FrancophonIA/ELRC3.0 huggingface dataset:
English: As a general rule, it is recommended that HIV and HBV infected women do not breast-feed their infants in order to avoid transmission of HIV and HBV to the infant.
Maltese: Bħala regola ġenerali, huwa rakkomandat li nisa infettati bl-HIV u bl-HBV ma jreddgħux lit-trabi tagħhom sabiex jevitaw li jgħaddu HIV u HBV lit-tarbija.
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% talpazjenti li kienu ttrattati b'tenofovir disoproxil.
English: 3, 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/mm 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: Assessment of adverse reactions is based on one randomised study (study GS-US-174-0115) in 106 adolescent patients (12 to < 18 years of age) with chronic hepatitis B receiving treatment with tenofovir disoproxil 245 mg (n = 52) or placebo (n = 54) for 72 weeks.
Maltese: L-istima ta' reazzjonijiet avversi hi bbażata fuq studju wieħed randomised (studju GS-US-174-0115) f'106 pazjenti adolexxenti (minn età ta' 12 sa < 18-il sena) b'epatite B kronika li kienu qed jirċievu kura b'tenofovir disoproxil 245 mg (n = 52) jew plaċebo (n = 54) għal 72 ġimgħa.
English: Ledipasvir/Sofosbuvir (90 mg/400 mg q.d.)
Maltese: Mediċini antivirali kontra l-virus tal-epatite C Ledipasvir/Sofosbuvir (90 mg/400 mg q.d.) +
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: In studies GS-US-174-0102 and GS-US-174-0103, after receiving double-blind treatment for 48 weeks (either tenofovir disoproxil 245 mg or adefovir dipivoxil 10 mg), patients rolled over with no interruption in treatment to open-label tenofovir disoproxil.
Maltese: GS-US-174-0102 u GS-US-174-0103, wara li rċivew kura double-blind għal 48 ġimgħa (jew tenofovir disoproxil 245 mg jew adefovir dipivoxil 10 mg), il-pazjenti li qalbu mingħajr l-ebda interruzzjoni fil-kura għal tenofovir disoproxil open-label.
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 ttwaqqif ta' tenofovir disoproxil (ara sezzjoni 4.4).
English: Moderate renal impairment (creatinine clearance 30-49 ml/min) Since administration of a lower dose with the 245 mg tablet is not possible, prolonged dose intervals using the 245 mg film-coated tablets may be used.
Maltese: Indeboliment renali moderat (tneħħija tal-krejatinina ta' 30-49 ml/min) Billi l-għoti ta' doża aktar baxxa mil-pillola ta' 245 mg mhijiex possibbli, l-intervalli mtawla tad-doża fit-tul bl-użu tal-pilloli miksija b'rita ta' 245 mg jistgħu jintużaw.
English: The safety of tenofovir disoproxil when used with sofosbuvir/velpatasvir/vox ilaprevir and a pharmacokinetic enhancer (e.g. ritonavir or cobicistat) has not been established.
Maltese: Is-sigurtà ta' tenofovir disoproxil meta użat ma' sofosbuvir/velpatasvir/voxilaprevir u potenzjatur farmakokinetiku (eż. ritonavir jew cobicistat) għadha ma ġietx stabbilita.
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 din it-terapija qabel ġew ippruvati fi provi fuq medda ta' 48 ġimgħa u 144 ġimgħa rispettivament.
English: Tolerability failure (permanent discontinuation of study drug due to a treatment emergent AE)
Maltese: Nuqqas ta' tollerabilità (twaqqif permanenti talmediċina tal-istudju minħabba li jiżviluppaw avvenimenti avversi (AE) mill-kura) n (%)
English: HIV-1 infection
Maltese: Infezzjoni bl-HIV-1
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: 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: Eight (2%) tenofovir disoproxil 245 mg treated patients developed the K65R mutation within the first 48 weeks.
Maltese: Tmien pazjenti (2%) li ħadu t-trattament b'245 mg tenofovir disoproxil 245 mg żviluppaw il-mutazzjoni K65R matul l-ewwel 48 ġimgħa.
English: These renal transport proteins may be responsible for tubular secretion and in part, renal elimination of tenofovir and cidofovir.
Maltese: Dawn il-proteini tat-trasportatur renali jistgħu jkunu responsabbli għas-sekrezzjoni tubulari u parzjalment, għall-eliminazzjoni ta' tenofovir u cidofovir mill-kliewi.
English: Co-administration of tenofovir disoproxil with ledipasvir/sofosbuvir, sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/voxilaprevir has been shown to increase plasma concentrations of tenofovir, especially when used together with an HIV regimen containing tenofovir disoproxil and a pharmacokinetic enhancer (ritonavir or cobicistat).
