FrancophonIA/ELRC3.0 huggingface dataset:
English: Accord Healthcare Limited Sage House, 319 Pinner Road North Harrow, Middlesex, HA1 4HF United Kingdom
Maltese: Accord Healthcare Limited Sage House, 319 Pinner Road North Harrow, Middlesex, HA1 4HF
English: Accord Healthcare Limited Sage House, 319 Pinner road North Harrow, Middlesex HA1 4HF United Kingdom
Maltese: Accord Healthcare Limited Sage House, 319 Pinner road North Harrow, Middlesex HA1 4HF
English: Cmax (ng/ml) (CV%)
Maltese: Cmas (ng/ml) (CV%)
English: Substitutions observed in clinical isolates (rtT184A, C, F, G, I, L, M or S; rtS202 C, G or I; and/or rtM250I, L or V) further decreased entecavir susceptibility 16- to 741-fold relative to wild-type virus.
Maltese: Is-sostituzzjonijiet osservati fl iżolati kliniċi (rtT184A, C, F, G, I, L, M jew S; rtS202 C, G jew I; u/jew rtM250I, L jew V) komplew inaqqsu s-suxxettibilità għal entecavir bejn 16 u 741 darba relattiv għall-virus wild-type.
English: Histological improvementb Ishak fibrosis score improvement Ishak fibrosis score worsening n
Maltese: Ishak fibrosis score aħjar Ishak fibrosis score agħar n
English: rare (at least 1 in 10,000 patients): severe allergic reaction.
Maltese: rari (tal-anqas 1 f'kull 10,000 pazjent): reazzjoni allerġika severa.
English: Nucleoside naïve patients
Maltese: Nucleoside Naive
English: Frequency is defined as very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000).
Maltese: Il-frekwenza hija ddefinita bħala komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1,000 sa < 1/100); rari (≥ 1/10,000 sa < 1/1,000).
English: Tablet core: Calcium carbonate, starch, pregelatinized, carmellose sodium, soy polysaccharides, citric acid monohydrate, sodium stearyl fumarate.
Maltese: Qalba tal-pillola: Calcium carbonate, starch, pregelatinized, carmellose sodium, soy polysaccharides, citric acid monohydrate, sodium stearyl fumarate.
English: Tel: 0044 208 863 1427
Maltese: Accord Healthcare Limited, UK Tel: 0044 208 863 1427
English: The randomization was stratified by age group (2 to 6 years; > 6 to 12 years; and > 12 to < 18 years).
Maltese: Ir-randomizzazzjoni kienet stratifikata skont il-grupp ta' età (sentejn sa 6 snin; > 6 sa 12-il sena; u > 12 sa < 18-il sena).
English: Dimension: Length 8.70 mm ± 0.20 mm, width 8.40 mm ± 0.20 mm and thickness 3.40 mm ± 0.30 mm.
Maltese: Daqs: Tul 8.70 mm ± 0.20 mm, wisa' 8.40 mm ± 0.20 mm u ħxuna 3.40 mm ± 0.30 mm.
English: Entecavir is not a substrate, an inducer or an inhibitor of cytochrome P450 (CYP450) enzymes (see section 5.2).
Maltese: Entecavir m'huwiex sottostrat, inducer jew impeditur ta' enżimi ta' cytochrome P450 (CYP450) (ara sezzjoni 5.2).
English: The cumulative probability of emerging genotypic entecavir resistance after 1, 2, 3, 4 and 5 years treatment in the lamivudine-refractory studies was 6%, 15%, 36%, 47% and 51%, respectively.
Maltese: reżistenza ġenotipika ġdida għal entecavir wara 1, 2, 3, 4 u 5 snin ta' kura fi studji dwar pazjenti li kienu refrattarji għal lamivudine kienet ta' 6%, 15%, 36%, 47% u 51%, rispettivament.
