FrancophonIA/ELRC3.0 huggingface dataset:
English: Histological improvement was seen regardless of baseline demographic and hepatitis B characteristics, including prior interferon-alpha therapy.
Maltese: Kien hemm titjib istoloġiku, kienu x'kienu l-karatteristiċi tal-linja bażi demografika u epatite B, fosthom terapija preċedenti bl-interferon-alpha.
English: Treatment with 10 mg adefovir dipivoxil showed similar efficacy regardless of the patterns of lamivudine-resistant HBV DNA polymerase mutations at baseline.
Maltese: Ittrattament b'10 mg ta' adefovir dipivoxil wera effikaċja simili minkejja l-proċessi ta' mutazzjoniet ta' polimerase tad-DNA tal-HBV reżistenti għal lamivudine fil-linja bażi.
English: Each bottle contains 30 tablets, silica gel desiccant and fibre packing material.
Maltese: Kull flixkun fih 30 pillola, ġel dessikant tas-silika u materjal ta' l-ippakkjar tal-fibra.
English: Clinical resistance in patients receiving adefovir dipivoxil as monotherapy and in combination with lamivudine: In several clinical studies (HBeAg positive, HBeAg negative, pre- and post-liver transplantation with lamivudine-resistant HBV and lamivudine-resistant HBV co-infected with HIV patients), genotypic analyses were conducted on HBV isolates from 379 of a total of 629 patients, treated with adefovir dipivoxil for 48 weeks.
Maltese: F'diversi studji kliniċi, (pazjenti pożittivi għal HBeAg, pazjenti negattivi għal HBeAg, pazjenti ta' qabel u ta' wara t-trapjant tal-fwied b'HBV reżistenti għal lamivudine u pazjenti b'HBV reżistenti għal lamivudine li huma infettati ukoll bl-HIV), saru analiżi ġenotipiċi fuq iżolati ta' HBV fuq 379 minn total ta' 629 pazjenti, ittrattati b'adefovir dipivoxil għal 48 ġimgħa.
English: Experience in patients with compensated liver disease: In two placebo-controlled studies (total n=522) in HBeAg positive or in HBeAg negative chronic hepatitis B patients with compensated liver disease, significantly more patients (p < 0.001) in the 10 mg adefovir dipivoxil groups (53 and 64 %,
Maltese: F'żewġ studji kkontrollati bil-plaċebo (total n=522) f'pazjenti b'epatite B kronika ta' HBeAg pożittiva jew HBeAg negattiva b'mard tal-fwied kumpensat, numru sinifikanti akbar ta' pazjenti (p < 0.001) fil-gruppi ta' 10 mg ta' adefovir dipivoxil (53 u 64%, rispettivament) kellhom titjib istoloġiku mil-linja bażi fil-Ġimgħa 48 minn dawk fil-gruppi plaċebo (25 u 33%).
English: Elderly: No data are available to support a dose recommendation for patients over the age of 65 years (see section 4.4).
Maltese: M'hemmx informazzjoni biex tissapportja rakkomandazzjoni ta' doża għall-pazjenti ta' età ta' 'l fuq minn 65 sena (ara sezzjoni 4.4).
English: In that case, the limited data available suggest that for patients with creatinine clearance between 10 and 29 ml/min, adefovir dipivoxil (one 10 mg tablet) may be administered every 72 hours; for haemodialysis patients, adefovir dipivoxil (one 10 mg tablet) may be administered every 7 days following 12 hours continuous dialysis (or 3 dialysis sessions, each of 4 hours duration).
Maltese: F'dak il-każ, l-informazzjoni limitata disponibbli tissuġġerixxi li għal pazjenti bi tneħħija tal-krejatinina ta' bejn 10 u 29 ml/min, adefovir dipivoxil (pillola waħda ta' 10 mg) jista' jingħata kull 72 siegħa; għall-pazjenti fuq dijaliżi tad-demm, adefovir dipivoxil (pillola waħda ta' 10 mg) jista' jingħata kull 7 ijiem wara 12-il siegħa ta' dijaliżi kontinwa (jew 3 seduti ta' dijaliżi, kull waħda ta' 4 sigħat).
