ġejjin: carnauba wax E903, hypromellose E464; iron oxide isfar E172; lactose monohydrate; titanium dioxide E171; u triacetin E1518.
English: Uncommon aspartate aminotransferase increased, lipase increased, amylase increased, haemoglobin decreased
Maltese: Mhux komuni żieda fl-aspartate aminotransferase, żieda fillipase, żieda fl-amylase, tnaqqis fl-emoglobina
English: Bone loss and mineralisation defects
Maltese: Difetti tal-mineralizzazzjoni
English: Respiratory, thoracic and mediastinal disorders Common cough*, nasal symptoms*
Maltese: Disturbi respiratorji, toraċiċi u medjastinali Komuni sogħla*, sintomi tal-imnieħer*
English: A panel of 96 diverse clinical isolates containing NNRTI-associated mutations was evaluated for susceptibility to doravirine in the presence of 10 % foetal bovine serum.
Maltese: Lista ta' 96 iżolat kliniku divers li kien fihom mutazzjonjiet assoċjati ma' NNRTI ġiet evalwata għassuxxettibbiltà għal doravirine fil-preżenza ta' 10 % serum tal-fetu tal-baqra.
English: • sofosbuvir/velpatasvir (medicines used to treat hepatitis C infection)
Maltese: • sofosbuvir/velpatasvir (mediċini użati biex jittrattaw infezzjoni tal-epatite Ċ)
English: HIV-1 isolates from patients (n = 20) whose HIV-1 expressed a mean of 3 zidovudine associated RT amino acid substitutions (M41L, D67N, K70R, L210W, T215Y/F, or K219Q/E/N) showed a 3.1-fold decrease in the susceptibility to tenofovir.
Maltese: Iżolati ta' HIV-1 minn pazjenti (n = 20) li l-HIV-1 tagħhom kien jesprimi medja ta' 3 sostituzzjonijiet fl-aċidi amminiċi ta' RT (M41L, D67N, K70R, L210W, T215Y/F, jew K219Q/E/N) assoċjati ma' zidovudine urew tnaqqis ta' 3.1 drabi fis-suxxettibbiltà għal tenofovir.
English: Metabolism and nutrition disorders Uncommon hypophosphataemia, hypokalaemia*
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni Mhux komuni ipofosfatimja, ipokalimja*
English: *For Week 96, certain subjects with missing HIV-1 RNA were excluded from the analysis.
Maltese: *Għal Ġimgħa 96, ċerti individwi b'RNA ta' HIV-1 nieqsa ġew esklużi mill-analiżi.
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Maltese: Pazjenti li għandhom problemi ereditarji rari ta' intolleranza għallgalactose, defiċjenza totali ta' lactase jew assorbiment ħażin ta' glucose-galactose m'għandhomx jieħdu din il-mediċina.
English: Based on administration of an IV microdose, the volume of distribution of doravirine is 60.5 L. Doravirine is approximately 76 % bound to plasma proteins.
Maltese: Abbażi ta' għoti ta' mikrodoża fil-vini, il-volum ta' distribuzzjoni ta' doravirine jkun 60.5 L. Madwar 76 % ta' doravirine jintrabat mal-proteini tal-plażma.
English: At baseline, the median age of subjects was 43 years, 16 % were female, and 24 % were nonwhite.
Maltese: Fil-linja bażi, l-età medjana tal-individwi kienet 43 sena, 16 % kienu nisa, u 24 % kienu mhux bojod.
English: In DRIVE-AHEAD, a lower proportion of subjects who discontinued due to an adverse event by Week 48 was seen for the Delstrigo group (3.0 %) compared with the EFV/FTC/TDF group (6.6 %).
Maltese: Fi DRIVE-AHEAD, deher proporzjon inqas ta' individwi li waqfu minħabba avveniment avvers sa Ġimgħa 48 għall-grupp ta' Delstrigo (3.0 %) meta mqabbel mal-grupp ta' trattament b'EFV/FTC/TDF
English: Use with CYP3A inducers
Maltese: (Induzzjoni ta' CYP3A)
English: Safety and efficacy of Delstrigo have not been established in patients younger than 18 years of age.
