FrancophonIA/ELRC3.0 huggingface dataset:
English: At week 48, 77% (46 of 60) of patients in the tenofovir disoproxil treatment group and 7% (2 of 29) of patients in the placebo group had HBV DNA < 400 copies/mL (69 IU/mL).
Slovenian: V 48. tednu je imelo 77 % (46 od 60) bolnikov v skupini, zdravljeni z dizoproksiltenofoviratom, in 7 % (2 od 29) bolnikov v skupini, ki je prejemala placebo, koncentracijo HBV DNA < 400 kopij/ml (69 i.e./ml).
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 (tenofovir disoproxil-tenofovir disoproxil group).
Slovenian: V pediatrični študiji (GS-US-174-0115) je 52 bolnikov (vključno s 6 bolniki z mutacijami, povezanimi z rezistenco na lamivudin ob izhodiščni točki) do 72 tednov najprej prejemalo slepo zdravljenje z dizoproksiltenofoviratom, nato pa je 51/52 bolnikov prešlo na nezaslepljeno zdravljenje z dizoproksiltenofoviratom (skupina dizoproksiltenofovirat-dizoproksiltenofovirat).
English: • That if serum phosphate is confirmed to be < 3.0 mg/dl (0.96 mmol/l) in any paediatric patient receiving tenofovir disoproxil fumarate, renal function should be re-evaluated within one week.
Slovenian: • če je pri katerem koli pediatričnem bolniku, ki prejema dizoproksiltenofovirijev fumarat, potrjena koncentracija serumskega fosfata < 3,0 mg/dl (0,96 mmol/l), je treba ponovno ovrednotiti delovanje ledvic v roku enega tedna.
English: Response to treatment with tenofovir disoproxil was also similar in subjects who were HBeAg-negative compared with those who were HBeAg-positive at baseline with 77% (43/56) HBeAg-positive and 75.0% (3/4) HBeAg-negative subjects achieving HBV DNA < 400 copies/mL (69 IU/mL) at Week 48.
Slovenian: Odziv na zdravljenje z dizoproksiltenofoviratom je bil pri bolnikih, ki so bili negativni na HBeAg, podoben kot pri tistih, ki so bili ob izhodiščni točki pozitivni na HBeAg, pri čemer je v 48. tednu 77 % (43/56) HBeAg-pozitivnih in 75,0 % (3/4) HBeAg-negativnih bolnikov doseglo koncentracijo HBV DNA < 400 kopij/ml (69 i.e./ml).
English: Emtricitabine 200 mg/ tenofovir disoproxil 245 mg (n = 45)
Slovenian: emtricitabin 200 mg/dizoproksil tenofovirat 245 mg (n = 45)
English: In study GS-US-174-0103 a significantly greater proportion of patients in the tenofovir disoproxil group than in the adefovir dipivoxil group had normalised ALT and achieved HBsAg loss at week 48 (see Table 4 below).
Slovenian: V študiji GS-US-174-0103 je imel v 48. tednu pomembno večji delež bolnikov v skupini, ki je prejemala dizoproksiltenofovirat, normalizirane ravni ALT in dosegel izgubo HBsAg, kot v skupini, ki je prejemala dipivoksiladefovirat (glejte preglednico 4 spodaj).
English: Mean changes at week 48 (end of double-blind phase) were -0.215 and -0.165 in lumbar spine BMD Z-score, and -0.254 and -0.179 in total body BMD Z-score for the tenofovir disoproxil and placebo groups, respectively.
Slovenian: Povprečni spremembi v 48. tednu (konec dvojno slepe faze) sta bili -0,215 oziroma -0,165 za Z-indeks MGK ledvene hrbtenice ter -0,254 oziroma-0,179 za Z-indeks MGK za celo telo za skupino, ki je prejemala dizoproksiltenofovirat oziroma za skupino, ki je prejemala placebo.
English: Viread 163 mg tablets are for use in children.
Slovenian: Zdravilo Viread 163 mg tablete je primerno za uporabo pri otrocih.
English: Cmax: ↓ 30% Cmin: N/A
Slovenian: AUC: ↔ Cmax: ↓ 30 % Cmin: N/V
English: Viread 123 mg tablets are for use in children.
