FrancophonIA/ELRC3.0 huggingface dataset:
English: Exposures of emtricitabine and tenofovir in 12 patients with end stage renal disease (estimated CrCl < 15 mL/min) on chronic haemodialysis who received Genvoya in Study GS-US-292-1825 were significantly higher than in patients with normal renal function.
Maltese: Esponimenti għal emtricitabine u tenofovir fi 12-il pazjent b'marda tal-kliewi fl-aħħar stadju (CrCl stmata ta' < 15-il mL/min) fuq emodijalisi kronika li rċivew Genvoya fl-Istudju GS-US-292-1825 kienu sinifikament ogħla milli f'pazjenti b'funzjoni renali normali.
English: headache, dizziness
Maltese: DATA TA' SKADENZA
English: diarrhoea, vomiting, abdominal pain, flatulence
Maltese: dijarea, rimettar, uġigħ addominali, gass
English: Cmin: ↑ 103% Cmax: ↔
Maltese: AUC: ↔ Cmin: ↑ 103% Cmax: ↔
English: In Study GS-US-292-1825, the efficacy and safety of Genvoya were evaluated in a single-arm, open-label clinical study in which 55 HIV-1 infected adults with end stage renal disease (eGFRCG < 15 mL/min) on chronic haemodialysis for at least 6 months before switching to Genvoya.
Maltese: Fi Studju GS-US-292-1825, l-effikaċja u s-sigurtà ta' Genvoya kienu evalwati fi studju kliniku, openlabel, bi grupp wieħed li fih 55 adult infettati bl-HIV-1 b'marda tal-kliewi fl-aħħar stadju (eGFRCG < 15-il mL/min) fuq emodijalisi kronika għal mill-inqas 6 xhur qabel ma qalbu għal Genvoya.
English: Each bottle contains silica gel desiccant and polyester coil.
Maltese: Kull flixkun fih desikkant tas-silica gel u kolja tal-polyester.
English: • immunosuppressants, used to control your body's immune response after a transplant, such as: ciclosporin, sirolimus and tacrolimus
Maltese: • immunosoppressanti, li jintużaw biex jikkontrollaw ir-rispons immuni ta' ġismek wara trapjant, bħal: ciclosporin, sirolimus u tacrolimus
English: Assessment of adverse reactions is based on safety data from across all Phase 2 and 3 studies in which 2,396 patients received Genvoya and from post-marketing experience.
Maltese: L-evalwazzjoni tar-reazzjonijiet avversi hi bbażata fuq dejta dwar is-sigurtà mill-istudji kollha ta' Fażi 2 u 3, li fihom 2,396 pazjent rċivew Genvoya u mill-esperjenza ta' wara t-tqegħid fis-suq.
English: Ex vivo rabbit studies and in vivo dog studies suggest that cobicistat has a low potential for QT prolongation, and may slightly prolong the PR interval and decrease left ventricular function at concentrations at least 11-fold higher than the human exposure at the recommended 150 mg daily dose.
Maltese: Studji ex vivo fil-fniek u studji in vivo fil-klieb jissuġġerixxu li cobicistat għandu potenzjal baxx għat-titwil tal-QT, u jista' jtawwal bi ftit l-intervall tal-PR u jnaqqas il-funzjoni ventrikulari fuq in-naħa taxxellug f'konċentrazzjonijiet li kienu mill-inqas 11-il darba ogħla mill-esponiment fil-bniedem fid-doża rakkomandata ta' kuljum ta' 150 mg.
English: Co-administration of Genvoya and lovastatin and simvastatin is contraindicated (see section 4.3).
Maltese: L-għoti ta' Genvoya flimkien ma' lovastatin u simvastatin hu kontraindikat (ara sezzjoni 4.3).
English: Interaction not studied with Genvoya.
Maltese: Mediċini oħra u Genvoya
English: An assessment of benefit/risk ratio is recommended to justify use of voriconazole with Genvoya.
Maltese: Hu rakkomandat li ssir evalwazzjoni tal-proporzjon talbenefiċċju/riskju biex tiġġustifika lużu ta' voriconazole ma' Genvoya.
