FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: • s kompenzirano jetrno boleznijo in dokazano aktivno imunsko boleznijo, tj. aktivno replikacijo virusov in persistentno zvišano vrednostjo ALT v serumu, ali histološko dokazanim zmernim do hudim vnetjem in/ali fibrozo.
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).
Slovenian: Če se jemanje zdravila Viread 123 mg filmsko obložene tablete prekine pri bolnikih s sočasno okužbo s HIV in virusom hepatitisa B (HBV), je treba pri teh bolnikih skrbno nadzorovati znake poslabšanja hepatitisa (glejte poglavje 4.4).
English: Viread 163 mg film-coated tablets are supplied in bottles containing 30 tablets.
Slovenian: Zdravilo Viread 163 mg filmsko obložene tablete so na voljo v plastenkah po 30 tablet.
English: Use with the supplied dosing scoop.
Slovenian: Uporabite priloženo merico za odmerjanje.
English: Adefovir dipivoxil
Slovenian: Dizoproksiltenofovirat
English: Adefovir dipivoxil 10 mg n = 125
Slovenian: 10 mg dipivoksiladefovirat a n = 125
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:
Slovenian: Zdravilo Viread 163 mg filmsko obložene tablete je indicirano za zdravljenje kroničnega hepatitisa B pri pediatričnih bolnikih, starih 6 do <12 let, s telesno maso 22 kg do manj kot 28 kg:
English: Each Viread tablet contains 163 mg of tenofovir disoproxil (as fumarate).
Slovenian: Ena tableta zdravila Viread vsebuje 163 mg dizoproksiltenofovirata (v obliki fumarata).
English: Viread granules should be measured with the supplied dosing scoop.
Slovenian: Zdravilo Viread zrnca se meri s priloženo merico za odmerjanje.
English: The following side effects are uncommon (these can affect up to 1 in every 100 patients):
Slovenian: Naslednji neželeni učinki so občasni (prizadenejo lahko do 1 od 100 bolnikov):
English: Viread 204 mg film-coated tablets contain lactose monohydrate.
Slovenian: Zdravilo Viread 204 mg filmsko obložene tablete vsebuje laktozo monohidrat.
English: Each Viread tablet contains 123 mg of tenofovir disoproxil (as fumarate).
Slovenian: Ena tableta zdravila Viread vsebuje 123 mg dizoproksiltenofovirata (v obliki fumarata).
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.
Slovenian: Glejte povzetka glavnih značilnosti zdravila Viread 123 mg in 163 mg filmsko obložene tablete za zdravljenje pediatričnih bolnikov, okuženih s HIV-1 in kroničnim hepatitisom B, starih 6 do < 12 let, s telesno maso 17 kg do < 22 kg oziroma 22 kg do < 28 kg.
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).
Slovenian: Farmakokinetiko tenofovirja v stanju dinamičnega ravnovesja so ovrednotili pri 8 mladostnikih, okuženih s HIV-1 (starih 12 do < 18 let) s telesno maso ≥ 35 kg in pri 23 otrocih, okuženih s HIV-1, starih 2 do < 12 let (glejte preglednico 10 spodaj).
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.
Slovenian: Glejte povzetka glavnih značilnosti zdravila Viread 163 mg in 204 mg filmsko obložene tablete za zdravljenje pediatričnih bolnikov, okuženih s HIV-1 in kroničnim hepatitisom B, starih 6 do < 12 let, s telesno maso 22 kg do < 28 kg oziroma 28 kg do < 35 kg.
English: • Children aged 6 to less than 12 years who weigh from 17 kg to less than 22 kg:
Slovenian: • Otroci, stari 6 do manj kot 12 let, s telesno maso od 17 kg do manj kot 22 kg:
English: • HBV infected children aged 6 to less than 12 years who weigh from 28 kg to less than 35 kg
Slovenian: • otroke, okužene s HBV, stare 6 do manj kot 12 let, s telesno maso od 28 kg do manj kot 35 kg.
English: • who weigh from 28 kg to less than 35 kg
Slovenian: • otroke s telesno maso od 28 kg do manj kot 35 kg.
