FrancophonIA/ELRC3.0 huggingface dataset:
English: A single 245 mg dose of tenofovir disoproxil was administered to non-HIV, non-HBV infected adult patients with varying degrees of hepatic impairment defined according to Child-Pugh-Turcotte (CPT) classification.
Maltese: Doża waħda ta' 245 mg tenofovir disoproxil ngħatat lill-pazjenti adulti li ma kienux infettati b'HIV u dawk mhux infettati blHBV li kellhom indeboliment tal-fwied fi stadji differenti skond il-klassifikazzjoni ta' Child Pugh Turcotte (CPT).
English: Experience in patients with HIV co-infection and prior lamivudine experience In a randomised, 48-week double-blind, controlled study of tenofovir disoproxil 245 mg in adult patients co-infected with HIV-1 and chronic hepatitis B with prior lamivudine experience (study ACTG 5127), the mean serum HBV DNA levels at baseline in patients randomised to the tenofovir arm were 9.45 log10 copies/ml (n = 27).
Maltese: L-esperjenza f'pazjenti infettati wkoll bl-HIV u li kellhom esperjenza ta' lamivudine fil-passat Fi studju randomised li dam 48 ġimgħa, ikkontrollat u double-blind, dwar tenofovir disoproxil 245 mg f'pazjenti adulti koinfettati bl-HIV-1 u bl-epatite B kronika li fil-passat ingħataw lamivudine (studju ACTG 5127), il-medja tal-livelli tas-serum DNA tal-HBV fil-linja bażi f'pazjenti randomised fil-parti tal-istudju dwar tenofovir kienet ta' 9.45 log10 kopja/ml (n = 27).
English: Tenofovir disoproxil should be avoided in antiretroviral experienced patients with strains harbouring the K65R mutation (see section 4.4).
Maltese: Tenofovir disoproxil għandu jkun evitat f'pazjenti li mhux l-ewwel darba li ngħataw sustanzi antiretrovirali bi strejns bil-mutazzjoni K65R (ara sezzjoni 4.4).
English: Package leaflet: Information for the user Tenofovir disoproxil Zentiva 245 mg film-coated tablets Tenofovir disoproxil
Maltese: Fuljett ta' tagħrif: informazzjoni għall-utent Tenofovir disoproxil Zentiva 245 mg pilloli miksija b'rita Tenofovir disoproxil
English: The 144-week, double-blind, active controlled phase of study GS-99-903 evaluated the efficacy and safety of tenofovir disoproxil 245 mg versus stavudine when used in combination with lamivudine and efavirenz in HIV-1 infected adult patients naïve to antiretroviral therapy.
Maltese: Il-fażi tal-istudju GS 99 903 ikkontrollat b'mod attiv li sar matul 144 ġimgħa u double-blind evalwa l effiċjenza u s-sigurtà ta' 245 mg tenofovir disoproxil kontra stavudine meta użat f'kumbinazzjoni ma' lamivudine u efavirenz f'pazjenti adulti infettati b'HIV-1, li qatt ma ħadu terapija antiretrovirali.
English: Tenofovir disoproxil Zentiva has not been studied in patients over 65 years of age.
Maltese: Tenofovir disoproxil Zentiva ma ġiex studjat f'pazjenti li għandhom iktar minn 65 sena.
English: g Figures presented are cumulative percentages based upon a Kaplan Meier analysis including data collected after the addition of emtricitabine to open-label tenofovir disoproxil (KM-ITT).
Maltese: Il-figuri ppreżentati huma perċentwali kumulattivi bbażati fuq analiżi Kaplan Meier li jinkludu dejta miġbura wara ż-żieda ta' emtricitabine ma' tenofovir disoproxil open-label (KM-ITT).
English: Data pertaining to HIV
Maltese: Dejta dwar l-HIV
English: Tenofovir disoproxil Zentiva can cause dizziness.
Maltese: Tenofovir disoproxil Zentiva.
English: Efavirenz/Emtricitabine/Tenofo vir disoproxil (600 mg/200 mg/245 mg q.d.)