English: Date of first authorisation: 26th September 2017
Maltese: Data ta' l-ewwel awtorizzazjoni: 26 ta 'Settembru 2017
English: Entecavir Accord 0.5 mg film-coated tablets Hypromellose, titanium dioxide (E171), macrogol, polysorbate 80
Maltese: Entecavir Accord 0.5 mg pilloli miksijin b'rita Hypromellose, titanium dioxide (E171), macrogol, polysorbate 80
English: Entecavir Accord 1 mg film-coated tablets Hypromellose, titanium dioxide (E171), macrogol, iron oxide red (E172)
Maltese: Entecavir Accord 1 mg pilloli miksijin b'rita Hypromellose, titanium dioxide (E171), macrogol, iron oxide red (E172)
English: Year 1 Year 2 Year 3a Year 4a Year 5a
Maltese: Sena 1 Sena 2 Sena 3a
English: Adefovir Dipivoxil 10 mg once daily n HBV DNA
Maltese: Adefovir Dipivoxil 10 mg darba kuljum n HBV DNA
English: Year 4 a
Maltese: Sena 4 a
English: e Baseline mean MELD score was 17.1 for ETV and 15.3 for adefovir dipivoxil.
Maltese: e Punteġġ MELD medju tal-linja bażi kien 17.1 għal ETV u 15.3 għal adefovir dipivoxil.
English: Adefovir Dipivoxil 10 mg once daily
Maltese: Adefovir Dipivoxil 10 mg darba kuljum
English: Prothrombin time (≤1 X ULN)b a Roche COBAS Amplicor PCR assay (LLOQ = 300 copies/ml).
Maltese: Bilirubin (≤1 X ULN)b Ħin protrombin (≤1 X ULN)b a Assaġġ Roche COBAS Amplicor PCR (LLOQ = 300 kopja/ml).
English: Protein binding to human serum protein in vitro is ≈ 13%.
Maltese: Ir-rabta ta' entecavir mal-proteini fis-serum uman in vitro huwa ta' madwar 13%.
English: Creatinine clearance (ml/min)
Maltese: Clearance tal kreatinina (ml/min)
English: Fertility: toxicology studies in animals administered entecavir have shown no evidence of impaired fertility (see section 5.3).
Maltese: Fertilità: studji tossikoloġiċi fl-annimali li ngħataw entecavir ma wrew ebda evidenza ta' fertilità indebolita (ara sezzjoni 5.3).
English: HBeAg Negative (study 027)
Maltese: (studju 027)
English: The on-study cumulative rate of hepatocellular carcinoma (HCC) was 12% (12/102).
Maltese: waqt l-istudju ta' karċinoma epatoċellulari (HCC) kienet ta' 12% (12/102).
English: LVD 100 mg once daily n
Maltese: LVD 100 mg darba kuljum n
English: No pharmacokinetic interactions between entecavir and lamivudine, adefovir or tenofovir were observed.
Maltese: Ma ġiet osservata ebda interazzjoni farmakokinetika bejn entecavir u lamivudine, adefovir jew tenofovir.
English: Healthy subjects who received up to 20 mg/day for up to 14 days, and single doses up to 40 mg had no unexpected adverse reactions.
Maltese: Pazjenti b'saħħithom li rċevew sa 20 mg/jum sa 14-il ġurnata, u dożi waħdiet sa 40 mg, ma kellhomx reazzjonijiet avversi mhux mistennija.
English: A risk to the infants cannot be excluded.
Maltese: dan ir-riskju ma jistax jiġi eskluż.
English: The Cmax, AUC(0-24), and Cmin for these subjects was 14.48 ng/ml, 38.58 ng∙h/ml, and 0.47 ng/ml, respectively.
Maltese: Is-Cmax, AUC (0-24), u s-Cmin għal dawn l-individwi kienu 14.48 ng/ml, 38.58 ng h/ml, u 0.47 ng/ml, rispettivament.
English: - genotypic ETVrc with virologic breakthrough d
Maltese: - ETVrc ġenotipika bi breakthrough viroloġikad
English: No evidence of genotoxicity was observed in an Ames microbial mutagenicity assay, a mammaliancell gene mutation assay, and a transformation assay with Syrian hamster embryo cells.
Maltese: L-ebda evidenza ta' ġenotossiċità ma ġiet osservata f'Ames microbial mutagenicity assay, cell gene mutation cell assay tal-mammiferi u transformation assay b'ċelloli embrijoniċi ta' ħamsters tas-Sirja.
English: Albumin levels < 2.5 g/dl occurred in 30% of patients, lipase levels > 3 times baseline in 10% and platelets < 50,000/mm3 in 20%.
Maltese: Livelli ta' albumina ta' < 2.5 g/dl seħħew fi 30% tal pazjenti, livelli ta' lipase > 3 darbiet il-linja bażi f'10% u plejtlits < 50,000/mm3 f'20%.