English: Genvoya should not be co-administered with other antiretroviral medicinal products (see section 4.5).
Maltese: Genvoya m'għandux jingħata-flimkien ma' prodotti mediċinali antiretrovirali oħrajn (ara sezzjoni 4.5).
English: N/A
Maltese: )b
English: While effective viral suppression with antiretroviral therapy has been proven to substantially reduce the risk of sexual transmission, a residual risk cannot be excluded.
Maltese: Filwaqt li soppressjoni virali effettiva b'terapija antiretrovirali ġiet ippruvata li tnaqqas b'mod sostanzjali r-riskju ta' trasmissjoni sesswali, riskju residwu ma jistax jiġi eskluż.
English: • swelling of the face, lips, tongue or throat (angioedema)
Maltese: • nefħa tal-wiċċ, xufftejn, ilsien jew griżmejn (anġjoedema)
English: Elvitegravir is primarily metabolised by CYP3A, and medicinal products that induce or inhibit CYP3A may affect the exposure of elvitegravir.
Maltese: Elvitegravir jiġi metabolizzat primarjament minn CYP3A, u prodotti mediċinali li jinduċu jew jinibixxu CYP3A jistgħu jaffettwaw l-esponiment ta' elvitegravir.
English: Interactions between the components of Genvoya and potential co-administered medicinal products are listed in Table 1 below (increase is indicated as “↑”, decrease as “↓”, no change as “↔”).
Maltese: Interazzjonijiet bejn il-komponenti ta' Genvoya u prodotti mediċinali li potenzjalment jingħataw flimkien huma elenkati fit-Tabella 1 hawn taħt (żieda hija indikata b'“↑”, tnaqqis b'“↓”, ebda bidla b'“↔”).
English: Concentrations of warfarin may be affected upon co-administration with Genvoya.
Maltese: Il-konċentrazzjonijiet ta' warfarin jistgħu jiġu affettwati meta jingħataw flimkien ma' Genvoya.
English: Tenofovir alafenamide was not mutagenic or clastogenic in conventional genotoxicity assays.
Maltese: Tenofovir alafenamide ma kienx mutaġeniku jew klastoġeniku f'assaġġi ta' ġenotossiċità konvenzjonali.
English: Ex vivo binding of tenofovir alafenamide to human plasma proteins in samples collected during clinical studies was approximately 80%.
Maltese: It-twaħħil ex vivo ta' tenofovir alafenamide ma' proteini tal-plażma umana fil-kampjuni miġbura waqt l-istudji kliniċi kien ta' madwar 80%.
English: In some patients with advanced HIV infection (AIDS) and a history of opportunistic infections (infections that occur in people with a weak immune system), signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started.
Maltese: F'xi pazjenti b'infezzjoni avvanzata tal-HIV (AIDS) u bi storja medika ta' infezzjonijiet opportunistiċi (infezzjonijiet li jseħħu f'nies b'sistema immuni dgħajfa), sinjali u sintomi ta' infjammazzjoni minn infezzjonijiet fil-passat jistgħu jseħħu dritt wara li tinbeda t-trattament kontra l-HIV.
English: 25-O-desacetyl-rifabutin
Maltese: < 50 sena ≥ 50 sena Sess tal-persuna Raġel
English: • antidepressants, used to treat depression: medicines containing trazodone or escitalopram
Maltese: • antidepressanti, li jintużaw għal trattament tad-dipressjoni: mediċini li fihom trazodone jew escitalopram
English: In treatment-naïve patients, a mean change from baseline of 0.04 ± 0.12 mg/dL (3.5 ± 10.6 µmol/L) was observed after 144 weeks of treatment.
Maltese: 12 mg/dL (3.5 ± 10.6 μmol/L) wara 144 ġimgħa ta' trattament.
English: Concomitant use of Genvoya and corticosteroids that are metabolised by CYP3A (e.g. fluticasone propionate or other inhaled or nasal corticosteroids) may increase the risk of development of systemic corticosteroid effects, including Cushing's syndrome and adrenal suppression.
