FrancophonIA/ELRC3.0 huggingface dataset:
English: Two hundred and fifteen HBeAg negative (GS-US-174-0102, n = 125) and HBeAg positive (GS-US-1740103, n = 90) patients initially randomised to double-blind adefovir dipivoxil treatment and then switched to open-label tenofovir disoproxil treatment were evaluated for genotypic changes in HBV polymerase from baseline.
Maltese: Mitejn u ħmistax-il pazjent li kienu negattivi għal HBeAg (GS-US-174-0102, n = 125) u pożittivi għal HBeAg (GS-US-174-0103, n = 90) li kienu inizjalment randomised għal kura double-blind b'adefovir dipivoxil u mbagħad qalbu għal kura b'tenofovir disoproxil open-label kienu evalwati għal tibdil ġenotipiku fil-polymerase tal-HBV mil-linja bażi.
English: Since tenofovir disoproxil can cause renal toxicity, close monitoring of renal function is recommended in adult patients with renal impairment treated with Tenofovir disoproxil Zentiva (see sections 4.2, 4.4 and 5.2).
Maltese: Billi tenofovir disoproxil jista' jikkawża tossiċità renali, monitoraġġ mill-qrib tal-funzjoni renali hu rakkomandat f' pazjenti adulti b'indeboliment renali kkurat b'Tenofovir disoproxil Zentiva (ara sezzjonijiet 4.2, 4.4 u 5.2).
English: Mean changes at week 48 (end of randomised phase) were 0.032 and 0.087 in lumbar spine BMD Z-score, and -0.184 and -0.027 in total body BMD Z-score for the tenofovir disoproxil and stavudine or zidovudine groups, respectively.
Maltese: 032 u 0.087 fil-punteġġ Ż tal-BMD tas-sinsla tad-dahar, u -0.184 u -0.
English: b 48 weeks of double-blind tenofovir disoproxil followed by 48 weeks open-label.
Maltese: b 48 ġimgħa ta' tenofovir disoproxil double-blind segwiti minn 48 ġimgħa open-label.
English: Oblong-shaped, light blue colored film-coated tablets with dimensions approx. 17.2 x 8.2 mm.
Maltese: Pilloli miksijin b'rita, f'għamla ta' oblong, ta' lewn ċelesti ċar b'qies ta' madwar 17.2 x 8.2 mm
English: Genotypic evaluations performed on all patients with HBV DNA > 400 copies/ml at week 48 (n = 16), 96 (n = 5), 144 (n = 1), 192 (n = 2), 240 (n = 1), 288 (n = 1) and 384 (n = 2) of tenofovir disoproxil monotherapy showed that no mutations associated with tenofovir disoproxil resistance have developed.
Maltese: (n = 1), 192 (n = 2), 240 (n = 1), 288 (n = 1) u 384 (n = 2) ta' monoterapija b'tenofovir disoproxil urew li ma żviluppawx mutazzjonijiet assoċjati ma' reżistenza għal tenofovir disoproxil.
English: What Tenofovir disoproxil Zentiva looks like and contents of the pack Tenofovir disoproxil Zentiva 245 mg film-coated tablets are oblong-shaped, light blue colored filmcoated tablets with dimensions approx. 17.2 x 8.2 mm.
Maltese: Kif jidher Tenofovir disoproxil Zentiva u l-kontenut tal-pakkett Il-pilloli Tenofovir disoproxil Zentiva 245 mg miksijin b'rita huma pilloli f'għamla ta' oblong, ta' lewn ċelesti ċar miksijin b'rita b'qies ta' madwar 17.2 x 8.2 mm.
English: At week 168, in this population of patients with decompensated liver disease, the rate of death was of 13% (6/45) in the tenofovir disoproxil group, 11% (5/45) in the emtricitabine plus tenofovir disoproxil group and 14% (3/22) in the entecavir group.
Maltese: Wara 168 ġimgħa, 16% (7/45) tal-grupp ta' tenofovir disoproxil, 4% (2/45) tal-grupp ta' emtricitabine u tenofovir disoproxil, u 14% (3/22) tal-grupp ta' entecavir esperjenzaw nuqqas ta' tollerabilità.
