FrancophonIA/ELRC3.0 huggingface dataset:
English: Severe renal impairment (creatinine clearance < 30 ml/min) and haemodialysis patients:
Maltese: Indeboliment renali sever (tneħħija tal-krejatinina ta' < 30 ml/min) u pazjenti fuq id-dijaliżi tad-demm:
English: Hepatitis B infection Tenofovir disoproxil Zentiva is indicated for the treatment of chronic hepatitis B in adults with:
Maltese: Infezzjoni b'epatite B Tenofovir disoproxil Zentiva huwa indikat għat-trattament ta' epatite B kronika f'adulti b':
English: Clinical studies in treatment-experienced patients have assessed the anti-HIV activity of tenofovir disoproxil 245 mg against strains of HIV-1 with resistance to nucleoside inhibitors.
Maltese: Studji kliniċi fuq pazjenti esperjenzati bil-kura evalwaw l-attività kontra l-HIV ta' tenofovir disoproxil 245 mg kontra strejns ta' HIV-1 b'reżistenza għal impedituri ta' nukleoside.
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 and 7.2%, rispettivament, ogħla mill-medda tal-konċentrazzjoni ta' tenofovir 0.01 sa 25 µg/ml.
English: The frequency category was estimated from a statistical calculation based on the total number of patients exposed to tenofovir disoproxil in randomised controlled clinical trials and the expanded access program (n = 7,319).
Maltese: Il-kategorija ta' frekwenza kienet stmata mill-kalkulazzjoni statistika bbażata fuq in-numru totali ta' pazjenti esposti għal tenofovir disoproxil fi studji kliniċi kkontrollati randomised u l-programm ta' aċċess imkabbar (n = 7,319).
English: A consistent response to treatment with tenofovir disoproxil 245 mg was seen regardless of baseline HIV-1 RNA and CD4 count.
Maltese: Reazzjoni konsistenti għat-trattament b'245 mg tenofovir disoproxil dehret irrispettivament bil-linja bażi ta' HIV-1 RNA u lgħadd ta' CD4.
English: Viruses containing the rtA181T mutation remained susceptible to tenofovir with EC50 values 1.5-fold that of wild-type virus.
Maltese: Viruses li kien fihom il-mutazzjoni rtA181T baqgħu sensittivi għal tenofovir b'valuri EC50 li kienu 1.5 drabi iżjed minn dik tal-istrejn naturali tal-virus.
English: At week 24 the time-weighted average change from baseline in log10 plasma HIV-1 RNA levels (DAVG24) was -0.03 log10 copies/ml and -0.61 log10 copies/ml for the placebo and tenofovir disoproxil 245 mg recipients (p < 0.0001).
Maltese: F'Ġimgħa 24, il-bidla medja imkejla fuq ħin bil-linja bażi f'log10 livelli ta' plażma HIV-1 RNA (DAVG24) kienet ta' 0.03 log10 kopja/ml u ta' 0.61 log10 kopja/ml għall-plaċebo u reċipjenti ta' 245 mg tenofovir disoproxil (p < 0.0001).
English: Cumulatively, there were 4 patients who experienced a viremic episode (HBV DNA > 400 copies/ml) at their last time point on tenofovir disoproxil.
Maltese: Kumulattivament, kien hemm 4 pazjenti li kellhom episodju viremiku (DNA talHBV ta' > 400 kopja/ml) fl-aħħar punt ta' żmien tagħhom fuq tenofovir disoproxil.
English: The safety of tenofovir disoproxil in the setting of ledipasvir/sofosbuvir, sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/voxilaprevir and a pharmacokinetic enhancer has not been established.
Maltese: Is-sigurtà ta' tenofovir disoproxil fl-ambjent ta' ledipasvir/sofosbuvir, sofosbuvir/velpatasvir jew sofosbuvir/velpatasvir/voxilaprevir u potenzjatur farmaċewtiku ma ġietx stabbilita.
