natgillin/translations-raw huggingface dataset:
Viread is also available as 33 mg/g granules for the treatment of HIV-1 infection and chronic hepatitis B in paediatric patients aged 2 to < 12 years who weigh < 17 kg or who are unable to swallow film-coated tablets.
Zdravilo Viread je na voljo tudi v obliki 33 mg/g zrnc za zdravljenje pediatričnih bolnikov, okuženih s HIV-1 in kroničnim hepatitisom B, starih 2 do < 12 let, s telesno maso < 17 kg, ali tistih, ki ne morejo pogoltniti filmsko obloženih tablet.
If you throw up less than 1 hour after taking Viread, take another tablet.
Če nastopi bruhanje manj kot 1 uro po zaužitju zdravila Viread, vzemite še eno tableto.
Co-administration of tenofovir disoproxil and didanosine is not recommended (see section 4.4).
Sočasna uporaba dizoproksiltenofovirata in didanozina ni priporočena (glejte poglavje 4.4).
• 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.
• Za HIV je zdravilo Viread 204 mg tablete primerno samo za otroke, predhodno že zdravljene z drugimi zdravili proti HIV, ki niso več polno učinkovita zaradi nastanka odpornosti ali so povzročala neželene učinke.
In the tenofovir disoproxil treatment arm, 7% of patients discontinued treatment due to an adverse event; 9% of patients experienced a confirmed increase in serum creatinine of ≥ 0.5 mg/dl or confirmed serum phosphate of < 2 mg/dl through week 48; there were no statistically significant differences between the combined tenofovir-containing arms and the entecavir arm. After 168 weeks, 16% (7/45) of the tenofovir disoproxil group, 4% (2/45) of the emtricitabine plus tenofovir disoproxil group, and 14% (3/22) of the entecavir group experienced tolerability failure.
V skupini, ki je bila zdravljena z dizoproksiltenofoviratom, je do 48. tedna zdravljenja 7 % bolnikov prekinilo zdravljenje zaradi neželenega učinka, 9 % bolnikov je imelo potrjeno zvišanje serumske koncentracije kreatinina za ≥ 0,5 mg/dl ali potrjeno serumsko koncentracijo fosfata < 2 mg/dl; statistično značilnih razlik med kombiniranima skupinama, ki sta prejemali tenofovir, in skupino, ki je prejemala entekavir, ni bilo.
Rarely, inflammation of the pancreas and lactic acidosis (excess lactic acid in the blood), which sometimes caused death, have been reported when medicines containing tenofovir disoproxil and didanosine were taken together.
Pri sočasnem jemanju zdravil, ki vsebujejo dizoproksiltenofovirat in didanozin, so redko poročali o vnetju trebušne slinavke in laktoacidozi
Viread 163 mg tablets are a treatment for HIV (Human Immunodeficiency Virus) infection.
Zdravilo Viread 163 mg tablete se uporablja za zdravljenje okužbe s HIV (virus človeške imunske pomanjkljivosti).
Each Viread tablet contains 245 mg of tenofovir disoproxil (as fumarate).
Ena tableta zdravila Viread vsebuje 245 mg dizoproksiltenofovirata (v obliki fumarata).
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.
V študiji GS-US-174-0144 so 89 bolnikov, negativnih na HBeAg in pozitivnih na HBeAg, starih 2 do < 12 let, s kroničnim hepatitisom B, 48 tednov zdravili z dizoproksiltenofoviratom 6,5 mg/kg do največjega odmerka 245 mg (n = 60) ali s placebom (n = 29) enkrat na dan. Bolniki so morali biti predhodno še nezdravljeni z dizoproksiltenofoviratom in so morali imeti ob presejanju koncentracijo
Viread should not be administered concomitantly with other medicinal products containing tenofovir disoproxil or tenofovir alafenamide.
Sočasna uporaba z drugimi zdravili ni priporočena Zdravila Viread se ne sme uporabljati sočasno z drugimi zdravili, ki vsebujejo dizoproksiltenofovirat ali tenofoviralafenamid.
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.
Priporočeni odmerek za zdravljenje pediatričnih bolnikov, okuženih s HIV-1 in kroničnim hepatitisom B, starih 6 do < 12 let, s telesno maso 22 do < 28 kg, ki lahko pogoltnejo filmsko obložene tablete, je ena 163 mg tableta enkrat dnevno, peroralno, s hrano.
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:
Zdravilo Viread 204 mg filmsko obložene tablete je indicirano za zdravljenje kroničnega hepatitisa B pri pediatričnih bolnikih, starih 6 do <12 let, s telesno maso 28 kg do manj kot 35 kg:
Twenty-five percent(14 of 56) of patients in the tenofovir disoproxil group and 24% (7 of 29) of patients in the placebo group achieved HBeAg seroconversion at Week 48.
