FrancophonIA/ELRC3.0 huggingface dataset:
English: Female patients of childbearing potential should use either a hormonal contraceptive containing at least 30 µg ethinyloestradiol and containing drospirenone or norgestimate as the progestogen or should use an alternative reliable method of contraception (see sections 4.5 and 4.6).
Maltese: 30 µg ta' ethinyloestradiol u li jkun fih drospirenone jew norgestimate bħala l-progestogen jew għandhom jużaw metodu affidabbli alternattiv ta' kontraċezzjoni (ara sezzjonijiet 4.5 u 4.6).
English: Adverse reactions to Stribild from Phase 3 clinical studies GS-US-236-0102 and GS-US-236-0103 and adverse reactions to treatment with emtricitabine and tenofovir disoproxil from clinical studies and post-marketing experience, when used with other antiretrovirals, are listed in Table 2, below, by body system organ class and highest frequency observed.
Maltese: GS-US-236-0103 u reazzjonijiet avversi għat-trattament b'emtricitabine u tenofovir disoproxil minn studji kliniċi u esperjenza wara t-tqegħid fis-suq, meta jintuża ma' mediċini antiretrovirali oħrajn, huma elenkati f'Tabella 2, hawn taħt, skont il-klassi ta' sistema tal-organi fil-ġisem u skont l-ogħla frekwenza osservata.
English: Aromatic and aliphatic hydroxylation or glucuronidation metabolites are present in very low levels, display considerably lower anti-HIV activity and do not contribute to the overall antiviral activity of elvitegravir.
Maltese: Hydroxylation aromatika u alifatika jew metaboliti tal-glukoronidazzjoni kienu preżenti f'livelli baxxi ħafna, urew attività kontra l-HIV li kienet iktar baxxa b'mod konsiderevoli, u ma jikkontribwixxux għall-attività antivirali globali ta' elvitegravir.
English: For patients with ClCr < 60 mL/min, alternative antibacterials should be considered.
Maltese: < 60 mL/min, antibatterjali alternattivi għandhom jiġu kkunsidrati.
English: AUC: ↑ 48% Cmin: ↑ 67%
Maltese: AUC: ↑ 48% Cmin: ↑ 67% Cmax: ↔
English: Paediatric patients with renal impairment
Maltese: Pazjenti pedjatriċi b'indeboliment renali
English: ANTICONVULSANTS Carbamazepine (200 mg twice daily)/Elvitegravir (150 mg once daily)/Cobicistat (150 mg once daily)
Maltese: MEDIĊINI KONTRA L-KONVULŻJONI Carbamazepine (200 mg darbtejn kuljum)/Elvitegravir (150 mg darba kuljum)/Cobicistat (150 mg darba kuljum)
English: No dose adjustment of clarithromycin is required for patients with normal renal function or mild renal impairment (ClCr 60-90 mL/min).
Maltese: L-ebda aġġustament fid-doża ta' clarithromycin mhu meħtieġ għal pazjenti b'funzjoni tal-kliewi normali jew b'indeboliment ħafif tal-kliewi (ClCr ta' 60-90 mL/min).
English: AUC: ↓ 21% Cmin: ↓ 67%
Maltese: AUC: ↓ 21% Cmin: ↓ 67% Cmax: ↔
English: • If you stopped treatment with any medicine containing tenofovir disoproxil on the advice of your doctor following problems with your kidney function.
Maltese: • Jekk tkun waqqaft it-trattament bi kwalunkwe mediċina li fiha tenofovir disoproxil fuq parir tat-tabib tiegħek wara problemi fil-funzjoni tal-kliewi tiegħek.
English: Table 3: Demographic and baseline characteristics of antiretroviral treatment-naïve HIV-1 infected adult subjects in studies GS-US-236-0102 and GS-US-236-0103
Maltese: Tabella 3: Karatteristiċi demografiċi u fil-linja bażi ta' individwi adulti infettati bl-HIV-1 li qatt ma ngħataw trattament b'mediċini antiretrovirali fil-passat fi studji
English: Treatment with cobicistat and elvitegravir during pregnancy results in lower elvitegravir exposure (see sections 4.4 and 5.2).
