FrancophonIA/ELRC3.0 huggingface dataset:
English: The oral bioavailability of tenofovir from tenofovir disoproxil in fasted subjects is approximately 25 %.
Maltese: Ilbijodisponibbiltà orali ta' tenofovir minn tenofovir disoproxil f'individwi sajma huwa madwar 25 %.
English: During the initial phase of combination antiretroviral treatment, patients whose immune system responds may develop an inflammatory response to indolent or residual opportunistic infections (such as Mycobacterium avium infection, cytomegalovirus, Pneumocystis jirovecii pneumonia [PCP], or tuberculosis), which may necessitate further evaluation and treatment.
Maltese: Matul il-fażi inizjali ta' trattament antiretrovirali kombinat, il-pazjenti li s-sistema immuni tagħhom tirrispondi jistgħu jiżviluppaw rispons infjammatorju għal infezzjonijiet opportunistiċi indolenti jew residwali (bħal infezzjoni b'Mycobacterium avium, ċitomegalovirus, pulmonite b'Pneumocystis jirovecii [PCP, Pneumocystis jirovecii pneumonia], jew tuberkulożi), li jistgħu jkunu jeħtieġu aktar evalwazzjoni u trattament.
English: Psychiatric disorders Common abnormal dreams, insomnia
Maltese: Disturbi psikjatriċi Komuni ħolm mhux normali, insomnja1
English: 5, abdominal distension, dyspepsia, faeces soft gastrointestinal motility disorder
Maltese: Mhux komuni stitikezza, skumdità fl-addome5, nefħa fladdome, dispepsja, ippurgar maħlul6, disturb filmotilità gastrointestinali7, pankreatite*
English: Hepatobiliary disorders Rare hepatic steatosis*, hepatitis*
Maltese: Disturbi fil-fwied u fil-marrara Rari steatożi fil-fwied*, epatite*
English: You can still pass on HIV when taking Delstrigo, although effective therapy lowers the risk.
Maltese: Inti xorta tista' tgħaddi l-HIV meta tkun qed tieħu Delstrigo, għalkemm terapija effettiva tnaqqas irriskju.
English: Severe acute exacerbation of hepatitis B in patients co-infected with HIV-1 and HBV All patients with HIV-1 should be tested for the presence of hepatitis B virus (HBV) before initiating antiretroviral therapy.
Maltese: Taħrix sever akut tal-epatite B f'pazjenti infettati b'HIV-1 u b'HBV fl-istess ħin Il-pazjenti kollha b'HIV-1 għandhom jiġu ttestjati għall-preżenza tal-virus tal-epatite B (HBV, hepatitis B virus) qabel jibdew terapija antiretrovirali.
English: • headache, dizziness, sleepiness
Maltese: ↑ = żieda, ↓ = tnaqqis, ↔ = l-ebda bidla
English: Consider more frequent monitoring of HIV-1 viral load when chronic co-administration cannot be avoided.
Maltese: Ikkunsidra monitoraġġ aktar frekwenti talpiż virali tal-HIV-1 meta l-għoti kroniku tagħhom flimkien ma jkunx jista' jiġi evitat.
English: • thioridazine (a medicine to treat psychiatric conditions such as schizophrenia)
Maltese: • thioridazine (mediċina biex tittratta kundizzjonijiet psikjatriċi bħal skizofrenja)
English: Film-coating Carnauba wax (E903) Hypromellose (E464) Iron oxide yellow (E172) Lactose monohydrate Titanium dioxide (E171) Triacetin (E1518)
Maltese: Carnauba wax (E903) Hypromellose (E464)
English: The clinical relevance of a 5-10 fold change reduction in susceptibility is unknown.
Maltese: Ir-rilevanza klinika ta' bidla ta' 5-10 darbiet ta' tnaqqis fis-suxxettibbiltà mhijiex magħrufa.
English: Treatment-naïve adult subjects
Maltese: Studji ta' interazzjoni twettqu biss fl-adulti.
