FrancophonIA/ELRC3.0 huggingface dataset:
English: After an initial decline of approximately -4.9 ml/min (using Cockcroft-Gault equation) or3.9 ml/min/1.73 m2 (using modification of diet in renal disease [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 m2 per year
Maltese: (bl-użu tal-ekwazzjoni tal-modifikazzjoni tad-dieta f'mard tal-kliewi [MDRD] wara l-ewwel 4 ġimgħat ta' kura, ir-rata ta' tnaqqis annwali tal-funzjoni tal-kliewi wara l-linja bażi 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 (bl-użu tal ekwazzjoni MDRD).
English: Reductions in BMD have been reported in paediatric patients.
Maltese: Tnaqqis fil BMD ġie rrappurtat f'pazjenti pedjatriċi.
English: In a paediatric study (GS-US-174-0144), genotypic data from paired baseline and on treatment HBV isolates from patients who received tenofovir disoproxil were available for 9 of 10 patients who had plasma HBV DNA > 400 copies/ml.
Maltese: Fi studju pedjatriku (GS-US-174-0144), data ġenotipika minn iżolati ta' HBV akkoppjati fil-linja bażi u waqt it-trattament minn pazjenti li rċivew tenofovir disoproxil kienet disponibbli għal 9 pazjenti minn 10 li kellhom DNA tal-HBV fil-plażma ta' > 400 kopja/ml.
English: Tenofovir disoproxil at a concentration of 100 µmol/l had no effect on any of the CYP450 isoforms, except CYP1A1/2, where a small (6%) but statistically significant reduction in metabolism of CYP1A1/2 substrate was observed.
Maltese: Tenofovir disoproxil f'konċentrazzjoni ta' 100 µmol/l ma kellux effett fuq xi iżoformi ta' CYP450 ħlief CYP1A1/2, fejn tnaqqis żgħir (6%) imma statistikament sinifikanti fil-metaboliżmu tas-sottostrat CYP1A1/2 kien osservat.
English: After 240 weeks of treatment, 117 of 141 subjects (83%) randomised to tenofovir disoproxil had HBV DNA < 400 copies/ml, and 51 of 79 subjects (65%) had ALT normalisation.
Maltese: Wara 240 ġimgħa ta' kura, 117 mill-141 individwu (83%) li ġew randomised biex jirċievu tenofovir disoproxil kellhom DNA tal-HBV ta' < 400 kopja/ml, u 51 mid-79 individwu (65%) kellhom normalizzazzjoni tal-ALT.
English: Of the 94 patients with cirrhosis at baseline (Ishak fibrosis score 5-6), 26% (24) experienced no change in Ishak fibrosis score and 72% (68) experienced regression of cirrhosis by week 240 with a reduction in Ishak fibrosis score of at least 2 points.
Maltese: Mill-94 pazjent b'ċirrożi fil-linja bażi (punteġġ tal-fibrożi ta' Ishak: 5-6), 26% (24) ma kellhom l-ebda bidla fil-punteġġ tal-fibrożi ta' Ishak u 72% (68) kellhom rigressjoni ta' ċirrożi sa ġimgħa 240 bi tnaqqis filpunteġġ tal-fibrożi ta' Ishak ta' mill-inqas 2 punti.
English: Studies have established the pathway of active tubular secretion of tenofovir to be influx into proximal tubule cell by the human organic anion transporters (hOAT) 1 and 3 and efflux into the urine by the multidrug resistant protein 4 (MRP 4).
Maltese: L-istudji stabbilixxew il-passaġġ tas-sekrezzjoni tubulari attiva ta' tenofovir li jkun influss ġoċ-ċellula tat-tubulu prossimali mittrasportaturi enajoniċi organiċi umani (hOAT) 1 u 3 u l-effluss ġol-awrina mill-proteina 4 reżistenti kontra ħafna mediċini (MRP 4 - multidrug resistant protein 4).
English: Tenofovir is a nucleotide reverse transcriptase inhibitor, generally known as an NRTI and works by interfering with the normal working of enzymes (in HIV reverse transcriptase; in hepatitis B DNA polymerase) that are essential for the viruses to reproduce themselves.
Maltese: Tenofovir hu impeditur tan-nukleotide reverse transcriptase, ġeneralment magħruf bħala NRTI u jaħdem billi jinterferixxi mal-ħidma normali tal-enzimi (fl-HIV reverse transcriptase; fl-epatite B polymerase tad-DNA) li huma essenzjali biex il-viruses jirriproduċu lilhom infushom.
