FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients in clinical trials initially treated with entecavir 0.5 mg (nucleoside-naive) or 1.0 mg (lamivudine-refractory) and with an on-therapy PCR HBV DNA measurement at or after Week 24 were monitored for resistance.
Maltese: Il-pazjenti fil-provi kliniċi inizjalment ittrattati b'entecavir 0.5 mg (nucleoside-naive) jew 1.0 mg (lamivudine-rifrattorji) u b'kejl tal-PCR HBV DNA waqt it-terapija f'Ġimgħa 24 jew wara ġew immonitorjati għar-reżistenza.
English: Histological improvementb
Maltese: Titjib istoloġikub
English: 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: 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: HAART regimens did not include emtricitabine or tenofovir disoproxil fumarate.
Maltese: Ir-reġimen ta' HAART ma nkludewx emtricitabine jew tenofovir disoproxil fumarate.
English: OPA/Aluminium/PVC-Aluminium perforated unit-dose foil blister packs containing 30 x 1 or 90 x 1 film-coated tablets.
Maltese: Pakketti bil-folji tal-fojl tal-OPA/Aluminju/PVC-Aluminju, perforati b'doża waħda, li fihom 30 x 1 u 90 x 1 pilloli miksija b'rita.
English: Albumin levels <2.5 g/dl occurred in <1% of patients, amylase levels >3 times baseline in 2%, lipase levels >3 times baseline in 11% and platelets <50,000/mm3 in <1%.
Maltese: Livelli ta' albumina ta' <2.5 g/dl seħħew f'<1 % tal- pazjenti, livelli ta' amylase ta' >3 darbiet tal-linja bażi fi 2%, livelli ta' lipase ta' >3 darbiet tal-linja bażi fi 11% u plejtlits ta' <50,000/mm3 f'<1%.
English: Study 038 included 67 HBeAg positive and 1 HBeAg negative patients co-infected with HIV.
Maltese: Fl-istudju 038 kien hemm 67 pazjent pożittiv għal HBeAg u pazjent wieħed negattiv għal HBeAg li kienu infettati wkoll bl-HIV.
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 tal-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: Entecavir exposure among nucleoside naïve subjects receiving once daily doses of entecavir 0.015 mg/kg up to a maximum dose of 0.5 mg was similar to the exposure achieved in adults receiving once daily doses of 0.5 mg.
Maltese: Espożizzjoni għal entecavir fost individwi nucleoside naïve li rċivew dożi ta' darba kuljum ta' entecavir 0.015 mg/kg sa doża massima ta' 0.5 mg kienet simili għallespożizzjoni miksuba f'pazjenti adulti li rċivew dożi darba kuljum ta' 0.5 mg.
English: How to take Entecavir Mylan
Maltese: Tiħux Entecavir Mylan
English: Viral load reduction (log10 copies/ml)c HBV DNA undetectable (<300 copies/ml by PCR)c ALT normalisation (≤1 times ULN) HBeAg Seroconversion
Maltese: Tnaqqis tal-ammont virali (log10 kopja/mL)c HBV DNA li ma jistax jiġi osservat (<300 kopja/mL skont PCR)c Normalizzazzjoni tal-ALT (≥1 drabi talULN)
English: In rats, maternal toxicity, embryo-foetal 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 fid-denb u vertebri, ossifikazzjoni imnaqqsa (vertebri, sternebrae u flanġi) u vertebra tal-ġenbejn u kustilji addizzjonali wara dożi qawwija.
English: Stable or improved CTP scoreb,d MELD score
Maltese: Stabbli jew punteġġ CTP imtejjebb,d
English: b NC=F (noncompleter=failure), meaning treatment discontinuations before the analysis week, including reasons such as death, lack of efficacy, adverse event, noncompliance/loss-to-follow-up, are counted as failures (e.g., HBV DNA ≥300 copies/ml) c NC=M (noncompleters=missing) d Defined as decrease or no change from baseline in CTP score.
