FrancophonIA/ELRC3.0 huggingface dataset:
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains dolutegravir sodium equivalent to 50 mg dolutegravir
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Each film-coated tablet contains dolutegravir sodium equivalent to 50 mg dolutegravir
English: Azole anti-fungal agents Ketoconazole Fluconazole Itraconazole Posaconazole Voriconazole
Maltese: Sustanzi antifungali azole Ketoconazole Fluconazole
English: In vitro, dolutegravir inhibited the renal uptake transporters, organic anion transporters (OAT1) and OAT3.
Maltese: In vitro, dolutegravir inibixxa t-trasportaturi tat-teħid mill-ġdid renali (OAT1) u OAT3.
English: Dolutegravir 50 mg + ABC/3TC Once Daily N=414
Maltese: Tivicay 50 mg + ABC/3TC Darba Kuljum N=414
English: RAL 400 mg Twice Daily + 2 NRTI N=411
Maltese: RAL 400 mg Darbtejn Kuljum + 2 NRTI N=411
English: Statistically fewer subjects failed therapy with treatment-emergent integrase resistance on Tivicay (4/354, 1%) than on raltegravir (17/361, 5%) (p=0.003) (refer to section ‘Resistance in vivo' above for details).
Maltese: Statistikament, numru anqas ta' individwi fallew it-terapija minħabba reżistenza ta' integrase li ħarġet mill-kura fuq Tivicay (4/354, 1%) milli fuq raltegravir (17/361, 5%) (p=0.003) (irreferi għas-sezzjoni ‘Reżistenza in vivo' aktar 'il fuq għad-dettalji).
English: In vitro, dolutegravir did not induce CYP1A2, CYP2B6 or CYP3A4.
Maltese: In vitro, dolutegravir ma wassalx għal induzzjoni ta' CYP1A2, CYP2B6 jew CYP3A4.
English: No primary IN mutation1
Maltese: L-ebda mutazzjoni IN primarja1
English: Tabulated list of adverse reactions
Maltese: Tabella 3 Reazzjonijiet Avversi
English: ≤100,000 cps/mL
Maltese: ≤50,000 kopja/mL >50,000 kopja/mL
English: R263K was reported from two ART experienced, INI naive individual patients with subtypes B and C in the clinical program, but without effects on dolutegravir susceptibility in vitro.
Maltese: R263K ġiet irrappurtata minn żewġ pazjenti individwali li kienu ħadu ART iżda li ma kinux ħadu INI, bis-sottotipi B u C fil-programm kliniku, iżda mingħajr effetti fuq is suxxettibilità ta' dolutegravir in vitro.
English: Virologic suppression (HIV-1 RNA <50 copies/mL) in the dolutegravir group (90%) was superior to the DRV/r group (83%) at 48 weeks.
Maltese: It-trażżin viroloġiku (HIV-1 RNA <50 kopja/mL) fil-grupp ta' dolutegravir (90%) kien superjuri għall-grupp DRV/r (83%) fi 48 ġimgħa.
English: In a combined analysis of VIKING-3 and VIKING-4 (n=186, VO population), the proportion of subjects with HIV RNA <50 copies/mL at Week 48 was 123/186 (66%).
Maltese: F'analiżi kombinata ta' VIKING-3 u VIKING-4 (n=186, popolazzjoni VO), il-proporzjon ta' individwi b'HIV RNA <50 kopja/mL fil-Ġimgħa 48 kien ta' 126/186 (68%).
English: Pharmacotherapeutic group: Antivirals for systemic use, other antivirals, ATC code: J05AX12
Maltese: Antivirali għall-użu sistemiku, antivirali oħra, Kodiċi ATC:
English: Currently available data are described in section 4.8, 5.1 and 5.2, but no recommendation on a posology can be made.
Maltese: Id-dejta attwalment disponibbli hija deskritta f'sezzjoni 4.8, 5.1 u 5.2, iżda ma tista' ssir l-ebda rakkomandazzjoni dwar pożoloġija.