Maltese: Tqala It-trattament b'cobicistat u elvitegravir matul it-tqala jirriżulta f'esponiment aktar baxx għal elvitegravir (ara sezzjonijiet 4.4 u 5.2).
English: Virologically-suppressed HIV-1 infected patients
Maltese: Pazjenti infettati b'HIV-1 b'soppressjoni virali
English: Discontinued study drug due to other reasons and last available HIV-1 RNA < 50 copies/mLe
Maltese: HIV-1 RNA < 50 kopja/mL disponibblie
English: Cobicistat exposures were unaffected by a light meal and although there was a modest decrease of 24% and 18% in Cmax and AUC respectively with a high-fat meal, no difference was observed in its pharmacoenhancing effect on elvitegravir.
Maltese: L-esponimenti għal cobicistat ma kinux affettwati minn ikla ħafifa u għalkemm kien hemm tnaqqis modest ta' 24% u 18% fis-Cmax u fl-AUC rispettivament b'ikla b'ammont għoli ta' xaħam, l-ebda differenza ma ġiet osservata fl-effett tiegħu li jtejjeb ilfarmakokinetika fuq elvitegravir.
English: In a pooled analysis of antiretroviral-naïve patients receiving Stribild in Phase 3 studies GS-US-236-0102 and GS-US-236-0103 through Week 144, genotyping was performed on plasma HIV-1 isolates from all patients with confirmed virologic failure or who had HIV-1 RNA > 400 copies/mL at virologic failure, at Week 48, at Week 96, at Week 144 or at the time of early study drug discontinuation.
Maltese: F'analiżi miġbura ta' pazjenti li qatt ma' kienu ngħataw mediċini antiretrovirali qabel irċivew Stribild fi studju ta' Fażi 3 GS-US-236-0102 u GS-US-236-0103 sal-Ġimgħa 144, il-genotyping sar fuq iżolati HIV-1 fil-plażma mill-pazjenti kollha li kellhom falliment viroloġiku kkonfermat jew li kellhom HIV-1 RNA ta' > 400 kopji/mL sa falliment viroloġiku, f'Ġimgħa 48, f'Ġimgħa 96, f'Ġimgħa 144 jew fiż-żmien tat-twaqqif bikri tal-mediċina.
English: Stribild is not usually taken with other medicines that can damage your kidneys (see Other medicines and Stribild).
Maltese: Stribild normalment ma jitteħidx ma' mediċini oħra li jistgħu jagħmlu ħsara lill-kliewi tiegħek (ara Mediċini oħra u Stribild).
English: Stribild met the non-inferiority criteria in achieving HIV-1 RNA < 50 copies/mL when compared to efavirenz/emtricitabine/tenofovir disoproxil and when compared to atazanavir/ritonavir + emtricitabine/tenofovir disoproxil.
Maltese: Stribild issodisfa l-kriterji ta' nuqqas ta' inferjorità meta kiseb HIV-1 RNA < 50 kopja/mL meta mqabbel ma' efavirenz/emtricitabine/tenofovir disoproxil u meta mqabbel ma' atazanavir/ritonavir +
English: In HIV-1 infected children (aged 2 to 15 years), the BMD Z-scores observed in subjects who switched to tenofovir disoproxil were lower than those observed in subjects who remained on their stavudine- or zidovudine-containing regimen (see sections 4.4 and 5.1).
Maltese: Fit-tfal infettati bl-HIV-1 (b'età ta' sentejn sa 15-il sena), il-punteġġi Z tal-BMD osservati f'individwi li qalbu għal tenofovir disoproxil kienu aktar baxxi minn dawk osservati f'individwi li baqgħu fuq il-kors tagħhom li kien fih stavudine jew zidovudine (ara sezzjonijiet 4.4 u 5.1).
English: Clinically relevant changes in tenofovir pharmacokinetics in patients with hepatic impairment were not observed.
Maltese: Tibdil klinikament rilevanti fil-farmakokinetika ta' tenofovir f'pazjenti b'indeboliment epatiku ma ġewx osservati.