Maltese: Efavirenz/Emtricitabine/Tenofovi r disoproxil (600 mg/200 mg/245 mg q.d.)
English: PHARMACOLOGICAL PROPERTIES
Maltese: Farmakokinetika intraċellulari
English: Overall, the data derived from this study are too limited to draw any definitive conclusions on the comparison of emtricitabine plus tenofovir disoproxil versus tenofovir disoproxil, (see Table 7 below).
Maltese: Globalment, id-dejta miskuba minn dan l-istudju hi limitata wisq biex wieħed jasal għal xi konklużjonijiet definittivi dwar il-paragun ta' emtricitabine flimkien ma' tenofovir disoproxil kontra tenofovir disoproxil, (ara Tabella 7 hawn taħt).
English: Didanosine Co-administration of tenofovir disoproxil and didanosine is not recommended (see section 4.4 and Table 1).
Maltese: Didanosine L-għoti flimkien ta' tenofovir disoproxil u didanosine mhuwiex rakkomandat (ara sezzjoni 4.4 u Tabella 1).
English: Outer cartons containing 1 bottle of 30 film-coated tablets and outer cartons containing 90 (3 bottles of 30) film-coated tablets.
Maltese: Kartun ta' barra li fihom flixkun wieħed ta' 30 pillola miksija b'rita u kartun ta' barra li fihom 90 (3 fliexken ta' 30) pillola miksija b'rita.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Ir-rekwiżiti biex jiġu ppreżentati tar- rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunke aġġornament sussegwenti ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: Genotypic analysis was conducted for 5 subjects in the tenofovir disoproxil arm post week 48.
Maltese: Saret analiżi ġenotipika għal 5 individwi fil-fergħa ta' tenofovir disoproxil wara ġimgħa 48.
English: Mean change from baseline in MELD score a p-value comparing the combined tenofovir-containing arms versus the entecavir arm = 0.622, b p-value comparing the combined tenofovir-containing arms versus the entecavir arm = 1.000.
Maltese: a valur p li qabbel il-fergħat tal-istudju dwar tenofovir kombinat kontra l-fergħa tal-istudju dwar entecavir = 0.622, b valur p li qabbel il-fergħat tal-istudju dwar tenofovir kombinat kontra l-fergħa tal-istudju dwar entecavir = 1.000.
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 rċivew kura b'tenofovir disoproxil jew bi plaċebo, il-medja tal-punteġġ Ż tal-BMD tal-parti t'isfel tas-sinsla kienet ta' -1.004 u -0.809, u l-medja tal-punteġġ Ż tal-BMD tal-ġisem kollu kienet ta' -0.866 u -0.584, rispettivament, fil-linja bażi.
English: AUC: ↓28% Cmax: ↓ 38%
Maltese: ↓28% Cmax: ↓ 38%
English: Co-administration of tenofovir disoproxil and didanosine results in a 40-60% increase in systemic exposure to didanosine that may increase the risk for didanosine-related adverse reactions.
Maltese: L-għoti ta' tenofovir disoproxil flimkien ma' didanosine jirriżulta f'żieda ta' 40-60% flesponiment sistemiku għad-didanosine li jista' jżid ir-riskju għal reazzjonijiet avversi relatati ma' didanosine.
English: Co-infection with HIV-1 and hepatitis B: Due to the risk of development of HIV resistance, tenofovir disoproxil should only be used as part of an appropriate antiretroviral combination regimen in HIV/HBV co-infected patients.
Maltese: Ko-infezzjoni bl-HIV-1 u epatite B: Minħabba r-riskju ta' żvilupp ta' reżistenza mill-HIV, tenofovir disoproxil għandu jintuża biss bħala parti minn kors ta' kumbinazzjoni antiretrovirali f'pazjenti ko-infettati bl-HIV/HBV.
English: BMD Z-scores declined by -0.012 for lumbar spine and by -0.338 for total body in the 64 subjects who were treated with tenofovir disoproxil for 96 weeks.
