FrancophonIA/ELRC3.0 huggingface dataset:
English: Lactose monohydrate Microcrystalline cellulose Croscarmellose sodium Povidone
Maltese: Qalba tal-pillola Lactose monohydrate Microcrystalline cellulose Croscarmellose sodium Povidone
English: Study 174-0102 (HBeAg negative)
Maltese: Studju 174-0102 (HbeAg negattiv)
English: Tablet core: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, povidone, magnesium stearate.
Maltese: Fil-qalba tal-pillola: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, povidone, magnesium stearate,
English: In studies GS-US-174-0102 and GS-US-174-0103, 77% and 61% of patients continued in the study through to 384 weeks, respectively.
Maltese: GS-US-174-0102 u GS-US-174-0103, 77% u 61% tal-pazjenti komplew fl-istudju sa 384 ġimgħa, rispettivament.
English: Mean (± SD) Cmax and AUCtau are 0.38 ± 0.13 μg/ml and 3.39 ± 1.22 μg h/ml, respectively.
Maltese: Il-medja (± SD) tas-Cmax u tal-AUCtau huma ta' 0.38 ± 0.13 μg/ml u 3.39 ± 1.22 μg·h/ml, rispettivament.
English: Parametera
Maltese: Parametru
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 15 September 2016
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 15 Settembru 2016
English: Normal ALT ≥ 2 point decrease in CPT from baseline n (%)
Maltese: Normali Tnaqqis ta' ≥ 2 punti f' CPT mil-linja bażi n (%)
English: Duration of therapy in adult and adolescent patients with chronic hepatitis B
Maltese: It-tul tat-terapija f'pazjenti adulti u adolexxenti b'epatite B kronika
English: Hepatitis B:
Maltese: Epatite B:
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1127/001 30 film-coated tablets EU/1/16/1127/002 90 (3x30) film-coated tablets
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/16/1127/001 30 pillola miksija b'rita EU/1/16/1127/002 90 (3x30) pillola miksija b'rita
English: HIV-1 and hepatitis B:
Maltese: HIV-1 u epatite B:
English: The active substance is tenofovir.
Maltese: Is-sustanza attiva hija tenofovir.
English: Hepatitis B
Maltese: Epatite B
English: Tenofovir shows activity in vitro against HIV-2, with an EC50 of 4.9 µmol/l in MT-4 cells.
Maltese: Tenofovir juri attività in vitro kontra HIV-2, b'EC50 ta' 4.9 µmol/l f'ċelluli MT 4.
English: There were no clinically significant pharmacokinetic interactions when tenofovir disoproxil was coadministered with emtricitabine, lamivudine, indinavir, efavirenz, nelfinavir, saquinavir (ritonavir boosted), methadone, ribavirin, rifampicin, tacrolimus, or the hormonal contraceptive norgestimate/ethinyl oestradiol.
Maltese: Ma kien hemm l-ebda interazzjonijiet farmakokinetiċi klinikament sinifikanti meta tenofovir disoproxil ingħata flimkien ma' emtricitabine, lamivudine, indinavir, efavirenz, nelfinavir, saquinavir (imsaħħaħ b'ritonavir), methadone, ribavirin, rifampicin, tacrolimus, jew il-kontraċettiv ormonali norgestimate/ethinyl oestradiol.
English: Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100) or rare (≥ 1/10,000 to < 1/1,000).
Maltese: Il-frekwenza hija deskritta bħala komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100) jew rari (≥ 1/10,000 sa < 1/1,000).
English: (4 subjects)
Maltese: (4 individwi)
English: HBV DNA n (%) < 400 copies/ml n (%)
Maltese: DNA tal-HBV n (%) < 400 kopja/ml n (%)
English: 1 Data generated from simultaneous dosing with ledipasvir/sofosbuvir.
Maltese: Dejta ġġenerata minn dożaġġ simultanju b'ledipasvir/sofosbuvir.
English: Tenofovir disoproxil was associated with significantly greater proportions of patients with undetectable HBV DNA (< 169 copies/ml [< 29 IU/ml]; the limit of quantification of the Roche Cobas Taqman HBV assay), when compared to adefovir dipivoxil (study GS-US-174-0102; 91%, 56% and study GS-US-174-0103; 69%, 9%), respectively.