English: At Week 144, the mean increase from baseline in CD4+ cell count was 280 cells/mm3 in the Stribild-treated patients and 293 cells/mm3 in the ATV/r+FTC/tenofovir disoproxil-treated patients.
Maltese: F'Ġimgħa 144, il-medja taż żieda mil-linja bażi fl-għadd ta' ċelluli CD4+ kienet ta' 280 ċellula/mm3 f'pazjenti ttrattati b'Stribild u ta' 293 ċellula/mm3 f'pazjenti ttrattati b'ATV/r+FTC/tenofovir disoproxil.
English: Elderly patients are more likely to have decreased renal function, therefore caution should be exercised when treating elderly patients with Stribild.
Maltese: Pazjenti anzjani huma aktar probabbli li jkollhom tnaqqis tal-funzjoni renali, għalhekk għandha tingħata attenzjoni partikulari meta pazjenti anzjani jkunu qed jingħataw it-trattament bi Stribild.
English: Resistance to emtricitabine or tenofovir has been seen in vitro and in the HIV-1 from some patients due to the development of the M184V or M184I emtricitabine resistance substitution in reverse transcriptase or the K65R tenofovir resistance substitution in reverse transcriptase.
Maltese: Ir-reżistenza għal emtricitabine jew tenofovir intweriet in vitro u fl-HIV-1 minn xi pazjenti minħabba l-iżvilupp tas-sostituzzjoni ta' M184V jew M184I f'reverse transcriptase li twassal għal reżistenza għal emtricitabine jew is-sostituzzjoni ta' K65R f'reverse transcriptase li twassal għal reżistenza għal tenofovir.
English: No additional proximal renal tubular dysfunction cases were reported from Week 48 to Week 144.
Maltese: L-ebda każ addizzjonali ta' disfunzjoni tubulari renali prossimali ma ġie rrappurtat mill-Ġimgħa 48 sal-Ġimgħa 144.
English: Twenty percent had baseline plasma HIV-1 RNA >100,000 copies/mL.
Maltese: Medja ta' plażma fil-linja bażi HIV-1 RNA (medda) log10 kopji/mL
English: Tenofovir is primarily excreted by the kidney by both filtration and an active tubular transport system (human organic anion transporter [hOAT1]) with approximately 70-80% of the dose excreted unchanged in urine following intravenous administration.
Maltese: Tenofovir jiġi eliminat mill-ġisem prinċipalment mill-kliewi kemm permezz tal-filtrazzjoni kif ukoll permezz ta' sistema attiva ta' trasport tubulari (trasportatur enajoniku organiku uman [hOAT1]) b'madwar 70-80% tad-doża titneħħa mingħajr tibdil fl-awrina wara l-għoti minn ġol-vina.
English: Stribild is indicated for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults aged 18 years and over who are antiretroviral treatment-naïve or are infected with HIV-1 without known mutations associated with resistance to any of the three antiretroviral agents in Stribild (see sections 4.2, 4.4 and 5.1).
Maltese: Stribild huwa indikat għall-trattament ta' infezzjoni bil-virus tal-immunodefiċjenza umana-1 (HIV-1) f'adulti b'età ta' 18-il sena u aktar li qatt ma ġew ittrattati fil-passat b'mediċini antiretrovirali jew li huma infettati b'HIV-1 mingħajr mutazzjonijiet magħrufa assoċjati ma' reżistenza għal kwalunkwe mit-tliet sustanzi antiretrovirali fi Stribild (ara sezzjonijiet 4.2, 4.4 u 5.1).
English: Therefore, information regarding drug-drug interactions with other antiretroviral products (including protease inhibitors and non-nucleoside reverse transcriptase inhibitors) is not provided (see section 4.4).
Maltese: Għalhekk, informazzjoni dwar interazzjonijiet bejn il-mediċini ma' prodotti antiretrovirali oħrajn (li jinkludu impedituri tal-protease u impedituri tan-non-nucleoside reverse transcriptase) mhijiex ipprovduta (ara sezzjoni 4.4).
