FrancophonIA/ELRC3.0 huggingface dataset:
English: At baseline, the median age of subjects was 31 years (range 18-70 years), 85 % were male, 52 % were non-white, 3 % had hepatitis B or C co-infection, 14 % had a history of AIDS, 21 % had HIV-1 RNA > 100,000 copies per mL, and 12 % had CD4
Maltese: Fil-linja bażi, l-età medjana tal-individwi kienet ta' 31 sena (firxa 18-70 sena), 85 % kienu rġiel, 52 % ma kinux bojod, 3% kellhom infezzjoni tal-epatite B jew Ċ fl-istess waqt, 14 % kellhom storja ta' AIDS, 21 % kellhom RNA ta' HIV-1 > 100,000 kopja f'kull mL, u 12% kellhom għadd ta' ċelluli T CD4+ < 200 ċellula f'kull mm3; dawn il-karatteristiċi kienu jixxiebhu bejn il-gruppi ta' trattament.
English: If co-administration with other moderate CYP3A inducers (e.g., dabrafenib, lesinurad, bosentan, thioridazine, nafcillin, modafinil, telotristat ethyl) cannot be avoided, one 100 mg tablet of doravirine should be taken daily, approximately 12 hours after the dose of Delstrigo (see section 4.5).
Maltese: Jekk l-għoti flimkien ma' indutturi moderati oħra ta' CYP3A (eż., dabrafenib, lesinurad, bosentan, thioridazine, nafcillin, modafinil, telotristat ethyl) ma jistax jiġi evitat, pillola waħda ta' 100 mg ta' doravirine għandha tittieħed kuljum, madwar 12-il siegħa wara d-doża ta' Delstrigo (ara sezzjoni 4.5).
English: In in vitro studies, doravirine was able to suppress the following NNRTI-associated substitutions; K103N, Y181C, and G190A under clinically relevant concentrations.
Maltese: Fi studji in vitro, doravirine kien kapaċi jissoppressa s-sostituzzjonijiet assoċjati ma' NNRTI li ġejjin; il-mutanti K103N, Y181C, u G190A f'konċentrazzjonijiet rilevanti b'mod kliniku.
English: Delstrigo should be avoided with concurrent or recent use of nephrotoxic medicinal products (e.g., high-dose or multiple nonsteroidal anti-inflammatory medicinal products [NSAIDs]) (see section 4.5).
Maltese: Delstrigo għandu jiġi evitat ma' prodotti mediċinali nefrotossiċi mogħtija fl-istess ħin jew użati riċentement (eż., numru jew dożi kbar ta' prodotti mediċinali antiinfjammatorji mhux sterojdi [NSAIDs, nonsteroidal anti-inflammatory drugs]) (ara sezzjoni 4.5).
English: Of the 7 subjects who developed high level doravirine resistance in the pivotal studies, 6 had phenotypic resistance to EFV and nevirapine, 3 to rilpivirine, and 2 had partial resistance to etravirine based on the Monogram Phenosense assay.
Maltese: Mis-7 individwi li żviluppaw reżistenza ta' livell għoli għal doravirine fl-istudji pivitali, 6 kellhom reżistenza fenotipika għal EFV u nevirapine, 3 għal rilpivirine, u 2 kellhom reżistenza parzjali għal etravirine abbażi tal-assaġġ Monogram Phenosense.
English: Week 48 and 96 outcomes for DRIVE-FORWARD and DRIVE-AHEAD are provided in Table 4.
Maltese: Riżultati għal Ġimgħa 48 u 96 għal DRIVE-FORWARD u DRIVE-AHEAD huma pprovduti f'Tabella 4.
English: The antiviral activity of doravirine was not antagonistic when combined with lamivudine and tenofovir disoproxil.
Maltese: L-attività antivirali ta' doravirine ma kinitx antagonistika meta ġie kombinat ma' lamivudine u tenofovir disoproxil.
English: NNRTI-associated mutations detected at screening were part of exclusion criteria in the Phase 2b/3-studies.
