FrancophonIA/ELRC3.0 huggingface dataset:
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: HBV hija primarjament ibbażata fuq l-esperjenza f'żewġ studji komparattivi, double-blind u kkontrollati li fihom 641 pazjent adult b'epatite B kronika u mard kumpensat tal-fwied li rċivew trattament b'tenofovir disoproxil 245 mg kuljum (n = 426) jew adefovir dipivoxil 10 mg kuljum (n = 215) għal 48 ġimgħa.
English: Lumbar spine BMD at
Maltese: BMD tal ispina lumbaria Bidla medja
English: • Not for children who weigh under 28 kg or 35 kg and over.
Maltese: • Mhux għal tfal li jiżnu inqas minn 28 kg jew 35 kg u aktar.
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 fil-punteġġ tal-fibrożi ta' Ishak ta' mill-inqas 2 punti.
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: 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: 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: Viread 33 mg/g granules are indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected paediatric patients, with NRTI resistance or toxicities precluding the use of first line agents, from 2 to < 6 years of age, and above 6 years of age for whom a solid dosage form is not appropriate.
Maltese: Viread 33 mg/g granijiet huma indikati flimkien ma' prodotti mediċinali oħra antiretrovirali għattrattament ta' pazjenti pedjatriċi infettati b'HIV-1, b'reżistenza għal NRTI jew tossiċitajiet li jipprekludu l-użu ta' prodotti mediċinali primarji, li għandhom minn sentejn sa < 6 snin, u aktar minn 6 snin li għalihom forma ta' dożaġġ solidu mhijiex adattata.
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 xieraq f'pazjenti ko-infettati bl-HIV/HBV.
English: • HBV infected children aged 6 to less than 12 years who weigh from 17 kg to less than 22 kg
Maltese: • tfal infettati bl-HBV li għandhom minn 6 sa inqas minn 12-il sena li jiżnu minn 17-il kg sa inqas minn 22 kg.
English: They are only suitable for:
Maltese: Taħrix wara t-twaqqif tat-trattament:
English: The proportion of subjects with ALT normalization at week 192 in the TDF-TDF 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 TDF-TDF kien ta' 75.8% (25/33) fost dawk li kienu pożittivi għal HBeAg fil-linja bażi u 100.
English: Dose adjustments using tenofovir disoproxil 33 mg/g granules are recommended for patients with creatinine clearance < 50 ml/min.
Maltese: Aġġustamenti tad-doża bl-użu ta' tenofovir disoproxil 33 mg/g granijiet huma rakkomandati għal pazjenti bi tneħħija tal-krejatinina ta' < 50 ml/min.
English: b 48 weeks of double-blind tenofovir disoproxil followed by 48 weeks open-label.
Maltese: b 48 ġimgħa ta' tenofovir disoproxil double blind segwiti minn 48 ġimgħa open label.
English: Viread 123 mg film-coated tablets Tenofovir disoproxil
Maltese: Kull pillola ta' Viread fiha 123 mg ta' tenofovir disoproxil
English: Please refer to the Summaries of Product Characteristics for Viread 123 mg and 204 mg film-coated tablets for the treatment of HIV-1 infect ion and chronic hepatitis B in paediatric patients aged 6 to < 12 years weighing 17 kg to < 22 kg and 28 kg to < 35 kg, respectively.
Maltese: Jekk jogħġbok irreferi għas-Sommarji tal-Karatteristiċi tal-Prodott għal Viread 123 mg u 204 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 28 kg sa < 35 kg, rispettivament.
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 8 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 8 hawn taħt).
English: • HBV infected children aged 6 to less than 12 years who weigh from 28 kg to less than 35 kg
Maltese: • tfal infettati bl-HBV li għandhom minn 6 sa inqas minn 12-il sena li jiżnu minn 28 kg sa inqas minn 35 kg.
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: Each Viread tablet contains 204 mg of tenofovir disoproxil (as fumarate).
Maltese: Kull pillola miksija b'rita fiha 204 mg ta' tenofovir disoproxil (bħala fumarate).
English: Experience in patients with decompensated liver disease at 48 weeks (study GS-US-174-0108) Study GS-US-174-0108 is a randomised, double-blind, active controlled study evaluating the safety and efficacy of tenofovir disoproxil (n = 45), emtricitabine plus tenofovir disoproxil (n = 45), and entecavir (n = 22), in patients with decompensated liver disease.