Maltese: Użu ta' ċerti sustanzi antivirali kontra l-virus tal-epatite Ċ L-għoti fl-istess ħin ta' tenofovir disoproxil ma' ledipasvir/sofosbuvir, sofosbuvir/velpatasvir jew sofosbuvir/velpatasvir/voxilaprevir ġie muri li jżid il-konċentrazzjonijiet ta' tenofovir fil-plażma, speċjalment meta jintuża flimkien ma' kors għal HIV li fih tenofovir disoproxil u potenzjatur farmaċewtiku (ritonavir jew cobicistat).
English: Renally eliminated medicinal products
Maltese: TAL-PRODOTT MEDIĊINALI
English: h 48 weeks of double-blind adefovir dipivoxil followed by 144 weeks open-label tenofovir disoproxil.
Maltese: h 48 ġimgħa ta' tenofovir disoproxil double-blind segwiti minn 144 ġimgħa open-label.
English: Tenofovir: AUC: ↔ Cmax: ↑ 25% Cmin: ↔
Maltese: AUC: ↔ Cmax: ↑ 25% Cmin: ↔
English: + Raltegravir (400 mg b.i.d) + Emtricitabine/Tenofovir disoproxil (200 mg/245 mg q.d.)
Maltese: + Darunavir (800 mg q.d.) + Ritonavir (100 mg q.d.) + Emtricitabine/Tenofovir disoproxil (200 mg/245 mg q.d.)
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: Median HBV DNA reduction from baseline c
Maltese: Tnaqqis medjan fidDNA tal-HBV millinja bażi c
English: Two subjects randomised to tenofovir disoproxil experienced HBsAg loss by Week 240, but not seroconversion to anti-HBs.
Maltese: Żewġ individwi li ġie randomised biex jirċievu tenofovir disoproxi kellhom telf ta' HBsAg sa ġimgħa 240, iżda mhux serokonverżjoni għal anti-HBs.
English: BGP Products UAB Tel: + 370 5 205 1288
Maltese: Tel: +370 5 205 1288
English: NRTIs
Maltese: FOLJA
English: Whole body BMD at least 6% decreaseb
Maltese: Tnaqqis tal-inqas ta' 6% fil-BMD tal-ispina lumbarib
English: • HIV-1 infected adolescents aged 12 to less than 18 years who weigh at least 35 kg and who have already been treated with other HIV medicines which are no longer fully effective due to development of resistance, or have caused side effects
Maltese: • Adolexxenti infettati bl-HIV-1 li għandhom minn 12 sa inqas minn 18-il sena li jiżnu millinqas 35 kg u li diġà ġew ikkurati fil-passat b'mediċini oħra kontra l-HIV li m'għadhomx aktar effettivi għal kollox minħabba l-iżvilupp ta' reżistenza, jew li kkawżaw effetti sekondarji
English: e 48 weeks of double-blind tenofovir disoproxil followed by 96 weeks open-label.
Maltese: e 48 ġimgħa ta' tenofovir disoproxil double-blind segwiti minn 96 ġimgħa open-label.
English: In patients with end-stage renal disease (ESRD) (CrCl < 10 ml/min) requiring haemodialysis, between dialysis tenofovir concentrations substantially increased over 48 hours achieving a mean Cmax of 1,032 ng/ml and a mean AUC0-48h of 42,857 ng·h/ml.
Maltese: F'pazjenti b'mard renali fl-aħħar stadju (ESRD) (CrCl < 10 ml/min) li jeħtieġu d-dijaliżi tad-demm, bejn is-sessjonijiet tad-dijaliżi, il-konċentrazzjonijiet ta' tenofovir żdiedu sostanzjalment fi żmien 48 siegħa u laħqu medja ta' Cmax ta' 1,032 ng/ml u medja ta' AUC0-48h ta' 42,857 ng·h/ml.
English: Emtricitabine: AUC: ↔ Cmax: ↔ Cmin: ↔
Maltese: AUC: ↔ Cmax: ↔ Cmin: ↔
English: Therapy should be initiated by a physician experienced in the management of HIV infection and/or treatment of chronic hepatitis B.
Maltese: It-terapija għandha tinbeda minn tabib b'esperjenza fl-immaniġġjar ta' infezzjoni HIV u/jew trattament ta' epatite B kronika.
