FrancophonIA/ELRC3.0 huggingface dataset:
English: Rare (may affect up to 1 in 1,000 people) - Excess of lactic acid in the blood (lactic acidosis) - Muscle breakdown (rhabdomyolysis)
Maltese: Rari (jista' jaffettwa minn persuna sa 1,000 persuna) - Lactic acid żejjed fid-demm (aċidożi lattika) - Dikompożizzjoni tal-muskoli (rabdomijoliżi)
English: Patients with sustained HBeAg seroconversion had a mean HBV DNA of 3.3 log10 copies/ml; and 73.7% had HBV DNA < 4 log10 copies/ml.
Maltese: Pazjenti b'serokonverżjoni sostenibbli ta' HBeAg kellhom medja ta' HBV DNA ta' 3.3 log10 kopji/ml; aund 73.7% kellhom HBV DNA <4 log10 kopji/ml.
English: Table 7 Key efficacy endpoints at week 104 by serum HBV DNA levels at week 24, telbivudine-treated patients in NV-02B-007 (GLOBE) study
Maltese: Tabella 7 Endpoints importanti ta' effikaċja fil-ġimgħa 104 permezz ta' livelli ta' HBV DNA fis-serum fil-ġimgħa 24, pazjenti ttrattati b'telbivudine fl-istudju NV-02B-007 (GLOBE)
English: The median treatment duration was 104 weeks.
Maltese: Id-dewmien medju tat-trattament kien ta' 104 ġimgħat.
English: In addition, telbivudine does not alter the pharmacokinetics of lamivudine, adefovir dipivoxil, tenofovir disoproxil fumarate or ciclosporin.
Maltese: Flimkien ma' dan, telbivudine ma jibdilx il-farmakokinetika ta' lamivudine, adefovir dipivoxil, tenofovir disoproxil fumarate jew ciclosporin.
English: Among HBeAg-positive patients, therapeutic response (63% vs 48%; p < 0.0001) and key secondary endpoints (mean log10 HBV DNA reduction: -5.74 vs -4.42; p < 0.0001, HBV DNA undetectability: 56% vs 39%; p < 0.0001 and ALT normalisation of 70% vs 62%) demonstrated a widening difference at week 104 between telbivudine and lamivudine, respectively.
Maltese: Fost il-pazjenti HBeAg-pożittivi, ir-rispons terapewtiku (63% vs 48%; p < 0.0001) u l-endpoints sekondarji importanti (tnaqqis medju log10 ta' HBV DNA: -5.74 vs -4.42; p < 0.0001, HBV DNA li ma setgħux jitkejlu: 56% vs 39%; p < 0.0001 u normalizzazzjoni ta' l-ALT ta' 70% vs 62%) wriet differenza li tiżdied fil-ġimgħa 104 bejn telbivudine u lamivudine, rispettivament.
English: Sebivo 20 mg/ml [folding box only]
Maltese: Sebivo 20 mg/ml [kaxxa li tintlewa biss]
English: Clinical resistance
Maltese: Esperjenza klinika
English: Sebivo contains sodium
Maltese: Sebivo fih is-sodium
English: Sebivo is indicated for the treatment of chronic hepatitis B in adult patients with compensated liver disease and evidence of viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis.
Maltese: Sebivo huwa indikat għall-kura ta' epatite B kronika f'pazjenti adulti b'mard tal-fwied kompensat u evidenza ta' replikazzjoni virali, livelli ta' alanine aminotransferase (ALT) li jibqgħu għoljin b'mod persistenti u evidenza istoloġika ta' infjammazzjoni attiva u/jew fibrożi.
English: C-telbivudine in humans.
Maltese: C-telbivudine fil-bnedmin.
English: HBeAg-negative patients: The mean age of patients was 43 years, 79% were male, 65% were Asian, 23% were Caucasian, and 11% had previously received alfa-interferon therapy.
Maltese: L-età medja tal-pazjenti kienet 43 sena, 79% kienu rġiel, 65% kienu Ażjatiċi, 23% kienu Kawkażi u 11% kienu rċevew qabel terapija b'alfa-interferon.