Maltese: Studju GS-US-174-0108 huwa studju randomised, double-blind, ikkontrollat b'mod attiv, li evalwa s-sigurtà u l-effikaċja ta' tenofovir disoproxil (n = 45), emtricitabine flimkien ma' tenofovir disoproxil (n = 45), u entecavir (n = 22), f'pazjenti b'mard tal-fwied mhux kumpensat.
English: Viread 245 mg film-coated tablets contain lactose monohydrate.
Maltese: Viread pilloli miksija b'rita ta' 245 mg fihom lactose monohydrate.
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 mgarm, 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 mgarm, 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: Please refer to the Summaries of Product Characteristics for Viread 163 mg and 204 mg film-coated tablets for the treatment of HIV-1 infection and chronic hepatitis B in paediatric patients aged 6 to < 12 years weighing 22 kg to < 28 kg and 28 kg to < 35 kg, respectively.
Maltese: Jekk jogħġbok irreferi għas-Sommarji tal-Karatteristiċi tal-Prodott għal Viread 163 mg u 204 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 22 kg sa < 28 kg u 28 kg sa < 35 kg, rispettivament.
English: Two hundred and fifteen HBeAg negative (GS-US-174-0102, n = 125) and HBeAg positive (GS-US-174-0103, 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 trattament double blind b'adefovir dipivoxil u mbagħad qalbu għal trattament b'tenofovir disoproxil open label kienu evalwati għal tibdil ġenotipiku fil-polymerase tal-HBV mil-linja bażi.
English: Adefovir dipivoxil 10 mg roll over to tenofovir disoproxil 245 mg n = 125d
Maltese: Adefovir dipivoxil 10 mg maqlub għal tenofovir disoproxil 245 mg n = 125d
English: Viread 163 mg tablets are a treatment for HIV (Human Immunodeficiency Virus) infection.
Maltese: Il-pilloli Viread 163 mg huma trattament għal infezzjoni bl-HIV (Virus ta' l-Immunodefiċjenza
English: Frequency Tenofovir disoproxil Metabolism and nutrition disorders:
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni:
English: NAME OF THE MEDICINAL PRODUCT Viread 204 mg film-coated tablets Tenofovir disoproxil
Maltese: Kull pillola ta' Viread fiha 204 mg ta' tenofovir disoproxil
English: Bone Mineral Density (BMD) data from Study GS-US-174-0115 are summarized in Table 9:
Maltese: Id-dejta dwar id-Densità tal-Minerali tal-Għadam (BMD) mill-Istudju GS-US-174-0115 hija mogħtija fil-qosor fit-Tabella 9:
English: Viread 245 mg tablets are suitable for:
Maltese: Il-pilloli Viread 245 mg huma adatti għal:
English: LIST OF EXCIPIENTS Contains mannitol.
Maltese: TA' EĊĊIPJENTI Fih mannitol.
English: Renal safety with tenofovir 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 kienet studjata biss b'mod limitat ħafna f'pazjenti adulti b'indeboliment fil-funzjoni tal-kliewi (tneħħija tal-krejatinina < 80 ml/min).
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: c 48 weeks of double-blind adefovir dipivoxil followed by 48 weeks open-label tenofovir disoproxil.
Maltese: c 48 ġimgħa ta' adefovir dipivoxil double blind segwiti minn 48 ġimgħa ta' tenofovir disoproxil open label.
English: HIV-1: Steady-state pharmacokinetics of tenofovir were evaluated in 8 HIV-1 infected adolescent patients (aged 12 to < 18 years) with body weight ≥ 35 kg and in 23 HIV-1 infected children aged 2 to < 12 years (see Table 11 below).
Maltese: Il-farmakokinetika fi stat fiss ta' tenofovir ġiet evalwata fi 8 pazjenti adolexxenti infettati b'HIV-1 (minn età ta' 12 sa < 18-il sena) li kienu jiżnu ≥ 35 kg u fi 23 tifel u tifla infettati bl-HIV-1 li kellhom minn sentejn sa < 12-il sena (ara Tabella 11 hawn taħt).
English: Viread 123 mg tablets are only suitable for:
Maltese: Il-pilloli Viread 123 mg huma adatti biss għal:
English: Steady-state pharmacokinetics of tenofovir were evaluated in 8 HIV-1 infected adolescent patients (aged 12 to < 18 years) with body weight ≥ 35 kg and in 23 HIV-1 infected children aged 2 to < 12 years (see Table 10 below).
Maltese: Il-farmakokinetika fi stat fiss ta' tenofovir ġiet evalwata fi 8 pazjenti adolexxenti infettati b'HIV-1 (minn età ta' 12 sa < 18-il sena) li kienu jiżnu ≥ 35 kg u fi 23 tifel u tifla infettati bl-HIV-1 li kellhom minn sentejn sa < 12-il sena (ara Tabella 10 hawn taħt).