Slovenian: Zdravilo Viread 123 mg tablete je primerno za uporabo pri otrocih.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each scoop delivers one gram of granules which contains 33 mg of tenofovir disoproxil (as fumarate).
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena merica vsebuje en gram zrnc, ki vsebujejo 33 mg dizoproksiltenofovirata (v obliki dizoproksiltenofovirijevega fumarata).
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.
Slovenian: Izpostavljenost tenofovirju, dosežena pri teh pediatričnih bolnikih, ki so peroralno prejemali dnevni odmerek 245 mg dizoproksiltenofovirata ali 6,5 mg/kg dizoproksiltenofovirata na telesno maso do največjega odmerka 245 mg, je bila podobna kot izpostavljenost, dosežena pri odraslih, ki so prejemali enkratni dnevni odmerek 245 mg dizoproksiltenofovirata.
English: • HIV paediatric educational brochure
Slovenian: • izobraževalno brošuro o pediatričnih bolnikih s HIV, • izobraževalno brošuro o pediatričnih bolnikih s HBV.
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.
Slovenian: 74 % (26/35) bolnikov v skupini, ki je prejemala dizoproksiltenofovirat, je imelo v 72. tednu normalizirani ALT, v primerjavi z 31 % (13/42) v skupini, ki je prejemala placebo.
English: Compared with patients with normal renal function, the mean (%CV) tenofovir exposure increased from 2,185 (12%) ng·h/ml in subjects with CrCl > 80 ml/min to respectively 3,064 (30%) ng·h/ml, 6,009 (42%) ng·h/ml and 15,985 (45%) ng·h/ml in patients with mild, moderate and severe renal impairment.
Slovenian: V primerjavi z bolniki z normalno ledvično funkcijo (CLCR > 80 ml/min) s srednjo vrednostjo (% koeficienta variacije) izpostavljenosti tenofovirju 2.185 (12%) ng·h/ml se je le-ta pri bolnikih z blago ledvično okvaro zvečala na 3.064 (30%) ng·h/ml, pri bolnikih z zmernimi motnjami na 6.009 (42%) ng·h/ml in na 15.985 (45%) ng·h/ml pri bolnikih z resnimi motnjami v delovanju ledvic.
English: Viread is also available as 33 mg/g granules for the treatment of HIV-1 infection and chronic hepatitis B in adults or adolescents for whom a solid dosage form is not appropriate.
Slovenian: Zdravilo Viread je na voljo tudi v obliki 33 mg/g zrnc za zdravljenje okužbe s HIV-1 in za zdravljenje kroničnega hepatitisa B pri odraslih ali mladoletnikih, pri katerih ni mogoče uporabiti trdne farmacevtske oblike.
English: Viread is also available as 123 mg, 163 mg, 204 mg film-coated tablets for the treatment of HIV-1 infection and chronic hepatitis B in paediatric patients aged 6 to < 12 years who weigh ≥ 17 and < 35 kg for whom a solid dosage form is appropriate.
Slovenian: Zdravilo Viread je na voljo tudi v obliki 123 mg, 163 mg, 204 mg filmsko obloženih tablet za zdravljenje pediatričnih bolnikov, okuženih s HIV-1 in kroničnim hepatitisom B, starih 6 do < 12 let, s telesno maso ≥ 17 in < 35 kg, pri katerih je mogoče uporabiti trdo obliko zdravila.
English: Viread 33 mg/g granules 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, from 2 to < 6 years of age, and above 6 years of age for whom a solid dosage form is not appropriate.
Slovenian: Zdravilo Viread 33 mg/g zrnca 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 2 do < 6 let, in starih več kot 6 let, pri katerih ni mogoče uporabiti trdne farmacevtske oblike.
English: Viread 33 mg/g granules are also indicated for the treatment of chronic hepatitis B in paediatric patients2 to < 18 years of age for whom a solid dosage form is not appropriate with:
Slovenian: Zdravilo Viread 33 mg/g zrnca je indicirano tudi za zdravljenje kroničnega hepatitisa B pri pediatričnih bolnikih, starih 2 do < 18 let, pri katerih ni mogoče uporabiti trdne farmacevtske oblike:
English: Table 8: Bone Mineral Density Evaluation at Baseline, Week 72 and 192
Slovenian: Preglednica 8: Ocenjevanje mineralne gostote kosti ob izhodišču, v 72. in 192. tednu Izhodišče
English: The following side effects are very common (these can affect at least 10 in every 100 patients):
Slovenian: Naslednji neželeni učinki so zelo pogosti (prizadenejo lahko najmanj 10 od 100 bolnikov):
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 mg and stavudine groups, respectively).