English: N/A = not applicable * Virological breakthrough: “1 log above nadir” definition assessed at week 104
Maltese: * Penetrazzjoni viroloġika: “1 log fuq in-nadir” tifsira stmata fil-ġimgħa 104
English: Table 8 Efficacy analysis in pooled data from NV-02B-007 (GLOBE), NV-02B-015 and CLDT600A2303 studies
Maltese: NV-02B-007 (GLOBE), NV-02B-015 u CLDT600A2303
English: * The population without viral resistance at entry into study CLDT600A2303 consisted of 502 patients (293 HBeAg-positive and 209 HBeAg-negative).
Maltese: *Il-popolazzjoni mingħajr reżistenza virali mat-tnedija tal-istudju CLDT600A2303 kien ta' 502 pazjenti (293 b'HBeAg pożittivi u 209 b'HBeAg negattivi).
English: N/A 13/17 (76)
Maltese: 14/18 (78) Ma japplikax 13/17 (76)
English: ALT normalisation HBeAg seroconversion HBeAg loss
Maltese: Serokonverżjoni ta' HBeAg
English: Bottle containing the oral solution.
Maltese: U KONTENUT Soluzzjoni orali
English: Table 5 Virological, biochemical and serological endpoints at week 52 in NV-02B-007 (GLOBE) study
Maltese: Tabella 5 Endpoints viroloġiċi, biokimiċi u seroloġiċi fit-52 ġimgħa fl-istudju NV-02B-007 (GLOBE)
English: The steady-state pharmacokinetics of telbivudine were unaltered following multiple dose administration in combination with lamivudine, adefovir dipivoxil, tenofovir disoproxil fumarate, ciclosporin or pegylated interferon alfa-2a.
Maltese: Il-farmakokinetiċi fi stat fiss ta' telbivudine ma nbidlux wara li ngħataw ħafna dożi wara xulxin fl-istess ħin ma' lamivudine, adefovir dipivoxil, tenofovir disoproxil fumarate, ciclosporin jew interferon alfa-2a pegilat.
English: Telbivudine pharmacokinetics are dose proportional over the range of 25 to 1,800 mg.
Maltese: Il-farmakokinetiċi ta' telbivudine huma proporzjonali mad-doża fuq il-medda ta 25 sa 1,800 mg.
English: Cases were more often secondary to other serious conditions (e.g. rhabdomyolysis) and/or associated with muscle-related events (e.g. myopathy, myositis).
Maltese: Il-każijiet ta' spiss kienu sekondarji għal kondizzjonijiet serji oħra (eż. rabdomijolisi) u/jew assoċjati ma' avvenimenti relatati mal-muskoli (eż. mijopatija, mijosite).
English: Among HBeAg-negative patients, differences in therapeutic response (78% vs 66%) and key secondary endpoints (mean log10 HBV DNA reduction: -5.00 vs -4.17, and HBV DNA undetectability: 82% vs 57%; p < 0.0001) were higher for telbivudine up to week 104.
Maltese: Fost pazjenti HBeAg-negattivi, id-differenzi fir-rispons terapewtiku (78% vs 66%) u l-endpoints sekondarji importanti (tnaqqis medju log10 ta' HBV DNA: -5.00 vs -4.17, u HBV DNA li ma setgħux jitkejlu: 82% vs 57%; p < 0.0001) kienu ogħla għal telbivudine sal-ġimgħa 104.
English: The most common adverse reactions were grade 3 or 4 blood creatine kinase elevations (6.8%), fatigue (4.4%), headache (3.0%) and nausea (2.6%).
Maltese: L-aktar reazzjonijiet avversi komuni kienu elevazzjonijiet ta' creatine kinase fid-demm (6.8%) ta' grad 3 jew 4, għeja (4.4%), uġigħ ta' ras (3.0%) u tqalligħ (2.6%).
English: Genotypic analysis of 203 evaluable sample pairs with HBV DNA ≥ 1,000 copies/ml at week 104 (NV-02B-007 (GLOBE)) demonstrated that the primary mutation associated with telbivudine resistance was rtM204I, often associated with mutations rtL180M and rtL80I/V and infrequently with rtV27A, rtL82M, rtV173L, rtT184I and rtA200V.
