FrancophonIA/ELRC3.0 huggingface dataset:
English: [MDRD] equation) 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: (prema Cockcroft-Gaultovoj jednadžbi) ili -3,9 ml/min/1,73 m2 (prema MDRD [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: Tel: + 420 910 871 986
Croatian: Gilead Sciences s.r.o. Tel: + 420 910 871 986
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).
Croatian: U bolesnika inficiranih HBV-om javili su se klinički i laboratorijski dokazi egzacerbacija hepatitisa nakon prekida terapije hepatitisa B (vidjeti dio 4.4).
English: Viread 123 mg film-coated tablets are 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: Viread 123 mg filmom obložene tablete bijele su, trokutaste, filmom obložene tablete, promjera 8,5 mm, s utisnutom oznakom „GSI” na jednoj strani te „150” na drugoj strani.
English: Viread 245 mg film-coated tablets Tenofovir disoproxil
Croatian: Viread 245 mg filmom obložene tablete tenofovirdizoproksil
English: One gram of Viread granules contains 33 mg of tenofovir disoproxil (as fumarate).
Croatian: Jedan gram Viread granula sadrži 33 mg tenofovirdizoproksila (u obliku tenofovirdizoproksilfumarata).
English: The recommended dose for the treatment of HIV-1 infection and chronic hepatitis B in paediatric patients aged 6 to < 12 years weighing 28 kg to < 35 kg who are able to swallow film-coated tablets is one 204 mg tablet once daily taken orally with food.
Croatian: Preporučena doza za liječenje pedijatrijskih bolesnika s infekcijom virusom HIV-1 i kroničnim hepatitisom B u dobi od 6 do < 12 godina i tjelesne težine od 28 kg do < 35 kg koji su u stanju progutati filmom obložene tablete je jedna tableta od 204 mg, jedanput na dan, primjenjena peroralno s hranom.
English: Viread 204 mg tablets are not suitable for the following groups:
Croatian: Viread 204 mg tablete nisu pogodne za sljedeće skupine:
English: Viread 123 mg tablets are not suitable for the following groups:
Croatian: Viread 123 mg tablete nisu pogodne za sljedeće skupine:
English: PHARMACEUTICAL FORM AND CONTENTS 30 film-coated tablets.
Croatian: 30 filmom obloženih tableta.
English: White, capsule-shaped, film-coated tablets, of dimensions 15.4 mm x 7.3 mm, debossed on one side with “GSI” and on the other side with “250”.
Croatian: Bijela filmom obložena tableta u obliku kapsule, dimenzija 15,4 mm × 7,3 mm, s utisnutom oznakom „GSI” na jednoj strani te „250” na drugoj strani.
English: * p-value versus adefovir dipivoxil < 0.05. a Complete response defined as HBV DNA levels < 400 copies/ml and Knodell necroinflammatory score improvement of at least 2 points without worsening in Knodell fibrosis.
Croatian: a Potpuni odgovor definiran kao razine HBV DNK < 400 kopija/ml i poboljšanje rezultata na Knodellovoj ljestvici nekroinflamatorne aktivnosti za najmanje dva boda bez pogoršanja na Knodellovoj ljestvici fibroze.
English: NA −0.16
Croatian: n = 176
English: Viread 123 mg tablets are only suitable for:
Croatian: Viread 123 mg tablete pogodne su samo za:
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.
Croatian: Izloženost tenofoviru postignuta u ovih pedijatrijskih bolesnika koji su primali peroralno dnevnu dozu tenofovirdizoproksila od 245 mg ili 6,5 mg tenofovirdizoproksila po kilogramu tjelesne težine do maksimalne doze od 245 mg bila je slična izloženosti postignutoj u odraslih koji su primali dozu tenofovirdizoproksila od 245 mg jedanput na dan.
English: In children whose mothers took medicines like Viread (NRTIs) during pregnancy, the benefit from the protection against the virus outweighed the risk of side effects.
Croatian: U djece čije su majke tijekom trudnoće uzimale lijekove kao što je Viread (NRTI)
English: Whole body BMD at least 6% decrease b
Croatian: Smanjenjeb BMDa cijelog tijela za najmanje 6%b
English: The recommended dose 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 who are able to swallow film-coated tablets is one 123 mg tablet once daily taken orally with food.