Maltese: Is-sigurtà u l-effikaċja ta' Delstrigo ma ġewx determinati f'pazjenti iżgħar minn 18-il sena.
English: Bone mineral density
Maltese: GĦAMLA KWALITATTIVA
English: Doravirine has not been studied in subjects with severe hepatic impairment (Child-Pugh score C) (see section 4.2).
Maltese: Doravirine ma ġiex studjat f'individwi b'indebolimet sever tal-fwied (punteġġ Ċ ta' Child-Pugh) (ara sezzjoni 4.2).
English: Discontinuation due to adverse events
Maltese: Twaqqif minħabba avvenimenti avversi
English: Single-dose administration of one doravirine/lamivudine/tenofovir disoproxil tablet to healthy subjects (N = 24) under fasted conditions provided comparable exposures of doravirine, lamivudine, and tenofovir to administration of doravirine tablets (100 mg) plus lamivudine tablets (300 mg) plus tenofovir disoproxil tablets (245 mg).
Maltese: Għoti ta' doża waħda ta' pillola waħda ta' doravirine/lamivudine/tenofovir disoproxil lill-individwi f'saħħithom (N = 24) f'kundizzjonijiet ta' sawm ipprovda esponimenti kumparabbli għal doravirine, lamivudine, u tenofovir ma' għoti ta' pilloli ta' doravirine (100 mg) flimkien ma' pilloli ta' lamivudine (300 mg) u ma' pilloli ta' tenofovir disoproxil (245 mg).
English: Tenofovir diphosphate inhibits the activity of HIV-1 RT by competing with the natural substrate deoxyadenosine 5´-triphosphate and, after incorporation into DNA, by DNA chain termination.
Maltese: Tenofovir diphosphate jinibixxi l-attività ta' RT ta' HIV-1 billi jikkompeti mas-sustrat naturali deoxyadenosine 5´-triphosphate u, wara l-inkorporazzjoni fid-DNA, permezz ta' terminazzjoni talkatina tad-DNA.
English: See “Other medicines and Delstrigo” section for a list of medicines.
Maltese: Ara s-sezzjoni “Mediċini oħra u Delstrigo” għal-lista ta' mediċini.
English: HIV-1 isolates selected by tenofovir expressed a K65R substitution in HIV-1 RT and showed a 2-4 fold reduction in susceptibility to tenofovir.
Maltese: Iżolati ta' HIV-1 magħżula minn tenofovir kienu jesprimu sostituzzjoni ta' K65R f'RT ta' HIV-1 u wrew tnaqqis ta' 2-4 darbiet fis-suxxettibbiltà għal tenofovir.
English: Lamivudine Lamivudine does not inhibit or induce CYP enzymes.
Maltese: Lamivudine Lamivudine ma jinibixxix u ma jinduċix l-enzimi CYP.
English: The efficacy of doravirine is based on the analyses of 96-week data from two randomised, multicentre, double-blind, active controlled Phase 3 trials, (DRIVE-FORWARD and DRIVE-AHEAD) in antiretroviral treatment-naïve, HIV-1 infected subjects (n = 1494).
Maltese: L-effikaċja ta' doravirine hija bbażata fuq l-analiżi ta' data ta' 96 ġimgħa minn żewġ provi arbitrarji, b'ħafna ċentri, ikkontrollati b'mod attiv, ta' Fażi 3, fejn la l-investigaturi u lanqas l-individwi ma kienu jafu liema sustanza qed tintuża (DRIVE-FORWARD u DRIVE-AHEAD) f'individwi nfettatti b'HIV-1 li qatt ma ħadu trattament antiretrovirali (n = 1494).
English: Available pharmacodynamic/toxicological data in animals have shown excretion of doravirine in milk (see section 5.3).
Maltese: Data farmakodinamika/tossikoloġika disponibbli fl-annimali uriet eliminazzjoni ta' doravirine fil-ħalib (ara sezzjoni 5.3).
English: Doravirine steady state pharmacokinetics following administration of 100 mg once daily to HIV-1 infected subjects, based on a population pharmacokinetics analysis are provided below.