Maltese: b NC=F (ma rnexxilux jasal sat-tmiem=nuqqas ta' suċċess), dan ifisser li waqfien mill-kura qabel il-ġimgħa tal-analiżi, inklużi raġunijiet bħal mewt, nuqqas ta' effikaċja, episodju avvers, nuqqas ta' konformità/loss-to-follow-up, huma meqjusin bħala nuqqas ta' suċċess (eż., DNA tal-HBV ≤300 kopja/mL) c NC=M (ma rnexxilhomx jaslu sat-tmiem=mhux magħduda) d Definit bħala żieda jew ebda bidla mil-linja bażi fl-iskor CTP.
English: Hepatic function should be monitored at repeated intervals with both clinical and laboratory follow-up for at least 6 months after discontinuation of hepatitis B therapy.
Maltese: Il-funzjoni epatika għandha tkun immonitorjata f'intervalli ripetuti b'follow-up kliniku u tal-laboratorju, għal mill-inqas 6 xhur wara t-twaqqif tat-terapija kontra epatite B.
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 5-7 ijiem
English: Year 4 a Year 5 a
Maltese: Sena 5a
English: The population pharmacokinetic analysis covering patients in the age range 16-75 years did not identify age as significantly influencing entecavir pharmacokinetics.
Maltese: L-analiżi farmakokinetika tal-popolazzjoni li kopriet pazjenti ta' età bejn 16-75 sena ma wrietx li l-età għandha effett b'mod sinifikanti fuq il-farmakokinetika ta' entecavir.
English: The safety profile of entecavir in a limited number of HIV/HBV co-infected patients on lamivudinecontaining HAART (highly active antiretroviral therapy) regimens was similar to the safety profile in monoinfected HBV patients (see section 4.4).
Maltese: 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 għallprofil tas-sigurtà ta' dawk infettati bl-HBV biss (ara sezzjoni 4.4).
English: In study 048, 191 patients with HBeAg positive or negative chronic HBV infection and evidence of hepatic decompensation, defined as a CTP score of 7 or higher, received entecavir 1 mg once daily or adefovir dipivoxil 10 mg once daily.
Maltese: Fi studju 048, 191 pazjent b'infezzjoni HBV kronika pożittiva jew negattiva tal-HBeAg u b'evidenza ta' distabbilizzazzjoni epatika, definita bħala punteġġ CTP ta' 7 jew ogħla, ingħataw entecavir 1 mg darba kuljum jew adefovir dipivoxil 10 mg darba kuljum.
English: 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: For patients who met protocol-defined response criteria, response was sustained throughout the 24-week 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: INFORMATION IN BRAILLE Entecavir Mylan 0.5 mg film-coated tablets 17.
Maltese: INFORMAZZJONI BIL-BRAILLE Entecavir Mylan 0.5 mg pilloli miksija b'rita 17.
English: Nucleoside Naive HBeAg Positive (study 022)
Maltese: Pożittivi għal HBeAg (studju 022)
English: Entecavir Mylan tablets are anti-viral medicines, used to treat chronic (long term) hepatitis B virus (HBV) infection in adults.
Maltese: Il-pilloli Entecavir Mylan huma mediċini kontra virusijiet, użati sabiex jittrattaw infezzjoni kronika (fit-tul) bil-virus tal-epatite B (HBV) fl-adulti.
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 adverse reactions observed in paediatric subjects who received treatment with entecavir were consistent with those observed in clinical trials of entecavir in adults (see Summary of the safety profile and section 5.1).
Maltese: Ir-reazzjonijiet avversi osservati f'individwi pedjatriċi li rċivew trattament b'entecavir, kienu konsistenti ma' dawk osservati fil-provi kliniċi ta' entecavir fl-adulti (ara Sommarju tal-profil tas-sigurtà u sezzjoni 5.1).
