FrancophonIA/ELRC3.0 huggingface dataset:
English: In adults, the demonstration of the benefit of tenofovir disoproxil in HIV-1 infection is based on results of one study in treatment-naïve patients, including patients with a high viral load (> 100,000 copies/ml) and studies in which tenofovir disoproxil was added to stable background therapy (mainly tritherapy) in antiretroviral pre-treated patients experiencing early virological failure (< 10,000 copies/ml, with the majority of patients having < 5,000 copies/ml).
Maltese: Fl-adulti, id-dimostrazzjoni tal-benefiċċju ta' tenofovir disoproxil f'infezzjoni bl-HIV-1 hija bbażata fuq riżultati ta' studju fuq pazjenti li qatt ma kienu ħadu din it-terapija qabel, li jinkludu pazjenti b'ammont ta' viri għoli (> 100,000 kopja/ml) u studji li fihom tenofovir disoproxil kien miżjud ma' sfond ta' terapija stabbli (fil-biċċa l-kbira terapija bi tliet mediċini) f'pazjenti li kienu ttrattati qabel b'antiretrovirali li ġarrbu ħsara viroloġika bikrija (< 10,000 kopja/ml, bil-maġġoranza tal-pazjenti jkollhom < 5,000 kopja/ml).
English: Tenofovir disoproxil Mylan 245 mg film-coated tablets contain lactose monohydrate.
Maltese: Tenofovir disoproxil Mylan pilloli miksija b'rita fiha 245 mg fihom lactose monohydrate.
English: Hepatitis B clinical studies: Assessment of adverse reactions from HBV clinical study data is primarily based on experience in two double-blind comparative controlled studies in which 641 adult patients with chronic hepatitis B and compensated liver disease received treatment with tenofovir disoproxil 245 mg daily (n = 426) or adefovir dipivoxil 10 mg daily (n = 215) for 48 weeks.
Maltese: Studji kliniċi dwar epatite B: L-istima ta' reazzjonijiet avversi minn dejta minn studju kliniku dwar HBV hija primarjament ibbażata fuq l-esperjenza f'żewġ studji komparattivi, double-blind u kkontrollati fuq 641 pazjent adult b'epatite B kronika u mard tal-fwied kumpensat li rċivew trattament b'tenofovir disoproxil 245 mg kuljum (n = 426) jew adefovir dipivoxil 10 mg kuljum (n = 215) għal 48 ġimgħa.
English: NA = Not Applicable a BMD Z-scores not adjusted for height and weight b Primary safety endpoint through week 72
Maltese: MA = Mhux Applikabbli a Punteġġi Z tal-BMD mhux aġġustati għat-tul u l-piż b Punt aħħari primarju tas-sigurtà matul Ġimgħa 72
English: Lumbar spine mean (SD) BMD Z-score a
Maltese: Bidla medja (SD) mill-punteġġ Z BMD tal-linja bażi tal-ġisem kollu a
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 bl-HBV li kellhom indeboliment tal-fwied fi stadji differenti skond ilklassifikazzjoni ta' Child-Pugh-Turcotte (CPT).
English: After 240 weeks of treatment with emtricitabine plus tenofovir disoproxil, 115 of 139 subjects (83%) had HBV DNA < 400 copies/ml, and 59 of 83 subjects (71%) had ALT normalisation.
Maltese: Wara 240 ġimgħa ta' kura b'emtricitabine flimkien ma' tenofovir disoproxil , 115 mill-139 individwu (83%) kellhom DNA tal-HBV ta' < 400 kopja/ml, u 59 mit83 individwu (71%) kellhom normalizzazzjoni tal-ALT.
English: < 400 copies/ml (< 69 IU/ml) ALT (%)
Maltese: (log10 kopja/ml) DNA tal-HBV (%) < 400 kopja/ml (< 69 IU/ml) ALT (%)
English: HBV strains expressing the adefovir-associated resistance mutations rtA181V and rtN236T showed a susceptibility to tenofovir ranging from 2.9- to 10-fold that of wild-type virus.
Maltese: Strejns tal-HBV li jesprimu mutazzjonijiet rtA181V u rtN236T assoċjati ma' reżistenza għal adefovir, urew sensittività għal tenofovir li tvarja minn 2.9 sa 10 darbiet iktar minn dik ta' l-istrejn naturali tal-virus.