English: In vitro, dolutegravir demonstrated no direct, or weak inhibition (IC50>50 μM) of the enzymes cytochrome P450 (CYP)1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 CYP3A, uridine diphosphate glucuronosyl transferase (UGT)1A1 or UGT2B7, or the transporters Pgp, BCRP, BSEP, OATP1B1, OATP1B3, OCT1, MATE2-K, MRP2 or MRP4.
Maltese: Interazzjoni bejn mediċini In vitro, dolutegravir ma wera ebda inibizzjoni diretta jew dgħajfa (IC50>50 μM) tal-enzimi cytochrome P450 (CYP)1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6
English: INFORMATION IN BRAILLE tivicay 10 mg
Maltese: INFORMAZZJONI BIL-BRAILLE tivicay 10 mg
English: Q148+1 secondary mutationb
Maltese: Q148+1 mutazzjoni sekondarjab
English: Tivicay tablets on a weight-band basis (20 mg, 25 mg, 35 mg, 50 mg) in children of at least 6 years of age weighing at least 15 kg provides comparable exposure to that observed in adults (50 mg), with the lowest weight band of 15 to <20 kg corresponding to 20 mg daily.
Maltese: 25 mg, 35 mg, 50 mg) fi tfal ta' mill-anqas età ta' 6 snin li jiżnu mill-anqas 15-il kg li jipprovdi esponiment paragunabbli ma' dak osservat fl-adulti (50 mg), bl-aktar kategorija ta' piż baxxa ta' 15 sa <20 kg li tikkorrispondi ma' 20 mg kuljum.
English: A study of the pharmacokinetics of dolutegravir was performed in subjects with severe renal impairment (CLcr <30 mL/min) and matched healthy controls.
Maltese: Sar studju tal-farmakokinetika ta' dolutegravir f'persuni b'indeboliment sever tal-kliewi (CLcr <30 mL/min) u qabbel kontrolli b'saħħithom.
English: Dolutegravir is eliminated mainly through metabolism by UGT1A1.
Maltese: Dolutegravir jiġi eliminat prinċipalment permezz tal-metaboliżmu minn UGT1A1.
English: Subjects were stratified by age, receiving Tivicay (70 mg, as 35 mg twice daily, n=1; 50 mg once daily, n=5; 35 mg once daily, n=6; 25 mg once daily, n= 8; and 20 mg once daily, n=3) plus OBR.
Maltese: 35 mg darbtejn kuljum, n=1; 50 mg darba kuljum, n=5; 35 mg darba kuljum, n=6; 25 mg darba kuljum, n= 8; u 20 mg darba kuljum, n=3) flimkien ma' OBR.
English: Bioavailability of dolutegravir depends on meal content: low, moderate, and high fat meals increased dolutegravir AUC(0-∞) by 33%, 41%, and 66%, increased Cmax by 46%, 52%, and 67%, prolonged Tmax to 3, 4, and 5 hours from 2 hours under fasted conditions, respectively.
Maltese: dolutegravir tiddependi fuq il-kontenut tal-ikel: ikliet b'kontenut baxx, moderat u għoli ta' xaħam żiedu l-AUC(0-∞) ta' dolutegravir bi 33%, 41%, u 66%, żiedu s-Cmax b'46%, 52%, u 67%, tawlu tTmax għal 3, 4, u 5 sigħat minn sagħtejn taħt kundizzjonijiet ta' stonku vojt, rispettivament.
English: Dolutegravir is also a substrate of UGT1A3, UGT1A9, CYP3A4, Pgp, and BCRP; therefore medicinal products that induce those enzymes may decrease dolutegravir plasma concentration and reduce the therapeutic effect of dolutegravir (see Table 2).
Maltese: Dolutegravir huwa wkoll substrat ta' UGT1A3, UGT1A9, CYP3A4, Pgp, u BCRP; għalhekk prodotti mediċinali li jinduċu dawn l-enzimi jistgħu jnaqqsu l-konċentrazzjoni ta' dolutegravir fil-plażma u jnaqqsu l-effett terapewtiku ta' dolutegravir (ara Tabella 2).
English: (induction of UGT1A1 and CYP3A enzymes)
Maltese: ( Inibizzjoni tal-enzimi UGT1A1 u CYP3A)
English: In vitro, dolutegravir was not a substrate of human OATP 1B1, OATP 1B3 or OCT 1.
