FrancophonIA/ELRC3.0 huggingface dataset:
English: Ninety-five percent of nucleos(t)ide-naïve patients, 84% of nucleos(t)ide- experienced patients, and 83% of lamivudine-resistant 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: If the patient vomits within 1 hour of taking Tenofovir disoproxil Zentiva another tablet should be taken.
Slovenian: Če bolnik v roku 1 ure od jemanja zdravila Dizoproksiltenofovirat Zentiva bruha, naj vzame drugo tableto.
English: Romania or
Slovenian: Romunija ali
English: Table 1: Interactions between tenofovir disoproxil and other medicinal products
Slovenian: Preglednica 1: Interakcije med dizoproksiltenofoviratom in drugimi zdravili Učinkovine po terapevtskih področjih (odmerek v mg)
English: Bone Mineral Density (BMD) data from Study GS-US-174-0144 are summarized in Table 9: Table 9: Bone Mineral Density Evaluation at Baseline and Week 48
Slovenian: Podatki o mineralni gostoti kosti (MGK) iz študije GS-US-174-0144 so povzeti v preglednici 9:
English: n Figures presented are cumulative percentages based upon a Kaplan Meier analysis excluding data collected after the addition of emtricitabine to open-label tenofovir disoproxil (KM-tenofovir disoproxil).
Slovenian: n Prikazane številke so kumulativni odstotki na podlagi Kaplan-Meierjeve analize, brez podatkov zbranih po dodajanju emtricitabina k odprtemu zdravljenju z dizoproksiltenofoviratom (KMdizoproksiltenofovirat).
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
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: Didanosine Co-administration of tenofovir disoproxil and didanosine is not recommended (see section 4.4 and Table 1).
Slovenian: Sočasna uporaba dizoproksiltenofovirata in didanozina ni priporočena (glejte poglavje 4.4 in preglednico 1).
English: No amino acid substitutions associated with resistance to tenofovir disoproxil were identified in these isolates by week 48.
Slovenian: V teh izolatih do 48. tedna niso identificirali nobenih substitucij aminokislin, ki bi bile povezane z rezistenco na dizoproksiltenofovirat.
English: Tenofovir disoproxil should not be administered concurrently with adefovir dipivoxil (see section 4.4).
Slovenian: Dizoproksiltenofovirata se ne sme uporabljati skupaj z dipivoksiladefoviratom (glejte poglavje 4.4).
English: 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.
Slovenian: V 48. tednu je 25 % (14 od 56) bolnikov v skupini, zdravljeni z dizoproksiltenofoviratom, in 24 % (7 od 29) bolnikov v skupini, ki je prejemala placebo, doseglo serološko konverzijo HBeAg.
English: The following side effects are rare (may affect up to 1 in 1,000 people):
Slovenian: Naslednji neželeni učinki so redki (prizadenejo lahko do 1 od 1.000 bolnikov):
English: Patients with lamivudine-resistant chronic hepatitis B: No new adverse reactions to tenofovir disoproxil were identified from a randomised, double-blind study (GS-US-174-0121) in which 280 lamivudineresistant patients received treatment with tenofovir disoproxil (n = 141) or emtricitabine/tenofovir disoproxil (n = 139) for 240 weeks.
Slovenian: Bolniki s kroničnim hepatitisom B, rezistentnim na lamivudin: Novih neželenih učinkov na dizoproksiltenofovirat v randomizirani, dvojno slepi študiji (GS-US-174-0121), v kateri je 280 na lamivudin rezistentnih bolnikov 240 tednov prejemalo zdravljenje z dizoproksiltenofoviratom (n = 141) ali emtricitabinom/dizoproksiltenofoviratom (n = 139), niso opredelili.
English: How to take Tenofovir disoproxil Zentiva
Slovenian: Kako jemati zdravilo Dizoproksiltenofovirat Zentiva
English: • drowsiness,
Slovenian: • omotičnost
English: The active substance tenofovir disoproxil phosphate and its main transformation products are persistent in the environment.
