FrancophonIA/ELRC3.0 huggingface dataset:
English: Viread granules should be mixed with soft food which does not require chewing (for example, yoghurt, applesauce or baby food).
Slovenian: Zdravilo Viread zrnca se premeša z mehko hrano, ki je ni treba prežvečiti (recimo z jogurtom, jabolčno čežano ali hrano za otroke).
English: Viread may affect your kidneys during treatment.
Slovenian: Zdravilo Viread lahko med zdravljenjem vpliva na ledvice.
English: These pharmacokinetic modelling data have not been confirmed in clinical studies.
Slovenian: Ti podatki farmakokinetičnega modeliranja v kliničnih študijah niso bili potrjeni.
English: Croscarmellose sodium Lactose monohydrate Magnesium stearate (E572) Microcrystalline cellulose (E460) Starch pregelatinised
Slovenian: Jedro tablete premreženi natrijev karmelozat laktoza monohidrat magnezijev stearat (E572) mikrokristalna celuloza (E460) predgelirani škrob
English: If you have been told by your child's doctor that your child has an intolerance to some sugars, contact your child's doctor before they take this medicinal product.
Slovenian: Če vam je otrokov zdravnik povedal, da ima vaš otrok intoleranco za nekatere sladkorje, se pred uporabo tega zdravila posvetujte z njegovim zdravnikom.
English: Refer to section 2 “Viread granules contain mannitol”.
Slovenian: Glejte poglavje 2 “Zdravilo Viread zrnca vsebuje manitol”.
English: If you take more Viread than you should
Slovenian: Če ste vzeli večji odmerek zdravila Viread, kot bi smeli
English: • children and adolescents aged 2 to less than 18 years.
Slovenian: • otroke in mladostnike, stare 2 do manj kot 18 let.
English: Co-administration of Viread and didanosine is not recommended as this may result in an increased risk of adverse reactions (see section 4.5).
Slovenian: Sočasna uporaba zdravila Viread in didanozina ni priporočljiva, saj lahko poveča tveganje neželenih učinkov (glejte poglavje 4.5).
English: HIV-1 and Chronic hepatitis B
Slovenian: HIV-1 in kronični hepatitis B
English: Therefore Viread should not be used during breast-feeding.
Slovenian: Zato se zdravilo Viread med dojenjem ne sme uporabljati.
English: Viread may affect your child's kidneys during treatment.
Slovenian: Zdravilo Viread lahko med zdravljenjem vpliva na otrokove ledvice.
English: In studies with nucleoside-naïve patients, on-treatment ALT elevations > 10 times ULN (upper limit of normal) and > 2 times baseline occurred in 2.6% of tenofovir disoproxil-treated patients.
Slovenian: V študijah pri bolnikih, ki še niso bili zdravljeni z nukleozidi, so se zvišanja ALT med zdravljenjem za > 10-kratno vrednost ZMN (zgornje meje normalne vrednosti) in > 2-kratno vrednost izhodiščne vrednosti pojavila pri 2,6 % bolnikov, zdravljenih z dizoproksiltenofoviratom.
English: • It is also important to tell your doctor if your child is taking ledipasvir/sofosbuvir, sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/voxilaprevir to treat hepatitis C infection.
Slovenian: • Prav tako je pomembno, da svojemu osebnemu zdravniku poveste, če vaš otrok jemlje ledipasvir/sofosbuvir, sofosbuvir/velpatasvir ali sofosbuvir/velpatasvir/voksilaprevir za zdravljenje okužbe s hepatitisom C.
English: If your child has a history of liver disease or chronic hepatitis B infection your child's doctor may conduct blood tests to monitor their liver function.
Slovenian: Če je vaš otrok imel jetrne bolezni ali ima okužbo s kroničnim hepatitisom B, bo njegov zdravnik morda opravil krvne preiskave za nadzorovanje otrokove jetrne funkcije.
English: Viread should be taken once daily, orally with food.
Slovenian: Zdravilo Viread je treba jemati enkrat dnevno, peroralno s hrano.
English: In subjects with end-stage renal disease (ESRD) (CrCl < 10 ml/min) requiring haemodialysis, a dose of 16.5 mg tenofovir disoproxil following completion of haemodialysis is predicted to limit tenofovir systemic accumulation to exposures approximately 2-fold compared to those observed in patients with normal renal function receiving tenofovir disoproxil 245 mg film-coated tablets.