English: 0.03 mg ethinyl oestradiol/ 0.15 mg levonorgestrel SD, doravirine 100 mg QD
Maltese: 15 mg levonorgestrel SD, doravirine 100 mg QD
English: Doravirine/lamivudine/tenofovir disoproxil should not be administered with doravirine unless needed for dose adjustment (e.g., with rifabutin) (see sections 4.2 and 4.5).
Maltese: Doravirine/lamivudine/tenofovir disoproxil m'għandux jingħata ma' doravirine ħlief jekk ikun meħtieġ għal aġġustament fid-doża (eż., ma' rifabutin) (ara sezzjonijiet 4.2 u 4.5).
English: See list under “Do not take Delstrigo” section.
Maltese: Dawn jistgħu jiġru f'persuni li jieħdu Delstrigo.
English: Lamivudine was not mutagenic in a microbial mutagenicity assay, in an in vitro cell transformation assay, in a rat micronucleus test, in a rat bone marrow cytogenetic assay, and in an assay for unscheduled DNA synthesis in rat liver.
Maltese: Lamivudine ma kienx mutaġeniku f'assaġġ mutaġenetiku fil-mikrobi, f'assaġġ ta' trasformazzjoni taċ-ċellula in vitro, fit-test tal-mikronukleju talfar, f'assaġġ ċitoġenetiku fil-mudullun tal-għadam tal-far, u f'assaġġ ta' sintesi mhux skedata tadDNA fil-fwied tal-far.
English: When Delstrigo is co-administered with rifabutin, a 100 mg dose of doravirine should be given daily, approximately 12 hours after doravirine/lamivudine/tenofovir disoproxil dose (see section 4.2).
Maltese: Meta Delstrigo jingħata flimkien ma' rifabutin, għandha tingħata doża ta' 100 mg ta' doravirine kuljum, madwar 12-il siegħa wara d-doża ta' doravirine/lamivudine/tenofovir disoproxil (ara sezzjoni 4.2).
English: Gastrointestinal disorders Common nausea, diarrhoea, abdominal pain 4, vomiting,
Maltese: Disturbi gastrointestinali Komuni nawsja, dijarea, uġigħ fl-addome4, rimettar, gass
English: Because lamivudine is primarily eliminated by the kidneys through a combination of glomerular filtration and active tubular secretion (see section 5.2), co-administration of doravirine/lamivudine/tenofovir disoproxil with medicinal products that reduce renal function or compete for active tubular secretion may increase serum concentrations of lamivudine.
Maltese: Minħabba li lamivudine jiġi eliminat primarjament mill-kliewi permezz ta' kombinazzjoni ta' filtrazzjoni mill-glomeruli u sekrezzjoni attiva mit-tubuli (ara sezzjoni 5.2), l-għoti ta' doravirine/lamivudine/tenofovir disoproxil flimkien ma' prodotti mediċinali li jnaqqsu l-funzjoni talkliewi jew jikkompetu għas-sekrezzjoni attiva mit-tubuli jista' jkun li jżid il-konċentrazzjonijiet ta' lamivudine fis-serum.
English: *This adverse reaction was not identified as an adverse reaction associated with doravirine from the Phase 3 clinical studies (DRIVE-FORWARD, DRIVE-AHEAD, DRIVE-SHIFT), but is included in this table as an adverse reaction based on the Summary of Product Characteristics of 3TC and/or TDF.
Maltese: * Din ir-reazzjoni avversa ma ġietx identifikata bħala reazzjoni avversa assoċjata ma' doravirine mill-istudji kliniċi ta' Fażi 3 (DRIVE-FORWARD, DRIVE-AHEAD, DRIVE-SHIFT), iżda hija nkluża f'din it-tabella bħala reazzjoni avversa bbażata fuq is-Sommarju tal-Karatteristiċi tal-Prodott ta' 3TC u/jew TDF.
English: Film-coated tablets 30 film-coated tablets 90 (3 bottles of 30) film-coated tablets
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 30 pillola miksija b'rita
English: A breakpoint for a reduction in susceptibility, yielded by various NNRTI substitutions, that is associated with a reduction in clinical efficacy has not been established.
