FrancophonIA/ELRC3.0 huggingface dataset:
English: No clinically relevant differences in tenofovir alafenamide, or tenofovir pharmacokinetics were observed between healthy subjects and patients with severe renal impairment (eGFRCG > 15 but < 30 mL/min) in studies of tenofovir alafenamide.
Maltese: Ma ġew osservati l-ebda differenzi rilevanti b'mod kliniku fil-farmakokinetika ta' tenofovir alafenamide, jew ta' tenofovir bejn individwi f'saħħithom u pazjenti b'indeboliment sever tal-kliewi (eGFRCG > 15 iżda < 30 mL/min) fi studji ta' tenofovir alafenamide.
English: Outcomes at Week 48
Maltese: Ġimgħa 48
English: Symtuza should be discontinued in patients with eGFRCG that declines below 30 mL/min during treatment (see sections 5.1 and 5.2).
Maltese: Symtuza għandu jitwaqqaf f'pazjenti b'eGFRCG li tinżel taħt 30 mL/min matul it-trattament (ara sezzjonijiet 5.1 u 5.2).
English: The following viral load values were observed for these subjects at Week 96: 54 copies/mL, 78 copies/mL, 111 copies/mL, 152 copies/mL, and 210 copies/mL.
Maltese: Il-valuri tal-ammonti virali li ġejjin ġew osservati f'dawn l-individwi f'Ġimgħa 96: 54 kopja/mL, 78 kopja/mL, 111 kopja/mL, 152 kopja/mL, u 210 kopja/mL.
English: Unchanged darunavir accounted for approximately 41.2% and 7.7% of the administered dose in faeces and urine, respectively.
Maltese: Darunavir mhux mibdul kien jgħodd madwar 41.2% u 7.7% tad-doża mogħtija fl-ippurgar u fl-awrina, rispettivament.
English: Tenofovir alafenamide is not an inhibitor of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, or CYP2D6 in vitro.
Maltese: Tenofovir alafenamide mhuwiex inibitur ta' CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, jew CYP2D6 in vitro.
English: Median Increase From Baseline at Week 48 D/C/F/TAF
Maltese: Medjan ta' Żieda mill-Linja Bażi f' Ġimgħa 48 D/C/F/TAF
English: Week 48 window: Day 295 - Day 378; Week 96 window: Day 631 - Day 714
Maltese: Perjodu tal-Ġimgħa 48: Jum 295 - Jum 378; perjodu tal-Ġimgħa 96: Jum 631 - Jum 714
English: Based on stratum adjusted MH test where stratification factors are HIV-1 RNA level (≤ 100,000 or > 100,000 copies/mL) and CD4+ cell count (< 200 or ≥ 200 cells/µL).
Maltese: Abbażi ta' test MH aġġustat skont l-istratum fejn il-fatturi ta' stratifikazzjoni huma l-livell ta' RNA ta' HIV-1 (≤100,000 jew > 100,000 kopja/mL) u l-għadd taċ-ċelluli CD4+ (< 200 or ≥200 ċellula/µL).
English: The most frequent (> 5%) adverse reactions reported in suppressed treatment-experienced patients (EMERALD Study TMC114IFD3013, Week 96 analysis) were diarrhoea (10.5%), headache (10.4%), arthralgia (7.7%), abdominal pain (7.5%), fatigue (5.9%), and rash (5.1%).
Maltese: L-aktar reazzjonijiet avversi frekwenti (> 5%) rrappurtati f'pazjenti soppressi li kienu ħadu trattament qabel (l-Istudju EMERALD TMC114IFD3013, analiżi f'Ġimgħa 96) kienu dijarea (10.5%), uġigħ ta' ras (10.4%), artralġja (7.7%), uġigħ fl-addome (7.5%), għeja (5.9%), u raxx (5.1%).
English: Virologic response was defined as a decrease in plasma HIV-1 RNA viral load of at least 1.0 log10 versus baseline (see Table 7).
Maltese: Rispons viroloġiku ġie ddefinit bħala tnaqqis ta' mill-inqas 1.0 log10 versus il-linja bażi fl-ammont virali talRNA tal-HIV-1 fil-plażma (ara Tabella 7).
English: The median terminal elimination half-life of tenofovir alafenamide was 0.3 hours when administered as Symtuza.