Maltese: Mutazzjonijiet assoċjati ma' NNRTI osservati waqt screening kienu parti mill-kriterji ta' esklużjoni fl-istudji ta' Fażi 2b/3.
English: In humans, the only known metabolite is the trans-sulphoxide metabolite (approximately 5 % of an oral dose after 12 hours).
Maltese: Fil-bniedem, l-uniku metabolit magħruf huwa l-metabolit trans-sulphoxide (madwar 5 % ta' doża orali wara 12-il siegħa).
English:  metformin AUC 0.94 (0.88, 1.00) Cmax 0.94 (0.86, 1.03)
Maltese: AUC 0.94 (0.88, 1.00) Cmax 0.94 (0.86, 1.03)
English: Information regarding potential medicinal product interactions with other antiretroviral medicines is not provided.
Maltese: Information dwar interazzjonijiet possibbli ta' prodotti mediċinali ma' mediċini antiretrovirali oħra mhijiex provduta.
English: Hepatitis C Antiviral Agents elbasvir + grazoprevir (50 mg elbasvir QD + 200 mg grazoprevir QD, doravirine 100 mg QD)
Maltese: Rakkomandazzjoni Dwar lGħoti Flimkien ma' doravirine/lamivudine/tenofo vir disoproxil elbasvir + grazoprevir (50 mg elbasvir QD + 200 mg grazoprevir QD, doravirine 100 mg QD)
English: Antiviral activity in cell culture
Maltese: Attività antivirali f'koltura ta' ċelluli
English: Subjects must have been virologically suppressed (HIV-1 RNA < 40 copies/mL) on their baseline regimen for at least 6 months prior to trial entry, with no history of virologic failure, and a documented absence of RT substitutions conferring resistance to doravirine, lamivudine and tenofovir (see section, Resistance).
Maltese: L-individwi riedu jkunu soppressi b'mod viroloġiku (RNA ta' HIV-1 < 40 kopja/mL) bl-iskeda ta' trattament tagħhom tal-linja bażi għal mill-inqas 6 xhur qabel ma ddaħħlu fl-istudju, mingħajr l-ebda storja ta' falliment viroloġiku, u nuqqas dokumentat ta' sostituzzjonijiet f'RT li jagħtu reżistenza għal doravirine, lamivudine u tenofovir (ara s-sezzjoni, Reżistenza).
English: What Delstrigo looks like and contents of the pack Delstrigo is available as a yellow, oval-shaped, film-coated tablet, and is debossed with the corporate logo and 776 on one side and plain on the other side.
Maltese: Delstrigo huwa disponibbli bħala pillola safra, ta' għamla ovali, miksija b'rita, u hija mnaqqxa billowgow tal-kumpanija u 776 fuq naħa waħda u bla marki fuq in-naħa l-oħra.
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, lamivudine, and tenofovir.
Maltese: Barra dan, sostituzzjoni K70E f'RT ta' HIV-1 intgħażlet minn tenofovir u twassal għal suxxettibiltà mnaqqsa ta' livell baxx għal abacavir, emtricitabine, lamivudine, u tenofovir.
English: Doravirine has not been evaluated in patients with previous virologic failure to any other antiretroviral therapy.
Maltese: Doravirine ma ġiex evalwat f'pazjenti b'falliment viroloġiku preċedenti għal xi terapija antiretrovirali oħra.
English: The K65R substitution in HIV-1 RT selected by tenofovir is also selected in some HIV-1 infected patients treated with abacavir or didanosine.
Maltese: Is-sostituzzjoni K65R f'RT ta' HIV-1 magħżula minn tenofovir tiġi wkoll magħżula f'xi pazjenti infettati b'HIV-1 ittrattati b'abacavir jew didanosine.
English: Although a limited number of subjects aged 65 years and over has been included (n = 36), no clinically relevant differences in the pharmacokinetics of doravirine have been identified in subjects at least 65 years of age compared to subjects less than 65 years of age in a Phase 1 trial or in a population pharmacokinetic analysis.
