FrancophonIA/ELRC3.0 huggingface dataset:
English: Liver chemistry 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: Kienu osservati elevazzjonijiet kimiċi fil-fwied konsistenti mas-sindromu ta' rikostituzzjoni immunitarja f'xi pazjenti b'epatite B u/jew C ko-infettati fil-bidu tat-terapija b'dolutegravir.
English: Frequencies are defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Maltese: Il-frekwenzi huma ddefiniti bħala: komuni ħafna (≥1/10), komuni (≥1/100 sa <1/10), mhux komuni (≥1/1,000 sa <1/100), rari
English: Following multipledose oral administration of lamivudine 300 mg once daily for seven days, the mean (CV) steady-state Cmax is 2.04 µg/mL (26%) and the mean (CV) AUC(0-24) is 8.87 µg.h/mL (21%).
Maltese: (26%) u l-AUC(0-24) (CV) medju huwa 8.87 µg.h/ml (21%).
English: Based on limited available data with the dolutegravir single entity or lamivudine single entity used in combination with other antiretroviral agents to treat adolescents (12 to 17 years), there were no additional types of adverse reactions beyond those observed in the adult population.
Maltese: sustanzi antiretrovirali oħra biex jiġu ttrattati l-adoloxxenti (12 sa 17-il sena), ma kien hemm ebda tipi addizzjonali ta' reazzjonijiet avversi lil hinn minn dawk osservati fil-popolazzjoni tal-adulti.
English: Dolutegravir is primarily metabolized and eliminated by the liver.
Maltese: Dolutegravir huwa metabolizzat u eliminat prinċipalment mill-fwied.
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: Patients with pre-existing liver dysfunction, including chronic active hepatitis have an increased frequency of liver function abnormalities during combination antiretroviral therapy, and should be monitored according to standard practice.
Maltese: Il-pazjenti b'disfunzjoni tal-fwied pre-eżistenti, inkluża epatite attiva kronika għandhom frekwenza miżjuda ta' anormalitajiet fil-funzjoni tal-fwied matul terapija antiretrovirali ta' kombinazzjoni, u għandhom jiġu ssorveljati skont il-prattika standard.
English: → Read the information ‘Allergic reactions' in section 4 of this leaflet.
Maltese: → Aqra l-informazzjoni “Reazzjonijiet allerġiċi” fis-sezzjoni 4 ta' dan il-fuljett.
English: Fosamprenavir/ritonavir decreases dolutegravir concentrations, but based on limited data, did not result in decreased efficacy in Phase III studies.
Maltese: Fosamprenavir/ritonavir inaqqas il konċentrazzjonijiet ta' dolutegravir, iżda abbażi ta' data limitata, ma rriżultax fi tnaqqis tal-effikaċja fl-istudji ta' Fażi
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 ↓ (Ma ġietx studjata, huwa mistenni tnaqqis minħabba l-induzzjoni talenzimi UGT1A1 u CYP3A, huwa mistenni tnaqqis simili fl esponiment bħal dak osservat b'carbamazepine).
English: If Dovato is discontinued in patients co-infected with hepatitis B virus, periodic monitoring of both liver function tests and markers of HBV replication is recommended, as withdrawal of lamivudine may result in an acute exacerbation of hepatitis.
Maltese: Jekk Dovato jitwaqqaf f'pazjenti ko-infettati bil-virus tal-epatite B, huwa rrakkomandat monitoraġġ perjodiku kemm tat-testijiet tal-funzjoni tal-fwied kif ukoll tall-markaturi tar-replikazzjoni HBV, peress li t twaqqif ta' lamivudine jista' jwassal għal aggravar akut tal-epatite.
English: Reproductive toxicology studies
Maltese: Prodotti mediċinali antiretrovirali
English: Antiretroviral medicinal products Non-nucleoside reverse transcriptase inhibitors Etravirine without boosted protease inhibitors /
Maltese: Inibituri non-nucleoside reverse transcriptase
English: • a high temperature (fever)
Maltese: • temperatura għolja (deni)
English: Drug Interactions Medicinal products by therapeutic areas
Maltese: Interazzjonijiet ma' prodotti mediċinali
English: Group O isolates from antiviral naïve patients tested for lamivudine activity were highly sensitive.