Maltese: Analiżi ġenotipika ta' 203 pari kampjun li setgħu jiġu evalwati b'HBV DNA ≥1,000 kopja/ml filġimgħa 104 (NV-02B-007 (GLOBE)) wriet li l-mutazzjoni primarja assoċjata mar-reżistenza għal telbivudine kienet rtM204I, ħafna drabi assoċjata ma' mutazzjonijiet rtL180M u rtL80I/V u b'mod mhux frekwenti ma' rtV27A, rtL82M, rtV173L, rtT184I u rtA200V.
English: Sebivo 20 mg/ml oral solution
Maltese: Sebivo 20 mg/ml soluzzjoni orali
English: Study CLDT600ACN04E1 - Impact of treatment on liver histology In study CLDT600ACN04E1, 57 patients with available paired liver biopsies at baseline and after mean treatment of 260.8 weeks were evaluated for changes in liver histology (38 HBeAg-positive and 19 HBeAg-negative patients).
Maltese: Studju CLDT600ACN04E1 - Impatt tat-trattament fuq l-istoloġija tal-fwied Fl-istudju CLDT600ACN04E1, 57 pazjent b'bijopsi disponibbli qabel u wara t-trattament fil-linja bażi u wara trattament medju ta' 260.8 ġimgħat kienu evalwati għal tibdiliet fl-istoloġija tal-fwied (38 pazjent b'HBeAg pożittivi u 19-il pazjent b'HBeAg negattivi).
English: Virological breakthrough* n/N (%)
Maltese: Penetrazzjoni viroloġika* n/N (%)
English: Patients with previous exposure to nucleoside/nucleotide analogues
Maltese: Pazjenti li qabel diġà kellhom esponiment għal analogi ta' nucleoside/nucleotide
English: Myopathy/myositis, arthralgia, myalgia, pain in the extremities, back pain, muscle spasm, neck pain, flank pain
Maltese: Mijopatija/mijosite, artralġja, mijalġja, uġigħ flidejn u fis-saqajn, uġigħ fid-dahar, spażmu talmuskolu, uġigħ fl-għonq, uġigħ 'l fuq millġenbejn
English: At week 24, 203 HBeAg-positive (44%) and 177 HBeAg-negative (80%) telbivudine-treated subjects achieved undetectable HBV DNA levels.
Maltese: F'Ġimgħa 24, 203 individwu pożittiv għall-HBeAg (44%) u 177 negattiv għall-HBeAg (80%) ikkurati b'telbivudine kisbu livelli ta' HBV DNA li ma setgħux jitkejlu.
English: Sebivo oral solution contains approximately 47 mg of sodium per 600 mg dose (30 ml).
Maltese: Is-soluzzjoni orali ta' Sebivo fiha bejn wieħed u ieħor 47 mg ta' sodium għal kull doża ta' 600 mg (30 ml).
English: Limited clinical data (less than 300 pregnancy outcomes) after exposure to telbivudine during the first trimester of pregnancy indicate no malformative toxicity and a large amount of data (more than 1000 pregnancy outcomes) after exposure during the second and third trimesters indicate no foetal/neonatal toxicity.
Maltese: Dejta klinika limitata (inqas minn 300 riżultat ta' tqala) wara esponiment għal telbivudine matul lewwel trimestru tat-tqala ma tindika l-ebda tossiċità malformattiva u ammont kbir ta' dejta (aktar minn 1000 riżultat ta' tqala) wara esponiment waqt it-tieni u t-tielet trimestri ma jindikax effetti tossiċi filfetu/tarbija tat-twelid.
English: Pharmacotherapeutic group: Antivirals for systemic use, nucleoside and nucleotide reverse transcriptase inhibitors, ATC code: J05AF11
Maltese: Antivirali għal użu sistematiku, inibituri tan-nucleoside u tannucleotide reverse transcriptase, Kodiċi ATC:
English: HBV encoding the adefovir resistance-associated substitutions rtN236T or rtA181V had around 0.3- and 4fold change in susceptibility to telbivudine in cell culture, respectively (see section 4.4).
Maltese: HBV li kien jesprimi s-sostituzzjonijiet rtN236T jew rtA181V assoċjati mar-reżistenza għal adefovir kellu bejn 0.3 drabi u 4 darbiet ta' bidla fis-suxxettibilità għal telbivudine fil-koltura taċċellula, rispettivament (ara sezzjoni 4.4).
English: Knodell necroinflammatory score ≤ 3 (no or minimal necroinflammation) was observed in 98.2% (56/57) of patients.
