FrancophonIA/ELRC3.0 huggingface dataset:
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.
Croatian: Viread 204 mg filmom obložene tablete indicirane su u kombinaciji s drugim antiretrovirusnim lijekovima za liječenje pedijatrijskih bolesnika s infekcijom virusom HIV-1 u dobi od 6 do < 12 godina i tjelesne težine od 28 kg do manje od 35 kg koji imaju rezistenciju na nukleozidne inhibitore reverzne transkriptaze (NRTI) ili toksičnost koja onemogućuje primjenu lijekova prve linije liječenja.
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: asthenia
Croatian: (uključujući akutni intersticijski nefritis)2, nefrogeni diabetes insipidus
English: Viread 163 mg film-coated tablets are supplied in bottles containing 30 tablets.
Croatian: Viread 163 mg filmom obložene tablete isporučuju se u bočicama koje sadrže 30 tableta.
English: by week 240.
Croatian: Do 144.
English: Viread 163 mg film-coated tablets are indicated for the treatment of chronic hepatitis B in paediatric patients aged 6 to < 12 years who weigh from 22 kg to less than 28 kg, with:
Croatian: Viread 163 mg filmom obložene tablete indicirane su za liječenje kroničnog hepatitisa B u pedijatrijskih bolesnika u dobi od 6 do < 12 godina i tjelesne težine od 22 kg do manje od 28 kg s:
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 ≥ 105 copies/ml, elevated serum ALT
Croatian: Kronični hepatitis B: U ispitivanju GS-US-174-0115, 106 HBeAg-negativnih i HBeAg-pozitivnih bolesnika u dobi od 12 do < 18 godina s kroničnom HBV-infekcijom [HBV DNK ≥ 105 kopija/ml, povišeni ALT (≥ 2 x ULN) u serumu ili povišene razine ALT-a u serumu u prethodna 24 mjeseca] bilo je liječeno tenofovirdizoproksilom od 245 mg (n = 52) ili je primalo placebo (n = 54) tijekom
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).
Croatian: Procjene genotipa provedene u svih bolesnika s vrijednostima HBV DNK > 400 kopija/ml u 48. (n = 16), 96. (n = 5), 144.
English: (GS-US-174-0108) in which adult patients received treatment with tenofovir disoproxil (n = 45) or emtricitabine plus tenofovir disoproxil (n = 45) or entecavir (n = 22) for 48 weeks.
Croatian: (n = 45) ili emtricitabinom u kombinaciji s tenofovirdizoproksilom (n = 45) ili entekavirom (n = 22) tijekom 48 tjedana.
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.
Croatian: Podaci koji se odnose na HBV: HBV antivirusna aktivnost in vitro: In vitro antivirusna aktivnost tenofovira protiv virusa HBV
English: Viread is also available as 245 mg film-coated tablets for the treatment of HIV-1 infection and chronic hepatitis B in adults and adolescents aged 12 to < 18 years who weigh ≥ 35 kg.
Croatian: Viread je također dostupan u obliku 245 mg filmom obloženih tableta za liječenje odraslih i adolescenata u dobi od 12 do < 18 godina i tjelesne težine ≥ 35 kg s infekcijom virusom HIV-1 i kroničnim hepatitisom B.
English: Tenofovir disoproxil 245 mg n = 250c
Croatian: Tenofovirdizoproksil 245 mg n = 250c
English: The proportion of subjects with ALT normalization at week 192 in the TDF-TDF group was 75.8% (25/33) among those who were HBeAg positive at baseline and 100.0% (2 of 2 subjects) among those who were HBeAg negative at baseline.
Croatian: 192. tjednu bio je 75,8% (25/33) kod onih koji su na početku bili HBeAg pozitivni, te 100,0% (2 od 2 bolesnika) kod onih koji su na početku bili HBeAg negativni.
English: Viread granules should be mixed with soft food which does not require chewing (for example, yoghurt, applesauce or baby food).