Slovenian: Pri osebah z ledvičnim obolenjem v končni fazi (ESRD, end stage renal disease) (CLCR < 10 ml/min), ki so potrebovali hemodializo, se predvideva, da odmerek 16,5 mg dizoproksiltenofovirata po končani hemodializi omeji sistemsko kopičenje tenofovirja do izpostavljenosti, ki so približno 2-kratne v primerjavi s tistimi, opaženimi pri bolnikih z normalno ledvično funkcijo, ki so prejemali dizoproksiltenofovirat 245 mg filmsko obložene tablete.
English: In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after your child starts taking medicines for the treatment of their HIV infection.
Slovenian: Poleg oportunističnih okužb se lahko po začetku jemanja zdravil za zdravljenje okužbe s HIV pri vašem otroku pojavijo tudi avtoimunske bolezni (stanja, do katerih pride, ko imunski sistem napade zdravo telesno tkivo).
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.
Slovenian: Pri otrocih, katerih matere so med nosečnostjo jemale zdravila, kot je zdravilo Viread (nukleozidne zaviralce reverzne transkriptaze (NRTI, nucleoside reverse transcriptase inhibitors), je korist zaščite pred virusom odtehtala tveganje za neželene učinke.
English: • If your child has taken Viread during their pregnancy, your child's doctor may request regular blood tests and other diagnostic tests to monitor the development of the baby.
Slovenian: • Če je vaša hči zdravilo Viread jemala med nosečnostjo, jo lahko zdravnik naroči na redne preiskave krvi in druge diagnostične preiskave, da bo spremljal razvoj njenega otroka.
English: Look out for signs of inflammation or infection soon after you start taking Viread.
Slovenian: Bodite pozorni na simptome vnetja ali okužbe kmalu po začetku jemanja zdravila Viread.
English: Please refer to the Summary of Product Characteristics for Viread 33 mg/g granules.
Slovenian: Glejte povzetek glavnih značilnosti zdravila Viread 33 mg/g zrnca.
English: Тел.
Slovenian: CART.
English: Administration of Viread 33 mg/g granules to provide a reduced daily dose of tenofovir disoproxil is recommended for adult patients with creatinine clearance < 50 ml/min, including haemodialysis patients.
Slovenian: Dajanje zdravila Viread 33 mg/g zrnca za dostavo zmanjšanega dnevnega odmerka dizoproksiltenofovirata je priporočljivo pri odraslih bolnikih, ki imajo očistek kreatinina < 50 ml/min, vključno z bolniki na hemodializi.
English: • If you are an adult and have problems with your kidneys, your doctor may advise you to reduce your daily dose of the granules.
Slovenian: • Če ste odrasla oseba in imate ledvične težave, vam bo zdravnik morda svetoval zmanjšanje dnevnega odmerka zrnc.
English: If your child stops taking Viread
Slovenian: Če je vaš otrok prenehal jemati zdravilo Viread
English: There were no clinically significant pharmacokinetic interactions when tenofovir disoproxil was co-administered with emtricitabine, lamivudine, indinavir, efavirenz, nelfinavir, saquinavir (ritonavir boosted), methadone, ribavirin, rifampicin, tacrolimus, or the hormonal contraceptive norgestimate/ethinyl oestradiol.
Slovenian: Pri sočasni uporabi dizoproksiltenofovirata in emtricitabina, lamivudina, indinavirja, efavirenza, nelfinavirja, sakinavirja (okrepljenega z ritonavirjem), metadona, ribavirina, rifampicina, takrolimusa ali hormonskega kontracepcijskega sredstva norgestimata/etinilestradiola ni bilo klinično pomembnih farmakokinetičnih interakcij.
English: Duration of therapy in paediatric patients with chronic hepatitis B
Slovenian: Trajanje zdravljenja pri pediatričnih bolnikih s kroničnim hepatitisom B
English: In non-proliferating human peripheral blood mononuclear cells (PBMCs) the half-life of tenofovir diphosphate was found to be approximately 50 hours, whereas the half-life in phytohaemagglutininstimulated PBMCs was found to be approximately 10 hours.
Slovenian: Razpolovni čas T½ za tenofovir difosfat je v ne-proliferajočih humanih mononuklearnih celicah periferne krvi (PBMC) približno 50 ur, T½ v fitohemaglutinin-stimuliranih PBMC pa približno 10 ur.