English: Pharmacokinetic parameters of tenofovir were determined following administration of a single dose of tenofovir disoproxil 245 mg to 40 non-HIV, non-HBV infected adult patients with varying degrees of renal impairment defined according to baseline creatinine clearance (CrCl) (normal renal function when CrCl > 80 ml/min; mild with CrCl = 50-79 ml/min; moderate with CrCl = 30 - 49 ml/min and severe with CrCl = 10 - 29 ml/min).
Maltese: Il-parametri farmakokinetiċi ta' tenofovir kienu deċiżi wara l-għoti ta' doża waħda ta' 245 mg tenofovir disoproxil lil 40 pazjent adulti mhux infettati b'HIV, u dawk mhux infettati bl-HBV b'livelli differenti ta' indeboliment renali definiti skond il-linja bażi tat-tneħħija tal-krejatinina (CrCl) (funzjoni renali normali meta CrCl > 80 ml/min; indeboliment ħafif b'CrCl = 50 79 ml/min; indeboliment moderat b'CrCl = 30
English: Moreover, at concentrations substantially higher (approximately 300-fold) than those observed in vivo, tenofovir did not inhibit in vitro drug metabolism mediated by any of the major human CYP450 isoforms involved in drug biotransformation (CYP3A4, CYP2D6, CYP2C9, CYP2E1, or CYP1A1/2).
Maltese: Barra minn hekk, f'konċentrazzjonijiet li huma sostanzjalment ogħla (madwar 300 darba iżjed) minn dawk osservati in vivo, tenofovir ma inibixxiex in vitro l-metaboliżmu tal-mediċina medjata minn xi wieħed mill-iżoformi umani maġġuri ta' CYP450 involuti filbijotrasformazzjoni tad-mediċina (CYP3A4, CYP2D6, CYP2C9, CYP2E1, jew CYP1A1/2).
English: In patients with CPT scores ≤ 9, 74% (29/39) of tenofovir disoproxil, and 94% (33/35) of emtricitabine plus tenofovir disoproxil treatment groups achieved HBV DNA < 400 copies/ml after 48 weeks of treatment.
Maltese: F'pazjenti b'punteġġi CPT ta' ≤ 9, 74% (29/39) ta' tenofovir disoproxil, u 94% (33/35) tal-gruppi tal-kura b'emtricitabine flimkien ma' tenofovir disoproxil, kisbu DNA tal-HBV < 400 kopja/ml wara 48 ġimgħa ta' kura.
English: (log10 copies/ml)
Maltese: kopji/mL (~
English: Tenofovir disoproxil Zentiva is also a treatment for chronic hepatitis B, an infection with HBV (hepatitis B virus).
Maltese: Tenofovir disoproxil Zentiva huwa wkoll trattament għall-epatite B kronika, infezzjoni bl-HBV (virus tal-epatite B).
English: At 144 weeks of treatment, the average change from baseline remained similar in both treatment groups (-3.07 and -3.03 log10 copies/ml; +263 and +283 cells/mm3 in the tenofovir disoproxil 245 mg and stavudine groups, respectively).
Maltese: F'144 ġimgħa ta' trattament, il-bidla medja mil-linja bażi baqgħet simili fiż-żewġ gruppi li ħadu t trattament (3.07 u -3.03 log10 kopja/ml; +263 u +283 ċellula/mm3 fil-gruppi ta' 245 mg tenofovir disoproxil u stavudine, rispettivament).
English: Tenofovir exposure in HBV infected paediatric patients 2 to <12 years of age receiving an oral daily dose of tenofovir disoproxil 6.5 mg/kg of body weight (tablet or granules) up to a maximum dose of 245 mg was similar to exposures achieved in HIV-1 infected paediatric patients 2 to <12 years of age receiving a once daily dose of tenofovir disoproxil 6.5 mg/kg up to a maximum dose of tenofovir disoproxil 245 mg.
Maltese: L-esponiment għal tenofovir f'pazjenti pedjatriċi infettati bl-HBV b'età minn sentejn sa < 12-il sena li kienu qed jirċievu dożi orali ta' kuljum ta' tenofovir disoproxil 6.5 mg/kg tal-piż tal-ġisem (pillola jew granijiet) sa doża massima ta' 245 mg kien simili għal esponimenti miksuba f'pazjenti pedjatriċi infettati bl-HIV-1 b'età minn sentejn sa < 12-il sena li kienu qed jirċievu doża darba kuljum ta' tenofovir disoproxil 6.5 mg/kg sa doża massima ta' 245 mg tenofovir disoproxil.