Maltese: In vitro, dolutegravir ma kienx substrat ta' OATP 1B1, OATP 1B3 jew OCT 1 tal-bniedem.
English: • joint pain, stiffness and bone problems You need to know about important signs and symptoms to look out for while you're taking Tivicay.
Maltese: • uġigħ fil-ġogi, ebusija u problemi fl-għadam Għandek tkun taf dwar sinjali u sintomi importanti li trid toqgħod attent għalihom waqt li tkun qed tieħu Tivicay.
English: Q148 +≥2 secondary mutations 3
Maltese: Q148 +≥2 mutazzjonijiet sekondarji 3
English: Each 10 mg tablet contains 1 mg sodium.
Maltese: Kull pillola ta' 10 mg fiha 1 mg tas-sodju.
English: The primary endpoint at Day 8 showed that dolutegravir 50 mg twice daily was superior to placebo, with an adjusted mean treatment difference for the change from Baseline in Plasma HIV-1 RNA of -1.2 log10 copies/mL (95% CI -1.5 -0.8log10 copies/mL, p<0.001).
Maltese: L-endpoint primarju f'Jum 8 wera li dolutegravir 50 mg darbtejn kuljum kien superjuri għall-plaċebo, b'differenza medja aġġustata bejn it-trattamenti għall-bidla mil-Linja bażi fl-HIV-1 RNA fil-Plażma ta' -1.2 log10 kopji/mL (95% CI -1.5 - -0.8log10 kopji/mL, p<0.001).
English: ‡ Adjusted mean treatment difference was statistically significant (p<0.001)
Maltese: Id-differenza medja aġġustata bejn il-kuri kienet statistikament sinifikanti (p<0.
English: INFORMATION IN BRAILLE tivicay 25 mg
Maltese: INFORMAZZJONI BIL-BRAILLE tivicay 25 mg
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 evidenza li pazjenti anzjani jeħtieġu doża differenti minn pazjenti adulti iżgħar fl-età (ara sezzjoni 5.2).
English: The efficacy of dolutegravir in HIV-infected, therapy naïve subjects is based on the analyses of 96-week data from two randomized, international, double-blind, active-controlled trials, SPRING-2 (ING113086) and SINGLE (ING114467).
Maltese: L-effikaċja ta' dolutegravir f'persuni infettati bl-HIV li ma ħadux terapija qabel hija bbażata fuq l-analiżijiet ta' dejta fuq 48 ġimgħa minn żewġ provi aleatorji, internazzjonali, double-blind u kkontrollati bis-sustanza attiva, SPRING-2 (ING113086) u SINGLE (ING114467).
English: INFORMATION IN BRAILLE tivicay 50 mg
Maltese: INFORMAZZJONI BIL-BRAILLE tivicay 50 mg
English: The R263K mutation was also selected in vitro (see above).
Maltese: Il-mutazzjoni R263K intgħażlet ukoll in vitro (ara aktar 'il fuq).
English: The adverse reactions considered at least possibly related to dolutegravir are listed by body system, organ class and absolute frequency.
Maltese: Ir-reazzjonijiet avversi kkunsidrati bħala tal-anqas possibbilment relatati ma' dolutegravir huma elenkati skont is-sistema tal-ġisem, il-klassifika tal-organi u l-frekwenza assoluta.
English: Antacid medicines
Maltese: Mediċini antiaċidi
English: There are limited data on subjects with hepatitis B co-infection.
Maltese: Hemm dejta limitata dwar individwi b'ko-infezzjoni tal-epatite B.
English: Dolutegravir has a less than or equal to 10 FC against 94% of the 705 clinical isolates.
Maltese: FC kontra 94% tas705 iżolati kliniċi.
English: Baseline Viral Load
Maltese: Sustanzi antivirali oħra
English: Dolutegravir had no pharmacodynamic effect on Luteinizing Hormone (LH), Follicle Stimulating Hormone (FSH) and progesterone.
Maltese: Dolutegravir ma kellu l-ebda effett farmakodinamiku fuq l-Ormon Lutejnizzanti (LH), l-Ormon li Jistimula l-Follikuli (FSH) u progesterone.
English: → Read the information in Section 4 of this leaflet.