Slovenian: V 144. tednu zdravljenja je ostala srednja vrednost spremembe od začetne vrednosti podobna v obeh zdravljenih skupinah (-3,07 log10 kopij/ml in +263 celic/mm3 v skupini z 245 mg dizoproksiltenofoviratom ter -3,03 log10 kopij/ml in +283 celic/mm3 v stavudinski skupini).
English: Each tablet contains 82 mg lactose (as monohydrate).
Slovenian: Ena tableta vsebuje 82 mg laktoze (v obliki laktoze monohidrata).
English: Do not give Viread
Slovenian: Otroku ne dajte zdravila Viread
English: Viread 33 mg/g granules are a treatment for HIV (Human Immunodeficiency Virus) infection.
Slovenian: Zdravilo Viread 33 mg/g zrnca se uporablja za zdravljenje okužbe s HIV (virus človeške imunske pomanjkljivosti).
English: Method of administration Viread 204 mg film-coated tablets should be taken once daily, orally with food.
Slovenian: Način uporabe Zdravilo Viread 204 mg filmsko obložene tablete se jemlje enkrat dnevno, peroralno s hrano.
English: If the patient vomits within 1 hour of taking Viread, another tablet should be taken.
Slovenian: Če bolnik v roku 1 ure od jemanja zdravila Viread bruha, naj vzame drugo tableto.
English: INFORMATION IN BRAILLE Viread 245 mg [Outer packaging only]
Slovenian: PODATKI V BRAILLOVI PISAVI Viread 245 mg [samo na zunanji ovojnini]
English: Method of administration Viread 163 mg film-coated tablets should be taken once daily, orally with food.
Slovenian: Način uporabe Zdravilo Viread 163 mg filmsko obložene tablete se jemlje enkrat dnevno, peroralno s hrano.
English: At week 72, overall 88% (46/52) of patients in the tenofovir disoproxil treatment group and 0% (0/54) of patients in the placebo group had HBV DNA < 400 copies/ml.
Slovenian: V 72. tednu je imelo skupaj 88 % (46/52) bolnikov v skupini, zdravljeni z dizoproksiltenofoviratom, in 0 % (0/54) bolnikov v skupini, ki je prejemala placebo, koncentracijo HBV DNA < 400 kopij/ml.
English: • Contact your child's doctor before your child restarts taking Viread tablets.
Slovenian: • Preden začne vaš otrok ponovno jemati zdravilo Viread tablete, se posvetujte z njegovim zdravnikom.
English: You do not need to take another tablet if you were sick more than 1 hour after taking Viread.
Slovenian: Še ene tablete vam ni treba vzeti, če je bruhanje nastopilo več kot 1 uro po zaužitju zdravila Viread.
English: Table 9: Bone Mineral Density Evaluation at Baseline, Week 72 and 192
Slovenian: Preglednica 9: Ocenjevanje mineralne gostote kosti ob izhodišču, 72. in 192. teden Izhodišče
English: If Viread is discontinued in patients with chronic hepatitis B with or without HIV co-infection, these patients should be closely monitored for evidence of exacerbation of hepatitis (see section 4.4).
Slovenian: Če se jemanje zdravila Viread prekine pri bolnikih s kroničnim hepatitisom B s sočasno okužbo z virusom HIV ali brez nje, je treba pri teh bolnikih skrbno nadzorovati znake poslabšanja hepatitisa (glejte poglavje 4.4).
English: Method of administration Viread tablets should be taken once daily, orally with food.
Slovenian: Način uporabe Tablete Viread se jemljejo enkrat dnevno, peroralno s hrano.
English: In general, treatment responses to tenofovir disoproxil were similar for genotypes A, B, C and E [75-100% of subjects achieved HBV DNA < 400 copies/mL (69 IU/mL) at Week 48] with a lower response rate in subjects with genotype D infection (55%).
Slovenian: Samo 1 bolnik, ki je bil randomiziran v skupino, ki je prejemala dizoproksiltenofovirat, je bil ob izhodišču okužen z genotipom E. Na splošno so bili odzivi na zdravljenje z dizoproksiltenofoviratom pri genotipih A, B, C in E podobni [75-100 % bolnikov je v 48. tednu doseglo koncentracijo HBV DNA < 400 kopij/ml (69 i.e./ml)], medtem ko je bila pri bolnikih z okužbo z genotipom D stopnja odziva nižja (55 %).
English: Table 4: Efficacy parameters in compensated HBeAg negative and HBeAg positive patients at week 48
Slovenian: Preglednica 4: Parametri učinkovitosti pri kompenziranih bolnikih, negativnih na HBeAg in pozitivnih na HBeAg, v 48. tednu
English: - If your child gets any side effects, talk to your child's doctor or pharmacist.
Slovenian: - Če pri svojem otroku opazite kateri koli neželeni učinek, se posvetujte z otrokovim zdravnikom ali farmacevtom.
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.
Slovenian: • otroke in mladostnike, stare 2 do manj kot 18 let, predhodno že zdravljenje z drugimi zdravili proti HIV, ki niso več polno učinkovita zaradi nastanka odpornosti ali so povzročala neželene učinke.
English: Bone Mineral Density (BMD) data from Study GS-US-174-0115 are summarized in Table 8:
Slovenian: Podatki o mineralni gostoti kosti (MGK) iz študije GS-US-174-0115 so povzeti v preglednici 8:
English: Both treatments produced similar results with regard to histological response (defined as Knodell necroinflammatory score improvement of at least 2 points without worsening in Knodell fibrosis) at week 48 (see Table 4 below).
Slovenian: Pri obeh zdravljenjih je bil v 48. tednu histološki odziv podoben (opredeljen kot izboljšanje za vsaj 2 točki na Knodellovi nekroinflamatorni lestvici brez poslabšanja na Knodellovi fibrozni lestvici (glejte preglednico 4 spodaj).
English: Method of administration Viread 123 mg film-coated tablets should be taken once daily, orally with food.
Slovenian: Način uporabe Zdravilo Viread 123 mg filmsko obložene tablete se jemlje enkrat dnevno, peroralno s hrano.
English: Similar percentages of subjects in the tenofovir disoproxil-tenofovir disoproxil and PLB-tenofovir disoproxil groups (37.5% and 41.7%, respectively) experienced seroconversion to anti-HBe through week 192.
Slovenian: Pri podobnem odstotku bolnikov v skupinah dizoproksiltenofoviratdizoproksiltenofovirat in PLB-dizoproksiltenofovirat (37,5 % oziroma 41,7 %) se je v 192. tednu pojavila serološka konverzija v anti-HBe.
English: HIV-1 clinical studies: Assessment of adverse reactions for tenofovir disoproxil is based on safety data from clinical studies and post-marketing experience.
Slovenian: Povzetek neželenih učinkov, prikazan v preglednici Klinične študije za HIV-1: Ocena neželenih učinkov za dizoproksiltenofovirat temelji na podatkih o varnosti iz kliničnih študij in izkušenj v obdobju trženja zdravila.
English: NAME OF THE MEDICINAL PRODUCT Viread 204 mg film-coated tablets
Slovenian: IME ZDRAVILA Viread 204 mg filmsko obložene tablete
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/200/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/01/200/003
English: If the patient vomits within 1 hour of taking Viread, another dose should be taken.
Slovenian: Če bolnik v roku 1 ure od jemanja zdravila Viread bruha, naj vzame drug odmerek.
English: Seventy-five percent (21/28) of immune-active patients in the tenofovir disoproxil group had normal ALT at week 72 compared to 34% (11/32) in the placebo group.
Slovenian: 75 % (21/28) imunsko aktivnih bolnikov v skupini, ki je prejemala dizoproksiltenofovirat, je imelo v 72. tednu normalne koncentracije ALT v primerjavi s 34% (11/32) v skupini, ki je prejemala placebo.
English: Viread 163 mg tablets are only suitable for:
Slovenian: Zdravilo Viread 163 mg tablete je primerno samo za:
English: If you accidentally take too much Viread, you may be at increased risk of experiencing possible side effects with this medicine (see section 4, Possible side effects).
Slovenian: Če ste pomotoma zaužili preveč zdravila Viread, se lahko poveča tveganje pojava možnih neželenih učinkov povezanih s tem zdravilom (glejte poglavje 4, Možni neželeni učinki).
