FrancophonIA/ELRC3.0 huggingface dataset:
English: Adefovir was not mutagenic in microbial mutagenicity assays involving Salmonella typhimurium (Ames) and Escherichia coli in the presence and absence of metabolic activation.
Maltese: Adefovir ma' kienx mutaġeniku fl-analiżi ta' mutaġeniċità mikrobjali li jinvolvu Salmonella typhimurium (Ames) u Escherichia coli, kemm fil-preżenza u kemm fl-assenza ta' l-attivazzjoni metabolika.
English: • A different dose may be given to patients with kidney problems.
Maltese: • Doża differenti tista' tingħata lill-pazjenti bi problemi tal-kliewi.
English: In these clinical studies patients had active viral replication (HBV DNA ≥ 100,000 copies/ml) and elevated ALT levels (≥ 1.2 x Upper Limit of Normal (ULN)).
Maltese: HBV ≥ 100,000 kopja/ml) u livelli ta' l-ALT għolja (≥ 1.2 x il-limitu ta' fuq tan-normal (Upper Limit of Normal, ULN)).
English: Package leaflet: Information for the user Hepsera 10 mg tablets
Maltese: Informazzjoni għall-utent Hepsera 10 mg pilloli
English: • vancomycin and aminoglycosides, used for bacterial infections
Maltese: • vancomycin u aminoglycosides, li jintużaw għall-infezzjonijiet batterjali
English: Patients with creatinine clearance between 30 and 49 ml/min:
Maltese: Pazjenti bi tneħħija tal-krejatinina ta' bejn 30 u 49 ml/min:
English: High baseline ALT levels (≥ 2 x ULN) and Knodell Histology Activity Index (HAI) scores (≥ 10) and low HBV DNA (< 7.6 log10 copies/ml) were associated with greater histological improvement.
Maltese: Livelli għolja tal-linja bażi fl-ALT (≥ 2 x ULN) u ta' l-Indiċi ta' l-Attività tal-Istoloġija (Histology Activity Index, HAI) ta' Knodell (≥ 10) u DNA tal-HBV baxxa (< 7.6 log10 kopja/ml) kienu assoċjati ma' titjib istoloġiku ikbar.
English: Adefovir is active against hepadnaviruses in vitro, including all common forms of lamivudine-resistant HBV (rtL180M, rtM204I, rtM204V, rtL180M/rtM204V), famciclovir-associated mutations (rtV173L, rtP177L, rtL180M, rtT184S or rtV207I) and hepatitis B immunoglobulin escape mutations (rtT128N and rtW153Q), and in in vivo animal models of hepadnavirus replication.
Maltese: famciclovir (rtV173L, rtP177L, rtL180M, rtT184S jew rtV207I) u l-mutazzjonijiet ta' l-immunoglobulina tal-epatite B li jaħarbu (rtT128N u rtW153Q), u in vivo f'mudelli ta' l-annimali tar-replikazzjoni tal-ħepadnavirus.
English: Hepsera contains lactose
Maltese: Hepsera fih lactose
English: In the pre-liver transplantation and post-liver transplantation cohorts 77 of 109 (71 %) patients and 64 of 159 (40 %) patients, respectively, achieved undetectable HBV DNA levels at week 48 (< 1,000 copies/ml Roche Amplicor Monitor PCR assay).
Maltese: Fil-gruppi ta' qabel it-trapjant u ta' wara t-trapjant tal-fwied, 77 minn 109 (71%) talpazjenti u 64 minn 159 (40%) tal-pazjenti rispettivament, laħqu livelli tad-DNA tal-HBV li ma setgħux jiġu osservati fil-Ġimgħa 48 (< 1,000 kopja/ml assay ta' Roche Amplicor Monitor PCR).
English: Rash, pruritus Musculoskeletal and connective tissue disorders:
Maltese: Disturbi muskolu-skeletriċi u tat-tessuti konnettivi:
English: Paediatric population: The pharmacokinetics of adefovir dipivoxil were studied in an efficacy and safety study of a daily dose of 0.25 mg/kg to 10 mg adefovir dipivoxil in children (aged 2 to < 18 years).