English: - evidence of lamivudine-resistant hepatitis B virus (see sections 4.8 and 5.1).
Maltese: - evidenza ta' virus tal-epatite B reżistenti għal lamivudine (ara sezzjonijiet 4.8 u 5.1). - mard tal-fwied mhux kumpensat (ara sezzjonijiet 4.4, 4.8 u 5.1).
English: HIV-1 clinical studies: Assessment of adverse reactions from HIV-1 clinical study data is based on experience in two studies in 653 treatment-experienced patients receiving treatment with tenofovir disoproxil (n = 443) or placebo (n = 210) in combination with other antiretroviral medicinal products for 24 weeks and also in a double-blind comparative controlled study in which 600 treatment-naïve patients received treatment with tenofovir disoproxil 245 mg (n = 299) or stavudine (n = 301) in combination with lamivudine and efavirenz for 144 weeks.
Maltese: L-istima ta' reazzjonijiet avversi minn dejta minn studju kliniku dwar HIV-1 hija bbażata fuq esperjenza miksuba f żewġ studji f'653 pazjent esperjenzati bil-kura b'tenofovir disoproxil (n = 443) jew plaċebo (n = 210) ikkombinati ma' prodotti mediċinali antiretrovirali oħra għal 24 ġimgħa u wkoll fi studju komparattiv double-blind ikkontrollat li fih 600 pazjent li qatt ma kienu ħadu trattament qabel, irċivew trattament b'245 mg tenofovir disoproxil (n = 299) jew stavudine (n = 301) ikkombinati ma' lamivudine u efavirenz għal 144 ġimgħa.
English: • That a multidisciplinary approach is recommended for the management of adolescent patients • That there is an increased risk of renal disease in HIV and HBV infected patients associated with tenofovir disoproxil-containing products such as Tenofovir disoproxil Zentiva
Maltese: • Li hemm żieda fir-riskju ta' mard renali f'pazjenti infettati bl-HIV u HBV assoċjata ma' prodotti li jkun fihom tenofovir disoproxil bħal Tenofovir disoproxil Zentiva
English: In HIV infected patients, in a 144-week controlled clinical study that compared tenofovir disoproxil with stavudine in combination with lamivudine and efavirenz in antiretroviral-naïve adult patients, small decreases in bone mineral density (BMD) of the hip and spine were observed in both treatment groups.
Maltese: Fi pazjenti infettati bl-HIV, fi studju kliniku kkontrollat ta' 144 ġimgħa fejn tqabblu tenofovir disoproxil ma' stavudine mogħti flimkien ma' lamivudine u efavirenz f'pazjenti adulti li qatt ma' kienu ngħataw mediċini antiretrovirali qabel, tnaqqis żgħir fiddensità minerali tal-għadam (BMD) tal-ġenbejn u tas-sinsla tad-dahar kienu osservati fiż-żewġ gruppi tat-trattament.
English: Assessment of adverse reactions is based on two randomised trials (studies GS-US-104-0321 and GS-US104-0352) 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: GS-US-104-0321 u GS GS-US-104-0352) f'184 pazjenti pedjatriċi infettati b'HIV-1 (minn età ta' sentejn sa < 18 il sena) li rċivew il-kura b'tenofovir disoproxil (n = 93) jew bil-plaċebo/komparatur attiv (n = 91) flimkien ma' mediċini antiretrovirali oħra għal 48 ġimgħa (ara sezzjoni 5.1).
English: The effects of tenofovir disoproxil in treatment-experienced and treatment-naïve HIV-1 infected adults have been demonstrated in trials of 48 weeks and 144 weeks duration, respectively.
Maltese: L-effetti ta' tenofovir disoproxil f'pazjenti adulti infettati b'HIV-1 esperjenzati bil-kura u pazjenti li qatt ma kienu ħadu terapija qabel ġew ippruvati fi provi fuq medda ta' 48 ġimgħa u 144 ġimgħa rispettivament.
English: Adefovir dipivoxil 10 mg roll over to tenofovir disoproxil 245 mg n = 125
Maltese: Adefovir dipivoxil 10 mg maqlub għal tenofovir disoproxil 245 mg n = 125
English: AUC: ↑ 39% Cmax: ↑ 55% Cmin: ↑ 52%
Maltese: ↑ 39% Cmax: ↑ 55% Cmin: ↑ 52%
English: The adverse reactions observed in paediatric patients who received treatment with tenofovir disoproxil were consistent with those observed in clinical studies of tenofovir disoproxil in adults (see section 4.8 Tabulated summary of adverse reactions and 5.1).