Maltese: Il-medjan tal-half-life terminali tal-eliminazzjoni ta' tenofovir alafenamide kien 0.3 sigħat meta ngħata bħala Symtuza.
English: Nucleoside and nucleotide analogues have been demonstrated in vitro and in vivo to cause a variable degree of mitochondrial damage.
Maltese: Analogi tan-nukleosid u n-nukleotid intwerew in vitro u in vivo jikkawżaw grad varjabbli ta' ħsara mitokondrijali.
English: Emerging Resistance in AMBER and EMERALD Trial (Week 96)
Maltese: Tabella 4: Reżistenza li Feġġet fil-Prova AMBER u EMERALD (Ġimgħa 96)
English: The safety of Symtuza in paediatric patients has not been investigated.
Maltese: Is-sigurtà ta' Symtuza f'pazjenti pedjatriċi ma ġietx investigata.
English: • tiredness (fatigue)
Maltese: • nuqqas t'aptit (anoreksja)
English: Symtuza 800 mg/150 mg/200 mg/10 mg film-coated tablets
Maltese: Symtuza 800 mg/150 mg/200 mg/10 mg pilloli miksija b'rita
English: Darunavir is approximately 95% bound to plasma protein.
Maltese: Bejn wieħed u ieħor 95% ta' darunavir jintrabat mal-proteini tal-plażma.
English: Immune Reactivation Syndrome
Maltese: Sindrom ta' Riattivazzjoni Immuni
English: Cobicistat is metabolised via CYP3A (major)- and CYP2D6 (minor)-mediated oxidation and does not undergo glucuronidation.
Maltese: Cobicistat hu metabolizzat permezz ta' CYP3A (maġġuri) u ossidazzjoni medjata minn CYP2D6 (minuri) u ma jgħaddix minn glukuronidazzjoni.
English: However, there are pharmacokinetic data for the different components of Symtuza, indicating that doses of 800 mg darunavir, 150 mg cobicistat, 200 mg emtricitabine and 10 mg tenofovir alafenamide result in similar exposures in adults and adolescents aged 12 years and older, weighing at least 40 kg.
Maltese: Madankollu, hemm dejta farmakokinetika għall-komponenti differenti ta' Symtuza, li tindika li dożi ta' 800 mg darunavir, 150 mg cobicistat, 200 mg emtricitabine u 10 mg tenofovir alafenamide jwasslu għal esponimenti simili fl-adulti u fl-adolexxenti li għandhom 12-il sena jew aktar, li jiżnu mill-anqas 40 kg.
English: The most frequent (> 5%) adverse reactions reported in treatment-naïve patients in the Phase 2 (GSUS-299-0102) and Phase 3 Study (AMBER, TMC114FD2HTX3001, Week 96 analysis) were diarrhoea (22.6%), headache (13.1%), rash (12.7%), nausea (9.7%), fatigue (8.0%), and abdominal pain (5.8%).
Maltese: L-aktar reazzjonijiet avversi frekwenti (> 5%) rrappurtati f'pazjenti li qatt ma kienu ħadu trattament qabel fil-Fażi 2 (GS-US-299-0102) u l-Fażi 3 (AMBER, TMC114FD2HTX3001, analiżi ta' Ġimgħa 96) tal-Istudju kienu dijarea (22.6%), uġigħ ta' ras (13.1%), raxx (12.7%), nawsja (9.7%), għeja (8.0%), u uġigħ fl-addome (5.8%).
English: Darunavir and cobicistat are metabolised by CYP3A.
Maltese: Darunavir u cobicistat huma metabolizzati permezz ta' CYP3A.
English: The intravenous clearance of darunavir alone (150 mg) and in the presence of low dose (100 mg) ritonavir was 32.8 l/h and 5.9 l/h, respectively.
Maltese: It-tneħħija mill-vini ta' darunavir (150 mg) waħdu u fil-preżenza ta' doża baxxa (100 mg) ta' ritonavir kienet 32.8 l/siegħa u 5.9 l/siegħa, rispettivament.