Maltese: Il-farmakokinetika ta' adefovir dipivoxil ġiet studjata fi studju dwar leffikaċja u s-sigurtà ta' doża kuljum ta' 0.25 mg/kg sa 10 mg ta' adefovir dipivoxil fit-tfal (ta' bejn 2 sa < 18-il sena).
English: Gilead Sciences Ireland UC Тел.
Maltese: Gilead Sciences Ireland UC
English: • pentamidine, for other types of infection.
Maltese: • pentamidine, għal tipi oħrajn ta' infezzjoni.
English: Clinical resistance in monotherapy studies in nucleoside naïve patients: In patients receiving adefovir dipivoxil monotherapy (HBeAg negative study) the cumulative probability of developing adefovir-associated resistance mutations was 0 %, 3 %, 11 %, 18 % and 29 % at 48, 96, 144, 192 and 240 weeks respectively.
Maltese: F'pazjenti li qed jirċievu monoterapija b'adefovir dipivoxil (studju dwar HBeAg negattiv) il-probabbiltà kumulattiva li jiżviluppaw mutazzjonijiet assoċjati mar-reżistenza għal adefovir kienet ta' 0%, 3%, 11%, 18% u 29% fil-Ġimgħa 48, 96, 144, 192 u 240 rispettivament.
English: Baseline Creatinine Clearance (ml/min)
Maltese: Bażi tat-Tneħħija tal-Krejatinina (ml/min)
English: In the two studies mentioned above, treatment with 10 mg adefovir dipivoxil was associated with significant reductions in serum HBV DNA (3.52 and 3.91 log10 copies/ml, respectively, versus 0.55 and 1.35 log10 copies/ml), increased proportion of patients with normalisation of ALT (48 and 72 % versus 16 and 29 %) or increased proportion of patients with serum HBV DNA below the limits of quantification (< 400 copies/ml Roche Amplicor Monitor PCR assay) (21 and 51 % versus 0 %) when compared with placebo.
Maltese: Fiż-żewġ studji msemmija hawn fuq, it-trattament b'10 mg ta' adefovir dipivoxil kien assoċjat ma' tnaqqis sinifikanti fis-serum tad-DNA tal-HBV (3.52 u 3.91 log10 kopja/ml, rispettivament, kontra 0.55 u 1.35 log10 kopja/ml), ma' numru akbar ta' pazjenti b'normalizzazzjoni ta' l-ALT (48 u 72% kontra 16 u 29%) jew ma' numru akbar ta' pazjenti bis-serum tad-DNA tal-HBV taħt il-limiti talkwantifikazzjoni (< 400 kopja/ml assay ta' Roche Amplicor Monitor PCR) (21 u 51% kontra 0%) meta mqabbla bl-plaċebo.
English: • Weakness
Maltese: Bla indeboliment
English: Table 1: Tabulated summary of adverse reactions associated with adefovir dipivoxil based on clinical study and post-marketing experience
Maltese: Tabella 1: Sommarju tabulat ta' reazzjonijiet avversi assoċjati ma' adefovir dipivoxil ibbażat fuq studju kliniku u esperjenza ta' wara t-tqegħid fis-suq
English: Forty-eight weeks of treatment with adefovir dipivoxil 10 mg alone or in combination with lamivudine resulted in a similar significant decrease in median serum HBV DNA levels from baseline (4.04 log10 copies/ml and 3.59 log10 copies/ml, respectively).
Maltese: Tmienja u erbgħin ġimgħa ta' trattament b'10 mg ta' adefovir dipivoxil waħdu jew flimkien ma' lamivudine wassal għal tnaqqis sinifikanti simili tal-livelli medjani fis-serum tad-DNA tal-HBV meta mqabbel mal-linja bażi (4.04 log10 kopja/ml u 3.59 log10 kopja/ml, rispettivament).
English: Other medicines and Hepsera
Maltese: Mediċini oħra u Hepsera
English: HBV that contains the rtA181T mutation, consideration should be given to alternative treatment regimens due to the risk of reduced susceptibility to adefovir (see section 5.1).