English: Since tenofovir is primarily eliminated by the kidneys, co-administration of tenofovir disoproxil with medicinal products that reduce renal function or compete for active tubular secretion via transport proteins hOAT 1, hOAT 3 or MRP 4 (e.g. cidofovir) may increase serum concentrations of tenofovir and/or the co-administered medicinal products.
Maltese: Prodotti mediċinali eliminati mill-kliewi Minħabba li tenofovir hu primarjament eliminat mill-kliewi, l-għoti flimkien ta' tenofovir disoproxil ma' prodotti mediċinali li jnaqqsu l-funzjoni tal-kliewi jew jikkompetu għas-sekrezzjoni tubulari attiva permezz tal-proteini tat-trasport hOAT 1, hOAT 3 jew MRP 4 (eż. cidofovir) jistgħu jżidu lkonċentrazzjonijiet fis-serum ta' tenofovir u/jew il-prodotti mediċinali li jingħataw flimkien.
English: When missing data were excluded, 91% of patients in the tenofovir disoproxil treatment group and 94% of patients in the stavudine or zidovudine treatment group had HIV-1 RNA concentrations < 400 copies/ml at week 48.
Maltese: Meta d-dejta nieqsa ġiet eskluża, 91% tal-pazjenti fil-grupp ta' kura b'tenofovir disoproxil u 94% tal-pazjenti fil grupp ta' kura bi stavudine jew zidovudine kellhom konċentrazzjonijiet ta' HIV-1 RNA ta' < 400 kopja/ml f'ġimgħa 48.
English: o 48 weeks of double-blind tenofovir disoproxil followed by 336 weeks open-label.
Maltese: o 48 ġimgħa ta' tenofovir disoproxil double blind segwiti minn 336 ġimgħa open label.
English: The use of tenofovir disoproxil is not recommended in paediatric patients with renal impairment (see sections 4.2 and 4.4).
Maltese: użu ta' tenofovir disoproxil mhuwiex rakkomandat f'pazjenti pedjatriċi b'indeboliment renali (ara sezzjonijiet 4.2 u 4.4).
English: This dosing recommendation balances the need to limit drug accumulation while attempting to maintain sufficient tenofovir concentrations over the dosing interval similar to trough concentrations observed in patients with normal renal function receiving tenofovir disoproxil 245 mg film-coated tablets.
Maltese: Din ir-rakkomandazzjoni dwar id-doża tibbilanċja l-bżonn li tiġi limitata l-akkumulazzjoni talmediċina filwaqt li tipprova żżomm konċentrazzjonijiet suffiċjenti ta' tenofovir matul l-intervalli taddoża simili għall-konċentrazzjonijiet minimi osservati f'pazjenti b'funzjoni renali normali li jiċievu tenofovir disoproxil 245 mg pilloli miksija b'rita.
English: Viread 204 mg tablets are a treatment for HIV (Human Immunodeficiency Virus) infection.
Maltese: Il-pilloli Viread 204 mg huma trattament għal infezzjoni bl-HIV (Virus ta' l-Immunodefiċjenza
English: • HBV infected children and adolescents aged 2 to less than 18 years.
Maltese: • tfal u adolexxenti infettati bl-HBV li għandhom minn sentejn sa inqas minn 18-il sena.
English: (log10 copies/ml) HBV DNA (%) < 400 copies/ml (< 69 IU/ml) ALT (%) Normalised ALT
Maltese: minn 29) tal-pazjenti fil-grupp tal-plaċebo kellhom DNA tal-HBV ta' < 400 kopja/mL (69 IU/mL).
English: j 48 weeks of double-blind adefovir dipivoxil followed by 192 weeks open-label tenofovir disoproxil.
Maltese: j 48 ġimgħa ta' adefovir dipivoxil double blind segwiti minn 192 ġimgħa ta' tenofovir disoproxil open label.
English: Viread 204 mg tablets are also a treatment for chronic hepatitis B, an infection with HBV (hepatitis B virus).
Maltese: Il-pilloli Viread 204 mg huma wkoll trattament għal epatite B kronika, infezzjoni bl-HBV (virus tal-epatite B).
English: fatigue
Maltese: LOTT
English: Bone Mineral Density (BMD) data from Study GS-US-174-0144 are summarized in Table 9:
Maltese: Id-data dwar id-Densità tal-Minerali tal-Għadam (BMD, Bone Mineral Density) mill-Istudju GS-US174-0144 hija mogħtija fil-qosor fit-Tabella 9:
English: Viread 163 mg tablets are also a treatment for chronic hepatitis B, an infection with HBV (hepatitis B virus).