Maltese: Punt li ogħla minnu jkun hemm tnaqqis fis-suxxettibbiltà, li jinkiseb b'riżultat ta' diversi sostituzzjonijiet ta' NNRTI, li huwa assoċjat ma' tnaqqis fl-effikaċja klinika ma ġiex stabbilit.
English: Proportion (%) of Subjects With HIV-1 RNA < 40 copies/mL by Baseline Regimen Received
Maltese: Proporzjon (%) ta' Individwi b'RNA ta' HIV-1 < 40 kopja/mL skont l-Iskeda ta' Trattament Mogħti fil-Linja Bażi
English: Includes subjects who discontinued study drug or study before Week 48 for ISG or before Week 24 for DSG for lack or loss of efficacy and subjects with HIV-1 RNA ≥ 40 copies/mL in the Week 48 window for ISG and in the Week 24 window for DSG.
Maltese: †Jinkludi individwi li waqqfu l-mediċina tal-istudju jew l-istudju qabel Ġimgħa 48 għal ISG jew qabel Ġimgħa 24 għal DSG minħabba nuqqas jew telf ta' effikaċja u individwi b'RNA ta' HIV-1 ≥ 40 kopja/mL fil-perjodu ta' żmien ta' Ġimgħa 48 għal ISG u fil-perjodu ta' żmien ta' Ġimgħa 24 għal DSG.
English: Clinical isolates containing the Y188L substitution or V106 substitutions in combination with A98G, H221Y, P225H, F227C or Y318F showed a greater than 100-fold reduced susceptibility to doravirine.
Maltese: Iżolati kliniċi li kien fihom is-sostituzzjoni Y188L jew is-sostituzzjonijiet V106 flimkien ma' A98G, H221Y, P225H, F227C jew Y318F urew suxxettibbiltà mnaqqsa aktar minn 100 darba għal doravirine.
English: Delstrigo is indicated for the treatment of adults infected with HIV-1 without past or present evidence of resistance to the NNRTI class, lamivudine, or tenofovir (see sections 4.4 and 5.1).
Maltese: Delstrigo huwa indikat għat-trattament ta' adulti infettati b'HIV-1 mingħajr xhieda fil-preżent jew filpassat ta' reżistenza għall-klassi ta' NNRTI, għal lamivudine, jew għal tenofovir (ara sezzjonijiet 4.4 u
English: Approximately 70-80 % of the intravenous dose of tenofovir is recovered as unchanged medicinal product in the urine within 72 hours of dosing.
Maltese: Madwar 70-80 % tad-doża ta' tenofovir fil-vini tiġi rkuprata bħala prodott mediċinali mhux mibdul fl-awrina fi żmien 72 siegħa mill-għoti tad-doża.
English: The marketing authorization holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq (MAH) għandu jwettaq l-attivitajiet u linterventi meħtieġa ta' farmakoviġilanza dettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-awtorizzazzjoni għat-tqegħid fis-suq u kwalunkwe aġġornament sussegwenti maqbul talRMP.
English: • modafinil (a medicine to treat excessive sleepiness)
Maltese: • modafinil (mediċina biex tittratta rqad eċċessiv)
English: Tenofovir is eliminated by a combination of glomerular filtration and active tubular secretion with a renal clearance in adults with CrCl greater than 80 mL per minute of 243.5 ± 33.3 mL per minute (mean ± SD).
Maltese: Tenofovir jitneħħa permezz ta' kombinazzjoni ta' filtrazzjoni mill-glomeruli u sekrezzjoni attiva mit-tubuli bi tneħħija mill-kliewi f'adulti li jkollhom CrCl ta' aktar minn 80 mL kull minuta ta' 243.5 ± 33.3 mL kull minuta (medja ± SD). Wara għoti mill-ħalq, il-half-life terminali ta' tenofovir hija madwar 12 sa 18-il siegħa.
