FrancophonIA/ELRC3.0 huggingface dataset:
English: Since Vedrop has been approved under exceptional circumstances, the company that markets the medicine is required to provide further data on the safety and effectiveness of Vedrop in patients with congenital or hereditary chronic cholestasis.
Maltese: Minħabba li Vedrop ġie approvat taħt ċirkostanzi ta' eċċezzjoni, il-kumpanija li tqiegħed il-mediċina fissuq hija meħtieġa li tipprovdi aktar data dwar is-sigurtà u l-effettività ta' Vedrop f'pazjenti b'kolestażi kronika konġenitali jew ereditarja.
English: For the full list of all side effects and restrictions with Vedrop, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u rrestrizzjonijiet kollha rrappurtati b'Vedrop, ara l-fuljett ta
English: Congenital or hereditary chronic cholestasis is an inherited disease causing problems with the flow of bile from the liver to the gut.
Maltese: Il-kolestażi kronika konġenitali jew ereditarja hija marda li tintiret li tikkawża problemi fil-fluss tal-bili mill-fwied għall-musrana.
English: How is Vedrop used?
Maltese: Kif jaħdem Vedrop?
English: Vitamin E is a natural substance that cannot be made by the body and is therefore needed in the diet.
Maltese: Il-vitamina E hija sustanza naturali li ma tistax issir mill-ġisem u għalhekk hija meħtieġa fid-dieta.
English: Tocofersolan can be absorbed from the gut in children who have difficulty absorbing fats and vitamin E from the diet.
Maltese: Tocofersolan jista' jiġi assorbit mill-musrana fit-tfal li għandhom diffikultà biex jassorbu x-xaħam u l-vitamina E mid-dieta.
English: The most common side effect with Vedrop (which may affect up to 1 in 10 people) is diarrhoea.
Maltese: L-effett sekondarju l-aktar komuni b'Vedrop (li jista' jaffettwa sa 1 minn kull 10) huwa dijarea.
English: The company also presented information on the use of Vedrop in patients with cystic fibrosis, but withdrew its application for this disease during the evaluation of the medicine.
Maltese: Il-kumpanija ppreżentat ukoll informazzjoni dwar l-użu ta' Vedrop f'pazjenti b'fibrożi ċistika, iżda rtirat l-applikazzjoni għal din il-marda waqt il-valutazzjoni tal-mediċina.
English: This can increase vitamin E levels in the blood and help to prevent damage to the nervous system due to vitamin E deficiency.
Maltese: Dan jista' jżid il-livelli tal-vitamina E fiddemm u jgħin biex jipprevjeni ħsara lis-sistema nervuża minħabba defiċjenza tal-vitamina E.
English: It is used in children up to the age of 18 years who have congenital or hereditary chronic cholestasis and who cannot absorb vitamin E from the gut.
Maltese: Dan jintuża fi tfal sal-età ta' 18-il sena li għandhom kolestażi kronika konġenitali jew ereditarja u li ma jistgħux jassorbu l-vitamina E mill-musrana.
English: This should be checked regularly.
Maltese: Dan għandu jiġi ċċekkjat regolarment.
English: Patients with cholestasis may have low vitamin E levels because they have problems absorbing fats from the gut.
Maltese: Il-pazjenti b'kolestażi jista' jkollhom livelli baxxi tal-vitamina E minħabba li jkollhom problemi bl-assorbiment tax-xaħam mill-musrana.
English: Vedrop has been authorised under ‘exceptional circumstances'.
Maltese: Vedrop ġie awtorizzat taħt ‘ċirkustanzi ta' eċċezzjoni'.
English: Angioedema1, urticaria1
Maltese: Anġjoedema1, urtikarja1
English: Age, gender and ethnicity
Maltese: Età, sess u etniċità
English: EU/1/16/1154/001 EU/1/16/1154/002
Maltese: EU/1/16/1154/002
English: d A sensitive CYP3A4 substrate.
Maltese: d Sottostrat sensittiv ta' CYP3A4.
English: -3.6% (95% CI = -9.8% to 2.6%)
Maltese: -3.6% (95% CI = -9.8% sa 2.6%)
English: 1.8% (95% CI = -3.6% to 7.2%)
Maltese: 1.8% (95% CI = -3.6% sa 7.2%)
English: Each tablet contains 95 mg lactose (as monohydrate).
Maltese: Kull pillola fiha 95 mg lactose (bħala monohydrate).