Maltese: Tenofovir disoproxil kien assoċjat ma' porzjonijiet akbar b'mod sinifikanti ta' pazjenti b'DNA tal-HBV li ma setgħetx tkun osservata (< 169 kopja/ml [< 29 IU/ml]; il-limitu tal-kwantifikazzjoni tal-assaġġ Roche Cobas Taqman HBV), meta mqabbel ma' adefovir dipivoxil (studju GS-US-174-0102; 91%, 56% u studju GS-US-174-0103; 69%, 9%), rispettivament.
English: Experience beyond 48 weeks in studies GS-US-174-0102 and GS-US-174-0103
Maltese: GS-US-174-0102 u GS-US-174-0103)
English: Tenofovir disoproxil is absorbed and converted to the active substance tenofovir, which is a nucleoside monophosphate (nucleotide) analogue.
Maltese: Tenofovir disoproxil huwa assorbit u mibdul għas-sustanza attiva tenofovir, li hija analoga ta' nukleoside monophosphate (nukleotide).
English: Serology (%)HBeAg loss/seroconversionHBsAg loss/seroconversion n/a n/a
Maltese: Seroloġija (%)Tnaqqis/serokonverżjoni ta' HbeAg
English: • diarrhoea,
Maltese: • dijarea,
English: • The importance of regular monitoring of renal function during Tenofovir disoproxil Zentiva therapy
Maltese: • L-importanza ta' monitoraġġ regolari tal-funzjoni renali matul it-terapija b' Tenofovir disoproxil Zentiva
English: HBV antiviral activity in vitro: The in vitro antiviral activity of tenofovir against HBV was assessed in the HepG2 2.2.15 cell line.
Maltese: L-attività antivirali in vitro ta' tenofovir kontra l-HBV kienet evalwata fir-razza ta' ċelluli HepG2 2.2.15.
English: Similar percentages of subjects in the tenofovir disoproxil-tenofovir disoproxil and PLB-tenofovir disoproxil groups (37.5% and 41.7%, respectively) experienced seroconversion to anti-HBe through week 192.
Maltese: Perċentwali simili ta' individwi fil-gruppi tenofovir disoproxil-tenofovir disoproxil u PLB-tenofovir disoproxil(37.5% u 41.7%, rispettivament) esperjenzaw serokonverżjoni għal anti-HBe matul Ġimgħa 192.
English: Confirmed increase in serum creatinine ≥ 0.5 mg/dl from baseline or confirmed serum phosphate of < 2 mg/dl n (%)b
Maltese: Żieda kkonfermata fil-krejatinina fis-serum ta' ≥ 0.5 mg/dl mil-linja bażi jew serum phosphate ikkonfermat ta' < 2 mg/dl n (%)b
English: Administration of multiple doses of tenofovir disoproxil with a meal to HIV infected patients resulted in mean (%CV) tenofovir Cmax, AUC, and Cmin values of 326 (36.6%) ng/ml, 3,324 (41.2%) ng h/ml and 64.4 (39.4%) ng/ml, respectively.
Maltese: L-għoti ta' dożi multipli ta' tenofovir disoproxil mal-ikel lill-pazjenti infettati b'HIV irriżulta f'medja (%CV) ta' valuri ta' tenofovir Cmax, AUC, u Cmin ta' 326 (36.6%) ng/ml, 3,324 (41.2%) ng·h/ml u 64.4 (39.4%) ng/ml, rispettivament.
English: ANTI-INFECTIVES Antiretrovirals Protease inhibitors Atazanavir/Ritonavir (300 mg q.d./100 mg q.d.)
Maltese: ANTI-INFETTIVI Antiretrovirali Impedituri ta' protease Atazanavir/Ritonavir (300 q.d./100 q.d.)
English: Pharmacotherapeutic group: Antiviral for systemic use; nucleoside and nucleotide reverse transcriptase inhibitors,
Maltese: Antivirali għal użu sistemiku; impedituri ta' nukleoside u nukleotide reverse transcriptase, Kodiċi ATC:
English: Lopinavir/Ritonavir (400 mg b.i.d./100 mg b.i.d.)
Maltese: Lopinavir/Ritonavir (400 b.i.d./100 mg b.i.d.)
English: Renal failure, renal impairment, elevated creatinine, hypophosphataemia and proximal tubulopathy (including Fanconi syndrome) have been reported with the use of tenofovir disoproxil in clinical practice (see section 4.8).
Maltese: Kollass renali, indeboliment renali, krejatinina għolja, ipofosfatimja u tubulopatija prossimali (inkluż is-sindromu ta' Fanconi) kienu rrappurtati bl-użu ta' tenofovir disoproxil fl-użu kliniku (ara sezzjoni 4.8).
English: Table 1: Interactions between tenofovir disoproxil and other medicinal products
Maltese: Tabella 1: Interazzjonijiet bejn tenofovir disoproxil u prodotti mediċinali oħrajn
English: Tenofovir disoproxil Zentiva contains lactose monohydrate.
Maltese: Tenofovir disoproxil Zentiva fih lactose monohydrate.
English: Baseline genotypic analysis of HIV isolates from 253 patients revealed that 94% of patients had HIV-1 resistance mutations associated with nucleoside reverse transcriptase inhibitors, 58% had mutations associated with protease inhibitors and 48% had mutations associated with non-nucleoside reverse transcriptase inhibitors.
Maltese: L-analiżi ġenotipika bażi ta' HIV iżolati minn 253 pazjenti wriet li 94% tal-pazjenti kellhom mutazzjonijiet reżistenti għal HIV-1 assoċjat ma' l-impedituri ta' nukleoside reverse transcriptase, 58% kellhom mutazzjonijiet assoċjati ma' l-impedituri ta' protease u 48% kellhom mutazzjonijiet assoċjati ma' l-impedituri ta' non-nukleoside reverse transcriptase.
English: Tenofovir disoproxil Zentiva is a treatment for HIV (Human Immunodeficiency Virus) infection.
Maltese: Tenofovir disoproxil Zentiva huwa trattament għal infezzjoni bl-HIV (Virus tal-Immunodefiċjenza Umana).
English: Tenofovir disoproxil Zentiva is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected adults.
Maltese: Tenofovir disoproxil Zentiva huwa indikat flimkien ma' prodotti mediċinali oħra antiretrovirali għat-trattament ta' adulti infettati b'HIV-1.
English: HIV-1 and chronic hepatitis B
Maltese: HIV-1 u Epatite B kronika
English: In study GS-99-907, 550 treatment-experienced adult patients were treated with placebo or tenofovir disoproxil 245 mg for 24 weeks.
Maltese: Fl-istudju GS-99-907, 550 pazjenti adulti esperjenzati bil-kura kienu ttrattati bi plaċebo jew 245 mg tenofovir disoproxil għal 24 ġimgħa.
English: INFORMATION IN BRAILLE Tenofovir disoproxil Zentiva [outer packaging only]
Maltese: INFORMAZZJONI BIL-BRAILLE Tenofovir disoproxil Zentiva [pakkett ta' barra biss]
English: CLINICAL PARTICULARS
Maltese: Reżistenza klinika
English: The majority of subjects were either genotypes C (43.8%) or D (41.6%) with a lower and similar frequency of genotypes A and B (6.7% each).
Maltese: Il-maġġoranza tal-individwi kienu ta' ġenotipi Ċ (43.8%) jew D (41.6%) bi frekwenza iktar baxxa u simili tal-ġenotipi A u B (6.7% kull wieħed).
English: Effects on drug levels Mean percent change in AUC, Cmax, Cmin
Maltese: Effetti fuq il-livelli tal-mediċina Bidla perċentwali medja fl-AUC, Cmax, Cmin
English: At weeks 96, 144, 192, 240, 288 and 384, viral suppression, biochemical and serological responses were maintained with continued tenofovir disoproxil treatment (see Tables 4 and 5 below).
Maltese: F'ġimgħat 96, 144, 192, 240, 288 u 384, it-trażżin virali, ir-risponsi bijokimiċi u serologiċi nżammu bit-tkomplija tal-kura b'tenofovir disoproxil (ara Tabelli 4 u 5 hawn taħt).
English: HIV-1: Steady-state pharmacokinetics of tenofovir were evaluated in 8 HIV-1 infected adolescent patients (aged 12 to < 18 years) with body weight ≥ 35 kg.
Maltese: HIV 1: Il-farmakokinetika fi stat fiss ta' tenofovir ġiet evalwata fi 8 pazjenti adolexxenti infettati b'HIV 1 (minn età ta' 12 sa < 18-il sena) li kienu jiżnu ≥ 35 kg.
English: Interaction with didanosine
Maltese: Interazzjoni ma' didanosine
English: Tenofovir disoproxil Zentiva contains the active substance tenofovir disoproxil.
Maltese: Tenofovir disoproxil Zentiva fih s-sustanza attiva, tenofovir disoproxil.
English: Immune reactivation syndrome
Maltese: Sindromu tar- riattivazzjoni immuni
English: 90 (3 bottles of 30) film-coated tablets
Maltese: 90 (3 fliexken ta' 30) pillola miksija b'rita
English: Co-administration and risk of renal toxicity
Maltese: L-għoti flimkien u riskju ta' tossiċità renali
English: • Bone problems.
Maltese: • problemi fil-frixa.
English: Zentiva Portugal, Lda Tel: +351210601360 PV-Portugal@zentiva.com
Maltese: Zentiva Portugal, Lda Tel: +351210601360
English: 2 The predominant circulating metabolite of sofosbuvir.
Maltese: Il-metabolit predominanti ta' sofosbuvir fiċ-ċirkolazzjoni.
English: Data pertaining to HBV
Maltese: Dejta dwar l-HBV
English: HBV DNA (%) < 400 copies/ml (< 69 IU/ml)
Maltese: DNA tal-HBV (%) < 400 kopja /ml (< 69 IU/ml) ALT (%)
English: acute renal failure, renal failure, acute tubular necrosis, nephritis (including acute interstitial nephritis)2, nephrogenic diabetes insipidus General disorders and administration site conditions: Very common:
Maltese: kollass tal-kliewi akut, kollass tal-kliewi, nekrożi tubulari akuta, nefrite (li tinkludi nefrite interstizzjali akuta) 2, dijabete insipidus nefroġenika Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata:
English: 50 Theodor Pallady Blvd. Bucharest 032266
Maltese: Bucharest 032266
English: Tenofovir disoproxil Zentiva is indicated for the treatment of chronic hepatitis B in adolescents 12 to < 18 years of age with:
Maltese: Tenofovir disoproxil Zentiva huwa indikat għat-trattament ta' epatite B kronika f'adolexxenti li jkollhom minn 12 sa < 18-il sena b':
English: Week 72
Maltese: Ġimgħa 72
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA PC: [outer packaging only]
Maltese: IDENTIFIKATUR UNIKU - DATA LI TINQARA MILL-BNIEDEM PC: [pakkett ta' barra biss]
English: However, a benefit is expected for the adolescent population based on extrapolation of adult data and comparative pharmacokinetic data (see section 5.2).
Maltese: Madankollu, hu mistenni benefiċċju għall-popolazzjoni adolexxenti ibbażat fuq extrapolazzjoni ta' dejta mill-adulti u dejta farmakoinetika komparattiva (ara sezzjoni 5.2).
English: In study GS-US-104-0352, 8 out of 89 paediatric patients (9.0%) exposed to tenofovir disoproxil discontinued study drug due to renal adverse events.
Maltese: Fi studju GS-US-104-0352, 8 minn 89 pazjent pedjartiku (9.0%) esposti għal tenofovir disoproxil waqqfu l-mediċina tal-istudju minħabba avvenimenti avversi renali.
English: Tenofovir is then converted to the active metabolite, tenofovir diphosphate, an obligate chain terminator, by constitutively expressed cellular enzymes.
Maltese: Imbagħad tenofovir jinbidel għall-metabolit attiv, tenofovir diphosphate, terminatur tal-katina obligate, permezz ta' enzimi ċellulari espressi b'mod konstituttiv.
English: Excipient with known effect: Each tablet contains 214.5 mg lactose monohydrate.
Maltese: Kull pillola fiha 214.5 mg lactose monohydrate.
English: NA = Not Applicable a BMD Z-scores only available for a limited set of subjects with matched reference data b Secondary endpoint through week 48
Maltese: NA = Mhux Applikabbli a Punteġġi Z tal-BMD disponibbli biss għal sett limitat ta' individwi b'data ta' referenza li taqbel b Punt aħħari sekondarju matul ġimgħa 48
English: Renal adverse reactions consistent with proximal renal tubulopathy have been reported in HIV-1 infected paediatric patients aged 2 to < 12 years in clinical study GS-US-104-0352 (see sections 4.8 and 5.1).
Maltese: Reazzjonijiet avversi renali konsistenti ma' tubulopatija renali prossimali ġew irrappurtati f'pazjenti pedjatriċi infettati b'HIV-1 li għandhom minn sentejn sa < 12-il sena fi studju kliniku GS-US-104-0352 (ara sezzjonijiet 4.8 u 5.1).
English: Tenofovir disoproxil Metabolism and nutrition disorders: Very common:
Maltese: Tenofovir disoproxil Disturbi fil-metaboliżmu u n-nutrizzjoni:
English: The rate of hepatocellular carcinoma was 18% (8/45) in the tenofovir disoproxil group, 7% (3/45) in the emtricitabine plus tenofovir disoproxil group and 9% (2/22) in the entecavir group.
Maltese: Ir-rata ta' karċinoma epatoċellulari kienet ta' 18% (8/45) fil-grupp ta' tenofovir disoproxil, 7% (3/45) fil-grupp ta' emtricitabine u tenofovir disoproxil u 9% (2/22) fil-grupp ta' entecavir.
English: rhabdomyolysis1, muscular weakness1
Maltese: rabdomijolosi 1, dgħjufija fil-muskoli
English: HBV strains expressing the rtL180M, rtT184G, rtS202G/I, rtM204V and rtM250V mutations associated with resistance to entecavir showed a susceptibility to tenofovir ranging from 0.6- to 6.9-fold that of wild- type virus.
Maltese: Strejns tal-HBV li jesprimu l-mutazzjonijiet rtL180M, rtT184G, rtS202G/I, rtM204V u rtM250V assoċjati ma' reżistenza għal entecavir, urew sensittività għal tenofovir li tvarja minn 0.6 sa 6.9 darbiet iktar minn dik tal-istrejn naturali tal-virus.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1127/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/16/1127/001
English: Response to treatment with tenofovir disoproxil was comparable in nucleoside-experienced (n = 51) and nucleoside-naïve (n = 375) patients and in patients with normal ALT (n = 21) and abnormal ALT (n = 405) at baseline when studies GS-US-174-0102 and GS-US-174-0103 were combined.
Maltese: Ir-rispons għat-trattament b'tenofovir disoproxil kien komparabbli f'pazjenti li fil-passat ingħataw nukleosides (n = 51) u pazjenti li qatt ma' ngħataw nukleosides (n = 375) u f'pazjenti b'ALT normali (n = 21) u ALT anormali (n = 405) fil-linja bażi meta l-istudji GS-US-174-0102 u GS-US-174-0103 kienu kkombinati.
English: The mean (%CV) tenofovir Cmax and AUC0-∞ values were 223 (34.8%) ng/ml and 2,050 (50.8%) ng·h/ml, respectively, in normal subjects compared with 289 (46.0%) ng/ml and 2,310 (43.5%) ng·h/ml in subjects with moderate hepatic impairment, and 305 (24.8%) ng/ml and 2,740 (44.0%) ng·h/ml in subjects with severe hepatic impairment.
Maltese: Il-medja (%CV) tal-valuri ta' Cmax ta' tenofovir u l-valuri tal-AUC0-∞ kienu ta' 223 (34.8%) ng/ml u 2,050 (50.8%) ng·h/ml rispettivament, f'individwi normali, meta pparagunata ma' 289 (46.0%) ng/ml u 2,310 (43.5%) ng·h/ml f'individwi b'indeboliment tal-fwied moderat, u 305 (24.8%) ng/ml u 2,740 (44.0%) ng·h/ml f'individwi b'indeboliment tal-fwied sever.
English: AUC: ↓ 34% Cmax: ↓ 34% Cmin: ↓ 34%
Maltese: ↓ 34% Cmax: ↓ 34% Cmin: ↓ 34%
English: Resistance: Strains of HIV-1 with reduced susceptibility to tenofovir and a K65R mutation in reverse transcriptase have been selected in vitro and in some patients (see Clinical efficacy and safety).