English: The average change from baseline for HIV-1 RNA and CD4 count at 48 weeks of treatment was similar in both treatment groups (-3.09 and -3.09 log10 copies/ml; +169 and 167 cells/mm3 in the tenofovir disoproxil
Maltese: Il-bidla medja tal-linja bażi għal HIV-1 RNA u l-għadd ta' CD4 fi 48 ġimgħa ta' trattament kienu simili fiż-żewġ gruppi li ħadu t-trattament ( 3.09 u 3.09 log10 kopja/ml; +169 u 167 ċellula/mm3 fil-gruppi ta' 245 mg tenofovir disoproxil u stavudine, rispettivament).
English: HIV-1 and hepatitis B: In patients receiving tenofovir disoproxil, rare events of renal impairment, renal failure and uncommon events of proximal renal tubulopathy (including Fanconi syndrome) sometimes leading to bone abnormalities (infrequently contributing to fractures) have been reported.
Maltese: HIV-1 u epatite B: F'pazjenti li jkunu qed jirċievu tenofovir disoproxil, avvenimenti rari ta' indeboliment renali, kollass renali u avvenimenti mhux komuni ta' tubulopatija renali prossimali (inkluż is-sindromu ta' Fanconi), li xi kultant wasslu għal anormalitajiet fl-għadam (li b'mod mhux frekwenti jikkontribwixxu għal ksur) kienu rrappurtati.
English: Use of tenofovir disoproxil 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).
Maltese: L-użu ta' tenofovir disoproxil flimkien ma' jew fi żmien qasir minn meta jkun ittieħed prodott mediċinali nefrotossiku (eż. aminoglycosides, amphotericin B, foscarnet, ganciclovir, pentamidine, vancomycin, cidofovir jew interleukin-2) għandu jiġi evitat.
English: Genotypic data from paired baseline and on treatment HBV isolates were available for 6/8 patients with HBV DNA > 400 copies/ml at week 48.
Maltese: HBV akkoppjati fil-linja bażi u waqt il-kura kienet disponibbli għal 6/8 pazjenti b'DNA tal-HBV ta' > 400 kopja/ml f'ġimgħa 48.
English: In general, treatment responses to tenofovir disoproxil were similar for genotypes A, B, C and E [75-100% of subjects achieved HBV DNA < 400 copies/ml (69 IU/ml) at Week 48] with a lower response rate in subjects with genotype D infection
Maltese: B'mod ġenerali, ir-risponsi għat-trattament għal tenofovir disoproxil kienu simili għall-ġenotipi A, B, Ċ u E [75-100% tal-individwi kisbu DNA tal-HBV ta' < 400 kopja/mL (69 IU/mL) f'Ġimgħa 48] b'rata aktar baxxa ta' rispons f'individwi b'infezzjoni tal-ġenotip D (55%).
English: Patients with pre-existing liver dysfunction including chronic active hepatitis have an increased frequency of liver function abnormalities during combination antiretroviral therapy (CART) and should be monitored according to standard practice.
Maltese: Pazjenti li diġà jbatu minn disfunzjoni tal-fwied, li tinkludi epatite kronika attiva għandhom żieda fil-frekwenza ta' anormalitajiet tal-fwied waqt it-terapija antiretrovirali kombinata (CART) u jeħtieġ li jiġu monitorjati skond il-prattika normali.
English: Study 174-0103 (HBeAg positive)
Maltese: Studju 174-0102 (HBeAgnegattiv)
English: The main adverse reactions reported are haematological disorders (anaemia, neutropenia) and metabolic disorders (hyperlactataemia, hyperlipasaemia).
Maltese: L-effetti avversi ewlenin li kienu rrappurtati huma disturbi ematoloġiċi (anemija, newtropenja), u disturbi fil-metaboliżmu (iperlaktejtimja, iperlajpejżimja).