English: If you accidentally take too many Viread tablets, you may be at increased risk of experiencing possible side effects with this medicine (see section 4, Possible side effects).
Slovenian: Če ste pomotoma zaužili preveč tablet zdravila Viread, se lahko poveča tveganje pojava možnih neželenih učinkov povezanih s tem zdravilom (glejte poglavje 4, Možni neželeni učinki).
English: 288m 384o 96c 144f
Slovenian: 144e 192h 240j 288m 384o 96c 144f
English: PLBtenofovir disoproxil
Slovenian: PLB Dizoproksiltenofovirat
English: In the HBeAg positive subjects randomised to emtricitabine plus tenofovir disoproxil, 13 of 68 subjects (19%) experienced HBeAg loss, and 7 of 68 subjects (10%) experienced anti-HBe seroconversion through week 240.
Slovenian: Pri bolnikih, pozitivnih na HBeAg, randomiziranih za emtricitabin in dizoproksiltenofovirat, je imelo 13 od 68 bolnikov (19 %) izgubo HBeAg in 7 od 68 bolnikov (10 %) je imelo serološko konverzijo anti HBe do konca 240. tedna.
English: Tenofovir is a nucleotide reverse transcriptase inhibitor, generally known as an NRTI and works by interfering with the normal working of an enzyme (in HIV reverse transcriptase, in hepatitis B DNA polymerase) that are essential for the viruses to reproduce themselves.
Slovenian: Tenofovir je nukleotidni zaviralec reverzne transkriptaze, ki je splošno znan pod imenom NRTI (nucleotide reverse transcriptase inhibitors), in deluje tako, da vpliva na normalno delovanje encima (reverzne transkriptaze pri virusu HIV in DNA-polimeraze pri virusu hepatitisa B), ki sta bistvena za pomnoževanje virusa.
English: Viread 33 mg/g granules Tenofovir disoproxil
Slovenian: Viread 33 mg zrnca dizoproksiltenofovirat
English: Co-administration of tenofovir disoproxil and didanosine results in a 40-60% increase in systemic exposure to didanosine that may increase the risk of didanosine-related adverse reactions (see section 4.5).
Slovenian: Sočasna uporaba dizoproksiltenofovirata in didanozina povzroča povečanje sistemske izpostavljenosti didanozinu za 40-60%, kar lahko poveča tveganje za pojav neželenih učinkov, povezanih z didanozinom (glejte poglavje 4.5).
English: Each tablet contains 164 mg lactose (as monohydrate).
Slovenian: Ena tableta vsebuje 164 mg laktoze (v obliki laktoze monohidrata).
English: NAME OF THE MEDICINAL PRODUCT Viread 245 mg film-coated tablets
Slovenian: IME ZDRAVILA Viread 245 mg filmsko obložene tablete
English: You do not need to take another dose if you were sick more than 1 hour after taking Viread.
Slovenian: Še enega odmerka vam ni treba vzeti, če je bruhanje nastopilo več kot 1 uro po zaužitju zdravila Viread.
English: Viread 163 mg tablets are not suitable for the following groups:
Slovenian: Zdravilo Viread 163 mg tablete ni primerno za naslednje skupine:
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.
Slovenian: MELD (Model for EndStage Liver Desease, Model za ledvično obolenje v končni fazi) v primerjavi z izhodiščno vrednostjo a Vrednost p za kombinirani skupini, ki sta vsebovali tenofovir, v primerjavi s skupino z entekavirjem = 0,622, b Vrednost p za kombinirani skupini, ki sta vsebovali tenofovir, v primerjavi s skupino z entekavirjem = 1,000.
English: INFORMATION IN BRAILLE Viread 163 mg [Outer packaging only]
Slovenian: PODATKI V BRAILLOVI PISAVI Viread 163 mg [samo na zunanji ovojnini]
English: NAME OF THE MEDICINAL PRODUCT Viread 33 mg/g granules Tenofovir disoproxil
Slovenian: IME ZDRAVILA Viread 33 mg/g zrnca dizoproksiltenofovirat
English: One gram of Viread granules contains 33 mg of tenofovir disoproxil (as fumarate).
Slovenian: En gram zdravila Viread zrnca vsebuje 33 mg dizoproksiltenofovirata (v obliki fumarata).