English: Of these patients, 55/57 (96%) had histological improvement as previously defined (see above), and 50/57 (88%) had a ≥1-point decrease in Ishak fibrosis score.
Maltese: Minn dawn il-pazjenti, 55/57 (96%) kellhom titjib istoloġiku kif definit qabel (ara hawn fuq), u 50/57 (88%) kellhom tnaqqis ta' ≤1 punt fil-punteġġ tal-fibrożi ta' Ishak.
English: As entecavir is a nucleoside analogue, this risk cannot be excluded.
Maltese: Minħabba li entecavir huwa nucleoside analogue, dan ir-riskju ma jistax jiġi eskluż.
English: INFORMATION IN BRAILLE Entecavir Mylan 1 mg film-coated tablets 17.
Maltese: INFORMAZZJONI BIL-BRAILLE Entecavir Mylan 1 mg pilloli miksija b'rita 17.
English: Experience in patients with decompensated liver disease: the safety profile of entecavir in patients with decompensated liver disease was assessed in a randomized open-label comparative study in which patients received treatment with entecavir 1 mg/day (n = 102) or adefovir dipivoxil 10 mg/day (n = 89) (study 048).
Maltese: Il-profil tas-sigurezza ta' entecavir f'pazjenti b'mard tal-fwied mhux stabbli ġie evalwat fi studju komparattiv open-label li fih il-pazjenti ntagħżlu b'mod każwali, li fih, pazjenti rċivew kura b'entecavir 1 mg/kuljum (n=102) jew adefovir dipivoxil 10 mg/kuljum (n = 89) (studju 048).
English: Pharmacokinetic parameters in patients with moderate or severe hepatic impairment were similar to those in patients with normal hepatic function.
Maltese: Il-parametri farmakokinetiċi f'pazjenti b'indeboliment moderat jew gravi tal-fwied kienu simili għal ta' dawk f'pazjenti b'funzjoni normali.
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 rċivew 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 rċivew dożi darba kuljum ta' 1.0 mg.
English: Of these 60 patients, 49 received more than 6 months of HBIg therapy.
Maltese: Minn dawn is- 60 pazjent, 49 irċevew aktar minn 6 xhur ta' terapija ta' HBIg.
English: Absorption
Maltese: Assorbiment:
English: Histological improvementb Ishak fibrosis score improvement Ishak fibrosis score worsening n
Maltese: It-titjib fil-punteġġ tal-fibrożi Ishak Deterjorament fil-punteġġ tal-fibrożi Ishak n
English: In juvenile rats administered entecavir from postnatal days 4 to 80, a moderately reduced acoustic startle response was noted during the recovery period (postnatal days 110 to 114) but not during the dosing period at AUC values ≥92 times those in humans at the 0.5 mg dose or paediatric equivalent dose.
Maltese: Fil-firien ta' età żgħira mogħtija entecavir minn 4 ijiem sa 80 jum wara t-twelid, ġie osservat rispons moderatament imnaqqas għal ħasda akustika matul il-perjodu ta' rkupru (110-114-il jum wara t-twelid) iżda mhux matul il-perjodu ta' dożaġġ f'valuri AUC ≤ 92 darba dawk fil-bnedmin fuq doża ta' 0.5 mg jew doża pedjatrika ekwivalenti.
English: The safety and efficacy of entecavir 1 mg once daily were assessed in a single-arm study in 65 patients who received a liver transplant for complications of chronic HBV infection and had HBV DNA <172 IU/ml (approximately 1000 copies/ml) at the time of transplant.
Maltese: Is-sigurtà u l-effikaċja ta' entecavir 1 mg darba kuljum ġew evalwati fi studju single-arm ta' 65 pazjent li rċevew trapjant tal-fwied minħabba kumplikazzjonijiet ta' infezzjoni ta' HBV kronika u kellhom HBV DNA <172 IU/ml (madwar 1000 kopja/ml) meta sar it- trapjant.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Maltese: Pazjenti li għandhom problemi ereditarji rari ta' intolleranza għall-galactose, nuqqas ta' Lapp lactase jew malassorbiment tal-glucose-galactose, m'għandhomx jieħdu din il-mediċina.