English: Repeated dosing of adefovir dipivoxil 10 mg daily did not influence the pharmacokinetics of adefovir.
Maltese: Dożaġġ ripetut ta' 10 mg ta' adefovir dipivoxil kuljum ma influwenzax il-farmakokinetika ta' adefovir.
English: On the basis of these data, the frequency of these adverse drug reactions is calculated to be 0.4% corresponding to the frequency category uncommon.
Maltese: Abbażi ta' din id-data, il-frekwenza ta' dawn ir-reazzjonijiet avversi għall-mediċina hija kkalkulata bħala 0.4% li tikkorrispondi għallkategorija tal-frekwenza mhux komuni.
English: Unimpaired
Maltese: Pożoloġija
English: Excipient(s) with known effect:
Maltese: Eċċipjent(i) b'effett magħruf:
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu
English: Patients with a confirmed increase in creatinine of ≥ 0.3 mg/dl by week 48 were at a statistically significant higher risk of a subsequent confirmed increase in creatinine of ≥ 0.5 mg/dl. Hypophosphatemia and a decrease in carnitine concentrations were reported each in 3 % of patients on extended treatment.
Maltese: Pazjenti b'żieda kkonfermata fil-krejatinina ta' ≥ 0.3 mg/dl sa ġimgħa 48 kienu f'riskju ogħla li kien statistikament sinifikanti, ta' żieda kkonfermata sussegwenti fil-krejatinina ta' ≥ 0.5 mg/dl.
English: Mechanism of action and pharmacodynamic effects: Adefovir dipivoxil is an oral prodrug of adefovir, an acyclic nucleotide phosphonate analogue of adenosine monophosphate, which is actively transported into mammalian cells where it is converted by host enzymes to adefovir diphosphate.
Maltese: Adefovir dipivoxil hu prodrug ta' adefovir li jittieħed mill-ħalq, acyclic nucleotide phosphonate analogue ta' adenosine monophosphate li jinġarr attivament fiċ-ċelluli tal-mammiferi fejn il-host enzymes jibdluh f'adefovir diphosphate.
English: Patients were all HBeAg positive and had median CD4 cell count of 441 cells/mm3 (no patient had CD4 count < 200 cells/mm3).
Maltese: Il-pazjenti kienu kollha HBeAg pożittivi u kellhom medjan ta' għadd taċċelluli CD4 ta' 441 ċelluli/mm3 (l-ebda pazjent ma kellu għadd ta' CD4 < 200 ċelluli/mm3).
English: The cumulative probabilities of developing these adefovir-associated resistance mutations in all patients treated with adefovir dipivoxil were 0 % at 48 weeks and approximately 2 %, 7 %, 14 % and 25 % after 96, 144, 192 and 240 weeks, respectively.
Maltese: Il-probabbiltajiet kumulattivi li dawn il-mutazzjonijiet assoċjati mar-reżistenza għal adefovir jiżviluppaw fil-pazjenti kollha ttrattati b'adefovir dipivoxil kienu ta' 0% wara 48 ġimgħa, u madwar 2%, 7%, 14% u 25% wara 96, 144, 192 u 240 ġimgħa, rispettivament.
English: See section 2 for more details.
Maltese: Ara sezzjoni 2 għal iktar dettalji.
English: Adefovir diphosphate inhibits viral polymerases by competing for direct binding with the natural substrate (deoxyadenosine triphosphate) and, after incorporation into viral DNA, causes DNA chain termination.
Maltese: Adefovir diphosphate jimpedixxi l-polimerases virali billi jikkompeti għat-twaħħil dirett mas-sottostrat naturali (deoxyadenosine triphosphate) u wara li jiġi inkorporat fid-DNA virali jikkawza t-terminazzjoni tal-katina tad-DNA.
English: In the study in HBeAg positive patients, HBeAg seroconversion (12 %) and HBeAg loss (24 %) was observed significantly more frequently in patients receiving 10 mg adefovir dipivoxil than in patients receiving placebo (6 % and 11 %, respectively) after 48 weeks of treatment.
Maltese: Fl-istudju f'pazjenti HBeAg pożittivi, serokonverżjoni ta' HBeAg (12%) u tnaqqis ta' HBeAg (24%) kienu osservati b'mod iżjed frekwenti sinifikanti f'pazjenti li kienu jieħdu 10 mg ta' adefovir dipivoxil milli f'pazjenti li kienu jieħdu l-plaċebo (6% u 11%, rispettivament) wara 48 ġimgħa ta' trattament.
English: Treatment with nucleoside analogues should be discontinued when rapidly elevating aminotransferase levels, progressive hepatomegaly or metabolic/lactic acidosis of unknown aetiology occur.
Maltese: It-trattament b'analogi tan-nukleosidi għandu jitwaqqaf meta l-livelli ta' aminotransferase jiżdiedu malajr, meta sseħħ epatomegalija progressiva jew aċidożi lattika/metabolika ta' etjoloġija mhux magħrufa.
English: common (≥ 1/100, < 1/10), uncommon (≥ 1/1000, < 1/100) or not known (identified through postmarketing safety surveillance and the frequency cannot be estimated from the available data).
Maltese: Il-frekwenzi huma deskritti bħala komuni ħafna (≥ 1/10), komuni (≥ 1/100, < 1/10), mhux komuni (≥ 1/1000, < 1/100) jew mhux magħrufa (identifikati permezz ta' sorveljanza tas-sigurtà wara t-tqegħid fis-suq u għall-frekwenza ma tistax tittieħed stima mid-data disponibbli).
English: Renal impairment: The mean (± SD) pharmacokinetic parameters of adefovir following administration of a single dose of 10 mg adefovir dipivoxil to patients with varying degrees of renal impairment are described in the table below:
Maltese: Il-parametri farmakokinetiċi medji (± SD) ta' adefovir wara l-għoti ta' doża waħda ta' 10 mg ta' adefovir dipivoxil lill-pazjenti b'rati varjabbli ta' indeboliment renali, huma deskritti fit-tabella t'hawn taħt:
English: With up to 3 years of exposure, no patients receiving both adefovir dipivoxil and lamivudine developed resistance to adefovir dipivoxil.
Maltese: Sa 3 snin ta' esponiment, ħadd mill-pazjenti li kienu qed jirċievu kemm adefovir dipivoxil kif ukoll lamivudine ma żviluppaw reżistenza għal adefovir dipivoxil.
English: Pharmacokinetic studies have not been conducted in the elderly.
Maltese: Ma sarux studji farmakokinetiċi fl-anzjani.
English: Adefovir induced chromosomal aberrations in the in vitro human peripheral blood lymphocyte assay without metabolic activation.
Maltese: Adefovir wassal għall-aberrazzjonijet kromożomali fl-analiżi in vitro tal-limfoċiti taddemm periferali tal-bniedem mingħajr attivazzjoni metabolika.
English: A clinical study in liver-transplant patients has shown that no pharmacokinetic interaction occurs when adefovir dipivoxil 10 mg once daily is administered concomitantly with tacrolimus, an immunosuppressant which is predominantly metabolised via the CYP450 system.
Maltese: Studju kliniku f'pazjenti li kellhom trapjant tal-fwied wera li ma sseħħ l-ebda interazzjoni farmakokinetika meta 10 mg ta' adefovir dipivoxil jingħataw darba kuljum flimkien ma' tacrolimus, immunosuppressant li hu fil-biċċa l-kbira tiegħu metabolat permezz tas-sistema CYP450.
English: In patients with compensated liver disease, the most frequently reported adverse reactions during 48 weeks of adefovir dipivoxil therapy were asthenia (13 %), headache (9 %), abdominal pain (9 %) and nausea (5 %).
Maltese: F'pazjenti b'mard tal-fwied kumpensat, l-aktar reazzjonijiet avversi li kienu rrappurtati b'mod frekwenti matul 48 ġimgħa ta' terapija b'adefovir dipivoxil kienu astenja (13%), uġigħ ta' ras (9%), uġigħ addominali (9%) u tqalligħ (5%).
English: Based on post-marketing data, long-term treatment with adefovir dipivoxil may lead to progressive alteration of renal function resulting in renal impairment (see section 4.4).
Maltese: Ibbażat fuq dejta ta' wara t-tqegħid fis-suq, kura fit-tul b'adefovir dipivoxil tista' twassal għal bidla progressiva fil-funzjoni renali li twassal għal indeboliment renali (ara sezzjoni 4.4).
English: Resistance: Resistance to adefovir dipivoxil (see section 5.1) can result in viral load rebound which may result in exacerbation of hepatitis B and, in the setting of diminished hepatic function, lead to liver decompensation and possible fatal outcome.
Maltese: Ir-reżistenza għal adefovir dipivoxil (ara sezzjoni 5.1) tista' tirriżulta f'viral load rebound li tista' tirriżulta fl-aggravament ta' epatite B u, fl-isfond ta' funzjoni epatika mnaqqsa, twassal għal dikumpensazzjoni epatika u għall-possibbiltà ta' riżultat fatali.
English: Experience in patients with compensated liver disease and lamivudine-resistant HBV: In a double-blind comparative study in chronic hepatitis B patients with lamivudine-resistant HBV (n=58), there was no median reduction in HBV DNA from baseline after 48 weeks of treatment with lamivudine.
Maltese: Fi studju komparat double-blind f'pazjenti b'epatite B kronika b'HBV reżistenti għal lamivudine (n=58), ma kienx hemm tnaqqis medjan fid-DNA tal-HBV mil-linja bażi wara 48 ġimgħa ta' trattament b'lamivudine.
English: After reviewing the description of the cases, 5 cases of possible proximal renal tubulopathy and/or Fanconi syndrome were sufficiently well documented with no alternative aetiology and/or having a temporal association with Hepsera treatment.
Maltese: Wara eżami mill-ġdid tad-deskrizzjoni tal-każijiet, 5 każijiet ta' possibiltà ta' tubulopatija prossimali renali u/jew sindrome ta' Fanconi kienu ddokumentati tajjeb biżżejjed mingħajr etjoloġija alternattiva u/jew b'assoċjazzjoni fiż-żmien mat-trattament b'Hepsera.
English: In the pre-liver transplantation cohort, 25 of 33 (76 %) patients achieved undetectable HBV DNA levels and 84 % of patients had ALT normalisation at 96 weeks.
Maltese: Fil-grupp ta' qabel it-trapjant tal-fwied, 25 minn 33 (76%) tal-pazjenti laħqu livelli tad-DNA tal-HBV li ma setgħux jiġu osservati u 84% tal-pazjenti kellhom normalizzazzjoni ta' l-ALT fil-Ġimgħa 96.
English: Overall, the safety profile of adefovir dipivoxil in children was consistent with the known safety profile in adult patients.
Maltese: Kollox ma' kollox, il-profil tas-sigurtà ta' adefovir dipivoxil fit-tfal kien konsistenti mal-profil tassigurtà magħruf f'pazjenti adulti.
English: In vitro binding of adefovir to human plasma or human serum proteins is ≤ 4 %, over the adefovir concentration range of 0.1 to 25 μg/ml.
Maltese: It-twaħħil in vitro ta' adefovir mal-plażma tal-bniedem jew ma' proteini fis-serum talbniedem hi ta' ≤ 4%, fuq il-medda ta' konċentrazzjonijiet ta' adefovir ta' 0.1 sa 25 μg/ml.
English: The role of adefovir and add-on lamivudine+adefovir in HBV therapy strategy should be regularly discussed in the light of emerging data.
Maltese: HBV għandha tiġi diskussa regolarment fid-dawl ta' dejta emerġenti.
English: Renal impairment: Adefovir is eliminated by renal excretion and adjustments of the dosing interval are required in patients with a creatinine clearance < 50 ml/min or on dialysis.
Maltese: Indeboliment renali: Adefovir huwa eliminat permezz ta' tneħħija renali u aġġustamenti fl-intervall tad-dożaġġ huma meħtieġa f'pazjenti bi tneħħija tal-krejatinina ta' < 50 ml/min jew li qegħdin fuq iddijaliżi.
English: Concomitant administration of 10 mg adefovir dipivoxil and 100 mg lamivudine did not alter the pharmacokinetic profile of either medicinal product.
Maltese: L-għoti flimkien ta' 10 mg ta' adefovir dipivoxil u ta' 100 mg lamivudine ma bidilx il-profil farmakokinetiku ta' l-ebda wieħed minn dawn il-prodotti mediċinali.
English: Do not store above 30ºC.
Maltese: Taħżinx f'temperatura 'l fuq minn 30ºC.
English: Preliminary clinical data suggest the adefovir-associated resistance mutation rtA181V may confer a reduced susceptibility to lamivudine, and the lamivudine-associated mutation rtA181T may confer a reduced susceptibility to adefovir dipivoxil.
Maltese: Informazzjoni klinika preliminarja tissuġġerixxi l-mutazzjoni rtA181V assoċjata marreżistenza għal adefovir tista' tikkawża tnaqqis fis-suxxettibilità għal lamivudine, u l-mutazzjoni rtA181T assoċjata ma' lamivudine tista' tikkawża tnaqqis fis-suxxettibbilità għal adefovir dipivoxil.
English: Gilead Sciences Sweden AB Tlf: + 46 (0) 8 5057 1849
Maltese: Tlf: + 46 (0) 8 5057 1849
English: Following oral administration of a single dose of 10 mg adefovir dipivoxil to chronic hepatitis B patients, the median (range) peak serum concentration (Cmax) was achieved after 1.75 h (0.58-4.0 h).
Maltese: Wara l-għoti mill-ħalq ta' doża waħda ta' 10 mg ta' adefovir dipivoxil lill-pazjenti b'epatite B kronika, il-medjan (medda) ta' l-ogħla konċentrazzjonijietjiet fis-serum (Cmax) intlaħaq wara 1.75 siegħa (0.58-4.0 sigħat).
English: It is recommended to administer adefovir dipivoxil (one 10 mg tablet) every 48 hours in these patients.
Maltese: Hu rakkomandat li tagħti adefovir dipivoxil (pillola waħda ta' 10 mg) kull 48 siegħa f'dawn ilpazjenti.
English: Not known:
Maltese: Mhux magħruf:
English: For renal safety in patients pre- and post-transplantation with lamivudine-resistant HBV, see section 4.8.
Maltese: Għas-sigurtà renali f'pazjenti ta' qabel u wara li kellhom it-trapjant, b'HBV reżistenti għal lamivudine, ara sezzjoni 4.8.
English: Some patients have experienced:
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq:
English: Hepsera belongs to a group of medicines called antiviral medicines.
Maltese: X'inhu Hepsera Hepsera huwa parti minn grupp ta' mediċini magħrufa bħala mediċini antivirali.
English: When adefovir was administered intravenously to pregnant rats at doses associated with notable maternal toxicity (systemic exposure 38 times that achieved in humans at the therapeutic dose) embryotoxicity and an increased incidence of foetal malformations (anasarca, depressed eye bulge, umbilical hernia and kinked tail) were observed.
Maltese: Meta adefovir ingħata ġol-vini lill-firien tqal f'dożi assoċjati ma' tossiċità materna notevoli (esponiment sistemiku ta' 38 darba aktar minn dak li ntlaħaq fil-bniedem bid-doża terapewtika) ġew innutati l-embrijutossiċità u żieda fl-inċidenza ta' malformazzjonijiet fetali (anasarka, nefħa ta' l-għajn fil-ħofra, ernja ta' l-umbeliku u denb mgħawweġ).
English: (may affect up to 1 in 100 people) • Damage to kidney tubule cells
Maltese: (jistgħu jaffettwaw sa persuna 1 minn kull 100)
English: A vaccine is available to protect those at risk from becoming infected with HBV.
Maltese: Hemm tilqima disponibbli biex tipproteġi lil dawk li huma f'riskju li jiġu infettati bl-HBV.
English: No differences in the median fibrosis score were seen between groups using the Knodell fibrosis score.
Maltese: L-ebda differenza filpunteġġ medjan tal-fibrożi ma kienet innutata bejn il-gruppi bl-użu tal-punteġġ tal-fibrożi ta' Knodell.
English: Adefovir is excreted renally, by a combination of glomerular filtration and active tubular secretion.
Maltese: Adefovir jitneħħa mill-ġisem permezz tal-kliewi b'kumbinazzjoni ta' filtrazzjoni glomerulari u sekrezzjoni tubulari attiva.
English: Serum HBV DNA levels remained undetectable and ALT levels normalised in approximately two thirds of patients following treatment with adefovir dipivoxil for up to 240 weeks.
Maltese: Il-livelli tad-DNA tal-HBV fis-serum baqgħu ma jistgħux jiġu osservati u l-livelli ta' l-ALT innormalizzaw f'madwar żewġ terzi tal-pazjenti wara t-trattament b'adefovir dipivoxil sa 240 ġimgħa.
English: Adefovir may be used in combination with lamivudine in lamivudine-refractory patients and in patients harbouring HBV with mutations at rtL180M and/or rtM204I/V.
Maltese: Adefovir jista' jintuża flimkien ma' lamivudine f'pazjenti li mhux qed jirrispondu għat-trattament bil-lamivudine u f'pazjenti bl-HBV b'mutazzjonijiet f'rtL180M u/jew rtM204I/V.
English: Tel: + 34 91 378 98 30
Maltese: Gilead Sciences, S.L. Tel: + 34 91 378 98 30
English: Paediatric population: Hepsera is not recommended for use in children below the age of 18 years due to limitations of the available data on safety and efficacy (see section 5.1).
Maltese: Hepsera mhuwiex irrakkomandat għall-użu fit-tfal taħt l-età ta' 18-il sena minħabba l-limitazzjonijiet fid-dejta disponibbli dwar is-sigurtà u l-effikaċja (ara sezzjoni 5.1).
English: Co-administration of 10 mg adefovir dipivoxil with other medicinal products that are eliminated by tubular secretion or alter tubular function may increase serum concentrations of either adefovir or the co-administered medicinal product (see section 4.4).
Maltese: L-għoti flimkien ta' 10 mg ta' adefovir dipivoxil ma' prodotti mediċinali oħra li huma eliminati permezz ta' sekrezzjoni tubulari jew li jibdlu l-funzjoni tubulari tista' żżid il konċentrazzjonijiet fis-serum jew ta' adefovir jew tal-prodott mediċinali mogħti flimkien (arasezzjoni 4.4).
English: Due to the small sample size and the study design, in particular the lack of treatment arms with pegylated interferon alpha-2a monotherapy and with adefovir monotherapy, it is not possible to draw formal conclusions on the best therapeutic management of HIV co-infected patients with lamivudine-resistant HBV.
Maltese: Minħabba d-daqs żgħir tal-kampjun u d-disinn ta' l-istudju, b'mod partikulari n-nuqqas ta' gruppi tattrattament bil-monoterapija b'pegylated interferon alpha-2a u bil-monoterapija b'adefovir, mhuwiex possibbli li tasal għal konklużjonijiet formali dwar l-aħjar immaniġġjar terapewtiku ta' pazjenti b'HBV reżistenti għal lamivudine li huma infettati ukoll bl-HIV.
English: General: Patients should be advised that therapy with adefovir dipivoxil has not been proven to reduce the risk of transmission of hepatitis B virus to others and therefore appropriate precautions should still be taken.
Maltese: Ġenerali: Il-pazjenti għandhom jiġu avżati li ma kienx ippruvat li t-terapija b'adefovir dipivoxil tnaqqas ir-riskju ta' trasmissjoni tal-virus tal-epatite B lil ħaddieħor u għalhekk xorta jridu jittieħdu prekawzjonijiet adegwati.
English: White to off-white, round, flat-faced, bevelled-edge tablets, 7 mm in diameter, debossed with “GILEAD” and “10” on one side and a stylised shape of a liver on the other side.