Maltese: Għakemm ġie inkluż numru limitat ta' individwi li kellhom 65 sena jew aktar (n = 36), ma ġew identifikati l-ebda differenzi rilevanti b'mod kliniku fil-farmakokinetika ta' doravirine f'individwi li kellhom mill-inqas 65 sena meta mqabbla ma' individwi li kellhom inqas minn 65 sena fi prova ta' Fażi 1 jew f'analiżi farmakokinetika ta' popolazzjoni.
English: Patients should be informed that fatigue, dizziness, and somnolence have been reported during treatment with Delstrigo (see section 4.8).
Maltese: Il-pazjenti għandhom jiġu infurmati li għeja, sturdament, u ħedla ta' ngħas ġew irrappurtati waqt it-trattament b'Delstrigo (ara sezzjoni 4.8).
English: Following a single 245 mg dose of tenofovir disoproxil, a 4-hour hemodialysis session removed approximately 10 % of the administered tenofovir dose.
Maltese: Wara doża waħda ta' 245 mg ta' tenofovir disoproxil, sessjoni ta' 4 sigħat ta' emodijalisi neħħiet madwar 10 % tad-doża mogħtija ta' tenofovir.
English: Expected:  doravirine (Induction of CYP3A)
Maltese: ↓ doravirine (Induzzjoni ta' CYP3A)
English: Uncommon disturbance in attention, memory impairment, paraesthesia, hypertonia, poor quality sleep
Maltese: Mhux komuni disturb fl-attenzjoni, indeboliment tal-memorja, parestesija, ipertonja, irqad ta' kwalità ħażina
English: The pharmacokinetics of lamivudine and tenofovir have not been studied in subjects older than 65 years.
Maltese: Il-farmakokinetika ta' lamivudine u tenofovir ma ġietx studjata f'individwi akbar minn 65 sena.
English: Doravirine/lamivudine/tenofovir disoproxil must not be co-administered with other medicinal products containing lamivudine, or with medicinal products containing tenofovir disoproxil, or tenofovir alafenamide, or with adefovir dipivoxil (see section 4.5).
Maltese: Doravirine/lamivudine/tenofovir disoproxil m'għandux jingħata flimkien ma' prodotti mediċinali oħra li fihom lamivudine, jew ma' prodotti mediċinali li fihom tenofovir disoproxil, jew tenofovir alafenamide, jew ma' adefovir dipivoxil (ara sezzjoni 4.5).
English: In the DRIVE-SHIFT clinical trial, no subjects developed genotypic or phenotypic resistance to DOR, 3TC, or TDF during the initial 48 weeks (immediate switch, N=447) or 24 weeks (delayed switch, N=209) of treatment with Delstrigo.
Maltese: Fil-prova klinika DRIVE-SHIFT, l-ebda individwu ma żviluppa reżistenza ġenotipika jew fenotipika għal DOR, 3TC, jew TDF matul l-ewwel 48 ġimgħa (bidla immedjata, N=447) jew 24 ġimgħa (bidla ttradjata, N=209) ta' trattament b'Delstrigo.
English: • increased levels of creatine phosphokinase
Maltese: • żieda fil-livelli tal-creatine phosphokinase
English: Doravirine has not been studied in patients with severe hepatic impairment (Child-Pugh Class C).
Maltese: Doravirine ma ġiex studjat f'pazjenti b'indeboliment sever tal-fwied (Klassi Ċ ta' Child-Pugh).
English: In clinical trials in HIV-1 infected adults, tenofovir disoproxil was associated with slightly greater decreases in bone mineral density (BMD) and increases in biochemical markers of bone metabolism, suggesting increased bone turnover relative to comparators.
Maltese: Fi provi kliniċi f'adulti infettati bl-HIV-1, tenofovir disoproxil kien assoċjat ma' tnaqqis kemxejn akbar fid-densità minerali tal-għadam (BMD, bone mineral density) u żidiet fil-markaturi bijokimiċi tal-metaboliżmu tal-għadam, li jissuġġerixxu żieda fir-rata tal-bdil tal-għadam meta mqabbel malkumparaturi.