English: This indicates that active tubular secretion is an important part of the elimination of tenofovir.
Maltese: Dan jindika li s-sekrezzjoni tubulari attiva hija parti importanti mill-eliminazzjoni ta' tenofovir.
English: AUC: ↔ Cmax: ↑ 47%
Maltese: AUC: ↔ Cmax: ↑ 47% Cmin: ↑ 47%
English: Tenofovir disoproxil has not been studied in patients over the age of 65.
Maltese: Tenofovir disoproxil ma ġiex studjat f'pazjenti li jkollhom iktar minn 65 sena.
English: These include:
Maltese: NN:
English: Tenofovir disoproxil Zentiva is also indicated for the treatment of HIV-1 infected adolescents, with NRTI resistance or toxicities precluding the use of first line agents, aged 12 to < 18 years.
Maltese: Tenofovir disoproxil Zentiva huwa indikat ukoll għat-trattament ta' adolexxenti infettati b'HIV-1, b'reżistenza għal NRTI jew tossiċitajiet li jipprekludu l-użu ta' prodotti mediċinali primarji, li jkollhom minn 12 sa < 18-il sena.
English: Ninety-five percent (225/237) of patients without cirrhosis at baseline and 99% (93/94) of patients with cirrhosis at baseline had either no change or an improvement in fibrosis (Ishak fibrosis score).
Maltese: Ħamsa u disgħin fil-mija (225/237) talpazjenti mingħajr ċirrożi fil-linja bażi u 99% (93/94) tal-pazjenti b'ċirrożi fil-linja bażi jew ma kellhom l-ebda bidla jew titjib fil-fibrożi (punteġġ tal-fibrożi ta' Ishak).
English: osteomalacia (manifested as bone pain and infrequently contributing to fractures)1, 2, myopathy1 Renal and urinary disorders: Uncommon:
Maltese: osteomalaċja (li tidher bħala wġigħ fl-għadam u b'mod mhux frekwenti tikkontribwixxi għal ksur) 2, majopatija1 Disturbi fil-kliewi u fis-sistema urinarja:
English: Genotypic evaluations were performed on all patients within this group with HBV DNA > 400 copies/ml at week 96 (n = 17), week 144 (n = 7), and week 192 (n = 8).
Maltese: Evalwazzjonijiet tal-ġenotip twettqu fuq il-pazjenti kollha f'dan il-grupp b'HBV DNA > 400 kopja/mL f'ġimgħa 96 (n = 17), f'ġimgħa 144 (n = 7), u f'ġimgħa 192 (n = 8).
English: Velpatasvir: AUC: ↔ Cmax: ↓ 24% Cmin: ↔
Maltese: AUC: ↔ Cmax: ↓ 24% Cmin: ↔
English: Tenofovir disoproxil should not be initiated in paediatric patients with renal impairment and should be discontinued in paediatric patients who develop renal impairment during tenofovir disoproxil therapy.
Maltese: Tenofovir disoproxil m'għandux jinbeda f'pazjenti pedjatriċi b'indeboliment renali u għandu jitwaqqaf f'pazjenti pedjatriċi li jiżviluppaw indeboliment renali matul it-terapija b'tenofovir disoproxil.
English: Seventy-four percent (26/35) of patients in the tenofovir disoproxil group had normalised ALT at week 72 compared to 31% (13/42) in the placebo group.
Maltese: Erba' u sebgħin fil-mija (26/35) tal-pazjenti fil-grupp ta' tenofovir disoproxil kellhom ALT normalizzat f'ġimgħa 72 meta mqabbla ma' 31% (13/42) fil-grupp tal-plaċebo.
English: In studies with nucleoside-naïve patients, on-treatment ALT elevations > 10 times ULN (upper limit of normal) and > 2-times baseline occurred in 2.6% of tenofovir disoproxil -treated patients.
Maltese: Fi studji fuq pazjenti li qatt ma' ngħataw nukleosides żidiet tal-ALT waqt it-trattament ta' > 10 darbiet iżjed mill-ULN (limitu ta' fuq tan-normal) u iktar mid-doppju tal-linja bażi seħħew fi 2.6% tal-pazjenti li kienu ttrattati b'tenofovir disoproxil.