English: 3 Study conducted with additional voxilaprevir 100 mg to achieve voxilaprevir exposures expected in HCV-infected patients.
Maltese: Studju mwettaq b'voxilaprevir 100 mg addizzjonali sabiex jinkisbu l-esponimenti ta' voxilaprevir mistennija f'pazjenti infettati b'HCV.
English: Using a noncompleter/switch = failure analysis, 50% (21/42) of subjects receiving tenofovir disoproxil, 76% (28/37) of subjects receiving emtricitabine plus tenofovir disoproxil and 52% (11/21) of subjects receiving entecavir achieved HBV DNA < 400 copies/ml at week 168.
Maltese: Bl-użu ta' wieħed li ma wasalx sal-aħħar/qlib = analiżi tal-falliment, 50% (21/42) tal-individwi li rċivew tenofovir disoproxil, 76% (28/37) tal-individwi li rċivew emtricitabine u tenofovir disoproxil u 52% (11/21) tal-individwi li rċivew entecavir kisbu DNA tal-HBV ta' < 400 kopja/ml f'ġimgħa 168.
English: Tenofovir disoproxil has not been clinically evaluated in patients receiving medicinal products which are secreted by the same renal pathway, including the transport proteins human organic anion transporter (hOAT) 1 and 3 or MRP 4 (e.g. cidofovir, a known nephrotoxic medicinal product).
Maltese: Tenofovir disoproxil ma ġiex klinikament evalwat f'pazjenti li kienu qed jirċievu prodotti mediċinali li huma mnixxija millistess passaġġ renali, li jinkludi t-trasportatur enajoniku organiku uman (hOAT) tal-proteini tat-trasport 1 u 3 jew MRP 4 (eż. cidofovir, prodott mediċinali nefrotossiku magħruf).
English: At Week 48, 77% (46 of 60) of patients in the tenofovir disoproxil treatment group and 7% (2 of 29) of patients in the placebo group had HBV DNA < 400 copies/ml (69 IU/ml).
Maltese: F'Ġimgħa 48, 77% (46 minn 60) tal-pazjenti fil-grupp tat-trattament b'tenofovir disoproxil u 7% (2 minn 29) tal-pazjenti fil-grupp tal-plaċebo kellhom DNA tal-HBV ta' < 400 kopja/mL (69 IU/mL).
English: The antiviral response to tenofovir disoproxil was durable through 48 weeks (DAVG48 was -0.57 log10 copies/ml, proportion of patients with HIV-1 RNA below 400 or 50 copies/ml was 41% and 18% respectively).
Maltese: Ir-reazzjoni antivirali għal tenofovir disoproxil kienet tajba tul it-48 ġimgħa (DAVG48 kien ta' 0.57 log10 kopja/ml, ilproporzjon ta' pazjenti b'HIV-1 RNA taħt 400 jew 50 kopja/ml kien ta' 41% u 18% rispettivament).
English: • Not for HIV-1 infected children under 12 years of age.
Maltese: • Mhux għal tfal infettati bl-HIV-1 li għandhom inqas minn 12-il sena.
English: S.C. Zentiva S.A.
Maltese: ZENTIVA S.A.
English: PHARMACEUTICAL FORM AND CONTENTS 30 film-coated tablets
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 30 pillola miksija b'rita
English: Experience beyond 48 weeks in study GS-US-174-0108
Maltese: Esperjenza lilhemm minn 48 ġimgħa fi studju GS-US-174-0108
English: Bone Mineral Density (BMD) data from Study GS-US-174-0115 are summarized in Table 8: Table 8: Bone Mineral Density Evaluation at Baseline, Week 72 and 192
Maltese: Id-dejta dwar id-Densità tal-Minerali tal-Għadam (BMD) mill-Istudju GS-US-174-0115 hija mogħtija fil-qosor fit-Tabella 8: Tabella 8: Evalwazzjoni tad-Densità tal-Minerali tal-Għadam fil-Linja Bażi, Ġimgħat 72 u 192
English: Gastrointestinal disorders: Very common:
Maltese: Disturbi gastro-intestinali:
English: A statistically significant difference in favour of tenofovir disoproxil 245 mg was seen in the time-weighted average change from baseline at week 24 (DAVG24) for CD4 count (+13 cells/mm3 for tenofovir disoproxil 245 mg versus -11 cells/mm3 for placebo, p-value = 0.0008).
