FrancophonIA/ELRC3.0 huggingface dataset:
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: Ir-reazzjonijiet avversi osservati f'pazjenti pedjatriċi li rċivew it-trattament b'tenofovir disoproxil kienu konsistenti ma' dawk osservati fi studji kliniċi ta' tenofovir disoproxil fl-adulti (ara sezzjonijiet 4.8 Sommarju tabulat ta' reazzjonijiet avversi u 5.1).
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 adult 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 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 = 30-49 ml/min u indeboliment sever b'CrCl = 10-29 ml/min).
English: Compared with patients with normal renal function, the mean (%CV) tenofovir exposure increased from 2,185 (12%) ng·h/ml in subjects with CrCl > 80 ml/min to respectively 3,064 (30%) ng·h/ml, 6,009 (42%) ng·h/ml and 15,985 (45%) ng·h/ml in patients with mild, moderate and severe renal impairment.
Maltese: Meta mqabbel ma' pazjenti b'funzjoni renali normali, l-esponiment medju tat-tenofovir (%CV) żdiedet minn 2,185 (12%) ng·h/ml f'individwi b'CrCl > 80 ml/min għal 3,064 (30%) ng·h/ml, 6,009 (42%) ng·h/ml u 15,985 (45%) ng·h/ml rispettivament f‘pazjenti b'indeboliment renali ħafif,
English: In adults, the demonstration of the benefit of Viread 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 Viread 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' Viread f'infezzjoni bl-HIV-1 hija bbażata fuq riżultati ta' studju fuq pazjenti li qatt ma kienu ħadu terapija qabel, li jinkludu pazjenti b'ammont ta' viri għoli (> 100,000 kopja/ml) u studji li fihom Viread kien miżjud ma' sfond ta' terapija stabbli (fil-biċċa lkbira 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: Viread 33 mg/g granules are not suitable for the following groups:
Maltese: Viread 33 mg/g granijiet mhumiex adatti għall-gruppi li ġejjin:
English: NRTIs Didanosine
Maltese: Bidla medja
English: Cmax: ↔ Cmin: ↔
Maltese: AUC: ↔ Cmax: ↔ Cmin: ↔
English: Table 9: Bone Mineral Density Evaluation at Baseline and Week 48 Baseline
Maltese: Tabella 9: Evalwazzjoni tad-Densità tal-Minerali tal-Għadam fil-Linja Bażi u Ġimgħa 48 Linja Bażi
English: At weeks 96, 144, 192, 240, 288 and 384, viral suppression, biochemical and serological responses were maintained with continued tenofovir disoproxil treatment (see Tables 5 and 6 below).
Maltese: F'ġimgħat 96, 144, 192, 240, 288 u 384, it-trażżin virali, ir-risponsi bijokimiċi u serologiċi nżammu bit-tkomplija tal-kura b'tenofovir disoproxil (ara Tabelli 5 u 6 hawn taħt).
English: Viread 123 mg film-coated tablets are white, triangle-shaped, film-coated tablets, 8.5 mm in diameter, debossed on one side with “GSI” and on the other side with “150”.
Maltese: Pilloli miksija b'rita, ta' lewn abjad, forma ta' trijangolu, b'dijametru ta' 8.5 mm, imnaqqxa fuq naħa waħda b'“GSI” u fuq in-naħa l-oħra b'“150”.
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
Maltese: Fi studju GS-US-174-0115, 106 pazjenti negattivi għal HBeAg u pożittivi għal HBeAg li kellhom minn 12 sa < 18-il sena b'infezzjoni ta' HBV kronika [DNA tal-HBV ta' ≥ 105 kopji/ml, b'livelli ta' ALT fis-serum li jkunu għolja (≥ 2 × ULN) jew passat mediku ta' livelli ta'
English: Tenofovir is converted intracellularly to tenofovir monophosphate and to the active component, tenofovir diphosphate.