English: HIV-1 RNA ≥ 50 copies/mL Virologic failure - leading to discontinuation Virologic failure - discontinued due to other reason and last available HIV-1 RNA ≥ 50 copies/mL No virologic data Reasons Discontinued trial due to adverse event or death Discontinued trial for other reasons Missing data during window but on trial Cumulative Protocol-Defined Virologic Rebound by subgroup, % Age < 50 years ≥ 50 years Sex Male Female
Maltese: ≥ 50 kopja/mL ta' RNA ta' HIV-1 Falliment Viroloġiku - li wassal waqfien Falliment Viroloġiku - ma komplewx minħabba raġuni oħra u l-aħħar RNA ta' HIV-1 disponibbli kien ≥ 50 kopja/mL L-ebda dejta viroloġika Raġunijiet Waqfu mill-prova minħabba avveniment avvers jew mewt Waqfu mill-prova minħabba raġunijiet oħra Dejta nieqsa matul il-perjodu iżda fil-prova Virus li Jfiġġ mill-Ġdid wara t-Trattament Kumulattiv Iddefinit mill-Protokoll skont is-sottogrupp, % Età < 50 sena ≥ 50 sena Sess tal-persuna Raġel Mara Razza Iswed/Sewda
English: In the Phase 3 trial of Symtuza in treatment-naïve patients, increases from baseline were observed in the fasting lipid parameters total cholesterol, direct LDL and HDL cholesterol, and triglycerides at Week 48 and 96 (see Table 3).
Maltese: Fil-prova ta' Fażi 3 ta' Symtuza f'pazjenti li qatt ma kienu ħadu trattament qabel, żidiet mil-linja bażi kienu osservati fil-parametri tal-lipidi tal-kolesterol totali, tal-kolesterol LDL u HDL dirett, u tattrigliċeridi waqt is-sawm fil-Ġimgħa 48 u 96 (ara Tabella 3).
English: Darunavir demonstrates antiviral activity in vitro against a broad panel of HIV-1 group M (A, B, C, D, E, F, G) and group O primary isolates with EC50 values ranging from < 0.1 to 4.3 nM.
Maltese: Darunavir juri attività antivirali in vitro kontra lista wiesa' ta' iżolati primarji ta' HIV-1 tal-grupp M (A, B, C, D, E, F, G) u l-grupp O
English: At least 3 oxidative metabolites of darunavir have been identified in humans; all showed activity that was at least 10-fold less than the activity of darunavir against wild type HIV.
Maltese: Fil-bnedmin ġew identifikati mill-inqas 3 metaboliti ossidattivi ta' darunavir; kollha wrew attività li kienet millinqas 10-darbiet anqas mill-attività ta' darunavir kontra l-HIV tat-tip li jinstab fin-natura.
English: Using Cyst C as filtration marker, the median change in estimated glomerular filtration rate calculated using the CKD-EPI (eGFRCKD-EPI Cyst C) formula (N=22) was +4.4 mL/min/1.73 m² with D/C/F/TAF.
Maltese: Bl-użu ta' Cyst C bħala markatur ta' filtrazzjoni, il-medjan ta' bidla fir-rata stmata ta' filtrazzjoni mill-glomeruli kkalkulata bl-użu tal-formola CKD-EPI (eGFRCKD-EPI Cyst C) (N=22) kien +4.4 mL/min/1.73 m² b'D/C/F/TAF.
English: Second trimester of pregnancy N = 7
Maltese: It-tieni trimestru tat-tqala N=7
English: Treatment with darunavir/cobicistat (two of the components of Symtuza) during pregnancy results in low darunavir exposure (see sections 4.4 and 5.2).
Maltese: It-trattament b'darunavir/cobicistat (tnejn mill-komponenti ta' Symtuza) waqt it-tqala jwassal għal esponiment baxx għal darunavir (ara sezzjonijiet 4.4 u 5.2).
English: Following intravenous administration, the volume of distribution of darunavir alone was 88.1 ± 59.0 L (mean ± SD) and increased to 131 ± 49.9 L (mean ± SD) in the presence of 100 mg twice-daily ritonavir.
Maltese: Wara għoti minn ġol-vini, il-volum ta' distribuzzjoni ta' darunavir waħdu kien 88.1 ± 59.0 L (medja ± SD) u żdied għal 131 ± 49.9 L (medja ± SD) fil-preżenza ta' 100 mg ta' ritonavir darbtejn kuljum.
