FrancophonIA/ELRC3.0 huggingface dataset:
English: Truvada should be avoided in antiretroviral-experienced patients with HIV-1 harbouring the K65R mutation (see section 5.1).
Maltese: Truvada għandu jiġi evitat f'pazjenti li ngħataw antiretrovirali fil-passat li għandhom l-HIV-1 bilmutazzjoni K65R (ara sezzjoni 5.1).
English: (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100) or rare (≥ 1/10,000 to
Maltese: Il-frekwenzi huma deskritti bħala komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100) jew rari (≥ 1/10,000 sa
English: Croscarmellose sodium Lactose monohydrate Magnesium stearate (E572) Microcrystalline cellulose (E460) Pregelatinised starch (gluten free)
Maltese: Magnesium stearate (E572) Microcrystalline cellulose (E460)
English: No dose adjustment of norgestimate/ethinyl oestradiol is required.
Maltese: Norgestimate/Ethinyl oestradiol/
English: Placebo (n = 1248)
Maltese: (n = 1248)
English: It is important not to stop taking Truvada without talking to your doctor: see section 3, Do not stop taking Truvada.
Maltese: Huwa importanti li ma tieqafx tieħu Truvada mingħajr ma tkellem lit-tabib tiegħek: ara sezzjoni 3, Tieqafx tieħu Truvada.
English: IMMUNOSUPPRESSANTS Tacrolimus/Tenofovir disoproxil/Emtricitabine
Maltese: Tacrolimus/Tenofovir disoproxil/Emtricitabine
English: Steady-state pharmacokinetics of tenofovir were evaluated in 8 HIV-1 infected adolescent patients (aged 12 to < 18 years) with body weight ≥ 35 kg and in 23 HIV-1 infected children aged 2 to < 12 years.
Maltese: Il farmakokinetika fl-istat fiss ta' tenofovir kienet evalwata fi 8 pazjenti adolexxenti infettati bl-HIV-1 (età minn 12 sa < 18 sena) b'piż tal-ġisem ta' ≥ 35 kg u fi 23 tifel u tifla infettati bl-HIV-1 li kellhom minn sentejn sa < 12 sena.
English: Placebo (n = 1584)
Maltese: (n = 1584)
English: Pre-exposure prophylaxis: The iPrEx study (CO-US-104-0288) evaluated Truvada or placebo in 2,499 HIV-uninfected men (or transgender women) who have sex with men and who were considered at high risk for HIV infection.
Maltese: L-istudju iPrEx (CO-US-104-0288) evalwa Truvada jew plaċebo f'2,499 raġel (jew mara transesswali) mhux infettat bl-HIV li jkollhom sess mal-irġiel u li kienu meqjusin f'riskju għoli għal infezzjoni tal-HIV.
English: Seroconversions / Nb a ‘Case' = HIV seroconverter; ‘Cohort' = 100 randomly selected subjects from each of the tenofovir disoproxil 245 mg and Truvada groups.
Maltese: a ‘Każ' = serokonvertitur tal-HIV; ‘Koorti' = 100 individwu magħżulin b'mod każwali minn kull wieħed mill-gruppi ta' tenofovir disoproxil 245 mg u Truvada.
English: Limited data from clinical studies support once daily dosing in HIV-1 uninfected individuals with CrCl 60-80 mL/min.
Maltese: Dejta limitata minn studji kliniċi tappoġġja doża ta' darba kuljum f'individwi mhux infettati bl-HIV-1 b'CrCl 60-80 mL/min.
English: Dose interval adjustments are recommended for HIV-1 infected patients with creatinine clearance 30-49 mL/min (see section 4.2).
Maltese: Aġġustamenti fl-intervall taddoża huma rakkomandati għal pazjenti infettati bl-HIV-1 bi tneħħija fil-kreatinina ta' 30-49 mL/min (ara sezzjoni 4.2).
English: Truvada film-coated tablets are blue, capsule-shaped tablets, engraved on one side with the word “GILEAD” and on the other side with the number “701”.
Maltese: Il-pilloli miksija b'rita ta' Truvada huma blu, f'forma ta' kapsula, b' “GILEAD” imnaqqxa fuq naħa waħda u n-numru “701” fuq in-naħa l-oħra.
English: HIV-1 RNA < 50 copies/mL (TLOVR) p-value % difference (95%CI)
Maltese: RNA tal-HIV-1 < 50 kopja/mL (TLOVR) Valur p
English: Table 3: Tabulated summary of adverse reactions associated with the individual components of Truvada based on clinical study and post-marketing experience
Maltese: Tabella 3: Sommarju tabulat ta' reazzjonijiet avversi assoċjati mal-komponenti individwali ta' Truvada bbażat fuq studju kliniku u esperjenza ta' wara t-tqegħid fis-suq
English: Assessment of adverse reactions related to tenofovir disoproxil is based on two randomised trials (studies GS-US 104-0321 and GS-US-104-0352) in 184 HIV-1 infected paediatric patients (aged 2 to < 18 years) who received treatment with tenofovir disoproxil (n = 93) or placebo/active comparator (n = 91) in combination with other antiretroviral agents for 48 weeks (see section 5.1).
Maltese: L-evalwazzjoni ta' reazzjonijiet avversi marbuta ma' tenofovir disoproxil hija bbażata fuq żewġ provi randomised (studji GS-US-104-0321 u GS-US-104-0352) f'184 pazjent pedjatriku infettat bl-HIV-1 (bejn l-etajiet ta' sentejn sa < 18-il sena) li rċevew trattament b'tenofovir disproxil (n = 93) jew plaċebo/komparatur attiv (n = 91) flimkien ma' sustanzi antiretrovirali oħra għal 48 ġimgħa (ara sezzjoni 5.1).
English: Pre-exposure prophylaxis: No new adverse reactions to Truvada were identified from two randomised placebo-controlled studies (iPrEx, Partners PrEP) in which 2,830 HIV-1 uninfected adults received Truvada once daily for pre-exposure prophylaxis.
Maltese: L-ebda reazzjoni avversa ġdida għal Truvada ma kienet identifikata minn żewġ studji każwali, bi plaċebo bħala kontroll (iPrEx, Partners PrEP) li fihom 2,830 adult mhux infettat bl-HIV-1 ingħataw Truvada darba kuljum għal profilassi ta' qabel l-esponiment.
English: Truvada contains two active substances, emtricitabine and tenofovir disoproxil.
Maltese: Truvada fiha żewġ sustanzi attivi, emtricitabine u tenofovir disoproxil.
English: In study GS-US-104-0321, 87 HIV-1 infected treatment-experienced patients 12 to < 18 years of age were treated with tenofovir disoproxil (n = 45) or placebo (n = 42) in combination with an optimised background regimen (OBR) for 48 weeks.
Maltese: Fl-istudju GS-US-104-0321, 87 pazjent infettat b'HIV-1 b'esperjenza fil-kura, ta' bejn 12 sa 18-il sena, kienu ttrattati b'tenofovir disoproxil (n = 45) jew plaċebo (n = 42) flimkien ma' kors ta' kura ottimizzata fl-isfond (OBR - optimised background regimen) għal 48 ġimgħa.
English: ANTI-INFECTIVES Antiretrovirals
Maltese: ANTI-INFETTIVI
English: In general, the pharmacokinetics of emtricitabine in infants, children and adolescents (aged 4 months up to 18 years) are similar to those seen in adults.
Maltese: B'mod ġenerali, il farmakokinetiċi ta' emtricitabine fit-trabi, tfal u adolexxenti (età ta' bejn 4 xhur sa 18-il sena) huma simili għal dawk osservati fl-adulti.
English: When missing data were excluded, 91% of patients in the tenofovir disoproxil treatment group and 94% of patients in the stavudine or zidovudine treatment group had HIV-1 RNA concentrations < 400 copies/mL at week 48.
Maltese: Meta t-tagħrif nieqes ġie eskluż, 91% tal-pazjenti fil-grupp ta' trattament ta' tenofovir disoproxil u 94% tal-pazjenti fil grupp ta' trattament ta' stavudine jew zidovudine kellhom konċentrazzjonijiet ta' HIV-1 RNA ta' < 400 kopja/mL f'ġimgħa 48.
English: • Provides information on how to store Truvada.
Maltese: • M'għandekx tredda' matul it-trattament bi Truvada.
English: In a randomised clinical study (M02-418), 190 antiretroviral-naïve adults were treated once daily with emtricitabine and tenofovir disoproxil in combination with lopinavir/ritonavir given once or twice daily.
Maltese: Fi studju kliniku randomised (M02-418), 190 pazjent adult li qatt ma' kienu ħadu terapija antiretrovirali, kienu ttrattati darba kuljum b'emtricitabine u tenofovir disoproxil flimkien ma'
English: • The M184V/I mutation developed in 2/19 (10.5%) isolates analysed from patients in the emtricitabine/tenofovir disoproxil/efavirenz group and in 10/29 (34.5%) isolates analysed from the lamivudine/zidovudine/efavirenz group (p-value < 0.05, Fisher's Exact test comparing the emtricitabine+tenofovir disoproxil group to the lamivudine/zidovudine group among all patients).
Maltese: • Il-mutazzjoni M184V/I żviluppat fi 2/19 (10.5%) iżolati analizzati minn pazjenti fil-grupp ta' emtricitabine/tenofovir disoproxil/efavirenz u f'10/29 (34.5%) iżolati analizzati fil-grupp ta'
English: Co-administration of tenofovir disoproxil and didanosine at a dose of 400 mg daily has been associated with a significant decrease in CD4 cell count, possibly due to an intracellular interaction increasing phosphorylated (i.e. active) didanosine.
Maltese: L-għoti flimkien ta' tenofovir disoproxil u didanosine f'doża ta' 400 mg kuljum kien assoċjat ma' tnaqqis sinifikanti flgħadd ta' ċelluli CD4, possibbilment minħabba interazzjoni intraċellulari li żżid id-didanosine fosforilat (jiġifieri attiv).
English: vesiculobullous rash, pustular rash, maculopapular rash, rash, pruritus, urticaria, skin discolouration (increased pigmentation)2
Maltese: raxx vesikulobullożu, raxx bil-ponot, raxx makulari bl-imfafet, raxx, ħakk,
English: In individuals at risk for renal disease more frequent monitoring of renal function is required.
Maltese: F'individwi f'riskju ta' mard tal-kliewi huwa meħtieġ monitoraġġ aktar frekwenti tal-funzjoni tal kliewi.
English: Each Truvada film-coated tablet contains 200 mg of emtricitabine and 245 mg of tenofovir disoproxil (equivalent to 300 mg of tenofovir disoproxil fumarate or 136 mg of tenofovir).
Maltese: Kull pillola miksija b'rita ta' Truvada fiha 200 mg ta' emtricitabine u 245 mg ta' tenofovir disoproxil (ekwivalenti għal 300 mg ta' tenofovir disoproxil fumarate jew 136 mg ta' tenofovir).
English: Didanosine: The co-administration of Truvada and didanosine is not recommended (see section 4.4 and Table 2).
Maltese: L-għoti ta' Truvada flimkien ma' didanosine mhuwiex rakkomandat (ara sezzjoni 4.4 u Tabella 2).
English: In a study of 498 men, the mean changes from baseline to week 24 in BMD ranged from -0.4% to -1.0% across hip, spine, femoral neck and trochanter in men who received daily Truvada prophylaxis (n = 247) vs. placebo (n = 251).
Maltese: Fi studju ta' 498 raġel, il-bidliet medji mil-linja bażi għal ġimgħa 24 fil-BMD varjaw minn - 0.4% sa - 1.0% fil ġenbejn, is-sinsla tad-dahar, l-għonq femorali u t-trokanter fl-irġiel li ngħataw profilassi ta' Truvada kuljum (n = 247) kontra plaċebo (n = 251).
English: Pharmacokinetic studies have not been performed with Truvada in children and adolescents (under 18 years of age).
Maltese: Ma twettqux studji farmakokinetiċi bi Truvada fit-tfal u adolexxenti (taħt l-età ta' 18-il sena).
English: Truvada 200 mg/245 mg film-coated tablets
Maltese: Truvada 200 mg/245 mg pilloli miksija b'rita
English: renal failure (acute and chronic), acute tubular necrosis, nephritis (including acute interstitial nephritis)3, nephrogenic diabetes insipidus
Maltese: nekrożi tubulari akuta, nefrite (li tinkludi nefrite interstizzjali akuta)3,
English: AUC: ↑ 26% (↑ 20 to ↑ 32) Cmax: ↓ 5% (↓ 11 to ↑ 1)
Maltese: AUC: ↑ 26% (↑ 20 sa ↑ 32) Cmax: ↓ 5% (↓ 11 sa ↑ 1) Cmin: NC
English: Use with ledipasvir and sofosbuvir, sofosbuvir and velpatasvir or sofosbuvir, velpatasvir and voxilaprevir
Maltese: sofosbuvir/velpatasvir jew sofosbuvir/velpatasvir/voxilaprevir biex tittratta infezzjoni bl-epatite Ċ.
English: Truvada is indicated in antiretroviral combination therapy for the treatment of HIV-1 infected adults (see section 5.1).
Maltese: Truvada huwa indikat f'terapija antiretrovirali kombinata għal trattament ta' adulti infettati b'HIV-1
English: In patients who received treatment with tenofovir disoproxil or placebo, mean lumbar spine BMD Z-score was -1.004 and -0.809, and mean total body BMD Z-score was -0.866 and -0.584, respectively, at baseline.
Maltese: F'pazjenti li rċevew trattament b'tenofovir disoproxil jew plaċebo, il-punteġġ Z medju tal-BMD tal ispina lumbari kien -1.004 u -0.809, il-punteġġ Z medju tal-BMD tal-ġisem totali kien -0.866 u -0.584,
English: HIV-1 RNA < 400 copies/mL (TLOVR) p-value % difference (95%CI)
Maltese: RNA tal-HIV-1 < 400 kopja/mL (TLOVR) Valur p
English: • That there is an increased risk of renal disease in HIV infected patients associated with tenofovir disoproxil fumarate-containing products such as Truvada
Maltese: • Li hemm riskju miżjud ta' mard tal-kliewi f'pazjenti infettati bl-HIV assoċjat ma' prodotti li fihom tenofovir disoproxil fumarate bħal Truvada
English: a Relative risk reduction calculated for mITT cohort based on incident (post-baseline) seroconversion.
Maltese: a Tnaqqis fir-riskju relattiv ikkalkulat għal koorti tal-mITT ibbażat fuq serokonverżjoni inċidentali (wara l-linja bażi).
English: ANTI-INFECTIVES Hepatitis B virus (HBV) antiviral agents Adefovir dipivoxil/Tenofovir disoproxil
Maltese: Aġenti antivirali tal-virus tal-epatite B (HBV)
English: Risk Estimate for HIV-1 Protection: Detection Versus No Detection of Tenofovir
Maltese: Stima tar-Riskju għall-Protezzjoni mill-HIV-1: Skoperta Kontra
English: Effects on drug levels Mean percent change in AUC, Cmax, Cmin with 90% confidence intervals if available (mechanism)
Maltese: Effetti fuq il-livelli tal-mediċina Bidla perċentwali medja flAUC, Cmax, Cmin b'intervalli ta' kunfidenza ta' 90% jekk disponibbli (mekkaniżmu)
English: Severe renal impairment (CrCl < 30 mL/min) and haemodialysis patients
Maltese: Pazjenti b'indeboliment tal-kliewi sever (CrCl < 30 mL/min) u fuq l-emodijaliżi
English: HIV/HBV or HCV co-infected patients: The adverse reaction profile of emtricitabine and tenofovir disoproxil in a limited number of HIV-infected patients in study GS-01-934 who were co-infected with HBV (n = 13) or HCV (n = 26) was similar to that observed in patients infected with HIV without co-infection.
Maltese: Il-profil tar-reazzjoni avversa ta' emtricitabine u tenofovir disoproxil f'numru limitat ta' pazjenti infettati bl-HIV fl-istudju GS-01-934 li kienu infetti kemm bl-HBV (n = 13) jew bl-HCV (n = 26) kien jixbah lil dak osservat f'pazjenti infettati bl-HIV biss.
English: Sofosbuvir/Velpatasvir/ Voxilaprevir (400 mg/100 mg/ 100 mg+100 mg q.d.
Maltese: Sofosbuvir/Velpatasvir/ Voxilaprevir (400 mg/100 mg/
English: Renal safety with Truvada has only been studied to a very limited degree in HIV-1 infected patients with impaired renal function (creatinine clearance < 80 mL/min).
Maltese: Is-sikurezza tal-kliewi bi Truvada ġiet studjata biss sa livell limitat ħafna f'pazjenti infettati bl-HIV-1 b'funzjoni tal-kliewi indebolita (tneħħija tal-kreatinina < 80 mL/min).
English: AUC: ↓ 4% (↓ 15 to ↑ 8) Cmax: ↑ 102% (↓ 96 to ↑ 108)
Maltese: AUC: ↓ 4% (↓ 15 sa ↑ 8) Cmax: ↑ 102% (↓ 96 sa ↑ 108) Cmin: NC
English: AUC: ↓ 11% (↓ 14 to ↓ 7) Cmax: ↓ 7% (↓ 13 to ↓ 0)
Maltese: AUC: ↓ 11% (↓ 14 sa ↓ 7) Cmax: ↓ 7% (↓ 13 sa ↓ 0) Cmin: NC
English: Table 8: Study population from study CO-US-104-0380 (Partners PrEP)
Maltese: Tabella 8: Popolazzjoni tal-istudju mill-istudju CO-US-104-0380 (Partners PrEP) Plaċebo
English: In vitro protein binding of tenofovir to plasma or serum protein was less than 0.7 and 7.2%, respectively, over the tenofovir concentration range 0.01 to 25 µg/mL.
Maltese: Ir-rabta in vitro ta' tenofovir ma' proteini tal-plażma jew proteini fis serum kienet anqas minn 0.7 u 7.2%, rispettivament, ogħla mill-medda tal-konċentrazzjoni ta'
English: Glycerol triacetate (E1518) Hypromellose (E464) Indigo carmine aluminium lake (E132) Lactose monohydrate Titanium dioxide (E171)
Maltese: Indigo carmine aluminium lake (E132)
English: Truvada has not been studied in individuals over the age of 65 years.
Maltese: Truvada ma ġiex studjat f'individwi li jkollhom iktar minn 65 sena.
English: The 144 week secondary endpoint data are also presented in Table 4.
Maltese: informazzjoni mir-riżultat aħħari sekondarju wara 144 ġimgħa hi ppreżentata wkoll f'Tabella 4.
English: Table 9: Efficacy in study CO-US-104-0380 (Partners PrEP)
Maltese: Tabella 9: Effikaċja fl-istudju CO-US-104-0380 (Partners PrEP) Plaċebo
English: Tenofovir disoproxil is indicated for the treatment of HBV and emtricitabine has shown activity against HBV in pharmacodynamic studies but the safety and efficacy of Truvada have not been specifically established in patients with chronic HBV infection.
Maltese: Tenofovir disoproxil huwa indikat għat-trattament tal-HBV u emtricitabine wera attività kontra l-HBV fi studji farmakodinamiċi iżda s-sigurtà u l-effikaċja ta' Truvada ma ġewx stabbiliti speċifikament f'pazjenti b'infezzjoni kronika tal-HBV.
English: Therefore, the same problems may be seen if Truvada is administered with a third nucleoside analogue.
Maltese: Għalhekk, l-istess problema tista' tiġi osservata jekk Truvada jingħata ma' tielet analogu tan-nucleosides.
English: Cases of acute renal failure after initiation of high dose or multiple non-steroidal anti-inflammatory drugs (NSAIDs) have been reported in HIV-1 infected patients treated with tenofovir disoproxil and with risk factors for renal dysfunction.
Maltese: Każijiet ta' falliment akut tal-kliewi wara l-bidu ta' doża għolja jew diversi mediċini kontra l infjammazzjoni mhux sterojdi (NSAIDs, non-steroidal anti-inflammatory drugs) kienu rrappurtati f'pazjenti infettati bl-HIV-1 ittrattati b'tenofovir disoproxil u b'fatturi ta' riskju għal disfunzjoni talkliewi.
English: Truvada should not be administered concomitantly with other medicinal products containing emtricitabine, tenofovir disoproxil, tenofovir alafenamide or other cytidine analogues, such as lamivudine (see section 4.4).
Maltese: Truvada m'għandhux jingħata fl-istess ħin ma' prodotti mediċinali oħrajn li fihom emtricitabine, tenofovir disoproxil, tenofovir alafenamide jew analogi ta' cytidine oħra, bħal lamivudine (ara sezzjoni 4.4).
English: HIV-1 infection: The most frequently reported adverse reactions considered possibly or probably related to emtricitabine and/or tenofovir disoproxil were nausea (12%) and diarrhoea (7%) in an open-label randomised clinical study in adults (GS-01-934, see section 5.1).
Maltese: L-iktar reazzjonijiet avversi li kienu rrappurtati b'mod frekwenti u li kienu kkunsidrati bħala possibbilment jew probabbilment relatati ma' emtricitabine u/jew tenofovir disoproxil, kienu t-tqalligħ (12%) u d-dijarea (7%) fi studju kliniku open-label u randomised fl-adulti
English: Protease inhibitors Atazanavir/Ritonavir/Tenofovir disoproxil (300 mg q.d./100 mg q.d./245 mg q.d.)
Maltese: Antiretrovirali Impedituri tal-protease Atazanavir/Ritonavir/Tenofovir disoproxil (300 mg q.d./100 mg q.d./245 mg q.d.)
English: AUC: ↓ 1% (↓ 8 to ↑ 6) Cmax: ↑ 7% (↓ 6 to ↑ 22)
Maltese: AUC: ↓ 1% (↓ 8 sa ↑ 6) Cmax: ↑ 7% (↓ 6 sa ↑ 22) Cmin: NC
English: Based on minimal hepatic metabolism and the renal route of elimination for emtricitabine, it is unlikely that a dose adjustment would be required for Truvada in patients with hepatic impairment (see sections 4.2 and 5.2).
Maltese: Fuq il-bażi tal-metaboliżmu epatiku minimu u r-rotta ta' eliminazzjoni tal kliewi għal emtricitabine, huwa improbabbli li jkun meħtieġ aġġustament fid-doża għal Truvada f'pazjenti b'indeboliment tal-fwied (ara sezzjonijiet 4.2 u 5.2).
English: Renally eliminated medicinal products: Since emtricitabine and tenofovir are primarily eliminated by the kidneys, co-administration of Truvada with medicinal products that reduce renal function or compete for active tubular secretion (e.g. cidofovir) may increase serum concentrations of emtricitabine, tenofovir and/or the co-administered medicinal products.
Maltese: Prodotti mediċinali eliminati mill-kliewi: Minħabba li emtricitabine u tenofovir huma primarjament eliminati mill-kliewi, l-għoti ta' Truvada flimkien ma' prodotti mediċinali li jnaqqsu l-funzjoni talkliewi jew jikkompetu għas-sekrezzjoni tubulari attiva (eż. cidofovir) jista' jżid il-konċentrazzjonijiet fis-serum ta' emtricitabine, tenofovir u/jew il-prodotti mediċinali li jingħataw flimkien.
English: Relative Risk Reduction (95% CI)b URAI Within 12 Weeks Prior to Screening, mITT Analysis Seroconversions / N
Maltese: Tnaqqis fir-Riskju Relattiv (95% CI)b a Valuri P skont il-logrank test.
English: In 3 of 10 subjects who had acute HIV infection at study enrollment, M184I and M184V mutations were detected in the HIV of 2 of 2 subjects in the Truvada group and 1 of 8 subjects in the placebo group.
Maltese: 10 individwi li kellhom infezzjoni akuta tal-HIV meta rreġistraw fl-istudju, kienu skoperti l mutazzjonijiet M184I u M184V fl-HIV ta' 2 minn 2 individwi fil-grupp ta' Truvada u 1 minn
English: Truvada is indicated in combination with safer sex practices for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents at high risk (see sections 4.2, 4.4 and 5.1).
Maltese: Profilassi ta' qabel l-esponiment (pre-exposure prophylaxis, PrEP): Truvada huwa indikat flimkien ma' prattiki ta' sess aktar sigur għal profilassi ta' qabel l-esponiment sabiex jitnaqqas ir-riskju ta' infezzjoni tal-HIV-1 miksuba sesswalment f'adulti u adolexxenti f'riskju għoli (ara sezzjonijiet 4.2, 4.4 u 5.1).
English: AUC: ↓ 2% (↓ 5 to ↑ 0) Cmax: ↓ 1% (↓ 7 to ↑ 6)
Maltese: AUC: ↓ 2% (↓ 5 sa ↑ 0) Cmax: ↓ 1% (↓ 7 sa ↑ 6) Cmin: NC
English: − Truvada can be administered in place of emtricitabine and tenofovir disoproxil used separately at the same doses.
Maltese: ­ Truvada jista' jingħata minflok emtricitabine u tenofovir disoproxil użati separatament fl-istess dożi.
English: In study GS-US-104-0352, 89 HIV-1 infected paediatric patients with a median age of 7 years (range 2 to 15 years) were exposed to tenofovir disoproxil for a median of 331 weeks.
Maltese: Fl-istudju GS-US-104-0352, 89 pazjent pedjatriku infettati bl-HIV-1 b'eta medjana ta' 7 snin (firxa bejn sentejn sa 15-il sena) kienu esposti għal tenofovir disoproxil għal medjan ta' 331 ġimgħa.
English: The mean (%CV) tenofovir drug exposure increased from 2,185 (12%) ng•h/mL in subjects with normal renal function, to 3,064 (30%) ng•h/mL, 6,009 (42%) ng•h/mL and 15,985 (45%) ng•h/mL, in subjects with mild, moderate and severe renal impairment, respectively.
Maltese: 3,064 (30%) ng•h/mL, 6,009 (42%) ng•h/mL u 15,985 (45%) ng•h/mL f'individwi b'indeboliment renali ħafif, moderat u sever, rispettivament.
English: AUC: ↓ 7% (↓ 13 to ↓ 1) Cmax: ↓ 11% (↓ 20 to ↑ 1)
Maltese: AUC: ↓ 7% (↓ 13 sa ↓ 1) Cmax: ↓ 11% (↓ 20 sa ↑ 1) Cmin: NC
English: Nucleos(t)ide analogues may impact mitochondrial function to a variable degree, which is most pronounced with stavudine, didanosine and zidovudine.
Maltese: Disfunzjoni mitokondrijali wara esponiment in utero Analogi tan-nukleos(t)idi jista' jkollhom impatt fuq il-funzjoni tal-mitokondrija sa grad varjabbli, li hu l-aktar notevoli bi stavudine, didanosine u zidovudine.
English: Among 28 patients receiving 96 weeks of treatment with tenofovir disoproxil, BMD Z-scores declined by -0.341 for lumbar spine and -0.458 for total body.
Maltese: Fost 28 pazjent li rċevew 96 ġimgħa ta' trattament b'tenofovir disoproxil, il-punteġġi Z tal-BMD naqsu bi -0.341 għallispina lumbari u -0.458 għall-ġisem kollu.
English: Key Couple Characteristics, N (%) or Median (Q1, Q3) Married to study partner
Maltese: Karatteristiċi Prinċipali tal-Koppja, N (%) jew Medjana (Q1, Q3) Miżżewweġ mas-sieħeb tal-istudju
English: AUC: ↓ 3% (↓ 8% to ↑ 15) Cmax: ↓ 24% (↓ 44 to ↓ 12)
Maltese: AUC: ↓ 3% (↓ 8% sa ↑ 15) Cmax: ↓ 24% (↓ 44 sa ↓ 12) Cmin: NC
English: AUC: ↑ 143% Cmax:↑ 72% Cmin: ↑ 300%
Maltese: Cmax:↑ 72% Cmin: ↑ 300%
English: Renal impairment: Emtricitabine and tenofovir are eliminated by renal excretion and the exposure to emtricitabine and tenofovir increases in individuals with renal dysfunction (see sections 4.4 and 5.2).
Maltese: Indeboliment renali: Emtricitabine u tenofovir huma eliminati permezz ta' tneħħija renali u lesponiment għal emtricitabine u tenofovir tiżdied f'individwi b'disfunzjoni renali (ara sezzjonijiet 4.4
English: Other medicines and Truvada
Maltese: Mediċini oħra u Truvada
English: AUC: ↓ 4% (↓ 7 to ↓ 1) Cmax: ↓ 4% (↓ 9 to ↑ 2)
Maltese: AUC: ↓ 4% (↓ 7 sa ↓ 1) Cmax: ↓ 4% (↓ 9 sa ↑ 2) Cmin: NC
English: A single 245 mg dose of tenofovir disoproxil was administered to non-HIV infected subjects with varying degrees of hepatic impairment defined according to Child-Pugh-Turcotte (CPT) classification.
Maltese: Doża waħda ta' 245 mg ta' tenofovir disoproxil ngħatat lil individwi li ma kienux infettati b'HIV li kellhom indeboliment epatiku fi stadji differenti skond il-klassifikazzjoni ta' Child Pugh Turcotte
English: The safety of tenofovir disoproxil when used with sofosbuvir/velpatasvir and a pharmacokinetic enhancer (e.g. ritonavir or cobicistat) has not been established.
Maltese: tenofovir disoproxil meta użat ma' sofosbuvir/velpatasvir u potenzjatur farmakokinetiku (eż. ritonavir jew cobicistat) għadha ma ġietx stabbilita.