Maltese: L-użu fl-istess ħin ta' Genvoya u kortikosterojdi li huma metabolizzati minn CYP3A eż. fluticasone propionate jew kortikosterojdi oħra li jinġibdu mannifs jew nażali jista' jżid ir-riskju tal-iżvilupp ta' effetti sistemiċi talkortikosterojdi, inkluż is-sindrome ta' Cushing u s-suppressjoni adrenali.
English: ANTIDEPRESSANTS Sertraline (50 mg single dose)/ Elvitegravir (150 mg once daily)/ Cobicistat (150 mg once daily)/ Emtricitabine (200 mg once daily)/ Tenofovir alafenamide (10 mg once daily)5
Maltese: Sertraline (50 mg doża waħda)/ Elvitegravir (150 mg darba kuljum)/Cobicistat (150 mg darba kuljum)/Emtricitabine (200 mg darba kuljum)/Tenofovir alafenamide (10 mg darba kuljum)5
English: In vitro and clinical pharmacokinetic drug-drug interaction studies have shown that the potential for CYP-mediated interactions involving tenofovir alafenamide with other medicinal products is low.
Maltese: Studji in vitro u studji kliniċi farmakokinetiċi dwar l-interazzjoni bejn mediċina u oħra wrew li lpotenzjal għal interazzjonijiet medjati minn CYP li jinvolvu tenofovir alafenamide ma' prodotti mediċinali oħrajn hu baxx.
English: Co-administration of apixaban, rivaroxaban or edoxaban is not recommended with Genvoya.
Maltese: Ġaladarba tibda tieħu Genvoya, oqgħod attent għal:
English: Contraception requirements
Maltese: Differenza fit-trattament
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Pazjenti li għandhom problemi ereditarji rari ta' intolleranza għallgalactose, nuqqas totali ta' lactase jew għandhom problemi biex jassorbu l-glucose-galactose m'għandhomx jieħdu dan il-prodott mediċinali.
English: Upon co-administration with the moderate CYP3A inducer probe efavirenz, tenofovir alafenamide exposure was not significantly affected.
Maltese: Meta ngħata flimkien ma' CYP3A inducer probe moderat efavirenz, l-esponiment ta' tenofovir alafenamide ma ġiex affettwat b'mod sinifikanti.
English: • medicines used to treat gout:
Maltese: • mediċini li jintużaw għal trattament tad-dijabete:
English: 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: E/C/F/TDF = elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate a Week 48 window was between Day 294 and 377 (inclusive); Week 144 window was between Day 966 and 1,049 (inclusive).
Maltese: E/C/F/TDF = elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate a L-intervall ta' żmien tal-Ġimgħa 48 kien bejn Jum 294
English: No clinically relevant pharmacokinetic differences due to gender or ethnicity have been identified for cobicistat-boosted elvitegravir, cobicistat, emtricitabine, or tenofovir alafenamide.
Maltese: L-ebda differenzi farmakokinetiċi klinikament rilevanti minħabba s-sess jew etniċità ma ġew identifikati għal elvitegravir imsaħħaħ b'cobicistat, cobicistat, emtricitabine jew tenofovir alafenamide.
English: Elderly No dose adjustment of Genvoya is required in elderly patients (see sections 5.1 and 5.2).
Maltese: L-ebda aġġustament fid-doża ta' Genvoya mhu meħtieġ f'pazjenti anzjani (ara sezzjonijiet 5.1 u 5.2).
English: Atorvastatin (10 mg single dose)/Elvitegravir (150 mg once daily)/Cobicistat (150 mg once daily)/Emtricitabine (200 mg once daily)/Tenofovir alafenamide (10 mg once daily)
Maltese: Atorvastatin (10 mg doża waħda)/Elvitegravir (150 mg darba kuljum)/Cobicistat (150 mg darba kuljum)/Emtricitabine (200 mg darba kuljum)/Tenofovir alafenamide (10 mg darba kuljum)
English: Patients were virologically suppressed (HIV-1 RNA < 50 copies/mL) for at least 6 months before switching to Genvoya.