English: OPA/Aluminium/PVC-Aluminium foil blister packs containing 30 film-coated tablets.
Maltese: Pakketti bil-folji tal-fojl tal-OPA/Aluminju/PVC-Aluminju li fihom 30 pillola miksija b'rita.
English: Other medicines and Entecavir Mylan
Maltese: Mediċini oħra u Entecavir Mylan
English: Psychiatric disorders:
Maltese: Esperjenza klinika:
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: 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: Ma kienx hemm differenza apparenti fil-profil tas-sigurtà ta' entecavir fir-rigward tal- ġeneru (≈25% tan-nisa fil-provi kliniċi) jew età (≈5% tal-pazjenti > 65 sena).
English: Genotypic evaluations were performed for all patients with available samples who had virologic breakthrough through Week 96 or HBV DNA ≥50 IU/ml at Week 48 or Week 96.
Maltese: L-evalwazzjonijiet ġenotipiċi twettqu għall-pazjenti kollha b'kampjuni disponibbli li kellhom avvanz viroloġiku f'Ġimgħa 96 jew HBV DNA ≤50 IU/mL f'Ġimgħa 48 jew 96.
English: For patients with baseline Ishak fibrosis score ≥2, 25/43 (58%) had a ≥2-point decrease.
Maltese: Għal pazjenti b'punteġġ fil-linja bażi tal-fibrożi ta' Ishak ta' ≤ 2, 25/43 (58%) kellhom tnaqqis ta' ≤ 2 punti.
English: In cell culture, entecavir selected for an M184I substitution at micromolar concentrations, confirming inhibitory pressure at high entecavir concentrations.
Maltese: F'kultura ta' ċelloli, entecavir magħżul għax kellu sostituzzjoni ta' M184I f'konċentrazzjonijiet mikromolari, ġiet ikkonfermata pressjoni inibitorja f'konċentrazzjonijiet għolja ta' entecavir.
English: HBV DNA <50 IU/mL and HBeAg seroconversiona HBV DNA <50 IU/mLa HBeAg seroconversiona ALT normalisationa HBV DNA <50 IU/mLa
Maltese: HBV DNA <50 IU/mL u serokonverżjoni ta' HBeAga
English: The ETVr substitutions at residues rtT184, rtS202 and rtM250 alone have only a modest effect on entecavir susceptibility, and have not been observed in the absence of LVDr substitutions in more than 1000 patient samples sequenced.
Maltese: Is- sostituzzjonijiet ETVr fir-residwi rtT184, rtS202 u rtM250 weħidhom għandhom biss effett modest fuq is-suxxettibilità għal entecavir, u ma ġewx osservati fin-nuqqas ta' sostituzzjonijiet LVDr f'aktar minn 1000 pazjent studjati.
English: In HIV antiviral assays, entecavir at micromolar concentrations was not antagonistic to the anti-HIV activity in cell culture of these six NRTIs or emtricitabine.
Maltese: F'assaġġi antivirali ta' l-HIV, entecavir f'konċentrazzjonijiet mikromolari ma kienx antagonistiku għall-attività kontra l-HIV f'kultura ta' ċelloli ta' dawn is-sitt NRTI jew emtricitabine.
English: Each film-coated tablet contains entecavir monohydrate equivalent to 0.5 mg entecavir.
Maltese: Kull pillola miksija b'rita fiha entecavir monohydrate, ekwivalenti għal 0.5 mg ta' entecavir.
English: The study population was 82% male, 39% Caucasian, and 37% Asian, with a mean age of 49 years; 89% of patients had HBeAgnegative disease at the time of transplant.