Maltese: (mingħajr nekroinfjammazzjoni jew inkella minima) dehret fi 98.2% (56/57) tal-pazjenti.
English: After 104 weeks of telbivudine therapy, 78% of patients (530/680) from study NV-02B-007 (GLOBE) and 82% (137/167) of patients from study NV-02B-015 enrolled into the extension study CLDT600A2303 (see section 5.1) to continue treatment for up to 208 weeks.
Maltese: Wara 104 ġimgħat ta' terapija b'telbivudine, 78% tal-pazjenti (530/680) mill-istudju NV-02B-007 (GLOBE) u 82% (137/167) ta' pazjenti mill-istudju NV-02B-015 inkitbu fl-estensjoni tal-istudju CLDT600A2303 (ara sezzjoni 5.1) sabiex ikomplu bit-trattament sa 208 ġimgħat.
English: In HBeAg-negative patients, telbivudine was non-inferior to lamivudine (75.2% and 77.2% responders; p = 0.6187).
Maltese: 2% u 77.2% ta' dawk li wrew rispons; p = 0.6187).
English: Race There are no significant race-related differences in telbivudine pharmacokinetics.
Maltese: Razza M'hemm differenzi sinifikanti relatati mar-razza fil-farmakokinetiċi ta' telbivudine.
English: Approximately 42% of the dose is recovered in the urine over 7 days following a single 600 mg oral dose of telbivudine.
Maltese: Madwar 42% tad-doża tiġi rkuprata mill-awrina fuq medda ta' 7 ijiem wara li tingħata doża waħda orali ta' 600 mg telbivudine.
English: In vitro, telbivudine was not active against the HBV strains containing rtM204V/rtL180M or rtM204I mutations (see section 5.1).
Maltese: Telbivudine ma kienx attiv in vitro kontra r-razez ta' HBV li fihom il-mutazzjonijiet rtM204V/rtL180M jew rtM204I (ara sezzjoni 5.1).
English: HBeAg-negative patients (n = 209*)
Maltese: Pazjenti negattivi għal HBeAg(n = 209*)
English: Transient reductions in HIV-1 RNA have been reported in a small number of patients after administration of telbivudine in the absence of antiretroviral therapy.
Maltese: Kien irrappurtat tnaqqis tranżitorju fl-HIV-1 RNA f'għadd żgħir ta' pazjenti wara li ngħataw telbivudine fin-nuqqas ta' terapija antiretrovirali.
English: The clinical significance of these reductions has not been determined.
Maltese: L-importanza klinika ta' dan it-tnaqqis ma kenitx iddeterminata.
English: In the pooled analysis from NV-02B-007 (GLOBE) and NV-02B-015, by 104 weeks of treatment grade 3 or4 CK elevations (> 7x ULN) occurred in 12.6% of telbivudine-treated patients (n = 847) and 4.0% of lamivudine-treated patients (n = 846).
Maltese: Fl-analiżi kollettiva minn NV-02B-007 (GLOBE) u NV-02B-015, sa 104 ġimgħat ta' kura żidiet (>7x ULN) fis-CK ta' gradi 3 jew 4 seħħew f'12.6% tal-pazjenti kurati b'telbivudine (n = 847) u f'4.0% talpazjenti kurati b'lamivudine (n = 846).
English: After reaching peak concentration, plasma disposition of telbivudine declined in a bi-exponential manner with a terminal elimination half-life (t1/2) of 41.8 ± 11.8 hours.
Maltese: Wara li jilħaq il-quċċata tal-konċentrazzjoni, it-tneħħija ta' telbivudine mill-plażma naqset b'mod biesponenzjali b'half-life ta' eliminazzjoni terminali (t1/2) ta' 41.8 ± 11.8 sigħat.
English: - The other ingredients are: cellulose, microcrystalline; povidone; sodium starch glycolate; silica,
Maltese: - Is-sustanzi mhux attivi l-oħra huma: cellulose, microcrystalline; povidone; sodium starch glycolate; silica, colloidal anhydrous; magnesium stearate; hypromellose; titanium dioxide
English: Musculoskeletal and connective tissue disorders
Maltese: Disturbi muskolu-skelettriċi u tat-tessuti konnettivi
English: An increased risk of developing peripheral neuropathy has been observed in one study when telbivudine and pegylated interferon alfa-2a were co-administered (see section 4.5).