English: ↔ GS-331007
Maltese: GS-331007g
English: b All No Effect Boundaries are 70%-143%.
Maltese: b Il-Limiti Kollha tal-Ebda Effett huma 70%-143%.
English: Vemlidy contains lactose monohydrate.
Maltese: Vemlidy fih lactose monohydrate.
English: Gastrointestinal disorders Common
Maltese: Disturbi gastrointestinali
English: ANTIFUNGALS Itraconazole Ketoconazole
Maltese: Itraconazole Ketoconazole
English: Contains lactose monohydrate.
Maltese: TA' EĊĊIPJENTI Fih lactose monohydrate.
English: HBV transmission
Maltese: Trasmissjoni tal-HBV
English: Effects on drug levels.a,b Mean ratio (90% confidence interval) for AUC, Cmax, Cmin
Maltese: a,b Proporzjon medju (90% intervall ta' kunfidenza) għal AUC, Cmax, Cmin
English: Polyvinyl alcohol (E1203) Titanium dioxide (E171) Macrogol (E1521) Talc (E553b) Iron oxide yellow (E172)
Maltese: Polyvinyl alcohol (E1203) Titanium dioxide (E171) Macrogol (E1521) Talc (E553b) Iron oxide isfar (E172)
English: The EC50 (50% effective concentration) values for tenofovir alafenamide ranged from 34.7 to 134.4 nM, with an overall mean EC50 of 86.6 nM.
Maltese: Il-valuri EC50 (50% konċentrazzjoni effettiva) għal tenofovir alafenamide ivarjaw minn 34.7 sa 134.4 nM, b'medja globali tal-EC50 ta' 86.6 nM.
English: Polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol (E1521), talc (E553b), iron oxide yellow (E172).
Maltese: Polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol (E1521), talc (E553b), iron oxide isfar (E172).
English: ALT Normalised ALT (Central lab)b
Maltese: ALT normalizzat (Laboratorju ċentrali)c
English: The active substance is tenofovir alafenamide.
Maltese: Is-sustanza attiva hi tenofovir alafenamide.
English: Tenofovir alafenamide is a phosphonamidate prodrug of tenofovir (2'-deoxyadenosine monophosphate analogue).
Maltese: Tenofovir alafenamide huwa promediċina tal-phosphonamidate ta' tenofovir (analogu ta' 2'-deoxyadenosine monophosphate).
English: Tenofovir alafenamide is a substrate of OATP1B1 and OATP1B3 in vitro.
Maltese: Tenofovir alafenamide huwa sottostrat ta' OATP1B1 u OATP1B3 in vitro.
English: It is not an inhibitor or inducer of CYP3A in vivo.
Maltese: Dan mhuwiex inibitur jew induttur ta' CYP3A in vivo.
English: In vitro, tenofovir alafenamide is not metabolised by CYP1A2, CYP2C8, CYP2C9, CYP2C19, or CYP2D6.
Maltese: In vitro, tenofovir alafenamide mhuwiex metabolizzat minn CYP1A2, CYP2C8, CYP2C9, CYP2C19 jew CYP2D6.
English: Tenofovir alafenamide is transported by P-gp and breast cancer resistance protein (BCRP).
Maltese: Tenofovir alafenamide huwa trasportat mill-P-gp u l-proteina ta' reżistenza tal-kanċer tas-sider (BCRP, breast cancer resistance protein).
English: rifabutin, rifampicin or rifapentine
Maltese: rifabutin, rifampicin jew rifapentine
English: The CC50 (50% cytotoxicity concentration) in HepG2 cells was > 44,400 nM.
Maltese: Is-CC50 (50% konċentrazzjoni taċ-ċitotossiċità) fiċ-ċelluli HepG2 kienet > 44,400 nM.
English: g The predominant circulating nucleoside metabolite of sofosbuvir.
Maltese: g Il-metabolit nukleosid predominanti li jiċċirkola ta' sofosbuvir.
English: HIV ANTIRETROVIRAL AGENTS - CCR5 RECEPTOR ANTAGONIST Maraviroc
Maltese: HIV - ANTAGONIST TAR-RIĊETTURI TA' CCR5 Maraviroc
English: EU/1/16/1154/001 30 film-coated tablets EU/1/16/1154/002 90 (3 bottles of 30) film-coated tablets
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/16/1154/001 30 pillola miksija b'rita EU/1/16/1154/002 90 (3 fliexken ta' 30) pillola miksija b'rita
English: The efficacy and safety of Vemlidy in patients with chronic hepatitis B are based on 48- and 96-week data from two randomised, double-blind, active-controlled studies, GS-US-320-0108 (“Study 108”) and GS-US-320-0110 (“Study 110”).
Maltese: L-effikaċja u s-sigurtà ta' Vemlidy f'pazjenti bl-epatite B kronika huma bbażati fuq id-dejta ta' 48 u 96 ġimgħa minn żewġ studji li fihom il-parteċipanti ntgħażlu b'mod każwali, double-blind, ikkontrollati attivament, GS-US-320-0108 (“Studju 108”) u GS-US-320-0110 (“Studju 110”).
English: ↔ GS-331007 ↔ Velpatasvir
Maltese: ↔ Sofosbuvir ↔ GS-331007 ↔ Velpatasvir ↑ Tenofovir alafenamide
English: Tenofovir has activity that is specific to hepatitis B virus and human immunodeficiency virus (HIV-1 and HIV-2).
Maltese: Tenofovir għandu attività li hija speċifika għall-virus tal-epatite B u l-virus tal-immunodefiċjenza umana (HIV-1 u HIV-2).
English: How to store Vemlidy
Maltese: Tiħux Vemlidy
English: TDF = tenofovir disoproxil fumarate a Missing = failure analysis.
Maltese: TDF = tenofovir disoproxil fumarate a Nieqsa = analiżi tal-falliment.
English: Tenofovir alafenamide is minimally metabolised by CYP3A4.
Maltese: Tenofovir alafenamide huwa ftit li xejn metabolizzat minn CYP3A4.
English: Tenofovir alafenamide is not an inhibitor of human uridine diphosphate glucuronosyltransferase (UGT) 1A1 in vitro.
Maltese: Tenofovir alafenamide mhuwiex inibitur ta' uridine diphosphate glucuronosyltransferase (UGT) 1A1 tal-bniedem in vitro.
English: Table 1: Interactions between Vemlidy and other medicinal products
Maltese: Tabella 1: Interazzjonijiet bejn Vemlidy u prodotti mediċinali oħrajn
English: Steady state Cmax for tenofovir alafenamide and tenofovir were 0.18 and 0.02 µg/mL, respectively.
Maltese: Is-Cmax fl-istat fiss għal tenofovir alafenamide u tenofovir kien ta' 0.18 u 0.02 µg/mL, rispettivament.
English: Tenofovir alafenamide and tenofovir have a median plasma half-life of 0.51 and 32.37 hours, respectively.
Maltese: Tenofovir alafenamide u tenofovir għandhom medjan ta' half-life fil-plażma ta' 0.51 u 32.37 siegħa, rispettivament.
English: Normalised ALT (Central lab)c Normalised ALT (AASLD)d Serology
Maltese: ALT normalizzat (AASLD)d Seroloġija
English: h Study conducted with tenofovir alafenamide 40 mg and emtricitabine 200 mg. i Study conducted with additional voxilaprevir 100 mg to achieve voxilaprevir exposures expected in HCV infected patients.
Maltese: h L-istudju twettaq b'tenofovir alafenamide 40 mg u emtricitabine 200 mg. i Studju mwettaq b'voxilaprevir 100 mg addizzjonali biex jinkisbu l-esponimenti għal voxilaprevir mistennija f'pazjenti infettati bl-HCV.
English: Clinical data
Maltese: KLINIKU
English: The mean age was 46 years, 61% were male, 72% were Asian, 25% were White and 2% (8 subjects) were Black.
Maltese: L-età medja kienet ta' 46 sena, 61% kienu rġiel, 72% kienu Asjatiċi, 25% kienu Bojod u 2% (8 individwi) kienu Suwed.
English: 90 (3 bottles of 30) film-coated tablets.
Maltese: 90 (3 fliexken ta' 30) pillola miksija b'rita.
English: Ethinylestradiol (0.025 mg orally, q.d.)
Maltese: Ethinylestradiol (0.025 mg mogħti mill-ħalq, q.d.)
English: No clinically relevant differences in tenofovir alafenamide or tenofovir pharmacokinetics were observed between adolescent and adult HIV-1 infected subjects.
Maltese: Ma ġew osservati l-ebda differenzi klinikament rilevanti fil-farmakokinetika ta' tenofovir alafenamide jew tenofovir bejn individwi adolexxenti u adulti infettati bl-HIV-1.
English: ORAL CONTRACEPTIVES Norgestimate (0.180 mg/0.215 mg/ 0.250 mg orally, q.d.)
Maltese: Norgestimate (0.180 mg/0.215 mg/0.250 mg mogħti mill-ħalq, q.d.)
English: Central laboratory ULN for ALT are as follows: ≤ 43 U/L for males aged 18 to < 69 years and ≤ 35 U/L for males ≥ 69 years; ≤ 34 U/L for females 18 to < 69 years and ≤ 32 U/L for females ≥ 69 years.
Maltese: ULN tal-laboratorju ċentrali għall-ALT huma kif ġej: ≤ 43 U/L għal irġiel li jkollhom minn 18 sa < 69 sena u ≤ 35 U/L għal irġiel li jkollhom ≥ 69 sena; ≤ 34 U/L għal nisa li jkollhom minn 18 sa < 69 sena u ≤ 32 U/L għal nisa li jkollhom ≥ 69 sena.
English: You must use an effective method of contraception.
Maltese: Inti għandek tuża metodu effettiv ta' kontraċezzjoni.
English: Based on Phase 3 population pharmacokinetic analysis in subjects with chronic hepatitis B, mean steady state AUC0-24 for tenofovir alafenamide (N = 698) and tenofovir (N = 856) were 0.22 µg•h/mL and 0.32 µg•h/mL, respectively.
Maltese: Ibbażat fuq analiżi farmakokinetika tal-popolazzjoni ta' Fażi 3 f'individwi b'epatite B kronika, il-medja tal-AUC0-24 fl-istat fiss għal tenofovir alafenamide (N = 698) u tenofovir (N = 856) kienet ta' 0.22 µg•siegħa/mL u 0.32 µg•siegħa/mL, rispettivament.
English: HBV DNA < 29 IU/mL Treatment differenceb
Maltese: HBV DNA < 29 IU/mL Differenza fil-kurab
English: Frequencies are defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10) or uncommon (≥ 1/1,000 to < 1/100).
Maltese: Il-frekwenzi huma definiti kif ġej: komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10) jew mhux komuni (≥ 1/1,000 sa < 1/100).
English: 21% were treatment-experienced (previous treatment with oral antivirals, including entecavir (N = 41), lamivudine (N = 42), tenofovir disoproxil fumarate (N = 21), or other (N = 18)).
Maltese: 24%, 38%, u 31% kellhom il-ġenotip tal-HBV B, Ċ, u D rispettivament. 21% kienu rċivew kura fil-passat (kura preċedenti b'antivirali orali, inklużi entecavir (N = 41), lamivudine (N = 42), tenofovir disoproxil fumarate (N = 21), jew oħrajn (N = 18)).
English: HBV DNA ≥ 29 IU/mL Baseline HBV DNA < 7 log10 IU/mL ≥ 7 log10 IU/mL
Maltese: HBV DNA ≥ 29 IU/mL HBV DNA fil-Linja Bażi < 7 log10 IU/mL ≥ 7 log10 IU/mL
English: HBV DNA < 29 IU/mL Baseline HBV DNA < 7 log10 IU/mL ≥ 7 log10 IU/mL
Maltese: HBV DNA < 29 IU/mL HBV DNA fil-Linja Bażi < 7 log10 IU/mL ≥ 7 log10 IU/mL
English: Normalised ALT (AASLD)c
Maltese: ALT normalizzat (AASLD)c Seroloġija
English: Table 2: Adverse drug reactions identified with tenofovir alafenamide
Maltese: Tabella 2: Reazzjonijiet avversi għall-mediċina identifikati b'tenofovir alafenamide
English: Patients with creatinine clearance < 30 mL/min
Maltese: Pazjenti bi tneħħija tal-kreatinina ta' < 30 mL/min
English: Tenofovir diphosphate is a weak inhibitor of mammalian DNA polymerases that include mitochondrial DNA polymerase γ and there is no evidence of mitochondrial toxicity in vitro based on several assays including mitochondrial DNA analyses.
Maltese: Tenofovir diphosphate huwa inibitur dgħajjef tad-DNA polymerases talmammali li jinkludu DNA polymerase γ mitokondrijali u ma hemm l-ebda evidenza ta' tossiċità mitokondrijali in vitro fuq il-bażi ta' diversi assaġġi inklużi analiżijiet tad-DNA mitokondrijali.
English: Tenofovir alafenamide is primarily hydrolysed to form tenofovir by carboxylesterase 1 in primary hepatocytes.
Maltese: Tenofovir alafenamide huwa idrolizzat primarjament biex jifforma tenofovir permezz ta' carboxylesterase 1 fl-epatoċiti primarji.
English: Table 3: HBV DNA efficacy parameters at Week 48a
Maltese: Tabella 3: Parametri tal-effikaċja tal-HBV DNA f'Ġimgħa 48a
English: Nucleoside naïvec Nucleoside experienced No Virologic data at Week 48
Maltese: Qatt ma ħadu nucleoside fil-passatc Ħadu nucleoside fil-passat Ebda dejta Viroloġika f'Ġimgħa 48
English: Musculoskeletal and connective tissue disorders Common
Maltese: Disturbi muskoluskeletriċi u tat-tessuti konnettivi
English: Spontaneous exacerbations in chronic hepatitis B are relatively common and are characterised by transient increases in serum alanine aminotransferase (ALT).
Maltese: Epatite B kronika li tirkadi b'mod spontanju hija relattivament komuni u hija karatterizzata minn żidiet temporanji f'alanine aminotransferase (ALT) tas-serum.
English: ANTICONVULSANTS Carbamazepine (300 mg orally, b.i.d.)
Maltese: MEDIĊINI ANTIKONVULŻIVI Carbamazepine (300 mg mogħti mill-ħalq, b.i.d.)
English: Tenofovir alafenamide ↓ Cmax 0.43 (0.36, 0.51) ↓ AUC 0.45 (0.40, 0.51)
Maltese: ↓ Cmax 0.43 (0.36, 0.51) ↓ AUC 0.45 (0.40, 0.51)
English: Vemlidy 25 mg film-coated tablets tenofovir alafenamide
Maltese: Vemlidy 25 mg pilloli miksija b'rita tenofovir alafenamide
English: ANTIDEPRESSANTS Sertraline (50 mg orally, s.d.) Tenofovir alafenamidee (10 mg orally, q.d.)
Maltese: Sertraline (50 mg mogħti mill-ħalq, s.d.) Tenofovir alafenamidee (10 mg mogħti mill-ħalq, q.d.)
English: Tenofovir ↑ Cmax 3.75 (3.19, 4.39)
Maltese: ↑ Cmax 3.75 (3.19, 4.39) ↑ AUC 4.16 (3.50, 4.96)
English: No clinically relevant differences in tenofovir alafenamide or tenofovir pharmacokinetics were observed between healthy subjects and patients with severe renal impairment (estimated CrCl > 15 but < 30 mL/min) in studies of tenofovir alafenamide.
Maltese: Ma kienu osservati l-ebda differenzi klinikament sinifikanti fil-farmakokinetika ta' tenofovir alafenamide jew tenofovir bejn l-individwi f'saħħithom u pazjenti b'indeboliment sever tal-kliewi (CrCl stmat ta' > 15 iżda < 30 mL/min) fi studji ta' tenofovir alafenamide.
English: Sofosbuvir/velpatasvir/ voxilaprevir (400 mg/100 mg/ 100 mg + 100 mgi orally, q.d.)
Maltese: Sofosbuvir/velpatasvir/ voxilaprevir (400 mg/100 mg/ 100 mg + 100 mgi mogħti mill-ħalq, q.d.)
English: HBsAg loss / seroconversion
Maltese: Telf ta' HBsAg / serokonverżjoni
English: Nucleoside-naïveb Nucleoside-experienced ALT
Maltese: Qatt ma ħadu nucleoside fil-passatb Ħadu nucleoside fil-passat
English: Usually this is for at least 6 to 12 months and may be for many years.
Maltese: Normalment dan ikun għal mill-inqas 6 xhur sa 12-il xahar u jista' jkun għal ħafna snin.
English: In analyses at Week 48 (N = 20) and Week 96 (N = 72), no amino acid substitutions associated with resistance to Vemlidy were identified in these isolates (genotypic and phenotypic analyses).
Maltese: F'analiżi f'Ġimgħa 48 (N = 20) u Ġimgħa 96 (N = 72), l-ebda sostituzzjonijiet ta' aċidi amminiċi assoċjati mar-reżistenza għal Vemlidy ma kienu identifikati f'dawn l-iżolati (analiżi ġenotipika u fenotipika).
English: Intracellular tenofovir is subsequently phosphorylated to the pharmacologically active metabolite tenofovir diphosphate.
Maltese: Tenofovir intraċellulari huwa fosforilat suċċessivament għallmetabolit farmakoloġikament attiv tenofovir diphosphate.
English: No clinically relevant differences in pharmacokinetics according to age or ethnicity have been identified.
Maltese: L-ebda differenza klinikament rilevanti fil-farmakokinetika skont l-età jew l-etniċità ma ġiet identifikata.
English: In both studies tenofovir alafenamide was associated with smaller changes in renal safety parameters (smaller median reductions in estimated CrCl by Cockcroft-Gault and smaller median percentage increases in urine retinol binding protein to creatinine ratio and urine beta-2-microglobulin to creatinine ratio) compared to tenofovir disoproxil fumarate after 96 weeks of treatment (see also section 4.4).
Maltese: Fiż-żewġ studji, tenofovir alafenamide kien assoċjat ma' bidliet iżgħar fil-parametri tas-sigurtà renali (tnaqqis medjan iżgħar fil-CrCl stmata b'Cockcroft-Gault u żidiet perċentwali medjani iżgħar filproporzjon ta' proteina li teħel ma' retinol għal kreatinina fl-awrina u l-proporzjon tal-mikroglobulina beta 2 għal kreatinina fl-awrina) meta mqabbel ma' tenofovir disoproxil fumarate wara 96 ġimgħa ta' kura (ara wkoll sezzjoni 4.4).
English: The safety of Vemlidy is also supported by pooled data from patients in Studies 108 and 110 who remained on blinded treatment from Week 96 through Week 120 and additionally from patients in the open-label phase of Studies 108 and 110 from Week 96 through Week 120 (N = 361 remained on Vemlidy; N = 180 switched from tenofovir disoproxil fumarate to Vemlidy at Week 96).
Maltese: Issigurtà ta' Vemlidy hija sostnuta wkoll minn dejta miġbura minn pazjenti fl-Istudji 108 u 110 li baqgħu fuq trattament blinded minn Ġimgħa 96 sa Ġimgħa 120 u addizzjonalment minn pazjenti filfażi open-label tal-Istudji 108 u 110 minn Ġimgħa 96 sa Ġimgħa 120 (N = 361 baqgħu fuq Vemlidy; N = 180 qalbu minn tenofovir disoproxil fumarate għal Vemlidy f'Ġimgħa 96).
English: Yellow, round, film-coated tablets, 8 mm in diameter, debossed with “GSI” on one side of the tablet and “25” on the other side of the tablet.
Maltese: Pilloli miksija b'rita sofor, tondi, b'dijametru ta' 8 mm, b'“GSI” imnaqqxa fuq naħa waħda tal-pillola u “25” fuq in-naħa l-oħra tal-pillola.
English: In a pooled analysis of patients receiving Vemlidy, sequence analysis was performed on paired baseline and on-treatment HBV isolates for patients who either experienced virologic breakthrough (2 consecutive visits with HBV DNA ≥ 69 IU/mL after having been < 69 IU/mL, or 1.0 log10 or greater increase in HBV DNA from nadir) or patients with HBV DNA ≥ 69 IU/mL at Week 96 or at early discontinuation at or after Week 24.
Maltese: F'analiżi miġbura ta' pazjenti li kienu qed jirċievu Vemlidy, twettqet analiżi tas-sekwenza fuq iżolati tal-HBV akkoppjati fil-linja bażi u ta' waqt il-kura għal pazjenti li jew kellhom penetrazzjoni viroloġika (2 żjarat konsekuttivi b'HBV DNA ≥ 69 IU/mL wara li kienet < 69 IU/mL, jew żieda ta' 1.0 log10 jew ikbar fl-HBV DNA mill-aktar livell baxx), jew pazjenti b'HBV DNA ≥ 69 IU/mL f'Ġimgħa 96 jew wara waqfien bikri f'Ġimgħa 24 jew wara.
English: Vemlidy 25 mg film-coated tablets.
Maltese: Vemlidy 25 mg pilloli miksija b'rita.