Maltese: Strejns ta' HIV-1 bi tnaqqis fis-sensittività għal tenofovir u b'mutazzjoni K65R f'reverse transcriptase intagħżlu in vitro u f'xi pazjenti (ara Effikaċja klinika u sigurtà).
English: Compared with patients with normal renal function, the mean (%CV) tenofovir exposure increased from 2,185 (12%) ng·h/ml in subjects with CrCl > 80 ml/min to respectively 3,064 (30%) ng h/ml, 6,009 (42%) ng·h/ml and 15,985 (45%) ng h/ml in patients with mild, moderate and severe renal impairment.
Maltese: Meta mqabbel ma' pazjenti b'funzjoni renali normali, l-esponiment medju tat-tenofovir (%CV) żdiedet minn 2,185 (12%) ng·h/ml f'individwi b'CrCl > 80 ml/min għal 3,064 (30%) ng·h/ml, 6,009 (42%) ng·h/ml u 15,985 (45%) ng·h/ml rispettivament f‘pazjenti b'indeboliment renali ħafif, moderat u sever.
English: Tenofovir is converted intracellularly to tenofovir monophosphate and to the active component, tenofovir diphosphate.
Maltese: Tenofovir jinbidel intraċellularment għall-monophosphate ta' tenofovir u għall-komponent attiv, tenofovir diphosphate.
English: There are limited clinical data with respect to the effect of tenofovir disoproxil on fertility.
Maltese: Hemm dejta klinika limitata dwar l-effett ta' tenofovir disoproxil fuq il-fertilità.
English: Table 4: Efficacy parameters in compensated HBeAg negative patients at week 96, 144, 192, 240, 288 and 384 open-label treatment
Maltese: Tabella 4: Parametri tal-effikaċja f'pazjenti li kienu negattivi għal HBeAg kumpensat f'ġimgħa 96, 144, 192, 240, 288 u 384 ta' kura open label
English: Genotypic evaluations performed on all patients with HBV DNA > 400 copies/ml at week 48 (n = 39), 96 (n = 24), 144 (n = 6), 192 (n = 5), 240 (n = 4), 288 (n = 6) and 384 (n = 2) of tenofovir disoproxil monotherapy showed that no mutations associated with tenofovir disoproxil resistance have developed.
Maltese: Levalwazzjonijiet ġenotipiċi li saru fuq il-pazjenti kollha b'DNA tal-HBV ta' > 400 kopja/ml f'ġimgħa 48 (n = 39), 96 (n = 24), 144 (n = 6), 192 (n = 5), 240 (n = 4), 288 (n = 6) u 384 (n = 2) ta' monoterapija b'tenofovir disoproxil urew li ma żviluppawx mutazzjonijiet assoċjati ma' reżistenza għal tenofovir disoproxil.
English: The mean baseline CD4 cell count was 279 cells/mm3, the mean baseline plasma HIV-1 RNA was 4.91 log10 copies/ml, 19% of patients had symptomatic HIV-1 infection and 18% had AIDS.
Maltese: Il-medja tal-linja bażi tal-għadd taċ-ċelluli CD4 kien ta' 279 ċellula/mm3, ilmedja bażi tal-plażma HIV-1 RNA kienet ta' 4.91 log10 kopja/ml, 19% tal-pazjenti kellhom infezzjoni sintomatika ta' HIV-1 u 18% kellhom AIDS.
English: Co-administration of tenofovir disoproxil and didanosine at a dose of 400 mg daily has been associated with a significant decrease in CD4 cell count, possibly due to an intracellular interaction increasing phosphorylated (i.e. active) didanosine.
Maltese: L-għoti flimkien ta' tenofovir disoproxil u didanosine f'doża ta' 400 mg kuljum kien assoċjat ma' tnaqqis sinifikanti fl-għadd taċ-ċelluli CD4, possibbilment minħabba interazzjoni intraċellulari li żiedet didanosine fosforilat (jiġifieri attiv).
English: Thirteen percent (6/45) of the tenofovir disoproxil group, 13% (6/45) of the emtricitabine plus tenofovir disoproxil group, and 9% (2/22) of the entecavir group had a confirmed increase in serum creatinine ≥ 0.5 mg/dl or confirmed serum phosphate of < 2 mg/dl.
Maltese: Tlettax fil-mija (6/45) tal-grupp ta' tenofovir disoproxil, 13% (6/45) tal-grupp ta' emtricitabine u tenofovir disoproxil, u 9% (2/22) tal-grupp ta' entecavir kellhom żieda kkonfermata fil-krejatinina fis-serum ta' ≥ 0.5 mg/dl jew phosphate fis-serum ikkonfermat ta' < 2 mg/dl.
English: • adolescents aged 12 to less than 18 years.
Maltese: • adolexxenti li għandhom minn 12 sa inqas minn 18-il sena.
English: Tenofovir diphosphate is a weak inhibitor of cellular polymerases α, β, and γ.
Maltese: Tenofovir diphosphate huwa impeditur dgħajjef tal-polimerases ċellulari α, β, u γ.
English: Do not take Tenofovir disoproxil Zentiva together with medicines containing adefovir dipivoxil (a medicine used to treat chronic hepatitis B).
Maltese: Tiħux Tenofovir disoproxil Zentiva flimkien ma' mediċini li fihom adefovir dipivoxil (mediċina li tintuża biex tittratta l-epatite B kronika).
English: No data are available to make dose recommendations (see sections 4.2 and 4.4).
Maltese: M'hemmx dejta disponibbli biex isiru rakkomandazzjonijiet dwar id-doża (ara sezzjonijiet 4.2 u 4.4).
English: Darunavir/Ritonavir (300 mg/100 mg b.i.d.)
Maltese: Darunavir/Ritonavir (300/100 b.i.d.)
English: - compensated liver disease, with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis (see section 5.1).
Maltese: - mard tal-fwied kumpensat, b'evidenza ta' replikazzjoni virali attiva, b'livelli ta' alanine aminotransferase (ALT) fis serum li jkunu għolja b'mod persistenti, u b'evidenza istoloġika ta' infjammazzjoni attiva u/jew fibrożi (ara sezzjoni 5.1).
English: - foscarnet, ganciclovir, or cidofovir (for viral infection) - interleukin-2 (to treat cancer) - adefovir dipivoxil (for HBV) - tacrolimus (for suppression of the immune system) - non-steroidal anti-inflammatory drugs (NSAIDs, to relieve bone or muscle pains)
Maltese: Dawn jinkludu: - aminoglycosides, pentamidine jew vancomycin (għal infezzjoni batterjali) - amphotericin B (għal infezzjoni fungali) - foscarnet, ganciclovir, jew cidofovir (għal infezzjoni virali) - interleukin-2 (għat-trattament tal -kanċer) - adefovir dipivoxil (għal HBV) - tacrolimus (għat-trażżin tas-sistema immuni) - mediċini anti-infjammatorji mhux sterojdi (NSAIDs, għas-serħan mill-uġigħ fl-għadam jew fil-muskoli)
English: Exacerbations of hepatitis after discontinuation of treatment In HBV infected patients, clinical and laboratory evidence of exacerbations of hepatitis have occurred after discontinuation of HBV therapy (see section 4.4).
Maltese: F'pazjenti infettati bl-HBV, evidenza klinika u mil-laboratorju ta' epatite li tmur għall-agħar seħħew wara t-twaqqif tat-terapija tal-HBV (ara sezzjoni 4.4).
English: Paired baseline and week 240 liver biopsy data were available for 331/489 patients who remained in studies GS-US-174-0102 and GS-US-174-0103 at week 240 (see Table 6 below).
Maltese: Dejta akkoppjata fil-linja bażi u minn bijopsija tal-fwied f'ġimgħa 240 kienet disponibbli għal 331/489 pazjenti li baqgħu fi istudji GS-US-174-0102 u GS-US-174-0103 f'ġimgħa 240 (ara Tabella 6 hawn taħt).
English: • HBV infected adolescents aged 12 to less than 18 years who weigh at least 35 kg.
Maltese: • Adolexxenti infettati bl-HBV li għandhom minn 12 sa inqas minn 18-il sena li jiżnu mill-inqas 35 kg.