Maltese: Differenza sinifikanti fl-istatistika favur 245 mg tenofovir disoproxil dehret fil-bidla medja imkejla fuq ħin minn linja bażi f'Ġimgħa 24 (DAVG24) għall-għadd ta' CD4 (+13 ċelluli/mm għal 245 mg tenofovir disoproxil kontra 11 ċelluli/mm għall-plaċebo, valur p = 0.0008).
English: Histology Histological response (%)b
Maltese: Istoloġija Rispons istoloġiku (%)
English: The mean baseline CD4 cell count was 427 cells/mm3, the mean baseline plasma HIV-1 RNA was 3.4 log10 copies/ml (78% of patients had a viral load of < 5,000 copies/ml) and the mean duration of prior HIV treatment was 5.4 years.
Maltese: Il-medja bażi tal-għadd taċ-ċelluli CD4 kien ta' 427 ċelluli/mm3, il-medja bażi tal-plażma HIV-1 RNA kienet ta' 3.4 log10 kopja/ml (78% tal-pazjenti kellhom ammont ta' viri ta' < 5,000 kopja/ml) u d-dewmien medju tat-trattament għal HIV mogħti qabel kien ta' 5.4 snin.
English: Chronic hepatitis B
Maltese: Epatite B kronika
English: Based on these data, it is unlikely that clinically significant interactions involving tenofovir disoproxil and medicinal products metabolised by CYP450 would occur.
Maltese: Skond din l-informazzjoni, mhuwiex probabbli li jseħħu interazzjonijiet klinikament sinifikanti li jinvolvu tenofovir disoproxil u prodotti mediċinali metabolizzati minn CYP450.
English: Interactions between tenofovir disoproxil and other medicinal products are listed in Table 1 below (increase is indicated as “↑”, decrease as “↓”, no change as “↔”, twice daily as “b.i.d.”, and once daily as “q.d.”).
Maltese: Interazzjonijiet bejn tenofovir disoproxil u prodotti mediċinali oħrajn huma elenkati fit-Tabella 1 hawn taħt (żieda hija indikata b'“↑”, tnaqqis b'“↓”, ebda bidla b'“↔”, darbtejn kuljum b'“b.i.d.” u darba kuljum b'“q.d.”).
English: • Look out for infections.
Maltese: • Oqgħod attent/a għall- infezzjonijiet.
English: At week 48, 83% of patients in the tenofovir disoproxil treatment group and 92% of patients in the stavudine or zidovudine treatment group had HIV-1 RNA concentrations < 400 copies/ml.
Maltese: F'ġimgħa 48, 83% tal-pazjenti fil-grupp ta' kura b'tenofovir disoproxil u 92% tal-pazjenti fil-grupp ta' kura bi stavudine jew zidovudine kellhom konċentrazzjonijiet ta' HIV-1 RNA ta' < 400 kopji/ml.
English: Among the subjects who received placebo during the double-blind period, the proportion of subjects with HBV DNA < 400 copies/ml rose sharply after they began treatment with open-label tenofovir disoproxil (PLB- tenofovir disoproxil group): 74.1% (40/54) of subjects in the PLB-tenofovir disoproxil group had HBV DNA < 400 copies/ml at week 192.
Maltese: Fost lindividwi li rċivew plaċebo matul il-perjodu double-blind, il-proporzjon ta' individwi b'HBV DNA < 400/mL żdied b'mod sinifikanti wara li bdew il-kura b'tenofovir disoproxil open-label (il-grupp PLB-tenofovir disoproxil): 74.1% (40/54) millindividwi fil-grupp PLB- tenofovir disoproxil kellhom HBV DNA < 400 kopja/mL f'Ġimgħa 192.