English: HIV patients aged 12 to < 18 years educational brochure HBV patients aged 12 to < 18 years educational brochure
Maltese: • Fuljett edukattiv dwar HBV għal pazjenti minn 12 sa <18
English: Four hundred and twenty-six HBeAg negative (GS-US-174-0102, n = 250) and HBeAg positive (GS-US-174-0103, n = 176) patients initially randomised to double-blind tenofovir disoproxil treatment and then switched to open-label tenofovir disoproxil treatment were evaluated for genotypic changes in HBV polymerase from baseline.
Maltese: Erba' mija u sitta u għoxrin pazjent li kienu HBeAg negattivi (GS-US-174-0102, n = 250) u HBeAg pożittivi (GS-US-174-0103, n = 176) li kienu inizjalment randomised għal kura double-blind b'tenofovir disoproxil u mbagħad qalbu għal kura b'tenofovir disoproxil open-label kienu evalwati għal tibdil ġenotipiku fil-polymerase tal-HBV mil-linja bażi.
English: In a paediatric study (GS-US-174-0115), 52 patients (including 6 patients with lamivudine resistance mutations at baseline) initially received blinded tenofovir disoproxil for up to 72 weeks and then 51/52 patients switched to open-label tenofovir disoproxil (tenofovir disoproxil-tenofovir disoproxil group).
Maltese: Fi studju pedjatriku (GS-US-174-0115), 52 pazjent (li jinkludu 6 pazjenti b'mutazzjonijiet reżistenti għal lamivudine fil-linja bażi) fil-bidu rċivew tenofovir disoproxil blinded għal mhux aktar minn 72 ġimgħa u mbagħad 51/52 pazjent qalbu għal tenofovir disoproxil open-label (il-grupp tenofovir disoproxil-tenofovir disoproxil).
English: Your doctor will carefully consider whether to treat you with combinations of tenofovir and didanosine.
Maltese: Ittabib tiegħek ikollu jikkunsidra b'attenzjoni jekk jagħtikx trattament mħallat ta' tenofovir u didanosine.
English: 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: Increased plasma concentrations of tenofovir resulting from coadministration of tenofovir disoproxil, sofosbuvir/velpatasvir/vox ilaprevir and darunavir/ritonavir may increase adverse reactions related to tenofovir disoproxil, including renal disorders.
Maltese: Żieda fil-konċentrazzjonijiet ta' tenofovir fil-plażma li tirriżulta mill-għoti fl-istess ħin ta' tenofovir disoproxil, sofosbuvir/velpatasvir/voxilaprevir u darunavir/ritonavir tista' żżid irreazzjonijiet avversi relatati ma' tenofovir disoproxil, li jinkludu disturbi renali.
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: m 48 weeks of double-blind adefovir dipivoxil followed by 240 weeks open-label tenofovir disoproxil.
Maltese: l 48 ġimgħa ta' tenofovir disoproxil double-blind segwiti minn 240 ġimgħa open-label.
English: No data are available on which to make a dose recommendation for patients over the age of 65 years (see section 4.4).
Maltese: M'hemmx informazzjoni fuqhiex wieħed jista' jagħti rakkomandazzjoni għall-pazjenti ta' 'l fuq minn 65 sena (ara sezzjoni 4.4).
English: Tenofovir disoproxil is a water soluble ester prodrug which is rapidly converted in vivo to tenofovir and formaldehyde.
Maltese: Tenofovir disoproxil huwa prodrug ta' l-ester li jinħall fl-ilma li jinbidel malajr in vivo għal tenofovir u formaldehyde.
English: Forty-two percent (19/45) of patients had at least 6 months of prior lamivudine experience, 20% (9/45) of patients had prior adefovir dipivoxil experience and 9 of 45 patients (20%) had lamivudine and/or adefovir dipivoxil resistance mutations at baseline.
Maltese: Tnejn u erbgħin fil-mija (19/45) tal-pazjenti kellhom mill-inqas 6 xhur li fihom fil-passat ingħataw lamivudine, 20% (9/45) tal-pazjenti ngħataw adefovir dipivoxil fil-passat u 9 minn 45 pazjent (20%) kellhom mutazzjonijiet assoċjati ma' reżistenza għal lamivudine u/jew adefovir dipivoxil fil-linja bażi.
English: Other interactions
Maltese: Attività antivirali
English: Each film-coated tablet contains 245 mg of tenofovir disoproxil (as maleate).
Maltese: Kull pillola miksija b'rita fiha 245 mg ta' tenofovir disoproxil (bħala maleate).