English: Multiple dose rifampicin (600 mg QD, doravirine 100 mg SD)
Maltese: Ħafna dożi ta' rifampicin (600 mg QD, doravirine 100 mg SD)
English: Based on more than 200 mother/child pairs treated for HIV, serum concentrations of lamivudine in breast-fed infants of mothers treated for HIV are very low (< 4 % of maternal serum concentrations) and progressively decrease to undetectable levels when breast-fed infants reach 24 weeks of age.
Maltese: Abbażi ta' iktar minn 200 par ta' omm/tarbija ttrattati għall-HIV, konċentrazzjonijiet ta' lamivudine fis-serum ta' trabi mreddgħin ta' ommijiet ittrattati għall-HIV huma baxxi ħafna (< 4 % tal-konċentrazzjonijiet fis-serum tal-omm) u jonqsu b'mod proggressiv għal-livelli li ma jistgħux jitkejlu meta t-tarbija mreddgħa tilħaq l-età ta' 24 ġimgħa.
English: There are limited data available on the use of doravirine, lamivudine, and tenofovir disoproxil in patients aged 65 years and over.
Maltese: Hemm data limitata disponibbli dwar l-użu ta' doravirine, lamivudine, u tenofovir disoproxil f'pazjenti li għandhom 65 sena u aktar.
English: How to store Delstrigo
Maltese: X'fih Delstrigo
English: In a study comparing 8 subjects with severe renal impairment to 8 subjects without renal impairment, the single dose exposure of doravirine was 31 % higher in subjects with severe renal impairment.
Maltese: Fi studju li qabbel 8 individwi b'indeboliment sever talkliewi ma' 8 individwi mingħajr indeboliment tal-kliewi, l-esponiment għal doża waħda ta' doravirine kien 31 % ogħla f'individwi b'indeboliment sever tal-kliewi.
English: Co-administration with other antiviral products
Maltese: L-għoti flimkien ma' prodotti antivirali oħra
English: Each film-coated tablet contains 100 mg of doravirine, 300 mg of lamivudine and 245 mg of tenofovir disoproxil.
Maltese: Kull pillola miksija b'rita fiha 100 mg ta' doravirine, 300 mg ta' lamivudine u 245 mg ta' tenofovir disoproxil.
English: Uncommon myalgia, arthralgia, rhabdomyolysis* muscular weakness*
Maltese: Mhux komuni mijalġja, artralġja, rabdomijolisi*†, dgħufija filmuskoli*†
English: Reproduction studies with orally administered doravirine have been performed in rats and rabbits at exposures approximately 9 times (rats) and 8 times (rabbits) the exposure in humans at the recommended human dose (RHD) with no effects on embryo-foetal (rats and rabbits) or pre/postnatal (rats) development.
Maltese: Studji dwar ir-riproduzzjoni b'doravirine mogħti mill-ħalq saru fuq il-firien u l-fniek b'esponimenti madwar 9 darbiet (firien) u 8 darbiet (fniek) aktar mill-esponiment fil-bnedmin bid-doża rakkomandata għall-bniedem (RHD, recommended human dose) mingħajr l-ebda effetti fuq l-iżvilupp tal-embriju u tal-fetu (firien u fniek) jew l-iżvilupp ta' qabel/wara t-twelid (firien).
English: It belongs to a group of medicines called ‘antiretroviral medicines'.
Maltese: Huwa jagħmel parti minn grupp ta' mediċini msejħa ‘mediċini antiretrovirali'.
English: Delstrigo should be discontinued if estimated CrCl declines below 50 mL per minute as dose interval adjustment required for lamivudine and tenofovir disoproxil cannot be achieved with the fixed dose combination tablet (see section 4.2).
Maltese: Delstrigo għandu jitwaqqaf jekk listima tal-CrCl tiddeterjora għal anqas minn 50 mL kull minuta minħabba li l-aġġustament meħtieġ flintervall bejn id-doża ta' lamivudine u tenofovir disoproxil ma jistax jinkiseb bil-pillola kombinata b'doża fissa (ara sezzjoni 4.2).