Maltese: Il-popolazzjoni tal-istudju kienu 82% irġiel, 39% Kawkasi, u 37% Asjatiċi, b'età medja ta' 49 sena; 89% tal-pazjenti kellhom il-marda negattiva għal HBeAg meta sar it-trapjant.
English: The absolute bioavailability has not been determined.
Maltese: Ilbijodisponibiltà assoluta ma ġietx stabbilita.
English: • compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis.
Maltese: • mard stabbli tal-fwied u b'evidenza ta' replikazzjoni virali attiva, b'livelli kostantament għoljin ta' alanine aminotransferase (ALT) fis-serum u b'evidenza istoloġika ta' infjammazzjoni attiva u/jew fibrożi.
English: Response criteria were HBV virological suppression (HBV DNA <0.7 MEq/ml by bDNA) and loss of HBeAg (in HBeAg positive patients) or ALT <1.25 times ULN (in HBeAg negative patients).
Maltese: Il-kriterji tar-rispons kienu trażżin viroloġiku HBV (HBV DNA <0.7 MEq/ml minn bDNA) u tnaqqis fl-HBeAg (f'pazjenti pożittivi għall-HBeAg) jew ALT <1.25 drabi l-ULN (f'pazjenti negattivi għall-HBeAg).
English: Race
Maltese: Razza:
English: Amylase levels >3 times baseline occurred in 2% of patients, lipase levels >3 times baseline in 18% and platelets <50,000/mm3 in <1%.
Maltese: Livelli ta' amylase ta' >3 darbiet tal-livell fillinja bażi seħħew fi 2% tal-pazjenti, livelli ta' lipase ta' >3 darbiet tal-linja bażi fi 18% u plejtlits ta' <50,000/mm3 f'<1%.
English: HBeAg positive (study 022): treatment with entecavir for up to 96 weeks (n = 354) resulted in cumulative response rates of 80% for HBV DNA <300 copies/ml by PCR, 87% for ALT normalisation, 31% for HBeAg seroconversion and 2% for HBsAg seroconversion (5% for HBsAg loss).
Maltese: Pożittivi għal HBeAg (studju 022): trattament b'entecavir sa 96 ġimgħa (n= 354) irriżulta f'rati ta' titjib kumulattiv ta' 80% għal DNA ta' HBV < 300 kopja/ml skont il-PCR, 87% għal normalizzazzjoni ta' ALT, 31% għal sirokonversjoni ta' HBeAg u 2% għal sirokonversjoni ta' HBsAg (5% għal tnaqqis ta' HBsAg).
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-viremija tal-HBV fuq reġimen b'lamivudine bħala parti mit-terapija HAART.
English: Each film-coated tablet contains entecavir monohydrate equivalent to 1 mg entecavir.
Maltese: Kull pillola miksija b'rita fiha entecavir monohydrate, ekwivalenti għal 1 mg ta' entecavir.
English: For children and adolescents (from 2 to less than 18 years of age), Entecavir Mylan 0.5 mg Filmcoated Tablets are available or an oral solution may be available.
Maltese: Għal tfal u adoloxxenti (minn 2 sa inqas minn 18-il sena), Entecavir Mylan 0.5 mg pilloli miksija b'rita huma disponibbli jew tista' tkun disponibbli soluzzjoni orali.
English: Entecavir is rapidly absorbed with peak plasma concentrations occurring between 0.5-1.5 hours.
Maltese: Entecavir jiġi assorbit malajr, bl-ogħla konċentrazzjonijiet fil-plażma jseħħu bejn 0.5 u 1.5 sigħat.
English: Liver biopsy results: 57 patients from the pivotal nucleoside-naive studies 022 (HBeAg positive) and 027 (HBeAg negative) who enrolled in a long-term rollover study were evaluated for long-term liver histology outcomes.