Maltese: L-iżolati talGrupp O minn pazjenti naïve għall-antivirali ttestjati għall-attività ta' lamivudine kienu sensittivi ħafna.
English: Double blind therapy will continue up to week 96, followed by open label therapy up to week 148.
Maltese: It-terapija double blind se tkompli sas-96 ġimgħa, segwita minn terapija miftuħa sal-148 ġimgħa.
English: • joint pain, stiffness and bone problems.
Maltese: • uġigħ fil‑ġogi, ebusija jew problemi fl‑għadam.
English: • lactic acidosis (excess lactic acid in the blood)
Maltese: • aċidożi lattika (aċidu lattiku żejjed fid-demm)
English: Polyvalent cationcontaining antacids are recommended to be taken 2 hours after or 6 hours before Dovato (see section 4.5).
Maltese: Huwa rrakkomandat li lantaċidi polivalenti li fihom katjoni jittieħdu sagħtejn wara jew 6 sigħat qabel Dovato (ara sezzjoni 4.5).
English: In vitro, lamivudine did not inhibit or induce CYP enzymes (such as CYP3A4, CYP2C9 or CYP2D6) and demonstrated no or weak inhibition of OATP1B1, OAT1B3, OCT3, BCRP, P-gp, MATE1 or MATE2-K. Lamivudine is therefore not expected to affect the plasma concentrations of medicinal products that are substrates of these enzymes or transporters.
Maltese: In vitro, lamivudine ma inibixxiex jew induċa enzimi CYP (bħal CYP3A4, CYP2C9 jew CYP2D6) u ma wera l-ebda inibizzjoni jew wera inibizzjoni baxxa ta' OATP1B1, OAT1B3, OCT3, BCRP, P-gp, MATE1
English: rhabdomyolysis
Maltese: Reazzjoni avversa
English: Dolutegravir ↔ AUC ↑ 7% Cmax ↑ 5% Cτ ↑ 8% Boceprevir ↔ (historical controls)
Maltese: Dolutegravir ↔ AUC ↑ 7% Cmax ↑ 5% Cτ ↑ 8% Boceprevir ↔
English: Dovato is used to treat HIV in adults and adolescents over 12 years old who weigh at least 40 kg.
Maltese: Dovato jintuża għat-trattament tal-HIV fl-adulti u fl-adolexxenti li jkollhom 12‑il sena u aktar, li jiżnu mill‑inqas 40 kg.
English: * The results of the pooled analysis are in line with those of the individual studies, for which the primary endpoint (difference in proportion <50 copies/mL plasma HIV-1 RNA at Week 48 based on the Snapshot algorithm for dolutegravir plus lamivudine versus dolutegravir plus tenofovir disoproxil /emtricitabine FDC) was met.
Maltese: * Ir-riżultati tal-analiżi kollettiva huma konformi ma' dawk tal-istudji individwali, li għalihom il-punt tat-tmiem primarju (id-differenza fil-proporzjon <50 kopja/mL HIV-1 RNA fil-plażma fit-48 Ġimgħa bbażata fuq l-algoritmu Snapshot għal dolutegravir flimkien ma' lamivudine meta mqabbel ma' dolutegravir flimkien ma' tenofovir disoproxil /emtricitabine FDC) kien issodisfat.
English: Metabolic parameters Weight and levels of blood lipids and glucose may increase during antiretroviral therapy (see section 4.4).
Maltese: Il‑piż u l‑livelli ta' lipidi u glukożju fid‑demm jistgħu jiżdiedu matul it‑terapija antiretrovirali (ara sezzjoni 4.4).
English: If Dovato is used in patients co-infected with hepatitis B an additional antiviral is therefore generally needed.
Maltese: Jekk Dovato jintuża f'pazjenti ko-infettati b'epatite B, huwa ġeneralment meħtieġ antivirali addizzjonali.
English: Changes in laboratory biochemistries
Maltese: Bidliet fil-bijokimiċi tal-laboratorju
English: Immune response syndrome
Maltese: Sindromu ta' rispons immuni
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: L-analiżi tal-farmakokinetika tal-popolazzjoni ta' dolutegravir permezz ta' data fl-adulti infettati b'HIV-1 uriet li ma kien ebda effett klinikament rilevanti tal-età fuq l-esponiment għal dolutegravir.
English: The apparent volume of distribution of dolutegravir (Vd/F) is 17-20 L. Intravenous studies with lamivudine showed that the mean apparent volume of distribution is 1.3 L/kg.
Maltese: Il-volum evidenti ta' distribuzzjoni ta' dolutegravir (Vd/F) huwa 17-20 L.
English: Dolutegravir inhibits HIV integrase by binding to the integrase active site and blocking the strand transfer step of retroviral Deoxyribonucleic acid (DNA) integration which is essential for the HIV replication cycle.
Maltese: Dolutegravir jinibixxi l-integrase tal-HIV billi jeħel mas-sit attiv tal-integrase u jimblokka l-pass tat trasferiment tal-fergħa tal-integrazzjoni ta' Deoxyribonucleic acid (DNA) retrovirali li huwa essenzjali għaċċiklu ta' replikazzjoni tal-HIV.
English: България ГлаксоСмитКлайн ЕООД
Maltese: ГлаксоСмитКлайн ЕООД Teл.:
English: In previously untreated patients receiving dolutegravir + 2 NRTIs in Phase IIb and Phase III, no development of resistance to the integrase inhibitor class, or to the NRTI class was seen (n=1118 follow-up of 48-96 weeks).
Maltese: F'pazjenti mhux ittrattati qabel li rċevew dolutegravir + 2 NRTIs fil-Fażi IIb u l-Fażi III, ma ntwera l-ebda żvilupp ta' reżistenza għall-klassi tal-inibitur tal-integrase, jew għall-klassi NRTI (n=1118, segwitu ta' 48-96
English: This combination may increase the risk for lactic acidosis in patients with moderate renal impairment (stage 3a creatinine clearance 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 tal-istadju 3a 45- 59 mL/min) u huwa rrakkomandat approċċ kawt.
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 Dovato) at the time of conception compared with mothers exposed to non-dolutegravir containing regimens (0.1%).
Maltese: Data preliminari minn studju ta' sorveljanza indikat inċidenza akbar ta' difett fit-tubu newrali (0.9%) f'ommijiet esposti għal dolutegravir (komponent ta' Dovato) fiż-żmien tal-konċepiment meta mqabbla ma' ommijiet esposti għal korsijiet li ma fihomx dolutegravir (0.1%).
English: nausea, diarrhoea
Maltese: dardir, dijarea
English: Anticonvulsants Carbamazepine/Dolutegravir
Maltese: Carbamazepine/Dolutegravir
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, ittessut ċervikali u t-tessut vaġinali kienet 6-10% ta' dawk fil-plażma korrispondenti fi stat fiss.
English: The adverse reactions from clinical study and post-marketing experience are listed in Table 2 by body system, organ class and absolute frequency.
Maltese: Ir-reazzjonijiet avversi minn studju kliniku u mill-esperjenza ta' wara t-tqegħid fis-suq huma elenkati fitTabella 2 skont is-sistema tal-ġisem, il-klassi tal-organi u l-frekwenza assoluta.
English: Active renal secretion of lamivudine in the urine is mediated through the organic cation transporter (OCT) 2 and multidrug and toxin extrusion transporters (MATE1 and MATE2-K).
Maltese: 2 u trasportaturi ta' diversi mediċini u tossini ta' estrużjoni (MATE1 u MATE2-K).
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: Abbażi ta' din id-data, dolutegravir mhuwiex mistenni li jaffettwa l-farmakokinetika ta' prodotti mediċinali li huma substrati ta' enzimi jew trasportaturi ewlenin (ara sezzjoni 4.5).