English: • joint pain, breakdown of muscle tissue, muscular weakness
Maltese: • uġigħ fil-ġogi, diżintegrazzjoni tat-tessut tal-muskolu, dgħufija fil-muskoli
English: indigestion, soft stools, stomach spasms, frequent bowel movements, inflammation of the pancreas (pancreatitis) (causing stomach pain, vomiting)
Maltese: ippurgar maħlul, spażmi fl-istonku, ippurgar ta' spiss, infjammazzjoni tal-frixa (pankreatite)
English: Skin and subcutaneous tissue disorders Common alopecia*, rash
Maltese: Disturbi fil-ġilda u fit-tessuti ta' taħt il-ġilda Komuni alopeċja*, raxx8
English: • decreased number of red blood cells in your blood (anaemia)
Maltese: • tnaqqis fin-numru ta' ċelluli ħomor tad-demm fid-demm tiegħek (anemija)
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Delstrigo in one or more subsets of the paediatric population in treatment of human immunodeficiency virus-1 (HIV-1) infection, as per Paediatric Investigation Plans (PIP) decision in the granted indication.
Maltese: L-Aġenzija Ewropea għall-Mediċini ddiferiet l-obbligu li jiġu ppreżentati riżultati tal-istudji b' Delstrigo f'wieħed jew iktar kategoriji tal-popolazzjoni pedjatrika fit-trattament tal-infezzjoni bil-virus 1 tal-immunodefiċjenza umana (HIV-1, human immunodeficiency virus 1), kif imniżżel fid-deċiżjoni tal-Pjanijiet ta' Investigazzjoni Pedjatrika (PIP, Paediatric Investigation Plans), fl-indikazzjoni mogħtija.
English: Autoimmune disorders (such as Graves' disease, autoimmune hepatitis, polymyositis, and GuillainBarré syndrome) have also been reported to occur in the setting of immune reactivation; however, the time to onset is more variable and can occur many months after initiation of treatment.
Maltese: Disturbi awtoimmuni (bħall-marda ta' Graves, epatite awtoimmuni, poljomijosite, u s-sindrome ta' Guillain-Barré) kienu wkoll irrappurtati li jseħħu fl-isfond ta' riattivazzjoni immuni; madankollu, iżżmien għall-bidu tagħhom huwa aktar varjabbli u jista' jseħħ ħafna xhur wara l-bidu tat-trattament.
English: Delstrigo contains doravirine, lamivudine, and tenofovir disoproxil, therefore any interactions identified for these individually are relevant to Delstrigo and are presented in Table 1.
Maltese: Delstrigo fih doravirine, lamivudine, u tenofovir disoproxil għalhekk, kwalunkwe interazzjonijiet identifikati għal dawn b'mod individwali huma rilevanti għal Delstrigo u huma ppreżentati f'Tabella 1.
English: Animal studies with tenofovir disoproxil do not indicate direct or indirect harmful effects of tenofovir disoproxil with respect to reproductive toxicity (see section 5.3).
Maltese: Studji fl-annimali b'tenofovir disoproxil ma jurux effetti ħżiena diretti jew indiretti ta' tenofovir disoproxil rigward l-effett tossiku fuq is-sistema riproduttiva (ara sezzjoni 5.3).
English: The bone toxicity in young adult rats and dogs occurred at exposures ≥ 5-fold the exposure in paediatric or adult patients; bone toxicity occurred in juvenile infected monkeys at very high exposures following subcutaneous dosing (≥ 40-fold the exposure in patients).
Maltese: It-tossiċità fl-għadam f'firien u klieb adulti żgħażagħ seħħet b'esponimenti ≥ 5 drabi aktar mill-esponiment f'pazjenti pedjatriċi jew adulti; tossiċità fl-għadam seħħet f'xadini żgħażagħ infettati b'esponimenti kbar ħafna wara għoti ta' dożi taħt il-ġilda (≥ 40 darba l-epsoniment f'pazjenti).
English: MSD Polska Sp. z o.o.
Maltese: MSD Danmark ApS
English: The pharmacokinetic properties of lamivudine have been determined in subjects with moderate to severe hepatic impairment.
Maltese: Il-kwalitajiet farmakoloġiċi ta' lamivudine ġew determinati f'individwi b'indeboliment minn moderat sa sever tal-fwied.