Maltese: Żieda fir-riskju li tiżviluppa newropatija periferali dehret fi studju wieħed meta telbivudine u interferon alfa-2a pegilat kienu ngħataw flimkien (ara sezzjoni 4.5).
English: Cumulative HBeAg seroconversion rates (%)
Maltese: Rati ta' serokonverżjoni kumulattivi ta' HbeAg (%)
English: Out of these 517 patients 159 patients (HBeAg-positive=135, HBeAg-negative=24) had detectable HBV DNA.
Maltese: Minn dawn il-517-il pazjent 159 pazjent (b'HBeAg pożittivi=135, HBeAg negattivi=24) kellhom HBV DNA li setgħu jitkejlu.
English: In HBeAg-negative patients with HBV DNA < 300 copies/ml at week 24, resistance was 0% (0/177) at 48 weeks and 5% (9/177) at week 104, whilst in patients with HBV DNA ≥ 300 copies/ml resistance was 11% (5/44) at 48 weeks and 34% (15/44) at week 104.
Maltese: Fil-pazjenti HBeAg-negattivi b'<300 kopja/ml ta' HBV DNA filġimgħa 24, ir-reżistenza kient ta' 0% (0/177) fit- 48 ġimgħa u 5% (9/177) fil-ġimgħa 104, filwaqt li f'pazjenti b' ≥300 kopja/ml ta' HBV DNA r-reżistenza kienet ta'11% (5/44) fit-48 ġimgħa u 34% (15/44) fil-ġimgħa 104.
English: At week 48 among HBeAg-positive and HBeAg-negative patients, 5% (23/458) and 2% (5/222), respectively, had virological rebound with detectable HBV resistance mutations.
Maltese: Fit-48 ġimgħa fost il-pazjenti b'HBeAg pożittivi u HBeAg negattivi, 5% (23/458) u 2% (5/222), rispettivament, kellhom rikaduta viroloġika b'mutazzjonijiet ta' reżistenza HBV li setgħu jitkejlu.
English: HBeAg-positive patients: The mean age of patients was 32 years, 74% were male, 82% were Asian, 12% were Caucasian, and 6% had previously received alfa-interferon therapy.
Maltese: L-età medja tal-pazjenti kienet 32 sena, 74% kienu rġiel, 82% kienu Ażjatiċi, 12% kienu Kawkażi, u 6% kienu rċevew qabel terapija b'alfa-interferon.
English: One ml contains 20 mg telbivudine.
Maltese: Kull ml fih 20 mg telbivudine.
English: Sebivo film-coated tablets are supplied in packs of 28 or 98 tablets.
Maltese: Il-pilloli miksija b'rita Sebivo jiġu f'pakketti ta' 28 jew 98 pillola.
English: Dizziness, headache
Maltese: Jekk tieqaf tieħu Sebivo
English: In assays relating to mitochondrial structure, function and DNA content, telbivudine lacked appreciable toxic effect at concentrations up to at 10 M and did not increase lactic acid production in vitro.
Maltese: F'assays dwar l-istruttura tal-mitokondriji, ilfunzjoni u l-kontenut ta' DNA, telbivudine ma kellux effett tossiku rilevanti f'konċentrazzjonijiet sa 10 M u ma żiedx il-produzzjoni ta' lactic acid in vitro.
English: 300 ml brown glass bottle with a child-resistant closure, including a polyethylene sealing disc and a guarantee ring, a polypropylene dosing cup with embossed graduations from 5 to 30 ml in 5 ml increments, and a polypropylene oral syringe with graduations of 1 ml to 10 ml in 0.5 ml increments.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Flixkun ta' 300 ml tal-ħġieġ kannella b'għatu li ma jinfetaħx mit-tfal, inkluż disk tal-polyethylene li tisiġilla u ċirku ta' garanzija, tazza tal-polypropylene tad-doża immarkata bi gradi ta' kejl ibbuzzat 'il barra minn 5 ml sa 30 ml b'żidiet ta' 5 ml, u siringa tal-ħalq tal-polypropylene bi gradi ta' kejl minn 1 ml sa 10 ml b'żidiet ta' 0.5 ml.
