FrancophonIA/ELRC3.0 huggingface dataset:
English: b Adjusted by baseline plasma HBV DNA categories and oral antiviral treatment status strata.
Maltese: b Aġġustat skont il-kategorija tal-HBV DNA tal-plażma fil-linja bażi u l-istrata tal-istat tal-kura antivirali orali.
English: Ledipasvir/sofosbuvir (90 mg/400 mg orally, q.d.)
Maltese: Ledipasvir/sofosbuvir (90 mg/400 mg mogħti millħalq, q.d.)
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Pazjenti li għandhom problemi ereditarji rari ta' intolleranza għallgalactose, nuqqas totali ta' lactase jew malassorbiment tal-glucose-galactose m'għandhomx jieħdu din il-mediċina.
English: Sertraline (50 mg orally, s.d.)
Maltese: Sertraline (50 mg mogħti mill-ħalq, s.d.)
English: Sertraline ↔ Cmax 1.14 (0.94, 1.38) ↔ AUC 0.93 (0.77, 1.13)
Maltese: ↔ Cmax 1.14 (0.94, 1.38) ↔ AUC 0.93 (0.77, 1.13)
English: Vemlidy contains lactose
Maltese: Vemlidy fih lactose
English: This is an antiviral medicine, known as a nucleotide reverse transcriptase inhibitor (NtRTI).
Maltese: Din hija mediċina antivirali, magħrufa bħala inibitur tan-nucleotide reverse transcriptase (NtRTI, nucleotide reverse transcriptase inhibitor).
English: HBeAg loss / seroconversione
Maltese: Telf ta' HBeAg / serokonverżjonie
English: Tenofovir ↑ Cmax 2.12 (1.86, 2.43)
Maltese: ↑ Cmax 2.12 (1.86, 2.43) ↑ AUC 2.62 (2.14, 3.20)
English: Hepatitis B and HIV co-infection
Maltese: Koinfezzjoni tal-epatite B u l-HIV
English: Darunavir/cobicistat (800 mg/150 mg orally, q.d.)
Maltese: Darunavir/cobicistat (800 mg/150 mg mogħti millħalq, q.d.)
English: Tenofovir alafenamide enters primary hepatocytes by passive diffusion and by the hepatic uptake transporters OATP1B1 and OATP1B3.
Maltese: Tenofovir alafenamide jidħol fl-epatoċiti primarji permezz taddiffużjoni passiva u permezz tat-trasportaturi tal-assorbiment epatiku OATP1B1 u OATP1B3.
English: Patients co-infected with HBV and hepatitis C or D virus
Maltese: Pazjenti koinfettati bl-HBV u virus tal-epatite Ċ jew D
English: In vivo, tenofovir alafenamide is hydrolysed within cells to form tenofovir (major metabolite), which is phosphorylated to the active metabolite, tenofovir diphosphate.
Maltese: In vivo, tenofovir alafenamide huwa idrolizzat fiċ-ċelluli biex jifforma tenofovir (metabolit maġġuri), li huwa fosforilat għall-metabolit attiv, tenofovir diphosphate.
English: In vitro studies have shown that tenofovir alafenamide is metabolised to tenofovir (major metabolite) by carboxylesterase-1 in hepatocytes; and by cathepsin A in peripheral blood mononuclear cells (PBMCs) and macrophages.
Maltese: L-istudji in vitro wrew li tenofovir alafenamide huwa metabolizzat f'tenofovir (metabolit maġġuri) permezz ta' carboxylesterase-1 fl-epatoċiti; u permezz ta' cathepsin A fiċ-ċelluli mononukleari tad-demm periferali (PBMCs, peripheral blood mononuclear cells) u l-makrofaġi.
English: Tenofovir alafenamide exposures are dose proportional over the dose range of 8 to 125 mg.
Maltese: L-esponimenti ta' tenofovir alafenamide huma proporzjonali għad-doża fuq il-firxa tad-doża ta' 8 mg sa 125 mg.
English: Assessment of adverse reactions is based on pooled safety data from 2 controlled Phase 3 studies in which 866 HBV infected patients received tenofovir alafenamide 25 mg once daily in a double-blind fashion through Week 96 (median duration of blinded study drug exposure of 104 weeks) and from post-marketing experience.
Maltese: Il-valutazzjoni ta' reazzjonijiet avversi hija bbażata fuq dejta ta' sigurtà miġbura minn 2 studji kkontrollati ta' Fażi 3 li fihom 866 pazjent infettat bl-HBV ingħataw tenofovir alafenamide 25 mg darba kuljum b'tali mod li la l-investigaturi u lanqas l-individwi ma kienu jafu liema sustanza qed tintuża (double-blind) sa Ġimgħa 96 (tul medjan ta' esponiment bla għarfien (blinded) tal-mediċina tal-istudju ta' 104 ġimgħat) u mill-esperjenza ta' wara t-tqegħid fis-suq.
English: Rilpivirine (25 mg orally, q.d.)
Maltese: Rilpivirine (25 mg mogħti mill-ħalq, q.d.)
English: Lopinavir/ritonavir (800 mg/200 mg orally, q.d.)
Maltese: Lopinavir/ritonavir (800 mg/200 mg mogħti millħalq, q.d.)
English: No additional adverse reactions to Vemlidy were identified from Week 96 through Week 120 in the double-blind phase and in the subset of subjects receiving open-label Vemlidy treatment (see section 5.1).
Maltese: L-ebda reazzjoni avversa addizzjonali għal Vemlidy ma ġiet identifikata minn Ġimgħa 96 sa Ġimgħa 120 fil-fażi double-blind u fis-sottosett ta' individwi li kienu qed jirċievu trattament b'Vemlidy open-label (ara sezzjoni 5.1).
English: Baseline HBV DNA < 8 log10 IU/mL ≥ 8 log10 IU/mL
Maltese: HBV DNA fil-Linja Bażi < 8 log10 IU/mL
English: HIV ANTIRETROVIRAL AGENTS - INTEGRASE INHIBITORS Dolutegravir (50 mg orally, q.d.)
Maltese: HIV - INIBITURI TA' INTEGRASE Dolutegravir (50 mg mogħti mill-ħalq, q.d.)
English: Sofosbuvir/velpatasvir (400 mg/100 mg orally, q.d.)
Maltese: Sofosbuvir/velpatasvir (400 mg/100 mg mogħti millħalq, q.d.)
English: HBV isolates expressing the rtV173L, rtL180M, and rtM204V/I substitutions associated with resistance to lamivudine remained susceptible to tenofovir alafenamide (< 2-fold change in EC50).
Maltese: L-iżolati tal-HBV li jesprimu s-sostituzzjonijiet rtV173L, rtL180M, u rtM204V/I assoċjati mar-reżistenza għal lamivudine baqgħu suxxettibbli għal tenofovir alafenamide (bidla ta' < 2 darbiet fl-EC50).
English: Diarrhoea, vomiting, nausea, abdominal pain, abdominal distension, flatulence Hepatobiliary disorders
Maltese: Dijarea, rimettar, nawsja, uġigħ fl-addome, distensjoni tal-addome, gass fl-istonku
English: Midazolam ↔ Cmax 1.02 (0.92, 1.13) ↔ AUC 1.13 (1.04, 1.23)
Maltese: ↔ Cmax 1.02 (0.92, 1.13) ↔ AUC 1.13 (1.04, 1.23)
English: Vemlidy may interact with other medicines.
Maltese: Vemlidy jista' jkollu interazzjoni ma' mediċini oħra.
English: Therefore, hepatobiliary and renal parameters should be closely monitored in this patient population (see section 5.2).
Maltese: Għalhekk, il-parametri epatobiljari u tal-kliewi għandhom jiġu mmonitorjati mill-qrib f'din il-popolazzjoni ta'pazjenti (ara sezzjoni 5.2).
English: Atazanavir/ritonavir (300 mg/100 mg orally, q.d.)
Maltese: Atazanavir/ritonavir (300 mg/100 mg mogħti millħalq, q.d.)
English: In Study 110, HBeAg-positive treatment-naïve and treatment-experienced patients with compensated liver function were randomised in a 2:1 ratio to receive Vemlidy (25 mg; N = 581) once daily or tenofovir disoproxil fumarate (300 mg; N = 292) once daily.
Maltese: Fl-Istudju 110, pazjenti pożittivi 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 = 581) darba kuljum jew tenofovir disoproxil fumarate (300 mg; N = 292) darba kuljum.
English: A potential risk of nephrotoxicity resulting from chronic exposure to low levels of tenofovir due to dosing with tenofovir alafenamide cannot be excluded (see section 5.3).
Maltese: Riskju potenzjali ta' nefrotossiċità li jirriżulta minn esponiment kroniku għal livelli baxxi ta' tenofovir minħabba l-għoti ta' dożi ta' tenofovir alafenamide ma jistax jiġi eskluż (ara sezzjoni 5.3).
English: The use of Vemlidy once daily in patients with CrCl ≥ 15 mL/min but < 30 mL/min and in patients with CrCl < 15 mL/min who are receiving haemodialysis is based on very limited pharmacokinetic data and on modelling and simulation.
Maltese: L-użu ta' Vemlidy darba kuljum f'pazjenti b'CrCl ≥ 15 mL/min iżda < 30 mL/min u f'pazjenti b'CrCl < 15 mL/min li qed jirċievu emodijalisi huwa bbażat fuq tagħrif farmakokinetiku limitat ħafna u fuq immudellar u simulazzjoni.
English: Adverse reaction Nervous system disorders Very common Headache Common
Maltese: Disturbi fis-sistema nervuża
English: A long-term oral carcinogenicity study in mice showed a low incidence of duodenal tumours, considered likely related to high local concentrations in the gastrointestinal tract at the high dose of 600 mg/kg/day.
Maltese: Studju fit-tul dwar ilkarċinoġeniċità minn għoti orali fil-ġrieden wera inċidenza baxxa ta' tumuri duodenali, meqjusin bħala probabbli relatati ma' konċentrazzjonijiet għoljin lokali fil-passaġġ gastrointestinali fid-doża għolja ta' 600 mg/kg/jum.
English: Norelgestromin ↔ Cmax 1.17 (1.07, 1.26) ↔ AUC 1.12 (1.07, 1.17) ↔ Cmin 1.16 (1.08, 1.24)
Maltese: ↔ Cmax 1.17 (1.07, 1.26) ↔ AUC 1.12 (1.07, 1.17) ↔ Cmin 1.16 (1.08, 1.24)
English: Darunavir/ritonavir (800 mg/100 mg orally, q.d.)
Maltese: Darunavir/ritonavir (800 mg/100 mg mogħti millħalq, q.d.)
English: • anticonvulsants used to treat epilepsy, such as: carbamazepine, oxcarbazepine, phenobarbital or phenytoin
Maltese: carbamazepine, oxcarbazepine, phenobarbital jew phenytoin
English: Norgestrel ↔ Cmax 1.10 (1.02, 1.18) ↔ AUC 1.09 (1.01, 1.18) ↔ Cmin 1.11 (1.03, 1.20)
Maltese: ↔ Cmax 1.10 (1.02, 1.18) ↔ AUC 1.09 (1.01, 1.18) ↔ Cmin 1.11 (1.03, 1.20)
English: Metabolism is a major elimination pathway for tenofovir alafenamide in humans, accounting for > 80% of an oral dose.
Maltese: Il-metaboliżmu huwa rotta ta' eliminazzjoni ewlenija għal tenofovir alafenamide fil-bnedmin, li jammonta għal > 80% ta' doża orali.
English: Tablet core:
Maltese: Tabella 5:
English: • Joint pain (arthralgia)
Maltese: • Uġigħ fil-ġogi (artralġija)
English: The binding of tenofovir to human plasma proteins is less than 0.7% and is independent of concentration over the range of 0.01-25 µg/mL.
Maltese: L-irbit ta' tenofovir mal-proteini tal-plażma umana huwa inqas minn 0.7% u huwa indipendenti mill-konċentrazzjoni fuq il-medda ta' 0.
English: Each film-coated tablet contains tenofovir alafenamide fumarate (equivalent to 25 mg of tenofovir alafenamide).
Maltese: Kull pillola miksija b'rita fiha tenofovir alafenamide fumarate (ekwivalenti għal 25 mg ta' tenofovir alafenamide).
English: c The population used for analysis of ALT normalisation included only patients with ALT above ULN of the American Association of the Study of Liver Diseases (AASLD) criteria (> 30 U/L males and > 19 U/L females) at baseline.
Maltese: c Il-popolazzjoni użata għall-analiżi tan-normalizzazzjoni tal-ALT kienet tinkludi biss pazjenti b'ALT ogħla mill-ULN talkriterji tal-Assoċjazzjoni Amerikana għall-Istudju ta' Mard tal-Fwied (AASLD - American Association of the Study of Liver Diseases) (> 30 U/L għall-irġiel u > 19-il U/L għan-nisa) fil-linja bażi.
English: Ethinylestradiol ↔ Cmax 1.22 (1.15, 1.29) ↔ AUC 1.11 (1.07, 1.16) ↔ Cmin 1.02 (0.93, 1.12)
Maltese: ↔ Cmax 1.22 (1.15, 1.29) ↔ AUC 1.11 (1.07, 1.16) ↔ Cmin 1.02 (0.93, 1.12)
English: • Itchiness
Maltese: • Nawsja
English: Darunavir ↔ Cmax 0.99 (0.91, 1.08) ↔ AUC 1.01 (0.96, 1.06) ↔ Cmin 1.13 (0.95, 1.34)
Maltese: ↔ Cmax 0.99 (0.91, 1.08) ↔ AUC 1.01 (0.96, 1.06) ↔ Cmin 1.13 (0.95, 1.34)
English: The antiviral activity of tenofovir alafenamide was evaluated against a panel of isolates containing nucleos(t)ide reverse transcriptase inhibitor mutations in HepG2 cells.
Maltese: L-attività antivirali ta' tenofovir alafenamide kienet evalwata kontra sensiela ta' iżolati li fihom mutazzjonjiet tal-inibituri nukleos(t)id ta' reverse transcriptase fiċ-ċelluli HepG2.
English: No dose adjustment of Vemlidy or norgestimate/ethinyl estradiol is required.
Maltese: Mhux meħtieġ aġġustament fid-doża ta' Vemlidy jew norgestimate/ethinyl estradiol.
English: TDF = tenofovir disoproxil fumarate a Missing = failure analysis b Treatment-naïve subjects received < 12 weeks of oral antiviral treatment with any nucleoside or nucleotide analogue including tenofovir disoproxil fumarate or tenofovir alafenamide.
Maltese: b Individwi li qatt ma rċivew kura fil-passat irċivew < 12-il ġimgħa ta' kura b'mediċina antivirali orali bi kwalunkwe analogu ta' nucleoside jew nucleotide, li jinkludu tenofovir disoproxil fumarate jew tenofovir alafenamide.
English: Tenofovir ↓ Cmax 0.70 (0.65, 0.74)
Maltese: ↓ Cmax 0.70 (0.65, 0.74) ↔ AUC 0.77 (0.74, 0.81)
English: Vemlidy should not be co-administered with medicinal products containing tenofovir disoproxil fumarate, tenofovir alafenamide or adefovir dipivoxil.
Maltese: Vemlidy ma għandux jingħata flimkien ma' prodotti mediċinali li fihom tenofovir disoproxil fumarate, tenofovir alafenamide jew adefovir dipivoxil.
English: Vemlidy is indicated for the treatment of chronic hepatitis B in adults and adolescents (aged 12 years and older with body weight at least 35 kg) (see section 5.1).
Maltese: Vemlidy huwa indikat għall-kura tal-epatite B kronika fl-adulti u l-adolexxenti (minn età ta' 12-il sena u ikbar li għandhom piż tal-ġisem ta' mill-inqas 35 kg) (ara sezzjoni 5.1).
English: d The population used for analysis of ALT normalisation included only patients with ALT above ULN of the AASLD criteria (> 30 U/L males and > 19 U/L females) at baseline.
Maltese: d Il-popolazzjoni użata għall-analiżi tan-normalizzazzjoni tal-ALT kienet tinkludi biss pazjenti b'ALT li kien ‘il fuq millULN tal-kriterji tal-AASLD (> 30 U/L għall-irġiel u > 19 U/L għan-nisa) fil-linja bażi.
English: Vemlidy should not be co-administered with medicinal products containing tenofovir alafenamide, tenofovir disoproxil fumarate or adefovir dipivoxil.
Maltese: Vemlidy ma għandux jingħata flimkien ma' prodotti mediċinali li fihom tenofovir alafenamide, tenofovir disoproxil fumarate jew adefovir dipivoxil.
English: HCV ANTIVIRAL AGENTS Sofosbuvir (400 mg orally, q.d.)
Maltese: KONTRA L-HCV Sofosbuvir (400 mg mogħti mill-ħalq, q.d.)
English: Tenofovir alafenamide was not mutagenic or clastogenic in conventional genotoxic assays.
Maltese: Tenofovir alafenamide ma kienx mutaġeniku jew klastoġeniku f'assaġġi ġenotossiċi konvenzjonali.
English: The following adverse drug reactions have been identified with tenofovir alafenamide in patients with chronic hepatitis B (Table 2).
Maltese: Ir-reazzjonijiet avversi għall-mediċina li ġejjin kienu identifikati b'tenofovir alafenamide f'pazjenti b'epatite B kronika (Tabella 2).
English: ↑ Cmin 1.85 (1.78, 1.92)
Maltese: ↑ Cmax 1.80 (1.48, 2.18) ↑ AUC 1.75 (1.55, 1.98)
English: Study 108 (HBeAg-Negative)
Maltese: Studju 108 (Negattivi għal HBeAg) Studju 110 (Pożittivi għal HBeAg) Vemlidy (N = 285)
English: N/A = not applicable
Maltese: N/A = Mhux applikabbli
English: Each Vemlidy film-coated tablet contains tenofovir alafenamide fumarate, equivalent to 25 mg of tenofovir alafenamide.
Maltese: Kull pillola miksija b'rita ta' Vemlidy fiha tenofovir alafenamide fumarate, ekwivalenti għal 25 mg ta' tenofovir alafenamide.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Vemlidy in one or more subsets of the paediatric population in the treatment of chronic hepatitis B (see sections 4.2 and 5.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini ddiferiet l-obbligu li jiġu ppreżentati riżultati tal-istudji b'Vemlidy f'wieħed jew iktar kategoriji tal-popolazzjoni pedjatrika fil-kura ta' epatite B kronika (ara sezzjonijiet 4.2 u 5.2 għal informazzjoni dwar l-użu pedjatriku).
English: There are no safety data on the use of Vemlidy to treat HBV infected patients with CrCl < 30 mL/min.
Maltese: Ma hemm l-ebda data dwar is-sigurtà tal-użu ta' Vemlidy għall-kura ta' pazjenti infettati bl-HBV b'CrCl < 30 mL/min.
English: Tenofovir alafenamidee (10 mg orally, q.d.)
Maltese: Tenofovir alafenamidee (10 mg mogħti mill-ħalq, q.d.)
English: HIV ANTIRETROVIRAL AGENTS - PROTEASE INHIBITORS Atazanavir/cobicistat (300 mg/150 mg orally, q.d.)
Maltese: TAL-PROTEASE Atazanavir/cobicistat (300 mg/150 mg mogħti millħalq, q.d.)
English: Co-administration of Vemlidy with certain anticonvulsants (e.g. carbamazepine, oxcarbazepine, phenobarbital and phenytoin), antimycobacterials (e.g. rifampicin, rifabutin and rifapentine) or St. John's wort, all of which are inducers of P-glycoprotein (P-gp) and may decrease tenofovir alafenamide plasma concentrations, is not recommended.
Maltese: Għoti flimkien ta' Vemlidy ma' ċerti antikonvulsanti (eż. carbamazepine, oxcarbazepine, phenobarbital u phenytoin), antimikobatteriċi (eż. rifampicin, rifabutin u rifapentine) jew St.
English: HIV ANTIRETROVIRAL AGENTS - NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS Efavirenz (600 mg orally, q.d.)
Maltese: HIV - INIBITURI TA' NON-NUCLEOSIDE REVERSE TRANSCRIPTASE
English: Vemlidy is used to treat chronic (long-term) hepatitis B in adults and adolescents 12 years of age and older, who weigh at least 35 kg.
Maltese: Vemlidy jintuża għall-kura tal-epatite B kronika (li tieħu fit-tul) fl-adulti u l-adolexxenti minn età ta' 12-il sena u ikbar, li jiżnu mill-inqas 35 kg.
English: b The population used for analysis of ALT normalisation included only patients with ALT above upper limit of normal (ULN) of the central laboratory range at baseline.