English: by week 240.
Slovenian: (n = 2), 240.
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).
Slovenian: Pri bolnikih s HIV, sočasno okuženih s HBV, so po prekinitvi zdravljenja z dizoproksiltenofoviratom opazili klinične in laboratorijske znake hepatitisa (glejte poglavje 4.4).
English: (increase is indicated as “↑”, decrease as “↓”, no change as “↔”, twice daily as “b.i.d.”, and once daily as “q.d.”).
Slovenian: Interakcije med dizoproksiltenofoviratom in drugimi zdravili so navedene v preglednici 2 spodaj (povečanje je označeno z znakom “↑”, zmanjšanje z “↓”, brez spremembe z “↔”, dvakrat na dan z “bid.”, enkrat na dan pa s “q.d.”).
English: If your child throws up less than 1 hour after taking Viread, give your child another tablet.
Slovenian: Če vaš otrok bruha manj kot 1 uro po zaužitju zdravila Viread, naj vzame še eno tableto.
English: Bone Mineral Density (BMD) data from Study GS-US-174-0144 are summarized in Table 9:
Slovenian: Podatki o mineralni gostoti kosti (MGK) iz študije GS-US-174-0144 so povzeti v preglednici 9:
English: Each tablet contains 109 mg lactose (as monohydrate).
Slovenian: Ena tableta vsebuje 109 mg laktoze (v obliki laktoze monohidrata).
English: NAME OF THE MEDICINAL PRODUCT Viread 123 mg film-coated tablets
Slovenian: IME ZDRAVILA Viread 123 mg filmsko obložene tablete
English: Table 3: Tabulated summary of adverse reactions associated with tenofovir disoproxil based on clinical study and post-marketing experience
Slovenian: Preglednica 3: Povzetek neželenih učinkov, povezanih z dizoproksiltenofoviratom na podlagi izkušenj iz kliničnih študij in izkušenj v obdobju trženja zdravila
English: Viread 204 mg tablets are not suitable for the following groups:
Slovenian: Zdravilo Viread 204 mg tablete ni primerno za naslednje skupine:
English: INFORMATION IN BRAILLE Viread 204 mg [Outer packaging only]
Slovenian: PODATKI V BRAILLOVI PISAVI Viread 204 mg [samo na zunanji ovojnini]
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.
Slovenian: Priporočeni odmerek za zdravljenje pediatričnih bolnikov, okuženih s HIV-1 in kroničnim hepatitisom B, starih 6 do < 12 let, s telesno maso 28 kg do < 35 kg, ki lahko pogoltnejo filmsko obložene tablete, je ena 204 mg tableta enkrat dnevno, peroralno, s hrano.
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”.
Slovenian: Bele, filmsko obložene tablete v obliki kapsule, z dimenzijami 15, 4 mm x 7,3 mm, z vtisnjenim znakom “GSI” na eni strani ter znakom “250” na drugi strani.
English: Ninety-five percent of nucleos(t)ide-naïve patients, 84% of nucleos(t)ide-experienced patients, and 83% of lamivudineresistant patients achieved HBV DNA < 400 copies/ml at week 72.
Slovenian: 95% bolnikov, ki se predhodno še niso zdravili z nukleoz(t)idi, 84 % bolnikov, ki so se predhodno že zdravili z nukleoz(t)idi, in 83 % bolnikov, rezistentnih na lamivudin, je doseglo koncentracijo HBV DNA < 400 kopij/ml v 72. tednu.
English: Chronic hepatitis B: Steady-state tenofovir exposure in HBV infected adolescent patients (12 to < 18 years of age) receiving an oral daily dose of tenofovir disoproxil 245 mg was similar to exposures achieved in adults receiving once-daily doses of tenofovir disoproxil 245 mg .
Slovenian: Kronični hepatitis B: Izpostavljenost tenofovirju v stanju dinamičnega ravnovesja pri mladostnikih (starih 12 do < 18 let), okuženih z virusom HBV, ki so peroralno prejemali dnevni odmerek 245 mg dizoproksiltenofovirata, je bila podobna kot izpostavljenost, dosežena pri odraslih, ki so prejemali enkratni dnevni odmerek 245 mg dizoproksiltenofovirata.
English: How to store Viread
Slovenian: Shranjevanje zdravila Viread