FrancophonIA/ELRC3.0 huggingface dataset:
English: 120 mg (6 ml) once daily 600 mg once every 96 hours * End stage renal disease ** In case use of the oral solution is not possible
Maltese: 120 mg (6 ml) darba kuljum 600 mg darba kull 96 siegħa * Mard renali fl-aħħar fażi ** F'każ li l-użu tas-soluzzjoni orali ma jkunx possibbli
English: The overall safety profile from the pooled analysis up to 104 and 208 weeks was similar.
Maltese: Il-profil sħiħ ta' sigurtà mill-analiżi kollettiva sa 104 u 208 ġimgħa kienu jixxiebhu.
English: Adults The recommended dose of Sebivo is 30 ml, providing a dose equivalent to 600 mg, once daily.
Maltese: Id-doża rakkomandata ta' Sebivo hija ta' 30 ml, li tipprovdi doża ekwivalenti għal 600 mg, darba kuljum.
English: Of those HBeAg-positive subjects, 95% achieved non-detectable HBV DNA, 39% achieved HBeAg seroconversion, 90% achieved ALT normalisation at week 52 and 0.5% exhibited resistance at week 48.
Maltese: Minn dawk il-pazjenti HBeAg-pożittivi, 95% kisbu livelli ta' HBV DNA li ma setgħux jitkejlu, 39% kisbu serokonverżjoni HBeAg, 90% kisbu livelli normali ta' ALT mat-52 ġimgħa u 0.5% saru reżistenti mat-48 ġimgħa.
English: For Ishak Fibrosis Score, improvement measured as ≥ 1 point reduction in Ishak Fibrosis Score from baseline to week 52.
Maltese: Ishak Score, it-titjib imkejjel bħala tnaqqis ta' ≥1 fil-Punteġġ Fibrożi
English: The in vitro antiviral activity of telbivudine was assessed in the HBV-expressing human hepatoma cell line 2.2.15.
Maltese: L-attività antivirali in vitro ta' telbivudine kienet stmata fil-linja ta' ċelluli ta' epatoma tal-bniedem 2.2.15 li jesprimu HBV.
English: In cell-based assays, lamivudine-resistant HBV strains containing either the rtM204I mutation or the rtL180M/rtM204V double mutation had ≥ 1,000-fold reduced susceptibility to telbivudine.
Maltese: F'assays bażati fuq ċelluli, razzez ta' HBV reżistenti għal lamivudine li kien fihom jew l-mutazzjoni rtM204I jew ilmutazzjoni doppja rtL180M/rtM204V kellhom tnaqqis fis-suxxettibilità għal telbivudine ta' ≥1,000 darba.
English: Sebivo 20 mg/ml oral solution Telbivudine
Maltese: Sebivo 20 mg/ml soluzzjoni orali telbivudine
English: At week 24, 203 HBeAg-positive and 177 HBeAg-negative subjects achieved non-detectable HBV DNA levels.
Maltese: Ma' l-24 ġimgħa, 203 pazjenti HBeAg-pożittivi u 177 pazjent HBeAg-negattivi kisbu livelli ta' HBV DNA li lanqas setgħu jitkejlu.
English: After a median off-treatment follow-up period of 120 weeks, the majority of HBeAg-positive telbivudine treated-patients showed sustained HBeAg loss (83.3%; 25/30), and sustained HBeAg seroconversion (79.2%; 19/24).
Maltese: Wara perjodu medju ta' viżti li saru wara li twaqqaf it-trattament ta' 120 ġimgħa, ilmaġġoranza tal-pazjenti kkurati b'telbivudine b'HBeAg pożittivi wrew tnaqqis sostenibbli ta' HBeAg (83.3%; 25/30), u serkonverżjoni sostenibbli ta' HBeAg (79.2%; 19/24).
English: Joint pain
Maltese: Mhux komuni
English: Following once-daily administration of telbivudine 600 mg, steady-state trough plasma concentrations were approximately 0.2-0.3 g/ml.
Maltese: Wara lgħotja ta' 600 mg telbivudine darba kuljum, stat-fiss tal-konċentrazzjonijiet fil-plażma l-aktar baxxi kienu madwar 0.2-0.3 g/ml.
