FrancophonIA/ELRC3.0 huggingface dataset:
English: Moderate renal impairment (creatinine clearance 30-49 ml/min) Administration of 132 mg (4 scoops) tenofovir disoproxil 33 mg/g granules once daily is recommended.
Maltese: Indeboliment renali moderat (tneħħija tal-krejatinina ta' 30-49 ml/min) L-għoti ta' 132 mg (4 mgħaref) ta' tenofovir disoproxil 33 mg/g granijiet darba kuljum hu rakkomandat.
English: Patients with pre-existing liver dysfunction, including chronic active hepatitis, have an increased frequency of liver function abnormalities during combination antiretroviral therapy (CART) and should be monitored according to standard practice.
Maltese: Pazjenti li diġà jbatu minn disfunzjoni tal-fwied, li tinkludi epatite kronika attiva, għandhom żieda fil-frekwenza ta' anormalitajiet tal-funzjoni tal-fwied waqt it-terapija antiretrovirali kombinata (CART) u jeħtieġ li jiġu monitorjati skond il-prattika normali.
English: Study 174-0103 (HBeAg positive)
Maltese: Studju 174-0103 (pożittivi għal HBeAg)
English: The mean baseline CD4 cell count was 279 cells/mm3, the mean baseline plasma HIV-1 RNA was 4.91 log10 copies/ml, 19% of patients had symptomatic HIV-1 infection and 18% had AIDS.
Maltese: Il-medja tal-linja bażi ta' l-għadd taċ-ċelluli CD4 kien ta' 279 ċellula/mm3, il-medja bażi tal-plażma HIV-1 RNA kienet ta' 4.91 log10 kopja/ml, 19% tal-pazjenti kellhom infezzjoni sintomatika ta' HIV-1 u 18% kellhom AIDS.
English: HBV strains expressing the rtL180M, rtT184G, rtS202G/I, rtM204V and rtM250V mutations associated with resistance to entecavir showed a susceptibility to tenofovir ranging from 0.6- to 6.9-fold that of wildtype virus.
Maltese: Strejns tal-HBV li jesprimu l-mutazzjonijiet rtL180M, rtT184G, rtS202G/I, rtM204V u rtM250V assoċjati ma' reżistenza għal entecavir, urew sensittività għal tenofovir li tvarja minn 0.6 sa 6.9 darbiet iktar minn dik tal-istrejn naturali tal-virus.
English: NAME OF THE MEDICINAL PRODUCT Viread 33 mg/g granules
Maltese: Viread 33 mg/g granijiet
English: n/a = not applicable.
Maltese: n/a = mhux applikabbli.
English: Viread 245 mg film-coated tablets are indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected adults.
Maltese: Viread 245 mg pilloli miksija b'rita huma indikati flimkien ma' prodotti mediċinali oħra antiretrovirali għat-trattament ta' adulti infettati b'HIV-1.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Maltese: Ewropea għall-Mediċini http://www.ema.europa.eu.
English: Mechanism of action and pharmacodynamic effects Tenofovir disoproxil fumarate is the fumarate salt of the prodrug tenofovir disoproxil.
Maltese: Tenofovir disoproxil fumarate huwa sustanza ta' fumarate tal-prodroga tenofovir disoproxil.
English: • Measure out the correct number of level scoops of granules into a container.
Maltese: • Kejjel in-numru korrett ta' mgħaref mhux imburġati ta' granijiet ġo kontenitur.
English: Co-administration of tenofovir disoproxil and didanosine at a dose of 400 mg daily has been associated with a significant decrease in CD4 cell count, possibly due to an intracellular interaction increasing phosphorylated (i.e. active) didanosine.
Maltese: tenofovir disoproxil u didanosine f'doża ta' 400 mg kuljum kien assoċjat ma' tnaqqis sinifikanti flgħadd taċ-ċelluli CD4, possibbilment minħabba interazzjoni intraċellulari li żiedet didanosine fosforilat (jiġifieri attiv).
English: INFORMATION IN BRAILLE Viread 163 mg [Outer packaging only]
Maltese: Viread 163 mg [Pakkett ta' barra biss]
English: One gram of Viread granules contains 33 mg of tenofovir disoproxil (as fumarate).