Maltese: Irreazzjonijiet avversi osservati f'pazjenti pedjatriċi li rċivew kura b'tenofovir disoproxil kienu konsistenti ma' dawk osservati fi studji kliniċi ta' tenofovir disoproxil fl-adulti (ara sezzjoni 4.8 Sommarju tabulat ta' reazzjonijiet avversi u 5.1).
English: Velpatasvir: AUC: ↔ Cmax: ↓ 30% Cmin: ↑ 63%
Maltese: AUC: ↔ Cmax: ↓ 30% Cmin: ↑ 63%
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 falliment viroloġiku bikri (< 10,000 kopja/ml, bil-maġġoranza tal-pazjenti jkollhom < 5,000 kopja/ml).
English: HIV antiviral activity in vitro: The concentration of tenofovir required for 50% inhibition (EC50) of the wild-type laboratory strain HIV-1IIIB is 1 - 6 µmol/l in lymphoid cell lines and 1.1 µmol/l against primary HIV-1 subtype B isolates in PBMCs.
Maltese: Il-konċentrazzjoni ta' tenofovir meħtieġa għall-inibizzjoni ta' 50% (EC50) tal-istrejn naturali mrobbi fil-laboratorju HIV- IIIB huwa 1 6 μmol/l f'razza ta' ċelluli tal-limfojde u 1.1 µmol/l kontra
English: Five subjects (5.6%) had laboratory findings clinically consistent with proximal renal tubulopathy, 4 of whom discontinued tenofovir disoproxil therapy.
Maltese: Ħames individwi (5.6%) kellhom sejbiet tal-laboratorju klinikament konsistenti ma' tubulopatija renali prossimali, b'4 minnhom li waqqfu tterapija b'tenofovir disoproxil.
English: Lumbar spine BMD mean % increaseb
Maltese: Żieda % fil-medja tal-BMD talispina lumbarib
English: Response to treatment with tenofovir disoproxil was comparable in nucleos(t)ide-naïve (n = 20) and nucleos(t)ide-experienced (n = 32) patients, including lamivudine- resistant patients (n = 6).
Maltese: Ir-rispons għall-kura b'tenofovir disoproxil kien komparabbli f'pazjenti li fil-passat qatt ma ngħataw nucleos(t)ide (n = 20) u f'pazjenti li fil-passat ingħataw nucleos(t)ide (n = 32), li jinkludu pazjenti reżistenti għal lamivudine (n = 6).
English: The EC50 values for tenofovir were in the range of 0.14 to 1.5 µmol/l, with CC50 (50% cytotoxicity concentration) values > 100 µmol/l.
Maltese: Il-valuri EC50 għal tenofovir kienu fil-medda ta' 0.14 sa 1.5 µmol/l, bil-valuri CC50
English: Tabulated summary of adverse reactions
Maltese: Sommarju tar-reazzjonijiet avversi miġbura f'tabella
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: Seventy-three percent of nucleoside-experienced and 69% of nucleoside-naïve patients achieved complete response to treatment; 90% of nucleoside-experienced and 88% of nucleoside-naïve patients achieved HBV DNA suppression < 400 copies/ml.
Maltese: Tlieta u sebgħin fil-mija ta' pazjenti li fil-passat ingħataw in-nukleosides u 69% tal-pazjenti li qatt ma ngħataw nukleosides irnexxielhom jiksbu rispons sħiħ għat-trattament; 90% tal-pazjenti li fil-passat ingħataw nukleosides u 88% li fil-passat qatt ma ngħataw nukleosides kisbu trażżin tad-DNA tal-HBV ta' < 400 kopja/ml.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall Mediċini http://www.ema.europa.eu.
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: Ittrattament 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: At week 48, six adolescents in the tenofovir disoproxil group and one adolescent in the placebo group had significant lumbar spine BMD loss (defined as > 4% loss).
Maltese: F'ġimgħa 48, sitt adolexxenti fil-grupp ta' tenofovir disoproxil u adolexxent wieħed fil-grupp tal-plaċebo kellhom telf sinifikanti fil-BMD tal-parti t'isfel tas-sinsla (definit bħala telf ta' > 4%).
English: Following the first dose of tenofovir disoproxil in fed patients, the median Cmax in serum ranged from 213 to 375 ng/ml.