English: Patients with ≥ one dose of study drug with evaluable baseline liver biopsies and baseline Knodell Histological Activity Index (HAI) score > 3.
Maltese: Pazjenti b' ≥ doża waħda tal-mediċina li qed tiġi studjata b'bijopsiji tal-fwied li ttieħdu mal-linja bażi li setgħu jiġu evalwati u b'punteġġ ta' l-Indiċi ta' Attività Istoloġika Knodell (HAI) mal-linja bażi >3.
English: In vitro binding of telbivudine to human plasma proteins is low (3.3%).
Maltese: L-irbit ta' telbivudine mal-proteini tal-plażma fil-bniedem huwa baxx (3.3%).
English: Clear, colourless to pale yellow solution.
Maltese: Soluzzjoni trasparenti, minn bla kulur sa safra ċara.
English: Assessment of adverse reactions is mainly based on two studies, NV-02B-007 (GLOBE) and NV-02B015, in which 1,699 patients with chronic hepatitis B received double-blind treatment with telbivudine 600 mg/day (n = 847) or lamivudine (n = 852) for 104 weeks.
Maltese: NV-02B-007 (GLOBE) u NV02B-015 li fihom 1,699 pazjent b'epatite B kronika rċevew kura double-blind b'telbivudine 600 mg/jum (n = 847) jew lamivudine (n = 852) għal 104 ġimgħat.
English: By contrast, telbivudine-5'-triphosphate at concentrations up to 100 M did not inhibit cellular DNA polymerases , , or .
Maltese: B'kuntrast, konċentrazzjonijiet ta' telbivudine-5'-triphosphate sa 100 M ma wasslux għallinibizzjoni ta' DNA polymerases ċellulari , , jew .
English: The incidence of on treatment alanine aminotransferase (ALT) flares in the two treatment arms according to AASLD (American Association for the Study of Liver Diseases) definition (ALT elevation > 2x baseline and > 10x ULN) are further described in Table 3 below.
Maltese: In-numru ta' drabi li fihom seħħew żiediet f'daqqa ta' alanine aminotransferase (ALT) waqt il-kura fiż-żewġ fergħat skond id-definizzjoni ta' l-AASLD (Assoċjazzjoni Amerikana għall-Istudji tal-Mard tal-Fwied) (żieda ta' l-ALT ta' >2 darbiet mill-linja bażi u >10 darbiet l-ULN) huma spjegati aktar f'Tabella 3 taħt.
English: Respiratory, thoracic and mediastinal disorders
Maltese: Disturbi respiratorji, toraċiċi u medjastinali Komuni
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini http://www.ema.europa.eu.
English: Rhabdomyolysis
Maltese: • Ir-riżultat
English: ALT flare:
Maltese: Pazjenti HBeAg-pożittivi:
English: Sebivo oral solution contains approximately 47 mg sodium per 600 mg dose (30 ml), which should be taken into consideration by patients on a controlled sodium diet.
Maltese: Sebivo soluzzjoni orali fiha bejn wieħed u ieħor 47 mg ta' sodium f'kull doża ta' 600 mg (30 ml), li għandu jiġi kkunsidrat mill-pazjenti li qegħdin fuq dieta tas-sodium kkontrollata.
English: Studies NV-02B-007 (GLOBE) and CLDT600A2303 - cumulative genotypic resistance rates The original analysis for cumulative genotypic resistance at week 104 and 208 was based on the ITT population and included all patients who continued treatment until 4 years, regardless of HBV DNA levels.
Maltese: NV-02B-007 (GLOBE) u CLDT600A2303 - rati kumulattivi ta' reżistenza ġenotipika L-analiżi oriġinali għar-reżistenza ġeneotipika kumulattiva fil-104 u l-208 ġimgħat kienet tissejjes fuq il-popolazzjoni ITT u kienet tinkludi pazjenti li komplet bit-trattament għal 4 snin, indipendentament mil-livelli ta' HBV DNA.
English: Telbivudine did not show any carcinogenic potential.
Maltese: Telbivudine ma deherx li kellu xi potenzjal kanċeroġenu.
English: The long-term safety population consisted of 655 patients including 518 from NV-02B-007 (GLOBE) and 137 from NV02B-015.
Maltese: Il-popolazzjoni magħżula biex tkun analizzata s-sigurtà fit-tul kienet tinkludi 655 pazjent li minnhom 518 kienu minn NV-02B-007 (GLOBE) u 137 minn NV-02B-015.
English: Cases of rhabdomyolysis have been reported during post-marketing use of telbivudine (see section 4.8).
Maltese: Monitoraġġ perjodiku tal-funzjoni epatika huwa kunsiljat waqt il-kura (ara sezzjoni 4.4).
English: Steady state was achieved after 5 to 7 days of once-daily administration with an approximate 1.5-fold accumulation in systemic exposure, suggesting an effective accumulation half-life of approximately 15 hours.
Maltese: Stat fiss inkiseb wara 5 sa 7 ijiem ta għotja ta' darba kuljum b'akkumulazzjoni ta' madwar 1.5-il darba flesponiment sistemiku, li jindika akkumulazzjoni ta' half-life effettiv ta' madwar 15-il siegħa.
English: HBV DNA undetectability n/N (%)
Maltese: HBV DNA li ma setgħux jitkejlu n/N (%)
English: Following initiation of antiviral treatment, serum ALT may rise in some patients while serum levels of HBV DNA fall (see section 4.8).
Maltese: Wara li tibda l-kura antivirali, f'xi pazjenti jista' jkun hemm żieda ta' ALT fis-serum filwaqt li l-livelli ta' HBV DNA fis-serum jaqaw (ara sezzjoni 4.8).
English: The recommended dose of Sebivo is 30 ml of oral solution (600 mg telbivudine) once a day.
Maltese: Id-doża rakkomandata ta' Sebivo hija 30 ml ta' soluzzjoni orali (600 mg telbivudine) darba kuljum.
English: One tablet contains 600 mg telbivudine.
Maltese: Kull pillola fiha 600 mg telbivudine.
English: Similarly of those HBeAg-negative subjects, 96% achieved non-detectable HBV DNA, 79% achieved ALT normalisation at week 52 and 0% exhibited resistance at week 48.
Maltese: Bl-istess mod, f'dawk l-individwi HBeAgnegattivi, 96% kisbu livelli ta' HBV DNA li ma setgħux jitkejlu, 79% kisbu livelli normali ta' ALT mat-52 ġimgħa u 0% saru reżistenti mat-48 ġimgħa.
English: Fertility was reduced in pairs given ≥ 1000 mg/kg/day as shown by decreases in fertility and mating indices, and reduced conception rate.
Maltese: Il-fertilità kienet imnaqqsa fil-pari li ngħataw ≥1000 mg/kg/kuljum kif intwera minn tnaqqis fl-indiċi tal-fertilità u tat-tgħammir, u r-rata mnaqqsa ta' konċepiment.
English: Sebivo has not been investigated in co-infected hepatitis B patients (e.g. patients co-infected with human immunodeficiency virus [HIV], hepatitis C virus [HCV] or hepatitis D virus [HDV]).
Maltese: [HCV] jew bil-virus tal-epatite D [HDV].
English: Since telbivudine is eliminated primarily by renal excretion, co-administration of Sebivo with substances that affect renal function (such as aminoglycosides, loop diuretics, platinum compounds, vancomycin, amphotericin B) may affect plasma concentrations of telbivudine and/or the coadministered substance.
Maltese: Peress li telbivudine jitneħħa mill-ġisem l-aktar permezz tal-kliewi, l-għotja ta' Sebivo fl-istess ħin ma' sustanzi li jeffettwaw il-funzjoni renali (bħal aminoglycosides, dijurtiċi loop, sustanzi li fihom platinum, vancomycin, amphotericin B) jistgħu jaffettwaw l-konċentrazzjonijiet ta' telbivudine filplażma u/jew tas-sustanza li tkun qed tiġi mogħtija fl-istess ħin.
English: The single- and multiple-dose pharmacokinetics of telbivudine were evaluated in healthy subjects and in patients with chronic hepatitis B. The pharmacokinetics of telbivudine were not evaluated with the recommended dose of 600 mg in patients with chronic hepatitis B. However telbivudine pharmacokinetics are similar between both populations.
Maltese: L-farmakokinetiċi ta' telbivudine ma kienux evalwati bid-doża rakkomandata ta' 600 mg f'pazjenti b'epatite B kronika.
English: The single-dose pharmacokinetics of telbivudine (200, 400 and 600 mg) have been evaluated in patients (without chronic hepatitis B) with various degrees of renal impairment (as assessed by creatinine clearance).
Maltese: Il-farmakoiknetiċi ta' doża waħda ta' telbivudine (200, 400 u 600 mg) kienu stmati f'pazjenti (mingħajr epatite B kronika) b'gradi varji ta' indeboliment renali (kif stmat mit-tneħħija talkrejatinina).
English: Haemodialysis (up to 4 hours) reduces systemic telbivudine exposure by approximately 23%.
Maltese: Il-ħemodijaliżi (sa 4 sigħat) tnaqqas l-esponiment ta' telbivudine sistemiku b'madwar 23%.
English: Grade 3 or 4 CK elevations newly occurred in 15.9% of patients treated with telbivudine for 208 weeks.
Maltese: Kien hemm elevazzjonijiet ġodda fi Grad 3 jew 4 f'15.9% talpazjenti ttratti b'telbivudine għal 208 ġimgħat.
English: HBeAg-positive patients (n = 293*)
Maltese: Pazjenti pożittivi għal HBeAg (n = 293*)
English: CLDT600A2303 - Off-treatment durability of HBeAg responses Study CLDT600A2303 included HBeAg-positive patients from studies NV-02B-007 (GLOBE) or NV-02B-015 for off-treatment follow up.
Maltese: CLDT600A2303 - Permanenza tar-rispons ta' HbeAg mhux waqt it-trattament L-istudju CLDT600A2303 kien jinkludi pazjenti b'HBeAg pożittivi mill-istudji
English: 28 film-coated tablets 98 film-coated tablets
Maltese: 28 pillola miksija b'rita
English: One isolated rtM204V mutation and two rtM204I/V/M mutations were reported in telbivudine-treated patients experiencing viral breakthrough up to week 208.
Maltese: Mutazzjoni waħda iżolata rtM204V u żewġ mutazzjonijiet rtM204I/V/M kienu rrappurtati f'pazjenti kkurati b'telbivudine u li kellhom penetrazzjoni virali sa ġimgħa 208.
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA [folding box only]
Maltese: IDENTIFIKATUR UNIKU - DATA LI TINQARA MILL-BNIEDEM [kaxxa li tintlewa biss]
English: Duration of therapy The optimal treatment duration is unknown.
Maltese: Mhux magħruf it-tul ta' terapija idejali.
English: When considering patients with viral breakthrough by 104 weeks in NV-02B-007 (GLOBE), the rate of resistance was lower in patients with HBV DNA < 300 copies/ml at week 24 than in patients with HBV DNA ≥ 300 copies/ml at week 24.
Maltese: Meta tikkunsidra pazjenti b'penetrazzjoni virali sal-ġimgħa 104 f'NV-02B-007 (GLOBE), ir-rata ta' reżistenza kienet inqas f'pazjenti b'<300 kopja/ml ta' HBV DNA fil-ġimgħa 24 milli f'pazjenti b'≥300 kopja/ml ta' HBV DNA fil-ġimgħa 24.
English: B. PACKAGE LEAFLET
Maltese: B'mod globali
English: Creatinine clearance (ml/min)
Maltese: Tneħħja talkrejatinina (ml/min)
English: Excipient with known effect: A 600 mg dose (30 ml) of oral solution contains approximately 47 mg sodium.
Maltese: Doża ta' 600 mg (30 ml) ta' soluzzjoni orali fiha bejn wieħed u ieħor 47 mg ta' sodium.
English: Baseline factors associated with development of genotypic drug resistance included: lamivudine treatment, higher baseline HBV DNA, lower baseline serum ALT, and increased body weight/BMI.
Maltese: Fatturi tal-linja bażi assoċjati ma' l-iżvilupp ta' reżistenza ġenotipika kienu jinkludu: kura b'lamivudine, linja bażi ogħla ta' HBV DNA, linja bażi aktar baxxa ta' ALT fis-serum, u żieda fil-piż tal-ġisem/BMI.
English: ALT normalisation n/N (%)
Maltese: Normalizzazzjoni ta' l-ALT n/N (%)
English: The pack contains an oral dosing cup made of polypropylene 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: Il-pakkett fih tazza tad-doża magħmula mill-polypropylene mmarkata 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: No definitive conclusion could be drawn regarding the effects of telbivudine on the pharmacokinetics of pegylated interferon due to high interindividual variability of pegylated interferon alfa-2a concentrations.
Maltese: Ma setgħetx tinstab konklużjoni definittiva dwar l-effetti ta' telbivudine fuq ilfarmakokinetiċi ta' interferon alfa pegilat minħabba l-varjabbiltà kbira bejn individwu u ieħor filkonċentrazzjonijiet ta' interferon alfa-2a pegilat.
English: Clinical experience
Maltese: KLINIKU
English: Incorporation of telbivudine-5'-triphosphate into viral DNA causes DNA chain termination, resulting in inhibition of HBV replication.
Maltese: Meta telbivudine-5'triphosphatase jiġi nkorporat fid-DNA tal-virus, il-katina tad-DNA tiġi terminata, u b'hekk irreplikazzjoni ta' HBV tieqaf.
English: Study CLDT600A2303 - Clinical results over 208 weeks Study CLDT600A2303 was an open-label 104-week extension study in patients with compensated chronic hepatitis B who were previously treated with telbivudine for 2 years including patients from studies NV-02B-007 (GLOBE) and NV-02B-015, providing efficacy and safety data after 156 and 208 weeks of continuous telbivudine therapy.
Maltese: Studju CLDT600A2303 - Riżultati kliniċi ‘l fuq minn 208 ġimgħat L-istudju CLDT600A2303 kien studju ta' estensjoni open-label ta' 104 ġimgħat fost pazjenti b'epatite kroinka B kkompensata li qabel kienu ttrattati b'telbivudine għal sentejn inkluż pazjenti mill-istudji
English: The no observed adverse effect level (NOAEL) for effects on fertility or mating parameters amounted to 250 mg/kg/day, which provided exposure levels 2.5 to 2.8 times higher than those achieved in humans with normal renal function at the therapeutic dose.
Maltese: Il-livell li fih ma jiġi osservat l-ebda effett avvers (NOAEL) għal effetti fuq il-parametri ta' fertilità jew ta' tgħammir kien ilaħħaq il-250 mg/kg/kuljum, li pprovda livelli ta' esponiment minn 2.5 sa 2.8 drabi aktar minn dawk li jinkisbu fil-bnedmin li għandhom funzjoni normali tal-kliewi, b'doża terapewtika.
English: The NV-02B-007 (GLOBE) study is a randomised, double-blind, multinational phase III study of telbivudine compared to lamivudine for a treatment period of 104 weeks in 1,367 nucleoside-naïve chronic hepatitis B HBeAg-positive and HBeAg-negative patients.
Maltese: III imqabbel ma' dak ta' lamivudine għal perijodu ta' kura ta' 104 ġimgħat f' 1,367 pazjent li qatt ma ingħataw nucleoside u li kellhom epatite B HBeAg-posittiva u HBeAgnegattiva kronika.
English: This study is a phase III, randomised, double-blind study of telbivudine 600 mg once daily compared to lamivudine 100 mg once daily for a treatment period of 104 weeks in 332 nucleosidenaïve chronic hepatitis B HBeAg-positive and HBeAg-negative Chinese patients.
Maltese: III, randomized, double-blind ta' telbivudine 600 mg darba kuljum imqabbel ma' lamivudine 100 mg darba kuljum għal perijodu ta' kura ta' 104 ġimgħat f'332 pazjent Ċiniż li ma ngħatawx nucleoside qabel pożittivi għall-HBeAg u negattivi għal HBeAg b'epatite B kronika.
English: End-stage renal disease patients For patients with ESRD, Sebivo should be administered after haemodialysis (see section 5.2).
Maltese: Għal pazjenti b'ESRD, Sebivo għandu jingħata wara l-ħemodijaliżi (ara sezzjoni 5.2).
English: Clinical results at week 104
Maltese: Riżultati kliniċi fil-ġimgħa 104
English: Renally impaired patients on haemodialysis
Maltese: Pazjenti b'indeboliment renali fuq il-ħemodijaliżi
English: A small number (total of 98) of Caucasian patients were treated with telbivudine.
Maltese: Numru żgħir (total ta' 98) ta' pazjenti Kawkażjatiċi ngħataw kura b'telbivudine.
English: EU/1/07/388/001 EU/1/07/388/002
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/07/388/003
English: Telbivudine was not active against HIV in vitro.
Maltese: Telbivudine ma kienx attiv kontra
English: N/A 131/159 (82)
Maltese: 146/177 (82) 156/177 (88) Ma japplikax 131/159 (82)
English: No evidence of impaired fertility was seen in other studies when either male or female rats were treated at doses up to 2000 mg/kg/day and mated with untreated rats (systemic exposure levels approximately 6-14 times higher than those achieved in humans).
Maltese: Ma dehret l-ebda evidenza ta' fertilità indebolita fi studji oħra meta jew firien irġiel jew firien nisa kienu kkurati b'dożi sa 2000 mg/kg/kuljum u kienu mgħammra ma' firien mhux ikkurati (livelli ta' esponimenti sistemiċi minn madwar 6-14-il darba aktar minn dawk miksuba fil-bnedmin).
English: ALT normalisation rates (78% vs 70%) continued to be higher by week 104.
Maltese: Ir-rati ta' normalizzazzjoni ta' l-ALT (78% vs 70%) komplew ikunu ogħla sal-ġimgħa 104.
English: Remove the dosing cup.
Maltese: Neħħi t-tazza tad-doża.
English: On-treatment response parameters at week 24 that predicted emergence of drug resistant virus by week 104 were HBV DNA > 300 copies/ml and elevation of serum ALT.
Maltese: Il-parametri ta' rispons waqt il-kura fil-ġimgħa 24 li bassret l-itfaċċar tal-virus reżistenti għall-mediċina sal-ġimgħa 104, kienu >300 kopja/ml ta' HBV DNA u żieda ta'ALT fis-serum.
English: - The other ingredients are: benzoic acid, sodium saccharin, passion fruit flavouring, sodium hydroxide, citrc acid anhydrous, water.
Maltese: - Is-sustanzi mhux attivi l-oħra huma: benzoic acid, sodium saccharin, passion fruit flavouring,
English: Such increased risk cannot be excluded for other interferon alfa (pegylated or standard).
Maltese: Żieda bħal din fir-riskju ma tistax tiġi eskluża għal interferon alfa oħrajn (pegilati jew standard).
English: Do not take Sebivo if you are using pegylated or standard interferon alfa (see “Do not take Sebivo”), because the combination of these medicines may increase your risk of developing peripheral neuropathy (numbness, tingling, and/or burning sensations in the arms and/or legs).
Maltese: Tiħux Sebivo jekk inti qed tieħu pegilat jew interferon alfa standard (ara “Tiħux Sebivo”), minħabba li meta qed tħallat flimkien dawn il-mediċini jista' jiżdied ir-riskju li inti tiżviluppa newropatija periferali (titrix, tingiż, u/jew sensazzjoni ta' ħruq fid-dirgħajn u/jew fir-riġlejn).
English: Selected virological, biochemical and serological outcome measures are shown in Table 5 and histological response in Table 6.
Maltese: Miżuri għall-konsegwenzi viroloġici, biokimiċi u seroloġiċi magħżula qed jintwerew f'Tabella 5 u rrispons istoloġiku f'Tabella 6.
English: The adverse effects on fertility were greater in a separate study in juvenile animals when both sexes received telbivudine (see section 5.3).
