FrancophonIA/ELRC3.0 huggingface dataset:
English: In a paediatric study (GS-US-174-0144), genotypic data from paired baseline and on treatment HBV isolates from patients who received tenofovir disoproxil were available for 9 of 10 patients who had plasma HBV DNA > 400 copies/ml.
Croatian: U pedijatrijskom ispitivanju (GS-US-174-0144), podaci o genotipu iz uparenih izolata HBV-a s početka ispitivanja i tijekom liječenja tenofovirdizoproksilom bili su dostupni za 9 od 10 bolesnika s razinom HBV DNK > 400 kopija/ml u 48. tjednu.
English: In cell based assays, HBV strains expressing the rtV173L, rtL180M, and rtM204I/V mutations associated with resistance to lamivudine and telbivudine showed a susceptibility to tenofovir ranging from 0.7- to 3.4-fold that of wild-type virus.
Croatian: U staničnim testovima sojevi virusa HBV koji izražavaju mutacije rtV173L, rtL180M i rtM204I/V povezane s rezistencijom na lamivudin i telbivudin pokazali su za 0,7 do 3,4 puta veću osjetljivost na tenofovir od divljeg tipa virusa.
English: The length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this disease.
Croatian: Između ostalih, neki od brojnih čimbenika rizika za razvoj te bolesti mogu biti duljina kombinirane antiretrovirusne terapije, primjena kortikosteroida, konzumiranje alkohola, teška imunosupresija, viši indeks tjelesne mase.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains tenofovir disoproxil phosphate (equivalent to 245 mg of tenofovir disoproxil).
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna filmom obložena tableta sadrži 245 mg tenofovirdizoproksila (u obliku tenofovirdizoproksilfosfata).
English: Intracellular pharmacokinetics
Croatian: Unutarstanična farmakokinetika
English: Tenofovir disoproxil Zentiva contains lactose monohydrate Tenofovir disoproxil Zentiva contains lactose monohydrate.
Croatian: Tenofovir disoproxil Zentiva sadrži laktozu hidrat Tenofovir disoproxil Zentiva sadrži laktozu hidrat.
English: HBV DNA (%) < 400 copies/ml (< 69 IU/ml)
Croatian: HBV DNK (%) < 400 kopija/ml (< 69 IU/ml) ALT (%) Normaliziran ALTd
English: Using a noncompleter/switch = failure analysis, 50% (21/42) of subjects receiving tenofovir disoproxil, 76% (28/37) of subjects receiving emtricitabine plus tenofovir disoproxil and 52% (11/21) of subjects receiving entecavir achieved HBV DNA < 400 copies/ml at week 168.
Croatian: Analiza podataka o ispitanicima koji nisu dovršili ispitivanje/promjeni terapije = neuspjeh, pokazala je da su 50% (21/42) ispitanika koji su primali tenofovirdizoproksil, 76% (28/37) ispitanika koji su primali emtricitabin i tenofovirdizoproksil i 52% (11/21) ispitanika koji su primali entekavir postigli HBV DNK < 400 kopija/ml u 168. tjednu.
English: Darunavir/Ritonavir (300 mg/100 mg b.i.d.)
Croatian: Darunavir/ritonavir (300/100 b.i.d.)
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).
Croatian: tjednu, ukupno je 77% (46 od 60) bolesnika u skupini liječenoj tenofovirdizoproksilom i 7% (2 od 29) bolesnika u skupini koja je primala placebo imalo razinu HBV DNK < 400 kopija/ml (69 IU/ml).
English: Lumbar spine BMD at least 6% decreaseb
Croatian: Smanjenje BMD-a lumbalne kralježnice za najmanje 6%b
English: Tenofovir disoproxil should not be administered concurrently with adefovir dipivoxil (see section 4.4).
Croatian: Tenofovirdizoproksil ne smije se primjenjivati istovremeno s adefovirdipivoksilom (vidjeti dio 4.4).
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.
Croatian: U usporedbi s bolesnicima s normalnom funkcijom bubrega, srednja se vrijednost (% koeficijenta varijacije) izloženosti tenofoviru povećala se s 2185 (12%) ng·h/ml u ispitanika s CrCl iznosio > 80 ml/min na 3064 (30%) ng·h/ml u bolesnika s blagim oštećenjem funkcije bubrega, 6009 (42%) ng·h/ml u bolesnika s umjerenim oštećenjem funkcije bubrega i 15 985 (45%) ng·h/ml u bolesnika s teškim oštećenjem funkcije bubrega.
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.