Maltese: Gramma waħda ta' Viread granijiet fiha 33 mg ta' tenofovir disoproxil (bħala fumarate).
English: Table 2: Interactions between tenofovir disoproxil and other medicinal products Medicinal product by therapeutic areas (dose in mg)
Maltese: Tabella 2: Interazzjonijiet bejn tenofovir disoproxil u prodotti mediċinali oħrajn Prodott mediċinali skond loqsma terapewtiċi (doża f'milligrammi)
English: In addition 55% (29/53) of patients treated with tenofovir disoproxil had undetectable HBV DNA (< 169 copies/ml [< 29 IU/ml]; the limit of quantification of the Roche Cobas TaqMan HBV assay) versus 60% (31/52) of patients treated with emtricitabine plus tenofovir disoproxil (p = 0.504).
Maltese: Flimkien ma' dan, 55% (29/53) tal-pazjenti ttrattati b'tenofovir disoproxil kellhom DNA tal-HBV li ma setgħetx tkun osservata (< 169 kopja/ml [< 29 IU/ml]; illimitu tal-kwantifikazzjoni tal-assaġġ Roche Cobas TaqMan HBV) kontra 60% (31/52) tal-pazjenti ttrattati b'emtricitabine flimkien ma' tenofovir disoproxil (p = 0.504).
English: • who weigh from 28 kg to less than 35 kg
Maltese: • li jiżnu minn 28 kg sa inqas minn 35 kg
English: - The other ingredients are microcrystalline cellulose (E460), starch pregelatinised, croscarmellose sodium, lactose monohydrate, and magnesium stearate (E572) which make up the tablet core, and lactose monohydrate, hypromellose (E464), titanium dioxide (E171) and glycerol triacetate (E1518) which make up the tablet coating.
Maltese: - Is-sustanzi l-oħra huma microcrystalline cellulose (E460), starch pregelatinised, croscarmellose sodium, lactose monohydrate u magnesium stearate (E572) li jiffurmaw il-qalba tal-pillola, u lactose monohydrate, hypromellose (E464), titanium dioxide (E171) u glycerol triacetate (E1518) li jiffurmaw il-kisja tal-pillola.
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 tal-EC50 għal tenofovir kienu fil-medda ta' 0.14 sa 1.5 µmol/l, b'valuri tas-CC50 (50% tal-konċentrazzjoni taċ-ċitotossiċità) ta' > 100 µmol/l.
English: Each tablet contains 109 mg lactose (as monohydrate).
Maltese: Eċċipjent b'effett magħruf Kull pillola fiha 109 mg ta' lactose (bħala monohydrate).
English: 1,000 patients) but serious side effect that can be fatal.
Maltese: minn kull 1,000 pazjent) iżda serju li jista' jkun fatali.
English: White, capsule-shaped, film-coated tablets, of dimensions 15.4 mm x 7.3 mm, debossed on one side with “GSI” and on the other side with “250”.
Maltese: Pilloli miksija b'rita, ta' lewn abjad, forma ta' kapsula, b'daqs ta' 15.4 mm x 7.3 mm, imnaqqxa fuq naħa waħda b'“GSI” u fuq in-naħa l-oħra b'“250”.
English: A consistent response to treatment with tenofovir disoproxil 245 mgwas seen regardless of baseline HIV-1 RNA and CD4 count.
Maltese: Reazzjoni konsistenti għat-trattament b'245 mg tenofovir disoproxil dehret irrispettivament mil-linja bażi ta' HIV-1 RNA u l-għadd ta' CD4.
English: HIV-1 infection and chronic hepatitis B in paediatric patients aged 6 to < 12 years (see section 5.1).
Maltese: pilloli għat-trattament ta' infezzjoni tal-HIV-1 u epatite B kronika f'pazjenti pedjatriċi li għandhom minn 6 sa < 12-il sena (ara sezzjoni 5.1).
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: 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).
English: In patients with CPT scores ≤ 9, 74% (29/39) of tenofovir disoproxil, and 94% (33/35) of emtricitabine plus tenofovir disoproxil treatment groups achieved HBV DNA < 400 copies/ml after 48 weeks of treatment.