Slovenian: Ocena tveganja za okolje (ERA, Environmental Risk Assessment) Učinkovina dizoproksiltenofovirijev fosfat in njeni glavni presnovki so v okolju obstojni.
English: Co-administration of tenofovir disoproxil and didanosine is not recommended as it 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 ni priporočljiva, saj povzroča povečanje sistemske izpostavljenosti didanozinu za 40-60%, kar lahko poveča tveganje za pojav neželenih učinkov, povezanih z didanozinom (glejte poglavje 4.5).
English: NAME OF THE MEDICINAL PRODUCT Tenofovir disoproxil Zentiva 245 mg film-coated tablets
Slovenian: IME ZDRAVILA Dizoproksiltenofovirat Zentiva 245 mg filmsko obložene tablete
English: The following pack sizes are available: Outer cartons containing 1 bottle of 30 film-coated tablets and 3 bottles of 30 film-coated tablets.
Slovenian: Škatle z 1 plastenko s 30 filmsko obloženimi tabletami in 3 plastenkami s 30 filmsko obloženimi tabletami.
English: Co-administration of tenofovir disoproxil with ledipasvir/sofosbuvir, sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/voxilaprevir has been shown to increase plasma concentrations of tenofovir, especially when used together with an HIV regimen containing tenofovir disoproxil and a pharmacokinetic enhancer (ritonavir or cobicistat).
Slovenian: Uporaba z nekaterimi protivirusnimi zdravili za hepatitis C Sočasno dajanje dizoproksiltenofovirata in ledipasvirja/sofosbuvirja, sofosbuvirja/velpatasvirja ali sofosbuvirja/velpatasvirja/voksilaprevirja poveča koncentracije tenofovirja v plazmi, še posebej, če se uporablja skupaj z zdravljenjem HIV, ki vključuje dizoproksiltenofovirat in farmakokinetični ojačevalec (ritonavir ali kobicistat).
English: Treatment with tenofovir disoproxil 245 mg was associated with a mean change in serum HBV DNA from baseline, in the patients for whom there was 48-week data, of -5.74 log10 copies/ml (n = 18).
Slovenian: Pri bolnikih, za katere obstajajo podatki za 48 tednov, je bilo zdravljenje z 245 mg dizoproksiltenofovirata povezano s povprečno spremembo koncentracije HBV DNA v serumu od izhodiščne točke -5,74 log10 kopij/ml (n = 18).
English: • pain in the tummy (abdomen) caused by inflammation of the pancreas, • damage to kidney tubule cells.
Slovenian: • bolečine v trebuhu zaradi vnetja trebušne slinavke • okvara celic ledvičnih tubulov
English: Consideration should also be given to interrupting treatment with tenofovir disoproxil in adult patients with creatinine clearance decreased to < 50 ml/min or decreases in serum phosphate to < 1.0 mg/dl (0.32 mmol/l).
Slovenian: Pri odraslih bolnikih z zmanjšanjem očistka kreatinina na < 50 ml/min ali z zmanjšanjem serumskega fosfata na < 1,0 mg/dl (0,32 mmol/l) je treba presoditi tudi o prekinitvi zdravljenja z dizoproksiltenofoviratom.
English: Intracellular pharmacokinetics
Slovenian: Znotrajcelične farmakokinetične lastnosti
English: Mean changes at week 48 (end of double-blind phase) were -0.215 and -0.165 in lumbar spine BMD Zscore, 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 oziroma0,165 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: 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: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 245 mg of tenofovir disoproxil (as phosphate).
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena filmsko obložena tableta vsebuje 245 mg dizoproksiltenofovirata (v obliki fosfata).
English: Median HBV DNA reduction from baselinec
Slovenian: Mediana zmanjšanja HBV DNA v primerjavi z izhodiščno točkoc
English: diarrhoea, vomiting, nausea
Slovenian: driska, bruhanje, navzea
English: Two hundred and fifteen HBeAg negative (GS-US-174-0102, n = 125) and HBeAg positive (GS-US-1740103, 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.