Maltese: Il-pazjenti kienu soppressi b'mod viroloġiku (RNA ta' HIV-1 ta' < 50 kopja/mL) għal millinqas 6 xhur qabel ma qalbu għal Genvoya.
English: Posology
Maltese: ANTAĊIDI
English: The use of Genvoya with oral contraceptives containing other progestogens should be avoided (see section 4.5).
Maltese: L-użu ta' Genvoya ma' kontraċettivi orali li jkun fihom progestogens oħra għandu jiġi evitat (ara sezzjoni 4.5).
English: Nephrotoxicity
Maltese: Nifedipine
English: There are no pharmacokinetic data on elvitegravir, cobicistat, emtricitabine or tenofovir alafenamide in patients with end stage renal disease (estimated CrCl < 15 mL/min) not on chronic haemodialysis.
Maltese: M'hemm l-ebda data farmakokinetika dwar elvitegravir, cobicistat, emtricitabine jew tenofovir alafenamide f'pazjenti b'marda tal-kliewi fl-aħħar stadju (CrCl stmata ta' < 15-il mL/min) mhux fuq emodijalisi kronika.
English: Interaction not studied with any of the components of Genvoya.
Maltese: L-interazzjoni ma ġietx studjata ma' kwalunkwe wieħed mill-komponenti ta' Genvoya.
English: Switching from a tenofovir disoproxil-based regimen to Genvoya was superior in maintaining HIV-1 RNA < 50 copies/mL compared to staying on the baseline regimen (Table 4).
Maltese: Il-qlib minn kors ibbażat fuq tenofovir disoproxil għal Genvoya kien superjuri fiż-żamma ta' HIV-1 RNA ta' < 50 kopja/mL meta mqabbel ma' li wieħed baqa' fuq il-kors tal-linja bażi (Tabella 4).
English: Renal excretion of intact tenofovir alafenamide is a minor pathway with < 1% of the dose eliminated in urine.
Maltese: It-tneħħija mill-kliewi ta' tenofovir alafenamide intatt, hu passaġġ minuri b'< 1% tad-doża li tiġi eliminata fl-awrina.
English: In a pooled analysis, genotyping was performed on plasma HIV-1 isolates from antiretroviral-naïve patients receiving Genvoya in Phase 3 studies GS-US-292-0104 and GS-US-292-0111 with HIV-1 RNA ≥ 400 copies/mL at confirmed virologic failure, Week 144, or time of early study drug discontinuation.
Maltese: GS-US-292-0104 u GS-US-292-0111, b'HIV-1 RNA ta' ≥ 400 kopja/mL meta kellhom falliment viroloġiku kkonfermat, Ġimgħa 144, jew meta seħħ it-twaqqif bikri tal-mediċina tal-istudju.
English: Elvitegravir, cobicistat, and emtricitabine have all demonstrated low carcinogenic potential in mice and rats.
Maltese: Elvitegravir, cobicistat, u emtricitabine kollha wrew riskju ta' kanċer baxx fil-ġrieden u l-firien.
English: atorvastatin and pitavastatin
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: When administering with Genvoya, the maximum daily dose of ketoconazole should not exceed 200 mg per day.
Maltese: Meta jingħata ma' Genvoya, iddoża massima ta' kuljum ta' ketoconazole m'għandhiex taqbeż 200 mg kuljum.
English: Metabolism is a major elimination pathway for tenofovir alafenamide in humans, accounting for > 80% of an oral dose.
Maltese: Il-metaboliżmu hu passaġġ maġġuri tal-eliminazzjoni għal tenofovir alafenamide fil-bnedmin, li jammonta għal > 80% ta' doża orali.