Maltese: F'pazjenti b'punteġġi CPT ta' ≤ 9, 74% (29/39) ta' tenofovir disoproxil, u 94% (33/35) tal-gruppi ta' trattament b'emtricitabine flimkien ma' tenofovir disoproxil, kisbu DNA tal-HBV ta' < 400 kopja/ml wara 48 ġimgħa ta' trattament.
English: INFORMATION IN BRAILLE Viread 245 mg [Outer packaging only]
Maltese: Viread 245 mg [Pakkett ta' barra biss]
English: Each tablet contains 82 mg lactose (as monohydrate).
Maltese: Eċċipjent b'effett magħruf Kull pillola fiha 82 mg ta' lactose (bħala monohydrate).
English: The mean baseline CD4 cell count was 427 cells/mm3, the mean baseline plasma HIV-1 RNA was 3.4 log10 copies/ml (78% of patients had a viral load of < 5,000 copies/ml) and the mean duration of prior HIV treatment was 5.4 years.
Maltese: Il-medja bażi ta' l-għadd taċ-ċelluli CD4 kien ta' 427 ċelluli/mm3, il-medja bażi tal-plażma HIV-1 RNA kienet ta' 3.4 log10 kopja/ml (78% tal-pazjenti kellhom ammont ta' viri ta' < 5,000 kopja/ml) u d-dewmien medju tat-trattament għal HIV mogħti qabel kien ta' 5.4 snin.
English: - The other ingredients are ethylcellulose (E462), hydroxypropyl cellulose (E463), mannitol
Maltese: - Is-sustanzi l-oħra huma ethylcellulose (E462), hydroxypropyl cellulose (E463), mannitol (E421) u silicon dioxide (E551).
English: 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, Ġimgħat 72 u 192
English: Mild renal impairment (creatinine clearance 50-80 ml/min) Limited data from clinical studies support once daily dosing of 245 mg tenofovir disoproxil, equivalent to 7.5 scoops of granules, in patients with mild renal impairment.
Maltese: Indeboliment renali ħafif (tneħħija tal-krejatinina ta' 50-80 ml/min) Informazzjoni limitata minn studji kliniċi jissapportjaw dożaġġ ta' 245 mg darba kuljum ta' tenofovir disoproxil, ekwivalenti għal 7.5 mgħaref ta' granijiet, f'pazjenti b'indeboliment renali ħafif.
English: Genotypic evaluations performed on all patients with HBV DNA > 400 copies/ml at week 48 (n = 39), 96 (n = 24), 144 (n = 6), 192 (n = 5), 240 (n = 4), 288 (n = 6) and 384 (n = 2) of tenofovir disoproxil monotherapy showed that no mutations associated with tenofovir disoproxil resistance have developed.
Maltese: (n = 24), 144 (n = 6), 192 (n = 5), 240 (n = 4), 288 (n = 6) u 384 (n = 2) ta' monoterapija b'tenofovir disoproxil urew li ma żviluppawx mutazzjonijiet assoċjati ma' reżistenza għal tenofovir disoproxil.
English: - The other ingredients are microcrystalline cellulose (E460), starch pregelatinised, croscarmellose sodium, lactose monohydrate, and magnesium stearate (E572) which make up the tablet core, and lactose monohydrate, hypromellose (E464), titanium dioxide (E171), glycerol triacetate (E1518) and indigo carmine aluminium lake (E132) which make up the tablet coating.
Maltese: croscarmellose sodium, lactose monohydrate u magnesium stearate (E572) li jiffurmaw il-qalba tal-pillola, u lactose monohydrate, hypromellose (E464), titanium dioxide (E171), glycerol triacetate (E1518) u indigo carmine aluminium lake (E132) li jiffurmaw il-kisja tal-pillola.
English: Table 10: Mean (± SD) tenofovir pharmacokinetic parameters by age groups for paediatric patients
Maltese: Medja (± SD) tal-parametri farmakokinetiċi ta' tenofovir skont gruppi ta' età għal pazjenti pedjatriċi
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this medicine.
Maltese: Pazjenti li għandhom problemi ereditarji rari ta' intolleranza għall-galactose, nuqqas totali ta' lactase jew malassorbiment tal-glucose galactose m'għandhomx jieħdu din il-mediċina.
English: The majority of subjects were either genotypes C (43.8%) or D (41.6%) with a lower and similar frequency of genotypes A and B (6.7% each).