Maltese: Tenofovir jinbidel intraċellularment għall-monophosphate ta' tenofovir u għall-komponent attiv,
English: Duration of therapy in paediatric patients with chronic hepatitis B
Maltese: It-tul tat-terapija f'pazjenti pedjatriċi b'epatite B kronika
English: Assessment of adverse reactions is based on two randomised trials (studies GS-US-104-0321 and GS-US-104-0352) in 184 HIV-1 infected paediatric patients (aged 2 to < 18 years) who received treatment with tenofovir disoproxil (n = 93) or placebo/active comparator (n = 91) in combination with other antiretroviral agents for 48 weeks (see section 5.1).
Maltese: GS-US-104-0321 u 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'
English: Do not take Viread together with medicines containing adefovir dipivoxil (a medicine used to treat chronic hepatitis B).
Maltese: Tiħux Viread flimkien ma' mediċini li fihom adefovir dipivoxil (mediċina li tintuża biex tittratta l-epatite B kronika).
English: Tenofovir and tenofovir disoproxil are not metabolised by liver enzymes.
Maltese: Tenofovir u tenofovir disoproxil ma jiġux metabolizzati minn enzimi tal-fwied.
English: At weeks 96, 144, 192, 240, 288 and 384, viral suppression, biochemical and serological responses were maintained with continued tenofovir disoproxil treatment (see Tables 4 and 5 below).
Maltese: F'ġimgħat 96, 144, 192, 240, 288 u 384, it-trażżin virali, ir-risponsi bijokimiċi u seroloġiċi nżammu bit-tkomplija tattrattament b'tenofovir disoproxil (ara Tabelli 4 u 5 hawn taħt).
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: Mean change from baseline in CPT score 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 b'tenofovir kombinat kontra l-fergħa tal-istudju b'entecavir = 0.622, b valur p li qabbel il-fergħat tal-istudju b'tenofovir kombinat kontra l-fergħa tal-istudju b'entecavir = 1.000.
English: Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections, and Pneumocystis jirovecii pneumonia.
Maltese: Eżempji rilevanti huma retinite ċitomegalovirus, infezzjonijiet mikobatterjali ġeneralizzati u/jew fokali, u pulmonite tat-tip
English: Other medicines and Viread
Maltese: Mediċini oħra u Viread
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 t-terapija b'tenofovir disoproxil.
English: Viread 204 mg film-coated tablets contain lactose monohydrate.
Maltese: Viread 204 mg pilloli miksija b'rita fihom lactose monohydrate.
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: Exacerbations of hepatitis after discontinuation of treatment In HIV infected patients co-infected with HBV, clinical and laboratory evidence of hepatitis have occurred after discontinuation of tenofovir disoproxil (see section 4.4).
Maltese: Epatite li tmur għall-agħar wara l-waqfien tat-trattament F'pazjenti infettati bl-HIV u li huma infettati wkoll bl-HBV, seħħet evidenza klinika u tal-laboratorju tal-epatite wara l-waqfien ta' tenofovir disoproxil (ara sezzjoni 4.4).
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: Hepatitis B infection Viread 245 mg film-coated tablets are indicated for the treatment of chronic hepatitis B in adults with:
Maltese: Viread 245 mg pilloli miksija b'rita huma indikati għat-trattament ta' epatite B kronika f'adulti b':
English: Viread 245 mg tablets are also a treatment for chronic hepatitis B, an infection with HBV (hepatitis B virus).
Maltese: Viread 245 mg pilloli huma wkoll trattament għall-epatite B kronika, infezzjoni bl-HBV (virus ta' l-epatite B).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/200/008
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/01/200/008
English: BMD Z-score a
Maltese: Rispons sħiħ (%)a
English: BMD Z-scorea
Maltese: BMD talġisem kollua
English: Exacerbations of hepatitis after discontinuation of treatment In HBV infected patients, clinical and laboratory evidence of exacerbations of hepatitis have occurred after discontinuation of HBV therapy (see section 4.4).