English: The efficacy of switching from a baseline regimen consisting of two nucleoside reverse transcriptase inhibitors in combination with a ritonavir- or cobicistat-boosted PI, or cobicistat-boosted elvitegravir, or an NNRTI to Delstrigo was evaluated in a randomized, open-label trial (DRIVE-SHIFT), in virologically suppressed HIV-1 infected adults.
Maltese: L-effikaċja ta' bidla minn skeda ta' trattament tal-linja bażi li jikkonsisti f'żewġ inibituri ta' nucleoside reverse transcriptase flimkien ma' PI imsaħħaħ b'ritonavir jew cobicistat, jew elvitegravir imsaħħaħ b'cobicistat, jew NNRTI għal Delstrigo ġiet evalwata fi prova arbitrarja, fejn kemm l-investigaturi kif ukoll l-individwi kienu jafu liema sustanza qed tintuża (DRIVE-SHIFT), f'individwi adulti infettati b'HIV-1 soppressi b'mod viroloġiku.
English: Interaction not studied with doravirine or doravirine/lamivudine/tenofovir disoproxil.
Maltese: L-interazzjoni ma ġietx studjata ma' doravirine jew doravirine/lamivudine/tenofovir disoproxil.
English: In HIV-infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic infections may arise.
Maltese: F'pazjenti infettati bl-HIV b'defiċjenza immuni serja fiż-żmien tal-bidu ta' terapija antiretrovirali ikkombinata (CART, combination antiretroviral therapy), tista' sseħħ reazzjoni infjammatorja għal infezzjonijiet opportunistiċi asintomatiċi jew residwi.
English: Serum parathyroid hormone levels and 1,25 Vitamin D levels were also higher in subjects receiving tenofovir disoproxil.
Maltese: Il-livelli tal-ormon tal-paratirojde fis-serum u l-livelli tal-Vitamina D 1,25 ukoll kienu ogħla f'individwi li kienu qed jirċievu tenofovir disoproxil.
English: Package leaflet: Information for the user Delstrigo 100 mg/300 mg/245 mg film-coated tablets doravirine/ lamivudine/ tenofovir disoproxil
Maltese: Informazzjoni għall-utent Delstrigo 100 mg/300 mg/245 mg pilloli miksija b'rita doravirine/ lamivudine/ tenofovir disoproxil
English: • if you are taking any of the following medicines: - carbamazepine, oxcarbazepine, phenobarbital, phenytoin (medicines for seizure) - rifampicin, rifapentine (medicines for tuberculosis) - St. John's wort (Hypericum perforatum, a herbal remedy used for depression and anxiety) or products that contain it - mitotane (a medicine to treat cancer) - enzalutamide (a medicine to treat prostate cancer) - lumacaftor (a medicine to treat cystic fibrosis)
Maltese: • inti qed tieħu xi waħda minn dawn il-mediċini li ġejjin: - carbamazepine, oxcarbazepine, phenobarbital, phenytoin (mediċini għall-aċċessjonijiet) - rifampicin, rifapentine (mediċini għat-tuberkulożi)
English: Treatment emergent doravirine resistance associated substitutions may confer cross-resistance to efavirenz, rilpivirine, nevirapine, and etravirine.
Maltese: Sostituzzjonijiet assoċjati ma' reżistenza għal doravirine li jfeġġu minħabba t-trattament jistgħu jagħtu reżistenza inkroċjata għal efavirenz, rilpivirine, nevirapine, u etravirine.
English: Each film-coated tablet contains 100 mg of doravirine, 300 mg of lamivudine, and 300 mg of tenofovir disoproxil fumarate equivalent to 245 mg of tenofovir disoproxil.
Maltese: Kull pillola miksija b'rita fiha 100 mg ta' doravirine, 300 mg ta' lamivudine, u 300 mg ta' tenofovir disoproxil fumarate ekwivalenti għal 245 mg ta' tenofovir disoproxil.