English: HAART regimens did not include emtricitabine or tenofovir disoproxil fumarate.
Maltese: ma nkludewx emtricitabine jew tenofovir disoproxil fumarate.
English: Exacerbations after discontinuation of treatment: acute exacerbations of hepatitis have been reported in patients who have discontinued anti-hepatitis B virus therapy, including therapy with entecavir (see section 4.4).
Maltese: Taħrix wara li jitwaqqaf it-trattament: ġie rrapportat taħrix akut ta' epatite f'pazjenti li waqqfu t terapija kontra l-virus ta' l-epatite B, inkluż terapija b'entecavir (ara sezzjoni 4.4).
English: The Cmax, AUC(024), and Cmin for these subjects was 6.31 ng/ml, 18.33 ng h/ml, and 0.28 ng/ml, respectively.
Maltese: Cmax, l-AUC (0-24), u s-Cmin għal dawn l-individwi kienu 6.31 ng/ml, 18.33 ng h/ml, u 0.28 ng/ml,
English: Entecavir Accord dosage*
Maltese: Doża ta' Entecavir Accord *
English: 0.05 mg once daily* OR 0.5 mg every 5-7 days
Maltese: 0.05 mg darba kuljum* JEW 0.5 mg kull 5 - 7t ijiem
English: Stable or improved CTP score b,d
Maltese: Punteġġ CTP stabbli jew imtejjeb b,d
English: d. Paediatric Population
Maltese: d. Popolazzjoni Pedjatrika
English: How to store Entecavir Accord Contents of the pack and other information
Maltese: Kontenut tal-pakkett u informazzjoni oħra
English: LVD 100 mg once daily
Maltese: LVD 100 mg darba kuljum
English: Elderly: the effect of age on the pharmacokinetics of entecavir was evaluated comparing elderly subjects in the age range 65-83 years (mean age females 69 years, males 74 years) with young subjects in the age range 20-40 years (mean age females 29 years, males 25 years).
Maltese: Anzjani: l-effett ta' l-età fuq il-farmakokinetika ta' entecavir ġie evalwat billi suġġetti anzjani ta'età bejn 65-83 (età medja ta' 69 fin-nisa, 74 fl-irġiel) tqabblu ma' suġġetti li għadhom żgħar fl-età, jiġifieri ta' bejn 20-40 sena (età medja ta' 29 fin-nisa, 25 fl-irġiel).
English: During Year 2, genotypic resistance to ETV was detected in 2 patients (1.1% cumulative probability of resistance through Year 2).
Maltese: Matul is-Sena 2 instabet reżistenza ġenotopika għal ETV f'2 pazjenti (1.1% probabbiltà kumulattiva ta' reżistenza f'Sena 2).
English: Entecavir Accord 1 mg tablets entecavir
Maltese: Entecavir Accord 1 mg pilloli entecavir
English: Among lamivudine-refractory patients with baseline HBV DNA < 107 log10 copies/ml, 64% (9/14)
Maltese: Fost il-pazjenti refrattarji għal lamivudine b'DNA tal-HBV fil-linja bażi ta' < 107 log10 kopji/ml, 64%
English: Dose adjustment is recommended for patients with creatinine clearance < 50 ml/min, including those on haemodialysis or continuous ambulatory peritoneal dialysis (CAPD).
Maltese: Huwa rrakkomandat aġġustament fid-doża għal pazjenti bi clearance tal-kreatinina < 50ml/min, inkluż dawk il-pazjenti fuq emodijaliżi jew fuq dialiżi peritoneali ambulatorja kontinwa (CAPD).
English: Gender/age: there was no apparent difference in the safety profile of entecavir with respect to gender (≈ 25% women in the clinical trials) or age (≈ 5% of patients > 65 years of age).
Maltese: Ġeneru/età: ma kienx hemm differenza apparenti fil-profil tas-sigurtà ta' entecavir fir-rigward talġeneru (≈25% tan-nisa fil-provi kliniċi) jew età (≈5% tal-pazjenti > 65 sena).
English: A 4 hour period of haemodialysis removed ≈ 13% of the dose, and 0.3% was removed by CAPD.
Maltese: 4 sigħat ta' emodijaliżi neħħa ≈ 13% tad-doża, u 0.3% tneħħew b'CAPD.