Maltese: Il-maġġoranza talindividwi kienu ta' ġenotipi Ċ (43.8%) jew D (41.6%) bi frekwenza iktar baxxa u simili tal-ġenotipi A u B (6.7% kull wieħed).
English: INFORMATION IN BRAILLE Viread 123 mg [Outer packaging only]
Maltese: Viread 123 mg [Pakkett ta' barra biss]
English: • HBV infected adolescents aged 12 to less than 18 years who weigh at least 35 kg.
Maltese: • Adolexxenti infettati bl-HBV li għandhom minn 12 sa inqas minn 18-il sena li jiżnu mill inqas 35 kg.
English: At week 72, 96% (27/28) of immune-active 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: F'ġimgħa 72, 96% (27/28) ta' pazjenti immuni-attivi (DNA tal-HBV ta' ≥ 105 kopji/ml, ALT fis-serum ta' > 1.5 × ULN) fil-grupp tat-trattament ta' tenofovir disoproxil u 0% (0/32) talpazjenti fil-grupp tal-plaċebo kellhom DNA tal-HBV ta' < 400 kopja/ml.
English: The adverse reactions observed with continued treatment for 384 weeks were consistent with the safety profile of tenofovir disoproxil.
Maltese: 384 ġimgħa kienu konsistenti mal-profil tas-sigurtà ta' tenofovir disoproxil.
English: INFORMATION IN BRAILLE Viread granules [Outer packaging only]
Maltese: Viread granijiet [Pakkett ta' barra biss]
English: All adverse reactions are presented in Table 2.
Maltese: Irreazzjonijiet avversi kollha huma ppreżentati f'Tabella 2.
English: Viread 33 mg/g granules are also indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected adults for whom a solid dosage form is not appropriate.
Maltese: Viread 33 mg/g granijiet huma indikati wkoll flimkien ma' prodotti mediċinali oħra antiretrovirali għat-trattament ta' adulti infettati b'HIV-1 li għalihom forma ta' dożaġġ solidu mhijiex adattata.
English: The antiviral response to tenofovir disoproxil was durable through 48 weeks (DAVG48 was -0.57 log10 copies/ml, proportion of patients with HIV-1 RNA below 400 or 50 copies/ml was 41% and 18% respectively).
Maltese: (DAVG48 kien ta' -0.57 log10 kopja/ml, il-proporzjon ta' pazjenti b'HIV-1 RNA taħt 400 jew 50 kopja/ml kien ta' 41% u 18% rispettivament).
English: Approximately 1% of tenofovir disoproxil-treated adult patients discontinued treatment due to the gastrointestinal events.
Maltese: Madwar 1% tal-pazjenti adulti li ħadu t trattament b'tenofovir disoproxil ma komplewx it-trattament minħabba l-effetti gastro-intestinali.
English: Mannitol may have a mild laxative effect.
Maltese: Mannitol jista' jkollu effett lassattiv ħafif.
English: INFORMATION IN BRAILLE Viread 204 mg [Outer packaging only]
Maltese: Viread 204 mg [Pakkett ta' barra biss]
English: Viread 245 mg film-coated tablets Tenofovir disoproxil
Maltese: Viread 245 mg pilloli miksija b'rita Tenofovir disoproxil
English: Viread contains lactose
Maltese: Viread fih lactose
English: Viread 33 mg/g granules are only suitable for:
Maltese: Viread 33 mg/g granijiet huma adatti biss għal:
English: The average change from baseline for HIV-1 RNA and CD4 count at 48 weeks of treatment was similar in both treatment groups (-3.09 and -3.09 log10 copies/ml; +169 and 167 cells/mm3 in the tenofovir disoproxil 245 mg and stavudine groups, respectively).
Maltese: Il-bidla medja tal-linja bażi għal HIV-1 RNA u l-għadd ta' CD4 fi 48 ġimgħa ta' trattament kienu simili fiż-żewġ gruppi li ħadu t-trattament (-3.09 u -3.09 log10 kopja/ml; +169 u 167 ċellula/mm3 filgruppi ta' 245 mg tenofovir disoproxil u stavudine, rispettivament).