English: Table 7: Changes in pharmacokinetic parameters from the IMPAACT P1026s study for elvitegravir and cobicistat in women receiving cobicistat and elvitegravir-containing regimens during the second and third trimesters of pregnancy compared to paired postpartum data
Maltese: Bidliet fil-parametri tal-farmakokinetika mill-istudju IMPAACT P1026s għal cobicistat u elvitegravir f'nisa li jirċievu korsijiet li jkun fihom cobicistat u elvitegravir matul ittieni u t-tielet trimestru ta' tqala meta mqabbla ma' dejta akkoppjata ta' wara t-twelid.
English: No dose adjustment of Genvoya is required in adults or adolescents (aged at least 12 years and of at least 35 kg body weight) with estimated creatinine clearance (CrCl) ≥ 30 mL/min.
Maltese: L-ebda aġġustament fid-doża ta' Genvoya mhu meħtieġ f'adulti u adolexxenti (li jkollhom 12-il sena u aktar u li jiżnu mill-inqas 35 kg) bi tneħħija tal-krejatinina (CrCl) stmata ta' ≥ 30 mL/min.
English: Tenofovir diphosphate inhibits HIV replication through incorporation into viral DNA by the HIV RT, which results in DNA chain-termination.
Maltese: Tenofovir diphosphate jinibixxi r-replikazzjoni tal-HIV permezz ta' inkorporazzjoni fid-DNA virali mill-HIV RT, li tirriżulta fit-terminazzjoni tal-katina tad-DNA.
English: The median increase from baseline for those parameters was greater in the Genvoya group compared with the E/C/F/TDF group at Week 144 (p < 0.001 for the difference between treatment groups for fasting total cholesterol, direct LDL- and HDL-cholesterol, and triglycerides).
Maltese: Il-medjan taż-żieda mil-linja bażi għal dawk il-parametri kien akbar fil-grupp ta' Genvoya meta mqabbel mal-grupp ta' E/C/F/TDF f'Ġimgħa 144 (p < 0.001 għad-differenza bejn ilgruppi tat-trattament għall-kolesterol totali fl-istat sajjem, kolesterol ta' LDL dirett u HDL, u trigliċeridi).
English: It is not known whether cobicistat, emtricitabine, or tenofovir alafenamide are inhibitors of other UGT enzymes.
Maltese: Mhux magħruf jekk cobicistat, emtricitabine, jew tenofovir alafenamide humiex impedituri ta' enzimi oħrajn ta' UGT.
English: ANTACIDS
Maltese: dardir
English: In a human clinical study of 35 healthy subjects, echocardiograms performed at baseline and after receiving 150 mg cobicistat once daily for at least 15 days indicated no clinically significant change in left ventricular function.
Maltese: Fi studju kliniku dwar il-bniedem li sar fuq 35 individwu b'saħħtu, twettqu ekokardjogrammi fil-linja bażi u wara li l-individwi rċivew 150 mg ta' cobicistat darba kuljum għal mill-inqas 15-il jum, ma ġie indikat l-ebda tibdil klinikament sinifikanti fil-funzjoni ventrikulari fuq in-naħa tax-xellug.
English: For elvitegravir, Cmax and AUC increased 22% and 36% with a light meal, and 56% and 91% with a high-fat meal, relative to fasting conditions.
Maltese: Għal elvitegravir, is-Cmax u l-AUC żdiedu bi 22% u 36% b'ikla ħafifa, u b'56% u 91% b'ikla b'ammont għoli ta' xaħam, meta mqabbla ma' kundizzjonijiet fl-istat sajjem.
English: In vitro and clinical pharmacokinetic drug-drug interaction studies have shown that the potential for CYP-mediated interactions involving emtricitabine with other medicinal products is low.
Maltese: Studji in vitro u studji kliniċi farmakokinetiċi dwar l-interazzjoni bejn mediċina u oħra wrew li lpotenzjal għal interazzjonijiet medjati minn CYP li jinvolvu emtricitabine ma' prodotti mediċinali oħrajn hu baxx.
English: This leaflet was last revised in <{MM/YYYY}> <{month YYYY}>
Maltese: DATA TA' REVIŻJONI TAT-TEST {XX/SSSS}
English: d Includes patients who had ≥ 50 copies/mL in the Week 48 or Week 96 window; patients who discontinued early due to lack or loss of efficacy; patients who discontinued for reasons other than an adverse event (AE), death or lack or loss of efficacy and at the time of discontinuation had a viral value of ≥ 50 copies/mL.