English: The safety and efficacy of long-term (104 weeks) Sebivo treatment were evaluated in two activecontrolled clinical studies that included 1,699 patients with chronic hepatitis B (NV-02B-007 (GLOBE) and NV-02B-015).
Maltese: Is-sigurtà u l-effikaċja ta' kura fit-tul (104 ġimgħat) ta' Sebivo ġew stmati f'żewġ studji kliniċi kkontrollati b'mod attiv li kienu jinkludu 1,699 pazjent b'epatite B kronika (NV-02B-007 (GLOBE) u NV-02B-015).
English: No data are available to support a specific dose recommendation for patients over the age of 65 years (see section 4.4).
Maltese: M'hemmx informazzjoni disponibbli li fuqha tista' tkun ibbażata rakkomandazzjoni għall-pazjenti 'l fuq minn 65 sena (ara sezzjoni 4.4).
English: ALT flares
Maltese: U LUŻU
English: Results from cell-based assays showed that the adefovir resistance-associated substitution A181V had 1.5- to approximately 4-fold reduced susceptibility to telbivudine.
Maltese: Riżultati minn analiżijiet ibbażati fuq iċ-ċellula wriet li s-sostituzzjoni A181V assoċjata mar-reżistenza ta' adefovir kellha suxxettibbilità mnaqqsa bejn 1.5 drabi u madwar 4 darbiet għal telbivudine.
English: It is efficiently phosphorylated by cellular kinases to the active triphosphate form, which has an intracellular half-life of 14 hours.
Maltese: Jiġi fosforilat b'mod effiċjenti bil-kinases taċ-ċelluli fil-forma triphosphate attiva, li fiċ-ċelluli għandu half-life ta' 14-il siegħa.
English: Myopathy, defined as persistent unexplained muscle aches and/or muscle weakness regardless of the degree of increases in creatine kinase (CK) levels, should be considered in any patient with diffuse unexplained myalgias, muscle tenderness, muscle weakness or myositis (defined as myopathy with histological evidence of muscle damage).
Maltese: Mijopatija, definita bħala weġgħat fil-muskoli persistenti u mingħajr spjegazzjoni u/jew dgħjufija filmuskoli mhux relatata ma' żiediet fil-livelli ta' creatine kinase (CK) abnormali, għandu jitqies f'kull pazjenti li jsofri b'majalġji mifrux mingħajr spjegazzjoni, tenerezza tal-muskoli, dgħjufija tal-muskoli jew mijożite (definita bħala mijopatija b'evidenza istoloġika ta' ħsara tal-muskoli).
English: In the overall ITT population the cumulative resistance rates at year 4 for HBeAg-positive and HBeAg-negative patients, was 40.8% (131/321) and 18.9% (37/196), respectively.
Maltese: Fil-popolazzjoni sħiħa ITT ir-rati kumulattivi ta' reżistenza fir-4a sena għal pazjenti b'HBeAg pożittivi u HBeAg negattivi, kienet ta' 40.8% (131/321) u 18.9% (37/196) rispettivament.
English: < 30 (not requiring dialysis)
Maltese: <30 (ma tinħtieġx dijalisi)
English: Pack sizes: 28 or 98 film-coated tablets
Maltese: Daqsijiet tal-pakketti: 28 jew 98 pillola miksija b'rita.
English: A clinical trial investigating the combination of telbivudine, 600 mg daily, with pegylated interferon alfa-2a, 180 micrograms once weekly by subcutaneous administration, indicates that this combination is associated with an increased risk of developing peripheral neuropathy.
Maltese: Prova klinika li kienet qed tinvestiga it-taħlita ta' telbivudine, 600 mg kuljum, ma interferon alfa-2a pegilat, 180 mikrogrammi darba fil-ġimgħa permezz ta' għotja taħt il-ġilda, tindika li din it-taħlita hija assoċjata ma' żieda fir-riskju li tiżviluppa newropatija periferali.
English: Blood creatine phosphokinase increased, blood alanine aminotransferase increased, blood amylase increased
Maltese: Żieda ta' creatine phosphokinase fid-demm, żieda ta' alanine aminotransferase fid-demm, żieda ta' amylase fid-demm
English: Following oral administration of a 600 mg single dose of telbivudine to healthy subjects (n = 42), the peak plasma concentration (Cmax) of telbivudine was 3.2  1.1 g/ml (mean  SD) and occurred at median 3.0 hours post dose.