English: Intracellular pharmacokinetics
Maltese: .1 Proprjetajiet farmakodinamiċi
English: The oral bioavailability of tenofovir from tenofovir disoproxil in fasted patients was approximately 25%.
Maltese: Il-biodisponibilità orali ta' tenofovir minn tenofovir disoproxil f'pazjenti sajmin kienet ta' madwar 25%.
English: Table 2: Tabulated summary of adverse reactions associated with tenofovir disoproxil based on clinical study and post-marketing experience
Maltese: Tabella 2: Sommarju tabulat ta' reazzjonijiet avversi assoċjati ma' tenofovir disoproxil bbażat fuq studju kliniku u esperjenza ta' wara t-tqegħid fis-suq
English: Five subjects (5.6%) had laboratory findings clinically consistent with proximal renal tubulopathy, 4 of whom discontinued tenofovir disoproxil therapy (median tenofovir disoproxil exposure 331 weeks).
Maltese: Ħames individwi (5.6%) kellhom sejbiet tal-laboratorju klinikament konsistenti ma' tubulopatija prossimali tal-kliewi, b'4 minnhom li waqqfu t-terapija b'tenofovir disoproxil (esponiment medjan ta' tenofovir disoproxil ta' 331 ġimgħa).
English: Chronic hepatitis B: In study GS-US-174-0115, 106 HBeAg negative and HBeAg positive patients aged 12 to < 18 years with chronic HBV infection [HBV DNA ≥ 105 copies/ml, elevated serum ALT (≥ 2 x ULN)
Maltese: Fi studju GS-US-174-0115, 106 pazjent negattivi għal HBeAg u pożittivi għal HBeAg li kellhom minn 12 sa < 18-il sena b'infezzjoni HBV kronika [DNA tal-HBV ta' ≥ 10
English: AUC: ↓ 25% Cmax: ↓ 28% Cmin: ↓ 26% Tenofovir:
Maltese: AUC: ↓ 25% Cmax: ↓ 28% Cmin: ↓ 26%
English: Mean changes at week 48 (end of double-blind phase) were -0.215 and -0.165 in lumbar spine BMD Zscore, 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 Ż tal-BMD tal-parti t'isfel tas-sinsla, u ta' -0.254 u -0.179 fil-punteġġ Ż tal-BMD tal-ġisem kollu għall-gruppi ta' tenofovir disoproxil u tal-plaċebo, rispettivament.
English: Experience in patients with lamivudine-resistant HBV at 240 weeks (study GS-US-174-0121) The efficacy and safety of 245 mg tenofovir disoproxil was evaluated in a randomised, double-blind study (GS-US-174-0121) in HBeAg positive and HBeAg negative patients (n = 280) with compensated liver disease, viraemia (HBV DNA ≥ 1,000 IU/ml), and genotypic evidence of lamivudine resistance (rtM204I/V +/- rtL180M).
Maltese: L-effikaċja u s-sigurtà ta' 245 mg ta' tenofovir disoproxil ġew evalwati fi studju randomised u double-blind (GS-US-174-0121) f'pazjenti HbeAg pożittivi u pazjenti HBeAg negattivi (n = 280) b' mard tal-fwied kumpensat, viremija (DNA talHBV ≥ 1,000 IU/ml), u evidenza ġenotipika ta' reżistenza għal lamivudine (rtM204I/V +/- rtL180M).
English: HIV-1: 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, f'87 pazjent adolexxenti infettati b'HIV-1 esperjenzati bil-kura minn età ta' 12 sa < 18il sena kienu kkurati b'tenofovir disoproxil (n = 45) jew bi plaċebo (n = 42) flimkien ma' kors ottimizzat fl-isfond (OBR) għal 48 ġimgħa.
English: Table 5: Efficacy parameters in compensated HBeAg positive patients at week 96, 144, 192, 240, 288 and 384 open-label treatment
Maltese: Parametri tal-effikaċja f'pazjenti li kienu pożittivi għal HBeAg kumpensat f'ġimgħa 96, 144, 192, 240, 288 u 384 ta' kura open label
English: Mitochondrial dysfunction following exposure in utero Nucleos(t)ide analogues may impact mitochondrial function to a variable degree, which is most pronounced with stavudine, didanosine and zidovudine.