Maltese: Madankollu, għal pazjenti bl-HBV li jkun fiha l-mutazzjoni rtA181T, għandha tingħata konsiderazzjoni lil korsijiet ta' kuri alternattivi minħabba r-riskju ta' tnaqqis fis-suxxettibilità għal adefovir (ara sezzjoni 5.1).
English: Adefovir dipivoxil is a dipivaloyloxymethyl ester prodrug of the active substance adefovir, an acyclic nucleotide analogue which is actively transported into cells where it is converted by host enzymes to adefovir diphosphate.
Maltese: Adefovir dipivoxil hu prodrug dipivaloyloxymethyl ester tas-sustanza attiva adefovir, acyclic nucleotide analogue li jinġarr attivament fiċ-ċelluli fejn il-host enzymes jibdluh f'adefovir diphosphate.
English: However, mild to moderate increases in serum creatinine concentrations, hypophosphatemia and a decrease in carnitine concentrations were reported in 3 %, 4 % and 6 % of patients, respectively, on extended treatment.
Maltese: Madankollu, żidiet minn ħfief sa moderati fil-konċentrazzjonijiet tal-krejatinina fis-serum, ipofosfatimja u nuqqas fil-konċentrazzjonijiet tal-carnitine kienu rrappurtati fi 3%, 4% u 6% tal-pazjenti rispettivament, li kienu fuq trattament imtawwal.
English: Proximal renal tubulopathy (including Fanconi syndrome) General disorders and administration site conditions: Very common:
Maltese: Tubulopatija prossimali renali (li tinkludi s-sindrome ta' Fanconi)
English: d. Paediatric population
Maltese: d. Popolazzjoni pedjatrika
English: • two placebo-controlled studies in which 522 patients with chronic hepatitis B and compensated liver disease received double-blind treatment with 10 mg adefovir dipivoxil (n=294) or placebo (n=228) for 48 weeks.
Maltese: • żewġ studji kkontrollati bi plaċebo, li fihom 522 pazjent b'epatite B kronika u mard tal-fwied kumpensat li ngħataw trattament double-blind b'10 mg ta' adefovir dipivoxil (n=294) jew plaċebo (n=228) għal 48 ġimgħa.
English: In the post-liver transplantation cohort, 61 of 94 (65 %) and 35 of 45 (78 %) of patients achieved undetectable HBV DNA levels at 96 and 144 weeks, respectively, and 70 % and 58 % of patients had ALT normalisation at these study visits.
Maltese: Fil-grupp ta' wara t-trapjant tal-fwied, 61 minn 94 (65%) u 35 minn 45 (78%) tal-pazjenti laħqu livelli tad-DNA tal-HBV li ma setgħux jiġu osservati fil-Ġimgħat 96 u 144 rispettivament, u 70% u 58% talpazjenti kellhom normalizzazzjoni ta' l-ALT f'dawn l-eżamijiet mediċi li saru matul dan l-istudju.
English: • compensated liver disease with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active liver inflammation and fibrosis.
Maltese: • mard tal-fwied kumpensat u b'evidenza ta' replikazzjoni virali attiva, b'livelli ta' serum alanine aminotransferase (ALT) għolja b'mod persistenti b'evidenza istoloġika ta' infjammazzjoni talfwied attiva u fibrożi.
English: Some of the signs of lactic acidosis are:
Maltese: Aċidożi lattika u l-epatomegalija gravi bi stejatożi:
English: No clinically significant changes in renal function were observed.
Maltese: L-ebda tibdil klinikament sinifikanti fil-funzjoni renali ma kienu osservati.
English: The demonstration of the benefit of adefovir dipivoxil is based on histological, virological, biochemical, and serological responses in adults with:
Maltese: Id-dimostrazzjoni tal-benefiċċji ta' adefovir dipivoxil hi bbażata fuq riżultati istoloġiċi, viroloġiċi, bijokimiċi u seroloġiċi f'adulti b':
English: Two novel conserved site mutations were identified in the HBV polymerase gene (rtN236T and rtA181V), which conferred clinical resistance to adefovir dipivoxil.
Maltese: Żewġ mutazzjonijiet ġodda (rtN236T u rtA181V) tal-lok konservat kienu identifikati fil-ġene tal-polimerase ta' HBV, li offrewiet reżistenza klinika għal adefovir dipivoxil.