25 % (14 od 56) bolnikov v skupini, ki je prejemala dizoproksiltenofovirat, in 24 % (7 od 29) bolnikov v skupini, ki je prejemala placebo, je v 48. tednu doseglo serološko konverzijo HBeAg.
Twenty-five percent (14 of 56) of patients in the tenofovir disoproxil group and 24% (7 of 29) of patients in the placebo group achieved HBeAg seroconversion at Week 48.
25% (14 od 56) bolnikov v skupini, ki je prejemala dizoproksiltenofovirat, in 24 % (7 od 29) bolnikov v skupini, ki je prejemala placebo, je v 48. tednu doseglo serološko konverzijo HBeAg.
The proportion of subjects with ALT normalization at week 192 in the tenofovir disoproxil-tenofovir disoproxil 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.
Izmed bolnikov, ki so bili ob izhodiščni točki HBeAg pozitivni, je bil v 192. tednu delež bolnikov z normalizirano ALT v skupini dizoproksiltenofoviratdizoproksiltenofovirat 75,8 % (25/33), izmed tistih, ki so bili ob izhodiščni točki HBeAg negativni, pa 100,0 % (2 od 2 bolnikov).
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”.
Zdravilo Viread 204 mg filmsko obložene tablete so bele, filmsko obložene tablete v obliki kapsule s premerom 15,4 mm x 7,3 mm, z vtisnjenim znakom “GSI” na eni strani ter znakom “250” na drugi strani.
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.
V analizi populacije namenjene za zdravljenje (pomanjkanje podatkov in sprememba protiretrovirusne terapije se smatra kot neuspeh) je bil delež bolnikov s HIV-1 RNA pod 400 kopij/ml 80% in bolnikov z manj kot 50 kopijami/ml 76% v 48. tednu zdravljenja z 245 mg dizoproksiltenofoviratom v primerjavi s 84% in 80% v stavudinski skupini.
Viread 245 mg tablets are a treatment for HIV (Human Immunodeficiency Virus) infection.
Zdravilo Viread 245 mg tablete se uporablja za zdravljenje okužbe s HIV (virus človeške imunske pomanjkljivosti).
Viread 163 mg film-coated tablets Tenofovir disoproxil
Viread 163 mg filmsko obložene tablete dizoproksiltenofovirat
• Not for children who weigh under 22 kg or 28 kg and over.
• ni za otroke s telesno maso manj kot 22 kg ali s telesno maso 28 kg in več.
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”.
Zdravilo Viread 123 mg filmsko obložene tablete so bele, trikotne, filmsko obložene tablete s premerom 8,5 mm, z vtisnjenim znakom“GSI” na eni strani ter znakom “150” na drugi strani.
Your child must always take this medicine exactly as their doctor or pharmacist has told you.
Pri jemanju tega zdravila naj vaš otrok natančno upošteva navodila njegovega zdravnika ali farmacevta.
• 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.
• Za HIV je zdravilo Viread 123 mg tablete primerno samo za otroke, predhodno že zdravljene z drugimi zdravili proti HIV, ki niso več polno učinkovita zaradi nastanka odpornosti ali so povzročala neželene učinke.
Response to treatment with tenofovir disoproxil was comparable in treatment-naïve and treatmentexperienced subjects with 76% (38/50) of treatment-naïve and 80% (8/10) of treatment-experienced subjects achieving HBV DNA < 400 copies/mL (69 IU/ml) at Week 48.
Odziv na zdravljenje z dizoproksiltenofoviratom je bil primerljiv pri bolnikih, ki se še niso zdravili, in pri bolnikih, ki so se predhodno že zdravili, pri čemer je v 48. tednu 76 % (38/50) bolnikov, ki se še niso zdravili, in 80 % (8/10) bolnikov, ki so se predhodno že zdravili, doseglo koncentracijo HBV DNA < 400 kopij/ml (69 i.e./ml).
White, triangle-shaped, film-coated tablets, 8.5 mm in diameter, debossed on one side with “GSI” and on the other side with “150”.
Bele, trikotne, filmsko obložene tablete, s premerom 8,5 mm, z vtisnjenim znakom “GSI” na eni strani ter znakom “150” na drugi strani.
Viread 204 mg film-coated tablets Tenofovir disoproxil
Viread 204 mg filmsko obložene tablete dizoproksiltenofovirat
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.
Zdravilo Viread 204 mg filmsko obložene tablete je indicirano v kombinaciji z drugimi protiretrovirusnimi zdravili za zdravljenje pediatričnih bolnikov, okuženih s HIV-1, odpornih na NRTI ali s toksičnostjo, ki onemogoča uporabo zdravil prve izbire, starih 6 do < 12 let, s telesno maso od 28 kg do manj kot 35 kg.
Serology (%) HBeAg loss/seroconversion n/a n/a
Serologija (%) Izguba/serološka konverzija HBeAg
Co-administration of tenofovir disoproxil and didanosine is not recommended (see section 4.4 and Table 1).
Sočasna uporaba dizoproksiltenofovirata in didanozina ni priporočena (glejte poglavje 4.4 in preglednico 1).
Tenofovir disoproxil 245 mg n = 176c
245 mg dizoproksil tenofovirata n = 176c
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 245 mg of tenofovir disoproxil (as fumarate).
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena filmsko obložena tableta vsebuje 245 mg dizoproksiltenofovirata (v obliki dizoproksiltenofovirijevega fumarata).
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).
Če se jemanje zdravila Viread 163 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).
Viread contains lactose
Zdravilo Viread vsebuje laktozo
Tenofovir disoproxil 245 mg n = 250c
245 mg dizoproksil tenofovirata n = 250c
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.
Zdravilo Viread 163 mg filmsko obložene tablete je indicirano v kombinaciji z drugimi protiretrovirusnimi zdravili za zdravljenje pediatričnih bolnikov, okuženih s HIV-1, odpornih na NRTI ali s toksičnostjo, ki onemogoča uporabo zdravil prve izbire, starih 6 do < 12 let, s telesno maso od 22 kg do manj kot 28 kg.
Viread 204 mg tablets are a treatment for HIV (Human Immunodeficiency Virus) infection.
Zdravilo Viread 204 mg tablete se uporablja za zdravljenje okužbe s HIV (virus človeške imunske pomanjkljivosti).
p 48 weeks of double-blind adefovir dipivoxil followed by 336 weeks open-label tenofovir disoproxil.
p 48-tedensko dvojno slepo zdravljenje z dipivoksiladefoviratom, ki mu sledi 336-tedensko nezaslepljeno zdravljenje z dizoproksiltenofoviratom.
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).
Če se jemanje zdravila Viread 204 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).
Viread 245 mg film-coated tablets contain lactose monohydrate.
Zdravilo Viread 245 mg filmsko obložene tablete vsebuje laktozo monohidrat.
Viread 123 mg film-coated tablets Tenofovir disoproxil
Viread 123 mg filmsko obložene tablete dizoproksiltenofovirat
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:
Zdravilo Viread 123 mg filmsko obložene tablete je indicirano za zdravljenje kroničnega hepatitisa B pri pediatričnih bolnikih, starih 6 do <12 let, s telesno maso 17 kg do manj kot 22 kg:
Viread 163 mg film-coated tablets contain lactose monohydrate.
Zdravilo Viread 163 mg filmsko obložene tablete vsebuje laktozo monohidrat.
Viread 33 mg/g granules are also a treatment for chronic hepatitis B, an infection with HBV (hepatitis B virus).
Zdravilo Viread 33 mg/g zrnca se uporablja tudi za zdravljenje kroničnega hepatitisa B, okužbe s HBV (virus hepatitisa B).
• 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
• otroke in mladostnike, okužene s HIV-1, stare 2 do manj kot 18 let, predhodno že zdravljene z drugimi zdravili proti HIV, ki niso več polno učinkovita zaradi nastanka odpornosti ali so povzročala neželene učinke;
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.
Pri 215 bolnikih, negativnih na HBeAg (GS-US-174-0102, n = 125) in pozitivnih na HBeAg (GS-US-174-0103, n = 90), ki so jih na začetku naključno razporedili v skupino, ki je prejemala dvojno slepo zdravljenje z dipivoksiladefoviratom, nato pa so nadaljevali z nezaslepljenim zdravljenjem z dizoproksiltenofoviratom, so ocenili genotipske spremembe HBV-polimeraze od izhodiščne točke.
Each Viread tablet contains 204 mg of tenofovir disoproxil (as fumarate).
Ena tableta zdravila Viread vsebuje 204 mg dizoproksiltenofovirata (v obliki fumarata).
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.
Zdravilo Viread 123 mg filmsko obložene tablete je indicirano v kombinaciji z drugimi protiretrovirusnimi zdravili za zdravljenje pediatričnih bolnikov, okuženih s HIV-1, odpornih na NRTI ali s toksičnostjo, ki onemogoča uporabo zdravil prve izbire, starih 6 do < 12 let, s telesno maso 17 kg do manj kot 22 kg.
Viread 123 mg tablets are a treatment for HIV (Human Immunodeficiency Virus) infection.
Zdravilo Viread 123 mg tablete se uporablja za zdravljenje okužbe s HIV (virus človeške imunske pomanjkljivosti).
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.
Pri 426 bolnikih, negativnih na HBeAg (GS-US-174-0102, n = 250) in pozitivnih na HBeAg (GS-US-174-0103, n = 176), ki so jih na začetku naključno razporedili v skupino, ki je prejemala dvojno slepo zdravljenje z dizoproksiltenofoviratom, nato pa so nadaljevali z nezaslepljenim zdravljenjem z dizoproksiltenofoviratom so ocenili genotipske spremembe HBV-polimeraze od izhodiščne točke.
Your child does not need to take another tablet if they were sick more than 1 hour after taking Viread.
Še ene tablete mu ni treba vzeti, če je bruhanje nastopilo več kot 1 uro po zaužitju zdravila Viread.
The following side effects are common (these can affect up to 10 in every 100 patients):
Naslednji neželeni učinki so pogosti (prizadenejo lahko do 10 od 100 bolnikov):
• Children aged 6 to less than 12 years who weigh from 28 kg to less than 35 kg:
• Otroci, stari 6 do manj kot 12 let, s telesno maso od 28 kg do manj kot 35 kg:
• 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.
• 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.
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).
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).
Viread 163 mg film-coated tablets are supplied in bottles containing 30 tablets.
Zdravilo Viread 163 mg filmsko obložene tablete so na voljo v plastenkah po 30 tablet.
Use with the supplied dosing scoop.
Uporabite priloženo merico za odmerjanje.
Adefovir dipivoxil
Dizoproksiltenofovirat
Adefovir dipivoxil 10 mg n = 125
10 mg dipivoksiladefovirat a n = 125
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:
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:
Each Viread tablet contains 163 mg of tenofovir disoproxil (as fumarate).
Ena tableta zdravila Viread vsebuje 163 mg dizoproksiltenofovirata (v obliki fumarata).
Viread granules should be measured with the supplied dosing scoop.
Zdravilo Viread zrnca se meri s priloženo merico za odmerjanje.
The following side effects are uncommon (these can affect up to 1 in every 100 patients):
Naslednji neželeni učinki so občasni (prizadenejo lahko do 1 od 100 bolnikov):
Viread 204 mg film-coated tablets contain lactose monohydrate.
Zdravilo Viread 204 mg filmsko obložene tablete vsebuje laktozo monohidrat.
Each Viread tablet contains 123 mg of tenofovir disoproxil (as fumarate).
Ena tableta zdravila Viread vsebuje 123 mg dizoproksiltenofovirata (v obliki fumarata).
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.
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.
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).
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).
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.
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.
• Children aged 6 to less than 12 years who weigh from 17 kg to less than 22 kg:
• Otroci, stari 6 do manj kot 12 let, s telesno maso od 17 kg do manj kot 22 kg:
• HBV infected children aged 6 to less than 12 years who weigh from 28 kg to less than 35 kg
• otroke, okužene s HBV, stare 6 do manj kot 12 let, s telesno maso od 28 kg do manj kot 35 kg.
• who weigh from 28 kg to less than 35 kg
• otroke s telesno maso od 28 kg do manj kot 35 kg.
f 48 weeks of double-blind adefovir dipivoxil followed by 96 weeks open-label tenofovir disoproxil.
f 48-tedensko dvojno slepo zdravljenje z dipivoksiladefoviratom, ki mu sledi 96-tedensko nezaslepljeno zdravljenje z dizoproksiltenofoviratom.
• Use the flat edge of clean knife to make the granules even with the top of the scoop (see Figure B).
• Uporabite ploski rob čistega noža in zrnca poravnajte z robom merice
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).
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).
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.
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.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 204 mg of tenofovir disoproxil (as fumarate).
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena filmsko obložena tableta vsebuje 204 mg dizoproksiltenofovirata (v obliki dizoproksiltenofovirijevega fumarata).
Viread 123 mg film-coated tablets contain lactose monohydrate.
Zdravilo Viread 123 mg filmsko obložene tablete vsebuje laktozo monohidrat.
Viread 204 mg film-coated tablets are supplied in bottles containing 30 tablets.
Zdravilo Viread 204 mg filmsko obložene tablete so na voljo v plastenkah po 30 tablet.
Co-administration of tenofovir disoproxil and didanosine is not recommended (see section 4.4 and Table 2).
Sočasna uporaba dizoproksiltenofovirata in didanozina ni priporočena (glejte poglavje 4.4 in preglednico 2).