Slovenian: Pri 215 bolnikih, negativnih na HBeAg (GS-US-174-0102, n = 125) in pozitivnih na HBeAg (GS-US174-0103, 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.
English: Tenofovir disoproxil Zentiva contains lactose monohydrate.
Slovenian: Zdravilo Dizoproksiltenofovirat Zentiva vsebuje laktozo monohidrat.
English: Total body bone gain was less in the tenofovir disoproxil treatment group compared to the stavudine or zidovudine treatment group.
Slovenian: Povečanje kostne gostote za celo telo je bilo v skupini, zdravljeni z dizoproksiltenofoviratom, manjše kot v skupini, zdravljeni s stavudinom ali zidovudinom.
English: HBV strains expressing the adefovir-associated resistance mutations rtA181V and rtN236T showed a susceptibility to tenofovir ranging from 2.9- to 10-fold that of wild-type virus.
Slovenian: Sevi virusa HBV z mutacijami rtA181V in rtN236T, povezanimi z rezistenco na adefovir, so bili 2,9- do 10-krat bolj občutljivi na tenofovir kot pri divjem tipu virusa.
English: or a history of elevated serum ALT levels in the past 24 months] were treated with tenofovir disoproxil 245 mg (n = 52) or placebo (n = 54) for 72 weeks.
Slovenian: kopij/ml, zvišano vrednostjo ALT v serumu (≥ 2 x ZMN) ali zvišano vrednostjo ALT v serumu v anamnezi v zadnjih 24 mesecih] 72 tednov zdravili s 245 mg dizoproksiltenofoviratom (n = 52) ali placebom (n = 54).
English: NAME OF THE MEDICINAL PRODUCT Tenofovir disoproxil Zentiva 245 mg film-coated tablets Tenofovir disoproxil
Slovenian: NAME OF THE MEDICINAL PRODUCT Dizoproksiltenofovirat Zentiva 245 mg filmsko obložene tablete dizoproksiltenofovirat
English: Tenofovir disoproxil 245 mg n = 176
Slovenian: 245 mg dizoproksiltenofovirata n = 176
English: HBV DNA (%) < 400 copies/ml (< 69 IU/ml)
Slovenian: HBV DNA (%) < 400 kopij/ml (< 69 i.e./ml) ALT (%) Normalizirana ALT
English: Proximal renal tubulopathy generally resolved or improved after tenofovir disoproxil discontinuation.
Slovenian: Proksimalna ledvična tubulopatija je po prekinitvi dizoproksiltenofovirata običajno izzvenela ali se je izboljšala.
English: No amino acid substitutions associated with resistance to tenofovir disoproxil were identified in these isolates.
Slovenian: V teh izolatih niso identificirali nobenih substitucij aminokislin, ki bi bile povezane z rezistenco na dizoproksiltenofovirat.
English: Clinical resistance 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.
Slovenian: Pri 426 bolnikih, negativnih na HBeAg (GS-US-174-0102, n = 250) in pozitivnih na HBeAg (GS-US174-0103, 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.
English: By intent to treat analysis (missing data and switch in antiretroviral therapy (ART) considered as failure), the proportion of patients with HIV-1 RNA below 400 copies/ml and 50 copies/ml at 48 weeks of treatment was 80% and 76% respectively in the tenofovir disoproxil 245 mg arm, 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 mg arm, compared to 64% and 63% in the stavudine arm.
Slovenian: 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.
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.
Slovenian: HIV-1: Farmakokinetiko tenofovirja v stanju dinamičnega ravnovesja so ovrednotili pri 8 mladostnikih, okuženih z virusom HIV-1 (starih 12 do < 18 let) s telesno maso ≥ 35 kg. Srednji (± SD) Cmax je bil 0,38 ± 0,13 μg/ml in srednji AUCtau 3,39 ± 1,22 μg·h/ml.