English: Cmin: N/A Velpatasvir:
Maltese: Sofosbuvir/Velpatasvir
English: The mean (%CV) tenofovir Cmax and AUC0-∞ values were 223 (34.8%) ng/ml and 2,050 (50.8%) ng·h/ml, respectively, in normal subjects compared with 289 (46.0%) ng/ml and 2,310 (43.5%) ng·h/ml in subjects with moderate hepatic impairment, and 305 (24.8%) ng/ml and 2,740 (44.0%) ng·h/ml in subjects with severe hepatic impairment.
Maltese: AUC0-∞ ta' tenofovir kienu ta' 223 (34.8%) ng/ml u 2,050 (50.8%) ng·h/ml rispettivament, f'individwi normali, meta pparagunata ma' 289 (46.0%) ng/ml u 2,310 (43.5%) ng·h/ml f'individwi b'indeboliment tal-fwied moderat, u 305 (24.8%) ng/ml u 2,740 (44.0%) ng·h/ml f'individwi b'indeboliment tal-fwied sever.
English: Viruses containing the rtA181T mutation remained susceptible to tenofovir with EC50 values 1.5-fold that of wild-type virus.
Maltese: Viruses li kien fihom il-mutazzjoni rtA181T baqgħu sensittivi għal tenofovir b'valuri EC50 li kienu 1.5 drabi iżjed minn dik ta' l-istrejn naturali tal-virus.
English: Croscarmellose sodium Lactose monohydrate Magnesium stearate (E572) Microcrystalline cellulose (E460) Starch pregelatinised
Maltese: Microcrystalline cellulose (E460) Starch pregelatinised
English: Tenofovir disoproxil Renal and urinary disorders: Uncommon:
Maltese: Tenofovir disoproxil Disturbi muskolu-skeletriċi u tat-tessuti konnetivi:
English: • who weigh from 17 kg to less than 22 kg
Maltese: • li jiżnu minn 17 kg sa inqas minn 22 kg
English: Experience beyond 48 weeks in study GS-US-174-0108
Maltese: Esperjenza wara 48 ġimgħa fi studju GS-US-174-0108
English: Viread 245 mg film-coated tablets are indicated for the treatment of chronic hepatitis B in adolescents 12 to < 18 years of age with:
Maltese: Viread 245 mg pilloli miksija b'rita huma indikati għat-trattament ta' epatite B kronika f'adolexxenti li jkollhom minn 12 sa < 18-il sena b':
English: (%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: 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, moderat u sever.
English: Sofosbuvir/Velpatasvir (400 mg/100 mg q.d.)
Maltese: Sofosbuvir/Velpatasvir (400 mg/100 mg q.d.) + Raltegravir
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-1 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: HIV-1 and hepatitis B: In patients receiving tenofovir disoproxil, rare events of renal impairment, renal failure and uncommon events of proximal renal tubulopathy (including Fanconi syndrome) sometimes leading to bone abnormalities (infrequently contributing to fractures) have been reported.
Maltese: HIV-1 u epatite B: F'pazjenti li jkunu qed jirċievu tenofovir disoproxil, avvenimenti rari ta' indeboliment renali, kollass renali u avvenimenti mhux komuni ta' tubulopatija renali prossimali
English: Paired baseline and week 240 liver biopsy data were available for 331/489 patients who remained in studies GS-US-174-0102 and GS-US-174-0103 at week 240 (see Table 7 below).
Maltese: Dejta akkoppjata fil-linja bażi u bijopsija tal-fwied f'ġimgħa 240 kienet disponibbli għal 331/489 pazjenti li baqgħu fi studji GS-US-174-0102 u GS-US-174-0103 f'ġimgħa 240 (ara Tabella 7 hawn taħt).
English: • who weigh from 22 kg to less than 28 kg
Maltese: • li jiżnu minn 22 kg sa inqas minn 28 kg
English: Tenofovir is a nucleotide reverse transcriptase inhibitor, generally known as an NRTI and works by interfering with the normal working of an enzyme (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 ta' enzima (fl-HIV reverse transcriptase, fl-epatite B DNA polymerase) li huma essenzjali biex il-viruses jirriproduċu lilhom infushom.
English: Response to treatment with tenofovir disoproxil was comparable in nucleos(t)ide-naïve (n = 20) and nucleos(t)ideexperienced (n = 32) patients, including lamivudine-resistant patients (n = 6).