Maltese: b Il-popolazzjoni użata għall-analiżi tan-normalizzazzjoni tal-ALT kienet tinkludi biss pazjenti b'ALT ogħla mil-limitu ta' fuq tan-normal (ULN, upper limit of normal) tal-medda tal-laboratorju ċentrali fil-linja bażi.
English: Tenofovir ↑ Cmax 2.42 (1.98, 2.95)
Maltese: ↑ Cmax 2.42 (1.98, 2.95) ↑ AUC 2.05 (1.54, 2.72)
English: f Study conducted with emtricitabine/rilpivirine/tenofovir alafenamide fixed-dose combination tablet.
Maltese: f L-istudju twettaq bil-pillola kombinata ta' doża fissa ta' emtricitabine/rilpivirine/tenofovir alafenamide.
English: Vemlidy film-coated tablets are yellow, round, printed (or marked) with “GSI” on one side of the tablet and “25” on the other side of the tablet.
Maltese: Il-pilloli miksija b'rita Vemlidy huma sofor, tondi, stampati (jew immarkati) b'“GSI” fuq naħa waħda tal-pillola u “25” fuq in-naħa l-oħra tal-pillola.
English: Tenofovir alafenamide is mainly eliminated following metabolism to tenofovir.
Maltese: Tenofovir alafenamide huwa eliminat l-aktar wara l-metaboliżmu f'tenofovir.
English: c Treatment-naïve subjects received < 12 weeks of oral antiviral treatment with any nucleoside or nucleotide analogue including tenofovir disoproxil fumarate or tenofovir alafenamide.
Maltese: c Individwi li qatt ma rċivew kura fil-passat irċivew < 12-il ġimgħa ta' kura b'mediċina antivirali orali bi kwalunkwe analogu ta' nucleoside jew nucleotide, li jinkludu tenofovir disoproxil fumarate jew tenofovir alafenamide.
English: At baseline, mean plasma HBV DNA was 7.6 log10 IU/mL, mean serum ALT was 120 U/L, and 7% of patients had a history of cirrhosis.
Maltese: IU/mL, il-medja tal-ALT tas-serum kienet ta' 120 U/L, u 7% tal-pazjenti kellhom ċirrożi fil-passat.
English: Changes in measures of bone mineral density In both studies tenofovir alafenamide was associated with smaller mean percentage decreases in bone mineral density (BMD; as measured by hip and lumbar spine dual energy X ray absorptiometry
Maltese: Fiż-żewġ studji tenofovir alafenamide kien assoċjat ma' tnaqqis perċentwali medju iżgħar fid-densità tal-minerali tal-għadam (BMD, bone mineral density; kif imkejjel b'analiżi tal-assorbimetrija tar-raġġi X b'enerġija doppja [DXA, dual energy X ray absorptiometry] tal-ġenbejn u s-sinsla lumbari) meta mqabbel ma' tenofovir disoproxil fumarate wara 96 ġimgħa ta' kura.
English: The use of Vemlidy is not recommended in patients with CrCl < 15 mL/min who are not receiving haemodialysis (see section 4.2).
Maltese: L-użu ta' Vemlidy mhux rakkomandat f'pazjenti b'CrCl < 15 mL/min li mhux qed jirċievu emodijalisi (ara sezzjoni 4.2).
English: When corrected for protein binding, unbound (free) plasma concentrations of tenofovir alafenamide in severe hepatic impairment and normal hepatic function are similar.
Maltese: Meta kkoreġuti għall-irbit tal-proteini, il-konċentrazzjonijiet fil-plażma mhux marbutin (ħielsa) ta' tenofovir alafenamide fil-każ ta' indeboliment sever tal-fwied u funzjoni normali tal-fwied huma simili.
English: Hepatitis B is an infection affecting the liver, caused by the hepatitis B virus.
Maltese: L-epatite B hija infezzjoni li taffettwa l-fwied, ikkawżata mill-virus tal-epatite B.
English: No dose adjustment of Vemlidy is required in adults or adolescents (aged at least 12 years and of at least 35 kg body weight) with estimated creatinine clearance (CrCl) ≥ 15 mL/min or in patients with CrCl < 15 mL/min who are receiving haemodialysis.
