FrancophonIA/ELRC3.0 huggingface dataset:
English: In the tenofovir disoproxil treatment arm, patients had a mean CPT score of 7.2, mean HBV DNA of 5.8 log10 copies/ml and mean serum ALT of 61 U/l at baseline.
Croatian: U skupini koja je primala tenofovirdizoproksil, bolesnici su imali srednju vrijednost CPT rezultata 7,2, srednju vrijednost HBV DNK od 5,8 log10 kopija/ml i srednju vrijednosti serumskog ALT-a od 61 I.
English: 30 film-coated tablets.
Croatian: Filmom obložena tableta 30 filmom obloženih tableta.
English: Seventy-three percent of nucleoside-experienced and 69% of nucleoside-naïve patients achieved complete response to treatment; 90% of nucleoside-experienced and 88% of nucleoside-naïve patients achieved HBV DNA suppression < 400 copies/ml.
Croatian: U 73% bolesnika koji su primali nukleozide i 69% bolesnika koji prethodno nisu primali nukleozide postigao se potpuni odgovor na liječenje; u 90% bolesnika koji su primali nukleozide i 88% bolesnika koji nisu primali nukleozide postigla se supresija HBV DNK na razinu manju od 400 kopija/ml.
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 se sumnja na abnormalnosti kostiju, da onda treba potražiti stručno mišljenje endokrinologa i/ili nefrologa.
English: If bone abnormalities are suspected or detected then appropriate consultation should be obtained.
Croatian: U slučaju sumnje na abnormalnosti na kostima, potrebno je odgovarajuće se konzultirati.
English: In studies GS-US-174-0102 and GS-US174-0103, 77% and 61% of patients continued in the study through to 384 weeks, respectively.
Croatian: U ispitivanju GS-US-174-0102, 77% bolesnika nastavilo je liječenje tijekom 384 tjedna, dok je u ispitivanju GS-US-174-0103 to učinilo 61% bolesnika.
English: Table 1: Interactions between tenofovir disoproxil and other medicinal products Medicinal product by therapeutic areas (dose in mg)
Croatian: Tablica 1: Interakcije između tenofovirdizoproksila i drugih lijekova
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 više od dva puta viša od početnih vrijednosti u 2,6% bolesnika koji su primali tenofovirdizoproksil.
English: Experience in patients with lamivudine-resistant HBV at 240 weeks (study GS-US-174-0121) The efficacy and safety of 245 mg tenofovir disoproxil was evaluated in a randomised, double-blind study (GS-US-174-0121) in HBeAg positive and HBeAg negative patients (n = 280) with compensated liver disease, viraemia (HBV DNA ≥ 1,000 IU/ml), and genotypic evidence of lamivudine resistance (rtM204I/V +/- rtL180M).
Croatian: Iskustva u bolesnika s HBV-om rezistentnim na lamivudin u 240 tjedana (ispitivanje GS-US-174-0121) Djelotvornost i sigurnost 245 mg tenofovirdizoproksila procijenjene su u randomiziranom, dvostruko slijepom ispitivanju GS-US-174-0121 u HBeAg-pozitivnih bolesnika i HBeAg-negativnih bolesnika (n = 280) s kompenziranom bolešću jetre, viremijom (HBV DNK ≥ 1000 IU/ml) i genotipskim dokazom rezistencije na lamivudin (rtM204I/V +/- rtL180M).
English: Tenofovir is converted intracellularly to tenofovir monophosphate and to the active component, tenofovir diphosphate.
Croatian: Tenofovir se unutar stanica pretvara u tenofovir fosfat i u djelatni sastojak tenofovir difosfat.
English: Tenofovir disoproxil 245 mg film-coated tablets are indicated for the treatment of chronic hepatitis B in adults with:
Croatian: Tenofovirdizoproksil 245 mg filmom obložene tablete su indicirane za liječenje kroničnog hepatitisa B u odraslih bolesnika s:
English: HIV patients aged 12 to < 18 years educational brochure HBV patients aged 12 to < 18 years educational brochure
Croatian: - Edukacijsku brošuru za bolesnike od 12 do ˂ 18 godina s HIV-om - Edukacijsku brošuru za bolesnike od 12 do ˂ 18 godina s HBV-om.
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).
Croatian: Prikazani brojevi su kumulativni postotci koji se temelje na Kaplan-Meierovoj analizi isključujući podatke prikupljene nakon dodavanja emtricitabina otvorenom liječenju tenofovirdizorproksilom (KM-tenofovirdizoproksil).