English: *p-value versus adefovir dipivoxil < 0.05, a Complete response defined as HBV DNA levels < 400 copies/ml and Knodell necroinflammatory score improvement of at least 2 points without worsening in Knodell fibrosis, b Knodell necroinflammatory score improvement of at least 2 points without worsening in Knodell fibrosis, c Median change from baseline HBV DNA merely reflects the difference between baseline HBV DNA and the limit of detection (LOD) of the assay, d The population used for analysis of ALT normalisation included only patients with ALT above ULN at baseline.
Slovenian: * Vrednost p v primerjavi z dipivoksiladefoviratom < 0,05. a Popolni odziv, opredeljen kot ravni HBV DNA < 400 kopij/ml in izboljšanje za vsaj 2 točki na Knodellovi nekroinflamatorni lestvici brez poslabšanja na Knodellovi fibrozni lestvici.
English: The safety of tenofovir disoproxil in the setting of ledipasvir/sofosbuvir, sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/voxilaprevir and a pharmacokinetic enhancer has not been established.
Slovenian: Varnost dizoproksiltenofovirata skupaj z ledipasvirjem/sofosbuvirjem, sofosbuvirjem/velpatasvirjem ali sofosbuvirjem/velpatasvirjem/voksilaprevirjem in farmakokinetičnim ojačevalcem ni bila ugotovljena.
English: In study GS-US-174-0144, 89 HBeAg-negative and -positive patients aged 2 to < 12 years with chronic hepatitis B were treated with tenofovir disoproxil 6.5 mg/kg up to a maximum dose of 245 mg (n = 60) or placebo (n = 29) once daily for 48 weeks.
Slovenian: 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 HBV DNA > 105 kopij/ml (~ 4,2 log10 i.e./ml) in ALT > 1,5 × zgornja meja normalne vrednosti (ZMN).
English: • pancreas problems.
Slovenian: • težave s trebušno slinavko
English: 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.
Slovenian: 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.
English: + Raltegravir (400 mg b.i.d) + Emtricitabine/Tenofovir disoproxil (200 mg/245 mg q.d.)
Slovenian: raltegravir (400 mg dvakrat dnevno) + emtricitabin/ dizoproksiltenofovirat (200 mg/245 mg enkrat dnevno)
English: In study GS-99-907, 550 treatment-experienced adult patients were treated with placebo or tenofovir disoproxil 245 mg for 24 weeks.
Slovenian: V študijo GS-99-907 je bilo vključenih 550 predhodno že zdravljenih odraslih bolnikov.
English: Adefovir dipivoxil 10 mg n = 90
Slovenian: 10 mg dipivoksiladefovirata n = 90
English: The distribution of HBV genotypes at baseline was similar between the TDF and Placebo groups.
Slovenian: Porazdelitev genotipov virusa HBV ob izhodišču v skupini, ki je prejemala dizoproksiltenofovirat, je bila podobna kot v skupini, ki je prejemala placebo.
English: Tenofovir disoproxil 245 mg (n = 45)
Slovenian: Parameter dizoproksiltenofovirat 245 mg (n = 45)
English: Adequate dose adjustments cannot be applied with this product due to lack of alternative tablet strengths, therefore use in this group of patients is not recommended.
Slovenian: Huda ledvična okvara (očistek kreatinina < 30 ml/min) in bolniki na hemodializi: Zaradi pomanjkanja alternativnih jakosti tablet ustrezne prilagoditve odmerka pri tem zdravilu ni mogoče uporabiti, zato uporaba pri tej skupini bolnikov ni priporočljiva.
English: 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: 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,
English: • headache,
Slovenian: • glavobol
English: The use of tenofovir disoproxil is not recommended in paediatric patients with renal impairment (see sections 4.2 and 4.4).
Slovenian: Uporaba dizoproksiltenofovirata pri pediatričnih bolnikih z ledvično okvaro ni priporočljiva (glejte poglavji 4.2 in 4.4).
English: • feeling tired,
Slovenian: • utrujenost
English: No amino acid substitutions associated with tenofovir disoproxil resistance were detected in any subject.