Maltese: 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: Mild renal impairment (creatinine clearance 50 - 80 ml/min) Limited data from clinical studies support once daily dosing of 245 mg tenofovir disoproxil in patients with mild renal impairment.
Maltese: Indeboliment renali ħafif (tneħħija tal-krejatinina ta' 50 - 80 ml/min) Informazzjoni limitata minn studji kliniċi jissaportja dożaġġ ta' 245 mg darba kuljum ta' tenofovir disoproxil f'pazjenti b'indeboliment renali ħafif.
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 d-dejta nieqsa ġiet eskluża, 91% tal-pazjenti fil-grupp ta' kura b'tenofovir disoproxil u 94% tal-pazjenti fil-grupp ta' kura bi stavudine jew zidovudine kellhom konċentrazzjonijiet ta' HIV-1 RNA ta' < 400 kopja/ml f'ġimgħa 48.
English: At week 72, overall 88% (46/52) of patients in the tenofovir disoproxil treatment group and 0% (0/54) of patients in the placebo group had HBV DNA < 400 copies/ml.
Maltese: F'ġimgħa 72, total globali ta' 88% (46/52) tal-pazjenti fil-grupp tal-kura b'tenofovir disoproxil u 0% (0/54) ta' pazjenti fil-grupp tal-plaċebo kellhom DNA tal-HBV ta' < 400 kopja/ml.
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Maltese: Pazjenti li għandhom problemi ereditarji rari ta' intolleranza għallgalactose, nuqqas totali ta' lactase jew malassorbiment tal-glucose-galactose m'għandhomx jieħdu din il-mediċina.
English: In study GS-US-174-0144, 89 HBeAg-negative and -positive patients aged 2 to < 12 years with chronic hepatitis B were treated with tenofovir disoproxil 6.5 mg/kg up to a maximum dose of 245 mg (n = 60) or placebo (n = 29) once daily for 48 weeks.
Maltese: Fi studju GS-US-174-0144, 89 pazjent negattivi għal HBeAg u pożittivi għal HBeAg li kellhom minn sentejn sa < 12-il sena b'epatite B kronika ġew ittrattati b'tenofovir disoproxil 6.5 mg/kg sa doża massima ta' 245 mg (n = 60) jew plaċebo (n = 29) darba kuljum għal 48 ġimgħa.
English: Week 192
Maltese: Ġimgħa 192
English: No significant effect on lopinavir/ritonavir PK parameters.
Maltese: L-ebda effett sinifikanti fuq il-parametri PK ta' lopinavir/ritonavir.
English: The K65R mutation occurred in a slightly higher percentage of patients in the tenofovir disoproxil group than the active control group (2.7% versus 0.7%).
Maltese: Il-mutazzjoni f'K65R seħħet f'perċentwal kemmxejn ogħla ta' pazjenti fil-grupp ta' tenofovir disoproxil milli fil-grupp ta' kontroll attiv (2.7% kontra 0.7%).
English: Response to treatment with tenofovir disoproxil was comparable in treatment-naïve and treatmentexperienced subjects with 76% (38/50) of treatment-naïve and 80% (8/10) of treatment-experienced subjects achieving HBV DNA < 400 copies/ml (69 IU/ml) at Week 48.
Maltese: Ir-rispons għat-trattament b'tenofovir disoproxil kien komparabbli f'individwi li qatt ma ngħataw trattament fil-passat u li jkunu ħadu trattament qabel b'76% (38/50) tal-individwi li qatt ma ngħataw trattament fil-passat u 80% (8/10) tal-individwi li jkunu ħadu trattament qabel jiksbu DNA tal-HBV ta' < 400 kopja/mL (69 IU/ml) f'Ġimgħa 48.
English: Tenofovir disoproxil Zentiva is suitable for:
Maltese: Tenofovir disoproxil Zentiva huwa adattat għal: