FrancophonIA/ELRC3.0 huggingface dataset:
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Gilead Sciences Intl Ltd
Maltese: Gilead Sciences Intl Ltd
English: Among subjects with a genotypic sensitivity score of ≤ 1, 76% and 69% had HIV-1 RNA < 50 copies/mL at week 48 in the elvitegravir and raltegravir treatment arms, respectively.
Maltese: Fost individwi b'punteġġ ta' sensittività ġenotipika ta' ≤ 1, 76% u 69% kellhom HIV-1 RNA ta' < 50 kopja/mL f'ġimgħa 48 fil-partijiet tal-istudju dwar elvitegravir u raltegravir, rispettivament.
English: Upon boosting with ritonavir (100 mg), net inhibition of elvitegravir metabolism is observed with significantly increased systemic exposures (20-fold higher AUC), high trough concentrations, and longer median elimination half-life (9.5 versus 3.5 hours).
Maltese: Malli jsir it-tisħiħ b'ritonavir (100 mg), l-inibizzjoni netta tal-metaboliżmu ta' elvitegravir tiġi osservata b'esponimenti sistemiċi miżjuda b'mod sinifikanti (AUC ogħla 20 darba aktar), konċentrazzjonijiet minimi ogħla, u medjan itwal tal-half-life ta' eliminazzjoni (9.5 kontra 3.5 sigħat).
English: Among subjects with a genotypic sensitivity score > 1, 57% and 56% had HIV-1 RNA < 50 copies/mL at week 48 in the elvitegravir and raltegravir treatment arms, respectively.
Maltese: Fost individwi b'punteġġ ta' sensittività ġenotipika ta' ≤ 1, 57% u 56% kellhom HIV-1 RNA ta' < 50 kopja/mL f'ġimgħa 48 fil-partijiet tal-istudju dwar elvitegravir u raltegravir, rispettivament.
English: When used in combination with atazanavir/ritonavir and lopinavir/ritonavir, the dose of Vitekta should be decreased from 150 mg once daily to 85 mg once daily (see section 4.2).
Maltese: Meta tintuża flimkien ma' atazanavir/ritonavir u lopinavir/ritonavir, id-doża ta' Vitekta għandha titnaqqas minn 150 mg darba kuljum għal 85 mg darba kuljum (ara sezzjoni 4.2).
English: In an analysis of HIV-1 isolates from treatment-failure subjects in study GS-US-183-0145 through week 96, the development of one or more primary elvitegravir resistance-associated substitutions was observed in 23 of the 86 subjects with evaluable genotypic data from paired baseline and elvitegravir treatment-failure isolates (23/351 elvitegravir-treated subjects, 6.6%).
Maltese: F'analiżi ta' iżolati ta' HIV-1 minn individwi li fihom it-trattament ma rnexxiex fi studju GS-US-183-0145 sa ġimgħa 96, ġie osservat żvilupp ta' sostituzzjoni primarja waħda jew iktar ta' reżistenza assoċjata ma' elvitegravir fi 23 mis-86 individwu b'dejta ġenotipika li setgħet tiġi evalwata minn linja bażi paired u iżolati ta' trattament b'elvitegravir li ma rnexxietx (23/351 individwu ttrattati b'elvitegravir, 6.6%).
English: Patients with HIV and hepatitis B or C virus co-infection Patients with chronic hepatitis B or C treated with antiretroviral therapy are at an increased risk for severe and potentially fatal hepatic adverse reactions.
Maltese: Pazjenti infettati kemm bl-HIV kif ukoll bil-virus ta' l-epatite B jew Ċ Pazjenti b'epatite kronika B jew Ċ u li huma ttrattati b'terapija antiretrovirali huma f'riskju akbar għal reazzjonijiet avversi epatiċi severi u potenzjalment fatali.
English: However, clinical data have shown there are no clinically relevant changes in the exposure of methadone (which is primarily metabolised by CYP2B6 and CYP2C19) following co-administration with boosted elvitegravir versus administration of methadone alone (see Table 2).