Maltese: d Jinkludi individwi li kellhom ≥ 50 kopja/mL fl-intervall ta' żmien ta' Ġimgħa 48 jew Ġimgħa 96; individwi li waqfu kmieni minħabba nuqqas jew telf ta' effikaċja; individwi li waqfu għal raġunijiet li m'humiex avveniment avvers (AE), mewt jew nuqqas jew telf ta' effikaċja u li meta waqfu kellhom valur virali ta' ≥ 50 kopja/mL.
English: BOTTLE AND CARTON LABELLING
Maltese: TIKKETTAR TAL-FLIXKUN U TAL-KARTUNA
English: Elvitegravir (150 mg once daily)/ Cobicistat (150 mg once daily)/ Emtricitabine (200 mg once daily)/ Tenofovir alafenamide (10 mg once daily)5
Maltese: Elvitegravir (150 mg darba kuljum)/Cobicistat (150 mg darba kuljum)/Emtricitabine (200 mg darba kuljum)/Tenofovir alafenamide (10 mg darba kuljum)5
English: Caution should be exercised when co-administering Genvoya with pitavastatin.
Maltese: Għandu jkun hemm kawtela meta Genvoya jingħata flimkien ma' pitavastatin.
English: The safety of Genvoya in 248 HIV-1 infected patients who were either treatment-naïve (n = 6) or virologically suppressed (n = 242) with mild to moderate renal impairment (estimated glomerular filtration rate by Cockcroft-Gault method [eGFRCG]: 30-69 mL/min) was evaluated through 144 weeks in an open-label clinical study (GS-US-292-0112).
Maltese: Is-sigurtà ta' Genvoya f'248 pazjent infettati bl-HIV-1 li jew qatt ma ngħataw trattament fil-passat (n = 6) jew li kienu b'soppressjoni virali (n = 242), b'indeboliment renali minn ħafif sa moderat (rata tal-filtrazzjoni glomerulari stmata bil-metodu Cockcroft-Gault [eGFRCG]:
English: Cobicistat was not mutagenic or clastogenic in conventional genotoxicity assays.
Maltese: Cobicistat ma kienx mutaġeniku jew klastoġeniku f'assaġġi ta' ġenotossiċità konvenzjonali.
English: c Includes patients who had ≥ 50 copies/mL in the Week 48 or 144 window; patients who discontinued early due to lack or loss of efficacy; patients who discontinued for reasons other than an adverse event (AE), death or lack or loss of efficacy and at the time of discontinuation had a viral value of ≥ 50 copies/mL.
Maltese: c Jinkludi pazjenti li kellhom ≥ 50 kopja/mL fl-intervall ta' żmien ta' Ġimgħa 48 jew 144; pazjenti li waqfu kmieni minħabba nuqqas jew telf ta' effikaċja;pazjenti li waqfu għal raġunijiet li m'humiex avveniment avvers (AE), mewt jew nuqqas jew telf ta' effikaċja u li meta waqfu kellhom valur virali ta' ≥ 50 kopja/mL.
English: Through 144 weeks of treatment, no subject discontinued Genvoya due to a treatment-emergent renal adverse event compared with 12 subjects who discontinued E/C/F/TDF (p < 0.001).
Maltese: Wara 144 ġimgħa ta' trattament, l-ebda individwu ma waqqaf Genvoya minħabba avveniment avvers fil-kliewi li żviluppa minħabba t-trattament meta mqabbel ma' 12-il individwu li waqqfu E/C/F/TDF (p < 0.001).
English: Elvitegravir plasma concentrations are lower with antacids due to local complexation in the gastrointestinal tract and not to changes in gastric pH.
Maltese: Il-konċentrazzjonijiet ta' elvitegravir fil-plażma huma iktar baxxi ma' antaċidi minħabba kumplessazzjoni lokali fl-apparat gastrointestinali u mhux minħabba tibdil fil-pH gastrika.