Maltese: Il-pilloli Viread 163 mg huma wkoll trattament għal epatite B kronika, infezzjoni bl-HBV (virus tal-epatite B).
English: i 48 weeks of double-blind adefovir dipivoxil followed by 144 weeks open-label tenofovir disoproxil.
Maltese: i 48 ġimgħa ta' adefovir dipivoxil double blind segwiti minn 144 ġimgħa ta' tenofovir disoproxil open label.
English: At week 168, in this population of patients with decompensated liver disease, the rate of death was of 13% (6/45) in the tenofovir disoproxil group, 11% (5/45) in the emtricitabine plus tenofovir disoproxil group and 14% (3/22) in the entecavir group.
Maltese: Wara 168 ġimgħa, 16% (7/45) tal-grupp ta' tenofovir disoproxil, 4% (2/45) tal grupp ta' emtricitabine u tenofovir disoproxil, u 14% (3/22) tal-grupp ta' entecavir esperjenzaw nuqqas ta' tollerabilità.
English: Adefovir dipivoxil 10 mg roll over to tenofovir disoproxil 245 mg n = 90d
Maltese: Adefovir dipivoxil 10 mg maqlub għal tenofovir disoproxil 245 mg n = 90d
English: Viread 33 mg/g granules are indicated for the treatment of chronic hepatitis B in adults for whom a solid dosage form is not appropriate with:
Maltese: Viread 33 mg/g granijiet huma indikati għat-trattament ta' epatite B kronika f'adulti li għalihom forma ta' dożaġġ solidu mhijiex adattata b':
English: Among the subjects who received placebo during the double-blind period, the proportion of subjects with HBV DNA < 400 copies/mL rose sharply after they began treatment with open-label TDF (PLB-TDF group): 74.1% (40/54) of subjects in the PLB-TDF group had HBV DNA < 400 copies/ml at week 192.
Maltese: Fost l-individwi li rċivew plaċebo matul il-perjodu double-blind, il-proporzjon ta' individwi b'DNA ta' HBV ta' < 400 kopja/mL żdied b'mod sinifikanti wara li bdew it-trattament b'TDF open-label (il-grupp PLB-TDF): 74.1% (40/54)
English: For patients with creatinine clearance 10-19 ml/min: Administration of 33 mg (1 scoop) tenofovir disoproxil 33 mg/g granules once daily is recommended.
Maltese: Għal pazjenti bi tneħħija tal-krejatinina ta' 10-19 ml/min: L-għoti ta' 33 mg (mgħarfa 1) ta' tenofovir disoproxil 33 mg/g granijiet darba kuljum hu rakkomandat.
English: There have been reports of a high rate of virological failure and of emergence of resistance at an early stage in HIV patients when tenofovir disoproxil was combined with lamivudine and abacavir as well as with lamivudine and didanosine as a once-daily regimen.
Maltese: Kien hemm rapporti ta' rata għolja ta' falliment viroloġiku, u ta' reżistenza li titfaċċa, li seħħew ittnejn li huma fi stadju bikri f'pazjenti bl-HIV, meta tenofovir disoproxil ngħata flimkien ma' lamivudine u abacavir, kif ukoll ma' lamivudine u didanosine bħala kors ta' għoti ta' darba kuljum.
English: • HBV infected children aged 6 to less than 12 years who weigh from 22 kg to less than 28 kg
Maltese: • tfal infettati bl-HBV li għandhom minn 6 sa inqas minn 12-il sena li jiżnu minn 22 kg sa inqas minn 28 kg.
English: NAME OF THE MEDICINAL PRODUCT Viread 245 mg film-coated tablets Tenofovir disoproxil
Maltese: Kull pillola ta' Viread fiha 245 mg ta' tenofovir disoproxil
English: Patients were stratified by baseline HIV-1 RNA and CD4 count.
Maltese: Studji kliniċi dwar l-HIV-1:
English: In studies with nucleoside-naïve patients, on-treatment ALT elevations > 10 times ULN (upper limit of normal) and > 2 times baseline occurred in 2.6% of tenofovir disoproxil-treated patients.
Maltese: Fi studji fuq pazjenti li qatt ma ngħataw nukleosides, żidiet tal-ALT waqt it-trattament ta' > 10 darbiet iżjed mill-ULN (limitu ta' fuq tan-normal) u iktar mid-doppju tal-linja bażi seħħew fi 2.6% tal pazjenti li kienu ttrattati b'tenofovir disoproxil.