English: EFV/FTC/ tenofovir disoproxil n = 352
Maltese: FTC/tenofo vir disoproxil n = 352
English: Renal function (creatinine clearance and urine glucose and urine protein) should be evaluated prior to treatment initiation, and creatinine clearance, serum phosphate, urine glucose and urine protein should be monitored during treatment as in HIV-1 infected adults (see above).
Maltese: Il-funzjoni renali (it-tneħħija tal-kreatinina u l-glucose fl-awrina u l-proteina fl-awrina) għandha tiġi evalwata qabel il-bidu tat-trattament, u t-tneħħija tal-kreatinina, il-phosphate fis-serum, il-glucose fl-awrina u l-proteina fl-awrina għandhom jiġu mmonitorjati matul it-trattament bħal fl-adulti infettati bl-HIV-1 (ara iktar 'il fuq).
English: There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of Stribild in pregnant women.
Maltese: M'hemmx data jew hemm data limitata (inqas minn 300 riżultat ta' tqala) dwar l-użu ta' Stribild f'nisa tqal.
English: If Stribild is discontinued in patients co-infected with HIV and hepatitis B virus (HBV), these patients should be closely monitored for evidence of exacerbation of hepatitis (see section 4.4).
Maltese: Jekk Stribild jitwaqqaf f'pazjenti infettati kemm bl-HIV kif ukoll bil-virus tal-epatite B (HBV), dawn il-pazjenti għandhom ikunu immonitorjati mill-qrib għal evidenza tal-epatite li tmur għall-agħar (ara sezzjoni 4.4).
English: hyperglycaemia1, hypertriglyceridaemia1, decreased appetite
Maltese: Kif għandek tieħu Stribild
English: For elvitegravir, Cmax and AUC increased 22% and 36% with a light meal, while increasing 56% and 91% with a high-fat meal, respectively.
Maltese: Għal elvitegravir, is-Cmax u l-AUC żdiedu bi 22% u 36% b'ikla ħafifa, filwaqt li żdiedu b'56% u 91% b'ikla b'ammont għoli ta' xaħam, rispettivament.
English: Mean baseline plasma HIV-1 RNA (range) log10 copies/mL Percentage of subjects with viral load > 100,000 copies/mL Mean baseline CD4+ cell count (range), x 106 cells/L
Maltese: Għoxrin fil-mija kellhom RNA ta' HIV-1 ta' >100,000 kopja/mL fil-plażma fil-linja bażi.
English: No development of resistance to cobicistat can be demonstrated in HIV-1 in vitro due to its lack of antiviral activity.
Maltese: L-ebda żvilupp ta' reżistenza għal cobicistat ma tista' tintwera f'HIV-1 in vitro minħabba n-nuqqas ta' attività antivirali tiegħu.
English: −0.12 for total body less head at Week 48.
Maltese: 12 għall-ġisem sħiħ mingħajr ir-ras f'Ġimgħa 48.
English: Your doctor will carefully consider whether to treat you with Stribild.
Maltese: M'għandekx tredda' matul it-trattament bi Stribild.
English: Due to limitations of the study, a benefit of tenofovir disoproxil over placebo was not demonstrated based on plasma HIV-1 RNA levels at week 24.
Maltese: Minħabba limitazzjonijiet tal-istudju, ma ntweriex benefiċċju ta' tenofovir disoproxil fuq plaċebo abbażi ta' livelli ta' RNA ta' HIV-1 fil-plażma f'ġimgħa 24.
English: No clinically relevant differences in elvitegravir or cobicistat pharmacokinetics were observed between subjects with moderate impairment and healthy subjects.
Maltese: L-ebda differenzi klinikament rilevanti fil-farmakokinetika ta' elvitegravir jew cobicistat ma ġew osservati bejn individwi b'indeboliment moderat u individwi b'saħħithom.
English: If serum phosphate is < 0.48 mmol/L (1.5 mg/dL) or creatinine clearance is decreased to < 70 mL/min, renal function should be re-evaluated within one week, including measurements of blood glucose, blood potassium and urine glucose concentrations (see section 4.8).