Maltese: Ir-rispons għat-trattament 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: Each tablet contains 137 mg lactose (as monohydrate).
Maltese: Eċċipjent b'effett magħruf Kull pillola fiha 137 mg ta' lactose (bħala monohydrate).
English: A statistically significant difference in favour of tenofovir disoproxil 245 mg was seen in the time-weighted average change from baseline at week 24 (DAVG24) for CD4 count (+13 cells/mm3 for tenofovir disoproxil 245 mg versus -11 cells/mm3 for placebo,
Maltese: Differenza sinifikanti fl-istatistika favur 245 mg tenofovir disoproxil dehret fil-bidla medja imkejla fuq ħin minn linja bażi f'Ġimgħa 24 (DAVG24) għall-għadd ta' CD4 (+13 ċelluli/mm3 għal 245 mg tenofovir disoproxil kontra -11 ċelluli/mm3 għall-plaċebo,
English: Table 9: Bone Mineral Density Evaluation at Baseline, Week 72 and 192
Maltese: Tabella 9: Evalwazzjoni tad-Densità tal-Minerali tal-Għadam fil-Linja Bażi, Ġimgħat 72 u 192 Linja Bażi
English: Cumulatively, there were 4 patients who experienced a viremic episode (HBV DNA>400 copies/ml) at their last timepoint on TDF.
Maltese: Kumulattivament, kien hemm 4 pazjenti li kellhom episodju viremiku (DNA tal-HBV ta' > 400 kopja/ml) fl-aħħar punt ta' żmien tagħhom fuq TDF.
English: Viread 163 mg film-coated tablets contain lactose monohydrate.
Maltese: Viread 163 mg pilloli miksija b'rita fihom lactose monohydrate.
English: In general, treatment responses to tenofovir disoproxil were similar for genotypes A, B, C and E [75-100% of subjects achieved HBV DNA < 400 copies/mL (69 IU/mL) at Week 48] with a lower response rate in subjects with genotype D infection (55%).
Maltese: B'mod ġenerali, ir-risponsi għat-trattament għal tenofovir disoproxil kienu simili għall-ġenotipi A, B, Ċ u E [75­100% tal-individwi kisbu DNA tal-HBV ta' < 400 kopja/mL (69 IU/mL) f'Ġimgħa 48]
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: 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
English: rhabdomyolysis
Maltese: Monitoraġġ renali
English: Experience in patients with HIV co-infection and prior lamivudine experience In a randomised, 48-week double-blind, controlled study of tenofovir disoproxil 245 mg in adult patients co-infected with HIV-1 and chronic hepatitis B with prior lamivudine experience (study ACTG 5127), the mean serum HBV DNA levels at baseline in patients randomised to the tenofovir arm were 9.45 log10 copies/ml (n = 27).
Maltese: Fi studju randomised li dam 48 ġimgħa, ikkontrollat u double blind, dwar tenofovir disoproxil 245 mg f'pazjenti adulti koinfettati bl-HIV-1 u bl-epatite B kronika li fil-passat ingħataw lamivudine (studju ACTG 5127), il-medja tal-livelli tad-DNA tal-HBV fis-serum fil-linja bażi f'pazjenti randomised għall-parti tal-istudju b'tenofovir kienet ta' 9.45 log10 kopji/ml (n = 27).
English: PHARMACEUTICAL FORM Granules.
Maltese: Pneumocystis jirovecii.
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 tal-pazjenti li fil-passat ingħataw in nukleosides u 69% tal-pazjenti li qatt ma ngħataw nukleosides irnexxielhom jiksbu rispons sħiħ għattrattament; 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: Each tablet contains 164 mg lactose (as monohydrate).
Maltese: Eċċipjent b'effett magħruf Kull pillola fiha 164 mg ta' lactose (bħala monohydrate).
English: At 144 weeks of treatment, the average change from baseline remained similar in both treatment groups (-3.07 and -3.03 log10 copies/ml; +263 and +283 cells/mm3 in the tenofovir disoproxil 245 mg and stavudine groups, respectively).
Maltese: u -3.03 log10 kopja/ml; +263 u +283 ċellula/mm3 fil-gruppi ta' 245 mg tenofovir disoproxil u stavudine, rispettivament).