FrancophonIA/ELRC3.0 huggingface dataset:
English: is available as tablets (200 mg emtricitabine and 245 mg tenofovir disoproxil).
Maltese: Emtricitabine/Tenofovir disoproxil Krka d.d. jiġi bħala pilloli (200 mg emtriċitabina u 245 mg tenofovir disoprossil).
English: contains two active substances: emtricitabine, which is a nucleoside reverse transcriptase inhibitor; and tenofovir disoproxil, which is a ‘prodrug' of tenofovir.
Maltese: Emtricitabine/Tenofovir disoproxil Krka d.d. fih żewġ sustanzi attivi: l-emtriċitabina, li hija inibitur nukleosidiku tat-transkrittażi inversa; u t-tenofovir disoprossil li hija “prodroga” tat-tenofovir.
English: can be found on the Agency's website: ema.europa.eu/en/medicines/human/EPAR/emtricitabinetenofovir-disoproxil-krka-dd. Information on the reference medicine can also be found on the Agency's website.
Maltese: Aktar informazzjoni dwar Emtricitabine/Tenofovir disoproxil Krka d.d. tista' tinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/en/medicines/human/EPAR/emtricitabinetenofovir-disoproxil-krka-dd.
English: Emtricitabine/Tenofovir disoproxil Krka d.d contains two active substances, emtricitabine and tenofovir disoproxil.
Maltese: Emtricitabine/Tenofovir disoproxil Krka d.d. fih żewġ sustanzi attivi, l-emtriċitabina u t-tenofovir disoprossil.
English: is an HIV medicine that is used in combination with at least one other HIV medicine to treat adults infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Maltese: Emtricitabine/Tenofovir disoproxil Krka d.d. huwa mediċina tal-HIV li tintuża f'kombinazzjoni ma' millanqas mediċina oħra tal-HIV għall-kura ta' adulti infettati bil-virus tal-immunodefiċjenza umana tattip 1 (HIV-1), virus li jikkawża s-sindromu tal-immunodefiċjenza akkwiżita (AIDS).
English: Emtricitabine/Tenofovir disoproxil Krka d.d., taken in combination with at least one other antiviral medicine, reduces the amount of HIV in the blood and keeps it at a low level.
Maltese: Emtricitabine/Tenofovir disoproxil Krka d.d., meħud flimkien ma' minn tal-inqas mediċina waħda oħra antivirali, inaqqas l-ammont ta' HIV fid-demm u jżommu f'livell baxx.
English: Both emtricitabine and tenofovir work in similar ways by blocking the activity of reverse transcriptase, an enzyme produced by HIV that allows it to reproduce itself in the cells it has infected.
Maltese: Kemm l-emtriċitabina kif ukoll it-tenofovir jaħdmu b'mod simili billi jimblokkaw l-attività tattranskrittażi inversa, enzima prodotta mill-HIV li jħalliha timmultiplika fiċ-ċelloli li tkun infettat.
English: Studies on the benefits and risks of the active substances in the authorised use have already been carried out with the reference medicine, Truvada, and do not need to be repeated for Emtricitabine/Tenofovir disoproxil Krka d.d.
Maltese: Diġà saru studji dwar il-benefiċċji u r-riskji tas-sustanzi attivi fl-użu awtorizzat bil-mediċina ta' referenza, Truvada, u m'għandhomx għalfejn jiġu ripetuti għal Emtricitabine/Tenofovir disoproxil Krka d.d.
English: Because Emtricitabine/Tenofovir disoproxil Krka d.d.
Maltese: Emtricitabine/Tenofovir disoproxil Krka d.d.?
English: is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Peress li Emtricitabine/Tenofovir disoproxil Krka d.d. huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, il-benefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: How is Emtricitabine/Tenofovir disoproxil Krka d.d.
Maltese: Kif jintuża Emtricitabine/Tenofovir disoproxil Krka d.d.?
English: Packaging
Maltese: Id-daqs tal-pakkett
English: EU Number
Maltese: Numru tal-proċedura tal-EU Isem
English: Route of Administration
Maltese: 7 pilloli
English: Ref. EMEA/CHMP/384874/2008
Maltese: EMEA/CHMP/554245/2008
English: London, 7 October 2008 Doc.
Maltese: Londra, 7 ta' Ottubru 2008 Dok. ref.
English: The Marketing Authorisation Holder provided supplementary information on 23 November 2007 and 22 April 2008.
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq ipprovda informazzjoni supplimentari fit-23 ta' Novembru 2007 u fit-22 ta' April 2008.
English: This medicinal product belongs to the list of products identified in 2007 for SPC harmonisation.
Maltese: Il-prodott mediċinali jagħmel parti mil-lista ta' prodotti li huma identifikati fl-2007 għall-armonizzazzjoni tal-SPC.
English: The procedure started on 19 July 2007.
Maltese: Il-proċedura ngħatat bidu fid-19 ta' Lulju 2007.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 30 REFERRAL FOR Ciprofloxacin Bayer and associated names International Non-Proprietary Name (INN): ciprofloxacin
Maltese: GĦALL-UŻU MILL-BNIEDEM (CHMP) OPINJONI WARA REFERENZA SKONT L-ARTIKOLU 30 GĦAL Ciprofloxacin Bayer u ismijiet assoċjati Denominazzjoni Komuni Internazzjonali (DKI): ciprofloxacin
English: On 22 June 2007, France presented to the EMEA a referral under Article 30 of Directive 2001/83/EC, as amended, in order to harmonise the nationally authorised Summaries of Product Characteristics (SPC), Labelling and Package Leaflet of the medicinal product Ciprofloxacin Bayer and associated names.
Maltese: Fit-22 ta' Ġunju 2007, Franza ppreżentat referenza lill-EMEA skont l-Artikolu 30 tad-Direttiva 2001/83/KE, kif emendata, bil-għan li tarmonizza s-Sommarji tal-Karatteristiċi tal-Prodott (SPC), it-Tikketta u l-Fuljett ta' Tagħrif awtorizzati fuq livell nazzjonali tal-prodott mediċinali Ciprofloxacin Bayer u ismijiet assoċjati.
English: Ciprofloxacin Bayer and associated names is an antibiotic, indicated for the treatment of uncomplicated and complicated infections, including severe infections, caused by ciprofloxacin susceptible pathogens.
Maltese: Ciprofloxacin Bayer u ismijiet assoċjati huwa antibijotiku, indikat għat-trattament ta' infezzjonijiet ikkumplikati u mhux ikkumplikati, fosthom infezzjonijiet gravi, ikkawżati minn patoġeni suxxettibbli għal ciprofloxacin.
English: The basis for referral was that there were divergences in the Summaries of Product Characteristics (SPC) of Ciprofloxacin Bayer and associated names approved across EU Member States, with respect to the indications, the posology, the contra-indications and the special warnings and precautions for use.
Maltese: Ir-referenza kienet ibbażata fuq diverġenzi fis-Sommarji tal-Karatteristiċi tal-Prodott (SPC) ta' Ciprofloxacin Bayer u ismijiet assoċjati approvati fl-Istati Membri tal-UE kollha, b'mod partikolari fir-rigward tal-indikazzjonijiet, il-pożoloġija, il-kontraindikazzjonijiet, it-twissijiet speċjali u l-prekawzjonijiet għall-użu.
English: It is available as immediate release film coated tablets, modified release film coated tablets, granules and solutions for oral suspension, solutions for infusion in bags, solutions for infusion in bottles and sachets.
Maltese: Huwa disponibbli f'pilloli miksija b'rita b'rilaxx immedjat, pilloli miksija b'rita b'rilaxx modifikat, granuli u soluzzjonijiet għal sospensjoni orali, soluzzjonijiet għal infużjoni f'boroż, soluzzjonijiet għal infużjoni fi fliexken u sachets.
English: During its July 2008 meeting, the CHMP, in the light of the overall submitted data and the scientific discussion within the Committee, was of the opinion that the proposal for the harmonisation of the SPC, Labelling and Package Leaflet was acceptable and that they should be amended.
Maltese: Waqt il-laqgħa tiegħu f'Lulju 2008, is-CHMP, fid-dawl tad-dejta kumplessiva mressqa u d-diskussjoni xjentifika li saret fi ħdan il-Kumitat, kien tal-opinjoni li l-proposta għall-armonizzazzjoni tal-SPC, it-Tikketta u l-Fuljett ta' Tagħrif kienet aċċettabbli u li dawn għandhom jiġu emendati.
English: The CHMP gave a positive opinion on 24 July 2008 recommending the harmonisation of the SPC, Labelling and Package Leaflet for Ciprofloxacin Bayer and associated names.
Maltese: Fl-24 ta' Lulju 2008, is-CHMP ta opinjoni pożittiva li fiha rrakkomanda l-armonizzazzjoni tal-SPC, it-Tikketta u l-Fuljett ta' Tagħrif għal Ciprofloxacin Bayer u ismijiet assoċjati.
English: Mylan Hungary Kft. Mylan utca 1, Komárom - 2900 Hungary
Maltese: Mylan Hungary Kft. Mylan utca 1, Komárom - 2900
English: Normalization of:f
Maltese: Normalizzazzjoni ta':f
English: common: insomnia
Maltese: komuni: insomnja
English: 117 Allée des Parcs 69800 Saint Priest France
Maltese: 117 Allée des Parcs 69800 Saint Priest Franza
English: Antiviral activity
Maltese: Attività antivirali:
English: uncommon: rash, alopecia
Maltese: mhux komuni: raxx, alopeċja
English: The randomization was stratified by age group (2 to 6 years; >6 to 12 years; and >12 to <18 years).
Maltese: Irrandomizzazzjoni kienet stratifikata skont il-grupp ta' età (sentejn sa 6 snin; >6 sa 12-il sena; u >12 sa <18-il sena).
English: Diameter: approximately 6.8 mm.
Maltese: Dijametru: madwar 6.8 mm.
English: Pharmacotherapeutic group: antivirals for systemic use, nucleoside and nucleotide reverse transcriptase inhibitors.
Maltese: Kategorija farmakoterapewtika: antivirali għal użu sistemiku, nucleoside u nucleotide reverse transcriptase inhibitors.
English: c Roche Cobas Amplicor PCR assay (LLOQ = 300 copies/ml)
Maltese: c Roche Cobas Amplicor PCR assay (LLOQ = 300 kopja/mL)
English: Diameter: approximately 8.8 mm.
Maltese: Dijametru: madwar 8.8 mm.
English: Substitutions observed in clinical isolates (rtT184A, C, F, G, I, L, M or S; rtS202 C, G or I; and/or rtM250I, L or V) further decreased entecavir susceptibility 16- to 741-fold relative to wild-type virus.
Maltese: Is-sostituzzjonijiet osservati fl- iżolati kliniċi (rtT184A, C, F, G, I, L, M jew S; rtS202 C, G jew I; u/jew rtM250I, L jew V) komplew inaqqsu s-suxxettibilità għal entecavir bejn 16 u 741 darba relattiv għall-virus wild-type.
English: Haemodialysis or CAPD**
Maltese: Emodijalisi jew CAPD**
English: Distribution
Maltese: Distribuzzjoni:
English: Year 1 Year 2 Year 3a Year 4 a Year 5a
Maltese: Sena 1 Sena 2 Sena 3a Sena 4a
English: Rare (at least 1 in 10,000 patients): severe allergic reaction.
Maltese: Rari (tal-anqas 1 f'kull 10,000 pazjent): reazzjoni allerġika severa.
English: HBeAg Negative (study 027)
Maltese: Negattivi għal HBeAg (studju 027)
English: The cumulative probability of emerging genotypic entecavir resistance after 1, 2, 3, 4 and 5 years treatment in the lamivudine-refractory studies was 6%, 15%, 36%, 47% and 51%, respectively.
Maltese: Il-probabbiltà kumulattiva ta' reżistenza ġenotipika ġdida għal entecavir wara 1, 2, 3, 4 u 5 snin ta' kura fi studji dwar pazjenti li kienu refrattarji għal lamivudine kienet ta' 6%, 15%, 36%, 47% u 51%, rispettivament.
English: HBeAg Seroconversion
Maltese: Serokonverżjoni ta' HBeAg
English: Frequency is defined as very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000).
Maltese: Il-frekwenza hija ddefinita bħala komuni ħafna (≤ 1/10); komuni (≤ 1/100 sa < 1/10); mhux komuni (≤ 1/1,000 sa < 1/100); rari (≤ 1/10,000 sa < 1/1,000).
English: 117 Allée des Parcs 69800 Saint Priest
Maltese: 69800 Saint Priest
English: *p<0.05 ULN=upper limit of normal, LLN=lower limit of normal.
Maltese: ULN=limitu ta' fuq tan-normal, LLN=limitu ta' isfel tan-normal.
English: common: increased transaminases
Maltese: komuni: żieda fit-transaminases
English: The median EC50 value for entecavir against LVDr HBV (rtL180M and rtM204V) was 0.026 µM (range 0.010-0.059 µM).
Maltese: Il-valur medju ta' EC50 għal entecavir kontra LVDr HBV (rtL180M u rtM204V) kien ta' 0.026 µM (medda ta' 0.010-0.059 µM).
English: UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included 18.
Maltese: IDENTIFIKATUR UNIKU - BARCODE 2D barcode 2D li jkollu l-identifikatur uniku inkluż.
English: Gender/age
Maltese: Ġeneru/età:
English: Also contains lactose.
Maltese: aċidożi lattika.
English: Each film-coated tablet contains 125 mg lactose monohydrate.
Maltese: Kull pillola miksija b'rita fiha 125 mg ta' lactose monohydrate.
English: common: vomiting, diarrhoea, nausea, dyspepsia
Maltese: komuni: rimettar, dijarea, tqallih, dispepsja
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'Cmax ta' 44-46%, u tnaqqis f'AUC ta' 18-20%.
English: Through Week 240, 3 of the 10 patients experienced virologic breakthrough (≥1 log10 increase above nadir).
Maltese: Sa Ġimgħa 240, 3 mill-10 pazjenti esperjenzaw breakthrough viroloġiku (żieda ta' ≤1 log10 'il fuq min-nadir).
English: - genotypic ETVr with virologic breakthrough d
Maltese: - ETVr ġenotipika bi breakthrough viroloġikud
English: Patients were randomized (2:1) to receive blinded treatment with entecavir 0.015 mg/kg up to 0.5 mg/day (N = 120) or placebo (N = 60).
Maltese: Il- pazjenti kienu randomizzati (2:1) biex jirċievu kura blinded b'entevacir 0.015 mg/kg sa 0.5 mg/jum (N = 120) jew placebo (N = 60).
English: Entecavir Mylan is indicated for the treatment of chronic hepatitis B virus (HBV) infection (see section 5.1) in adults with:
Maltese: Entecavir Mylan huwa indikat għat-trattament ta' infezzjoni kronika bil-virus tal-epatite B (HBV) (ara sezzjoni 5.1) f'adulti bi:
English: Prothrombin time (≤1 X ULN)b a Roche COBAS Amplicor PCR assay (LLOQ = 300 copies/ml).
Maltese: Ħin ta' prothrombin (≥1 X ULN)b a Assaġġ Roche COBAS Amplicor PCR (LLOQ = 300 kopja/mL).
English: whether you have kidney problems.
Maltese: • jekk għandekx problemi fil-kliewi.
English: Moderate (n = 6)
Maltese: Moderat (n = 6)
English: Acute exacerbations of hepatitis have been reported in patients who have discontinued anti-hepatitis B virus therapy, including therapy with entecavir (see section 4.4).
Maltese: Ġie rrapportat taħrix akut ta' epatite f'pazjenti li waqqfu t- terapija kontra l-virus ta' l-epatite B, inkluż terapija b'entecavir (ara sezzjoni 4.4).
English: Each film-coated tablet contains 62.5 mg lactose monohydrate.
Maltese: Kull pillola miksija b'rita fiha 62.5 mg ta' lactose monohydrate.
English: The Cmax, AUC (0-24), and Cmin for these subjects was 6.31 ng/ml, 18.33 ng h/ml, and 0.28 ng/ml, respectively.
Maltese: Is-Cmax, AUC (0-24), u s-Cmin għal dawn l-individwi kienu 6.31 ng/mL, 18.33 ng h/mL, u 0.28 ng/mL, rispettivament.
English: Adefovir Dipivoxil 10 mg once daily n
Maltese: Adefovir Dipivoxil 10 mg darba kuljum n
English: <200 cells/mm3).
Maltese: ċellola/mm3).
English: ETV 1 mg once daily
Maltese: ETV 1 mg darba kuljum
English: No evidence of genotoxicity was observed in an Ames microbial mutagenicity assay, a mammalian cell gene mutation assay, and a transformation assay with Syrian hamster embryo cells.
Maltese: L-ebda evidenza ta' ġenotossiċità ma ġiet osservata f'Ames microbial mutagenicity assay, cell gene mutation cell assay tal-mammiferi u transformation assay b'ċelloli embrijoniċi ta' ħamsters tas-Sirja.
English: Age/gender
Maltese: Età/ġeneru
English: Clinical resistance in adults
Maltese: Reżistenza klinika fl-Adulti:
English: For patients weighing from 10 kg to 32.5 kg, an entecavir oral solution is recommended.
Maltese: Għal pazjenti li jiżnu minn 10 kg sa 32.5 kg, soluzzjoni orali ta' entecavir hija rakkomandata.
English: Cmax and Cmin at steady-state are 4.2 and 0.3 ng/ml, respectively, for a dose of 0.5 mg, and 8.2 and 0.5 ng/ml, respectively, for 1 mg.
Maltese: Cmax u Cmin f'konċentrazzjoni fissa huma 4.2 u 0.3 ng/mL, rispettivament, għal doża ta' 0.5 mg, u 8.2 u 0.5 ng/mL, rispettivament għal 1 mg.
English: The time to onset of HCC or death (whichever occurred first) was comparable in the two treatment groups; on-study cumulative death rates were 23% (23/102) and 33% (29/89) for patients treated with entecavir and adefovir dipivoxil, respectively, and on-study cumulative rates of HCC were 12% (12/102) and 20% (18/89) for entecavir and adefovir dipivoxil, respectively.
Maltese: Il-ħin għall-bidu ta' HCC jew mewt (skont liema seħħ l-ewwel) kien komparabbli fiż-żewġ gruppi ta' kura; ir-rati kumulattivi ta' mwiet waqt l-istudju kienu 23% (23/102) u 33% (29/89) għal pazjenti kkurati b'entecavir u adefovir dipivoxil, rispettivament, u r-rati kumulattivi waqt l-istudju ta' HCC kienu 12% (12/102) u 20% (18/89) għal entecavir u adefovir dipivoxil, rispettivament.
English: 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: 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: The demonstration of benefit is based on histological, virological, biochemical, and serological responses after 48 weeks of treatment in active-controlled clinical trials of 1,633 adults with chronic hepatitis B infection, evidence of viral replication and compensated liver disease.
Maltese: It-turija tal-benefiċċju hija bbażata fuq istoloġija, viroloġija, bijokimika u effetti seroloġiċi wara 48 ġimgħa ta' trattament fi provi kliniċi attivi kkontrollati ta' 1,633 adult b'epatite B kronika, b'evidenza ta' replikazzjoni virali u mard tal-fwied stabbli.
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: *valur p vs lamivudine < 0.05 a pazjenti b'istoloġija fil-linja bażi li tista' tiġi evalwata (Knodell Necroinflammatory Score fil-linja bażi ta' ≤2) b punt aħħari primarju c Roche Cobas Amplicor PCR assay (LLOQ = 300 kopja/mL)
English: The Cmax, AUC(0-24), and Cmin for these subjects was 14.48 ng/ml, 38.58 ng·h/ml, and 0.47 ng/ml, respectively.
Maltese: Is-Cmax, AUC (0-24), u s-Cmin għal dawn lindividwi kienu 14.48 ng/mL, 38.58 ng h/mL, u 0.47 ng/mL, rispettivament.
English: ALT (≤1 X ULN)b
Maltese: ALT (≥1 X ULN
English: 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: L-effett ta' l-età fuq il-farmakokinetika ta' entecavir ġie evalwat billi suġġetti anzjani ta'età bejn 65-83 (età medja ta' 69 fin-nisa, 74 fl-irġiel) tqabblu ma' suġġetti li għadhom żgħar fl-età, jiġifieri ta' bejn 20-40 sena (età medja ta' 29 fin-nisa, 25 fl-irġiel).
English: Through Week 240 in nucleoside-naive studies, genotypic evidence of ETVr substitutions at rtT184, rtS202, or rtM250 was identified in 3 patients treated with entecavir, 2 of whom experienced virologic breakthrough (see table).
Maltese: Sa Ġimgħa 240 fi studji dwar pazjenti li qatt ma ħadu nukleoside, evidenza ġenotipika ta' sostituzzjonijiet ETVr f'rtT184, rtS202, jew rtM250 kienet identifikati fi 3 pazjenti kkurati b'entecavir, u 2 minnhom kellhom breakthrough viroloġiku (ara t-tabella).
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: Toxicology studies in animals administered entecavir have shown no evidence of impaired fertility (see section 5.3).
Maltese: Studji tossikoloġiċi fl-annimali li ngħataw entecavir ma wrew ebda evidenza ta' fertilità indebolita (ara sezzjoni 5.3).
English: Dose adjustment is recommended for patients with creatinine clearance <50 ml/min, including those on haemodialysis or continuous ambulatory peritoneal dialysis (CAPD).
Maltese: Huwa rrakkomandat aġġustament fid-doża għal pazjenti bi clearance tal-kreatinina < 50ml/min, inkluż dawk il-pazjenti fuq emodijaliżi jew fuq dialiżi peritoneali ambulatorja kontinwa (CAPD).
English: Bilirubin (≤1 X ULN)b
Maltese: Bilirubina(≥1 X ULN
English: After reaching peak levels, entecavir plasma concentrations decreased in a bi-exponential manner with a terminal elimination half-life of ≈ 128-149 hours.
Maltese: Wara li jilħqu l-ogħla livelli, ilkonċentrazzjonijiet ta' entecavir fil-plażma jitbaxxew b'mod bi-esponenzjali b'half-life taleliminazzjoni terminali ta' ≈ 128-149 sigħat.
English: Entecavir Mylan 0.5 mg film-coated tablets Entecavir Mylan 1 mg film-coated tablets are supplied in blisters packs containing 30 tablets, perforated blister packs containing 30 x 1 or 90 x 1 tablets, and in bottles containing 30 or 90 tablets.