Maltese: Ġestjoni tal-kliewi Jekk il-phosphate fis-serum huwa < 0.48 mmol/L (1.5 mg/dL) jew it-tneħħija tal-krejatinina tonqos għal < 70 mL/min, il-funzjoni renali għandha tkun evalwata mill-ġdid fi żmien ġimgħa, inkluż il-kejl tal-konċentrazzjonijiet tal-glucose fid-demm, tal-potassium fid-demm u tal-glucose fl-awrina (ara sezzjoni 4.8).
English: Following oral administration of Stribild with food in HIV-1 infected subjects, peak plasma concentrations were observed 4 hours post-dose for elvitegravir, 3 hours post-dose for cobicistat, 3 hours post-dose for emtricitabine, and 2 hours for tenofovir following the rapid conversion of tenofovir disoproxil.
Maltese: Wara l-għoti ta' Stribild mill-ħalq mal-ikel f'individwi infettati bl-HIV-1, il-konċentrazzjonijiet massimi fil-plażma ġew osservati 4 sigħat wara d-doża għal elvitegravir, 3 sigħat wara d-doża għal cobicistat, 3 sigħat wara d-doża għal emtricitabine, u sagħtejn għal tenofovir, wara l-konverżjoni mgħaġġla ta' tenofovir disoproxil.
English: • Use effective contraception while taking Stribild.
Maltese: • Uża kontraċezzjoni effettiva waqt li tkun qed tieħu Stribild.
English: Cmin: N/A Velpatasvir: AUC: ↔
Maltese: N/A Velpatasvir:
English: One tenofovir disoproxil treated subject and no stavudine or zidovudine treated subjects experienced significant (> 4%) lumbar spine BMD loss at week 48.
Maltese: Individwu wieħed ittrattat b'tenofovir disoproxil u l-ebda individwu ttrattat bi stavudine jew zidovudine esperjenzaw telf sinifikanti (> 4%) fil-BMD tas-sinsla tad-dahar lumbari f'ġimgħa 48.
English: Mean changes at week 48 (end of double blind phase) were -0.215 and -0.165 in lumbar spine BMD Z-score, and -0.254 and -0.179 in total body BMD Z-score for the tenofovir disoproxil and placebo groups, respectively.
Maltese: 215 u -0.165 fil-punteġġ Z tal-BMD tas-sinsla tad-dahar lumbari, u -0.254 u -0.
English: At Week 144, the mean increase from baseline in CD4+ cell count was 321 cells/mm3 in the Stribild-treated patients and 300 cells/mm3 in the EFV/FTC/tenofovir disoproxil-treated patients.
Maltese: F'Ġimgħa 144, il-medja taż-żieda mil-linja bażi fl-għadd ta' ċelluli CD4+ kienet ta' 321 ċellula/mm3 f'pazjenti ttrattati b'Stribild u ta' 300 ċellula/mm3 f'pazjenti ttrattati b'EFV/FTC/tenofovir disoproxil.
English: The pharmacokinetics of emtricitabine and tenofovir are altered in subjects with renal impairment.
Maltese: Il-farmakokinetika ta' emtricitabine u tenofovir tinbidel f'individwi b'indeboliment renali.
English: No emergent resistance to Stribild was identified in clinical studies of virologically-suppressed patients who switched from a regimen containing a ritonavir-boosted protease inhibitor (PI+RTV) (Study GS-US-236-0115), an NNRTI (Study GS-US-236-0121) or raltegravir (RAL) (Study GS-US-236-0123).
Maltese: GS-US-236-0115), NNRTI (studju GS-US-236-0121) jew raltegravir (RAL) (studju
English: Studies with tenofovir disoproxil
Maltese: tenofovir disoproxil.