Maltese: F'pazjenti infettati bl-HBV, evidenza klinika u mil-laboratorju ta' taħrix tal-epatite seħħet wara ttwaqqif tat-terapija għall-HBV (ara sezzjoni 4.4).
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 pożittivi għal HBeAg u pazjenti negattivi għal HBeAg (n = 280) b'mard kumpensat tal-fwied, viremija (DNA tal-HBV ta' ≥ 1,000 IU/ml), u evidenza ġenotipika ta' reżistenza għal lamivudine (rtM204I/V +/- rtL180M).
English: Experience in patients with compensated liver disease at 48 weeks (studies GS-US-174-0102 and GS-US-174-0103)
Maltese: Esperjenza lilhemm minn 48 ġimgħa fi studji GS-US-174-0102 u GS-US-174-0103
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 għall-grupp ta' trattament b'emtricitabine flimkien ma' tenofovir disoproxil, kienu ttrattati fil-passat b'lamivudine.
English: Lumbar spine BMD mean % increaseb
Maltese: Żieda % fil-medja tal-BMD tal ispina lumbarib
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: Lumbar spine mean (SD) BMD Z-scorea Lumbar spine mean (SD) change from baseline BMD Z-score a
Maltese: Medja (SD) talpunteġġ Z tal-BMD tal-ġisem kollua Bidla medja (SD) millpunteġġ Z tal-BMD tal-linja bażi tal-ġisem kollua
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: acute renal failure, renal failure, acute tubular necrosis, nephritis (including acute interstitial nephritis)2, nephrogenic diabetes insipidus General disorders and administration site conditions: Very common: asthenia
Maltese: kollass tal-kliewi akut, kollass tal-kliewi, nekrożi tubulari akuta, nefrite (li tinkludi nefrite interstizzjali akuta)2, dijabete insipidus nefroġenika
English: Most frequent side effects
Maltese: l-effetti sekondarji.
English: Viread 163 mg tablets are only suitable for:
Maltese: Il-pilloli Viread 163 mg huma adatti biss għal:
English: Table 3: Tabulated summary of adverse reactions associated with tenofovir disoproxil based on clinical study and post-marketing experience
Maltese: Tabella 3: Sommarju tabulat ta' reazzjonijiet avversi assoċjati ma' tenofovir disoproxil bbażat fuq studju kliniku u esperjenza ta' wara t-tqegħid fis-suq
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 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 il portal elettroniku Ewropew tal-mediċini.
English: Duration of therapy in adults and paediatric patients with chronic hepatitis B
Maltese: It-tul tat-terapija f'pazjenti adulti u pedjatriċi b'epatite B kronika
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) talindividwi pożittivi għal HBeAg u 75.0% (3/4) tal-individwi negattivi għal HBeAg jiksbu DNA talHBV ta' < 400 kopja/mL (69 IU/mL) f'Ġimgħa 48.
English: c Median change from baseline HBV DNA merely reflects the difference between baseline HBV DNA and the limit of detection (LOD) of the assay.
Maltese: c Tibdil medjan minn DNA tal-HBV fil-linja bażi sempliċiment jirrifletti d-differenza bejn id-DNA tal-HBV fil-linja bażi u llimitu tal-osservazzjoni (LOD, limit of detection) tal-assaġġ.
English: Viread 123 mg film-coated tablets contain lactose monohydrate.
Maltese: Viread 123 mg pilloli miksija b'rita fihom lactose monohydrate.
English: 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 (using MDRD equation).
Maltese: wara l-ewwel 4 ġimgħat ta' trattament, ir-rata ta' tnaqqis annwali wara l-linja bażi tal-funzjoni renali rrappurtata f'pazjenti ttrattati b'tenofovir disoproxil kienet ta' -1.41 ml/min kull sena (bl-użu tal ekwazzjoni Cockcroft Gault) u -0.74 ml/min/1.73 m² kull sena (bl-użu tal-ekwazzjoni MDRD).