Maltese: Il-farmakokinetika ta' doravirine fi stat fiss wara għoti ta' 100 mg darba kuljum lill-individwi infettati b'HIV-1, abbażi ta' analiżi farmakokinetika ta' popolazzjoni hija pprovduta taħt.
English: Delstrigo should be discontinued if estimated CrCl declines below 50 mL per minute (see section 4.4).
Maltese: Delstrigo għandu jitwaqqaf jekk il-CrCl stmata tiddeterjora għal anqas minn 50 mL kull minuta (ara sezzjoni 4.4).
English: The antiviral activity of tenofovir against laboratory and clinical isolates of HIV-1 was assessed in T lymphoblastoid cell lines, primary monocyte/macrophage cells and peripheral blood lymphocytes.
Maltese: L-attività antivirali ta' tenofovir kontra iżolati tal-laboratorju u kliniċi tal-HIV-1 ġiet stmata f'linji ta' ċelluli T limfoblastojd, ċelluli monoċiti/makrofaġi primarji u limfoċiti tad-demm periferali.
English: Emergent doravirine associated resistance substitutions in RT included one or more of the following: A98G, V106I, V106A, V106M/T, Y188L, H221Y, P225H, F227C, F227C/R, and Y318Y/F.
Maltese: A98G, V106I, V106A, V106M/T, Y188L, H221Y, P225H, F227C, F227C/R, u Y318Y/F.
English: NRTI background therapy
Maltese: Terapija ta' NRTI fl-isfond
English: 3, 84 % were male, 27 % were non-white, 4 % had hepatitis B and/or C virus co-infection, 10 % had a history of AIDS, 20 % had HIV-1 RNA greater than 100,000 copies per mL, 13 % received ABC/3TC and 87 % received FTC/TDF; these characteristics were similar between treatment groups.
Maltese: kellhom għadd ta' ċelluli T CD4+ ta' aktar minn 200 ċellula kull mm3, 84% kienu rġiel, 27% ma kinux bojod, 4% kellhom infezzjoni fl-istess waqt bil-virus tal-epatite B u/jew C, 10% kellhom AIDS filpassat, 20% kellhom RNA ta' HIV-1 ta' aktar minn 100,000 kopja kull mL, 13% irċevew ABC/3TC u 87% irċevew FTC/TDF; dawn il-karatteristiċi kienu simili bejn il-gruppi ta' trattament.
English: Table 3: Resistance development up to week 96 in protocol defined virologic failure population + early discontinuation population
Maltese: Tabella 3: Żvilupp ta' reżistenza sa ġimgħa 96 fil-popolazzjoni b'falliment viroloġiku definit mill-protokoll + il-popolazzjoni b'waqfien bikri
English: Tenofovir disoproxil requires initial diester hydrolysis for conversion to tenofovir and subsequent phosphorylations by cellular enzymes to form tenofovir diphosphate.
Maltese: Tenofovir disoproxil jeħtieġ idroliżi inizjali ta' diester għall-konverżjoni f'tenofovir u fosforilazzjonijiet sussegwenti permezz ta' enzimi taċ-ċelluli biex jifforma tenofovir diphosphate.
English: NNRTI substitutions and use of doravirine
Maltese: Sostituzzjonijiet ta' NNRTI u l-użu ta' doravirine
English: 2D barcode carrying the unique identifier included
Maltese: IDENTIFIKATUR UNIKU - BARCODE 2D Barcode 2D li jkollu l-identifikatur uniku inkluż
English: Genotypic analysis showed that the resistance was due to a specific amino acid substitution in the HIV-1 RT at codon 184 changing the methionine to either isoleucine or valine (M184V/I).
Maltese: Analiżi ġenotipika wriet li r-reżistenza kienet minħabba sostituzzjoni ta' aċidu amminiku speċifiku f'RT ta' HIV-1 fil-kodon 184 li bidel il-methionine f'isoleucine jew valine (M184V/I).
English: • It is important that you do not miss or skip doses of Delstrigo.
Maltese: • Huwa importanti li inti ma titlifx u ma taqbiżx dożi ta' Delstrigo.