Slovenian: Pri nobenem bolniku niso ugotovili nobenih substitucij aminokislin, povezanih z rezistenco na dizoproksiltenofovirat.
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 (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 = 1029 ml/min).
English: • pain in the tummy (abdomen) caused by inflammation of the liver,
Slovenian: • bolečine v trebuhu zaradi vnetja jeter
English: 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.
Slovenian: 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).
English: Entecavir
Slovenian: • napenjanje
English: Sofosbuvir/Velpatasvir/ Voxilaprevir (400 mg/100 mg/ 100 mg+100 mg q.d.
Slovenian: Priporočilo glede sočasne uporabe z 245 mg dizoproksiltenofovirata sofosbuvir/velpatasvir/ voksilaprevir (400 mg/100 mg/ 100 mg+100 mg enkrat dnevno)
English: Lactose monohydrate Microcrystalline cellulose Croscarmellose sodium Povidone
Slovenian: Jedro tablete laktoza monohidrat mikrokristalna celuloza premreženi natrijev karmelozat povidon magnezijev stearat
English: Flares on treatment: Spontaneous exacerbations in chronic hepatitis B are relatively common and are characterised by transient increases in serum ALT. After initiating antiviral therapy, serum ALT may increase in some patients (see section 4.8).
Slovenian: Poslabšanje med zdravljenjem: Spontana poslabšanja kroničnega hepatitisa B so sorazmerno običajna, zanje pa so značilna prehodna zvišanja ALT v serumu.
English: Tenofovir disoproxiltenofovir disoproxil
Slovenian: Dizoproksiltenofovirat
English: asthenia
Slovenian: Zdravljenje
English: Tenofovir disoproxil Zentiva contains the active substance tenofovir disoproxil.
Slovenian: Zdravilo Dizoproksiltenofovirat Zentiva vsebuje učinkovino dizoproksiltenofovirat.
English: Given that tacrolimus can affect renal function, close monitoring is recommended when it is co-administered with tenofovir disoproxil.
Slovenian: Takrolimus lahko vpliva na delovanje ledvic, zato je ob sočasni uporabi takrolimusa in dizoproksiltenofovirata priporočeno skrbno nadzorovati bolnika.
English: Hepatic function should be monitored at repeated intervals with both clinical and laboratory follow-up for at least 6 months after discontinuation of hepatitis B therapy.
Slovenian: Delovanje jeter je treba spremljati v rednih intervalih s kliničnimi in laboratorijskimi preiskavami vsaj še nadaljnjih 6 mesecev po prekinitvi zdravljenja proti hepatitisu B. Če je ustrezno, se lahko ponovno uvede zdravljenje hepatitisa B. Pri bolnikih z napredovalo boleznijo jeter ali cirozo, prekinitev zdravljenja ni priporočena, saj poslabšanja hepatitisa po zdravljenju lahko povzročijo jetrno dekompenzacijo.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
Slovenian: PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI Oznaka na plastenki in škatla
English: One hundred forty-one and 139 adult subjects were randomised to a tenofovir disoproxil and emtricitabine plus tenofovir disoproxil treatment arm, respectively.
Slovenian: 141 odraslih bolnikov je bilo randomiziranih v skupino z dizoproksiltenofoviratom in 139 odraslih bolnikov v skupino z emtricitabinom in dizoproksiltenofoviratom.
English: The following side effects are uncommon (may affect up to 1 in 100 people):
Slovenian: Naslednji neželeni učinki so občasni (prizadenejo lahko do 1 od 100 bolnikov):
English: Adefovir dipivoxil 10 mg n = 125
Slovenian: 10 mg dipivoksiladefovirata n = 125
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: Tenofovir disoproxil Zentiva should not be administered concomitantly with adefovir dipivoxil.
Slovenian: Zdravilo Dizoproksiltenofovirat Zentiva se ne sme uporabljati sočasno z dipivoksiladefoviratom.
English: Gastrointestinal disorders: Very common:
Slovenian: Bolezni prebavil: Zelo pogosti: