FrancophonIA/ELRC3.0 huggingface dataset:
English: It interferes with the normal function and repair of DNA and RNA, the genetic instructions that cells need to function and multiply.
Maltese: Din tinterferixxi mal-funzjoni normali u t-tiswija tad-DNA u tar-RNA, l-istruzzjonijiet ġenetiċi li jeħtieġu liċ-ċelloli biex jiffunzjonaw u jimmultiplikaw.
English: Because Carmustine Obvius is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Minħabba li Carmustine Obvius huwa mediċina ġenerika, il-benefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: Carmustine Obvius is a cancer medicine that is used, on its own or with other cancer medicines and treatments, to treat the following types of cancer:
Maltese: Carmustine Obvius huwa mediċina ta' kontra l-kanċer li tintuża, waħidha jew ma' mediċini u kuri oħrajn kontra l-kanċer, biex tikkura t-tipi ta' kanċer li ġejjin:
English: There was no need for ‘bioequivalence' studies to investigate whether Carmustine Obvius is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood.
Maltese: Ma kienx hemm bżonn ta' studji ta' "bijoekwivalenza" biex jiġi investigat jekk Carmustine Obvius jiġix assorbit bl-istess mod bħall-mediċina ta' referenza biex jipproduċi l-istess livell tas-sustanza attiva fid-demm.
English: This means that Carmustine Obvius contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Carmubris.
Maltese: Dan ifisser li Carmustine Obvius fih l-istess sustanza attiva u jaħdem bl-istess mod bħal ‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) imsejħa Carmubris.
English: • Hodgkin's lymphoma and non-Hodgkin's lymphomas, types of cancer that originate from white blood cells.
Maltese: • limfoma ta' Hodgkin u limfomi mhux ta' Hodgkin, tipi ta' kanċer li joriġinaw minn ċelloli bojod tad demm.
English: How is Carmustine Obvius used?
Maltese: Carmustine Obvius?
English: As for every medicine, the company provided studies on the quality of Carmustine Obvius.
Maltese: Bħal kull mediċina, il-kumpanija pprovdiet studji dwar il-kwalità ta ' Carmustine Obvius.
English: How has Carmustine Obvius been studied?
Maltese: Kif ġie studjat Carmustine Obvius?
English: Side effects reported with Carmustine Obvius are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Carmustine Obvius huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Carmustine Obvius has been shown to be comparable to Carmubris.
Maltese: L-Aġenzija Ewropea għall-Mediċini kkonkludiet li, b'mod konformi mar-rekwiżiti tal-UE, Carmustine Obvius wera li huwa komparabbli għal Carmubris.
English: Therefore, the Agency's view was that, as for Carmubris, the benefit of Carmustine Obvius outweighs the identified risk and it can be authorised for use in the EU.
Maltese: Għaldaqstant, l-opinjoni tal-Aġenzija kienet li, ilbenefiċċju ta' Carmustine Obvius huwa akbar mir-riskju identifikat u jista' jiġi awtorizzat għall-użu flUE.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Carmustine Obvius have been included in the summary of product characteristics and the package leaflet.
Maltese: Fis-sommarju tal-karatteristiċi tal-prodott u fil-fuljett ta' tagħrif ġew inklużi r-rakkomandazzjonijiet u lprekawzjonijiet li għandhom jiġu segwiti mill-professjonisti fil-qasam tal-kura tas-saħħa u mill-pazjenti għall-użu sigur u effettiv ta' Carmustine Obvius.
English: • brain tumours, both those that develop directly in the brain and cancers that have spread from elsewhere in the body (metastatic brain tumours);
Maltese: • tumuri tal-moħħ, kemm dawk li jiżviluppaw direttament fil-moħħ kif ukoll kanċers li jkunu nfirxu minn x'imkien ieħor fil-ġisem (tumuri tal-moħħ metastatiċi);
English: This is because Carmustine Obvius is given by infusion into a vein, so the active substance is delivered straight into the bloodstream.
Maltese: Dan għaliex Carmustine Obvius jingħata minn infużjoni ġol-vina, sabiex is-sustanza attiva titwassal direttament fid-demm.
English: The measuring spoon is manufactured by: Comar Plastics Division, One Comar Place, Buena, NJ 08310, USA.
Maltese: L-imgħarfa tad-dożi hija ffabbrikata minn: Comar Plastics Division, One Comar Place, Buena, NJ 08310, USA.
English: Luxembourg/Luxemburg
Maltese: Luxembourg/Luxemburg N.V.
English: Year 1 Year 2 Year 3a Year 4a Year 5a
Maltese: Sena 1 Sena 2 Sena 3a Sena 4a Sena 5a
English: Also contains: maltitol, preservatives E216, E218.
Maltese: TA' EĊĊIPJENTI Fih ukoll: maltitol, preservatives E216, E218.
English: Haemodialysis or CAPD**
Maltese: Emodijaliżi jew CAPD**
English: Tablet core: crospovidone, lactose monohydrate, magnesium stearate, cellulose microcrystalline and povidone.
Maltese: Qalba tal-pillola: crospovidone, lactose monohydrate, magnesium stearate, cellulose microcrystalline u povidone.
English: Also contains lactose monohydrate.
Maltese: Lactose monohydrate
English: Tablet coating: hypromellose, macrogol 400, titanium dioxide (E171), and iron oxide red.
Maltese: Kisja tal-pillola: hypromellose, macrogol 400, titanium dioxide (E171), u iron oxide red.
English: Lactose monohydrate Magnesium stearate Cellulose, Microcrystalline Povidone
Maltese: Magnesium stearate Cellulose, Microcrystalline
English: At least 32.6 kgb
Maltese: Tal--anqas 32.6 kgb
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 fliżolati 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: Maltitol: Baraclude oral solution contains maltitol.
Maltese: Baraclude soluzzjoni orali fiha maltitol.
English: Outer carton: Baraclude 1 mg
Maltese: Baraclude 1 mg
English: Histological improvementb Ishak fibrosis score improvement Ishak fibrosis score worsening n
Maltese: Titijib istoloġikub Ishak fibrosis score aħjar Ishak fibrosis score agħar n
English: Name and address of the manufacturer responsible for batch release Bristol-Myers Squibb S.r.l., Contrada Fontana del Ceraso, 03012 Anagni (FR), Italy
Maltese: GĦALL-ĦRUĠ TAL-LOTT Isem u indirizz tal-manifattur responsabbli għall-ħruġ tal-lott Bristol-Myers Squibb S.r.l., Contrada Fontana del Ceraso, 03012 Anagni (FR), L-Italja
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 0.75 sigħat sajma), u tnaqqis f'Cmas ta' 44-46%, u tnaqqis f'AUC ta' 18-20%.
English: Tablet coating: hypromellose, macrogol 400, titanium dioxide (E171), and polysorbate 80 (E433).
Maltese: Kisja tal-pillola: hypromellose, macrogol 400, titanium dioxide (E171), u polysorbate 80
English: N.V. Bristol-Myers Squibb Belgium S.A. Tél/Tel: + 32 2 352 76 11
Maltese: Bristol-Myers Squibb Belgium S.A. Tél/Tel: + 32 2 352 76 11
English: Authorised Representative in the EEA for Comar Plastics: MDSS GmbH, Schiffgraben 41, 30175 Hannover, Germany
Maltese: MDSS GmbH, Schiffgraben 41, 30175
English: Antiviral activity: entecavir inhibited HBV DNA synthesis (50% reduction, EC50) at a concentration of 0.004 µM in human HepG2 cells transfected with wild-type HBV.
Maltese: Attività antivirali: entecavir impedixxa s-sintesi ta' DNA ta' HBV (tnaqqis ta' 50%, EC50) f'konċentrazzjoni ta' 0.004 µM f'ċelloli HepG2 umani transinfettati b'HBV wild-type.
English: HBV DNA < 50 IU/mLa
Maltese: HBV DNA < 50
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% talpazjenti, livelli ta' lipase > 3 darbiet il-linja bażi f'10% u plejtlits < 50,000/mm3 f'20%.
English: Excipients with known effect 380 mg maltitol/ml 1.5 mg methylhydroxybenzoate/ml 0.18 mg propylhydroxybenzoate/ml 0.3 mg sodium/ml
Maltese: 1.5 mg methylhydroxybenzoate/ml 0.18 mg propylhydroxybenzoate/ml
English: Baraclude contains lactose
Maltese: Baraclude fih lactose
English: Genotypic Entecavir Resistance Through Year 5, Lamivudine-Refractory Studies Year 1 Year 2 Year 3a Year 4 a
Maltese: Reżistenza Ġenotipika għal Entecavir Sa Sena 5, Studji dwar Pazjenti Refrattarji għal Lamivudine Sena 1 Sena 2 Sena 3a Sena 4 a
English: Blanchardstown Corporate Park 2 Dublin 15, D15 T867
Maltese: Dublin 15, D15 T867
English: Baraclude 1 mg tablets entecavir
Maltese: Baraclude 1 mg pilloli entecavir
English: Of these 60 patients, 49 received more than 6 months of HBIg therapy.
Maltese: 60 pazjent, 49 irċevew aktar minn 6 xhur ta' terapija ta' HBIg.
English: Baraclude 0.5 mg film-coated tablets Blister packs: EU/1/06/343/003
Maltese: Baraclude 0.5 mg pilloli miksijin b'rita Pakkett tal-folji: EU/1/06/343/003
English: Outer carton: Baraclude 0.5 mg
Maltese: Baraclude 0.5 mg
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: l-HBV DNA medju kien 8.1 log10 IU/ml u l-ALT medju kien 103 U/l fost il-popolazzjoni tal-istudju.
English: Each 1 mg film-coated tablet contains 241 mg lactose.
Maltese: Kull pillola ta' 1 mg miksija b'rita fiha 241 mg ta' lactose.
English: Baraclude 1 mg film-coated tablets Pink and triangular-shaped tablet with “BMS” debossed on one side and “1612” on the other.
Maltese: Pillola ta' lewn roża f'għamla triangolari b'“BMS” imnaqqxa fuq naħa u “1612” fuq in-naħa l-oħra.
English: This medicine contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially ‘sodiumfree'.
Maltese: Din il-mediċina fiha anqas minn 1 mmol (23 mg) sodium f'kull ml, jiġifieri essenzjalment ‘ħieles mis sodium'.
English: The other ingredients are: citric acid anhydrous, maltitol (E965), methylhydroxybenzoate (E218), propylhydroxybenzoate (E216), orange flavour (acacia and natural flavours), sodium citrate, sodium hydroxide, hydrochloric acid and purified water.
Maltese: Is-sustanzi l-oħra huma: citric acid anhydrous, maltitol (E965), methylhydroxybenzoate (E218), propylhydroxybenzoate (E216), togħma ta' larinġ (togħma ta' akaċja u togħma naturali), sodium citrate, sodium hydroxide, hydrochloric acid u ilma ppurifikat.
English: Baraclude 0.5 mg tablets entecavir
Maltese: Baraclude 0.5 mg pilloli entecavir
English: Maltitol (E965)
Maltese: FARMAĊEWTIKU 6.1 Lista ta' eċċipjenti Maltitol (E965)
English: Baraclude will not control your HIV infection.
Maltese: Baraclude ma jikkontrollax l-infezzjoni ta' l-HIV tiegħek.
English: - emerging genotypic ETVrc - genotypic ETVrc with virologic breakthroughd
Maltese: Probabbiltà kumuluttiva ta': - ETVrc ġenotipika ġdida - ETVrc ġenotipika bi breakthrough viroloġikud
English: Among lamivudine-refractory patients with baseline HBV DNA < 107 log10 copies/ml, 64% (9/14) achieved HBV DNA < 300 copies/ml at Week 48.
Maltese: Fost il-pazjenti refrattarji għal lamivudine b'DNA tal-HBV fil-linja bażi ta' < 107 log10 kopji/ml, 64% (9/14) kisbu DNA tal-HBV ta' < 300 kopji/ml f'Ġimgħa 48.
English: Bristol-Myers Squibb Kft. Tel.: +36 1 9206 550
Maltese: Magyarország Bristol-Myers Squibb Kft. Tel.: +36 1 9206 550
English: Clinical resistance in Adults: 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: Reżistenza klinika fl-Adulti: 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: Sodium: Each ml of this medicinal product contains 0.015 mmol (or 0.3 mg) sodium.
Maltese: Kull ml ta' dan il-prodott mediċinali fih 0.015 mmol (jew 0.3 mg) sodium.
English: Baraclude contains maltitol, methylhydroxybenzoate (E218), propylhydroxybenzoate (E216) and sodium
Maltese: Baraclude fih maltitol, methylhydroxybenzoate (E218), propylhydroxybenzoate (E216) u sodium Dan il-prodott mediċinali fih maltitol.
English: Methylhydroxybenzoate (E218) Propylhydroxybenzoate (E216) Orange flavour (acacia and natural flavours) Sodium hydroxide to adjust pH to approximately 6 Hydrochloric acid to adjust pH to approximately 6 Purified water
Maltese: Methylhydroxybenzoate (E218) Propylhydroxybenzoate (E216) Orange flavour (togħma ta' akaċja u togħma naturali) Sodium hydroxide għall-aġġustament tal-pH għal madwar 6 Hydrochloric acid għall-aġġustament tal-pH għal madwar 6
English: c. Description of selected adverse reactions
Maltese: ċ. Deskrizzjoni ta' reazzjonijiet avversi selettivi
English: Outer carton: Baraclude 0.05 mg/ml
Maltese: Baraclude 0.05 mg/ml
English: Each ml contains 0.05 mg entecavir.
Maltese: Kull ml fih 0.05 mg ta' entecavir.
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: Other medicines and Baraclude
Maltese: Mediċini oħra u Baraclude
English: Baraclude should be taken orally.
Maltese: Użu orali.
English: Baraclude 0.05 mg/ml oral solution entecavir
Maltese: Baraclude 0.05 mg/ml soluzzjoni orali entecavir
English: Contrada Fontana del Ceraso 03012 Anagni (FR) Italy
Maltese: Bristol-Myers Squibb S.r.l. Contrada Fontana del Ceraso 03012 Anagni (FR)
English: *p value vs lamivudine < 0.05 a patients with evaluable baseline histology (baseline Knodell Necroinflammatory Score ≥ 2) b a primary endpoint c Roche Cobas Amplicor PCR assay (LLOQ = 300 copies/ml)
Maltese: a pazjenti b'istoloġija ta' linja bażi li tista' tiġi evalwata (Knodell Necroinflammatory Score ta' linja bażi ≥ 2) b punt aħħari primarju c Roche Cobas Amplicor PCR assay (LLOQ = 300 kopja/ml)
English: (ng·h /ml) (CV)
Maltese: AUC(0-T) (ng·h /ml) (CV)
English: Also, lamivudine-refractory patients who achieved HBV DNA < 104 log10 copies/ml by PCR at Week 24 had a lower rate of resistance than those who did not (5-year cumulative probability 17.6% [n= 50] versus 60.5% [n= 135], respectively).
Maltese: Flimkien ma' dan, pazjenti refrattarji għal lamivudine li kisbu DNA tal-HBV ta' < 104 log10 kopji/ml minn PCR f'Ġimgħa 24, kellhom rata ta' reżistenza iktar baxxa minn f'dawk li ma kisbuhiex (probabbiltà kumulattiva wara 5 sena ta' 17.6% [n=50] kontra 60.5% [n=135], rispettivament).
English: - emerging genotypic ETVrc - genotypic ETVrc with virologic breakthroughd a Results reflect use of a 1-mg dose of entecavir for 147 of 149 patients in Year 3 and all patients in Years 4 and 5 and of combination entecavir-lamivudine therapy (followed by long-term entecavir therapy) for a median of 20 weeks for 130 of 149 patients in Year 3 and for 1 week for 1 of 121 patients in Year 4 in a rollover study.
Maltese: Pazjenti kkurati u mmonitorjati għalreżistenzab Pazjenti f'sena speċifika b': - ETVrc ġenotipika ġdida - ETVrc ġenotipika bi breakthrough viroloġikad Probabbiltà kumuluttiva ta': - ETVrc ġenotipika ġdida - ETVrc ġenotipika bi breakthrough viroloġikad a Ir-riżultati jirriflettu l-użu ta' doża ta' 1 mg ta' entecavir għal 147 minn 149 pazjent f'Sena 3 u fil-pazjenti kollha fi Snin 4 u 5 u ta' terapija kkombinata ta' entecavir-lamivudine (segwita minn terapija fit-tul b'entecavir) għal medjan ta' 20 ġimgħa għal 130 minn 149 pazjenti f'Sena 3 u għal ġimgħa waħda għal 1 minn 121 pazjent f'Sena 4 fi studju rollover.
English: Baraclude oral solution comes with a measuring spoon with markings from 0.5 up to 10 milliliters.
Maltese: Baraclude soluzzjoni orali tiġi b'mgħarfa ta' dożaġġ b'marki minn 0.5 sa 10 millilitri.
English: Baraclude 0.05 mg/ml oral solution is supplied in a bottle containing 210 ml oral solution.
Maltese: Baraclude 0.05 mg/ml soluzzjoni orali tiġi fi flixkun li fih 210 ml ta' soluzzjoni orali.
English: DNA < 8 log10 IU/ml Baseline HBV DNA ≥ 8 log10 IU/ml aNC=F (noncompleter=failure) * Patients randomized to placebo who did not have HBe- seroconversion by Week 48 rolled over to open-label entecavir for the second year of the study; therefore randomized comparison data are available only through Week 48.
Maltese: ≥ 8 log10 IU/ml aNC=F (ma rnexxilux itemm l-istudju=falliment) * Pazjenti randomizzati għall-plaċebo li ma kellhomx serokonverżjoni HBe- sa Ġimgħa 48 qalbu għal entecavir b'tikketta mikxufa għat-tieni sena tal-istudju; għalhekk id-data ta' paragun randomizzata hija disponibbli biss f'Ġimgħa 48.
English: EU/1/06/343/001 Baraclude 1 mg film-coated tablets Blister packs: EU/1/06/343/004 EU/1/06/343/007
Maltese: EU/1/06/343/006 Pakkett tal-flixkun:EU/1/06/343/001
English: n
Maltese: b.
English: Prothrombin time (≤1 X ULN)b a Roche COBAS Amplicor PCR assay (LLOQ = 300 copies/ml).
Maltese: Normalizzazzjoni ta':f ALT (≤1 X ULN)b Albumina (≥1 X LLN)b Bilirubin (≤1 X ULN)b Ħin protrombin (≤1 X ULN)b a Assaġġ Roche COBAS Amplicor PCR (LLOQ = 300 kopja/ml).
English: Baraclude is indicated for the treatment of chronic hepatitis B virus (HBV) infection (see section 5.1) in adults with: 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: Baraclude huwa indikat għat-trattament ta' infezzjoni kronika bil-virus ta' l-epatite B (HBV) (ara sezzjoni 5.1) f'adulti bi: 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. mard tal-fwied mhux stabbli (ara sezzjoni 4.4).
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,
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: 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: Baraclude 0.05 mg/ml oral solution
Maltese: Baraclude 0.05 mg/ml soluzzjoni orali
English: Baseline Creatinine Clearance (ml/min) Unimpaired
Maltese: Clearance tal-Kreatinina ta' Linja Bażi (ml/min) Normali
English: Incorporation of additional ETVr amino acid changes rtT184, rtS202 or rtM250 decreases entecavir susceptibility in cell culture.
Maltese: ETVr tbiddel l-rtT184, rtS202 u/jew l-rtM250 tnaqqas is-suxxettibilità għal entecavir f'kultura ta' ċelloli.
English: PC: SN: <NN:>
Maltese: <NN:>
English: Liver transplant recipients: 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: Riċevituri tat-trapjant tal-fwied: is-sigurtà u l-effikaċja ta' entecavir 1 mg darba kuljum kienu evalwati fi studju single-arm ta' 65 pazjent li rċevew trapjant tal-fwied minħabba komplikazzjonijiet ta' infezzjoni ta' HBV kronika u kellhom HBV DNA<172 IU/ml (madwar 1000 kopja/ml) meta sar ittrapjant .
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) dDefined as decrease or no change from baseline in CTP score.
Maltese: 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) dDefinit bħala żieda jew ebda bidla mil-linja bażi fl-iskor CTP.
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 kienu tnaqqis tal-virus HBV (DNA ta' HBV < 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: Parahydroxybenzoates: Baraclude oral solution contains the preservatives methylhydroxybenzoate and propylhydroxybenzoate, that may cause allergic reactions (possibly delayed).
Maltese: Baraclude soluzzjoni orali fiha l-preservattivi methylhydroxybenzoate u propylhydroxybenzoate, li jistgħu jikkawżaw reazzjonijiet allerġiċi (possibbilment imdewmin).
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 talviremja ta' l-HBV fuq reġimen b'lamivudine bħala parti mit-terapija HAART.
English: Patients with rare hereditary problems of fructose intolerance should not take this medicine.
Maltese: Pazjenti li għandhom problemi ereditarji rari ta' intolleranza għall-fructose m'għandhomx jieħdu din il-mediċina.
English: Patients with decompensated liver disease: 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: Pazjenti b'mard tal-fwied mhux stabbli: 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: HBV DNA < 50 IU/mL and HBeAg seroconversiona HBV DNA < 50 IU/mLa HBeAg seroconversiona ALT normalizationa
Maltese: IU/mL u serokonverżjonia HBeAg HBV DNA < 50
English: Experience in lamivudine-refractory patients with compensated liver disease: In a randomised, double-blind study in HBeAg positive lamivudine-refractory patients (026), with 85% of patients presenting LVDr mutations at baseline, patients receiving lamivudine at study entry either switched to entecavir 1 mg once daily, with neither a washout nor an overlap period (n = 141), or continued on lamivudine 100 mg once daily (n = 145).
Maltese: Fi studju b'mod każwali, double blind f'pazjenti pożittivi għal HBeAg u refrattorji għal lamivudine (026), b'85% tal-pazjenti jippreżentaw mutazzjonijiet ta' LVDr fil-linja bażi, pazjenti li rċevew lamivudine malli daħlu fl-istudju jew qalbu għal 1 mg ta' entecavir darba kuljum, mingħajr washout u mingħajr perijodu ta' overlap (n= 141), jew komplew b'100 mg ta' lamivudine darba kuljum (n= 145).
English: Each carton includes a measuring spoon (polypropylene) with markings from 0.5 ml up to 10 ml
Maltese: Kull kartuna tinkludi mgħarfa għall-qies (polypropylene) b'marki minn 0.5 ml sa 10 ml.