English: In rabbits, maternal toxicity (decreased food consumption, scant/no faeces/urine, suppressed body weight gain) was observed at 1000 mg/kg (0.55 times the 50 mg human clinical exposure, based on AUC following single dose in the fasted state).
Maltese: Fil-fniek, kienet osservata tossiċità materna (tnaqqis fil-konsum talikel, ftit jew xejn ippurgar/awrina, żieda mrażżna fil-piż tal-ġisem) f'1000 mg/kg (0.55 darba l-50 mg esponiment kliniku tal-bniedem, abbażi tal-AUC wara doża waħda fuq stonku vojt).
English: The results from two in vivo rat micronucleus tests with lamivudine were negative.
Maltese: Irriżultati ta' żewġ testijiet tal-mikronukleu tal-firien in vivo b'lamivudine kienu negattivi.
English: For patients receiving lamivudine 300 mg once daily, the terminal intracellular half-life of lamivudine-TP was 16 to 19 hours.
Maltese: Għal pazjenti li jirċievu lamivudine 300 mg darba kuljum, il-half-life intraċellulari terminali ta' lamivudine-TP kienet 16 sa 19
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: 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 tal-kampjuni tal farmakoġenomika miġbura fi studji kliniċi f'individwi b'saħħithom, individwi b'ġenotipi UGT1A1 (n=7) li jikkonferixxu metaboliżmu ħażin ta' dolutegravir kellhom 32% inqas tneħħija ta' dolutegravir u AUC 46% ogħla meta mqabbla ma' individwi b'ġenotipi assoċjati b'metaboliżmu normali permezz ta' UGT1A1
English: Exposure to dolutegravir was generally similar between healthy subjects and HIV-1-infected subjects.
Maltese: L-esponiment għal dolutegravir kien ġeneralment simili bejn l-individwi b'saħħithom u l-individwi infettati bl-HIV-1.
English: Liver chemistry elevations consistent with immune reconstitution syndrome were observed in some subjects with hepatitis B and/or C co-infection at the start of dolutegravir therapy, particularly in those whose anti-hepatitis B therapy was withdrawn (see section 4.4).
Maltese: Żidiet fil-kimika tal-fwied konsistenti mas-sindromu ta' rikostituzzjoni immuni kienu osservati f'xi persuni b'ko-infezzjoni b'epatite B u/jew C fil-bidu tat-terapija b'dolutegravir, partikolarment f'dawk li t-terapija tagħhom kontra l-epatite B twaqqfet (ara sezzjoni 4.4).
English: The mean ratio of CSF/serum lamivudine concentrations 2-4 hours after oral administration was approximately 12%.
Maltese: Il-proporzjon medju ta' konċentrazzjonijiet ta' lamivudine fis-CSF/seru 2-4 sigħat wara l-għoti orali kien madwar 12%.
English: This was supported by the pooled analysis, see Table 3.
Maltese: Dan kien appoġġat mill-analiżi kollettiva, ara Tabella 3.
English: Based on more than 200 mother/child pairs treated for HIV, serum concentrations of lamivudine in breastfed infants of mothers treated for HIV are very low (< 4% of maternal serum concentrations) and progressively decrease to undetectable levels when breastfed infants reach 24 weeks of age.
Maltese: Skont aktar minn 200 par ta' omm/wild ittrattati għall-HIV, il-konċentrazzjonijiet ta' lamivudine fis-seru fittrabi mreddgħin ta' ommijiet ittrattati għall-HIV huma baxxi ħafna (< 4% ta' konċentrazzjonijiet tas-seru talomm) u jonqsu progressivament għal livelli mhux perċettibbli meta t-trabi mreddgħin jgħalqu 24 ġimgħa.
English: Antacid medicines
Maltese: IL-PRODOTT MEDIĊINALI
English: You can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy.
Maltese: Il‑piż u l‑livelli ta' lipidi u glukożju fid‑demm jistgħu jiżdiedu matul it‑terapija antiretrovirali.
English: Etravirine ↔ (induction of UGT1A1 and CYP3A enzymes)
Maltese: Etravirine ↔ (induzzjoni tal-enzimi UGT1A1 u CYP3A)
English: Population pharmacokinetic analysis indicated that hepatitis C virus co-infection had no clinically relevant effect on the exposure to dolutegravir.
Maltese: Analiżi tal-farmakokinetika tal-popolazzjoni indikat li l-ko-infezzjoni tal-virus tal-epatite C ma kellha ebda effett rilevanti fuq l-esponiment għal dolutegravir.
English: Oral administration of dolutegravir to pregnant rats at doses up to 1000 mg/kg daily from days 6 to 17 of gestation did not elicit maternal toxicity, developmental toxicity or teratogenicity (37.2 times the 50 mg human clinical exposure, based on AUC following single dose in the fasted state).
Maltese: L-għoti orali ta' dolutegravir lill-firien tqal f'dożi sa 1000 mg/kg kuljum mis-6 jum sas-17-il jum talġestazzjoni ma wassalx għal tossiċità materna, tossiċita fl-iżvilupp jew teratoġeniċità (37.2 darbiet il-50 mg esponiment kliniku tal-bniedem, abbażi tal-AUC wara doża waħda fuq stonku vojt).
English: Administration of a single Dovato tablet with a high fat meal increased dolutegravir AUC(0-∞) and Cmax by 33% and 21%, respectively, and decreased the lamivudine Cmax by 30% compared to fasted conditions.
Maltese: L-għoti ta' pillola waħda Dovato flimkien ma' ikla b'ħafna xaħam żied l-AUC(0-∞) u s-Cmax ta' dolutegravir bi 33% u 21%, rispettivament, u naqqas is-Cmax ta' lamivudine bi 30% meta mqabbel mal-kundizzjonijiet fuq stonku vojt.
English: 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: Sodium stearyl fumarate
Maltese: (teħid fuq stonku vojt)
English: Patients with chronic hepatitis B or C and treated with combination antiretroviral therapy are at an increased risk of severe and potentially fatal hepatic adverse reactions.
Maltese: Mard epatiku Il-pazjenti b'epatite kronika B jew C u kkurati b'terapija antiretrovirali ta' kombinazzjoni huma f'riskju miżjud ta' reazzjonijiet epatiċi avversi severi u potenzjalment fatali.
English: No dose adjustment is necessary (see section 5.2).
Maltese: Mhuwiex meħtieġ aġġustament għad-doża (ara sezzjoni 5.2).
English: The observed lamivudine half-life of elimination is 18 to 19 hours.
Maltese: Il-half-life ta' eliminazzjoni osservata ta' lamivudine hija 18 sa 19-il siegħa.
English: • suicidal attempt (particularly in patients who have had depression or mental health problems before)
Maltese: • tentattiv ta' suwiċidju (partikolarment f'pazjenti li kellhom dipressjoni jew problemi ta' saħħa mentali fil-passat)
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: Ilkonċentrazzjoni ta' sustanza attiva meħtieġa biex taffettwa r-replikazzjoni virali b'50% (nofs ilkonċentrazzjoni inibitorja massima - IC50) varjat skont il-virus u t-tip ta' ċellula ospitanti.
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 għoti orali ta' doża waħda lil individwi Ġappuniżi tidher simili għal parametri osservati fl-individwi tal-Punent (Stati Uniti).
English: Although lamivudine is a substrate of BCRP and P-gp in vitro, given its high absolute bioavailability, (see section 5.2), inhibitors of these efflux transporters are unlikely to result in a clinically relevant impact on lamivudine concentrations.
Maltese: Għalkemm lamivudine huwa substrat ta' BCRP u P-gp in vitro, minħabba l-bijodisponibilità assoluta għolja tiegħu, (ara sezzjoni 5.2), huwa improbabbli li l-inibituri ta' dawn it-trasportaturi ta' efluss jirriżultaw f'impatt klinikament rilevanti fuq il-konċentrazzjonijiet ta' lamivudine.
English: Dovato 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, facial oedema, eosinophilia, angioedema).