English: Do not take Viread together with medicines containing adefovir dipivoxil (a medicine used to treat chronic hepatitis B).
Slovenian: Ne jemljite zdravila Viread skupaj z zdravili, ki vsebujejo dipivoksiladefovirat (zdravilo, ki se uporablja za zdravljenje kroničnega hepatitisa B).
English: HBsAg loss/ seroconversion n k n n a Based upon Long Term Evaluation algorithm (LTE Analysis) - Patients who discontinued the study at any time prior to week 384 due to a protocol defined endpoint, as well as those completing week 384, are included in the denominator.
Slovenian: 1/1n a Na podlagi algoritma dolgoročne ocenitve (Long Term Evaluation algorithm - LTE) - Bolniki, ki prenehajo sodelovati v študiji kadar koli pred 384. tednom zaradi izida, opredeljenega v protokolu, kot tudi tisti, ki dopolnijo 384 tednov, so vključeni v denominator.
English: What Viread looks like and contents of the pack
Slovenian: Izgled zdravila Viread in vsebina pakiranja
English: Severe renal impairment (creatinine clearance < 30 ml/min) and haemodialysis patients For patients unable to take the granule formulation of tenofovir disoproxil and with no alternative treatment available, prolonged dose intervals using the 245 mg film-coated tablets may be used as follows:
Slovenian: Huda ledvična okvara (očistek kreatinina < 30 ml/min) in bolniki na hemodializi Za bolnike, ki formulacije dizoproksiltenofovirata v obliki zrnc ne morejo jemati in pri katerih ni na voljo alternativne oblike zdravljenja, se lahko uporabijo podaljšani odmerni intervali z 245 mg filmsko obložene tablet, kot sledi:
English: - In HBeAg positive patients without cirrhosis, treatment should be administered for at least 12 months after HBe seroconversion (HBeAg loss and HBV DNA loss with anti-HBe detection on two consecutive serum samples at least 3-6 months apart) is confirmed or until HBs seroconversion or there is loss of efficacy (see section 4.4).
Slovenian: - Pri HBeAg pozitivnih bolnikih brez ciroze naj zdravljenje traja najmanj 12 mesecev po potrditvi HBe serološke konverzije (izguba HBeAg in izguba HBV DNA z detekcijo anti-HBe pri najmanj dveh vzorcih seruma v razmaku najmanj 3-6 mesecev) ali do HBs serološke konverzije ali dokler ne pride do izgube učinkovitosti (glejte poglavje 4.4).
English: Refer to Table 1.
Slovenian: Glejte preglednico 1.
English: Normal ALT ≥ 2 point decrease in CPT from baseline n (%)
Slovenian: ALT n (%) normalne koncentracije ALT ≥ 2 točki nižje število točk po CPT lestvici v primerjavi z izhodiščno vrednostjo n (%)
English: If your child has advanced HIV infection (AIDS) and has an infection, they may develop symptoms of infection and inflammation or worsening of the symptoms of an existing infection once treatment with Viread is started.
Slovenian: Če ima vaš otrok napredovalo okužbo s HIV (AIDS) in ima kakšno okužbo, se lahko ob uvedbi zdravljenja z zdravilom Viread razvijejo simptomi okužbe in vnetja ali poslabšanje simptomov že obstoječe okužbe.
English: If you are an adult, your doctor may advise you to reduce your daily dose of the granules.
Slovenian: Če ste odrasla oseba, vam bo zdravnik morda svetoval zmanjšanje dnevnega odmerka zrnc.
English: A pharmacokinetic study has been performed in non-HIV infected adult patients with various degrees of hepatic impairment.
Slovenian: Izvedli so farmakokinetično študijo pri odraslih bolnikih z različnimi stopnjami ledvične okvare, ki niso bili okuženi s HIV.
English: If your child is pregnant or breast-feeding, or they think they may be pregnant, ask your child's doctor or pharmacist for advice before they take this medicine.
Slovenian: Če je vaša hči noseča ali doji, meni, da bi lahko bila noseča ali načrtuje zanositev, se posvetujte z njenim zdravnikom ali farmacevtom, preden vzame to zdravilo.
English: Keep the granules bottle with you so that you can easily describe what you have taken.
Slovenian: S seboj imejte plastenko zrnc, da boste lahko opisali, kaj ste zaužili.