English: Baseline Regimen DSG
Maltese: Skeda ta' Trattament talLinja Bażi DSG
English: The pharmacokinetics of tenofovir following a 245 mg dose of tenofovir disoproxil have been studied in healthy subjects with moderate to severe hepatic impairment.
Maltese: Il-farmakokinetika ta' tenofovir wara doża ta' 245 mg ta' tenofovir disoproxil ġiet studjata f'individwi f'saħħithom b'indeboliment minn moderat sa sever tal-fwied.
English: There was no clinically relevant difference in the pharmacokinetics of doravirine in a study comparing 8 subjects with moderate hepatic impairment (classified as Child-Pugh score B primarily due to increased encephalopathy and ascites scores) to 8 subjects without hepatic impairment.
Maltese: M'hemm l-ebda differenza rilevanti b'mod kliniku fil-farmakokinetika ta' doravirine fi studju li qabbel 8 individwi b'indeboliment moderat tal-fwied (ikklassifikat bħala punteġġ B ta' Child-Pugh l-aktar minħabba żieda fil-punteġġi ta' enċefalopatija u axxite) ma' 8 individwi mingħajr indeboliment tal-fwied.
English: CLINICAL PARTICULARS
Maltese: Esperjenza klinika
English: Lamivudine was mutagenic in an L5178Y mouse lymphoma assay and clastogenic in a cytogenetic assay using cultured human lymphocytes.
Maltese: Lamivudine kien mutaġeniku f'assaġġ L5178Y ta' limfoma fil-ġurdien u klastoġeniku f'assaġġ ċitoġenetiku bl-użu ta' koltura ta' limfoċiti tal-bniedem.
English: • lesinurad (a medicine to treat gout)
Maltese: • lesinurad (mediċina biex tittratta l-gotta)
English: Because tenofovir 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 via OAT1, OAT3 or MRP4 may increase serum concentrations of tenofovir.
Maltese: Minħabba li tenofovir 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 għal sekrezzjoni attiva mit-tubuli permezz ta' OAT1, OAT3 jew MRP4 jista' jkun li jżid il-konċentrazzjonijiet ta' tenofovir fis-serum.
English: As a precautionary measure, it is preferable to avoid the use of Delstrigo during pregnancy.
Maltese: Bħala prekawzjoni, hu preferribli li jiġi evitat l-użu ta' Delstrigo waqt it-tqala.
English: Doravirine at a dose of 100 mg once daily is not likely to have a clinically relevant effect on the plasma concentrations of medicinal products that are dependent on transport proteins for absorption and/or elimination or that are metabolised by CYP enzymes.
Maltese: Doravirine bid-doża ta' 100 mg darba kuljum mhux probabbli li jkollu effett rilevanti b'mod kliniku fuq il-konċentrazzjonijiet fil-plażma ta' prodotti mediċinali li huma dipendenti fuq il-proteini tattrasport għall-assorbiment u/jew l-eliminazzjoni jew li huma metabolizzati mill-enzimi CYP.
English: Antipsychotics thioridazine
Maltese: Antipsikotiċi
English: • increasing the number of white blood cells called ‘CD4
Maltese: • iżid in-numru ta' ċelluli bojod imsejħa ‘CD4+ T' fid-demm.
English: Delstrigo should not be initiated in patients with estimated CrCl < 50 mL/min (see sections 4.4 and 5.2).
Maltese: Delstrigo m'għandux jinbeda f'pazjenti b'CrCl stmata li hija < 50 mL/min (ara sezzjonijiet 4.4 u 5.2).
English: Expected:  doravirine (Inhibition of CYP3A due to ritonavir)
Maltese: ↑ doravirine (Inibizzjoni ta' CYP3A minħabba ritonavir)
English: Renal impairment, including cases of acute renal failure and Fanconi syndrome (renal tubular injury with severe hypophosphataemia), has been reported with the use of tenofovir disoproxil, a component of Delstrigo.