English: f 48 weeks of double-blind adefovir dipivoxil followed by 96 weeks open-label tenofovir disoproxil.
Slovenian: f 48-tedensko dvojno slepo zdravljenje z dipivoksiladefoviratom, ki mu sledi 96-tedensko nezaslepljeno zdravljenje z dizoproksiltenofoviratom.
English: • Use the flat edge of clean knife to make the granules even with the top of the scoop (see Figure B).
Slovenian: • Uporabite ploski rob čistega noža in zrnca poravnajte z robom merice
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 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).
Slovenian: Stopnja ledvične okvare je bila določena glede na začetno vrednost očistka kreatinina pri odraslih (CLCR) (normalna ledvična funkcija je pri CLCR > 80 ml/min; blaga ledvična okvara pri CLCR = 50-79 ml/min, zmerna pri CLCR = 30-49 ml/min in resna pri CLCR = 10-29 ml/min).
English: After week 72, virologic suppression was maintained for those receiving double-blind tenofovir disoproxil followed by open-label tenofovir disoproxil (tenofovir disoproxil-tenofovir disoproxil group): 86.5% (45/52) of subjects in the tenofovir disoproxil-tenofovir disoproxil group had HBV DNA < 400 copies/ml at week 192.
Slovenian: Po 72. tednu se je virološka supresija pri bolnikih, ki so prejemali dvojno slepo zdravljenje z dizoproksiltenofoviratom, kateremu je sledilo nezaslepljeno zdravljenje z dizoproksiltenofoviratom (skupina dizoproksiltenofovirat-dizoproksiltenofovirat), ohranila: v 192. tednu je 86,5 % (45/52) bolnikov v skupini dizoproksiltenofoviratdizoproksiltenofovirat imelo koncentracijo HBV DNA < 400 kopij/ml.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 204 mg of tenofovir disoproxil (as fumarate).
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena filmsko obložena tableta vsebuje 204 mg dizoproksiltenofovirata (v obliki dizoproksiltenofovirijevega fumarata).
English: Viread 123 mg film-coated tablets contain lactose monohydrate.
Slovenian: Zdravilo Viread 123 mg filmsko obložene tablete vsebuje laktozo monohidrat.
English: Viread 204 mg film-coated tablets are supplied in bottles containing 30 tablets.
Slovenian: Zdravilo Viread 204 mg filmsko obložene tablete so na voljo v plastenkah po 30 tablet.
English: Co-administration of tenofovir disoproxil and didanosine is not recommended (see section 4.4 and Table 2).
Slovenian: Sočasna uporaba dizoproksiltenofovirata in didanozina ni priporočena (glejte poglavje 4.4 in preglednico 2).
English: Viread granules contain mannitol
Slovenian: Zdravilo Viread zrnca vsebuje manitol.
English: AUC: ↑ 22% Cmin: ↑ 37%
Slovenian: AUC: ↔ Cmax: ↑ 47% Cmin: ↑ 47%
English: AUC: ↔ Cmax: ↑ 38%
Slovenian: AUC: ↔ Cmax: ↔ Cmin: ↑ 48%
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 163 mg of tenofovir disoproxil (as fumarate).
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena filmsko obložena tableta vsebuje 163 mg dizoproksiltenofovirata (v obliki dizoproksiltenofovirijevega fumarata).
English: Viread should not be administered concomitantly with adefovir dipivoxil.
Slovenian: Zdravila Viread se ne sme uporabljati sočasno z dipivoksiladefoviratom.
English: Nervous system disorders:
Slovenian: Motnje v delovanju jeter
English: Tenofovir disoproxil 245 mg n = 176
Slovenian: 245 mg dizoproksil tenofovirata n = 176
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).
Slovenian: g Prikazane številke so kumulativni odstotki na podlagi Kaplan-Meierjeve analize, vključno s podatki, zbranimi po dodajanju emtricitabina k odprtemu zdravljenju z dizoproksiltenofoviratom (KM-ITT).
English: Adefovir dipivoxil 10 mg roll over to tenofovir disoproxil 245 mg n = 125d
Slovenian: 10 mg dipivoksiladefovirat a prehod na 245 mg dizoproksil tenofovirata n = 125d
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.
Slovenian: Glejte povzetka glavnih značilnosti zdravila Viread 123 mg in 204 mg filmsko obložene tablete za zdravljenje pediatričnih bolnikov, okuženih s HIV-1 in kroničnim hepatitisom B, starih 6 do < 12 let, s telesno maso 17 kg do < 22 kg oziroma 28 kg do < 35 kg.
English: • HBV infected children aged 6 to less than 12 years who weigh from 17 kg to less than 22 kg
Slovenian: • otroke, okužene s HBV, stare 6 do manj kot 12 let, s telesno maso od 17 kg do manj kot 22 kg.
English: Viread 245 mg tablets are also a treatment for chronic hepatitis B, an infection with HBV (hepatitis B virus).
Slovenian: Zdravilo Viread 245 mg tablete se uporablja tudi za zdravljenje kroničnega hepatitisa B, okužbe s HBV (virus hepatitisa B).
English: • Children aged 6 to less than 12 years who weigh from 22 kg to less than 28 kg:
Slovenian: • Otroci, stari 6 do manj kot 12 let, s telesno maso od 22 kg do manj kot 28 kg:
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 123 mg of tenofovir disoproxil (as fumarate).
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena filmsko obložena tableta vsebuje 123 mg dizoproksiltenofovirata (v obliki dizoproksiltenofovirijevega fumarata).
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
Slovenian: Zdravilo Viread je na voljo tudi v obliki zrnc za zdravljenje okužbe s HIV-1 in za zdravljenje kroničnega hepatitisa B pri pediatričnih bolnikih, starih 2 do < 12 let, ter v obliki tablet manjše jakosti za zdravljenje pediatričnih bolnikov, okuženih s HIV-1 in kroničnim hepatitisom B, starih 6 do < 12 let (glejte poglavje 5.1).
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).
Slovenian: HIV-1: Farmakokinetiko tenofovirja v stanju dinamičnega ravnovesja so ovrednotili pri 8 mladostnikih, okuženih s HIV-1 (starih 12 do < 18 let) s telesno maso ≥ 35 kg in pri 23 otrocih, okuženih s HIV-1, starih 2 do < 12 let (glejte preglednico 11 spodaj).
English: • HBV infected children aged 6 to less than 12 years who weigh from 22 kg to less than 28 kg
Slovenian: • otroke, okužene s HBV, stare 6 do manj kot 12 let, s telesno maso od 22 kg do manj kot 28 kg.
English: Viread 163 mg tablets are also a treatment for chronic hepatitis B, an infection with HBV (hepatitis B virus).
Slovenian: Zdravilo Viread 163 mg tablete se uporablja tudi za zdravljenje kroničnega hepatitisa B, okužbe s HBV (virus hepatitisa B).
English: • fatty liver  If you think that your child may have any of these serious side effects, talk to your child's doctor.
Slovenian:  Če menite, da bi lahko vaš otrok imel katerega koli od teh resnih neželenih učinkov, se posvetujte z njegovim zdravnikom.
English: Viread 204 mg tablets are also a treatment for chronic hepatitis B, an infection with HBV (hepatitis B virus).
Slovenian: Zdravilo Viread 204 mg tablete se uporablja tudi za zdravljenje kroničnega hepatitisa B, okužbe s HBV (virus hepatitisa B).
English: c 48 weeks of double-blind adefovir dipivoxil followed by 48 weeks open-label tenofovir disoproxil.
Slovenian: c 48-tedensko dvojno slepo zdravljenje z dipivoksiladefoviratom, ki mu sledi 48-tedensko nezaslepljeno zdravljenje z dizoproksiltenofoviratom.
English: Viread 123 mg film-coated tablets are supplied in bottles containing 30 tablets.
Slovenian: Zdravilo Viread 123 mg filmsko obložene tablete so na voljo v plastenkah po 30 tablet.
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).
Slovenian: HIV-1: Farmakokinetiko tenofovirja v stanju dinamičnega ravnovesja so ovrednotili pri 8 mladostnikih, okuženih s HIV-1 (starih 12 do < 18 let) s telesno maso ≥ 35 kg in pri 23 otrocih, okuženih s HIV-1, starih 2 do < 12 let (glejte preglednico 10 spodaj).
English: - Viread should not be administered concomitantly with adefovir dipivoxil.
Slovenian: - Zdravila Viread se ne sme uporabljati sočasno z dipivoksiladefoviratom.
English: • who weigh from 22 kg to less than 28 kg
Slovenian: • otroke s telesno maso od 22 kg do manj kot 28 kg.
English: The safety of tenofovir disoproxil when used with sofosbuvir/velpatasvir and a pharmacokinetic enhancer (e.g. ritonavir or cobicistat) has not been established.
Slovenian: Varnost dizoproksiltenofovirata ob sočasni uporabi s sofosbuvirjem/velpatasvirjem in farmakokinetičnim ojačevalcem (npr. ritonavirjem ali kobicistatom) ni bila ugotovljena.
English: • who weigh from 17 kg to less than 22 kg
Slovenian: • otroke s telesno maso od 17 kg do manj kot 22 kg.
English: • HIV-1 infected children aged 6 to less than 12 years who weigh from 28 kg to less than 35 kg 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
Slovenian: • otroke, okužene s HIV-1, stare 6 do manj kot 12 let, s telesno maso od 28 kg do manj kot 35 kg, ki so se predhodno že zdravili z drugimi zdravili proti HIV, ki niso več polno učinkovita zaradi nastanka odpornosti ali so povzročala neželene učinke;
English: Tenofovir disoproxil 245 mg n = 250
Slovenian: 245 mg dizoproksil tenofovirata n = 250
English: Your child does not have to have HIV to be treated with Viread for HBV.
Slovenian: Vaš otrok se lahko zdravi z zdravilom Viread za HBV, tudi če ni okužen z virusom HIV.
English: Viread 123 mg tablets are also a treatment for chronic hepatitis B, an infection with HBV (hepatitis B virus).
Slovenian: Zdravilo Viread 123 mg tablete se uporablja tudi za zdravljenje kroničnega hepatitisa B, okužbe s HBV (virus hepatitisa B).
English: AUC: ↔ Cmax: ↓ 30%
Slovenian: AUC: ↔ Cmax: ↔ Cmin: ↓ 34 %
English: e 48 weeks of double-blind tenofovir disoproxil followed by 96 weeks open-label.
Slovenian: e 48-tedensko dvojno slepo zdravljenje z dizoproksiltenofoviratom, ki mu sledi 96-tedensko nezaslepljeno zdravljenje.
English: • Contact your doctor before you restart taking Viread granules.
Slovenian: • Preden začnete ponovno jemati zdravilo Viread, se posvetujte z zdravnikom.
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
Slovenian: Kronični hepatitis B: V študiji GS-US-174-0115 so 106 bolnikov, negativnih na HBeAg in pozitivnih na HBeAg, starih 12 do < 18 let, s kronično okužbo z virusom HBV [HBV DNA ≥ 105 kopij/ml, zvišano vrednostjo ALT v serumu (≥ 2 × ZMN) ali zvišano vrednostjo ALT v serumu v anamnezi v zadnjih 24 mesecih] 72 tednov zdravili z dizoproksiltenofoviratom 245 mg (n = 52) ali placebom (n = 54).
English: Whole body mean (SD) BMD Z-scorea
Slovenian: Povprečni (SD) Zindeks MGK za celo teloa Povprečna (SD)
English: b 48 weeks of double-blind tenofovir disoproxil followed by 48 weeks open-label.
Slovenian: b 48-tedensko dvojno slepo zdravljenje z dizoproksiltenofoviratom, ki mu sledi 48-tedensko nezaslepljeno zdravljenje.
English: • HIV-1 infected children aged 6 to less than 12 years who weigh from 17 kg to less than 22 kg 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
Slovenian: • otroke, okužene s HIV-1, stare 6 do manj kot 12 let, s telesno maso od 17 kg do manj kot 22 kg, ki so se predhodno že zdravili z drugimi zdravili proti HIV, ki niso več polno učinkovita zaradi nastanka odpornosti ali so povzročala neželene učinke;
English: • HIV-1 infected children aged 6 to less than 12 years who weigh from 22 kg to less than 28 kg 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.