Maltese: 012 fis-sinsla tad-dahar u b'-0.338 għallġisem totali fl-64 individwu li kienu kkurati b'tenofovir disoproxil għal 96 ġimgħa.
English: Elderly patients are more likely to have decreased renal function, therefore caution should be exercised when treating elderly patients with tenofovir disoproxil (see section 4.4).
Maltese: Pazjenti anzjani huma aktar probabbli li jkollhom tnaqqis tal-funzjoni renali, għalhekk għandha tingħata attenzjoni partikulari meta pazjenti anzjani jkunu qed jingħataw ittrattament b'tenofovir disoproxil (ara sezzjoni 4.4).
English: Lumbar spine mean (SD) BMD Z-scorea
Maltese: Medja (SD) tal-punteġġ Z tal-BMD talispina
English: p 48 weeks of double-blind adefovir dipivoxil followed by 336 weeks open-label tenofovir disoproxil.
Maltese: p 48 ġimgħa ta' adefovir dipivoxil double-blind segwiti minn 336 ġimgħa ta' tenofovir disoproxil open-label.
English: Tel: + 48 22 375 92 00 PV-Poland@zentiva.com
Maltese: Zentiva Polska Sp. z o.o. Tel: + 48 22 375 92 00 PV-Poland@zentiva.com
English: (11 subjects)
Maltese: (11-il individwu)
English: Each tablet contains tenofovir disoproxil phosphate (equivalent to 245 mg of tenofovir disoproxil).
Maltese: Kull pillola fiha tenofovir disoproxil phosphate (ekwivalenti għal 245 mg ta' tenofovir disoproxil).
English: At baseline, 57% of patients randomised to tenofovir disoproxil versus 60% of patients randomised to emtricitabine plus tenofovir disoproxil treatment group had previously been treated with lamivudine.
Maltese: Fil-linja bażi, 57% tal-pazjenti randomised għal tenofovir disoproxil kontra 60% tal-pazjenti randomised għal emtricitabine flimkien ma' grupp tal-kura b'tenofovir disoproxil, kienu kkurati fil-passat b'lamivudine.
English: Do not take Tenofovir disoproxil Zentiva
Maltese: Tieħux Tenofovir disoproxil Zentiva
English: There are limited data on the safety and efficacy of tenofovir disoproxil in adult patients with moderate and severe renal impairment (creatinine clearance < 50 ml/min) and long-term safety data has not been evaluated for mild renal impairment (creatinine clearance 50 - 80 ml/min).
Maltese: Hemm dejta limitata dwar is-sigurtà u l-effikaċja ta' tenofovir disoproxil f'pazjenti adulti b'indeboliment renali moderat u sever (tneħħija tal-krejatinina ta' < 50 ml/min) u dejta dwar is-sigurtà fuq tul ta' żmien ma kinitx evalwata għal indeboliment renali ħafif (tneħħija tal-krejatinina ta' 50 - 80 ml/min).
English: NAME OF THE MEDICINAL PRODUCT Tenofovir disoproxil Zentiva 245 mg film-coated tablets
Maltese: IL-PRODOTT MEDIĊINALI Tenofovir disoproxil Zentiva 245 mg pilloli miksija b'rita
English: • Not for HBV infected children under 12 years of age.
Maltese: • Mhux għal tfal infettati bl-HBV li għandhom inqas minn 12-il sena.
English: Among the HBeAg positive subjects randomised to tenofovir disoproxil, 16 of 65 subjects (25%) experienced HBeAg loss, and 8 of 65 subjects (12%) experienced anti-HBe seroconversion through week 240.
Maltese: Fost l-individwi HbeAg pożittivi li ġew randomised biex jirċievu tenofovir disoproxil, 16 minn 65 individwu (25%) kellhom telf ta' HBeAg, u 8 minn 65 individwu (12%) kellhom serokonverżjoni anti-HBe sa ġimgħa 240.