English: Tenofovir diphosphate inhibits HIV-1 reverse transcriptase and the HBV polymerase by direct binding competition with the natural deoxyribonucleotide substrate and, after incorporation into DNA, by DNA chain termination.
Maltese: Tenofovir diphosphate jinibixxi l-polimerases tar-reverse transcriptase talHIV u l-polymerase tal-HBV permezz ta' kompetizzjoni diretta li teħel mas-sottostrat naturali taddeoxyribonukleotide u, wara l-inkorporazzjoni ġod-DNA, permezz tat-terminazzjoni tal-katina tadDNA.
English: Treatment with tenofovir disoproxil 245 mg was also associated with significantly greater proportions of patients with HBV DNA < 400 copies/ml, when compared to adefovir dipivoxil 10 mg treatment.
Maltese: It-trattament b'tenofovir disoproxil 245 mg kien ukoll assoċjat ma' porzjonijiet akbar b'mod sinifikanti ta' pazjenti b'DNA tal-HBV ta' < 400 kopja/ml, meta mqabbel mat-trattament b'adefovir dipivoxil 10 mg.
English: Treatment with tenofovir disoproxil 245 mg was associated with a mean change in serum HBV DNA from baseline, in the patients for whom there was 48-week data, of -5.74 log10 copies/ml (n = 18).
Maltese: It-trattament b'tenofovir disoproxil 245 mg kien assoċjat ma' bidla medja tad-DNA tal-HBV fis-serum mil-linja bażi, fil-pazjenti li għalihom kien hemm dejta ta' 48 ġimgħa, ta' -5.74 log10 kopja/ml (n = 18).
English: Severe renal impairment: 245 mg tenofovir disoproxil may be administered every 72-96 hours (dosing twice a week).
Maltese: Indeboliment renali sever: 245 mg ta' tenofovir disoproxil jistgħu jingħataw kull 72-96 siegħa (dożaġġ darbtejn fil-ġimgħa).
English: Ninety-five percent of nucleos(t)ide-naïve patients, 84% of nucleos(t)ide- experienced patients, and 83% of lamivudineresistant patients achieved HBV DNA < 400 copies/ml at week 72.
Maltese: Ħamsa u disgħin fil-mija tal-pazjenti li fil-passat qatt ma ngħataw nucleos(t)ide, 84% tal-pazjenti li fil-passat ingħataw nucleos(t)ide, u 83% tal-pazjenti reżistenti għal lamivudine, kisbu DNA tal-HBV ta' < 400 kopja/ml f'ġimgħa 72.
English: Each Tenofovir disoproxil Mylan tablet contains 245 mg of tenofovir disoproxil (as maleate).
Maltese: Kull pillola ta' Tenofovir disoproxil Mylan fiha 245 mg ta' tenofovir disoproxil (bħala maleate).
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 tal-kliewi (tneħħija tal-krejatinina < 80 ml/min).
English: HBeAg loss/ seroconversion
Maltese: Seroloġija (%) Tnaqqis/ serokonverżjoni ta' HbeAg
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 għall-ġisem totali fl-64 individwu li kienu kkurati b'tenofovir disoproxil għal 96 ġimgħa.
English: At concentrations of up to 300 µmol/l, tenofovir has also shown no effect on the synthesis of mitochondrial DNA or the production of lactic acid in in vitro assays.
Maltese: F'konċentrazzjonijiet sa 300 µmol/l, tenofovir ma wera l-ebda effett fuq is-sintesi mitokondrijali tadDNA jew fuq il-produzzjoni ta' l-aċidu lattiku f'assay in vitro.
English: Film-coated tablet.
Maltese: fil-linja bażi.
English: Nucleos(t)ide analogues may impact mitochondrial function to a variable degree, which is most pronounced with stavudine, didanosine and zidovudine.
Maltese: Disfunzjoni tal-mitokondrija 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: Elderly patients are more likely to have decreased renal function; therefore caution should be exercised when treating elderly patients with tenofovir disoproxil.