Maltese: Wara l-għotja ta' doża orali ta' 600 mg telbivudine lill-individwi b'saħħithom (n = 42), il-quċċata talkonċentrazzjoni fil-plażma (Cmax) ta' telbivudine kienet 3.2  1.1 g/ml (medja  SD) u seħħet medja ta' 3.0 sigħat wara li ngħatat id-doża.
English: HBeAg seroconversion n/N (%)
Maltese: Serokonverżjoni ta' HBeAg n/N (%)
English: In HBeAg-positive patients with HBV DNA < 300 copies/ml at week 24, resistance was 1% (3/203) at 48 weeks and 9% (18/203) at week 104, whilst in patients with HBV DNA ≥ 300 copies/ml resistance was 8% (20/247) at 48 weeks and 39% (97/247) at week 104.
Maltese: HBeAg-pożittivi b'<300 kopja/ml ta' HBV DNA fil-ġimgħa 24, ir-reżistenza kienet ta' 1% (3/203) fit-48 ġimgħa u 9% (18/203) fil-ġimgħa 104, filwaqt li f'pazjenti b' ≥300 kopja/ml ta' HBV DNA ir-reżistenza kienet ta' 8% (20/247) fit-48 ġimgħa u 39% (97/247) fil-ġimgħa 104.
English: The concentration of telbivudine that effectively inhibited 50% of viral synthesis (EC50) was approximately 0.2 M.
Maltese: Il-konċentrazzjoni ta' telbivudine li għamlet inibizzjoni effettiva ta' 50% tassinteżi virali (EC50) kienet madwar 0.2 M.
English: Renal function (creatinine clearance in ml/min)
Maltese: Funzjoni Renali (tneħħija tal-krejatinina mfissra f' ml/min)
English: A vaccine is available to prevent infection with HBV.
Maltese: Hemm tilqima sabiex jiġu evitati infezzjonijiet b'HBV.
English: ALT elevation > 2x baseline and > 10x ULN
Maltese: Żieda ta' l-ALT >2 darbiet il-linja bażi u >10 darbiet ULN
English: Aspartate aminotransferase increased * This adverse reaction was identified through post-marketing surveillance but not observed in controlled clinical trials.
Maltese: Żieda ta' aspartate aminotransferase * Din ir-reazzjoni mhux mixtieqa kienet identifikata permezz ta' stħarriġ wara t-tqegħid talprodott fis-suq imma ma dehritx waqt provi kliniċi kkontrollati.
English: Conversions at position 80, 180 and polymorphic positions 91, 229 were always detected in sequences that harboured the M204I mutation that confers genotypic resistance.
Maltese: Seħħew konverżjonijiet f'pożizzjoni 80, 180 u f'pożizzjonijiet polimorfiċi 91, 229 li dehru dejjem f'sekwenza li pproteġiet il-mutazzjoni M204I li twassal għal reżistenza ġenotipika.
English: Method of administration
Maltese: Reżistenza klinika
English: The antiviral activity of telbivudine is specific to the hepatitis B virus and related hepadnaviruses.
Maltese: L-attività antivirali ta' telbivudine hija speċifika għallvirus ta' epatite B u l-ħepadnaviruses relatati.
English: Sebivo 20 mg/ml oral solution is supplied as 300 ml of a clear, colourless to pale yellow solution in an brown glass bottle with a child-resistant white polypropylene closure, including a polyethylene sealing disc and a guarantee ring.
Maltese: Is-soluzzjoni orali Sebivo 20 mg/ml hija fornuta bħala 300 ml ta' soluzzjoni trasparenti, minn bla kulur sa safra ċara fi flixkun tal-ħġieġ kannella b'għatu abjad tal-polypropylene li ma jinfetaħx mittfal, inkluż disk tal-polyethylene li tisiġilla u ċirku ta' garanzija.
English: Genotypic analysis of 50 HBV isolates from telbivudine-treated patients at week 208 (CLDT600A2303) revealed a similar resistance profile as reported at week 104.
Maltese: Analiżi ġenotipika ta' 50 iżolat b'HBV minn fost il-pazjenti kkurati b'telbivudine fil-ġimgħa 208 (CLDT600A2303) wriet profil ta' reżistenza simili għal dak kif irrappurtat fil-ġimgħa 104.