English: a The population used for analysis of histology included only patients with available liver biopsy data (Missing = Excluded)
Slovenian: Histološki odziva,b a V populaciji, ki so jo uporabili za histološko analizo, so bili samo bolniki, za katere so bili na voljo podatki o biopsiji jeter (manjkajoči = izključeni) do 240. tedna.
English: If you forget to take Viread
Slovenian: Če ste pozabili vzeti zdravilo Viread
English: Viread has not been studied in patients over 65 years of age.
Slovenian: Zdravila Viread niso proučevali pri bolnikih starejših od 65 let.
English: A statistically significant difference in favour of tenofovir disoproxil 245 mg was seen in the time-weighted average change from baseline at week 24 (DAVG24) for CD4 count (+13 cells/mm3 for tenofovir disoproxil 245 mg versus -11 cells/mm3 for placebo,
Slovenian: Statistično značilna razlika v prid 245 mg dizoproksiltenofoviratu je bila opažena v časovno vrednoteni srednji vrednosti spremembe od začetne vrednosti v 24. tednu (DAVG24) pri številu CD4 (+13 celic/mm3 za 245 mg dizoproksiltenofovirat proti -11 celic/mm3 za placebo, p = 0,0008).
English: Genotypic evaluations were performed on all patients within this group with HBV DNA > 400 copies/ml at week 48 (n = 6), week 72 (n = 5), week 96 (n = 4), week 144 (n = 2), and week 192 (n = 3).
Slovenian: Genotipsko ocenitev so opravili pri vseh bolnikih v tej skupini s koncentracijo HBV DNA > 400 kopij/ml v 48. tednu (n = 6), 72. tednu (n = 5), 96. tednu (n = 4), 144. tednu (n = 2) in 192. tednu (n = 3).
English: • Do not breast-feed during treatment with Viread.
Slovenian: • Med zdravljenjem z zdravilom Viread ne dojite.
English: Experience in patients with compensated liver disease at 48 weeks (studies GS-US-174-0102 and GS-US-174-0103)
Slovenian: Izkušnje pri bolnikih s kompenzirano jetrno boleznijo v 48. tednu (študiji GS-US-174-0102 in GS-US-174-0103)
English: High density polyethylene (HDPE) bottle with a polypropylene child-resistant closure containing 60 g of granules and a dosing scoop.
Slovenian: Plastenka iz zgoščenega polietilena (HDPE, High Density Polyethylene) s polipropilensko, za otroke varno zaporko vsebuje 60 g zrnc in merico za odmerjanje.
English: If you have advanced HIV infection (AIDS) and have an infection, you may develop symptoms of infection and inflammation or worsening of the symptoms of an existing infection once treatment with Viread is started.
Slovenian: Če imate napredovalo okužbo s HIV (AIDS) in imate kakšno okužbo, se lahko ob uvedbi zdravljenja z zdravilom Viread pri vas razvijejo simptomi okužbe in vnetja ali poslabšanje simptomov že obstoječe okužbe.
English: In some patients with advanced liver disease or cirrhosis, stopping treatment is not recommended as this may lead to worsening of your child's hepatitis.
Slovenian: Pri bolnikih z napredovalo boleznijo jeter ali cirozo se prekinitev zdravljenja ne priporoča, saj pri vašem otroku lahko povzroči poslabšanje hepatitisa.
English: • Talk to your doctor before you stop taking Viread for any reason, particularly if you are experiencing any side effects or you have another illness.
Slovenian: • Preden prenehate jemati zdravilo Viread iz katerega koli razloga, se pogovorite z zdravnikom, še zlasti če imate kakršne koli neželene učinke ali kakšno drugo bolezen.
English: In studies GS-US-174-0102 and GS-US-174-0103, after receiving double-blind treatment for 48 weeks (either tenofovir disoproxil 245 mg or adefovir dipivoxil 10 mg), patients rolled over with no interruption in treatment to open-label tenofovir disoproxil.
Slovenian: V študijah GS-US-174-0102 in GS-US-174-0103, po 48-tedenskem dvojno slepem zdravljenju (bodisi z dizoproksiltenofoviratom 245 mg ali z dipivoksiladefoviratom 10 mg), so bolniki brez prekinitve prešli na nezaslepljeno zdravljenje z dizoproksiltenofoviratom.