English: Co-administration with Genvoya may result in increased plasma concentrations of sildenafil and tadalafil, which may result in PDE-5 inhibitor-associated adverse reactions.
Maltese: L-għoti flimkien ma' Genvoya jista' jirriżulta f'żieda talkonċentrazzjonijiet ta' sildenafil u tadalafil fil-plażma, li jista' jirriżulta f'reazzjonijiet avversi assoċjati ma' impeditur ta' PDE-5.
English: Hepatitis B and/or hepatitis C virus co-infection
Maltese: Pazjenti infettati b'HIV-1 b'soppressjoni virali
English: Although there were no new safety issues identified, the implications of increased emtricitabine exposure remain uncertain (see sections 4.8 and 5.2).
Maltese: Għalkemm ma ġew identifikati l-ebda problemi ġodda ta' sigurtà, limplikazzjonijiet ta' esponiment għal emtricitabine miżjud jibqgħu inċerti (ara sezzjonijiet 4.8 u 5.2).
English: • Autoimmune disorders, when the immune system attacks healthy body tissue, may also occur after you start taking medicines for HIV infection.
Maltese: • Disturbi awtoimmuni, meta s-sistema immuni tattakka tessut tal-ġisem b'saħħtu, jistgħu jseħħu wkoll wara li tibda tieħu mediċini għall-infezzjoni tal-HIV.
English: Co-administration is contraindicated with medicinal products that are strong inducers of CYP3A due to the potential for loss of virologic response and possible resistance to Genvoya.
Maltese: L-għoti flimkien mal-prodotti mediċinali li huma indutturi qawwija ta' CYP3A minħabba l-potenzjal għal telf ta' rispons viroloġiku u reżistenza possibbli għal Genvoya, huwa kontraindikat.
English: Some medicinal products should not be co-administered with Genvoya (see sections 4.3 and 4.5).
Maltese: Xi prodotti mediċinali m'għandhomx jingħataw flimkien ma' Genvoya (ara sezzjonijiet 4.3 u 4.5).
English: Pooled treatment outcomes at 48 and 144 weeks are shown in Table 3.
Maltese: Irriżultati miġbura tat-trattament wara 48 u 144 ġimgħa qed jintwerew f'Tabella 3.
English: However increased post-implantation loss and decreased foetal weights were observed in rats associated with significant decreases in maternal body weights at 125 mg/kg/day.
Maltese: Madankollu żieda fit-telf ta' wara limpjantazzjoni u tnaqqis fil-piżijiet fetali ġew osservati fil-firien, assoċjati ma' tnaqqis sinifikanti fil-piżijiet tal-ġisem tal-omm f'doża ta' 125 mg/kg/kuljum.
English: ANTI-HYPERTENSIVES Metoprolol
Maltese: Parametri tal-piż u metaboliċi
English: Treatment with cobicistat and elvitegravir during the second and third trimesters of pregnancy has been shown to result in lower elvitegravir exposures (see section 5.2).
Maltese: It-trattament b'cobicistat u elvitegravir matul it-tieni u t-tielet trimestru tat-tqala intwera li jirriżulta f'esponimenti aktar baxxi għal elvitegravir (ara sezzjoni 5.2).
English: Concentrations of these antiarrhythmic drugs may be increased when co-administered with cobicistat.
Maltese: Il-konċentrazzjonijiet ta' mediċini antidepressanti jistgħu jiżdiedu meta jingħataw ma' cobicistat.
English: It is important not to miss a dose of Genvoya.
Maltese: Huwa importanti li ma tinsa tieħu ebda doża ta' Genvoya.
English: In animal studies there were no effects of elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide on mating or fertility parameters (see section 5.3).
Maltese: Studji ta' tenofovir alafenamide f'annimali ma wrew l-ebda evidenza ta' effetti ħżiena fuq il-parametri tal-fertilità, tqala, jew l-iżvilupp tal-fetu ta' tenofovir alafenamide (ara sezzjoni 5.3).