Maltese: Indeboliment ġdid jew li jmur għall-agħar tal-kliewi Indeboliment tal-kliewi, inklużi każijiet ta' insuffiċjenza akuta tal-kliewi u sindrome ta' Fanconi (ħsara fit-tubuli tal-kliewi b'ipofosfatemija severa), ġie rrappurtat bl-użu ta' tenofovir disoproxil, komponent ta' Delstrigo.
English: • bosentan (a medicine to treat lung disease)
Maltese: • bosentan (mediċina biex tittratta mard fil-pulmun)
English: Proportion (%) of Subjects With HIV-1 RNA < 40 copies/mL by Baseline CD4
Maltese: Proporzjon (%) ta' Individwi b'RNA ta' HIV-1 < 40 kopja/mL skont l-Għadd ta' Ċelluli T CD4+ filLinja Bażi (ċelluli/mm3)
English: HIV Antiviral Agents tenofovir disoproxil (300 mg QD, doravirine 100 mg SD)
Maltese: tenofovir disoproxil (300 mg QD, doravirine 100 mg SD)
English: Based on the results of in vitro experiments and the known elimination pathway of tenofovir, the potential for CYP-mediated interactions involving tenofovir with other medicinal products is low.
Maltese: Abbażi tar-riżultati ta' esperimenti in vitro u s-sensiela ta' reazzjonijiet magħrufa għall-eliminazzjoni ta' tenofovir, il-possibbiltà ta' interazzjonijiet medjati minn CYP li jinvolvu tenofovir ma' prodotti mediċinali oħra hija baxxa.
English: At baseline, the median age of subjects was 33 years (range 18 to 69 years), 86 % had CD4
Maltese: Fil-linja bażi, l-età medjana tal-individwi kienet ta' 33 sena (firxa 18 sa 69 sena), 86%
English: Co-administration with the moderate CYP3A inducer rifabutin decreased doravirine concentrations (see Table 1).
Maltese: L-għoti flimkien mal-induttur moderat ta' CYP3A rifabutin naqqas il-konċentrazzjonijiet ta' doravirine (ara Tabella 1).
English: Infections and infestations Rare rash pustular
Maltese: Infezzjonijiet u infestazzjonijiet Rari raxx bl-imsiemer
English: In patients at risk of renal dysfunction, including patients who have previously experienced renal events while receiving adefovir dipivoxil, it is recommended that estimated CrCl, serum phosphorus, urine glucose, and urine protein be assessed prior to initiation of Delstrigo and more frequent renal function monitoring should be assessed as appropriate per the patient's medical condition during Delstrigo therapy.
Maltese: F'pazjenti b'riskju ta' funzjoni ħażina talkliewi, inklużi pazjenti li kellhom avvenimenti renali qabel waqt li kienu qed jirċievu adefovir dipivoxil, huwa rakkomandat li l-CrCl stmata, il-phosphorus fis-serum, il-glucose fl-awrina, u lproteina fl-awrina jiġu stmati qabel il-bidu ta' Delstrigo u għandu jiġi stmat il-monitoraġġ aktar frekwenti tal-funzjoni tal-kliewi skont kif ikun xieraq għall-kundizzjoni medika tal-pazjent waqt itterapija b'Delstrigo.
English: Pharmacokinetic parameters were not altered by diminishing hepatic function.
Maltese: Il-parametri farmakokinetiċi ma nbidlux b'funzjoni tal-fwied li kienet qed tonqos.
English: In some subjects treated with zidovudine plus didanosine, isolates resistant to multiple RT inhibitors, including lamivudine, have emerged.
Maltese: F'xi individwi ttrattati b'zidovudine flimkien ma' didanosine, feġġew iżolati reżistenti għal ħafna inibituri ta' RT, inkluż lamivudine.
English: daclatasvir
Maltese: dasabuvir
English: Each film-coated tablet contains100 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:  ethinyl oestradiol AUC 0.98 (0.94, 1.03) Cmax 0.83 (0.80, 0.87)
Maltese: AUC 0.98 (0.94, 1.03) Cmax 0.83 (0.80, 0.87)
English: Single dose rifampicin (600 mg SD, doravirine 100 mg SD)
Maltese: Doża waħda ta' rifampicin (600 mg SD, doravirine 100 mg SD)
English: Oral use.
Maltese: rispettivament.
English: insomnia includes: insomnia, initial insomnia and sleep disorder depression includes: depression, depressed mood, major depression, and persistent depressive disorder anxiety includes: anxiety and generalised anxiety disorder abdominal pain includes: abdominal pain, and abdominal pain upper abdominal discomfort includes: abdominal discomfort, and epigastric discomfort faeces soft includes: faeces soft and abnormal faeces.
Maltese: 1insomnja tinkludi: insomnja, insomnja fil-bidu tal-irqad u disturb fl-irqad 2depressjoni tinkludi: depressjoni, burdata depressa, depressjoni maġġuri, u disturb depressiv persistenti 3ansjetà tinkludi: ansjetà u disturb ta' ansjetà ġenerali
English: Lamivudine has been identified in breast-fed newborns/infants of treated women.
Maltese: Lamivudine ġie identifikat fi trabi tat-twelid/trabi mreddgħin minn nisa ttrattati.
English: Delstrigo tablets contains lactose
Maltese: Il-pilloli Delstrigo fihom lactose
English: None of the 24 subjects (11 in the immediate switch group, 13 in the delayed switch group) with baseline NNRTI mutations (RT K103N, G190A, or Y181C) experienced virologic failure through Week 48, or at time of discontinuation.
Maltese: L-ebda wieħed mill-24 individwu (11 fil-grupp ta' bidla immedjata, 13 fil-grupp ta' bidla ttradjata) b'mutazzjonijiet (K103N, G190A, jew Y181C f'RT) għal NNRTI fil-linja bażi ma' kellu falliment viroloġiku sa Ġimgħa 48, jew fiż-żmien meta twaqqaf it-trattament.
English: Subjects were randomized to either switch to Delstrigo at baseline [N= 447, Immediate Switch Group (ISG)], or stay on their baseline regimen until Week 24, at which point they switched to Delstrigo [N= 223, Delayed Switch Group (DSG)].
Maltese: L-individwi ntagħżlu b'mod arbitrarju biex jew jaqilbu għal Delstrigo fil-linja bażi [N= 447, Grupp b'Bidla Immedjata (ISG, Immediate Switch Group)], jew jibqgħu fuq l-iskeda ta' trattament tagħhom tal-linja bażi sa Ġimgħa 24, meta qalbu għal Delstrigo [N= 223, Grupp b'Bidla Ttardjata (DSG, Delayed Switch Group)].
English: Recommendation Concerning Co-administration with doravirine/lamivudine/tenofo vir disoproxil ledipasvir + sofosbuvir (90 mg ledipasvir SD + 400 mg sofosbuvir SD, doravirine 100 mg SD)
Maltese: ledipasvir + sofosbuvir (90 mg ledipasvir SD + 400 mg sofosbuvir SD, doravirine 100 mg SD)
English: This can happen when you start taking any HIV medicine, including Delstrigo.
Maltese: Dan jista' jiġri meta inti tibda tieħu kwalunkwe mediċina tal-HIV, inkluż Delstrigo.
English: • increased levels in liver enzymes (AST)
Maltese: • żieda fil-livelli tal-enzimi tal-fwied (AST)
English: Bone toxicity was diagnosed as osteomalacia (monkeys) and reduced bone mineral density (BMD) (rats and dogs).
Maltese: Tossiċità fl-għadam ġiet dijanjostikata bħala osjomalaċja (xadini) u tnaqqis fid-densità talminerali tal-għadam (BMD, bone mineral density) (firien u klieb).
English: • rifabutin (a medicine to treat some bacterial infections such as tuberculosis)
Maltese: • rifabutin (mediċina biex tittratta xi infezzjonijiet bil-batterji bħat-tuberkulożi)
English: Antiretroviral pregnancy registry
Maltese: Reġistru ta' antiretrovirali fit-tqala