English: Hepatitis C virus antiviral agents
Croatian: Antivirusni lijekovi za virus hepatitisa C
English: In clinical trials of HBV infected patients, the most frequently occurring adverse reaction to tenofovir disoproxil was nausea
Croatian: U kliničkim ispitivanjima s bolesnicima zaraženima HBV-om, najčešće zabilježena nuspojava na tenofovirdizoproksil bila je mučnina (5,4%).
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 s 2 185 (12%) ng·h/ml u ispitanika s CrCl > 80 ml/min na 3 064 (30%) ng·h/ml u bolesnika s blagim oštećenjem funkcije bubrega, 6 009 (42%) ng·h/ml u bolesnika s umjerenim oštećenjem bubrega i 15 985 (45%) ng·h/ml u bolesnika s teškim oštećenjem bubrežne funkcije.
English: Co-administration of other medicinal products - Tenofovir disoproxil Mylan should not be administered concomitantly with other medicinal products containing tenofovir disoproxil or tenofovir alafenamide.
Croatian: Istovremena primjena drugih lijekova - Tenofovir disoproxil Mylan se ne smije davati zajedno s drugim lijekovima koji sadrže tenofovirdizoproksil ili tenofoviralafenamid.
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 0,7 do 3,4 puta veću osjetljivost na tenofovir od divljeg tipa virusa.
English: No amino acid substitutions associated with resistance to tenofovir disoproxil were identified in these isolates.
Croatian: U tih izolata nisu utvrđene nikakve supstitucije aminokiselina povezane s rezistencijom na tenofovirdizoproksil.
English: Tenofovir disoproxil Mylan 245 mg tablets are a treatment for HIV (Human Immunodeficiency Virus) infection.
Croatian: Tenofovir disoproxil Mylan 245 mg tablete su lijek za liječenje infekcije virusom humane imunodeficijencije (HIV).
English: Overall at week 24, treatment with tenofovir disoproxil resulted in 66% (35/53) of patients with HBV DNA < 400 copies/ml (< 69 IU/ml) versus 69% (36/52) of patients treated with emtricitabine plus tenofovir disoproxil (p = 0.672).
Croatian: Ukupno u 24. tjednu, liječenje tenofovirdizoproksilom rezultiralo je u 66% bolesnika (35/53) s HBV DNK < 400 kopija/ml (< 69 I.
English: Experience in patients with persistent viral replication (study GS-US-174-0106) The efficacy and safety of tenofovir disoproxil 245 mg or tenofovir disoproxil 245 mg plus 200 mg emtricitabine has been evaluated in a randomised, double-blind study (study GS-US-174-0106), in HBeAg positive and HBeAg negative adult patients who had persistent viraemia (HBV DNA ≥ 1,000 copies/ml) while receiving adefovir dipivoxil 10 mg for more than 24 weeks.
Croatian: Iskustva u bolesnika s perzistentnom replikacijom virusa (ispitivanje GS-US-174-0106) Djelotvornost i sigurnost 245 mg tenofovirdizoproksila ili 245 mg tenofovirdizoproksila u kombinaciji s 200 mg emtricitabina ocijenjene su u randomiziranom, dvostruko slijepom ispitivanju (ispitivanju GS-US-174-0106) u HBeAg negativnih i HBeAg pozitivnih odraslih bolesnika koji su imali perzistentnu viremiju (HBV DNK ≥ 1000 kopija/ml) za vrijeme terapije s 10 mg adefovirdipivoksila tijekom više od 24 tjedna.
English: Patients receiving ledipasvir/sofosbuvir, sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/voxilaprevir concomitantly with tenofovir disoproxil and a boosted HIV protease inhibitor should be monitored for adverse reactions related to tenofovir disoproxil.
Croatian: Kod bolesnika koji primaju ledipasvir/sofosbuvir, sofosbuvir/velpatasvir ili sofosbuvir/velpatasvir/voksilaprevir istovremeno s tenofovirdizoproksilom i pojačanim inhibitorom HIV proteaze potrebno je pratiti nuspojave vezane uz tenofovirdizoproksil.
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 na ili se otkriju abnormalnosti, onda je potrebno dobiti stručno mišljenje nefrologa i razmotriti prekid liječenja tenofovirdizoproksilom.
English: Each film-coated tablet contains 245 mg of tenofovir disoproxil (corresponding to 300 mg of tenofovir disoproxil maleate).
Croatian: Jedna filmom obložena tableta sadrži 245 mg tenofovirdizoproksila (koji odgovara 300 mg tenofovirdizoproksilmaleata).