Slovenian: • otroke, okužene s HIV-1, stare 6 do manj kot 12 let, s telesno maso od 22 kg do manj kot 28 kg, ki so se predhodno že zdravili z drugimi zdravili proti HIV, ki niso več polno učinkovita zaradi nastanka odpornosti ali so povzročala neželene učinke;
English: Adefovir dipivoxil 10 mg roll over to tenofovir disoproxil 245 mg n = 90d
Slovenian: 10 mg dipivoksiladefovirat a prehod na 245 mg dizoproksil tenofovirata n = 90d
English: Breast-feeding
Slovenian: dipivoksiladefovirat
English: Efavirenz/Emtricitabine/Tenofovir disoproxil (600 mg/200 mg/245 mg q.d.)
Slovenian: efavirenz/emtricitabin/ dizoproksiltenofovirat (600 mg/200 mg/245 mg enkrat dnevno)
English: Talk to your doctor or pharmacist before taking Viread.
Slovenian: Pred začetkom jemanja zdravila Viread se posvetujte z zdravnikom ali farmacevtom.
English: d 48 weeks double-blind adefovir dipivoxil followed by up to 192 weeks open-label tenofovir disoproxil.
Slovenian: d 48-tedensko dvojno slepo zdravljenje z dipivoksiladefoviratom, ki mu sledi do 192-tedensko nezaslepljeno zdravljenje z dizoproksiltenofoviratom.
English: m 48 weeks of double-blind adefovir dipivoxil followed by 240 weeks open-label tenofovir disoproxil.
Slovenian: m 48-tedensko dvojno slepo zdravljenje z dipivoksiladefoviratom, ki mu sledi 240-tedensko nezaslepljeno zdravljenje z dizoproksiltenofoviratom.
English: Viread should not be given to adolescents with existing kidney problems.
Slovenian: Mladostniki, ki imajo težave z ledvicami, ne smejo prejeti zdravila Viread.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each scoop delivers one gram of granules which contains 33 mg of tenofovir disoproxil (as fumarate).
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena merica vsebuje en gram zrnc, ki vsebujejo 33 mg dizoproksiltenofovirata (v obliki dizoproksiltenofovirijevega fumarata).
English: (log10 copies/ml) HBV DNA (%) < 400 copies/ml (< 69 IU/ml) ALT (%) Normalised ALT
Slovenian: Mediana zmanjšanja HBV DNA v primerjavi z izhodiščno točkoc (log10 kopij/ml) HBV DNA (%) < 400 kopij/ml (<69 i.e./ml) ALT (%) Normalizirana ALTd
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 245 mg of tenofovir disoproxil (as fumarate).
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena filmsko obložena tableta vsebuje 245 mg dizoproksiltenofovirata (v obliki dizoproksiltenofovirijevega fumarata).
English: n 48 weeks of double-blind adefovir dipivoxil followed by 240 weeks open-label tenofovir disoproxil.
Slovenian: n 48-tedensko dvojno slepo zdravljenje z dipivoksiladefoviratom, ki mu sledi 240-tedensko nezaslepljeno zdravljenje z dizoproksiltenofoviratom.
English: j 48 weeks of double-blind adefovir dipivoxil followed by 192 weeks open-label tenofovir disoproxil.
Slovenian: j 48-tedensko dvojno slepo zdravljenje z dipivoksiladefoviratom, ki mu sledi 192-tedensko nezaslepljeno zdravljenje z dizoproksiltenofoviratom.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/200/004 30 film-coated tablets EU/1/01/200/005 90 (3 bottles of 30) film-coated tablets
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/01/200/004 30 filmsko obloženih tablet.
English: i 48 weeks of double-blind adefovir dipivoxil followed by 144 weeks open-label tenofovir disoproxil.
Slovenian: i 48-tedensko dvojno slepo zdravljenje z dipivoksiladefoviratom, ki mu sledi 144-tedensko nezaslepljeno zdravljenje z dizoproksiltenofoviratom.
English: Tell your child's doctor before giving Viread.
Slovenian: Preden začne vaš otrok jemati zdravilo Viread, obvestite njegovega zdravnika.
English: h 48 weeks of double-blind adefovir dipivoxil followed by 144 weeks open-label tenofovir disoproxil.
Slovenian: h 48-tedensko dvojno slepo zdravljenje z dipivoksiladefoviratom, ki mu sledi 144-tedensko nezaslepljeno zdravljenje z dizoproksiltenofoviratom.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 204 mg of tenofovir disoproxil (as fumarate).
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena filmsko obložena tableta vsebuje 204 mg dizoproksiltenofovirata (v obliki dizoproksiltenofovirijevega fumarata).
English: Assessment of adverse reactions is based on one randomised study (Study GS-US-174-0115) in 106 adolescent patients (12 to < 18 years of age) with chronic hepatitis B receiving treatment with tenofovir disoproxil 245 mg (n = 52) or placebo (n = 54) for 72 weeks and another randomized study (study GS-US-174-0144) in 89 patients with chronic hepatitis B (2 to < 12 years of age) receiving treatment with tenofovir disoproxil (n = 60) or placebo (n = 29) for 48 weeks.
Slovenian: Ocena neželenih učinkov temelji na eni randomizirani študiji (študija GS-US-174-0115) s 106 mladostniki (starimi 12 do < 18 let) s kroničnim hepatitisom B, ki so se 72 tednov zdravili z 245 mg dizoproksiltenofoviratom (n = 52) ali placebom (n = 54), in drugi randomizirani študiji (študija GS-US-174-0144) z 89 bolniki s kroničnim hepatitisom B (starih 2 do < 12 let), ki so se 48 tednov zdravili z dizoproksiltenofoviratom (n = 60) ali placebom (n = 29).
English: Lumbar spine mean (SD) change from baseline BMD Z-scorea
Slovenian: Povprečni (SD) Z-indeks MGK ledvene hrbtenicea
English: Table 5: Efficacy parameters in compensated HBeAg negative patients at week 96, 144, 192, 240, 288 and 384 open-label treatment
Slovenian: Preglednica 5: Parametri učinkovitosti pri kompenziranih bolnikih, negativnih na HBeAg, v 96., 144., 192., 240., 288. in 384. tednu nezaslepljenega zdravljenja
English: + Emtricitabine/Rilpivirine/Tenofovir disoproxil (200 mg/25 mg/245 mg q.d.)
Slovenian: emtricitabine/rilpivirine/ dizoproksiltenofovirat (200 mg/25 mg/245 mg enkrat dnevno)
English: Lumbar spine mean (SD) BMD Z-scorea
Slovenian: Z-indeks MGK ledvene hrbtenicea Povprečna (SD)
English: Table 4: Efficacy parameters in compensated HBeAg negative patients at week 96, 144, 192, 240, 288 and 384 open-label treatment
Slovenian: Preglednica 4: Parametri učinkovitosti pri kompenziranih bolnikih, negativnih na HBeAg, v 96., 144., 192., 240., 288. in 384. tednu nezaslepljenega zdravljenja
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.
Slovenian: Med bolniki, ki so v dvojno slepem obdobju prejemali placebo, je delež bolnikov s koncentracijo HBV DNA < 400 kopij/ml po začetku nezaslepljenega zdravljenja z dizoproksiltenofoviratom (skupina PLB-dizoproksiltenofovirat) strmo narasel: v 192. tednu je 74,1% (40/54) bolnikov v skupini PLB-dizoproksiltenofovirat imelo koncentracijo HBV DNA < 400 kopij/ml.
English: Table 6: Efficacy parameters in compensated HBeAg positive patients at week 96, 144, 192, 240, 288 and 384 open-label treatment
Slovenian: Preglednica 6: Parametri učinkovitosti pri kompenziranih bolnikih, pozitivnih na HBeAg, v 96., 144., 192., 240., 288. in 384. tednu nezaslepljenega zdravljenja