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: thymidine (TAMs) li kienu jinkludu l-mutazzjoni M41L jew L210W reverse transcriptase wrew tnaqqis fir-respons għat-terapija ta' 245 mg tenofovir disoproxil .
English: Patients at risk of renal impairment (such as patients with baseline renal risk factors, advanced HIV disease, or patients receiving concomitant nephrotoxic medications) are at increased risk of experiencing incomplete recovery of renal function despite tenofovir disoproxil discontinuation (see section 4.4).
Maltese: Pazjenti f'riskju ta' indeboliment renali (bħal pazjenti b'fatturi ta' riskju renali fil-linja bażi, mard ta' l-HIV li jkun fi stadju avvanzat, jew pazjenti li jkunu qed jirċievu prodotti mediċinali nefrotossiċi flistess ħin) ghandhom riskju akbar li jkollhom irkupru mhux komplet tal-funzjoni renali minkejja t twaqqif ta' tenofovir disoproxil (ara sezzjoni 4.4).
English: Viread 123 mg tablets are a treatment for HIV (Human Immunodeficiency Virus) infection.
Maltese: Il-pilloli Viread 123 mg huma trattament għal infezzjoni bl-HIV (Virus ta' l-Immunodefiċjenza
English: h 48 weeks of double-blind adefovir dipivoxil followed by 144 weeks open-label tenofovir disoproxil.
Maltese: h 48 ġimgħa ta' adefovir dipivoxil double blind segwiti minn 144 ġimgħa ta' tenofovir disoproxil open label.
English: Table 4: Efficacy parameters in compensated HBeAg negative patients at week 96, 144, 192, 240, 288 and 384 open-label treatment
Maltese: Tabella 4: Parametri tal-effikaċja f'pazjenti kumpensati li kienu negattivi għal HBeAg f'ġimgħa 96, 144, 192, 240, 288 u 384 ta' trattament open label
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 mqabbel ma' 34% (11/32) fil-grupp tal-plaċebo.
English: Lumbar spine mean (SD) BMD Z-scorea
Maltese: Bidla medja (SD) mill-punteġġ
English: Light blue, almond-shaped, film-coated tablets, of dimensions 16.8 mm x 10.3 mm, debossed on one side with “GILEAD” and “4331” and on the other side with “300”.
Maltese: 3 mm, imnaqqxa fuq naħa waħda b'“GILEAD” u “4331” u fuq in-naħa l-oħra bi “300”.
English: GS-331007
Maltese: GS-US-174-0103)
English: Viread 33 mg/g granules are also a treatment for chronic hepatitis B, an infection with HBV (hepatitis B virus).
Maltese: Viread 33 mg/g granijiet huma wkoll trattament għall-epatite B kronika, infezzjoni bl-HBV
English: Each Viread tablet contains 245 mg of tenofovir disoproxil (as fumarate).
Maltese: Kull pillola miksija b'rita fiha 245 mg ta' tenofovir disoproxil (bħala fumarate).
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: Indeboliment tal-fwied Doża waħda ta' 245 mg tenofovir disoproxil ngħatat lill-pazjenti adulti li ma kienux infettati b'HIV, u mhux infettati bl-HBV li kellhom indeboliment tal-fwied fi stadji differenti skond il-klassifikazzjoni ta' Child-Pugh-Turcotte (CPT).
English: Viread 123 mg tablets are also a treatment for chronic hepatitis B, an infection with HBV (hepatitis B virus).
Maltese: Il-pilloli Viread 123 mg huma wkoll trattament għal epatite B kronika, infezzjoni bl-HBV (virus tal-epatite B).
English: HBV DNA (%) < 400 copies/ml (< 69 IU/ml) ALT (%) Normalised ALT
Maltese: < 400 kopja/ml (< 69 IU/ml)
English: least 4% decrease b
Maltese: Tnaqqis tal-inqas ta' 4% fil
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 163 mg of tenofovir disoproxil (as fumarate).
Maltese: Kull pillola miksija b'rita fiha 163 mg ta' tenofovir disoproxil (bħala fumarate).
English: Lumbar spine BMD at least 6% decrease b
Maltese: Tnaqqis talinqas ta' 6% fil-BMD tal ispina lumbarib
English: g 48 weeks of double-blind tenofovir disoproxil followed by 144 weeks open-label.
Maltese: g 48 ġimgħa ta' tenofovir disoproxil double blind segwiti minn 144 ġimgħa open label.