Croatian: Viread granule treba promiješati s mekanom hranom koju nije potrebno žvakati (na primjer,
English: g 48 weeks of double-blind tenofovir disoproxil followed by 144 weeks open-label.
Croatian: g 48 tjedana dvostruko slijepog tenofovirdizoproksila nakon čega je slijedilo 144 tjedna otvorenog liječenja.
English: Steady-state pharmacokinetics of tenofovir were evaluated in 8 HIV-1 infected adolescent patients (aged 12 to < 18 years) with body weight ≥ 35 kg and in 23 HIV-1 infected children aged 2 to < 12 years (see Table 10 below).
Croatian: Farmakokinetika tenofovira u stanju dinamičke ravnoteže procijenjena je u 8 adolescentnih bolesnika s infekcijom virusom HIV-1 (u dobi od 12 do < 18 godina) s tjelesnom težinom ≥ 35 kg i 23 djece s infekcijom virusom HIV-1 u dobi od 2 do < 12 godina (vidjeti tablicu 10 niže).
English: Tenofovir disoproxil 245 mg n = 176c
Croatian: Tenofovirdizoproksil 245 mg n = 176c
English: Tenofovir disoproxiltenofovir disoproxil
Croatian: Tenofovird izoproksiltenofovirdi zoproksil
English: • children and adolescents aged 2 to less than 18 years who have already been treated with other HIV medicines which are no longer fully effective due to development of resistance, or have caused side effects.
Croatian: • odraslih • djece i adolescenata u dobi od 2 do manje od 18 godina koji su već bili liječeni drugim lijekovima protiv HIV-a koji više nisu potpuno djelotvorni zbog razvoja rezistencije ili su prouzročili nuspojave.
English: after the first 4 weeks of treatment, the rate of annual decline post baseline of renal function reported in tenofovir disoproxil treated patients was -1.41 ml/min per year (using Cockcroft-Gault equation) and -0.74 ml/min/1.73 m2 per year (using MDRD equation).
Croatian: Nakon početnog smanjenja za približno -4,9 ml/min (prema Cockcroft-Gaultovoj jednadžbi) ili -3,9 ml/min/1,73 m2 (prema MDRD jednadžbi [engl. modification of diet in renal disease]) nakon prva 4 tjedna liječenja, brzina godišnjeg smanjenja funkcije bubrega u odnosu na početnu vrijednost zabilježena u bolesnika liječenih tenofovirdizoproksilom iznosila je -1,41 ml/min godišnje (prema Cockcroft-Gaultovoj jednadžbi) i -0,74 ml/min/1,73 m2 godišnje (prema MDRD jednadžbi).
English: Serology (%) HBeAg loss/ seroconversion n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a
Croatian: N/ P N/P N/P N/P N/P N/P N/ P N/P N/P N/P N/P N/P
English: Moderate renal impairment (creatinine clearance 30-49 ml/min) For patients unable to take the granule formulation of tenofovir disoproxil, prolonged dose intervals using the 245 mg film-coated tablets may be used.
Croatian: Za bolesnike koji ne mogu uzimati tenofovirdizoproksil u obliku granula mogu se primjenjivati produženi intervali između doza 245 mg filmom obloženih tableta.
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”.
Croatian: Bijela filmom obložena trokutasta tableta, promjera 8,5 mm, s utisnutom oznakom „GSI” na jednoj strani te „150” na drugoj strani.
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.
Croatian: Viread 163 mg filmom obložene tablete indicirane su u kombinaciji s drugim antiretrovirusnim lijekovima za liječenje pedijatrijskih bolesnika s infekcijom virusom HIV-1 u dobi od 6 do < 12 godina i tjelesne težine 22 kg do manje od 28 kg koji imaju rezistenciju na nukleozidne inhibitore reverzne transkriptaze (NRTI) ili toksičnost koja onemogućuje primjenu lijekova prve linije liječenja.