Croatian: Preporučena doza 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 koji su u stanju progutati filmom obložene tablete je jedna tableta od 123 mg, jedanput na dan, primjenjena peroralno s hranom.
English: Viread 204 mg tablets are only suitable for:
Croatian: Viread 204 mg tablete pogodne su samo za:
English: • Tell your doctor immediately about new or unusual symptoms after you stop treatment, particularly symptoms you associate with hepatitis B infection.
Croatian: • Liječnika odmah obavijestite o novim ili neobičnim simptomima nakon što se prestanete liječiti,
English: Mean change from baseline in CPT score Mean change from baseline in MELD score a p-value comparing the combined tenofovir-containing arms versus the entecavir arm = 0.622, b p-value comparing the combined tenofovir-containing arms versus the entecavir arm = 1.000.
Croatian: MELD rezultata od početne vrijednosti a p-vrijednost za usporedbu skupina koje primaju kombinirane lijekove koji sadrže tenofovir nasuprot skupine na entekaviru = 0,622. b p-vrijednost za usporedbu skupina koje primaju kombinirane lijekove koji sadrže tenofovir nasuprot skupine na entekaviru = 1,000.
English: • For HIV, Viread 204 mg tablets are only suitable for children 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: • Za HIV, Viread 204 mg tablete pogodne su samo za djecu koja su već bila liječena drugim lijekovima protiv HIV-a koji više nisu potpuno djelotvorni zbog razvoja rezistencije ili su prouzročili nuspojave.
English: Table 4: Efficacy parameters in compensated HBeAg negative and HBeAg positive patients at week 48
Croatian: Tablica 4: Parametri djelotvornosti u kompenziranih HbeAg negativnih i HbeAg pozitivnih bolesnika u 48. tjednu
English: The recommended dose 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 who are able to swallow film-coated tablets is one 163 mg tablet once daily taken orally with food.
Croatian: Preporučena doza za liječenje pedijatrijskih bolesnika s infekcijom virusom HIV-1 i s kroničnim hepatitisom B u dobi od 6 do < 12 godina i tjelesne težine od 22 kg do < 28 kg koji su u stanju progutati filmom obložene tablete je jedna tableta od 163 mg, jedanput na dan, primjenjena peroralno s hranom.
English: The decision to treat paediatric patients should be based on careful consideration of individual patient needs and with reference to current paediatric treatment guidelines including the value of baseline histological information.
Croatian: Odluka o liječenju pedijatrijskih bolesnika treba se temeljiti na pažljivom razmatranju potreba pojedinog bolesnika te se trebaju uzeti u obzir trenutne smjernice za liječenje pedijatrijskih bolesnika, uključujući početnu vrijednost histoloških značajki.
English: • For HIV, Viread 163 mg tablets are only suitable for children 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: • Za HIV, Viread 163 mg tablete pogodne su samo za djecu koja su već bila liječena drugim lijekovima protiv HIV-a koji više nisu potpuno djelotvorni zbog razvoja rezistencije ili su prouzročili nuspojave.
English: Flares on treatment: Spontaneous exacerbations in chronic hepatitis B are relatively common and are characterised by transient increases in serum ALT. After initiating antiviral therapy, serum ALT may increase in some patients (see section 4.8).
Croatian: Reaktivacija bolesti (engl. flares) tijekom liječenja: Spontane egzacerbacije kroničnog hepatitisa B relativno su česte i karakterizira ih prolazni porast razine serumskog ALT-a.
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:
Croatian: Viread 204 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 28 kg do manje od 35 kg s:
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).
Croatian: g Prikazani brojevi su kumulativni postoci koji se temelje na Kaplan-Meierovoj analizi uključujući podatke prikupljene nakon dodavanja emtricitabina otvorenom ispitivanju tenofovirdizoproksila (KM-ITT).
English: By intent to treat analysis (missing data and switch in antiretroviral therapy (ART) considered as failure), the proportion of patients with HIV-1 RNA below 400 copies/ml and 50 copies/ml at 48 weeks of treatment was 80% and 76% respectively in the tenofovir disoproxil 245 mgarm, compared to 84% and 80% in the stavudine arm. At 144 weeks, the proportion of patients with HIV-1 RNA below 400 copies/ml and 50 copies/ml was 71% and 68% respectively in the tenofovir disoproxil 245 mgarm, compared to 64% and 63% in the stavudine arm.
Croatian: Analizom bolesnika s namjerom liječenja (podaci koji su nedostajali i promjena antiretrovirusne terapije (ART) smatrale su se neuspjehom) udio bolesnika s HIV-1 RNK manjom od 400 kopija/ml odnosno 50 kopija/ml u 48. tjednu liječenja bio je 80% odnosno 76% u skupini koja je primala 245 mg tenofovirdizoproksila u usporedbi s 84% odnosno 80% u skupini koja je primala stavudin.
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).
Croatian: 331/489 bolesnika koji su ostali u ispitivanjima GS-US-174-0102 i GS-US-174-0103 u 240. tjednu (vidjeti tablicu 6 niže).
English: Viread 245 mg film-coated tablets contain lactose monohydrate.
Croatian: Viread 245 mg filmom obložene tablete sadrže laktozu hidrat.
English: Table 9: Bone Mineral Density Evaluation at Baseline and Week 48
Croatian: Tablica 9: Ocjena mineralne gustoće kostiju na početku ispitivanja i u 48. tjednu
English: There are uncertainties associated with the long term effects of bone and renal toxicity.
Croatian: Učinci na bubrege i kosti u pedijatrijske populacije Nije sigurno kakvi su dugotrajni učinci koštane i bubrežne toksičnosti.
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”.
Croatian: Bijela, okrugla filmom obložena tableta, promjera 10,7 mm, s utisnutom oznakom „GSI” na jednoj strani te „200” na drugoj strani.
English: Viread should not be given to children with existing kidney problems.
Croatian: Viread se ne smije davati djeci sa bubrežnim tegobama.
English: • For HIV, Viread 123 mg tablets are only suitable for children 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: • Za HIV, Viread 123 mg tablete pogodne su samo za djecu koja su već bila liječena drugim lijekovima protiv HIV-a koji više nisu potpuno djelotvorni zbog razvoja rezistencije ili su prouzročili nuspojave.
English: Viread 204 mg film-coated tablets Tenofovir disoproxil
Croatian: Viread 204 mg filmom obložene tablete tenofovirdizoproksil
English: Tablet core
Croatian: Nadzor funkcije bubrega
English: Viread 204 mg film-coated tablets are white, capsule-shaped, film-coated tablets, of dimensions 15.4 mm x 7.3 mm, debossed on one side with “GSI” and on the other side with “250”.
Croatian: Viread 204 mg filmom obložene tablete bijele su filmom obložene tablete u obliku kapsula dimenzija 15,4 mm x 7,3 mm, s utisnutom oznakom „GSI” na jednoj strani te „250” na drugoj strani.
English: Viread 163 mg film-coated tablets Tenofovir disoproxil
Croatian: Viread 163 mg filmom obložene tablete tenofovirdizoproksil
English: Lumbar spine BMD at least 6% decrease b
Croatian: Smanjenjeb BMDa lumbalne kralježnice za najmanje 6%b
English: Viread 123 mg tablets are a treatment for HIV (Human Immunodeficiency Virus) infection.
Croatian: Viread 123 mg tablete su lijek za liječenje infekcije virusom humane imunodeficijencije (HIV).
English: • flatulence
Croatian: • odraslih
English: Table 7: Histological response (%) in compensated HBeAg negative and HBeAg positive subjects at week 240 compared to baseline
Croatian: Tablica 7: Histološki odgovor (%) u kompenziranih HBeAg-negativnih i HBeAg-pozitivnih ispitanika u 240. tjednu u usporedbi s početnim stanjem Ispitivanje 174-0102 (HBeAg-negativni)
English: Table 2: Interactions between tenofovir disoproxil and other medicinal products Medicinal product by therapeutic areas (dose in mg)
Croatian: Tablica 2: Interakcije između tenofovirdizoproksila i drugih lijekova
English: Co-administration of tenofovir disoproxil and didanosine is not recommended (see section 4.4 and Table 2).
Croatian: Ne preporučuje se istovremena primjena tenofovirdizoproksila i didanozina (vidjeti dio 4.4 i Tablicu 2).
English: Viread 163 mg film-coated tablets contain lactose monohydrate.
Croatian: Viread 163 mg filmom obložene tablete sadrže laktozu hidrat.
English: Exacerbations of hepatitis after discontinuation of treatment In HIV infected patients co-infected with HBV, clinical and laboratory evidence of hepatitis have occurred after discontinuation of tenofovir disoproxil (see section 4.4).
Croatian: U bolesnika s HIV-om koji su istovremeno imali infekciju HBV-om, nakon prekida liječenja tenofovirdizoproksilom hepatitis se mogao klinički i laboratorijski dokazati (vidjeti dio 4.4).
English: Viread 204 mg tablets are a treatment for HIV (Human Immunodeficiency Virus) infection.
Croatian: Viread 204 mg tablete su lijek za liječenje infekcije virusom humane imunodeficijencije (HIV).
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).
Croatian: Ako se prekine liječenje sa Viread 163 mg filmom obloženim tabletama u bolesnika s istovremenom infekcijom virusom HIV-a i hepatitisa B (HBV), te je bolesnike potrebno pomno nadzirati zbog praćenja pojave znakova egzacerbacije hepatitisa (vidjeti dio 4.4).
English: In a paediatric study (GS-US-174-0115), 52 patients (including 6 patients with lamivudine resistance mutations at baseline) initially received blinded tenofovir disoproxil for up to 72 weeks and then 51/52 patients switched to open-label tenofovir disoproxil (TDF-TDF group).
Croatian: U pedijatrijskom ispitivanju (GS-US-174-0115), 52 bolesnika (uključujući 6 bolesnika s mutacijama za rezistenciju na lamivudin na početku) početno je slijepo primalo tenofovirdizoproksil do 72 tjedna,
English: Viread 204 mg film-coated tablets contain lactose monohydrate.
Croatian: Viread 204 mg filmom obložene tablete sadrže laktozu hidrat.
English: If Viread 204 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).
Croatian: Ako se prekine liječenje sa Viread 204 mg filmom obloženim tabletama u bolesnika s istovremenom infekcijom virusom HIV-a i hepatitisa B (HBV), te je bolesnike potrebno pomno nadzirati zbog praćenja pojave znakova egzacerbacije hepatitisa (vidjeti dio 4.4).
English: (800 mg q.d.)
Croatian: < 2 mg/dl.
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 7 below).
Croatian: 331/489 bolesnika koji su ostali u ispitivanjima GS-US-174-0102 i GS-US-174-0103 u 240. tjednu (vidjeti tablicu 7 niže).
English: Method of administration Viread tablets should be taken once daily, orally with food.
Croatian: Tablete Viread potrebno je uzimati peroralno s hranom, jedanput na dan.
English: PHARMACEUTICAL FORM Granules.
Croatian: Pneumocystis jirovecii.
English: Pharmacokinetic parameters of tenofovir were determined following administration of a single dose of tenofovir disoproxil 245 mg to 40 non-HIV, non-HBV infected adult patients with varying degrees of renal impairment defined according to baseline adult creatinine clearance (CrCl) (normal renal function when CrCl > 80 ml/min; mild with CrCl = 50-79 ml/min; moderate with CrCl = 30-49 ml/min and severe with CrCl = 10-29 ml/min).
Croatian: Farmakokinetički parametri tenofovira određeni su nakon primjene jednokratne doze tenofovirdizoproksila od 245 mg u 40 odraslih bolesnika koji nisu bili zaraženi virusom HIV-a a ni virusom HBV-a, s različitim stupnjevima oštećenja funkcije bubrega, definiranima prema početnoj vrijednosti klirensa kreatinina (CrCl) u odraslih (normalna funkcija bubrega kada je CrCl > 80 ml/min;
English: Viread 123 mg film-coated tablets are indicated for the treatment of chronic hepatitis B in paediatric patients aged 6 to < 12 years who weigh from 17 kg to less than 22 kg, with:
Croatian: Viread 123 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 17 kg do manje od 22 kg s:
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.
Croatian: HIV-1: Farmakokinetika tenofovira u stanju dinamičke ravnoteže procijenjena je u 8 adolescentnih bolesnika zaraženih HIVom (u dobi od 12 do < 18) s tjelesnom težinom ≥ 35 kg.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each scoop delivers one gram of granules which contains 33 mg of tenofovir disoproxil (as fumarate).
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna mjerna žličica sadrži jedan gram granula, koji sadrži 33 mg tenofovirdizoproksila (u obliku tenofovirdizoproksilfumarata).
English: 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: 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 prethodno neliječenih odraslih bolesnika 144 tjedna dobivalo tenofovirdizoproksil u dozi od 245 mg (n = 299) ili stavudin (n = 301) u kombinaciji s lamivudinom i efavirenzom.
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.
Croatian: (GS-US-174-0103, n = 176) bolesnika početno randomiziranih u skupinu dvostruko slijepog liječenja tenofovirdizoproksilom, a potom prebačenih u skupinu otvorenog liječenja tenofovirdizoproksilom procjenjivala se promjena u genotipu HBV polimeraze u odnosu na početne rezultate.
English: If Viread 123 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).
Croatian: Ako se prekine liječenje sa Viread 123 mg filmom obloženim tabletama u bolesnika s istovremenom infekcijom virusom HIV-a i hepatitisa B (HBV), te je bolesnike potrebno pomno nadzirati zbog praćenja pojave znakova egzacerbacije hepatitisa (vidjeti dio 4.4).
English: Each Viread tablet contains 245 mg of tenofovir disoproxil (as fumarate).
Croatian: Jedna tableta Vireada sadrži 245 mg tenofovirdizoproksila (u obliku tenofovirdizoproksilfumarata).
English: Viread is also available as granules for the treatment of HIV-1 infection and chronic hepatitis B in paediatric patients aged 2 to < 12 years and as reduced tablet strengths for the treatment of
Croatian: Viread je također dostupan u obliku granula za liječenje infekcije virusom HIV-1 i kroničnog hepatitisa B u pedijatrijskih bolesnika u dobi od 2 do < 12 godina i u obliku tableta smanjene jačine za liječenje pedijatrijskih bolesnika s infekcijom virusom HIV-1 i kroničnim hepatitisom B u dobi od 6 do < 12 godina (vidjeti dio 5.1).
English: Viread 123 mg film-coated tablets Tenofovir disoproxil
Croatian: Viread 123 mg filmom obložene tablete tenofovirdizoproksil
English: Lumbar spine mean (SD) BMD Z-scorea
Croatian: Srednja vrijednost (SD) BMD Z-rezultataa lumbalne kralježnice
English: Two hundred and fifteen HBeAg negative (GS-US-174-0102, n = 125) and HBeAg positive (GS-US-174-0103, n = 90) patients initially randomised to double-blind adefovir dipivoxil treatment and then switched to open-label tenofovir disoproxil treatment were evaluated for genotypic changes in HBV polymerase from baseline.
Croatian: (GS-US-174-0103, n = 90) bolesnika početno randomiziranih u skupinu dvostruko slijepog liječenja adefovirdipivoksilom, a potom prebačenih u skupinu otvorenog liječenja tenofovirdizoproksilom procjenjivala se promjena u genotipu HBV polimeraze od početnih rezultata.
English: o 48 weeks of double-blind tenofovir disoproxil followed by 336 weeks open-label.
Croatian: o 48 tjedana dvostruko slijepog ispitivanja tenofovirdizoproksila nakon čega slijedi 336 tjedana otvorenog ispitivanja.
English: In study GS-US-174-0144, 89 HBeAg-negative and -positive patients aged 2 to < 12 years with chronic hepatitis B were treated with tenofovir disoproxil 6.5 mg/kg up to a maximum dose of 245 mg (n = 60) or placebo (n = 29) once daily for 48 weeks.
Croatian: 2 do < 12 godina s kroničnim hepatitisom B liječeno je tenofovirdizoproksilom od 6,5 mg/kg do najveće doze od 245 mg (n = 60) ili placebom (n = 29) jedanput na dan tijekom 48 tjedana.
English: Viread 245 mg film-coated tablets are supplied in bottles containing 30 tablets.
Croatian: Viread 245 mg filmom obložene tablete isporučuju se u bočicama koje sadrže 30 tableta.
English: Viread 123 mg film-coated tablets contain lactose monohydrate.
Croatian: Viread 123 mg filmom obložene tablete sadrže laktozu hidrat.
English: You can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy.
Croatian: iako je tada rizik od prijenosa manji zbog učinkovite antiretrovirusne terapije.
English: LIST OF EXCIPIENTS Contains mannitol.
Croatian: Sadrži manitol.