Maltese: L-effetti avversi fuq il-fertilità kienu akbar fi studju separat f'annimali żgħażagħ meta ż-żewġ sessi ngħataw telbivudine (ara sezzjoni 5.3).
English: How to take Sebivo
Maltese: Inti u tieħu Sebivo:
English: Most grade 3 or 4 CK elevations were asymptomatic and transient.
Maltese: Bosta mill-elevazzjonijiet fis-CK fi grad 3 jew 4 kienu asintomatiċi u tranżitorji.
English: Fertility was assessed in conventional studies performed in adult rats, and as part of a juvenile toxicology study.
Maltese: Il-fertilità kienet stmata fi studji konvenzjonali li saru fuq firien adulti, u bħala parti minn studju ta' tossiċità fuq firien żgħażagħ.
English: Patients who achieve HBV DNA levels < 3 log10 copies/ml by week 24 had optimal responses to treatment; conversely patients with HBV DNA levels > 4 log10 copies/ml at 24 weeks had less favourable outcomes at week 52.
Maltese: Pazjenti li jiksbu livelli ta' HBV DNA ta' <3 log10 kopji/ml ma' ġimgħa 24 kellhom l-aqwa rispons għall-kura, bil-kontra pazjenti b'livelli ta' HBV DNA ta' >4 log10 kopji/ml ma' ġimgħa 24 ma kellhomx riżultati daqshekk tajbin ma' ġimgħa 52.
English: How to store Sebivo
Maltese: Rispons istoloġiku Titjib
English: Baseline ALT levels > 2x ULN and baseline HBV DNA < 9 log10 copies/ml were associated with higher rates of HBeAg seroconversion in HBeAg-positive patients.
Maltese: Bill-kontra, pazjenti li kellhom livelli ta' HBV DNA >4 log10 kopji/ml wara 24 ġimgħa kellhom konsegwenzi anqas favorevoli fit-52 ġimgħa.
English: The efficacy and safety results of the NV-02B-007 (GLOBE) study were confirmed in study NV-02B015.
Maltese: Ir-riżultati ta' l-effikaċja u s-sigurtà ta' l-istudju NV-02B-007 (GLOBE) kienu ikkonfermati fi studju NV-02B-015.
English: Literature shows that exposure to telbivudine in the second and/or third trimester of pregnancy has been shown to reduce the risk of HBV transmission from mother to infant if telbivudine is given in addition to Hepatitis B immune globulin and Hepatitis B vaccine.
Maltese: Il-letteratura turi li esponiment għal telbivudine fit-tieni u/jew fit-tielet trimestru tat-tqala ġie muri li jnaqqas ir-riskju ta' trasmissjoni ta' HBV mill-omm għat-tarbija jekk telbivudine jingħata flimkien ma' immunoglobulini għall-Epatite B u vaċċin tal-epatite B.
English: Cases of myopathy and myalgia have been reported with telbivudine use several weeks to months after starting therapy (see section 4.8).
Maltese: Każijiet ta' mijopatija u majalġja kienu rappurtati bl-użu ta' telbivudine għall-perjodu bejn numru ta' ġimgħat għall-numru ta' xhur wara li tibda t-terapija (ara sezzjoni 4.8).
English: Sebivo belongs to a group of medicines called antiviral medicines, which are used to treat infections caused by viruses.
Maltese: Sebivo jagħmel parti minn grupp ta' mediċini magħrufin bħala mediċini antivirali, li jintużaw biex jikkuraw infezzjonijiet ikkawżati minn viruses.
English: Telbivudine 20 mg/ml oral solution
Maltese: Soluzzjoni orali ta' telbivudine 20 mg/ml
English: Histological response defined as a ≥ 2 point decrease in Knodell Necroinflammatory Score from baseline with no worsening of the Knodell Fibrosis Score.
Maltese: Rispons Istoloġiku definit bħala tnaqqis ta' ≥2 punti fil-Punteġġ Nekro-infjammatorju Knodell mil-linja bażi mingħajr ma l-Punteġġ ta' Fibrożi Knodell ma jmur għall-agħar.
English: No novel mutation was reported.
Maltese: Dawn il-mutazzjonijiet x'aktarx huma mutazzjonijiet li jikkumpensaw.