English: In patients with decompensated liver disease, the most frequently reported adverse reactions during up to 203 weeks of adefovir dipivoxil therapy were increased creatinine (7 %) and asthenia (5 %).
Maltese: F'pazjenti b'mard tal-fwied dikumpensat, l-aktar reazzjonijiet avversi rrappurtati b'mod frekwenti matul sa 203 ġimgħa ta' terapija b'adefovir dipivoxil kienu żieda fil-krejatinina (7%) u astenja (5%).
English: • If you are over 65 years of age your doctor may monitor your health more closely.
Maltese: • Jekk għandek iktar minn 65 sena, it-tabib tiegħek jista' jimmonitorja s-saħħa tiegħek iktar millqrib.
English: Adefovir dipivoxil was mutagenic in the in vitro mouse lymphoma cell assay (with or without metabolic activation), but was not clastogenic in the in vivo mouse micronucleus assay.
Maltese: Adefovir dipivoxil kien mutaġeniku fl-analiżi in vitro taċ-ċellula tal-limfoma tal-ġrieden (kemm bl-attivazzjoni metabolika u kemm mingħajrha) iżda ma kienx klastoġeniku fl-analiżi mikronuklejari in vivo tal-ġrieden.
English: A pharmacokinetic interaction between adefovir and the immunosuppressant, cyclosporin, is also considered unlikely as cyclosporin shares the same metabolic pathway as tacrolimus.
Maltese: Interazzjoni farmakokinetika bejn adefovir u l-immunosuppressant cyclosporin, hi wkoll ikkunsidrata li x'aktarx li mhux ser isseħħ, għax cyclosporin jaqsam l-istess rotta metabolika ta' tacrolimus.
English: Five patients achieved and maintained HBsAg seroconversion (HBsAg negative/HBsAb positive).
Maltese: Ħamsa pazjenti laħqu u żammew serokonverżjoni ta' l-HBsAg (HBsAg negattiv/HBsAb pożittiv).
English: Pharmacotherapeutic group: Nucleoside and nucleotide reverse transcriptase inhibitors, ATC code: J05AF08.
Maltese: Impedituri ta' nucleoside u nucleotide reverse transcriptase, kodiċi
English: As adefovir is structurally related to nucleoside analogues, this risk cannot be excluded.
Maltese: Peress li adefovir huwa strutturalment relatat ma' analogi tannukleosidi, dan ir-riskju ma jistax ikun eskluż.
English: Based on a PRAC request, the MAH has reconsidered the frequency categories of Fanconi syndrome and proximal renal tubulopathy in the SmPC for Hepsera.
Maltese: Abbażi ta' talba tal-PRAC, l-MAH ikkunsidra mill-ġdid il-kategoriji tal-frekwenza ta' sindrome ta' Fanconi u tubulopatija prossimali renali fl-SmPC għal Hepsera.
English: Renal function: Adefovir is excreted renally, by a combination of glomerular filtration and active tubular secretion.
Maltese: Funzjoni renali: Adefovir jitneħħa mill-ġisem permezz tal-kliewi b'kumbinazzjoni ta' filtrazzjoni glomerulari u sekrezzjoni tubulari attiva.
English: • an open-label study in which pre- (n=226) and post-liver transplantation patients (n=241) with lamivudine-resistant HBV were treated with 10 mg adefovir dipivoxil once daily, for up to 203 weeks (median 51 and 99 weeks, respectively).
Maltese: • fi studju open-label li fih pazjenti ta' qabel (n=226) u wara t-trapjant tal-fwied (n=241) b'HBV reżistenti għal lamivudine kienu kkurati b'10 mg ta' adefovir dipivoxil darba kuljum, għal sa 203 ġimgħa (medjan 51 u 99 ġimgħa, rispettivament).
English: Hepatic impairment: Pharmacokinetic properties were similar in patients with moderate and severe hepatic impairment compared to healthy volunteers (see section 4.2).
Maltese: Il-karatteristiċi farmakokinetiċi kienu simili f'pazjenti b'indeboliment epatiku moderat jew sever meta mqabbla ma' voluntiera f'saħħithom (ara sezzjoni 4.2).