English: The following side effects are rare (these can affect up to 1 in every 1,000 patients):
Croatian: Sljedeće nuspojave su rijetke (mogu se javiti u do 1 na svakih 1000 bolesnika):
English: Tenofovir disoproxil Mylan contains the active substance tenofovir disoproxil.
Croatian: Tenofovir disoproxil Mylan sadrži djelatnu tvar tenofovirdizoproksil.
English: Sofosbuvir/Velpatasvir/ Voxilaprevir (400 mg/100 mg/ 100 mg+100 mg q.d.)
Croatian: Sofosbuvir/velpatasvir/ voksilaprevir (400 mg/100 mg/100 mg+10 0 mg q.d.)
English: Tenofovir disoproxil should not be administered concomitantly with other medicinal products containing tenofovir disoproxil or tenofovir alafenamide.
Croatian: Tenofovirdizoproksil se ne smije primjenjivati istovremeno s drugim lijekovima koji sadrže tenofovirdizoproksil ili tenofoviralafenamid.
English: Tenofovir disoproxil Mylan is available only as 245 mg film-coated tablets.
Croatian: Tenofovir disoproxil Mylan dostupan je samo u obliku filmom obloženih tableta od 245 mg.
English: • feeling sick (nausea), being sick (vomiting) and stomach pain
Croatian: • mučnina, povraćanje i bol u trbuhu.
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 lamivudine-resistant 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-174-0121) u kojem je 280 bolesnika rezistentnih na lamivudin 240 tjedana primalo liječenje tenofovirdizoproksilom (n = 141) odnosno liječenje emtricitabinom/ tenofovirdizoproksilom (n = 139).
English: One hundred forty-one and 139 adult subjects were randomised to a tenofovir disoproxil and emtricitabine plus tenofovir disoproxil treatment arm, respectively.
Croatian: Stotinu četrdeset jedan i 139 odraslih ispitanika bili su randomizirani u skupinu koja je bila liječena tenofovirdizoproksilom, odnosno u skupinu koja
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.
Croatian: Sličan postotak bolesnika u skupinama tenofovirdizoproksil-tenofovirdizoproksil i PLB- tenofovirdizoproksil (37,5% odnosno 41,7%)imalo je anti
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 40-60%, što može povećati rizik od nuspojava povezanih s didanozinom.
English: Histological response b
Croatian: Histologija Histološki odgovor (%)
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 su 2,9 do 10 puta veću osjetljivost na tenofovir od virusa divljeg tipa.
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: Co-administration of tenofovir disoproxil and didanosine is not recommended (see section 4.4).
Croatian: Ne preporučuje se istovremena primjena tenofovirdizoproksila i didanozina (vidjeti dio 4.4).
English: Recommendation concerning co-administration with 245 mg tenofovir disoproxil
Croatian: Preporuka o istovremenoj primjeni s 245 mg tenofovirdizoproksila
English: Renal function should be closely monitored (see section 4.4).
Croatian: Treba pažljivo pratiti funkciju bubrega (vidjeti dio 4.4).
English: • That a multidisciplinary approach is recommended for the management of patients aged 12 to < 18 years
Croatian: • Da se u liječenju bolesnika od 12 do ˂ 18 godina preporučuje multidisciplinarni prisup
English: The combination should be used with caution with frequent renal monitoring (see section
Croatian: Tu je kombinaciju potrebno koristiti uz oprez i često praćenje bubrežne funkcije (vidjeti dio 4.4).
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 jedne od nuspojava, 9% bolesnika imalo je dokazano povećanje serumskog kreatinina od > 0,5 mg/dl ili dokazano povećanje serumskih fosfata od < 2 mg/dl kroz 48 tjedana; nije bilo statistički značajnih razlika između skupina koje su primale kombinirano liječenje tenofovirdizoproksilom i skupine na entekaviru.
English: • inflammation of the kidney, passing a lot of urine and feeling thirsty
Croatian: • upala bubrega, prekomjerno mokrenje i žeđ
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: The adverse reactions observed in adolescent patients who received treatment with tenofovir disoproxil were consistent with those observed in clinical studies of tenofovir disoproxil in adults (see section 4.8 Tabulated summary of adverse reactions and 5.1).
Croatian: Nuspojave opažene u adolescentnih bolesnika liječenih tenofovirdizoproksilom bile su sukladne onima opaženima u kliničkim ispitivanjima tenofovirdizoproksila u odraslih (vidjeti dio 4.8 Tablični prikaz nuspojava i 5.1).
English: Therefore, clinical response to treatment and renal function should be closely monitored (see sections 4.4 and 5.2).