English: NAME OF THE MEDICINAL PRODUCT Viread 163 mg film-coated tablets Tenofovir disoproxil
Maltese: Kull pillola ta' Viread fiha 163 mg ta' tenofovir disoproxil
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: Bone Mineral Density (BMD) data from Study GS-US-174-0115 are summarized in Table 8:
Maltese: Id-dejta dwar id-Densità tal-Minerali tal-Għadam (BMD) mill-Istudju GS-US-174-0115 hija mogħtija fil-qosor fit-Tabella 8:
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-1740106), f'pazjenti adulti li kienu pożittivi għal HBeAg u pazjenti adulti li kienu negattivi għal HBeAg 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: 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 tat trattament b'tenofovir disoproxil, il-pazjenti kellhom medja ta' punteġġ CPT ta' 7.2, medja ta' DNA tal-HBV ta' 5.8 log10 kopji/ml u medja ta' ALT fis-serum ta' 61 U/l fil-linja bażi.
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'
English: Median HBV DNA reduction from baseline c
Maltese: DNA tal-HBV millinja bażic
English: NA = Not Applicable a BMD Z-scores not adjusted for height and weight b Primary safety endpoint through week 72
Maltese: NA = Mhux Applikabbli a Punteġġi Z tal-BMD mhux aġġustati għat-tul u l-piż b Punt aħħari primarju tas-sigurtà matul ġimgħa 72
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: tal-proteini tat-trasport 1 u 3 jew MRP 4 (eż. cidofovir, prodott mediċinali nefrotossiku magħruf).
English: All adverse reactions are presented in Table 3.
Maltese: Ir-reazzjonijiet avversi kollha huma ppreżentati f'Tabella 3.
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, f'intervalli ripetuti, b'eżaminazzjonijiet kliniċi u tal-laboratorju għal mill-inqas 6 xhur wara t-twaqqif tat-terapija kontra l epatite B.
English: Acute exacerbation of hepatitis has been reported in patients on treatment as well as in patients who have discontinued hepatitis B therapy (see section 4.4).
Maltese: Taħrix akut tal-epatite kien irrappurtat f'pazjenti li kienu qed jirċievu t-trattament kif ukoll f'pazjenti li waqqfu t-terapija kontra l-epatite B (ara sezzjoni 4.4).
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 mhuwiex rakkomandat għax jista' jirriżulta f'żieda ta' 40-60% fl-esponiment sistemiku għal didanosine li jista' jżid ir-riskju għal reazzjonijiet avversi relatati ma' didanosine (ara sezzjoni 4.5).
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'
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: Viread has not been studied in patients over 65 years of age.
Maltese: Viread ma ġiex studjat f'pazjenti li għandhom iktar minn 65 sena.
English: Tolerability failure (permanent discontinuation of study drug due to a treatment emergent AE) n (%)
Maltese: Nuqqas ta' tollerabilità (twaqqif permanenti tal-mediċina talistudju minħabba li jiżviluppaw avvenimenti avversi (AE) mittrattament)
English: Please refer to the Summaries of Product Characteristics for Viread 123 mg and 163 mg film-coated tablets for the treatment of HIV-1 infection and chronic hepatitis B in paediatric patients aged 6 to < 12 years weighing 17 kg to < 22 kg and 22 kg to < 28 kg, respectively.
Maltese: Jekk jogħġbok irreferi għas-Sommarji tal-Karatteristiċi tal-Prodott għal Viread 123 mg u 163 mg pilloli miksija b'rita għat-trattament ta' infezzjoni bl-HIV-1 u epatite B kronika f'pazjenti pedjatriċi li għandhom minn 6 sa < 12-il sena u li jiżnu minn 17 kg sa < 22 kg u 22 kg sa < 28 kg, rispettivament.
English: Week 192
Maltese: f'Ġimgħa 192.