English: Each Viread tablet contains 204 mg of tenofovir disoproxil (as fumarate).
Croatian: Jedna tableta Vireada sadrži 204 mg tenofovirdizoproksila (u obliku tenofovirdizoproksilfumarata).
English: Please refer to the Summaries of Product Characteristics for Viread 123 mg and 163 mg film-coated tablets for the treatment of HIV-1 infection and chronic hepatitis B in paediatric patients aged 6 to < 12 years weighing 17 kg to < 22 kg and 22 kg to < 28 kg, respectively.
Croatian: Molimo pročitajte Sažetke opisa svojstava lijeka za Viread 123 mg odnosno 163 mg filmom obložene tablete za liječenje pedijatrijskih bolesnika s infekcijom virusom HIV-1 i kroničnim hepatitisom B, u dobi od 6 do < 12 godina i tjelesne težine od 17 kg do < 22 kg odnosno 22 kg do < 28 kg.
English: • HBV infected children aged 6 to less than 12 years who weigh from 28 kg to less than 35 kg
Croatian: • djecu zaraženu virusom HBV u dobi od 6 do manje od 12 godina, čija je tjelesna težina od 28 kg do manje od 35 kg
English: If the patient vomits within 1 hour of taking Viread, another tablet should be taken.
Croatian: U slučaju da bolesnik povraća a prošlo je manje od 1 sata od uzimanja Vireada, treba uzeti drugu tabletu.
English: NAME OF THE MEDICINAL PRODUCT Viread 245 mg film-coated tablets
Croatian: Viread 245 mg filmom obložene tablete
English: Please refer to the Summaries of Product Characteristics for Viread 163 mg and 204 mg film-coated tablets for the treatment of HIV-1 infection and chronic hepatitis B in paediatric patients aged 6 to < 12 years weighing 22 kg to < 28 kg and 28 kg to < 35 kg, respectively.
Croatian: Molimo pročitajte sažetke opisa svojstava lijeka za Viread 163 mg odnosno 204 mg filmom obložene tablete za liječenje pedijatrijskih bolesnika s infekcijom virusom HIV-1 i kroničnim hepatitisom B, u dobi od 6 do < 12 godina i tjelesne težine od 22 kg do < 28 kg odnosno 28 kg do < 35 kg.
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.
Croatian: Viread 123 mg filmom obložene tablete indicirane su u kombinaciji s drugim antiretrovirusnim lijekovima za liječenje pedijatrijskih bolesnika s infekcijom virusom HIV-1 u dobi od 6 do < 12 godina i tjelesne težine od 17 kg do manje od 22 kg koji imaju rezistenciju na nukleozidne inhibitore reverzne transkriptaze (NRTI) ili toksičnost koja onemogućuje primjenu lijekova prve linije liječenja.
English: • HIV-1 infected children and adolescents aged 2 to less than 18 years who have already been treated with other HIV medicines which are no longer fully effective due to development of resistance, or have caused side effects
Croatian: • djecu i adolescente zaražene virusom HIV-1 koji su u dobi od 2 do manje od 18 godina i već su bili liječeni drugim lijekovima protiv HIV-a koji više nisu potpuno djelotvorni zbog razvoja rezistencije (otpornosti na lijek) ili su prouzročili nuspojave
English: Viread 123 mg film-coated tablets are supplied in bottles containing 30 tablets.
Croatian: Viread 123 mg filmom obložene tablete isporučuju se u bocama koje sadrže 30 tableta.
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).
Croatian: Iskustva u bolesnika s HBV-om rezistentnim na lamivudin u 240 tjedana (ispitivanje GS-US-174-0121) Djelotvornost i sigurnost 245 mg tenofovirdizoproksila procijenjene su u randomiziranom, dvostruko slijepom ispitivanju GS-US-174-0121 u HBeAg-pozitivnih bolesnika i HBeAg-negativnih bolesnika
English: Viread 204 mg film-coated tablets are supplied in bottles containing 30 tablets.
Croatian: 204 mg filmom obložene tablete isporučuju se u bočicama koje sadrže 30 tableta.
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.
Croatian: U 74% (26/35) bolesnika u skupini liječenoj tenofovirdizoproksilom ALT se normalizirao u 72. tjednu u usporedbi s
English: A single 245 mg dose of tenofovir disoproxil was administered to non-HIV, non-HBV infected adult patients with varying degrees of hepatic impairment defined according to Child-Pugh-Turcotte (CPT) classification.
Croatian: HIV-om, bez infekcije HBV-om, koji su imali različiti stupanj oštećenja funkcije jetre definiran prema klasifikaciji Child-Pugh-Turcotte (CPT).
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.
Croatian: Sigurnost tenofovirdizoproksila prilikom istovremene primjene s sofosbuvirom/velpatasvirom/voks ilaprevirom i farmakokinetičkim pojačivačem (npr. ritonavirom ili kobicistatom) nije ustanovljena.
English: Mild renal impairment (creatinine clearance 50-80 ml/min) Limited data from clinical studies support once daily dosing of 245 mg tenofovir disoproxil, equivalent to 7.5 scoops of granules, in patients with mild renal impairment.
Croatian: Ograničeni podaci iz kliničkih ispitivanja govore u prilog doziranju tenofovirdizoproksila u dozi od 245 mg, što odgovara 7,5 mjernih žličica granula, jedanput na dan u bolesnika s blagim oštećenjem funkcije bubrega.
English: • HBV infected children aged 6 to less than 12 years who weigh from 17 kg to less than 22 kg
Croatian: • djecu zaraženu virusom HBV u dobi od 6 do manje od 12 godina, čija je tjelesna težina od 17 kg do manje od 22 kg
English: Suomi/Finland Gilead Sciences Sweden AB Puh/Tel: + 46 (0) 8 5057 1849
Croatian: Gilead Sciences Sweden AB Puh/Tel: + 46 (0) 8 5057 1849
English: NAME OF THE MEDICINAL PRODUCT Viread 245 mg film-coated tablets Tenofovir disoproxil
Croatian: Uputa o lijeku: Informacija za bolesnika Viread 245 mg filmom obložene tablete tenofovirdizoproksil
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.
Croatian: (n = 1), 192. (n = 2), 240. (n = 1), 288. (n = 1) i 384. tjednu (n = 2) na monoterapiji tenofovirdizoproksilom pokazale su da se nisu razvile mutacije povezane s rezistencijom na tenofovirdizoproksil.
English: Please refer to the Summaries of Product Characteristics for Viread 123 mg and 204 mg film-coated tablets for the treatment of HIV-1 infect ion and chronic hepatitis B in paediatric patients aged 6 to < 12 years weighing 17 kg to < 22 kg and 28 kg to < 35 kg, respectively.
Croatian: Molimo pročitajte Sažetke opisa svojstava lijeka za Viread 123 mg odnosno 204 mg filmom obložene tablete za liječenje pedijatrijskih bolesnika s infekcijom virusom HIV-1 i kroničnim hepatitisom B, u dobi od 6 do < 12 godina i tjelesne težine od 17 kg do < 22 kg odnosno 28 kg do < 35 kg.
English: Lumbar spine BMD at least 4% decreaseb
Croatian: Smanjenjeb BMD-a lumbalne kralježnice za najmanje 4%
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 and in 23 HIV-1 infected children aged 2 to < 12 years (see Table 11 below).
Croatian: HIV-1: Farmakokinetika tenofovira u stanju dinamičke ravnoteže procijenjena je u 8 adolescentnih bolesnika zaraženih virusom HIV-1 (u dobi od 12 do < 18 godina) s tjelesnom težinom ≥ 35 kg i 23 djece zaražene virusom HIV-1 u dobi od 2 do < 12 godina (vidjeti tablicu 11 niže).
English: NAME OF THE MEDICINAL PRODUCT Viread 204 mg film-coated tablets Tenofovir disoproxil
Croatian: Uputa o lijeku: Informacija za bolesnika Viread 204 mg filmom obložene tablete tenofovirdizoproksil
English: A granules formulation of tenofovir disoproxil is available for patients having difficulty in swallowing film-coated tablets.
Croatian: Za bolesnike koji otežano gutaju filmom obložene tablete, tenofovirdizoproksil dostupan je u obliku granula.
English: • HIV-1 infected adolescents aged 12 to less than 18 years who weigh at least 35 kg and who have already been treated with other HIV medicines which are no longer fully effective due to development of resistance, or have caused side effects
Croatian: • adolescente zaražene virusom HIV-1 koji su u dobi od 12 do manje od 18 godina i imaju tjelesnu težinu od najmanje 35 kg i već su bili liječeni drugim lijekovima protiv HIV-a koji više nisu potpuno djelotvorni zbog razvoja rezistencije (otpornosti na lijek) ili su prouzročili nuspojave
English: NAME OF THE MEDICINAL PRODUCT Viread 204 mg film-coated tablets
Croatian: Viread 204 mg filmom obložene tablete
English: • Adults and adolescents aged 12 to less than 18 years and weighing at least 35 kg: 245 mg, equivalent to 7.5 scoops of granules, once a day.
Croatian: 35 kg: 245 mg, što odgovara 7,5 mjernih žličica granula, jedanput na dan.
English: Each Viread tablet contains 163 mg of tenofovir disoproxil (as fumarate).
Croatian: Jedna tableta Vireada sadrži 163 mg tenofovirdizoproksila (u obliku tenofovirdizoproksilfumarata).
English: • HBV infected children aged 6 to less than 12 years who weigh from 22 kg to less than 28 kg
Croatian: • djecu zaraženu virusom HBV u dobi od 6 do manje od 12 godina, čija je tjelesna težina od 22 kg do manje od 28 kg
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 and in 23 HIV-1 infected children aged 2 to < 12 years (see Table 10 below).
Croatian: HIV-1: Farmakokinetika tenofovira u stanju dinamičke ravnoteže procijenjena je u 8 adolescentnih bolesnika s infekcijom virusom HIV-1 (u dobi od 12 do < 18 godina) s tjelesnom težinom ≥ 35 kg i 23 djece s infekcijom virusom HIV-1 u dobi od 2 do < 12 godina (vidjeti tablicu 10 niže).
English: NAME OF THE MEDICINAL PRODUCT Viread 123 mg film-coated tablets
Croatian: Viread 123 mg filmom obložene tablete
English: NAME OF THE MEDICINAL PRODUCT Viread 163 mg film-coated tablets Tenofovir disoproxil
Croatian: Uputa o lijeku: Informacije za bolesnika Viread 163 mg filmom obložene tablete tenofovirdizoproksil
English: Each Viread tablet contains 123 mg of tenofovir disoproxil (as fumarate).
Croatian: Jedna tableta Vireada sadrži 123 mg tenofovirdizoproksila (u obliku tenofovirdizoproksilfumarata).
English: l 48 weeks of double-blind tenofovir disoproxil followed by 240 weeks open-label.
Croatian: l 48 tjedana dvostruko slijepog ispitivanja tenofovirdizoproksila nakon čega slijedi 240 tjedana otvorenog ispitivanja.
English: If the patient vomits within 1 hour of taking Viread, another dose should be taken.
Croatian: U slučaju da bolesnik povraća a prošlo je manje od 1 sata od uzimanja Vireada, treba uzeti drugu dozu.
English: m 48 weeks of double-blind adefovir dipivoxil followed by 240 weeks open-label tenofovir disoproxil.
Croatian: m 48 tjedana dvostruko slijepog ispitivanja adefovirdipivoksila nakon čega slijedi 240 tjedana otvorenog ispitivanja tenofovirdizoproksila.
English: AUC: ↑ 45% Cmax: ↑ 60%
Croatian: Cmax: ↑ 64% Cmin: ↑ 59%
English: • Children aged 6 to less than 12 years who weigh from 28 kg to less than 35 kg:
Croatian: • Djeca u dobi od 6 do manje od 12 godina čija je tjelesna težina od 28 kg do manje od
English: NAME OF THE MEDICINAL PRODUCT Viread 123 mg film-coated tablets Tenofovir disoproxil
Croatian: Uputa o lijeku: Informacije za bolesnika Viread 123 mg filmom obložene tablete tenofovirdizoproksil
English: least 4% decrease b
Croatian: 6%b
English: • Check your child's age and weight to see if Viread 204 mg tablets are suitable, see Children and adolescents.
Croatian: • Provjerite odgovaraju li Viread 204 mg tablete
English: • Children aged 6 to less than 12 years who weigh from 17 kg to less than 22 kg:
Croatian: • Djeca u dobi od 6 do manje od 12 godina čija je tjelesna težina od 22 kg do manje od
English: NAME OF THE MEDICINAL PRODUCT Viread 163 mg film-coated tablets
Croatian: Viread 163 mg filmom obložene tablete
English: Lumbar spine BMD mean % increase
Croatian: Srednja vrijednost povećanja BMD-a lumbalne kralježnice u %
English: Adefovir dipivoxil 10 mg roll over to tenofovir disoproxil 245 mg n = 125d
Croatian: Adefovirdipivoksil 10 mg prebacivanje na tenofovirdizoproksil 245 mg n = 125d
English: - If your child gets any side effects, talk to your child's doctor or pharmacist.
Croatian: - Ako primijetite bilo koju nuspojavu kod Vašeg djeteta, potrebno je obavijestiti liječnika Vašeg djeteta ili ljekarnika.
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).
Croatian: n Prikazani brojevi su kumulativni postotci koji se temelje na Kaplan-Meierovoj analizi isključujući podatke prikupljene nakon dodavanja emtricitabina otvorenom liječenju tenofovirdizoproksilom (KM-tenofovirdizoproksil).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/200/006 30 film-coated tablets EU/1/01/200/007 90 (3 bottles of 30) film-coated tablets
Croatian: EU/1/01/200/006 30 filmom obloženih tableta EU/1/01/200/007 90 (3 boce s 30) filmom obloženih tableta
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.
Croatian: Klinička ispitivanja HIV-1: Procjena nuspojava u kliničkim ispitivanjima HIV-1 temelji se na iskustvu iz dva ispitivanja na 653 prethodno liječena odrasla bolesnika, koji su 24 tjedna dobivali tenofovirdizoproksil (n = 443) ili placebo (n = 210) u kombinaciji s drugim antiretrovirusnim lijekovima te također iz dvostruko slijepog komparativnog kontroliranog ispitivanja u kojem je 600
English: At 144 weeks of treatment, the average change from baseline remained similar in both treatment groups (-3.07 and -3.03 log10 copies/ml; +263 and +283 cells/mm3 in the tenofovir disoproxil 245 mgand stavudine groups, respectively).
Croatian: U 144. tjednu liječenja, prosječna je promjena od početne vrijednosti ostala slična u obje terapijske skupine (-3,07 i -3,03 log10 kopija/ml;
English: Hepatitis B clinical studies: Assessment of adverse reactions from HBV clinical study data is primarily based on experience in two double-blind comparative controlled studies in which 641 adult patients with chronic hepatitis B and compensated liver disease received treatment with tenofovir disoproxil 245 mg daily (n = 426) or adefovir dipivoxil 10 mg daily (n = 215) for 48 weeks.
Croatian: 641 odrasli bolesnik s kroničnim hepatitisom B i kompenziranom bolešću jetre liječen s 245 mg tenofovirdizoproksila dnevno (n = 426) ili 10 mg adefovirdipivoksila dnevno (n = 215) tijekom 48