English: • Periodic Safety Update Reports (PSURs)
Maltese: • Rapporti perjodiċi aġġornati dwar is-sigurtà (PSURs)
English: + T'.
Maltese: Differenza (CI ta'
English: The use of Delstrigo in people aged less than 18 years has not yet been studied.
Maltese: L-użu ta' Delstrigo f'persuni li għandhom inqas minn 18-il sena għadu ma ġiex studjat.
English: Treatment naïve adult subjects
Maltese: Individwi adulti li qatt ma ħadu trattament
English: • hair loss, rash
Maltese: • jaqa' x-xagħar, raxx
English: What Delstrigo is
Maltese: Delstrigo”.
English: Caution should be given to prescribing doravirine with medicinal products that may reduce the exposure of doravirine (see sections 4.3 and 4.5).
Maltese: Għandu jkun hemm attenzjoni meta wieħed jippreskrivi doravirine flimkien ma' prodotti mediċinali li jistgħu jnaqqsu l-epsoniment għal doravirine (ara sezzjonijiet 4.3 u 4.5).
English: HIV-1 isolates with the K65R substitution also showed reduced susceptibility to emtricitabine and lamivudine.
Maltese: Iżolati ta' HIV-1 bis-sostituzzjoni K65R urew ukoll suxxettibbiltà mnaqqsa għal emtricitabine u lamivudine.
English: • nafcillin (a medicine to treat some bacterial infections)
Maltese: • nafcillin (mediċina biex tittratta xi infezzjonijiet bil-batterji)
English: No clinically relevant racial differences in the pharmacokinetics of doravirine have been identified based on a population pharmacokinetic analysis of doravirine in healthy and HIV-1-infected subjects.
Maltese: Ma ġew identifikati l-ebda differenzi rilevanti b'mod kliniku minħabba r-razza fil-farmakokinetika ta' doravirine abbażi ta' analiżi farmakokinetika ta' popolazzjoni ta' doravirine f'individwi f'saħħithom u infettati bl-HIV-1.
English: There is not sufficient clinical evidence to support the use of doravirine in patients infected with HIV-1 with evidence of resistance to the NNRTI class.
Maltese: M'hemmx evidenza klinika suffiċjenti biex tappoġġja l-użu ta' doravirine f'pazjenti infettati bl-HIV-1 b'evidenza ta' reżistenza għall-klassi ta' NNRTI.
English: Subsequently F227(L/C/V) or L234I emerged in addition to V106 substitutions (double mutants yielding a fold change of > 100).
Maltese: Sussegwentement barra mis-sostituzzjoni V106 dehru s-sostituzzjonijiet F227(L/C/V) jew L234I (mutazzjonijiet doppji li jagħtu drabi ta' bidla ta' > 100).
English: • trouble concentrating, memory problems, tingling of hands and feet, stiff muscles, poor quality of sleep
Maltese: • problema biex tikkonċentra, problemi bil-memorja, tnemnim fl-idejn u s-saqajn, muskoli ibsin,
English: The principal mode of action of 3TC-TP is inhibition of RT via DNA chain termination after incorporation of the nucleotide analogue.
Maltese: Il-mekkaniżmu prinċipali ta' azzjoni ta' 3TC-TP huwa inibizzjoni ta' RT permezz ta' terminazzjoni tal-katina tad-DNA wara linkorporazzjoni tal-analogu tan-nucleotide.
English: Acid-Reducing Agents antacid (aluminium and magnesium hydroxide oral suspension) (20 mL SD, doravirine 100 mg SD)
Maltese: Sustanzi li Jnaqqsu l-Aċtu antaċidu (suspensjoni orali ta' aluminium u magnesium hydroxide)
English: No clinically relevant differences in tenofovir pharmacokinetics were observed between subjects with hepatic impairment and healthy subjects.
Maltese: Ma ġew osservati l-ebda differenzi rilevanti b'mod kliniku fil-farmakokinetika ta' tenofovir bejn individwi b'indeboliment tal-fwied u individwi f'saħħithom.