Maltese: Pazjenti anzjani huma aktar probabbli li jkollhom tnaqqis tal-funzjoni renali; għalhekk għandha tingħata attenzjoni partikulari meta pazjenti anzjani jkunu qed jingħataw it-trattament b'tenofovir disoproxil.
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 fiddemm, tal-potassium fid-demm u tal-glucose fl-awrina (ara sezzjoni 4.8, tubulopatija prossimali).
English: [MDRD] equation) after the first 4 weeks of treatment, the rate of annual decline post baseline of renal function reported in tenofovir disoproxil treated patients was -1.41 ml/min per year (using Cockcroft-Gault equation) and -0.74 ml/min/1.73 m per year (using MDRD equation).
Maltese: (bl-użu tal-ekwazzjoni tal-modifikazzjoni tad-dieta f'mard renali [MDRD]) wara l-ewwel 4 ġimgħat ta' kura, ir-rata ta' tnaqqis annwali wara llinja bażi tal-funzjoni renali rrappurtata f'pazjenti kkurati b'tenofovir disoproxil kienet ta' -1.41 ml/min kull sena (bl-użu tal-ekwazzjoni Cockcroft-Gault) u -0.74 ml/min/1.73 m kull sena
English: Co-administration of tenofovir disoproxil and didanosine is not recommended (see section 4.4).
Maltese: Mhux rakkomandat li tenofovir disoproxil jingħata flimkien ma' didanosine (ara sezzjoni 4.4).
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 webportal.
Maltese: Ir-rekwiżiti biex jiġu ppreżentatitar-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 lArtikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikati fuq ilportal web Ewropew tal-mediċini.
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: 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/sofosbivir, 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: The tablets are also available in blister packs containing 10, 30 or 30 x 1 (unit dose) tablets.
Maltese: Il-pilloli huma disponibbli wkoll f'pakketti bil-folji li jkun fihom 10, 30, jew 30 x 1 (doża waħda) pillola.
English: In patients who received treatment with tenofovir disoproxil or placebo, mean lumbar spine BMD Zscore 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 talparti 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: Tenofovir disoproxil Mylan 245 mg film-coated tablets tenofovir disoproxil
Maltese: Tenofovir disoproxil Mylan 245 mg pilloli miksija b'rita tenofovir disoproxil
English: Experience in patients with compensated liver disease at 48 weeks (studies GS-US-174-0102 and GSUS-174-0103)
Maltese: Esperjenza lilhemm minn 48 ġimgħa fi studji GS-US-174-0102 u GS-US-174-0103
English: Mechanism of action and pharmacodynamic effects Tenofovir disoproxil maleate is the maleate salt of the prodrug tenofovir disoproxil.
Maltese: Tenofovir disoproxil maleate huwa sustanza ta' maleate tal-prodroga tenofovir disoproxil.
English: Deutschland Mylan Healthcare GmbH
Maltese: IL-PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
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: 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% fl-esponiment sistemiku għad-didanosine, li jista' jżid ir-riskju għal reazzjonijiet avversi relatati ma' didanosine.
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-proporzjon 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: Genotypic evaluations were performed on all patients within this group with HBV DNA > 400 copies/ml at week 48 (n = 6) week 72 (n = 5), week 96 (n = 4), week 144 (n = 2), and week 192 (n = 3).
Maltese: Evalwazzjonijiet ġenotipiċi saru fuq il-pazjenti kollha f'dan il-grupp b'DNA tal-HBV ta' > 400 kopja/ml f'ġimgħa 48 (n = 6), f'ġimgħa 72 (n = 5), f'ġimgħa 96 (n = 4), f'ġimgħa 144 (n = 2), u f'ġimgħa 192 (n = 3).
English: Chronic hepatitis B: In adolescents aged 12 to < 18 years and weighing ≥ 35 kg, the recommended dose of tenofovir disoproxil is 245 mg (one tablet) once daily, taken orally with food (see sections 4.8 and 5.1).
Maltese: F'adolexxenti li jkollhom minn 12 sa < 18-il sena u li jiżnu ≥ 35 kg, id-doża rakkomandata ta' tenofovir disoproxil hija ta' 245 mg (pillola waħda) darba kuljum meħuda mill-ħalq mal-ikel (ara sezzjonijiet 4.8 u 5.1).
