FrancophonIA/ELRC3.0 huggingface dataset:
English: The decision to use dolutegravir in the presence of integrase class resistance should take into account that the activity of dolutegravir is considerably compromised for viral strains harbouring Q148+≥2 secondary mutations from G140A/C/S, E138A/K/T, L74I (see section 5.1).
Maltese: Id-deċiżjoni li jintuża dolutegravir fil-preżenza ta' reżistenza għall-klassi ta' integrase għandha tikkunsidra li l-attività ta' dolutegravir hija kompromessa b'mod konsiderevoli għar-razez virali li għandhom mutazzjonijiet sekondarji ta' Q148+>2 minn G140A/C/S, E138A/K/T, L74I (ara sezzjoni 5.1).
English: The mean IC50 for 3 HIV-2 isolates was 0.18 nM (range 0.09-0.61).
Maltese: L-IC50 għal 3 iżolati talHIV-2 kien 0.18 nM (medda 0.
English: Patients with prior treatment failure, but not exposed to the integrase class In the international multicentre, double-blind SAILING study (ING111762), 719 HIV-1 infected, antiretroviral therapy (ART)-experienced adults were randomized and received either dolutegravir 50 mg once daily or raltegravir 400 mg twice daily with investigator selected background regimen consisting of up to 2 agents (including at least one fully active agent).
Maltese: Fl-istudju internazzjonali multiċentri, double-blind SAILING (ING111762), 719-il persuna adulta infettati bl-HIV-1 li diġà kienu ħadu terapija antiretrovirali (ART) qabel, ġew magħżula b'mod aleatorju u rċevew Tivicay 50 mg darba kuljum jew raltegravir 400 mg darbtejn kuljum flimkien ma' terapija ta' sfond magħżula mill-investigatur li kien jinkludi sa 2 sustanzi (inkluż mill-anqas sustanza kompletament attiva waħda).
English: Changes in laboratory biochemistries
Maltese: Bidliet fil-bijokimika tal-laboratorju
English: Tivicay 10 mg film-coated tablets
Maltese: Tivicay 10 mg pilloli dolutegravir
English: Population pharmacokinetic analysis of dolutegravir using data in HIV-1 infected adults showed that there was no clinically relevant effect of age on dolutegravir exposure.
Maltese: Analiżi farmakokinetika tal-popolazzjoni dwar dolutegravir bl-użu ta' dejta minn persuni adulti infettati bl-HIV-1 uriet li ma kien hemm l-ebda effett klinikament rilevanti tal-età fuq l esponiment għal dolutegravir.
English: When excluding patients who stopped therapy for non-efficacy reasons, and those with major protocol deviations (incorrect dolutegravir dosing, intake of prohibited co-medication), namely, “the Virological Outcome (VO)-population)”, the corresponding response rates were 75% (120/161, week 24) and 69% (111/160, week 48).
Maltese: Ilpazjenti li waqqfu t-terapija b'dolutegravir għal raġunijiet ta' nuqqas ta' effikaċja, jew li kienu devjazzjonijiet mill-protokoll għal dożaġġ ħażin ta' dolutegravir jew użu ta' medikazzjoni pprojbita huma esklużi fl-analiżi tal-popolazzjoni b'Riżultati Viroloġiku (VO). Ir-rispons korrispondenti għall-popolazzjoni VO kien ta' 75% (120/161, ġimgħa 24 ) u 69% (111/160,
English: Atazanavir ↔ Ritonavir ↔ (inhibition of UGT1A1 and CYP3A enzymes)
Maltese: Etravirine ↔ (induzzjoni tal-enzimi UGT1A1 u CYP3A)
English: Uncommon Hypersensitivity (see section 4.4) Uncommon Immune Reconstitution Syndrome (see section 4.4)** Psychiatric disorders Common Insomnia Common Abnormal dreams
Maltese: Mhux komuni Sindrome tar-Rikostituzzjoni Immuni (ara sezzjoni 4.4)**
English: In SINGLE, 833 subjects were randomized and received at least one dose of either dolutegravir 50 mg once daily with fixed-dose abacavir-lamivudine (DTG + ABC/3TC) or fixed-dose efavirenz-tenofoviremtricitabine (EFV/TDF/FTC).