Maltese: Riżultati tal-bijopsija tal-fwied: minn studji importanti ħafna fuq 57 pazjent nucleoside-naive 022 (pożittivi għall-HBeAg) u 027 (negattiv għall-HBeAg) li ħadu sehem fi studju rollover fit-tul, li kienu evalwati bl-istoloġija tal-fwied fit-tul.
English: In repeat-dose toxicology studies in dogs, reversible perivascular inflammation was observed in the central nervous system, for which no-effect doses corresponded to exposures 19 and 10 times those in humans (at 0.5 and 1 mg respectively).
Maltese: Fi studji tossikoliġiċi b'dożi ripetuti fuq il-klieb, ġiet osservata infjammazzjoni perivaskulari riversibbli fis-sistema nervuża ċentrali, li għaliha, dożi bla effett ikkorrispondew għal dożi ta' 19 u 10 darbiet dawk fl-umani (f'0.5 u 1 mg rispettivament).
English: 0.25 mg once daily* OR 0.5 mg every 48 hours
Maltese: 0.25 mg darba kuljum* JEW 0.5 mg kull 48 siegħa
English: Hepatic impairment
Maltese: Bla indeboliment
English: The safety and efficacy of entecavir were also evaluated in an active-controlled clinical trial of 191 HBV-infected patients with decompensated liver disease and in a clinical trial of 68 patients co-infected with HBV and HIV.
Maltese: Is-sigurtà u l-effikaċja ta' entecavir ġew evalwati wkoll fi prova klinika kkontrollata b'mod attiv ta' 191 pazjent infettati b'HBV b'mard tal-fwied mhux stabbli u fi prova klinika ta' 68 pazjent ko-infettati b'HBV u b'HIV.
English: 0.3 mg once daily* OR 0.5 mg every 48 hours
Maltese: 0.3 mg darba kuljum* JEW 0.5 mg kull 48 siegħa
English: Uncommon (at least 1 in 1,000 patients): rash, hair loss.
Maltese: Mhux komuni (tal-anqas 1 f'kull 1,000 pazjent): raxx, telf ta' xagħar.
English: EU/1/17/1227/001 EU/1/17/1227/002 EU/1/17/1227/003 EU/1/17/1227/004 EU/1/17/1227/005 EU/1/17/1227/006 EU/1/17/1227/007 EU/1/17/1227/008 EU/1/17/1227/009 EU/1/17/1227/010
Maltese: EU/1/17/1227/006 EU/1/17/1227/007 EU/1/17/1227/008 EU/1/17/1227/009 EU/1/17/1227/010
English: Common (at least 1 in 100 patients): headache, insomnia (inability to sleep), fatigue (extreme tiredness), dizziness, somnolence (sleepiness), vomiting, diarrhoea, nausea, dyspepsia (indigestion), and increased blood levels of liver enzymes.
Maltese: Komuni (għall-inqas pazjent 1 minn kull 100): uġigħ ta' ras, insomnja (diffikultà biex wieħed jorqod), għeja (għeja kbira), sturdament, ngħas (ħedla), rimettar, dijarea, dardir, dispepsja (indiġestjoni), u livelli ogħla ta' enzimi tal-fwied fid-demm.
English: (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: common: fatigue
Maltese: komuni: għeja
English: Entecavir Mylan 0.5 mg film-coated tablets Entecavir Mylan 1 mg film-coated tablets entecavir
Maltese: Entecavir Mylan 0.5 mg pilloli miksija b'rita Entecavir Mylan 1 mg pilloli miksija b'rita entecavir
English: Testicular changes (seminiferous tubular degeneration) were evident in repeat-dose toxicology studies in rodents and dogs at exposures ≥26 times those in humans.
Maltese: Bidliet testikolari (deġenerazzjoni tubulari seminiferuża) kienu evidenti fi studji tossikoloġiċi b'doża ripetuta f'annimali li jgerrmu u klieb b'dozi ≤ 26 darba dawk fl-umani.