English: fatigue
Maltese: Tqala
English: In the tenofovir disoproxil treatment arm, 7% of patients discontinued treatment due to an adverse event; 9% of patients experienced a confirmed increase in serum creatinine of ≥ 0.5 mg/dl or confirmed serum phosphate of < 2 mg/dl through week 48; there were no statistically significant differences between the combined tenofovir-containing arms and the entecavir arm. After 168 weeks, 16% (7/45) of the tenofovir disoproxil group, 4% (2/45) of the emtricitabine plus tenofovir disoproxil group, and 14% (3/22) of the entecavir group experienced tolerability failure.
Maltese: Fil-fergħa tal-istudju dwar tenofovir disoproxil, 7% tal-pazjenti waqqfu l-kura minħabba avveniment avvers; 9% tal-pazjenti kellhom żieda kkonfermata fil-krejatinina fis-serum ta' ≥ 0.5 mg/dl jew phosphate fis-serum ikkonfermat ta' < 2 mg/dl sa ġimgħa 48; ma kien hemm l-ebda differenzi statistikament sinifikanti bejn il-fergħat tal-istudju dwar tenofovir kombinat u l-fergħa tal-istudju dwar entecavir.
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: 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 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: If you take more Tenofovir disoproxil Mylan than you should If you accidentally take too many Tenofovir disoproxil Mylan tablets, you may be at increased risk of experiencing possible side effects with this medicine (see section 4, Possible side effects).
Maltese: Jekk tieħu Tenofovir disoproxil Mylan aktar milli suppost Jekk aċċidentalment tieħu pilloli żejda ta' Tenofovir disoproxil Mylan, tista' tkun f'riskju miżjud li jkollok effetti sekondarji possibbli b'din il-mediċina (ara sezzjoni 4, Effetti sekondarji possibbli).
English: Co-administration of tenofovir disoproxil and didanosine is not recommended (see section 4.4 and Table 1).
Maltese: L-għoti flimkien ta' tenofovir disoproxil u didanosine mhuwiex rakkomandat (ara sezzjoni 4.4 u Tabella 1).
English: In HIV-1 infected children, the BMD Z-scores observed in subjects who switched to tenofovir disoproxil were lower than those observed in subjects who remained on their stavudine- or zidovudine-containing regimen (see sections 4.4 and 5.1).
Maltese: Fi tfal infettati b'HIV-1, il-punteġġi Ż tal-BMD osservati f'individwi li qalbu għal tenofovir disoproxil kienu iktar baxxi minn dawk osservati f'individwi li baqgħu fuq il-kors tagħhom li kien fih stavudine jew zidovudine (ara sezzjonijiet 4.4 u 5.1).
English: 48 weeks of double-blind adefovir dipivoxil followed by 192 weeks open-label tenofovir disoproxil.
Maltese: i 48 ġimgħa ta' tenofovir disoproxil double-blind segwiti minn 192 ġimgħa open-label.
English: Tenofovir disoproxil 245 mg film-coated tablets are also indicated for the treatment of HIV-1 infected adolescents, with NRTI resistance or toxicities precluding the use of first line agents, aged 12 to < 18 years.
Maltese: Tenofovir disoproxil 245 mg pilloli miksija b'rita huma indikati wkoll għat-trattament ta' adolexxenti infettati b'HIV-1 b'reżistenza għal NRTI jew tossiċitajiet li jipprekludu l-użu ta' prodotti mediċinali primarji,li jkollhom minn 12 sa < 18-il sena.
English: If you forget to take Tenofovir disoproxil Mylan It is important not to miss a dose of Tenofovir disoproxil Mylan.
Maltese: Huwa importanti li ma tinsa tieħu ebda doża ta' Tenofovir disoproxil Mylan.
English: Mean changes at week 48 (end of double-blind phase) were -0.215 and -0.165 in lumbar spine BMD Z-score, and -0.254 and -0.179 in total body BMD Z-score for the tenofovir disoproxil and placebo groups, respectively.
Maltese: 215 u -0.165 fil-punteġġ Ż tal-BMD tal-parti t'isfel tas-sinsla, u ta' -0.254 u -0.
English: Whole body mean (SD) BMD Z-score a
Maltese: Medja (SD) talpunteġġ Z talBMD tal-ġisem kollu a
English: Lumbar spine BMD mean % increase
Maltese: Żieda % fil-medja talBMD tal-ispina lumbari
English: If tenofovir disoproxil is discontinued in patients with chronic hepatitis B with or without HIV coinfection, these patients should be closely monitored for evidence of exacerbation of hepatitis (see section 4.4).
Maltese: Jekk tenofovir disoproxil jitwaqqaf f'pazjenti b'epatite B kronika infettati jew mhux infettati bl-HIV, dawn il-pazjenti għandhom ikunu immonitorjati mill-qrib għal evidenza jekk l-epatite tmur għallagħar (ara sezzjoni 4.4).