English: Mean changes from baseline BMD Z-scores (height-age adjusted) were −0.09 for lumbar spine and
Maltese: Il-bidliet medji fil-punteġġi Z talBMD mil-linja bażi (aġġustati skont it-tul u l-età) kienu ta' −0.09 għas-sinsla tad-dahar lumbari u
English: headache, dizziness Gastrointestinal disorders: Very common:
Maltese: Disturbi gastro-intestinali:
English: Virologic failurec
Maltese: Insuffiċjenza viroloġikaċ
English: Table 1: Interactions between the individual components of Stribild and other medicinal products
Maltese: Tabella 1: Interazzjonijiet bejn il-komponenti individwali ta' Stribild u prodotti mediċinali oħra Prodott mediċinali skont iż-żoni terapewtiċi
English: Primary mutations for raltegravir/elvitegravir do not affect the in vitro susceptibility of dolutegravir as single mutations, and the additional presence of secondary mutations (except Q148) also does not result in relevant fold changes in experiments with site directed mutants.
Maltese: Il-mutazzjonijiet primarji għal raltegravir/elvitegravir ma jaffettwawx is-suxxettibilità in vitro ta' dolutegravir bħala mutazzjonijiet uniċi, u l-preżenza addizzjonali ta' mutazzjonijiet sekondarji (ħlief Q148) ukoll ma tirriżultax f'tibdil fin-numru ta' drabi f'esperimenti b'mutanti diretti mis-sit.
English: • If you are allergic to elvitegravir, cobicistat, emtricitabine, tenofovir, tenofovir disoproxil,
Maltese: • Jekk inti allerġiku għal elvitegravir, cobicistat, emtricitabine, tenofovir, tenofovir disoproxil, jew għal xi sustanza oħra ta' din il-mediċina (imniżżla fis-sezzjoni 6 ta' dan il fuljett).
English: Stribild should not be initiated in patients with creatinine clearance below 70 mL/min (see sections 4.4 and 5.2).
Maltese: Stribild m'għandux jinbeda f'pazjenti bi tneħħija tal-krejatinina taħt 70 mL/min (ara sezzjonijiet 4.4 u 5.2).
English: • any signs of inflammation or infection • bone problems
Maltese: • kwalunkwe sinjal ta' infjammazzjoni jew infezzjoni • problemi fl-għadam
English: It is recommended that the international normalised ratio (INR) be monitored upon co-administration of Stribild.
Maltese: Hu rakkomandat li l-proporzjon normalizzat internazzjonali (INR) jiġi mmonitorjat meta jingħata flimkien ta' Stribild.
English: Co-administration of Stribild and sildenafil for the treatment of pulmonary arterial hypertension is contraindicated.
Maltese: pressjoni għolja arterjali pulmonari hu kontraindikat.
English: Women of childbearing potential / contraception in males and females The use of Stribild must be accompanied by the use of effective contraception (see section 4.5).
Maltese: L-użu ta' Stribild irid jiġi akkompanjat mill-użu ta' kontraċettiv effettiv (ara sezzjoni 4.5).
English: Concomitant use with nephrotoxic medicinal products Use of Stribild should be avoided with concurrent or recent use of a nephrotoxic medicinal product, e.g. aminoglycosides, amphotericin B, foscarnet, ganciclovir, pentamidine, vancomycin, cidofovir or interleukin 2 (also called aldesleukin) (see section 4.5).
Maltese: L-użu flimkien ma' prodotti mediċinali nefrotossiċi L-użu ta' Stribild flimkien ma' jew fi żmien qasir minn meta jkun ittieħed prodott mediċinali nefrotossiku, eż. aminoglycosides, amphotericin B, foscarnet, ganciclovir, pentamidine, vancomycin,
English: Contents of the pack and other information What Stribild contains
Maltese: Kontenut tal-pakkett u informazzjoni oħra X'fih Stribild
English: • pain in the abdomen (tummy) caused by inflammation of the pancreas (pancreatitis)
Maltese: • uġigħ fl-addome (żaqq) ikkawżat minn infjammazzjoni tal-frixa (pankreatite)
English: HMG CO-A REDUCTASE INHIBITORS Rosuvastatin (10 mg single dose)/Elvitegravir (150 mg single dose)/Cobicistat (150 mg single dose)
Maltese: Rosuvastatin (10 mg doża waħda)/Elvitegravir (150 mg doża waħda)/Cobicistat (150 mg doża waħda)
English: Orally administered midazolam Triazolam
Maltese: It-testijiet jistgħu juru wkoll:
English: As of Week 144, the development of one or more primary elvitegravir, emtricitabine, or tenofovir resistance-associated substitutions was observed in 18 of the 42 patients with evaluable genotypic data from paired baseline and Stribild treatment-failure isolates (2.6%, 18/701 patients).