English: Entecavir Accord 0.5 mg tablets entecavir
Maltese: Entecavir Accord 0.5 mg pilloli entecavir
English: Lamivudine-resistant strains harboring rtL180M plus rtM204V in combination with amino acid substitution rtA181C conferred 16- to 122-fold reductions in entecavir phenotypic susceptibility.
Maltese: Razez reżistenti għal lamivudine li jospitaw rtL180M u rtM204V flimkien mas-sostituzzjoni rtA181C ta' aċidu amminiku wrew tnaqqis ta' bejn 16 u 122 darba fis-suxxettibilità fenotipika għal entecavir.
English: The median EC50 value for entecavir against LVDr HBV (rtL180M and rtM204V) was 0.026 µM (range 0.010-0.059 µM).
Maltese: Il-valur medju ta' EC50 għal entecavir kontra LVDr HBV (rtL180M u rtM204V) kien ta' 0.026 µM (medda ta'
English: Paediatric population: A lower rate of virologic response (HBV DNA < 50 IU/ml) was observed in paediatric patients with baseline HBV DNA ≥ 8.0 log10 IU/ml (see section 5.1).
Maltese: IU/ml) f'pazjenti pedjatriċi b'HBV DNA ≥ 8.0 log10 IU/ml fil-linja bażi (ara sezzjoni 5.1).
English: Other medicines and Entecavir Accord
Maltese: Mediċini oħra u Entecavir Accord
English: Therefore CYP450 mediated drug interactions are unlikely to occur with entecavir.
Maltese: Għalhekk interazzjonijiet bejn id-drogi b'CYP450 bħala medjatur, mhux probabbli li jseħħu b'entecavir.
English: Assessment of adverse reactions is based on experience from postmarketing surveillance and four clinical studies in which 1,720 patients with chronic hepatitis B infection and compensated liver disease received double-blind treatment with entecavir (n = 862) or lamivudine (n = 858) for up to 107 weeks (see section 5.1).
Maltese: L-evalwazzjoni tar-reazzjonijiet avversi hija bbażata fuq esperjenza minn sorveljanza ta' wara ttqegħid fis-suq u fuq erba' studji kliniċi fejn 1,720 pazjent b'infezzjoni kronika tal-epatite B u mard tal-fwied stabbli irċivew trattament double blind b'entecavir (n= 862), jew lamivudine (n= 858) sa 107 ġimgħat (ara sezzjoni 5.1).
English: For patients weighing from 10 kg to 32.5 kg, an entecavir oral solution is recommended.
Maltese: Għall-pazjenti li jiżnu 10 kg sa 32.5 kg, hija rakkomandata soluzzjoni orali ta' entecavir.
English: 30 x 1 film-coated tablets 90 x 1 film-coated tablets
Maltese: 30 x 1 pillola miksija b'rita 90 x 1 pillola miksija b'rita
English: Psychiatric disorders: common : insomnia
Maltese: Disturbi gastro-intestinali: komuni
English: An analysis of the inhibitory activity of entecavir against a panel of laboratory and clinical HIV-1 isolates using a variety of cells and assay conditions yielded EC50 values ranging from 0.026 to > 10 µM; the lower EC50 values were observed when decreased levels of virus were used in the assay.
Maltese: Analiżi ta' l-attività inibitorja ta' entecavir kontra gruppi ta'viruses HIV-1 iżolati minn pazjenti u minn kulturi fil-laboratorju li jużaw varjetà ta' ċelloli u kundizzjonijiet ta' assaġġi taw valuri EC50 li varjaw minn 0.026 sa > 10 µM; il-valuri EC50 l-baxxi ġew osservati meta ntużaw livelli mnaqqsa tal-virus flassaġġ.
English: For lamivudine (n = 355), cumulative response rates were 39% for HBV DNA < 300 copies/ml by PCR, 79% for ALT normalisation, 26% for HBeAg seroconversion, and 2% for HBsAg seroconversion (3% for HBsAg loss).
Maltese: Għal lamivudine (n= 355), ir-rati kienu 39% għal DNA ta' HBV < 300 kopja/ml skont ilPCR, 79% għal normalizzazzjoni ta' l-ALT, 26% għal sirokonversjoni ta' HBeAg u 2% għal sirokonversjoni ta' HBsAg (3% għal tnaqqis ta' HBsAg).