Maltese: Madankollu, dejta klinika ma wriet l-ebda tibdil kliniku rilevanti fl-esponiment ta' methadone (li hu primarjament metabolizzat minn CYP2B6 u CYP2C19) wara l-għoti flimkien ma' elvitegravir imsaħħaħ versus lgħoti ta' methadone waħda (ara Tabella 2).
English: Mean steady-state exposure (AUCtau) of unboosted elvitegravir is ~ 20% lower after multiple dosing versus a single dose, indicating modest autoinduction of its metabolism.
Maltese: L-esponiment medju fl-istat stabbli (AUCtau) ta' elvitegravir mhux imsaħħaħ hu ~ 20% inqas wara dożaġġ multiplu kontra doża waħda, li jindika awtoinduzzjoni modest tal-metaboliżmu tiegħu.
English: Consequently, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Konsegwentement, pazjenti li għandhom problemi ereditarji rari ta' intolleranza għall-galactose, nuqqas ta' Lapp lactase jew għandhom problemi biex jassorbu l-glucose-galactose m'għandhomx jieħdu dan il-prodott mediċinali.
English: Elvitegravir is a modest inducer and may have the potential to induce CYP2C9 and/or inducible UGT enzymes.
Maltese: Elvitegravir hu induttur modest u jista' jkollu l-potenzjal li jinduċi CYP2C9 u/jew enzimi UGT li jistgħu jiġu indotti.
English: Patients using oestrogens as hormone replacement therapy should be clinically monitored for signs of oestrogen deficiency (see section 4.5).
Maltese: Pazjenti li jużaw estroġeni bħala terapija ta' sostituzzjoni tal-ormoni għandhom jiġu mmonitorjati klinikament għal sinjali ta' defiċjenza tal-estroġenu (ara sezzjoni 4.5).
English: Virologic success HIV-1 RNA < 50 copies/mL
Maltese: Elvitegravir ma kienx inferjuri fil-kisba ta' HIV-1 RNA < 50 kopja/mL meta mqabbel ma' raltegravir.
English: Stavudine: AUC: ↔ Cmax: ↔
Maltese: AUC: ↔ Cmax: ↔
English: Breast-feeding
Maltese: Rilpivirine
English: Adverse reactions to elvitegravir from clinical study experience are listed in Table 3 below, by body system organ class and frequency.
Maltese: Reazzjonijiet avversi għal elvitegravir mill-esperjenza tal-istudji kliniċi huma elenkati f'Tabella 3 hawn taħt, skont il-klassi ta' sistema tal-organi fil-ġisem u l-frekwenza.
English: As such, elvitegravir may decrease the plasma concentration of substrates of CYP2C9 (such as warfarin) or UGT (such as ethinyl estradiol).
Maltese: Minħabba f'hekk, elvitegravir jista' jnaqqas il-konċentrazzjoni ta' substrati ta' CYP2C9 (bħal warfarin) jew UGT (bħal ethinyl estradiol) fil-plażma.
English: Accordingly, when used in combination with atazanavir/ritonavir and lopinavir/ritonavir, the dose of Vitekta should be decreased from 150 mg once daily to 85 mg once daily (see sections 4.2 and 4.4).
Maltese: Għaldaqstant, meta tintuża flimkien ma' atazanavir/ritonavir u lopinavir/ritonavir, id-doża ta' Vitekta għandha titnaqqas minn 150 mg darba kuljum għal 85 mg darba kuljum (ara sezzjonijiet 4.2 u 4.4).
English: The efficacy of elvitegravir is primarily based on the analyses through 96 weeks from one randomised, double-blind, active-controlled study, study GS-US-183-0145, in treatment-experienced, HIV-1 infected patients (n = 702).
Maltese: F'pazjenti infettati bl-HIV li rċivew trattament fil-passat L-effikaċja ta' elvitegravir hi primarjament ibbażata fuq l-analiżijiet sa ġimgħa 96 minn studju wieħed, GS-US-183-0145, li fih il-parteċipanti ntgħażlu b'mod każwali, double-blind, ikkontrollat b'mod attiv, fit-trattament ta' pazjenti infettati bl-HIV-1 li rċivew trattament fil-passat (n = 702).
English: §Due to inhibition of CYP3A by ritonavir, ketoconazole exposure is increased.