English: What Viread is and what it is used for What you need to know before you take Viread How to take Viread
Slovenian: Kaj je zdravilo Viread in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Viread Kako jemati zdravilo Viread Možni neželeni učinki
English: Viread granules should be mixed in a container with soft food not requiring chewing, for example yoghurt, applesauce or baby food.
Slovenian: Zdravilo Viread zrnca je treba v vsebniku premešati z majhno količino mehke hrane, ki je ni treba prežvečiti, recimo z jogurtom, jabolčno čežano ali hrano za otroke.
English: • HBV infected children and adolescents aged 2 to less than 18 years.
Slovenian: • otroke in mladostnike, okužene s HBV, stare 2 do manj kot 18 let.
English: • If you are an adult and have problems with your kidneys, your doctor may advise you to take Viread less frequently.
Slovenian: • Če ste odrasla oseba in imate ledvične težave, vam bo zdravnik morda svetoval, da jemljete zdravilo Viread manj pogosto.
English: (4 subjects)
Slovenian: (4 bolnika)
English: Table 7: Histological response (%) in compensated HBeAg negative and HBeAg positive subjects at week 240 compared to baseline
Slovenian: Preglednica 7: Histološki odziv (%) pri kompenziranih bolnikih, negativnih na HBeAg in pozitivnih na HBeAg v 240. tednu v primerjavi z izhodiščno točko
English: Your child's doctor will monitor their weight.
Slovenian: Otrokov zdravnik bo nadziral otrokovo telesno maso.
English: Hepatitis B infection Viread 245 mg film-coated tablets are indicated for the treatment of chronic hepatitis B in adults with:
Slovenian: Zdravilo Viread 245 mg filmsko obložene tablete je indicirano za zdravljenje kroničnega hepatitisa B pri odraslih:
English: Glycerol triacetate (E1518) Hypromellose (E464) Lactose monohydrate Titanium dioxide (E171)
Slovenian: Filmska obloga triacetin (E1518) hipromeloza (E464) laktoza monohidrat titanov dioksid (E171)
English: Severe renal impairment (creatinine clearance < 30 ml/min) and haemodialysis patients For patients with creatinine clearance 20-29 ml/min: Administration of 65 mg (2 scoops) tenofovir disoproxil 33 mg/g granules once daily is recommended.
Slovenian: Huda ledvična okvara (očistek kreatinina < 30 ml/min) in bolniki na hemodializi Za bolnike z očistkom kreatinina 20-29 ml/min: Priporoča se dajanje 65 mg (2 merici) dizoproksiltenofovirata 33 mg/g zrnca enkrat na dan.
English: NA = Not Applicable a BMD Z-scores not adjusted for height and weight b Primary safety endpoint through week 72
Slovenian: navedba smiselno ni potrebna navedba smiselno ni potrebna a Z-indeks MGK ni prilagojen za telesno višino in maso b Primarni varnostni izid v 72. tednu
English: There are uncertainties associated with the long term effects of bone and renal toxicity.
Slovenian: Učinki na ledvice in kosti pri pediatrični populaciji V povezavi z dolgoročnimi toksičnimi učinki na kosti in ledvice obstajajo negotovosti.
English: • Check your child's age and weight to see if Viread 163 mg tablets are suitable, see Children and adolescents.
Slovenian: • Preverite starost in telesno maso svojega otroka, da se prepričate, ali je zdravilo Viread 163 mg tablete primerno, glejte Otroci in mladostniki.
English: If you stop taking Viread
Slovenian: Če ste prenehali jemati zdravilo Viread
English: Moderate renal impairment (creatinine clearance 30-49 ml/min) For patients unable to take the granule formulation of tenofovir disoproxil, prolonged dose intervals using the 245 mg film-coated tablets may be used.
Slovenian: Zmerna ledvična okvara (očistek kreatinina od 30-49 ml/min) Za bolnike, ki formulacije dizoproksiltenofovirata v obliki zrnc ne morejo jemati, se lahko uporabijo podaljšani odmerni intervali z 245 mg filmsko obložene tablete.
English: Light blue, almond-shaped, film-coated tablets, of dimensions 16.8 mm x 10.3 mm, debossed on one side with “GILEAD” and “4331” and on the other side with “300”.
Slovenian: Svetlo modre, mandljaste oblike, filmsko obložene tablete, z dimenzijami 16,8 mm x 10,3 mm, z vtisnjenima znakoma “GILEAD” in “4331” na eni strani ter znakom “300” na drugi strani.