English: hypophosphataemia1
Maltese: Infezzjoni bl-HIV-1
English: With respect to the decision to initiate treatment in paediatric patients, see sections 4.2, 4.4, 4.8 and 5.1.
Maltese: Fir-rigward tad-deċiżjoni biex jinbeda t-trattament f'pazjenti pedjatriċi, ara sezzjonijiet 4.2, 4.4, 4.8 u 5
English: In the tenofovir disoproxil treatment arm, patients had a mean CPT score of 7.2, mean HBV DNA of 5.8 log10 copies/ml and mean serum ALT of 61 U/l at baseline.
Maltese: Fil-fergħa tal-istudju bil-kura b'tenofovir disoproxil, il-pazjenti kellhom medja ta' punteġġ CPT ta' 7.2, medja ta' DNA tal-HBV ta' 5.8 log10 kopja/ml u medja ta' ALT fis-serum ta' 61 U/l fil-linja bażi.
English: Adults and adolescents aged 12 to < 18 years and weighing ≥ 35 kg The recommended dose of Tenofovir disoproxil Zentiva for the treatment of HIV or for the treatment of chronic hepatitis B is 245 mg (one tablet) once daily taken orally with food.
Maltese: Adulti u adolexxenti li għandhom minn 12 sa < 18-il sena u li jiżnu ≥ 35 kg Id-doża rakkomandata ta' Tenofovir disoproxil Zentiva għat-trattament tal-HIV jew għat-trattament tal-epatite B kronika hija ta' 245 mg (pillola waħda) darba kuljum meħuda mill-ħalq mal-ikel.
English: Lumbar spine mean (SD) change from baseline BMD Z-scorea NA
Maltese: Bidla medja (SD) mill-punteġġ Z talBMD tal-linja bażi tal-ispina lumbaria
English: The demonstration of benefit of tenofovir disoproxil in compensated and decompensated disease is based on virological, biochemical and serological responses in adults with HBeAg positive and HBeAg negative chronic hepatitis B. Treated patients included those who were treatment-naïve, lamivudine-experienced, adefovir dipivoxil-experienced and patients with lamivudine and/or adefovir dipivoxil resistance mutations at baseline.
Maltese: Id-dimostrazzjoni tal-benefiċċju ta' tenofovir disoproxil f'mard kumpensat u mhux kumpensat hi bbażata fuq risponsi viroloġiċi, bijokimiċi u serologiċi f'pazjenti adulti b'epatite B kronika b'HBeAg pożittiv u b'HBeAg negattiv.
English: Experience in patients with compensated liver disease at 48 weeks (studies GS-US-174-0102 and GS-US
Maltese: L-esperjenza f'pazjenti b'replikazzjoni virali persistenti (studju GS-US-174-0106)
English: - compensated liver disease and evidence of immune active disease, i.e. active viral replication and persistently elevated serum ALT levels, or histological evidence of moderate to severe inflammation and/or fibrosis.
Maltese: - mard tal-fwied kumpensat u evidenza ta' mard immuni attiv, i.e. replikazzjoni virali attiva u livelli ta' ALT fis-serum li jkunu għoljin b'mod persistenti, jew evidenza istoloġika ta' infjammazzjoni moderata sa severa u/jew fibrożi.
English: h 48 weeks of double-blind adefovir dipivoxil followed by 144 weeks open-label tenofovir disoproxil .
Maltese: h 48 ġimgħa ta' tenofovir disoproxil double-blind segwiti minn 144 ġimgħa open-label.
English: Late-onset neurological disorders have been reported rarely (hypertonia, convulsion, abnormal behaviour).
Maltese: Disturbi newroloġiċi li dehru iktar tard ġew irrappurtati b'mod rari (ipertonja, konvulżjoni, imġieba mhux normali).
English: Clinical resistance Four hundred and twenty-six HBeAg negative (GS-US-174-0102, n = 250) and HBeAg positive (GS-US-174-0103, n = 176) patients initially randomised to double-blind tenofovir disoproxil treatment and then switched to open-label tenofovir disoproxil treatment were evaluated for genotypic changes in HBV polymerase from baseline.
Maltese: Erba' mija u sitta u għoxrin pazjent li kienu HBeAg negattivi (GS-US-174-0102, n = 250) u HBeAg pożittivi (GS-US-174-0103, n = 176) li kienu inizjalment randomised għal kura double-blind b'tenofovir disoproxil u mbagħad qalbu għal kura b'tenofovir disoproxil open-label kienu evalwati għal tibdil ġenotipiku fil-polymerase tal-HBV mil-linja bażi.
English: In the HBeAg positive subjects randomised to emtricitabine plus tenofovir disoproxil, 13 of 68 subjects (19%) experienced HBeAg loss, and 7 of 68 subjects (10%) experienced anti-HBe seroconversion through week 240.
Maltese: Fl-individwi HbeAg pożittivi li ġew randomised biex jirċievu emtricitabine flimkien ma' tenofovir disoproxil, 13 minn 68 individwu (19%) kellhom telf ta' HBeAg, u 7 minn 68 individwu (10%) kellhom serokonverżjoni anti-HBe sa ġimgħa 240.
English: Administration of tenofovir disoproxil with a high fat meal enhanced the oral bioavailability, with an increase in tenofovir AUC by approximately 40% and Cmax by approximately 14%.
Maltese: L-għoti ta' tenofovir disoproxil ma' ikla li fiha ħafna xaħam għolliet il-biodisponibilità orali, bi żieda fl-AUC ta' tenofovir ta' madwar 40% u Cmax b'madwar 14%.
English: Whole body BMD at least 6% decreaseb
Maltese: Tnaqqis tal-inqas ta' 6% fil-BMD talġisem kollub
English: In HIV-1 infected children, the BMD Z-scores observed in subjects who switched to tenofovir disoproxil were lower than those observed in subjects who remained on their stavudine- or zidovudine-containing regimen (see sections 4.4 and 5.1).
Maltese: Fi tfal infettati b'HIV-1, il-punteġġi Ż tal BMD osservati f'individwi li qalbu għal tenofovir disoproxil kienu iktar baxxi minn dawk osservati f'individwi li baqgħu fuq il-kors tagħhom li kien fih stavudine jew zidovudine (ara sezzjonijiet 4.4 u 5.1).
English: Sixty-six percent (38 of 58) of patients in the tenofovir disoproxil group had normalized ALT at week 48 compared with 15% (4 of 27) in the placebo group.
Maltese: Sitta u sittin fil-mija (38 minn 58) tal-pazjenti fil-grupp ta' tenofovir disoproxil kellhom ALT normalizzat f'ġimgħa 48 meta mqabbel ma' 15% (4 minn 27) fil-grupp tal-plaċebo.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains tenofovir disoproxil phosphate (equivalent to 245 mg of tenofovir disoproxil).
Maltese: Kull pillola miksija b'rita fiha tenofovir disoproxil phosphate (ekwivalenti għal 245 mg ta' tenofovir disoproxil).
English: Metabolic parameters Weight and levels of blood lipids and glucose may increase during antiretroviral therapy (see section 4.4)
Maltese: Il-piż u l-livelli ta' lipidi u glukożju fid-demm jistgħu jiżdiedu matul it-terapija antiretrovirali (ara sezzjoni 4.4).
English: Experience in patients with decompensated liver disease at 48 weeks (study GS-US-174-0108) Study GS-US-174-0108 is a randomised, double-blind, active controlled study evaluating the safety and efficacy of tenofovir disoproxil (n = 45), emtricitabine plus tenofovir disoproxil (n = 45), and entecavir (n = 22), in patients with decompensated liver disease.
Maltese: Esperjenza f'pazjenti b'mard tal-fwied mhux kumpensat f'48 ġimgħa (studju GS-US-174-0108) Studju GS-US-174-0108 huwa studju randomised, double-blind, ikkontrollat b'mod attiv, li evalwa s-sigurtà u l-effikaċja ta' tenofovir disoproxil (n = 45), emtricitabine flimkien ma' tenofovir disoproxil (n = 45), u entecavir (n = 22), f'pazjenti b'mard tal-fwied mhux kumpensat.
English: headache
Maltese: Tqala
English: The safety of tenofovir disoproxil when used with sofosbuvir/velpatasvir/voxil aprevir and a pharmacokinetic enhancer (e.g. ritonavir or cobicistat) has not been established.
Maltese: Is-sigurtà ta' tenofovir disoproxil meta użat ma' sofosbuvir/velpatasvir/voxilaprevir u potenzjatur farmakokinetiku (eż. ritonavir jew cobicistat) għadha ma ġietx stabbilita.
English: As Tenofovir disoproxil Zentiva may cause renal damage monitoring of renal function is recommended (see sections 4.4 and 4.8 Summary of the safety profile).
Maltese: Billi Tenofovir disoproxil Zentiva jista' jikkawża ħsara renali, il-monitoraġġ tal-funzjoni renali hu rakkomandat (ara sezzjonijiet 4.4 u 4.8 Sommarju tal-profil tas-sigurtà).
English: Renal clearance has been estimated to be approximately 160 ml/h/kg (approximately 210 ml/min), which is in excess of the glomerular filtration rate.
Maltese: It-tneħħija mill-kliewi ġiet stmata li hi madwar 160 ml/h/kg (madwar 210 ml/min), li huwa iżjed mir-rata tal-filtrazzjoni glomerulari.
English: Reduced doses of tenofovir (the active ingredient of Tenofovir disoproxil Zentiva) are also used for the treatment of HIV-1 infection and chronic hepatitis B in paediatric patients aged 2 to < 12 years.
Maltese: Dożi mnaqqsa ta' tenofovir (is-sustanza attiva ta' Tenofovir disoproxil Zentiva) jintużaw ukoll għat-trattament ta' infezzjoni talHIV-1 u epatite B kronika f'pazjenti pedjatriċi li jkollhom minn 2 sa < 12-il sena.
English: m 48 weeks of double-blind adefovir dipivoxil followed by 240 weeks open-label tenofovir disoproxil .
Maltese: l 48 ġimgħa ta' tenofovir disoproxil double-blind segwiti minn 240 ġimgħa open-label.
English: • Adolescents aged 12 to less than 18 years who weigh at least 35 kg: one tablet each day with food (for example, a meal or a snack).
Maltese: • Adolexxenti li għandhom minn 12 sa inqas minn 18-il sena li jiżnu mill-inqas 35 kg: pillola 1 kuljum mal-ikel (per eżempju, ma' ikla jew ma' ikla ħafifa).
English: Tenofovir exposure achieved in adolescent patients receiving oral daily doses of tenofovir disoproxil 245 mg was similar to exposures achieved in adults receiving once-daily doses of tenofovir disoproxil 245 mg.
Maltese: L-esponiment ta' tenofovir miksub f'pazjenti adolexxenti li kienu qed jirċievu dożi orali ta' kuljum ta' 245 mg tenofovir disoproxil kien simili għal esponimenti miksuba f'persuni adulti li kienu qed jirċievu doża waħda kuljum ta' 245 mg tenofovir disoproxil.
English: Tenofovir disoproxil is a water soluble ester prodrug which is rapidly converted in vivo to tenofovir and formaldehyde.
Maltese: Tenofovir disoproxil huwa prodrug tal-ester li jinħall fl-ilma li jinbidel malajr in vivo għal tenofovir u formaldehyde.
English: Forty-two percent (19/45) of patients had at least 6 months of prior lamivudine experience, 20% (9/45) of patients had prior adefovir dipivoxil experience and 9 of 45 patients (20%) had lamivudine and/or adefovir dipivoxil resistance mutations at baseline.
Maltese: Tnejn u erbgħin fil-mija (19/45) tal-pazjenti kellhom mill-inqas 6 xhur li fihom fil-passat ingħataw lamivudine, 20% (9/45) tal-pazjenti ngħataw adefovir dipivoxil fil-passat u 9 minn 45 pazjent (20%) kellhom mutazzjonijiet ta' reżistenza għal lamivudine u/jew adefovir dipivoxil fil-linja bażi.
English: BATCH NUMBER
Maltese: Linja bażi
English: Lumbar spine BMD at least 4% decrease
Maltese: Tnaqqis tal-inqas ta' 4% filBMD tal-ispina lumbari
English: Osteonecrosis
Maltese: ipofosfatimja
English: (21/28) of immune-active patients in the tenofovir disoproxil group had normal ALT at week 72 compared to 34% (11/32) in the placebo group.
Maltese: Ħamsa u sebgħin fil-mija (21/28) tal-pazjenti immuni-attivi fil-grupp ta' tenofovir disoproxil kellhom ALT normali f'ġimgħa 72 meta mqabbla ma' 34% (11/32) fil-grupp tal-plaċebo.
English: • If you are allergic to tenofovir, tenofovir disoproxil phosphate or any of the other ingredients of this medicine (listed in section 6).
Maltese: • Jekk inti allerġiku għal tenofovir, tenofovir disoproxil phosphate, jew għal xi sustanza oħra ta' din il-mediċina (imniżżla fis-sezzjoni 6).
English: In a paediatric study (GS-US-174-0115), 52 patients (including 6 patients with lamivudine resistance mutations at baseline) initially received blinded tenofovir disoproxil for up to 72 weeks and then 51/52 patients switched to open-label tenofovir disoproxil (tenofovir-disoproxil-tenofovir disoproxil group).
Maltese: Fi studju pedjatriku (GS-US-174-0115), 52 pazjent (li jinkludu 6 pazjenti b'mutazzjonijiet reżistenti għal lamivudine fil-linja bażi) fil-bidu rċivew tenofovir disoproxil blinded għal mhux aktar minn 72 ġimgħa u mbagħad 51/52 pazjent qalbu għal tenofovir disoproxil open-label (il-grupp tenofovir disoproxil--tenofovir disoproxil).
English: • Recommended schedule for monitoring renal function considering the presence or absence of additional risk factors for renal impairment
Maltese: • L-iskeda rakkomandata għall-monitoraġġ tal-funzjoni renali meta wieħed jikkunsidra l-preżenza jew l-assenza ta' fatturi addizzjonali ta' riskju għal indeboliment renali
English: Elderly patients are more likely to have decreased renal function; therefore caution should be exercised when treating elderly patients with tenofovir disoproxil.
Maltese: Pazjenti anzjani huma aktar probabbli li jkollhom tnaqqis tal-funzjoni renali; għalhekk għandha tingħata attenzjoni partikulari meta pazjenti anzjani jkunu qed jingħataw ittrattament b'tenofovir disoproxil.
English: Tenofovir disoproxil Zentiva is not suitable for the following groups:
Maltese: Tenofovir disoproxil Zentiva mhuwiex adattat għall-gruppi li ġejjin:
English: Patients were stratified by baseline HIV-1 RNA and CD4 count.
Maltese: Studji kliniċi dwar HIV-1:
English: k 48 weeks of double-blind adefovir dipivoxil followed by 192 weeks open-label tenofovir disoproxil .
Maltese: k 48 ġimgħa ta' adefovir dipivoxil double-blind segwiti minn 192 ġimgħa ta' tenofovir disoproxil open-label.
English: Do not store above 30 °C.
Maltese: Taħżinx f'temperatura 'l fuq minn 30°C.
English: Flares on treatment: Spontaneous exacerbations in chronic hepatitis B are relatively common and are characterised by transient increases in serum ALT. After initiating antiviral therapy, serum ALT may increase in some patients (see section 4.8).
Maltese: Wara li tinbeda terapija antivirali, l-ALT tas-serum jista' jiżdied f'xi pazjenti (ara sezzjoni 4.8).
English: There have been reports of a high rate of virological failure and of emergence of resistance at an early stage in HIV patients when tenofovir disoproxil was combined with lamivudine and abacavir as well as with lamivudine and didanosine as a once daily regimen.
Maltese: Kien hemm rapporti ta' rata għolja ta' falliment viroloġiku u ta' reżistenza li titfaċċa li seħħew it-tnejn li huma fi stadju bikri f'pazjenti bl-HIV, meta tenofovir disoproxil ingħata flimkien ma' lamivudine u abacavir, kif ukoll ma' lamivudine u didanosine bħala kors ta' għoti ta' darba kuljum.
English: i 48 weeks of double-blind adefovir dipivoxil followed by 144 weeks open-label tenofovir disoproxil .
Maltese: 48 ġimgħa ta' adefovir dipivoxil double-blind segwiti minn 144 ġimgħa ta' tenofovir disoproxil open-label.
English: Bone abnormalities (infrequently contributing to fractures) may be associated with proximal renal tubulopathy (see section 4.8).
Maltese: Anormalitajiet fl-għadam (li b'mod mhux frekwenti jikkontribwixxu għal ksur) jistgħu jkunu assoċjati ma' tubulopatija renali prossimali (ara sezzjoni 4.8).
English: hepatic steatosis, hepatitis Skin and subcutaneous tissue disorders: Very common:
Maltese: stejatożi epatika, epatite Disturbi fil-ġilda u fit-tessuti ta' taħt il-ġilda:
English: Based on the results of in vitro experiments and the known elimination pathway of tenofovir, the potential for CYP450 mediated interactions involving tenofovir with other medicinal products is low.
Maltese: Ibbażat fuq riżultati ta' esperimenti in vitro u r-rotta tal-eliminazzjoni magħrufa ta' tenofovir, potenzjal għall- interazzjonijiet medjata minn CYP450 li tinvolvi tenofovir ma' prodotti mediċinali oħra hija baxxa.
English: Approximately 1% of tenofovir disoproxil -treated adult patients discontinued treatment due to the gastrointestinal events.
Maltese: Madwar 1% tal-pazjenti adulti li ħadu t-trattament b'tenofovir disoproxil ma komplewx it-trattament minħabba leffetti gastro-intestinali.
English: Two subjects randomised to tenofovir disoproxil experienced HBsAg loss by Week 240, but not seroconversion to anti-HBs.
Maltese: Żewġ individwi li ġew randomised biex jirċievu tenofovir disoproxil ma kellhomx telf ta' HBsAg sa ġimgħa 240, iżda mhux serokonverżjoni għal anti-HBs.
English: Increased plasma concentrations of tenofovir resulting from coadministration of tenofovir disoproxil, sofosbuvir/velpatasvir/voxil aprevir and darunavir/ritonavir may increase adverse reactions related to tenofovir disoproxil, including renal disorders.
Maltese: Żieda fil-konċentrazzjonijiet ta' tenofovir fil-plażma li tirriżulta mill-għoti fl-istess ħin ta' tenofovir disoproxil, sofosbuvir/velpatasvir/voxilaprevir and darunavir/ritonavir tista' żżid ir-reazzjonijiet avversi relatati ma' tenofovir disoproxil, li jinkludu disturbi renali.
English: Tenofovir can be removed by haemodialysis; the median haemodialysis clearance of tenofovir is 134 ml/min.
Maltese: Tenofovir jista' jitneħħa permezz ta'dijaliżi tad-demm; tneħħija b'dijaliżi tad-demm medjana ta' tenofovir ta' 134 ml/min.
English: • stomach pain,
Maltese: • sturdament,
English: c 48 weeks of double-blind adefovir dipivoxil followed by 48 weeks open-label tenofovir disoproxil .
Maltese: 48 ġimgħa ta' adefovir dipivoxil double-blind segwiti minn 48 ġimgħa ta' tenofovir disoproxil open-label.
English: Since tenofovir is primarily eliminated by the kidneys, co-administration of tenofovir disoproxil with medicinal products that reduce renal function or compete for active tubular secretion via transport proteins hOAT 1, hOAT 3 or MRP 4 (e.g. cidofovir) may increase serum concentrations of tenofovir and/or the co-administered medicinal products.
Maltese: Minħabba li tenofovir hu primarjament eliminat mill-kliewi, l-għoti flimkien ta' tenofovir disoproxil ma' prodotti mediċinali li jnaqqsu l-funzjoni tal-kliewi jew jikkompetu għas-sekrezzjoni tubulari permezz tal-proteini tat-trasport hOAT 1, hOAT 3 jew MRP 4 (eż. cidofovir) jistgħu jżidu l-konċentrazzjonijiet fis-serum ta' tenofovir u/jew il-prodotti mediċinali li jingħataw flimkien miegħu.
English: Renally eliminated medicinal products
Maltese: Prodotti mediċinali eliminati mill-kliewi