English: Findings in the rat and monkey studies indicated that there was a substance related decrease in intestinal absorption of phosphate with potential secondary reduction in BMD.
Maltese: Sejbiet fl-istudji fil-firien u x-xadini ndikaw li kien hemm tnaqqis marbut mas-sustanza fl-assorbiment ta' phosphate mill-imsaren bil-possibbiltà ta' tnaqqis sekondarju fil-BMD.
English: Doravirine was not genotoxic in a battery of in vitro or in vivo assays.
Maltese: Doravirine ma kienx ġenotossiku f'sensiela ta' assaġġi in vitro jew in vivo.
English: Subjects whose virus expressed an L74V RT substitution without zidovudine resistance-associated substitutions (n = 8) had reduced response to tenofovir disoproxil.
Maltese: Individwi li lvirus tagħhom esprima sostituzzjoni L74V f'RT mingħajr sostituzzjonijiet assoċjati ma' reżistenza għal zidovudine (n = 8) kellhom rispons imnaqqas għal tenofovir disoproxil.
English: Co-administration of doravirine/lamivudine/tenofovir disproxil and medicinal products that are inhibitors of CYP3A may result in increased plasma concentrations of doravirine.
Maltese: L-għoti ta' doravirine/lamivudine/tenofovir disoproxil flimkien ma' prodotti mediċinali li huma inibituri ta' CYP3A jista' jwassal għal żidiet fil-konċentrazzjonijie ta' doravirine fil-plażma.
English: Outcome
Maltese: Parametru
English: If doravirine/ lamivudine/ tenofovir disoproxil is coadministered with rifabutin, a 100 mg dose of doravirine should be taken daily, approximately 12 h after dose of doravirine/lamivudine/tenofovir disoproxil.
Maltese: Jekk doravirine/lamivudine/tenofovir disoproxil jingħata flimkien ma' rifabutin, doża ta' 100 mg ta' doravirine għandha tittieħed kuljum, madwar 12-il siegħa wara d-doża ta' doravirine/lamivudine/tenofovir disoproxil.
English: Approximately 71 % of an intravenous dose of lamivudine is recovered as unchanged medicinal product in the urine.
Maltese: Madwar 71 % ta' doża ta' lamivudine fil-vini tiġi rkuprata bħala prodott mediċinali mhux mibdul fl-awrina.
English: Patients receiving doravirine/lamivudine/tenofovir disoproxil concomitantly with sofosbuvir/velpatasvir should be monitored for adverse reactions associated with tenofovir disoproxil.
Maltese: Minħabba l-komponent tenofovir disoproxil f'doravirine/lamivudine/tenofovir disoproxil, l-użu talprodott għandu jiġi evitat mal-użu fl-istess waqt jew riċenti ta' prodotti mediċinali nefrotossiċi.
English: • medicines (usually liquids) containing sorbitol and other sugar alcohols (such as xylitol,
Maltese: • mediċini (normalment likwidi) li fihom sorbitol u alkoħol taz-zokkor ieħor (bħal xylitol,mannitol, lactitol jew maltitol), jekk jittieħdu b'mod regolari
English: Delstrigo is used to treat HIV infection in people 18 years of age and older.
Maltese: Delstrigo jintuża għat-trattament ta' infezzjoni tal-HIV f'persuni li għandhom 18-il sena u aktar.
English: Doravirine-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 doravirine ntgħażlu f'koltura ta' ċelluli li bdiet minn HIV-1 li jinsab fin-natura minn oriġini u ta' sottotipi differenti, kif ukoll HIV-1 reżistenti għal NNRTI.
English: Successful genotype, n Genotypic resistance to DOR or control (DRV or EFV) 2 (DOR)
Maltese: DOR jew kontroll (DRV jew EFV)
English: Doravirine pharmacokinetics are similar in healthy subjects and HIV-1-infected subjects.
Maltese: Il-farmakokinetika ta' doravirine ġiet studjata f'individwi f'saħħithom u f'individwi infettati bl-HIV-1.