English: For dosage see section 3, How to take Tenofovir disoproxil Mylan.
Maltese: Għad-dożaġġ ara sezzjoni 3, Kif gћandek tieћu Tenofovir disoproxil Mylan.
English: Renal and bone effects in paediatric population
Maltese: Effetti renali u fuq l-għadam fil-popolazzjoni adulta Effetti renali
English: Based on the results of in vitro experiments and the known elimination pathway of tenofovir, the potential for CYP450-mediated interactions involving tenofovir with other medicinal products is low.
Maltese: Ibbażat fuq riżultati ta' esperimenti in vitro u r-rotta ta' l-eliminazzjoni magħrufa ta' tenofovir, ilpotenzjal għall-interazzjonijiet medjata minn CYP450 li tinvolvi tenofovir ma' prodotti mediċiali oħra hija baxxa.
English: Tenofovir disoproxil Mylan 245 mg tablets are suitable for:
Maltese: Il-pilloli Tenofovir disoproxil Mylan 245 mg huma adatti għal:
English: m
Maltese: MA
English: Tenofovir diphosphate has an intracellular half-life of 10 hours in activated and 50 hours in resting peripheral blood mononuclear cells (PBMCs).
Maltese: Il-ħin biex illivell ta' tenofovir diphosphate jonqos bin-nofs huwa ta' 10 sigħat ġewwa ċ-ċellula f'celluli mononukleari tad-demm periferali (peripheral blood mononuclear cells, PBMCs) attivati u 50 siegħa f'dawk li qed jistrieħu.
English: 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.
Maltese: 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: BLISTER
Maltese: sturdament
English: Both treatments produced similar results with regard to histological response (defined as Knodell necroinflammatory score improvement of at least 2 points without worsening in Knodell fibrosis) at week 48 (see Table 3 below).
Maltese: Iż-żewġ trattamenti pproduċew riżultati simili fir-rigward ta' rispons istoloġiku (definit bħala titjib fil-punteġġ nekroinfjammatorju ta' Knodell ta' mill-inqas 2 punti mingħajr ma marret għall-agħar il-fibrożi ta' Knodell) f'ġimgħa 48 (ara Tabella 3 hawn taħt).
English: As tenofovir disoproxil may cause renal damage monitoring of renal function is recommended (see sections 4.4 and 4.8 Summary of the safety profile).
Maltese: Billi tenofovir disoproxil jista' jikkawża ħsara renali, il-monitoraġġ tal-funzjoni renali hu rakkomandat (ara sezzjonijiet 4.4 u 4.8 Sommarju tal-profil tas-sigurtà).
English: The pharmacokinetics of tenofovir were independent of tenofovir disoproxil dose over the dose range 75 to 600 mg and were not affected by repeated dosing at any dose level.
Maltese: Il-farmakokinetiċi ta' tenofovir independenti mid-doża ta' tenofovir disoproxil kontra l-medda taddożaġġ ta' 75 sa 600 mg u ma kienux affettwati b'doża ripetuta f'xi livell ta' dożaġġ.
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 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
English: asthenia
Maltese: pankreatite
English: Osteonecrosis
Maltese: anġjoedema
English: In non-proliferating human peripheral blood mononuclear cells (PBMCs) the half-life of tenofovir diphosphate was found to be approximately 50 hours, whereas the half-life in phytohaemagglutininstimulated PBMCs was found to be approximately 10 hours.
Maltese: F'ċelluli mononukleari umani tad-demm periferali mhux proliferattivi (PBMCs) il-ħin tenofovir diphosphate jonqos bin-nofs instab li huwa ta' madwar 50 siegħa, filwaqt li l-ħin biex il-livell ta' PBMCs stimulati minn phytohaemagglutinin jonqos bin-nofs instab li huwa ta' madwar 10 sigħat.
English: The length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this disease.
Maltese: It-tul tat-terapija antiretrovirali kombinata, l-użu ta' kortikosterojdi, konsum tal-alkoħol, immunosoppressjoni severa, indiċi ogħla tal-piż tal-ġisem, fost l-oħrajn, jistgħu jkunu xi wħud mill-ħafna fatturi ta' riskju li wieħed jista' jiżviluppa din il-marda.
English: The safety and efficacy of tenofovir disoproxil in children with chronic hepatitis B aged 2 to < 12 years or weighing < 35 kg have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' tenofovir disoproxil fi tfal infettati b'epatite B kronika li għandhom minn sentejn sa < 12-il sena jew li jiżnu < 35 kg ma ġewx determinati.
English: hypophosphataemia
Maltese: aċidożi lattika