Croatian: U skupini koja je primala tenofovirdizoproksil, 7% bolesnika prekinulo je liječenje zbog štetnog događaja, 9% bolesnika imalo je dokazano povećanje serumskog kreatinina od ≥ 0,5 mg/dl ili potvrđene fosfate u serumu < 2 mg/dl kroz 48 tjedana; nije bilo statistički značajnih razlika između skupina koje su primale kombinirano liječenje tenofovirdizoproksilom i skupine na entekaviru.
English: • That if bone abnormalities are detected or suspected then consultation with an endocrinologist and/or nephrologist should be obtained
Croatian: • Ako se otkriju ili osumnja na abnormalnosti kostiju, da onda treba potražiti stručno mišljenje endokrinologa i/ili nefrologa.
English: Tenofovir disoproxil Zentiva should not be administered concomitantly with other medicinal products containing tenofovir disoproxil or tenofovir alafenamide.
Croatian: Tenofovir disoproxil Zentiva ne smije se primjenjivati istovremeno s drugim lijekovima koji sadrže tenofovirdizoproksil ili tenofoviralafenamid.
English: hepatic steatosis, hepatitis Skin and subcutaneous tissue disorders: Very common:
Croatian: Tenofovirdizoproksil Poremećaji kože i potkožnog tkiva: Vrlo često:
English: • feeling sick (nausea), being sick (vomiting) and stomach pain.
Croatian: • mučnina, povraćanje i bol u trbuhu
English: Serology (%) HBeAg loss/ seroconversion n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a
Croatian: nestanak HBeAg / serokonverzija n/p n/p n/p n/p n/p n/p n/p n/p n/p n/p n/p n/p nestanak HBsAg / serokonverzija
English: Experience in patients with HIV co-infection and prior lamivudine experience In a randomised, 48-week double-blind, controlled study of tenofovir disoproxil 245 mg in adult patients co-infected with HIV-1 and chronic hepatitis B with prior lamivudine experience (study ACTG 5127), the mean serum HBV DNA levels at baseline in patients randomised to the tenofovir arm were 9.45 log10 copies/ml (n = 27).
Croatian: U randomiziranom, kontroliranom, dvostruko slijepom 48-tjednom ispitivanju 245 mg tenofovirdizoproksila u odraslih bolesnika s istovremenom infekcijom virusom HIV-1 i kroničnim hepatitisom B, a koji su prethodno dobivali lamivudin (ispitivanje ACTG 5127), srednja vrijednost razine HBV DNK u serumu na početku kod bolesnika randomiziranih u skupini koja je dobivala tenofovir bila je 9,45 log10 kopija/ml (n = 27).
English: If you stop taking Tenofovir disoproxil Zentiva
Croatian: Ako prestanete uzimati lijek Tenofovir disoproxil Zentiva
English: Tenofovir disoproxiltenofovir disoproxil
Croatian: Tenofovir dizoproksiltenofovir dizoproksil
English: Co-administration of other medicinal products - Tenofovir disoproxil Zentiva should not be administered concomitantly with other medicinal products containing tenofovir disoproxil or tenofovir alafenamide.
Croatian: Istovremena primjena drugih lijekova - Tenofovir disoproxil Zentiva ne smije se davati zajedno s drugim lijekovima koji sadrže tenofovirdizoproksil ili tenofoviralafenamid.
English: Tenofovir is converted intracellularly to tenofovir monophosphate and to the active component, tenofovir diphosphate.
Croatian: Tenofovir se unutar stanica pretvara u tenofovir monofosfat i djelatnu tvar, tenofovirdifosfat.
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.
Croatian: Bolesnici s kroničnim hepatitisom B rezistentnim na lamivudin:Nove nuspojave na tenofovirdizoproksil nisu zabilježene u randomiziranom, dvostruko slijepom ispitivanju (GS-US-1740121) u kojem je 280 bolesnika rezistentnih na lamivudin 240 tjedana primalo liječenje tenofovirdizoproksilom (n = 141) odnosno liječenje emtricitabinom/ tenofovirdizoproksilom (n = 139).
English: If serum phosphate is confirmed to be < 3.0 mg/dl (0.96 mmol/l) in any paediatric patient receiving tenofovir disoproxil renal function should be re-evaluated within one week, including measurements of blood glucose, blood potassium and urine glucose concentrations (see section 4.8, proximal tubulopathy).
Croatian: Ako se u nekog pedijatrijskog bolesnika koji prima tenofovirdizoproksil potvrdi da je fosfat u serumu < 3,0 mg/dl (0,96 mmol/l), potrebno je ponovno procijeniti funkciju bubrega unutar jednog tjedna, uključujući mjerenje koncentracija glukoze u krvi, kalija u krvi i glukoze u mokraći (vidjeti dio 4.8, proksimalna tubulopatija).
English: Metabolic parameters Weight and levels of blood lipids and glucose may increase during antiretroviral therapy (see section 4.4)
Croatian: Tijekom antivirusne terapije mogu se povećati tjelesna težina i povisiti razine lipida i glukoze u krvi (vidjeti dio 4.4).
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.
Croatian: Sigurnost tenofovirdizoproksila primijenjenog uz ledipasvir/sofosbuvir, sofosbuvir/velpatasvir ili sofosbuvir/velpatasvir/voksilaprevir i farmakokinetički pojačivač nije ustanovljena.
English: Reductions in BMD have been observed in HBV infected paediatric patients 2 to < 18 years of age.
Croatian: U djece u dobi od 2 do < 18 godina.zaražene HBV-om opaženo je smanjenje BMD-a.
English: If renal abnormalities are suspected or detected then consultation with a nephrologist should be obtained to consider interruption of tenofovir disoproxil treatment.
Croatian: Ako se sumnja ne ili se otkriju abnormalnosti, onda je potrebno dobiti stručno mišljenje nefrologa i razmotriti prekid liječenja tenofovirdizoproksilom.
English: Renal function should be closely monitored (see section 4.4).
Croatian: Mora se pažljivo pratiti funkciju bubrega (vidjeti dio 4.4).
English: Tablet core: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, povidone, magnesium stearate.
Croatian: Drugi sastojci su: - Jezgra tablete: laktoza hidrat, mikrokristalična celuloza, umrežena karmelozanatrij, povidon,
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.
Croatian: Sojevi virusa HBV koji izražavaju mutacije rtA181V i rtN236T povezane s rezistencijom na adefovir pokazali za 2,9 do 10 puta veću osjetljivost na tenofovir od virusa divljeg tipa.
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.
Croatian: Odgovor na liječenje tenofovirdizoproksilom bio je usporediv u prethodno neliječenih i prethodno liječenih ispitanika sa 76% (38/50) prethodno neliječnih i 80% (8/10) prethodno liječenih ispitanika koji su postigli HBV DNK < 400 kopija/ml (< 69 IU/ml) u 48. tjednu.
English: • headache,
Croatian: • glavobolja
English: Do not take Tenofovir disoproxil Zentiva
Croatian: Nemojte uzimati lijek Tenofovir disoproxil Zentiva
English: Sixty-six percent (38 of 58) of patients in the tenofovir disoproxil group had normalized ALT at week 48 compared with 15% (4 of 27) in the placebo group.
Croatian: U 48. tjednu ALT se normalizirao u 66% (38 od 58) bolesnika u skupini liječenoj tenofovirdizoproksilom u usporedbi s 15% (4 od 27) bolesnika u skupini koja je primala placebo.
English: Didanosine Co-administration of tenofovir disoproxil and didanosine is not recommended (see section 4.4 and Table 1).
Croatian: Didanozin Ne preporučuje se istovremena primjena tenofovirdizoproksila i didanozina (vidjeti dio 4.4 i Tablicu
English: Sofosbuvir/Velpatasvir/ Voxilaprevir (400 mg/100 mg/ 100 mg+100 mg q.d.
Croatian: Sofosbuvir/velpatasvir/voksil aprevir (400 mg/100 mg/ 100 mg+100 mg q.d.)3 +
English: • Talk to your doctor or pharmacist if you are over 65.
Croatian: • Ako ste stariji od 65 godina, razgovarajte s liječnikom ili ljekarnikom.
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).
Croatian: Ne preporučuje se istovremena primjena tenofovirdizoproksila i didanozina, jer rezultira 40 - 60%-tnim povećanjem sistemske izloženosti didanozinu što može povećati rizik od nuspojava povezanih s didanozinom (vidjeti dio 4.5).
English: 90 (3 bottles of 30) film-coated tablets
Croatian: OBLIK I SADRŽAJ 30 filmom obloženih tableta 90 (3 boce s 30) filmom obloženih tableta
English: Only 1 subject randomized to the TDF group was genotype E at baseline.
Croatian: Samo je jedan ispitanik randomiziran u skupinu tenofovirdizoproksila imao genotip E na početku.
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).
Croatian: Istovremena primjena tenofovirdizoproksila i didanozina rezultira 40-60%-tnim povećanjem sistemske izloženosti didanozinu, što može povećati rizik od nuspojava povezanih s didanozinom (vidjeti dio 4.5).
English: 245 mg and stavudine groups, respectively).
Croatian: 245 mg tenofovirdizoproksila, odnosno u skupini stavudina).