English: In study GS-US-174-0103 a significantly greater proportion of patients in the tenofovir disoproxil group than in the adefovir dipivoxil group had normalised ALT and achieved HBsAg loss at week 48 (see Table 3 below).
Maltese: Fi studju GS-US-174-0103, proporzjon akbar b'mod sinifikanti ta' pazjenti fil-grupp ta' tenofovir disoproxil milli fil-grupp ta' adefovir dipivoxil, kellu ALT normalizzat u kiseb tnaqqis ta' HBsAg f'ġimgħa 48 (ara Tabella 3 hawn taħt).
English: n Figures presented are cumulative percentages based upon a Kaplan Meier analysis excluding data collected after the addition of emtricitabine to open-label tenofovir disoproxil (KM-tenofovir disoproxil).
Maltese: n Il-figuri ppreżentati huma perċentwali kumulattivi bbażati fuq analiżi Kaplan Meier li jeskludu dejta miġbura wara ż-żieda ta' emtricitabine ma' tenofovir disoproxil open-label (KM-tenofovir disoproxil).
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: Tenofovir disoproxil Mylan is not usually taken with other medicines that can damage your kidneys (see Other medicines and Tenofovir disoproxil Mylan).
Maltese: Tenofovir disoproxil Mylan normalment ma jitteħidx ma' mediċini oħra li jistgħu jagħmlu ħsara lill-kliewi tiegħek (ara Mediċini oħra u Tenofovir disoproxil Mylan).
English: <For inner carton of multipack:> Component of a multipack, can't be sold separately.
Maltese: 30 pillola miksija b'rita <Għall-kartuna ta' ġewwa tal-pakkett multiplu:> Komponent ta' pakkett multiplu, ma jistax jinbiegħ separatament.
English: Seventy-five percent (21/28) of immune-active patients in the tenofovir disoproxil group had normal ALT at week 72 compared to 34% (11/32) in the placebo group.
Maltese: Ħamsa u sebgħin fil-mija (21/28) tal-pazjenti immuni-attivi fil-grupp ta' tenofovir disoproxil kellhom ALT normali f'ġimgħa 72 meta mqabbla ma' 34% (11/32) fil-grupp tal-plaċebo.
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) talpazjenti kkurati b'tenofovir disoproxil kellhom DNA tal-HBV li ma setgħetx tkun osservata (< 169 kopja/ml [< 29 IU/ml]; il-limitu tal-kwantifikazzjoni ta' l-assaġġ Roche Cobas TaqMan HBV) kontra 60% (31/52) tal-pazjenti kkurati b'emtricitabine flimkien ma' tenofovir disoproxil (p = 0.504).
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 antiinfjammatorji mhux sterojdi (NSAIDs, non-steroidal anti-inflammatory drugs) ġew irrappurtati f'pazjenti kkurati b'tenofovir disoproxil, u b'fatturi ta' riskju għal disfunzjoni renali.
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: Two hundred and fifteen HBeAg negative (GS-US-174-0102, n = 125) and HBeAg positive (GS-US174-0103, n = 90) patients initially randomised to double-blind adefovir dipivoxil treatment and then switched to open-label tenofovir disoproxil treatment were evaluated for genotypic changes in HBV polymerase from baseline.
Maltese: Mitejn u ħmistax-il pazjent li kienu negattivi għal HBeAg (GS-US-174-0102, n = 125) u pożittivi għal HBeAg (GS-US-174-0103, n = 90) li kienu inizjalment randomised għal kura double-blind b'adefovir dipivoxil u mbagħad qalbu għal kura b'tenofovir disoproxil open-label kienu evalwati għal tibdil ġenotipiku fil-polymerase tal-HBV mil-linja bażi.
English: All patients with normal ALT at baseline and 88% of patients with abnormal ALT at baseline achieved HBV DNA suppression < 400 copies/ml.
Maltese: Il-pazjenti kollha b'ALT normali fil-linja bażi u 88% ta' pazjenti b'ALT anormali fil-linja bażi kisbu trażżin tad-DNA tal-HBV ta' < 400 kopja/ml.