English: - Buprenorphine/naloxone, methadone (medicines to treat opioid dependence) - Salmeterol (medicine to treat asthma) - Artemether/lumefantrine (a combination medicine to treat malaria) - Dasatinib, irinotecan, nilotinib, vinblastine, vincristine (medicines to treat cancer) - Prednisone (corticosteroid) - Sildenafil, tadalafil, vardenafil (for erectile dysfunction or to treat a heart and lung disorder called pulmonary arterial hypertension) - Glecaprevir/pibrentasvir, simeprevir, boceprevir (to treat hepatitis C virus infection).
Maltese: - Dasatinib, irinotecan, nilotinib, vinblastine, vincristine (mediċini biex jitrattaw il-kanċer) - Prednisone (kortikosterojd) - Sildenafil, tadalafil, vardenafil (għall-impotenza jew biex jittrattaw kundizzjoni tal-qalb u l pulmuni msejħa pressjoni għolja fl-arterji tal-pulmun) - Glecaprevir/pibrentasvir, simeprevir, boceprevir (biex jitrattaw infezzjoni bil-virus tal epatite C).
English: Third trimester of pregnancy N = 6
Maltese: It-tielet trimestru tat-tqala N=6
English: In the study GS-US-292-0106, the efficacy, safety, and pharmacokinetics of emtricitabine and tenofovir alafenamide were evaluated in an open-label study in which 50 HIV-1 infected, treatment-naïve adolescents received emtricitabine and tenofovir alafenamide (10 mg) given with elvitegravir and cobicistat as a fixed-dose combination tablet.
Maltese: Fl-istudju GS-US-292-0106, l-effikaċja, is-sigurtà u l-farmakokinetika ta' emtricitabine u tenofovir alafenamide ġew evalwati fi studju fejn kemm l-investigaturi kif ukoll l-individwi kienu jafu liema sustanza qed tintuża li fih 50 adoloxxent infettati bl-HIV-1 li qatt ma kienu ħadu trattament qabel irċivew emtricitabine u tenofovir alafenamide (10 mg) mogħti flimkien ma' elvitegravir u cobicistat bħala pillola kkombinata b'doża fissa.
English: C]-emtricitabine, complete recovery of the emtricitabine dose was achieved in urine (approximately 86%) and faeces (approximately 14%).
Maltese: C], l-irkupru komplet tad-doża ta' emtricitabine inkiseb fl-awrina (madwar 86%) u flippurgar (madwar 14%).
English: At Week 96, the median change in eGFRCG was -5.2 mL/min with D/C/F/TAF.
Maltese: F'Ġimgħa 96, il-medjan ta' bidla fleGFRCG kien -5.2 mL/min b'D/C/F/TAF.
English: The pharmacokinetics of Symtuza have not been investigated in paediatric patients.
Maltese: Il-farmakokinetika ta' Symtuza ma ġietx investigata f'pazjenti pedjatriċi.
English: Mean systemic emtricitabine exposure was higher in patients with severe renal impairment (eGFRCG < 30 mL/min) (33.7 mcg•h/mL) than in subjects with normal renal function (11.8 mcg•h/mL).
Maltese: Il-medja tal-esponiment sistemiku għal emtricitabine kienet ogħla f'pazjenti b'indeboliment sever talkliewi (eGFRCG < 30 mL/min) (33.7 mcg•siegħa/mL) milli f'individwi b'funzjoni normali tal-kliewi (11.8 mcg•siegħa/mL).
English: These EC50 values are well below the 50% cellular toxicity concentration range of 87 µM to > 100 µM.
Maltese: Dawn il-valuri EC50 huma ħafna inqas mill-firxa li tvarja minn 87 µM sa > 100 µM għal konċentrazzjoni ta' tossiċità ċellulari ta' 50%.
English: d.o.o.
Maltese: TAL-ERGOT eż.
English: Darunavir is extensively metabolised by the hepatic CYP system and almost exclusively by isozyme CYP3A4.
Maltese: Darunavir jiġi metabolizzat b'mod estensiv permezz tas-sistema CYP tal-fwied u kważi b'mod esklussiv permezz tal-isozima CYP3A4.
English: • if you have had problems with your liver, including hepatitis B or C infection.
Maltese: • jekk kellek problemi bil-fwied, inkluż infezzjoni bl-epatite B jew Ċ.
English: Discontinued study drug due to other reasons and last available HIV-1 RNA < 50 copies/mL Missing data during window but on trial Virologic response (HIV-1-RNA < 50 copies/mL; Snapshot Analysis) by subgroup, n/N (%)
Maltese: Rispons viroloġiku (<50 kopja/mL RNA ta' HIV-1; Analiżi Snapshot) skont is-sottogrupp, n/N (%)
English: Reverse transcriptase
Maltese: Reverse transcriptase b'PDVF
English: Ethinyl estradiol
Maltese: Ethinylestradiol
English: Cobicistat is primarily metabolised and eliminated by the liver.
Maltese: Cobicistat jiġi metabolizzat u eliminat l-aktar mill-fwied.
English: At baseline, median plasma HIV-1 RNA was 4.7 log10 copies/mL, median CD4+ cell count was 456 cells/mm
Maltese: Fil-linja bażi, il-medjan tal-RNA tal-HIV-1 fil-plażma kien 4.7 log10 kopja/mL, l-għadd medjan ta' ċelluli CD4+ kien 456 ċelluli/mm
English: Tenofovir alafenamide is permeable into cells and due to increased plasma stability and intracellular activation through hydrolysis by cathepsin A, tenofovir alafenamide is more efficient than tenofovir disoproxil in concentrating tenofovir in peripheral blood mononuclear cells (PBMC) (including lymphocytes and other HIV target cells) and macrophages.
Maltese: Tenofovir alafenamide jgħaddi għal ġoċ-ċelluli u minħabba żieda fl-istabilità fil-plażma u attivazzjoni intraċellulari permezz ta' idroliżi minn cathepsin A, tenofovir alafenamide huwa aktar effiċjenti minn tenofovir disoproxil biex jikkonċentra tenofovir fiċ-ċelluli mononukleari fid-demm periferali (PBMC, peripheral blood mononuclear cells) (inklużi limfoċiti u ċelluli oħra fil-mira tal-HIV) u fil-makrofaġi.
English: Cumulative Protocol-Defined Virologic Rebound a, %
Maltese: Virus li Jfiġġ mill-Ġdid wara t-Trattament Kumulattiv Iddefinit mill-Protokoll a, %
English: The main adverse reactions reported are haematological disorders (anaemia, neutropenia) and metabolic disorders (hyperlactataemia, hyperlipasaemia).
Maltese: L-effetti avversi ewlenin irrappurtati huma disturbi ematoloġiċi (anemija, newtropenija) u disturbi fil-metaboliżmu (iperlaktejtimja, iperlajpejżimja).
English: Patients had a median age of 15 years (range: 12-17), and 56% were female, 12% were Asian, and 88% were Black.
Maltese: Il-pazjenti kellhom medjan ta' età ta' 15-il sena (firxa: 12-17), u 56% kienu nisa, 12% kienu Asjatiċi, u 88% kienu Suwed.
English: Tenofovir alafenamide is mainly eliminated following metabolism to tenofovir.
Maltese: Tenofovir alafenamide jiġi eliminat l-aktar wara l-metaboliżmu ta' tenofovir.
English: The distribution of tenofovir alafenamide in the body may be affected by the activity of OATP1B1 and OATP1B3.
Maltese: Id-distribuzzjoni ta' tenofovir alafenamide fil-ġisem tista' tiġi affettwata mill-attività ta' OATP1B1 u OATP1B3.
English: Based on theoretical considerations DRV/COBI is expected to increase the plasma concentrations of fluvastatin, pitavastatin, pravastatin, lovastatin and simvastatin.
Maltese: Abbażi ta' konsiderazzjonijiet teoretiċi DRV/COBI huwa mistenni li jżid ilkonċentrazzjonijiet ta' fluvastatin, pitavastatin, pravastatin, lovastatin u simvastatin.
English: Symtuza is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and adolescents (aged 12 years and older with body weight at least 40 kg).
Maltese: Symtuza huwa indikat għat-trattament ta' infezzjoni bil-virus tal-immunodefiċjenza umana tat-tip 1 (HIV-1, human immunodeficiency virus type 1) f'adulti u adolexxenti (li għandhom 12-il sena u aktar b'piż tal-ġisem ta' mill-inqas 40 kg).
English: The emtricitabine-resistant virus with the M184M/I/V mutation was cross-resistant to lamivudine, but retained sensitivity to abacavir, stavudine, tenofovir, and zidovudine.
Maltese: Il-virus reżistenti għal emtricitabine bil-mutazzjoni M184M/I/V kien reżistenti ukoll għal lamivudine, iżda baqa' sensittiv għal abacavir, stavudine, tenofovir, u zidovudine.
English: ALPHA ADRENORECEPTOR ANTAGONISTS Alfusozin
Maltese: ALPHA Alfusozin
English: (CYP3A inhibition)
Maltese: (inibizjoni ta' CYP3A)
English: The median increases from baseline were greater in the D/C/F/TAF group compared with the DRV/ cobicistat (COBI)+F/ tenofovir disoproxil fumarate (TDF) group at Week 48.
Maltese: Il-medjan taż-żidiet mil-linja bażi kienu akbar fil-grupp ta' D/C/F/TAF meta mqabbel mal-grupp ta' DRV/ cobicistat (COBI)+F/ tenofovir disoproxil fumarate (TDF) fil-Ġimgħa 48.
English: Darunavir, emtricitabine and tenofovir alafenamide demonstrated additive to synergistic antiviral effects in two-drug combination studies in cell culture.
Maltese: Darunavir, emtricitabine u tenofovir alafenamide urew effetti antivirali minn addittivi sa sinerġistiċi fi studji ta' kombinazzjoni ta' żewġ mediċini f'koltura ta'ċelluli.
English: Limited PK information is available in the elderly (age ≥ 65 years of age) for Symtuza as well as its individual components.
Maltese: Fl-anzjani (età ≥ 65 sena) hija disponibbli informazzjoni PK limitata għal Symtuza kif ukoll għallkomponenti individwali tiegħu.
English: Other severe side effects, seen up to 1 patient in 10, were diabetes, increased blood fat levels and symptoms of infection.
Maltese: Effetti sekondarji severi oħra, li dehru f'sa pazjent 1 minn kull 10, kienu dijabete, żieda fil-livelli taxxaħmijiet fid-demm u sintomi ta' infezzjoni.
English: The median terminal plasma half-life of darunavir following administration of Symtuza is 5.5 hours.
Maltese: Il-medjan tal-half-life terminali ta' darunavir filplażma wara l-għoti ta' Symtuza huwa 5.5 sigħat.
English: This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially ‘sodium-free'.
Maltese: Din il-mediċina fiha inqas minn 1 mmol sodium (23 mg) f'kull unità tad-doża, li tista' tgħid hija essenzjalment ‘mingħajr sodium'.
English: Symtuza might increase the risk for elevated potassium levels by drospirenone.
Maltese: Symtuza jista' jżid ir-riskju ta' żieda fil-livelli tal-potassium minn drospirenone.
English: The mean baseline plasma HIV-1 RNA and the median baseline CD4+ cell count were 4.48 log10 copies/mL (SD = 0.61) and 453 x 10
Maltese: Il-medja tal-linja bażi tal-RNA tal-HIV-1 fil-plażma u lmedjan tal-linja bażi tal-għadd taċ-ċelluli CD4+ kienu 4.48 log10 kopji/mL (SD = 0.61) u 453 x 10
English: • emtricitabine, an anti-HIV medicine known as a nucleoside reverse transcriptase inhibitor
Maltese: • emtricitabine, mediċina kontra l-HIVmagħrufa bħala inibitur nucleoside ta' reverse transcriptase
English: Each film-coated tablet contains 800 mg darunavir (as ethanolate), 150 mg cobicistat, 200 mg emtricitabine, and 10 mg tenofovir alafenamide (as fumarate).
Maltese: Kull pillola miksija b'rita fiha 800 mg darunavir (bħala ethanolate), 150 mg cobicistat, 200 mg emtricitabine, u 10 mg tenofovir alafenamide (bħala fumarate).
English: In women receiving darunavir/cobicistat during the second trimester of pregnancy, mean intra-individual values for total darunavir Cmax, AUC24h and Cmin were 49%, 56% and 92% lower, respectively, as compared with postpartum; during the third trimester of pregnancy, total darunavir Cmax, AUC24h and Cmin values were 37%, 50% and 89% lower, respectively, as compared with postpartum.
Maltese: F'nisa li kienu qed jirċievu darunavir/cobicistat matul it-tieni trimestru tat-tqala, valuri medji fl-istess individwu għas-Cmax, l-AUC24h u s-Cmin ta' darunavir totali kienu 49%, 56% u 92% aktar baxxi, rispettivament, meta mqabbla ma wara t-twelid; matul it-tielet trimestru tat-tqala, il-valuri tas-Cmax, l-AUC24h u s-Cmin ta' darunavir totali kienu 37%, 50% u 89% aktar baxxi rispettivament, meta mqabbla ma' wara t-twelid.
English: Medicinal products that induce P-gp activity (e.g., rifampicin, rifabutin, carbamazepine, phenobarbital) are expected to decrease the absorption of tenofovir alafenamide, resulting in decreased plasma concentration of tenofovir alafenamide, which may lead to loss of therapeutic effect of tenofovir alafenamide and development of resistance.
Maltese: Prodotti mediċinali li jikkaġunaw l-attività ta' P-gp (eż., rifampicin, rifabutin, carbamazepine, phenobarbital) huma mistennija li jnaqqsu l-assorbiment ta' tenofovir alafenamide, li jwassal għal tnaqqis fil-konċentrazzjoni ta' tenofovir alafenamide fil-plażma, li jista' jwassal għal telf tal-effett terapewtiku ta' tenofovir alafenamide u l-iżvilupp ta' reżistenza.
English: Patients with severe (Child-Pugh Class C) hepatic impairment.
Maltese: Pazjenti b'indeboliment sever tal-fwied (Klassi Ċ ta' Child-Pugh).
English: For tenofovir alafenamide, the Cmax was 1.82-fold higher in fasted condition, while the AUC was 20% lower to comparable in a fasted compared to fed condition.
Maltese: Għal tenofovir alafenamide, is-Cmax kienet 1.82 drabi ogħla fl-istat ta' sawm, filwaqt li l-AUC kienet 20% inqas fl-istat sajjem meta mqabbel mal-istat mitmugħ.
English: The effect of severe hepatic impairment (Child-Pugh Class C) on the pharmacokinetics of tenofovir alafenamide has not been studied.
Maltese: L-effetti ta' indeboliment sever tal-fwied (Child-Pugh Klassi Ċ) fuq il-farmakokinetika ta' tenofovir alafenamide ma ġiex studjat.
English: Concomitant use of Symtuza may increase the risk for development of systemic corticosteroid effects, including Cushing's syndrome and adrenal suppression.
Maltese: L-użu flimkien ma' Symtuza jista' jżid ir-riskju tal-iżvilupp ta' effetti sistemiċi talkortikosterojdi, inkluż is-sindrom ta' Cushing u soppressjoni talglandoli adrenali.
English: Medicinal products that induce CYP3A activity would be expected to increase the clearance of darunavir and cobicistat, resulting in lowered plasma concentrations of darunavir and cobicistat (e.g. efavirenz, carbamazepine, phenytoin, phenobarbital, rifampicin, rifapentine, rifabutin, St. John's wort) (see section 4.3 and interaction table below).
Maltese: Prodotti mediċinali li jinduċu lattività ta' CYP3A jkunu mistennija li jżidu t-tneħħija ta' darunavir u cobicistat, li jwassal għal konċentrazzjonijiet aktar baxxi ta' darunavir u cobicistat fil-plażma (eż. efavirenz, carbamazepine, phenytoin, phenobarbital, rifampicin, rifapentine, rifabutin, St.
English: (CYP2D6 and/or CYP3A inhibition)
Maltese: (inibizzjoni ta' CYP2D6 u/jew ta' CYP3A)
English: In some patients with advanced HIV infection (AIDS) and a history of opportunistic infection (unusual infections due to a weakened immune system), signs and symptoms of inflammation from previous infections may occur soon after HIV treatment is started, including Symtuza.
Maltese: F'xi pazjenti b'infezzjoni avvanzata tal-HIV (AIDS) u storja ta' infezzjoni opportunistika (infezzjonijiet mhux tas-soltu minħabba sistema immuni mdgħajfa), sinjali u sintomi ta' infjammazzjoni minn infezzjonijiet preċedenti jistgħu jseħħu ftit wara li jinbeda t-trattament għall-HIV, inkluż Symtuza.