English: Other special population(s)
Croatian: Druge posebne populacije
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.
Croatian: U 215 HBeAg negativnih bolesnika (GS-US-174-0102, n = 125) i HBeAg pozitivnih (GS-US-1740103, n = 90) bolesnika početno randomiziranih u skupinu dvostruko slijepog liječenja adefovirdipivoksilom, a potom prebačenih u skupinu otvorenog liječenja tenofovirdizoproksilom procjenjivala se promjena u genotipu HBV polimeraze od početnih rezultata.
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.
Croatian: Iskustva nakon 48. tjedna u ispitivanjima GS-US-174-0102 i GS-US-174-0103 U ispitivanjima GS-US-174-0102 i GS-US-174-0103 nakon uzimanja dvostruko slijepe terapije tijekom 48 tjedana (ili 245 mg tenofovirdizoproksil ili 10 mg adefovirdipivoksil) bolesnici su bez prekida liječenja prešli u otvoreno ispitivanje tenofovirdizoproksila.
English: Tenofovir disoproxil Zentiva is suitable for:
Croatian: Djeca i adolescenti Tenofovir disoproxil Zentiva pogodan je za:
English: The following side effects are rare (may affect up to 1 in 1,000 people):
Croatian: Sljedeće nuspojave su rijetke (mogu se javiti u do 1 na 1000 osoba):
English: The following side effects are very common (may affect more than 1 in 10 people):
Croatian: Sljedeće nuspojave su vrlo česte (mogu se javiti u više od 1 na 10 osoba):
English: NAME OF THE MEDICINAL PRODUCT Tenofovir disoproxil Zentiva 245 mg film-coated tablets
Croatian: NAZIV LIJEKA Tenofovir disoproxil Zentiva 245 mg filmom obložene tablete
English: • Do not breast-feed during treatment with Tenofovir disoproxil Zentiva.
Croatian: • Nemojte dojiti tijekom liječenja lijekom Tenofovir disoproxil Zentiva.
English: Table 1: Interactions between tenofovir disoproxil and other medicinal products
Croatian: Tablica 1: Interakcije između tenofovirdizoproksila i drugih lijekova Lijekovi po terapijskim područjima (doza u mg)
English: Recommendation concerning Co-administration with 245 mg tenofovir disoproxil
Croatian: Preporuka o istovremenoj primjeni s 245 mg tenofovirdizoproksila
English: Package leaflet: Information for the user Tenofovir disoproxil Zentiva 245 mg film-coated tablets Tenofovir disoproxil
Croatian: Uputa o lijeku: Informacija za bolesnika Tenofovir disoproxil Zentiva 245 mg filmom obložene tablete Tenofovirdizoproksil
English: Serology (%)HBeAg loss/seroconversionHBsAg loss/seroconversion n/a n/a
Croatian: nestanak HBeAg / serokonverzija nestanak HBsAg / serokonverzija n/p n/p
English: (2 subjects)
Croatian: (2 bolesnika
English: Therefore, clinical response to treatment and renal function should be closely monitored in these patients (see sections 4.4 and 5.2).
Croatian: Zato je u tih bolesnika nužno pažljivo pratiti klinički odgovor na liječenje i funkciju bubrega (vidjeti dijelove 4.4 i 5.2).
English: Hepatic impairment No dose adjustment is required in patients with hepatic impairment (see sections 4.4 and 5.2).
Croatian: U bolesnika s oštećenjem funkcije jetre nije potrebno prilagođavati dozu (vidjeti dijelove 4.4 i 5.2).
English: Tenofovir disoproxil Zentiva contains the active substance tenofovir disoproxil.
Croatian: Tenofovir disoproxil Zentiva sadrži djelatnu tvar tenofovirdizoproksil.
English: No data are available to make dose recommendations (see sections 4.2 and 4.4).
Croatian: Budući da nema dostupnih podataka nije moguće dati preporuku o doziranje (vidjeti dijelove 4.2 i
English: Whole body BMD at least 6% decreaseb
Croatian: Smanjenje BMD-a cijelog tijela za najmanje 6%b
English: 288m 384o 96c 144f
Croatian: 288l 384o 96c 144f 192h 240j 288m 384p
English: • inflammation of the kidney, passing a lot of urine and feeling thirsty,
Croatian: • upala bubrega, prekomjerno mokrenje i žeđ
English: lactic acidosis Nervous system disorders: Very common:
Croatian: Poremećaji živčanog sustava: Vrlo često:
English: Tenofovir disoproxil 245 mg (n = 45)
Croatian: Tenofovirdizoproksil 245 mg (n = 45)
English: No clinically significant pharmacokinetic interactions when tenofovir disoproxil was co-administered with entecavir.