Croatian: Zbog toga je nužno pažljivo pratiti klinički odgovor na liječenje i funkciju bubrega (vidjeti dijelove 4.4 i
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: 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: Tenofovir disoproxil Mylan 245 mg tablets are suitable for:
Croatian: Tenofovir disoproxil Mylan 245 mg tablete pogodne su za:
English: Knodell necroinflammatory score improvement of at least 2 points without worsening in Knodell fibrosis score.
Croatian: b Poboljšanje rezultata na Knodellovoj nekroupalnoj ljestvici za najmanje dva boda bez pogoršanja Knodellove fibroze.
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 tenofovirdizoproksila ili 10 mg adefovirdipivoksila) bolesnici su bez prekida liječenja prešli u otvoreno ispitivanje tenofovirdizoproksila.
English: Two hundred and fifteen HBeAg negative (GS-US-174-0102, n = 125) and HBeAg positive (GS-US174-0103, n = 90) patients initially randomised to double-blind adefovir dipivoxil treatment and then switched to open-label tenofovir disoproxil treatment were evaluated for genotypic changes in HBV polymerase from baseline.
Croatian: U 215 HBeAg negativnih bolesnika (GS-US-174-0102, n = 125) i HBeAg pozitivnih (GS-US-174-0103, 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: 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-174-0103, 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: Adefovir dipivoxil 10 mg n = 125
Croatian: Adefovirdipivoks il 10 mg n = 125
English: Tenofovir disoproxil can cause dizziness.
Croatian: Tenofovirdizoproksil može uzrokovati omaglicu.
English: Use of tenofovir disoproxil should be avoided with concurrent or recent use of a nephrotoxic medicinal product.
Croatian: Treba izbjegavati primjenu tenofovirdizoproksila istovremeno s primjenom ili nakon nedavne primjene nefrotoksičnih lijekova.
English: If the patient vomits within 1 hour of taking tenofovir disoproxil, another tablet should be taken.
Croatian: U slučaju da bolesnik povraća a prošlo je manje od 1 sata od uzimanja tenofovirdizoproksila, treba uzeti drugu tabletu.
English: Tenofovir disoproxil Mylan 245 mg film-coated tablets contain lactose monohydrate.
Croatian: Tenofovir disoproxil Mylan 245 mg filmom obložene tablete sadrži laktozu hidrat.
English: • That if serum phosphate is confirmed to be < 3.0 mg/dl (0.96 mmol/l) in any patient aged 12 to < 18 years receiving tenofovir disoproxil, renal function should be re-evaluated within one week.
Croatian: • Ako se u bilo kojeg bolesnika od 12 do ˂ 18 godina koji uzima tenofovirdizoproksil potvrdi da je fosfat u serumu < 3,0 mg/dl (0,96 mmol/l), bubrežnu funkciju treba ponovno procijeniti u roku od tjedan dana.
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 je 80% odnosno 76% u skupini koja je primala 245 mg tenofovirdizoproksila u usporedbi s 84% odnosno 80% u skupini koja je primala stavudin.
English: Co-administration of tenofovir disoproxil and didanosine is not recommended as it results in a 4060% 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: Tenofovir disoproxil Mylan 245 mg film-coated tablets
Croatian: Tenofovir disoproxil Mylan 245 mg filmom obložene tablete
English: How to take Tenofovir disoproxil Mylan
Croatian: Kako uzimati Tenofovir disoproxil Mylan
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 iznosila -1,034, 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: Lumbar spine BMD mean % increase
Croatian: Srednja vrijednost povećanja BMD-a lumbalne kralježnic e u %
English: Administration of 245 mg tenofovir disoproxil every 48 hours can be used based on modelling of single-dose pharmacokinetic data in HIV negative and non-HBV infected subjects with varying degrees of renal impairment, including end-stage renal disease requiring haemodialysis, but has not been confirmed in clinical studies.
Croatian: Na temelju modela podataka o farmakokinetici jednokratnih doza u ispitanika koji su bili HIV negativni i koji nisu bili zaraženi virusom hepatitisa B, a imali su oštećenje funkcije bubrega različitih stupnjeva, uključujući i bubrežnu bolest u završnoj fazi za koju je bila potrebna hemodijaliza, može se primjenjivati doza od 245 mg tenofovirdizoproksila svakih 48 sati, ali ona nije potvrđena u kliničkim ispitivanjima.
English: Each film-coated tablet contains 245 mg of tenofovir disoproxil (as maleate).
Croatian: Jedna filmom obložena tableta sadrži 245 mg tenofovirdizoproksila (u obliku maleata).