Maltese: Minħabba l-inibizzjoni ta' CYP3A minn ritonavir, lesponiment għal ketoconazole jiżdied.
English: Vitekta 150 mg film-coated tablets Elvitegravir
Maltese: Vitekta 150 mg pilloli miksija b'rita Elvitegravir
English: Co-administration of Vitekta with moderate CYP3A inducers (including, but not limited to, efavirenz and bosentan) is not
Maltese: L-għoti flimkien ta' Vitekta ma' indutturi moderati ta' CYP3A (li jinkludu, iżda mhumiex limitati għal, efavirenz u bosentan)
English: No clinically relevant pharmacokinetic differences due to ethnicity have been identified for boosted
Maltese: L-ebda differenza farmakokinetika klinikament rilevanti minħabba l-etniċità ma ġiet identifikata għal
English: Elvitegravir has not been studied in patients with severe hepatic impairment (Child-Pugh Class C).
Maltese: Elvitegravir ma ġiex studjat f'pazjenti b'indeboliment epatiku sever (Child-Pugh Klassi Ċ).
English: The choice of dose of Vitekta depends on the co-administered protease inhibitor (see Table 1 and sections 4.4 and 4.5).
Maltese: L-għażla tad-doża ta' Vitekta tiddependi fuq l-inibitur talprotease mogħti flimkien (ara Tabella 1 u sezzjonijiet 4.4 u 4.5).
English: Metabolites produced by aromatic and aliphatic hydroxylation or glucuronidation are present in very low levels and do not contribute to the overall antiviral activity of elvitegravir.
Maltese: Il-metaboliti prodotti minn hydroxylation aromatika u alifatika jew metaboliti tal-glukoronidazzjoni huma preżenti f'livelli baxxi ħafna u ma jikkontribwixxux għall-attività antivirali globali ta' elvitegravir.
English: The hormonal contraceptive should contain at least 30 µg ethinylestradiol and contain norgestimate as the progestagen or patients should use an alternative reliable method of contraception (see sections 4.4 and 4.6).
Maltese: Ilkontraċettiv ormonali għandu jkun fih mill-inqas 30 µg ta' ethinylestradiol u fih norgestimate bħala l-progestagen jew il-pazjenti għandhom jużaw metodu affidabbli alternattiv ta' kontraċezzjoni (ara sezzjonijiet 4.4 u 4.6).
English: In phenotypic analyses of HIV-1 isolates with resistance substitutions from elvitegravir-treated subjects, 14/20 (70%) had reduced susceptibility to elvitegravir and 12/20 (60%) had reduced susceptibility to raltegravir.
Maltese: F'analiżijiet fenotipiċi ta' iżolati ta' HIV-1 b'sostituzzjonijiet tar-reżistenza minn individwi ttrattati b'elvitegravir, 14/20 (70%) kellhom suxxetibilità mnaqqsa għal elvitegravir, u 12/20 (60%) kellhom suxxettibilità mnaqqsa għal raltegravir.
English: In an in vitro chromosomal aberration test, elvitegravir was negative with metabolic activation; however, an equivocal response was observed
Maltese: F'test in vitro dwar aberrazzjonijiet kromosomali, elvitegravir kien negattiv b'attivazzjoni metabolika; madankollu, ġie osservat rispons
English: Although limited by the small number of female subjects in study GS-US-183-0145, subgroup analysis by gender showed that the rates of virologic success in female subjects at weeks 48 and 96 (HIV-1 RNA < 50 copies/mL) were numerically lower in the elvitegravir treatment arm than in the raltegravir treatment arm. Virologic success rates at week 48 for elvitegravir and raltegravir were 47.5% (28/59) and 62.7% (42/67) (difference: -12.3% [95% CI: -30.1% to 5.5%]), respectively, for female subjects, and 62.3% (182/292) and 56.3% (160/284) (difference: 5.3% [95% CI: -2.5% to 13.2%]), respectively, for male subjects.
Maltese: Ir-rati ta' success viroloġiku f'ġimgħa 48 għal elvitegravir u raltegravir kienu 47.5% (28/59) u 62.7% (42/67) (differenza: -12.3% [95% CI: -30.