English: b Includes patients with at least one on-therapy HBV DNA measurement by PCR at or after week 24 through week 58 (Year 1), after week 58 through week 102 (Year 2), after week 102 through week 156 (Year 3), after week 156 through week 204 (Year 4), or after week 204 through week 252 (Year 5).
Maltese: b Jinkludi pazjenti b'mill-inqas kejl wieħed tad-DNA tal-HBV minn PCT waqt li l-pazjent ikun qed jieħu t-terapija, fi jew wara ġimgħa 24 sa ġimgħa 58 (Sena 1), wara ġimgħa 58 sa ġimgħa 102 (Sena 2), wara ġimgħa 102 sa ġimgħa 156 (Sena 3), wara ġimgħa 156 sa ġimgħa 204 (Sena 4), jew wara ġimgħa 204 sa ġimgħa 252 (Sena 5).
English: After reaching peak levels, entecavir plasma concentrations decreased in a biexponential manner with a terminal elimination half-life of ≈ 128-149 hours.
Maltese: Wara li jilħqu l-ogħla livelli, il-konċentrazzjonijiet ta' entecavir fil-plażma jitbaxxew b'mod bi-esponenzjali b'half-life ta' leliminazzjoni terminali ta' ≈ 128-149 sigħat.
English: For patients with LVDr substitutions at baseline, the percentage of patients with HBV DNA <300 copies/ml was 44% for entecavir and 20% for adefovir at week 24 and 50% for entecavir and 17% for adefovir at week 48.
Maltese: Għal pazjenti b'sostituzzjonijiet ta' LVDr fil-linja bażi, il-perċentwal ta' pazjenti b'HBV DNA < 300 kopja/ml kien 44% għal entecavir u 20% għal adefovir f'ġimgħa 24, u 50% għal entecavir u 17% għal adefovir f'ġimgħa 48.
English: These substitutions were observed only in the presence of LVDr substitutions (rtM204V and rtL180M).
Maltese: Dawn is-sostituzzjonijiet kienu osservati biss fil-preżenza ta' sostituzzjonijiet LVDr (rtM204V u rtL180M).
English: At study entry, the mean HBV DNA was 8.1 log10 IU/ml and mean ALT was 103 U/l across the study population.
Maltese: Fil-livell tal-istudju, l-HBV DNA medju kien 8.1 log10 IU/ml u l-ALT medju kien 103 U/l fost il-popolazzjoni tal-istudju.
English: - emerging genotypic ETVrc - genotypic ETVrc with virologic breakthroughd
Maltese: - ETVrc ġenotipika ġdida - ETVrc ġenotipika bi breakthrough viroloġikud
English: Of these 60 patients, 49 received more than 6 months of HBIg therapy.
Maltese: Minn dawn is60 pazjent, 49 irċevew aktar minn 6 xhur ta' terapija ta' HBIg.
English: Integrated Analysis of Phase 2 and 3 Clinical Studies: In a post-approval integrated analysis of entecavir resistance data from 17 Phase 2 and 3 clinical studies, an emergent entecavir resistanceassociated substitution rtA181C was detected in 5 out of 1461 subjects during treatment with entecavir.
Maltese: Analiżi integrata tal-Istudji Kliniċi ta' Fażijiet 2 u 3: F'analiżi integrata wara l-approvazzjoni tad-dejta dwar ir-reżistenza għal entecavir minn 17-il studju kliniku ta' Fażijiet 2 u 3, instabet sostituzzjoni rtA181C emerġenti assoċjata mar-reżistenza għal entecavir f'5 minn 1461 individwi waqt it-trattament b'entecavir.
English: Each 1 mg film-coated tablet contains 52 mg soy polysaccharides.
Maltese: Kull pillola ta' 1 mg miksija b'rita fiha 52 mg ta' polysaccharides tas-sojja.
English: (see a. Summary of the safety profile and section 5.1)
Maltese: sigurtà u sezzjoni 5.1)
English: Entecavir Accord contains soy polysaccharides
Maltese: Entecavir Accord fih polysaccharides tas-sojja
English: Experience in patients co-infected with HIV: the safety profile of entecavir in a limited number of HIV/HBV co-infected patients on lamivudine-containing HAART (highly active antiretroviral therapy) regimens was similar to the safety profile in monoinfected HBV patients (see section 4.4).