English: Viread can cause dizziness.
Slovenian: Zdravilo Viread lahko povzroči omotičnost.
English: • Check your child's age and weight to see if Viread 204 mg tablets are suitable, see Children and adolescents.
Slovenian: • Preverite starost in telesno maso svojega otroka, da se prepričate, ali je zdravilo Viread 204 mg tablete primerno, glejte Otroci in mladostniki.
English: It is recommended that renal function (creatinine clearance and serum phosphate) is assessed in all patients prior to initiating therapy with tenofovir disoproxil and that it is also monitored after two to four weeks of treatment, after three months of treatment and every three to six months thereafter in patients without renal risk factors.
Slovenian: Pred začetkom zdravljenja z dizoproksiltenofoviratom se pri vseh bolnikih priporoča ocena ledvične funkcije (očistek kreatinina in koncentracija serumskega fosfata) in nadzor delovanja ledvic po dveh do štirih tednih zdravljenja, po treh mesecih zdravljenja in zatem vsake tri do šest mesecev pri bolnikih brez dejavnikov tveganja za ledvice.
English: LIST OF EXCIPIENTS Contains mannitol.
Slovenian: SEZNAM POMOŽNIH SNOVI Vsebuje manitol.
English: Viread 33 mg/g granules are not suitable for the following groups:
Slovenian: Zdravilo Viread 33 mg/g zrnca ni primerno za naslednje skupine:
English: If your child has hepatitis B or HIV and hepatitis B together (co-infection), it is very important not to stop their Viread treatment without talking to your child's doctor first.
Slovenian: Če je vaš otrok okužen s hepatitisom B ali z virusom HIV in hepatitisom B (sočasna okužba), je zelo pomembno, da ne preneha z zdravljenjem z zdravilom Viread, ne da bi se prej posvetovali z otrokovim zdravnikom.
English: The decision to treat paediatric patients (adolescents and children) 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.
Slovenian: Odločitev za zdravljenje pediatričnih bolnikov (mladostnikov in otrok) mora temeljiti na skrbnem upoštevanju individualnih potreb bolnika in upoštevati trenutne smernice za zdravljenje pediatričnih bolnikov, vključno z vrednostjo izhodiščnih histoloških podatkov.
English: • Do not take Viread if you are already taking other medicines containing tenofovir disoproxil or tenofovir alafenamide.
Slovenian: • Zdravila Viread ne jemljite, če že jemljete druga zdravila, ki vsebujejo dizoproksiltenofovirat ali tenofoviralafenamid.
English: What Viread looks like and contents of the pack This medicine consists of white coated granules.
Slovenian: To zdravilo so bela obložena zrnca.
English: Viread 33 mg/g granules are also indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected adults for whom a solid dosage form is not appropriate.
Slovenian: Zdravilo Viread 33 mg/g zrnca je indicirano tudi v kombinaciji z drugimi protiretrovirusnimi zdravili za zdravljenje odraslih, okuženih s HIV-1, pri katerih ni mogoče uporabiti trdne farmacevtske oblike.
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).
Slovenian: Podatki o biopsiji jeter ob izhodišču in v 240. tednu so na voljo za 331/489 bolnikov, ki so ostali v študijah GS-US-174-0102 in GS-US-174-0103 v 240. tednu (glejte preglednico 7 spodaj).
English: 90 (3 bottles of 30) tablets.
Slovenian: 90 (3 plastenke s 30) filmsko obloženih tablet 90 (3 plastenke s 30) tablet
English: Subjects must have been naïve to tenofovir disoproxil, with HBV DNA > 105 copies/mL (~ 4.2 log10 IU/mL) and ALT >1.5 × the upper limit of normal (ULN) at screening.
Slovenian: HBV DNA > 105 kopij/ml (~ 4,2 log10 i.e./ml) in ALT > 1,5 × zgornja meja normalne vrednosti (ZMN).
English: Confirmed increase in serum creatinine ≥ 0.5 mg/dl from baseline or confirmed serum phosphate of < 2 mg/dl n (%)b
Slovenian: Potrjeno zvišanje serumske koncentracije kreatinina za ≥ 0,5 mg/dl od izhodiščne vrednosti ali potrjena serumska koncentracija fosfata za < 2 mg/dl (%) n (%)b