English: The tablets are marked with “GILEAD” and “10” on one side and a stylised shape of a liver on the other side.
Maltese: “GILEAD” u “10” fuq naħa waħda u b'forma stilizzata ta' fwied fuq in-naħa l-oħra.
English: Experience in patients with HIV co-infection and lamivudine-resistant HBV: In an open-label investigator study in 35 chronic hepatitis B patients with lamivudine-resistant HBV and co-infected with HIV, continued treatment with 10 mg adefovir dipivoxil resulted in progressive reductions in serum HBV DNA levels and ALT levels throughout the course of treatment up to 144 weeks.
Maltese: Fi studju open label investigattiv f'35 pazjent b'epatite B kronika b'HBV reżistenti għal lamivudine u li huma infettati ukoll bl-HIV, trattament kontinwu b'10 mg ta' adefovir dipivoxil irriżulta fi tnaqqis progressiv fil-livelli ta' serum tad-DNA tal-HBV u fil-livelli ta' l-ALT matul il-kors tat-trattament sa
English: The safety data derived from 5 pivotal randomized controlled studies, including a total of 1,174 patients, were reviewed.
Maltese: Id-data dwar is-sigurtà dderivata minn 5 studji ta' importanza kbira, randomised u kkontrollati, li jinkludu total ta' 1,174 pazjent, ġiet eżaminata mill-ġdid.
English: The potential for CYP450 mediated interactions involving adefovir with other medicinal products is low, based on the results of in vitro experiments in which adefovir did not influence any of the common CYP isoforms known to be involved in human drug metabolism and based on the known elimination pathway of adefovir.
Maltese: Il-potenzjal ta' interazzjonijiet medjati minn CYP450 li jinvolvu adefovir ma' prodotti mediċinali oħra hu baxx, ibbażat fuq ir-riżultati ta' esperimenti in vitro li fihom adefovir ma influwenzax l-ebda waħda mill-iżoformi komuni CYP magħrufa li huma involuti fil-metaboliżmu tal-mediċini fil-bnedmin u li huma bbażati fuq ir-rotta ta' eliminazzjoni magħrufa ta' adefovir.
English: Administration of 500 mg adefovir dipivoxil daily for 2 weeks and 250 mg daily for 12 weeks has been associated with the gastrointestinal disorders listed above and anorexia.
Maltese: L-għoti ta' 500 mg ta' adefovir dipivoxil għal ħmistax, u 250 mg kuljum għal 12-il ġimgħa kien assoċjat mal-disturbi gastrointestinali elenkat hawn fuq u l-anoressija.
English: Severe cases, sometimes with fatal outcome, were associated with pancreatitis, liver failure/hepatic steatosis, renal failure and higher levels of serum lactate.
Maltese: Każi gravi, xi kultant b'riżultati fatali, kienu assoċjati ma' pankreatite, kollass tal-fwied/stejatożi epatika, kollass tal-kliewi, livelli għolja ta' lactate fis-serum.
English: Pharmacokinetic studies were principally conducted in Caucasian patients.
Maltese: L-istudji farmakokinetiċi saru prinċipalment fuq pazjenti Kawkasi.
English: The adverse reactions considered at least possibly related to treatment are listed below, by body system organ class, and frequency (see Table 1).
Maltese: Ir-reazzjonijiet avversi kkunsidrati li kienu possibbilment assoċjati mat-trattament huma elenkati hawn taħt, skond il-klassi ta' sistema ta' l-organi fil-ġisem u skond il-frekwenza (ara Tabella 1).
English: By the end of the study, 7 of 12 patients (58 %) with bridging fibrosis or cirrhosis at baseline, had an improved Ishak fibrosis score of ≥ 2 points.
Maltese: Sat-tmiem ta' l-istudju, 7 minn 12-il pazjent (58%) b'fibrożi bridging jew ċirrożi fil-linja bażi, kellhom titjib fil-punteġġ tal-fibrożi ta' Ishak ta' ≥ 2 punti.
English: Absorption: The oral bioavailability of adefovir from 10 mg adefovir dipivoxil is 59 %.
Maltese: Il-biodisponibilità mill-ħalq ta' adefovir minn 10 mg ta' adefovir dipivoxil hi ta' 59%.
English: At week 48, in children aged 2 to 11 years old, no statistically significant difference was observed in the proportions of patients that achieved the primary endpoint of serum HBV DNA < 1,000 copies/ml and normal ALT levels between the placebo arm and the adefovir dipivoxil arm.
Maltese: Fil-ġimgħa 48, fit-tfal ta' bejn 2 u 11-il sena, l-ebda differenza statistikament sinifikanti ma kienet osservata fil-proporzjonijiet ta' pazjenti li laħqu r-riżultat aħħari primarju ta' serum tad-DNA tal-HBV ta' < 1,000 kopja/ml u livelli normali ta' ALT bejn il-fergħa fuq il-plaċebo u dik fuq adefovir dipivoxil.
English: Experience in patients pre- and post-liver transplantation with lamivudine-resistant HBV: In a clinical study in 394 chronic hepatitis B patients with lamivudine-resistant HBV (pre-liver transplantation (n=186) and post-liver transplantation (n=208)), treatment with 10 mg adefovir dipivoxil resulted in a median reduction in serum HBV DNA of 4.1 and 4.2 log10 copies/ml, respectively, at week 48.
Maltese: Fi studju kliniku fi 394 pazjent b'epatite B kronika u b'HBV lamivudine reżistenti (ta' qabel it-trapjant tal-fwied (n=186) u ta' wara t-trapjant tal-fwied (n=208)), it-trattament b'10 mg ta' adefovir dipivoxil irriżulta fi tnaqqis medjan tad-DNA ta' HBV ta' 4.1 u ta' 4.2 log10 kopja/ml, rispettivament, filĠimgħa 48.
English: A high rate (30%) of hepatic flares was reported following discontinuation of adefovir dipivoxil during the 3 years open-label phase of the study.
Maltese: Rata għolja (30%) ta' aggravamenti epatiċi ġiet irrapportata wara t-twaqqif ta' adefovir dipivoxil matul il-fażi open-label ta' 3 snin tal-istudju.
English: Co-infection with HIV: Limited data are available on the safety and efficacy of 10 mg adefovir dipivoxil in patients with chronic hepatitis B, co-infected with HIV.
Maltese: Hemm informazzjoni limitata dwar is-sigurtà u l-effikaċja ta' 10 mg ta' adefovir dipivoxil f'pazjenti b'epatite B kronika, li huma infettati ukoll bl-HIV.
English: The efficacy and safety of a daily dose of 0.25 mg/kg to 10 mg adefovir dipivoxil in children (aged from 2 to < 18 years) were examined in a double-blind, randomised, placebo-controlled study in 173 paediatric patients (115 on adefovir dipivoxil, 58 on placebo) who had HBeAg positive chronic hepatitis B, serum ALT levels ≥ 1.5 x upper limit of normal (ULN) and compensated liver disease.
Maltese: L-effikaċja u s-sigurtà ta' doża ta' kuljum ta' 0.25 mg/kg sa 10 mg ta' adefovir dipivoxil fit-tfal (ta' bejn 2 sa < 18-il sena) kienu eżaminati fi studju double-blind, randomised, ikkontrollat bil-plaċebo li sar fuq 173 pazjenti pedjatriċi (115 fuq adefovir dipivoxil, 58 fuq il-plaċebo) li kellhom HbeAg pożittiva għal epatite B kronika, livelli ta' ALT fis-serum ≥ 1.5 x il-limitu ta' fuq tan-normal (ULN) u mard tal-fwied kumpensat.
English: Patients with creatinine clearance < 30 ml/min and dialysis patients:
Maltese: Pazjenti bi tneħħija tal-krejatinina ta' < 30 ml/min u pazjenti li qegħdin fuq id-dijaliżi:
English: After repeated administration of 10 mg adefovir dipivoxil, 45 % of the dose is recovered as adefovir in the urine over 24 hours.
Maltese: Wara l-għoti ripetut ta' 10 mg ta' adefovir dipivoxil, 45% mid-doża tinġabar bħala adefovir fl-awrina fuq medda ta' 24 siegħa.