Maltese: Esperjenza f'pazjenti infettati fl-istess ħin bl-HIV: il-profil tas-sigurtà ta'entecavir f'numru limitat ta' pazjenti infettati bl-HIV/HBV li kienu fuq lamivudine bħala parti mit-terapija HAART (terapija antiretrovirali attiva ħafna), kien simili għall-profil tas-sigurtà ta' dawk infettati bl-HBV biss (ara sezzjoni 4.4).
English: In rats, maternal toxicity, embryofoetal toxicity (resorptions), lower foetal body weights, tail and vertebral malformations, reduced ossification (vertebrae, sternebrae, and phalanges), and extra lumbar vertebrae and ribs were observed at high exposures.
Maltese: Fil-firien, ġew osservati tossiċità materna, tossiċità embrijo-fetali (riassorbimenti), piż inqas tal-ġisem tal-fetu, malformazzjonijiet fiddenb u vertebri, ossifikazzjoni imnaqqsa (vertebri, sternebrae u flanġi) u vertebra tal-ġenbejn u kustilji addizzjonali wara dożi qawwija.
English: For patients who met protocol-defined response criteria, response was sustained throughout the 24week post-treatment follow-up in 75% (83/111) of entecavir responders vs 73% (68/93) for lamivudine responders in study 022 and 46% (131/286) of entecavir responders vs 31% (79/253) for lamivudine responders in study 027.
Maltese: Għal pazjenti li ssodisfaw il-kriterji li ġew definiti fi protokoll, it-titjib kompla matul il-follow-up ta' 24 ġimgħa wara t-trattament f'75% (83/111) tal-pazjenti li rrispondew għal entecavir kontra 73% (68/93) għal dawk li rrispondew għal lamivudine fi studju 022 u 46% (131/286) ta' dawk li rrispondew għal entecavir meta mqabbel ma' 31% (79/253) għal pazjenti li rrispondew għal lamivudine fi studju 027.
English: Entecavir exposure among lamivudine-experienced subjects receiving once daily doses of entecavir 0.030 mg/kg up to a maximum dose of 1.0 mg was similar to the exposure achieved in adults receiving once daily doses of 1.0 mg.
Maltese: Espożizzjoni għal entecavir fost individwi li esperjenzaw lamivudine li rċievew dożi ta' darba kuljum ta' entecavir 0.030 mg/kg sa doża massima ta' 1.0 mg kienet simili għall-espożizzjoni miksuba f'pazjenti adulti li rċievew dożi darba kuljum ta' 1.0 mg.
English: 90 x 1 film-coated tablet; 9 blister cards of 10 x 1 film-coated tablet each in Alu/Alu perforated unit dose blisters.
Maltese: 90 x 1 pillola miksija b'rita; 9 folji ta' 10 x 1 pillola miksija b'rita, kull waħda f'folji ta' doża waħda, mtaqqbin ta' Alu/Alu.
English: Administration of 0.5 mg entecavir with a standard high-fat meal (945 kcal, 54.6 g fat) or a light meal (379 kcal, 8.2 g fat) resulted in a minimal delay in absorption (1-1.5 hour fed vs. 0.75 hour fasted), a decrease in Cmax of 44-46%, and a decrease in AUC of 18-20%.
Maltese: Għoti ta' 0.5 mg ta' entecavir ma' ikla standard b'ħafna xaħam (945 kcal, 54.6 g ta' xaħam) jew ikla ħafifa (379 kcal, 8.2 g xaħam) irriżulta f'dewmien minimu fl-assorbiment (1-1.5 sigħat bl-ikel vs
English: Patients who did not have a virologic response were offered alternative treatment.
Maltese: Pazjenti li ma kellhomx rispons viroloġiku ġew offruti trattament alternattiv.
English: Therefore, clinical and laboratory parameters should be closely monitored in this patient population (see also sections 4.8 and 5.1).
Maltese: Għaldaqstant, f'din il-popolazzjoni ta' pazjenti, il-parametri kliniċi u tal-laboratorju għandhom jiġu mmonitorjati mill-qrib (ara wkoll sezzjonijiet 4.8 u 5.1).