English: HBV isolates expressing the rtA181T, rtA181V, or rtN236T single substitutions associated with resistance to adefovir remained susceptible to tenofovir alafenamide; however, the HBV isolate expressing rtA181V plus rtN236T exhibited reduced susceptibility to tenofovir alafenamide (3.7-fold change in EC50).
Maltese: L-iżolati talHBV li jesprimu s-sostituzzjonijiet uniċi rtA181T, rtA181V, jew rtN236T assoċjati mar-reżistenza għal adefovir baqgħu suxxettibbli għal tenofovir alafenamide; madankollu, l-iżolat tal-HBV li jesprimi rtA181V flimkien ma' rtN236T wera tnaqqis fis-suxxettibbiltà għal tenofovir alafenamide (bidla ta' 3.7 darbiet fl-EC50).
English: The following pack sizes are available: outer cartons containing 1 bottle of 30 film-coated tablets and outer cartons containing 90 (3 bottles of 30) film-coated tablets.
Maltese: Id-daqsijiet tal-pakketti li ġejjin huma disponibbli: kartun ta' barra li fihom flixkun 1 ta' 30 pillola miksija b'rita u kartun ta' barra li fihom 90 (3 fliexken ta' 30) pillola miksija b'rita.
English: After initiating antiviral therapy, serum ALT may increase in some patients.
Maltese: Wara li tinbeda t-terapija antivirali, lALT tas-serum jista' jiżdied f'ċerti pazjenti.
English: Renal excretion of intact tenofovir alafenamide is a minor pathway with < 1% of the dose eliminated in urine.
Maltese: It-tneħħija renali ta' tenofovir alafenamide intatt hija rotta minuri b'< 1% tad-doża eliminata fl-awrina.
English: In the open-label phase of Studies 108 and 110, the mean (±SD) change in serum creatinine from Week 96 to Week 120 was -0.002 (0.10) mg/dL in those who remained on Vemlidy, compared to -0.008 (0.09) mg/dL in those who switched from tenofovir disoproxil fumarate to Vemlidy at Week 96.
Maltese: Fil-fażi open-label tal-Istudji 108 u 110, il-bidla medja (±SD) fil-kreatinina fisserum minn Ġimgħa 96 sa Ġimgħa 120 kienet -0.002 (0.10) mg/dL f'dawk li baqgħu fuq Vemlidy, meta mqabbla ma' -0.008 (0.09) mg/dL f'dawk li qalbu minn tenofovir disoproxil fumarate għal Vemlidy f'Ġimgħa 96.
English: Drug interaction information for Vemlidy with potential concomitant medicinal products is summarised in Table 1 below (increase is indicated as “↑”, decrease as “↓”, no change as “↔”; twice daily as “b.i.d.”, single dose as “s.d.”, once daily as “q.d.”; and intravenously as “IV”).
Maltese: L-informazzjoni dwar l-interazzjoni bejn mediċina u oħra għal Vemlidy ma' prodotti mediċinali konkomitanti potenzjali hija mogħtija fil-qosor fit-Tabella 1 hawn taħt (żieda hija indikata bħala “↑”, tnaqqis bħala “↓”, l-ebda bidla bħala “↔”; darbtejn kuljum bħala “b.i.d.”, doża waħda bħala “s.d.”, darba kuljum bħala “q.d.”; u ġol-vini bħala “IV”).
English: In Study 108, HBeAg-negative treatment-naïve and treatment-experienced patients with compensated liver function were randomised in a 2:1 ratio to receive Vemlidy (25 mg; N = 285) once daily or tenofovir disoproxil fumarate (300 mg; N = 140) once daily.
Maltese: Fl-Istudju 108, pazjenti negattivi għal HBeAg li qatt ma rċivew kura fil-passat u li rċivew kura b'funzjoni kumpensata tal-fwied, intgħażlu b'mod każwali fi proporzjon ta' 2:1 biex jirċievu Vemlidy (25 mg; N = 285) darba kuljum jew tenofovir disoproxil fumarate (300 mg; N = 140) darba kuljum.
English: HBV isolates expressing the rtL180M, rtM204V plus rtT184G, rtS202G, or rtM250V substitutions associated with resistance to entecavir remained susceptible to tenofovir alafenamide.
Maltese: L-iżolati tal-HBV li jesprimu s-sostituzzjonijiet rtL180M, rtM204V flimkien ma' rtT184G, rtS202G, jew rtM250V assoċjati mar-reżistenza għal entecavir baqgħu suxxettibbli għal tenofovir alafenamide.