English: Raltegravir: AUC: ↔ Cmax: ↔ Cmin: ↓ 21%
Maltese: AUC: ↔ Cmax: ↔ Cmin: ↓ 21%
English: increased transaminases
Maltese: żieda fit-transaminases
English: Tenofovir disoproxil Zentiva with food and drink Take Tenofovir disoproxil Zentiva with food (for example, a meal or a snack).
Maltese: Tenofovir disoproxil Zentiva mal-ikel u xorb Ħu Tenofovir disoproxil Zentiva mal-ikel (per eżempju, ma' ikla jew ma' ikla ħafifa).
English: Subjects must have been naïve to tenofovir disoproxil, with HBV DNA > 105 copies/ml (~ 4.2 log10 IU/ml) and ALT > 1.5 × the upper limit of normal (ULN) at screening.
Maltese: IU/mL) u ALT > 1.5 × il-limitu ta' fuq tan-normal (ULN - upper limit of normal) fl-ittestjar.
English: There are limited data on the safety and efficacy of tenofovir disoproxil in HBV infected patients with decompensated liver disease and who have a Child-Pugh-Turcotte (CPT) score > 9.
Maltese: Hemm dejta limitata dwar is-sigurtà u l-effikaċja ta' tenofovir disoproxil f'pazjenti infettati bl-HBV b'mard tal-fwied mhux kumpensat u li għandhom punteġġ ta' Child-Pugh-Turcotte (CPT) ta' > 9.
English: Moderate renal impairment (creatinine clearance 30 - 49 ml/min) If administration of a lower dose is not possible, prolonged dose intervals using the 245 mg film-coated tablets may be used.
Maltese: Indeboliment renali moderat (tneħħija tal-krejatinina ta' 30 - 49 ml/min) Jekk l-għoti ta' doża inqas ma jkunx possibbli, jistgħu jintużaw intervalli itwal bl-użu tal-pilloli miksijin b'rita bid-doża ta' 245 mg.
English: Bone Mineral Density (BMD) data from Study GS-US-174-0144 are summarized in Table 9: Table 9: Bone Mineral Density Evaluation at Baseline and Week 48
Maltese: Id-data dwar id-Densità tal-Minerali tal-Għadam (BMD, Bone Mineral Density) mill-Istudju GS-US-174-0144 hija mogħtija filqosor fit-Tabella 9:
English: If serum phosphate is < 1.5 mg/dl (0.48 mmol/l) or creatinine clearance is decreased to < 50 ml/min in any adult patient receiving tenofovir disoproxil , renal function should be re-evaluated within one week, including measurements of blood glucose, blood potassium and urine glucose concentrations (see section 4.8, proximal tubulopathy).
Maltese: Jekk il-phosphate fis-serum huwa < 1.5 mg/dl (0.48 mmol/l) jew it-tneħħija tal-krejatinina tonqos għal < 50 ml/min, fi kwalunkwe pazjent adult li jkun qed jirċievi tenofovir disoproxil, il-funzjoni renali għandha tkun evalwata mill-ġdid fi żmien ġimgħa, inkluż il-kejl tal-konċentrazzjonijiet tal- glucose fid-demm, tal-potassium fid-demm u tal-glucose fl-awrina (ara sezzjoni 4.8, tubulopatija prossimali).
English: No data are available on which to make a dose recommendation for patients over the age of 65 years (see section 4.4).
Maltese: Anzjani M'hemmx informazzjoni fuqhiex wieħed jista' jagħti rakkomandazzjoni għall-pazjenti ta' fuq minn 65 sena (ara sezzjoni 4.4).
English: Renal safety with tenofovir disoproxil has only been studied to a very limited degree in adult patients with impaired renal function (creatinine clearance < 80 ml/min).
Maltese: Is-sigurtà renali b'tenofovir disoproxil kienet studjata biss b'mod limitat ħafna f'pazjenti adulti b'indeboliment fil-funzjoni talkliewi (tneħħija tal-krejatinina ta' < 80 ml/min).
English: Assessment of adverse reactions is based on a randomised study (study GS-US-174-0115) in 106 adolescent patients (12 to < 18 years of age) with chronic hepatitis B receiving treatment with tenofovir disoproxil 245 mg (n = 52) or placebo (n = 54) for 72 weeks and a randomised study (Study GS-US-1740144) in 89 patients with chronic hepatitis B (2 to < 12 years of age) receiving treatment with tenofovir disoproxil (n = 60) or placebo (n = 29) for 48 weeks.
Maltese: L-istima ta' reazzjonijiet avversi hi bbażata fuq studju randomised (studju GS-US-174-0115) f'106 pazjenti adolexxenti (minn età ta' 12 sa < 18 il sena) b'epatite B kronika li kienu qed jirċievu kura b'tenofovir disoproxil 245 mg (n = 52) jew plaċebo (n = 54) għal 72 ġimgħa u studju randomised (Studju GS-US-174-0144) f'89 pazjent b'epatite B kronika (b'età minn sentejn sa < 12-il sena) li kienu qed jirċievu trattament b'tenofovir disoproxil (n = 60) jew plaċebo (n = 29) għal 48 ġimgħa.
English: Lumbar spine BMD at least 6% decreaseb
Maltese: Tnaqqis tal-inqas ta' 6% fil-BMD talispina lumbarib
English: f 48 weeks of double-blind adefovir dipivoxil followed by 96 weeks open-label tenofovir disoproxil .
Maltese: f 48 ġimgħa ta' adefovir dipivoxil double-blind segwiti minn 96 ġimgħa ta' tenofovir disoproxil open-label.
English: Co-administration of tenofovir disoproxil with ledipasvir/sofosbuvir, sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/voxilaprevir has been shown to increase plasma concentrations of tenofovir, especially when used together with an HIV regimen containing tenofovir disoproxil and a pharmacokinetic enhancer (ritonavir or cobicistat).
Maltese: L-għoti fl-istess ħin ta' tenofovir disoproxil ma' ledipasvir/sofosbuvir, sofosbuvir/velpatasvir jew sofosbuvir/velpatasvir/voxilaprevir ġie muri li jżid il-konċentrazzjonijiet ta' tenofovir fil-plażma, speċjalment meta jintuża flimkien ma' kors għal HIV li fih tenofovir disoproxil u potenzjatur farmaċewtiku (ritonavir jew cobicistat).
English: Overall at week 24, treatment with tenofovir disoproxil resulted in 66% (35/53) of patients with HBV DNA < 400 copies/ml (< 69 IU/ml) versus 69% (36/52) of patients treated with emtricitabine plus tenofovir disoproxil (p = 0.672).
Maltese: Globalment, f'ġimgħa 24, it-trattament b'kors li kien fih tenofovir disoproxil, irriżulta f'66% (35/53) tal-pazjenti b'DNA tal-HBV ta' < 400 kopja/ml (< 69 IU/ml) kontra 69% (36/52) tal-pazjenti kkurati b'emtricitabine flimkien ma' tenofovir disoproxil (p = 0.672). Flimkien ma' dan, 55% (29/53) tal-pazjenti kkurati b'tenofovir disoproxil kellhom DNA tal-HBV li ma setgħetx tkun osservata (< 169 kopja/ml [< 29 IU/ml]; il-limitu tal-kwantifikazzjoni talassaġġ Roche Cobas TaqMan HBV) kontra 60% (31/52) tal-pazjenti kkurati b'emtricitabine flimkien ma' tenofovir disoproxil (p = 0.504).
English: In children whose mothers took NRTIs during pregnancy, the benefit from the protection against HIV outweighed the risk of side effects.
Maltese: Fi tfal li ommhom ħadet -NRTIs waqt it-tqala, ilbenefiċċju mill-protezzjoni kontra l-HIV kien ikbar mir-riskju tal-effetti sekondarji.
English: The proportion of subjects with ALT normalization at week 192 in the tenofovir disoproxil-tenofovir disoproxil group was 75.8% (25/33) among those who were HBeAg positive at baseline and 100.0% (2 of 2 subjects) among those who were HBeAg negative at baseline.
Maltese: Il-proprozjon ta' individwi li kellhom normalizzazzjoni tal-ALT f'Ġimgħa 192 fil-grupp tenofovir disoproxil-tenofovir disoproxil kien 75.8% (25/33) fost dawk li kienu pożittivi għal HBeAg fil-linja bażi u 100.
English: The results indicate that patients whose HIV expressed 3 or more thymidine-analogue associated mutations (TAMs) that included either the M41L or L210W reverse transcriptase mutation showed reduced response to tenofovir disoproxil 245 mg therapy.
Maltese: Ir-riżultati jindikaw li pazjenti li l-marda tal-HIV tagħhom kellha 3 jew aktar mutazzjonijiet assoċjati ma' l-analogi ta' thymidine (TAMs) li kienu jinkludu l-mutazzjoni M41L jew L210W reverse transcriptase wrew tnaqqis fir-respons għat-terapija ta' 245 mg tenofovir disoproxil.
English: Cases of acute renal failure after initiation of high dose or multiple non-steroidal anti-inflammatory drugs (NSAIDs) have been reported in patients treated with tenofovir disoproxil and with risk factors for renal dysfunction.
Maltese: Każijiet ta' kollass tal-kliewi akuta wara l-bidu ta' doża għolja jew mediċini multipli anti-infjammatorji mhux sterojdi (NSAIDs, non-steroidal anti-inflammatory drugs) ġew irrappurtati f'pazjenti kkurati b'tenofovir disoproxil u b'fatturi ta' riskju disfunzjoni renali.
English: Total clearance has been estimated to be approximately 230 ml/h/kg (approximately 300 ml/min).
Maltese: It-tneħħija totali ġiet stmata li hi madwar 230 ml/h/kg (madwar 300 ml/min).
English: Ledipasvir/Sofosbuvir (90 mg/400 mg q.d.)
Maltese: Sustanzi antivirali konta l-virus tal-Epatite C Ledipasvir/Sofosbuvir (90 mg/400 mg q.d.) +
English: o 48 weeks of double-blind tenofovir disoproxil followed by 336 weeks open-label.
Maltese: 48 ġimgħa ta' tenofovir disoproxil double-blind segwiti minn 336 ġimgħa open-label.
English: Reductions in BMD have been observed in HBV infected paediatric patients 2 to < 18 years of age.
Maltese: Tnaqqis fil-BMD ġie osservat f'pazjenti pedjatriċi infettati bl-HBV b'età minn sentejn sa < 18-il sena.
English: The use of tenofovir disoproxil is not recommended in paediatric patients with renal impairment (see sections 4.2 and 4.4).
Maltese: L-użu ta' tenofovir disoproxil mhuwiex rakkomandat f'pazjenti pedjatriċi b'indeboliment renali (ara sezzjonijiet 4.2 u 4.4).
English: Patients receiving ledipasvir/sofosbuvir, sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/voxilaprevir concomitantly with tenofovir disoproxil and a boosted HIV protease inhibitor should be monitored for adverse reactions related to tenofovir disoproxil.
Maltese: Pazjenti li rċivew ledipasvir/sofosbuvir, sofosbuvir/velpatasvir jew sofosbuvir/velpatasvir/voxilaprevir fl-istess ħin ma' tenofovir disoproxil u impeditur tal- protease ta' HIV imsaħħaħ għandhom jiġu mmonitorjati għal reazzjonijiet avversi relatati ma' tenofovir disoproxil.
English: In studies GS-US-174-0102 and GS-US-174-0103, after receiving double-blind treatment for 48 weeks (either tenofovir disoproxil 245 mg or adefovir dipivoxil 10 mg), patients rolled over with no interruption in treatment to open-label tenofovir disoproxil.
Maltese: GS-US-174-0102 u GS-US-174-0103, wara li rċivew kura double blind għal 48 ġimgħa (jew tenofovir disoproxil 245 mg jew adefovir dipivoxil 10 mg), il-pazjenti li qalbu mingħajr l-ebda interruzzjoni fil-kura għal tenofovir disoproxil open label.