Maltese: Wara l-ewwel doża ta' tenofovir disoproxil f'pazjenti li kienu kielu, il-medjana ta' Cmax fis-serum kienet ta' bejn 213 u 375 ng/ml.
English: Patients with lamivudine-resistant chronic hepatitis B: No new adverse reactions to tenofovir disoproxil were identified from a randomised, double-blind study (GS-US-174-0121) in which 280 lamivudineresistant patients received treatment with tenofovir disoproxil (n = 141) or emtricitabine/tenofovir disoproxil (n = 139) for 240 weeks.
Maltese: L-ebda reazzjonijiet avversi ġodda għal tenofovir disoproxil ma kienu identifikati minn studju randomised double-blind (GS-US-174-0121) li fih 280 pazjent reżistenti għal lamivudine irċivew kurab'tenofovir disoproxil (n = 141) jew emtricitabine/tenofovir disoproxil (n = 139) għal 240 ġimgħa.
English: Adefovir dipivoxil 10 mg roll over to tenofovir disoproxil 245 mg n = 90
Maltese: Adefovir dipivoxil 10 mg maqlub għal tenofovir disoproxil 245 mg n = 90
English: Consideration should also be given to interrupting treatment with tenofovir disoproxil in adult patients with creatinine clearance decreased to < 50 ml/min or decreases in serum phosphate to < 1.0 mg/dl (0.32 mmol/l).
Maltese: Konsiderazzjoni għandha tingħata wkoll għall-waqfien tat-trattament b'tenofovir disoproxil f'pazjenti adulti bi tneħħija tal-krejatinina mnaqqsa għal < 50 ml/min jew tnaqqis tal-phosphate fis-serum għal < 1.0 mg/dl (0.
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 mit-83 individwu (71%) kellhom normalizzazzjoni tal-ALT.
English: Lot:
Maltese: Tel:
English: Response to treatment with tenofovir disoproxil was also similar in subjects who were HBeAg-negative compared with those who were HBeAg-positive at baseline with 77% (43/56) HBeAg-positive and 75.0% (3/4) HBeAg-negative subjects achieving HBV DNA < 400 copies/ml (69 IU/ml) at Week 48.
Maltese: Ir-rispons għat-trattament b'tenofovir disoproxil kien simili wkoll f'individwi li kienu negattivi għal HBeAg meta mqabbla ma' dawk li kienu pożittivi għal HBeAg fil-linja bażi b'77% (43/56) tal-individwi pożittivi għal HBeAg u 75.0% (3/4) tal-individwi negattivi għal HBeAg jiksbu DNA tal-HBV ta' < 400 kopja/mL (69 IU/mL) f'Ġimgħa 48.
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 tad-DNA jew fuq ilproduzzjoni tal-aċidu lattiku f'assay in vitro.
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: 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 ilpazjenti kollha 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: *p-value versus adefovir dipivoxil < 0.05, a Complete response defined as HBV DNA levels < 400 copies/ml and Knodell necroinflammatory score improvement of at least 2 points without worsening in Knodell fibrosis, b Knodell necroinflammatory score improvement of at least 2 points without worsening in Knodell fibrosis, c Median change from baseline HBV DNA merely reflects the difference between baseline HBV DNA and the limit of detection (LOD) of the assay, d The population used for analysis of ALT normalisation included only patients with ALT above ULN at baseline.
Maltese: * Valur p versus adefovir dipivoxil ta' < 0.05, a Rispons sħiħ definit bħala livelli tad-DNA tal-HBV ta' < 400 kopja/ml u titjib fil-punteġġ nekroinfjammatorju ta' Knodell ta' mill-inqas 2 punti mingħajr ma marret għall-agħar il-fibrożi ta' Knodell,
English: Study GS-US-174-0103 was conducted in 266 (randomised and treated) HBeAg positive patients while study GS-US-174-0102 was conducted in 375 (randomised and treated) patients negative for HBeAg and positive for HBeAb.
Maltese: Studju GS-US-174-0103 twettaq fuq 266 (randomised u ttrattati) pazjenti li kienu HBeAg pożittivi filwaqt li studju GS-US-174-0102 twettaq fi 375 (randomised u ttrattati) pazjenti li kienu HBeAg negattivi u HBeAb pożittivi.
English: NAME OF THE MEDICINAL PRODUCT Tenofovir disoproxil Zentiva 245 mg film-coated tablets Tenofovir disoproxil
Maltese: TAL-PRODOTT MEDIĊINALI Tenofovir disoproxil Zentiva 245 mg pilloli miksijin b'rita Tenofovir disoproxil
English: Co-administration of tenofovir disoproxil and didanosine results in a 40 - 60% increase in systemic exposure to didanosine that may increase the risk of didanosine-related adverse reactions (see section 4.5).