English: Limited data are available for patients whose virus expressed a Y115F substitution (n = 3), Q151M substitution (n = 2), or T69 insertion (n = 4) in HIV-1 RT, all of whom had a reduced response in clinical trials.
Maltese: (n = 3), is-sostituzzjoni Q151M (n = 2), jew iż-żieda ta' T69 (n = 4) f'RT ta' HIV-1, li kollha kemm huma kellhom rispons imnaqqas fi provi kliniċi.
English: Lamivudine-resistant HIV-1 mutants were also cross resistant to didanosine (ddI).
Maltese: Mutanti ta' HIV-1 reżistenti għal lamivudine kienu wkoll reżistenti b'mod inkroċjat għal didanosine (ddI).
English: Expected: ↑ tenofovir
Maltese: ↔ doravirine ↑ tenofovir
English: Expected:  rosuvastatin  simvastatin
Maltese: ↔ rosuvastatin ↔ simvastatin
English: Table 5: Efficacy response (Snapshot approach) in the DRIVE-SHIFT study
Maltese: Rispons ta' effikaċja (approċ Snapshot) fl-studju DRIVE-SHIFT
English: Doravirine/lamivudine/tenofovir disoproxil should not be co-administered with medicinal products that are strong CYP3A enzyme inducers as significant decreases in doravirine plasma concentrations are expected to occur, which may decrease the effectiveness of doravirine/lamivudine/tenofovir disoproxil (see sections 4.3 and 5.2).
Maltese: Doravirine/lamivudine/tenofovir disoproxil m'għandhomx jingħataw flimkien ma' prodotti mediċinali li huma indutturi qawwija tal-enzima CYP3A minħabba li jkun mistenni li jseħħ tnaqqis sinifikanti filkonċentrazzjonijiet ta' doravirine fil-plażma, li jista' jnaqqas l-effikaċja ta' doravirine/lamivudine/tenofovir disoproxil (ara sezzjonijiet 4.3 u 5.2).
English: There is no evidence that elderly patients require a different dose than younger adult patients (see section 5.2).
Maltese: Ma hemm l-ebda xhieda li pazjenti anzjani jeħtieġu doża differenti minn pazjenti adulti iżgħar (ara sezzjoni 5.2).
English: Other medicines and Delstrigo
Maltese: Mediċini oħra u Delstrigo
English: Cobicistat-boosted elvitegravir
Maltese: Ir-rekwiżiti biex jiġu ppreżentati
English: Co-administration with medicinal products that are strong cytochrome P450 CYP3A enzyme inducers is contraindicated as significant decreases in doravirine plasma concentrations are expected to occur, which may decrease the effectiveness of Delstrigo (see sections 4.4 and 4.5).
Maltese: L-għoti flimkien ma' prodotti mediċinali oħra li huma indutturi qawwija tal-enzima taċ-ċitokrom P450 CYP3A huwa kontraindikat minħabba li huwa mistenni li jseħħ tnaqqis sinifikanti filkonċentrazzjonijiet ta' doravirine fil-plażma, li jista' jnaqqas l-effikaċja ta' Delstrigo (ara sezzjonijiet 4.4 u 4.5).
English: gastrointestinal motility disorder includes: gastrointestinal motility disorder, and frequent bowel movements rash includes: rash, rash macular, rash erythematous, rash generalised, rash maculo-papular, rash papular, and urticarial alanine aminotransferase increased includes: alanine aminotransferase increased and hepatocellular injury
Maltese: 7disturb fil-motilità gastrointestinali jinkludi: disturb fil-motilità gastrointestinali, u ppurgar frekwenti 8raxx jinkludi: raxx, raxx makulari, raxx eritematuż, raxx mifrux, raxx makulopapulari, raxx papulari, u urtikarja
English: Studies in pregnant rats and rabbits showed that doravirine is transferred to the foetus through the placenta, with foetal plasma concentrations of up to 40 % (rabbits) and 52 % (rats) that of maternal concentrations observed on gestation Day 20.