Maltese: Pilloli bojod għal abjad jagħti fil-griz, tondi, b'wiċċ ċatt u bi xfar immolati, b'dijametru ta' 7 mm, b' “GILEAD” u “10” imnaqqxa fuq naħa waħda u b'forma stilizzata ta' fwied fuq in-naħa l-oħra.
English: It is recommended that the dosing interval of 10 mg adefovir dipivoxil is modified in patients with creatinine clearance between 30 and 49 ml/min.
Maltese: Hu rrakkomandat li l-intervall tad-dożaġġ ta' 10 mg ta' adefovir dipivoxil jinbidel f'pazjenti li għandhom rata ta' tneħħija tal-krejatinina ta' bejn 30 u 49 ml/min.
English: Adefovir can be removed by haemodialysis; the median haemodialysis clearance of adefovir is 104 ml/min.
Maltese: Adefovir jista' jitneħħa permezz ta' dijaliżi tad-demm; it-tneħħija b'dijaliżi tad-demm medjana ta' adefovir hi ta' 104 ml/min.
English: Name and address of the manufacturer(s) responsible for batch release
Maltese: Isem u indirizz tal-manifattur(i) responsabbli għall-ħruġ tal-lott
English: Very few patients developed adefovirassociated mutations up to 5 years; however, the number of patients who remained on drugs above week 96 was limited.
Maltese: Ftit ħafna mill-pazjenti żviluppaw mutazzjonijiet assoċjati ma' adefovir sa 5 snin; madankollu, in-numru ta' pazjenti li baqgħu fuq prodotti mediċinali lil hemm minn ġimgħa 96 kien limitat.
English: 5.3 Preclinical safety data
Maltese: Sommarju tal-profil tas-sigurtà
English: The dosing interval of adefovir dipivoxil should be adjusted in these patients (see section 4.2).
Maltese: adefovir fit-tfal b'epatite B kronika (ara sezzjoni 4.2).
English: foscarnet, pentamidine, vancomycin, or medicinal products which are secreted by the same renal transporter, human Organic Anion Transporter 1 (hOAT1), such as cidofovir).
Maltese: Hi rakkomandata kawtela f'pazjenti li jkunu qegħdin jirċievu prodotti mediċinali oħrajn li jistgħu jaffettwaw il-funzjoni renali jew li jitneħħew mill-ġisem permezz tal-kliewi (eż. cyclosporin u tacrolimus, aminoglycosides ġol-vini, amphotericin B, foscarnet, pentamidine, vancomycin, jew prodotti mediċinali li joħroġu mill-istess trasportatur renali, it-Trasportatur Enajoniku Organiku uman 1 (human Organic Anion Transporter, hOAT 1) bħal cidofovir).
English: Experience in patients with decompensated liver disease and lamivudine-resistant HBV: In 40 HBeAg positive or HBeAg negative patients with lamivudine-resistant HBV and decompensated liver disease receiving treatment with 100 mg lamivudine, addition of 10 mg adefovir dipivoxil treatment for 52 weeks resulted in a median reduction in HBV DNA of 4.6 log10 copies/ml.
Maltese: F'40 pazjent b'HBeAg pożittiv jew HBeAg negattiv b'HBV reżistenti għal lamivudine u b'mard talfwied mhux kumpensat li kienu jirċievu trattament b'100 mg ta' lamivudine, iż-żieda ta' trattament b'10 mg ta' adefovir dipivoxil għal 52 ġimgħa wassal għal tnaqqis medjan fid-DNA tal-HBV ta' 4.6 log10 kopja/ml.
English: In clinical studies of wait-listed and post-liver transplantation patients, four percent (19/467) of patients discontinued treatment with adefovir dipivoxil due to renal adverse events.
Maltese: Fi studji kliniċi fuq pazjenti li kienu qed jistennew it-trapjant u ta' pazjenti ta' wara t-trapjant tal-fwied, erba' fil-mija (19/467) tal-pazjenti waqfu t-trattament b'adefovir dipivoxil minħabba effetti avversi renali.