Maltese: Entecavir Mylan 0.5 mg film miksija b'rita Entecavir Mylan 1 mg pilloli miksija b'rita huma fornuti f'pakketti bil-folji li fihom 30 pillola, pakketti b'folji perforati li fihom 30 x 1 jew 90 x 1 pilloli, u fi fliexken li fihom 30 jew 90 pillola.
English: In HBV combination assays in cell culture, abacavir, didanosine, lamivudine, stavudine, tenofovir or zidovudine were not antagonistic to the anti-HBV activity of entecavir over a wide range of concentrations.
Maltese: F'assaġġi ta' kombinazzjoni ta' HBV f'kultura ta' ċelloli, abacavir, didanosine, lamivudine, stavudine, tenefovir u zidovudine ma kienux antagonistiċi għall-attività ta' entecavir kontra
English: DNA <8 log10 IU/mL Baseline HBV DNA ≥8 log10 IU/mL
Maltese: HBV fil-linja bażi DNA <8 log10 IU/mL HBV DNA fil-Linja Bażi ≤8 log10 IU/mL
English: The on-study cumulative rate of hepatocellular carcinoma (HCC) was 12% (12/102).
Maltese: Ir-rata kumulattiva ta' waqt l-istudju ta' karċinoma epatoċellulari (HCC) kienet ta' 12% (12/102).
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: reżistenza iktar baxxa milli minn dawk li ma kisbuhiex (probabbiltà kumulattiva wara 5 sena ta' 17.6% [n=50] kontra 60.5% [n=135], rispettivament).
English: A 4-hour period of haemodialysis removed ≈ 13% of the dose, and 0.3% was removed by CAPD.
Maltese: Perijodu ta' 4 sigħat ta' emodijaliżi neħħa ≈ 13% tad-doża, u 0.3% tneħħew b'CAPD.
English: Severe Managed with CAPD (n = 4)
Maltese: Sever Immaniġġjat bis-CAPD (n = 4)
English: Tablet core: microcrystalline cellulose, crospovidone, lactose monohydrate (see section 2, “Entacavir Mylan contains lactose”), magnesium stearate
Maltese: Qalba tal-pillola: microcrystalline cellulose, crospovidone, lactose monohydrate (ara sezzjoni 2, “Entacavir Mylan fih il-lactose”), magnesium stearate Kisja tal-pillola: titanium dioxide (E171), hypromellose, macrogol 400, polysorbate 80.
English: For lamivudine (n = 355), cumulative response rates were 39% for HBV DNA <300 copies/ml by PCR, 79% for ALT normalisation, 26% for HBeAg seroconversion, and 2% for HBsAg seroconversion (3% for HBsAg loss).
Maltese: Għal lamivudine (n= 355), ir-rati kienu 39% għal DNA ta' HBV < 300 kopja/ml skont ilPCR, 79% għal normalizzazzjoni ta' l-ALT, 26% għal sirokonversjoni ta' HBeAg u 2% għal sirokonversjoni ta' HBsAg (3% għal tnaqqis ta' HBsAg).
English: * p value vs lamivudine <0.05 a patients with evaluable baseline histology (baseline Knodell Necroinflammatory Score ≥ 2) b a primary endpoint.
Maltese: *valur p vs lamivudine < 0.05 a pazjenti b'istoloġija fil-linja bażi li tista' tiġi evalwata (Knodell Necroinflammatory Score fil-linja bażi ta' ≤2) b punt aħħari primarju.
English: Entecavir is not a substrate, inhibitor or inducer of the CYP450 enzyme system.
Maltese: Entecavir mhuwiex sottostrat, inibitur jew inducer tas-sistema ta' enżimi CYP450.
English: Among lamivudine-refractory patients with baseline HBV DNA <107 log10 copies/ml, 64% (9/14)
Maltese: Fost il-pazjenti refrattarji għal lamivudine b'DNA tal-HBV fil-linja bażi ta' <107 log10 kopji/mL, 64%