Maltese: Studji f'firien u fniek tqal urew li doravirine jiġi trasferit għall-fetu mill-plaċenta, b'konċentrazzjonijiet fil-plażma talfetu sa 40 % (fniek) u 52 % (firien) tal-konċentrazzjonijiet tal-omm osservati fil-Jum 20 tat-tqala.
English: Delstrigo Once Daily ISG
Maltese: Delstrigo Darba Kuljum ISG
English: Effects of doravirine, lamivudine, and tenofovir disoproxil on other medicinal products Doravirine
Maltese: Effetti ta' doravirine, lamivudine, u tenofovir disoproxil fuq prodotti mediċinali oħra Doravirine
English: If co-administration with other moderate CYP3A inducers (e.g., debrafenib, lesinurad, bosentan, thioridazine, nafcillin, modafinil, telotristat ethyl) cannot be avoided, a 100 mg dose of doravirine should be administered daily, approximately 12 hours after the administration of doravirine/lamivudine/tenofovir disoproxil dose (see section 4.2).
Maltese: Jekk lgħoti flimkien ma' indutturi moderati oħra ta' CYP3A (eż., debrafenib, lesinurad, bosentan, thioridazine, nafcillin, modafinil, telotristat ethyl) ma jistax jiġi evitat, għandha tingħata doża ta' 100 mg ta' doravirine kuljum, madwar 12-il siegħa wara l-għoti tad-doża ta' doravirine/lamivudine/tenofovir disoproxil (ara sezzjoni 4.2).
English: In DRIVE-AHEAD, 728 subjects were randomized and received at least 1 dose of either doravirine/lamivudine/tenofovir disoproxil 100/300/245 mg (DOR/3TC/TDF) or efavirenz/emtricitabine/tenofovir disoproxil (EFV/FTC/TDF) once daily.
Maltese: Fi DRIVE-AHEAD, 728 individwu ntagħżlu b'mod arbitrarju u rċivew mill-inqas doża waħda ta' doravirine/lamivudine/tenofovir disoproxil 100/300/245 mg (DOR/3TC/TDF) jew efavirenz/emtricitabine/tenofovir disoproxil (EFV/FTC/TDF) darba kuljum.
English: Baseline regimen = ritonavir or cobicistat-boosted PI (specifically atazanavir, darunavir, or lopinavir), or cobicistat-boosted elvitegravir, or NNRTI (specifically efavirenz, nevirapine, or rilpivirine), each administered with two NRTIs.
Maltese: L-Iskeda ta' trattament fil-linja bażi = PI imsaħħaħ b'ritonavir jew b'cobicistat (b'mod speċifiku atazanavir, darunavir, jew lopinavir), jew elvitegravir imsaħħaħ b'cobicistat, jew NNRTI (b'mod speċifiku efavirenz, nevirapine, jew rilpivirine), kull wieħed minnhom mogħti flimkien ma' żewġ NRTIs.
English: While effective viral suppression with antiretroviral therapy has been proven to substantially reduce the risk of sexual transmission of HIV-1, a residual risk cannot be excluded.
Maltese: Filwaqt li soppressjoni virali effettiva b'terapija antiretrovirali ġiet ippruvata li tnaqqas b'mod sostanzjali r-riskju ta' trasmissjoni sesswali ta' HIV-1, ma jistax jiġi eskluż li jkun għad fadal riskju.
English: • ledipasvir/sofosbuvir (medicines used to treat hepatitis C infection)
Maltese: • ledipasvir/sofosbuvir (mediċini użati biex jittrattaw infezzjoni tal-epatite Ċ)
English: lamivudine + tenofovir disoproxil (300 mg lamivudine SD + 245 mg tenofovir disoproxil SD, doravirine 100 mg SD)
Maltese: (300 mg lamivudine SD + 245 mg tenofovir disoproxil SD, doravirine 100 mg SD)
English: No clinically relevant pharmacokinetic differences have been identified between men and women for doravirine, lamivudine, and tenofovir.
Maltese: Ma ġew identifikati l-ebda differenzi farmakokinetiċi rilevanti b'mod kliniku bejn irġiel u nisa għal doravirine, lamivudine, u tenofovir.
English: No dose adjustment of Delstrigo is required in adults with estimated creatinine clearance (CrCl) ≥ 50 mL/min.