Maltese: Sa Ġimgħa 144, l-iżvilupp ta' wieħed jew iktar sostituzzjonijiet primarji assoċjati ma' reżistenza għal elvitegravir, emtricitabine, jew tenofovir, ġie osservat fi 18 minn 42 pazjent b'dejta ġenotipika li setgħet tiġi evalwata minn linja bażi akkopjata u iżolati minn trattament bi Stribild (2.6%, 18/701 pazjent) li ma rnexxietx.
English: The mean increase from baseline in CD4+ cell count at Week 48 was 23 cells/mm3.
Maltese: Iż-żieda medja mil-linja bażi fl-għadd ta' ċelluli CD4+ f'Ġimgħa 48 kienet ta' 23 ċellula/mm3.
English: Elvitegravir is metabolised by CYP3A and, to a minor extent, by UGT1A1.
Maltese: Elvitegravir jiġi metabolizzat minn CYP3A u, fi grad anqas, minn UGT1A1.
English: ANTI-GOUT Colchicine
Maltese: ANALĠESIĊI NARKOTIĊI
English: Norgestimate (0.180/0.215 mg once daily)/Ethinyloestradiol (0.025 mg once daily)/
Maltese: 215 mg darba kuljum)/Ethinyloestradiol (0.025 mg darba kuljum)/ Elvitegravir (150 mg darba kuljum)/Cobicistat (150 mg darba kuljum)4
English: The use of Stribild is not recommended in paediatric patients with renal impairment (see section 4.2).
Maltese: L-użu ta' Stribild mhuwiex rakkomandat f'pazjenti pedjatriċi b'indeboliment renali (ara sezzjoni 4.2).
English: Plasma concentrations of drospirenone are expected to be increased following co-administration with Stribild and clinical monitoring is recommended due to the potential for hyperkalaemia (see section 4.5).
Maltese: Stribild u huwa rakkomandat monitoraġġ kliniku minħabba l-potenzjal għal iperkalemja (ara sezzjoni 4.5).
English: lactic acidosis1
Maltese: aċidożi lattika1
English: 3 These are drugs within class where similar interactions could be predicted.
Maltese: 3 Dawn huma mediċini fi ħdan il-klassi fejn interazzjonijiet simili setgħu jitbassru.
English: Sirolimus
Maltese: Osteonekrożi
English: The following pack sizes are available: outer cartons containing 1 bottle of 30 film-coated tablets and 90 (3 bottles of 30) film-coated tablets.
Maltese: 30 pillola miksija b'rita u kartun ta' barra li fihom 90 (3 fliexken ta' 30) pillola miksija b'rita.
English: That a multidisciplinary approach is recommended for the management of adolescent patients.
Maltese: Li hu rakkomandat approċċ multidixxiplinari għall-ġestjoni ta' pazjenti adolexxenti.
English: In Study GS-US-236-0103, the mean increase from baseline in CD4+ cell count at Week 48 was 207 cells/mm3 in the Stribild-treated patients and 211 cells/mm3 in the ATV/r+FTC/tenofovir disoproxil-treated patients.
Maltese: Fl-Istudju GS-US-236-0103, il-medja taż-żieda mil-linja bażi flgħadd ta' ċelluli CD4+ f'Ġimgħa 48 kienet ta' 207 ċellula/mm3 f'pazjenti ttrattati b'Stribild u ta' 211
English: The results reported from a prospective study (IMPAACT P1026s) showed that treatment with cobicistat and elvitegravir-containing regimens during pregnancy results in lower elvitegravir and cobicistat exposures (Table 5).
Maltese: Tqala u wara t-twelid Ir-riżultati rrappurtati minn studju prospettiv (IMPAACT P1026s) urew li t-trattament b'cobicistat u elvitegravir li jkun fih korsijiet matul it-tqala jirriżulta f'esponimenti aktar baxxi għal cobicistat u elvitegravir (Tabella 5).