FrancophonIA/ELRC3.0 huggingface dataset:
English: In study GS-US-174-0103 a significantly greater proportion of patients in the tenofovir disoproxil group than in the adefovir dipivoxil group had normalised ALT and achieved HBsAg loss at week 48 (see Table 4 below).
Maltese: Fi studju GS-US-174-0103, proporzjon akbar b'mod sinifikanti ta' pazjenti fil-grupp ta' tenofovir disoproxil milli fil-grupp ta' adefovir dipivoxil, kellu ALT normalizzat u kiseb tnaqqis ta' HBsAg f'ġimgħa 48 (ara Tabella 4 hawn taħt).
English: • It is also important to tell your doctor if you are taking ledipasvir/sofosbuvir, sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/voxilaprevir to treat hepatitis C infection.
Maltese: sofosbuvir/velpatasvir jew sofosbuvir/velpatasvir/voxilaprevir għat-trattament tal-infezzjoni tal
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: 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: 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: 280 pazjent reżistenti għal lamivudine rċivew trattament b'tenofovir disoproxil (n = 141) jew emtricitabine/tenofovir disoproxil (n = 139) għal 240 ġimgħa.
English: Increased plasma concentrations of tenofovir resulting from coadministration of tenofovir disoproxil, sofosbuvir/velpatasvir/voxila previr and darunavir/ritonavir may increase adverse reactions related to tenofovir disoproxil, including renal disorders.
Maltese: tenofovir fil-plażma li tirriżulta mill-għoti fl-istess ħin ta' tenofovir disoproxil, sofosbuvir/velpatasvir/voxi laprevir u darunavir/ritonavir tista' żżid ir-reazzjonijiet avversi relatati ma' tenofovir disoproxil, li jinkludu disturbi renali.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/200/008 30 film-coated tablets EU/1/01/200/009 90 (3 bottles of 30) film-coated tablets
Maltese: EU/1/01/200/009 90 (3 fliexken ta' 30) pillola miksija b'rita
English: • Not for children who weigh under 22 kg or 28 kg and over.
Maltese: • Mhux għal tfal li jiżnu inqas minn 22 kg jew 28 kg u aktar.
English: Viread is not usually taken with other medicines that can damage your child's kidneys (see Other medicines and Viread).
Maltese: Viread normalment ma jitteħidx ma' mediċini oħra li jistgħu jagħmlu ħsara lill-kliewi tiegħek (ara Mediċini oħra u Viread).
English: Adjustments of the daily dose of tenofovir disoproxil 33 mg/g granules are recommended in patients with moderate (creatinine clearance 30-49 ml/min) or severe (creatinine clearance < 30 ml/min) renal impairment based on modelling of single-dose pharmacokinetic data in HIV negative and non-HBV infected subjects with varying degrees of renal impairment, including end-stage renal disease requiring haemodialysis.
Maltese: L-aġġustamenti tad-doża ta' kuljum ta' tenofovir disoproxil 33 mg/g granijiet huma rakkomandati f'pazjenti b'indeboliment renali moderat (tneħħija tal-krejatinina ta' 30-49 ml/min) jew sever (tneħħija tal-krejatinina ta' < 30 ml/min), ibbażati fuq l-immudellar ta' tagħrif farmakokinetiku ta' doża waħda f'individwi li huma negattivi għal HIV u dawk li ma kienux infettati bl-HBV b'livelli differenti ta'
English: Overall, the data derived from this study are too limited to draw any definitive conclusions on the comparison of emtricitabine plus tenofovir disoproxil versus tenofovir disoproxil, (see Table 7 below).
Maltese: Globalment, id-data miskuba minn dan l-istudju hi limitata wisq biex wieħed jasal għal xi konklużjonijiet definittivi dwar il-paragun ta' emtricitabine flimkien ma' tenofovir disoproxil kontra tenofovir disoproxil, (ara Tabella 7 hawn taħt).
English: m 48 weeks of double-blind adefovir dipivoxil followed by 240 weeks open-label tenofovir disoproxil.
Maltese: m 48 ġimgħa ta' adefovir dipivoxil double blind segwiti minn 240 ġimgħa ta' tenofovir disoproxil open label.
English: 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: Reżistenza klinika 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: Periodic monitoring of hepatic function is recommended during treatment (see section 4.4).
Maltese: Il monitoraġġ perjodiku tal-funzjoni epatika hu rakkomandat matul it-trattament (ara sezzjoni 4.4).
English: + Raltegravir (400 mg b.i.d) + Emtricitabine/Tenofovir disoproxil (200 mg/245 mg q.d.)
Maltese: Sofosbuvir/Velpatasvir (400 mg/100 mg q.d.) + Emtricitabine/Rilpivirine/Tenofovir disoproxil (200 mg/25 mg/245 mg q.d.)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/200/006
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/01/200/006
English: The safety of tenofovir disoproxil when used with sofosbuvir/velpatasvir/voxilaprevir and a pharmacokinetic enhancer (e.g. ritonavir or cobicistat) has not been established.
Maltese: sofosbuvir/velpatasvir/voxilaprevir u potenzjatur farmakokinetiku (eż.
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 ttrattament f'pazjenti pedjatriċi, ara sezzjonijiet 4.2, 4.4, 4.8 u 5
English: Each Viread tablet contains 123 mg of tenofovir disoproxil (as fumarate).
Maltese: Kull pillola miksija b'rita fiha 123 mg ta' tenofovir disoproxil (bħala fumarate).
English: Lumbar spine mean (SD) BMD Z-score a
Maltese: Medja (SD) tal-punteġġ Z tal
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: (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: 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) tal-pazjenti mingħajr ċirrożi fil-linja bażi u 99% (93/94) tal-pazjenti b'ċirrożi fil-linja bażi jew ma kellhom l-ebda bidla jew kellhom titjib fil-fibrożi (punteġġ tal-fibrożi ta' Ishak).
English: d 48 weeks double-blind adefovir dipivoxil followed by up to 192 weeks open-label tenofovir disoproxil.
Maltese: d 48 ġimgħa ta' adefovir dipivoxil double-blind segwiti minn sa 192 ġimgħa ta' tenofovir disoproxil open-label.
English: Viread 204 mg tablets are only suitable for:
Maltese: Il-pilloli Viread 204 mg huma adatti biss għal:
English: Viread 204 mg film-coated tablets are indicated for the treatment of chronic hepatitis B in paediatric patients aged 6 to < 12 years who weigh from 28 kg to less than 35 kg, with:
Maltese: Viread 204 mg pilloli miksija b'rita huma indikati għat-trattament tal-epatite B kronika f'pazjenti pedjatriċi li għandhom minn 6 sa < 12-il sena u li jiżnu minn 28 kg sa inqas minn 35 kg, b':
English: Viread 204 mg film-coated tablets are indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected paediatric patients, with NRTI resistance or toxicities precluding the use of first line agents, aged 6 to < 12 years who weigh from 28 kg to less than 35 kg.
Maltese: Viread 204 mg pilloli miksija b'rita huma indikati flimkien ma' prodotti mediċinali oħra antiretrovirali għat-trattament ta' pazjenti pedjatriċi infettati b'HIV-1 b'reżistenza għal NRTI jew tossiċitajiet li jipprekludu l-użu ta' prodotti mediċinali primarji li għandhom minn 6 sa < 12-il sena u li jiżnu minn
English: Flares after treatment discontinuation: Acute exacerbation of hepatitis has also been reported in patients who have discontinued hepatitis B therapy.
Maltese: Taħrix akut tal-epatite kien irrappurtat ukoll f'pazjenti li kienu waqqfu t-terapija kontra l-epatite B.
English: White, round-shaped, film-coated tablets, 10.7 mm in diameter, debossed on one side with “GSI” and on the other side with “200”.
Maltese: 7 mm, imnaqqxa fuq naħa waħda b' “GSI” u fuq in-naħa l-oħra b'“200”.
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: After 240 weeks of treatment with emtricitabine plus tenofovir disoproxil, 115 of 139 subjects (83%) had HBV DNA < 400 copies/ml, and 59 of 83 subjects (71%) had ALT normalisation.
Maltese: tenofovir disoproxil, 115 mill-139 individwu (83%) kellhom DNA tal-HBV ta' < 400 kopja/ml, u 59
English: PHARMACEUTICAL FORM AND CONTENTS 60 g granules.
Maltese: 60 g granijiet.
English: After week 72, virologic suppression was maintained for those receiving double-blind tenofovir disoproxil followed by open-label tenofovir disoproxil (TDF-TDF group): 86.5% (45/52) of subjects in the TDF-TDF group had HBV DNA < 400 copies/ml at week 192.
Maltese: Fost l-individwi pożittivi għal HBeAg li ġew randomised biex jirċievu tenofovir disoproxil, 16 minn 65 individwu (25%) kellhom telf ta' HBeAg, u 8 minn 65 individwu (12%) kellhom serokonverżjoni anti-HBe sa ġimgħa 240.
English: A pharmacokinetic study has been performed in non-HIV infected adult patients with various degrees of hepatic impairment.
Maltese: Twettaq studju farmakokinetiku f'pazjenti adulti mhux infettati bl-HIV bi gradi varji ta' indeboliment tal-fwied.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each scoop delivers one gram of granules which contains 33 mg of tenofovir disoproxil (as fumarate).
Maltese: Kull mgħarfa għall-qies tforni gramma waħda ta' granijiet li fiha 33 mg ta' tenofovir disoproxil (bħala fumarate).
English: Each level dosing scoop provides 1 g of the granules which contains 33 mg tenofovir disoproxil (as fumarate).
Maltese: Kull imgħarfa tad-dożaġġ mhux imburġata tipprovdi 1 g ta' granijiet li fiha 33 mg ta' tenofovir disoproxil (bħala fumarate).
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 adult 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 adult patients received treatment with tenofovir disoproxil 245 mg (n = 299) or stavudine (n = 301) in combination with lamivudine and efavirenz for 144 weeks.
Maltese: HIV-1 hija bbażata fuq l-esperjenza miksuba f'żewġ studji f'653 pazjent adulti esperjenzati bil-kura li rċivew trattament 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 adulti li qatt ma kienu ħadu trattament qabel, irċivew it-trattament b'245 mg tenofovir disoproxil (n = 299) jew stavudine (n = 301) ikkombinati ma' lamivudine u efavirenz għal
English: Viread 163 mg film-coated tablets are indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected paediatric patients, with NRTI resistance or toxicities precluding the use of first line agents, aged 6 to < 12 years who weigh from 22 kg to less than 28 kg.
Maltese: Infezzjoni bl-HIV-1 Viread 163 mg pilloli miksija b'rita huma indikati flimkien ma' prodotti mediċinali oħra antiretrovirali għat-trattament ta' pazjenti pedjatriċi infettati b'HIV-1 b'reżistenza għal NRTI jew tossiċitajiet li jipprekludu l-użu ta' prodotti mediċinali primarji li għandhom minn 6 sa < 12-il sena u li jiżnu minn
English: Pharmacokinetic modelling of single-dose pharmacokinetic data in non-HIV and non-HBV infected adult subjects with varying degrees of renal impairment was used to determine dose and dosing interval recommendations for adult subjects with varying degrees of renal impairment (see section 4.2).
Maltese: L-immudellar farmakokinetiku ta' tagħrif farmakokinetiku ta' doża waħda f'individwi adulti mhux infettati bl-HIV u mhux infettati bl-HBV b'livelli differenti ta' indeboliment renali intuża biex jiġu stabbiliti r-rakkomandazzjonijiet dwar id-doża u l-intervall tad-doża għal individwi adulti b'livelli differenti ta' indeboliment renali (ara sezzjoni 4.2).
English: At week 48, 77% (46 of 60) of patients in the tenofovir disoproxil treatment group and 7% (2 of 29) of patients in the placebo group had HBV DNA < 400 copies/mL (69 IU/mL).
Maltese: F'ġimgħa 48, 77% (46 minn 60) tal-pazjenti fil-grupp tat-trattament b'tenofovir disoproxil u 7% (2
English: At Week 48, 77% (46 of 60) of patients in the tenofovir disoproxil treatment group and 7% (2 of 29) of patients in the placebo group had HBV DNA < 400 copies/mL (69 IU/mL).
Maltese: F'Ġimgħa 48, 77% (46 minn 60) tal-pazjenti fil-grupp tat-trattament b'tenofovir disoproxil u 7% (2
English: n Figures presented are cumulative percentages based upon a Kaplan Meier analysis excluding data collected after the addition of emtricitabine to open-label tenofovir disoproxil (KM-TDF).
Maltese: l Il-figuri ppreżentati huma perċentwali kumulattivi bbażati fuq analiżi Kaplan Meier li jeskludu data miġbura wara ż-żieda ta' emtricitabine ma' tenofovir disoproxil open label (KM-TDF).
English: Please refer to the Summary of Product Characteristics for Viread 33 mg/g granules.
Maltese: Jekk jogħġbok irreferi għas-Sommarju tal-Karatteristiċi tal-Prodott għal Viread 33 mg/g granijiet.
English: If bone abnormalities are detected or suspected in paediatric patients, consultation with an endocrinologist and/or nephrologist should be obtained.
Maltese: konsultazzjoni xierqa għandha tinkiseb ma' endokrinologu u/jew nefrologu.
English: Viread 245 mg film-coated tablets are light blue, almond-shaped, film-coated tablets, of dimensions 16.8 mm x 10.3 mm, debossed on one side with “GILEAD” and “4331” and on the other side with “300”.
Maltese: Il-pilloli miksija b'rita ta' Viread 245 mg huma ċelesti ċar, f'forma ta' lewża, pilloli miksija b'rita, b'daqs ta' 16.8 mm x 10.
English: Haemodialysis patients: 16.5 mg (0.5 scoop) tenofovir disoproxil 33 mg/g granules may be administered following completion of each 4-hour haemodialysis session.
Maltese: L-għoti ta' 65 mg (2 mgħaref) ta' tenofovir disoproxil 33 mg/g granijiet darba kuljum hu rakkomandat.
English: The distribution of HBV genotypes at baseline was similar between the TDF and Placebo groups.
Maltese: Id-distribuzzjoni talġenotipi tal-HBV fil-linja bażi kienet simili bejn il-grupp ta' TDF u tal-Plaċebo.
English: n 48 weeks of double-blind adefovir dipivoxil followed by 240 weeks open-label tenofovir disoproxil.
Maltese: n 48 ġimgħa ta' adefovir dipivoxil double blind segwiti minn 240 ġimgħa ta' tenofovir disoproxil open label.
English: Sofosbuvir/Velpatasvir/ Voxilaprevir (400 mg/100 mg/ 100 mg+100 mg q.d.
Maltese: Sofosbuvir/Velpatasvir (400 mg/100 mg q.d.) + Darunavir/Ritonavir (800 mg q.d./100 mg q.d.) + Emtricitabine/Tenofovir disoproxil
English: 245 mg film-coated tablet 12 to < 18 years (n = 8)
Maltese: 12 sa < 18-il sena (n = 8)
English: Sofosbuvir/Velpatasvir/ Voxilaprevir (400 mg/100 mg/ 100 mg+100 mg q.d.)
Maltese: Sofosbuvir/Velpatasvir (400 mg/100 mg q.d.) + Lopinavir/Ritonavir (800 mg/200 mg q.d.) + Emtricitabine/Tenofovir disoproxil
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 kumpensat tal-fwied u evidenza ta' mard immuni attiv, jiġifieri 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: MARKETING AUTHORISATION NUMBER(S) EU/1/01/200/004
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/01/200/004
English: m 48 weeks of double-blind tenofovir disoproxil followed by 240 weeks open-label.
Maltese: m 48 ġimgħa ta' tenofovir disoproxil double blind segwiti minn 240 ġimgħa open label.
English: If Viread 163 mg film-coated tablets are discontinued in patients co-infected with HIV and hepatitis B virus (HBV), these patients should be closely monitored for evidence of exacerbation of hepatitis (see section 4.4).
Maltese: Jekk Viread 163 mg pilloli miksija b'rita jitwaqqaf f'pazjenti infettati bil-virus tal-HIV kif ukoll bl epatite B (HBV), dawn il-pazjenti għandhom ikunu immonitorjati mill-qrib għal evidenza jekk lepatite tmur għall-agħar (ara sezzjoni 4.4).
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: HIV-1 hija bbażata fuq l-esperjenza miksuba f'żewġ studji f'653 pazjent esperjenzati bil-kura li rċivew trattament 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 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: White, triangle-shaped, film-coated tablets, 8.5 mm in diameter, debossed on one side with “GSI” and on the other side with “150”.
Maltese: b'dijametru ta' 8.5 mm, imnaqqxa fuq naħa waħda b' “GSI” u fuq in-naħa l-oħra b'“150”.
English: Tenofovir exposure achieved in these paediatric patients receiving oral daily doses of tenofovir disoproxil 245 mg or 6.5 mg/kg body weight tenofovir disoproxil up to a maximum dose of 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'dawn il pazjenti pedjatriċi li kienu qed jirċievu dożi orali ta' kuljum ta' 245 mg tenofovir disoproxil jew 6.5 mg/kg piż tal-ġisem ta' tenofovir disoproxil sa doża massima ta' 245 mg kien simili għal esponimenti miksuba f'persuni adulti li kienu qed jirċievu doża waħda kuljum ta' 245 mg tenofovir disoproxil.
English: 1, muscular weakness
Maltese: .8 Effetti mhux mixtieqa
English: The increased exposure of tenofovir could potentiate tenofovirassociated adverse events, including renal disorders.
Maltese: tenofovir tista' ssaħħaħ effetti avversi marbuta ma' tenofovir, li jinkludu disturbi renali.
English: The potential risks and benefits associated with co-administration of ledipasvir/sofosbuvir, sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/voxilaprevir with tenofovir disoproxil given in conjunction with a boosted HIV protease inhibitor (e.g. atazanavir or darunavir) should be considered, particularly in patients at increased risk of renal dysfunction.
Maltese: Ir-riskji u l-benefiċċji potenzjali assoċjati mal-għoti fl-istess ħin ta' ledipasvir/sofosbuvir, sofosbuvir/velpatasvir jew sofosbuvir/velpatasvir/voxilaprevir ma' tenofovir disoproxil mogħti flimkien ma' impeditur tal-protease ta' HIV imsaħħaħ (eż. atazanavir jew darunavir) għandhom jiġu kkunsidrati, b'mod partikolari f'pazjenti b'riskju miżjud ta' disfunzjoni renali.
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 kellhom telf ta' HBsAg sa Ġimgħa 240, iżda mhux serokonverżjoni għal anti-HBs.
English: n Figures presented are cumulative percentages based upon a Kaplan Meier analysis excluding data collected after the addition of emtricitabine to open-label tenofovir disoproxil (KM-tenofovir disoproxil).
Maltese: l Il-figuri ppreżentati huma perċentwali kumulattivi bbażati fuq analiżi Kaplan Meier li jeskludu dejta miġbura wara ż-żieda ta' emtricitabine ma' tenofovir disoproxil open-label (KM-tenofovir disoproxil).
English: Viread 123 mg film-coated tablets are indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected paediatric patients, with NRTI resistance or toxicities precluding the use of first line agents, aged 6 to < 12 years who weigh from 17 kg to less than 22 kg.
Maltese: Viread 123 mg pilloli miksija b'rita huma indikati flimkien ma' prodotti mediċinali oħra antiretrovirali għat-trattament ta' pazjenti pedjatriċi infettati b'HIV-1 b'reżistenza għal NRTI jew tossiċitajiet li jipprekludu l-użu ta' prodotti mediċinali primarji li għandhom minn 6 sa < 12-il sena u li jiżnu minn
English: AUC: ↔ Cmax: ↓ 30%
Maltese: AUC: ↔ Cmax: ↓ 30% Cmin: ↑ 63%
English: j 48 weeks of double-blind tenofovir disoproxil followed by 192 weeks open-label.
Maltese: i 48 ġimgħa ta' tenofovir disoproxil double blind segwiti minn 192 ġimgħa open label.
English: g Figures presented are cumulative percentages based upon a Kaplan Meier analysis including data collected after the addition of emtricitabine to open-label tenofovir disoproxil (KM-ITT).
Maltese: g Il-figuri ppreżentati huma perċentwali kumulattivi bbażati fuq analiżi Kaplan Meier li jinkludu data miġbura wara ż-żieda ta' emtricitabine ma' tenofovir disoproxil open label (KM-ITT).
English: c 48 weeks double-blind tenofovir disoproxil followed by up to 192 weeks open-label.
Maltese: c 48 ġimgħa ta' tenofovir disoproxil double-blind segwiti minn sa 192 ġimgħa open-label.
English: Use with certain hepatitis C virus antiviral agents
Maltese: Użu ma' ċerti sustanzi antivirali kontra l-virus tal-epatite Ċ
English: Lumbar spine mean (SD) change from baseline BMD Z-scorea
Maltese: (SD) millpunteġġ Z BMD tallinja bażi talġisem kollua
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 ta' trattament b'tenofovir disoproxil u 0% (0/54) tal-pazjenti filgrupp tal-plaċebo kellhom DNA tal-HBV ta' < 400 kopja/ml. Erbgħa u sebgħin fil-mija (26/35) talpazjenti fil-grupp ta' tenofovir disoproxil kellhom ALT normalizzat f'ġimgħa 72 meta mqabbel ma'
English: Week b e g i l o c f h j m p
Maltese: Tabella 8: Parametri tas-sigurtà u l-effikaċja f'pazjenti mhux kumpensati f'ġimgħa 48