Croatian: Ne postoje klinički značajne farmakokinetičke interakcije kod istovremene primjene tenofovirdizoproksila i entekavira.
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.
Croatian: U 426 HBeAg negativnih bolesnika (GS-US-174-0102, n = 250) i HBeAg pozitivnih (GS-US-1740103, n = 176) bolesnika početno randomiziranih u skupinu dvostruko slijepog liječenja tenofovirdizoproksilom, a potom prebačenih u skupinu otvorenog liječenja tenofovirdizoproksilom procjenjivala se promjena u genotipu HBV polimeraze u odnosu na početne rezultate.
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.
Croatian: Analizom bolesnika s namjerom liječenja (podaci koji su nedostajali i promjena antiretrovirusne terapije (ART) smatrale su se neuspjehom) udio bolesnika s HIV-1 RNK manjom od 400 kopija/ml odnosno 50 kopija/ml u 48. tjednu liječenja bio 80% odnosno 76% u skupini koja je primala 245 mg tenofovirdizoproksila u usporedbi s 84% odnosno 80% u skupini koja je primala stavudin.
English: The use of tenofovir disoproxil is not recommended in paediatric patients with renal impairment (see sections 4.2 and 4.4).
Croatian: Primjena tenofovirdizoproksila ne preporučuje se u pedijatrijskih bolesnika s oštećenjem funkcije bubrega (vidjeti dijelove 4.2 i 4.4).
English: Co-administration of tenofovir disoproxil and didanosine results in a 40-60% increase in systemic exposure to didanosine that may increase the risk for didanosine-related adverse reactions.
Croatian: Istovremena primjena tenofovirdizoproksila i didanozina povećava sistemsku izloženost didanozinu za 4060%, što može povećati rizik od nuspojava povezanih s didanozinom.
English: Tenofovir disoproxil 245 mg n = 176
Croatian: Tenofovirdizoproksil 245 mg n = 176
English: If tenofovir disoproxil is co-administered with an NSAID, renal function should be monitored adequately.
Croatian: Ako se tenofovirdizoproksil primjenjuje istovremeno s NSAIL-om, potrebno je provjeravati funkciju bubrega na odgovarajući način.
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).
Croatian: Primjena s određenim antivirusnim lijekovima za virus hepatitisa C Primijećeno je da istovremena primjena tenofovirdizoproksila s ledipasvirom/sofosbuvirom, sofosbuvirom/velpatasvirom ili sofosbuvirom/velpatasvirom/voksilaprevirom povećava koncentraciju tenofovira u plazmi, posebno prilikom istovremene primjene s režimom liječenja HIV-a koji sadrži tenofovirdizoproksil i farmakokinetički pojačivač (ritonavir ili kobicistat).
English: In patients who received treatment with tenofovir disoproxil, or stavudine or zidovudine, mean lumbar spine BMD Z-score was -1.034 and -0.498, and mean total body BMD Z-score was -0.471 and -0.386, respectively, at baseline.
Croatian: Srednja vrijednost BMD Z-rezultata lumbalne kralježnice u bolesnika koji su bili liječeni tenofovirdizoproksilom na početku je iznosila1,034, a u liječenih stavudinom ili zidovudinom -0,498, dok je srednja vrijednost BMD Z-rezultata cijelog tijela u liječenih tenofovirdizoproksilom iznosila -0,471, a u liječenih stavudinom ili zidovudinom -0,386.
English: Lactose monohydrate Microcrystalline cellulose Croscarmellose sodium Povidone
Croatian: Jezgra tablete laktoza hidrat mikrokristalična celuloza umrežena karmelozanatrij povidon magnezijev stearat
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.
Croatian: U ispitivanjima na bolesnicima koji prethodno nisu dobivali nukleozide tijekom liječenja zabilježeno je povišenje razine ALT-a čija je vrijednost bila 10 puta viša od gornje granice normale i dva puta viša od početnih vrijednosti u 2,6% bolesnika koji su primali tenofovirdizoproksil.
English: Exacerbations of hepatitis
Croatian: Egzacerbacija hepatitisa
English: AUC: ↓ 25% Cmax: ↓ 28% Cmin: ↓ 26% Tenofovir:
Croatian: AUC: ↓ 25% Cmax: ↓ 28% Cmin: ↓ 26%
English: No dosing recommendations can be given for non-haemodialysis patients with creatinine clearance < 10 ml/min.
Croatian: Za bolesnike s klirensom kreatinina < 10 ml/min koji nisu na hemodijalizi nije moguće dati preporuke doziranja.