English: Tenofovir disoproxil Mylan with food and drink Take Tenofovir disoproxil Mylan with food (for example, a meal or a snack).
Maltese: Tenofovir disoproxil Mylan mal-ikel u xorb Ħu Tenofovir disoproxil Mylan mal-ikel (per eżempju, ma' ikla jew ma' ikla ħafifa).
English: Tenofovir disoproxil 245 mg film-coated tablets are indicated for the treatment of chronic hepatitis B in adults with:
Maltese: Tenofovir disoproxil 245 mg pilloli miksija b'rita huma indikati għat-trattament ta' epatite B kronika f'adulti b':
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: Tabella 8: Evalwazzjoni tad-Densità tal-Minerali tal-Għadam fil-Linja Bażi, Ġimgħa 72 u 192
English: Medicinal product by therapeutic areas (dose in mg)
Maltese: Prodott mediċinali skond loqsma terapewtiċi (doża f'milligrammi)
English: 48 weeks of double-blind adefovir dipivoxil followed by 336 weeks open-label tenofovir disoproxil.
Maltese: o 48 ġimgħa ta' tenofovir disoproxil double-blind segwiti minn 336 ġimgħa open-label.
English: The adverse reactions observed with continued treatment for 384 weeks were consistent with the safety profile of tenofovir disoproxil.
Maltese: Ir-reazzjonijiet avversi osservati bit-tkomplija tal-kura għal 384 ġimgħa kienu konsistenti mal-profil tas-sigurtà ta' tenofovir disoproxil.
English: The mean baseline CD4 cell count was 279 cells/mm
Maltese: Il-medja tal-linja bażi ta' l-għadd taċ-ċelluli CD4 kien ta' 279 ċellula/mm
English: Seventy-four percent (26/35) of patients in the tenofovir disoproxil group had normalised ALT at week 72 compared to 31% (13/42) in the placebo group.
Maltese: Erba' u sebgħin fil-mija (26/35) tal-pazjenti filgrupp ta' tenofovir disoproxil kellhom ALT normalizzat f'ġimgħa 72 meta mqabbla ma' 31% (13/42) fil-grupp tal-plaċebo.
English: • Adolescents aged 12 to less than 18 years who weigh at least 35 kg: 1 tablet each day with food (for example, a meal or a snack).
Maltese: • Adolexxenti li għandhom minn 12 sa inqas minn 18-il sena li jiżnu mill-inqas 35 kg: Pillola 1 kuljum mal-ikel (per eżempju, ma' ikla jew ma' ikla ħafifa).
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 koinfettati bl-HIV/HBV.
English: In the tenofovir disoproxil treatment arm, patients had a mean CPT score of 7.2, mean HBV DNA of 5.8 log10 copies/ml and mean serum ALT of 61 U/l at baseline.
Maltese: Fil-fergħa tal-istudju bil-kura b'tenofovir disoproxil, il-pazjenti kellhom medja ta' punteġġ CPT ta' 7.2, medja ta' DNA talHBV ta' 5.8 log10 kopja/ml u medja ta' ALT fis-serum ta' 61 U/l fil-linja bażi.
English: 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: g 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: Since tenofovir disoproxil can cause renal toxicity, close monitoring of renal function is recommended in adult patients with renal impairment treated with Tenofovir disoproxil Mylan (see sections 4.2, 4.4 and 5.2).
Maltese: Billi tenofovir disoproxil jista' jikkawża tossiċità renali, monitoraġġ mill-qrib tal-funzjoni renali hu rakkomandat f' pazjenti adulti b'indeboliment renali kkurat b'Tenofovir disoproxil Mylan (ara sezzjonijiet 4.2, 4.4 u 5.2).
English: Ninety-five percent (225/237) of patients without cirrhosis at baseline and 99% (93/94) of patients with cirrhosis at baseline had either no change or an improvement in fibrosis (Ishak fibrosis score).
Maltese: Ħamsa u disgħin fil-mija (225/237) tal-pazjenti mingħajr ċirrożi fil-linja bażi u 99% (93/94) tal-pazjenti b'ċirrożi fil-linja bażi jew ma kellhom l-ebda bidla jew titjib fil-fibrożi (punteġġ tal-fibrożi ta' Ishak).