English: abdominal pain, abdominal distension, flatulence
Maltese: uġigħ addominali, nefħa addominali, gass fl-istonku
English: Chronic hepatitis B: Steady-state tenofovir exposure in HBV infected adolescent patients (12 to < 18 years of age) receiving an oral daily dose of tenofovir disoproxil 245 mg was similar to exposures achieved in adults receiving once-daily doses of tenofovir disoproxil 245 mg.
Maltese: L-esponiment ta' tenofovir fl-istat fiss f'pazjenti adolexxenti infettati bl-HBV (minn età ta' 12 sa < 18 il sena) li kienu qed jirċievu dożi orali ta' kuljum ta' 245 mg tenofovir disoproxil kien simili għal esponimenti miksuba f'persuni adulti li kienu qed jirċievu doża waħda kuljum ta' 245 mg tenofovir disoproxil.
English: By intent to treat analysis (missing data and switch in antiretroviral therapy (ART) considered as failure), the proportion of patients with HIV-1 RNA below 400 copies/ml and 50 copies/ml at 48 weeks of treatment was 80% and 76% respectively in the tenofovir disoproxil 245 mg arm, compared to 84% and 80% in the stavudine arm. At 144 weeks, the proportion of patients with HIV-1 RNA below 400 copies/ml and 50 copies/ml was 71% and 68% respectively in the tenofovir disoproxil 245 mg arm, compared to 64% and 63% in the stavudine arm.
Maltese: F'144 ġimgħa, il-proporzjon ta' pazjenti b'HIV-1 RNA taħt l-400 kopja/ml u l-50 kopja/ml kien ta' 71% u 68% rispettivament fil-fergħa ta' 245 mg tenofovir disoproxil, meta mqabbel ma' 64% u 63% fil-fergħa ta' stavudine.
English: If you take more Tenofovir disoproxil Zentiva than you should If you accidentally take too many Tenofovir disoproxil Zentiva tablets, you may be at increased risk of experiencing possible side effects with this medicine (see section 4, Possible side effects).
Maltese: Jekk aċċidentalment tieħu pilloli żejda ta' Tenofovir disoproxil Zentiva, tista' tkun f'riskju miżjud li jkollok effetti sekondarji possibbli b'din il-mediċina (ara sezzjoni 4, Effetti sekondarji possibbli).
English: These renal transport proteins may be responsible for tubular secretion and in part, renal elimination of tenofovir and cidofovir.
Maltese: Dawn il-proteini tat-trasportatur renali jistgħu jkunu responsabbli għassekrezzjoni tubulari u parzjalment, għall-eliminazzjoni ta' tenofovir u cidofovir mill-kliewi.
English: In patients with end-stage renal disease (ESRD) (CrCl < 10 ml/min) requiring haemodialysis, between dialysis tenofovir concentrations substantially increased over 48 hours achieving a mean Cmax of 1,032 ng/ml and a mean AUC0-48h of 42,857 ng h/ml.
Maltese: F'pazjenti b'mard renali fl-aħħar stadju (ESRD) (CrCl < 10 ml/min) li jeħtieġu d dijaliżi tad-demm, bejn is-sessjonijiet taddijaliżi, il-konċentrazzjonijiet ta' tenofovir żdiedu sostanzjalment fi żmien 48 siegħa u laħqu medja ta' Cmax ta' 1,032 ng/ml u medja ta' AUC0 48h ta' 42,857 ng·h/ml.
English: All adverse reactions are presented in Table 2.
Maltese: Ir-reazzjonijiet avversi kollha huma ppreżentati f'Tabella 2.
English: + Raltegravir (400 mg b.i.d) + Emtricitabine/Tenofovir disoproxil (200 mg/245 mg q.d.)
Maltese: (800 mg q.d.) + Ritonavir (100 mg q.d.) + Emtricitabine/Tenofovir disoproxil (200 mg/245 mg q.d.)