Maltese: F'SINGLE, 833 persuna ġew magħżula b'mod aleatorju u rċevew mill-anqas doża waħda ta' Tivicay 50 mg darba kuljum ma' doża fissa ta' abacavir-lamivudine (DTG + ABC/3TC) jew doża fissa ta' efavirenz-tenofovir-emtricitabine (EFV/TDF/FTC).
English: When mutations listed as secondary integrase inhibitor associated mutations (for raltegravir/elvitegravir) are added to these primary mutations in experiments with site directed mutants, dolutegravir susceptibility is still unchanged (FC <2 vs wild type virus), except in the case of Q148-mutations, where a FC of 5-10 or higher is seen with combinations of certain secondary mutations.
Maltese: Meta mutazzjonijiet elenkati bħala mutazzjonijiet sekondarji assoċjati mal-inibituri ta' integrase (għal raltegravir/elvitegravir) jiġu miżjuda ma' dawn il-mutazzjonijiet primarji f'esperimenti b'mutanti diretti mis-sit, is-suxxettibilità għal dolutegravir xorta ma tinbidilx (FC <2 vs virus fl-istat naturali (wild type)), ħlief fil-każ tal-mutazzjoni Q148, fejn tidher FC ta' 5-10 jew ogħla bilkombinazzjoni ta' mutazzjonijiet sekondarji.
English: At baseline, median patient age was 35 years, 16% were female, 32% nonwhite, 7% had hepatitis C co-infection and 4% were CDC Class C, these characteristics were similar between treatment groups.
Maltese: Fil-linja bażi, l-età medjana talpazjenti kienet 35, 16% kienu nisa, 32% ma kinux bojod, 7% kellhom ko-infezzjoni tal-epatite C u 4% kienu CDC ta' Klassi C, dawn il-karatteristiċi kienu simili bejn il-gruppi ta' kura.
English: To what extent dolutegravir provides added efficacy in the presence of such integrase class resistance is uncertain (see section 5.2).
Maltese: Mhux ċert sa liema livell dolutegravir jipprovdi effikaċja addizzjonali fil-preżenza ta' tali reżistenza għall-klassi ta' integrase (ara sezzjoni 5.2).
English: At baseline, median patient age was 36 years, 14% were female, 15% non-white, 11% had hepatitis B and/or C co-infection and 2% were CDC Class C, these characteristics were similar between treatment groups.
Maltese: Fil-linja bażi, l-età medjana tal-pazjenti kienet 36 sena, 14% kienu nisa, 15% ma kinux bojod, 11% kellhom ko infezzjoni tal-epatite B u/jew Ċ u 2% kienu CDC ta' Klassi C, dawn il-karatteristiċi kienu simili bejn il-gruppi ta' kura.
English: Adolescents aged 12 and above
Maltese: Adolexxenti minn 12-il sena 'l fuq
English: Dolutegravir ↔ AUC ↓ 5% Cmax ↑ 16% Cτ ↓ 30% (induction of UGT1A1 and CYP3A enzymes)
Maltese: Dolutegravir ↔ AUC ↓ 5% Cmax ↑ 16% Cτ ↓ 30% (induzzjoni tal-enzimi UGT1A1 u CYP3A)
English: § 4 subjects were excluded from the efficacy analysis due to data integrity at one study site *The Genotypic Susceptibility Score (GSS) was defined as the total number of ARTs in BR to which a subject's viral isolate showed susceptibility at baseline based upon genotypic resistance tests.
Maltese: *Il-Punteġġ tas-Suxxettibilità Ġenotipika (GSS) ġie definit bħala n-numru totali ta' ARTs fil-BR li iżolat virali ta' individwu wera suxxettibilità għalihom fil-linja bażi, abbażi ta' testijiet tarreżistenza ġenotipika.
English: In the double blind, placebo controlled VIKING-4 study (ING116529), 30 HIV-1 infected, ART-experienced adults with primary genotypic resistance to INIs at Screening, were randomised to receive either dolutegravir 50 mg twice daily or placebo with the current failing regimen for 7 days followed by an open label phase with all subjects receiving dolutegravir.
Maltese: Fl-istudju double-blind, ikkontrollat bil-plaċebo, VIKING-4 (ING116529), 30 persuna adulta infettati bl-HIV-1, li kienu ħadu ART qabel u li kellhom reżistenza ġenotipika primarja għall-INIs fl-Iskrining, ġew magħżula b'mod aleatorju sabiex jirċievu dolutegravir 50 mg darbtejn kuljum jew plaċebo mat-terapija kurrenti li ma ħadmitx, għal 7 ijiem segwit minn fażi open label bil persuni kollha jirċievu dolutegravir.
English: Dolutegravir ↓ (Not studied, decrease expected due to induction of UGT1A1 and CYP3A enzymes, a similar reduction in exposure as observed with carbamazepine is expected)
Maltese: Dolutegravir ↓ (Mhix studjata, huwa mistenni tnaqqis minħabba l-induzzjoni tal-enzimi UGT1A1 u CYP3A, huwa mistenni li jkun hemm tnaqqis simili fl espożizzjoni kif ġie osservat b'carbamazepine)
English: If you could get pregnant while receiving Tivicay, you need to use a reliable method of barrier contraception (for example, a condom) with other methods of contraception including oral (pill) or other hormonal contraceptives (for example, implants, injection), to prevent pregnancy.
Maltese: Jekk tista' toħroġ tqila waqt li tkun qed tirċievi Tivicay, jeħtieġ li tuża metodu ta' kontraċettiv barriera affidabbli (pereżempju, kondom) ma' metodi oħra ta' kontraċezzjoni inkluż orali (pillola) jew kontraċettivi ormonali oħra (pereżempju, impjanti, injezzjoni), biex tipprevjeni t-tqala.
English: Dolutegravir ↓ AUC ↓ 59% Cmax ↓ 47% Cτ ↓ 76% (induction of UGT1A1 and CYP3A enzymes)
Maltese: Dolutegravir ↓ AUC ↓ 59% Cmax ↓ 47% Cτ ↓ 76% (induzzjoni tal-enzimi UGT1A1 u CYP3A)
English: AUC ↓ 49% Cmax ↓ 33% Cτ ↓ 73%
Maltese: Dolutegravir ↓ AUC ↓ 49% Cmax ↓ 33% Cτ ↓ 73%
English: Q148 + 1 secondary mutation3
Maltese: Q148 + mutazzjoni sekondarja 13
English: The IC50 for dolutegravir in various labstrains using PBMC was 0.5 nM, and when using MT-4 cells it ranged from 0.7-2 nM.
Maltese: PBMC kien 0.5 nM, u meta ntużaw ċelloli MT-4 din varjat minn 0.7-2 nM.
English: Preliminary data from a surveillance study has suggested an increased incidence of neural tube defects (0.9%) in mothers exposed to dolutegravir at the time of conception compared with mothers exposed to nondolutegravir 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 meta ssir il-konċezzjoni meta mqabbel ma' ommijiet esposti għal reġimens li ma fihomx duletgravir (0.1%).
English: When co-administered with dolutegravir 50mg twice daily:
Maltese: dolutegravir 50mg 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: Relazzjoni(jiet) farmakokinetika(ċi)/farmakodinamika(ċi) Fi prova aleatorja b'firxa ta' dożi, il-pazjenti infettati bl-HIV-1 u li kienu qed jingħataw monoterapija b'dolutegravir (ING111521) urew attività antivirali rapida u dipendenti fuq id-doża, bi tnaqqis medju fl-HIV-1 RNA ta' 2.5 log10 f'jum 11 għad-doża ta' 50 mg.
English: Raltegravir/elvitegravir was part of the current failing regimen in 98/183 patients (part of prior failing therapies in the others).
Maltese: Raltegravir/elvitegravir kien parti mit-terapija kurrenti li ma ħadmitx f'90/183 pazjent (parti mit-terapiji preċedenti li ma ħadmux fl-oħrajn).
English: The incidence of neural tube defects in the general population ranges from 0.5-1 case per 1,000 live births (0.05-0.1%).
Maltese: L-inċidenza ta' difetti fit-tubu newrali fil-popolazzjoni ġenerali tvarja minn 0.5-1 każ għal kull 1,000 twelid (0.05-0.1%).
English: Liver biochemistry elevations consistent with immune reconstitution syndrome were observed in some hepatitis B and/or C co-infected patients at the start of dolutegravir therapy.
Maltese: Żidiet fil-bijokimika tal-fwied konsistenti mas-sindrome tar-rikostituzzjoni immunitarja kienu osservati f'xi pazjenti koinfettati bl-epatite B u/jew Ċ fil-bidu tat-terapija b'dolutegravir.
English: In FLAMINGO (ING114915), an open-label, randomised and active-controlled study, 484 HIV-1 infected antiretroviral naïve adults received one dose of either dolutegravir 50 mg once daily (n=242) or darunavir/ritonavir (DRV/r) 800 mg/100 mg once daily (n=242), both administered with either ABC/3TC or TDF/FTC.
Maltese: 50 mg darba kuljum (n=242) jew darunavir/ritonavir (DRV/r) 800 mg/100 mg darba kuljum (n=242), it-tnejn mogħtija jew ma' ABC/3TC jew ma' TDF/FTC.
English: Tivicay 50 mg film-coated tablets
Maltese: Tivicay 50 mg pilloli dolutegravir
English: At baseline, median patient age was 49 years, 20% were female, 58% non-white, and 23% had hepatitis B and/or C co-infection.
Maltese: Fil-linja bażi, l-età medjana tal-pazjenti kienet ta' 49 sena, 20% kienu nisa, 58% ma kinux bojod, u 23% kellhom ko-infezzjoni tal-epatite B u/jew C.
English: By BL HIV-1 RNA
Maltese: Sustanzi Antivirali għall-HIV-1
English: Tivicay 25 mg film-coated tablets
Maltese: Tivicay 25 mg pilloli dolutegravir
English: In a Phase I/II 48 week multicentre, open-label study (P1093/ING112578), the pharmacokinetic parameters, safety, tolerability and efficacy of Tivicay has been evaluated in combination regimens in HIV-1 infected, treatment-experienced, INI naive children and adolescents (6 to less than 18 years of age).
Maltese: I/II fuq 48 ġimgħa (P1093/ING112578), il-parametri farmakokinetiċi, is-sigurtà, it-tollerabbiltà u l-effikaċja ta' Tivicay ġew evalwati f'terapiji kombinati fi tfal u adolexxenti (minn 6 snin sa taħt it-18-il sena) infettati bl-HIV-1, li ħadu l-kura u li ma kinux ħadu INI L-individwi ġew stratifikati skont l-età, li ħadu Tivicay (70 mg, bħala
English: Dolutegravir ↓ AUC ↓ 35% Cmax ↓ 24% Cτ ↓ 49% (induction of UGT1A1 and CYP3A enzymes)
Maltese: Dolutegravir ↓ AUC ↓ 35% Cmax ↓ 24% Cτ ↓ 49% (induzzjoni tal-enzimi UGT1A1 u CYP3A)
English: The recommended adult dose of dolutegravir is 50 mg twice daily when co-administered with tipranavir/ritonavir.
Maltese: 50 mg darbtejn kuljum meta jingħata fl-istess ħin ma' tipranavir/ritonavir.
English: Mean change from baseline in HIV RNA at day 8 (primary endpoint) was -1.4log10 copies/mL (95% CI -1.3 - -1.5log10, p<0.001).
Maltese: Il-bidla medja fl-HIV RNA f'jum 8 (endpoint primarju) kienet ta' -1.4log10 kopji/mL (95% CI
English: In contrast, starting with mutants harbouring mutation Q148H (FC 1), a variety of secondary mutations were seen with a consequent increase of FC to values >10.
Maltese: B'kuntrast, meta l-bidu kien b'mutanti li kellhom il-mutazzjoni Q148H (FC 1), dehru varjetà ta' mutazzjonijiet sekondarji b'żieda konsegwenti fl-FC għal valuri ta' >10.
English: HIV-1 Antiviral Agents Non-nucleoside Reverse Transcriptase Inhibitors Etravirine without boosted protease inhibitors
Maltese: Non-nucleoside Reverse Transcriptase Inhibitors Etravirine mingħajr inibituri tal-protease msaħħa
English: The day 8 responses in this placebo controlled study were fully in line with those seen in VIKING-3 (not placebo controlled), including by baseline integrase resistance categories.
Maltese: Ir-risponsi ta' jum 8 f'dan l-istudju kkontrollat bil-plaċebo kienu kompletament konsistenti ma' dawk li dehru f'VIKING-3 (mhux ikkontrollat bil-plaċebo), inkluż skont ilkategoriji ta' reżistenza ta' integrase fil-linja bażi.
English: Within-subject variability (CVw%) is lower than between-subject variability.
Maltese: Il-varjabilità fi ħdan l-istess individwu (CVw%) hija aktar baxxa mill-varjabilità bejn individwi differenti.
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 t-tessut vaġinali kienu 6-10% ta' dawk fil-plażma korrispondenti fl-istat fiss.
English: Based on limited available data in children and adolescents (6 to less than 18 years of age and weighing at least 15 kg), there were no additional types of adverse reactions beyond those observed in the adult population.
Maltese: Abbażi tad-dejta limitata disponibbli fit-tfal u adolexxenti (6 snin sa taħt it-18-il sena u li jiżnu mill-anqas 15-il kg), ma kienx hemm tipi addizzjonali ta' reazzjonijiet avversi minbarra dawk osservati fil-popolazzjoni adulta.
English: Median baseline CD4+ was 160 cells/mm3, median duration of prior ART was 13 years, and 63% were CDC Class C. Subjects showed multiple class ART resistance at baseline: 80% had ≥2 NRTI, 73% ≥1 NNRTI, and 67% ≥2 PI major mutations; 83% had non-R5 virus.
Maltese: L-individwi wrew reżistenza multipla għallklassi ta' ART fil-linja bażi: 80% kellhom ≥2 NRTI, 73% ≥1 NNRTI, u 67% ≥2 mutazzjonijiet maġġuri ta' PI; 83 kellhom virus mhux R5.
English: A clinically relevant phenotypic cut-off value (FC vs wild type virus) has not been determined; genotypic resistance was a better predictor for outcome.
Maltese: Ma ġiex stabbilit valur fenotipiku ta' qtugħ il-linja klinikament rilevanti (FC vs virus fl-istat naturali); ir-reżistenza ġenotipika kienet fattur ta' tbassir aħjar għar-riżultat.
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-frazzjon mhux imwaħħal ta' dolutegravir fil-plażma jiżdied f'livelli baxxi ta' albumina fis-serum (<35 g/L) kif jidher f'individwi b'indeboliment moderat tal-fwied.
English: Pale yellow, round, biconvex tablets approximately 7 mm in diameter debossed with ‘SV 572' on one side and ‘25' on the other side.
Maltese: Pilloli sofor, tondi, bikonvessi, b'dijametru ta' madwar 7 mm u mnaqqxa b'‘SV 572' fuq naħa u ‘25' fuq in-naħa l-oħra.
English: Based on in vivo and/or in vitro data, dolutegravir is not expected to affect the pharmacokinetics of medicinal products that are substrates of any major enzyme or transporter such as CYP3A4, CYP2C9 and P-gp (for more information see section 5.2).
Maltese: Fuq il-bażi ta' dejta in vivo u/jew in vitro, dolutegravir mhuwiex mistenni li jaffettwa l-farmakokinetika tal-prodotti mediċinali li huma substrati ta' xi enzim jew trasportatur maġġuri bħal CYP3A4, CYP2C9 u P-gp (għal aktar informazzjoni ara sezzjoni 5.2).
English: In the presence of integrase class resistance this combination should be avoided (see section 4.4).
Maltese: Fil-preżenza ta' reżistenza għall-klassi integrase din il-kombinazzjoni għandha tiġi evitata (ara sezzjoni 4.4).
English: The pharmacokinetics of dolutegravir following single dose oral administration to Japanese subjects appear similar to observed parameters in Western (US) subjects.
Maltese: Il-farmakokinetika ta' dolutegravir wara l-għoti ta' doża unika mill-ħalq lil individwi Ġappuniżi tidher simili għall-parametri osservati f'persuni tal-Punent (Stati Uniti).
English: Resistance
Maltese: Depressjoni
English: This is supported by 96 week data from an open-label, randomized and activecontrolled study FLAMINGO (ING114915) and additional data from the open-label phase of SINGLE to 144 weeks.
Maltese: Dan huwa appoġġat minn dejta ta' 96 ġimgħa minn studju b'tikketta mikxufa, randomizzat u kkontrollat b'mod attiv FLAMINGO (ING114915) u dejta addizzjonali mill-fażi tat-tikketta mikxufa ta' SINGLE għal 144 ġimgħa.
English: CD4+ Cell Count
Maltese: CD4+ fil-Linja bażi (ċelloli/
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% fit-tneħħija tal-krejatinina (il-frazzjon sekretorju huwa dipendenti fuq it-trasport ta'
English: Warnings and precautions Look out for important symptoms
Maltese: Oqgħod attent għal xi sintomi importanti
English: Co-administration with dofetilide (see section 4.5).
Maltese: Għoti fl-istess ħin ma' dofetilide (ara sezzjoni 4.5). 4.4
English: NRTI, 75% ≥1 NNRTI, and 71% ≥2 PI major mutations; 62% had non-R5 virus.
Maltese: Il-pazjenti wrew reżistenza multipla għall-klassi ta' ART fil-linja bażi: 79% kellhom ≥2 NRTI, 75% ≥1 NNRTI, u 71% ≥2 mutazzjonijiet maġġuri ta' PI; 62% kellhom virus mhux
English: The absolute bioavailability of dolutegravir has not been established.
Maltese: Il-bijodisponibilità assoluta ta' dolutegravir ma ġietx stabbilita.
English: 25 mg once daily
Maltese: 25 mg darba kuljum
English: Following oral administration of tablet formulations, in general, dolutegravir exhibited nonlinear pharmacokinetics with less than dose-proportional increases in plasma exposure from 2 to 100 mg; however increase in dolutegravir exposure appears dose proportional from 25 mg to 50 mg for the tablet formulation.
Maltese: Wara l-għoti mill-ħalq ta' formulazzjonijiet tal-pillola, b'mod ġenerali, dolutegravir wera farmakokinetika mhux lineari b'żidiet inqas milli proporzjonali mad-doża fl-esponiment talplażma minn 2 għal 100 mg; madankollu, iż-żieda fl-esponiment għal dolutegravir tidher proporzjonali mad-doża minn 25 mg għal 50 mg għall-formulazzjoni tal-pillola.
English: Dolutegravir ↓ (Not studied, a similar reduction in exposure as observed with efavirenz is expected, due to induction)
Maltese: Dolutegravir ↓ (Mhix studjata, huwa mistenni tnaqqis simili flesponiment kif osservat b'efavirenz, minħabba l induzzjoni)
English: AUC in semen was 7% and 17% in rectal tissue of those in corresponding plasma at steady state.
Maltese: L-AUC fis-semen kienet 7% u 17% fit-tessut tar-rektum ta' dawk fil plażma korrispondenti fl-istat fiss.
English: Particular diligence should be applied in initiating or maintaining effective hepatitis B therapy (referring to treatment guidelines) when starting dolutegravir-based therapy in hepatitis B co-infected patients (see section 4.8).
Maltese: Għandha ssir attenzjoni partikolari fil-bidu jew fiż-żamma ta' terapija effettiva għall-epatite B (b'referenza għal-linji gwida dwar il-kura) meta tinbeda terapija bbażata fuq dolutegravir f'pazjenti ko-infettati bl-epatite B (ara sezzjoni 4.8).
English: Dolutegravir and other suspect medicinal products should be discontinued immediately if signs or symptoms of hypersensitivity reactions develop (including, but not limited to, severe rash or rash accompanied by raised liver enzymes, fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis,
Maltese: Dolutegravir u prodotti mediċinali oħra ta' suspett għandhom jitwaqqfu immedjatament jekk jiżviluppaw sinjali jew sintomi ta' reazzjonijiet ta' sensittività eċċessiva (li jinkludu, iżda li mhumiex limitati għal, raxx sever jew raxx akkumpanjat minn żieda fl-enzimi tal-fwied, deni, telqa ġenerali, għeja, uġigħ fil-muskoli jew fil-ġogi, infafet, leżjonijiet fil-ħalq, konġuntivite, edima fil-wiċċ, esinofilija, anġjoedima).
English: Yellow, round, biconvex tablets approximately 9 mm in diameter debossed with ‘SV 572' on one side and ‘50' on the other side.
Maltese: Pilloli sofor, tondi, bikonvessi, b'dijametru ta' madwar 9 mm u mnaqqxa b'‘SV 572' fuq naħa u ‘50' fuq in-naħa l-oħra.
English: Tivicay 25 mg film-coated tablets are pale yellow, round, biconvex tablets marked with the code ‘SV 572' on one side and ‘25' on the other side.
Maltese: Tivicay 25 mg pilloli miksijin b'rita huma pilloli sofor ċari, tondi, bikonvessi u mmarkati bil kodiċi ‘SV 572' fuq naħa u ‘25' fuq in-naħa l-oħra.
English: The primary effect of dolutegravir was gastrointestinal intolerance or irritation in rats and monkeys at doses that produce systemic exposures approximately 21 and 0.82 times the 50 mg twice daily human clinical exposure based on AUC, respectively.
Maltese: L-effett primarju ta' dolutegravir kien intolleranza jew irritazzjoni gastrointestinali fil-firien u x-xadini b'dożi li jipproduċu esponimenti sistemiċi ta' madwar 21 u 0.
English: A dose adjustment of metformin should be considered when starting and stopping coadministration of dolutegravir with metformin, to maintain glycaemic control.
Maltese: Fejn ikun possibbli għandhom jintużaw kombinazzjonijiet alternattivi li ma jinkludux dawn l-indutturi metaboliċi f'pazjenti reżistenti għal INI.
English: Because gastrointestinal (GI) intolerance is considered to be due to local active substance administration, mg/kg or mg/m2 metrics are appropriate determinates of safety cover for this toxicity.
Maltese: metriċi ta' mg/kg jew mg/m2 huma determinati xierqa tal-kopertura tas-sigurtà għal dan l-effett tossiku.
English: Dolutegravir is primarily metabolized through glucuronidation via UGT1A1 with a minor CYP3A component.
Maltese: Dolutegravir jiġi metabolizzat prinċipalment bi glukuronidazzjoni permezz ta' UGT1A1 ma' komponent żgħir ta' CYP3A.
English: In 13 treatment-naïve subjects on a stable dolutegravir plus abacavir/lamivudine regimen, dolutegravir concentration in CSF averaged 18 ng/mL (comparable to unbound plasma concentration, and above the IC50).
Maltese: Fi 13-il pazjent li ma kinux ħadu kura qabel fuq reġim stabbli ta' dolutegravir flimkien ma' abacavir/lamivudine, il konċentrazzjoni ta' dolutegravir fis-CSF kienet medja ta' 18 ng/mL (komparabbli mal konċentrazzjoni mhux imwaħħla mal-plażma, u 'l fuq mill-IC50).