English: ALT normalizationa HBV DNA < 50 IU/mL
Maltese: n HBV DNA < 50
English: HBeAg Seroconversion
Maltese: Sirokonversjoni ta' HBeAg
English: Mechanism of action: entecavir, a guanosine nucleoside analogue with activity against HBV polymerase, is efficiently phosphorylated to the active triphosphate (TP) form, which has an intracellular half-life of 15 hours.
Maltese: Mekkaniżmu ta' azzjoni: entecavir, analogue ta' guanosine nucleoside b'attività kontra polymerase tal-HBV, huwa fosforilatat b'mod effiċjenti mal-forma attiva ta' triphosphat (TP), li għandha half-life ta' 15-il siegħa.
English: HBeAg negative (study 027): treatment with entecavir up to 96 weeks (n = 325) resulted in cumulative response rates of 94% for HBV DNA < 300 copies/ml by PCR and 89% for ALT normalisation versus 77% for HBV DNA < 300 copies/ml by PCR and 84% for ALT normalisation for lamivudine-treated patients (n = 313).
Maltese: Negattivi għal HBeAg (studju 027): trattament b'entecavir sa 96 ġimgħa (n= 325) irriżulta f'rati ta' titjib kumulattiv ta' 94% għal DNA ta' HBV < 300 kopja/ml skont il-PCR u 89% għal normalizzazzjoni ta' l-ALT meta mqabbel ma' 77% għal DNA ta' HBV < 300 kopja/ml skont il-PCR u 84% għal normalizzazzjoni ta' l-ALT f'pazjenti ttrattati b'lamivudine (n= 313).
English: The optimal duration of treatment is unknown.
Maltese: Il-perjodu ottimali ta' kura mhuwiex magħruf.
English: Patients had stable controlled HIV (HIV RNA < 400 copies/ml) with recurrence of HBV viraemia on a lamivudine-containing HAART regimen.
Maltese: Il-pazjenti kellhom HIV stabbli u kkontrollata (HIV RNA < 400 kopji/ml) b'rikorrenza tal viremja ta' l-HBV fuq reġimen b'lamivudine bħala parti mit-terapija HAART.
English: With respect to patients with lamivudine-refractory hepatitis B, see sections 4.2, 4.4 and 5.1.
Maltese: Fir-rigward ta' pazjenti b'epatite B refrattarja għal lamivudine, ara sezzjonijiet 4.2, 4.4 u 5
English: It is important that you do not miss any doses.
Maltese: Huwa importanti li ma taqbeż ebda doża.
English: Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Maltese: Huwa importanti li jiġu rrappurtati reazzjonijiet avversi suspettati wara l-awtorizzazzjoni tal-prodott mediċinali.
English: *p<0.05
Maltese: *valur p vs lamivudine < 0.05
English: The absolute bioavailability has not been determined.
Maltese: Il-bijodisponibiltà assoluta ma ġietx stabbilita.
English: By competing with the natural substrate deoxyguanosine TP, entecavir-TP functionally inhibits the 3 activities of the viral polymerase: (1) priming of the HBV polymerase, (2) reverse transcription of the negative strand DNA from the pregenomic messenger RNA, and (3) synthesis of the positive strand HBV DNA.
Maltese: (1) priming ta' polymerase ta' HBV, (2) traskrizzjoni bil-maqlub ta' l-istrand negattiv tad-DNA mill-messaġġier pregenomiku RNA, u (3) sintesi ta' listrand pożittiv tad-DNA tal-HBV.
English: Baseline ALT levels ≥ 2 times ULN and baseline HBV DNA ≤ 9.0 log10 copies/ml were both associated with higher rates of virologic response (Week 48 HBV DNA < 400 copies/ml) in nucleoside-naive HBeAg-positive patients.
Maltese: Livelli ta' ALT ta' linja bażi ta' ≥ darbtejn l-ULN u DNA ta' HBV ta' linja bażi ≤ 9.0 log10 kopji/ml kienu t-tnejn li huma assoċjati ma' rati ogħla ta' titjib viroloġiku (Ġimgħa 48 DNA ta' HBV < 400 kopja/ml) f'pazjenti li huma nucleoside naïve u pożittivi għal HBeAg.
English: Each 0.5 mg film-coated tablet contains 26 mg soy polysaccharides.
Maltese: Kull pillola ta' 0.5 mg miskija b'rita fiha 26 mg ta' polysaccharides tas-sojja.