English: In study GS-US-183-0145, patients were randomised in a 1:1 ratio to receive either elvitegravir (150 mg or 85 mg) once daily or raltegravir 400 mg twice daily, each administered with a background regimen (BR) containing a fully-active ritonavir-boosted protease inhibitor (either atazanavir, darunavir, fosamprenavir, lopinavir or tipranavir) and a second agent.
Maltese: Fi studju GS-US-183-0145, il-pazjenti ntgħażlu b'mod każwali fi proporzjon ta' 1:1 biex jirċievu jew elvitegravir (150 mg jew 85 mg) darba kuljum jew raltegravir 400 mg darbtejn kuljum, kull wieħed mogħti ma' kors fl-isfond (BR) li kien fih inibitur tal-protease imsaħħaħ b'ritonavir attiv b'mod sħiħ (jew atazanavir, darunavir, fosamprenavir, lopinavir jew tipranavir) u t-tieni mediċina.
English: Elvitegravir undergoes oxidative metabolism by CYP3A (major route), and glucuronidation via
Maltese: Elvitegravir jgħaddi minn metaboliżmu ossidattiv minn CYP3A (rotta prinċipali), u glukoronidazzjoni
English: No dose adjustment of Vitekta is required in patients with mild (Child-Pugh Class A) or moderate hepatic impairment (Child-Pugh Class B).
Maltese: L-ebda aġġustament fid-doża ta' Vitekta mhu meħtieġ f'pazjenti b'indeboliment epatiku ħafif (Child-Pugh Klassi A) jew moderat (Child-Pugh Klassi B).
English: Baseline characteristics and treatment outcomes through 96 weeks for study GS-US-183-0145 are presented in Tables 4 and 5 respectively.
Maltese: Il-karatteristiċi fil-linja bażi u r-riżultati tat-trattament sa 96 ġimgħa għal GS-US-183-0145 huma ppreżentati f'Tabelli 4 u 5, rispettivament.
English: A study of the pharmacokinetics of boosted elvitegravir was performed in non HIV-1 infected subjects with severe renal impairment (estimated creatinine clearance below 30 mL/min).
Maltese: Studju dwar il-farmakokinetika ta' elvitegravir imsaħħaħ twettaq f'individwi li ma kinux infettati blHIV-1 b'indeboliment renali sever (tneħħija tal-krejatinina taħt 30 mL/min).
English: Elvitegravir
Maltese: Osteonekrożi
English: Interactions between elvitegravir and potential co-administered medicinal products are listed in Table 2 below (increase is indicated as “↑”, decrease as “↓”, no change as “↔”).
Maltese: Interazzjonijiet bejn elvitegravir u prodotti mediċinali li potenzjalment jingħataw flimkien huma elenkati fit-Tabella 2 hawn taħt (żieda hija indikata b'“↑”, tnaqqis b'“↓”, ebda bidla b'“↔”).
English: Vitekta 85 mg film-coated tablets
Maltese: Vitekta 85 mg pilloli miksija b'rita
English: • Use effective contraception while taking Vitekta.
Maltese: • Uża kontraċezzjoni effettiva waqt li tkun qed tieħu Vitekta.
English: CB21 6GT
Maltese: GĦALL-ĦRUĠ TAL
English: The most frequently reported adverse reactions to elvitegravir were diarrhoea (7.1%) and nausea
Maltese: L-iktar reazzjonijiet avversi li kienu rrappurtati b'mod frekwenti għal elvitegravir kienu dijarea (7.1%)
English: integrase strand transfer inhibitor, fusion inhibitor, or CCR5 co-receptor antagonist classes showed no antagonism.
Maltese: inibitur tat-trasferiment ta' integrase strand, inibitur tal-fużjoni, jew klassijiet ta' antagonisti ta' koriċettur CCR5, ma wriet l-ebda antagoniżmu.
English: Limited data from population pharmacokinetic analysis (n = 56) indicated that hepatitis B and/or C virus infection had no clinically relevant effect on the exposure of boosted elvitegravir.