Maltese: Ma huwa meħtieġ l-ebda aġġustmanent fid-doża ta' Delstrigo f'adulti bi tneħħija stmata tal-kreatinina (CrCl, creatinine clearance) ≥ 50 mL/min.
English: In vitro studies have determined that neither tenofovir disoproxil nor tenofovir are substrates for the CYP450 enzymes.
Maltese: Studji in vitro iddeterminaw li la tenofovir disoproxil u lanqas tenofovir ma huma sustrati għall-enzimi ta' CYP450.
English: • The active substances are 100 mg of doravirine, 300 mg of lamivudine and 245 mg of tenofovir disoproxil (as fumarate)
Maltese: • Is-sustanzi attivi huma 100 mg ta' doravirine, 300 mg ta' lamivudine u 245 mg ta' tenofovir disoproxil (bħala fumarate)
English: Refer to Resistance section for NNRTI substitutions that were part of exclusion criteria.
Maltese: Irreferi għas-sezzjoni dwar ir-Reżistenza ta' sostituzzjonijiet ta' NNRTI li kienu parti mill-kriterji ta' esklużjoni.
English: Exclusionary NNRTI substitutions were those listed above (DRIVE-FORWARD and DRIVE-AHEAD), with the exception of substitutions RT K103N, G190A and Y181C (accepted in DRIVE-SHIFT).
Maltese: Sostituzzjonijiet li jeskludu NNRTI kienu dawk elenkati fuq (DRIVE-FORWARD u DRIVEAHEAD), ħlief għas-sostituzzjonijiet K103N, G190A u Y181C f'RT (aċċettati fi DRIVE-SHIFT).
English: No dose adjustment of doravirine/lamivudine/tenofovir disoproxil is required in patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment.
Maltese: Ma huwa meħtieġ l-ebda aġġustament fid-doża ta' doravirine/lamivudine/tenofovir disoproxil f'pazjenti b'indeboliment ħafif (Klassi A ta' Child-Pugh) jew moderat (Klassi B ta' Child-Pugh) talfwied.
English: One subject developed RT M184M/I mutation and phenotypic resistance to 3TC and FTC during treatment with their baseline regimen.
Maltese: Individwu wieħed żviluppa mutazzjoni M184M/I f'RT u reżistenza fenotipika għal 3TC u FTC matul it-trattament bl-iskeda ta' trattament tagħhom fil-linja bażi.
English: Geometric Mean Ratio (90 % CI)*
Maltese: Effetti fuq il-Proporzjon Ġeometriku Medju tal-Livelli talProdott Mediċinali (CI ta' 90 %)*
English: In DRIVE-FORWARD, 766 subjects were randomised and received at least 1 dose of either doravirine 100 mg or darunavir + ritonavir 800+100 mg once daily, each in combination with emtricitabine/tenofovir disoproxil (FTC/TDF) or abacavir/lamivudine (ABC/3TC) selected by the investigator.
Maltese: Fi DRIVE-FORWARD, 766 individwu kienu randomised u rċevew mill-inqas doża waħda ta' doravirine 100 mg jew darunavir + ritonavir 800+100 mg darba kuljum, kull waħda flimkien ma' emtricitabine/tenofovir disoproxil (FTC/TDF) jew abacavir/lamivudine (ABC/3TC) magħżula millinvestigatur.
English: • 90 film-coated tablets (3 bottles of 30 film-coated tablets)
Maltese: • 90 pillola miksija b'rita (3 fliexken ta' 30 pillola miksija b'rita)
English: The doravirine-based regimens demonstrated consistent efficacy across demographic and baseline prognostic factors.
Maltese: Il-korsijiet ibbażati fuq doravirine urew effikaċja konsistenti għall-fatturi demografiċi u pronostiċi kollha fil-linja bażi.
English: Table 2: Tabulated summary of adverse reactions associated with doravirine/lamivudine/tenofovir disoproxil
Maltese: Tabella 2: Sommarju ta' reazzjonijiet avversi miġbura f'tabella assoċjati ma' doravirine/lamivudine/tenofovir disoproxil