Maltese: Dovato u prodotti mediċinali suspettużi oħrajn għandhom jitwaqqfu minnufih jekk jiżviluppaw sinjali jew sintomi ta' reazzjonijiet ta' sensittività eċċessiva (li jinkludu, iżda mhux biss, raxx sever jew raxx akkumpanjat b'żieda fl-enzimi tal-fwied, deni, telqa ġenerali, għeja, uġigħ fil-muskoli jew fil-ġogi, bżieżaq, leżjonijiet orali, konġuntivite, edema fil-wiċċ, esinofilja, anġjoedema).
English: Pharmacokinetic parameters are comparable to those reported in adults.
Maltese: Ilparametri tal-farmakokinetika huma komparabbli ma' dawk irrapportati fl-adulti.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (INDIVIDUAL PACKS ONLY)
Maltese: KARTUNA TA' BARRA (PAKKETTI INDIVIDWALI
English: Tipranavir ↔ Ritonavir ↔ (induction of UGT1A1 and CYP3A enzymes)
Maltese: Tipranavir ↔ Ritonavir ↔ (induzzjoni tal-enzimi UGT1A1 u CYP3A)
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%
English: Tablet coating
Maltese: Kisja tal-pillola
English: Dolutegravir was not mutagenic or clastogenic using in vitro tests in bacteria and cultured mammalian cells, and an in vivo rodent micronucleus assay.
Maltese: Karċinoġenesi u mutaġenesi Dolutegravir ma kienx mutaġeniku jew klastoġeniku permezz ta' testijiet in vitro fil-batterji u ċ-ċelloli tal mammiferi kulturati, u f'analiżi tal-mikronukleu tal-annimali gerriema in vivo.
English: Renal clearance of unchanged active substance is a minor pathway of elimination for dolutegravir.
Maltese: It-tneħħija renali tas-sustanza attiva mhux mibdula huwa passaġġ minuri ta' eliminazzjoni għal dolutegravir.
English: Lamivudine was not significantly metabolised by CYP enzymes.
Maltese: Lamivudine mhumiex metabolizzati b'mod sinifikanti minn enzimi CYP. Eliminazzjoni
English: The primary effect of dolutegravir was gastrointestinal intolerance or irritation in rats and monkeys at doses that produce systemic exposures approximately 28.5 and 1.1 times the 50 mg human clinical exposure following single dose in the fasted state based on AUC, respectively.
Maltese: L-effett primarju ta' dolutegravir kien intolleranza gastrointestinali jew irritazzjoni fil-firien u x-xadini b'dożi li jipproduċu esponimenti sistemiċi ta' madwar 28.5 u darba u nofs il-50 mg esponiment kliniku tal-bniedem wara doża waħda fuq stonku vojt abbażi tal-AUC, rispettivament.
English: Dovato is a medicine that contains two active ingredients used to treat human immunodeficiency virus (HIV) infection: dolutegravir and lamivudine.
Maltese: Dovato huwa mediċina li fih żewġ ingredjenti attivi li jintużaw biex jittrattaw l-infezzjoni mill-virus talimmunodefiċjenza umana (HIV): dolutegravir u lamivudine.
English: The mean systemic clearance of lamivudine is approximately 0.32 L/h/kg, predominantly by renal clearance (> 70%) via the organic cationic transport system.
Maltese: 32 L/h/kg, fil-biċċa kbira bi tneħħija mill kliewi (> 70%) permezz tas-sistema ta' trasport katjoniku organiku.
English: Fosamprenavir↔ Ritonavir ↔ (induction of UGT1A1 and CYP3A enzymes)
Maltese: Fosamprenavir↔ Ritonavir ↔ (induzzjoni tal-enzimi UGT1A1 u CYP3A)
English: fatigue
Maltese: Lott
English: Dolutegravir ↓ AUC ↓ 54% Cmax ↓ 57% C24 ↓ 56% (Complex binding to polyvalent ions)
Maltese: Dolutegravir ↓ AUC ↓ 54% Cmax ↓ 57% C24 ↓ 56%
English: • a decreased number of cells involved in blood clotting (thrombocytopenia)
Maltese: • numru inqas ta' ċelluli involuti fil-koagulazzjoni (tromboċitopenija).