Maltese: Infezzjoni bil-virus tal-epatite B u/jew epatite Ċ ukoll Dejta limitata minn analiżi farmakokinetika tal-popolazzjoni (n = 56) indikat li infezzjoni bil-virus talepatite B u/jew Ċ ma kellha l-ebda effett klinikament rilevanti fuq l-espożizzjoni ta' elvitegravir
English: Excipient with known effect: Each tablet contains 10.9 mg lactose (as monohydrate).
Maltese: 9 mg ta' lactose (bħala monohydrate).
English: ANTIRETROVIRALS
Maltese: KONTRAĊETTIVI ORALI
English: Lopinavir/Ritonavir (400/100 mg twice daily)
Maltese: kuljum) Ritonavir (100 mg darba kuljum)
English: Discontinued study drug
Maltese: TAL-PRODOTT MEDIĊINALI
English: Elvitegravir (simultaneous
Maltese: TWISSIJA(IET) SPEĊJALI
English: Take the 85 mg tablet at the same time as atazanavir and ritonavir, or at the same time as the first dose of lopinavir/ritonavir.
Maltese: Ħu l-pillola ta' 85 mg fl-istess ħin bħal atazanavir u ritonavir, jew flistess ħin bħal-ewwel doża ta' lopinavir/ritonavir.
English: Co-administration of Vitekta with medicinal products that are moderate inducers of CYP3A (including, but not limited to, efavirenz and bosentan) is not recommended as the expected decrease in plasma concentrations of elvitegravir can lead to loss of therapeutic effect and possible development of resistance to elvitegravir (see section 4.4).
Maltese: L-għoti ta' Vitekta ma' prodott mediċinali li huma indutturi moderati ta' CYP3A (li jinkludu, iżda mhumiex limitati għal, efavirenz u bosentan) mhuwiex rakkomandat għax it-tnaqqis mistenni filkonċentrazzjonijiet ta' elvitegravir fil-plażma jista' jwassal għat-telf tal-effett terapewtiku u l-iżvilupp possibbli ta' reżistenza għal elvitegravir (ara sezzjoni 4.4).
English: For use of the 85 mg tablet, please refer to the Summary of Product Characteristics for Vitekta 85 mg tablets.
Maltese: Għall-użu tal-pillola ta' 85 mg, jekk jogħġbok irreferi għas-Sommarju tal-Karatteristiċi tal-Prodott għal Vitekta 85 mg pilloli.
English: No clinically relevant differences in elvitegravir pharmacokinetics were observed between subjects with moderate impairment and healthy subjects.
Maltese: L-ebda differenzi klinikament rilevanti fil-farmakokinetika ta' elvitegravir ma ġew osservati bejn individwi b'indeboliment moderat u individwi b'saħħithom.
English: a Week 48 window is between day 309 and 364 (inclusive), week 96 window is between day 645 and 700 (inclusive).
Maltese: L-intervall ta' żmien ta' gimgħa 48 hu bejn jum 309 u 364 (inklużiv), l-intervall ta' żmien ta' ġimgħa 96 hu bejn jum 645
English: • if you are taking one of these medicines: carbamazepine, phenobarbital, phenytoin, used to treat epilepsy and prevent seizures rifampicin, used to prevent and treat tuberculosis and other infections St. John's wort (Hypericum perforatum), a herbal remedy used for depression and anxiety, or products that contain it
Maltese: • Jekk qed tieħu xi waħda minn dawn il-mediċini: - carbamazepine, phenobarbital, phenytoin, jintużaw għall-kura ta' epilessija u lprevenzjoni ta' aċċessjonijiet - rifampicin, jintuża għal prevenzjoni u għal trattament ta' tuberkulosi u infezzjonijiet oħrajn - St.
English: In study GS-US-183-0145, the mean increase from baseline in CD4+ cell count at week 96 was in the elvitegravir-treated patients and 198 cells/mm in the raltegravir-treated patients.
Maltese: Fi studju GS-US-183-0145, il-medja taż-żieda mil-linja bażi fl-għadd taċ-ċelluli CD4+ f'ġimgħa 96 fil-pazjenti ttrattati b'elvitegravir u 198 ċellula/mm fil-pazjenti ttrattati
English: • efavirenz
Maltese: Reazzjoni avversa
English: Co-administration with the following medicinal products due to the potential for loss of virologic response and possible development of resistance (see section 4.5):
Maltese: L-għoti flimkien mal-prodotti mediċinali li ġejjin minħabba l-potenzjal għal nuqqas ta' rispons viroloġiku u l-iżvilupp possibbli ta' reżistenza (ara sezzjoni 4.5):
English: §Due to inhibition of CYP3A by ritonavir, maraviroc exposure is significantly increased.
Maltese: §Minħabba l-inibizzjoni ta' CYP3A minn ritonavir, lesponiment għal maraviroc jiżdied b'mod sinifikanti.
English: HMG-CoA REDUCTASE INHIBITORS
Maltese: IMPEDITURI TA' HMG-CoA REDUCTASE Rosuvastatin (10 mg doża waħda)
English: Famotidine (40 mg once daily) Elvitegravir (150 mg once daily) Cobicistat (150 mg once daily)
Maltese: Ethinylestradiol (0.025 mg darba kuljum)/Elvitegravir (150 mg darba kuljum)
English: Elvitegravir: AUC: ↔ Cmax: ↔ Cmin: ↔
Maltese: Darunavir: AUC: ↔ Cmax: ↔ Cmin: ↓ 17%
English: Animal studies do not indicate harmful effects of elvitegravir on fertility.
Maltese: Studji f'annimali ma jurux effetti ħżiena ta' elvitegravir fuq il-fertilità.
English: Women of childbearing potential / contraception in males and females The use of Vitekta must be accompanied by the use of effective contraception (see sections 4.4 and 4.5).
Maltese: Nisa f'età li jista' jkollhom it-tfal/kontraċezzjoni fl-irġiel u n-nisa L-użu ta' Vitekta irid jiġi akkompanjat mill-użu ta' kontraċettiv effettiv (ara sezzjonijiet 4.4 u 4.5).
English: Elvitegravir-resistant viruses show varying degrees of cross-resistance to the integrase strand transfer inhibitor raltegravir depending on the type and number of substitutions.
Maltese: Viruses reżistenti għal elvitegravir juru gradi varji ta' reżistenza inkroċjata għall-inibitur tattrasferiment ta' integrase strand raltegravir skont it-tip u n-numru ta' sostituzzjonijiet.
English: Administration of once-daily ritonavir (20-200 mg) results in an increased elvitegravir exposure following repeat once-daily administration, with elvitegravir exposure reaching a plateau with approximately 100 mg of ritonavir.
Maltese: L-għoti ta' ritonavir (20-200 mg) darba kuljum jirriżulta f'żieda fl-esponiment ta' elvitegravir wara l-għoti ripetut darba kuljum, bl-esponiment ta' elvitegravir li jilħaq livell għoli u stabbli b'madwar 100 mg ta' ritonavir.
English: ANTACIDS
Maltese: Sess
English: 150 mg once daily darunavir 600 mg and ritonavir 100 mg twice daily fosamprenavir 700 mg and ritonavir 100 mg twice daily
Maltese: Atazanavir 300 mg u ritonavir 100 mg darba kuljum Lopinavir 400 mg u ritonavir 100 mg darbtejn kuljum 150 mg darba kuljum Darunavir 600 mg u ritonavir 100 mg darbtejn kuljum Fosamprenavir 700 mg u ritonavir 100 mg darbtejn kuljum M'hemm l-ebda dejta li tirrakkomanda l-użu ta' Vitekta ma' frekwenzi ta' dożaġġ jew inibituri talprotease HIV-1, ħlief dawk ippreżentati f'Tabella 1.
English: Slovenská republika Gilead Sciences International Ltd Tel: + 44 (0) 20 7136 8820
Maltese: Gilead Sciences International Ltd Tel: + 44 (0) 20 7136 8820 Slovenská republika Gilead Sciences International Ltd Tel: + 44 (0) 20 7136 8820 Suomi/Finland
English: It is important not to miss a dose of Vitekta.
Maltese: Huwa importanti li ma tinsa tieħu ebda doża ta' Vitekta.
English: For use of the 150 mg tablet, please refer to the Summary of Product Characteristics for Vitekta 150 mg tablets.
Maltese: Għall-użu tal-pillola ta' 150 mg, jekk jogħġbok irreferi għas-Sommarju tal-Karatteristiċi tal-Prodott għal Vitekta 150 mg pilloli.
English: Viruses expressing the T66I/A substitutions maintain susceptibility to raltegravir, while most other patterns of elvitegravir-associated substitutions are associated with reduced susceptibility to raltegravir.
Maltese: Viruses li jesprimu s-sostituzzjonijiet T66I/A iżommu s-suxxettibbilità għal raltegravir, filwaqt li l-biċċa l-kbira tal-andamenti oħrajn ta' sostituzzjonijiet assoċjati ma' elvitegravir huma assoċjati ma' suxxettibbilità mnaqqsa għal raltegravir.
English: • didanosine (see also section 3 of this leaflet)  Tell your doctor if you are taking any of these HIV medicines.
Maltese: • didanosine (ara wkoll sezzjoni 3 ta' dan il-fuljett)  Għid lit-tabib tiegħek jekk qed tieħu xi waħda minn dawn il-mediċini kontra l-HIV.
English: Refer to the package leaflet for Vitekta 150 mg tablets.
Maltese: Irreferi għall-fuljett ta' tagħrif għal Vitekta 150 mg pilloli.
English: When used in combination with Vitekta, the recommended dose of atazanavir is 300 mg with ritonavir 100 mg once daily.
Maltese: Meta jintuża flimkien ma' Vitekta, id-doża rakkomandata ta' atazanavir hi ta' 300 mg ma' ritonavir 100 mg darba kuljum.
English: elvitegravir.
Maltese: Bijotrasformazzjoni
English: Integrase is an HIV-1 encoded enzyme that is required for viral replication.
Maltese: Integrase hu enzima ikkodifikata ta' HIV-1 li hi meħtieġa għal replikazzjoni virali.
English: The active substance elvitegravir is persistent in the environment.
Maltese: Is-sustanza attiva elvitegravir hi persistenti fl-ambjent.
English: This study was conducted using the fixed-dose combination tablet elvitegravir/cobicistat/emtricitabine/tenofovir
Maltese: Dan l-istudju sar bl-użu ta' pillola ta' kombinazzjoni ta' doża fissa ta' elvitegravir/cobicistat/emtricitabine/tenofovir
English: Uncommon dizziness, paraesthesia, somnolence, dysgeusia abdominal pain, diarrhoea, vomiting, nausea dyspepsia, abdominal distension, flatulence
Maltese: Komuni uġigħ ta' ras sturdament, parestesija, ngħas, tibdil fis-sens tat-togħma uġigħ ta' żaqq, dijarea, rimettar, dardir Disturbi fil-ġilda u fit-tessuti ta' taħt il-ġilda:
English: The effect of severe hepatic impairment (Child-Pugh Class C) on the pharmacokinetics of elvitegravir has not been studied.
Maltese: L-effett ta' indeboliment epatiku sever (Child-Pugh Klassi Ċ) fuq il-farmakokinetika ta' elvitegravir
English: Each film-coated tablet contains 85 mg of elvitegravir.
Maltese: Kull pillola miksija b'rita fiha 85 mg ta' elvitegravir.
English: When used in combination with fosamprenavir, the dose of Vitekta should be 150 mg once daily.
Maltese: Meta jintuża flimkien ma' fosamprenavir, id-doża ta' Vitekta għandha tkun ta' 150 mg darba kuljum.
English: Vitekta 150 mg film-coated tablets
Maltese: Vitekta 150 mg pilloli miksija b'rita
English: Virologic failure No virologic data at week 48 or week 96 window
Maltese: L-ebda dejta viroloġika fl-intervall ta' żmien ta' ġimgħa 48 jew ġimgħa 96
English: Elvitegravir (150 mg once daily) Cobicistat (150 mg once daily)
Maltese: Cobicistat (150 mg darba kuljum)1
English: Ísland
Maltese: Eesti
English: Dose of co-administered ritonavir-boosted protease inhibitor
Maltese: KONDIZZJONIJIET JEW RESTRIZZJONIJIET FIR-RIGWARD TAL-UŻU SIGUR U EFFIKAĊI TAL-PRODOTT MEDIĊINALI