FrancophonIA/ELRC3.0 huggingface dataset:
English: 10 film-coated tablets 30 film-coated tablets 30 x 1 film-coated tablets
Maltese: Pillola miksija b'rita 10 pilloli miksija b'rita 30 pillola miksija b'rita 30 × 1 pillola miksija b'rita
English: Tenofovir disoproxil has not been clinically evaluated in patients receiving medicinal products which are secreted by the same renal pathway, including the transport proteins human organic anion transporter (hOAT) 1 and 3 or MRP 4 (e.g. cidofovir, a known nephrotoxic medicinal product).
Maltese: Tenofovir disoproxil ma ġiex klinikament evalwat f'pazjenti li kienu qed jirċievu prodotti mediċinali li huma mnixxija mill-istess passaġġ renali, li jinkludi t-trasportatur enajoniku organiku uman (hOAT) tal-proteini tat-trasport 1 u 3 jew MRP 4 (eż. cidofovir, prodott mediċinali nefrotossiku magħruf).
English: Chronic hepatitis B: In study GS-US-174-0115, 106 HBeAg negative and HBeAg positive patients aged 12 to < 18 years with chronic HBV infection [HBV DNA ≥ 10
Maltese: Fi studju GS-US-174-0115, 106 pazjent negattivi għal HBeAg u pożittivi għal HBeAg li kellhom minn 12 sa < 18-il sena b'infezzjoni HBV kronika [DNA tal-HBV ta'
English: HIV-1: In study GS-US-104-0321, 87 HIV-1 infected treatment-experienced patients 12 to < 18 years of age were treated with tenofovir disoproxil (n = 45) or placebo (n = 42) in combination with an optimised background regimen (OBR) for 48 weeks.
Maltese: Fl-istudju GS-US-104-0321, f'87 pazjent adolexxenti infettati b'HIV-1 esperjenzati bil-kura minn età ta' 12 sa < 18-il sena kienu kkurati b'tenofovir disoproxil (n = 45) jew bi plaċebo (n = 42) flimkien ma' kors ottimizzat fl-isfond (OBR) għal 48 ġimgħa.
English: Hepatitis B infection
Maltese: Infezzjoni b'epatite B
English: [only for the carton] Tenofovir disoproxil Mylan 245 mg
Maltese: [kartuna biss] Tenofovir disoproxil Mylan 245 mg
English: 3 Study conducted with additional voxilaprevir 100 mg to achieve voxilaprevir exposures expected in HCVinfected patients.
Maltese: 3 Studju mwettaq b'voxilaprevir 100 mg addizzjonali sabiex jinkisbu l-esponimenti għal voxilaprevir mistennija f'pazjenti infettati b'HCV.
English: At week 72, overall 88% (46/52) of patients in the tenofovir disoproxil treatment group and 0% (0/54) of patients in the placebo group had HBV DNA < 400 copies/ml.
Maltese: F'ġimgħa 72, total globali ta' 88% (46/52) tal-pazjenti fil-grupp tal-kura b'tenofovir disoproxil u 0% (0/54) ta' pazjenti fil-grupp talplaċebo kellhom DNA tal-HBV ta' < 400 kopja/ml.
English: In study GS-US-104-0352, 8 out of 89 paediatric patients (9.0%) exposed to tenofovir disoproxil (median tenofovir disoproxil exposure 331 weeks) discontinued study drug due to renal adverse events.
Maltese: Fi studju GS-US-104-0352, 8 minn 89 pazjent pedjatriku (9.0%) esposti għal tenofovir disoproxil (esponiment medjan ta' tenofovir disoproxil ta' 331 ġimgħa) waqqfu l-mediċina tal-istudju minħabba avvenimenti avversi renali.
English: HBV DNA (%)
Maltese: Rispons sħiħ (%)
English: OPA/Aluminium/PE/Desiccant/PE- Aluminium perforated unit dose blister pack containing 30 x 1 film-coated tablets.
Maltese: Pakketti bil-folji tal-OPA/Aluminju/PE/Dessikant/PE-Aluminju li fihom 10 jew 30 pillola miksija b'rita.
English: A statistically significant difference in favour of tenofovir disoproxil 245 mg was seen in the time-weighted average change from baseline at week 24 (DAVG24) for CD4 count (+13 cells/mm for tenofovir disoproxil 245 mg versus -11 cells/mm for placebo, p-value = 0.0008).
Maltese: Differenza sinifikanti fl-istatistika favur 245 mg tenofovir disoproxil dehret fil-bidla medja imkejla fuq ħin minn linja bażi f'Ġimgħa 24 (DAVG24) għall-għadd ta' CD4 (+13 ċelluli/mm għal 245 mg tenofovir disoproxil kontra -11 ċelluli/mm għall-plaċebo, valur p = 0.0008).
English: Among the subjects who received placebo during the double-blind period, the proportion of subjects with HBV DNA < 400 copies/mL rose sharply after they began treatment with open-label tenofovir disoproxil (PLB-tenofovir disoproxil group): 74.1% (40/54) of subjects in the PLB-tenofovir disoproxil group had HBV DNA < 400 copies/ml at week 192.
Maltese: Fost l-individwi li rċivew plaċebo matul il-perjodu double-blind, il-proporzjon ta' individwi b'HBV DNA < 400/mL żdied b'mod sinifikanti wara li bdew il-kura b'tenofovir disoproxil open-label (il-grupp PLB-tenofovir disoproxil): 74.1% (40/54) mill-individwi fil-grupp PLB-tenofovir disoproxil kellhom HBV DNA < 400 kopja/mL f'Ġimgħa 192.
English: The main adverse reactions reported are haematological disorders (anaemia, neutropenia) and metabolic disorders (hyperlactataemia, hyperlipasaemia).
Maltese: newrotropenija), u disturbi fil-metaboliżmu (iperlaktejtemija, iperlajpejżemija).
English: The antiviral response to tenofovir disoproxil was durable through 48 weeks (DAVG48 was -0.57 log10 copies/ml, proportion of patients with HIV-1 RNA below 400 or 50 copies/ml was 41% and 18% respectively).
Maltese: Ir-reazzjoni antivirali għal tenofovir disoproxil kienet tajba tul it-48 ġimgħa (DAVG48 kien ta' -0.57 log10 kopja/ml, il-proporzjon ta' pazjenti b'HIV-1 RNA taħt 400 jew 50 kopja/ml kien ta' 41% u 18% rispettivament).
English: Table 5: Efficacy parameters in compensated HBeAg positive patients at week 96, 144, 192, 240, 288 and 384 open-label treatment
Maltese: Parametri tal-effikaċja f'pazjenti li kienu pożittivi għal HBeAg kumpensat f'ġimgħa 96, 144, 192, 240, 288 u 384 ta' kura open-label
English: Interactions between tenofovir disoproxil and other medicinal products are listed in Table 1 below (increase is indicated as “↑”, decrease as “↓”, no change as “↔”, twice daily as “b.i.d.”, and once daily as “q.d.”).
Maltese: Interazzjonijiet bejn tenofovir disoproxil u prodotti mediċinali oħrajn huma elenkati fit-Tabella 1 hawn taħt (żieda hija indikata b'“↑”, tnaqqis b'“↓”, ebda bidla b'“↔”, darbtejn kuljum b'“b.i.d.” u darba kuljum bi “q.d.”).
English: A consistent response to treatment with tenofovir disoproxil 245 mg was seen regardless of baseline HIV-1 RNA and CD4 count.
Maltese: Reazzjoni konsistenti għat-trattament b'245 mg tenofovir disoproxil dehret irrispettivament bil-linja bażi ta' HIV-1 RNA u l-għadd ta' CD4.
English: The safety of tenofovir disoproxil in the setting of ledipasvir/sofosbuvir, sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/voxilaprevir and a pharmacokinetic enhancer has not been established.
Maltese: Is-sigurtà ta' tenofovir disoproxil fl-ambjent ta' ledipasvir/sofosbivir, sofosbuvir/velpatasvir jew sofosbuvir/velpatasvir/voxilaprevir u potenzjatur farmaċewtiku għadha ma ġietx stabbilità.
English: Tenofovir disoproxil Mylan 245 mg tablets are also a treatment for chronic hepatitis B, an infection with HBV (hepatitis B virus).
Maltese: Tenofovir disoproxil Mylan 245 mg pilloli huma wkoll trattament għall-epatite B kronika, infezzjoni bl-HBV (virus ta' l-epatite B).
English: angioedema Musculoskeletal and connective tissue disorders: Uncommon:
Maltese: Disturbi muskolu-skeletriċi u tat-tessuti konnetivi:
English: High density polyethylene (HDPE) bottle with polypropylene (PP) child resistant closure with wad containing aluminium induction sealing liner and desiccant (silica gel), available in the following pack sizes: 30 film-coated tablets and multipacks containing 90 (3 packs of 30) film-coated tablets.
Maltese: Flixkun tal-high density polyethylene (HDPE) b'tapp li ma jinfetaħx mit-tfal tal-polypropylene (PP) b'tajjara li fiha inforra tas-siġillar tal-induzzjoni tal-aluminju u dessikant (silica gel), disponibbli fiddaqsijiet tal-pakketti li ġejjin: 30 pillola miksija b'rita u pakketti multipli li fihom 90 (3 pakketti ta' 30) pillola miksija b'rita.
English: Excipient with known effect Each tablet contains 155 mg lactose monohydrate.
Maltese: Eċċipjent b'effett magħruf Kull pillola fiha 155 mg ta' lactose monohydrate.
English: When missing data were excluded, 91% of patients in the tenofovir disoproxil treatment group and 94% of patients in the stavudine or zidovudine treatment group had HIV-1 RNA concentrations < 400 copies/ml at week 48.
Maltese: Meta d-dejta nieqsa ġiet eskluża, 91% tal-pazjenti fil-grupp ta' kura b'tenofovir disoproxil u 94% tal-pazjenti filgrupp ta' kura bi stavudine jew zidovudine kellhom konċentrazzjonijiet ta' HIV-1 RNA ta' < 400 kopja/ml f'ġimgħa 48.
English: acute renal failure, renal failure, acute tubular necrosis, nephritis (including acute interstitial nephritis)
Maltese: kollass tal-kliewi akut, kollass tal-kliewi, nekrożi tubulari akuta, nefrite (li tinkludi nefrite interstizzjali akuta)
English: Mild renal impairment (creatinine clearance 50-80 ml/min) Limited data from clinical studies support once daily dosing of 245 mg tenofovir disoproxil in patients with mild renal impairment.
Maltese: Indeboliment renali ħafif (tneħħija tal-krejatinina ta' 50-80 ml/min) Informazzjoni limitata minn studji kliniċi jissapportjaw dożaġġ ta' 245 mg darba kuljum ta' tenofovir disoproxil f'pazjenti b'indeboliment renali ħafif.
English: Tenofovir disoproxil 245 mg film-coated tablets are indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected adults.
Maltese: Tenofovir disoproxil 245 mg pilloli miksija b'rita huma indikati flimkien ma' prodotti mediċinali oħra antiretrovirali għat-trattament ta' adulti infettati b'HIV-1.
English: Co-administration of tenofovir disoproxil and didanosine results in a 40-60% increase in systemic exposure to didanosine that may increase the risk of didanosine-related adverse reactions (see section 4.5).
Maltese: L-għoti flimkien ta' tenofovir disoproxil u didanosine jirriżulta f'żieda ta' 40-60% flesponiment sistemiku għad-didanosine, li jista' jżid ir-riskju ta' reazzjonijiet avversi relatati ma' didanosine (ara sezzjoni 4.5).
English: Each film-coated tablet contains 245 mg of tenofovir disoproxil (corresponding to 300 mg of tenofovir disoproxil maleate).
Maltese: Kull pillola miksija b'rita fiha 245 mg ta' tenofovir disoproxil (li jikkorrispondu għal 300 mg ta' tenofovir disoproxil maleate).
English: Experience in patients with lamivudine-resistant HBV at 240 weeks (study GS-US-174-0121) The efficacy and safety of 245 mg tenofovir disoproxil was evaluated in a randomised, double-blind study (GS-US-174-0121) in HBeAg positive and HBeAg negative patients (n = 280) with compensated liver disease, viraemia (HBV DNA ≥ 1,000 IU/ml), and genotypic evidence of lamivudine resistance (rtM204I/V +/- rtL180M).
Maltese: L-effikaċja u s-sigurtà ta' 245 mg ta' tenofovir disoproxil ġew evalwati fi studju randomised u double-blind (GS-US-174-0121) f'pazjenti HbeAg pożittivi u pazjenti HBeAg negattivi (n = 280) b' mard tal-fwied kumpensat, viremija (DNA tal-HBV ≥ 1,000 IU/ml), u evidenza ġenotipika ta' reżistenza għal lamivudine (rtM204I/V +/- rtL180M).
English: Tenofovir disoproxil 245 mg film-coated tablets are indicated for the treatment of chronic hepatitis B in adolescents 12 to < 18 years of age with:
Maltese: Tenofovir disoproxil 245 mg pilloli miksija b'rita huma indikati għat-trattament ta' epatite B kronika f'adolexxenti li jkollhom minn 12 sa < 18-il sena b':
English: Elderly patients are more likely to have decreased renal function, therefore caution should be exercised when treating elderly patients with tenofovir disoproxil (see section 4.4).
Maltese: Pazjenti anzjani huma aktar probabbli li jkollhom tnaqqis tal-funzjoni renali, għalhekk għandha tingħata attenzjoni partikulari meta pazjenti anzjani jkunu qed jingħataw it-trattament b'tenofovir disoproxil (ara sezzjoni 4.4).
English: BOTTLE CARTON AND BOTTLE LABEL
Maltese: <kartuna biss>
English: • Do not breast-feed during treatment with Tenofovir disoproxil Mylan.
Maltese: • Ipprova tinqabadx tqila matul it-trattament b'Tenofovir disoproxil Mylan.
English: Of the 94 patients with cirrhosis at baseline (Ishak fibrosis score 5-6), 26% (24) experienced no change in Ishak fibrosis score and 72% (68) experienced regression of cirrhosis by week 240 with a reduction in Ishak fibrosis score of at least 2 points.
Maltese: Mill-94 pazjent b'ċirrożi fil-linja bażi (punteġġ tal-fibrożi ta' Ishak: 5-6), 26% (24) ma kellhom l-ebda bidla fil-punteġġ tal-fibrożi ta' Ishak u 72% (68) kellhom rigressjoni ta' ċirrożi sa ġimgħa 240 bi tnaqqis fil-punteġġ tal-fibrożi ta' Ishak ta' mill-inqas 2 punti.
English: • That there is an increased risk of renal disease in HIV and HBV infected patients associated with tenofovir disoproxil-containing products such as Tenofovir disoproxil Mylan
Maltese: • Li hemm żieda fir-riskju ta' mard renali f'pazjenti infettati bl-HIV u HBV assoċjata ma' prodotti li jkun fihom tenofovir disoproxil bħal Tenovir disoproxil Mylan
English: EU/1/16/1129/003 EU/1/16/1129/004 EU/1/16/1129/005
Maltese: EU/1/16/1129/003 EU/1/16/1129/004
English: Studies have established the pathway of active tubular secretion of tenofovir to be influx into proximal tubule cell by the human organic anion transporters (hOAT) 1 and 3 and efflux into the urine by the multidrug resistant protein 4 (MRP 4).
Maltese: L-istudji stabbilixxew il-passaġġ tas-sekrezzjoni tubulari attiva ta' tenofovir li jkun influss ġoċ-ċellula tat-tubulu prossimali mit-trasportaturi enajoniċi organiċi umani (hOAT) 1 u 3 u l-effluss ġol-awrina mill-proteina 4 reżistenti kontra ħafna mediċini (MRP 4 - multidrug resistant protein 4).
English: HIV-1 clinical studies: Assessment of adverse reactions from HIV-1 clinical study data is based on experience in two studies in 653 treatment-experienced patients receiving treatment with tenofovir disoproxil (n = 443) or placebo (n = 210) in combination with other antiretroviral medicinal products for 24 weeks and also in a double-blind comparative controlled study in which 600 treatment-naïve patients received treatment with tenofovir disoproxil 245 mg (n = 299) or stavudine (n = 301) in combination with lamivudine and efavirenz for 144 weeks.
Maltese: L-istima ta' reazzjonijiet avversi minn dejta minn studju kliniku dwar HIV-1 hija bbażata fuq l-esperjenza miksuba f'żewġ studji f'653 pazjent esperjenzati bil-kura b'tenofovir disoproxil (n = 443) jew plaċebo (n = 210) ikkombinati ma' prodotti mediċinali antiretrovirali oħra għal 24 ġimgħa u ukoll fi studju komparattiv double-blind ikkontrollat li fih 600 pazjent li qatt ma kienu ħadu din it-trattament qabel, irċivew it-trattament b'245 mg tenofovir disoproxil (n = 299) jew stavudine (n = 301) ikkombinati ma' lamivudine u efavirenz għal 144 ġimgħa.
English: copies/ml, elevated serum ALT (≥ 2 x ULN) or a history of elevated serum ALT levels in the past 24 months] were treated with tenofovir disoproxil 245 mg (n = 52) or placebo (n = 54) for 72 weeks.
Maltese: kopji/ml, b'livelli ta' ALT fis-serum li jkunu għolja (≥ 2 x ULN) jew passat mediku ta' livelli ta' ALT fis-serum li jkunu għolja fl-aħħar 24 xahar] kienu kkurati b'tenofovir disoproxil 245 mg (n = 52) jew plaċebo (n = 54) għal 72 ġimgħa.
English: HBeAg loss/seroconversio n
Maltese: Tnaqqis/serokonverżjoni ta' HBsAg
English: This adverse reaction may occur as a consequence of proximal renal tubulopathy.
Maltese: 1 Din ir-reazzjoni avversa tista' sseħħ bħala konsegwenza ta' tubulopatija renali prossimali.
English: Bone toxicity was diagnosed as osteomalacia (monkeys) and reduced bone mineral density (BMD) (rats and dogs).
Maltese: It-tossiċità flgħadam kienet dijanjostikata bħala osteomalaċja (fix-xadini) u tnaqqis fid-densità minerali tal-għadam (BMD) (fil-firien u l-klieb).
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall Mediċini http://www.ema.europa.eu
English: Tenofovir disoproxil Mylan 245 mg film-coated tablets are light blue, round, biconvex, debossed with ‘TN245' on one side and ‘M' on other side.
Maltese: Il-pilloli miksija b'rita ta' Tenofovir disoproxil Mylan 245 mg huma ċelesti ċar, tondi, imżaqqa fuq żewġ naħat, imnaqqxa fuq naħa waħda b'“TN245” u fuq in-naħa l-oħra b'“M”.
English: Table 1: Interactions between tenofovir disoproxil and other medicinal products Medicinal product by therapeutic areas (dose in mg)
Maltese: Tabella 1: Interazzjonijiet bejn tenofovir disoproxil u prodotti mediċinali oħrajn
English: In HIV infected patients, in a 144-week controlled clinical study that compared tenofovir disoproxil with stavudine in combination with lamivudine and efavirenz in antiretroviral-naïve adult patients, small decreases in bone mineral density (BMD) of the hip and spine were observed in both treatment groups.
Maltese: Fi pazjenti infettati bl-HIV, fi studju kliniku kkontrollat ta' 144 ġimgħa fejn tqabblu tenofovir disoproxil ma' stavudine mogħti flimkien ma' lamivudine u efavirenz f'pazjenti adulti li qatt ma' kienu ngħataw mediċini antiretrovirali qabel, tnaqqis żgħir fid-densità minerali ta' l-għadam (BMD) tal-ġenbejn u tas-sinsla tad-dahar kienu osservati fiż-żewġ gruppi tat-trattament.
English: Assessment of adverse reactions is based on two randomised trials (studies GS-US-104-0321 and GS-US-104-0352) in 184 HIV-1 infected paediatric patients (aged 2 to < 18 years) who received treatment with tenofovir disoproxil (n = 93) or placebo/active comparator (n = 91) in combination with other antiretroviral agents for 48 weeks (see section 5.1).
Maltese: GS-US-104-0321 u GS-US-104-0352) f'184 pazjenti pedjatriċi infettati b'HIV-1 (minn età ta' sentejn sa < 18-il sena) li rċivew il-kura b'tenofovir disoproxil (n = 93) jew bil-plaċebo/komparatur attiv (n = 91) flimkien ma' mediċini antiretrovirali oħra għal 48 ġimgħa (ara sezzjoni 5.1).
English: Hepatic function should be monitored at repeated intervals with both clinical and laboratory follow-up for at least 6 months after discontinuation of hepatitis B therapy.
Maltese: Il-funzjoni epatika għandha tiġi mmonitorjata mill-qrib, ripetutament, b'eżaminazzjonijiet kliniċi u tal-laboratorju għal mill-inqas 6 xhur wara t-twaqqif tat-terapija kontra epatite B.
English: BMD Z-scorea
Maltese: Dejta dwar l-HIV
English: lactic acidosis Nervous system disorders:
Maltese: Disturbi fis-sistema nervuża:
English: Response to treatment with tenofovir disoproxil was comparable in nucleos(t)ide-naïve (n = 20) and nucleos(t)ideexperienced (n = 32) patients, including lamivudine- resistant patients (n = 6).
Maltese: Ir-rispons għall-kura b'tenofovir disoproxil kien komparabbli f'pazjenti li filpassat qatt ma ngħataw nucleos(t)ide (n = 20) u f'pazjenti li fil-passat ingħataw nucleos(t)ide (n = 32), li jinkludu pazjenti reżistenti għal lamivudine (n = 6).
English: Tenofovir disoproxil Mylan contains lactose
Maltese: Tenofovir disoproxil Mylan fih lactose
English: headache Gastrointestinal disorders: Very common:
Maltese: Disturbi gastro-intestinali:
English: Approximately 1% of tenofovir disoproxil -treated adult patients discontinued treatment due to the gastrointestinal events.
Maltese: Madwar 1% tal-pazjenti adulti li ħadu ttrattament b'tenofovir disoproxil ma komplewx it-trattament minħabba l-effetti gastro-intestinali.
English: Do not take Tenofovir disoproxil Mylan together with medicines containing adefovir dipivoxil (a medicine used to treat chronic hepatitis B).
Maltese: mediċini li fihom adefovir dipivoxil (mediċina li tintuża biex tittratta l-epatite B kronika).
English: No significant effect on darunavir/ritonavir PK parameters.
Maltese: L-ebda effett sinifikanti fuq ilparametri PK ta' lopinavir/ritonavir.
English: The 144-week, double-blind, active controlled phase of study GS-99-903 evaluated the efficacy and safety of tenofovir disoproxil 245 mg versus stavudine when used in combination with lamivudine and efavirenz in HIV-1 infected adult patients naïve to antiretroviral therapy.
Maltese: Il-fażi ta' l-istudju GS-99-903 ikkontrollat b'mod attiv li sar matul 144 ġimgħa u double-blind evalwa l-effiċjenza u s-sigurtà ta' 245 mg tenofovir disoproxil kontra stavudine meta użat f'kumbinazzjoni ma' lamivudine u efavirenz f'pazjenti adulti infettati b'HIV-1, li qatt ma ħadu terapija antiretrovirali.
English: OTHER
Maltese: ALT
English: This medicine is not a cure for HIV infection.
Maltese: Din il-mediċina ma tfejjaqx l-infezzjoni ta' HIV.
English: Lumbar spine BMD at least 6% decrease b NA
Maltese: Tnaqqis tal-inqas ta' 6% fil-BMD tal-ġisem kollu b
English: How to take Tenofovir disoproxil Mylan
Maltese: Mediċini oħra u Tenofovir disoproxil Mylan
English: Experience in patients with HIV co-infection and prior lamivudine experience In a randomised, 48-week double-blind, controlled study of tenofovir disoproxil 245 mg in adult patients co-infected with HIV-1 and chronic hepatitis B with prior lamivudine experience (study ACTG 5127), the mean serum HBV DNA levels at baseline in patients randomised to the tenofovir arm were 9.45 log10 copies/ml (n = 27).
Maltese: L-esperjenza f'pazjenti infettati wkoll bl-HIV u li kellhom esperjenza ta' lamivudine fil-passat Fi studju randomised li dam 48 ġimgħa, ikkontrollat u double-blind, dwar tenofovir disoproxil 245 mg f'pazjenti adulti ko-infettati bl-HIV-1 u bl-epatite B kronika li fil-passat ingħataw lamivudine (studju ACTG 5127), il-medja tal-livelli tas-serum DNA tal-HBV fil-linja bażi f'pazjenti randomised fil-parti ta' l-istudju dwar tenofovir kienet ta' 9.45 log10 kopja/ml (n = 27).
English: Patients with lamivudine-resistant chronic hepatitis B: No new adverse reactions to tenofovir disoproxil were identified from a randomised, double-blind study (GS-US-174-0121) in which 280 lamivudine-resistant patients received treatment with tenofovir disoproxil (n = 141) or emtricitabine/tenofovir disoproxil (n = 139) for 240 weeks.
Maltese: L-ebda reazzjonijiet avversi ġodda għal tenofovir disoproxil ma kienu identifikati minn studju randomised u double-blind (GS-US-174-0121) li fih 280 pazjent reżistenti għal lamivudine irċivew kura b'tenofovir disoproxil (n = 141) jew emtricitabine/tenofovir disoproxil (n = 139) għal 240 ġimgħa.
English: The adverse reactions observed in adolescent patients who received treatment with tenofovir disoproxil were consistent with those observed in clinical studies of tenofovir disoproxil in adults (see section 4.8 Tabulated summary of adverse reactions and 5.1).
Maltese: Ir-reazzjonijiet avversi osservati f'pazjenti adolexxenti li rċivew il-kura b'tenofovir disoproxil kienu konsistenti ma' dawk osservati fi studji kliniċi ta' tenofovir disoproxil fl-adulti (ara sezzjonijiet 4.8 Sommarju tabulat ta' reazzjonijiet avversi u 5.1).
English: Tenofovir disoproxil should be avoided in antiretroviral-experienced patients with strains harbouring the K65R mutation (see section 4.4).
Maltese: Tenofovir disoproxil għandu jkun evitat f'pazjenti li mhux l-ewwel darba li ngħataw sustanzi antiretrovirali bi strejns bilmutazzjoni K65R (ara sezzjoni 4.4).
English: Tel: + 39 02 612 46921
Maltese: Mylan Italia S.r.l Tel: + 39 02 612 46921
English: In cell based assays, HBV strains expressing the rtV173L, rtL180M, and rtM204I/V mutations associated with resistance to lamivudine and telbivudine showed a susceptibility to tenofovir ranging from 0.7- to 3.4-fold that of wild-type virus.
Maltese: F'assaġġi bbażati fuq iċ-ċelluli, strejns tal-HBV li jesprimu l-mutazzjonijiet rtV173L, rtL180M, u rtM204I/V assoċjati ma' reżistenza għal lamivudine u telbivudine, urew sensittività għal tenofovir li tvarja minn 0.7 sa 3.4 darbiet iktar minn dik ta' listrejn naturali tal-virus.