Maltese: L-ebda aġġustament fid-doża ta' Vemlidy ma hu meħtieġ fl-adulti jew fl-adolexxenti (minn età ta' mill-inqas 12-il sena u li għandhom piż tal-ġisem ta' mill-inqas 35 kg) bi tneħħija tal-kreatinina stmata ta' (CrCl) ≥ 15 mL/min jew f'pazjenti b'CrCl < 15 mL/min li qed jirċievu emodijalisi.
English: Tenofovir diphosphate inhibits HBV replication through incorporation into viral DNA by the HBV reverse transcriptase, which results in DNA chain termination.
Maltese: Tenofovir diphosphate jinibixxi rreplikazzjoni tal-HBV permezz tal-inkorporazzjoni fid-DNA virali mill-HBV reverse transcriptase, li jirriżulta fit-tmiem tal-katina tad-DNA.
English: Vemlidy comes in bottles of 30 tablets (with a silica gel desiccant that must be kept in the bottle to help protect your tablets).
Maltese: Vemlidy jiġi fi fliexken ta' 30 pillola (b'dessikant talġel tas-silica li irid jinżamm fil-flixkun biex jipproteġi l-pilloli tiegħek).
English: A minimal infiltration of histiocytes was present in the eye in dogs at tenofovir alafenamide and tenofovir exposures of approximately 4 and 17 times greater, respectively, than those expected after administration of tenofovir alafenamide.
Maltese: tenofovir alafenamide u tenofovir ta' madwar 4 u 17-il darba ikbar, rispettivament, minn dawk mistennija wara l-għoti ta' tenofovir alafenamide.
English: c Study conducted with emtricitabine/tenofovir alafenamide fixed-dose combination tablet.
Maltese: c L-istudju twettaq bil-pillola kombinata ta' doża fissa ta' emtricitabine/tenofovir alafenamide.
English: Each film-coated tablet contains tenofovir alafenamide fumarate equivalent to 25 mg of tenofovir alafenamide.
Maltese: Kull pillola miksija b'rita fiha tenofovir alafenamide fumarate ekwivalenti għal 25 mg ta' tenofovir alafenamide.
English: Adults and adolescents (aged 12 years and older with body weight at least 35 kg): one tablet once daily.
Maltese: Adulti u adolexxenti (li jkollhom 12-il sena u aktar, li jiżnu mill-inqas 35 kg): pillola waħda darba kuljum.
English: The pharmacokinetics of tenofovir alafenamide and tenofovir were evaluated in HIV-1 infected, treatment-naïve adolescents who received tenofovir alafenamide (10 mg) given with elvitegravir,
Maltese: Il-farmakokinetika ta' tenofovir alafenamide u tenofovir ġew evalwati f'adolexxenti infettati bl-HIV-1, adolexxenti li qatt ma rċivew kura fil-passat li rċivew tenofovir alafenamide (10 mg) mogħti ma' elvitegravir, cobicistat u emtricitabine bħala pillola kombinata ta' doża fissa (E/C/F/TAF; Genvoya).
English: The antiviral activity of tenofovir alafenamide was assessed in HepG2 cells against a panel of HBV clinical isolates representing genotypes A-H.
Maltese: L-attività antivirali ta' tenofovir alafenamide kienet ivvalutata fiċ-ċelluli HepG2 kontra sensiela ta' iżolati kliniċi tal-HBV li jirrappreżentaw il-ġenotipi A-H.
English: There are no data on the safety and efficacy of Vemlidy in HBV infected patients with decompensated liver disease and who have a Child Pugh Turcotte (CPT) score > 9 (i.e. class C).
Maltese: Ma hemm l-ebda data dwar is-sigurtà u l-effikaċja ta' Vemlidy f'pazjenti infettati bl-HBV b'mard dikumpensat tal-fwied u li għandhom punteġġ ta' Child Pugh Turcotte (CPT) ta' > 9 (jiġifieri talklassi Ċ).
English: Pharmacotherapeutic group: Antiviral for systemic use, nucleoside and nucleotide reverse transcriptase inhibitors; ATC code: J05AF13.
Maltese: Mediċina antivirali għal użu sistemiku, inibituri nukleosidi u nukleotidi ta' reverse transcriptase;
English: Flares on treatment
Maltese: TAL-PRODOTT MEDIĊINALI