FrancophonIA/ELRC3.0 huggingface dataset:
English: In 100% human serum, the mean fold shift for dolutegravir activity was 75-fold, resulting in protein adjusted IC90 of 0.064 ug/mL.
Maltese: F'serum tal-bnedmin 100%, il-bidla medja fil-valur għall-attività ta' dolutegravir kienet ta' 75 darba, u dan irriżulta f'IC90 aġġustat għall-proteina ta' 0.064 ug/mL.
English: Primary mutations for raltegravir/elvitegravir (Q148H/R/K, N155H, Y143R/H/C, E92Q, T66I) do not affect the in vitro susceptibility of dolutegravir as single mutations.
Maltese: Il-mutazzjonijiet primarji għal raltegravir/elvitegravir (Q148H/R/K, N155H, Y143R/H/C, E92Q,
English: In vitro, dolutegravir was not a substrate of human OATP 1B1, OATP 1B3 or OCT 1.
Maltese: In vitro, dolutegravir ma kienx sottostrat ta' OATP 1B1, OATP 1B3 jew OCT 1 tal-bniedem.
English: Immune system disorders: Common hypersensitivity (see section 4.4)
Maltese: Komuni sensittività eċċessiva (ara sezzjoni 4.4)
English: In vitro, abacavir was an inhibitor of MATE1; the clinical consequences are not known.
Maltese: In vitro, abacavir kien inibitur ta' MATE1; il-konsegwenzi kliniċi mhumiex magħrufa.
English: Very rarely cases of erythema multiforme, Stevens-Johnson syndrome or toxic epidermal necrolysis have been reported where abacavir hypersensitivity could not be ruled out.
Maltese: Ġew irrapportati każijiet rari ħafna ta' eritema multiforme, sindromu ta' Stevens-Johnson jew nekrolisi epidermali tossika fejn ma setgħetx tiġi eskluża sensittività eċċessiva għal abacavir.
English: • phenytoin and phenobarbital, to treat epilepsy
Maltese: • fenitojin u fenobarbitu, għat-trattament ta' epilessija
English: 28 days
Maltese: 14-il jum)
English: Abacavir was not significantly metabolised by CYP enzymes.
Maltese: Abacavir ma ġiex metabolizzat b'mod sinifikanti minn enzimi CYP.
English: In vivo, a 10-14% decrease of creatinine clearance (secretory fraction is dependent on OCT2 and MATE-1 transport) was observed in patients.
Maltese: In vivo, kien osservat tnaqqis ta' 10-14% ta' tneħħija tal-kreatinina (frazzjoni tas-sekretorji hija dipendenti fuq it-trasport ta' OCT2 u
English: GI intolerance in monkeys occurred at 30 times the human mg/kg equivalent dose (based on 50 kg human), and 11 times the human mg/m2 equivalent dose for a total daily clinical dose of 50 mg.
Maltese: Intolleranza GI fix-xadini seħħet fi 30 darba d-doża ekwivalenti mg/kg tal-bniedem (abbażi ta' 50 kg tal-bniedem ), u 11-il darba d-doża ekwivalenti mg/m2 tal-bniedem għal doża klinika ta' kuljum totali ta' 50 mg.
English: Moderate amount of data (more than 600 outcomes from first trimester) indicates no malformative toxicity for abacavir.
Maltese: Ammont moderat ta' dejta (aktar minn 600 eżitu mill-ewwel trimestru) ma jindika ebda tossiċità malformattiva għal abacavir.
English: 48 weeks DTG 50 mg + ABC/3TC once daily N=414
Maltese: DTG 50 mg + ABC/3TC darba kuljum N=414
English: NAME OF THE MEDICINAL PRODUCT Triumeq 50 mg/600 mg/300 mg tablets dolutegravir/abacavir/lamivudine
Maltese: Triumeq 50 mg/600 mg/300 mg pilloli dolutegravir/abacavir/lamivudine
English: Using strain NL432 mutations E92Q (fold change 3) and G193E (fold change 3) were selected.
Maltese: Permezz tar-razza NL432 intgħażlu l-mutazzjonijiet E92Q (bidla fil-valur ta' 3 darbiet) u G193E (bidla fil-valur ta' 3 darbiet).
English: In previously untreated patients receiving dolutegravir + 2 NRTIs in Phase IIb and Phase III, no development of resistance to the integrase class, or to the NRTI class was seen (n=876, follow-up of 48-96 weeks).
Maltese: F'pazjenti mhux ikkurati qabel li jirċievu dolutegravir + 2 NRTIs fil-Fażi IIb u l-Fażi III, ma ntwera lebda żvilupp għal reżistenza għal klassi ta' integrase, jew għall-klassi NRTI (n=876, segwitu ta' 4896 ġimgħa).
English: Abacavir is metabolised by UGT (UGT2B7) and alcohol dehydrogenase; co-administration of inducers (e.g. rifampicin, carbamazepine and phenytoin) or inhibitors (e.g. valproic acid) of UGT enzymes or with compounds eliminated through alcohol dehydrogenase could alter abacavir exposure.
Maltese: Abacavir huwa metabolizzat minn UGT (UGT2B7) u dehydrogenase tal-alkoħol; l-għoti flimkien ta' indutturi (eż. rifampicin, carbamazepine u phenytoin) jew inibituri (eż. valproic acid) tal-enzimi ta' UGT jew b'sustanzi komposti permezz ta' dehydrogenase tal-alkoħol jista' jibdel l-esponiment għal abacavir.
English: The observed lamivudine half-life of elimination is 5 to 7 hours.
Maltese: Il-half-life ta' eliminazzjoni osservata ta' lamivudine hija 5 sa 7 sigħat.
English: A study of the pharmacokinetics of dolutegravir was performed in subjects with severe renal impairment (CLcr <30 mL/min).
Maltese: Twettaq studju tal-farmakokinetika ta' dolutegravir f'individwi b'indeboliment renali sever (CLcr <30 mL/min).
English: The combination of abacavir and lamivudine has demonstrated antiviral activity in cell culture against non-subtype B isolates and HIV-2 isolates with equivalent antiviral activity as for subtype B isolates.
Maltese: Il-kombinazzjoni ta' abacavir u lamivudine wriet attività antivirali fil-kultura taċ-ċelloli kontra iżolati mhux tas-sottotip B u l-iżolati tal-HIV-2 b'attività antivirali ekwivalenti bħall-iżolati tas-sottotip B.
English: The R263K mutation was also selected in vitro (see above).
Maltese: Il-mutazzjoni R263K kienet ukoll magħżula in vitro (ara hawn fuq).
English: Multipacks containing 90 (3 packs of 30) film-coated tablets.
Maltese: Pakketti multipli li fihom 90 (3 pakketti ta' 30) pillola miksijin b'rita.
English: Pharmacokinetic/pharmacodynamic relationship(s)
Maltese: Relazzjoni(jiet) farmokokinetika/farmakodinamika
English: Other possible side effects of combination therapy for HIV
Maltese: terapija kombinata għal HIV'.
English: Dolutegravir has a <10-fold change against 94% of the 705 clinical isolates.
Maltese: Dolutegravir għandu bidla fil-valur ta' <10 darbiet meta mqabbel ma' 94% tas-705 iżolat kliniku.
English: Triumeq is not recommended in patients with moderate to severe hepatic impairment (see sections 4.2 and 5.2).
Maltese: Triumeq mhuwiex irrakkomandat f'pazjenti b'indeboliment epatiku moderat sa sever (ara sezzjonijiet 4.2 u 5.2).
English: Co-administration of Triumeq and other medicinal products that inhibit UGT1A1, UGT1A3, UGT1A9, CYP3A4, and/or P-gp may therefore increase dolutegravir plasma concentration.
Maltese: L-għoti flimkien ta' Triumeq u prodotti mediċinali oħra li jinibixxu UGT1A1, UGT1A3, UGT1A9, CYP3A4, u/jew P-gp jista' għalhekk iżid il-konċetrazzjoni fil-plażma ta' dolutegravir.
English: The unbound fraction of dolutegravir in plasma is increased at low levels of serum albumin (<35 g/L) as seen in subjects with moderate hepatic impairment.
Maltese: Il-frazzjoni mhux marbuta ta' dolutegravir filplażma tiżdied f'livelli baxxi ta' albumin fis-serum (<35 g/L) kif jidher f'individwi b'indeboliment epatiku moderat.
English: Other signs and symptoms that have been observed as part of abacavir HSR are described in detail in section 4.8 (Description of selected adverse reactions), including respiratory and gastrointestinal symptoms.
Maltese: Sinjali u sintomi oħra li ġew osservati bħala parti minn HSR b'abacavir huma deskritti fid-dettall fis-sezzjoni 4.8 (Deskrizzjoni ta' reazzjonijiet avversi magħżula), inkluż sintomi respiratorji u gastrointestinali.
English: This is not considered clinically significant (see Absorption).
Maltese: Dan mhuwiex ikkunsidrat klinikament sinifikanti (ara Assorbiment).
English: Antiretroviral medicinal products Non-nucleoside reverse transcriptase inhibitors Etravirine without boosted protease inhibitors /
Maltese: Inibituri non-nucleotide reverse transcriptase
English: The adjusted difference in proportion and 95% CI [ABC/DTG/3TC vs current ART] were 3.4%; 95% CI: [-9.1, 2.4].
Maltese: Id-differenzi aġġustati fil-proporzjon u 95% CI [ABC/DTG/3TC vs ART attwali] kienu ta' 3.4%; 95% CI: [-9.1, 2.4]. Wara 24 ġimgħa l-individwi kollha li kien fadal qalbu għal ABC/DTG/3TC FDC (Qlib Tardiv).
English: Dyspnoea, cough, sore throat, adult respiratory distress syndrome, respiratory failure
Maltese: Dispneja, sogħla, uġigħ fil-griżmejn, sindromu ta' diffikultà biex jittieħed nifs fl-adulti, insuffiċjenza respiratorja
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOTTLE CARTON (MULTIPACKS ONLY - WITH BLUE BOX)
Maltese: KARTUNA TAL-FLIXKUN (PAKKETTI MULTIPLI BISS - BIL-KAXXA BLU)
English: • wind (flatulence)
Maltese: • gass fl-istonku (flatulenza)
English: The clinical relevance of this finding has not been determined.
Maltese: Ir-rilevanza klinika ta' din is-sejba ma ġietx iddeterminata.
English: For lamivudine, the IC50 values against HIV-1 subtypes (A-G) ranged from 0.001 to 0.170 µM, against Group O from 0.030 to 0.160 µM and against HIV-2 isolates from 0.002 to 0.120 µM in peripheral blood mononuclear cells.
Maltese: Għal lamivudine, il-valuri IC50 meta mqabbel mas-sottotipi ta' HIV-1 (A-G) varjaw minn 0.001 sa 0.170 µM, meta mqabbel mal-Grupp O minn 0.030 għal 0.160 µM u meta mqabbel mal-iżolati ta' HIV-2 minn 0.002 sa 0.120 µM f'ċelloli mononukleari taddemm periferali.
English: HLA-B*5701 is the only identified pharmacogenetic marker that is consistently associated with clinical diagnosis of an ABC HSR reaction.
Maltese: HLA-B*5701 huwa l-uniku markatur farmakoġenetiku identifikat li huwa konsistentament assoċjat ma' dijanjożi klinika ta' reazzjoni ABC
English: Thirty-two percent of the total oral dose is excreted in the urine, represented by ether glucuronide of dolutegravir (18.9% of total dose), N-dealkylation metabolite (3.6% of total dose), and a metabolite formed by oxidation at the benzylic carbon (3.0% of total dose).
Maltese: N-dealkylation (3.6% tad-doża totali), u metabolit ffurmat bl-ossidazzjoni fil-karbonju benzylic (3.0%
English: Pharmacokinetic data for dolutegravir, abacavir and lamivudine in subjects >65 years of age are limited.
Maltese: Id-dejta dwar il-farmokokinetika għal dolutegravir, abacavir u lamivudine f'individwi >65 sena ta' età hija limitata.
English: The observed values of the peak concentrations are 9-fold greater than the IC50 of abacavir of 0.08 µg/ml or 0.26 µM when abacavir is given at 600 mg twice daily.
Maltese: Il-valuri osservati tal-ogħla konċentrazzjonijiet huma 9 darbiet akbar mill-IC50 ta' abacavir ta' 0.08 µg/ml jew 0.26 µM meta abacavir jingħata 600 mg darbtejn kuljum.
English: In a randomized, dose-ranging trial, HIV-1-infected subjects treated with dolutegravir monotherapy (ING111521) demonstrated rapid and dose-dependent antiviral activity with mean decline in HIV-1 RNA of 2.5 log10 at day 11 for 50 mg dose.
Maltese: Fi prova randomizzata b'varjazzjoni fid-doża, l-individwi infettati b'HIV-1. ikkurati b'monoterapija b'dolutegravir (ING111521) urew attività antivirali rapida u dipendenti fuq id-doża u b'tnaqqis medju fl-HIV-1 RNA ta' 2.5 log10 fil-11-il jum għal doża ta' 50 mg.
English: Uncommon side effects These may affect up to 1 in 100 people:
Maltese: Effetti sekondarji mhux komuni Dawn jistgħu jaffetwaw sa 1 minn kull 100 persuna:
English: The combination of lamivudine with cladribine is not recommended (see section 4.5).
Maltese: Il-kombinazzjoni ta' lamivudine ma' cladribine mhijiex rakkomandata (ara sezzjoni 4.5).
English: The main adverse reactions reported are haematological disorders (anaemia, neutropenia), and metabolic disorders (hyperlactatemia, hyperlipasemia).
Maltese: Irreazzjonijiet avversi ewlenin irrapportati huma disturbi ematoloġiċi (anemija, newtropenja), u disturbi metaboliċi (iperlaktatemija, iperlipejżemja).
English: The adjusted mean change in CD4+ T cell count from baseline were 267 cells versus 208 cells/mm3, respectively (p<0.001).
Maltese: Il-bidla medja aġġustata fl-għadd ta' ċelloli CD4+ T mil-linja bażi kienet 267 ċellola meta mqabbel ma' 208 ċellola/mm3, rispettivament, (p<0.001).
English: The primary pathways of metabolism in man are by alcohol dehydrogenase and by glucuronidation to produce the 5'-carboxylic acid and 5'-glucuronide which account for about 66% of the administered dose.
Maltese: Il-passaġġi prinċipali tal-metaboliżmu fl-irġiel huma bl-alkoħol dehydrogenase u bil-glukuronidazzjoni biex jiġi prodott l-aċidu 5'carboxylic u 5'-glucuronide li jirrappreżentaw 66% tad-doża mogħtija.
English: In vitro, abacavir was not a substrate of OATP1B1, OATP1B3, OCT1, OCT2, OAT1, MATE1, MATE2-K, MRP2 or MRP4 therefore drugs that modulate these transporters are not expected to affect abacavir plasma concentrations.
Maltese: In vitro, abacavir ma kienx sottostrat ta' OATP1B1, OATP1B3, OCT1, OCT2, OAT1, MATE1, MATE2-K, MRP2 jew MRP4 għalhekk il-mediċini li jimmodulaw dawn it-trasportaturi mhumiex mistennija li jaffettwaw il konċentrazzjonijiet ta' abacavir fil-plażma.
English: Lamivudine was not significantly metabolised by CYP enzymes.
Maltese: Lamivudine ma ġiex metabolizzat b'mod sinifikanti minn enzimi CYP. Eliminazzjoni
English: EFV/TDF/FTC once daily N=419
Maltese: EFV/TDF/FTC darba kuljum N=419
English: The concentration of active substance necessary to effect viral replication by 50% (IC50 - half maximal inhibitory concentration) varied according to virus and host cell type.
Maltese: Il-konċentrazzjoni ta' sustanza attiva meħtieġa biex tiġi effettwata rreplikazzjoni virali b'50% (nofs konċentrazzjoni inibitorja massima - IC50) varjat skont il-virus u it-tip ta' ċellula ospitanti.
English: Based on this data, dolutegravir is not expected to affect the pharmacokinetics of medicinal products that are substrates of major enzymes or transporters (see section 4.5).
Maltese: prodotti mediċinali li huma sottostrati ta' enzimi jew trasportaturi maġġuri (ara sezzjoni 4.5).
English: HIV-1 RNA <50 copies/mL by baseline covariates
Maltese: HIV-1 RNA <50 kopja/mL skont kovarjanti tal-linja bażi
English: Data from clinical trials showed limited numbers of myocardial infarction and could not exclude a small increase in risk.
Maltese: Dejta minn studji kliniċi wrew numri limitati ta' infart mijokardijaku u ma setgħux jeskludu żieda żgħira fir-riskju.
English: Dolutegravir is primarily metabolized via UGT1A1 with a minor CYP3A component (9.7% of total dose administered in a human mass balance study).
Maltese: Dolutegravir huwa prinċipalment metabolizzat permezz ta' UGT1A1 b'komponent minuri ta' CYP3A (9.7% tad-doża totali mogħtija fi studju tal-piż tal-bilanċ tal-piż tal-bniedem).
English: Lamivudine-TP (an analogue for cytidine) and carbovir-TP (the active triphosphate form of abacavir, an analogue for guanosine) are substrates for and competitive inhibitors of HIV reverse transcriptase (RT).
Maltese: Lamivudine-TP (analogu għal cytidine) u carbovir-TP (il-forma trifosfata attiva ta'
English: Symptoms have included rash, constitutional findings, and sometimes, organ dysfunction, including severe liver reactions.
Maltese: Is-sintomi inkludew raxx, sejbiet kostituzzjonali, u xi drabi, disfunzjoni tal-organi, inkluż reazzjonijiet severi tal-fwied.
English: The mean IC50 against lab-strains of HIV-2 (LAV2 and EHO) ranged from 1.57 to 7.5 µM for abacavir and from 0.16 to 0.51 µM for lamivudine.
Maltese: L-IC50 medju meta mqabbel mar-razez tallaboratorju ta' HIV-2 (LAV2 u EHO) varja minn 1.57 sa 7.5 µM għal abacavir u minn 0.16 sa
English: Miscellaneous Alcohol
Maltese: Alkoħol
English: IMPORTANT - PATIENT ALERT CARD Triumeq (dolutegravir / abacavir / lamivudine) tablets Carry this card with you at all times
Maltese: IMPORTANTI - KARD TA' TWISSIJA TAL-PAZJENT Triumeq (dolutegravir / abacavir / lamivudine) pilloli
English: Renal clearance of unchanged active substance is a minor pathway of elimination for dolutegravir.
Maltese: It-tneħħija renali ta' sustanza attiva mhux mibdula huwa passaġġ minuri ta' eliminazzjoni għal dolutegravir.
English: In a meta-analysis using pharmacogenomics samples collected in clinical studies in healthy subjects, subjects with UGT1A1 (n=7) genotypes conferring poor dolutegravir metabolism had a 32% lower clearance of dolutegravir and 46% higher AUC compared with subjects with genotypes associated with normal metabolism via UGT1A1 (n=41).
Maltese: F'meta-analiżi permezz talkampjuni tal-farmakoġenomika miġbura fi studji kliniċi f'individwi b'saħħithom, individwi b'ġenotipi UGT1A1 (n=7) li jikkonferixxu metaboliżmu ħażin ta' dolutegravir kellhom tneħħija ta' 32% aktar baxxa ta' dolutegravir u 46% AUC ogħla meta mqabbel ma' individwi b'ġenotipi assoċjati b'metaboliżmu normali permezz ta' UGT1A1 (n=41).
English: Abacavir is primarily metabolised by the liver.
Maltese: Abacavir huwa primarjament metabolizzat fil-fwied.
English: The statistically higher responses on DTG+ABC/3TC were driven by a higher rate of withdrawals due to AEs in the EFV/TDF/FTC arm, irrespective of viral load strata.
Maltese: Ir-risponsi statistikament ogħla fuq DTG+ABC/3TC kienu xprunati minn rata ogħla ta' rtirar minħabba AEs fil-fergħa EFV/TDF/FTC, irrispettivament millistrata ta' tagħbija virali.
English: Pharmacogenetic Testing
Maltese: Testjar Farmakoġenetiku
English: Mitochondrial dysfunction Nucleoside and nucleotide analogues have been demonstrated in vitro and in vivo to cause a variable degree of mitochondrial damage.
Maltese: Intwera li nukleosidi u nukleotidi in vitro u in vivo jikkaġunaw gradi varjabbli ta' ħsara mitokondrijali.
English: Preliminary data from a surveillance study has suggested an increased incidence of neural tube defects (0.9%) in mothers exposed to dolutegravir (a component of Triumeq) at the time of conception compared with mothers exposed to non-dolutegravir containing regimens (0.1%).
Maltese: Dejta preliminari minn studju ta' sorveljanza ssuġġeriet żieda fl-inċidenza ta' difetti fit-tubu newrali (0.9%) f'ommijiet esposti għal dolutegravir (komponent ta' Triumeq) meta ssir il-konċezzjoni meta mqabbel ma' ommijiet esposti għal reġimens li ma fihomx duletgravir (0.1%).
English: AUC in cervicovaginal fluid, cervical tissue and vaginal tissue were 6-10% of those in corresponding plasma at steady state.
Maltese: L-AUC fil-fluwidu ċervikovaġinali, it-tessut ċervikali u tessut vaġinali kienet 6-10% ta' dawk fil-plażma korrispondenti fi stat fiss.
English: hypertriglyceridaemia, hyperglycaemia
Maltese: ipertrigliċeridimja, ipergliċemija
English: G118R lowers the susceptibility to dolutegravir in site directed mutants (fold change 10), but was not detected in patients receiving dolutegravir in the Phase III program.
Maltese: G118R ibaxxi s-suxxettibbiltà għal dolutegravir f'mutanti diretti lejn is-sit (bidla fil-valur ta' 10 darbiet), iżda ma ġiex identifikat f'pazjenti li jirċievu dolutegravir fil-programm talFażi
English: This was demonstrated in a single dose, 2-way crossover bioequivalence study of Triumeq (fasted) versus 1 x 50 mg dolutegravir tablet, plus 1 x 600mg abacavir/300 mg lamivudine tablet (fasted) in healthy subjects (n=66).
Maltese: meta mqabbel ma' 1 x 50 mg pillola ta' dolutegravir, flimkien ma' pillola ta' 1 x 600 mg abacavir/300 mg lamivudine (sajjem) f'individwi b'saħħithom (n=66).
English: Limited data are available in adolescents receiving a daily dose of 600 mg of abacavir and 300 mg of lamivudine.
Maltese: Dejta limitata hija disponibbli fl-adoloxxenti li jirċievu doża ta' kuljum ta' 600 mg ta' abacavir u 300 mg ta' lamivudine.
English: Baseline Plasma Viral Load (copies/mL)
Maltese: Tagħbija Virali fil-Plażma tal-Linja Bażi (kopji/mL)
English: Studies with abacavir demonstrate a CSF to plasma AUC ratio of between 30 to 44%.
Maltese: L-istudji b'abacavir urew proporzjon AUC ta' CSF għal plażma ta' bejn 30 sa 44%.
English: Main prior transmission routes were homosexual (73%) or heterosexual (29%) contact.
Maltese: Ir rotot ta' trażmissjoni ewlenin preċedenti kienu kuntatt omosesswali (73%) jew eterosesswali (29%).
English: Antiviral activity in combination with other antiviral agents No antagonistic effects in vitro were seen with dolutegravir and other antiretrovirals (tested agents: stavudine, abacavir, efavirenz, nevirapine, lopinavir, amprenavir, enfuvirtide, maraviroc, adefovir and raltegravir).
Maltese: stavudine, abacavir, efavirenz, nevirapine, lopinavir, amprenavir, enfuvirtide, maraviroc, adefovir u raltegravir).
English: The Triumeq tablet has been shown to be bioequivalent to dolutegravir single entity tablet and abacavir/lamivudine fixed-dose combination tablet (ABC/3TC FDC) administered separately.
Maltese: kombinazzjoni b'doża fissa ta' abacavir/lamivudine (ABC/3TC FDC) mogħtija separatament.
English: AUC in semen was 7% and 17% in rectal tissue of those in corresponding plasma at steady state.
Maltese: L-AUC fl-isperma kienet ta' 7% u 17% fit-tessut rettali ta' dawk fil-plażma korrispondenti fi stat fiss.
English: The mean IC50 for 3 HIV-2 isolates was 0.18 nM (range 0.09-0.61).
Maltese: L-IC50 medja għal 3 iżolati ta' HIV-2 kienet 0.18 nM (medda 0.
English: For the comparators typical resistance was detected with TDF/FTC/EFV (SINGLE; six with NNRTI associated resistance and one with major NRTI resistance) and with 2 NRTIs + raltegravir (SPRING2; four with major NRTI resistance and one with raltegravir resistance), while no de novo resistance was detected in patients treated with 2 NRTIs + DRV/RTV (FLAMINGO).
Maltese: Għall-komparaturi, ġiet identifikata reżistenza tipika b'TDF/FTC/EFZ (SINGLE; sitta b'reżistenza assoċjata ma' NNRTI u waħda b'reżistenza NRTI ewlenija waħda) u 2 NRTIs + raltegravir (SPRING2; erbgħa b'reżistenza NRTI ewlenija u reżistenza għal raltegravir waħda) iżda ma ġiet skoperta ebda reżistenza de novo f'pazjenti kkurati b'NRTIs + DRV/RTV (FLAMINGO).
English: Triumeq contains abacavir and dolutegravir.
Maltese: Triumeq fih abacavir u dolutegravir.
English: Overall, the safety profile in patients co-infected with hepatitis B and/or C was similar to that observed in patients without hepatitis B or C co-infection, although the rates of AST and ALT abnormalities were higher in the subgroup with hepatitis B and/or C co-infection for all treatment groups.
Maltese: Globalment, il-profil tas-sigurtà f'pazjenti ko-infettati b'epatite B u/jew C kien simili għal dak osservat f'pazjenti mingħajr il-ko-infezzjoni ta' epatite B jew C, għalkemm ir-rati ta' annormalitajiet AST u ALT kienu għoljin fis-sottogrupp bil-ko-infezzjoni ta' epatite B u/jew C għall gruppi ta' kura kollha.
English: Table 5: Demographics and Week 48 virologic outcomes of randomized treatment of FLAMINGO (snapshot algorithm)
Maltese: Demografija u eżiti viroloġiċi ta' Ġimgħa 48 ta' kura randomizzata ta' FLAMINGO (algoritmu snapshot)
English: Purple, biconvex, film-coated oval tablets, approximately 22 x 11 mm, debossed with “572 Trı” on one side.
Maltese: Pillola miksija b'rita (pillola) Pilloli ovali, vjola, bikonvessi, miksijin b'rita, madwar 22 × 11 mm, imnaqqxa b'"572 Tri" fuq naħa waħda.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/940/001
Maltese: EU/1/14/940/001
English: AUC ↔ Cmax ↓35% Methadone: CL/F ↑22%
Maltese: Methadone: CL/F ↑22%
English: Early Switch ABC/DTG/3TC FDC N=275 n (%)
Maltese: Qlib Bikri ABC/DTG/3TC FDC N=275 n (%)
English: Retinoids
Maltese: Retinojdi
English: • inflammation of the liver (hepatitis)
Maltese: • infjammazjoni tal-fwied (epatite)
English: Abacavir is primarily metabolised by the liver with approximately 2% of abacavir excreted unchanged in the urine.
Maltese: Abacavir huwa primarjament metabolizzat mill-fwied b'madwar 2% ta' abacavir eliminat mhux mibdul fl-awrina.
English: Lamivudine exhibits linear pharmacokinetics over the therapeutic dose range and displays limited plasma protein binding in vitro (< 36%).
Maltese: Lamivudine jesibixxi farmakokinetika lineari fuq il-medda tad-doża terapewtika u juri twaħħil malproteina tal-plażma baxx in vitro (< 36%).
English: Dolutegravir ↔ AUC ↑ 11% Cmax ↑ 6%
Maltese: Dolutegravir ↔ AUC ↑ 11% Cmax ↑ 6% Cτ ↑ 17%
English: Effect of other medicinal products on the pharmacokinetics of dolutegravir, abacavir and lamivudine
Maltese: Effett ta' prodotti mediċinali oħra fuq il-farmakokinetika ta' dolutegravir, abacavir u lamivudine
English: Each tablet contains dolutegravir sodium equivalent to 50 mg dolutegravir, 600 mg abacavir (as sulfate) and 300 mg lamivudine.
Maltese: Kull pillola fiha dolutegravir sodium ekwivalenti għal 50 mg dolutegravir, 600 mg abacavir (bħala sulfat) u 300 mg lamivudine.