English: Pharmacokinetic analysis revealed that adefovir exposure was comparable among 3 age groups, 2 to 6 years (0.3 mg/kg), 7 to 11 years (0.25 mg/kg) and 12 to 17 years (10 mg) and all age groups achieved adefovir exposure in the target range (for efficacy results see section 5.1), which was based on adefovir plasma concentrations in adult patients with chronic hepatitis B with established safety and efficacy profiles.
Maltese: L-analiżi farmakokinetika rrivelat illi l-esponiment għal adefovir kien paragunabbli bejn 3 gruppi ta' etajiet, 2 sa 6 snin (0.3 mg/kg), 7 sa 11-il sena (0.25 mg/kg) u 12 sa 17-il sena (10 mg) u kull grupp laħaq esponiment ta' adefovir fil-medda immirata (għar-riżultati tal-effikaċja ara sezzjoni 5.1), li kienet ibbażata fuq il-konċentrazzjonijiet ta' adefovir fil-plażma ta' pazjenti adulti b'epatite B kronika li għandhom profil ta' sigurtà u effikaċja stabbilit.
English: • Kidney failure - common
Maltese: • Insuffiċjenza tal-kliewi - komuni
English: Diarrhoea, vomiting, abdominal pain, dyspepsia, nausea, flatulence
Maltese: Dijarrea, rimettar, uġigħ addominali, dispepsja, tqalligħ, gass fl-istonku
English: Clinical and laboratory evidence of exacerbations of hepatitis have occurred after discontinuation of treatment with 10 mg adefovir dipivoxil (see section 4.4).
Maltese: Evidenza klinika u tal-laboratorju ta' epatite li tmur għall-agħar seħħet wara l-waqfien tat-trattament b'10 mg ta' adefovir dipivoxil (ara sezzjoni 4.4).
English: Clinically and statistically significant improvement in fibrosis was seen in the changes in Ishak scores from the start of adefovir dipivoxil treatment to the end of the study (week 240) (median change: Δ= -1).
Maltese: Titjib klinikament u statistikament sinifikanti fil-fibrożi ntwera fit-tibdil fil-punteġġi ta' Ishak mill-bidu tat-trattament b'adefovir dipivoxil sattmiem ta' l-istudju (Ġimgħa 240) (tibdil medjan: Δ= -1).
English: The elimination of adefovir by peritoneal dialysis has not been studied.
Maltese: It-tneħħija ta' adefovir bid-dijaliżi peritoneali ma ġietx studjata.
English: Renal toxicity is an important feature of the safety profile of adefovir dipivoxil in patients with decompensated liver disease.
Maltese: It-tossiċità renali hi karatteristika importanti tal-profil tas-sigurtà ta' adefovir dipivoxil f'pazjenti b'mard tal-fwied dikumpensat.
English: Treatment with adefovir dipivoxil resulted in improvement in the liver fibrosis from baseline to 96 weeks therapy when analysed using the Ishak score (median change: Δ= -1).
Maltese: It-trattament b'adefovir dipivoxil irriżulta f'titjib fil-fibrożi tal-fwied mil-linja bażi sa 96 ġimgħa ta' terapija meta analizzat bl-użu tal-punteġġ ta' Ishak (tibdil medjan: Δ= -1).
English: Adefovir dipivoxil is not recommended in patients with creatinine clearance of < 30 ml/min or in patients on dialysis (see section 4.2 and 4.4).
Maltese: Adefovir dipivoxil mhux rakkomandat f'pazjenti bi tneħħija tal-krejatinina ta' < 30 ml/min jew f'pazjenti li qegħdin fuq iddijaliżi (ara sezzjonijiet 4.2 u 4.4).
English: Hepatic function: Spontaneous exacerbations in chronic hepatitis B are relatively common and are characterised by transient increases in serum ALT. After initiating antiviral therapy, serum ALT may increase in some patients as serum HBV DNA levels decline.
Maltese: Epatite B kronika b'aggravar spontanju hija relattivament komuni u din tkun ikkaratterizzata minn żieda temporanja fl-ALT fis-serum.
English: (may affect up to 1 in 10,000 people)
Maltese: (jistgħu jaffettwaw sa persuna 1 minn kull 10,000)