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 ta' reazzjonijiet avversi relatati ma' didanosine (ara sezzjoni 4.5).
English: At week 72, 96% (27/28) of immuneactive patients (HBV DNA ≥ 105 copies/ml, serum ALT > 1.5 x ULN) in the tenofovir disoproxil treatment group and 0% (0/32) of patients in the placebo group had HBV DNA < 400 copies/ml.
Maltese: kopji/ml, ALT fis-serum ta' > 1.5 x ULN) fil-grupp tal-kura ta' tenofovir disoproxil u 0% (0/32) tal-pazjenti fil-grupp talplaċebo kellhom DNA tal-HBV ta' < 400 kopja/ml.
English: lactic acidosis Nervous system disorders: Very common:
Maltese: Disturbi fis-sistema nervuża:
English: Hepatic function should be monitored at repeated intervals with both clinical and laboratory follow-up for at least 6 months after discontinuation of hepatitis B therapy.
Maltese: Il-funzjoni epatika għandha tiġi mmonitorjata mill-qrib, ripetutament, b'eżaminazzjonijiet kliniċi u tallaboratorju għal mill-inqas 6 xhur wara t-twaqqif tat-terapija kontra epatite B.
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: Ilpazjenti 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: 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 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: 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 tal-istrejn naturali tal-virus.
English: Experience in patients with persistent viral replication (study GS-US-174-0106) The efficacy and safety of tenofovir disoproxil 245 mg or tenofovir disoproxil 245 mg plus 200 mg emtricitabine has been evaluated in a randomised, double-blind study (study GS-US-174-0106), in HBeAg positive and HBeAg negative adult patients who had persistent viraemia (HBV DNA ≥ 1,000 copies/ml) while receiving adefovir dipivoxil 10 mg for more than 24 weeks.
Maltese: L-effikaċja u s-sigurtà ta' tenofovir disoproxil 245 mg jew ta' tenofovir disoproxil 245 mg flimkien ma' 200 mg ta' emtricitabine ġiet evalwata fi studju randomised u double-blind (studju GS-US-174-0106), f'pazjenti adulti li kienu HBeAg pożittivi u pazjenti adulti li kienu HBeAg negattivi li kellhom viremija persistenti (DNA tal-HBV ta' ≥ 1,000 kopja/ml) waqt li kienu qed jirċievu adefovir dipivoxil 10 mg għal iktar minn 24 ġimgħa.
English: Ninety-five percent of nucleos(t)ide-naïve patients, 84% of nucleos(t)ide- experienced patients, and 83% of lamivudine-resistant patients achieved HBV DNA < 400 copies/ml at week 72.
Maltese: Ħamsa u disgħin fil-mija talpazjenti 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: • Do not breast-feed during treatment with Tenofovir disoproxil Zentiva.
Maltese: • M'għandekx tredda' matul it-trattament b'Tenofovir disoproxil Zentiva.
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 tal-HIV u l-polymerase tal-HBV permezz ta' kompetizzjoni diretta li teħel mas-sottostrat naturali tad-deoxyribonukleotide u, wara l-inkorporazzjoni ġod-DNA, permezz tatterminazzjoni tal-katina tad-DNA.
English: In cell based assays, HBV strains expressing the rtV173L, rtL180M, and rtM204I/V mutations associated with resistance to lamivudine and telbivudine showed a susceptibility to tenofovir ranging from 0.7- to 3.4-fold that of wild-type virus.
Maltese: F'assaġġi bbażati fuq iċ-ċelluli, strejns tal-HBV li jesprimu l-mutazzjonijiet rtV173L, rtL180M, u rtM204I/V assoċjati ma' reżistenza għal lamivudine u telbivudine, urew sensittività għal tenofovir li tvarja minn 0.7 sa 3.4 darbiet iktar minn dik tal-istrejn naturali tal-virus.
English: Tél/Tel: +32 280 86 420 PV-Belgium@zentiva.com
Maltese: +32 280 86 420 PV-Belgium@zentiva.com
English: No significant effect on darunavir/ritonavir PK parameters.
Maltese: L-ebda effett sinifikanti fuq il-parametri PK ta' darunavir/ritonavir.
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 ta' sigurtà ta' tenofovir disoproxil.