Maltese: → Aqra l-informazzjoni f'Sezzjoni 4 ta' dan il-fuljett.
English: Tivicay is always used in combination with other anti-retroviral medicines (combination therapy).
Maltese: Tivicay jintuża dejjem f'kombinazzjoni ma' mediċini antiretrovirali oħra (terapija kombinata).
English: Dolutegravir 50 mg Once Daily + 2 NRTI N=411
Maltese: Tivicay 50 mg Darba Kuljum + 2 NRTI N=411
English: Q148+≥2 secondary mutationsb *Of 98 on RAL/EVG as part of current failing regimen, 88 had detectable primary INI mutations at Baseline and a Day 8 Plasma HIV-1 RNA outcome for evaluation a Included primary IN resistance mutations N155H, Y143C/H/R, T66A, E92Q b Secondary mutations from G140A/C/S, E138A/K/T, L74I.
Maltese: *Minn 98 fuq RAL/EVG bħala parti mill-kors li ma rnexxiex attwali, 88 kellhom mutazzjonijiet INI primarji li setgħu jinkixfu fil-Linja bażi u riżultat ta' RNA ta' HIV-1 talPlasma ta' Jum 8 għal evalwazzjoni a Inklużi mutazzjonijiet primarji ta' reżistenza IN, N155H, Y143C/H/R, T66A, E92Q
English: - This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially ‘sodium-free'.
Maltese: - Din il-mediċina fiha inqas minn 1 mmol sodium (23 mg) għal kull unità ta 'dożaġġ, jiġifieri essenzjalment' mingħajr sodium '.
English: 3 G140A/C/S, E138A/K/T, L74I
Maltese: b Mutazzjonijiet sekondarji minn G140A/C/S, E138A/K/T, L74I.
English: Immune Reactivation Syndrome
Maltese: Sindrome tar-Riattivazzjoni Immunitarja
English: At week 48, dolutegravir was non-inferior to raltegravir in the SPRING-2 study, and in the SINGLE study dolutegravir + ABC/3TC was superior to efavirenz/TDF/FTC (p=0.003), table 4 above.
Maltese: F'Ġimgħa 48, dolutegravir ma kienx inferjuri għal raltegravir fl-istudju SPRING-2, u fl-istudju SINGLE, dolutegravir + ABC/3TC kien superjuri għal efavirenz/TDF/FTC (p=0.003), Tabella 4 fuq.
English: Table 7 Virologic response (day 8) after 7 days of functional monotherapy, in patients with RAL/EVG as part of current failing regimen, VIKING 3
Maltese: Tabella 6 Rispons viroloġiku (jum 8) wara 7 ijiem ta' monoterapija funzjonali, f'pazjenti b'RAL/EVG bħala parti mit-terapija kurrenti li ma ħadmitx, VIKING 3
English: Baseline parameters
Maltese: Parametri fil-linja bażi
English: Each 50 mg tablet contains 4 mg sodium.
Maltese: Kull pillola ta' 50 mg fiha 4 mg tas-sodju.
English: There is currently limited experience with overdosage in dolutegravir.
Maltese: Attwalment hemm esperjenza limitata dwar doża eċċessiva b'dolutegravir.
English: VO Population (HIV-1 RNA <50 c/mL, Snapshot algorithm)
Maltese: RNA <50 c/mL, Algoritmu ritratt)
English: Treatment-emergent mutations observed were consistent with those observed in the VIKING-3 study.
Maltese: Il mutazzjonijiet emerġenti mill-kura osservati kienu konsistenti ma' dawk osservati fl-istudju VIKING-3.
English: Based on data from other CYP3A4 inhibitors, a marked increase is not expected.
Maltese: Abbażi ta' dejta minn inibituri oħra ta' CYP3A4, mhix mistennija żieda evidenti.
English: Tivicay 10 mg film-coated tablets Tivicay 25 mg film-coated tablets Tivicay 50 mg film-coated tablets dolutegravir
Maltese: Tivicay 10 mg pilloli miksijin b'rita Tivicay 25 mg pilloli miksijin b'rita Tivicay 50 mg pilloli miksijin b'rita dolutegravir
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20 January 2014
Maltese: Data tal-ewwel awtorizzazzjoni: 20 ta' Jannar 2014
English: Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections, and Pneumocystis jirovecii pneumonia.
Maltese: Eżempji rilevanti huma r-retinite miċ-ċitomegalovirus, infezzjonijiet mikobatteriċi ġeneralizzati u/jew fokali, u l-pulmonite kkawżata mill-Pneumocystis jirovecii.
English: A single dose of 50 mg of dolutegravir was administered to 8 subjects with moderate hepatic impairment (Child-Pugh class B) and to 8 matched healthy adult controls.
Maltese: 50 mg ta' dolutegravir lil 8 individwi b'indeboliment tal-fwied moderat (Child-Pugh klassi B) u lil 8 kontrolli adulti b'saħħithom imqabbla.
English: Q148H/K/Ra
Maltese: Mutazzjoni primarja għajr Q148H/K/Ra
English: The proportion of responders (HIV-1 RNA <50 c/mL) at week 24 was predicted to increase around 4-18% in the subjects with Q148 + ≥2 secondary mutations from G140A/C/S, E138A/K/T, L74I.
Maltese: Il-proporzjon ta' dawk li rrispondew (HIV-1 RNA <50 c/mL) fil-ġimgħa 24 kien previst li jiżdied b'madwar 4-18% flindividwi b'mutazzjonijiet sekondarji Q148 + ≥2 minn G140A/C/S, E138A/K/T, L74I.
English: • calcium supplements, iron supplements and multivitamins.
Maltese: • supplimenti tal-kalċju, supplimenti tal-ħadid u multivitamini.
English: EU/1/13/892/004 EU/1/13/892/005 EU/1/13/892/006
Maltese: EU/1/13/892/001 EU/1/13/892/002 EU/1/13/892/003 EU/1/13/892/004
English: Acute hepatic failure
Maltese: Insuffiċjenza epatika akuta
English: Derived IN mutation group at
Maltese: Grupp b'mutazzjoni IN
English: Dofetilide ↑ (Not studied, potential increase via inhibition of OCT2 transporter)
Maltese: (Mhix studjata, żieda potenzjali permezz talinibizzjoni tat-trasportatur OCT2)
English: G118R lowers the susceptibility to dolutegravir in site directed mutants (FC 10), but was not detected in patients receiving dolutegravir in the Phase III program.
Maltese: G118R tbaxxi s-suxxettibilità għal dolutegravir f'mutanti diretti mis-sit (FC 10), iżda ma nstabitx f'pazjenti li rċevew dolutegravir fil-programm ta' Fażi
English: Each tablet contains dolutegravir sodium equivalent to 10 mg, 25 mg or 50 mg dolutegravir.
Maltese: 10 mg, 25 mg jew 50 mg dolutegravir.
English: In patients without a primary mutation detected at baseline (N=60) (i.e. RAL/EVG not part of current failing therapy) there was a 1.63 log10 reduction in viral load at day 8.
Maltese: F'pazjenti mingħajr mutazzjonijiet primarji identifikati fil-linja bażi (N=60) (jiġifieri RAL/EVG ma kienx parti mit-terapija kurrenti li ma ħadmitx) kien hemm tnaqqis ta' 1.63 log10 fit-tagħbija virali f'jum 8.
English: Bioequivalence has not been unequivocally shown for 1x50 mg tablet compared to 5x10 mg tablets.
Maltese: Il-bijoekwivalenza ma ntwerietx mingħajr ekwivoku għall-pillola 1x50 mg meta mqabbla mal pilloli 5x10 mg.
English: WOCBP who are taking dolutegravir should use effective contraception throughout treatment.
Maltese: WOCBP li qegħdin jieħdu dolutegravir għandhom jużaw kontraċettiv effettiv matul it-trattament.
English: Table 9 Virologic (Snapshot algorithm) and Immunologic Activity of Treatment for Subjects 6 Years and Older in P1093
Maltese: Tabella 8 Attività Viroloġika u Immunoloġika (Algoritmu Snapshot) tal-Kura għall
English: The apparent volume of distribution is 17 L to 20 L in HIV-infected patients, based on a population pharmacokinetic analysis.
Maltese: Ilvolum apparenti ta' distribuzzjoni huwa 17 L sa 20 L f'pazjenti infettati bl-HIV, fuq il-bażi ta'
English: Each 25 mg tablet contains 2 mg sodium.
Maltese: Kull pillola ta' 25 mg fiha 2 mg tas-sodju.
English: Dolutegravir belongs to a group of anti-retroviral medicines called integrase inhibitors (INIs).
Maltese: Dolutegravir jappartjeni għal grupp ta' mediċini antiretrovirali msejħa inibituri ta' integrase (INIs).
English: The apparent oral clearance (CL/F) is approximately 1L/hr in HIV-infected patients based on a population pharmacokinetic analysis.
Maltese: It-tneħħija orali apparenti (CL/F) hija madwar 1L/siegħa fil-pazjenti infettati bl-HIV, fuq il-bażi ta' analiżi farmakokinetika talpopolazzjoni.
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 li fiha ntużaw kampjuni ta' farmakoġenomiċi miġbura fi studji kliniċi fuq individwi b'saħħithom, persuni b'ġenotipi ta' UGT1A1 (n=7) li jagħtu metaboliżmu fqir ta' dolutegravir kellhom tneħħija 32% aktar baxxa ta' dolutegravir u AUC 46% ogħla meta mqabbel ma' individwi b'ġenotipi assoċjati ma' metaboliżmu normali permezz ta' UGT1A1 (n=41).
English: Antiviral activity in combination with other antiviral agents No antagonistic effects in vitro were seen with dolutegravir and other antiretrovirals tested: stavudine, abacavir, efavirenz, nevirapine, lopinavir, amprenavir, enfuvirtide, maraviroc and raltegravir.
Maltese: stavudine, abacavir, efavirenz, nevirapine, lopinavir, amprenavir, enfuvirtide, maraviroc u raltegravir.
English: Similar IC50s were seen for clinical isolates without any major difference between subtypes; in a panel of 24 HIV-1 isolates of clades A, B, C, D, E, F and G and group O the mean IC50 value was 0.2 nM (range 0.02-2.14).
Maltese: Kienu osservati IC50s għal iżolati kliniċi mingħajr l-ebda differenza kbira bejn is-sottotipi; f'ġabra ta' 24 iżolat tal-HIV-1 tal-gruppi A, B, C, D, E, F u G u l-grupp O, il-valur IC50 medju kien 0.2 nM (medda 0.
English: 1 Historical or phenotypic evidence of INI resistance only.
Maltese: 1 Evidenza storika jew fenotipika ta' reżistenza INI biss.
English: There were no new target organs identified in juveniles compared to adults.
Maltese: Ma ġewx identifikati organi fil-mira ġodda fiż-żgħar paragunabbli mal-adulti.
English: In the presence of integrase class-resistance (VIKING-3 study) the following mutations were selected in 32 patients with protocol defined virological failure (PDVF) through Week 24 and with paired genotypes (all treated with dolutegravir 50 mg twice daily + optimized background agents): L74L/M (n=1), E92Q (n=2), T97A (n=9), E138K/A/T (n=8), G140S (n=2), Y143H (n=1), S147G (n=1), Q148H/K/R (n=4), and N155H (n=1) and E157E/Q (n=1).
Maltese: (n=1), E92Q (n=2), T97A (n=8), E138K/A (n=7), G140S (n=2), Y143H (n=1), S147G (n=1), Q148H/K/R (n=4), u N155H (n=1) u E157E/Q (n=1).
English: In SPRING-2, dolutegravir was still noninferior to raltegravir (viral suppression in 81% vs 76% of patients), and with a median change in CD4 count of 276 vs 264 cells/mm3, respectively.
Maltese: dolutegravir kien għadu mhux inferjuri għal raltegravir (trażżin virali f'81% vs 76% tal-pazjenti), u b'bidla medja fl-għadd ta' CD4 ta' 276 vs 264 ċelloli/mm3, rispettivament.
English: The linearity of dolutegravir pharmacokinetics is dependent on dose and formulation.
Maltese: Linearità/nuqqas ta' linearità Il-linearità tal-farmakokinetika ta' dolutegravir hija dipendenti fuq id-doża u l-formulazzjoni.
English: The proportion of subjects with HIV RNA <50 copies/mL was 96/126 (76%) for No Q148 mutations, 22/41 (54%) for Q148+1 and 5/19 (26%) for Q148+≥2 secondary mutations.
Maltese: 22/41 (54%) għal Q148+1 u 5/19 (26%) għal mutazzjonijiet sekondarji Q148+≥2.
English: Dolutegravir should be administered twice daily in this population when co-administered with some medicines (e.g. efavirenz, nevirapine, tipranavir/ritonavir, or rifampicin).
Maltese: Tivicay għandu jingħata darbtejn kuljum f'din il-popolazzjoni meta jingħata fl-istess ħin ma' xi mediċini oħra (eż. efavirenz, nevirapine, tipranavir/ritonavir, jew rifampicin).
English: HIV-1 RNA <50 copies/mL Treatment Difference*
Maltese: HIV-1 RNA <50 kopja/mL Differenza fil-Kura*
English: 3705 LZ Zeist
Maltese: Huis ter Heideweg 62 3705 LZ Zeist L-Olanda
English: Derived IN Mutation Group
Maltese: Grupp b'Mutazzjoni IN derivata
English: • abnormal dreams
Maltese: Ħolm abnormali
English: Analgesics Methadone
Maltese: Methadone
English: Table 4 Response in SPRING-2 and SINGLE at 48 Weeks (Snapshot algorithm, <50 copies/mL) SPRING-2
Maltese: Tabella 4 Rispons fi SPRING-2 u SINGLE wara 48 Ġimgħa (Algoritmu ritratt, <50
English: When co-administered with dolutegravir 50mg once daily:
Maltese: dolutegravir 50mg darba kuljum:
English: Dolutegravir ↓ AUC ↓ 22% Cmax ↓ 11% C24 ↓ 38% (induction of UGT1A1 and CYP3A enzymes)
Maltese: Dolutegravir ↓ AUC ↓ 22% Cmax ↓ 11% C24 ↓ 38% (induzzjoni tal-enzimi UGT1A1 u CYP3A)
English: At 96 weeks, virologic suppression in the dolutegravir group (80%) was superior to the DRV/r group (68%), (adjusted treatment difference [DTG-(DRV+RTV)]: 12.4%; 95% CI: [4.7, 20.2].
Maltese: (DRV+RTV)]: 12.4%; 95% CI: [4.7, 20.
English: At 144 weeks in the openlabel phase of SINGLE, virologic suppression was maintained, the dolutegravir + ABC/3TC arm (71%) was superior to the EFV/TDF/FTC arm (63%), treatment difference was 8.3% (2.0, 14.6).
Maltese: Wara 144 ġimgħa fil-fażi bit-tikketta mikxufa ta' SINGLE, it-trażżin viroloġiku inżamm, il-fergħa ta' dolutegravir + ABC/3TC (71%) kienet superjuri għall-fergħa EFV/TDF/FTC (63%), id-differenza fil-kura kienet 8.3% (2.0, 14.6).
English: This combination may increase the risk for lactic acidosis in patients with moderate renal impairment (stage 3a creatinine clearance [CrCl] 45- 59 mL/min) and a cautious approach is recommended.
Maltese: Din il-kombinazzjoni tista' żżid ir-riskju għal aċidożi lattika f'pazjenti b'indeboliment moderat tal-kliewi (tneħħija tal-kreatinina fl-istadju 3a [CrCl] 45- 59 mL/min) u huwa rakkomandat approċċ kawt.
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: (3.6% tad-doża totali), u metabolit iffurmat permezz ta' ossidazzjoni fil-karbonju benziliku (3.0% tad-doża totali).
English: In SINGLE, dolutegravir + ABC/3TC was still superior to EFV/TDF/FTC (viral suppression in 80% vs 72%, treatment difference 8.0% (2.3, 13.8), p=0.006, and with an adjusted mean change in CD4 count of 325 vs 281 cells/ mm3, respectively.
Maltese: 72%, differenza fil-kura 8.0% (2.3, 13.8), p=0.006, u b'bidla medja aġġustata fl-għadd ta' CD4 ta' 325 vs 281 ċelloli/ mm3, rispettivament.